Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter F. HEMOPHILIA ASSISTANCE PROGRAM
The Texas Department of Health (department) proposes the repeal of §§37.111
- 37.125 and new §§37.111 - 37.119, concerning the hemophilia assistance
program. The repeal and new sections provide for clarity and consistency of
language and facilitate compliance with and administration of the rules.
In accordance with the requirements of the Government Code, §2001.039,
the sections have been reviewed and the department has determined that reasons
for adopting the sections continue to exist because rules on this subject
are needed. However, the sections require revision as described in the preamble.
The department published a Notice of Intention to Review for §§37.111
- 37.125 in the
Texas Register
on April 28,
2000 (25 TexReg 2799). No comments were received due to publication of this
notice.
Specifically, the sections cover general requirements; recipient eligibility
requirements; residency and residency documentation requirements; application
and eligibility date; financial criteria; limitations and benefits provided;
participating providers; forms; and confidentiality of information.
The new rules define medical, financial and residency requirements, benefits
and limitations, and participation criteria for providers.
Phillip Walker, Chief, Bureau of Kidney Health Care, has determined that
for each year of the first five years the sections are in effect, there will
be no fiscal implications for state and local government as a result of enforcing
or administering the sections as proposed.
Mr. Walker has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing the sections is that program access and eligibility will be easier
to comply with and understand. There will be no costs to small businesses
or micro-businesses resulting from compliance with these sections as proposed
because none of the entities or persons affected constitute micro-businesses
or small businesses. There are no anticipated economic costs to persons who
are required to comply with the sections as proposed. There is no anticipated
impact on local employment.
Comments may be submitted to Mr. Phillip Walker, Chief, Bureau of Kidney
Health Care, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756, (512) 834-6770. Comments will be accepted for 30 days following publication
of the proposal in the
Texas Register
.
25 TAC §§37.111 - 37.125
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under Health and Safety
Code, §12.001, which provides the Texas Board of Health (board) with
the authority to adopt rules for the performance of every duty imposed by
law on the board, the department, and the commissioner of health; and Health
and Safety Code, Chapter 41, relating to hemophilia.
The repeals affect Health and Safety Code, Chapter 41. The review of the
rules implements Government Code, §2001.039.
§37.111.Purpose.
§37.112.Definitions.
§37.113.Eligibility for Patient Services.
§37.114.Services Provided to Patients.
§37.115.Application Process.
§37.116.Authorization of Blood Product Purchases.
§37.117.Denial/Modification/Suspension/Termination of Program Benefits.
§37.118.Rights and Responsibilities of Parents/Guardian/Conservator or the Adult Patient.
§37.119.Providers.
§37.120.Contracts and Written Agreements.
§37.121.Payment of Services.
§37.122.Payment Suspension or Cancellation.
§37.123.Cooperation with Other Agencies.
§37.124.Appeals, Confidentiality, Gifts, and Nondiscrimination.
§37.125.Income Guidelines.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 16, 2004.
TRD-200400324
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§37.111 - 37.119
The new sections are proposed under Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health; and Health and Safety Code, Chapter 41, relating
to hemophilia.
The new sections affect Health and Safety Code, Chapter 41. The review
of the rules implements Government Code, §2001.039.
§37.111.General.
(a)
Purpose. The purpose of this chapter is to establish rules
for the Hemophilia Assistance Program (HAP). The authority for these rules
is granted in the Texas Health and Safety Code, Chapter 41.
(b)
Definitions. The following words and terms, when used in
this chapter, shall have the following meaning unless the context clearly
indicates otherwise.
(1)
Allowable product--Blood derivatives, blood concentrates,
and manufactured pharmaceutical products indicated for the treatment of hemophilia
and approved for payment by the Hemophilia Assistance Program.
(2)
Applicant--An individual whose application has been submitted
through a participating provider and has not received a final determination
of eligibility. This includes an individual whose application is submitted
by a representative or person with legal authority to act for the individual.
(3)
Department--The Texas Department of Health.
(4)
HAP--The Hemophilia Assistance Program.
(5)
Hemophilia--A human physical condition, characterized by
bleeding, resulting from a genetically determined deficiency of a blood coagulation
factor or hereditarily resulting in an abnormal or deficient plasma procoagulant.
(6)
Inhibitor--A type of antibody, more common in severe hemophilia
A than hemophilia B, which requires the use of higher doses of blood factor
to contain a bleeding episode. This is usually confirmed by the Bethesda inhibitor
assay and reported as the Bethesda titer. The development of an inhibitor
rarely occurs in those with mild hemophilia.
(7)
Participating provider--Any individual or entity with HAP
approval to provide allowable products to HAP recipients.
(8)
Recipient--An individual who is eligible to receive HAP
benefits.
§37.112.Recipient Requirements.
(a)
A person shall meet all of the following requirements to
be eligible for benefits from the Hemophilia Assistance Program (HAP):
(1)
have a diagnosis of hemophilia certified by a licensed
physician;
(2)
be 21 years of age or older;
(3)
be a resident of Texas as determined in §37.113 of
this title (relating to Residency and Residency Documentation Requirements)
and not be:
(A)
incarcerated in a city, county, state, or federal jail,
or prison; or
(B)
a ward of the state.
(4)
submit an application for benefits to the HAP;
(5)
meet, or the person(s) who have a legal obligation to support
the applicant meet, the financial guidelines as outlined in §37.115 of
this title (relating to Financial Criteria). The person or persons who have
a legal obligation to support the recipient will be determined by the applicable
state law; and
(6)
not be eligible for Medicare or Medicaid.
(b)
A recipient may have all HAP benefits modified, suspended,
or terminated for any of the following reasons:
(1)
failure to maintain Texas residency or, upon demand, furnish
evidence of such using the criteria in §37.113 of this title;
(2)
failure to provide income data as requested to determine
continued HAP eligibility;
(3)
recipient is incarcerated in a city, county, state, or
federal jail, or prison;
(4)
recipient becomes a ward of the state;
(5)
recipient makes a material misstatement or misrepresentation
on their application or any document required to support their application;
(6)
failure to continue premium payments on individual or group
insurance, prepaid medical plan, and health insurance plans under the Social
Security Act, Title XVIII, as amended, where such plans provide benefits for
the care and treatment of persons who have hemophilia and the person's eligibility
for benefits under the plan(s) was effective prior to eligibility for HAP,
or provide a statement on the application form outlining the reason(s) why
such insurance cannot be maintained; or
(7)
failure to receive services through a participating provider.
(c)
When eligibility for HAP benefits is terminated for any
of the reasons outlined in subsection (b) of this section, an applicant shall
reapply for HAP benefits.
(d)
A recipient whose benefits are modified, suspended, or
terminated may appeal the HAP decision under the procedure contained in §§1.51
- 1.55 of this title (relating to Fair Hearing Procedures).
§37.113.Residency and Residency Documentation Requirements.
(a)
The following conditions shall be met by an applicant and
maintained by a recipient to satisfy the residency requirements in this section:
(1)
physically reside within the state; and
(2)
maintain a home or abode within the state.
(b)
If the applicant is a legal dependent of, and residing
with, a resident (such as an adult child or spouse); or is a person under
legal guardianship, then the resident providing support or the legal guardian
of the applicant shall meet the requirements of subsection (a) of this section.
(c)
If the applicant is a parent residing with their adult
child who is a resident of Texas, residency may be determined through the
adult child. If the applicant is a parent being supported by their adult child,
whether or not the child is a resident of Texas, the residency may be determined
by the adult child providing the required documents supporting the Texas residency
of the parent. These provisions apply even if no legal guardianship has been
established.
(d)
All documents submitted to establish the residency of an
applicant shall be in English or accompanied by an accurate English translation,
if required by the Hemophilia Assistance Program (HAP).
(e)
An applicant, or person establishing residency for the
applicant under subsections (b) and (c) of this section, who is currently
a Texas resident and has been currently approved to receive benefits from
Texas Medicaid, Temporary Assistance for Needy Families (TANF), or Food Stamps,
is not required to provide additional residency verification.
(f)
An applicant, or person establishing residency for the
applicant under subsections (b) and (c) of this section, may submit a copy
of any one of the following documents as evidence of residency. All documents
shall be in the applicant's name, or in the name of the person establishing
residency for the applicant, and provide some verification of a Texas address
or domicile:
(1)
a valid Texas driver's license, or an identification card
issued by the Texas Department of Public Safety;
(2)
a valid Texas voter's registration card, or a copy of a
validated (at the county clerk's office) application for a voter's registration
card;
(3)
a current Texas motor vehicle registration or automobile
license plate registration renewal form;
(4)
a mortgage payment receipt from any of the three months
immediately preceding the date of the application;
(5)
a rent payment receipt from any of the three months immediately
preceding the date of the application;
(6)
a statement reflecting that the applicant is currently
receiving rent-free housing. The statement must be signed by the individual
providing the rent-free housing and must include the address and phone number
of the individual providing the rent-free housing;
(7)
a utility payment receipt from any of the three months
immediately preceding the date of the application;
(8)
a Texas property tax receipt for the most recently completed
tax year;
(9)
a payroll or retirement check dated within the three months
immediately preceding the date of the application;
(10)
employment/unemployment records prepared within the three
months immediately preceding the date of the application;
(11)
a statement from a financial institution issued within
the three months preceding the date of the application; or
(12)
social security supplemental income or disability income
records, or social security retirement benefit records issued within the three
months immediately preceding the date of the application.
(g)
Applications submitted under subsections (b) and (c) of
this section shall also include evidence of the legal relationship between
the applicant and the resident, such as:
(1)
a marriage license or declaration of non-ceremonial marriage
to document the marriage of the applicant and spouse;
(2)
a birth certificate establishing the parent/child relationship
between the applicant and the resident;
(3)
a final order naming the applicant's managing conservator;
or
(4)
an income tax return showing name and relationship of the
applicant to the resident.
(h)
Any difference between the name of the applicant and the
name on any document must be explained by additional documentation (Example:
marriage license, divorce decree, or adoption decree).
§37.114.Applications and Eligibility Date.
Persons meeting the eligibility requirements set forth in §37.112(a)(1),
(2), (3), (5) and (6) of this title (relating to Recipient Requirements) must
make an application for benefits through the Hemophilia Assistance Program
(HAP).
(1)
Complete application. A complete application is required
before any eligibility determination will be made. A complete application
shall consist of all of the following:
(A)
a complete Application for Benefits, with the applicant's,
or the applicant's representative's, original signature or "mark";
(B)
a diagnosis of hemophilia certified by a licensed physician;
(C)
documentation of Texas residency as required by §37.113
of this title (relating to Residency and Residency Documentation Requirements);
(D)
applicant financial data. Acceptable data to establish
the applicant's financial qualifications shall be submitted with the application.
If the applicant, or person(s) who has a legal obligation to support the applicant
is currently approved to receive benefits from Texas Medicaid, Temporary Assistance
for Needy Families (TANF), or Food Stamps, no verification of income is required.
Changes in income or financial qualifications that would affect the applicant's
eligibility shall be reported to the HAP.
(i)
The applicant, or the person(s) who has a legal obligation
to support the applicant, may submit any of the following documents to verify
income:
(I)
copy of the most recent paycheck;
(II)
copy of the most recent paycheck stub or monthly employee
earnings statement;
(III)
employee's written verification of gross monthly income;
(IV)
pension/allotment award letters;
(V)
a copy of the IRS individual income tax return form and
supporting schedules for the most recently completed tax year; or
(VI)
any other documents considered valid by HAP.
(ii)
If the applicant, or person(s) who has a legal obligation
to support the applicant, is unemployed, a statement of termination from the
employer, or other documentation acceptable to HAP, is required.
(2)
Incomplete applications. Any application which does not
meet all of the requirements of paragraph (1) of this subsection is incomplete.
Incomplete applications may be returned to the submitting person for correction
or completion.
(3)
Eligibility date for HAP benefits. The HAP eligibility
date will be either:
(A)
the date HAP receives a completed application; or
(B)
the date of conditional authorization for allowable products,
if all written information to establish eligibility is received within 30
days of the date of conditional authorization.
(4)
Eligibility date for reinstatement of HAP benefits. If
HAP benefits are terminated, the eligibility date for any subsequent benefit
period will be the date on which HAP receives a subsequent completed application
for HAP benefits.
(5)
An applicant whose eligibility for benefits is denied may
appeal HAP's decision under the procedure contained in §§1.51 -
1.55 of this title (relating to Fair Hearing Procedures).
§37.115.Financial Criteria.
Financial need is established on the basis of income legally available
to the applicant or the person(s) who have a legal obligation to support the
applicant.
(1)
The income used to determine eligibility is the combined
gross income of the applicant and of all persons who have a legal obligation
to support the applicant.
(2)
Income includes earned wages, pensions or allotments, alimony,
or any monies received on a regular basis for support purposes. Supplemental
Security Income (SSI) for the disabled applicant is not included as income.
Verification of income data will be required as set out in §37.114(1)(D)
of this title (relating to Applications and Eligibility Date).
(3)
The income level for eligibility is based on a percentage
of the Federal Poverty Level Guidelines currently published by the U.S. Health
and Human Services and adopted by the Texas Department of Health (department).
Priority levels are based on available funds and may be adjusted by the department
in order to meet budgetary limitations. Priority levels are as follows.
(A)
Priority 1 - 100% or below;
(B)
Priority 2 - 101% - 115%;
(C)
Priority 3 - 116% - 130%;
(D)
Priority 4 - 131% - 145%;
(E)
Priority 5 - 146% - 160%;
(F)
Priority 6 - 161% - 185%; or
(G)
Priority 7 - 186% - 200%.
§37.116.Limitations and Benefits Provided.
(a)
The Hemophilia Assistance Program (HAP) provides limited
reimbursement to participating providers for blood derivatives, blood concentrates,
and manufactured pharmaceutical products indicated for the treatment of hemophilia
and prescribed to eligible recipients for use in medical or dental facilities
or in the home.
(b)
All HAP benefits are limited to those prescribed by a licensed
physician and received in Texas from a participating provider.
(c)
Depending on the recipient's eligibility status, HAP will
pay for allowable products based upon:
(1)
available funds;
(2)
established limits for allowable products by type or category
of product; and
(3)
the reimbursement rates established by the Texas Department
of Health (department).
(d)
Recipients eligible for coverage of allowable products
under a private/group health insurance plan are not eligible to receive HAP
benefits. A recipient that has exhausted this coverage may be eligible to
receive benefits from HAP.
(e)
To meet budgetary limitations, the department may:
(1)
adjust the priority level for receipt of benefits, as outlined
in §37.115(3) of this title (relating to Financial Criteria);
(2)
adjust the reimbursement rates established by the department;
(3)
restrict the allowable products paid for under the HAP;
(4)
adjust the established limits for allowable products;
(5)
adjust the limits established based on the inhibitor status
of the recipient or applicant;
(6)
limit the number of providers approved to participate in
the HAP; or
(7)
establish a waiting list of persons eligible for HAP. Appropriate
information will be collected from each applicant who is placed on a waiting
list. The information will be used to facilitate contacting the applicant
when benefits become available and to allow efficient enrollment of the applicant
for those benefits.
§37.117.Participating Providers.
In order for a provider to qualify for participation in the Hemophilia
Assistance Program (HAP), the provider shall meet the following criteria:
(1)
enter into an agreement to participate in HAP;
(2)
submit a completed HAP provider enrollment form to HAP;
(3)
be a current Texas Medicaid provider;
(4)
reimburse HAP for any overpayments made to the provider
by HAP upon request; and
(5)
not currently be on suspension as a HAP provider or a Texas
Medicaid provider.
§37.118.Forms.
Forms which have been developed by the Texas Department of Health (department)
for use in the Hemophilia Assistance Program (HAP) will be provided to applicants,
recipients and providers, as necessary.
§37.119.Confidentiality of Information.
(a)
All information required by this chapter to be submitted
may be verified at the discretion of the Texas Department of Health (department)
and without notice to the applicant or recipient of benefits of the Hemophilia
Assistance Program (HAP), or to the providers of HAP services. This information
is confidential to the extent authorized by law.
(b)
Information may be disclosed in summary, statistical, or
other forms which do not identify particular individuals.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400325
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
Subchapter B. DIABETIC EYE DISEASE DETECTION INITIATIVE
25 TAC §§61.21 - 61.24
The Texas Department of Health, Diabetes Program/Council
proposes amendments to §§61.21 - 61.24, concerning the Diabetic
Eye Disease Program (DEDP). The amended sections update language, clarify
eligibility requirements and procedures for eligible persons, and update program
benefits.
The sections are being amended to comply with Government Code, §2001.039,
that requires a state agency to review a rule not later than the fourth anniversary
of the date on which the rule takes effect and every four years after that
date. The department has reviewed the rules and has determined that revisions
are necessary in order to reflect changes in program administration.
Health and Safety Code, Chapter 103, §103.013(a), "Texas Diabetes
Council," requires the Texas Diabetes Council to "develop and implement a
state plan for diabetes treatment." Health and Safety Code, Chapter 103, §103.013(c),
states that "The council shall make written recommendations for performing
its duties under this chapter to the (board) and the legislature. If the council
considers a recommendation that will affect an agency not represented on the
council, the council shall seek the advice and assistance of the agency before
taking action on the recommendation. The council's recommendations shall be
implemented by the agencies affected by the recommendations." Furthermore,
Health and Safety Code, §103.014(e), states "the department shall accept
funds appropriated for the purposes of this chapter and shall allocate those
funds." The Diabetes Program budget has included funds for the DEDP since
1989, and the council at its October 2003, meeting approved of these changes
to the rules.
A notice of intent to review for §§61.21 - 61.24 was published
in the January 7, 2000, issue of the
Texas Register
(25 TexReg 218). No comments were received as a result of publication
of the notice.
The proposed amendments to §61.21 update language, provide current
contact information, and clarify the scope of coverage.
The proposed amendments to §61.22 clarify patient/client eligibility
criteria and change the financial eligibility reference from the department's
guidelines for clinical health services to the HHS-TDH poverty guidelines.
The proposed amendments to §61.23 include editorial changes and clarify
that the reimbursement rate for funduscopic eye exams is up to $60 as recommended
by the Texas Diabetes Council rather than the previously published $40.
The proposed amendments to §61.24 are editorial for consistent terminology
and provide updated contact information.
At their public meeting in El Paso on October 16, 2003, the Texas Diabetes
Council approved these proposed amendments to affirm previous recommendations
on provider reimbursement and client financial eligibility and to update the
language overall regarding diabetes and the use of TDH-HHS poverty guidelines.
Jan Ozias, Program Director, has determined that for each year of the first
five years the sections are in effect, there are no foreseeable fiscal implications
to state or local government as a result of enforcing or administering the
sections as proposed. The program can increase payment rate to providers and
limit the number of referral forms available annually statewide in order to
not exceed the budget for this function within the Diabetes Program allocation.
Dr. Ozias, has also determined that for each year of the first five years
the rules are in effect, the public benefit anticipated as a result of enforcing
the sections will be a more effective and efficient provision of the Diabetic
Eye Disease Program. Additionally, the proposed sections will provide more
specific guidance to providers and recipients. The amendments will have no
adverse economic effect on small businesses or micro-businesses because the
sections do not add any new or additional requirements on either eligible
providers or recipients. There is no fee for eligible providers or recipients,
thus there are no economic costs to persons who are required to comply with
the sections as proposed, as the purpose of the amendments are to clarify
and update current requirements. There is no anticipated effect on local employment.
Comments on the proposal may be submitted to Jan Ozias, Program Director,
Texas Department of Health, Diabetes Program/Council, 1100 West 49th Street,
Austin, Texas 78756, (512) 458-7490. Comments will be accepted for 30 days
following publication of this proposal in the
Texas
Register
.
The amendments are proposed under Health and Safety Code, §103.13,
which requires affected state agencies to implement recommendations of the
Texas Diabetes Council; and §12.001, which provides the Texas Board of
Health with the authority to adopt rules for the performance of each duty
imposed by law on the board, the department, and the commissioner.
The amendments affect the Health and Safety Code, Chapter 103.
§61.21.General Information.
(a)
Background. Diabetes is a major cause of blindness in the
United States and in Texas. It is estimated that up to 50% of blindness due
to proliferative diabetic retinopathy could be prevented, or at least delayed,
by prompt detection and treatment. Annual funduscopic examinations are recommended
for nearly all
people with diabetes
[
(b)
Introduction. The purpose of the Diabetic Eye Disease
Program
[
(c)
Participating providers.
Health care professionals
[
[
(d)
[
§61.22. Client [
(a)
Eligible persons[
[
(1)
[
(2)
[
(3)
[
(4)
reside in the State of Texas
.
[
(b)
People
[
(1)
people with type 1 diabetes
[
(2)
all
people with type 2 diabetes, regardless of when
they were diagnosed
[
§61.23.Program Benefits.
(a)
Scope of services.
(1)
Reimbursement will be limited to
a maximum of $60
[
(2)
These examinations will also include acuity testing, tonometry,
and
assessment of lens opacity[
(b)
Maximum allowable benefits. Maximum allowable benefits
per
client
[
(c)
Funding limitations. Payment will not be made for any diagnostic
test
, corrective lenses,
or [
§61.24.Payment for Services.
(a)
Payee identification number. Payment for services is made
to providers who have a State of Texas payee identification number. To obtain
a payee identification number, providers must complete the State of Texas
Application For Payee Identification Number, Form AP-107, and return it to
the
Texas
Diabetes [
(b)
Conditions for payment. The
DEDP
[
(c)
Time limit. The eye examination must be completed within
60 days of the service approval date and the signed tracking forms described
in §61.21(e) of this title (relating to General Information) must be
received by the
DEDP
[
(d)
Procedures for claims payment. The procedures for claims
payment shall be in accordance with the
DEDP
[
(e)
Claim denials. Payment for eye examinations will not be
made if:
(1)
the
patient is ineligible;
(2)
the
services provided were not specifically
covered by benefits of the
DEDP
[
(3)
the
patient failed to appear for treatment and
no service was rendered (no-shows); or
(4)
claims for the same eye examination were previously paid
for by the
DEDP
[
(f)
Reconsideration of denied claims. A claim that has been
denied in error by the
DEDP
[
(1)
the original claims with the error identified and corrected
is returned to the
DEDP
[
(2)
the claim is accompanied by a copy of the
DEDP
[
(g)
Payment of claims
that
[
(h)
Due process hearing. In the event the provider contract
is terminated or suspended, or any claim for payment is denied following reconsideration,
the provider will be afforded an opportunity for a due process hearing. The
provider must request such
a
hearing in writing to the Chief, Bureau
of [
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400288
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §§100.1-100.11
and new §§100.1-100.8, concerning the immunization registry.
The immunization registry is a statewide repository for immunization information
on Texas children. The information is available to public health districts,
local health departments, physicians, schools, child-care facilities, and
parents when record request criteria are met. The proposed rules are necessary
to simplify reporting immunization histories to the department and to enhance
the effectiveness of the immunization registry under its current authorized
legislation. As mandated by House Bill 1921, 78th Legislature, Regular Session
(2003), amended Health and Safety Code, §161.007, the proposed rules
will help populate the registry by relieving payors and providers of the responsibility
for maintaining consent for the registry; will allow parents to submit immunization
histories directly to the department; will require healthcare providers to
send immunization records directly to the department; will require the department
to verify parental consent for each record submitted; and will expand data
access to any provider authorized to administer vaccines, payors, and state
agencies with legal custody of a child.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). The department
has reviewed §§100.1-100.11 and has determined that reasons for
adopting the sections continue to exist; however, a repeal of the current
rules and the proposal of new rules are necessary to simplify the rules and
implement House Bill 1921.
The department published a Notice of Intention to Review for §§100.1-100.11
in the
Texas Register
on May 31, 2002 (27
TexReg 4745).
Casey S. Blass, Chief, Bureau of Immunization and Pharmacy Support, has
determined that for each year of the first five years the sections are in
effect there will be no fiscal implications to state government as a result
of enforcing and administering the sections as proposed. Additional immunization
histories submitted by providers and parents will be processed using existing
resources. There will be no fiscal impact on local government, because the
immunization registry is a state registry maintained by the department.
Mr. Blass has also determined that for each year of the first five years
the sections are in effect the public benefit anticipated through enforcement
and administration of the sections as proposed will be to enhance the effectiveness
of the registry by providing parents with more complete and accurate immunization
histories for their children. The proposed changes will benefit small and
micro- businesses such as clinics and physicians' offices by reducing confusion
regarding parental consent and eliminating the responsibility for providers
to maintain evidence of consent. Providers and payors will benefit from expanded
access to more complete immunization histories. Providers who currently report
immunization records to payors are not required to report those records to
the registry. Under House Bill 1921, as reflected in the proposed rules, these
providers will be required to report to the registry. There will be no impact
on local employment.
Comments on the proposal may be submitted to Janie Garcia, Immunization
Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756, (512) 458-7284, extension 6430, or (800) 252-9152. Comments will be
accepted for 30 days following publication of this proposal in the
Texas Register
.
25 TAC §§100.1 - 100.11
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the authority of Health
and Safety Code, §161.007, which gives the Texas Board of Health (board)
the right to develop rules to implement the immunization registry; and Health
and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
The repeals affect the Health and Safety Code, Chapters 12 and 161. The
review of the rules implements Government Code, §2001.039.
§100.1.Definitions.
§100.2.Inclusion of Information and Confidentiality.
§100.3.Providers and Health Plans.
§100.4.Withdrawal of Consent.
§100.5.Reportable Information.
§100.6.Information Included in the Immunization Registry Prior to September 1, 1997.
§100.7.Data Quality Assurance.
§100.8.Health Plans Shall Provide Immunization History to the Department.
§100.9.Reports.
§100.10.Acceptability As An Immunization Record.
§100.11.Confidentiality.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400289
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§100.1 - 100.8
The new sections are proposed under the authority of Health
and Safety Code, §161.007, which gives the Texas Board of Health (board)
the right to develop rules to implement the immunization registry; and Health
and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
The new sections affect the Health and Safety Code, Chapters 12 and 161.
The review of the rules implements Government Code, §2001.039.
§100.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Child--The person or individual younger than 18 years of
age to whom a vaccine has been administered.
(2)
Consent--A statement signed by a parent agreeing that the
child's immunization history can be included in the registry and that the
child's immunization record may be released from the registry.
(3)
Data elements--Consistent with 42 U.S.C. §300aa-25,
as amended, data elements are defined as the information a provider who administers
a vaccine is required to record in a medical record, including:
(A)
the date the vaccine is administered;
(B)
the type of vaccine administered, vaccine manufacturer
and lot number; and
(C)
the name, address, and, if appropriate, the title of the
provider administering the vaccine.
(4)
Department--The Texas Department of Health.
(5)
Immunization history--An accounting of all vaccines that
a child has received, or evidence of immunity, and other identifying information.
(6)
Immunization record--An immunization record contains the
name and date of birth of the person to whom a vaccine was administered; dates
of vaccine administration; types of vaccine administered; and name and address
of the provider that administered the vaccines; or other evidence of immunity
to a vaccine-preventable disease. The report generated from the immunization
registry is considered an official immunization record.
(7)
Immunization registry--The database or single repository
that contains immunization histories, which include necessary personal data
for identification. This database is confidential, and access to content is
limited to authorized users.
(8)
Parent--A parent, managing conservator, or legal guardian.
(9)
Payor--An insurance company, a health maintenance organization,
or another organization that pays a health care provider to provide health
care benefits, including the administration of vaccines to a person younger
than 18 years of age.
(10)
Provider--Any physician, health care professional, or
facility personnel duly licensed or authorized to administer vaccines.
(11)
User--An entity or individual authorized by the department
to access immunization registry data.
(12)
Vaccine--Includes toxoids and other immunologic agents
which are administered to children to elicit an immune response and thus protect
against infectious diseases.
§100.2.Confidentiality.
(a)
Information that individually identifies a child, and is
received by the department for the immunization registry, is confidential
and may be used by the department for registry purposes only. Unless specifically
authorized by Health and Safety Code, Chapter 161, Subchapter A, the department
may not release registry information to any individual or entity without the
written consent of the person or, if a minor, the parent.
(b)
A written confidentiality statement shall be signed by
an authorized representative of the user. Any user of the registry shall protect
the confidentiality of all immunization histories, records, and reports. A
person required to report information to the department for registry purposes
or authorized to receive information from the registry may not disclose individually
identifiable information to any individual or entity without the written consent
of the person or, if a minor, the parent, or except as provided by the Occupations
Code, Chapter 159, or the Insurance Code, Article 28B.04.
(c)
Registry information is not subject to discovery, subpoena,
or other means of legal compulsion for release to any person or entity, except
as provided by Health and Safety Code, Chapter 161, Subchapter A. Registry
information is not admissible in any civil, administrative, or criminal proceeding.
§100.3.Informing Parent, Managing Conservator, or Guardian.
(a)
A parent shall be informed that the department has established
and maintains a single repository of immunization records to be used in aiding,
coordinating, and promoting efficient and cost-effective childhood communicable
disease prevention and control efforts.
(b)
The department shall provide written materials and forms
to providers for the purpose of informing a parent about the immunization
registry and specific information collected in that registry.
(c)
The department and providers may use the registry to provide
notices by mail, telephone, personal contact, or other means to a parent regarding
his or her child who may be due or overdue for a particular type of immunization
according to the department's immunization schedule.
(d)
The first time the department receives registry data, from
a person other than the child's parent, for a child for whom the department
has received consent to be included in the registry, the department shall
send a written notice to the parent disclosing:
(1)
that providers and payors may be sending the child's immunization
information to the department;
(2)
the information that is included in the registry;
(3)
the persons to whom the information may be released;
(4)
the purpose of the registry;
(5)
the procedure to exclude a child from the registry; and
(6)
the procedure to report a violation if a parent discovers
a child is included in the registry after exclusion has been requested.
§100.4.Registry Consent and Withdrawal.
(a)
A parent may consent to the inclusion of the child's immunization
history in the immunization registry by doing one of the following:
(1)
indicating consent at birth certificate registration, including
by electronic signature;
(2)
submitting written notification to the department in a
format prescribed by the department or substantially similar and mailed to
the Texas Department of Health, Immunization Division, 1100 West 49th Street,
Austin, Texas 78756, or by calling the Immunization Division at (800) 252-9152
to request a consent form; or
(3)
completing written consent to be submitted to the department
by a provider or payor.
(b)
Consent is required to be obtained only one time, and is
valid until the child becomes 18 years of age, unless the consent is withdrawn
in writing.
(c)
A parent may withdraw consent for the child to be included
in the registry at any time by submitting written notification to the department
in a format prescribed by the department or substantially similar and mailed
to the Texas Department of Health, Immunization Division, 1100 West 49th Street,
Austin, Texas 78756, or by calling the Immunization Division at (800) 252-9152
to request a consent withdrawal form. The department shall remove information
from the immunization registry for any person for whom consent has been withdrawn,
and the department shall send the parent a written confirmation of the removal
of the information. The department may not retain individually identifiable
information about any person for whom consent has been withdrawn.
(d)
A parent may request exclusion of the child's immunization
history from the immunization registry by doing one of the following:
(1)
indicating the request for exclusion at birth certificate
registration, including by electronic signature; or
(2)
submitting written notification to the department in a
format prescribed by the department or substantially similar and mailed to
the Texas Department of Health, Immunization Division, 1100 West 49th Street,
Austin, Texas 78756, or by calling the Immunization Division at (800) 252-9152
to request an exclusion form. On receipt of a written request to exclude a
child's immunization records from the registry, the department shall send
the parent a written confirmation of receipt of the request, and shall exclude
the child's records from the registry. The department may not retain individually
identifiable information about any person for whom an exclusion has been requested.
§100.5.Receipt and Release of Registry Data.
(a)
The department may obtain the data constituting an immunization
record for a child from a public health district, a local health department,
the child's parent, a physician to the child, a payor, or any health care
provider licensed or otherwise authorized to administer vaccines.
(b)
Effective January 1, 2005, the department shall verify
consent before including information received from a person other than the
child's parent in the immunization registry. Effective January 1, 2005, the
department may not retain individually identifiable information about a person
for whom consent cannot be verified.
(c)
The department may release the data constituting an immunization
record for a child to any entity that is described by subsection (a) of this
section to a school or child care facility in which the child is enrolled,
or to a state agency having legal custody of the child.
(d)
A person, including a provider, a payor, or an employee
of the department, that submits in good faith an immunization history or data
to or obtains in good faith an immunization history or data from the department
in compliance with this section is not liable for any civil damages.
(e)
The department may release nonidentifying summary statistics
related to the registry that do not individually identify a child.
§100.6.Reporting to the Registry.
(a)
Data elements regarding an immunization record provided
to the department, whether electronically or by other means, shall be submitted
in a format prescribed by the department.
(b)
Effective January 1, 2005, a health care provider who administers
an immunization to a person younger than 18 years of age shall provide data
elements regarding an immunization to the department within 30 days of administration
of the vaccine. Effective January 1, 2005, the department shall verify consent
before including the reported information in the immunization registry, and
the department may not retain individually identifiable information about
a person for whom consent cannot be verified. For immunizations administered
prior to January 1, 2005, providers shall provide an immunization history
for persons for whom consent to participate in the registry has been obtained
unless the immunization history is submitted to a payor.
(c)
Effective January 1, 2005, a payor that receives data elements
from a provider who administers an immunization to a person younger than 18
years of age shall provide the data elements to the department within 30 days
of receipt of the data elements from a provider. Effective January 1, 2005,
the department shall verify consent before including the reported information
in the immunization registry, and the department may not retain individually
identifiable information about a person for whom consent cannot be verified.
For immunizations administered prior to January 1, 2005, payors shall provide
an immunization history for persons for whom consent to participate in the
registry has been obtained.
(d)
A parent may provide evidence of a child's immunization
history, in a format provided by the department or one substantially similar,
directly to the department for inclusion in the registry. The department shall
ensure that the immunization history submitted by a parent is medically verified
immunization information by requiring the parent to submit evidence that includes
a copy of one or more of the following:
(1)
the child's medical record indicating the immunization
history and including a provider's signature and the name and address of the
provider;
(2)
A vaccine-specific invoice from a health care provider
for the immunization;
(3)
vaccine-specific documentation showing that a claim for
the immunization was paid by a payor;
(4)
an immunization record signed by a school official; or
(5)
an immunization history provided by a local or state immunization
registry.
(e)
The department shall provide notice to a provider that
submits an immunization history for a person for whom consent cannot be verified.
The notice shall contain instructions for obtaining consent and resubmitting
the immunization history to the department.
(f)
A provider shall, upon request of the department, provide
additional information to clarify an immunization history submitted to the
department.
(g)
The department shall provide instruction and education
to providers about the immunization registry provider application and enrollment
process and expedite processing of provider applications.
§100.7.Official Immunization Record.
An immunization record obtained from the immunization registry shall
be accepted as an official immunization record of the child.
§100.8.Complaints.
(a)
A person may file a complaint with the department related
to the department's failure to comply with a request for exclusion of an individual
from the registry by mailing written notification to: Director, Immunization
Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756; or by e-mail to the attention of Director, Immunization Division at
feedback.ImmDirector@tdh.state.tx.us. The department shall respond to the
written complaint within 30 days of receipt of the complaint.
(b)
A person may report an incident of discrimination for requesting
exclusion of an individual from the registry, or for using an exemption for
a required immunization, by mailing written notification to: Director, Immunization
Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756; or by e-mail to the attention of Director, Immunization Division at
feedback.ImmDirector@tdh.state.tx.us. The department shall respond to the
written notification within 30 days of receipt of the notification.
(c)
The department shall report to the Legislative Budget Board,
the governor, the lieutenant governor, the speaker of the house of representatives,
and appropriate committees of the legislature not later than September 30
of each even-numbered year. The report shall:
(1)
include the number of complaints received by the department
related to the department's failure to comply with requests for exclusion
of individuals from the registry; and
(2)
identify all reported incidents of discrimination for requesting
exclusion of individuals from the registry or for using an exemption for a
required immunization.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 15, 2004.
TRD-200400290
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §§117.3,
117.11 - 117.14, new §§117.11 - 117.14, and amendments to §§117.15,
117.16 and 117.84, concerning the regulation of end stage renal disease facilities.
The amendments and new sections are required as a result of the provisions
of Senate Bill (SB) 1152, which amended Government Code, Chapter 2054, regarding
the Texas Online Authority; the revisions to the Health and Safety Code (HSC),
Chapter 251, required by Senate Bill 162, adding probation as a new penalty
alternative; and House Bill 2292, 78th Legislature, 2003, which revised HSC, §12.0111
and §12.0112, regarding fees for two-year license cycles.
Specifically, the sections proposed for repeal address licensing fees,
general requirements for a license, application and issuance of a temporary
initial license and first annual license, application and issuance of annual
renewal license, and change of ownership or services. The proposed new sections
cover general requirements for a license, application and issuance of initial
license, application and issuance of renewal license, and fees. The proposed
repeal of existing rules and proposed new sections allows for the reorganization
and renumbering of the sections for clarification, and for the inclusion of
language to implement the provisions of the new legislation. New §117.13
addresses the conversion to two-year license cycles beginning January 1, 2005.
New §117.14 includes fees for both 12-month and two-year license renewal
cycles, and for the recovery of costs associated with application and renewal
application processing through TexasOnline. The amendment to §117.15
updates references to other sections. Amendment to §117.16 eliminates
unnecessary language and clarifies that inspections are conducted to determine
compliance with HSC, Chapter 251, and this chapter. The amendment to §117.84
addresses the addition of probation and emergency suspension to the list of
enforcement actions that can be taken against a facility.
Lisa Subia, Associateship for Consumer Health Protection, has determined
that for each year of the first five years the sections are in effect, there
will be fiscal implications to state government as a result of the administering
the sections as proposed. This impact is related to the conversion to the
two-year license renewal cycle. For Fiscal Year (FY) 2005, which will be the
first year in a two-year phase-in process for the two-year renewal cycle,
there will be a temporary increase in revenue to approximately $1,082,242.
This estimate is based on the fact that during FY 2005, one-half of the facilities
will be renewing their licenses to be effective for two years, and will pay
a corresponding fee to cover the two-year period (this amount will be double
the amount collected during FY 2004 for this group of facilities). The remainder
of the facilities will be renewing their licenses for a one-year period in
FY 2005, which will result in the estimated additional revenue. This second
group of facilities will renew their licenses for the two-year period in FY
2006, so the anticipated revenue will return to the FY 2004 level, and there
will be no anticipated fiscal impact for Fiscal Years 2006 through 2009. There
will be no fiscal impact for local government.
Ms. Subia has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
enforcing or administering the sections will be to insure compliance by end
stage renal disease (ESRD) facilities with new legislative mandates. There
will be economic costs for micro-businesses, small businesses, and persons
who are required to comply with the amended sections. These costs are related
to the conversion to two-year license renewal cycles. The current license
fees range from a minimum of $1,000 to a maximum of $2,500, based on the number
of treatments for the preceding 12 months. Once conversion to the two-year
license renewal cycle begins, an ESRD facility will be required to pay the
license fee for the two-year period. The new two-year fee structure will require
facilities to pay fees based on the number of treatments administered that
will range from a minimum of $2,000 to a maximum of $5,000. Senate Bill 1152,
78th Legislature, Regular Session, 2003, directs all departments that administer
licensing programs to participate in Texas Online, an electronic fee payment
system developed and maintained by the Texas Online Authority. Wording is
added that authorizes the department to collect subscription and convenience
fees, in amounts to be determined by the Texas Online Authority, to recover
costs associated with application and renewal application processing. There
will be no anticipated impact on local employment.
Comments may be submitted to Cindy Bednar, Director of Licensing Programs,
Health Facility Licensing and Compliance Division, Texas Department of Health,
1100 West 49th Street, Austin, Texas, 78756, (512) 834-6646. Comments will
be accepted for 30 days following publication of this proposal in the
Subchapter A. GENERAL PROVISIONS
25 TAC §117.3
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under Health and Safety Code, §251.003,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The repeal affects the Health and Safety Code, Chapters 251 and 12.
§117.3.Licensing Fees.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 16, 2004.
TRD-200400320
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§117.11 - 117.14
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under Health and Safety
Code, §251.003, concerning rules and minimum standards to protect and
promote the public health and welfare by providing for the issuance, renewal,
denial, suspension, and revocation of each level of license; and Health and
Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and commissioner of health.
The repeals affect the Health and Safety Code, Chapters 251 and 12.
§117.11.General Requirements for a License.
§117.12.Application and Issuance of Temporary Initial License and First Annual License.
§117.13.Application and Issuance of Annual Renewal License
§117.14.Change of Ownership or Services.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400321
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§117.11 - 117.16
The amendments and new sections are proposed under Health
and Safety Code, §251.003, concerning rules and minimum standards to
protect and promote the public health and welfare by providing for the issuance,
renewal, denial, suspension, and revocation of each level of license; and
Health and Safety Code, §12.001, which provides the Texas Board of Health
(board) with the authority to adopt rules for the performance of every duty
imposed by law on the board, the department, and commissioner of health.
The amendments and new sections affect the Health and Safety Code, Chapters
251 and 12.
§117.11.General Requirements for a License.
(a)
License required. A facility shall obtain a license prior
to admitting patients.
(b)
Display. A facility shall prominently and conspicuously
display the license in a public area of the licensed premises that is readily
visible to patients, employees, and visitors.
(c)
Alteration. A facility license shall not be altered.
(d)
Transfer or assignment prohibited. A facility license shall
not be transferred or assigned. The facility shall comply with the provisions
of §117.12(h) of this title (relating to Application and Issuance of
Initial License) in the event of a change in the ownership.
(e)
Changes which affect the license.
(1)
A facility shall notify the department in writing prior
to the occurrence of any of the following:
(A)
any construction, renovation, or modification of the facility
buildings;
(B)
cessation of operation of the facility; or,
(C)
change in facility name, telephone number or administrator.
(2)
A facility shall obtain written approval from the department
prior to the utilization of added services or an increased number of stations.
The written request shall be submitted 30 calendar days prior to the planned
change.
(A)
For an additional service or increase in stations, the
department may request that the facility provide evidence of appropriate staffing
and policies and procedures which demonstrate the intent to comply with the
applicable requirements, and any other documentation it determines is necessary
to evaluate the request.
(B)
For an increase in stations, the facility shall also be
required to submit written evidence that the water treatment system is of
sufficient size to accommodate the increase and maintain a safe water supply.
(C)
The department may conduct on on-site inspection prior
to taking action on the requested change.
(D)
No later than three weeks after initiating the use of the
new stations, the facility is required to complete chemical and bacteriological
cultures of the product water to ensure they are in compliance with §4.2.1
(relating to Water Bacteriology) and §4.2.2 (relating to Maximum Level
of Chemical Contaminants) of the American National Standard, Water Treatment
Equipment for Hemodialysis Applications, August 2001 Edition, published by
the Association for the Advancement of Medical Instrumentation, 1110 North
Glebe Road, Suite 200, Arlington, Virginia 22201, 703-525-4890. Deviations
from acceptable levels must be immediately reported to the department. The
reports must be kept on file at the facility and made available to department
staff during the next on-site inspection.
(3)
The department shall send the facility written notice of
the approval or disapproval of the requested change.
(f)
Facility relocation.
(1)
A facility planning to relocate shall notify the department
a minimum of 60 days prior to the planned relocation. Relocations must be
within the same geographical area, and services shall continue to be provided
to the facility's existing patient population.
(2)
The facility shall submit the following to the department:
(A)
a copy of a current fire safety survey indicating approval
by the local fire authority in whose jurisdiction the new location is based;
(B)
results of chemical and bacteriological cultures of the
product water at the new location to ensure they are in compliance with §§4.2.1
(relating to Water Bacteriology) and 4.2.2 (relating to Maximum Level of Chemical
Contaminants) of the American National Standard, Water Treatment Equipment
for Hemodialysis Applications, August 2001 Edition, published by the Association
for the Advancement of Medical Instrumentation, 1110 North Glebe Road, Suite
200, Arlington, Virginia 22201, (703) 525-4890;
(C)
documentation verifying compliance with paragraph (1) of
this subsection; and
(D)
a written plan for the orderly transition of all patient
services to the new location.
(3)
The department shall conduct the design and space inspection
described in §117.16(b)(1)(A) of this title (relating to Inspections)
prior to issuance of the initial license, unless the department waives the
requirement.
(4)
The department may conduct additional on-site inspections,
or request additional information, before approving the relocation.
(5)
The department will notify the facility in writing of the
approval or disapproval of relocation. If approved, the license will be reissued
for the new location effective on the day that patient services are transferred
to the new location.
§117.12.Application and Issuance of Initial License.
(a)
Application submittal. The applicant shall submit the following
documents to the department no earlier than 60 calendar days prior to the
projected opening date of the facility:
(1)
an accurate and complete application form;
(2)
an approved fire safety report from the local fire authority;
and
(3)
the appropriate license fee as required in §117.14
of this title (relating to Fees).
(b)
Design and space inspection. The department shall conduct
the design and space inspection described in §117.16(b)(1)(A) of this
title (relating to Inspections) prior to issuance of the initial license,
unless the department waives the requirement.
(c)
Presurvey conference. The applicant or the applicant's
representative shall attend a presurvey conference at the office designated
by the department. The purpose of the presurvey conference, which is conducted
by department staff, is to review facility staff qualifications, facility
policies and procedures, results of water cultures and analysis of product
water, survey documents and licensure rules, and to provide consultation prior
to the on-site licensure survey. The department staff conducting the presurvey
conference is responsible for making a recommendation regarding the issuance
of the initial license. The department may waive the presurvey conference
requirement.
(d)
Issuance of license. When it is determined that the facility
has complied with subsections (a)-(c) of this section, the department shall
issue the license to the applicant.
(1)
Effective date. The license shall be effective on the date
the facility is determined to be in compliance with subsections (a)-(c) of
this section.
(2)
Expiration date.
(A)
For initial licenses issued prior to January 1, 2005.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 11th month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
12th month after issuance.
(B)
For initial licenses issued January 1, 2005, or after.
(i)
If the effective date of the license is the first day of
a month, the license expires on the last day of the 23rd month after issuance.
(ii)
If the effective date of the license is the second or
any subsequent day of a month, the license expires on the last day of the
24th month after issuance.
(e)
Withdrawal of application. If an applicant decides not
to continue the application process for a license or renewal of a license,
the application may be withdrawn. The department shall acknowledge receipt
of the request to withdraw.
(f)
Denial of a license. Denial of a license shall be governed
by §117.84 of this title (relating to Enforcement).
(g)
Inspections. During the initial licensing period, the department
shall conduct an inspection of the facility to ascertain compliance with the
provisions of the Health and Safety Code, Chapter 251, and this chapter.
(1)
A facility shall request an on-site inspection to be conducted
after one inpatient has been admitted and provided services.
(2)
A facility shall be providing services to at least one
inpatient in the facility at the time of the inspection.
(h)
Change of ownership. A change of ownership occurs when
there is a change in the person legally responsible for the operation of the
facility, whether by lease or by ownership. If a corporate licensee amends
its articles of incorporation to revise its name and the tax identification
number does not change, this subsection does not apply, except that the corporation
must notify the department within 10 calendar days after the effective date
of the name change. The sale of stock of a corporate licensee does not cause
this subsection to apply. A change of ownership requires submission of an
initial license application.
(1)
The new owner shall submit an application for an initial
license to the department prior to the date of the change of ownership or
not later than 10 calendar days following the date of a change of ownership.
The application shall be in accordance with subsections (a) - (c) of this
section. The applicant shall include the effective date of the change of ownership.
(2)
Inspections. The design and space and health inspections
required by subsections (b) and (g) of this section may be waived by the department.
(3)
Issuance of license. When the new owner has complied with
the provisions of subsections (a) - (c) of this section, the department shall
issue a license which shall be effective the date of the change of ownership.
(4)
Expiration of license. The expiration date of the license
shall be in accordance with subsection (d) of this section.
(5)
License void. The previous owner's license shall be void
on the effective date of the new owner's license.
(i)
Temporary initial license. The department may issue a temporary
initial license in lieu of the initial license.
§117.13.Application and Issuance of Renewal License.
(a)
Renewal notice. The department may send a renewal notice
to a facility up to 60 calendar days before the expiration date of a license.
(1)
If the facility has not received the renewal notice from
the department within 30 calendar days prior to the expiration date, it is
the duty of the facility to notify the department and request a renewal application
for a license.
(2)
If the facility fails to submit the application and fee
within 15 calendar days prior to the expiration date of the license, the department
shall send to the facility a letter advising that unless the license is renewed,
the facility must cease operations upon the expiration of the license.
(b)
Renewal license. The department shall issue a renewal license
to a facility that meets the minimum requirements for a license.
(1)
The facility shall submit the following to the department
prior to the expiration date of the license:
(A)
a complete and accurate application form;
(B)
a copy of a fire safety survey indicating approval by the
local fire authority in whose jurisdiction the facility is based that is dated
no earlier than one year prior to the application date;
(C)
the renewal license fee; and
(D)
verification that the facility submitted the annual reports
required by §117.42 of this title (relating to Indicators of Quality
of Care).
(2)
The department may conduct an inspection prior to issuing
a renewal license in accordance with §117.16 of this title (relating
to Inspections).
(3)
Renewal licenses issued prior to January 1, 2005, will
be valid for 12 months.
(4)
Renewal licenses issued January 1, 2005, through December
31, 2005, will be valid for either 12 or 24 months, to be determined by the
department prior to the time of license renewal.
(5)
Renewal licenses issued January 1, 2006, or after will
be valid for 24 months.
(c)
Notice to cease operation and return license. If a facility
fails to submit the application, documents, and fee by the expiration date
of the license, the department shall notify the facility that it must cease
operation and immediately return the license by certified mail to the department.
If the facility wishes to provide services after the expiration date of the
license, it shall apply for a license under §117.12 of this title (relating
to Application and Issuance of Initial License).
§117.14.Fees.
(a)
General.
(1)
All fees paid to the department are nonrefundable.
(2)
All fees shall be paid to the department.
(b)
License fees.
(1)
The fee for an initial license is $2,000 per 12-month period.
(2)
Renewal license fees.
(A)
For renewal licenses issue prior to January 1, 2005, the
license fee is determined by multiplying the number of treatments in the previous
12-month period by $.25, except that the minimum fee is $1,000 and the maximum
fee is $2,500.
(B)
For renewal licenses issued January 1, 2005 or later, the
license fee will be determined as follows.
(i)
For licenses that the department determines will be valid
for 12 months, the license fee is the total number of treatments in the past
12-month period multiplied by $.25, except that the minimum fee is $1,000
and the maximum fee is $2,500.
(ii)
For licenses that the department determines will be valid
for 24 months, the license fee is the total number if treatments in the past
12-month period multiplied by $.50, except that the minimum fee is $2,000
and the maximum fee is $5,000.
(c)
Other fees. For all applications and renewal applications,
the department is authorized to collect subscription and convenience fees,
in amounts determined by the Texas Online Authority, to recover costs associated
with application and renewal application processing through TexasOnline, in
accordance with Texas Government Code, §2054.111.
§117.15.Time Periods for Processing and Issuing a License.
(a)
General.
(1)
(No change.)
(2)
An application for
an
[
(3)
An application for an annual renewal license is complete
when the department has received, reviewed and found acceptable the information
described in §117.13 of this title (relating to Application and Issuance
of [
[
(b)
Time Periods. An application from a facility for
an
[
(1)-(2)
(No change.)
(c)-(d)
(No change.)
(e)
Hearings. If a hearing is proposed during the processing
of the application, the
hearing shall be conducted pursuant to the Administrative
Procedure Act, Texas Government Code, Chapter 2001, and the department's formal
hearing procedures in Chapter 1 of the title (relating to the Texas Board
of Health)
[
§117.16.Inspections.
(a)
General. The Texas Department of Health (department) may
conduct an inspection at any time to verify compliance with the statute or
this chapter. By applying for or holding a license, the facility consents
to entry and inspection of the facility by the department or representative
of the department in accordance with the statute and this chapter.
(1)-(2)
(No change.)
[
(b)
Types of inspections.
(1)
(No change.)
(2)
Initial inspection for the issuance of the
initial
[
(3)-(7)
(No change.)
(c)
Inspection procedures.
(1)
(No change.)
(2)
Evaluation of compliance. Except for the purposes of conducting
an inspection under subsection (b)(1), (4), (6), or (7) of this section, an
onsite inspection will include an evaluation to determine compliance with
the statute and this chapter.
[
[
[
[
[
[
[
[
[
[
[
[
[
[
(3)
(No change.)
(4)
Written notice of findings.
(A)-(B)
(No change.)
(C)
If the written notice of findings includes deficiencies,
the department and the facility shall comply with the procedure set out in
this subparagraph.
(i)-(v)
(No change.)
(vi)
The facility may challenge any deficiency cited after
receipt of the statement of deficiencies. A challenge to a deficiency(ies)
shall be in accordance with this subparagraph.
(I)-(V)
(No change.)
(VI)
If the facility does not come into compliance by the required
date of correction reflected on the corrective action plan(s), the department
may:
(-a-) - (b-)
(No change.)
(-c-)
propose to deny, suspend, or revoke the license in accordance
with §117.84 of this title (relating to
Enforcement
[
(-d-) - (-e-)
(No change.)
(VII)-(IX)
(No change.)
This agency hereby certifies that the
proposal has been reviewed by legal counsel and found to be within the agency's
legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400322
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §117.84
The amendment is proposed under Health and Safety Code, §251.003,
concerning rules and minimum standards to protect and promote the public health
and welfare by providing for the issuance, renewal, denial, suspension, and
revocation of each level of license; and Health and Safety Code, §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
The amendment affects the Health and Safety Code, Chapters 251 and 12.
§117.84. Enforcement [
(a)
The department may deny, suspend, or revoke a license if
the applicant or facility:
(1)-(3)
(No change.)
(4)
aids, abets, or permits the commission of an illegal act;
[
(5)
fails to comply with an order of the commissioner of health
or another enforcement procedure under the statute
; or
[
(6)
fails to comply with applicable
requirements within a designated probation period.
(b)
(No change.)
(c)
The department may suspend or revoke an existing valid
license or disqualify a person from receiving a license because of a person's
conviction of a felony or misdemeanor if the crime directly relates to the
duties and responsibilities of a licensed facility.
(1)
In determining whether a criminal conviction directly relates,
the department shall consider the provisions of Texas
Occupations Code, §§53.022
and 53.023
[
(2)
The following felonies and misdemeanors directly relate
because these criminal offenses indicate an inability or a tendency for the
person to be unable to own or operate a facility:
(A)-(F)
(No change.)
(G)
other misdemeanors and felonies which indicate an inability
or tendency for the person to be unable to own or operate a facility if action
by the department will promote the intent of the statute, this chapter, or
Texas
Occupations Code, §§53.022 and 53.023
[
(3)
(No change.)
(d)-(g)
(No change.)
(h)
The department may issue an
emergency order to suspend a license issued under this chapter if the department
has reasonable cause to believe that the conduct of a license holder creates
an immediate danger to the public health and safety.
(1)
An emergency suspension is effective immediately
without a hearing or notice to the license holder.
(2)
On written request of the license holder, the
department shall conduct a hearing not earlier than the 10th day or later
than the 30th day after date the hearing request is received to determine
if the emergency suspension is to be continued, modified, or rescinded. The
hearing and any appeal are governed by the department's rules for a contested
case hearing and Government Code, Chapter 2001.
(i)
The department may schedule
the facility for a probation period of not less than 30 days if the facility
is found in repeated non-compliance, and the facility's non-compliance does
not endanger the health and safety of the public.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400323
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§157.1,
157.11, 157.14, 157.32-157.34, 157.38, 157.40, 157.43, 157.44, 157.49, 157.122,
and 157.125, concerning regulation of EMS certificants, licensees, providers,
training institutions, educators and EMS/Trauma systems, the repeal of §157.4,
concerning request for EMS training at the local level, the repeal of §157.31,
concerning automated external defibrillator training course, §157.123,
concerning regional emergency medical services/trauma systems, and §157.129,
concerning state trauma registry, new §157.4 concerning regulatory audit
activities by the Bureau of Emergency Management and new §157.123, concerning
regional emergency medical services/trauma systems. Specifically, the sections
cover purpose; audits; provider licenses; disciplinary actions; training and
course approval; personnel certification, Regional/EMS trauma systems, trauma
facility designation and the trauma care system fund.
Rule amendments regarding licensing fees are required as a result of revisions
to Chapter 12 of the Texas Health and Safety Code, §12.0111 and §12.0112,
pursuant to House Bill (HB) 2292 of the 78th Regular Session of the Texas
Legislature. Rule amendments for the clarification of standards for regional
advisory councils are required as a result of revisions to Chapter 773 of
the Texas Health and Safety Code, §773.113, pursuant to Senate Bill 530
of the 78th Regular Session of the Texas Legislature. Rule amendments for
clarification of standards for emergency care attendants are required as a
result of revisions to Chapter 773 of the Texas Health and Safety Code, §773.046,
pursuant to HB 861 of the 78th Regular Session of the Texas Legislature.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedures Act). The sections
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however, revisions to the sections are necessary
and described in this preamble. Authority for the board to propose and adopt
rules in this section is found in the Health and Safety Code, Chapter 773.
The department published a Notice of Intention to review and consider for
readoption, revision, or repeal Chapter 157, Emergency Medical Care, Subchapter
A, Emergency Medical Services - Part A, §§157.1 - 157.4; Subchapter
B, Emergency Medical Services Provider Licenses, §§157.11 - 157.14,
157.16, and 157.25; Subchapter C, Emergency Medical Services Training and
Course Approval, §§157.31 - 157.34, 157.36 - 157.38, 157.40, and
157.41; Subchapter D, Emergency Medical Services Personnel Certification, §§157.43,
157.44, and 157.49; and Subchapter G, Emergency Medical Services Trauma Systems, §§157.122,
157.123, 157.125, and 157.128 - 157.130 in the September 12, 2003, issue of
the
Texas Register
(28 TexReg 8013). There
were no comments received due to the publication of the notice.
Kathryn C. Perkins, Bureau Chief of the Bureau of Emergency Management,
has determined that for first five years the sections are in effect, there
will be fiscal implications to state and local government as a result of administering
the sections as proposed. The impact is related to proposed fee increases
as authorized by HB 2292 in the 78th Regular Session of the Texas Legislature.
Proposed fees represent a 20% increase which will result in an estimated increase
of $280,000 per year in revenue.
Kathryn C. Perkins has also determined that for each year of the first
five years the proposed sections are in effect the public health benefit anticipated
as a result of these amendments and repeal will be increased standards for
the certification or licensure of EMS personnel, providers, training institutions
and educators. There is an anticipated cost to small businesses, micro-businesses
and to persons who are required to comply with the sections as proposed, because
the rules make additional requirements of providers, except those that are
exempt under the given rules. There is an increase in the fee charged for
a certification or license. One proposed section also authorizes an increase
on administrative penalties that may be imposed on course coordinators for
violations of the Health and Safety Code. There is no anticipated effect on
local employment.
Comments on the proposal may be submitted to Kathryn C. Perkins, Chief,
Bureau of Emergency Management, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756, telephone (512) 834-6700, or kathy.perkins@tdh.state.tx.us.
Comments will be accepted for 30 days after publication of the proposal in
the
Texas Register
.
Subchapter A. EMERGENCY MEDICAL SERVICES - PART A
25 TAC §157.1, §157.4
The amendment and new section are proposed under the Texas
Health and Safety Code, Chapter 773, which provides the department with the
authority to adopt rules concerning certification and licensing of EMS certificants,
providers, training institutions and educators; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for its
procedure and for the performance of each duty imposed by law on the board,
the department or the commissioner of health.
The amendment and new section affect the Health and Safety Code, Chapter
773. The review of the rules implements Government Code, §2001.039.
§157.1.Purpose.
(a)
(No change.)
(b)
This chapter will provide minimum requirements for an emergency
medical services (EMS) provider license;
authorization
[
§157.4.Audits.
(a)
The department may randomly and for cause audit the records
relating to licensing or certification of individuals and/or entities which
are currently certified or licensed by the department or which have applied
for certification or licensure by the department.
(b)
The department may automatically audit certified or licensed
EMS personnel or entities shown to be non-compliant in an immediately preceding
audit.
(c)
Failure to notify the department of a current mailing address
shall not absolve the certificant, licensee or entity from audit requirements.
(d)
Within 20 business days following notification of audit,
certified or licensed EMS personnel or licensed entities shall submit documentation
as specified by the department to verify compliance with any requirement set
forth in Chapter 773 of the Texas Health and Safety Code or of the rules in
this title.
(e)
Falsification of documentation shall be cause for reprimand,
probation, suspension, or revocation of a certificate, license, provider license
or EMS program/course approval in accordance with §157.16 of this title
(relating to Emergency Suspension, Suspension, Probation, Revocation or Denial
of a Provider License); and/or §157.32 of this title (relating to Emergency
Medical Services Education Program and Course Approval); and/or §157.34
of this title (relating to Recertification); and/or §157.36 of this title
(relating to Criteria for Denial and Disciplinary Actions for EMS Personnel
and Voluntary Surrender of a Certificate or License); and/or §157.38
of this title (relating to Continuing Education); and/or §157.43 of this
title (relating to Course Coordinator Certification); and/or §157.44
of this title (relating to Emergency Medical Service Instructor Certification).
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on January 16, 2004.
TRD-200400327
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §157.4
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Texas Health and
Safety Code, Chapter 773, which provides the department with the authority
to adopt rules concerning certification and licensing of EMS certificants,
providers, training institutions and educators; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for its
procedure and for the performance of each duty imposed by law on the board,
the department or the commissioner of health.
The repeal affects the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.4.Request for EMS Training at the Local Level.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400328
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §157.11, §157.14
The amendments are proposed under the Texas Health and Safety
Code, Chapter 773, which provides the department with the authority to adopt
rules concerning certification and licensing of EMS certificants, providers,
training institutions and educators; and §12.001, which provides the
Texas Board of Health (board) with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department
or the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.11.Requirements for an EMS Provider License.
(a)
Application requirements for an Emergency Medical Services
(EMS) Provider License.
(1)
Candidates for an EMS provider license shall submit a completed
application (application, all other required information described in a provider
licensing instruction document provided by the Texas Department of Health
(department) and a nonrefundable [
(2)
A nonrefundable application fee of $500 plus $180
for each EMS vehicle to be operated under the license shall accompany the
application. The department will implement the fee requirement for initial
applicants 20 days following adoption of the rule and at the time of the next
re-license period of currently certified licensed providers following adoption.
[
(3)
(No change.)
(4)
A fixed-wing or rotor-wing air ambulance provider,
appropriately licensed by the state governments of New Mexico, Oklahoma, Arkansas
or Louisiana may apply for a reciprocal issuance of a provider license. A
nonrefundable administrative fee of $500 shall accompany the application in
addition to a nonrefundable fee of $180 for each EMS aircraft to be operated
in Texas under the reciprocal license.
[
(5)
(No change.)
(b) - (l)
(No change.)
(m)
License renewal process.
(1) - (2)
(No change.)
(3)
If a provider has not met all requirements for a provider
license, the provider may apply for a provisional license by submitting a
request and, in addition to the regular nonrefundable licensure fee if applicable,
a nonrefundable fee of
$30
[
(n) - (o)
(No change.)
(p)
Unannounced inspections. Randomly and/or in response to
complaints, the department may conduct unannounced inspections to insure compliance
of the provider license holder. Inspections may be conducted at any time,
including nights or weekends. The department may review all components of
provider licensure during an unannounced inspection. Violations or deficiencies
may result in disciplinary action as authorized by §157.16 of this title
(relating to Emergency Suspension, Suspension, Probation, Revocation or Denial
of a Provider License). The department may grant a reasonable period of time
for the provider to correct deficiencies. If the department must reinspect
the provider because of noncompliance noted during a previous inspection,
the provider shall pay a nonrefundable fee of
$30
[
(q)
(No change.)
(r)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.14.Requirements for First Responder Organization Registration.
(a)
(No change.)
(b)
Application requirements. The applicant shall submit a
completed application to the department. A complete application consists of
the following:
(1) - (4)
(No change.)
(5)
a nonrefundable application fee, if applicable.
(A)
Any FRO which is, or has a contract with, an entity such
as a business, corporation or department and whose first responder employees
or members are compensated by that entity for providing first responder service
shall pay a nonrefundable
$60
[
(B)
(No change.)
(c) - (g)
(No change.)
(h)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400329
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §157.31
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Texas Health and
Safety Code, Chapter 773, which provides the department with the authority
to adopt rules concerning certification and licensing of EMS certificants,
providers, training institutions and educators; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for its
procedure and for the performance of each duty imposed by law on the board,
the department or the commissioner of health.
The repeal affects the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.31.Automated External Defibrillator Training Course.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400330
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§157.32 - 157.34, 157.38, 157.40
The amendments are proposed under the Texas Health and Safety
Code, Chapter 773, which provides the department with the authority to adopt
rules concerning certification and licensing of EMS certificants, providers,
training institutions and educators; and §12.001, which provides the
Texas Board of Health (board) with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department
or the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.32.Emergency Medical Services Education Program and Course Approval.
(a) - (p)
(No change.)
(q)
Fees.
(1)
The following nonrefundable fees shall apply:
(A)
$30
[
(B)
$90
[
(C)
$60
[
(D)
$250
[
(E)
$30
[
(F)
$60
[
(2)
(No change.)
(r)
Course Notification and Approval.
(1) - (2)
(No change.)
(3)
A nonrefundable course fee, unless program is not remunerated
for the course in any way, shall be submitted as follows:
(A)
$30
[
(B)
$60
[
(C)
$30
[
(D)
$60
[
(4)
(No change.)
(s) - (t)
(No change.)
(u)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.33.Certification.
(a)
Certification requirements. A candidate for emergency medical
services (EMS) certification shall:
(1)
(No change.)
(2)
have a high school diploma or GED certificate
:
[
(A)
the high school diploma must
be from a school accredited by the Texas Education Agency (TEA) or a corresponding
agency from another state. Candidates who received a high school education
in another country must have their transcript evaluated by a foreign credentials
evaluation service that attests to its equivalency. A home school diploma
is acceptable if it is accompanied by a letter of acceptance into a regionally
accredited college;
(B)
an emergency care attendant
(ECA) who provides emergency medical care exclusively as a volunteer for a
licensed provider or registered FRO is exempt from paragraph (2) of this subsection.
(3)
(No change.)
(4)
submit an application and the following nonrefundable fees
as applicable:
(A)
$60
[
(B)
$90
[
(C)
EMS volunteer - no fee. However, if such an individual
receives compensation during the certification period, the exemption ceases
and the individual shall pay a prorated fee to the department based on the
number of years remaining in the certification period when employment begins.
The nonrefundable fee for ECA or EMT certification shall be
$15
[
(5)
(No change.)
(b) - (d)
(No change.)
(e)
Retesting.
(1)
A candidate who does not pass the department's written
examination may retest after:
(A)
(No change.)
(B)
paying a nonrefundable fee of
$30
[
(2)
A candidate who does not pass a retest may request a second
retest after:
(A) - (B)
(No change.)
(C)
paying a nonrefundable fee of
$30
[
(3)
(No change.)
(f)
(No change.)
(g)
Non-transferability of certificate. A certificate is not
transferable. A duplicate certificate may be issued if requested with a nonrefundable
fee of
$10
[
(h) - (i)
(No change.)
(j)
Inactive status. A certified EMT, EMT-I, or EMT-P may make
application to the department for inactive status at any time during or after
the certification period so long as the certification can be verified by
the
department.
(1)
The request for inactive status shall be accompanied by
a nonrefundable fee of
$30
[
(2) - (5)
(No change.)
(k)
Reciprocity. A person currently certified by the National
Registry or in another state may be certified by submitting an application
and a nonrefundable fee of
$120
[
(1) - (3)
(No change.)
(l)
(No change.)
(m)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.34.Recertification.
(a)
Recertification.
(1) - (3)
(No change.)
(4)
The certificant shall submit an application and the following
non-refundable fees as applicable:
(A)
$60
[
(B)
$90
[
(C)
EMS volunteer - no fee. However, if such an individual
receives compensation during the certification period, the exemption ceases
and the individual shall pay a prorated fee to the department based on the
number of years remaining in the certification period when employment begins.
The non-refundable fee for ECA or EMT certification shall be
$15
[
(5) - (7)
(No change.)
(b)
Recertification Options. Upon submission of a completed
application for recertification, the applicant shall commit to, and recertify
through, only one of the options described in paragraphs (1)-(5) of this subsection.
(1)
Option 1 - Written Examination Recertification Process
.
(A)
(No change.)
(B)
If the applicant fails the examination for recertification,
the applicant may attempt two retests of the examination after:
(i)
(No change.)
(ii)
submitting a non-refundable retest fee of
$30
[
(C) - (F)
(No change.)
(2) - (5)
(No change.)
(c) - (f)
(No change.)
(g)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.38.Continuing Education.
(a) - (f)
(No change.)
(g)
Approval of Continuing Education Provider.
(1)
(No change.)
(2)
A person, agency, entity, or organization seeking approval
as a continuing education provider shall file an application with the department
along with a nonrefundable fee of $60 in accordance with the course approval
process described in §157.32 of this title (relating to Emergency Medical
Services Education Program and Course Approval)
.
(3) - (4)
(No change.)
(h) - (k)
(No change.)
(l)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.40.Paramedic Licensure.
(a)
Requirements for paramedic licensure.
(1)
(No change.)
(2)
Initial paramedic license. A candidate for initial paramedic
licensure under this section shall:
(A)
(No change.)
(B)
submit an application and a nonrefundable fee, if applicable,
of
$120
[
(C) - (G)
(No change.)
(3) - (4)
(No change.)
(5)
Duplicate copies of the [
(6)
(No change.)
(b)
Renewal of license.
(1) - (4)
(No change.)
(5)
Licensure fee.
(A)
The licensee shall submit a non-refundable fee of
$120
[
(B)
EMS volunteer--no fee
;
[
(6) - (7)
(No change.)
(c) - (e)
(No change.)
(f)
Inactive status. A licensed paramedic may make application
to the department for inactive status at any time during the licensure period
or months after the license expiration date, if the license can be verified
by the department.
The request for inactive status shall be accompanied
by a nonrefundable fee of $30 in addition to the regular nonrefundable application
fee in subsection (a)(2)(B) of this section.
(1) - (5)
(No change.)
(g)
(No change.)
[
(h)
[
(i)
[
(1)
A candidate for licensure who completed EMS training outside
the United States or its possessions, or a candidate who is certified or licensed
in another healthcare discipline may apply for licensure by meeting the requirements
set forth in subsection (a)(1) of this section and the following additional
requirements:
(A)
be at least 18 years of age;
(B)
submit a copy of the course completion certification from
an accredited post secondary institution approved by the department to sponsor
an EMS education program;
(C)
submit an application and appropriate nonrefundable fee
as follows:
(i)
a candidate who completed EMS training outside the United
States or its possessions--
$180
[
(ii)
a candidate who is certified or licensed in another healthcare
discipline--
$120
[
(D)
achieve National Registry paramedic certification.
(2)
Evaluations of curricula conducted by post secondary educational
institutions under this subsection shall be consistent with the institution's
established policies and procedures for awarding credit by transfer or advanced
placement.
(j)
[
(k)
[
(1)
The inactive certificant shall:
(A)
submit an application for inactive licensure to the department
along with a nonrefundable fee of
$120
[
(B)
submit evidence of the issuance of a degree from an accredited
college or university as defined in subsection (a)(1) of this section.
(2)
After verification by the department of the information
submitted, the license will be issued in an inactive status for four years
beginning on the day of issuance.
(l)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400331
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§157.43, 157.44, 157.49
The amendments are proposed under the Texas Health and Safety
Code, Chapter 773, which provides the department with the authority to adopt
rules concerning certification and licensing of EMS certificants, providers,
training institutions and educators; and §12.001, which provides the
Texas Board of Heath (board) with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department
or the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.43.Course Coordinator Certification.
(a) - (c)
(No change.)
(d)
Basic coordinator requirements. To be certified as a basic
course coordinator, the candidate shall:
(1)
submit an application for basic course coordinator certification
along with the nonrefundable fee of
$60
[
(2) - (7)
(No change.)
(8)
after completing all the above requirements, pass the EMS
coordinator exam and retest, if necessary, no later than one year after course
completion date. The nonrefundable retest fee is
$30
[
(e)
Advanced coordinator requirements. To be certified as an
advanced course coordinator, the candidate shall:
(1)
submit an application for advanced course coordinator certification
along with the nonrefundable fee of
$60
[
(2) - (8)
(No change.)
(9)
after completing all the above requirements, pass the EMS
coordinator exam and retest, if necessary, no later than one year after course
completion date. The nonrefundable retest fee is
$30
[
(10)
(No change.)
(f) - (l)
(No change.)
(m)
Disciplinary actions.
(1)
Administrative penalty. The department may impose an administrative
penalty on a course coordinator not to exceed
$7,500
[
(2) - (6)
(No change.)
(n)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.44.Emergency Medical Service Instructor Certification.
(a)
(No change.)
(b)
Certification. To obtain certification, a candidate shall:
(1) - (3)
(No change.)
(4)
submit an application to the department with a nonrefundable
fee of
$30
[
(5)
pass the instructor examination conducted by the department.
(c)
The instructor candidate who
does not pass the exam may have one opportunity to retest by submitting the
retest application and $30 retest fee, if applicable. The retest must be completed
no later than one year after the course completion date. The candidate who
fails the retest must complete another instructor course to become eligible
for instructor certification.
(d)
[
(e)
[
(f)
[
(1)
conducting classroom and laboratory sessions in accordance
with lesson objectives as assigned by the course coordinator;
(2)
conducting skills proficiency verifications and other student
evaluations as assigned by the course coordinator;
(3)
assisting the course coordinator in preparing and maintaining
records and performing other duties necessary to insure the integrity, efficiency
and effectiveness of the course.
(g)
[
(1)
Prior to the expiration of a certificate, the department
shall send a notice of expiration to the certificant at the address shown
in the current records of the department. It is the responsibility of EMS
personnel to notify the department of any change of address.
(2)
If a certificant has not received notice of expiration
from the department 30 days prior to the expiration, the certificant shall
request an application for recertification from the department or download
an application from the Internet. Failure to apply for recertification shall
result in expiration of the certificate.
(3)
To be eligible for recertification, the instructor shall
meet recertification requirements during the latest instructor certification
period:
(A)
maintain active status EMS certification; and
(B)
submit the application for recertification and a nonrefundable
fee of
$30
[
(4)
After verification by the department of the information
submitted, the candidate who meets the requirements of this section shall
be recertified for two years commencing on the day following the expiration
of the current certificate.
(h)
[
(1)
An application for renewal of a certificate shall be considered
late if:
(A)
the application and nonrefundable fee are received after
the most recent certificate has expired or;
(B)
all requirements for recertification are not met prior
to the end of the most recent certification period.
(2)
An instructor who has not recertified prior to the end
of his most recent certification period is not certified.
(i)
[
(1)
A candidate whose certificate has been expired for 90 days
or less may renew the certificate by submitting an application and paying
a nonrefundable renewal fee that is equal to 1-1/2 times the normally required
application renewal fee for that level as listed in subsection (b)(4) of this
section;
(2)
A candidate whose certificate has been expired for more
than 90 days but less than one year may renew the certificate by submitting
an application and paying a nonrefundable renewal fee that is equal to two
times the normally required application renewal fee as listed in subsection
(b)(4) of this section.
(3)
A candidate must complete all the requirements for recertification
no later than one year after the expiration of the most recent certificate.
(4)
After verification by the department of the information
submitted by the candidate, the candidate who meets the requirements of this
subsection shall be recertified for two years commencing on the day of issuance
of a certificate.
(5)
A candidate whose certification is expired more than one
year must meet the requirements of subsection (b) of this section including
the completion of another initial course to be certified.
(j)
[
(1)
Emergency suspension. The bureau chief of the Bureau of
Emergency Management may issue an emergency order to suspend an instructor
if the bureau chief has reasonable cause to believe continued activity of
the individual constitutes a threat to the public health or safety.
(A)
An emergency suspension shall be effective immediately
without a hearing or written notice to the certificate holder. Notice to the
certificant shall be established on the date that a copy of the signed emergency
suspension order is sent to the address shown in the current records of the
department, or by return receipt. Notice shall also be sent to any sponsoring
entity.
(B)
If a written request for a hearing is received from the
certificate holder within 15 days of the date of notice, the department shall
conduct a hearing not later than the 30th day after the date on which a hearing
request is received to determine if the emergency suspension is to be continued,
modified, or rescinded. The hearing and appeal from a disciplinary action
related to the hearing shall be in accordance with the Administrative Procedure
Act, Government Code, Chapter 2001.
(2)
Suspension or revocation. An instructor's certification
may be suspended or revoked for, but not limited to, the following reasons:
(A)
failing to maintain active status EMS personnel certification
at the appropriate level;
(B)
failing to comply with the responsibilities of an instructor
as in subsection
(f)
[
(C)
falsifying an application for EMS certification;
(D)
falsifying a program approval application, a self-study,
a course approval application, or any supporting documentation;
(E)
falsifying a course completion certificate or any other
document that records or verifies course activity and/or is a part of the
course record;
(F)
compromising department or program standards for verification
of skills proficiency or falsifying proficiency verification records;
(G)
assisting another to obtain or to attempt to obtain personnel
certification or recertification by fraud, forgery, deception or misrepresentation;
(H)
failing to complete and submit student documents within
the established time frames;
(I)
compromising or failing to maintain the order, discipline
and fairness of a department-approved course or program;
(J)
delivering or allowing inadequate class presentations;
(K)
compromising an examination or examination process administered
or approved by the department;
(L)
cheating or assisting another in cheating on an EMS examination,
other evaluation or any other activity offered or conducted by the department,
a training program approved by the department, or a provider licensed by the
department;
(M)
accepting any benefit to which there is no entitlement
or benefits in any manner through fraud, deception, falsification, misrepresentation,
theft, misappropriation or coercion;
(N)
failing to maintain appropriate policies, procedures and
safeguards to ensure the safety of students, fellow instructors or other class
participants;
(O)
allowing recurrent use of inadequate, inoperable, or malfunctioning
equipment;
(P)
issuing a check to the department which is returned unpaid;
(Q)
failing to maintain education course records for initial
or continuing education (CE) courses;
(R)
demonstrating an unwillingness or inability to comply with
the Health and Safety Code and rules adopted thereunder;
(S)
failing to give the department true and complete information
when asked regarding any alleged or actual violation of the Health and Safety
Code, or the rules adopted thereunder, or failing to report a violation;
(T)
committing any violation during a probationary period;
and
(U)
functioning or attempting to function as an instructor
during a period of suspension shall be cause for revocation of the instructor
certification.
(3)
Notification. If the department proposes to take disciplinary
action against an EMS instructor, the certificant shall be notified at the
address shown in the current records of the department. The notice must state
the alleged facts or conduct warranting the action and state that the certificant
has an opportunity to request a hearing.
(A)
The certificant may request a hearing within 15 days after
the date of the notice. This request shall be in writing and submitted to
the bureau chief. The hearing shall be conducted pursuant to the Administrative
Procedure Act, Government Code, Chapter 2001.
(B)
If the certificant does not request a hearing, after being
sent the notice of opportunity, the certificant waives the opportunity for
a hearing and the department shall implement its proposal.
(4)
Probation. The department may probate any penalty assessed
under this section and may specify terms and conditions of any probation issued.
(5)
Reapplication.
(A)
Two years after the revocation of an instructor certification
an individual may petition the department, in writing, for the opportunity
to reapply for certification.
(B)
The department shall evaluate the petition and may allow
or deny the opportunity to submit an application for recertification.
(C)
In evaluating a petition for permission to reapply for
certification the department shall consider, but is not limited to, the following
issues:
(i)
the likelihood of a repeat of the actions or inactions
that led to revocation;
(ii)
the petitioners overall record as an instructor;
(iii)
letters of support or recommendation;
(iv)
letters in protest or nonsupport of the petition; and
(v)
the need for the services of an instructor in a given area.
(D)
The petitioner shall be notified of the department's decision
to allow or deny the submission of reapplication within 60 days of the request.
(E)
An instructor whose certificate expires during a suspension
or revocation period may not petition to reapply for certification until the
end of the suspension or revocation period.
(k)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
§157.49.Emergency Medical Services Operator and Operator Instructor Training and Certification.
(a) - (g)
(No change.)
(h)
Course approval.
(1)
Prior to starting a course, an EMS information operator
instructor shall:
(A)
(No change.)
(B)
submit a non-refundable course approval fee of
$60
[
(C) - (D)
(No change.)
(2) - (3)
(No change.)
(i)
(No change.)
(j)
EMS information operator instructor certification.
(1)
To become certified as an EMS information operator instructor,
a person must:
(A) - (E)
(No change.)
(F)
submit an application to the department with a nonrefundable
fee of
$60
[
(G)
(No change.)
(2)
(No change.)
(3)
Persons holding EMS information operator instructor certification
from any department-approved training program prior to the effective date
of this rule are considered to have met the requirements as set forth in this
section and may apply for certification by submitting to the department:
(A)
a written application with a nonrefundable fee of
$60
[
(B)
(No change.)
(4)
Retesting.
(A)
A certificant who does not pass the department's written
examination may retest after:
(i)
(No change.)
(ii)
paying a nonrefundable fee of
$30
[
(B)
(No change.)
(k)
EMS information operator instructor recertification.
(1) - (2)
(No change.)
(3)
To be eligible for recertification, the EMS information
operator instructor shall:
(A) - (C)
(No change.)
(D)
submit an application for recertification with a nonrefundable
fee of
$60
[
(E)
(No change.)
(4) - (8)
(No change.)
(l) - (n)
(No change.)
(o)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400332
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §§157.122, 157.123, 157.125
The amendments and new section are proposed under the Texas
Health and Safety Code, Chapter 773, which provides the department with the
authority to adopt rules concerning certification and licensing of EMS certificants,
providers, training institutions and educators; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for its
procedure and for the performance of each duty imposed by law on the board,
the department or the commissioner of health.
The amendments and new section affect the Health and Safety Code, Chapter
773. The review of the rules implements Government Code, §2001.039.
§157.122.Trauma Service Areas.
(a)
(No change.)
(b)
The state has been geographically divided by counties into
22 TSAs; however:
(1)
(No change.)
(2)
each TSA shall have at least a lead general trauma facility
within its boundaries [
(3) - (4)
(No change.)
(c)
The counties included in the 22 TSAs are grouped as follows
(updated lists will be maintained by the bureau):
(1)
(No change.)
(2)
Area B - Bailey, Borden, Castro, Cochran, Cottle, Crosby,
Dawson, Dickens, Floyd, Gaines, Garza, Hale, Hockley, Kent, King, Lamb, Lubbock,
Lynn, [
(3)
(No change.)
(4)
Area D - Brown, Callahan, Coleman, Comanche, Eastland,
Fisher, Haskell, Jones, Knox,
Mitchell,
Nolan, Shackelford, Stephens,
Stonewall, Taylor, Throckmorton;
(5) - (22)
(No change.)
(d)
(No change.)
§157.123.Regional Emergency Medical Services/Trauma Systems.
(a)
The bureau of emergency management (bureau) shall recognize
the establishment of a regional emergency medical services (EMS)/trauma system
(system) within a trauma service area (TSA) as described in §157.122
of this title (relating to Trauma Service Areas).
(b)
Establishment of a regional EMS/trauma system consists
of three phases.
(1)
The first phase begins with the establishment of a regional
advisory council (RAC) and ends with recognition of the RAC by the bureau.
(A)
All health care entities who care for trauma patients should
be offered membership on the RAC. RACs shall:
(i)
be operated in a manner that maximizes inclusion of their
constituents and ensures membership approval of "participation requirements";
(ii)
have documented evidence that participation guidelines
have been discussed and affirmed by vote of the entire RAC voting membership;
(iii)
have clear definitions of participation guidelines in
the organization's by-laws and/or other official RAC files;
(iv)
have documentation that participation guidelines have
been communicated to EMS providers and hospitals, regardless of past participation
history;
(v)
have documented attendance records;
(vi)
have consistency in the annual participation reporting
period;
(vii)
send participation "progress reports" to EMS providers
and hospitals at some period during the reporting year;
(viii)
send participation requirements "non-compliancy" letters
to appropriate EMS providers and hospitals at end of reporting year;
(ix)
be cognizant of the direct and indirect fiscal roles they
play on behalf of their members; and
(x)
be particularly cognizant of the logistical challenges
faced by rural and volunteer agencies and open to considering viable alternatives
to members' physical presence at all meetings.
(B)
The bureau shall recognize only one official RAC for a
TSA.
(C)
At least quarterly, a RAC shall submit evidence of on-going
activity, such as meeting notices and minutes, to the bureau.
(D)
Annually, the RAC shall file a report with the bureau which
describes progress toward system development, demonstrates on-going activity,
and includes evidence that members of the RAC are currently involved in trauma
care.
(E)
The RAC functions without the expectation of comprehensive,
permanent and/or unrestricted state funding.
(F)
RACs may request technical assistance from the bureau at
any time.
(2)
The second phase begins with RAC recognition by the bureau
and ends with approval of a complete EMS/trauma system plan (plan) by the
bureau.
(A)
The RAC shall develop a system plan based on standard guidelines
for comprehensive system development. The system plan is subject to approval
by the bureau.
(B)
The bureau shall review the plan to assure that:
(i)
all counties within the TSA have been included unless a
specific county, or portion thereof, has been aligned within an adjacent system;
(ii)
all health care entities and interested specialty centers
have been given an opportunity to participate in the planning process; and
(iii)
the following components have been addressed:
(I)
injury prevention;
(II)
access to the system;
(III)
communications;
(IV)
medical oversight;
(V)
pre-hospital triage criteria;
(VI)
diversion policies;
(VII)
bypass protocols;
(VIII)
regional medical control;
(IX)
regional trauma treatment guidelines;
(-a-)
Guidelines consistent with current Advanced Trauma Life
Support (ATLS), Advanced Pediatric Life Support (APLS), Basic Trauma Life
Support (BTLS), Pre-Hospital Trauma Life Support (PHTLS), Trauma Nurse Core
Course (TNCC), Emergency Nurse Pediatric Course (ENPC), Pediatric Advanced
Life Support (PALS) and Pediatric Education For Pre-Hospital Providers (PEPP)
standards shall be developed, implemented, and evaluated.
(-b-)
Individual agencies and medical directors may, and are
encouraged, to exceed the minimum standards.
(-c-)
Major/severe trauma patients will be cared for by health
professionals with documented education and skill in the assessment and care
of injuries throughout their pre-hospital and hospital course.
(-d-)
Major/severe trauma patients will have their medical
care, as documented by pre-hospital run forms and hospital charts, reviewed
by the individual entity's medical director for appropriateness and quality
of care.
(-e-)
Major/severe trauma patients will have deviations from
standard of care addressed through a documented trauma performance improvement
process.
(X)
facility triage criteria;
(XI)
inter-hospital transfers;
(XII)
planning for the designation of trauma facilities, including
the identification of the lead facility(ies); and
(XIII)
regional guidelines for disaster preparedness; and
(XIV)
a performance improvement program that evaluates processes
and outcomes from a system perspective.
(C)
Bureau approval of the completed plan may qualify health
care entities participating in the system to receive state funding for trauma
care if funding is available.
(3)
The third phase begins with approval of a complete plan
by the bureau and ends with the regional EMS/trauma system being recognized
by the bureau.
(A)
Upon approval, a RAC implements the plan to include:
(i)
education of all entities about the plan components;
(ii)
on-going review of resource, process, and outcome data;
and
(iii)
if necessary, revision and re-approval of the plan or
plan components by the bureau.
(B)
Following implementation of the plan, the bureau shall
recommend to the commissioner of health (commissioner) the designation of
a regional EMS/trauma system if the applicant RAC meets or exceeds the current
Texas EMS/trauma systems essential criteria; actively participates at the
bureau's quarterly RAC Chairs meetings; and submits data as requested.
(C)
The designation process shall consist of three phases:
(i)
The first phase is the application phase which begins with
completing and submitting to the bureau a complete application and non-refundable
fee for designation as a regional EMS/trauma system and ends when the bureau
approves a site survey (survey);
(ii)
The second phase is the review phase which begins with
the survey and ends with a bureau recommendation to the commissioner to designate
a regional EMS/trauma system; and
(iii)
The third phase is the final phase which begins with
the commissioner reviewing the recommendations and ends with his/her final
decision. This phase also includes an appeal procedure for the denial of a
designation application in accordance with the Administrative Procedure Act,
Government Code, Chapter 2001.
(D)
The bureau's analysis of submitted application materials,
which may result in recommendations for corrective action when deficiencies
are noted, shall include a review of:
(i)
evidence of participation at the bureau's quarterly RAC
Chairs meetings;
(ii)
the completeness and appropriateness of the application
materials submitted, including the non-refundable application fee.
(iii)
the non-refundable application fee shall be based on
the trauma service area's geographic size, population and trauma death rate.
(iv)
a RAC's non-refundable application fee shall be no more
than $10,000 and not less than $2500.
(E)
When the application phase results in a bureau approval
for survey, the bureau shall notify the regional EMS/trauma system's RAC that
will then contract for the survey by a team of approved non-Texas Department
of Health (department) surveyors.
(i)
The bureau, at its discretion, may appoint an observer
to accompany the survey team. In this event, the cost for the observer(s)
shall be borne by the bureau. A RAC shall have the right to refuse to allow
non-department observers to participate in a survey.
(ii)
The survey shall be completed within one year of the date
of the approval of the application.
(iii)
At any time, a RAC may file a complaint with the bureau
regarding the conduct of a surveyor. The bureau will investigate and notify
the RAC of the outcome.
(F)
The survey team composition shall consist of at minimum
a physician; an EMS provider representative; a trauma nurse from a designated
trauma facility; all of which shall have demonstrated knowledge and experience
with system development. A fourth surveyor with experience in system management
may be requested by the RAC or the bureau.
(G)
Non-department surveyors must meet the following criteria:
(i)
have at least three years experience in the care of trauma
patients and active participation in a regional EMS/trauma system;
(ii)
be currently employed in the coordination of care for
trauma patients;
(iii)
have direct experience in the preparation for and successful
completion of regional EMS/trauma system designation;
(iv)
have successfully completed the department Regional EMS/Trauma
System Site Surveyor Course; and
(v)
on-going bureau evaluation of survey reports for compliance
with bureau reporting requirements.
(H)
All members of the survey team, except department staff,
should come from a non-adjacent public health region and/or trauma service
area (TSA). There shall be no business or patient care relationship between
the surveyor and/or the surveyor's place of employment and regional EMS/trauma
system being surveyed.
(I)
The survey team shall evaluate the regional EMS/trauma
system by:
(i)
attendance records, performance improvement committee meeting
minutes and other documents specifically relevant to regional EMS/trauma system
development;
(ii)
visiting EMS provider stations and hospitals within the
TSA; and
(iii)
conducting interviews with RAC members and non-members.
(J)
Findings of the survey team shall be forwarded to the RAC
Executive Board within thirty calendar days of the date of the survey. If
a RAC wants to continue the designation process, the complete survey report
must be submitted to the bureau within three months after receipt of the survey
or the application will expire. A request for an extension could be requested
for extenuating circumstances.
(K)
The bureau shall review the findings for compliance with
the criteria. If a regional EMS/trauma system does not meet the criteria for
designation, the bureau shall notify the RAC executive board of the requirements
it must meet to achieve designation.
(L)
A recommendation for designation shall be made to the commissioner
based on compliance with the criteria.
(M)
In the event there is a problem area in which a regional
EMS/trauma system does not comply with the criteria, the bureau shall notify
the applicant of deficiencies and recommend corrective action.
(N)
The regional EMS/trauma system shall submit a report to
the bureau which outlines the corrective action taken. The bureau may require
a second survey to insure compliance with the criteria. If the regional EMS/trauma
system and/or bureau report substantiates action that brings the regional
EMS/trauma system into compliance with the criteria, the bureau shall recommend
designation to the commissioner.
(O)
If a regional EMS/trauma system disagrees with a bureau
decision regarding its designation application or status, it may request a
secondary review by a designation review committee. Membership on the designation
review committee will:
(i)
be voluntary;
(ii)
be appointed by the bureau chief;
(iii)
be representative of trauma care providers within a designated
regional EMS/trauma system; and
(iv)
include representation from the department and the Trauma
Systems Committee of the Governor's EMS and Trauma Advisory Council (GETAC).
(P)
If the designation review committee disagrees with the
bureau recommendation for corrective action, the records shall be referred
to the associate commissioner for consumer health protection for recommendation
to the commissioner.
(Q)
The bureau shall provide a copy of the survey report, for
surveys conducted by or contracted for by the department and results to the
applicant regional EMS/trauma system.
(R)
At the end of the secondary review and final phases of
the designation process, if a regional EMS/trauma system disagrees with the
bureau recommendations, opportunity for an appeal in accordance with the Administrative
Procedure Act, Government Code, Chapter 2001 shall be offered.
(S)
The bureau may grant an exception to this section if it
finds that compliance with this section would not be in the best interests
of the persons served in the affected local system.
(T)
The applicant regional EMS/trauma system shall have the
right to withdraw its application at any time prior to the department making
a final decision on the application for designation.
(U)
If the commissioner concurs with the recommendation to
designate, the RAC shall receive a letter of designation for two years. Site
surveys will be required every six years, or more frequently at the bureau's
discretion. Additional actions, such as a site review or submission of information,
to maintain designation may be required by the department.
(V)
It shall be necessary to repeat the designation process
as described in this section prior to expiration of a regional EMS/trauma
system designation or the designation will be considered expired.
(W)
A designated regional EMS/trauma system shall:
(i)
notify the bureau within five days if temporarily unable
to comply with the essential trauma system criteria;
(ii)
notify the bureau and RAC membership within five days
if it is unable to provide the resources as required by its designation.
(I)
If the resources are not critical, the bureau will determine
a 30-day to 90-day period from onset date of deficiency for the RAC to achieve
compliance.
(II)
If the resources are critical, the bureau will determine
a no greater than 30-day period from onset date of the deficiency for the
RAC to achieve compliance.
(iii)
notify the bureau if the RAC will no longer provide services
commensurate with designation. If the regional EMS/trauma system chooses to
permanently relinquish its designation, it shall provide at least 30 days
notice to the bureau.
(iv)
comply with the provisions within these sections, all
current state and system standards as described in this chapter, and all policies,
guidelines, and procedures as set forth in the system plan;
(v)
continue its commitment to provide the resources as required
by its designation; and
(vi)
utilize the state trauma registry.
(X)
A regional EMS/trauma system may not use the terms "regional
trauma system", "trauma system", or similar terminology in its signs or advertisements
or in the printed materials and information it provides to the public unless
the regional EMS/trauma system has been designated as a regional EMS/trauma
system according to the process described in this section. This subsection
also applies to regional EMS/trauma systems whose designation has lapsed.
(Y)
The bureau shall have the right to review, inspect, evaluate,
and audit all RAC performance improvement committee minutes and other documents
relevant to trauma care in any designated regional EMS/trauma system at any
time to verify compliance with the statute and these rules, including the
designation criteria. The bureau shall maintain confidentiality of such records
to the extent authorized by the Public Information Act, (Government Code,
Chapter 552), the Texas Health and Safety Code, Chapter 773 and/or any other
relevant confidentiality law or regulation. Such inspections shall be scheduled
by the bureau when appropriate.
(c) Regional EMS/trauma system criteria.
§157.125.Requirements for Trauma Facility Designation.
(a) - (b) (No change.)
(c) The bureau's analysis of submitted application materials,
which may result in recommendations for corrective action when deficiencies
are noted, shall include a review of:
(1) (No change.)
(2) the completeness and appropriateness of the application
materials submitted, including the non-refundable application fee as follows:
(A)
for comprehensive and major trauma facility applicants,
the fee will be no more than
$10
[
(B)
for general trauma facility applicants, the fee will be
no more than
$10
[
(C)
for basic trauma facility applicants, the fee will be no
more than
$10
[
(d) - (t)
(No change.)
(u)
For all applications and renewal
applications, the department (or the board) is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400333
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §157.123, §157.129
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Texas Health and
Safety Code, Chapter 773, which provides the department with the authority
to adopt rules concerning certification and licensing of EMS certificants,
providers, training institutions and educators; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for its
procedure and for the performance of each duty imposed by law on the board,
the department or the commissioner of health.
The repeals affect the Health and Safety Code, Chapter 773. The review
of the rules implements Government Code, §2001.039.
§157.123.Regional Emergency Medical Services/Trauma Systems.
§157.129.State Trauma Registry.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400334
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
Subchapter D. GENERAL
25 TAC §289.204
The Texas Department of Health (department) proposes an amendment
to §289.204, concerning fees for certificates of registration, radioactive
material licenses, emergency planning and implementation, and other regulatory
services.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.204
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist; however, revisions to the rule are necessary
as outlined in this preamble.
The department published a Notice of Intention to Review for §289.204
regarding Government Code, §2001.039, in the
Texas Register
(28 TexReg 9549) on October 31, 2003. No comments were
received by the department on this section following publication of the notice.
The proposed revision incorporates legislation passed by the 78th Legislature,
Regular Session. House Bill 2292 requires two-year terms for radioactive material
licenses and certificates of registration and requires recovery through fees
of 100% of regulatory program costs for the two-year term of the licenses
and registrations. Therefore, references to annual fees are deleted throughout
the section. The department is also simplifying its fee structure for certificates
of registration. Registrants now have one specified fee, rather than a base
fee plus machine fee. References to base fee and machine fee are deleted throughout
the section. A definition of "processor of radioactive material" is added
to clarify the meaning of the category listed in the fee schedule for radioactive
material licenses. The current exemption that states no fee is required for
a general license that does not require a general license acknowledgement
is deleted because the general license category has never been listed in the
fee schedule for radioactive material licenses. Specific exemption wording
is unnecessary. References to application fees for mammography accreditation
and industrial radiographer certification have been added. These application
fees are also specified in other sections of this title that are specific
to mammography and industrial radiography. However, the department is repeating
the application fees for these categories in this section in order to represent
the full scope of radiation fees. The fees for mammography accreditation are
increased to reflect an increase in the amount the American College of Radiology
charges the department to perform image reviews.
Health and Safety Code, §401.301, authorizes the department to collect
an additional 5% charge from radioactive material licensees. The funds from
the additional 5% charge are to be used to prevent or mitigate adverse effects
of abandonment of radioactive materials, default on lawful obligation, insolvency,
or other inability of licensees to meet the requirements in this title. House
Bill 1678, 78th Legislature, Regular Session, provides the mechanism for the
funds from the additional 5% charge to be deposited to the credit of the Radiation
and Perpetual Care Account. The provisions of these two House Bills are added
to this section.
Fee amounts in the fee schedules for radioactive materials licenses and
certificates of registration are doubled to reflect the two-year term for
licenses and registrations. Licensees and registrants will receive a fee bill
from the department every two years rather than every year. In addition, the
categories in the fee schedule for certificates of registration are changed.
The Bureau of Radiation Control is reallocating x-ray and nonionizing resources
based on prioritization of risk to public health and safety. Risk to public
health and safety is primarily based on machine type and type of use rather
than the category of facility in which they are used. Therefore, the categories
in the fee schedule are changed to reflect machine type and type of use. Several
of the categories are also clarified by referencing definitions of the categories
in other sections of this title. The requirement for an annual late payment
fee is deleted. The provisions of House Bill 2292 mandate a two-year term
for the license or certificate of registration and corresponding 100% cost
recovery through fees. Failure to pay the fee means the license or certificate
of registration is expired and the licensee or registrant is subject to compliance
procedures provided in §289.205 of this title (relating to Hearing and
Enforcement Procedures). Senate Bill 1152, 78th Legislature, Regular Session,
directs the department to participate in Texas Online, an electronic fee payment
system developed and maintained by the Texas Online Authority. Wording is
added that authorizes the department to collect subscription and convenience
fees, in amounts determined by the Texas Online Authority, to recover costs
associated with application and renewal application processing through Texas
Online. Other minor grammatical changes are made and reference citations are
corrected for clarification.
This amendment is part of the department's continuing effort to update,
clarify, and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, or other
factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed. The department will receive an additional $65,000
in revenue for each year of the first five-year period from the additional
5% charge to licensees. Collection of this additional charge will continue
until the fees collected reach $500,000 and the fees must be deposited to
the credit of the Radiation and Perpetual Care Account. If the balance of
fees collected from the 5% additional charge is reduced to $350,000 or less,
the department must reinstitute assessment of the fee until the balance reaches
$500,000. The fiscal impact to state or local government entities licensed
to possess radioactive material will increase by an amount ranging from $5
to $764 per year. For those mammography registrants who choose accreditation
by the department, the department will recover an additional $30 for the first
mammography machine, for each additional mammography machine, and for reinstatement
of a mammography machine. The department will recover an additional $20 for
each re-evaluation of clinical images due to failure during the accreditation
process and an additional $10 for re-evaluation of phantom images due to failure
during the accreditation process. It is the mammography registrant's choice
whether to seek accreditation from the department or from the American College
of Radiology. When implemented, the subscription and convenience fees determined
by Texas Online will be $10 for each registrant for payment by credit card.
Licensees will only be allowed to use bank draft transactions on Texas Online
and the fee of will be $10. The fees will be collected by the department and
paid to the Texas Online Authority.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section is in effect, the public benefit anticipated as
a result of enforcing the section will be to ensure continued protection of
the public, workers, and the environment from unnecessary exposure to radiation
by ensuring funds are available to fund the program and to prevent or mitigate
adverse effects of abandonment of radioactive materials, default on a lawful
obligation, insolvency, or other inability by a licensee to meet requirements.
Licensees that are small businesses and micro-businesses and other persons
required to comply with the section as proposed, excluding the diagnostic
nuclear medicine licensees, will incur an additional cost equal to 5% of their
respective fee, ranging from $14 to $18,090. Registrants that are small businesses
and micro-businesses and other persons required to comply with the section
as proposed will vary depending on the number of machines possessed and the
type of machines or services authorized because the fees are changed from
a base fee plus a machine fee to a single fee for each category of machine
type or type of use. The range is from an average decrease of $858 to an average
increase of $650. The cost recovery to the department from each category of
registrant is approximately the same and the overall cost recovery to the
department from registrants is approximately the same. For mammography registrants
who apply for accreditation with the department, there will be an increase
of $30 for the first mammography machine, for each additional mammography
machine, and for reinstatement of a mammography machine. There will be an
increase of $20 for each re-evaluation of clinical images due to failure during
the accreditation process and a $10 increase for re-evaluation of phantom
images due to failure during the accreditation process. When implemented,
the subscription and convenience fees determined by Texas Online will be $10
for credit card use by registrants and $10 for bank draft transactions by
licensees. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Wednesday,
February 11, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with the authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The amendment affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.204.Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services.
(a)
(No change.)
(b)
Scope. Except as otherwise specifically provided, the requirements
in this section apply to any person who is the following:
(1)
(No change.)
(2)
the holder of a fixed nuclear facility construction permit
or operating license issued by the United States Nuclear Regulatory Commission
(NRC) in accordance with
Title
10
,
Code of Federal Regulations
,
Part 50; or
(3)
(No change.)
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning, unless the context clearly
indicates otherwise.
(1)-(6)
(No change.)
(7)
Processor of Radioactive Material - A manufacturer/distributor
who converts normal form radioactive material into special form or a manufacturer/distributor
of radioactive sealed sources.
[
(d)
[
(1)
Each application for a
specific
license, general
license acknowledgement, or certificate of registration for which a fee is
prescribed in subsections
(e), (g), (j), or (m)
[
(A)
An application for a license covering more than one
category of specific
license [
(B)
An application for a certificate of registration
covering more than one category
shall be accompanied by the prescribed
[
(C)
No application will be accepted for filing or processed
prior to payment of the full amount specified.
(2)
A nonrefundable fee, in accordance with subsection
(e) and (m)
[
(3)
A nonrefundable fee, in accordance with
subsection
(j)
[
(4)
In the case of a single certificate of registration that
authorizes more than one category of
machine/type of
use, the category
listed in subsection
(j)
[
(5)
An additional nonrefundable fee equal to
five percent of the total fee for each specific license shall be paid with
the specified fee by each holder of a specific license, excluding diagnostic
nuclear medicine licensees.
(A)
The fees collected by the agency in accordance
with this paragraph shall be deposited to the credit of the Radiation and
Perpetual Care Account, until the fees collectively total $500,000.
(B)
If the balance of fees collected in accordance
with this paragraph is subsequently reduced to $350,000 or less, the agency
shall reinstitute assessment of the fee until the balance reaches $500,000.
(6)
[
(7)
[
(8)
[
(9)
[
(e)
[
[
(f)
[
(1)
Each time a manufacturer submits a request for evaluation
of a unique sealed source, one of the following fees shall be paid:
(A)
for an initial evaluation, a fee of $3,614; or
(B)
for an amendment requiring re-evaluation, a fee of $1,804.
(2)
Each time a manufacturer submits a request for evaluation
of a unique device, one of the following fees shall be paid:
(A)
for an initial evaluation, a fee of $7,233; or
(B)
for an amendment requiring re-evaluation, a fee of $3,619.
(3)
No request for evaluation will be processed prior to payment
of the full amount specified.
(g)
[
(1)
An application for certification of mammography systems
shall be accompanied by a fee of $422 for each unit.
(2)
The annual fee for mammography systems is $422 for each
unit.
(h)
Fees for accreditation of mammography facilities.
(1)
Each application for accreditation or re-accreditation
of a mammography facility shall be accompanied by a nonrefundable fee. No
application will be accepted for filing or processed prior to payment of the
full amount specified in paragraph (2) of this subsection.
(2)
Fees for accreditation of mammography facilities
are as follows.
(A)
The accreditation fee for the first mammography
machine is $880.
(B)
The accreditation fee for each additional
mammography machine is $490.
(C)
The fee for re-evaluation of clinical images
due to failure during the accreditation process is $270 per mammography machine.
(D)
The fee for re-evaluation of phantom images
due to failure during the accreditation process is $210 per machine.
(E)
The fee for an additional mammography review
will be based on the number of clinical image sets reviewed and the type of
review.
(F)
The fee for reinstatement of a mammography
machine is $610.
(G)
The fee for replacement of thermoluminescent
dosimeters (TLD) is $70.
(H)
Each facility for which a targeted clinical
image review is required will be charged for actual expenses to the agency
arising from the visit.
(I)
Each facility for which an on-site visit
due to three denials of accreditation is required will be charged for actual
expenses to the agency arising from such visit.
(J)
Payment of the fees in subparagraphs (H)
and (I) of this paragraph shall be made within 60 days following the date
of invoice.
(i)
Fees for industrial radiographer certification
and for radiographer certification examinations.
(1)
The nonrefundable application fee for examination
shall be $25 and shall be submitted to the agency with the application for
examination.
(2)
The nonrefundable application fee for radiographer
certification shall be $100 and shall be submitted to the agency with the
application for radiographer certification.
(j)
[
[
(k)
[
(l)
[
(1)
In any case where the agency finds that an applicant for
a license or certificate of registration has failed to pay the fee prescribed
in this section, the agency will not process that application until such fee
is paid.
[
(2)
[
(3)
[
(m)
[
[
(n)
[
(1)
If additional noncontiguous uranium recovery facility sites
are authorized under the same license, the appropriate [
(2)
If an authorization for disposal of byproduct material
is added to a license, the appropriate [
(o)
[
(1)
$22,389 for in situ wellfield on noncontiguous property;
(2)
$55,977 for in situ satellite;
(3)
$8,777 for wellfield on contiguous property;
(4)
$39,653 for non-vacuum dryer; or
(5)
$55,977 for disposal (including processing, if applicable)
of byproduct material.
(p)
Fees for Texas Online participation. For
all applications and renewal applications, the department is authorized to
collect subscription and convenience fees, in amounts determined by the Texas
Online Authority, to recover costs associated with application and renewal
application processing through Texas Online.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400297
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §289.226
and new §289.226, concerning registration of radiation machine use and
services.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.226
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist in that a rule on this subject is needed; however,
the rule needs revisions as described in this preamble.
The department published a Notice of Intention to Review for §289.226
regarding Government Code, §2001.039, in the
Texas Register
(28 TexReg 6029) on August 1, 2003. No comments were
received by the department on this section following publication of this notice.
The new section incorporates legislation passed by the 78th Legislature,
Regular Session. House Bill 2292 requires two-year terms for certificates
of registration. The department has historically required renewal of some
certificates of registration that includes submission to the department of
updated technical information regarding the radiation machines possessed by
the registrant, operating and safety procedures, and personnel responsible
for the security and safe use of the machines. In order to incorporate the
provisions of HB 2292 concerning two-year terms and to continue requiring
a renewal that includes pertinent technical information, the department is
implementing an administrative renewal and a technical renewal. The registrant
will be required to renew the certificate of registration every two years
by paying the required fee and having a satisfactory compliance history. This
administrative renewal will not involve review of technical information regarding
the certificate of registration. At a longer interval, the registrant will
be required to submit certain technical information for review. This technical
renewal date will be specified in the certificate of registration and will
be for an interval of an even number of years in order to eventually coincide
with the administrative renewal. Maintaining the more resource-intensive technical
renewal allows the department to ensure continued security and safe use of
radiation machines.
House Bill 253, 78th Legislature, Regular Session, requires the department
to deny a certificate of registration application, amendment or renewal if
the applicant's compliance history reveals a recurring pattern of conduct
that demonstrates a consistent disregard for the regulatory process through
significant violations of the Radiation Control Act or the department's radiation
control rules. The department has defined "a recurring pattern of conduct
that demonstrates a consistent disregard for the regulatory process through
significant violations..." by adding a requirement that states the department
will deny an application if at least three department or judicial orders are
issued that assess administrative or civil penalties against the registrant
or if an order is issued to revoke or suspend the certificate of registration.
Requirements for registering veterinary facilities are deleted and incorporated
in a separate new section, §289.233 (concerning Radiation Control Regulations
for Radiation Machines used in Veterinary Medicine). Registration requirements
for personnel monitoring device processors are likewise deleted from the rules.
Requirements for use of radiation machines in morgues are clarified as are
types of services registered in accordance with this section. A requirement
is added to allow the agency to request and the registrant to provide additional
information after the certificate of registration has been issued in order
to be consistent with other permitting sections of this title. The language
that allowed the agency to accept an assembler's notification of installation
in lieu of notification by the registrant of machine installation is deleted.
Requirements for assembler's obligations in one subsection are deleted because
they are repetitive of language in another subsection. A requirement for registrants
to annually inventory their radiation machines is added. An inventory requirement
is added to ensure registrants, especially those with multiple radiation machines,
are aware of the location of machines and how many machines the registrant
possesses. Receipt, transfer, and disposal requirements for radiation machines
is moved to this section from another section of this title in order to more
logically place it with inventory requirements. Notification requirements
are clarified to state that the registrant must notify the department if the
authorized type of machine or use changes or if the number of machines in
any category of machine type or use changes. The requirements for radiation
machines used for clinical trial evaluations and loaner or demonstration radiation
machines are revised to reflect changes in the administrative and technical
renewals and the notification requirements. In addition, revisions are made
to the requirements for expiration of certificates of registration to correspond
with the requirements for administrative and technical renewals. Language
is also added to the expiration and termination subsections to clarify requirements
for the disposition or transfer of radiation machines if a registrant terminates
a certificate of registration or it expires.
The section was reformatted for better flow of language and easier readability.
Other minor grammatical changes are made and reference citations are corrected
for clarification.
This new section and repeal are part of the department's continuing effort
to update, clarify, and simplify its rules regarding the control of radiation
based upon technological advances, public concerns, legislative directives,
or other factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific, that those persons regulated
are informed of the appropriate registration procedures and that registrants
are aware of the number and location of radiation machines for purposes of
safety and security. There will be a slight increase in a registrant's time
required to perform an annual inventory. Depending on the number and location
of machines and locations of sub-sites, a facility could spend from 10 minutes
to over eight hours in this endeavor. There will be no significant fiscal
impact on applicants/registrants that are small businesses, micro-businesses,
or other persons required to comply with the rule. No additional costs will
be incurred because no additional requirements are added. There is no anticipated
impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
February 10, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
25 TAC §289.226
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, Chapter 401, which provides the Texas Board of Health (board) with the
authority to adopt rules and guidelines relating to the control of radiation;
and §12.001, which provides the board with the authority to adopt rules
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The repeal affects Health and Safety Code, Chapters 12 and 401. The review
of the rule implements Government Code, §2001.039.
§289.226.Registration of Radiation Machine Use and Services.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400291
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.226
The new section is proposed under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with the authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, or the commissioner
of health.
The new section affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.226.Registration of Radiation Machine Use and Services.
(a)
Purpose. This section provides for the registration of
persons using radiation machines and persons who are in the business of providing
radiation machine installation or radiation services. No person shall use
radiation machines or perform radiation services except as authorized in a
certificate of registration issued by the agency in accordance with the requirements
of this section. A person who receives, possesses, uses, owns, or acquires
radiation machines prior to receiving a certificate of registration is subject
to the requirements of this chapter.
(b)
Scope.
(1)
In addition to the requirements of this section, all registrants
are subject to the requirements of §289.203 of this title (relating to
Notices, Instructions, and Reports to Workers; Inspections), §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), and §289.231 of this title (relating to General Provisions
and Standards for Protection Against Machine-Produced Radiation).
(2)
Registrants using radiation machines in the healing arts
are also subject to the requirements of §289.227 of this title (relating
to Use of Radiation Machines in the Healing Arts). Morgues and educational
facilities utilizing radiation machines for non-human use are subject to the
specific requirements of §289.227 of this title.
(3)
Registrants using analytical and other industrial radiation
machines, such as x-ray equipment used for cathodoluminescence, ion implantation,
gauging, or electron beam welding, are subject to the requirements of §289.228
of this title (relating to Radiation Safety Requirements for Analytical and
Other Industrial Radiation Machines).
(4)
Registrants using accelerators, therapeutic radiation machines,
and simulators are also subject to the requirements of §289.229 of this
title (relating to Radiation Safety Requirements for Accelerators, Therapeutic
Radiation Machines, and Simulators).
(5)
Registrants using mammography radiation machines are also
subject to the requirements of §289.230 of this title (relating to Certification
of Mammography Systems and Accreditation of Mammography Facilities).
(6)
Registrants using radiation machines in industrial radiographic
operations are also subject to the requirements of §289.255 of this title
(relating to Radiation Safety Requirements and Licensing and Registration
Procedures for Industrial Radiography).
(7)
Registrants using dental radiation machines are subject
to the requirements of §289.232 of this title (relating to Radiation
Control Regulations for Dental Radiation Machines).
(8)
Registrants using veterinary radiation machines are subject
to the requirements of §289.233 of this title (relating to Radiation
Control Regulations for Veterinary Radiation Machines).
(9)
For radiation machines for human use, performance of exposure
rate or dose measurements to determine compliance with exposure rate or dose
measurement requirements of diagnostic radiation machines in this chapter
must be performed by a licensed medical physicist with a specialty in diagnostic
radiological physics.
(10)
For the purposes of this section, radiation services shall
include, but may not be limited to the following:
(A)
for radiation machines that are not for human use, performance
of exposure rate or dose measurements;
(B)
for radiation machines for human use, gathering of radiation
machine output measurements under the direction of a licensed medical physicist;
(C)
for radiation machines for human use, performance of services
specified in paragraph (9) of this subsection or services required by a licensed
medical physicist as specified in §289.229 of this title;
(D)
presentation of agency-accepted training courses that are
specifically required by this chapter;
(E)
calibration of survey and radiation measurement instruments:
(F)
demonstration and sales of radiation machines that require
the individual to operate or cause a radiation machine to be operated in order
to demonstrate or sell;
(G)
assembly, installation or repair to ensure a radiation
machine is operating according to manufacturer's specifications;
(H)
completion of equipment performance evaluations on dental
radiation machines;
(I)
provision of radiation machines on a routine basis to a
facility for limited time periods. For purposes of this section, a person
providing the services described in this subparagraph is a provider of equipment.
For healing arts facilities, the use of radiation machines shall be directed
by a practitioner employed by the contracting facility.
(11)
For purposes of this section, a practitioner of the healing
arts is a person licensed to practice healing arts by either the Texas State
Board of Medical Examiners as a physician, the Texas Board of Chiropractic
Examiners, or the Texas State Board of Podiatry Examiners.
(c)
Prohibition. Exposure of an individual for training, demonstration,
or other non-healing arts purposes is prohibited.
(d)
Exemptions.
(1)
Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration and notification
requirements of this section, provided that the dose equivalent rate averaged
over an area of 10 square centimeters (cm
2
) does
not exceed 0.5 millirem per hour (mrem/hr) at 5 centimeters (cm) from any
accessible surface of such equipment. The production, testing, or factory
servicing of such equipment shall not be exempt.
(2)
Radiation machines in transit or in storage incident to
transit are exempt from the requirements of this section. This exemption does
not apply to the providers of radiation machines for mobile services. Facilities
that have placed all radiation machines in storage, including on-site storage,
and have notified the agency in writing, are exempt from the requirements
of this section. This exemption is void if any radiation machine is energized
resulting in the production of radiation.
(3)
Domestic television receivers, video display terminals,
and electron microscopes, including the servicing of such devices, are exempt
from the requirements of this section.
(4)
Inoperable radiation machines are exempt from the requirements
of this section. For the purposes of this section, an inoperable radiation
machine means a radiation machine that cannot be energized when connected
to a power supply without repair or modification.
(5)
Financial institutions that take possession of radiation
machines as the result of foreclosure, bankruptcy, or other default of payment
are exempt from the requirements in this section to the extent that they demonstrate
that the unit is operable for the sole purpose of selling, leasing, or transferring.
(6)
Facilities, including academic institutions and research
or development facilities, registered for the use of radiation machines are
exempt from the registration requirements of subsection (j) of this section
to the extent that their personnel perform radiation services only for the
registrant by whom they are employed.
(e)
General requirements for application for registration.
(1)
Application for registration shall be completed on forms
prescribed by the agency and shall contain all the information required by
the form and accompanying instructions.
(2)
A radiation safety officer (RSO) shall be designated on
each application form. The qualifications of that individual shall be submitted
to the agency with the application. The RSO shall meet the applicable requirements
of subsection (t)(1) of this section and carry out the responsibilities of
subsection (t)(2) of this section.
(3)
The agency may at any time after the filing of the original
application, require further statements in order to enable the agency to determine
whether the certificate of registration should be issued or denied.
(4)
An application for a certificate of registration may include
a request for a certificate of registration authorizing one or more activities.
Applications for certification of mammography systems shall be made separately.
(5)
Applications and documents submitted to the agency may
be made available for public inspection except that the agency may withhold
any document or part thereof from public inspection in accordance with §289.231(aa)
of this title.
(6)
Each application for a certificate of registration shall
be accompanied by the fee prescribed in §289.204 of this title.
(7)
Each application shall be accompanied by a completed BRC
Form 226-1 (Business Information Form).
(f)
Application for registration for human use of radiation
machines. In addition to the requirements of subsection (e) of this section,
each applicant shall comply with the following.
(1)
Each person having a radiation machine used in the healing
arts shall apply for registration with the agency within 30 days after beginning
use of the radiation machine, except for mobile services that shall be registered
in accordance with subsection (g) of this section, and healing arts screening
and medical research programs that shall be approved in accordance with subsection
(h) of this section.
(2)
Each person having an accelerator or therapeutic radiation
machine at or above 1 million electron volts (MeV) for human use shall apply
for and receive a certificate of registration from the agency before energizing
the accelerator, including performing acceptance testing.
(3)
Each person having a simulator and/or therapeutic radiation
machine below 1 MeV for human use shall apply for registration with the agency
within 30 days of energizing the equipment.
(4)
The applicant shall be qualified by reason of training
and experience to use the radiation machine for the purpose requested in accordance
with this section in such a manner as to minimize danger to occupational and
public health and safety.
(5)
The applicant's proposed equipment, facilities, and operating
and safety procedures shall be adequate to minimize danger to occupational
and public health and safety.
(6)
An application for healing arts shall be signed by a licensed
practitioner The signature of the administrator, president, or chief executive
officer will be accepted in lieu of a licensed practitioner's signature if
the facility has more than one licensed practitioner who may direct the operation
of radiation machines. The application shall also be signed by the RSO if
the RSO is someone other than the licensed practitioner.
(7)
An application for accelerators or therapeutic radiation
machines for human use shall be signed by a practitioner licensed by the Texas
State Board of Medical Examiners. The signature of the administrator, president,
or chief executive officer will be accepted in lieu of a licensed practitioner's
signature if the facility has more than one licensed practitioner who may
direct the operation of radiation machines. The application shall also be
signed by the RSO if the RSO is someone other than the licensed practitioner.
Each applicant shall submit operating and safety procedures as described in §289.229(h)(1)(D)
of this title and a description of the proposed facilities in accordance with
the following:
(A)
§289.229(h)(2)(B) and (C) of this title for equipment
with energies below 1 MeV; and
(B)
§289.229(h)(3)(B) of this title for equipment with
energies above 1 MeV.
(g)
Application for registration of mobile service operation.
In addition to the requirements of subsections (e) and (f) of this section
or §289.230(t) of this title, as applicable, each applicant shall apply
for and receive authorization for mobile service operation before beginning
mobile service operation. The following shall be submitted:
(1)
an established main location where the machine(s), records,
etc. will be maintained for inspection. This shall be a street address, not
a post office box number;
(2)
a sketch or description of the normal configuration of
each radiation machine's use, including the operator's position and any ancillary
personnel's location during exposures. If a mobile van is used with a fixed
unit inside, furnish the floor plan indicating protective shielding and the
operator's location; and
(3)
a current copy of the applicant's operating and safety
procedures regarding radiological practices for protection of patients, operators,
employees, and the general public.
(h)
Application for registration of healing arts screening
and medical research.
(1)
In addition to the requirements of subsections (e) and
(f) of this section, each applicant shall apply for and receive authorization
for healing arts screening before initiating a screening program. The information
and evaluation in subsection (t)(4) of this section shall be submitted with
the application.
(2)
In addition to the requirements of subsections (e) and
(f) of this section, any research using radiation machines on humans shall
be approved by an Institutional Review Board (IRB) as required by Title 45,
CFR, Part 46 and Title 21, CFR, Part 56. The IRB shall include at least one
practitioner of the healing arts to direct any use of radiation in accordance
with §289.231(b)(1) of this title.
(i)
Application for registration of radiation machines for
non-human use, including use in morgues. In addition to the requirements of
subsection (e) of this section, each applicant shall comply with the following.
(1)
Each person having an accelerator for non-human use shall
apply for and receive a certificate of registration from the agency before
beginning use of the accelerator.
(2)
Each person having an accelerator for non-human use shall
submit the following:
(A)
operating and safety procedures as described in §289.229(f)(3)(B)
of this title; and
(B)
a description of the applicant's proposed facilities in
accordance with §289.229(f)(2) and (f)(3)(A), (D) and (E) of this title.
(3)
Each person having a radiation machine for non-human use,
other than those specified in paragraph (1) of this subsection and those used
for industrial radiographic operations, shall apply for registration with
the agency within 30 days after beginning use of the machine.
(4)
Each applicant for use of radiation machines in industrial
radiographic operations shall submit the information required in §289.255(u)(7)
of this title before beginning use of the machine(s).
(5)
An application for the uses specified in this subsection
shall be signed by the applicant or registrant or a person duly authorized
to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO if the RSO is someone other than the applicant
or registrant.
(j)
Application for registration of radiation machine services.
In addition to the requirements of subsection (e) of this section, each applicant
shall comply with the following.
(1)
Each person who intends to provide radiation services described
in subsections (b)(10) of this section shall apply for and receive a certificate
of registration from the agency before providing such service.
(2)
An application for radiation services shall be signed by
the applicant or registrant or a person duly authorized to act for and on
the applicant's or registrant's behalf. The application shall also be signed
by the RSO if the RSO is someone other than the applicant or registrant.
(3)
The applicant shall submit written documentation to the
agency of the specific training and experience that qualifies each individual
to discharge the duties of this service. As a minimum, each applicant shall
submit the following:
(A)
for individuals performing assembly, installation, or repair
of radiation machines in (b)(10)(G), the qualifications listed in subsection
(t)(3) of this section;
(B)
for individuals performing the services specified in subsection
(b)(9) and (10)(C) of this section, a copy of the individual's license from
the Texas Board of Licensure for Professional Medical Physicists;
(C)
for all other services, the qualifications listed in subsection
(t)(1)(A)(i)-(iii) of this section.
(4)
No person shall perform services specified in subsection
(b)(9) and (10) of this section that are not specifically authorized by the
agency.
(5)
No person shall perform radiation machine services, other
than initial installation of the first machine(s) on the premises, for an
individual who cannot produce evidence of registration with the agency authorizing
the possession and use of the machines in question.
(6)
Each applicant for providers of equipment shall also submit
the following:
(A)
an established main location where the machines, records,
etc. will be maintained for inspection. This shall be a street address, not
a post office box number;
(B)
evidence that the healing arts facility responsible for
administering or supervising the administering of radiation is registered
in accordance with the requirements in this section; and
(C)
a current copy of the applicant's operating and safety
procedures. A current copy of the applicant's operating and safety procedures
is required when personnel are provided in addition to equipment.
(7)
Each applicant for calibration of survey and radiation
measurement instruments shall also submit the following:
(A)
procedures for calibration;
(B)
qualifications of personnel performing the calibration;
(C)
a copy of the calibration certificate to be used; and
(D)
a copy of the expiration sticker to be used.
(8)
Each applicant for agency-accepted training courses specifically
required by §289.253 (relating to Radiation Safety Requirements for Well
Logging Service Operation and Tracer Studies), and §289.255 of this title
shall also submit the following:
(A)
a course syllabus;
(B)
the number of instructional hours for each subject;
(C)
a list of training resources, for example, reference books,
texts, workbooks, physical facilities, etc.;
(D)
all test questions and corresponding answers; and
(E)
the radiation safety training, education, and experience
of each instructor.
(k)
Issuance of certificate of registration.
(1)
A certificate of registration application will be approved
if the agency determines that an application meets the requirements of the
Texas Radiation Control Act (Act) and the requirements of this chapter. The
certificate of registration authorizes the proposed activity in such form
and contains such conditions and limitations as the agency deems appropriate
or necessary.
(2)
The agency may incorporate in the certificate of registration
at the time of issuance, or thereafter by amendment, such additional requirements
and conditions with respect to the registrant's possession, use, and transfer
of radiation machines subject to this chapter as it deems appropriate or necessary
in order to:
(A)
minimize danger to occupational and public health and safety;
(B)
require additional reports and the keeping of additional
records as may be appropriate or necessary; and
(C)
prevent loss or theft of radiation machines subject to
this section.
(3)
The agency may request, and the registrant shall provide,
additional information after the certificate of registration has been issued
to enable the agency to determine whether the certificate of registration
should be modified in accordance with subsection (r) of this section.
(l)
Specific terms and conditions of certificates of registration.
(1)
Each certificate of registration issued in accordance with
this section shall be subject to the applicable provisions of the Act, now
or hereafter in effect, and to the applicable rules and orders of the agency.
(2)
No certificate of registration issued or granted under
this section shall be transferred, assigned, or in any manner disposed of,
either voluntarily or involuntarily, to any person unless the agency authorizes
the transfer in writing.
(3)
Each person registered by the agency for radiation machine
use in accordance with this section shall confine use and possession of the
radiation machine registered to the locations and purposes authorized in the
certificate of registration.
(4)
In making a determination whether to grant, deny, amend,
renew, revoke, suspend, or restrict a certificate of registration, the agency
may consider the technical competence and compliance history of an applicant
or holder of a certificate of registration. After an opportunity for a hearing,
the agency shall deny an application for a certificate of registration, an
amendment to a certificate of registration, or renewal of a certificate of
registration if the applicant's compliance history reveals that at least three
agency or judicial orders have been issued against the applicant that assess
administrative or civil penalties against the applicant, or that revoke or
suspend the certificate of registration.
(m)
Responsibilities of registrant.
(1)
The registrant shall notify the agency in writing of any
changes that would render the information contained in the application for
registration and/or the certificate of registration inaccurate.
(A)
Notification is required within 30 days of the following
changes:
(i)
name and mailing address;
(ii)
street address where machine will be used;
(iii)
RSO; or
(iv)
type of servicing and/or services provided;
(B)
Each registrant shall inventory all radiation machines
in its possession at an interval not to exceed one year. The inventory record
shall be maintained for three years for inspection by the agency and shall
include:
(i)
manufacturer's name;
(ii)
model and serial number of the control panel; and
(iii)
location of radiation machine(s) (for example, room number).
(C)
Notification to the agency concerning radiation machine
inventory is required within 30 days of either of the following:
(i)
any change in the category(ies) of machine type or type
of use as specified in §289.231(ll) and as authorized in the certificate
of registration, or;
(ii)
any increase in the number of machines authorized by the
certificate of registration in any machine type or type of use category.
(D)
Each registrant shall maintain records of receipt, transfer,
and disposal of radiation machines for inspection by the agency. The records
shall include the following information and shall be kept until termination
of the certificate of registration.
(i)
manufacturer's name;
(ii)
model and serial number from the control panel;
(iii)
date of the receipt, transfer, and disposal;
(iv)
name and address of person machine(s) received from, transferred
to, or disposed of; and
(v)
name of the individual recording the information.
(2)
The following criteria applies to radiation machines used
for clinical trial evaluations and loaner or demonstration radiation machines.
For persons having a valid certificate of registration, radiation machines
used for clinical trial evaluations and loaner or demonstration radiation
machines may be used for up to 60 days. After 60 days, the registrant shall
notify the agency of the following:
(A)
a change in the category(ies) of machine type or type of
use as specified in §289.231(ll) and as authorized in the certificate
of registration, or:
(B)
any increase in the number of machines authorized by the
certificate of registration in any machine type or type of use category.
(3)
No registrant shall engage any person for services described
in subsection (j) of this section until such person provides to the registrant
evidence of registration with the agency.
(4)
Records of training and experience required by this section
shall be maintained for inspection by the agency until disposal is authorized
by the agency.
(5)
The following applies to voluntary or involuntary petitions
for bankruptcy.
(A)
Each registrant shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
by the registrant or its parent company. This notification shall include:
(i)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(ii)
the date of the filing of the petition.
(B)
A copy of the "petition for bankruptcy" shall be submitted
to the agency along with the written notification.
(6)
The registrant is responsible for complying with this chapter
and the conditions of the certificate of registration.
(7)
No person shall use radiation machines or perform services
that are not authorized in the certificate of registration issued by the agency.
(8)
Providers of equipment shall keep a log of radiation machines
provided in Texas. The record shall be maintained for five years for inspection
by the agency and shall list the following current information:
(A)
date machine is provided; and
(B)
name of customer and customer's certificate of registration
number.
(n)
Sale, lease, loan, installation, assembly, disposal, and
transfer of radiation machines.
(1)
No person shall transfer a radiation machine to or install
for, other than initial installation of the first machine on the premises,
any person who does not possess a current certificate of registration issued
by the agency in accordance with this section.
(2)
Any person who sells, leases, lends, disposes, assembles,
installs, or otherwise transfers radiation machines in the state shall notify
the agency of the following information within 30 days of such action:
(A)
the name, address, and certificate of registration number,
except in the case of initial machine installation, of persons who have received
such machines;
(B)
the type of radiation machine, the manufacturer's name,
model number, and control panel serial number of each radiation machine; and
(C)
the date of transfer or disposal of each radiation machine.
(3)
No person shall make, sell, lease, transfer, lend, assemble,
or install radiation machines or the components of such machines unless such
machines and equipment, when properly placed in operation and used, meet the
applicable requirements of this chapter.
(o)
Expiration of certificates of registration and administrative
renewal.
(1)
Effective September 1, 2004, the term of the certificate
of registration is two years. Except as provided by subsection (q) of this
section, each certificate of registration expires at the end of the day, in
the month and year stated in the certificate of registration. Upon payment
of the fee required by §289.204 of this title and if the agency does
not deny the renewal in accordance with subsection (l)(4) of this section,
the certificate of registration will be administratively renewed.
(2)
If the fee is not paid and the certificate of registration
is not renewed in accordance with paragraph (1) of this subsection, the certificate
of registration expires, and the registrant is in violation of the requirements
in this chapter and is subject to administrative penalties in accordance with §289.205
of this title.
(A)
If the registrant pays the fee required by §289.204
of this title within 30 days after expiration of the certificate of registration,
the certificate of registration will be reinstated and the registrant will
not be required to file an application in accordance with subsection (e) of
this section.
(B)
If the registrant fails to pay the fee within 30 days after
expiration of the certificate of registration, the registrant shall file an
application in accordance with subsection (e) of this section.
(3)
If a registrant fails to pay the fee required by §289.204
of this title and the certificate of registration is not renewed, the registrant
shall:
(A)
terminate use of all radiation machines and/or terminate
radiation machine servicing or radiation services; and
(B)
submit to the agency a record of the disposition of the
radiation machines, if applicable, and if transferred, to whom it was transferred
within 30 days following the expiration date.
(4)
Expiration of the certificate of registration does not
relieve the registrant of the requirements of this chapter.
(p)
Termination of certificates of registration. When a registrant
decides to terminate all activities involving radiation machines or services
authorized under the certificate of registration, the registrant shall immediately
do the following:
(1)
request termination of the certificate of registration
in writing;
(2)
submit to the agency a record of the disposition of the
radiation machines, if applicable; and if transferred, to whom it was transferred;
and
(3)
pay any outstanding fees in accordance with §289.204
of this title.
(q)
Technical renewal of certificate of registration.
(1)
If required by the certificate of registration, an application
for technical renewal of a certificate of registration shall be filed in accordance
with subsection (e)(1)-(5) of this section and applicable paragraphs of subsections
(f) - (j) of this section. An application for a technical renewal of a certificate
of registration shall be submitted to the agency by the date specified in
the existing certificate of registration. If the registrant fails to apply,
or the agency does not approve the application in accordance with subsection
(k)(1) of this section, the certificate of registration expires and the registrant
is in violation of the requirements in this chapter and is subject to administrative
penalties in accordance with §289.205 of this title. The registrant shall
comply with the requirements of subsection (o)(3)(A)-(C) of this section.
(2)
Expiration of the certificate of registration does not
relieve the registrant of the requirements of this chapter.
(3)
If a registrant files an application for a technical renewal
in proper form before the existing certificate of registration expires, such
existing certificate of registration shall not expire until the application
status has been determined by the agency.
(r)
Modification, suspension, and revocation of certificates
of registration.
(1)
The terms and conditions of all certificates of registration
shall be subject to revision or modification. A certificate of registration
may be suspended or revoked by reason of amendments to the Act, by reason
of rules in this chapter or orders issued by the agency.
(2)
Any certificate of registration may be revoked, suspended,
or modified, in whole or in part, for any of the following:
(A)
any material false statement in the application or any
statement of fact required under provisions of the Act;
(B)
conditions revealed by such application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a certificate of registration on an original
application;
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, the certificate of registration, or order
of the agency; or
(D)
existing conditions that constitute a substantial threat
to the public health or safety or the environment.
(3)
Each certificate of registration revoked by the agency
ends at the end of the day on the date of the agency's final determination
to revoke the certificate of registration, or on the revocation date stated
in the determination, or as otherwise provided by the agency order.
(4)
Except in cases in which the occupational and public health,
interest or safety requires otherwise, no certificate of registration shall
be suspended, or revoked unless, prior to the institution of proceedings therefore,
facts or conduct that may warrant such action shall have been called to the
attention of the registrant in writing and the registrant shall have been
afforded an opportunity to demonstrate compliance with all lawful requirements.
(s)
Reciprocal recognition of out-of-state certificates of
registration.
(1)
Whenever any radiation machine is to be brought into the
state for any temporary use, the person proposing to bring the machine into
the state shall apply for and receive a notice from the agency granting reciprocal
recognition prior to beginning operations. The request for reciprocity shall
include the following:
(A)
completed BRC Form 226-1 (Business Information Form);
(B)
completed BRC Form 252-3 (Notice of Intent to Work in Texas
Under Reciprocity);
(C)
completed qualification forms (BRC Forms 255-E, 255-T and/or
255-OS) for each radiographer who will be working in Texas if the reciprocity
request is for industrial radiography;
(D)
name and Texas licensing board number of the practitioner
if the machines are used to irradiate humans;
(E)
copy of the applicant's current certificate of registration
or equivalent document;
(F)
copy of the applicant's current operating and safety procedures
pertinent to the proposed use;
(G)
fee as specified in §289.204(e) of this title; and
(H)
qualifications of personnel who will be operating the machines.
(2)
Upon a determination that the request for reciprocity meets
the requirements of the agency, the agency may issue a notice granting reciprocal
recognition authorizing the proposed use.
(3)
Once reciprocity is granted, the out-of-state registrant
shall file a BRC Form 252-3 with the agency prior to each entry into the state.
This form shall be filed at least three working days before the radiation
machine is to be used in the state. If, for a specific case, the three-day
period would impose an undue hardship, the out-of-state registrant may, at
the determination of the agency, obtain permission to proceed sooner.
(4)
When radiation machines are used as authorized under reciprocity,
the out-of-state registrant shall have the following in its possession at
all times for inspection by the agency:
(A)
completed BRC Form 252-3;
(B)
copy of the notice from the agency granting reciprocity;
(C)
copy of the out-of-state registrant's operating and safety
procedures; and
(D)
copy of the applicable rules as specified in the notice
granting reciprocity.
(5)
If the state from which the radiation machine is proposed
to be brought does not issue certificates of registration or equivalent documents,
a certificate of registration shall be obtained from the agency in accordance
with the requirements of this section.
(6)
The agency may withdraw, limit, or qualify its acceptance
of any certificate of registration or equivalent document issued by another
agency upon determining that such action is necessary in order to prevent
undue hazard to occupational and public health and safety or property.
(7)
Reciprocal recognition will expire one year from the date
it is granted. A new request for reciprocity shall be submitted to the agency
each year. Reciprocity requests made after the initial request shall include
only the following:
(A)
completed BRC Form 226-1 (Business Information Form);
(B)
completed BRC Form 252-3 (Notice of Intent to Work in Texas
Under Reciprocity);
(C)
completed qualification forms (BRC Forms 255-E, 255-T and/or
255-OS) for each radiographer who will be working in Texas if the reciprocity
request is for industrial radiography;
(D)
name and Texas licensing board number of the practitioner
if the machines are used to irradiate humans;
(E)
copy of the applicant's current certificate of registration
or equivalent document;
(F)
copy of the applicant's current operating and safety procedures
pertinent to the proposed use;
(G)
fee as specified in §289.204(e) of this title; and
(H)
qualifications of personnel who will be operating the machines.
(8)
Radiation services provided by a person from out-of-state
will not be granted reciprocity. Whenever radiation services are to be provided
by a person from out-of-state, that person shall apply for and receive a certificate
of registration from the agency before providing radiation services. The application
shall be filed in accordance with subsections (e), (j), and (i) of this section,
as applicable.
(t)
Appendices.
(1)
Requirements for RSOs for registrants.
(A)
All RSOs shall meet the following general requirements
in addition to requirements in specific categories, except for industrial
radiography RSOs:
(i)
knowledge of potential radiation hazards and emergency
precautions; and
(ii)
completed educational courses related to ionizing radiation
safety or a radiation safety officer course; or
(iii)
experience in the use and familiarity of the type of
equipment used.
(B)
Specific requirements for RSOs by facility are as follows.
(i)
Healing arts facilities shall have:
(I)
licensed practitioner RSOs with documentation of licensing
board number; or
(II)
non-practitioner RSOs with the following:
(-a-)
evidence of a valid general certificate issued under
the Medical Radiologic Technologist Certification Act, Texas Occupations Code,
Chapter 601, and at least two years of supervised use of radiation machines;
(-b-)
evidence of a valid limited general certificate issued
under the Medical Radiologic Technologist Certification Act, Texas Occupations
Code, Chapter 601, and at least four years of supervised use of radiation
machines;
(-c-)
evidence of registry by the American Registry of Radiologic
Technologists (ARRT) or the American Registry of Clinical Radiologic Technologists
(ARCRT) and at least two years of supervised use of radiation machines;
(-d-)
evidence of associate degree in radiologic technology,
health physics, or nuclear technology, and at least two years of supervised
use of radiation machines;
(-e-)
evidence of registration with the Board of Nurse Examiners
as a Registered Nurse or a Registered Nurse with an extended scope of practice
(Nurse Practitioner) performing radiologic procedures, and at least two years
of supervised use of radiation machines in the respective practitioners' specialty;
(-f-)
evidence of registration with the Texas State Board of
Physician Assistant Examiners, and at least two years of supervised use of
radiation machines in the respective practitioners' specialty;
(-g-)
evidence of:
(-1-)
registration with the Texas State Board of Medical Examiners
performing radiologic procedures under a physician's instruction and direction;
(-2-)
registration with the Texas State Board of Chiropractic
Examiners performing radiologic procedures under a chiropractor's instruction
and direction; or
(-3-)
registration with the Texas State Board of Podiatry Examiners
performing radiologic procedures under a podiatrist's instruction and direction;
and
(-4-)
at least four years of supervised use of radiation machines
in the respective practitioners' specialty;
(-h-)
for radiotherapy facilities, evidence of registry by
the ARRT or ARCRT and at least four years of supervised experience in radiotherapy;
(-i-)
evidence of bachelor's (or higher) degree in a natural
or physical science, health physics, radiological science, nuclear medicine,
or nuclear engineering; or
(-j-)
evidence of a current Texas license under the Medical
Physics Practice Act, Texas Occupations Code, Chapter 602, in one or more
of the following appropriate specialties:
(-1-)
medical health physics, diagnostic radiological physics,
or medical nuclear physics for diagnostic x-ray facilities; or
(-2-)
medical health physics or therapeutic radiological physics
for radiotherapy facilities.
(ii)
Academic institutions and/or research and development
facilities shall have RSOs who are faculty or staff members in radiation protection,
radiation engineering, or related disciplines. (This individual may also serve
as the RSO over the healing arts section of the facility.)
(iii)
Industrial radiography operations shall have RSOs who
meet the requirements of §289.255(m)(4)(B) of this title.
(C)
Exemptions. The RSO identified on a certificate of registration
issued before September 1, 1993, need not comply with the training requirements
in this subsection.
(2)
Responsibilities of RSOs. Specific duties of the RSO include,
but are not limited to, the following:
(A)
establishing and overseeing operating and safety procedures
that maintain radiation exposures as low as reasonably achievable (ALARA),
and to review them regularly to ensure that the procedures are current and
conform with this chapter;
(B)
ensuring that individual monitoring devices are properly
used by occupationally-exposed personnel, that records are kept of the monitoring
results, and that timely notifications are made as required by §289.203
of this title;
(C)
investigating and reporting to the agency each known or
suspected case of radiation exposure to an individual or radiation level detected
in excess of limits established by this chapter and each theft or loss of
source(s) of radiation, determining the cause, and taking steps to prevent
its recurrence;
(D)
having a thorough knowledge of management policies and
administrative procedures of the registrant and keeping management informed
on a periodic basis of the performance of the registrant's radiation protection
program, if applicable;
(E)
assuming control and having the authority to institute
corrective actions including shut-down of operations when necessary in emergency
situations or unsafe conditions;
(F)
maintaining records as required by this chapter;
(G)
ensuring that personnel are adequately trained and complying
with this chapter, the conditions of the certificate of registration, and
the operating and safety procedures of the registrant.
(3)
Minimum education and training for persons performing radiation
machine assembly, installation or repair. All persons performing radiation
machine assembly, installation or repair shall meet the general requirements
in subparagraph (A) of this paragraph and one or more of the specialized requirements
in subparagraph (B) of this paragraph.
(A)
General requirements include:
(i)
experience or education providing familiarity with the
type(s) of equipment to be serviced, to include radiation safety;
(ii)
knowledge of protective measures to reduce potentially
hazardous conditions; and
(iii)
six months of supervised assembly and repair of the type(s)
of equipment to be serviced.
(B)
Specialized requirements include:
(i)
one year of formal training (may be satisfied by factory
school, military technical training school, or other courses in radiation
machine assembly, installation or repair techniques) or an associate's degree
in biomedical equipment repair;
(ii)
a bachelor's degree in electrical engineering with specialized
training in radiation producing devices; or
(iii)
a combination of training and experience equal to clause
(i) of this subparagraph.
(C)
Exemptions. A registrant holding a valid certificate of
registration who has hired individuals to perform services before September
1, 1993, need not comply with the education and training requirements in this
paragraph. Individuals hired after September 1, 1993, shall comply with the
education and training requirements in this paragraph.
(4)
Information to be submitted by persons proposing to conduct
healing arts screening. Persons requesting that the agency approve a healing
arts screening program shall submit the following information and evaluation.
(A)
Administrative controls to include the following:
(i)
the name and address of the applicant and, where applicable,
the names and addresses of agents within Texas;
(ii)
the diseases or conditions for which the x-ray examinations
are to be used in diagnoses;
(iii)
a detailed description of the x-ray examinations proposed
in the screening program;
(iv)
a description of the population to be examined in the
screening program, for example, age, sex, physical condition, and other appropriate
information;
(v)
an evaluation of any known alternate methods not involving
ionizing radiation that could achieve the goals of the screening program and
why these methods are not used instead of the x-ray examination; and
(vi)
for mobile screening operations, location(s) where radiation
machines are used and maintained.
(B)
Operating procedures for all x-ray systems (except bone
densitometers) to include the following:
(i)
an evaluation of the x-ray systems to be used in the screening
program. The evaluation shall be performed by a licensed medical physicist
with a specialty in diagnostic radiological physics. The evaluation shall
show that such systems do satisfy all requirements of this section;
(ii)
a description of the diagnostic imaging quality control
program; and
(iii)
a copy of the technique chart for the x-ray examination
procedures to be used.
(C)
Operating procedures for bone densitometers to include
the manufacturer's evaluation of the system to be used in the screening program.
The evaluation shall show that such systems satisfy all requirements of this
section.
(D)
Training data to include the following:
(i)
the qualifications of each individual who will be operating
the x-ray systems;
(ii)
the qualifications of the individual who will be supervising
the operators of the x-ray systems. The extent of supervision and the method
of work performance evaluation shall be specified; and
(iii)
the name and address of the practitioner licensed in
Texas who will interpret the radiographs.
(E)
Records to include the following:
(i)
a description of the procedures to be used in advising
the individuals screened, and their private practitioners of the healing arts,
of the results of the screening procedure and any further medical needs indicated;
and
(ii)
a description of the procedures for the retention or disposition
of the radiographs and other records pertaining to the x-ray examinations.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed
with the Office of the Secretary of State on January 15, 2004.
TRD-200400292
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.227
The Texas Department of Health (department) proposes an amendment
to §289.227, concerning use of radiation machines in the healing arts.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.227
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist; however, revisions to the rule are necessary
as outlined in this preamble.
The department published a Notice of Intention to Review for §289.227
as required by Government Code, §2001.039, in the
Texas Register
(28 TexReg 6029) on August 1, 2003. No comments were
received by the department on this section.
The Bureau of Radiation Control is reallocating resources for regulation
of x-ray and nonionizing radiation based on prioritization of risk to public
health and safety. Rules governing the use of radiation machines in the healing
arts are revised to reflect this prioritization. Risk to public health and
safety is primarily based on machine type and type of use rather than the
category of facility in which they are used. Therefore, some requirements
in this section have been rearranged and are found under categories of machine
type and type of use, rather than type of facility in which they are used.
Radiation machines used in veterinary medicine are for non-human use and pose
a lower risk. Also, veterinary registrants are a significant portion of all
registrants. Therefore, requirements for veterinary facilities are deleted
and incorporated in a separate section, §289.233 (concerning Radiation
Control Regulations for Radiation Machines Used in Veterinary Medicine). Multiple
definitions are deleted as they are not used in the body of the rule. The
definitions for mobile services and x-ray equipment were revised to more clearly
state the intent of the rule. In addition, requirements for use of radiation
machines in morgues are delineated because not all requirements for human
use of radiation machines are applicable. The requirements for operating and
safety procedures are expanded to include documentation that each individual
operating a radiation machine has read the procedures, in order to ensure
such individuals are aware of operating and safety issues. The requirement
for a skin-to-image distance indicator to be present is clarified to state
the indicator must be numerical in order to determine the required accuracy.
The source-to-skin distance requirements for fluoroscopy are revised to be
compatible with the United States Food and Drug Administration fluoroscopy
requirements. Requirements for warning labels, visual indication of x-ray
production, and technique factor accuracy found for other machine types are
repeated for computerized tomography (CT) x-ray systems because they are applicable
to CT machines also. Measurements of radiation output of the CT x-ray system
are now required to be performed using the computed tomography dose index
as recommended by national and international professional technical organizations.
The requirements for acquisition of images using a phantom and made by a licensed
medical physicist are clarified and requirements for acquisition of quality
control images using a phantom and made by the registrant are added to differentiate
between the two situations. Entrance exposure limits measurements for patients
are added to the list of tests for equipment performance evaluations as well
as language that delineates who may perform equipment performance evaluations.
In addition, the frequency of performing equipment performance evaluations
is changed for some types of equipment. The department considers measurements
to determine compliance with entrance exposure limits to be as critical to
properly operating machines and minimization of radiation exposure as the
other required tests. Requirements are added for digital imaging acquisition
systems to ensure the registrant is performing appropriate quality assurance
and quality control for digital imaging acquisition systems. The rule is reformatted
and renumbered and other minor grammatical changes are made and reference
citations are corrected for clarification.
This amendment is part of the department's continuing effort to update,
clarify, and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, or other
factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section is in effect, the public benefit anticipated as
a result of enforcing the section will be to ensure continued protection of
the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific and that those persons required
to operate radiation machines do so in ways that ensure such protection. There
will be fiscal impact on applicants/registrants that are small businesses,
micro-businesses or other persons required to comply with the rule. There
will be an increase in the costs for all registrants except educational facilities,
morgues, and facilities with bone density machines, to have entrance exposure
limits performed by a licensed medical physicist as a part of the equipment
performance evaluation. The cost would range from $25 to $150 per radiographic
machine for those registrants who have a licensed medical physicist perform
the other tests required for the equipment performance evaluation. If computed
tomography quality control images are not already being performed, there will
be an increase in time from approximately 15 to 30 minutes per occasion per
machine for registrants to perform quality control phantom images on computed
tomography units. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
February 10, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with authority to adopt rules
and guidelines relating to the control of radiation; and §12.001, which
provides the board with the authority to adopt rules for its procedure and
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The amendment affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.227.Use of Radiation Machines in the Healing Arts [
(a)
Purpose. This section establishes requirements for the
use of radiation machines in the healing arts [
(b)
Scope.
(1)
The registrant shall be responsible for directing the operation
of the radiation machines under the administrative control of the registrant.
The registrant shall assure that the requirements of this section are met
in the operation of such radiation machines. All usage of such machines under
this section shall be made by or under the supervision of a practitioner of
the healing arts [
(2)
(No change.)
(3)
The use of mammography radiation machines is subject to
the requirements in §289.230 of this title (relating to Certification
of Mammography Systems and Accreditation of Mammography Facilities), with
the exceptions listed in §289.230(e)(1) and (2) of this title. The use
of dental radiation machines is subject to the requirements in §289.232
of this title (relating to Radiation Control Regulations for Dental Radiation
Machines). However, dental radiation machines located in a facility that also
has other healing arts radiation machines will be inspected at the intervals
specified in §289.231(ll)(1) of this title, and equipment performance
evaluations performed at the interval specified for a medical facility in
subsection
(o)(1)
[
(c)
Prohibitions.
(1)
(No change.)
(2)
Individuals shall not be exposed to the useful beam except
for healing arts purposes and unless such exposure has been authorized by
a licensed practitioner of the healing arts. This provision specifically prohibits
deliberate exposure for the following purposes:
(A)
(No change.)
(B)
exposure of an individual for the purpose of healing arts
screening, except as authorized by
§289.226(h)(1)
[
(C)
exposure of an individual for the purpose of research,
except as authorized by
§289.226(h)(2)
[
(3)
(No change.)
(d)
Exemptions.
(1)
(No change.)
[
[
[
[
(2)
[
(A)
§289.203(b) of this title, "Posting of notices to
workers;"
(B)
§289.203(c) of this title, "Instructions to workers;"
and
(C)
operating and safety procedures in accordance with subsection
(i)(2) of this section.
(3)
[
[
(e)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise.
(1) - (12)
(No change.)
[
(13)
[
(14)
[
(15)
[
Figure: 25 TAC §289.227(e)(15)
[
(16)
[
(17)
[
[
[
[
(18)
[
(19)
[
(20)
[
[
[
(21)
[
(22)
[
[
(23)
[
(24)
[
(25)
[
(26)
[
(27)
[
(28)
[
(29)
[
[
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
(37)
[
(38)
[
(39)
[
(40)
[
(41)
[
(42)
[
(43)
[
(44)
[
(A)
for diagnostic source assemblies intended for capacitor
energy storage equipment, the maximum-rated peak tube potential and the maximum-rated
number of exposures in an hour for operation at the maximum-rated peak tube
potential with the quantity of charge per exposure being 10 millicoulombs
(10 milliampere-second (mAs)) or the minimum obtainable from the unit, whichever
is larger;
(B)
for diagnostic source assemblies intended for field emission
equipment rated for pulsed operation, the maximum-rated peak tube potential
and the maximum-rated number of x-ray pulses in an hour for operation at the
maximum-rated peak tube potential; or
(C)
for all other diagnostic source assemblies, the maximum-rated
peak tube potential and the continuous tube current for the maximum-rated
peak tube potential.
(45)
[
[
(46)
[
(47)
[
(48)
[
(49)
[
[
(50)
[
(51)
[
(52)
[
(53)
[
(54)
[
(55)
[
(56)
[
(57)
[
(58)
[
(59)
[
(60)
[
(61)
[
(A)
primary protective barrier--A barrier sufficient to attenuate
the useful beam to the required degree.
(B)
secondary protective barrier--A barrier sufficient to attenuate
the stray radiation to the required degree.
(62)
[
(63)
[
(64)
[
(65)
[
(66)
[
(67)
[
(68)
[
(69)
[
(70)
[
(71)
[
(72)
[
(73)
[
(74)
[
(75)
[
[
(76)
[
(77)
[
(78)
[
(79)
[
(80)
[
(81)
[
(82)
[
(83)
[
(84)
[
(85)
[
(A)
for capacitor energy storage equipment, peak tube potential
in kV and quantity of charge in mAs;
(B)
for field emission equipment rated for pulsed operation,
peak tube potential in kV and number of x-ray pulses;
(C)
for CT equipment designed for pulsed operations, peak tube
potential in kV, scan time in seconds, and either tube current in mA, x-ray
pulse width in seconds, and the number of x-ray pulses per scan or the product
of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(D)
for CT equipment not designed for pulsed operation, peak
tube potential in kV, and either tube current in mA and scan time in seconds
or the product of tube current and exposure time in mAs when the scan time
and exposure time are equivalent; and
(E)
for all other equipment, peak tube potential in kV and
either tube current in mA and exposure time in seconds or the product of tube
current and exposure time in mAs.
(86)
[
(87)
[
(88)
[
(89)
[
(90)
[
(91)
[
(92)
[
[
(93)
[
(94)
[
(A)
portable x-ray equipment
[
[
(B)
[
(95)
[
(96)
[
(97)
[
(98)
[
(99)
[
(f)
Morgues and educational facilities.
(1)
Morgues shall comply with the following
requirements:
(A)
subsection (b)(1) and (2) of this section
concerning scope;
(B)
subsection (c) of this section concerning
prohibitions;
(C)
subsection (e) of this section concerning
definitions, as applicable;
(D)
subsection (i)(2) of this section concerning
operating and safety procedures;
(E)
subsection (i)(4) of this section concerning
protective devices;
(F)
subsection (i)(11) of this section concerning
holding of tube;
(G)
subsection (k)(1) of this section concerning
warning labels;
(H)
subsection (m)(1)(A) of this section concerning
fluoroscopy; and
(I)
subsection (s)(1)(A)-(I), and (R) of this
section concerning records.
(2)
Facilities conducting training using non-humans
shall comply with all the requirements of this section except for the following:
(A)
subsection (i)(5) of this section concerning
operator credentialing;
(B)
subsection (j) of this section concerning
radiographic entrance exposure limits;
(C)
subsections (p), (q) and (r) of this section
concerning film processing; and
(D)
subsection (o) of this section concerning
equipment performance evaluation.
[
(g)
Requirements for bone densitometers. Bone densitometers
shall be exempt from this chapter except for the following:
(1)
(No change.)
(2)
healing arts screening and medical research in accordance
with
§289.226(h)
[
(3) - (4)
(No change.)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(h)
Certified equipment [
(i)
General
operating
requirements
.
[
(1)
(No change.)
(2)
Operating and safety procedures. Each registrant
shall have and implement written operating and safety procedures. These procedures
shall include, but are not limited to, the items in subsection (t) of this
section. The procedures shall be made available to each individual operating
a radiation machine, including any restrictions of the operating technique
required for the safe operation of the particular x-ray system. The registrant
shall document that each individual operating a radiation machine has read
the operating and safety procedures and shall maintain this documentation
for inspection by the agency. The documentation shall include the following:
(A)
name and signature of individual;
(B)
date individual read the operating and
safety procedures; and
(C)
initials of the RSO.
[
(3)
(No change.)
(4)
Protective devices. Protective devices shall be utilized
when required, as in subsection (i)(8)(B) and (D), (i)(10),
(i)(13)
and
(m)(8)
[
(A)
Protective devices shall be of no less than 0.25 millimeter
(mm) lead equivalent material
except as specified in subsections (i)(13)
and (m)(8)(B)(i) of this section
.
(B)
Protective devices, including aprons, gloves, and shields
shall be checked annually for defects such as holes, cracks, and tears. These
checks may be performed by the registrant by visual or tactile means, or x-ray
imaging. If a defect is found, protective devices shall be replaced or removed
from service until repaired. A record of this test shall be made and maintained
by the registrant in accordance with subsection
(s)(1)
[
(5) - (8)
(No change.)
(9)
Viewing system
and contact with patient
. [
(A)
Windows, mirrors, closed circuit television,
or another method shall be provided to permit the operator to continuously
observe the patient during irradiation.
(B)
The operator shall be able to maintain
verbal, visual, and aural contact with the patient.
(10) - (11)
(No change.)
[
(12)
[
[
(13)
[
(j)
[
[
(k)
[
(1)
Warning label. The warning label will meet the requirements
of §289.231(z) of this title.
(2)
Mechanical support of tube head. The tube housing assembly
shall be adjusted to remain stable during an exposure unless tube housing
movement is a designed function of the x-ray system.
(3)
Battery charge indicator. On battery-powered x-ray generators,
visual means shall be provided on the control panel to indicate whether the
battery is in a state of charge adequate for proper operation.
[
(4)
[
(A)
Half-value layer.
(i)
The half-value layer of the useful beam for a given x-ray
tube potential shall not be less than the values shown in the following Table
II. If it is necessary to determine such half-value layer at an x-ray tube
potential that is not listed in Table II, linear interpolation may be made.
Figure: 25 TAC §289.227(k)(4)(A)(i)
[
(ii)
For capacitor energy storage equipment, compliance with
the requirements of paragraph
(4)
[
(B)
Filtration controls.
(i)
For x-ray systems that have variable kVp and variable filtration
for the useful beam, a device shall link the kVp selector with the filters
and shall prevent an exposure unless the minimum amount of filtration required
by subparagraph (A) of this paragraph is in the useful beam for the given
kVp that has been selected.
(ii)
Any other system having removable filters shall be required
to have the minimum amount of filtration as required by subparagraph (A)(i)
of this paragraph permanently located in the useful beam during each exposure.
(5)
[
(6)
[
(A)
The technique factors to be used during an exposure shall
be indicated before the exposure begins except when automatic exposure controls
are used, in which case the technique factors that are set prior to the exposure
shall be indicated.
(B)
On equipment having fixed technique factors, the requirement
of subparagraph (A) of this paragraph may be met by permanent markings.
(C)
The x-ray control shall provide visual indication of the
production of x rays.
(D)
The indicated technique factors shall be accurate to meet
manufacturer's specifications. If these specifications are not available from
the manufacturer, the factors shall be accurate to within plus or minus 10%
of the indicated setting.
(7)
X-ray control. An x-ray control shall be
incorporated into each x-ray system such that an exposure can be terminated
by the operator at any time except for an exposure of 0.5 seconds or less
or during serial radiography when means shall be provided to permit completion
of any single exposure of the series in process.
(l)
[
(1)
Beam limitation. Beam limitation shall be as follows.
(A)
Stationary general purpose x-ray systems.
(i)
Beam-limiting devices shall restrict the useful beam to
the area of clinical interest as follows:
(I)
the misalignment of the x-ray field for a manual rectangular
collimator shall be within 2.0% of the SID for the length or width of the
image receptor;
(II)
the x-ray field for a circular or polygon collimator shall
not exceed the diagonal of the image receptor by more than 2.0% of the SID;
or
(III)
the misalignment of the x-ray field for an automatic
or semi-automatic collimator shall be within 3.0% of the SID for the length
and width of the image receptor and shall be within 4.0% of the SID, without
regard to the sign, of the sum of the difference of the length and width of
the image receptor.
(ii)
A method shall be provided for visually defining the perimeter
of the x-ray field. The total misalignment of the edges of the visually defined
field with the respective edges, either the length or width, of the x-ray
field shall not exceed 2.0% of the SID.
(iii)
A
numerical
SID indicator shall be present
and shall be accurate to within 2.0% of the SID.
(iv)
The system shall indicate when the axis of the x-ray field
is perpendicular to the plane of the image receptor.
(v)
The center of the x-ray field, when perpendicular to the
image receptor, shall be accurate to within 2.0% of the SID with respect to
the center of the image receptor.
(vi)
The beam-limiting device shall numerically indicate the
field size in the plane of the image receptor.
(vii)
Indication of field size dimensions and SIDs shall be
specified in inches and/or centimeters.
(viii)
The field size indicated on the beam-limiting device
shall be within 2.0% of the SID along the width and length, separately, of
the actual x-ray field size.
(B)
Portable x-ray equipment. Portable x-ray equipment
[
(C)
Radiographic systems designed for one image receptor size.
Radiographic equipment designed for only one image receptor size at a fixed
SID shall provide a means to do the following:
(i)
limit the x-ray field to no greater than the dimensions
of the image receptor at the SID, and to align the center of the x-ray field
with the center of the image receptor to within 2.0% of the SID center; or
(ii)
align the x-ray field such that the x-ray field does not
extend beyond any edge of the image receptor at the SID.
(D)
Special purpose x-ray systems.
(i)
When the x-ray beam is perpendicular to the plane of the
image receptor, a means shall be provided to do the following:
(I)
limit the x-ray field such that the x-ray field does not
exceed each dimension of the image receptor by more than 2.0% of the SID;
and
(II)
align the center of the x-ray field with the center of
the image receptor to within 2.0% of the SID.
(ii)
The requirements of clause (i) of this subparagraph may
be met with a system that meets the requirements for a general purpose x-ray
system as specified in subparagraphs (A)(i)-(iv) of this paragraph or, when
alignment means are also provided, may be met with either of the following:
(I)
an assortment of removable, fixed-aperture, beam-limiting
devices sufficient to meet the requirement for each combination of image receptor
size and SID for which the unit is designed with each such device having clear
and permanent markings to indicate the image receptor size and SID for which
it is designed; or
(II)
a beam-limiting device having multiple fixed apertures
sufficient to meet the requirement for each combination of image receptor
size and SID for which the radiation machine is designed. Permanent, clearly
legible markings shall indicate the image receptor size and SID for which
each aperture is designed and shall indicate which aperture is in position
for use.
(2)
Radiation exposure control devices. Radiation exposure
control devices shall include the following:
[
(A)
[
(B)
[
(i)
Indication shall be made on the control panel when this
mode of operation is selected.
(ii)
If the x-ray tube potential is equal to or greater than
50 kVp, the minimum exposure time for field emission equipment rated for pulsed
operation shall be equal to or less than a time interval equivalent to two
pulses.
(iii)
The minimum exposure time for all equipment other than
that specified in clause (ii) of this subparagraph shall be equal to or less
than 0.0167 second or a time interval required to deliver 5 mAs, whichever
is greater.
(iv)
Either the product of peak x-ray tube potential, current,
and exposure time shall be limited to not more than 60 kWs per exposure, or
the product of x-ray tube current and exposure time shall be limited to not
more than 600 mAs per exposure except that, when the x-ray tube potential
is less than 50 kVp, the product of x-ray tube current and exposure time shall
be limited to not more than 2,000 mAs per exposure.
(v)
A visible and/or audible signal shall indicate when an
exposure has been terminated at the limits required by clause (iv) of this
subparagraph, and manual resetting shall be required before further automatically
timed exposures can be made.
(C)
[
(3)
SSD. All mobile or portable radiographic systems shall
be provided with means to limit the SSD to equal to or greater than 30 cm.
(4)
Exposure reproducibility. When all technique factors are
held constant, including control panel selections associated with AEC systems,
the coefficient of variation of exposure for both manual and AEC systems shall
not exceed 0.05. This requirement applies to clinically used techniques.
(5)
Linearity.
The average ratios of exposure mR to the
indicated mAs product obtained at any two consecutive mA or mAs settings shall
not differ by more than 0.10 times their sum, where X
1
and X
2
are the average mR/mAs values
obtained at each of two consecutive tube current settings:
[
(6)
Radiation from capacitor energy storage equipment in standby
status. Radiation emitted from the x-ray tube when the exposure switch or
timer is not activated shall not exceed a rate of 2 milliroentgens per hour
(mR/hr) at 5 cm from any accessible surface of the diagnostic source assembly,
with the beam-limiting device fully open.
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
(m)
[
(1)
Limitation of the useful beam. Limitation of the useful
beam shall be as follows.
(A)
Primary barrier.
(i)
The fluoroscopic imaging assembly shall be provided with
a primary protective barrier that intercepts the entire cross section of the
useful beam at any SID.
(ii)
The x-ray tube used for fluoroscopy shall not produce
x rays unless the barrier is in position to intercept the useful beam and
the imaging device is in place and operable.
(iii)
The exposure rate due to transmission through the barrier
with the attenuation block in the useful beam, combined with radiation through
the image intensifier if provided, shall not exceed 3.34 x 10
-3
% of the entrance exposure rate at a distance of 10 cm from any accessible
surface of the fluoroscopic imaging assembly beyond the plane of the image
receptor.
(B)
Measuring compliance of barrier transmission.
(i)
The exposure rate due to transmission through the primary
protective barrier combined with radiation through the image intensifier shall
be determined by measurements averaged over an area of 100 cm
2
with no linear dimension greater than 20 cm.
(ii)
If the source is below the tabletop, the measurement shall
be made with the input surface of the fluoroscopic imaging assembly positioned
30 cm above the tabletop.
(iii)
If the source is above the tabletop and the SID is variable,
the measurement shall be made with the end of the beam-limiting device or
spacer as close to the tabletop as it can be placed, provided that it shall
not be closer than 30 cm.
(iv)
Movable grids and compression devices shall be removed
from the useful beam during the measurement.
(v)
The attenuation block shall be positioned in the useful
beam 10 cm from the point of measurement of entrance exposure rate and between
this point and the input surface of the fluoroscopic imaging assembly.
(vi)
The collimator shall be fully open when the measurement
is made.
(C)
X-ray field.
(i)
Compliance with clauses (ii)-(vii) of this subparagraph
shall be determined with the beam axis perpendicular to the plane of the image
receptor.
(ii)
Equipment with a fixed SID and the capability of a visible
area of no greater than 300 cm
2
shall be provided
with either stepless adjustment of the x-ray field or a means to further limit
the x-ray field at the image receptor to 125 cm
2
or
less. If the equipment is provided with stepless adjustment, the minimum x-ray
field size at the maximum SID shall be less than or equal to 5 cm by 5 cm
at the image receptor.
(iii)
Equipment with a variable SID or a fixed SID with the
capability of a visible area of greater than 300 cm
2
shall be provided with stepless adjustment of the field size. The
minimum x-ray field size at the maximum SID shall be less than or equal to
5 cm by 5 cm at the image receptor.
(iv)
Neither the length nor the width of the x-ray field in
the plane of the image receptor shall exceed that of the visible area of the
image receptor by more than 3.0% of the SID. The sum of the excess length
and the excess width shall be no greater than 4.0% of the SID.
(v)
For rectangular x-ray fields used with circular image receptors,
the error in alignment shall be determined along the length and width dimensions
of the x-ray field that pass through the center of the visible area of the
image receptor.
(vi)
For fluoroscopic equipment with only a manual mode of
collimation, the x-ray field produced shall be limited to the area of the
spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy,
the beam shall be restricted to the area of the input phosphor.
(vii)
Spot-film devices shall meet the following additional
requirements.
(I)
Means shall be provided between the source and the patient
for adjustment of the x-ray field size in the plane of the film to the size
of that portion of the film that has been selected on the spot-film selector.
(-a-)
Such adjustment shall be automatically accomplished except
when the x-ray field size in the plane of the film is smaller than that of
the selected portion of the film.
(-b-)
The total misalignment of the edges of the x-ray field
with the respective edges of the selected portion of the image receptor along
the length or width dimensions of the x-ray field in the plane of the image
receptor shall not exceed 3.0% of the SID when adjusted for full coverage
of the selected portion of the image receptor.
(-c-)
The sum, without regard to sign of the misalignment along
any two orthogonal dimensions, shall not exceed 4.0% of the SID.
(II)
The center of the x-ray field in the plane of the film
shall be aligned with the center of the selected portion of the film to within
2.0% of the SID.
(2)
Activation of the fluoroscopic tube. X-ray production in
the fluoroscopic mode shall be controlled by a device that requires continuous
pressure by the fluoroscopist for the entire time of the exposure (continuous
pressure type switch). When recording serial fluoroscopic images, the fluoroscopist
shall be able to terminate the x-ray exposures at any time, but means may
be provided to permit completion of any single exposure of the series in process.
(3)
Entrance exposure rate allowable limits.
(A)
The following requirements apply to fluoroscopic equipment
manufactured prior to May 19, 1995.
(i)
Equipment with AERC. Fluoroscopic equipment that is provided
with AERC shall not be operable at any combination of tube potential and current
that will result in an exposure rate in excess of 2.58 x 10
-3
coulomb per kilogram per minute (C/kg/min) (10 roentgens per minute
(10 R/min)) at the point where the center of the useful beam enters the patient,
except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when an optional high-level control is provided. When
so provided, the equipment shall not be operable at any combination of tube
potential and current that will result in an exposure rate in excess of 1.29
x 10
-3
C/kg/min (5 R/min) at the point where
the center of the useful beam enters the patient, unless the high-level control
is activated. Special means of activation of high-level controls shall be
required. The high-level control shall be operable only when continuous manual
activation is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high-level control is being employed.
(ii)
Equipment without AERC (manual mode). Fluoroscopic equipment
that is not provided with AERC shall not be operable at any combination of
tube potential and current that will result in an exposure rate in excess
of 1.29 x 10
-3
C/kg/min (5 R/min) at the point
where the center of the useful beam enters the patient, except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when an optional high-level control is activated. Special
means of activation of high-level controls shall be required. The high-level
control shall be operable only when continuous manual activation is provided
by the operator. A continuous signal audible to the fluoroscopist shall indicate
that the high-level control is being employed.
(iii)
Equipment with both an AERC mode and a manual mode. Fluoroscopic
equipment that is provided with both an AERC mode and a manual mode shall
not be operable at any combination of tube potential and current that will
result in an exposure rate in excess of 2.58 x 10
-3
C/kg/min (10 R/min) in either mode at the point where the center of
the useful beam enters the patient except:
(I)
during recording of fluoroscopic images, excluding last
image hold; or
(II)
when the mode or modes have an optional high-level control,
in which case that mode or modes shall not be operable at any combination
of tube potential and current that will result in an exposure rate in excess
of 1.29 x 10
-3
C/kg/min (5 R/min) at the point
where the center of the useful beam enters the patient, unless the high level
control is activated. Special means of activation of high-level control shall
be required. The high level control shall be operable only when continuous
manual activation is provided by the operator. A continuous signal audible
to the fluoroscopist shall indicate that the high-level is being employed.
(iv)
Measuring compliance. Compliance with subparagraph (A)
of this paragraph shall be determined as follows.
(I)
If the source is below the x-ray table, the exposure rate
shall be measured at 1 cm above the tabletop or cradle.
(II)
If the source is above the x-ray table, the exposure rate
shall be measured at 30 cm above the tabletop with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
(III)
In a C-arm type of fluoroscope, the exposure rate shall
be measured at 30 cm from the input surface of the fluoroscopic imaging assembly
provided that the end of the beam-limiting device or spacer is no closer than
30 cm from the input surface of the fluoroscopic imaging assembly. The applicable
limit shall not be exceeded at any available SID.
(IV)
In a lateral (horizontal) type of fluoroscope, the exposure
rate shall be measured at a point 15 cm from the centerline of the x-ray table
and in the direction of the x-ray source with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
If the table top is movable, it shall be positioned as closely as possible
to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 cm to the centerline of the x-ray table.
(B)
The following requirements apply to fluoroscopic equipment
manufactured on and after May 19, 1995.
(i)
Fluoroscopic equipment operable at any combination of tube
potential and current that will result in an exposure rate greater than 1.29
x 10
-3
C/kg/min (5 R/min) at the point where
the center of the useful beam enters the patient shall be equipped with AERC.
Provision for manual selection of technique factors may be provided.
(ii)
Fluoroscopic equipment shall not be operable at any combination
of tube potential and current that will result in an exposure rate in excess
of 2.58 x 10
-3
C/kg/min (10 R/min) at the point
where the center of the useful beam enters the patient except:
(I)
During the recording of images from an x-ray image-intensifier
tube using photographic film or a video camera when the x-ray source is operated
in a pulsed mode.
(II)
When the high-level control is activated, the equipment
shall not be operable at any combination of tube potential and current that
will result in an exposure rate in excess of 5.16 x 10
-3
C/kg/min (20 R/min) at the point where the center of the useful
beam enters the patient. Special means of activation of high-level controls
shall be required. The high-level control shall only be operable when continuous
manual activation is provided by the operator. A continuous signal audible
to the fluoroscopist shall indicate that the high-level control is being employed.
(iii)
Measuring compliance. Compliance with subparagraph (B)
of this paragraph shall be determined as follows.
(I)
If the source is below the x-ray table, the exposure rate
shall be measured at 1 cm above the tabletop or cradle.
(II)
If the source is above the x-ray table, the exposure rate
shall be measured at 30 cm above the tabletop with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
(III)
In a C-arm type of fluoroscope, the exposure rate shall
be measured at 30 cm from the input surface of the fluoroscopic imaging assembly
provided that the end of the beam-limiting device or spacer is no closer than
30 cm from the input surface of the fluoroscopic imaging assembly. The applicable
limit shall not be exceeded at any available SID.
(IV)
In a lateral (horizontal) type of fluoroscope, the exposure
rate shall be measured at a point 15 cm from the centerline of the x-ray table
and in the direction of the x-ray source with the end of the beam-limiting
device or spacer positioned as closely as possible to the point of measurement.
If the table top is movable, it shall be positioned as closely as possible
to the lateral x-ray source, with the end of the beam-limiting device or spacer
no closer than 15 cm to the centerline of the x-ray table.
(C)
For hand-held fluoroscopes, the exposure rate shall be
measured at the point closest to the source.
(D)
Periodic measurement of entrance exposure rate shall be
performed as follows by a licensed medical physicist [
(i)
Such measurements shall be made within 30 days of installation,
annually, and within 30 days after any maintenance of the system that might
affect the exposure rate.
(ii)
Results of these measurements shall be posted where any
fluoroscopist may have ready access to such results while using the fluoroscope
and maintained in accordance with subsection
(s)(1)
[
(iii)
Conditions of periodic measurement of entrance exposure
rate are as follows.
(I)
The measurement shall be made in accordance with subparagraph
(A)(iv) or (B)(iii) of this paragraph, as applicable.
(II)
X-ray systems that do not incorporate an AERC shall utilize
a milliamperage and kVp typical of the clinical use of the x-ray system. Materials
should be placed in the useful beam between the detection and imaging systems
when conducting these periodic measurements to protect the imaging system.
(III)
X-ray systems that do incorporate an AERC shall have
sufficient material placed in the useful beam to produce a milliamperage and
kVp typical of the clinical use of the x-ray system.
(4)
Measurements of the output rate. Measurements of the output
rate of the fluoroscopic unit shall be performed with a calibrated dosimetry
system. The dosimetry system shall have been calibrated within the preceding
24 months and the calibration shall be traceable to a national standard. During
the calendar year in which the dosimetry system is not calibrated, an intercomparison
to a system calibrated within the previous 12 months shall be performed.
(5)
Indication of potential and current. During fluoroscopy
and cinefluorography, the kV and the mA shall be continuously indicated at
the control panel and/or the fluoroscopist's position.
(6)
Source-to-skin distance (SSD).
(A)
Means shall be provided to limit the SSD
to the following:
(i)
not less than 38 centimeters on stationary
fluoroscopes; and
(ii)
not less than 30 centimeters on mobile
and portable fluoroscopes.
(B)
For image-intensified fluoroscopes intended
for specific surgical application that would be prohibited at the SSDs specified
in subparagraph (A) of this paragraph, provisions may be made for operation
at shorter SSDs, but in no case less than 20 cm. The registrant's written
operating and safety procedures shall provide precautionary measures to be
adhered to during the use of the shorter source to skin distance in accordance
with manufacturer's precautions, if provided.
[
[
[
[
[
(C)
[
(7)
Fluoroscopic timer.
(A)
Means shall be provided to preset the cumulative on-time
of the fluoroscopic x-ray tube. The maximum cumulative time of the timing
device shall not exceed five minutes without resetting.
(B)
A signal audible to the fluoroscopist shall indicate the
completion of any preset cumulative on-time. Such signal shall continue to
sound while x rays are produced until the timing device is reset. In lieu
of such signal, the timer shall terminate the beam after the preset cumulative
on-time is completed.
(8)
Control of scattered radiation.
(A)
Fluoroscopic configuration, including fluoroscopic table
designs, shall not permit any portion of any individual's body, except the
head, neck, and extremities, to be exposed to scattered radiation emanating
from above or below the tabletop unless the radiation has passed through not
less than a total of 0.25 mm lead equivalent material. The material may be,
but is not limited to, drapes, self-supporting curtains, or viewing shields,
in addition to any lead equivalency provided by a protective apron.
(B)
Where sterile fields or special procedures prohibit the
use of normal protective barriers or drapes, all of the following conditions
shall be met.
(i)
All persons, except the patient, in the room where fluoroscopy
is performed shall wear protective aprons that provide a shielding equivalent
of 0.5 mm of lead.
(ii)
The fluoroscopic field size shall be reduced to the absolute
minimum required for the procedure being performed (area of clinical interest).
(iii)
Operating and safety procedures shall reflect the above
conditions, and fluoroscopy personnel shall exhibit awareness of situations
requiring the use and/or nonuse of the protective drapes.
(C)
For image-intensified fluoroscopic equipment with only
a manual mode of collimation, the x-ray field produced shall be limited to
the area of the spot-film cassette at 16 inches above tabletop. Additionally,
during fluoroscopy, the beam shall be restricted to the area of the input
phosphor.
(n)
[
(1)
Equipment requirements shall include the following.
(A)
Warning label. The warning label will meet
the requirements of §289.231(z) of this title.
(B)
The x-ray control shall provide visual
indication of the production of x rays.
(C)
The indicated technique factors shall be
accurate to meet manufacturer's specifications. If these specifications are
not available from the manufacturer, the factors shall be accurate to within
plus or minus 10% of the indicated setting.
(D)
[
(i)
For any single tomogram system, means shall be provided
to permit visual determination of the tomographic plane or a reference plane
offset from the tomographic plane.
(ii)
For any multiple
slice
tomogram system, means
shall be provided to permit visual determination of the location of a reference
plane. The reference plane can be offset from the location of the tomographic
planes.
(iii)
If a device using a light source is used to satisfy the
requirements of clause (i) or (ii) of this subparagraph, the light source
shall provide illumination levels sufficient to permit visual determination
of the location of the tomographic plane or reference plane under ambient
light conditions of up to 500 lux.
(E)
[
(F)
[
(i)
The x-ray control and gantry shall provide visual indication
whenever x rays are produced and, if applicable, whether the shutter is open
or closed.
(ii)
Means shall be provided to require operator initiation
of each individual scan or series of scans.
(iii)
All emergency buttons/switches shall be clearly labeled
as to their functions.
(G)
[
(i)
Means shall be provided to terminate the x-ray exposure
automatically by either de-energizing the x-ray source or shuttering the x-ray
beam in the event of equipment failure affecting data collection. Such termination
shall occur within an interval that limits the total scan time to no more
than 110% of its preset value through the use of either a backup timer or
devices that monitor equipment function.
(ii)
A signal visible to the operator shall indicate when the
x-ray exposure has been terminated through the means required by clause (i)
of this subparagraph.
(iii)
The operator shall be able to terminate the x-ray exposure
at any time during a scan or series of scans under CT x-ray system control,
of greater than 0.5 seconds duration. Termination of the x-ray exposure shall
necessitate resetting of the CT conditions of operation prior to initiation
of another scan.
(H)
[
(i)
The total error in the indicated location of the tomographic
plane or reference plane shall not exceed 5 mm.
(ii)
If the x-ray production period is less than 0.5 seconds,
the indication of x-ray production shall be actuated for at least 0.5 seconds.
Indicators at or near the gantry shall be discernible from any point external
to the patient opening where insertion of any part of the human body into
the primary beam is possible.
(iii)
The deviation of indicated scan increment versus actual
increment shall not exceed plus or minus 1 mm with any mass from 0 to 100
kilograms (kg) resting on the support device. The patient support device shall
be incremented from a typical starting position to the maximum incremented
distance or 30 cm, whichever is less, and then returned to the starting position.
Measurement of actual versus indicated scan increment can be taken anywhere
along this travel.
(2)
Facility design requirements shall include the following.
(A)
Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(B)
Windows, mirrors, closed-circuit television, or an equivalent
shall be provided to permit continuous observation of the patient during irradiation
and shall be so located that the operator can observe the patient from the
control panel.
(i)
Should the viewing system described in subparagraph (B)
of this paragraph fail or be inoperative, treatment shall not be performed
with the unit until the system is restored.
(ii)
In a facility that has a primary viewing system by electronic
means and an alternate viewing system, should the viewing system described
in subparagraph (B) of this paragraph fail or be inoperative, treatment shall
not be performed with the unit until one of the systems is restored.
(3)
Measurements
[
(A)
Performance of the measurements shall be:
(i)
at intervals not to exceed 12 months;
(ii)
when major maintenance, except x-ray tube replacement,
that could affect radiation output is performed; and
(iii)
when a major change in equipment operation is accomplished,
for example, introduction of a new software package.
(B)
Measurements of the radiation output of a CT x-ray system
shall be performed with a calibrated dosimetry system. The dosimetry system
shall have been calibrated within the preceding 24 months and the calibration
shall be traceable to a national standard. During the calendar year in which
the dosimetry system is not calibrated, an intercomparison to a system calibrated
within the previous 12 months shall be performed.
(C)
Records of dose measurements
in this paragraph
shall
be maintained by the registrant in accordance with subsection
(s)(1)
[
(4)
A maintenance schedule shall be developed
and followed
. This schedule shall be included in the registrant's operating and
safety procedures and shall include but may not be limited to the following:
(A)
dose measurements required by paragraph (3)(A) of this
subsection; [
(B)
acquisition of images
by a licensed medical physicist
obtained with phantoms
and
using the same processing mode
and CT conditions of operation as are used to perform dose measurements required
by paragraph (3)(A) of this subsection
; and
[
[
[
(C)
acquisition of images by the registrant
for quality control purposes obtained with phantoms and using protocol and
intervals recommended by the manufacturer or the licensed medical physicist.
(5)
The registrant shall maintain the images
specified in paragraph (4)(B) and (C) of this subsection in accordance with
subsection (s)(1) of this section for inspection by the agency. The images
may be maintained by either of the following methods:
(A)
photographic copies of the images obtained
from the image display device; or
(B)
images stored in digital form.
(o)
[
(1)
For radiographic, fluoroscopic, and CT x-ray systems,
the tests listed in paragraphs (5)-(7) of this subsection shall be performed
by or under the supervision of a licensed medical physicist, at the frequency
listed in the following table.
[
[
(2)
Records of the test results, including any numerical readings
shall be maintained by the registrant in accordance with subsection
(s)(1)
[
(3)
Any items not meeting the specifications of the tests shall
be corrected or repaired. The correction or repair shall begin within 30 days
following the check and shall be performed according to a plan designated
by the registrant. Correction or repair shall be completed no longer than
90 days from discovery unless authorized by the agency. Records of corrections
or repairs shall be maintained by the registrant in accordance with subsection
(s)(1)
[
(4)
The registrant shall ensure that measurements
[
(5)
Radiographic x-ray equipment performance evaluation.
(A)
Timer. The accuracy of the timer shall meet the manufacturer's
specifications. If the manufacturer's specifications are not obtainable, the
timer accuracy shall be plus or minus 10% of the indicated time with testing
performed at 0.5 second.
(B)
Exposure reproducibility. Exposure reproducibility shall
meet the requirements of subsection
(l)(4)
[
(C)
Linearity. mR/mAs stations shall meet the requirements
of subsection
(l)(5)
[
(D)
kVp. If the registrant possesses documentation of the appropriate
manufacturer's kVp specifications, the radiation machine shall meet those
specifications. If the registrant does not possess documentation of the appropriate
manufacturer's kVp specifications, the indicated kVp shall be accurate to
within plus or minus 10% of the indicated setting at no less than three points
over the usual operating range of the machine.
(E)
Tube stability. The x-ray tube shall remain physically
stable during exposures. In cases where tubes are designed to move during
exposure, the registrant shall assure proper and free movement of the unit.
(F)
Collimation. The following items shall meet the requirements
of subsection
(l)(1)
[
(i)
numerical indicators of x-ray field size;
(ii)
light field versus x-ray field congruence;
(iii)
automatic and semi-automatic collimators unless disabled;
and
(iv)
center of x-ray field alignment with center of image receptor.
(G)
Entrance exposure limits. Entrance exposure
limits shall meet the requirements specified in subsection (j) of this section.
(6)
Fluoroscopic x-ray systems and spot film devices equipment
performance evaluation. Fluoroscopic equipment shall meet the requirements
of subsection
(m)(1)(C) and (m)(3) and (4)
[
(7)
CT x-ray systems equipment performance evaluation. CT x-ray
systems shall meet the requirements of subsection
(n)(1)(H) and (n)(3)
[
(p)
[
(1)
Films shall be developed in accordance with the time-temperature
relationships recommended by the film manufacturer. The specified developer
temperature for automatic processing and the time-temperature chart for manual
processing shall be posted in the darkroom. If the registrant determines an
alternate time-temperature relationship is more appropriate for a specific
facility, that time-temperature relationship shall be documented and posted.
(2)
Chemicals shall be replaced according to the chemical manufacturer's
or supplier's recommendations or at an interval not to exceed three months.
(3)
Darkroom light leak tests shall be performed and any light
leaks corrected at intervals not to exceed six months.
(4)
Lighting in the film processing/loading area shall be maintained
with the filter, bulb wattage, and distances recommended by the film manufacturer
for that film emulsion or with products that provide an equivalent level of
protection against fogging.
(5)
Corrections or repairs of the light leaks or other deficiencies
in paragraphs (2)-(4) of this subsection shall be initiated within 72 hours
of discovery and completed no longer than 15 days from detection of the deficiency
unless a longer time is authorized by the agency. Records of the correction
or repairs shall include the date and initials of the individual performing
these functions and shall be maintained in accordance with subsection
(s)(1)
[
(6)
Documentation of the items in paragraphs (2), (3), and
(5) of this subsection shall be maintained at the site where performed and
shall include the date and initials of the individual completing these items.
These records shall be maintained in accordance with subsection
(s)(1)
[
(q)
[
(r)
Digital imaging acquisition systems. Users
of digital imaging acquisition systems shall follow quality assurance/quality
control protocol for image processing established by the manufacturer, or
if no manufacturer's protocol is available, by the registrant. The registrant
shall include the protocols, whether established by the registrant or the
manufacturer, in its operating and safety procedures. The registrant shall
document the frequency at which the quality assurance/quality control protocol
is performed. Documentation shall include the date and initials of the individual
completing the document and shall be maintained at the site where performed
in accordance with subsection (s)(1) of this section for inspection by the
agency.
(s)
[
(1)
Each registrant shall maintain the following records/documents
at each site, including authorized records sites for mobile services at the
time intervals specified, for inspection by the agency. The records may be
maintained in electronic format.
[
(2)
Records required in
items F and S of the graphic figure
in paragraph 1
[
(A)
manufacturer's name, model and serial number [
(B)
unique identification of the calibrated
dosimetry system and results of the intercomparison; and
[
(C)
name of the individual recording the information.
(3)
Copies of the records/documents in
items (A)-(D),
(H), (J), and (N)-(Q) of the graphic figure in paragraph 1
[
(t)
[
(1)
posting notices to workers in accordance with §289.203(b)
of this title;
(2)
instructions to workers in accordance with §289.203(c)
of this title;
(3)
notifications and reports to individuals in accordance
with §289.203(d) of this title;
(4)
ordering x-ray exams in accordance with §289.231(b)(1)
of this title;
(5)
occupational dose requirements in accordance with §289.231(m)
of this title;
(6)
personnel monitoring requirements in accordance with §289.231(n),
(q), and (s) of this title;
(7)
posting of a radiation area in accordance with §289.231(x)
of this title;
(8)
use of a technique chart in accordance with subsection
(i)(1) of this section;
(9)
use of protective devices in accordance with subsection
(i)(4) of this section;
(10)
credentialing requirements for individuals operating radiation
machines in accordance with subsection (i)(5) of this section;
(11)
exposure of individuals other than the patient in accordance
with subsection (i)(7) of this section;
(12)
holding of patients or image receptors in accordance with
subsection (i)(8) of this section;
(13)
gonadal shielding in accordance with subsection
(i)(13)
[
[
(14)
[
(15)
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400296
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.231
The Texas Department of Health (department) proposes an amendment
to §289.231, concerning general provisions and standards for protection
against machine-produced radiation.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.231
has been reviewed, and the department has determined that the reasons for
adopting the section continue to exist; however, revisions to the rule are
necessary as outlined in this preamble.
The department published a Notice of Intention to Review for §289.231
regarding Government Code, §2001.039, in the
Texas Register
(28 TexReg 6029) on August 1, 2003. No comments were
received by the department on this section following publication of this notice.
The Bureau of Radiation Control (BRC) is reallocating resources for regulation
of x-ray and nonionizing radiation based on prioritization of risk to public
health and safety. Rules governing the use of radiation machines in the healing
arts are revised to reflect this prioritization. Risk to public health and
safety is primarily based on machine type and type of use rather than the
category of facility in which the machines are used. A definition of "Act,"
which is the statutory authority for the BRC rules, is added as it was inadvertently
omitted from a previous version. The words "with license in good standing"
are deleted from the definitions of chiropractor, dentist, physician, podiatrist,
and veterinarian because they are unnecessary. The word "registrant" is changed
to "person" in the definition of dosimetry processor because dosimetry processors
are no longer registered by the department. They are required to be certified
by the National Voluntary Laboratory Accreditation Program, so it is unnecessary
to also require them to register. The definition of laser radiation is changed
as a result of Health and Safety Code, §401.003(17). The wording in the
requirements for occupational dose, including the definition of shallow dose
equivalent, is being revised for clarification to be compatible with the United
States Nuclear Regulatory Commission. Requirements providing for on-site routine
inspections and remote inspections to be alternated are added for facilities
using minimal threat radiation machines and radiation machines used for podiatry.
A definition of remote inspection is added. The requirement in the certificate
of registration referencing the time period an individual monitoring device
shall be worn is deleted because the department no longer regulates dosimetry
processors. Other references to certificates of registration for dosimetry
processors in the requirements for general surveys and monitoring are deleted
for the same reason. The requirement to make and maintain receipt, transfer,
and disposal records for radiation machines is deleted and moved to §289.226
of this title (relating to Registration of Radiation Machine Use and Services).
The word "medical" has been added to language relating to training for inspectors
to clarify that the training applies specifically to radiation machines used
for medical purposes. The inspection intervals are changed to reflect a more
frequent interval for those machines that present a higher risk versus those
with lower or minimal risk. Definitions of machine types and types of use
are added to reflect the new categories based on prioritization of risk. Electron
microscopes have been removed from the list of minimal threat devices and
will no longer be required to be registered. The term, "airport baggage x-ray"
has been deleted since these machines are now under the jurisdiction of the
Transportation Security Administration. Other minor grammatical changes are
made and reference citations are corrected for clarification.
This amendment is part of the department's continuing effort to update,
clarify, and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, or other
factors.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section is in effect, the public benefit anticipated as
a result of enforcing the section will be to ensure continued protection of
the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific and that use of those machines
that pose a higher risk have the appropriate resource allocation. There will
be no fiscal impact on applicants/licensees that are small businesses, micro-businesses
or other persons required to comply with the rule. No additional costs will
be incurred because no new requirements are added. The revisions correct reference
citations and clarify the intent. There is no anticipated impact on local
employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
February 10, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with the authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The amendment affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.231.General Provisions and Standards for Protection Against Machine-Produced Radiation.
(a) - (b)
(No change.)
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning, unless the context clearly
indicates otherwise.
(1)
(No change.)
(2)
Act - Texas Radiation Control Act, Health
and Safety Code, Chapter 401.
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(22)
[
(23)
[
(24)
[
(25)
[
(26)
[
(27)
[
(28)
[
(29)
[
(A)
individual monitoring devices; or
(B)
survey data.
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
(37)
[
(38)
[
(39)
[
(40)
[
(41)
[
(42)
[
(A)
no deliberate exposure of an individual occurs;
(B)
the radiation is not emitted in an open beam configuration;
and
(C)
no known physical injury to an individual has occurred.
(43)
[
(44)
[
(45)
[
(46)
[
(47)
[
(48)
[
(49)
[
(50)
[
(51)
[
(52)
[
(53)
[
(54)
[
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
radiation emitted to energy density levels that could
reasonably cause bodily harm from an electronic device
[
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(55)
[
(56)
[
(57)
[
(58)
[
(59)
[
(60)
[
(61)
Remote inspection - An examination by
the agency of information submitted by the registrant on a form provided by
the agency.
(62)
[
(A)
theoretical analysis, exploration, or experimentation;
or
(B)
the extension of investigative findings and theories of
a scientific or technical nature into practical application for experimental
and demonstration purposes, including the experimental production and testing
of models, devices, equipment, materials, and processes.
(63)
[
(64)
[
(65)
[
(66)
[
(67)
[
(68)
[
(69)
[
(70)
[
(71)
[
(72)
[
(73)
[
(74)
[
(75)
[
(76)
[
(77)
[
(78)
[
(79)
[
(80)
[
(81)
[
(82)
[
(d) - (f)
(No change.)
(g)
Violations.
A court
[
(h) - (i)
(No change.)
(j)
Interpretations. Except as specifically authorized by the
agency in writing, no interpretation of the meaning of this chapter by any
officer or employee of the agency other than a written
legal
interpretation
by the
agency,
[
(k)
Mean quality factors and absorbed dose equivalencies.
(1)
(No change.)
(2)
If it is more convenient to measure the neutron fluence
rate than to determine the neutron dose equivalent rate in sievert per hour
or rem per hour, as provided in paragraph (1) of this subsection, 1 rem (0.01
Sv) of neutron radiation of unknown energies may, for purposes of this section,
be assumed to result from a total fluence of 25 million neutrons per square
centimeter incident upon the body. If sufficient information exists to estimate
the approximate energy distribution of the neutrons, the licensee or registrant
may use the fluence rate per unit DE or the appropriate Q value from the following
table to convert a measured tissue dose in rad (gray) to DE in rem (Sv).
(l)
(No change.)
(m)
Occupational dose limits.
(1)
The registrant shall control the occupational dose to individuals
to the following dose limits.
(A)
(No change.)
(B)
The annual limits to the lens of the eye, to the skin
of the whole body,
and to the
skin of the
extremities shall
be:
(i)
an LDE of 15 rems (0.15 Sv); and
(ii)
an SDE of 50 rems (0.5 Sv) to the skin
of the whole
body
, or to
the skin of
any extremity.
(C) - (D)
(No change.)
(2)
The assigned DDE [
(3)
(No change.)
(4)
The DDE, LDE, and SDE may be assessed from surveys[
(5)
(No change.)
(n)
Conditions requiring individual monitoring of occupational
dose.
(1)
(No change.)
(2)
Notwithstanding the requirements of paragraph (1)(A) of
this subsection, no personnel monitoring shall be required for personnel operating
only minimal threat radiation machines as specified in subsection
(ll)(3)
[
(o) - (p)
(No change.)
(q)
Location and use of individual monitoring devices.
(1)
Each registrant shall ensure that individuals who are required
to monitor occupational doses in accordance with subsection (n)(l) of this
section wear and use individual monitoring devices as follows.
(A) - (E)
(No change.)
[
(2) - (3)
(No change.)
(r)
Determination of occupational dose for the current year.
(1) - (4)
(No change.)
(5)
If an individual has incomplete (
for example,
[
(A) - (C)
(No change.)
(6)
Administrative controls established in accordance with
paragraph (4) of this subsection shall be documented and maintained for inspection
by the agency. Occupational dose assessments made in accordance with paragraph
(5) of this subsection and records of data used to make the assessment shall
be maintained for inspection by the agency. The registrant shall retain the
records in accordance with subsection
(ll)(6)
[
(s)
General surveys and monitoring.
(1)
(No change.)
(2)
The registrant shall ensure that instruments and equipment
used for
qualitative and
quantitative radiation measurements, for
example, dose rate, are operable and calibrated:
(A) - (E)
(No change.)
(3)
All individual monitoring devices, except for direct and
indirect reading pocket dosimeters, electronic personal dosimeters, and those
individual monitoring devices used to measure the dose to any extremity, that
require processing to determine the radiation dose and that are used by registrants
to comply with subsection (m) of this section, with other applicable provisions
of this chapter, [
(A)
holding current personnel dosimetry accreditation from
the National Voluntary Laboratory Accreditation Program (NVLAP) of the National
Institute of Standards and Technology;
and
(B)
approved in this accreditation process for the type of
radiation or radiations included in the NVLAP program that most closely approximates
the type of radiation or radiations for which the individual wearing the dosimeter
is monitored
.
[
[
(t)
Control of access to high radiation areas.
(1) - (4)
(No change.)
(5)
The registrant is not required to control entrance or access
to rooms or other areas containing radiation machines capable of producing
a high radiation area as described in this subsection if the registrant has
met all the specific requirements for access and control specified in other
applicable sections of this chapter, such as [
(u)
Control of access to very high radiation areas.
(1)
(No change.)
(2)
The registrant is not required to control entrance or access
to rooms or other areas containing radiation machines capable of producing
a very high radiation area as described in paragraph (1) of this subsection
if the registrant has met all the specific requirements for access and control
specified in other applicable sections of this chapter, such as [
(3)
(No change.)
(v)
(No change.)
(w)
Caution signs. Unless otherwise authorized by the agency,
the standard radiation symbol prescribed shall use the colors magenta, or
purple, or black on yellow background. The standard radiation symbol prescribed
is the three-bladed design as follows:
Figure: 25 TAC §289.231(w) (No change.)
(1)
the cross-hatched area of the symbol is to be magenta,
[
(2)
(No change.)
(x) - (z)
(No change.)
(aa)
Open records.
(1) - (2)
(No change.)
(3)
The agency will determine whether information falls within
one of the exceptions to the Texas Public Information Act. The
agency
[
(4)
(No change.)
(bb)
General provisions for records.
(1)
All records required by this chapter shall
be accurate and factual. These records shall be maintained by the registrant
in accordance with subsection (ll)(6) of this section. Additional record requirements
are specified elsewhere in this chapter.
[
(2) - (4)
(No change.)
(5)
Records required in accordance with [
(6)
Copies of records required in accordance with [
(cc)
Records of surveys.
(1)
Each registrant shall make and maintain records showing
the results of surveys and calibrations required by subsection (s) of this
section. The registrant shall retain these records in accordance with subsection
(ll)(6)
[
(2)
The registrant shall retain the results of surveys to determine
the dose from external sources of radiation used, in the absence of or in
combination with individual monitoring data, in the assessment of individual
DEs in accordance with subsection
(ll)(6)
[
(dd)
Records of individual monitoring results.
(1)
Each registrant shall make and maintain records in accordance
with subsection (r) of this section of the doses received by all individuals
for whom monitoring was required in accordance with subsection (n) of this
section, and records of doses received during accidents, and emergency conditions.
Assessments of DE and records made using units in effect before January 1,
1994, need not be changed. These records shall include, when applicable:
(A)
the DDE to the whole body, LDE, SDE to the skin
of
the whole body
, and SDE to the
skin of any
extremities;
and
(B)
(No change.)
(2)
The registrant shall make entries of the records specified
in paragraph (1) of this subsection at intervals not to exceed one year and
within
90
[
(3) - (4)
(No change.)
(5)
The registrant shall retain each required form or record
required by this subsection
and records used in preparing BRC Form 231-3
or equivalent
in accordance with subsection
(ll)(6)
[
(ee)
Records of dose to individual members of the public.
(1)
(No change.)
(2)
The registrant shall retain the records required by paragraph
(1) of this subsection in accordance with subsection
(ll)(6)
[
(ff) - (gg)
(No change.)
(hh)
Notification of incidents.
(1)
Notwithstanding other requirements for notification, each
registrant shall immediately report each event involving a radiation machine
possessed by the registrant that may have caused or threatens to cause an
individual to receive:
(A) - (B)
(No change.)
(C)
an SDE to the skin
of the whole body
or
to the skin of the
extremities of 250 rads (2.5 grays) or more.
(2)
Each registrant shall, within 24 hours of discovery of
the event, report to the agency each event involving loss of control of a
radiation machine possessed by the registrant that may have caused, or threatens
to cause an individual to receive, in a period of 24 hours:
(A) - (B)
(No change.)
(C)
an SDE to the skin
of the whole body
or
to the skin of the
extremities exceeding 50 rems (0.5 Sv).
(3) - (4)
(No change.)
(ii) - (jj)
(No change.)
(kk)
Inspections.
(1) - (3)
(No change.)
(4)
Inspection
[
(A)
Routine inspections by agency personnel will be made no
more frequently than the intervals specified in subsection
(ll)(2)
[
[
(B)
[
(i)
the persistence or severity of violations found during
an inspection;
(ii)
investigation of an incident or complaint concerning the
facility;
(iii)
a request for an inspection by a worker(s) in accordance
with §289.203 of this title;
(iv)
any change in a facility or equipment that might cause
a significant increase in radiation output or hazard; or
(v)
a mutual agreement between the agency and registrant.
(C)
On-site routine inspections and remote
inspections may be alternated.
(D)
On-site routine inspections and remote
inspections will be alternated for the following:
(i)
facilities possessing and using only radiation
machines defined as minimal threat machines in accordance with subsection
(ll)(3) of this section; and
(ii)
facilities possessing and using only radiographic
machines for podiatry.
(E)
For remote inspection of radiation machines,
each registrant shall respond to a request from the agency for a remote inspection
by perfuming the following:
(i)
completing the remote inspection forms
in accordance with the instructions included with the forms; and
(iii)
returning to the agency the completed
remote inspection forms with documentation of the most recent equipment performance
evaluation performed in accordance with section §289.227(q) of this title,
by the deadline indicated on the form.
(F)
[
(5)
A person who inspects medical [
(6)
Each registrant shall perform, upon instructions from the
agency, or shall permit the agency to perform such reasonable surveys as the
agency deems appropriate or necessary including, but not limited to, surveys
of:
(A)
(No change.)
(B)
facilities
where
[
(C) - (D)
(No change.)
(ll)
Appendices.
(1)
Definitions of Machine Types and Types of Use. For
the purposes of this section, the listed machine types and types of use have
the following meanings:
[
[
(A)
CT - computerized tomography machines used
for medical purposes;
(B)
fluoroscopy - fluoroscopic machines used
for medical purposes;
(C)
accelerators, simulators and other therapeutic
machines used for medical purposes;
(D)
radiographic only - facilities possessing
and using only radiographic machines for medical purposes, including but not
limited to, tomography, chiropractic machines, and bone densitometers;
(E)
podiatric radiographic only - facilities
possessing and using only radiographic machines for podiatry. This category
may also include bone densitometers;
(F)
minimal threat only - facilities possessing
and using only machines defined as minimal threat machines;
(G)
industrial radiography only - facilities
possessing and using radiographic machines for industrial radiography, including
accelerators. This category includes machines used at permanent and temporary
job sites;
(H)
other industrial - facilities possessing
and using radiation machines for other industrial purposes (non-human use),
including diffraction, hand-held light intensifying imaging devices, flash
radiography, accelerators, CT, and fluoroscopy;
(I)
services - persons providing the services
listed in §289.226(b)(10) of this title;
(J)
laser (human use/research/academic) - lasers
used for medical and/or research or academic purposes, including veterinary
use; and
(K)
laser other (industrial/entertainment/services)
- lasers used for industrial purposes, for demonstration/sales, and for stationary/mobile
entertainment light shows. This category also includes facilities that provide
calibration/repair services for lasers and that provide lasers to facilities
for short periods of time.
(2)
Inspection intervals for registrants.
Figure: 25 TAC §289.231(ll)(2)
(3)
[
[
(A)
[
(B)
[
(C)
[
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(4)
[
(A)
Objectives. Training of agency
individuals performing
inspections of
[
(i)
select and operate the necessary testing equipment used
to perform an inspection of radiation machines;
(ii)
utilize radiation protection principles;
(iii)
operate radiation detection instruments;
(iv)
define basic regulatory terminology;
(v)
apply this section regarding radiation machines;
(vi)
perform routine agency inspections of radiation machines;
(vii)
complete agency inspection documentation;
(viii)
demonstrate knowledge of agency ethics, professional,
and technical policies; and
(ix)
successfully achieve the objectives in this subparagraph.
(B)
Initial training program.
(i)
Initial training will be conducted during a six-month period.
(ii)
All training evaluation instruments will be developed
by the agency.
(iii)
Instruments to be used in determining a proficiency level
are as follows:
(I)
evaluation of each inspector's training needs prior to
initial training;
(II)
evaluation of knowledge obtained and verification of tasks
performed by each inspector subsequent to training received by the agency;
and
(III)
evaluation of each inspector's task performance by the
agency.
(C)
Continuing education.
(i)
The agency inspector of radiation machines
for human
use
will accumulate 24 hours of continuing education regarding radiation
machines
for human use
, at intervals not to exceed 24 months. These
hours of continuing education may be acquired as follows:
(I)
documented continuing education earned in an agency-accepted
training format; and
(II)
agency staff meetings.
(ii)
Failure to obtain 24 hours of continuing education within
each 24-month interval may result in a reassessment by the agency of an agency
inspector's proficiency level.
(iii)
After the initial training period, each inspector of
radiation machines
for human use
will be evaluated by the agency,
at intervals not to exceed 12 months.
(D)
Agency proficiency standards. The agency proficiency standards
for agency inspectors of radiation machines
for human use
are as
follows.
(i)
Level I. The agency inspector has not successfully achieved
the objectives in subparagraph (A) of this paragraph after the initial training
period. Additional training is required. Unsupervised inspections will not
be performed.
(ii)
Level II. The agency inspector has partially achieved
the objectives in subparagraph (A) of this paragraph, but has not achieved
the objective in subparagraph (A)(ix) of this paragraph after the initial
training period. Additional training is required. Unsupervised inspections
are not permitted for the type of radiation machines
for human use
for
which the objectives of subparagraph (A)(ix) of this paragraph have not been
achieved. Unsupervised inspections may be performed for the type of radiation
machines
for human use
for which the objectives in subparagraph
(A)(ix) of this paragraph have been successfully achieved.
(iii)
Level III. The agency inspector has successfully achieved
the objectives in subparagraph (A) of this paragraph. Supervision is not required
for routine inspections.
(5)
[
(6)
[
Figure: 25 TAC §289.231(ll)(6)
[
(7)
[
Figure: 25 TAC §289.231(ll)(7) (.pdf)
[
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400293
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.233
The Texas Department of Health (department) proposes new §289.233,
concerning radiation control regulations for radiation machines used in veterinary
medicine.
The new section consolidates requirements that are applicable only to persons
using radiation machines in veterinary medicine from the current requirements
in §289.203 (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 (relating to Fees for Certificates of Registration,
Radioactive Material Licenses, Emergency Planning and Implementation, and
Other Regulatory Services), §289.205 (relating to Hearing and Enforcement
Procedures), §289.226 (relating to Registration of Radiation Machine
Use and Services), §289.227 (relating to Use of Radiation Machines in
the Healing Arts and Veterinary Medicine), and §289.231 (relating to
General Provisions and Standards for Protection Against Machine-Produced Radiation).
The requirements for other types of radiation machines found in those sections
are much lengthier and more complex. Therefore, separating and consolidating
the requirements applicable only to radiation machines used in veterinary
medicine will provide for a more efficient rule and less burden on the persons
required to comply with these requirements.
In addition to the consolidation of requirements, the proposed new rule
incorporates legislation passed by the 78th Legislature, Regular Session.
House Bill (HB) 2292 requires two-year terms for certificates of registration
and requires recovery through fees of 100% of regulatory program costs for
the two-year term of the certificate of registration. Therefore, references
to annual fees are omitted throughout the section. The department is also
simplifying its fee structure for certificates of registration. Registrants
that use radiation machines in veterinary medicine now have one specified
fee of $240 every two years, rather than a base fee plus machine fee. References
to base fee and machine fee are omitted throughout the section. The registrant
will be required to renew the certificate of registration every two years
by paying the required fee and having a satisfactory compliance history. Registrants
will receive a fee bill from the department every two years rather than every
year. The requirement for an annual late payment fee is omitted. Senate Bill
1152, 78th Legislature, Regular Session, directs the department to participate
in Texas Online, an electronic fee payment system developed and maintained
by the Texas Online Authority. Wording is added that authorizes the department
to collect subscription and convenience fees, in amounts determined by the
Texas Online Authority, to recover costs associated with application and renewal
application processing through Texas Online. The implementation of these requirements
is reflected in subsections (g) and (h)(6).
The revision changed references to the Formal Hearing Procedures throughout
the rule to properly cite the references. A definition of "Act," which is
the statutory authority for the radiation control rules, is added as it was
inadvertently omitted from a previous version. The definitions of "notice
of violation," "radiation," "shallow dose equivalent," and "supervision" are
revised to be consistent with language used in other sections in this title.
The definitions of "mobile service operation" and "x-ray equipment" are revised
to more clearly state the intent of the rule. The wording in the requirements
concerning occupational dose, including the definition of shallow dose equivalent,
is clarified to be compatible with the United States Nuclear Regulatory Commission
(NRC), and as an agreement state, Texas must adopt these requirements. The
word "registrant" was replaced with "person" in several subsections because
the applicable requirements are not limited to registrants. The requirements
apply to any person not complying with the provisions of this chapter.
House Bill 253, 78th Legislature, Regular Session, requires the department
to deny a certificate of registration application, amendment or renewal if
the applicant's compliance history reveals a recurring pattern of conduct
that demonstrates a consistent disregard for the regulatory process through
significant violations of the Radiation Control Act or the department's radiation
control rules. The department has defined "a recurring pattern of conduct
that demonstrates a consistent disregard for the regulatory process through
significant violations..." by adding a requirement that states the department
will deny an application if at least three department or judicial orders are
issued that assess administrative or civil penalties against the registrant
or to revoke or suspend the certificate of registration. The requirement is
reflected in subsection (h)(4)(D).
Subsection (h)(5)(A) and (B) includes inventory requirements to ensure
registrants, especially those with multiple radiation machines, are aware
of the location of machines and how many machines the registrant possesses.
The requirements for radiation machines used for loaner or demonstration radiation
machines include specific notification requirements. Language is included
for the expiration and termination subsections to clarify requirements for
the disposition or transfer of radiation machines if a registrant terminates
a certificate of registration or it expires. In subsection (h)(8)(B), clause
(iv) states that a certificate of registration may also be modified, suspended,
or revoked in whole or in part as a result of existing conditions that constitute
a substantial threat to the public health or safety or the environment to
be consistent with language used in other sections of this title. Subsections
(h)(9)(A)(vii) and (h)(9)(G) expand the requirements for requesting reciprocal
recognition to be consistent with language used throughout this chapter. Subsection
(i)(2)(A) specifies that a registrant shall document that each individual
operating a radiation machine has read the operating and safety procedures.
Subsection (i)(5)(S) requires registrants using radiation machines in veterinary
medicine to perform, or cause to be performed, tests necessary to assure proper
function of equipment with the indicated standard for the machine timer, kilovolt
peak, tube stability, and collimation. Paragraphs (6) and (7) of subsection
(i) include only a limited number of requirements for fluoroscopic and CT
x-ray systems used on animals compared to the requirements for fluoroscopic
and CT x-ray systems used on humans. Subsection (i)(11) specifies that users
of digital imaging acquisition systems shall follow quality assurance/quality
control protocols, that such protocols shall be included in the registrant's
operating and safety procedures, and that the frequency at which the protocols
are performed shall be documented. The method by which inspections are performed
is modified based upon a review of how radiation machines used in veterinary
medicine are regulated, compliance history, and the health and safety risk
associated with the use of such machines is reflected in subsection (k)(1)(R)
and (S).
This new rule is part of the department's continuing effort to update,
clarify, and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, other factors,
or to incorporate requirements that are items of compatibility with NRC regulations
because as an agreement state, Texas must adopt compatible requirements.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed. The subscription and convenience fees for electronic
payment of fees as determined by Texas Online will be collected by the department
and paid directly to the Texas Online Authority to offset the costs to state
government for operating Texas Online.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section will be in effect, the public benefit anticipated
as a result of enforcing the section will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific and that those persons required
to operate radiation machines do so in ways that ensure such protection. There
will be fiscal impact on applicants/licensees that are small businesses, micro-businesses
or other persons required to comply with the rule. The fee amounts will increase
for some registrants and will decrease for others because the department is
implementing one specified fee, rather than a base fee plus a machine fee.
Approximately 19% of veterinary registrants will have an average decrease
in fee of $25. Approximately 81% will have an average increase in fee of $5.
There will also be an additional cost to registrants ranging from $25 to $150
per radiographic machine to have the equipment performance evaluations performed
for the radiographic machines that are required every five years. When implemented,
the subscription and convenience fees determined by Texas Online will be $10
for credit card use by registrants. There is no anticipated impact on local
employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:00 p.m., Tuesday,
February 10, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The new rule is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with the authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The new rule affects Health and Safety Code, Chapters 12 and 401.
§289.233.Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine.
(a)
Purpose. This section establishes the following.
(1)
Fees for certificates of registration for veterinary facilities
and provisions for their payment.
(2)
Requirements for the registration of persons using radiation
machines. No person shall use radiation machines except as authorized in a
certificate of registration issued by the agency in accordance with the requirements
of this section. A person who receives, possesses, uses, owns, or acquires
radiation machines prior to receiving a certificate of registration is subject
to the requirements of this chapter.
(3)
Requirements intended to control the receipt, possession,
use, and transfer of radiation machines by any person so the total dose to
an individual, including doses resulting from all radiation machines other
than background radiation, does not exceed the standards for protection against
radiation prescribed in this section. However, nothing in this section shall
be construed as limiting actions that may be necessary to protect health and
safety in an emergency.
(4)
Requirements for the use of radiation machines used in
veterinary medicine. The registrant shall assure that the requirements of
this section are met in the operation of such radiation machines.
(5)
Specific record keeping requirements and general provisions
for records and reports.
(6)
Requirements for providing notices to employees and instructions
and options available to such individuals in connection with agency inspections
of registrants to ascertain compliance with the provisions of the Texas Radiation
Control Act (Act), Health and Safety Code, Chapter 401, and requirements of
this chapter, orders, and certificates of registration issued thereunder regarding
radiological working conditions.
(7)
Governing of the following in accordance with the Act,
Health and Safety Code, Chapter 401; the Texas Administrative Procedure Act,
Texas Government Code, Chapter 2001; Title 1, Texas Administrative Code (TAC),
Chapter 155; and the Formal Hearing Procedures, §§1.21, 1.23, 1.25,
and 1.27 of this title (relating to the Texas Board of Health).
(A)
proceedings for the granting, denying, renewing, transferring,
amending, suspending, revoking, or annulling of a certificate of registration;
(B)
determining compliance with or granting of exemptions from
requirements of this chapter, an order, or a condition of certificate of registration;
(C)
assessing administrative penalties; and
(D)
determining propriety of other agency orders.
(b)
Scope.
(1)
Except as specifically provided in other sections of this
chapter, this section applies to persons who receive, possess, use, or transfer
radiation machines used in veterinary medicine. The dose limits in this section
do not apply to doses due to background radiation or voluntary participation
in medical research programs. No radiation may be deliberately applied to
animals except by or under the supervision of a veterinarian authorized by
the Texas Board of Veterinary Medical Examiners to engage in veterinary medicine.
(2)
Registrants who are also registered by the agency to receive,
possess, acquire, transfer, or use class IIIb and class IV lasers in veterinary
medicine shall also comply with the requirements of §289.301 of this
title (relating to Registration of Radiation Safety Requirements for Lasers).
(3)
Registrants who are also registered by the agency to receive,
possess, transfer, or use accelerators, therapeutic radiation machines, and
radiation therapy simulation systems for use in veterinary medicine shall
also comply with the requirements of §289.229 of this title (relating
to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines,
and Simulators).
(4)
Registrants who are also licensed by the agency to receive,
possess, use, and transfer radioactive materials must also comply with the
applicable requirements of §289.201 of this title (relating to General
Provisions for Radioactive Material), §289.202 of this title (relating
to Standards for Protection Against Radiation from Radioactive Materials), §289.252
of this title (relating to Licensing of Radioactive Material), §289.256
of this title (relating to Medical and Veterinary Use of Radioactive Material),
and §289.257 of this title (relating to Packaging and Transportation
of Radioactive Material).
(5)
The agency may, by requirements in this chapter, an order,
or a condition of certificate of registration, impose upon any registrant
such requirements in addition to those established in this chapter as it deems
appropriate or necessary to minimize danger to public health and safety or
property or the environment.
(c)
Definitions.
(1)
Absorbed dose--The energy imparted by ionizing radiation
per unit mass of irradiated material. The units of absorbed dose are the gray
(Gy) and the rad.
(2)
Accessible surface--The external surface of the enclosure
or housing provided by the manufacturer.
(3)
Act--Texas Radiation Control Act, Health and Safety Code,
Chapter 401.
(4)
Administrative Law Judge (ALJ)--Administrative law judge
from the State Office of Administrative Hearings.
(5)
Administrative penalty--A monetary penalty assessed by
the agency in accordance with the Act, Health and Safety Code, §401.384,
to emphasize the need for lasting remedial action and to deter future violations.
(6)
Adult--An individual 18 or more years of age.
(7)
Agency--The Texas Department of Health.
(8)
Agreement State--Any state with which the United States
Nuclear Regulatory Commission (NRC) has entered into an effective agreement
under Section 274b. of the Atomic Energy Act of 1954, as amended (73 Stat.
689).
(9)
As low as is reasonably achievable (ALARA)--Making every
reasonable effort to maintain exposures to radiation as far below the dose
limits in this chapter as is practical, consistent with the purpose for which
the registered activity is undertaken, taking into account the state of technology,
the economics of improvements in relation to the state of technology, the
economics of improvements in relation to benefits to the public health and
safety, and other societal and socioeconomic considerations, and in relation
to utilization of ionizing radiation and radiation machines in the public
interest.
(10)
Attenuate--To reduce the exposure rate upon passage of
radiation through matter.
(11)
Attenuation block--A block or stack, having dimensions
20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other
materials having equivalent attenuation. The nominal chemical composition
of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper.
(12)
Background radiation--Radiation from cosmic sources; non-technologically
enhanced naturally occurring radioactive material, including radon, except
as a decay product of source or special nuclear material, and including global
fallout as it exists in the environment from the testing of nuclear explosive
devices or from past nuclear accidents, such as Chernobyl, that contribute
to background radiation and are not under the control of the registrant. "Background
radiation" does not include radiation from radiation machines regulated by
the agency.
(13)
Barrier--(See definition for protective barrier.)
(14)
Beam axis--A line from the source through the centers
of the x-ray fields.
(15)
Beam-limiting device--A device that provides a means to
restrict the dimensions of the x-ray field.
(16)
Beam quality (diagnostic x-ray)--A term that describes
the penetrating power of the x-ray beam. This is identified numerically by
half-value layer and is influenced by kilovolt peak (kVp) and filtration.
(17)
Board--The Texas Board of Health.
(18)
Certificate of registration--A form of permission given
by the agency to an applicant who has met the requirements for registration
set out in the Act and this chapter.
(19)
Coefficient of variation or C--The ratio of the standard
deviation to the mean value of a population of observations. It is estimated
using the following equation:
Figure: 25 TAC §289.233(c)(19)
(20)
Collective dose--The sum of the individual doses received
in a given period of time by a specified population from exposure to a specified
source of radiation.
(21)
Computed tomography (CT)--The production of a tomogram
by the acquisition and computer processing of x-ray transmission data.
(22)
Control panel--The part of the radiation machine control
upon which are mounted the switches, knobs, push buttons, and other hardware
necessary for manually setting the technique factors.
(23)
CT conditions of operation--All selectable parameters
governing the operation of a CT x-ray system including, but not limited to,
nominal tomographic section thickness, filtration, and the technique factors
as defined in this subsection.
(24)
CT gantry--The tube housing assemblies, beam-limiting
devices, detectors, and the supporting structures and frames that hold these
components.
(25)
Declared pregnant woman--A woman who has voluntarily informed
the registrant, in writing, of her pregnancy and the estimated date of conception.
The declaration remains in effect until the declared pregnant woman voluntarily
withdraws the declaration in writing or is no longer pregnant.
(26)
Deep dose equivalent (DDE), that applies to external whole
body exposure--The DE at a tissue depth of 1 centimeter (cm) (1,000 milligrams
per square centimeter (mg/cm
2
)).
(27)
Diagnostic source assembly--The tube housing assembly
with a beam-limiting device attached.
(28)
Diagnostic x-ray system--An x-ray system designed for
irradiation of any part of any animal for the purpose of diagnosis or visualization.
(29)
Director--The director of the radiation control program
under the agency's jurisdiction.
(30)
Dose--For external exposure to x-ray radiation from radiation
machines, a generic term that means absorbed dose, DE, or total effective
dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent
term.
(31)
Dose equivalent (DE)--The product of the absorbed dose
in tissue, quality factor, and all other necessary modifying factors at the
location of interest. The units of DE are the sievert (Sv) and rem.
(32)
Dose limits--The permissible upper bounds of radiation
doses established in accordance with this chapter. For purposes of this chapter,
"limits" is an equivalent term.
(33)
Embryo/fetus--The developing human organism from conception
until the time of birth.
(34)
Enforcement conference--A meeting held by the agency with
a person to discuss the following:
(A)
safety, safeguards, or environmental problems;
(B)
compliance with regulatory or registration condition requirements;
(C)
proposed corrective measures including, but not limited
to, schedules for implementation; and
(D)
enforcement options available to the agency.
(35)
Exposure--The quotient of dQ by dm where "dQ" is the absolute
value of the total charge of the ions of one sign produced in air when all
the electrons (negatrons and positrons) liberated by photons in a volume element
of air having mass "dm" are completely stopped in air. The SI unit of exposure
is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure.
For purposes of this chapter, this term is used as a noun.
(36)
Exposure rate--The exposure per unit of time.
(37)
External dose--That portion of the DE received from any
source of radiation outside the body.
(38)
Extremity--Hand, elbow, arm below the elbow, foot, knee,
and leg below the knee. The arm above the elbow and the leg above the knee
are considered part of the whole body.
(39)
Field emission equipment--Equipment that uses an x-ray
tube in which electron emission from the cathode is due solely to the action
of an electric field.
(40)
Field size--The dimensions along the major axes of an
area in a plane perpendicular to the central axis of the beam at the normal
treatment or examination source to image distance and defined by the intersection
of the major axes and the 50% isodose line.
(41)
Filter--Material placed in the useful beam to preferentially
absorb selected radiation.
(42)
Fluoroscopic imaging assembly--A subsystem in which x-ray
photons produce a fluoroscopic image. It includes the image receptors such
as the image intensifier and spot-film device, electrical interlocks, if any,
and structural material providing linkage between the image receptor and diagnostic
source assembly.
(43)
Gray (Gy)--The SI unit of absorbed dose. One gray is equal
to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad.
(44)
Half-value layer (HVL)--The thickness of a specified material
that attenuates the beam of radiation to an extent such that the exposure
rate is reduced to one-half of its original value.
(45)
Healing arts--Any system, treatment, operation, diagnosis,
prescription, or practice for the ascertainment, cure, relief, palliation,
adjustment, or correction of any human disease, ailment, deformity, injury,
or unhealthy or abnormal physical or mental condition.
(46)
Hearing--A proceeding to examine an application or other
matter before the agency in order to adjudicate rights, duties, or privileges.
(47)
High radiation area--An area, accessible to individuals,
in which radiation levels from radiation machines external to the body could
result in an individual receiving a DE in excess of 0.1 rem (1 millisievert
(mSv)) in one hour at 30 cm from any source of radiation or from any surface
that the radiation penetrates.
(48)
Image intensifier--A device, installed in its housing,
that instantaneously converts an x-ray pattern into a corresponding light
image of higher energy density.
(49)
Image receptor--Any device, such as a fluorescent screen
or radiographic film, that transforms incident x-ray photons either into a
visible image or into another form that can be made into a visible image by
further transformations.
(50)
Individual--Any human being.
(51)
Individual monitoring--The assessment of DE to an individual
by the use of:
(A)
individual monitoring devices; or
(B)
survey data.
(52)
Individual monitoring devices--Devices designed to be
worn by a single individual for the assessment of DE. For purposes of this
chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples
of individual monitoring devices include, but are not limited to, film badges,
thermoluminescence dosimeters (TLDs), optically stimulated luminescence dosimeters
(OSLs), pocket ionization chambers (pocket dosimeters), and electronic personal
dosimeters.
(53)
Inspection--An official examination and/or observation
including, but not limited to, records, tests, surveys, and monitoring to
determine compliance with the Act and rules, orders, requirements, and conditions
of the agency.
(54)
Ionizing radiation--Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x rays, alpha and
beta particles, high speed electrons, neutrons, and other nuclear particles.
(55)
Irradiation--The exposure of matter to ionizing radiation.
(56)
kV--Kilovolt.
(57)
kVp--Kilovolt peak (See definition for peak tube potential).
(58)
Lead equivalent--The thickness of lead affording the same
attenuation, under specified conditions, as the material in question.
(59)
Lens dose equivalent (LDE)--The external DE to the lens
of the eye at a tissue depth of 0.3 cm (300 mg/cm
2
).
(60)
Lost or missing radiation machine(s)--A radiation machine(s)
whose location is unknown.
(61)
mA--Milliampere.
(62)
Machine-produced radiation--A stimulated emission of radiation
from a manufactured product or device or component part of a manufactured
product or device that has an electronic circuit that during operation can
generate or emit a physical field of radiation.
(63)
mAs--Milliampere-second.
(64)
Member of the public--Any individual, except when that
individual is receiving an occupational dose.
(65)
Minor--An individual less than 18 years of age.
(66)
Mobile service operation--The provision of radiation machines
and personnel at temporary sites for limited time periods. The radiation machines
may be fixed inside a motorized vehicle or may be a portable radiation machine
that may be removed from the vehicle and taken into a facility for use.
(67)
Monitoring--The measurement of radiation and the use of
the results of these measurements to evaluate potential exposures and doses.
For purposes of this chapter, "radiation monitoring" and "radiation protection
monitoring" are equivalent terms.
(68)
Notice of violation--A written statement of one or more
alleged infringements of a legally binding requirement. The notice requires
the person receiving the notice to provide a written statement describing
the following:
(A)
corrective steps taken by the registrant and the results
achieved;
(B)
corrective steps to be taken to prevent recurrence; and
(C)
the projected date for achieving full compliance. The agency
may require responses to notices of violation to be under oath.
(69)
Occupational dose--The dose received by an individual
in the course of employment in which the individual's assigned duties involve
exposure to sources of radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. Occupational dose does not include dose received from background
radiation, from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released in
accordance with this chapter, from voluntary participation in medical research
programs, or as a member of the public.
(70)
Order--A specific directive contained in a legal document
issued by the agency.
(71)
Party--A person designated as such by the hearing examiner.
A party may consist of the following:
(A)
the agency; and
(B)
an applicant, licensee, registrant, accredited mammography
facility, or certified industrial radiographer.
(72)
Peak tube potential--The maximum value of the potential
difference in kilovolts across the x-ray tube during an exposure.
(73)
Person--Any individual, corporation, partnership, firm,
association, trust, estate, public or private institution, group, agency,
local government, any other state or political subdivision or agency thereof,
or any other legal entity, and any legal successor, representative, agent,
or agency of the foregoing, other than the United States Nuclear Regulatory
Commission (NRC) and other federal government agencies licensed or exempted
by the NRC.
(74)
Personnel monitoring equipment--(See definition for individual
monitoring devices.)
(75)
Phototimer--A method for controlling exposures to image
receptors by the amount of radiation that reaches a radiation monitoring device.
The radiation monitoring device is part of an electronic circuit that controls
the duration of time the tube is activated (See definition for automatic exposure
control.)
(76)
Portable x-ray equipment--(See definition for x-ray equipment.)
(77)
Primary protective barrier--(See definition for protective
barrier.)
(78)
Protective apron--An apron made of radiation absorbing
materials used to reduce radiation exposure.
(79)
Protective barrier--A barrier of radiation absorbing materials
used to reduce radiation exposure. The types of protective barriers are as
follows:
(A)
Primary protective barrier--A barrier sufficient to attenuate
the useful beam to the required degree; or
(B)
Secondary protective barrier--A barrier sufficient to attenuate
the stray radiation to the required degree.
(80)
Protective glove--A glove made of radiation absorbing
materials used to reduce radiation exposure.
(81)
Public dose--The dose received by a member of the public
from exposure to sources of radiation released by a licensee or registrant,
or to any other source of radiation under the control of a licensee/registrant.
It does not include occupational dose or doses received from background radiation,
from any medical administration the individual has received, from exposure
to individuals administered radioactive material and released in accordance
with this chapter, or from voluntary participation in medical research programs.
(82)
Rad--The special unit of absorbed dose. One rad is equal
to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 gray).
(83)
Radiation--One or more of the following:
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
radiation emitted to energy density levels that could reasonably
cause bodily harm from an electronic device; or
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(84)
Radiation area--Any area, accessible to individuals, in
which radiation levels could result in an individual receiving a DE in excess
of 0.005 rem (0.05 mSv) in one hour at 30 cm from the radiation machine or
from any surface that the radiation penetrates.
(85)
Radiation machine--Any device capable of producing ionizing
radiation except those devices with radioactive material as the only source
of radiation.
(86)
Radiation safety officer (RSO)--An individual who has
a knowledge of and the authority and responsibility to apply appropriate radiation
protection rules, standards, and practices, who must be specifically authorized
on a certificate of registration, and who is the primary contact with the
agency.
(87)
Radiograph--An image receptor on which the image is created
directly or indirectly by an x-ray exposure and results in a permanent record.
(88)
Registrant--Any person issued a certificate of registration
by the agency in accordance with the Act and this chapter.
(89)
Regulation--(See definition for rule.)
(90)
Rem--The special unit of any of the quantities expressed
as DE. The DE in rem is equal to the absorbed dose in rad multiplied by the
quality factor (1 rem = 0.01 sievert (Sv)).
(91)
Remote inspection--An examination by the agency of information
submitted by the registrant on a form provided by the agency.
(92)
Research and development--Research and development is
defined as:
(A)
theoretical analysis, exploration, or experimentation;
or
(B)
the extension of investigative findings and theories of
a scientific or technical nature into practical application for experimental
and demonstration purposes, including the experimental production and testing
of models, devices, equipment, materials, and processes.
(93)
Restricted area--An area, access to which is limited by
the registrant for the purpose of protecting individuals against undue risks
from exposure to radiation. Restricted area does not include areas used as
residential quarters, but separate rooms in a residential building may be
set apart as a restricted area.
(94)
Roentgen (R)--The special unit of exposure. One roentgen
(R) equals 2.58 x 10
-4
C/kg of air. (See definition
for exposure.)
(95)
Rule--Any agency statement of general applicability that
implements, interprets, or prescribes law or policy, or describes the procedure
or practice requirements of an agency. The term includes the amendment or
repeal of a prior section but does not include statements concerning only
the internal management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as "regulation."
(96)
Scan--The complete process of collecting x-ray transmission
data for the production of a tomogram. Data can be collected simultaneously
during a single scan for the production of one or more tomograms.
(97)
Scan time--The period of time between the beginning and
end of x-ray transmission data accumulation for a single scan.
(98)
Scattered radiation--Radiation that has been deviated
in direction during passage through matter.
(99)
Secondary protective barrier--(See definition for protective
barrier.)
(100)
Severity level--A classification of violations based
on relative seriousness of each violation and the significance of the effect
of the violation on the occupational or public health or safety or the environment.
(101)
Shallow dose equivalent (SDE)--The DE at a tissue depth
of 0.007 cm (7 mg/cm
2
) that applies to the external
exposure of the skin of the whole body or the skin of an extremity.
(102)
Shutter--A device attached to the tube housing assembly
that can totally intercept the useful beam and that has a lead equivalency
not less than that of the tube housing assembly.
(103)
SI--The abbreviation for the International System of
Units.
(104)
Sievert (Sv)--The SI unit of any of the quantities expressed
as DE. The DE in sievert is equal to the absorbed dose in gray multiplied
by the quality factor (1 Sv = 100 rem.)
(105)
Source--The focal spot of the x-ray tube.
(106)
Source of radiation--Any radioactive material, or any
device or equipment emitting or capable of producing radiation.
(107)
Source-to-image receptor distance (SID)--The distance
from the source to the center of the input surface of the image receptor.
(108)
Source-to-skin distance (SSD)--The distance from the
source to the skin of the patient.
(109)
Special units--The conventional units historically used
by registrants, for example, rad (absorbed dose), and rem (DE).
(110)
Spot film--A radiograph that is made during a fluoroscopic
examination to permanently record conditions that exist during that fluoroscopic
procedure.
(111)
Stationary x-ray equipment--(See definition for x-ray
equipment.)
(112)
Stray radiation--The sum of leakage and scattered radiation.
(113)
Supervision--The delegating of the task of applying radiation
in accordance with this section to persons who perform tasks under the veterinarian's
control. The veterinarian assumes full responsibility for these tasks and
shall assure that the tasks will be administered correctly.
(114)
Survey--An evaluation of the radiological conditions
and potential hazards incident to the production, use, transfer, disposal,
and/or presence of radiation machines. When appropriate, such survey includes,
but is not limited to, tests, physical examination of location of equipment,
measurements of levels of radiation present, and evaluation of administrative
and/or engineered controls.
(115)
Technique chart--A chart that provides all necessary
generator control settings and geometry needed to make clinical radiographs
when the radiography system is in manual mode.
(116)
Technique factors--The conditions of operation that are
specified as follows:
(A)
for capacitor energy storage equipment, peak tube potential
in kV and quantity of charge in mAs;
(B)
for field emission equipment rated for pulsed operation,
peak tube potential in kV and number of x-ray pulses;
(C)
for CT equipment designed for pulsed operations, peak tube
potential in kV, scan time in seconds, and either tube current in mA, x-ray
pulse width in seconds, and the number of x-ray pulses per scan or the product
of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(D)
for CT equipment not designed for pulsed operation, peak
tube potential in kV, and either tube current in mA and scan time in seconds
or the product of tube current and exposure time in mAs when the scan time
and exposure time are equivalent; and
(E)
for all other equipment, peak tube potential in kV and
either tube current in mA and exposure time in seconds or the product of tube
current and exposure time in mAs.
(117)
Termination--A release by the agency of the obligations
and authorizations of the registrant under the terms of the certificate of
registration. It does not relieve a person of duties and responsibilities
imposed by law.
(118)
Texas Regulations for Control of Radiation (TRCR)--All
sections of Title 25 Texas Administrative Code (TAC), Chapter 289.
(119)
Total effective dose equivalent (TEDE)--For external
exposures only to x-ray radiation from radiation machines, the TEDE is equal
to the DDE. If an individual receives an occupational dose from both radiation
machines and radioactive materials, the TEDE is the sum of the DDE for external
exposures and the committed effective dose equivalent for internal exposures
as defined in §289.201(b) of this title.
(120)
Tube--An x-ray tube, unless otherwise specified.
(121)
Tube housing assembly--The tube housing with tube installed.
It includes high-voltage and/or filament transformers and other appropriate
elements when such are contained within the tube housing.
(122)
Unrestricted area (uncontrolled area)--An area, access
to which is neither limited nor controlled by the registrant. For purposes
of this chapter, "uncontrolled area" is an equivalent term.
(123)
Useful beam--Radiation that passes through the window,
aperture, cone, or other collimating device of the source housing. Also referred
to as the primary beam.
(124)
Veterinarian--An individual licensed by the Texas Board
of Veterinary Medical Examiners.
(125)
Very high radiation area--An area, accessible to individuals,
in which radiation levels from radiation machines external to the body could
result in an individual receiving an absorbed dose in excess of 500 rads (5
grays) in one hour at 1 meter (m) from a radiation machine or from any surface
that the radiation penetrates. At very high doses received at high dose rates,
units of absorbed dose, gray and rad, are appropriate, rather than units of
DE, Sv and rem.
(126)
Violation--An infringement of any rule, license or registration
condition, order of the agency, or any provision of the Act.
(127)
Whole body--For purposes of external exposure, head,
trunk including male gonads, arms above the elbow, or legs above the knee.
(128)
Worker--An individual engaged in work under a certificate
of registration issued by the agency and controlled by a registrant, but does
not include the registrant.
(129)
X-ray control--A device that controls input power to
the x-ray high-voltage generator and/or the x-ray tube. It includes equipment
such as timers, phototimers, automatic brightness stabilizers, and similar
devices that control the technique factors of an x-ray exposure.
(130)
X-ray equipment--An x-ray system, subsystem, or component
thereof. For the purposes of this rule, types of x-ray equipment are as follows:
(A)
portable x-ray equipment--x-ray equipment mounted on a
permanent base with wheels and/or casters for moving while completely assembled.
Portable x-ray equipment may also include equipment designed to be hand-carried;
or
(B)
stationary x-ray equipment--x-ray equipment that is installed
in a fixed location.
(131)
X-ray field--That area of the intersection of the useful
beam and any one of the set of planes parallel to and including the plane
of the image receptor, whose perimeter is the locus of points at which the
exposure rate is one-fourth of the maximum in the intersection.
(132)
X-ray high-voltage generator--A device that transforms
electrical energy from the potential supplied by the x-ray control to the
tube operating potential. The device may also include means for transforming
alternating current to direct current, filament transformers for the x-ray
tubes, high-voltage switches, electrical protective devices, and other appropriate
elements.
(133)
X-ray system--An assemblage of components for the controlled
production of x rays. It includes minimally an x-ray high-voltage generator,
an x-ray control, a tube housing assembly, a beam-limiting device, and the
necessary supporting structures. Additional components that function with
the system are considered integral parts of the system.
(134)
X-ray subsystem--Any combination of two or more components
of an x-ray system.
(135)
X-ray tube--Any electron tube that is designed to be
used primarily for the production of x rays.
(136)
Year--The period of time beginning in January used to
determine compliance with the provisions of this chapter. The registrant may
change the starting date of the year used to determine compliance by the registrant
provided that the change is made at the beginning of the year and that no
day is omitted or duplicated in consecutive years.
(d)
Exemptions.
(1)
Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration and notification
requirements of this section, provided that the dose equivalent rate averaged
over an area of 10 square centimeters (cm
2
) does
not exceed 0.5 millirem per hour (mrem/hr) at 5 centimeters (cm) from any
accessible surface of such equipment. The production, testing, or factory
servicing of such equipment shall not be exempt.
(2)
Radiation machines in transit or in storage incident to
transit are exempt from the requirements of this section. This exemption does
not apply to the providers of radiation machines for mobile services. Facilities
that have placed all radiation machines in storage, including on-site storage,
and have notified the agency in writing, are exempt from the requirements
of this section. This exemption is void if any radiation machine is energized
resulting in the production of radiation.
(3)
Domestic television receivers and video display terminals,
including the servicing of such devices, are exempt from the requirements
of this section.
(4)
Inoperable radiation machines are exempt from the requirements
of this section. For the purposes of this section, an inoperable radiation
machine means a radiation machine that cannot be energized when connected
to a power supply without repair or modification.
(5)
Financial institutions that take possession of radiation
machines as the result of foreclosure, bankruptcy, or other default of payment
are exempt from the requirements in this section to the extent that they demonstrate
that the unit is operable for the sole purpose of selling, leasing, or transferring.
(6)
Individuals who are sole veterinarians, sole operators,
and the only occupationally exposed individual are exempt from the following
requirements:
(A)
subsection (i)(4)(B) of this "Posting of notices to workers;"
(B)
subsection (i)(3)(G) of this section "Instructions to workers;"
and
(C)
operating and safety procedures in accordance with subsection
(i)(2) of this section.
(e)
Communications.
(1)
Except where otherwise specified, all communications and
reports concerning this chapter and applications filed under them should be
addressed to the Bureau of Radiation Control, Texas Department of Health,
1100 West 49th Street, Austin, Texas, 78756-3189. Communications, reports,
and applications may be delivered in person to the agency's office located
at 8407 Wall Street, Austin, Texas.
(2)
Documents transmitted to the agency will be deemed submitted
on the date of the postmark, telegram, telefacsimile, or electronic media
transmission.
(f)
Interpretations. Except as specifically authorized by the
agency in writing, no interpretation of the meaning of this chapter by any
officer or employee of the agency other than a written legal interpretation
by the agency, will be considered binding upon the agency.
(g)
Fees for certificates of registration for veterinary facilities.
(1)
Payment of fees.
(A)
Each application for a certificate of registration shall
be accompanied by a nonrefundable fee of $240.
(B)
A nonrefundable fee shall be paid for each certificate
of registration for radiation machines used in veterinary medicine. The fee
shall be for the two-year term of the certificate of registration. The fee
shall be paid in full on or before the last day of the expiration month and
year of the certificate of registration. In the case of a single certificate
of registration that authorizes more than one category of use, the category
listed in §289.204(h) of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning and Implementation,
and Other Regulatory Services) and assigned the higher fee will be used. For
each additional use location on a single certificate of registration, the
registrant shall pay an additional $72.
(C)
Each application for reciprocal recognition of an out-of-state
registration in accordance with subsection (h)(9) of this section shall be
accompanied by the $240 fee, provided that no such fee has been submitted
within 24 months of the date of commencement of the proposed activity.
(D)
Fee payments shall be in cash or by check or money order
made payable to the Texas Department of Health. The payments may be made by
personal delivery to the central office, Bureau of Radiation Control, Texas
Department of Health, 1100 West 49th Street, Austin, Texas, or mailed to the
Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street,
Austin, Texas, 78756-3189.
(2)
Failure to pay prescribed fees.
(A)
In any case where the agency finds that an applicant for
a certificate of registration has failed to pay the fee prescribed in this
section, the agency will not process that application until such fee is paid.
(B)
In any case where the agency finds that a registrant has
failed to pay a fee prescribed by this section by the due date, the certificate
of registration has expired and the agency may implement compliance procedures
as provided in subsection (k)(2) of this section.
(3)
Fees for Texas Online participation. For all applications
and renewal applications, the department is authorized to collect subscription
and convenience fees, in amounts determined by the Texas Online Authority,
to recover costs associated with application and renewal application processing
through Texas Online.
(h)
Registration of radiation machine use.
(1)
Requirements for application for registration for use of
radiation machines for veterinary medicine.
(A)
Each person having a radiation machine used in veterinary
medicine shall apply for registration with the agency within 30 days after
beginning use of the radiation machine, except for mobile services that shall
be registered in accordance with subsection (h)(2) of this section.
(B)
Application for registration shall be completed on forms
prescribed by the agency and shall contain all the information required by
the form and accompanying instructions.
(C)
The applicant shall be qualified by reason of training
and experience to use the radiation machine for the purpose requested in accordance
with this section in such a manner as to minimize danger to occupational and
public health and safety.
(D)
The applicant's proposed equipment, facilities, and operating
and safety procedures shall be adequate to minimize danger to occupational
and public health and safety.
(E)
A radiation safety officer (RSO) shall be designated on
each application form. The qualifications of that individual shall be submitted
to the agency with the application.
(i)
The RSO shall have the following qualifications:
(I)
knowledge of potential hazards and emergency precautions;
and
(II)
completed educational courses related to ionizing radiation
safety or a radiation safety officer course; or
(III)
experience in the use and familiarity of the type of
equipment used; and
(ii)
In addition to the qualifications in clause (i) of this
subparagraph, documentation of the following shall be submitted to the agency:
(I)
for veterinarian RSOs, veterinary license board number;
or
(II)
for non-veterinarian RSOs, two years minimum experience
in the use of radiation machines in veterinary medicine under the supervision
of a licensed veterinarian.
(iii)
The RSO identified on a certificate of registration issued
before September 1, 1993, need not comply with the training requirements in
this subsection.
(iv)
Specific duties of the RSO include, but are not limited
to, the following:
(I)
establishing and overseeing operating and safety procedures
that maintain radiation exposures as low as reasonably achievable (ALARA),
and to review them regularly to ensure that the procedures are current and
conform with this chapter;
(II)
ensuring that individual monitoring devices are properly
used by occupationally-exposed personnel, that records are kept of the monitoring
results, and that timely notifications are made as required by subsections
(i)(4)(B) and (C) and (j)(3)(B)-(D) of this section;
(III)
investigating and reporting to the agency each known
or suspected case of radiation exposure to an individual or radiation level
detected in excess of limits established by this chapter and each theft or
loss of source(s) of radiation, determining the cause, and taking steps to
prevent its recurrence;
(IV)
having a thorough knowledge of management policies and
administrative procedures of the registrant and keeping management informed
on a periodic basis of the performance of the registrant's radiation protection
program, if applicable;
(V)
assuming control and having the authority to institute
corrective actions including shut-down of operations when necessary in emergency
situations or unsafe conditions;
(VI)
making and maintaining records as required by this chapter;
and
(VII)
ensuring that personnel are adequately trained and complying
with this chapter, the conditions of the certificate of registration, and
the operating and safety procedures of the registrant.
(F)
An application for use of radiation machines for veterinary
medicine shall be signed by a licensed veterinarian. The signature of the
administrator, president, or chief executive officer will be accepted in lieu
of a veterinarian's signature if the facility has more than one veterinarian
who may direct the operation of radiation machines. The application shall
also be signed by the RSO if the RSO is someone other than the licensed veterinarian.
(G)
Each application for a certificate of registration shall
be accompanied by the fee prescribed in subsection (g) of this section. No
application will be accepted for filing or processed prior to payment of the
full amount specified.
(H)
Each application shall be accompanied by a completed BRC
Form 226-1 (Business Information Form).
(I)
The agency may at any time after the filing of the original
application, require further statements in order to enable the agency to determine
whether the certificate of registration should be issued or denied.
(J)
An application for a certificate of registration may include
a request for a certificate of registration authorizing one or more activities.
(K)
Applications and documents submitted to the agency may
be made available for public inspection except that the agency may withhold
any document or part thereof from public inspection in accordance with subsection
(j)(1)(K)-(N) of this section.
(2)
Application for registration of mobile service operation
used in veterinary medicine. In addition to the requirements of paragraph
(1) of this subsection, as applicable, each applicant shall apply for and
receive authorization for mobile service operation before beginning mobile
service operation. The following shall be submitted:
(A)
an established main location where the machine(s), records,
etc. will be maintained for inspection. This shall be a street address, not
a post office box number;
(B)
a sketch or description of the normal configuration of
each radiation machine's use, including the operator's position and any ancillary
personnel's location during exposures. If a mobile van is used with a fixed
unit inside, furnish the floor plan indicating protective shielding and the
operator's location; and
(C)
a current copy of the applicant's operating and safety
procedures regarding radiological practices for protection of operators, employees,
and the general public.
(3)
Issuance of certificate of registration.
(A)
Upon a determination that an application meets the requirements
of the Act and the requirements of the agency, the agency may issue a certificate
of registration authorizing the proposed activity in such form and containing
such conditions and limitations as the agency deems appropriate or necessary.
(B)
The agency may incorporate in the certificate of registration
at the time of issuance, or thereafter by amendment, such additional requirements
and conditions with respect to the registrant's possession, use, and transfer
of radiation machines subject to this chapter as it deems appropriate or necessary
in order to:
(i)
minimize danger to occupational and public health and safety;
(ii)
require additional reports and the keeping of additional
records as may be appropriate or necessary; and
(iii)
prevent loss or theft of radiation machines subject to
this section.
(4)
Specific terms and conditions of certificates of registration.
(A)
Each certificate of registration issued in accordance with
this section shall be subject to the applicable provisions of the Act, now
or hereafter in effect, and to the applicable requirements of this chapter
and orders of the agency.
(B)
No certificate of registration issued or granted under
this section shall be transferred, assigned, or in any manner disposed of,
either voluntarily or involuntarily, to any person unless the agency authorizes
the transfer in writing.
(C)
Each person registered by the agency for radiation machine
use in accordance with this section shall confine use and possession of the
radiation machine registered to the locations and purposes authorized in the
certificate of registration.
(D)
In making a determination whether to grant, deny, amend,
renew, revoke, suspend, or restrict a certificate of registration, the agency
may consider the technical competence and compliance history of an applicant
or holder of a certificate of registration. After an opportunity for a hearing,
the agency shall deny an application for a certificate of registration, an
amendment to a certificate of registration, or renewal of a certificate of
registration if the applicant's compliance history reveals that at least three
agency or judicial orders have been issued against the applicant that assess
administrative or civil penalties against the applicant, or that revoke or
suspend the certificate of registration.
(5)
Responsibilities of the registrant.
(A)
Each registrant shall inventory all radiation machines
at an interval not to exceed one year. The inventory shall be made and maintained
for inspection by the agency in accordance with subsection (j)(2) of this
section and shall include:
(i)
manufacturer's name;
(ii)
model and serial number of the control panel; and
(iii)
location of radiation machine(s), for example, room number.
(B)
Notification to the agency concerning radiation machine
inventory is required within 30 days of either of the following:
(i)
any change in the category(ies) of machine type or type
of use as authorized in the certificate of registration (for example, addition
of a computerized tomography machine to the authorized veterinary radiographic
machine); or
(ii)
any increase in the number of machines authorized by the
certificate of registration in any machine type or type of use category.
(C)
The registrant shall notify the agency in writing of any
changes that would render the information contained in the application for
registration and/or the certificate of registration inaccurate. Notification
is required within 30 days of the following changes:
(i)
name and mailing address;
(ii)
street address where machine will be used;
(iii)
RSO; or
(iv)
name of entity contracted for "provider of equipment,"
registered in accordance with §289.226 of this title (relating to Registration
of Radiation Machines Use and Services.)
(D)
The following criteria applies to radiation machines used
for loaner or demonstration radiation machines. For persons having a valid
certificate of registration, radiation machines used for loaner or demonstration
radiation machines may be used for up to 60 days. After 60 days, the registrant
shall notify the agency of the following:
(i)
any change in the category(ies) of machine type or type
of use as authorized in the certificate of registration (for example, addition
of a computerized tomography machine to the authorized veterinary radiographic
machine); or
(ii)
any increase in the number of machines authorized by the
certificate of registration in any machine type or type of use category.
(E)
No registrant shall engage any person for services described
in §289.226(b)(9) and (10) of this title until such person provides to
the registrant evidence of registration with the agency.
(F)
Records of training and experience required by this section
shall be made and maintained by the registrant for inspection by the agency
until disposal is authorized by the agency.
(G)
The following applies to voluntary or involuntary petitions
for bankruptcy.
(i)
Each registrant shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
by the registrant or its parent company. This notification shall include:
(I)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(II)
the date of the filing of the petition.
(ii)
A copy of the "petition for bankruptcy" shall be submitted
to the agency along with the written notification.
(H)
The registrant is responsible for complying with this chapter
and the conditions of the certificate of registration.
(I)
No person shall use radiation machines that are not authorized
in the certificate of registration issued by the agency.
(J)
Records of training and experience required by this section
shall be maintained for inspection by the agency until disposal is authorized
by the agency.
(6)
Expiration of certificates of registration.
(A)
Effective September 1, 2004, the term of the certificate
of registration is two years. Each certificate of registration expires at
the end of the day, in the month and year stated in the certificate of registration.
Upon payment of the fee required by subsection (g) of this section and if
the agency does not deny the renewal in accordance with paragraph (4)(D) of
this subsection, the certificate of registration will be renewed.
(B)
If the fee is not paid and the certificate of registration
is not renewed in accordance with subparagraph (A) of this paragraph, the
certificate of registration expires, and the registrant is in violation of
the requirements in this chapter and is subject to administrative penalties
in accordance with §289.205 of this title.
(i)
If the registrant pays the fee required by §289.204
of this title within 30 days after expiration of the certificate of registration,
the certificate of registration will be reinstated and the registrant will
not be required to file an application in accordance with subsection (h) of
this section.
(ii)
If the registrant fails to pay the fee within 30 days
after expiration of the certificate of registration, the registrant shall
file an application in accordance with subsection (h) of this section.
(C)
If a registrant fails to pay the fee required by subsection
(g) of this section and the certificate of registration is not renewed, the
registrant shall:
(i)
terminate use of all radiation machines and/or terminate
radiation machine servicing or radiation services within 30 days following
the expiration date; and
(ii)
submit to the agency a record of the disposition of the
radiation machines and if transferred, to whom transferred within 30 days
following the expiration date.
(D)
Expiration of the certificate of registration does not
relieve the registrant of the requirements of this chapter.
(7)
Termination of certificates of registration. When a registrant
decides to terminate all activities involving radiation machines authorized
under the certificate of registration, the registrant shall notify the agency
immediately and do the following:
(A)
request termination of the certificate of registration
in writing;
(B)
submit to the agency a record of the disposition of the
radiation machines and if transferred, to whom transferred; and
(C)
pay any outstanding fees in accordance with subsection
(g) of this section.
(8)
Modification, suspension, and revocation of certificates
of registration.
(A)
The terms and conditions of all certificates of registration
shall be subject to revision or modification. A certificate of registration
may be suspended or revoked by reason of amendments to the Act, by reason
of requirements of this chapter or orders issued by the agency.
(B)
Any certificate of registration may be revoked, suspended,
or modified, in whole or in part, for any of the following:
(i)
any material false statement in the application or any
statement of fact required under provisions of the Act;
(ii)
conditions revealed by such application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a certificate of registration on an original
application;
(iii)
violation of, or failure to observe any of the terms
and conditions of the Act, this chapter, the certificate of registration,
or order of the agency; or
(iv)
existing conditions that constitute a substantial threat
to the public health or safety or the environment.
(C)
Each certificate of registration revoked by the agency
ends at the end of the day on the date of the agency's final determination
to revoke the certificate of registration, or on the revocation date stated
in the determination, or as otherwise provided by the agency order.
(D)
Except in cases in which the occupational and public health
or safety requires otherwise, no certificate of registration shall be suspended
or revoked unless, prior to the institution of proceedings therefore, facts
or conduct that may warrant such action shall have been called to the attention
of the registrant in writing and the registrant shall have been afforded an
opportunity to demonstrate compliance with all lawful requirements.
(9)
Reciprocal recognition for out-of-state certificates of
registration.
(A)
Whenever any radiation machine is to be brought into the
state for any temporary use, the person proposing to bring the machine into
the state shall apply for and receive a notice from the agency granting reciprocal
recognition prior to beginning operations. The request for reciprocity shall
include the following:
(i)
completed BRC Form 226-1 (Business Information Form);
(ii)
completed BRC Form 252-3 (Notice of Intent to Work in
Texas Under Reciprocity);
(iii)
name and Texas licensing board number of the veterinarian
if the machines are used to irradiate animals;
(iv)
copy of the applicant's current state certificate of registration
or equivalent document;
(v)
copy of the applicant's current operating and safety procedures
pertinent to the proposed use;
(vi)
fee as specified in subsection (g) of this section; and
(vii)
qualifications of personnel who will be operating the
machines.
(B)
Upon a determination that the request for reciprocity meets
the requirements of the agency, the agency may issue a notice granting reciprocal
recognition authorizing the proposed use.
(C)
Once reciprocity is granted, the out-of-state registrant
shall file a BRC Form 252-3 with the agency prior to each entry into the state.
This form shall be filed at least three working days before the radiation
machine is to be used in the state. If, for a specific case, the three-day
period would impose an undue hardship, the out-of-state registrant may, at
the determination of the agency, obtain permission to proceed sooner.
(D)
When radiation machines are used as authorized under reciprocity,
the out-of-state registrant shall have the following in its possession at
all times for inspection by the agency:
(i)
completed BRC Form 252-3;
(ii)
copy of the notice from the agency granting reciprocity;
(iii)
copy of the out-of-state registrant's operating and safety
procedures; and
(iv)
copy of the applicable rules as specified in the notice
granting reciprocity.
(E)
If the state from which the radiation machine is proposed
to be brought does not issue certificates of registration or equivalent documents,
a certificate of registration shall be obtained from the agency in accordance
with the requirements of this section.
(F)
The agency may withdraw, limit, or qualify its acceptance
of any certificate of registration or equivalent document issued by another
agency upon determining that such action is necessary in order to prevent
undue hazard to occupational and public health and safety or property.
(G)
Reciprocal recognition will expire one year from the date
it is granted. A new request for reciprocity shall be submitted to the agency
each year. Reciprocity requests made after the initial request shall include
only the following:
(i)
a completed BRC Form 226-1;
(ii)
a completed BRC Form 252-3;
(iii)
the fee as specified in subsection (g) of this section;
and
(iv)
copy of the applicant's current state certificate of registration
or equivalent document;
(v)
copy of the applicant's current operating and safety procedures
pertinent to the proposed use; and
(vi)
qualifications of personnel who will be operating the
machines.
(i)
Use of radiation machines for veterinary medicine.
(1)
As low as reasonably achievable. The registrant shall use,
to the extent practical, procedures and engineering controls based upon sound
radiation protection principles to achieve occupational doses and public doses
that are as low as reasonably achievable.
(2)
Operating and safety procedures. Each registrant shall
have and implement written operating and safety procedures. These procedures
shall be made available to each individual operating a radiation machine,
including any restrictions of the operating technique required for the safe
operation of the particular x-ray system.
(A)
The registrant shall document that each individual operating
a radiation machine has read the operating and safety procedures and shall
maintain this documentation for inspection by the agency in accordance with
subsection (j)(2) of this section. The documentation shall include the following:
(i)
name and signature of individual;
(ii)
date individual read the operating and safety procedures;
and
(iii)
initials of the RSO.
(B)
The operating and safety procedures shall include, but
are not limited to, the following procedures as applicable:
(i)
posting notices to workers in accordance with paragraph
(4)(B) of this subsection;
(ii)
instructions to workers in accordance with paragraph (3)(G)
of this subsection;
(iii)
notifications and reports to individuals in accordance
with paragraph (4)(B) and (C) of this subsection and subsection (j)(3)(B)-(D)
of this section;
(iv)
ordering x-ray exams in accordance with subsection (b)(1)
of this section;
(v)
occupational dose requirements in accordance with paragraph
(3)(A) of this subsection;
(vi)
personnel monitoring requirements in accordance with paragraphs
(3)(B), (D) and (E) and (4)(F)(iii) of this subsection;
(vii)
posting of a radiation area in accordance with paragraph
(4)(D) of this subsection;
(viii)
use of a technique chart in accordance with paragraph
(5)(A) of this subsection;
(ix)
use of protective devices in accordance with paragraph
(3)(H) of this subsection;
(x)
exposure of individuals other than the animal in accordance
with paragraph (3)(I) of this subsection;
(xi)
holding of animals or image receptors in accordance with
paragraph (3)(J) of this subsection;
(xii)
control of scattered radiation in accordance with paragraph
(6)(C) of this subsection; and
(xiii)
film processing program or digital image processing
in accordance with paragraphs (9)-(11) of this subsection.
(3)
Personnel requirements.
(A)
Occupational dose limits. Except as otherwise exempted,
all individuals who are associated with the operation of a radiation machine
are subject to the occupational dose limits of this subparagraph regarding
dose limits to individuals, and the personnel monitoring requirements of subparagraph
(B) of this paragraph.
(i)
The registrant shall control the occupational dose to individuals
to the following dose limits.
(I)
An annual limit shall be the TEDE being equal to 5 rems
(0.05 Sv).
(II)
The annual limits to the lens of the eye, to the skin
of the whole body, and to the skin of the extremities shall be:
(-a-)
an LDE of 15 rems (0.15 Sv); and
(-b-)
an SDE of 50 rems (0.5 Sv) to the skin of the whole body
or to the skin of any extremity.
(III)
The annual limits for a minor shall be 10% of the annual
occupational dose limits specified in subclauses (I) and (II) of this clause.
(IV)
If a woman declares her pregnancy, the registrant shall
ensure that the DE to an embryo/fetus during the entire pregnancy, due to
occupational exposure of a declared pregnant woman, does not exceed 0.5 rem
(5 mSv). If a woman chooses not to declare pregnancy, the occupational dose
limits specified in subclauses (I) and (II) of this clause are applicable
to the woman.
(-a-)
The registrant shall make efforts to avoid substantial
variation above a uniform monthly exposure rate to a declared pregnant woman
so as to satisfy the limit in clause (i) of this subparagraph. The National
Council on Radiation Protection and Measurements recommended in NCRP Report
No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June
1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received
in any one month.
(-b-)
If by the time the woman declares pregnancy to the registrant,
the DE to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the registrant
shall be deemed to be in compliance with clause (i) of this subparagraph,
if the additional DE to the embryo/fetus does not exceed 0.05 rem (0.5 mSv)
during the remainder of the pregnancy.
(-c-)
The DE to an embryo/fetus shall be taken as the DE that
is most representative of the DE to the embryo/fetus from external radiation,
that is, in the mother's lower torso region.
(-d-)
If multiple measurements have been made, assignment of
the DDE for the declared pregnant woman from the individual monitoring device
that is most representative of the DE to the embryo/fetus shall be the DE
to the embryo/fetus. Assignment of the highest DDE for the declared pregnant
woman to the embryo/fetus is not required unless that dose is also the most
representative DDE for the region of the embryo/fetus.
(-e-)
If multiple measurements have not been made, assignment
of the highest DDE for the declared pregnant woman shall be the DE to the
embryo/fetus.
(ii)
The assigned DDE shall be for the portion of the body
receiving the highest exposure. The assigned SDE shall be the dose averaged
over the contiguous 10 cm
2
of skin receiving
the highest exposure.
(iii)
When a protective apron is worn while working with fluoroscopic
equipment used for clinical diagnostic or research purposes, the effective
dose equivalent (EDE) for external radiation shall be determined as follows:
(I)
when only one individual monitoring device is used and
it is located at the neck (collar) outside the protective apron, the reported
DDE shall be the EDE for external radiation; or
(II)
when only one individual monitoring device is used and
it is located at the neck (collar) outside the protective apron, and the reported
dose exceeds 25% of the limit specified in clause (i) of this subparagraph,
the reported DDE value multiplied by 0.3 shall be the EDE for external radiation;
or
(III)
when individual monitoring devices are worn, both under
the protective apron at the waist and outside the protective apron at the
neck (collar), the EDE for external radiation shall be assigned the value
of the sum of the DDE reported for the individual monitoring device located
at the waist under the protective apron multiplied by 1.5 and the DDE reported
for the individual monitoring device located at the neck (collar) outside
the protective apron multiplied by 0.04.
(iv)
The DDE, LDE, and SDE may be assessed from surveys or
radiation measurements for the purpose of demonstrating compliance with the
occupational dose limits, if the individual monitoring device was not in the
region of highest potential exposure, or the results of individual monitoring
are unavailable.
(v)
The registrant shall reduce the dose that an individual
may be allowed to receive in the current year by the amount of occupational
dose received from radiation machines or radioactive materials while employed
by any other person. See subparagraph (F)(iv) of this paragraph.
(B)
Conditions requiring individual monitoring of occupational
dose. Each registrant shall monitor exposures from radiation machines at levels
sufficient to demonstrate compliance with the occupational dose limits of
this section. As a minimum, each registrant shall monitor occupational exposure
to radiation from radiation machines and shall supply and require the use
of individual monitoring devices by:
(i)
adults likely to receive, in one year from sources external
to the body, a dose in excess of 10% of the limits in subparagraph (A)(i)
of this paragraph;
(ii)
minors likely to receive, in one year from radiation machines
external to the body, a DDE in excess of 0.1 rem (1 mSv), an LDE in excess
of 0.15 rem (1.5 mSv), or an SDE to the skin of the whole body or to the skin
of any extremities in excess of 0.5 rem (5 mSv);
(iii)
declared pregnant women likely to receive during the
entire pregnancy, from radiation machines external to the body, a DDE in excess
of 0.1 rem (1 mSv); and
(iv)
individuals entering a high or very high radiation area.
(C)
Dose limits for individual members of the public.
(i)
Each registrant shall conduct operations so that:
(I)
the TEDE to individual members of the public from exposure
to radiation from radiation machines does not exceed 0.5 rem (5 mSv) in a
year, exclusive of the dose contribution from background radiation, exposure
of patients to radiation for the purpose of medical diagnosis or therapy,
or to voluntary participation in medical research programs; and
(II)
the dose in any unrestricted area from registered external
sources does not exceed 0.002 rem (0.02 mSv) in any one hour.
(ii)
If the registrant permits members of the public to have
access to restricted areas, the limits for members of the public continue
to apply to those individuals.
(iii)
The agency may impose additional restrictions on radiation
levels in unrestricted areas in order to restrict the collective dose.
(D)
Compliance with dose limits for individual members of the
public.
(i)
The registrant shall make or cause to be made surveys of
radiation levels in unrestricted areas to demonstrate compliance with the
dose limits for individual members of the public as required in subparagraph
(C) of this paragraph.
(ii)
A registrant shall show compliance with the annual dose
limit in subparagraph (C) of this paragraph by demonstrating by measurement
or calculation that the TEDE to the individual likely to receive the highest
dose from the registered operation does not exceed the annual dose limit.
(iii)
Registrants exempt from individual monitoring requirements
in accordance with subparagraph (B)(ii) of this paragraph are exempt from
the requirements of clauses (i) and (ii) of this subparagraph.
(E)
Location and use of individual monitoring devices.
(i)
Each registrant shall ensure that individuals who are required
to monitor occupational doses in accordance with subparagraph (B) of this
paragraph wear and use individual monitoring devices as follows.
(I)
An individual monitoring device shall be assigned to and
worn by only one individual.
(II)
An individual monitoring device used for monitoring the
dose to the whole body shall be worn at the unshielded location of the whole
body likely to receive the highest exposure. When a protective apron is worn,
the location of the individual monitoring device is typically at the neck
(collar).
(III)
If an additional individual monitoring device is used
for monitoring the dose to an embryo/fetus of a declared pregnant woman, in
accordance with subparagraph (B)(iii) of this paragraph, it shall be located
at the waist under any protective apron being worn by the woman.
(IV)
An individual monitoring device used for monitoring the
LDE, to demonstrate compliance with subparagraph (A)(i)(II)(-a-) of this paragraph,
shall be located at the neck (collar) or at a location closer to the eye,
outside any protective apron being worn by the monitored individual.
(V)
An individual monitoring device used for monitoring the
dose to the extremities, to demonstrate compliance with subparagraph (A)(i)(II)(-b-)
of this paragraph, shall be worn on the extremity likely to receive the highest
exposure. Each individual monitoring device, to the extent practicable, shall
be oriented to measure the highest dose to the extremity being monitored.
(ii)
Each registrant shall ensure that individual monitoring
devices are returned to the dosimetry processor for proper processing.
(iii)
Each registrant shall ensure that adequate precautions
are taken to prevent a deceptive exposure of an individual monitoring device.
(F)
Determination of occupational dose for the current year.
(i)
For each individual who is likely to receive, in a year,
an occupational dose requiring monitoring in accordance with subparagraph
(B) of this paragraph, the registrant shall determine the occupational radiation
dose received during the current year. Occupational dose includes doses received
from exposure to registered/licensed or unregistered/unlicensed sources of
radiation as defined in subsection (c) of this section.
(ii)
In complying with the requirements of clause (i) of this
subparagraph, a registrant may:
(I)
accept, as a record of the occupational dose that the individual
received during the current year, BRC Form 233-1 (Occupational Exposure Record
for a Monitoring Period) from prior or other current employers, or other clear
and legible record, of all information required on that form and indicating
any periods of time for which data are not available; or
(II)
accept, as a record of the occupational dose that the
individual received during the current year, a written signed statement from
the individual, or from the individual's prior or other current employer(s)
for work involving radiation exposure, that discloses the nature and the amount
of any occupational dose that the individual received during the current year;
or
(III)
obtain reports of the individual's DE from prior or other
current employer(s) for work involving radiation exposure, or the individual's
current employer, if the individual is not employed by the registrant, by
telephone, telegram, facsimile, or letter. The registrant shall request a
written verification of the dose data if the authenticity of the transmitted
report cannot be established.
(iii)
The registrant shall record the exposure data for the
current year, as required by clause (i) of this subparagraph, on BRC Form
233-1, or other clear and legible record, of all the information required
on BRC Form 233-1.
(iv)
If the registrant is unable to obtain a complete record
of an individual's current occupational dose while employed by any other registrant
or licensee, the registrant shall assume in establishing administrative controls
in accordance with subsection (m)(5) of this section for the current year,
that the allowable dose limit for the individual is reduced by 1.25 rems (12.5
millisieverts (mSv)) for each quarter; or 416 millirems (mrem) (4.16 mSv)
for each month for which records were unavailable and the individual was engaged
in activities that could have resulted in occupational radiation exposure.
(v)
If an individual has incomplete (for example, a lost or
damaged personnel monitoring device) current occupational dose data for the
current year and that individual is employed solely by the registrant during
the current year, the registrant shall:
(I)
assume that the allowable dose limit for the individual
is reduced by 1.25 rems (12.5 mSv) for each quarter;
(II)
assume that the allowable dose limit for the individual
is reduced by 416 mrem (4.16 mSv) for each month; or
(III)
assess an occupational dose for the individual during
the period of missing data using surveys, radiation measurements, or other
comparable data for the purpose of demonstrating compliance with the occupational
dose limits.
(vi)
Administrative controls established in accordance with
clause (iv) of this subparagraph shall be documented and maintained for inspection
by the agency. Occupational dose assessments made in accordance with clause
(v) of this subparagraph and records of data used to make the assessment shall
be made and maintained for inspection by the agency. The registrant shall
retain the records in accordance with subsection (j)(2) of this section.
(vii)
Occupational exposure form. The following BRC Form 233-1
(Occupational Exposure Record for a Monitoring Period), is to be used to document
occupational exposures for a monitoring period.
Figure: 25 TAC §289.233(i)(3)(F)(vii) (.pdf)
(G)
Instructions to workers.
(i)
All individuals likely to receive in a year an occupational
dose in excess of 100 millirem (1 millisievert) shall be:
(I)
kept informed of the storage, transfer, or use of sources
of radiation in the licensee's or registrant's workplace;
(II)
instructed in the health protection problems associated
with exposure to sources of radiation, in precautions or procedures to minimize
exposure, and in the purposes and functions of protective devices employed;
(III)
instructed in, and instructed to observe, to the extent
within the worker's control, the applicable provisions of agency requirements
and certificates of registration, for the protection of personnel from exposures
to sources of radiation occurring in such areas;
(IV)
instructed of their responsibility to report promptly
to the registrant any condition that may constitute, lead to, or cause a violation
of agency requirements or certificate of registration conditions, or unnecessary
exposure to sources of radiation;
(V)
instructed in the appropriate response to warnings made
in the event of any unusual occurrence or malfunction that may involve exposure
to sources of radiation; and
(VI)
advised as to the radiation exposure reports that workers
may request in accordance with subsection (j)(3)(D)(i) and (ii) of this section.
(ii)
The extent of these instructions shall be commensurate
with potential radiological health protection problems associated with the
source(s) of radiation in the workplace.
(H)
Protective devices. Protective devices shall be utilized
when required, as in subparagraphs (J)(i) and (ii) and (K) of this paragraph
and paragraph (6)(C) of this subsection.
(i)
Protective devices shall be of no less than 0.25 millimeter
(mm) lead equivalent material except as specified in paragraph (6)(C)(ii)(I)
of this subsection.
(ii)
Protective devices, including aprons, gloves, and shields
shall be checked annually for defects such as holes, cracks, and tears. These
checks may be performed by the registrant by visual or tactile means, or x-ray
imaging. If a defect is found, protective devices shall be replaced or removed
from service until repaired. A record of this test shall be made and maintained
by the registrant in accordance with subsection (j)(2) of this section for
inspection by the agency.
(I)
Exposure of individuals other than the animal. No individual
other than the animal, operator, and ancillary personnel shall be in the x-ray
room or area while exposures are being made unless such individual's assistance
is required.
(J)
Holding of animal or image receptor.
(i)
When an animal or image receptor must be held in position
during radiography, mechanical supporting or restraining devices shall be
used when the exam permits.
(ii)
If an animal or image receptor must be held by an individual
during an exposure, that individual shall be protected with appropriate shielding
devices described in subparagraph (H) of this paragraph.
(iii)
The registrant's written operating and safety procedures
required by paragraph (2) of this subsection shall include the following:
(I)
a list of circumstances in which mechanical holding devices
cannot be routinely utilized; and
(II)
a procedure used for selecting an individual to hold or
support the animal or image receptor.
(K)
Operator position. The operator position during the exposure
shall be such that the operator's exposure is as low as reasonably achievable
(ALARA) and the operator is a minimum of six feet from the radiation machine
or protected by an apron, gloves, or other shielding having a minimum of 0.25
lead equivalent material.
(L)
Holding of tube. In no case shall an individual hold the
tube or tube housing assembly supports during any radiographic exposure.
(4)
Facility requirements.
(A)
Caution signs. Unless otherwise authorized by the agency,
the standard radiation symbol prescribed shall use the colors magenta, or
purple, or black on yellow background. The standard radiation symbol prescribed
is the three-bladed design as follows:
Figure: 25 TAC §289.233(i)(4)(A)
(i)
the cross-hatched area of the symbol is to be magenta,
or purple, or black; and
(ii)
the background of the symbol is to be yellow.
(B)
Posting of notices to workers.
(i)
Each registrant shall post current copies of the following
documents:
(I)
§289.233 of this title;
(II)
the certificate of registration and conditions or documents
incorporated into the certificate of registration by reference, and amendments
thereto;
(III)
the operating procedures applicable to work under the
certificate of registration; and
(IV)
any notice of violation, if applicable, involving radiological
working conditions, or order issued in accordance with subsection (k)(2) of
this section.
(ii)
If posting of a document specified in clause (i) of this
subparagraph is not practicable, the registrant shall post a notice that describes
the document and states where it may be examined.
(iii)
Bureau of Radiation Control (BRC) Form 233-2, "Notice
to Employees," which is found at the end of the section, or an equivalent
document containing at least the same wording as BRC Form 233-2.
Figure: 25 TAC §289.233(i)(4)(B)(iii) (.pdf)
(iv)
Documents, notices, or forms posted in accordance with
this subsection shall:
(I)
appear in a sufficient number of places to permit individuals
engaged in work under the certificate of registration to observe them on the
way to or from any particular work location to which the document applies;
(II)
be conspicuous; and
(III)
be replaced if defaced or altered.
(C)
Posting requirements.
(i)
The registrant shall post each radiation area with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION
AREA."
(ii)
The registrant shall post each high radiation area with
a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
(iii)
The registrant shall post each very high radiation area
with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE
DANGER, VERY HIGH RADIATION AREA."
(D)
Exceptions to posting requirements. A registrant is not
required to post caution signs in areas or rooms containing radiation machines
for periods of less than 8 hours, if each of the following conditions is met:
(i)
the radiation machines are constantly attended during these
periods by an individual who takes the precautions necessary to prevent the
exposure of individuals to radiation in excess of the limits established in
this section; and
(ii)
the area or room is subject to the registrant's control.
(E)
General surveys and monitoring.
(i)
Each registrant shall make, or cause to be made, surveys
that:
(I)
are necessary for the registrant to comply with this section;
and
(II)
are necessary under the circumstances to evaluate:
(-a-)
the magnitude and extent of radiation levels; and
(-b-)
the potential radiological hazards.
(ii)
The registrant shall ensure that instruments and equipment
used for qualitative and quantitative radiation measurements, for example,
dose rate, are operable and calibrated:
(I)
by a person licensed or registered by the agency, another
agreement state, a licensing state, or the United States Nuclear Regulatory
Commission to perform such service;
(II)
at intervals not to exceed 12 months unless a different
time interval is specified in another section of this chapter;
(III)
after each instrument or equipment repair;
(IV)
for the types of radiation used and at energies appropriate
for use; and
(V)
at an accuracy within 20% of the true radiation level.
(iii)
All individual monitoring devices, except for direct
and indirect reading pocket dosimeters, electronic personal dosimeters, and
those individual monitoring devices used to measure the dose to any extremity,
that require processing to determine the radiation dose and that are used
by registrants to comply with subparagraph (A) of this paragraph, with other
applicable provisions of this chapter, shall be processed and evaluated by
a dosimetry processor:
(I)
holding current personnel dosimetry accreditation from
the National Voluntary Laboratory Accreditation Program (NVLAP) of the National
Institute of Standards and Technology; and
(II)
approved in this accreditation process for the type of
radiation or radiations included in the NVLAP program that most closely approximates
the type of radiation or radiations for which the individual wearing the dosimeter
is monitored.
(F)
Control of access to high radiation areas.
(i)
The registrant shall ensure that each entrance or access
point to a high radiation area has one or more of the following features:
(I)
a control device that, upon entry into the area, causes
the level of radiation to be reduced below that level at which an individual
might receive a DDE of 0.1 rem (1 mSv) in one hour at 30 cm from the source
of radiation from any surface that the radiation penetrates;
(II)
a control device that energizes a conspicuous visible
or audible alarm signal so that the individual entering the high radiation
area and the supervisor of the activity are made aware of the entry; or
(III)
entryways that are locked, except during periods when
access to the areas is required, with positive control over each individual
entry.
(ii)
In place of the controls required by clause (i) of this
subparagraph for a high radiation area, the registrant may substitute continuous
direct or electronic surveillance that is capable of preventing unauthorized
entry.
(iii)
The registrant may apply to the agency for approval of
alternative methods for controlling access to high radiation areas.
(iv)
The registrant shall establish the controls required by
clauses (i) and (iii) of this subparagraph in a way that does not prevent
individuals from leaving a high radiation area.
(G)
Control of access to very high radiation areas.
(i)
In addition to the requirements in subparagraph (F) of
this paragraph, the registrant shall institute measures to ensure that an
individual is not able to gain unauthorized or inadvertent access to areas
in which radiation levels could be encountered at 500 rads (5 grays) or more
in one hour at 1 m from a radiation machine or any surface through which the
radiation penetrates at this level.
(ii)
The entry control devices required by clause (i) of this
subparagraph shall be established in such a way that no individual will be
prevented from leaving the area.
(H)
Security and control of radiation machines.
(i)
The registrant shall secure radiation machines from unauthorized
removal.
(ii)
The registrant shall use devices and/or administrative
procedures to prevent unauthorized use of radiation machines.
(5)
Radiation Machine Requirements.
(A)
Technique chart. A technique chart relevant to the particular
radiation machine shall be provided or electronically displayed in the vicinity
of the control panel and used by all operators.
(B)
Labeling radiation machines. Each registrant shall ensure
that each radiation machine is labeled in a conspicuous manner that cautions
individuals that radiation is produced when it is energized. This label shall
be affixed in a clearly visible location on the face of the control unit.
(C)
Mechanical support of tube head. The tube housing assembly
shall be adjusted to remain stable during an exposure unless tube housing
movement is a designed function of the x-ray system.
(D)
Battery charge indicator. On battery-powered x-ray generators,
visual means shall be provided on the control panel to indicate whether the
battery is in a state of charge adequate for proper operation.
(E)
Beam quality. The following requirements apply to beam
quality.
(i)
Half-value layer.
(I)
The half-value layer of the useful beam for a given x-ray
tube potential shall not be less than the values shown in the following Table
I. If it is necessary to determine such half-value layer at an x-ray tube
potential that is not listed in Table I, linear interpolation may be made.
Figure: 25 TAC §289.233(i)(5)(E)(i)(I)
(II)
For capacitor energy storage equipment, compliance with
the requirements of subparagraph (K) of this paragraph shall be determined
with the maximum quantity of charge per exposure.
(ii)
Filtration controls.
(I)
For x-ray systems that have variable kVp and variable filtration
for the useful beam, a device shall link the kVp selector with the filters
and shall prevent an exposure unless the minimum amount of filtration required
by subparagraph (A) of this paragraph is in the useful beam for the given
kVp that has been selected.
(II)
Any other system having removable filters shall be required
to have the minimum amount of filtration as required by subparagraph (E)(i)(I)
of this paragraph permanently located in the useful beam during each exposure.
(F)
Multiple tubes. Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes that have been selected
shall be clearly indicated prior to initiation of the exposure. This indication
shall be both on the x-ray control panel and at or near the tube housing assembly
that has been selected.
(G)
Technique and exposure indicators.
(i)
The technique factors to be used during an exposure shall
be indicated before the exposure begins except when automatic exposure controls
are used, in which case the technique factors that are set prior to the exposure
shall be indicated.
(ii)
On equipment having fixed technique factors, the requirement
of subparagraph (A) of this paragraph may be met by permanent markings.
(iii)
The x-ray control shall provide visual indication of
the production of x rays.
(iv)
The indicated technique factors shall be accurate to meet
manufacturer's specifications. If these specifications are not available from
the manufacturer, the factors shall be accurate to within plus or minus 10%
of the indicated setting.
(H)
The x-ray control shall provide visual or audible indication
of the production of x-rays observable at or from the operator's protected
position whenever x-rays are produced.
(I)
Beam limiting devices shall do the following:
(i)
provide the same degree of protection as is required of
the housing;
(ii)
restrict the useful beam to the area of clinical interest;
(iii)
the numerical SID indicator shall be present and shall
be accurate to within 2.0% of the SID; and
(iv)
limit the x-ray field such that the x-ray field shall
not exceed:
(I)
2.0% of the SID for the length or width of the rectangular
image receptor; or
(II)
2.0% of the SID for the diagonal of the image receptor
for circular image receptors.
(J)
A means shall be provided to center the primary beam to
the image receptor within 2.0% of the SID.
(K)
A means shall be provided to terminate the exposure at
the following:
(i)
a preset time interval;
(ii)
a preset product of current and time;
(iii)
a preset number of pulses; or
(iv)
a preset radiation exposure to the image receptor.
(L)
The radiation machine shall not be able to make an exposure
when the timer is set to a "zero" or "off" position if either position is
provided.
(M)
All stationary, mobile, or portable x-ray systems used
for veterinary x rays shall be provided with the following:
(i)
a continuous pressure type exposure switch; and
(ii)
either a six and one-half foot high protective barrier
for operator protection during exposures; or
(iii)
a means for the operator to be at least six feet from
the tube housing assembly.
(N)
Operators using portable radiation machines designed to
be hand-held are exempt from the requirements of subparagraph (M) of this
paragraph. The hand-held portable radiation machine shall be held by the tube
housing support or handle. The operator shall wear protective devices in accordance
with paragraph (3)(H) of this subsection.
(O)
The technique factors to be used during an exposure shall
be indicated before the exposure begins. If AECs are used, the technique factors
that are set prior to the exposure shall be indicated.
(P)
For machines having fixed technique factors, the requirements
of subparagraph (O) of this paragraph may be met by permanent markings on
the equipment. Indication of technique factors shall be visible from the operator's
position except in the case of spot films made by the fluoroscopist.
(Q)
Portable machines shall be used in a manner that complies
with this section.
(R)
All exams and retakes shall be ordered by the veterinarian.
(S)
Equipment performance evaluations.
(i)
For all radiation machines used in veterinary medicine,
the registrant shall perform, or cause to be performed, tests necessary to
assure proper function of equipment with the indicated standard for each of
the following items. After installation, the tests listed shall be performed
every five years.
(I)
Timer.
(-a-)
The accuracy of the timer shall meet the manufacturer's
specifications. If the manufacturer's specifications are not obtainable, the
timer accuracy shall be plus or minus 10% of the indicated time with testing
performed at 0.5 second.
(-b-)
Means shall be provided to terminate the exposure at
a preset time interval, a preset product of current and time, a preset number
of pulses, or a preset radiation exposure to the image receptor. In addition,
it shall not be possible to make an exposure when the timer is set to a "zero"
or "off" position if either position is provided.
(II)
Kilovolt peak. If the registrant possesses documentation
of the appropriate manufacturer's kilovolt peak specifications, the radiation
machine shall meet those specifications. If the registrant does not possess
documentation of the appropriate manufacturer's kilovolt peak specifications,
the indicated kilovolt peak shall be accurate to within plus or minus 10%
of the indicated setting(s). For radiation machines with fewer than three
fixed kilovolt peak settings, the radiation machine shall be checked at those
settings.
(III)
Tube stability. The x-ray tube shall remain physically
stable during exposures. In cases where tubes are designed to move during
exposure, the registrant shall assure proper and free movement of the radiation
machine.
(IV)
Collimation. Field limitation shall meet the requirements
of subparagraph (I) of this paragraph.
(ii)
Records of the test results, including any numerical readings
shall be maintained by the registrant in accordance with subsection (j)(2)
of this section.
(iii)
Any items not meeting the specifications of the tests
shall be corrected or repaired. Correction or repair shall begin within 30
days following the check and shall be performed according to a plan designated
by the registrant. Correction or repair shall be completed no longer than
90 days from discovery unless authorized by the agency. Records of corrections
or repairs shall be maintained by the registrant in accordance with subsection
(j)(2) of this section for inspection by the agency.
(iv)
Measurements of the radiation output of an x-ray system
shall be performed with a calibrated dosimetry system. The dosimetry system
shall have been calibrated within the preceding 24 months and the calibration
shall be traceable to a national standard. During the calendar year in which
the dosimetry system is not calibrated, an intercomparison to a system calibrated
within the previous 12 months shall be performed.
(6)
Additional requirements for fluoroscopic x-ray systems.
(A)
Limitation of the useful beam. Limitation of the useful
beam shall be as follows.
(i)
Primary barrier.
(I)
The fluoroscopic imaging assembly shall be provided with
a primary protective barrier that intercepts the entire cross section of the
useful beam at any SID.
(II)
The x-ray tube used for fluoroscopy shall not produce
x rays unless the barrier is in position to intercept the useful beam and
the imaging device is in place and operable.
(III)
The exposure rate due to transmission through the barrier
with the attenuation block in the useful beam, combined with radiation through
the image intensifier if provided, shall not exceed 3.34 x 10
-3
% of the entrance exposure rate at a distance of 10 cm from any accessible
surface of the fluoroscopic imaging assembly beyond the plane of the image
receptor.
(ii)
Measuring compliance of barrier transmission.
(I)
The exposure rate due to transmission through the primary
protective barrier combined with radiation through the image intensifier shall
be determined by measurements averaged over an area of 100 cm
2
with no linear dimension greater than 20 cm.
(II)
If the source is below the tabletop, the measurement shall
be made with the input surface of the fluoroscopic imaging assembly positioned
30 cm above the tabletop.
(III)
If the source is above the tabletop and the SID is variable,
the measurement shall be made with the end of the beam-limiting device or
spacer as close to the tabletop as it can be placed, provided that it shall
not be closer than 30 cm.
(IV)
Movable grids and compression devices shall be removed
from the useful beam during the measurement.
(V)
The attenuation block shall be positioned in the useful
beam 10 cm from the point of measurement of entrance exposure rate and between
this point and the input surface of the fluoroscopic imaging assembly.
(VI)
The collimator shall be fully open when the measurement
is made.
(iii)
X-ray field.
(I)
Compliance with subclauses (II)-(VII) of this clause shall
be determined with the beam axis perpendicular to the plane of the image receptor.
(II)
Equipment with a fixed SID and the capability of a visible
area of no greater than 300 cm
2
shall be provided
with either stepless adjustment of the x-ray field or a means to further limit
the x-ray field at the image receptor to 125 cm
2
or
less. If the equipment is provided with stepless adjustment, the minimum x-ray
field size at the maximum SID shall be less than or equal to 5 cm by 5 cm
at the image receptor.
(III)
Equipment with a variable SID or a fixed SID with the
capability of a visible area of greater than 300 cm
2
shall be provided with stepless adjustment of the field size. The
minimum x-ray field size at the maximum SID shall be less than or equal to
5 cm by 5 cm at the image receptor.
(IV)
Neither the length nor the width of the x-ray field in
the plane of the image receptor shall exceed that of the visible area of the
image receptor by more than 3.0% of the SID. The sum of the excess length
and the excess width shall be no greater than 4.0% of the SID.
(V)
For rectangular x-ray fields used with circular image receptors,
the error in alignment shall be determined along the length and width dimensions
of the x-ray field that pass through the center of the visible area of the
image receptor.
(VI)
For fluoroscopic equipment with only a manual mode of
collimation, the x-ray field produced shall be limited to the area of the
spot-film cassette at 16 inches above tabletop. Additionally, during fluoroscopy,
the beam shall be restricted to the area of the input phosphor.
(VII)
Spot-film devices shall meet the following additional
requirements.
(-a-)
Means shall be provided between the source and the animal
for adjustment of the x-ray field size in the plane of the film to the size
of that portion of the film that has been selected on the spot-film selector.
(-1-)
Such adjustment shall be automatically accomplished except
when the x-ray field size in the plane of the film is smaller than that of
the selected portion of the film.
(-2-)
The total misalignment of the edges of the x-ray field
with the respective edges of the selected portion of the image receptor along
the length or width dimensions of the x-ray field in the plane of the image
receptor shall not exceed 3.0% of the SID when adjusted for full coverage
of the selected portion of the image receptor.
(-3-)
The sum, without regard to sign of the misalignment along
any two orthogonal dimensions, shall not exceed 4.0% of the SID.
(-b-)
The center of the x-ray field in the plane of the film
shall be aligned with the center of the selected portion of the film to within
2.0% of the SID.
(B)
Activation of the fluoroscopic tube. X-ray production in
the fluoroscopic mode shall be controlled by a device that requires continuous
pressure by the fluoroscopist for the entire time of the exposure (continuous
pressure type switch). When recording serial fluoroscopic images, the fluoroscopist
shall be able to terminate the x-ray exposures at any time, but means may
be provided to permit completion of any single exposure of the series in process.
(C)
Control of scattered radiation.
(i)
Fluoroscopic configuration, including fluoroscopic table
designs, shall not permit any portion of any individual's body, except the
head, neck, and extremities, to be exposed to scattered radiation emanating
from above or below the tabletop unless the radiation has passed through not
less than a total of 0.25 mm lead equivalent material. The material may be,
but is not limited to, drapes, self-supporting curtains, or viewing shields,
in addition to any lead equivalency provided by a protective apron.
(ii)
Where sterile fields or special procedures prohibit the
use of normal protective barriers or drapes, all of the following conditions
shall be met.
(I)
All persons in the room where fluoroscopy is performed
shall wear protective aprons that provide a shielding equivalent of 0.5 mm
of lead.
(II)
The fluoroscopic field size shall be reduced to the absolute
minimum required for the procedure being performed (area of clinical interest).
(III)
Operating and safety procedures shall reflect the above
conditions, and fluoroscopy personnel shall exhibit awareness of situations
requiring the use and/or nonuse of the protective drapes.
(iii)
For image-intensified fluoroscopic equipment with only
a manual mode of collimation, the x-ray field produced shall be limited to
the area of the spot-film cassette at 16 inches above tabletop. Additionally,
during fluoroscopy, the beam shall be restricted to the area of the input
phosphor.
(7)
Additional requirements for CT x-ray systems.
(A)
Initiation of operation.
(i)
The x-ray control and gantry shall provide visual indication
whenever x rays are produced and, if applicable, whether the shutter is open
or closed.
(ii)
Means shall be provided to require operator initiation
of each individual scan or series of scans.
(iii)
All emergency buttons/switches shall be clearly labeled
as to their functions.
(B)
Termination of exposure.
(i)
Means shall be provided to terminate the x-ray exposure
automatically by either de-energizing the x-ray source or shuttering the x-ray
beam in the event of equipment failure affecting data collection. Such termination
shall occur within an interval that limits the total scan time to no more
than 110% of its preset value through the use of either a backup timer or
devices that monitor equipment function.
(ii)
A signal visible to the operator shall indicate when the
x-ray exposure has been terminated through the means required by clause (i)
of this subparagraph.
(iii)
The operator shall be able to terminate the x-ray exposure
at any time during a scan or series of scans under CT x-ray system control
of greater than 0.5 seconds duration. Termination of the x-ray exposure shall
necessitate resetting of the CT conditions of operation prior to initiation
of another scan.
(8)
Educational facilities. Facilities conducting training
using animals are held to the requirements of this section except for paragraphs
(9)-(11) of this subsection concerning film processing.
(9)
Automatic and manual film processing for veterinary facilities
and mobile veterinary services.
(A)
Films shall be developed in accordance with the time-temperature
relationships recommended by the film manufacturer. The specified developer
temperature for automatic processing and the time-temperature chart for manual
processing shall be posted in the darkroom. If the registrant determines an
alternate time-temperature relationship is more appropriate for a specific
facility, that time-temperature relationship shall be documented and posted.
(B)
Chemicals shall be replaced according to the chemical manufacturer's
or supplier's recommendations or at an interval not to exceed three months.
(C)
Darkroom light leak tests shall be performed and any light
leaks corrected at intervals not to exceed six months.
(D)
Lighting in the film processing/loading area shall be maintained
with the filter, bulb wattage, and distances recommended by the film manufacturer
for that film emulsion or with products that provide an equivalent level of
protection against fogging.
(E)
Corrections or repairs of the light leaks or other deficiencies
in paragraphs (2)-(4) of this subsection shall be initiated within 72 hours
of discovery and completed no longer than 15 days from detection of the deficiency
unless a longer time is authorized by the agency. Records of the correction
or repairs shall include the date and initials of the individual performing
these functions and shall be maintained in accordance with subsection (t)(1)
of this section for inspection by the agency.
(F)
Documentation of the items in subparagraphs (B, (C), and
(E) of this paragraph shall be maintained at the site where performed and
shall include the date and initials of the individual completing these items.
These records shall be made and maintained in accordance with subsection (j)(2)
of this section for inspection by the agency.
(10)
Alternative processing systems. Users of daylight processing
systems, laser processors, self-processing film units, or other alternative
processing systems shall follow manufacturer's recommendations for image processing.
Documentation that the registrant is following manufacturer's recommendations
shall include the date and initials of the individual completing the document
and shall be maintained at the site where performed in accordance with subsection
(j)(2) of this section for inspection by the agency.
(11)
Digital imaging acquisition systems. Users of digital
imaging acquisition systems shall follow quality assurance/quality control
protocol for image processing established by the manufacturer, or if no manufacturer's
protocol is available, by the registrant. The registrant shall include the
protocols, whether established by the registrant or the manufacturer, in its
operating and safety procedures. The registrant shall document the frequency
at which the quality assurance/quality control protocol is performed. Documentation
shall include the date and initials of the individual completing the document
and shall be maintained at the site where performed in accordance with subsection
(j)(2) of this section for inspection by the agency. Documentation that the
registrant is following manufacturer's recommendations shall include the date
and initials of the individual completing the document and shall be maintained
at the site where performed in accordance with subsection (j)(2) of this section
for inspection by the agency.
(j)
Records and reports.
(1)
General provisions for records and reports.
(A)
Each registrant shall maintain records at each site including
sites authorized by certificate of registration condition and records sites
for mobile services. The records shall include those specified in paragraph
(2) of this subsection and shall be maintained at the time interval indicated
for inspection by the agency. Additional record requirements are specified
elsewhere in this chapter. All records required by this chapter shall be accurate
and factual.
(B)
Records are only valid if stamped, initialed, or signed
and dated by authorized personnel or otherwise authenticated. Records such
as letters, drawings, and specifications, shall include all pertinent information,
such as stamps, initials, and signatures.
(C)
Each registrant shall use the SI units gray, sievert, and
coulomb per kilogram, or the special units rad, rem, and roentgen, including
multiples and subdivisions, and shall clearly indicate the units of all quantities
on records required by this chapter.
(D)
The registrant shall make a clear distinction among the
quantities entered on the records required by this section, such as TEDE,
SDE, LDE, or DDE.
(E)
Each record required by this section shall be legible throughout
the specified retention period.
(F)
The record shall be the original or a reproduced copy or
a mircroform, provided that the copy or microform is authenticated by authorized
personnel and that the microform is capable of producing a clear copy throughout
the required retention period.
(G)
The record may also be stored in electronic format with
the capability for producing legible, accurate, and complete records during
the required retention period.
(H)
Each registrant shall maintain records of receipt, transfer,
and disposal of radiation machines for inspection by the agency. The records
shall include the following information and shall be kept until disposal is
authorized by the agency:
(i)
manufacturer's name;
(ii)
model and serial number from the control panel;
(iii)
date of the receipt, transfer, and disposal; and
(iv)
name of the individual recording the information.
(I)
The registrant shall maintain adequate safeguards against
tampering with and loss of records.
(J)
Subject to the limitations provided in the Texas Public
Information Act, Government Code, Chapter 552, all information and data collected,
assembled, or maintained by the agency are public records open to inspection
and copying during regular office hours.
(K)
Any person who submits written information or data to the
agency and requests that the information be considered confidential, privileged,
or otherwise not available to the public under the Texas Public Information
Act, shall justify such request in writing, including statutes and cases where
applicable, addressed to the agency.
(i)
Documents containing information that is claimed to fall
within an exception to the Texas Public Information Act shall be marked to
indicate that fact. Markings shall be placed on the document on origination
or submission.
(I)
The words "NOT AN OPEN RECORD" shall be placed conspicuously
at the top and bottom of each page containing information claimed to fall
within one of the exceptions.
(II)
The following wording shall be placed at the bottom of
the front cover and title page, or first page of text if there is no front
cover or title page:
Figure: 25 TAC §289.233(j)(1)(K)(i)(II)
(ii)
The agency requests, whenever possible, that all information
submitted under the claim of an exception to the Texas Public Information
Act be extracted from the main body of the application and submitted as a
separate annex or appendix to the application.
(iii)
Failure to comply with any of the procedures described
in clauses (i) and (ii) of this subparagraph may result in all information
in the agency file being disclosed upon an open records request.
(L)
The agency will determine whether information falls within
one of the exceptions to the Texas Public Information Act. The agency will
determine whether or not there has been a previous determination that the
information falls within one of the exceptions to the Texas Public Information
Act. If there has been no previous determination and the agency believes that
the information falls within one of the exceptions, an opinion of the Attorney
General will be requested. If the agency agrees in writing to the request,
the information shall not be open for public inspection unless the Attorney
General's office subsequently determines that it does not fall within an exception.
(M)
Requests for information.
(i)
All requests for open records information must be in writing
and refer to documents currently in possession of the agency.
(ii)
The agency will ascertain whether the information may
be released or whether it falls within an exception to the Texas Public Information
Act.
(I)
The agency may take a reasonable period of time to determine
whether information falls within one of the exceptions to the Texas Public
Information Act.
(II)
If the information is determined to be public, it will
be presented for inspection and/or copies of documents will be furnished within
a reasonable period of time. A fee will be charged to recover agency costs
for copies.
(iii)
Original copies of public records may not be removed
from the agency. Under no circumstances shall material be removed from existing
records.
(N)
Records of surveys.
(i)
Each registrant shall make and maintain records showing
the results of surveys required by subsection (i)(4)(D) of this section for
inspection by the agency. The registrant shall retain these records in accordance
with subsection (j)(2) of this section.
(ii)
The registrant shall retain the results of surveys to
determine the dose from external sources of radiation used, in the absence
of or in combination with individual monitoring data, in the assessment of
individual DEs in accordance with subsection (j)(2) of this section.
(O)
Records of individual monitoring results.
(i)
Each registrant shall make or cause to be made and maintain
records in accordance with subsection (i)(3)(F) of this section of the doses
received by all individuals for whom monitoring was required in accordance
with subsection (i)(3)(B) of this section, and records of doses received during
accidents, and emergency conditions. Assessments of DE and records made using
units in effect before January 1, 1994, need not be changed. These records
shall include, when applicable:
(I)
the DDE to the whole body, LDE, SDE to the skin of the
whole body, and SDE to the skin of any extremities; and
(II)
the data used to make occupational dose assessments in
accordance with subsection (i)(3)(F)(v) of this section.
(ii)
The registrant shall make entries of the records specified
in clause (i) of this subparagraph at intervals not to exceed one year and
within 90 days of the end of the year.
(iii)
The registrant shall make or cause to be made and maintain
the records specified in clause (i) of this subparagraph on BRC Form 233-1,
in accordance with the instructions for BRC Form 233-1, or in clear and legible
records containing all the information required by BRC Form 233-1.
(iv)
The registrant shall make or cause to be made and maintain
the records of dose to an embryo/fetus with the records of dose to the declared
pregnant woman. The declaration of pregnancy, including the estimated date
of conception, shall also be kept on file, but may be maintained separately
from the dose records.
(v)
The registrant shall retain each required form or record
required by this subsection in accordance with subsection (j)(2) of this section
for inspection by the agency. The registrant shall retain records used in
preparing BRC Form 233-1 or equivalent in accordance with subsection (j)(2)
of this section.
(P)
Records of dose to individual members of the public.
(i)
Each registrant shall make and maintain records sufficient
to demonstrate compliance with the dose limit for individual members of the
public for inspection by the agency. See subsection (i)(3)(C) and (D) of this
section.
(ii)
The registrant shall retain the records required by clause
(i) of this subparagraph in accordance with subsection (j)(2) of this section.
(2)
Record/document requirements. Each registrant shall maintain
the following records/documents at each site, including authorized records
sites for mobile services at the time intervals specified and make available
to the agency for inspection.
(3)
Reports.
(A)
Reports of stolen, lost, or missing radiation machines.
(i)
Each registrant shall report to the agency by telephone
a stolen, lost, or missing radiation machine immediately after its occurrence
becomes known to the registrant.
(ii)
Each registrant required to make a report in accordance
with clause (i) of this subparagraph shall, within 30 days after making the
telephone report, make a written report to the agency that includes the following
information:
(I)
a description of the radiation machine involved, including,
the manufacturer and model and serial number;
(II)
a description of the circumstances under which the loss
or theft occurred;
(III)
a statement of disposition, or probable disposition,
of the radiation machine involved;
(IV)
exposures of individuals to radiation, circumstances under
which the exposures occurred, and the possible TEDE to persons in unrestricted
areas;
(V)
actions that have been taken, or will be taken, to recover
the radiation machine; and
(VI)
procedures or measures that have been, or will be, adopted
to ensure against a recurrence of the loss or theft of radiation machines.
(iii)
Subsequent to filing the written report, the registrant
shall also report additional substantive information on the loss or theft
within 30 days after the registrant learns of such information.
(iv)
The registrant shall prepare any report filed with the
agency in accordance with this subsection so that names of individuals who
may have received exposure to radiation are stated in a separate and detachable
portion of the report.
(B)
Reports of incidents.
(i)
Notwithstanding other requirements for notification, each
registrant shall immediately report each event involving a radiation machine
possessed by the registrant that may have caused or threatens to cause an
individual to receive:
(I)
a TEDE of 25 rems (0.25 Sv) or more;
(II)
an LDE of 75 rems (0.75 Sv) or more; or
(III)
an SDE to the skin of the whole body or to the skin of
any extremities of 250 rads (2.5 grays) or more.
(ii)
Each registrant shall, within 24 hours of discovery of
the event, report to the agency each event involving loss of control of a
radiation machine possessed by the registrant that may have caused, or threatens
to cause an individual to receive, in a period of 24 hours:
(I)
a TEDE exceeding 5 rems (0.05 Sv);
(II)
an LDE exceeding 15 rems (0.15 Sv); or
(III)
an SDE to the skin of the whole body or to the skin of
any extremities exceeding 50 rems (0.5 Sv).
(iii)
Registrants shall make the initial notification reports
required by clauses (i) and (ii) of this subparagraph by telephone to the
agency and shall confirm the initial notification report within 24 hours by
telegram, mailgram, or facsimile to the agency.
(iv)
The registrant shall prepare each report filed with the
agency in accordance with this section so that names of individuals who have
received exposure to radiation are stated in a separate and detachable portion
of the report.
(C)
Reports of exposures and radiation levels exceeding the
limits.
(i)
In addition to the notification required by subparagraph
(B) of this paragraph, each registrant shall submit a written report within
30 days after learning of any of the following occurrences:
(I)
incidents for which notification is required by subparagraph
(B) of this paragraph;
(II)
doses in excess of any of the following:
(-a-)
the occupational dose limits for adults in subsection
(i)(3)(A)(i)(I) of this section;
(-b-)
the occupational dose limits for a minor in subsection
(i)(3)(A)(i)(III) of this section;
(-c-)
the limits for an embryo/fetus of a declared pregnant
woman in subsection (i)(3)(A)(i)(IV) of this section;
(-d-)
the limits for an individual member of the public in
subsection (i)(3)(C) of this section; or
(-e-)
any applicable limit in the registration;
(III)
levels of radiation in:
(-a-)
a restricted area in excess of applicable limits in the
certificate of registration; or
(-b-)
an unrestricted area in excess of 10 times the applicable
limit set forth in this section or in the registration, whether or not involving
exposure of any individual in excess of the limits in subsection (i)(3)(C)
of this section.
(ii)
Each report required by clause (i) of this subparagraph
shall describe the extent of exposure of individuals to radiation, including,
as appropriate:
(I)
estimates of each individual's dose;
(II)
the levels of radiation involved;
(III)
the cause of the elevated exposures, dose rates; and
(IV)
corrective steps taken or planned to ensure against a
recurrence, including the schedule for achieving conformance with applicable
limits, and associated registration conditions.
(iii)
Each report filed in accordance with clause (i) of this
subparagraph shall include for each individual exposed: the name, social security
number, and date of birth. With respect to the limit for the embryo/fetus
in subsection (i)(3)(A)(i)(IV) of this section, the identifiers should be
those of the declared pregnant woman. The report shall be prepared so that
this information is stated in a separate and detachable portion of the report.
(iv)
All registrants who make reports in accordance with clause
(i) of this subparagraph shall submit the report in writing to the agency.
(D)
Reports to individuals of exposures.
(i)
Radiation exposure data for an individual shall be reported
annually to the individual as specified in this section. The information reported
shall include data and results obtained in accordance with agency requirements,
orders, certificate of registration conditions, as shown in records maintained
by the registrant in accordance with paragraph (3)(D) of this subsection.
Each notification and report shall:
(I)
be in writing;
(II)
include appropriate identifying data such as the name
of the registrant, the name of the individual, and the individual's identification
number;
(III)
include the individual's exposure information; and
(IV)
contain the following statement: "This report is furnished
to you under the provisions of the Texas Regulations for Control of Radiation,
25 Texas Administrative Code §289.233. You should preserve this report
for further reference."
(ii)
Each registrant shall advise each worker annually of the
worker's dose as shown in records maintained by the registrant in accordance
with paragraph (1)(P) of this subsection.
(iii)
At the written request of a worker formerly engaged in
activities controlled by the registrant, each registrant shall furnish a written
report of the worker's exposure to radiation machines. The report shall include
the dose record for each year the worker was required to be monitored in accordance
with subsection (i)(3)(B) of this section. Such report shall be furnished
within 30 days from the date of the request, or within 30 days after the dose
of the individual has been determined by the registrant, whichever is later.
The report shall cover the period of time that the worker's activities involved
exposure to radiation machines and the dates and locations of work under the
certificate of registration in which the worker participated during this period.
(iv)
When a registrant is required, in accordance with subparagraphs
(B) and (C) of this paragraph, to report to the agency any exposure of an
individual to radiation machines, the registrant shall also provide the individual
a written report of that individual's exposure data included therein. Such
reports shall be transmitted at a time not later than the transmittal to the
agency.
(v)
At the written request of a worker who is terminating employment
with the registrant in work involving exposure to radiation machines during
the current year, each registrant shall provide at termination to each such
worker, or to the worker's designee, a written report regarding the radiation
dose received by that worker from operations of the registrant during the
current year or fraction thereof. If the most recent individual monitoring
results are not available at that time, a written estimate of the dose shall
be provided together with a clear indication that this is an estimate. When
the final individual monitoring results are available, those written results
shall be provided to the worker or the worker's designee.
(vi)
When a registrant is required in accordance with paragraph
(3)(C) of this subsection to report to the agency any exposure of an identified
occupationally exposed individual, or an identified member of the public,
to radiation, the registrant shall also notify the individual and provide
a copy of the report submitted to the agency, to the individual. Such notice
shall be transmitted at a time not later than the transmittal to the agency,
and shall comply with the provisions of paragraph (3)(D) of this subsection.
(k)
Compliance and hearing procedures.
(1)
Inspections.
(A)
The agency may enter public or private property at reasonable
times to determine whether, in a matter under the agency's jurisdiction, there
is compliance with the Act, the agency's rules, certificate of registration
conditions, and orders issued by the agency.
(B)
Each registrant shall afford the agency, at all reasonable
times, opportunity to inspect machines, activities, facilities, premises,
and records in accordance with this section.
(C)
Each registrant shall make available to the agency for
inspection, upon reasonable notice, records made and maintained in accordance
with this chapter.
(D)
During an inspection, agency inspectors may consult privately
with workers as specified in subparagraphs (J)-(L) of this paragraph. The
registrant may accompany agency inspectors during other phases of an inspection.
(E)
If, at the time of inspection, an individual has been authorized
by the workers to represent them during agency inspections, the registrant
shall notify the inspectors of such authorization and shall give the workers'
representative an opportunity to accompany the inspectors during the inspection
of physical working conditions.
(F)
Each worker's representative shall be routinely engaged
in work under control of the registrant and shall have received instructions
as specified in subsection (i)(3)(K) of this section.
(G)
Different representatives of registrants and workers may
accompany the inspectors during different phases of an inspection if there
is no resulting interference with the conduct of the inspection. However,
only one worker's representative at a time may accompany the inspectors.
(H)
With the approval of the registrant and the worker's representative,
an individual who is not routinely engaged in work under control of the registrant,
for example, a consultant to the registrant or to the worker's representative,
shall be afforded the opportunity to accompany agency inspectors during the
inspection of physical working conditions.
(I)
Notwithstanding the other provisions of this section, agency
inspectors are authorized to refuse to permit accompaniment by any individual
who deliberately interferes with a fair and orderly inspection. With regard
to any area containing proprietary information, the worker's representative
for that area shall be an individual previously authorized by the registrant
to enter that area.
(J)
Agency inspectors may consult privately with workers concerning
matters of occupational radiation protection and other matters related to
applicable provisions of agency regulations and certificates of registration
to the extent the inspectors deem necessary for the conduct of an effective
and thorough inspection.
(K)
During the course of an inspection any worker may bring
privately to the attention of the inspectors, either orally or in writing,
any past or present condition which that individual has reason to believe
may have contributed to or caused any violation of the Act, the requirements
in this chapter, certificate of registration conditions, or any unnecessary
exposure of an individual to radiation from any source of radiation under
the registrant's control. Any such notice in writing shall comply with the
requirements of subparagraph (m) of this paragraph.
(L)
The provisions of subparagraph (K) of this paragraph shall
not be interpreted as authorization to disregard instructions in accordance
with subsection (i)(3)(K) of this section.
(M)
Any worker or representative of workers who believes that
a violation of the Act, the requirements of this chapter, or certificate of
registration conditions exists or has occurred in work under a certificate
of registration with regard to radiological working conditions in which the
worker is engaged, may request an inspection by giving notice of the alleged
violation to the agency. Any such notice shall be in writing, shall set forth
the specific grounds for the notice, and shall be signed by the worker or
representative of the workers. A copy shall be provided to the registrant
by the agency no later than at the time of inspection except that, upon the
request of the worker giving such notice, the worker's name and the name(s)
of individual(s) referred to therein shall not appear in such copy or on any
record published, released, or made available by the agency, except for good
cause shown.
(N)
If, upon receipt of such notice, the agency determines
that the request meets the requirements set forth in subparagraph (M) of this
paragraph, and that there are reasonable grounds to believe that the alleged
violation exists or has occurred, an inspection shall be made as soon as practicable
to determine if such alleged violation exists or has occurred. Inspections
in accordance with this section need not be limited to matters referred to
in the request.
(O)
No registrant, contractor or subcontractor of a registrant
shall discharge or in any manner discriminate against any worker because of
the following:
(i)
such worker has filed any request or instituted or caused
to be instituted any proceeding under this chapter;
(ii)
such worker has testified or is about to testify in any
such proceeding; or
(iii)
because of the exercise by such worker on behalf of that
individual or others of any option afforded by this section.
(P)
If the agency determines, with respect to a request under
subparagraphs (M)-(O) of this paragraph, that an inspection is not warranted
because there are no reasonable grounds to believe that a violation exists
or has occurred, the agency shall notify the requestor in writing of such
determination. The requestor may obtain review of such determination in accordance
with the provisions of the Act and the Government Code, Chapters 2001 and
2002.
(Q)
If the agency determines that an inspection is not warranted
because the requirements of subparagraph (M) of this paragraph have not been
met, the agency shall notify the requestor in writing of such determination.
Such determination shall be without prejudice to the filing of a new request
meeting the requirements of subparagraph (M) of this paragraph.
(R)
The routine inspection interval for veterinary facilities
is five years. On-site inspections and remote inspections may be alternated.
The inspection interval specified is based upon the average number of health-related
violations per inspection, as determined from compliance history data. This
interval will be reviewed at least every two years, and appropriate adjustments
will be made.
(S)
For remote inspection of radiation machines for veterinary
medicine, each registrant shall:
(i)
respond to a request from the agency for a remote inspection;
(ii)
complete the remote inspection forms in accordance with
the instructions included with the forms; and
(iii)
return to the agency the completed remote inspection
forms including documentation of the most recent equipment performance evaluation
performed in accordance with subsection (i)(5)(S) of this section and an inventory
in accordance with subsection (h)(5)(A) and (B) of this section by the deadline
indicated on the forms.
(T)
Notwithstanding the inspection intervals specified in this
section, the agency may inspect registrants more frequently due to:
(i)
the persistence or severity of violations found during
an inspection;
(ii)
investigation of an incident or complaint concerning the
facility;
(iii)
a request for an inspection by a worker(s) in accordance
with subparagraphs (M)-(O) of this paragraph;
(iv)
any change in a facility or equipment that might cause
a significant increase in radiation output or hazard; or
(v)
a mutual agreement between the agency and registrant.
(U)
The agency will conduct inspections of veterinary radiation
machines in a manner designed to cause as little disruption of a veterinary
practice as is practicable.
(V)
Each registrant shall perform, upon instructions from the
agency, or shall permit the agency to perform such reasonable surveys as the
agency deems appropriate or necessary including, but not limited to, surveys
of:
(i)
radiation machines;
(ii)
facilities where radiation machines are used or stored;
(iii)
radiation detection and monitoring instruments; and
(iv)
other equipment and devices used in connection with utilization
or storage of radiation machines.
(W)
A person who performs on-site inspections of veterinary
radiation machines will have training in the design and use of the machines
and will receive the following training.
(i)
Objectives. Training of agency inspectors of radiation
machines will be conducted by the agency. Upon completion of training, the
inspector will be able to:
(I)
select and operate the necessary testing equipment used
to perform an inspection of radiation machines;
(II)
utilize radiation protection principles;
(III)
operate radiation detection instruments;
(IV)
define basic regulatory terminology;
(V)
apply this section regarding radiation machines;
(VI)
perform routine agency inspections of radiation machines;
(VII)
complete agency inspection documentation;
(VIII)
demonstrate knowledge of agency ethics, professional,
and technical policies; and
(IX)
successfully achieve the objectives in this subparagraph.
(ii)
Initial training program.
(I)
Initial training will be conducted during a six-month period.
(II)
All training evaluation instruments will be developed
by the agency.
(III)
Instruments to be used in determining a proficiency level
are as follows:
(-a-)
evaluation of each inspector's training needs prior to
initial training;
(-b-)
evaluation of knowledge obtained and verification of
tasks performed by each inspector subsequent to training received by the agency;
and
(-c-)
evaluation of each inspector's task performance by the
agency.
(iii)
Continuing education.
(I)
The agency inspector of radiation machines will accumulate
24 hours of continuing education regarding radiation machines, at intervals
not to exceed 24 months. These hours of continuing education may be acquired
as follows:
(-a-)
documented continuing education earned in an agency-accepted
training format; and
(-b-)
agency staff meetings.
(II)
Failure to obtain 24 hours of continuing education within
each 24 month interval may result in a reassessment by the agency of an agency
inspector's proficiency level.
(III)
After the initial training period, each inspector of
radiation machines will be evaluated by the agency, at intervals not to exceed
12 months.
(iv)
Agency proficiency standards. The agency proficiency standards
for agency inspectors of veterinary radiation machines are as follows.
(I)
Level I. The agency inspector has not successfully achieved
the objectives in clause (i) of this subparagraph after the initial training
period. Additional training is required. Unsupervised inspections will not
be performed.
(II)
Level II. The agency inspector has partially achieved
the objectives in clause (i) of this subparagraph, but has not achieved the
objective in clause (i)(IX) of this subparagraph after the initial training
period. Additional training is required. Unsupervised inspections are not
permitted for the type of veterinary radiation machines for which the objectives
of clause (i)(IX) of this subparagraph have not been achieved. Unsupervised
inspections may be performed for the type of veterinary radiation machines
for which the objectives in clause (i)(IX) of this subparagraph have been
successfully achieved.
(III)
Level III. The agency inspector has successfully achieved
the objectives in clause (i) of this subparagraph. Supervision is not required
for routine inspections.
(2)
Hearing and enforcement procedures.
(A)
Violations. A court injunction or agency order may be issued
prohibiting any violation of any provision of the Act or any rule or order
issued thereunder. Any person who willfully violates any provision of the
Act or any rule or order issued thereunder may be subject to civil and/or
administrative penalties. Such person may also be guilty of a misdemeanor
and upon conviction, may be punished by fine or imprisonment or both, as provided
by law.
(B)
Denial of an application for a certificate of registration.
(i)
When the agency contemplates denial of an application for
a certificate of registration, the registrant shall be afforded the opportunity
for a hearing. Notice of the denial shall be delivered by personal service
or certified mail, addressed to the last known address, to the registrant.
(ii)
Any applicant or registrant against whom the agency contemplates
an action described in clause (i) of this subparagraph may request a hearing
by submitting a written request to the director within 30 days of service
of the notice.
(I)
The written request for a hearing must contain the following:
(-a-)
statement requesting a hearing; and
(-b-)
name and address of the applicant or registrant;
(II)
Failure to submit a written request for a hearing within
30 days will render the agency action final.
(C)
Compliance procedures for registrants and other persons.
(i)
A registrant or other person who commits a violation(s)
will be issued a notice of violation.
(ii)
The terms and conditions of all certificates of registration
shall be subject to amendment or modification. A certificate of registration
may be modified, suspended, or revoked by reason of amendments to the Act,
or for violation of the Act, the requirements of this chapter, a condition
of the certificate of registration, or an order of the agency.
(iii)
Any certificate of registration may be modified, suspended,
or revoked in whole or in part, for any of the following:
(I)
any material false statement in the application or any
statement of fact required in accordance with provisions of the Act;
(II)
conditions revealed by such application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a certificate of registration on an original
application;
(III)
violation of, or failure to observe applicable terms
and conditions of the Act, this chapter, or of the certificate of registration
or order of the agency; or
(IV)
existing conditions that constitute a substantial threat
to the public health or safety or the environment.
(iv)
If another state or federal entity takes an action such
as modification, revocation, or suspension of the certificate of registration,
the agency may take a similar action against the registrant.
(v)
When the agency determines that the action provided for
in clause (viii) of this subparagraph or subparagraph (D) of this paragraph
is not to be taken immediately, the agency may offer the registrant an opportunity
to attend an enforcement conference to discuss the following with the agency:
(I)
methods and schedules for correcting the violation(s);
or
(II)
methods and schedules for showing compliance with applicable
provisions of the Act, the requirements of this chapter, certificate of registration
conditions, or any orders of the agency.
(vi)
Notice of any enforcement conference shall be delivered
by personal service, or certified mail, addressed to the last known address.
An enforcement conference is not a prerequisite for the action to be taken
under clause (viii) of this subparagraph or subparagraph (D) of this paragraph.
(vii)
Except in cases in which the occupational and public
health, or safety requires otherwise, no certificate of registration shall
be suspended or revoked unless, prior to the institution of proceedings therefore,
facts or conduct that may warrant such action shall have been called to the
attention of the registrant in writing, and the registrant shall have been
accorded an opportunity to demonstrate compliance with all lawful requirements.
(viii)
When the agency contemplates modification, suspension,
or revocation of the certificate of registration, the registrant shall be
afforded the opportunity for a hearing. Notice of the contemplated action,
along with a complaint, shall be given to the registrant by personal service
or certified mail, addressed to the last known address.
(ix)
Any applicant or registrant against whom the agency contemplates
an action described in clause (viii) of this subparagraph may request a hearing
by submitting a written request to the director within 30 days of service
of the notice.
(I)
The written request for a hearing must contain the following:
(-a-)
statement requesting a hearing;
(-b-)
name, address, and identification number of the registrant
against whom the action is being taken.
(II)
Failure to submit a written request for a hearing within
30 days will render the agency action final.
(D)
Assessment of administrative penalties.
(i)
When the agency determines that monetary penalties are
appropriate, proposals for assessment of and hearings on administrative penalties
shall be made in accordance with the Act, Health and Safety Code, §401.384,
Title 1, TAC, Chapter 155, and applicable sections of Formal Hearing Procedures, §§1.21,
1.23, 1.25, and 1.27 of this title.
(ii)
Assessment of administrative penalties shall be based
on the following criteria:
(I)
the seriousness of the violation(s);
(II)
previous compliance history;
(III)
the amount necessary to deter future violations;
(IV)
efforts to correct the violation; and
(V)
any other mitigating or enhancing factors.
(iii)
Application of administrative penalties. The agency may
impose differing levels of penalties for different severity level violations
and different classes of users as follows.
(I)
Administrative penalties may be imposed for severity level
I and II violations. Administrative penalties may be imposed for severity
level III, IV, and V violations when they are combined with those of higher
severity level(s) or for repeated violations.
(II)
The following Tables IIA and IIB show the base administrative
penalties.
Figure: 25 TAC §289.233(k)(2)(D)(iii)(II)
(III)
Adjustments to the severity levels and percentages in
Table IIB may be made for the presence or absence of the following factors:
(-a-)
prompt identification and reporting;
(-b-)
corrective action to prevent recurrence;
(-c-)
compliance history;
(-d-)
prior notice of similar event;
(-e-)
multiple occurrences; and
(-f-)
negligence that resulted in or increased adverse effects.
(IV)
The penalty may be in an amount not to exceed $10,000
a day for a person who violates the Act or requirements of this chapter, order,
certificate of registration issued under the Act. Each day a violation continues
may be considered a separate violation for purposes of penalty assessment.
(iv)
The agency may conduct settlement negotiations.
(E)
Severity levels of violations for registrants or other
persons.
(i)
Violations for registrants or other persons shall be categorized
by one of the following severity levels.
(I)
Severity level I are violations that are most significant
and may have a significant negative impact on occupational and/or public health
and safety or on the environment.
(II)
Severity level II are violations that are very significant
and may have a negative impact on occupational and/or public health and safety
or on the environment.
(III)
Severity level III are violations that are significant
and which, if not corrected, could threaten occupational and/or public health
and safety or the environment.
(IV)
Severity level IV are violations that are of more than
minor significance, but if left uncorrected, could lead to more serious circumstances.
(V)
Severity level V are violations that are of minor safety
or environmental significance.
(ii)
Criteria to elevate or reduce severity levels.
(I)
Violations may be elevated to a higher severity level for
the following reasons:
(-a-)
more than one violation resulted from the same underlying
cause;
(-b-)
a violation contributed to or was the consequence of
the underlying cause, such as a management breakdown or breakdown in the control
of licensed or registered activities;
(-c-)
a violation occurred multiple times between inspections;
(-d-)
a violation was willful. This means the violation was
the result of careless regard for requirements, deception, or other indications
of willfulness by the registrant or employees of the registrant; or
(-e-)
compliance history.
(II)
Violations may be reduced to a lower level for the following
reasons:
(-a-)
the registrant identified and corrected the violation
prior to the agency inspection; or
(-b-)
the registrant's actions corrected the violation and
prevented recurrence.
(iii)
Examples of severity levels. Examples of severity levels
are available upon request to the agency.
(F)
Impoundment of radiation machines. Radiation machines shall
be subject to impounding in accordance with the Act, Health and Safety Code, §401.068,
and this paragraph.
(i)
In the event of an emergency, the agency shall have the
authority to impound or order the impounding of radiation machines possessed
by any person not equipped to observe or failing to observe the provisions
of the Act, Health and Safety Code, Chapter 401, or any rules, certificate
of registration conditions, or orders issued by the agency. The agency shall
submit notice of the action to be published in the
Texas Register
no later than 30 days following the end of the month
in which the action was taken.
(ii)
At the agency's discretion, the impounded radiation machines
may be disposed of by:
(I)
returning the source of radiation to a properly registered
owner, upon proof of ownership, who did not cause the emergency;
(II)
releasing the source of radiation as evidence to police
or courts;
(III)
returning the source of radiation to a registrant after
the emergency is over and settlement of any compliance action; or
(IV)
sale, destruction or other disposition within the agency's
discretion.
(iii)
If agency action is necessary to protect the public health
and safety, no prior notice need be given the owner or possessor. If agency
action is not necessary to protect the public health and safety, the agency
will give written notice to the owner and/or the possessor of the radiation
machine of the intention to dispose of the radiation machine. Notice shall
be the same as provided in subparagraph (C)(viii) of this paragraph. The owner
or possessor shall have 30 days from the date of personal service or mailing
to request a hearing under Title 1, TAC, Chapter 155, and the Formal Hearing
Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title, and in accordance
with subparagraph (C)(ix) of this paragraph, concerning the intention of the
agency. If no hearing is requested within that period of time, the agency
may take the contemplated action, and such action is final.
(iv)
Upon agency disposition of a radiation machine, the agency
may notify the owner and/or possessor of any expense the agency may have incurred
during the impoundment and/or disposition and request reimbursement. If the
amount is not paid within 60 days from the date of notice, the agency may
request the Attorney General to file suit against the owner/possessor for
the amount requested.
(v)
If the agency determines from the facts available to the
agency that an impounded radiation machine is abandoned, with no reasonable
evidence showing its owner or possessor, the agency may make such disposition
of the radiation machine as it sees fit.
(G)
Emergency orders.
(i)
When an emergency exists requiring immediate action to
protect the public health or safety or the environment, the agency may, without
notice or hearing, issue an order citing the existence of such emergency and
require that certain actions be taken as it shall direct to meet the emergency.
The agency shall, no later than 30 days following the end of the month in
which the action was taken, submit notice of the action for publication in
the
Texas Register
. The action taken will
remain in full force and effect unless and until modified by subsequent action
of the agency.
(ii)
An emergency order takes effect immediately upon service.
(iii)
Any person receiving an emergency order shall comply
immediately.
(iv)
The person receiving the order shall be afforded the opportunity
for a hearing on an emergency order. Notice of the action, along with a complaint,
shall be given to the person by personal service or certified mail, addressed
to the last known address. A hearing shall be held on an emergency order if
the person receiving the order submits a written request to the director within
30 days of the date of the order.
(I)
The hearing shall be held not less than 10 days nor more
than 20 days after receipt of the written application for hearing.
(II)
At the conclusion of the hearing and after the proposal
for decision is made as provided in the Texas Administrative Procedure Act,
Texas Government Code, Chapter 2001, the commissioner shall take one of the
following actions:
(-a-)
determine that no further action is warranted;
(-b-)
amend the certificate of registration;
(-c-)
revoke or suspend the certificate of registration;
(-d-)
rescind the emergency order; or
(-e-)
issue such other order as is appropriate.
(III)
The application and hearing shall not delay compliance
with the emergency order.
(H)
Miscellaneous provisions.
(i)
Computation of time. A time period established by the requirements
of this chapter shall begin on the first day after the event that invokes
the time period. When the last day of the period falls on a Saturday, Sunday,
or state or federal holiday, the period shall end on the next day that is
not a Saturday, Sunday, or state or federal holiday. The time period shall
expire at 5:00 p.m. of the last day of the computed period.
(ii)
Hearing location. Hearings will be held at the offices
of the State Office of Administrative Hearings in Austin unless the ALJ specifies
another location.
(iii)
Non-party witness and mileage fees.
(I)
A witness or deponent who is not a party (or an employee,
agent, or representative of a party) and who is subpoenaed or otherwise compelled
to attend an agency hearing or a proceeding to give a deposition, or to produce
books, records, papers, accounts, documents, or other objects necessary and
proper for the purposes of the hearing or proceeding may receive reimbursement
for transportation and other costs at rates established by the current Appropriations
Act for state employees.
(II)
The person requesting the attendance of the witness or
deponent must deposit with the agency the funds estimated to accrue in accordance
with subclause (I) of this clause when filing a motion for the issuance of
a subpoena or a commission to take a deposition.
(iv)
Service. A return of service by the person who performed
personal service, postal return receipt, or proof of mailing to the last known
address shall be conclusive evidence of service.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State on January 15, 2004.
TRD-200400298
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §289.251
and new §289.251, concerning radiation control exemptions, general licenses,
and general license acknowledgements.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.251
has been reviewed, and the department has determined that the reasons for
adopting the section continue to exist; however, revisions to the rule are
necessary as outlined in this preamble.
The department published a Notice of Intention to Review for §289.251
regarding Government Code, §2001.039, in the
Texas Register
(27 TexReg 1537) on March 1, 2002. No comments were
received by the department on this section following publication of the notice.
The proposed revision incorporates legislation passed by the 78th Legislature,
Regular Session. House Bill (HB) 2292 requires two-year terms for radioactive
material licenses and requires recovery through fees of 100% of regulatory
program costs for the two-year term of the license. In order to incorporate
the provisions of HB 2292 concerning two-year terms, the department is implementing
an administrative renewal. The general licensee will be required to renew
the general license acknowledgement every two years by paying the required
fee and having a satisfactory compliance history. The change to the rule is
reflected in subsection (j).
House Bill 253, 78th Legislature, Regular Session, requires the department
to deny a radioactive material application, amendment or renewal if the applicant's
compliance history reveals a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations
of the Radiation Control Act or the department's radiation control rules.
The department has defined "a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations..."
by adding a requirement that states the department will revoke, suspend, or
restrict a general license if at least three department or judicial orders
are issued that assess administrative or civil penalties against the general
licensee or revoke or suspend the general license. The change to the rule
is reflected in subsection (f)(1).
The entire section has been reorganized and reformatted to better differentiate
between general licenses for source material and general licenses for material
other than source material.
The definitions of "general license" and "general license acknowledgement"
in subsection (c) are clarified, as these requirements are items of compatibility
with the United States Nuclear Regulatory Commission (NRC) regulations, and
as an agreement state, Texas must adopt these requirements.
The revisions to §289.251 incorporate items of compatibility regarding
general licensed devices. NRC has implemented a "registration" of certain
generally licensed devices based on not only type of generally licensed device,
but also quantities of radioactive material contained in the device. The "registration"
requirement is similar to the department's general license acknowledgement
(GLA) concept and many of the NRC compatibility requirements already exist
in this section. However, requirements are added specifying how long a device
that is not in use may be held and requiring a quarterly physical inventory
of devices being kept in standby for future use. A GLA for generally licensed
This repeal and new section are part of the department's continuing effort
to update, clarify, and simplify its rules regarding the control of radiation
based upon technological advances, public concerns, legislative directives,
other factors, or to incorporate requirements that are items of compatibility
with NRC regulations because as an agreement state, Texas must adopt compatible
requirements.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section is in effect, there will be fiscal implications
for state government as a result of enforcing or administering the section
as proposed.
In vitro
testing general licensees
will no longer be required to obtain a general license acknowledgment and
will no longer pay a fee for a general license acknowledgement. The department
will have a decrease in fee recovery of approximately $3,036 for each year
of the first five years the section will be in effect. There will be no fiscal
implications for local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section is in effect, the public benefit anticipated as
a result of enforcing the section will be to ensure continued protection of
the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that rules are clear and specific and that security of certain
gauging, measuring, and controlling devices is enhanced. There will be a fiscal
impact on all general license acknowledgement holders who hold devices that
are not in use for longer than two years and do not perform a quarterly physical
inventory of devices in standby for future use. Such devices must be disposed
of, typically by return to the manufacturer. The cost to return devices to
the manufacturer ranges from approximately $655 for a device containing a
10 millicurie source to $1,195 for a device containing a 200 millicurie source.
There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:00 p.m., Wednesday,
February 11, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
25 TAC §289.251
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, §401.051, which provides the Texas Board of Health (board) with
authority to adopt rules and guidelines relating to the control of radiation;
and §12.001, which provides the board with the authority to adopt rules
for its procedure and for the performance of each duty imposed by law on the
board, the department, or the commissioner of health.
The repeal affects Health and Safety Code, Chapters 12 and 401. The review
of the rule implements Government Code, §2001.039.
§289.251.Exemptions, General Licenses, and General License Acknowledgements.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on January 16, 2004.
TRD-200400318
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.251
The new section is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with authority to adopt rules
and guidelines relating to the control of radiation; and §12.001, which
provides the board with the authority to adopt rules for its procedure and
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The new section affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.251.Exemptions, General Licenses, and General License Acknowledgements.
(a)
Purpose. This section provides for exemptions to licensing
requirements, general licensing of radioactive material, and acknowledgement
of general licenses.
(b)
Scope. Except as otherwise authorized, no person shall
receive, possess, use, transfer, own, or acquire radioactive material except
as authorized in a general license or general license acknowledgement issued
in accordance with this section, or in a specific license issued in accordance
with §289.252 of this title (relating to Licensing of Radioactive Material), §289.254
of this title (relating to Licensing of Radioactive Waste Processing and Storage
Facilities), §289.255 of this title (relating to Radiation Safety Requirements
and Licensing and Registration Procedures for Industrial Radiography), §289.256
of this title (relating to Medical and Veterinary Use of Radioactive Material), §289.258
of this title (relating to Licensing and Radiation Safety Requirements for
Irradiators), §289.259 of this title (relating to Licensing of Naturally
Occurring Radioactive Material (NORM)), or §289.260 of this title (relating
to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities).
(c)
Definitions. The following words and terms when used in
this section shall have the following meanings unless the context clearly
indicates otherwise.
(1)
General license--An authorization in accordance with this
section that grants authority to a person for certain activities involving
radioactive material, and is effective without the filing of applications
with the agency or the issuance of licensing documents to the particular persons.
The general licensee is subject to all other applicable portions of this chapter
and any limitations of the general license.
(2)
General license acknowledgement--A written recognition
of a general license issued in accordance with this section. The issuance
of a general license acknowledgement requires the submission of an application
to the agency. A written acknowledgement of a general license granted in accordance
with this section is issued by the agency. The holder of a general license
acknowledgement is subject to all other applicable portions of this chapter
as well as any conditions specified in the acknowledgement document.
(d)
Exemptions for source material.
(1)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers source
material in any chemical mixture, compound, solution, or alloy in which the
source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture,
compound, solution, or alloy.
(2)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers unrefined
and unprocessed ore containing source material; provided that, except as authorized
in a specific license, such person shall not refine or process such ore. This
exemption does not apply to the mining of ore containing source material.
(3)
Any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, or transfers:
(A)
any quantities of thorium contained in:
(i)
incandescent gas mantles;
(ii)
vacuum tubes;
(iii)
welding rods;
(iv)
electric lamps for illuminating purposes provided that
each lamp does not contain more than 50 milligrams (mg) of thorium;
(v)
germicidal lamps, sunlamps, and lamps for outdoor or industrial
lighting provided that each lamp does not contain more than two grams of thorium;
(vi)
rare earth metals and compounds, mixtures, and products
containing not more than 0.25% by weight thorium, uranium, or any combination
of these; or
(vii)
personnel neutron dosimeters, provided that each dosimeter
does not contain more than 50 mg of thorium;
(B)
source material contained in the following products:
(i)
glazed ceramics, for example tableware, provided that the
glaze contains not more than 20% by weight source material;
(ii)
glassware containing not more than 10% by weight source
material, but not including commercially manufactured glass brick, pane glass,
ceramic tile, or other glass or ceramic used in construction;
(iii)
glass enamel or glass enamel frit containing not more
than 10% by weight source material imported or ordered for importation into
the United States, or initially distributed by manufacturers in the United
States, before July 25, 1983; or
(iv)
piezoelectric ceramic containing not more than 2.0% by
weight source material;
(C)
photographic film, negatives, and prints containing uranium
or thorium;
(D)
any finished product or part fabricated of, or containing,
metal-thorium alloys, provided that the thorium content of the alloy does
not exceed 4% by weight and that the exemption contained in this subparagraph
shall not be deemed to authorize the chemical, physical, or metallurgical
treatment or processing of any such product or part;
(E)
depleted uranium contained in counterweights installed
in aircraft, rockets, projectiles, and missiles, or stored or handled in connection
with installation or removal of such counterweights, provided that:
(i)
the counterweights are manufactured in accordance with
a specific license issued by the United States Nuclear Regulatory Commission
(NRC) authorizing distribution by the licensee in accordance with Title 10,
Code of Federal Regulations (CFR), Part 40;
(ii)
each counterweight has been impressed with the following
legend clearly legible through any plating or other covering: "DEPLETED URANIUM"
(The requirements specified in this clause need not be met by counterweights
manufactured prior to December 31, 1969, provided that such counterweights
are impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM,"
as previously required by this chapter);
(iii)
each counterweight is durably and legibly labeled or
marked with the identification of the manufacturer and the statement: "UNAUTHORIZED
ALTERATIONS PROHIBITED" (The requirements specified in this clause need not
be met by counterweights manufactured prior to December 31, 1969, provided
that such counterweights are impressed with the legend, "CAUTION - RADIOACTIVE
MATERIAL - URANIUM," as previously required by this chapter); and
(iv)
the exemption contained in this subparagraph shall not
be deemed to authorize the chemical, physical, or metallurgical treatment
or processing of any such counterweights other than repair or restoration
of any plating, covering, or labeling;
(F)
depleted uranium used as shielding constituting part of
any shipping container, provided that:
(i)
the shipping container is conspicuously and legibly impressed
with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM;" and
(ii)
the uranium metal is encased in a one-eighth inch minimum
wall thickness of mild steel or equally fire resistant material;
(G)
thorium contained in finished optical lenses, provided
that each lens does not contain more than 30% by weight of thorium, and that
the exemption contained in this subparagraph shall not be deemed to authorize
either:
(i)
the shaping, grinding, or polishing of such lens or manufacturing
processes other than the assembly of such lens into optical systems and devices
without any alteration of the lens; or
(ii)
the receipt, possession, use, or transfer of thorium contained
in contact lenses, or in spectacles, or in eyepieces in binoculars or in other
optical instruments;
(H)
uranium contained in detector heads for use in fire detection
units, provided that each detector head contains not more than 0.005 microcurie
(µCi) of uranium; or
(I)
thorium contained in any finished aircraft engine part
containing nickel-thoria alloy, provided that:
(i)
the thorium is dispersed in the nickel-thoria alloy in
the form of finely divided thoria (thorium dioxide); and
(ii)
the thorium content in the nickel-thoria alloy does not
exceed 4.0% by weight.
(4)
The exemptions in subsection (d)(3) of this section do
not authorize the manufacture of any of the products described.
(e)
Exemptions for radioactive material other than source material.
(1)
Exempt concentrations.
(A)
Except as provided in subparagraph (B) of this paragraph,
any person is exempt from this section and §289.252 of this title if
that person receives, possesses, uses, transfers, or acquires products or
materials containing radioactive material in concentrations not in excess
of those listed in subsection (q)(1) of this section.
(B)
No person may introduce radioactive material into a product
or material, including waste, knowing or having reason to believe that it
will be transferred to persons exempt in accordance with subparagraph (A)
of this paragraph or equivalent regulations of the NRC, any agreement state,
or any licensing state, except in accordance with a specific license issued
in accordance with §289.252(i) of this title or the general license provided
in §289.252(ee) of this title.
(2)
Exempt quantities.
(A)
Except as provided in subparagraph (C) of this paragraph,
any person is exempt from these rules if that person receives, possesses,
uses, transfers, or acquires radioactive material in individual quantities,
each of which does not exceed the applicable quantity set forth in subsection
(q)(2) of this section.
(B)
Any person who possesses radioactive material received
or acquired, prior to September 25, 1971, in accordance with the general license
provided in subsection (f)(4)(A) of this section, is exempt from the requirements
for a license set forth in §289.252 of this title if that person possesses,
uses, or transfers such radioactive material.
(C)
This paragraph does not authorize the production, packaging,
or repackaging of radioactive material for purposes of commercial distribution,
or the incorporation of radioactive material into products intended for commercial
distribution.
(D)
No person may, for purposes of commercial distribution,
transfer radioactive material in quantities greater than the individual quantities
set forth in subsection (q)(2) of this section, knowing or having reason to
believe that such quantities of radioactive material will be transferred to
persons exempt in accordance with this paragraph or equivalent regulations
of the NRC, any agreement state, or any licensing state, except in accordance
with a specific license issued by the NRC in accordance with Title 10, CFR, §32.18
or by the agency in accordance with §289.252(j) of this title, which
states that the radioactive material may be transferred by the licensee to
persons exempt in accordance with this paragraph or the equivalent regulations
of the NRC, any agreement state, or any licensing state.
(E)
The schedule of quantities set forth in subsection (q)(2)
of this section applies only to radioactive materials distributed as exempt
quantities in accordance with a specific license issued by the agency, another
licensing state, or the commission. Subsection (q)(2) of this section does
not apply to radioactive materials that have decayed from quantities not originally
exempt and does not make such material, or the sources or devices in which
the material is contained, exempt from the licensing requirements in this
section or §289.252 of this title.
(3)
Exempt items.
(A)
Certain items containing radioactive material.
(i)
Except for persons who apply radioactive material to, or
persons who incorporate radioactive material into the following products,
any person is exempt from this chapter if that person receives, possesses,
uses, transfers, or acquires the following products:
(I)
timepieces, hands, or dials containing not more than the
following specified quantities of radioactive material and not exceeding the
following specified levels of radiation:
(-a-)
25 millicuries (mCi) of tritium per timepiece;
(-b-)
5 mCi of tritium per hand;
(-c-)
15 mCi of tritium per dial (bezels when used shall be
considered as part of the dial);
(-d-)
100 µCi of promethium-147 per watch or 200 µCi
of promethium-147 per any other timepiece;
(-e-)
20 µCi of promethium-147 per watch hand or 40 µCi
of promethium-147 per other timepiece hand;
(-f-)
60 µCi of promethium-147 per watch dial or 120 µCi
of promethium-147 per other timepiece dial (bezels when used shall be considered
as part of the dial);
(-g-)
the levels of radiation from hands and dials containing
promethium-147 will not exceed, when measured through 50 milligrams per square
centimeter (mg/cm
2
) of absorber:
(-1-)
for wrist watches, 0.1 millirad per hour (mrad/hr) at
10 centimeters (cm) from any surface;
(-2-)
for pocket watches, 0.1 mrad/hr at 1 cm from any surface;
and
(-3-)
for any other timepiece, 0.2 mrad/hr at 10 cm from any
surface; or
(-h-)
1 µCi of radium-226 per timepiece in timepieces,
hands, or dials manufactured or initially distributed prior to January 1,
1986;
(II)
lock illuminators containing not more than 15 mCi of tritium
or not more than 2 mCi of promethium-147 installed in automobile locks. The
levels of radiation from each lock illuminator containing promethium-147 will
not exceed 1 mrad/hr at 1 cm from any surface when measured through 50 mg/cm
(III)
balances of precision containing not more than 1 mCi
of tritium per balance or not more than 0.5 mCi of tritium per balance part;
(IV)
automobile shift quadrants containing not more than 25
mCi of tritium;
(V)
marine compasses containing not more than 750 mCi of tritium
gas and other marine navigational instruments containing not more than 250
mCi of tritium gas;
(VI)
thermostat dials and pointers containing not more than
25 mCi of tritium per thermostat;
(VII)
electron tubes, provided that each tube does not contain
more than one of the following specified quantities of radioactive material
and that the levels of radiation from each electron tube containing byproduct
material do not exceed 1 mrad/hr at 1 cm from any surface when measured through
7 mg/cm
2
of absorber (For purposes of this clause,
"electron tubes" include spark gap tubes, power tubes, gas tubes including
glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes,
radiation detection tubes, and any other completely sealed tube designed to
control electrical currents):
(-a-)
150 mCi of tritium per microwave receiver protector tube
or 10 mCi of tritium per any other electron tube;
(-b-)
1 µCi of cobalt-60;
(-c-)
5 µCi of nickel-63;
(-d-)
30 µCi of krypton-85;
(-e-)
5 µCi of cesium-137; or
(-f-)
30 µCi of promethium-147;
(VIII)
ionizing radiation measuring instruments containing,
for purposes of internal calibration or standardization, a source of radioactive
material not exceeding the applicable quantity set forth in subsection (q)(2)
of this section or 0.05 µCi of americium-241; or
(IX)
spark gap irradiators containing not more than 1 µCi
of cobalt-60 per spark gap irradiator for use in electrically ignited fuel
oil burners having a firing rate of at least 3 gallons per hour.
(ii)
Authority to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source material or byproduct material whose subsequent possession,
use, transfer, and disposal by all other persons are exempted from regulatory
requirements may be obtained only from the United States Nuclear Regulatory
Commission, Washington, DC 20555.
(B)
Self-luminous products containing tritium, krypton-85,
promethium-147, or radium-226.
(i)
Except for persons who manufacture, process, or produce
self-luminous products containing tritium, krypton-85, or promethium-147,
any person is exempt from this chapter if that person receives, possesses,
uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147
in self-luminous products manufactured, processed, produced, imported, or
transferred in accordance with a specific license issued by the NRC in accordance
with Title 10, CFR, §32.22, which authorizes the transfer of the product
to persons who are exempt from regulatory requirements. The exemption in this
subparagraph does not apply to tritium, krypton-85, or promethium-147 used
in products for frivolous purposes or in toys or adornments.
(ii)
Any person is exempt from this chapter if that person
receives, possesses, uses, transfers, or owns articles acquired prior to January
1, 1986, each of which contains less than 0.1 µCi of radium-226.
(C)
Gas and aerosol detectors containing radioactive material.
(i)
Except for persons who manufacture, process, or produce
gas and aerosol detectors containing radioactive material, any person is exempt
from this chapter if that person receives, possesses, uses, transfers, owns,
or acquires radioactive material in gas and aerosol detectors designed to
protect life or property from fires and airborne hazards provided that:
(I)
detectors containing radioactive material shall have been
manufactured, imported, or transferred in accordance with a specific license
issued by the NRC in accordance with Title 10, CFR, §32.26, or an agreement
state or a licensing state in accordance with §289.252(k) of this title;
and
(II)
the specific license issued in accordance with §289.252
of this title authorizes the transfer of the detectors to persons who are
exempt from regulatory requirements.
(ii)
Authority to transfer possession or control by the manufacturer,
processor, or producer of any equipment, device, commodity, or other product
containing source material or byproduct material whose subsequent possession,
use, transfer, and disposal by all other persons are exempted from regulatory
requirements may be obtained only from the United States Nuclear Regulatory
Commission, Washington, DC 20555.
(iii)
Gas and aerosol detectors previously manufactured and
distributed to general licensees in accordance with a specific license issued
by an agreement state or a licensing state shall be considered exempt in accordance
with clause (i) of this subparagraph, provided that the devices are labeled
in accordance with the specific license authorizing distribution of the generally
licensed device, and provided further that they meet the requirements of §289.252
of this title.
(D)
Resins containing scandium-46 and designed for sand consolidation
in oil wells. Any person is exempt from this chapter if that person receives,
possesses, uses, transfers, or acquires synthetic plastic resins containing
scandium-46, which are designed for sand consolidation in oil wells. Such
resins shall have been manufactured or imported in accordance with a specific
license issued by the NRC, or shall have been manufactured in accordance with
the specifications contained in a specific license issued by the agency or
any agreement state to the manufacturer of such resins in accordance with
licensing requirements equivalent to those in Title 10, CFR, §§32.16
and 32.17. This exemption does not authorize the manufacture of any resins
containing scandium-46.
(4)
Exemption for capsules containing carbon-14 urea for "in
vivo" diagnostic use in humans.
(A)
Except as provided in subparagraphs (B) and (C) of this
paragraph, a person is exempt from the requirements of this section and §289.256
of this title provided that such person receives, possesses, uses, transfers,
owns, or acquires capsules containing 1 µCi (37 kilobecquerels) or less
of carbon-14 urea each (allowing for nominal variation that may occur during
the manufacturing process), for "in vivo" diagnostic use in humans.
(B)
A person desiring to use the capsules for research involving
human subjects shall apply for and receive a specific license in accordance
with §289.256 of this title.
(C)
A person desiring to manufacture, prepare, process, produce,
package, repackage, or transfer for commercial distribution such capsules
shall apply for and receive a specific license in accordance with Title 10,
CFR, §32.21.
(D)
Nothing in this subsection relieves a person from complying
with applicable requirements of the United States Food and Drug Administration
(FDA) and other federal and state requirements governing the receipt, administration,
and use of drugs.
(f)
General licenses. In addition to the requirements of this
section, all general licenses, unless otherwise specified, are subject to
the requirements of §289.201 of this title (relating to General Provisions
for Radioactive Material), §289.202(ww) and (xx) of this title (relating
to Standards for Protection Against Radiation from Radioactive Materials), §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), and §289.257 of this title (relating to Packaging and Transportation
of Radioactive Material).
(1)
In making a determination whether to revoke, suspend, or
restrict a general license, the agency may consider the technical competence
and compliance history of a general licensee. After an opportunity for a hearing,
the agency may revoke, suspend, or restrict a general license if the general
licensee's compliance history reveals that at least three agency or judicial
orders have been issued against the general licensee that assess administrative
or civil penalties against the general licensee, or that revoke or suspend
the general license.
(2)
Modification, suspension, and revocation of a general license.
(A)
The terms and conditions of all general licenses shall
be subject to revision or modification.
(B)
A general license may be suspended or revoked by reason
of amendments to the Texas Radiation Control Act (Act), Health and Safety
Code, Chapter 401, by reason of rules in this chapter, or orders issued by
the agency.
(C)
Any general license may be revoked, suspended, or modified,
in whole or in part, for any of the following:
(i)
any material false statement in the application for a general
license acknowledgement or any statement of fact required in accordance with
provisions of the Act;
(ii)
conditions revealed by such application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a general license on an original application;
(iii)
violation of, or failure to observe, any of the terms
and conditions of the Act, this chapter, or of the general license, or order
of the agency; or
(iv)
existing conditions that constitute a substantial threat
to the public health or safety or the environment.
(D)
Except in cases in which the occupational and public health,
interest, or safety requires otherwise, no general license shall be suspended
or revoked unless, prior to the institution of proceedings therefore, facts
or conduct that may warrant such action shall have been called to the attention
of the holder of the general license in writing and the holder of the general
license shall have been afforded an opportunity to demonstrate compliance
with all lawful requirements.
(E)
Each general license revoked by the agency expires at the
end of the day on the date of the agency's final determination to revoke the
general license, or on the revocation date stated in the determination, or
as otherwise provided by agency order.
(3)
General licenses for source material.
(A)
A general license is issued authorizing commercial and
industrial firms, research, educational and medical institutions, and state
and local government agencies to use and transfer not more than 15 pounds
of source material at any one time for research, development, educational,
commercial, or operational purposes.
(i)
A person authorized to use or transfer source material,
in accordance with this general license, may not possess more than a total
of 150 pounds of source material in any one calendar year.
(ii)
Persons who receive, possess, use, or transfer source
material in accordance with the general license in subparagraph (A) of this
paragraph are prohibited from administering source material, or the radiation
therefrom, either externally or internally, to humans except as may be authorized
by the agency in a specific license.
(B)
A general license is issued to own source material without
regard to quantity. This general license does not authorize any person to
receive, possess, use or transfer source material.
(C)
A general license is issued to mine, transport, and transfer
ores containing source material without regard to quantity. In addition to
the provisions of subsection (f) of this section, persons who mine, transport,
and transfer ores containing source material in accordance with this section
shall comply with the provisions of §289.202(n) and (ff) of this title.
(D)
A general license is issued to receive, acquire, possess,
use, or transfer depleted uranium contained in products or devices for the
purpose of providing shielding, including beam shaping and collimation, in
accordance with the provisions of clauses (i)-(iv) of this subparagraph.
(i)
The general license in this paragraph applies only to products
or devices that have been manufactured either in accordance with a specific
license issued by the agency to the manufacturer of the products or devices
in accordance with §289.252(s) of this title or in accordance with a
specific license issued to the manufacturer by another agreement state or
the NRC that authorizes manufacture of the products or devices for distribution
to persons generally licensed by another agreement state or the NRC.
(ii)
Persons who receive, acquire, possess, or use depleted
uranium in accordance with the general license in this paragraph shall notify
the agency within 30 days after the first receipt of acquisition of such depleted
uranium. The general licensee shall furnish the following information and
such other information as may be required by the agency:
(I)
name and address of the general licensee;
(II)
a statement that the general licensee has developed and
will maintain procedures designed to establish physical control over the depleted
uranium in accordance with this paragraph and designed to prevent transfer
of such depleted uranium in any form, including metal scrap, to persons not
authorized to receive the depleted uranium; and
(III)
name and/or title, address, and telephone number of the
individual duly authorized to act for and on behalf of the general licensee
in supervising the procedures identified in clause (ii) of this subparagraph.
(iii)
The general licensee possessing or using depleted uranium
in accordance with the general license in this paragraph shall report in writing
to the agency any changes in information furnished by the general licensee.
The report shall be submitted within 30 days after the effective date of such
change.
(iv)
A person who receives, acquires, possesses, or uses depleted
uranium in accordance with the general license in this paragraph:
(I)
shall not introduce such depleted uranium, in any form,
into a chemical, physical, or metallurgical treatment or process, except a
treatment or process for repair or restoration of any plating or other covering
of the depleted uranium;
(II)
shall not abandon such depleted uranium;
(III)
shall transfer or dispose of such depleted uranium only
in accordance with the provisions of §289.252(cc) of this title. In the
case where the transferee receives the depleted uranium in accordance with
the general license in this paragraph or equivalent rule of the NRC or an
agreement state, the transferor shall furnish the transferee a copy of this
paragraph;
(IV)
within 30 days of transfer, shall report in writing to
the agency the name and address of the person receiving the depleted uranium
in accordance with such transfer; and
(V)
shall not export such depleted uranium except in accordance
with a license issued by the NRC in accordance with Title 10, CFR, Part 110.
(v)
Any person receiving, acquiring, possessing, using, or
transferring depleted uranium in accordance with the general license in this
paragraph is exempt from the requirements of §289.202 of this title and §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections) with respect to the depleted uranium covered by that general
license.
(4)
General licenses for radioactive material other than source
material.
(A)
General licenses for static elimination devices and ion
generating tubes. A general license is issued to transfer, receive, acquire,
possess, and use radioactive material incorporated in the devices or equipment
specified in clauses (i) and (ii) of this subparagraph that have been manufactured,
tested, and labeled by the manufacturer in accordance with a specific license
issued to the manufacturer by the NRC. In addition to the provisions of subsection
(f) of this section, this general license is subject to the provisions of
subsection (e)(1)(B) of this section and §289.252(cc) of this title:
(i)
static elimination devices designed for use as static eliminators
that contain, as a sealed source or sources, radioactive material totaling
not more than 500 µCi of polonium-210 per device; or
(ii)
ion generating tubes designed for ionization of air that
contain, as a sealed source or sources, radioactive material totaling not
more than 500 µCi of polonium-210 per device or a total of not more
than 50 mCi of tritium per device.
(B)
General license for luminous safety devices for aircraft.
(i)
A general license is issued to receive, acquire, possess,
and use tritium or promethium-147 contained in luminous safety devices for
use in aircraft, provided:
(I)
each device contains not more than 10 curies (Ci) of tritium
or 300 mCi of promethium-147; and
(II)
each device has been manufactured, assembled, or initially
transferred in accordance with a specific license issued by the NRC, or each
device has been manufactured or assembled in accordance with the specifications
contained in a specific license issued by the agency or any agreement state
that authorizes the manufacture or assembly of the device to persons generally
licensed by the agency or an agreement state.
(ii)
The general license in clause (i) of this subparagraph
does not authorize the manufacture, assembly, or repair of luminous safety
devices containing tritium or promethium-147.
(iii)
The general license in clause (i) of this subparagraph
does not authorize the receipt, acquisition, possession, or use of tritium
or promethium-147 contained in instrument dials.
(C)
General license for ownership of radioactive material.
A general license is issued to own radioactive material without regard to
quantity. Notwithstanding any other provisions of this section, this general
license does not authorize the manufacture, production, transfer, receipt,
possession, or use of radioactive material.
(D)
General license for calibration, stabilization, and reference
sources.
(i)
A general license is issued to own, receive, acquire, possess,
use, and transfer, in accordance with the provisions of clauses (ii) and (iii)
of this subparagraph, americium-241, plutonium, and/or radium-226, in the
form of calibration, stabilization, or reference sources to any person who
holds a specific license issued by the:
(I)
agency that authorizes that person to receive, possess,
use, and transfer radioactive material; and
(II)
NRC that authorizes that person to receive, possess, use,
and transfer radioactive material.
(ii)
The general license in clause (i) of this subparagraph
applies only to calibration, stabilization, or reference sources that have
been manufactured or initially transferred in accordance with the specifications
contained in a specific license issued to the manufacturer or importer of
the sources by the NRC in accordance with Title 10, CFR, §32.57 or Title
10, CFR, §70.39 or that have been manufactured or initially transferred
in accordance with the authorizations contained in a specific license issued
to the manufacturer by the agency, any agreement state, or any licensing state,
in accordance with licensing requirements equivalent to those contained in
Title 10, CFR, §32.57 or 10 CFR, §70.39.
(iii)
Persons who own, receive, acquire, possess, use, or transfer
one or more calibration or reference sources in accordance with these general
licenses:
(I)
shall not possess at any one time, at any one location
of storage or use, more than 5 µCi each of americium-241, plutonium-238,
plutonium-239, and radium-226 in such sources;
(II)
shall not receive, possess, use, or transfer such source
unless the source or the storage container bears a label that includes the
following statements, or a substantially similar statement that contains the
information in the following statements:
(-a-)
option 1, as appropriate:
Figure: 25 TAC §289.251(f)(4)(D)(iii)(II)(-a-)
(-b-)
option 2, as appropriate:
Figure: 25 TAC §289.251(f)(4)(D)(iii)(II)(-b-)
(III)
shall not transfer, abandon, or dispose of such source
except by transfer to a person authorized by a specific license from the agency,
the NRC, an agreement state, or a licensing state to receive the source;
(IV)
shall store such source, except when the source is being
used, in a closed container adequately designed and constructed to contain
americium-241, plutonium-238, plutonium-239, or radium-226 that might otherwise
escape during storage; and
(V)
shall not use such source for any purpose other than the
calibration of radiation detectors or the standardization of other sources.
(iv)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture of calibration or reference sources containing
americium-241, plutonium-238, plutonium-239, or radium-226.
(E)
General license for ice detection devices.
(i)
A general license is issued to own, receive, acquire, possess,
use, and transfer strontium-90 contained in ice detection devices, provided
each device contains not more than 50 µCi of strontium-90 and each device
has been manufactured or initially transferred in accordance with a specific
license issued by the NRC or each device has been manufactured in accordance
with the authorizations contained in a specific license issued by the agency
or any agreement state to the manufacturer of such device in accordance with
licensing requirements equivalent to those in Title 10, CFR, §32.61.
(ii)
Persons who receive, acquire, possess, use, or transfer
strontium-90 contained in ice detection devices in accordance with the general
license in clause (i) of this paragraph shall do the following:
(I)
upon occurrence of visually observable damage, such as
bend or crack or discoloration from overheating to the device, discontinue
use of the device until it has been inspected, tested for leakage, and repaired
by a person holding a specific license from the NRC or an agreement state
to manufacture or service such devices; or dispose of the device by transfer
to a person authorized by a specific license from the agency, the NRC, or
an agreement state; and
(II)
assure that all labels affixed to the device at the time
of receipt, and which bear a statement prohibiting removal of the labels,
are maintained on the device.
(iii)
The general license in subparagraph (A) of this paragraph
does not authorize the manufacture, assembly, disassembly, or repair of strontium-90
in ice detection devices.
(F)
General license for intrastate transportation of radioactive
material.
(i)
A general license is issued to any common or contract carrier
to transport and store radioactive material in the regular course of their
carriage for another or storage incident to transport, provided the transportation
and storage is in accordance with the applicable requirements of §289.257
of this title insofar as such requirements relate to the loading and storage
of packages, placarding of the transporting vehicle, and incident reporting.
Any notification of incidents referred to in those requirements shall be filed
with the agency and the United States Department of Transportation (DOT).
Persons who transport and store radioactive material in accordance with the
general license in this paragraph are exempt from the requirements of §§289.202
and 289.203 of this title.
(ii)
A general license is issued to any private carrier to
transport radioactive material, provided the transportation is in accordance
with the applicable requirements, appropriate to the mode of transport, of
the DOT insofar as such requirements relate to the loading and storage of
packages, placarding of the transporting vehicle, and incident reporting.
Any notification of incidents referred to in those requirements shall be filed
with the agency and the DOT.
(G)
General license for the use of radioactive material for
certain
in vitro
clinical or laboratory testing,
not to include research and development. (The New Drug provisions of the Federal
Food, Drug, and Cosmetic Act also govern the availability and use of any specific
diagnostic drugs in interstate commerce.)
(i)
A general license is issued to any physician, veterinarian,
clinical laboratory, or hospital to receive, acquire, possess, transfer, or
use, for any of the following stated tests, in accordance with the provisions
of clauses (ii)-(iii) of this subparagraph, the following radioactive materials
in prepackaged units:
(I)
iodine-125, in units not exceeding 10 µCi each for
use in
in vitro
clinical or laboratory tests
not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals;
(II)
iodine-131, in units not exceeding 10 µCi each for
use in
in vitro
clinical or laboratory tests
not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals;
(III)
carbon-14, in units not exceeding 10 µCi each for
use in
in vitro
clinical or laboratory tests
not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals;
(IV)
hydrogen-3 (tritium), in units not exceeding 50 µCi
each for use in
in vitro
clinical or laboratory
tests not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals;
(V)
iron-59, in units not exceeding 20 µCi each for use
in
in vitro
clinical or laboratory tests not
involving internal or external administration of radioactive material, or
the radiation therefrom, to humans or animals;
(VI)
selenium-75, in units not to exceed 10 µCi each
for use in
in vitro
clinical or laboratory
tests not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals;
(VII)
mock iodine-125 reference or calibration sources, in
units not exceeding 0.05 µCi of iodine-129 and 0.005 µCi of americium-241
each for use in
in vitro
clinical or laboratory
tests not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals; or
(VIII)
cobalt-57, in units not exceeding 10 µCi each
for use in
in vitro
clinical or laboratory
tests not involving internal or external administration of radioactive material,
or the radiation therefrom, to humans or animals.
(ii)
A person who receives, acquires, possesses, or uses radioactive
material in accordance with the general license in clause (i) of this subparagraph
shall comply with the following.
(I)
The general licensee shall not possess at any one time,
at any one location of storage or use, a total amount of iodine-125, iodine-131,
selenium-75, iron-59, and/or cobalt-57 in excess of 200 µCi.
(II)
The general licensee shall store the radioactive material
in the original shipping container or in a container providing equivalent
radiation protection and meeting the requirements of §289.202(cc) of
this title until used.
(III)
The general licensee shall use the radioactive material
only for the uses authorized by clause (i) of this subparagraph.
(IV)
The general licensee shall not transfer the radioactive
material to a person who is not authorized to receive it in accordance with
a specific license issued by the agency, the NRC, any agreement state, or
any licensing state, nor transfer the radioactive material in any manner other
than in the unopened, labeled shipping container as received from the supplier.
(V)
The general licensee shall dispose of the mock iodine-125
reference or calibration sources described in clause (i)(VII) of this subparagraph
as required by §289.202(ff) of this title.
(iii)
The general licensee shall not receive, acquire, possess,
or use radioactive material in accordance with the general license in clause
(i) of this subparagraph:
(I)
except as prepackaged units that are labeled in accordance
with the provisions of an applicable specific license issued in accordance
with §289.252(p) of this title or in accordance with the provisions of
a specific license issued by the NRC, any agreement state, or any licensing
state that authorizes the manufacture and distribution of iodine-125, iodine-131,
carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or mock
iodine-125 to general licensees in accordance with this subparagraph or its
equivalent; and
(II)
unless one of the statements in the following figures,
as appropriate, or a substantially similar statement that contains the information
called for in one of the following statements, appears on a label affixed
to each prepackaged unit or appears in a leaflet or brochure that accompanies
the package:
(-a-)
option 1, as appropriate:
Figure: 25 TAC §289.251(f)(4)(G)(iii)(II)(-a-)
(-b-)
option 2, as appropriate:
Figure: 25 TAC §289.251(f)(4)(G)(iii)(II)(-b-)
(iv)
No person shall receive, acquire, possess, use, or transfer
radioactive material in accordance with the general license in clause (i)
of this subparagraph until that person has filed an application for registration
on a form prescribed by the agency and has received from the agency a notification
of receipt with an assigned registration number. The applicant shall submit
the following information and any other information as may be required by
the agency:
(I)
name and address of the physician, veterinarian, clinical
laboratory, or hospital;
(II)
the location of use; and
(III)
a statement that the physician, veterinarian, clinical
laboratory, or hospital has appropriate radiation measuring instruments to
carry out
in vitro
clinical or laboratory
tests with radioactive material as authorized in accordance with clause (i)
of this subparagraph, and that such tests will be performed only by personnel
competent in the use of such instruments and in the handling of the radioactive
material.
(H)
General license for certain detecting, measuring, gauging,
or controlling devices and certain devices for producing light or an ionized
atmosphere.
(i)
A general license is issued to commercial and industrial
firms and to research, educational, and medical institutions, individuals
in the conduct of their business, and state or local government agencies to
receive, acquire, possess, use, or transfer in accordance with the provisions
of clauses (ii)-(iv) of this subparagraph, radioactive material, excluding
special nuclear material, contained in devices designed and manufactured for
the purpose of detecting, measuring, gauging or controlling thickness, density,
level, interface location, radiation, leakage, or qualitative or quantitative
chemical composition or for producing light or an ionized atmosphere.
(ii)
The general license in clause (i) of this subparagraph
applies only to radioactive material contained in devices that have been manufactured
or initially transferred and labeled in accordance with the specifications
contained in a specific license issued by the agency in accordance with §289.252(l)
of this title or in a specific license issued by the NRC, an agreement state,
or a licensing state that authorizes distribution of devices to persons generally
licensed by the NRC, an agreement state, or a licensing state.
(iii)
The devices must have been received from a specific licensee
described in clause (ii) of this subparagraph or through a transfer made in
accordance with clause (iv)(XII) of this subparagraph.
(iv)
Any person who receives, acquires, possesses, uses, or
transfers radioactive material in a device in accordance with the general
license in this subparagraph shall do the following:
(I)
assure that all labels, affixed to the device at the time
of receipt and bearing a statement that removal of the label is prohibited
are maintained on the device and are clearly visible and legible. The general
licensee shall comply with all instructions and precautions provided by such
labels;
(II)
assure that the device is tested for leakage of radioactive
material and proper operation of the "on-off" mechanism and indicator, if
any, at no longer than six-month intervals or at such other intervals as specified
in the label; however:
(-a-)
devices containing only krypton need not be tested for
leakage of radioactive material; and
(-b-)
devices containing only tritium or not more than 100 µCi
of other beta and/or gamma emitting material or 10 µCi of alpha emitting
material and devices held in storage in the original shipping container prior
to initial installation need not be tested for any purpose, provided that
each source is tested for leakage within six months prior to being used or
transferred;
(III)
assure that the tests required by subclause (II) of this
clause and other testing, installation (removal of the manufacturer's lock
and initial alignment of the radiation beam), servicing, and removal from
location of installation involving the radioactive materials, its shielding
or containment, are performed:
(-a-)
in accordance with the instructions provided by the labels;
(-b-)
in accordance with written instructions provided by the
manufacturer as specified in §289.252(l)(3) of this title; or
(-c-)
by a person holding a specific license from the agency,
the NRC, an agreement state, or a licensing state to perform such activities;
(IV)
maintain records for inspection by the agency showing
compliance with the requirements of subclauses (II) and (III) of this clause.
The records shall show the test results. The records also shall identify the
device tested by manufacturer, model and serial number of the device, serial
number of the sealed source, and show the dates of performance of and the
names of persons performing testing, installation, servicing, and removal
from location of installation, of the radioactive material, its shielding
or containment. Retention shall be as follows:
(-a-)
records for tests for leakage or radioactive material
required by subclause (II) of this clause must be kept for three years after
the next required leak text is performed or until the sealed source is transferred
or disposed of; and
(-b-)
records of the test of the on-off mechanism and indicator
required by subclause (II) of this clause must be kept for three years after
the next required test of the on-off mechanism and indicator is performed
or until the sealed source is transferred or disposed of.
(-c-)
records of the testing, installation (removal of the
manufacturer's lock and initial alignment of the radiation beam), servicing,
and removal from location of installation involving the radioactive materials,
its shielding or containment required by subclause (III) of this clause shall
be kept for three years from the date of the recorded event or until the device
is transferred or disposed of.
(V)
maintain assignment records (utilization records) for portable
or mobile devices for inspection by the agency at the location listed in the
general license acknowledgement in accordance with subsection (g) of this
section. These records shall include:
(-a-)
a unique identification (for example, serial number)
of each portable or mobile device;
(-b-)
the location(s) where each portable or mobile device
is assigned; and
(-c-)
the date(s) each portable or mobile device is assigned
to the location(s) in accordance with item (-b-) of this subclause;
(VI)
have a copy of the appropriate operating and instruction
manual at each temporary site for agency inspection;
(VII)
immediately suspend operation of the device if there
is a failure of, or damage to, or any indication of a possible failure of
or damage to, the shielding of the radioactive material or the "on-off" mechanism,
or indicator, or upon the detection of 1.85 becquerels (0.005 µCi) or
more of removable radioactive material. The device shall not be operated until
it has been repaired by the manufacturer or other person holding a specific
license from the agency, the NRC, an agreement state, or a licensing state
to repair such devices. The device and any radioactive material from the device
may only be disposed of by transfer to a person authorized by a specific license
to receive the radioactive material in the device. A report containing a brief
description of the event and the remedial action taken and in the case of
detection of 1.85 becquerels (0.005 µCi) or more removable radioactive
material or failure of, or damage to a source likely to result in contamination
of the premises or the environs, a plan for ensuring that the premises and
environs are acceptable for unrestricted use shall be furnished to the agency
within 30 days. Under these circumstances, the requirements in §289.202(ddd)
of this title may be applicable, as determined by the agency on a case-by-case
basis;
(VIII)
not abandon the device containing radioactive material;
(IX)
transfer or dispose of the device containing radioactive
material only by transfer to another general licensee as authorized in subclause
(XII) of this clause or to a person authorized to receive the device by a
specific license issued by the agency in accordance with §289.252(l)
of this title, or an equivalent specific license issued by the NRC, an agreement
state, or a licensing state, or as otherwise approved under subclause (XI)
of this clause;
(X)
furnish a report to the agency within 30 days after the
transfer of a device to a specific licensee. The report must contain the following:
(-a-)
identification of the device by manufacturer's (or initial
transferor's) name, model and serial number;
(-b-)
name, address, and license number of the person receiving
the device; and
(-c-)
date of the transfer.
(XI)
obtain written agency approval before transferring the
device to any other specific licensee not specifically identified in subclause
(IX) of this clause;
(XII)
transfer the device to another general licensee only
if:
(-a-)
the device remains in use at a particular location. In
such case, the transferor shall give the transferee a copy of this section
and any safety documents identified in the label on the device. Within 30
days of the transfer, the transferor shall report the following to the agency:
(-1-)
manufacturer's (or initial transferor's) name;
(-2-)
model and serial number of the device transferred;
(-3-)
transferee's name and mailing address for the location
of use; and
(-4-)
name, title, and phone number of the responsible individual
identified by the transferee in accordance with subclause (XIII) of this clause
to have knowledge of and authority to take actions to ensure compliance with
the appropriate regulations and requirements; or
(-b-)
the device is held in storage by an intermediate person
in the original shipping container at its intended location of use prior to
initial use by a general licensee.
(XIII)
appoint an individual responsible for having knowledge
of the appropriate agency requirements and the authority for taking required
actions to comply with appropriate agency requirements. The general licensee,
through this individual, shall ensure the day-to-day compliance with appropriate
agency requirements. This appointment does not relieve the general licensee
of any of its responsibility in this regard;
(XIV)
report changes to the mailing address for the location
of use (including change in name of general licensee) to the agency within
30 days of the effective date of the change. If it is a portable device, a
report of address change is only required for a change in the device's primary
place of storage; and
(XV)
not hold devices that are not in use for longer than two
years. If devices with shutters are not being used, the shutter shall be locked
in the closed position. The testing required by clause (iv) of this subparagraph
need not be performed during the period of storage only. However, when devices
are put back into service or transferred to another person, and have not been
tested within the required test interval, they shall be tested for leakage
before use or transfer and the shutter tested before use. Devices kept in
standby for future use are excluded from the two-year time limit if the general
licensee performs quarterly physical inventories of these devices while they
are in standby. The licensee shall make and maintain, for intervals of five
years, records of the quarterly physical inventories for inspection by the
agency.
(I)
The general license in subparagraph (H) of this paragraph
does not authorize the manufacture or import of devices containing radioactive
material.
(J)
The written instructions specified in subparagraph (H)(iv)(III)(-a-)
of this paragraph shall be followed while performing the testing and shall
be maintained for inspection by the agency.
(g)
General license acknowledgements for radioactive material
other than source material. In addition to the requirements of this section,
all general license acknowledgement holders, unless otherwise specified, are
subject to the requirements of §§289.201, 289.202(ww) and (xx),
289.204, 289.205, and 289.257 of this title.
(1)
Persons possessing a general license for devices in accordance
with subsection (f)(4)(H) of this section and being in the possession of radioactive
material in devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7
MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 37 MBq (1 mCi)
of americium-241, or any transuranic (for example, element with atomic number
greater than uranium (92)), based on the activity indicated on the label on
the device, shall file an application for acknowledgement within 30 days of
receipt, acquisition, or possession of such a device. The application shall
be on a form prescribed by the agency to include the following information
and any other information specifically requested by the agency:
(A)
name and mailing address of the general licensee;
(B)
information about each device to include the manufacturer
(or initial transferor), model number, and serial number of the device, and
the radioisotope and activity (as indicated on the label);
(C)
name, title, and telephone number of the responsible person
designated as a representative of the general licensee in accordance with
subparagraph (H)(iv)(XIII) of this paragraph;
(D)
address or location at which the device(s) are used and/or
stored. For portable devices, the address of the primary place of storage;
(E)
certification by the responsible representative of the
general licensee that the information concerning the device(s) has been verified
through a physical inventory and checking of label information;
(F)
certification by the responsible representative of the
general licensee that they are aware of the requirements of this section;
and
(G)
a completed BRC Form 252-1, Business Information Form and
the applicable fee as required by §289.204 of this title.
(2)
Persons generally licensed by the agency with respect to
devices meeting the criteria in paragraph (1) of this subsection, are not
subject to the requirements of paragraph (1) of this subsection if the devices
are used in areas subject to agency jurisdiction for a period less than 30
days in any calendar year.
(h)
Issuance of general license acknowledgements.
(1)
When the agency determines that an application meets the
requirements of the Act and the rules of the agency, the agency will issue
a general license acknowledgement recognizing the general license authorizing
the activity in such form and containing the conditions and limitations as
it deems appropriate or necessary.
(2)
The agency may incorporate in any general license acknowledgement
at the time of issuance, or thereafter by amendment, additional requirements
and conditions with respect to the licensee's receipt, possession, use, and
transfer of radioactive material subject to this section as the agency deems
appropriate or necessary in order to:
(A)
minimize danger to occupational and public health and safety
or the environment;
(B)
require reports and the keeping of records, and to provide
for inspections of activities in accordance with the license as may be appropriate
or necessary; and
(C)
prevent loss or theft of material subject to this section.
(3)
The agency may request, and the licensee shall provide,
additional information after the general license acknowledgement has been
issued to enable the agency to determine whether the general license acknowledgement
should be modified in accordance with subsection (l) of this section.
(i)
Specific terms and conditions.
(1)
Each general license acknowledgement issued in accordance
with this section shall be subject to the applicable provisions of the Act,
now or hereafter in effect, and to the applicable rules and orders of the
agency.
(2)
Each person holding a general license acknowledgement issued
by the agency in accordance with this section shall confine use and possession
of the devices and radioactive material identified in the general license
acknowledgement to the locations specified in the general license acknowledgement.
(3)
Each holder of a general license acknowledgement shall
notify the agency, in writing, immediately following the filing of a voluntary
or involuntary petition for bankruptcy by the general license acknowledgement
holder or its parent company.
(4)
The notification in paragraph (3) of this subsection shall
include:
(A)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(B)
the date of the filing of the petition.
(5)
A copy of the "Petition for Bankruptcy" shall be submitted
to the agency with the written notification.
(j)
Expiration of general license acknowledgement and administrative
renewal.
(1)
Effective September 1, 2004, the term of the general license
acknowledgement is two years. Each general license acknowledgement expires
at the end of the day, in the month and year stated in the general license
acknowledgement. Upon payment of the fee required by §289.204 of this
title and if the agency does not deny the renewal in accordance with subsection
(f)(1) of this section, the general license acknowledgement will be administratively
renewed.
(2)
Expiration of the general license acknowledgement does
not relieve the holder of the general license acknowledgement of the requirements
of this chapter.
(3)
If the holder of the general license acknowledgement does
not pay the fee required by §289.204 of this title and the general license
acknowledgement is not renewed, the holder of the general license acknowledgement
shall:
(A)
terminate use of all generally licensed devices; and
(B)
submit to the agency a record of the disposition of the
devices and if transferred, to whom it was transferred, within 30 days following
the expiration date.
(k)
Termination of general license acknowledgements.
(1)
Each holder of a general license acknowledgement shall
notify the agency immediately, in writing, and request termination of the
general license acknowledgement when the holder of the general license acknowledgement
decides to terminate all activities involving materials specified in the general
license acknowledgement.
(2)
Each holder of a general license acknowledgement shall,
no less than 30 days before vacating or relinquishing possession of control
of premises that have been used as a place of storage or use of radioactive
material as a result of general licensed activities, notify the agency in
writing of intent to vacate and do the following:
(A)
terminate use of radioactive material;
(B)
dispose of radioactive material in accordance with this
section and/or §289.202(ff) of this title; and
(C)
pay any outstanding fees in accordance with §289.204
of this title.
(l)
Amendment of general license acknowledgements.
(1)
The holder of the general license acknowledgement required
by subsection (g)(1) of this section shall report in writing to the agency
any changes in information furnished by the holder of the general license
acknowledgement. The report shall be submitted within 30 days after the effective
date of such change.
(2)
Applications for amendments of a general license acknowledgement
shall be filed in accordance with subsection (g)(1)(A)-(F) of this section,
as applicable, and shall specify the respects in which the holder of a general
license acknowledgement desires a general license acknowledgement to be amended.
(m) Appendices.
(1) Exempt concentrations.
(2) Exempt quantities.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State on January 16, 2004.
TRD-200400317
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
25 TAC §289.252
The Texas Department of Health (department) proposes an amendment
to §289.252, concerning licensing of radioactive material.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.252
has been reviewed and the department has determined that the reasons for adopting
the section continue to exist; however, revisions to the rule are necessary
as outlined in this preamble.
The department published a Notice of Intention to Review for §289.252
regarding Government Code, §2001.039, in the
Texas Register
(28 TexReg 11118) on December 12, 2003. No comments
were received by the department on this section following publication of the
notice.
The proposed revision incorporates legislation passed by the 78th Legislature,
Regular Session. House Bill (HB) 2292 requires two-year terms for radioactive
material licenses and requires recovery through fees of 100% of regulatory
program costs for the two-year term of the license. The department has historically
required renewal of specific licenses that includes submission to the department
of updated technical information regarding the radioactive material possessed,
operating, safety and emergency procedures, and personnel responsible for
the security of safe use of the radioactive materials. In order to incorporate
the provisions of HB 2292 concerning two-year terms and to continue requiring
a renewal that includes pertinent technical information, the department is
implementing an administrative renewal and a technical renewal. The licensee
will be required to renew the license every two years by paying the required
fee and having a satisfactory compliance history. This administrative renewal
will not involve review of technical information regarding the license. At
a longer interval, the licensee will be required to submit certain technical
information for review. This technical renewal date will be specified in the
license and will be for an interval of an even number of years in order to
eventually coincide with the fee renewal. Maintaining the more resource-intensive
technical renewal allows the department to ensure continued security and safe
use of radioactive material. The change to the rule is reflected in revised
subsections (y) and (z).
House Bill 253, 78th Legislature, Regular Session, requires the department
to deny a radioactive material application, amendment or renewal if the applicant's
compliance history reveals a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations
of the Radiation Control Act or the department's radiation control rules.
The department has defined "a recurring pattern of conduct that demonstrates
a consistent disregard for the regulatory process through significant violations..."
by adding a requirement that states the department will deny an application
if at least three department or judicial orders are issued that assess administrative
or civil penalties against the licensee or to revoke or suspend the radioactive
material license. The change to the rule is reflected in new subsection (x)(7).
The proposed revision changes references to the Formal Hearing Procedures
throughout the rule to properly cite the references. In subsection (f)(1),
the sentence "A single individual may be designated as RSO for more than one
license if authorized by the agency." is added to clearly state the department's
current practice in approving an individual to be a radiation safety officer
(RSO) for a license. New subsection (f)(3)(L) is added as a requirement of
the RSO to ensure both licensees and the department have an accounting of
all authorized sources. This requirement is being added to enhance security
by increasing accountability for sources of radiation.
Several revisions are made to the subsection concerning specific licenses
for the manufacture and commercial distribution of devices to persons generally
licensed. The requirements are items of compatibility with the United States
Nuclear Regulatory Commission and as an agreement state, Texas is required
to adopt them. These revisions include new subsection (l)(1)(D) and (E) concerning
labeling, new (l)(4)(G) concerning enforcement, and new subsection (l)(5)
concerning alternative approaches to informing customers. The revisions also
include addition of new and clarification of existing language concerning
reports that are required by the licensee.
Subsection (x)(4) is revised to add the words "by the licensee or its parent
company, if the parent company is involved in the bankruptcy" at the end of
the sentence to be consistent with language used throughout this chapter.
New subsection (y)(5)(A) adds the words "or has been revoked" after "expired"
to clearly state that the license can also be revoked as is intended by the
rule. Subsection (dd) adds the word ", suspension," after "Modification" to
state the complete list of options for this subsection as is intended within
the rule language. New subparagraph (D) is added to subsection (dd) to state
that a license may also be modified, suspended, or revoked in whole or in
part as a result of existing conditions that constitute a substantial threat
to the public health or safety or the environment. Subsection (gg)(6)(B)(ii)
replaced the word "Fund" with "Account" after "Care" to accurately state the
name of the account as a result of implementing changes authorized by House
Bill 1678 (78th Legislature 2003). In the figure for subsection (ii)(2), the
radionuclides "Th-232" and "U-238" are deleted from the category of the 0.01µCi
limit and moved to the category of the 1.0 mCi limit so these radionuclides
are included in the correct limit category.
Concerning the entire section, several changes were made to rule citations
to state the correct citations and for renumbering purposes as needed due
to language being added or deleted throughout the section. Other minor grammatical
changes have been made throughout the section.
This amendment is part of the department's continuing effort to update,
clarify, and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, other factors,
or to incorporate requirements that are items of compatibility with NRC regulations
because as an agreement state, Texas must adopt compatible requirements.
Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration
and Standards, Bureau of Radiation Control, has determined that for each year
of the first five years the section is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the section as proposed.
Mrs. McBurney has also determined that for each year of the first five
years the proposed section is in effect, the public benefit anticipated as
a result of enforcing the section will be to ensure continued protection of
the public, workers, and the environment from unnecessary exposure to radiation
by ensuring adequate requirements relative to the risk associated with radioactive
material. There will be no fiscal impact on applicants/licensees that are
small businesses, micro-businesses or other persons required to comply with
the rule. No additional costs will be incurred because the additional requirements
are relatively minor changes to existing requirements to current reporting
and record-keeping requirements. The revisions correct reference citations
and clarify the intent. There is no anticipated impact on local employment.
Comments on the proposal may be submitted to Ruth E. McBurney, C.H.P.,
Director, Division of Licensing, Registration and Standards, Bureau of Radiation
Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas
78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.McBurney@tdh.state.tx.us.
Public comments will be accepted for 30 days following publication of this
proposal in the
Texas Register
. In addition,
a public meeting to accept oral comments will be held at 1:00 p.m., Wednesday,
February 11, 2004, in Conference Room N-218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
The amendment is proposed under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with the authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
The amendment affects Health and Safety Code, Chapters 12 and 401. The
review of the rule implements Government Code, §2001.039.
§289.252.Licensing of Radioactive Material.
(a)-(c)
(No change.)
(d)
Filing application for specific licenses. The agency may,
at any time after the filing of the original application, require further
statements in order to enable the agency to determine whether the application
should be denied or the license should be issued.
(1)-(8)
(No change.)
(9)
Notwithstanding the provisions of
§289.204(d)(1)
[
(A)-(B)
(No change.)
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with
Title 1, Texas Administrative
Code, Chapter 155, and
the Formal Hearing Procedures, §§1.21,
1.23, 1.25, and 1.27 of this title (relating to the Texas Board of Health).
(10)
(No change.)
(e)
General requirements for the issuance of specific licenses.
A license application will be approved if the agency determines that:
(1)-(9)
(No change.)
(10)
there is no reason to deny the license as specified in
subsection (d)(10)
or (x)(7)
of this section.
(f)
Radiation safety officer.
(1)
An RSO shall be designated for every license issued by
the agency.
A single individual may be designated as RSO for more than
one license if authorized by the agency.
(2)
(No change.)
(3)
The specific duties of the RSO include, but are not limited
to, the following:
(A)-(K)
(No change.)
(L)
to perform an inventory of
the radioactive material sources authorized for use on the license every six
months and make and maintain records of the inventory of the radioactive material
sources authorized for use on the license every six months, to include, but
not be limited to the following:
(i)
isotope(s);
(ii)
quantity(ies);
(iii)
activity(ies);
(iv)
form(s);
(v)
last date(s) of use;
(vi)
name of individual making the inventory; and
(vii)
signature of individual making the inventory.
(M)
[
(N)
[
(4)-(5)
(No change.)
(g)-(h)
(No change.)
(i)
Specific licenses for introduction of radioactive material
into products in exempt concentrations.
(1)
(No change.)
(2)
the applicant provides reasonable assurance that:
(A)
the concentrations of radioactive material at the time
of transfer will not exceed the concentrations in
§289.251(m)(1)
[
(B)
reconcentration of the radioactive material in concentrations
exceeding those in
§289.251(m)(1)
[
(C)-(D)
(No change.)
(3)-(4)
(No change.)
(j)-(k)
(No change.)
(l)
Specific licenses for the manufacture and commercial distribution
of devices to persons generally licensed in accordance with
§289.251(f)(4)(H)
[
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture or commercially distribute devices
containing radioactive material to persons generally licensed in accordance
with
§289.251(f)(4)(H)
[
(A)-(C)
(No change.)
(D)
Each device having a separable
source housing that provides the primary shielding for the source also bears,
on the source housing, a durable label containing the device model number
and serial numbers, the isotope and quantity, the words, "Caution-Radioactive
Material," the radiation symbol described in §289.202(z) of this title,
and the name of the manufacturer or initial distributor.
(E)
Each device meeting the criteria
of §289.251(g)(1) of this title, bears a permanent (for example, embossed,
etched, stamped, or engraved) label affixed to the source housing if separable,
or the device if the source housing is not separable, that includes the words,
"Caution-Radioactive Material," and, if practicable, the radiation symbol
described in §289.202(z) of this title.
(2)
(No change.)
(3)
In the event the applicant desires that the general licensee
in accordance with
§289.251(f)(4)(H)
[
(4)
Before the device may be transferred, each person licensed
in accordance with this subsection to commercially distribute devices to generally
licensed persons shall furnish:
(A)
a copy of the general license in
§289.251(f)(4)(H)
[
(B)
a copy of the general license in the NRC's, agreement state's,
or licensing state's regulation equivalent to
§289.251(f)(4)(H)
[
(C)
a copy of
§289.251(g)
[
(D)
(No change.)
(E)
information on acceptable disposal options including estimated
costs of disposal; [
(F)
the name
or position
, address, and phone number
of a contact person at the agency, an agreement state, or licensing state
, or the NRC
from which additional information may be obtained
; and
[
(G)
an indication that it is the
NRC's policy to issue high civil penalties for improper disposal if the device
is commercially distributed to a general licensee of the NRC.
(5)
An alternative approach to
informing customers may be submitted by the licensee for approval by the agency.
(6)
[
(7)
[
(A)
report to the agency all commercial distributions of devices
to persons for use in accordance with the general license in
§289.251(f)(4)(H)
[
(i)
The report shall
:
(I)
cover each calendar quarter
;
[
(II)
[
(III)
be submitted on a form prescribed
by the agency or in a clear and legible report containing all of the data
required by the form;
(IV)
clearly indicate the period
covered by the report;
(V)
clearly identify the specific
licensee submitting the report and include the license number of the specific
licensee;
(VI)
[
(VII)
[
(VIII)
[
(IX)
[
(X)
include the date of transfer.
(ii)
If one or more intermediate persons will temporarily possess
the device at the intended place of use prior to its possession by the user,
the report shall also include
the information in accordance with paragraph
(7)(A)(i) of this subsection for both the intended user and
[
(iii)
If no commercial distributions have been made to persons
generally licensed in accordance with
§289.251(f)(4)(H)
[
(iv)
For devices received from
a general licensee, the report shall include the identity of the general licensee
by name and address, the type, model number, and serial number of the device
received, the date of receipt, and, in the case of devices not initially transferred
by the reporting licensee, the name of the manufacturer or initial transferor.
(B)
report the following to the NRC to include covering each
calendar quarter to be filed within 30 days thereafter
, clearly indicating
the period covered by the report, the identity of the specific licensee submitting
the report, and the license number of the specific licensee
:
(i)
all commercial distributions of such devices to persons
for use in accordance with the NRC general license in Title 10, CFR, §31.5
and all receipts of devices from general licensees in areas under NRC jurisdiction
including
the following
:
(I)
identity of each general licensee by name and address;
[
(II)
[
(III)
[
(IV)
the date of transfer; or
(ii)
if the licensee makes changes
to a device possessed in accordance with the general license in §289.251(f)(4)(H)
of this title, such that the label must be changed to update required information,
the report shall identify the licensee, the device, and the changes to information
on the device label;
(iii)
in the case of devices not
initially transferred by the reporting licensee, the name of the manufacturer
or initial transferor;
(iv)
[
(C)
report to the appropriate agreement state or licensing
state all transfers of devices manufactured and commercially distributed in
accordance with this subsection for use in accordance with a general license
in that state's requirements equivalent to
§289.251(f)(4)(H)
[
(i)
The report shall
:
(I)
be submitted within 30 days after the end of
each calendar quarter in which such a device is commercially distributed to
the generally licensed person
;
[
(II)
clearly indicate the period
covered by the report;
(III)
clearly identify the specific
licensee submitting the report and include the license number of the specific
licensee;
(IV)
[
(V)
[
(VI)
[
(VII)
[
(VIII)
date of receipt.
(ii)
If one or more intermediate persons will temporarily possess
the device at the intended place of use prior to its possession by the user,
the report shall also include
the same information for both the intended
user and
[
(iii)
If no commercial distributions have been made to persons
in the agreement state or licensing state during the reporting period, the
report shall so indicate.
(iv)
For devices received from
a general licensee, the report shall include the identity of the general licensee
by name and address, the type, model number, and serial number of the device
received, the date of receipt, and, in the case of devices not initially transferred
by the reporting licensee, the name of the manufacturer or initial transferor.
(D)
keep records
for three years following the date of
the recorded event,
showing the name, address, and the point of contact
for each general licensee to whom the licensee directly or through an intermediate
person commercially distributes radioactive material in devices for use in
accordance with the general license provided in
§289.251(f)(4)(H)
[
(i)
The records shall show the following:
(I)
date of each commercial distribution;
(II)
the isotope and the quantity of radioactivity in each
device commercially distributed;
(III)
the identity of any intermediate person; and
(IV)
compliance with the reporting requirements of this subsection.
(ii)
If no commercial distributions have been made to persons
generally licensed in accordance with
§289.251(f)(4)(H)
[
(8)
[
(9)
Each device that is transferred
after February 19, 2002, shall meet the labeling requirements in accordance
with paragraph (1)(C)-(E) of this subsection.
(m)
Specific licenses for the manufacture, assembly, or repair
of luminous safety devices for use in aircraft for commercial distribution
to persons generally licensed in accordance with
§289.251(f)(4)(B)
[
(n)
Specific licenses for the manufacture of calibration sources
containing americium-241, plutonium, or radium-226 for commercial distribution
to persons generally licensed in accordance with
§289.251(f)(4)(D)
[
(o)
(No change.)
(p)
Specific licenses for the manufacture and commercial distribution
of radioactive material for certain
in vitro
clinical
or laboratory testing in accordance with the general license. In addition
to the requirements in subsection (e) of this section, a specific license
to manufacture or commercially distribute radioactive material for use in
accordance with the general license in
§289.251(f)(4)(G)
[
(1)-(4)
(No change.)
(q)
Specific licenses for the manufacture and commercial distribution
of ice detection devices. In addition to the requirements of subsection (e)
of this section, a specific license to manufacture and commercially distribute
ice detection devices to persons generally licensed in accordance with
§289.251(f)(4)(E)
[
(r)
(No change.)
(s)
Specific licenses for the manufacture and commercial distribution
of products containing depleted uranium for mass-volume applications.
(1)
In addition to the requirements in subsection (e) of this
section, a specific license to manufacture products and devices containing
depleted uranium for use in accordance with
§289.251(f)(3)(D)
[
(A)-(B)
(No change.)
(2)-(3)
(No change.)
(4)
Each person licensed in accordance with paragraph (1) of
this subsection shall:
(A)-(C)
(No change.)
(D)
furnish a copy of the following:
(i)
the general license in
§289.251(f)(3)(D)
[
(ii)
the NRC's or agreement state's requirements equivalent
to the general license in
§289.251(f)(3)(D)
[
(iii)
alternately, a copy of the general license in
§289.251(f)(3)(D)
[
(E)
report to the agency all commercial distributions of products
or devices to persons for use in accordance with the general license in
§289.251(f)(3)(D)
[
(i)
(No change.)
(ii)
If no commercial distributions have been made to persons
generally licensed in accordance with
§289.251(f)(3)(D)
[
(F)
report to the NRC and each responsible agreement state
agency all commercial distributions of industrial products or devices to persons
for use in accordance with the general license in the NRC's or agreement state's
equivalent requirements to
§289.251(f)(3)(D)
[
(G)
keep records showing the name, address, and point of contact
for each general licensee to whom the licensee commercially distributes depleted
uranium in products or devices for use in accordance with the general license
provided in
§289.251(f)(3)(D)
[
(t)-(v)
(No change.)
(w)
Issuance of specific licenses.
(1)
When the agency determines that an application meets the
requirements of the Act and the rules of the agency, the agency will issue
a specific license authorizing the proposed activity in such form and containing
the conditions and limitations as
the agency
[
(2)
The agency may incorporate in any license at the time of
issuance, or thereafter by amendment, additional requirements and conditions
with respect to the licensee's receipt, possession, use, and transfer of radioactive
material subject to this section as
the agency
[
(A)-(C)
(No change.)
(3)
The agency may request
,
and the licensee shall
provide, additional information after the license has been issued to enable
the agency to determine whether the license should be modified in accordance
with subsection (dd) of this section.
(x)
Specific terms and conditions of licenses.
(1)-(3)
(No change.)
(4)
Each licensee shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
by the licensee or its parent company, if the parent company is involved in
the bankruptcy
.
(5)-(6)
(No change.)
(7)
In making a determination whether
to grant, deny, amend, renew, revoke, suspend, or restrict a license, the
agency may consider the technical competence and compliance history of an
applicant or holder of a license. After an opportunity for a hearing, the
agency shall deny an application for a license, an amendment to a license,
or renewal of a license if the applicant's compliance history reveals that
at least three agency or judicial orders have been issued against the applicant
that assess administrative or civil penalties against the applicant, or that
revoke or suspend the license.
(y)
Expiration and termination of licenses
, and administrative
renewal;
[
(1)
Effective September 1, 2004, the term of the specific
license is two years.
Except as provided in paragraph
(3)
[
(2)
If the fee is not paid and
the license is not renewed in accordance with paragraph (1) of this subsection,
the license expires, and the licensee is in violation of the rules and is
subject to administrative penalties in accordance with §289.205 of this
title.
(A)
If the licensee pays the fee required by §289.204
of this title within 30 days after expiration of the license, the license
will be reinstated and the licensee will not be required to file an application
in accordance with subsection (d) of this section.
(B)
If the licensee fails to pay the fee within
30 days after expiration of the license, the licensee shall file an application
in accordance with subsection (d) of this section.
(3)
Expiration of the specific
license does not relieve the licensee of the requirements of this chapter.
(4)
[
(A)
be limited to actions involving radioactive material that
are related to decommissioning; and
(B)
continue to control entry to restricted areas until the
location(s) is suitable for release for unrestricted use in accordance with
the requirements in §289.202(ddd) of this title.
(5)
[
(A)
the license has expired
or has been revoked
in
accordance with this subsection or subsection
(dd)
[
(B)
the licensee has decided to permanently cease principal
activities, as defined in §289.201(b) of this title, at the entire site
or in any separate building or outdoor area;
(C)
no principal activities under the license have been conducted
for a period of 24 months; or
(D)
no principal activities have been conducted for a period
of 24 months in any separate building or outdoor area that contains residual
radioactivity such that the building or outdoor area is unsuitable for release
in accordance with §289.202(eee) of this title.
(6)
[
(7)
[
(8)
[
(A)
procedures would involve techniques not applied routinely
during cleanup or maintenance operations;
(B)
workers would be entering areas not normally occupied where
surface contamination and radiation levels are significantly higher than routinely
encountered during operation;
(C)
procedures could result in significantly greater airborne
concentrations of radioactive materials than are present during operation;
or
(D)
procedures could result in significantly greater releases
of radioactive material to the environment than those associated with operation.
(9)
[
(10)
[
(11)
[
(A)
a description of the conditions of the site or separate
building or outdoor area sufficient to evaluate the acceptability of the plan;
(B)
a description of planned decommissioning activities;
(C)
a description of methods used to ensure protection of workers
and the environment against radiation hazards during decommissioning;
(D)
a description of the planned final radiation survey;
(E)
an updated detailed cost estimate for decommissioning,
comparison of that estimate with present funds set aside for decommissioning,
and a plan for assuring the availability of adequate funds for completion
of decommissioning; and
(F)
for decommissioning plans calling for completion of decommissioning
later than 24 months after plan approval, a justification for the delay based
on the criteria in paragraph
(15)
[
(12)
[
(13)
[
(14)
[
(15)
[
(A)
whether it is technically feasible to complete decommissioning
within the allotted 24 month period;
(B)
whether sufficient waste disposal capacity is available
to allow completion of decommissioning within the allotted 24 month period;
(C)
whether a significant volume reduction in wastes requiring
disposal will be achieved by allowing short-lived radionuclides to decay;
(D)
whether a significant reduction in radiation exposure to
workers can be achieved by allowing short-lived radionuclides to decay; and
(E)
other site-specific factors that the agency may consider
appropriate on a case-by-case basis, such as the regulatory requirements of
other government agencies, lawsuits, groundwater treatment activities, monitored
natural ground-water restoration, actions that could result in more environmental
harm than deferred cleanup, and other factors beyond the control of the licensee.
(16)
[
(A)
certify the disposition of all licensed material, including
accumulated wastes; and
(B)
conduct a radiation survey of the premises where the licensed
activities were carried out and submit a report of the results of this survey
unless the licensee demonstrates that the premises are suitable for release
in accordance with the radiological requirements for license termination specified
in §289.202(ddd) of this title. The licensee shall do the following,
as appropriate:
(i)
report the following levels:
(I)
gamma radiation in units of microroentgen per hour (µR/hr)
(millisieverts per hour (mSv/hr)) at 1 meter (m) from surfaces;
(II)
radioactivity, including alpha and beta, in units of disintegrations
per minute (dpm) or microcuries (µCi) (megabecquerels (MBq)) per 100
square centimeters (cm
2
) for surfaces;
(III)
µCi (MBq) per milliliter for water; and
(IV)
picocuries (pCi) (becquerels (Bq)) per gram (g) for solids
such as soils or concrete; and
(ii)
specify the manufacturer's name and model and serial number
of survey instrument(s) used and certify that each instrument is properly
calibrated and tested.
(17)
[
(A)
radioactive material has been properly disposed;
(B)
reasonable effort has been made to eliminate residual radioactive
contamination, if present;
(C)
a radiation survey has been performed that demonstrates
that the premises are suitable for release in accordance with the radiological
requirements for license termination specified in §289.202(ddd) of this
title, or other information submitted by the licensee is sufficient to demonstrate
that the premises are suitable for release in accordance with the radiological
requirements for license termination specified in §289.202(ddd) of this
title; and
(D)
any outstanding fees in accordance with §289.204 of
this title are paid and any outstanding notices of violations of this chapter
or of license conditions are resolved.
(18)
[
(z)
Technical renewal of licenses
[
(1)
An application
[
(2)
In any case in which a licensee, [
(3)
An application for technical
renewal of a license will be approved if the agency determines that the requirements
of subsection (e) of this section have been satisfied.
(4)
If the application for technical
renewal of the license is not approved in accordance with paragraph (3) of
this subsection, the license expires, and the former licensee is in violation
of the rules and is subject to administrative penalties.
(5)
Expiration of the specific
license does not relieve the former licensee of the requirements of this chapter.
(aa)-(cc)
(No change.)
(dd)
Modification
, suspension,
and revocation of
licenses.
(1)
The terms and conditions of all licenses shall be subject
to [
(2)
Any license may be revoked, suspended, or modified, in
whole or in part, for any of the following:
(A)
(No change.)
(B)
conditions revealed by such application or statement of
fact or any report, record, or inspection, or other means that would warrant
the agency to refuse to grant a license on an original application; [
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, the license, or order of the agency
; or
[
(D)
existing conditions that constitute
a substantial threat to the public health or safety or the environment.
(3)
(No change.)
(4)
Except in cases in which the occupational and public health[
(ee)
Reciprocal recognition of licenses.
(1)
Subject to this section, any person who holds a specific
license from NRC, any agreement state, or any licensing state, and issued
by the agency having jurisdiction where the licensee maintains an office for
directing the licensed activity and at which radiation safety records are
normally maintained, is granted a general license to conduct the activities
authorized in such licensing document within the
State
[
(A)
(No change.)
(B)
the out-of-state licensee notifies the agency in writing
at least three working days prior to engaging in such activity. If, for a
specific case, the three-working-day period would impose an undue hardship
on the out-of-state licensee, the licensee may, upon application to the agency,
obtain permission to proceed sooner. The agency may waive the requirement
for filing additional written notifications during the remainder of the calendar
year following the receipt of the initial notification from a person engaging
in activities in accordance with the general license provided in this subsection.
Such notification shall include:
(i)-(iii)
(No change.)
(iv)
a copy of the
applicant's
pertinent license;
(v)
(No change.)
(vi)
a
[
(C)-(E)
(No change.)
(2)
In addition to the provisions of paragraph (1) of this
subsection, any person who holds a specific license issued by NRC, an agreement
state, or a licensing state authorizing the holder to manufacture, transfer,
install, or service the device described in
§289.251(f)(4)(H)
[
(A)-(C)
(No change.)
(D)
the holder of the specific license furnishes to each general
licensee to whom the holder of the specific license transfers the device,
or on whose premises the holder of the specific license installs the device,
a copy of the general license contained in
§289.251(f)(4)(H)
[
(3)
(No change.)
(ff)
(No change.)
(gg)
Financial assurance and record keeping for decommissioning.
(1)-(5)
(No change.)
(6)
Financial assurance for decommissioning shall be provided
by one or more of the following methods. The financial instrument obtained
shall be continuous for the term of the license in a form prescribed by the
agency. The applicant or licensee shall obtain written approval of the financial
instrument or any amendment to it from the agency.
(A)
(No change.)
(B)
A surety method, insurance, or other guarantee method.
These methods guarantee that decommissioning costs will be paid. A surety
method may be in the form of a surety bond, letter of credit, or line of credit.
A parent company guarantee of funds for decommissioning costs based on a financial
test may be used if the guarantee and test are as contained in subsection
(ii)(3) of this section. A parent company guarantee may not be used in combination
with other financial methods to satisfy the requirements of this section.
For commercial corporations that issue bonds, a guarantee of funds by the
applicant or licensee for decommissioning costs based on a financial test
may be used if the guarantee and test are as contained in subsection (ii)(4)
of this section. For commercial companies that do not issue bonds, a guarantee
of funds by the applicant or licensee for decommissioning costs may be used
if the guarantee and test are as contained in subsection (ii)(5) of this section.
For nonprofit entities, such as colleges, universities, and nonprofit hospitals,
a guarantee of funds by the applicant or licensee may be used if the guarantee
and test are as contained in subsection (ii)(6) of this section. A guarantee
by the applicant or licensee may not be used in combination with any other
financial methods to satisfy the requirements of this section or in any situation
where the applicant or licensee has a parent company holding majority control
of the voting stock of the company. Any surety method or insurance used to
provide financial assurance for decommissioning shall contain the following
conditions.
(i)
(No change.)
(ii)
The surety method or insurance shall be payable in the
State
[
(iii)
(No change.)
(C)-(E)
(No change.)
(7)-(8)
(No change.)
(hh)
(No change.)
(ii)
Appendices.
(1) (No change.)
(2) Isotope quantities (for use in subsection (gg) of this section).
Figure: 25 TAC §289.252(ii)(2)
(3)-(4) (No change.)
(5) Criteria relating to use of financial tests and self guarantees
for providing reasonable assurance of funds for decommissioning by commercial
companies that have no outstanding rated bonds.[
(A)-(C) (No change.)
(6)-(8) (No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the
Office of the Secretary of State on January 16, 2004.
TRD-200400319
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
Subchapter J. TEXAS MOLD ASSESSMENT AND REMEDIATION RULES
25 TAC §§295.301 - 295.338
The Texas Department of Health (department) proposes new §§295.301
- 295.338, concerning the regulation of mold-related activities that affect
indoor air quality. The sections cover the following: general provisions;
definitions; exceptions and exemptions to licensing and registration; code
of ethics; general conditions; general responsibilities; requirements for
licensing, registration, and accreditation; minimum work practices and procedures
for mold assessment and mold remediation; and enforcement.
These rules are required as a result of House Bill 329, 78th Legislative
Session, 2003, which added Chapter 1958 to the Occupations Code, and requires
the department to develop rules to regulate mold-related activities, including
licensing and regulation of mold assessors and remediators and to establish
minimum performance standards for the licensees; Senate Bill 1152, 78th Legislative
Session, 2003, which amended Government Code, Chapter 2054, regarding the
TexasOnline Authority; and House Bill 2292, 78th Legislative Session, 2003,
which revised Health and Safety Code, §§12.0111 and 12.0112, and
requires two-year licenses effective January 1, 2005, with a provision for
staggering the issuance and renewal of licenses.
Alan Morris, Director, Toxic Substances Control Division, has determined
that for each year of the first five years the sections are in effect there
will be fiscal implications as a result of administering the rules as proposed.
The effect on state government will be increased revenue to the department
estimated to be $361,500 in fiscal year 2004, and $343,225 in each of fiscal
years 2005 to 2008 from collection of licensing, registration, accreditation,
notification and examination fees. It is estimated that the costs to the department
to administer the new program will equal the estimated revenue increases.
No significant fiscal impact to units of local government is anticipated.
Situations where mold affects more than 25 square feet for a project may require
a licensed mold assessor or remediator and could cause a fiscal impact. Factors
that could increase the cost to local government include fees for training
and licensing in-house personnel, fees for the state exam, notification fees,
and increased costs of third-party services. Factors that could decrease the
cost to local government include savings from using licensed in-house personnel
rather than third-party services, from more efficient remediation practices
by both in-house and third-party personnel, from fewer sick days for occupants
working in remediated buildings, and from a decreased risk of lawsuits due
to concern over mold exposure. Whether these rules create increased costs
or savings will depend on the circumstances of each case.
Mr. Morris has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
administering the sections will be to ensure compliance by mold assessors
and mold remediators with the new legislative mandates. There will be a varying
impact on micro-businesses, small businesses, and individuals who are required
to comply with the sections. These are outlined in the paragraphs that follow.
Economic costs to persons who are required to comply with the rules will be
the fees for licensing, registration, or accreditation; costs to take required
training courses and refresher training through accredited training providers;
fees for the state exam; project notification fees; and costs to maintain
required liability insurance. There will be no impact on local employment.
Prior to January 1, 2005, individuals who meet the qualifications to be
a mold assessment technician, mold assessment consultant, or mold remediation
contractor, may take the state licensing examination required for those categories
without attending a state-accredited training course. For these individuals,
costs will be $25 to take the state examination, and licensing costs as follows:
$100 for a one-year mold assessment technician license; $300 for a one-year
mold assessment consultant license; and $250 for a one-year mold remediation
contractor license. Individuals seeking initial licenses in these categories
after January 1, 2005, will be required to attend, depending on the license
sought, a three- to five-day state-accredited training course taught by a
training provider from the private sector at an estimated tuition cost of
$450-$750. Mold remediation workers will be required to attend a four-hour
training course provided by either their employer or a state-accredited training
provider from the private sector at an estimated tuition cost of $75 and to
pay $30 for a one-year registration prior to January 1, 2005.
House Bill 2292 requires all licenses, including registrations, issued
by the state on or after January 1, 2005, to be for a two-year period, with
a provision for staggering the issuance and renewal of licenses. For 2005,
licenses will be valid for either one or two years, depending upon the birth
year of the applicant. Effective January 1, 2006, all licenses will be issued
for a two-year period. Fees for two-year licenses will be double the fees
for one-year licenses. Costs for a mold assessment or remediation company,
mold analysis laboratory, or training provider are $500 for a one-year license
or accreditation and $1000 for a two-year license or accreditation. Companies
may pay the licensing or registration fees for individual employees, which
shifts the cost but results in no change in fees or revenues to the department.
Licensed companies and sole proprietors are required to have a minimum amount
of $1 million of liability insurance. Many micro-businesses and small businesses
conducting mold assessment and remediation already carry such insurance, at
an approximate cost of $50-$1,000 per month (depending on the amount of business
activity), so this requirement is not an increased cost to those companies.
Some companies in these categories may cease operation, including those that
conduct only a few projects per year and may not generate adequate income
to pay the costs of insurance, training, licensing and notification fees.
In-house and third-party remediation contractors and companies are also required
to remit a $100 notification fee to the department for each remediation project
conducted when the mold contamination affects a total surface area for the
project of 25 contiguous square feet or greater.
There may be increased costs of an estimated 1-5% to property owners that
hire licensed mold companies, as these companies may raise their rates as
a result of the new rules. On the other hand, costs may decrease for some
property owners, particularly homeowners, as the new regulations may discourage
fraudulent or overzealous practices by licensees. Based on reports in the
news media, some companies took advantage of the public's fear of "toxic mold"
resulting in unneeded or excessive testing and remediation. Some companies,
having no performance standards as guidance in remediation, would unnecessarily
remove or clean items and areas. Increased education of the public regarding
the prevention, control and mitigation of mold, as required by House Bill
329, should decrease costs.
Written comments on the proposal may be sent to Mr. Alan Morris, Director,
Toxic Substances Control Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas 78756, or by e-mail to alan.morris@tdh.state.tx.us.
Comments will be accepted for 30 days following publication of the proposal
in the
Texas Register
. In addition, a public
hearing on the proposed sections will be held at 9:00 a.m., Friday, February
13, 2004, in the Texas Department of Health Auditorium, Room K-100, 1100 West
49th Street, Austin, Texas.
Individuals needing additional information should contact Quade Stahl,
Ph.D., Chief, Environmental Lead and Indoor Air Quality Branch, at (512) 834-4509
or (800) 293-0753, extension 2444. Those needing ADA assistance should contact
Mr. Redge Westbrook at (512) 458-7627 or T.D.D. (877) 432-7232.
The new sections are proposed under the Occupations Code, §1958.053,
which provides the department with the authority to adopt necessary regulations
to discharge the powers and duties of Chapter 1958; and Health and the Safety
Code, §12.001, which provides the Texas Board of Health (board) with
the authority to adopt rules for the performance of every duty imposed by
law on the board, the department, and the commissioner of health.
These new sections affect the Occupations Code, Chapter 1958.
§295.301.General Provisions.
(a)
Purpose. This subchapter implements the provisions of the
Texas Occupations Code, Chapter 1958 (relating to Mold Assessors and Remediators),
concerning the regulation of mold assessors and remediators conducting mold-related
activities that affect indoor air quality in regulated buildings.
(b)
Scope. This subchapter contains requirements for the licensing
and registration of persons performing mold assessments and mold remediation,
requirements for the accreditation of mold training providers, minimum work
standards for the conduct of mold assessments and remediation by licensed
and registered persons, a code of ethics, and penalties.
(c)
Severability. Should any section or subsection in this
subchapter be found to be void for any reason, such finding shall not affect
any other sections.
(d)
TexasOnline. The department is authorized to collect subscription
and convenience fees, in amounts determined by the TexasOnline Authority,
to recover costs associated with processing applications, examinations, and
notifications specified under this subchapter through TexasOnline, in accordance
with the Texas Government Code, Chapter 2054, §2054.111 (relating to
Use of TexasOnline Project).
§295.302.Definitions.
The following words and terms within this subchapter shall have the
following meanings, unless the context clearly indicates otherwise.
(1)
Accredited training program--A training program that has
been accredited by the department to provide training for persons seeking
licensure or registration under this subchapter.
(2)
Act--The Texas Occupations Code, Chapter 1958 (relating
to Mold Assessors and Remediators).
(3)
Allied field--Mold assessment, mold remediation, and any
field whose principles and practices are applicable to mold analysis or mold
remediation, including asbestos abatement, lead abatement, industrial hygiene,
building sciences, public health, and environmental remediation.
(4)
Assessor--A person who conducts mold assessment as defined
in this section and who is licensed under this subchapter as a mold assessment
technician, consultant, or company.
(5)
Board--The Texas Board of Health.
(6)
Building sciences--The field of study covering the design,
construction, management, and performance of building systems, including structures,
enclosures, electrical and mechanical systems, environmental systems (such
as temperature and moisture control), safety systems (such as fire suppression
and alarms), lighting, acoustics, and diagnosis and correction of problems
with building systems.
(7)
Commissioner--The Texas Commissioner of Health.
(8)
Containment area--An area that has been enclosed to prevent
the release of mold or mold-containing dust or materials into surrounding
areas.
(9)
Contiguous--In close proximity; neighboring.
(10)
Contiguous square feet--See "Total surface area of contiguous
square feet".
(11)
Credential--A license, registration, or accreditation
issued under this subchapter.
(12)
Department--The Texas Department of Health.
(13)
Direct microscopic examination--Visible examination of
a surface (as opposed to a sample collected from a surface) through a microscope
having a minimum magnification of 100 times (100X), during which particles
that are or resemble mold are counted by a licensed mold assessment consultant.
(14)
Dwelling unit--A room or rooms occupied or intended for
occupancy as separate living quarters, including such rooms that are vacant
or under construction. Examples of dwelling units include single houses, individual
apartments or condominiums, mobile homes, and rooms other than common areas
in dormitories, fraternity houses, sorority houses, rooming houses, and boarding
houses.
(15)
Employee--An individual who is paid a salary, wage, or
remuneration by another person or entity for services performed and over whom
the person or entity exerts supervision or control as to the place, time,
and manner of the individual's work.
(16)
Facility--Any institutional, commercial, public, governmental,
industrial or residential structure or building.
(17)
Indoor air--Air within the envelope of a building, including
air in spaces normally occupied by persons in the building.
(18)
Indoor mold--Mold contamination that was not purposely
grown or brought into a building and that has the potential to affect the
indoor air quality of the building.
(19)
License--Any license issued under this subchapter. The
term "license" does not include a registration, accreditation, or approval
issued under this subchapter.
(20)
Mold--Any living or dead fungi or related products or
parts, including spores, hyphae, and mycotoxins.
(21)
Mold analysis--The examination of a sample collected during
a mold assessment for the purpose of:
(A)
determining the amount or presence of or identifying the
genus or species of any living or dead mold or related parts (including spores
and hyphae) present in the sample;
(B)
growing or attempting to grow fungi for the purposes of
subparagraph (A) of this paragraph; or
(C)
identifying or determining the amount or presence of any
fungal products, including but not limited to mycotoxins and fungal volatile
organic compounds, present in the sample.
(22)
Mold assessment--Activity that involves:
(A)
an inspection, investigation, or survey of a dwelling or
other structure to provide the owner or occupant with information regarding
the presence, identification, or evaluation of mold;
(B)
the development of a mold management plan or mold remediation
protocol; or
(C)
the collection or analysis of a mold sample.
(23)
Mold assessment report--A document, prepared by a licensed
mold assessment consultant for a client, that describes any observations made,
measurements taken, and locations and analysis results of samples taken by
the consultant or by a licensed mold assessment technician during a mold assessment.
An assessment report can be either a stand-alone document or a part of a mold
management plan or mold remediation protocol.
(24)
Mold management plan--A document, prepared by a licensed
mold assessment consultant for a client, that provides guidance on how to
prevent and control indoor mold growth at a location.
(25)
Mold-related activities--The performance of mold assessment,
mold remediation or any other related activities.
(26)
Mold remediation--The removal, cleaning, sanitizing, demolition,
or other treatment, including preventive activities, of mold or mold-contaminated
matter that was not purposely grown at a location. Preventive activities include
those intended to prevent future mold contamination of a remediated area,
including applying biocides or anti-microbial compounds.
(27)
Mold remediation protocol (mold remediation work analysis)--A
document, prepared by a licensed mold assessment consultant for a client,
that specifies the estimated quantities and locations of materials to be remediated
and the proposed remediation methods and clearance criteria for each type
of remediation in each type of area for a mold remediation project.
(28)
Mold remediation work plan--A document, prepared by a
licensed mold remediation contractor that provides specific instructions and/or
standard operating procedures for how a mold remediation project will be performed.
(29)
Office--A stationary physical location assigned a street
address by the United States Postal Service, where a licensee or an employee
of a licensee may be contacted to conduct business related to mold assessment
and/or mold remediation.
(30)
Person--An individual, corporation, company, contractor,
subcontractor, association, firm, partnership, joint stock company, foundation,
institution, trust, society, union, governmental entity, or any other association
of individuals.
(31)
Program administrator--The administrator of the Texas
Department of Health's Mold Licensing Program.
(32)
Project--All activities connected with a mold remediation
work plan, including activities necessary for the preparation of the work
plan and any associated mold remediation protocol(s), site preparation, and
post-remediation assessment and clearance.
(33)
Remediator--A person who conducts mold remediation as
defined in this section and who is credentialed under this subchapter as a
mold remediation worker, contractor, or company.
(34)
Residential property--A building, group of buildings,
or portion of a building that is intended to provide living quarters for a
person for an extended period of time, including a residential property that
is vacant or under construction and portions of non-residential properties
that serve as living quarters for employees (such as a caretaker's dwelling
at a commercial property or staff housing at an institutional facility). Residential
properties do not include:
(A)
lodgings (such as hotels and motels) that rent units on
a transient basis;
(B)
institutional facilities that provide care for residents
or inmates (such as hospitals, nursing homes, homes for children with physical
or mental disabilities, mental institutions, jails, prisons and detention
centers); and
(C)
former residential properties that do not currently provide
living quarters (such as houses converted into shops or restaurants).
(35)
Responsible person--An employee or principal designated
by a licensed mold assessment company, mold remediation company, or mold analysis
laboratory or by an accredited mold training provider as responsible for its
operations and compliance with rules concerning mold-related activities or
mold-related training.
(36)
Start date--The date on which the actual remediation of
mold begins.
(37)
Stop date (completion date)--The date following the date
on which final clearance is achieved following a mold remediation project.
(38)
Supervise--To direct and exercise control over the activities
of a person by being physically present at the job site or, if not physically
present, accessible by telephone and able to be at the site within one hour
of being contacted.
(39)
Survey--An activity undertaken in a building to determine
the presence, location, or quantity of indoor mold or to determine the underlying
condition(s) contributing to indoor mold growth, whether by visual or physical
examination or by collecting samples of potential mold for further analysis.
(40)
Total surface area of contiguous square feet--The contiguous
area of surface material that needs to be cleaned or removed to remediate
visible mold contamination.
(41)
Training hours--Hours spent in classroom instruction,
hands-on activities, and field trips, including time used for course tests
and brief breaks but not including scheduled lunch periods.
(42)
Visible--Exposed to view; capable of being seen.
(43)
Work analysis--A mold remediation protocol.
(44)
Work plan--A mold remediation work plan.
(45)
Working days--Monday through Friday, including holidays
that fall on those days.
§295.303.Exceptions and Exemptions.
(a)
Exceptions. This subchapter does not apply to:
(1)
the following activities when not conducted for the purpose
of mold assessment or mold remediation:
(A)
routine cleaning;
(B)
the diagnosis, repair, cleaning, or replacement of plumbing,
heating, ventilation, air conditioning, electrical, or air duct systems or
appliances;
(C)
commercial or residential real estate inspections; and
(D)
the incidental discovery or emergency containment of potential
mold contamination during the conduct or performance of services listed in
this subsection. For purposes of this subsection, an emergency exists if a
delay in mold remediation services in response to a water damage occurrence
would increase mold contamination;
(2)
the repair, replacement, or cleaning of construction materials
during the building phase of the construction of a structure;
(3)
the standard performance of custodial activities for, preventive
maintenance of, and the routine assessment of property owned or operated by
a governmental entity; or
(4)
a pest control inspection conducted by a person regulated
under the Texas Occupations Code, Chapter 1951 (relating to Structural Pest
Control).
(b)
Minimum area exemption. A person is not required to be
licensed under this subchapter to perform mold remediation in an area in which
the mold contamination for the project affects a total surface area of less
than 25 contiguous square feet.
(c)
Residential property exemption. An owner, or a managing
agent or employee of an owner, is not required to be licensed under this subchapter
to perform mold assessment or mold remediation on a residential property which
is owned by that person, and which has fewer than 10 dwelling units. This
exemption applies regardless of the total surface area within the residential
property that is affected by mold growth. This exemption does not apply to
a managing agent or employee who engages in the business of performing mold
assessment or mold remediation for the public.
(d)
Facility exemption. An owner or tenant, or a managing agent
or employee of an owner or tenant, is not required to be licensed under this
subchapter to perform mold assessment or mold remediation on property owned
or leased by the owner or tenant. This exemption does not apply:
(1)
if the managing agent or employee engages in the business
of performing mold assessment or mold remediation for the public;
(2)
if the mold remediation is performed in an area in which
the mold contamination affects a total surface area of 25 contiguous square
feet or more; or
(3)
to a person exempt under subsection (c) of this section.
(e)
Construction and improvement exemption. A person is not
required to be licensed under this subchapter to perform mold assessment or
mold remediation in a one-family or two-family dwelling that the person constructed
or improved if the person performs the mold assessment or mold remediation
at the same time the person performs the construction or improvement or at
the same time the person performs repair work on the construction or improvement.
This exemption applies regardless of the total surface area that is affected
by mold growth. This exemption does not apply if the person engages in the
business of performing mold assessment or mold remediation for the public.
For purposes of this subsection, "improve" means "to build, construct, or
erect a new building or structure or a new portion of a building or structure
that is attached to an existing building or structure" and "improvement" means
"a building or structure, or a portion of a building or structure, that was
built, constructed, or erected as an attachment to an existing building or
structure after the construction or erection of the existing building or structure".
(f)
Supervised employee exemption. An employee of a license
holder is not required to be licensed under this subchapter to perform mold
assessment or mold remediation while supervised by the license holder. Such
an employee must, however, be registered as provided under §295.314 of
this title (relating to Mold Remediation Worker: Registration Requirements).
(g)
Loss of exemption. A person who is performing mold remediation
under the licensing exemptions of subsection (b) or (d) of this section and
identifies additional mold such that the total mold contamination affects
a total surface area of 25 contiguous square feet or more shall:
(1)
immediately cease all remediation work and implement emergency
containment if necessary; and
(2)
advise the person requesting the remediation that the exemption
under subsection (b) or (d) of this section has been lost and that any additional
mold remediation and post-remediation assessment in the area must be done
by a person licensed or registered under this subchapter.
§295.304.Code of Ethics.
(a)
The purpose of this section is to establish the standards
of professional and ethical conduct required of all persons holding credentials
or approvals issued under this subchapter.
(b)
All credentialed persons or approved instructors shall,
as applicable to their discipline:
(1)
undertake to perform only services for which they are qualified
by license, education, training or experience in the specific technical fields
involved;
(2)
meet or exceed the minimum standards for mold assessment
and remediation as set forth in this subchapter;
(3)
not participate in activities where a conflict of interest
might arise, pursuant to §295.307 of this title (relating to Conflict
of Interest and Disclosure Requirement) and disclose any known or potential
conflicts of interest to any party affected or potentially affected by such
conflicts;
(4)
provide only necessary and desired services to a client
and not sell unnecessary or unwanted products or services;
(5)
to the extent required by law, keep confidential any personal
information regarding a client (including medical conditions) obtained during
the course of a mold-related activity;
(6)
not misrepresent any professional qualifications or credentials;
(7)
not provide to the department any information that is false,
deceptive, or misleading;
(8)
cooperate with the department by promptly furnishing required
documents or information and by promptly responding to requests for information;
(9)
not work if impaired as a result of drugs, alcohol, sleep
deprivation or other conditions and not allow those under their supervision
to work if known to be impaired;
(10)
maintain knowledge and skills for continuing professional
competence and participate in continuing education programs and activities;
(11)
not make any false, misleading, or deceptive claims, or
claims that are not readily subject to verification, in any advertising, announcement,
presentation, or competitive bidding;
(12)
not make a representation that is designed to take advantage
of the fears or emotions of the public or a customer;
(13)
provide cost-effective mold-related activities; and
(14)
notify each client of the name, mailing address, and telephone
number of the department for the purpose of directing complaints to the department:
(A)
on each written contract for services; or
(B)
in each bill for services provided to the client.
(c)
Duty to report ethical violations. All credentialed persons:
(1)
have the responsibility of promptly reporting alleged misrepresentations
or violations of the Act or this subchapter to the department;
(2)
are responsible for competent and efficient performance
of their duties and shall report to the department incompetent, illegal or
unethical conduct of any practitioner of mold assessment and/or remediation;
and
(3)
shall not retaliate against any person who reported in
good faith to the department alleged incompetent, illegal or unethical conduct.
§295.305.Credentials: General Conditions.
(a)
Licensing or registration requirement. A person must be
licensed or registered in compliance with this subchapter to engage in mold
assessment or mold remediation unless specifically exempted under §295.303
of this title (relating to Exceptions and Exemptions).
(b)
Accreditation requirement. A person must be accredited
as a mold training provider in compliance with this subchapter to offer mold
training for fulfillment of specific training requirements for licensing under
this subchapter.
(c)
Age requirement. Each individual applying to be licensed
or registered under this subchapter must be at least 18 years old at the time
of application.
(d)
Office requirement. A person licensed under this subchapter
must maintain an office in Texas. An individual employed by a person licensed
under this subchapter is considered to maintain an office in Texas through
that employer.
(e)
Training requirement.
(1)
An applicant for an initial license under §295.311
of this title (relating to Mold Assessment Technician: Licensing Requirements), §295.312
of this title (relating to Mold Assessment Consultant: Licensing Requirements),
or §295.315 of this title (relating to Mold Remediation Contractor: Licensing
Requirements) must successfully complete an initial training course offered
by a department-accredited training provider in the discipline for which the
credential is sought and receive a course-completion certificate before applying
for the license. This paragraph does not apply to applicants who submit complete
applications to the department before January 1, 2005, as evidenced by a postmark
or shipping paperwork.
(2)
Except as described under subsection (g)(3) of this section,
an applicant for renewal of a license listed under paragraph (1) of this subsection
must successfully complete a refresher training course offered by a department-accredited
training provider in the discipline for which renewal is sought and receive
a course-completion certificate before applying for the renewal. The applicant
must successfully complete the refresher course no later than 24 months after
successful completion of the previous course and no earlier than 12 months
prior to the expiration date of the license.
(3)
Except as described under subsection (g)(3) of this section,
an applicant for an initial or renewal registration under §295.314 of
this title (relating to Mold Remediation Worker: Registration Requirements)
must successfully complete a training course as described under §295.320(d)
and (f) of this title (relating to Training: Required Mold Training Courses)
and receive a course-completion certificate before applying for the registration.
If a refresher course is required, the applicant must successfully complete
the refresher course no later than 24 months after successful completion of
the previous course and no earlier than 12 months prior to the expiration
date of the registration.
(f)
Examination requirement. In accordance with §295.310
of this title (relating to Licensing: State Licensing Examination), an applicant
for an initial license under §§295.311, 295.312, or 295.315 of this
title must pass the state licensing examination in the discipline for which
licensure is sought with a score of at least 70% correct before applying for
the license. All applicants must pass the state examination within six months
of completing any training course required under subsection (e)(1) of this
section in three or fewer attempts or must successfully complete a new initial
training course before re-taking the state examination.
(g)
Applications. Each application for a credential or approval
must provide all required information. An applicant shall indicate that a
question does not apply by answering "not applicable" or "N/A". Applicants
must submit complete applications, including all supporting documents, for
each credential or approval sought.
(1)
An applicant for an initial license under §§295.311,
295.312, or 295.315 of this title must submit the complete application to
the department within six months of passing the required state licensing examination,
as evidenced by a postmark or shipping documents, or must successfully complete
a new initial training course, receive a new training certificate, and pass
a new state examination before submitting a new initial license application.
(2)
An applicant for an initial or renewal registration under §295.314
of this title must submit the complete application to the department within
five working days of successfully completing the required training course,
as evidenced by a postmark or shipping paperwork.
(3)
An applicant for a renewal of a license listed under paragraph
(1) of this subsection must successfully complete a required refresher training
course and receive a course-completion certificate before applying for renewal,
except that this paragraph does not apply to a holder of an initial license
that is valid for one year, as described under subsections (h)(1) and (h)(2)(A)
of this section. The applicant must complete the refresher course before the
expiration date of the license but no earlier than 12 months prior to the
expiration date of the license and no later than 24 months after completion
of the previous course.
(h)
Term and expiration.
(1)
All credentials issued before January 1, 2005, are valid
for one year and expire on the anniversary of the effective date.
(2)
A credential issued between January 1, 2005, and December
31, 2005, (including renewal of a credential issued before January 1, 2005,
regardless of the issue date of the renewal) is valid for:
(A)
one year and expires on the anniversary of the effective
date, if the birth year of the applicant (or the birth year of the mold training
manager or the first individual named as a responsible person, as described
under subsection (j) of this section, if the applicant is not an individual)
is an odd number; or
(B)
two years and expires on the second anniversary of the
effective date, if the birth year of the applicant (or the birth year of the
mold training manager or the first individual named as a responsible person,
as described under subsection (j) of this section, if the applicant is not
an individual) is an even number.
(3)
All credentials issued on or after January 1, 2006, except
as specified in paragraph (2) of this subsection, are valid for two years
and expire on the second anniversary of the effective date.
(4)
Fees commensurate with a two-year credential must be included
with any application for a credential that will expire on the second anniversary
of its effective date.
(5)
A credential holder is in violation of this subchapter
if the holder practices with lapsed qualifications.
(i)
Condition of issuance. No credential, identification (ID)
card, or approval issued under this subchapter shall be sold, assigned, or
transferred. ID cards issued by the department must be present at the worksite
any time an individual is engaged in mold-related activities. The department
retains the right to confiscate and revoke any credential, ID card, or approval
that has been altered.
(j)
Persons other than individuals. A mold assessment company,
mold remediation company, mold analysis laboratory, or mold training provider
that has been issued a credential under this subchapter:
(1)
shall designate one or more individuals as responsible
persons. The credentialed person must notify the department in writing of
any additions or deletions of responsible persons within 10 days of such occurrences;
(2)
shall not transfer that credential to any other person,
including to any company that has bought the credentialed entity. The credentialed
entity must apply for a new credential within 60 days of being bought; and
(3)
must submit to the department a name-change application
and a processing fee of $20 within 60 days of any change.
§295.306.Credentials: General Responsibilities.
(a)
Persons who are licensed, registered, or accredited under
this subchapter shall:
(1)
adhere to the code of ethics prescribed by §295.304
of this title (relating to Code of Ethics);
(2)
comply with work practices and procedures of this subchapter;
(3)
refrain from engaging in activity prohibited under §295.307(a)
of this title (relating to Conflict of Interest and Disclosure Requirement);
(4)
maintain any insurance required under §295.309 of
this title (relating to Licensing: Insurance Requirements) while engaging
in mold-related activities regulated under this subchapter;
(5)
cooperate with department personnel in the discharge of
their official duties, as described in §295.329 of this title (relating
to Compliance: Inspections and Investigations); and
(6)
notify the department of changes in mailing address and
telephone number.
(b)
All individuals who are required to be licensed or registered
under this subchapter must have a valid department-issued identification card
present at the worksite when engaged in mold-related activities, except as
provided under §295.314(e) of this title (relating to Mold Remediation
Worker: Registration Requirements) for applicants for registration as mold
remediation workers.
(c)
The license holder overseeing mold-related activities,
with the exception of activities performed by a mold analysis laboratory,
must ensure that a client is provided a copy of the department Consumer Mold
Information Sheet prior to the initiation of any mold-related activity.
(d)
A credentialed person who becomes aware of violations of
this subchapter must report these violations within 24 hours to the department
if, to that person's knowledge, the responsible party has not corrected the
violations within that timeframe.
(e)
The individual that is designated by a licensed mold assessment
company or mold remediation company as its responsible person shall not be
the responsible person for another licensee with the same category of license.
§295.307.Conflict of Interest and Disclosure Requirement.
(a)
Conflict of interest.
(1)
A licensee shall not perform both mold assessment and mold
remediation on the same project.
(2)
A person shall not own an interest in an entity that performs
mold assessment services and an entity that performs mold remediation services
on the same project.
(b)
Disclosure requirement. At the time of application for
licensing, an applicant that is not an individual shall disclose to the department
the name, address, and occupation of each person that has an ownership interest
of 10% or more in the applicant. A licensee shall report to the department
within 10 days any change related to a person who has an ownership interest
of 10% or more including additions to or deletions from any list of such persons
previously supplied to the department and any changes in the names, addresses,
or occupations of any persons on such a list.
§295.308.Credentials: Applications and Renewals.
(a)
General requirements. Applications for a license, registration
or accreditation must be made on forms provided by the department and signed
by the applicant. The department shall consider only complete applications.
The application form must be accompanied by:
(1)
a check or money order for the amount of the required fee
made payable to the Texas Department of Health, unless the application fee
is paid through TexasOnline, as provided under the Texas Government Code,
Chapter 2054, §2054.252 (relating to TexasOnline Project);
(2)
a current one-inch by one-inch photograph of the applicant's
face (or, if the application is for a company license, of the face of the
individual designated as the responsible person for the company) with a white
background. The photograph of the face is not required with applications for
approvals. If the application is for an individual license and successful
completion of a department-approved training course is being used to satisfy
the training requirement, a copy of the wallet-size photo-identification card
from the applicable training course as required under §295.318(f)(6)(B)
of this title (relating to Mold Training Provider: Accreditation) must also
be submitted; and
(3)
proof that the applicant meets all other requirements for
obtaining the credential being sought.
(b)
Inquiries. Applicants who wish to discuss or obtain information
concerning qualification requirements may call the program administrator at
(512) 834-4509 or (800) 293-0753 (toll-free). Applicants may visit the Mold
Licensing Program's website at www.tdh.state.tx.us/beh/mold to obtain information
and download forms.
(c)
Denials. The department may deny a credential to a person
who fails to meet the standards established by this subchapter.
(d)
Processing applications and renewals.
(1)
Reimbursement of fees. The department shall refund application
fees, less an administrative fee of $50 ($20 for remediation worker applications),
if an applicant does not meet the requirements for the credential. The department
shall refund fees paid in excess of the amounts required under this subchapter,
less a $10 administrative fee. The department will not refund fees if the
application was abandoned due to the applicant's failure to respond to a written
request from the department for a period of 90 days.
(2)
Contested case hearing. The applicant has the right to
request a hearing in writing within 30 days of the date on the department's
letter denying the credential. The hearing will be conducted in accordance
with the Administrative Procedure Act (Texas Government Code, Chapter 2001)
and the department's formal hearing rules in Chapter 1 of this title (relating
to the Board of Health).
(e)
Renewal notices. At least 60 days before a person's license,
registration, or accreditation is scheduled to expire, the department shall
send a renewal notice by first-class mail to the person's last known address
from the department's records. A person credentialed by the department retains
full responsibility for supplying the department with a correct current address
and phone number. The renewal notice will state:
(1)
the type of credential requiring renewal;
(2)
the time period allowed for renewal;
(3)
the amount of the renewal fee; and
(4)
how to obtain and submit a renewal application.
(f)
Renewal requirements. A person seeking to renew a license,
registration, or accreditation shall submit a renewal application no sooner
than 60 days before the credential expires. The department shall renew the
license, registration, or accreditation for a term as provided under §295.305(h)
of this title (relating to Credentials: General Conditions) if the person:
(1)
is qualified to be credentialed;
(2)
pays to the department the nonrefundable renewal fee;
(3)
submits to the department a renewal application on the
prescribed form along with all required documentation; and
(4)
has complied with all final orders resulting from any violations
of this subchapter, unless an exception is granted in writing by the department
and submitted with the application.
(g)
Renewals and late fees. A person shall not perform any
mold-related activity with an expired license, registration, or accreditation.
If a person makes a timely and complete application for the renewal of a valid
credential, the credential does not expire until the department has finally
granted or denied the application. The department shall renew a credential
that has been expired for 180 days or less if the person meets the requirements
of subsection (f) of this section. A person whose credential has been expired
for more than 180 days must obtain a new credential and must comply with current
requirements and procedures, including any state examination requirements.
(h)
Replacements. A person desiring a replacement credential
or ID card shall submit a request in writing on a department-issued form with
a $20 fee.
§295.309.Licensing: Insurance Requirements.
(a)
Persons required to have insurance must obtain policies
for general liability insurance in the amount of not less than $1 million
per occurrence. Self-insurance is allowed for persons who meet the self-insurance
requirements under the insurance laws of Texas and receive written approval
from the Texas Department of Insurance (TDI). An individual required to have
insurance must obtain individual coverage unless covered under the policy
of the individual's employer or employed by a person approved by TDI to be
self-insured. Insurance policies required under this section must be currently
in force and must be written by:
(1)
an insurance company authorized to do business in Texas;
(2)
an eligible Texas surplus lines insurer as defined in the
Texas Insurance Code, Article 1.14-2 (relating to Surplus Lines Insurance);
(3)
a Texas registered risk retention group; or
(4)
a Texas registered purchasing group.
(b)
The certificate of insurance must be complete, including
all applicable coverages and endorsements, and must name the Texas Department
of Health, Toxic Substances Control Division, as a certificate holder. Each
required policy shall be endorsed to provide the department with at least
a ten-day notice of cancellation.
(c)
An applicant for initial or renewal licenses must provide
proof of insurance in one of the following forms:
(1)
a copy of the required certificate of insurance;
(2)
a copy of the approval for self-insurance granted by the
TDI; or
(3)
proof that the applicant is employed by a licensed mold
assessment or remediation company that has the required insurance.
(d)
The department may impose an administrative penalty or
take other disciplinary action against any person who fails to have the insurance
required under this section.
(1)
If a policy is canceled, the licensee shall notify the
department in writing not later than 10 working days prior to the cancellation
effective date. A licensed company may file a single notification for the
company and its licensed employees.
(2)
If a policy expires or is canceled, the policy shall promptly
be renewed or replaced without any lapse in coverage. If no insurance is in
effect, the licensee shall cease work. The licensee must provide a certificate
of the renewal or replacement policy to the department prior to resuming work.
(3)
If an individual licensee ceases to be covered under an
employer's insurance, the individual must obtain replacement coverage either
individually or through a new employer. The individual must submit the documentation
required under subsection (c) of this section to the department before engaging
in any mold-related activities.
§295.310.Licensing: State Licensing Examination.
(a)
Examination requirements.
(1)
An applicant for an initial individual license who has
successfully completed the required training from a department-accredited
training provider must pass the state examination prior to applying for the
license. The applicant must pass the examination within six months of completing
the training course.
(2)
An applicant is permitted to take the state examination
before January 1, 2005, without completing a department-approved training
course. The applicant must pass the examination with a score of at least 70%
correct and submit a complete application to the department before January
1, 2005, (as evidenced by a postmark or shipping paperwork). An applicant
who fails to pass the examination in three or fewer attempts or to submit
a complete application before January 1, 2005, must successfully complete
a state accredited training course and then pass a state examination with
a score of at least 70% correct before re-applying for a license.
(b)
Re-examination. An individual is permitted to take two
re-examinations after failing an initial examination. An individual who fails
both re-examinations must repeat the initial training course, submit a new
application for the licensing examination, and provide a copy of the new training
certificate.
(c)
Scheduling and registration. Annually, the department shall
publish a schedule of examination dates and locations. Training providers
shall provide state examination schedules as a part of their instruction.
Registrations must be submitted by mailing, faxing, or e-mailing a registration
form to the administrator and must be received by the department no later
than five working days before the examination date. Information on the examination
schedule and assistance with registration is available by calling the Mold
Licensing Program at (512) 834-4509 or (800) 293-0753 (toll-free in Texas).
Entrance into the examination site will be allowed only upon presentation
of a valid photo identification from an accredited training provider. Companies
with 30 or more employees to be tested may call the department to arrange
an additional examination date for a $50 per person examination fee.
(d)
Fees. A fee of $25 is required for any examination or re-examination.
A fee of $50 per person shall be paid for examinations administered at locations
and times other than those published. The department must receive the required
fees no later than five working days before the examination.
(e)
Grading and reporting of examination scores. A grade of
at least 70% correct must be achieved in order to pass the examination. Scores
will be reported only by mail no later than 30 working days after the date
the examination is taken. Information regarding re-examination, if necessary,
will be included.
(f)
Request for information concerning examination. If requested
in writing by an individual who fails a licensing examination, the department
shall furnish the individual with a written analysis of the individual's performance
on the examination.
§295.311.Mold Assessment Technician: Licensing Requirements.
(a)
Licensing requirement. Unless exempted under §295.303
of this title (relating to Exceptions and Exemptions), as of January 1, 2005,
an individual must be licensed as a mold assessment technician to perform
activities listed under subsection (b) of this section, except that an individual
licensed under §295.312 of this title (relating to Mold Assessment Consultant:
Licensing Requirements) is not required to be separately licensed under this
section.
(b)
Scope. An individual licensed under this section is authorized
to determine the location and extent of mold or suspected mold present in
a facility. A mold assessment technician is licensed to:
(1)
record visual observations and take on-site measurements,
including temperature, humidity, and moisture levels, during an initial or
post-remediation mold assessment;
(2)
collect samples for mold analysis during an initial mold
assessment; and
(3)
as directed by an on-site assessment consultant, collect
samples during a post-remediation mold assessment.
(c)
Qualifications. In addition to the requirements for all
applicants listed in §295.305 of this title (relating to Credentials:
General Conditions) and §295.309 of this title (relating to Licensing:
Insurance Requirements), an applicant must be a high-school graduate or have
obtained a General Educational Development (GED) certificate. If the application
is for an initial license and a complete application is submitted to the department
before January 1, 2005, as evidenced by a postmark or shipping paperwork,
the applicant may satisfy the training requirement under §295.305(e)(1)
of this title by either:
(1)
successfully completing an initial mold assessment technician
course offered by a department-accredited training provider and receiving
a course-completion certificate; or
(2)
successfully completing, within two years prior to the
application date, a minimum of 24 hours of instruction in mold assessment.
The applicant is not required to receive all 24 hours of instruction from
the same organization. Successful completion shall be shown by a certificate
of course completion. Any instruction used to satisfy this requirement must
be offered by one of the following:
(A)
a college or university accredited by an organization recognized
by the Council for Higher Education Accreditation;
(B)
a training provider accredited by the federal government
to provide instruction on hazardous materials;
(C)
a national professional organization that is administered
by an active board of directors and whose criteria for full membership include
minimum education and experience requirements and adherence to a published
code of ethics;
(D)
an organization that is administered by an active board
of directors, that offers certification to individuals who fulfill minimum
education and experience requirements at least equivalent to the education
and experience requirements under this section, and that requires passing
a certification examination with a score of at least 70% correct in order
to receive the certification; or
(E)
a training provider that is approved by an organization
meeting the requirements under subparagraph (D) of this paragraph to offer
training required by the organization.
(d)
Fees. The fees for a mold assessment technician license
are:
(1)
$100 for a one-year license issued before January 1, 2006;
and
(2)
$200 for a two-year license issued on or after January
1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following:
(1)
if the application is for an initial license and a complete
application is submitted to the department before January 1, 2005, as evidenced
by a postmark or shipping paperwork:
(A)
a copy of a high school diploma or GED certificate;
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(C)
proof of successfully fulfilling the training requirement
under subsection (c)(1)-(2) of this section; and
(D)
proof of successfully passing the state licensing examination
with a score of at least 70% correct;
(2)
if the application is for an initial license and a complete
application is submitted to the department on or after January 1, 2005:
(A)
a copy of a high school diploma or GED certificate;
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(C)
a copy of a certificate of training as described in §295.320(b)
of this title (relating to Training: Required Mold Training Courses); and
(D)
proof of successfully passing the state licensing examination
with a score of at least 70% correct; or
(3)
if the application is for renewal of a license:
(A)
a copy of a certificate of training as described in §295.320(g)
of this title, unless the applicant is exempt under §295.305(g)(3) of
this title; and
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title.
(f)
Responsibilities. In addition to the requirements listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
a licensed mold assessment technician shall:
(1)
perform only activities allowed under subsection (b) of
this section;
(2)
comply with mold sampling protocols accepted as industry
standards, as presented in training course materials or as required by his/her
employer; and
(3)
utilize the services of a laboratory that is licensed by
the department to provide analysis of mold samples, except as provided under §295.312(b)(4)
of this title.
§295.312.Mold Assessment Consultant: Licensing Requirements.
(a)
Licensing requirements. Unless exempted under §295.303
of this title (relating to Exceptions and Exemptions), as of January 1, 2005,
an individual must be licensed as a mold assessment consultant to perform
activities listed under subsection (b) of this section. A licensed mold assessment
consultant who employs one or more individuals required to be licensed under
this section or §295.311 of this title (relating to Mold Assessment Technician:
Licensing Requirements) must be separately licensed as a mold assessment company
under §295.313 of this title (relating to Mold Assessment Company: Licensing
Requirements), except that an individual licensed as a mold assessment consultant
and doing business as a sole proprietorship is not required to be separately
licensed under §295.313 of this title.
(b)
Scope. An individual licensed under this section is also
licensed to perform all activities of a mold assessment technician listed
in §295.311(b) and (f) of this title. In addition, a licensed mold assessment
consultant is licensed to:
(1)
plan surveys to identify conditions favorable for indoor
mold growth or to determine the presence, extent, amount, or identity of mold
or suspected mold in a building;
(2)
conduct activities recommended in a plan developed under
paragraph (1) of this subsection and describe and interpret the results of
those activities;
(3)
determine locations at which a licensed mold assessment
technician will record observations, take measurements, or collect samples;
(4)
perform direct microscopic examination;
(5)
prepare a mold assessment report, including the observations
made, measurements taken, and locations and analysis results of samples taken
by the consultant or by a licensed mold assessment technician during the mold
assessment;
(6)
develop a mold management plan for a building, including
recommendations for periodic surveillance, response actions, and prevention
and control of mold growth;
(7)
prepare a mold remediation protocol, including the evaluation
and selection of appropriate methods, personal protective equipment, engineering
controls, project layout, and preparation of plans and specifications;
(8)
evaluate a mold remediation project for the purpose of
certifying that mold contamination identified for the remediation project
has been remediated as outlined in a mold remediation protocol;
(9)
evaluate a mold remediation project for the purpose of
certifying that the underlying cause of the mold has been remediated so that
it is reasonably certain that the mold will not return from that remediated
cause; and
(10)
complete appropriate sections of a mold remediation certificate
as specified under §295.327(b) of this title (relating to Photographs;
Certificate of Mold Remediation; Duty of Property Owner).
(c)
Qualifications. In addition to the requirements for all
applicants listed in §295.305 of this title (relating to Credentials:
General Conditions) and §295.309 of this title (relating to Licensing:
Insurance Requirements), an applicant must:
(1)
meet at least one of the following education and/or experience
requirements:
(A)
a bachelor's degree from an accredited college or university
with a major in a natural or physical science, engineering, architecture,
building construction, or building sciences, and at least one year of experience
in an allied field;
(B)
at least 60 college credit hours with a grade of C or better
in the natural sciences, physical sciences, environmental sciences, building
sciences, or a field related to any of those sciences, and at least three
years of experience in an allied field;
(C)
a high-school diploma or a General Educational Development
(GED) certificate and at least five years of experience in an allied field;
or
(D)
certification as an industrial hygienist, a professional
engineer, a professional registered sanitarian, a certified safety professional,
or a registered architect and at least one year of experience in an allied
field; and
(2)
if a complete application for an initial license is submitted
to the department before January 1, 2005 as evidenced by a postmark or shipping
paperwork, satisfy the training requirement under §295.305(e)(1) of this
title by either:
(A)
successfully completing an initial mold assessment consultant
course offered by a department-accredited training provider and receiving
a course-completion certificate; or
(B)
successfully completing, within two years prior to the
application date, a minimum of 40 hours of instruction in mold assessment.
The applicant is not required to receive all 40 hours of instruction from
the same organization. Successful completion shall be shown by a certificate
of course completion. Any instruction used to satisfy this requirement must
include classroom and hands-on training and must be offered by an entity meeting
one of the qualifications listed under §295.311(c)(2)(A)-(E) of this
title.
(d)
Fees. The fees for a mold assessment consultant license
are:
(1)
$300 for a one-year license issued before January 1, 2006;
and
(2)
$600 for a two-year license issued on or after January
1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following in the application
package:
(1)
if the application is for an initial license and a complete
application is submitted to the department before January 1, 2005, as evidenced
by a postmark or shipping paperwork:
(A)
verifiable evidence that the applicant meets at least one
of the eligibility requirements under subsection (c)(1)(A)-(D) of this section;
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(C)
proof of successfully fulfilling the training requirement
under subsection (c)(2) of this section; and
(D)
proof of successfully passing the state licensing examination
with a score of at least 70% correct;
(2)
if the application is for an initial license and a complete
application is submitted to the department on or after January 1, 2005:
(A)
all documentation required under paragraphs (1)(A), (1)(B),
and (1)(D) of this subsection; and
(B)
a copy of a certificate of training as described in §295.320(c)
of this title (relating to Training: Required Mold Training Courses); or
(3)
if the application is for renewal of a license:
(A)
a copy of a certificate of training as described in §295.320(g)
of this title, unless the applicant is exempt under §295.305(g)(3) of
this title; and
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title.
(f)
Responsibilities. In addition to the requirements listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
a licensed mold assessment consultant shall:
(1)
provide adequate consultation to the client to diminish
or eliminate hazards or potential hazards to building occupants caused by
the presence of mold growth in buildings;
(2)
provide, in accordance with a client's instructions, professional
services concerning surveys, building conditions that have or might have contributed
to mold growth, proper building operations and maintenance to prevent mold
growth, and compliance with work practices and standards;
(3)
comply with mold sampling protocols as presented in training
course materials or as required by his/her employer;
(4)
inquire of the client whether any hazardous materials,
including lead-based paint and asbestos, are present in the project area;
(5)
provide to the client a mold assessment report following
an initial (pre-remediation) mold assessment. If the consultant includes the
results of the initial assessment in a mold remediation protocol or a mold
management plan, a separate assessment report is not required;
(6)
provide to the client a mold remediation protocol before
a remediation project begins;
(7)
utilize the services of a laboratory that is licensed by
the department to provide analysis of mold samples, except as permitted under
subsection (b)(4) of this section;
(8)
if he/she performs post-remediation assessment on a project
and ceases to be involved with the project before it achieves clearance, provide
a final status report to the client and to the mold remediation contractor
or company performing mold remediation work for the client as specified under §295.324(f)
of this title (relating to Post-Remediation Assessment and Clearance);
(9)
provide a passed clearance report to the client as specified
under §295.324(e) of this title and complete applicable sections of a
certificate of mold remediation as specified under §295.327(b) of this
title (relating to Photographs; Certificate of Mold Remediation; Duty of Property
Owner);
(10)
comply with recordkeeping responsibilities under §295.326(c)
of this title (relating to Recordkeeping);
(11)
sign and date each mold assessment report and each mold
management plan that he/she prepares and include his/her license number and
expiration date on each report and each plan;
(12)
sign and date each mold remediation protocol on the cover
page, including his/her license number and expiration date. The consultant
must also initial the protocol on every page that addresses the scope of work
and on all drawings related to the remediation work; and
(13)
review and approve changes to any protocol by signing
or initialing according to paragraph (11) of this subsection.
§295.313.Mold Assessment Company: Licensing Requirements.
(a)
Licensing requirements. A person performing mold assessment
work on or after January 1, 2005 must be licensed as a mold assessment company
if the person employs two or more individuals required to be licensed under §295.311
of this title (relating to Mold Assessment Technician: Licensing Requirements)
or §295.312 of this title (relating to Mold Assessment Consultant: Licensing
Requirements), except that an individual licensed as a mold assessment consultant
and doing business as a sole proprietorship is not required to be separately
licensed under this section. A mold assessment company shall designate one
or more individuals licensed as mold assessment consultants as its responsible
person(s).
(b)
Authorization and conditions. As a condition of licensure,
a mold assessment company must:
(1)
notify the department in writing of any changes in individual
licensed mold assessment consultants as responsible persons within 10 days
of such occurrences;
(2)
maintain general liability insurance, as described in §295.309
of this title (relating to Licensing: Insurance Requirements);
(3)
refrain from mold assessment activity during any period
without the active employment of at least one individual licensed mold assessment
consultant designated as the responsible person for the company;
(4)
notify the department in writing of any change related
to a person who has an ownership interest of 10% or more (including additions
to or deletions from any list of such persons previously supplied to the department
and any changes in the names, addresses, or occupations of any persons on
such a list) within 10 days of the change; and
(5)
refrain from engaging in activity prohibited under §295.307(a)
of this title (relating to Conflict of Interest and Disclosure Requirement).
(c)
Eligibility for licensing. To be eligible for licensing,
an applicant must:
(1)
employ at least one licensed mold assessment consultant;
and
(2)
maintain an office in Texas.
(d)
Fees. The fees for a mold assessment company license are:
(1)
$500 for a one-year license issued before January 1, 2006;
and
(2)
$1,000 for a two-year license issued on or after January
1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following in the application
package:
(1)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(2)
the name, address, and occupation of each person that has
an ownership interest of 10% or more in the company; and
(3)
the name and license number of each licensed mold assessment
consultant designated by the applicant as a responsible person.
(f)
Responsibilities. In addition to the requirements as listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
a licensed mold assessment company shall:
(1)
follow the recordkeeping requirements, at both the Texas
office and work site locations, as described in §295.326(c) of this title
(relating to Recordkeeping);
(2)
provide each client with a mold assessment report following
an initial (pre-remediation) mold assessment. If the company includes the
results of the initial assessment in a mold remediation protocol or a mold
management plan, a separate assessment report is not required;
(3)
provide each client a mold remediation protocol before
remediation begins;
(4)
ensure that all employees who will conduct mold assessment
activities are provided with, fit tested for, and trained in the correct use
of personal protection equipment appropriate for the activities to be performed;
(5)
ensure that the training and license of each licensed employee
are current, as described in §295.320 of this title (relating to Training:
Required Mold Training Courses);
(6)
utilize the services of a laboratory that is licensed by
the department to provide analysis of mold samples, except as permitted under §295.312(b)(4)
of this title;
(7)
maintain general liability insurance, as described in §295.309
of this title;
(8)
if the company performs post-remediation assessment on
a project and ceases to be involved with the project before it achieves clearance,
provide a final status report to the client and to the mold remediation contractor
or company performing mold remediation work for the client as specified under §295.324(f)
of this title (relating to Post-Remediation Assessment and Clearance); and
(9)
provide a passed clearance report to the client as specified
under §295.324(e) of this title and provide a certificate of mold remediation,
with applicable sections completed by a mold assessment consultant, to a mold
remediation company or contractor, as specified under §295.327(b) of
this title (relating to Photographs; Certificate of Mold Remediation; Duty
of Property Owner).
§295.314.Mold Remediation Worker: Registration Requirements.
(a)
Registration requirement. Unless exempted under §295.303
of this title (relating to Exceptions and Exemptions), as of January 1, 2005,
an individual must be registered as a mold remediation worker to perform mold
remediation, except that an individual licensed under §295.315 of this
title (relating to Mold Remediation Contractor: Licensing Requirements) is
not required to be separately registered under this section.
(b)
Qualifications. In addition to the requirements for all
applicants listed in §295.305 of this title (relating to Credentials:
General Conditions), an applicant must:
(1)
be employed by a licensed mold remediation contractor or
company; and
(2)
complete a mold remediation worker training course provided
by either the applicant's employer or an accredited mold training provider,
as described under §295.320(d) of this title (relating to Training: Required
Mold Training Courses).
(c)
Fees. The fees for a mold remediation worker registration
are:
(1)
$30 for a one-year registration issued before January 1,
2006; and
(2)
$60 for a two-year registration issued on or after January
1, 2005.
(d)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals) and shall include a copy of the training certificate required
under §295.320(d)(5)(A) of this title, unless the applicant is exempt
under §295.305(g)(3) of this title. An applicant must submit an application
to the department within five working days of completing a worker training
course, as evidenced by a postmark or shipping paperwork.
(e)
Temporary registration. An individual who has successfully
completed remediation worker training and received a training certificate
may perform mold remediation work allowed under this section for a period
of not more than 30 days from the training date if:
(1)
the individual has submitted an application for registration
to the department as required under subsection (d) of this section;
(2)
a copy of the training certificate is present at the work
site at all times while the individual engages in mold remediation; and
(3)
the individual is in possession of a valid government-issued
photo identification at all times while performing mold remediation work.
(f)
Responsibilities. In addition to the requirements as listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
a registered mold remediation worker shall use remediation techniques specified
in the project mold remediation work plan.
(g)
Prohibitions. Registered mold remediation workers are prohibited
from:
(1)
performing mold remediation except under the supervision,
as defined in §295.303(f) of this title, of a licensed remediation contractor;
and
(2)
engaging in any mold-related activity as a contractor.
§295.315.Mold Remediation Contractor: Licensing Requirements.
(a)
Licensing requirements. Unless exempted under §295.303
of this title (relating to Exceptions and Exemptions), as of January 1, 2005,
an individual must be licensed as a mold remediation contractor to perform
activities listed under subsection (b) of this section. A licensed mold remediation
contractor who employs one or more individuals required to be licensed under
this section or §295.314 of this title (relating to Mold Remediation
Worker: Registration Requirements) must be separately licensed as a mold remediation
company under §295.316 of this title (relating to Mold Remediation Company:
Licensing Requirements), except that an individual licensed as a mold remediation
contractor and doing business as a sole proprietorship is not required to
be separately licensed under §295.316 of this title. A mold remediation
company shall designate one or more individuals licensed as mold remediation
contractors as its responsible person(s).
(b)
Scope. An individual licensed under this section may perform
mold remediation and supervise registered mold remediation workers performing
mold remediation. In addition, a licensed mold remediation contractor is licensed
to provide mold remediation services including:
(1)
preparing a mold remediation work plan providing instructions
for the remediation efforts to be performed for a mold remediation project;
and
(2)
conducting and interpreting the results of activities recommended
in a work plan developed under paragraph (1) of this subsection, including
any of the activities of a registered mold remediation worker under §295.314
of this title.
(c)
Qualifications. In addition to the requirements for all
applicants listed in §295.305 of this title (Credentials: General Conditions)
and §295.309 of this title (relating to Licensing: Insurance Requirements),
an applicant must:
(1)
meet at least one of the following education and/or experience
requirements:
(A)
a bachelor's degree from an accredited college or university
with a major in a natural or physical science, engineering, architecture,
building construction, or building sciences and at least one year of experience
either in an allied field or as a general contractor in building construction;
(B)
at least 60 college credit hours with a grade of C or better
in the natural sciences, physical sciences, environmental sciences, building
sciences, or a field related to any of those sciences, and at least three
years of experience in an allied field or as a general contractor in building
construction;
(C)
a high school diploma or General Educational Development
(GED) certificate, plus at least five years of experience in an allied field
or as a general contractor in building construction; or
(D)
certification as an industrial hygienist, a professional
engineer, a professional registered sanitarian, a certified safety professional,
or a registered architect, and at least one year of experience in an allied
field or as a general contractor in building construction; and
(2)
if the application is for an initial license and a complete
application is submitted to the department before January 1, 2005, as evidenced
by a postmark or shipping paperwork, satisfy the training requirement under §295.305(e)(1)
of this title by either:
(A)
successfully completing an initial mold remediation contractor
course offered by a department-accredited training provider and receiving
a course-completion certificate; or
(B)
successfully completing, within two years prior to the
application date, a minimum of 40 hours of instruction in mold remediation.
The applicant is not required to receive all 40 hours of instruction from
the same organization. Successful completion shall be shown by a certificate
of course completion. Any instruction used to satisfy this requirement must
include classroom and hands-on training and must be offered by an entity meeting
one of the qualifications listed under §295.311(c)(2)(A)-(E) of this
title (relating to Mold Assessment Technician: Licensing Requirements).
(d)
Fees. The fees for a mold remediation contractor license
are:
(1)
$250 for a one-year license issued before January 1, 2006;
and
(2)
$500 for a two-year license issued on or after January
1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following in the application
package:
(1)
if the application is for an initial license and a complete
application is submitted to the department before January 1, 2005, as evidenced
by a postmark or shipping paperwork:
(A)
verifiable evidence that the applicant meets at least one
of the eligibility requirements under subsection (c)(1) of this section;
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(C)
proof of successfully fulfilling the training requirement
under subsection (c)(2) of this section; and
(D)
proof of successfully passing the state licensing examination
with a score of at least 70% correct;
(2)
if the application is for an initial license and a complete
application is submitted to the department on or after January 1, 2005:
(A)
verifiable evidence that the applicant meets at least one
of the qualifications under subsection (c)(1) of this section;
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(C)
a copy of a certificate of training indicating successful
completion within the past six months of an initial training course offered
by a department-accredited training provider as described in §295.320(e)
of this title (relating to Training: Required Mold Training Courses); and
(D)
proof of successfully passing the state licensing examination;
or
(3)
if the application is for renewal of a license:
(A)
a copy of a certificate of training as described in §295.320(g)
of this title, unless the applicant is exempt under §295.305(g)(3) of
this title; and
(B)
proof of compliance with the insurance requirement specified
in §295.309 of this title.
(f)
Responsibilities. In addition to the requirements as listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
the mold remediation contractor shall be responsible for:
(1)
accurate interpretation of field notes, drawings, and reports
relating to mold assessments;
(2)
advising clients about options for mold remediation;
(3)
complying with standards for preparing work plans, as presented
in training course materials or as required by the mold remediation company
by whom the contractor is employed;
(4)
providing to a client a mold remediation project work plan
before the mold remediation begins;
(5)
inquiring of the client whether any known or suspected
hazardous materials, including lead-based paint and asbestos, are present
in the project area;
(6)
signing and dating each mold remediation work plan that
he/she prepares on the cover page. The cover page shall also include his/her
license number and expiration date. He/she must also initial the work plan
on every page that addresses the scope of work and on all drawings related
to the remediation work;
(7)
submitting the required notification to the department,
as described in §295.325 of this title (relating to Notifications), unless
employed by a licensed mold remediation company;
(8)
ensuring that all individuals who conduct activities specified
under paragraph (4) of this subsection are provided with, fit tested for,
and trained in the correct use of personal protection equipment required under §295.322(c)
of this title (relating to Minimum Work Practices and Procedures for Mold
Remediation);
(9)
if the mold remediation contractor is doing business as
a sole proprietorship and is not required to be separately licensed as a mold
remediation company under §295.316 of this title (Mold Remediation Company:
Licensing Requirements):
(A)
ensuring that the training, as described in §295.320
of this title (relating to Training: Required Mold Training Courses), and
license of each employee who is required to be licensed under this subchapter
is current;
(B)
ensuring that the training, as described in §295.320
of this title, and registration of each registered employee is current;
(C)
ensuring that each unregistered employee who is required
to be registered under this subchapter is provided the training required under §295.320(d)
of this title before performing any mold remediation work;
(D)
complying with all requirements under §295.320(d)
of this title if the contractor provides the training; and
(E)
ensuring that a previously unregistered employee who is
provided training as specified in subparagraph (C) of this paragraph:
(i)
has applied to the department for registration before allowing
that employee to perform any mold remediation work, except as provided under §295.314(e)
of this title; and
(ii)
is registered before allowing that employee to perform
any mold remediation work more than 30 days after the date of the training,
in accordance with §295.314(e) of this title;
(10)
complying with recordkeeping responsibilities under §295.326
of this title (relating to Recordkeeping); and
(11)
providing to the property owner a completed mold remediation
certificate as specified under §295.327 of this title (relating to Photographs;
Certificate of Mold Remediation; Duty of Property Owner).
§295.316.Mold Remediation Company: Licensing Requirements.
(a)
Licensing requirements. A person performing mold remediation
work on or after January 1, 2005 must be licensed as a mold remediation company
if the person employs one or more individuals required to be licensed under §295.314
of this title (relating to Mold Remediation Worker: Registration Requirements)
or §295.315 of this title (relating to Mold Remediation Contractor: Licensing
Requirements), except that an individual licensed as a mold remediation contractor
and doing business as a sole proprietorship is not required to be separately
licensed under this section.
(b)
Authorization and conditions. A licensed mold remediation
company is specifically authorized to employ mold remediation contractors
and mold remediation workers who are currently licensed or registered under
this subchapter to assist in the company's mold remediation activity. As a
condition of licensure, a mold remediation company must:
(1)
employ at least one licensed mold remediation contractor
and refrain from mold remediation activity during any period without the active
employment of at least one individual licensed mold remediation contractor
designated as the responsible person for the company;
(2)
notify the department in writing of any additions or deletions
of responsible persons within 10 days of such occurrences;
(3)
maintain general liability insurance, as described under §295.309
of this title (relating to Licensing: Insurance Requirements);
(4)
notify the department in writing of any change related
to a person who has an ownership interest of 10% or more (including additions
to or deletions from any list of such persons previously supplied to the department
and any changes in the names, addresses, or occupations of any persons on
such a list) within 10 days of the change; and
(5)
refrain from engaging in activity prohibited under §295.307(a)
of this title (relating to Conflict of Interest and Disclosure Requirement).
(c)
Fees. The fees for a mold remediation company license are:
(1)
$500 for a one-year license issued before January 1, 2006;
and
(2)
$1,000 for a two-year license issued on or after January
1, 2005.
(d)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following in the application
package:
(1)
proof of compliance with the insurance requirement specified
in §295.309 of this title;
(2)
the name, address, and occupation of each person that has
an ownership interest of 10% or more in the company; and
(3)
the name and license number of each licensed mold remediation
contractor designated by the applicant as a responsible person.
(e)
Responsibilities. In addition to the requirements as listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
the mold remediation company shall be responsible for:
(1)
complying with recordkeeping requirements, at both central
office and work site locations, as described in §295.326 of this title
(relating to Recordkeeping);
(2)
submitting the required notification to the department,
as required under §295.325 of this title (relating to Notifications);
(3)
providing to each client a mold remediation work plan project
before the mold remediation begins;
(4)
ensuring that all employees who will conduct mold remediation
activities are provided with, fit tested for, and trained in the correct use
of personal protection equipment required under §295.322 of this title
(relating to Minimum Work Practices and Procedures for Mold Remediation);
(5)
ensuring that the training, as described in §295.320
of this title (relating to Training: Required Mold Training Courses), and
license of each employee who is required to be licensed under this subchapter
is current;
(6)
ensuring that the training, as described in §295.320
of this title, and registration of each registered employee is current;
(7)
ensuring that each unregistered employee who is required
to be registered under this subchapter is provided the training required under §295.320(d)
of this title before performing any mold remediation work;
(8)
complying with all requirements under §295.320(d)
of this title if the company provides the training; and
(9)
ensuring that a previously unregistered employee who is
provided training as specified in paragraph (7) of this subsection:
(A)
has applied to the department for registration before allowing
that employee to perform any mold remediation work, except as provided under §295.314(e)
of this title; and
(B)
is registered before allowing that employee to perform
any mold remediation work more than 30 days after the date of the training,
in accordance with §295.314(e) of this title.
§295.317.Mold Analysis Laboratory: Licensing Requirements.
(a)
Licensing requirement. A person other than an individual
must be licensed in compliance with the provisions of this section to engage
in activities listed under subsection (b) of this section on or after January
1, 2005. Branch offices that perform mold analysis must fulfill the same equipment
and operational standards as the main office that has been licensed and must
be accredited in accordance with subsection (c) of this section for the types
of analysis they will be performing.
(b)
Scope. A person licensed under this section is authorized
to analyze samples collected during mold-related activities to:
(1)
determine the presence, identity, or amount of mold present;
(2)
provide any other information regarding the sample that
the submitter requests; or
(3)
obtain any other information that the laboratory deems
useful.
(c)
Qualifications. Applicants must submit documentation showing
that:
(1)
the laboratory is either:
(A)
accredited by the American Industrial Hygiene Association
under the Environmental Microbiology Laboratory Accreditation Program (EMLAP);
or
(B)
accredited or certified by a program deemed equivalent
by the department; and
(2)
mold analysis activity at the laboratory is overseen by
a full-time mycologist or microbiologist with an advanced academic degree.
(d)
Fees. The fees for a mold analysis laboratory license are:
(1)
$500 for a one-year license issued before January 1, 2006;
and
(2)
$1,000 for a two-year license issued on or after January
1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include the following in the application
package:
(1)
the name, address, and occupation of each person that has
an ownership interest of 10% or more in the laboratory;
(2)
evidence of laboratory accreditation and the most recently
available results of proficiency analytical testing in accordance with subsection
(c) of this section;
(3)
proof of compliance with the insurance requirements specified
in §295.309 of this title (relating to Licensing: Insurance Requirements);
and
(4)
the name of each individual designated by the applicant
as a responsible person.
(f)
Responsibilities. In addition to the requirements as listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
the mold analysis laboratory shall be responsible for:
(1)
following recordkeeping requirements as described in §295.326(d)
of this title (relating to Recordkeeping);
(2)
providing to a client, as applicable, details of analysis
methods used, amounts (percentages) analyzed, raw counts for each genus of
mold that is identified, magnification used for counting and identifying mold,
and culture media and conditions used;
(3)
ensuring that all employees who will conduct mold analysis
are properly trained in analysis techniques;
(4)
maintaining accreditation required under subsection (c)
of this section. A licensed mold assessment laboratory that loses the required
accreditation must:
(A)
provide to the department written notification of a change
in accreditation status within 10 working days of the change; and
(B)
cease providing services related to the licensure until
the accreditation is reinstated;
(5)
notifying the department in writing of any additions or
deletions of responsible persons within 10 days of such occurrences; and
(6)
maintaining general liability insurance, as described in §295.309
of this title.
§295.318.Mold Training Provider: Accreditation.
(a)
Accreditation requirement. A person must be accredited
as a mold training provider to offer mold training courses that are prerequisites
for licensing.
(b)
Authorizations and Conditions. The following shall apply
to issuance of accreditations under this section.
(1)
No person shall advertise or offer as initial or refresher
training courses, for fulfillment of requirements for licensing under this
subchapter, any courses that the department has not approved under §295.319
of this title (relating to Training: Approval Of Training Courses and Instructors).
Accredited training providers may offer, without department approval, mold
remediation technician training courses and other courses relevant to mold-related
activities, including, but not limited to, courses on respirator training
and compliance.
(2)
Accredited training providers must offer approved courses
as described below.
(A)
Each initial and refresher course shall address only one
discipline and shall not be combined with other disciplines. Initial training
courses shall not be combined with refresher courses. This prohibition against
combined training applies to hands-on training sessions as well as other aspects
of the course.
(B)
Each course shall be conducted in one language throughout
and not combined with the same course taught in another language. A training
provider may offer a course in a language other than English if all instructors
and guest speakers are fluent in that language and all books, training materials,
and course tests are in that language.
(3)
Each accredited training provider shall submit schedules
for approved training courses to the department at least 14 calendar days
prior to the start of any course on the schedule. Requests for exceptions
to the 14-day rule shall be submitted in writing to the program administrator
along with a written justification describing why the notice could not be
submitted earlier. Approval requests for shorter notice must be received by
the department 72 hours prior to the start of the course and will be granted
in writing if approved. A training provider that cancels a scheduled course
must notify the department in writing at least 24 hours prior to the scheduled
start time of the course. The department will accept facsimiles of cancellation
notices. If the training provider cannot provide written notice of cancellation
at least 24 hours in advance, the training provider shall notify the department
by phone not later than two hours after the scheduled class start time and
provide a written explanation of the short cancellation notice within 24 hours
of the phone call.
(4)
Training courses must be conducted during scheduled hours
as notified in accordance with paragraph (3) of this subsection. Training
providers shall not conduct any approved course for more than eight training
hours (including hands-on portions) in a calendar day.
(5)
A training provider must require instructors and guest
speakers to present in person at least 50% of the classroom instruction and
all of the hands-on instruction. The training provider may allow an instructor
or guest speaker to use training films and videotapes, but audiovisual materials
shall not be used as substitutes for the required in-person presentations
or the hands-on instruction.
(6)
Courses requiring hands-on practical training must be presented
in an environment that permits each student to have actual experience performing
tasks associated with the mold-related activity.
(7)
The maximum number of students in a lecture session shall
be 40. Hands-on training sessions shall maintain a student-to-instructor ratio
of not more than 15 to one and must be conducted so that the instructor is
able to assist and evaluate each student individually. Field trips shall maintain
a student-to-instructor ratio of not more than 40 to one.
(8)
Approved training courses shall be conducted in facilities
acceptable as classrooms and conducive to learning. The facilities must have
restrooms available for the students.
(9)
Course instructors shall maintain a master attendance record
for each course and take attendance at the beginning of each four-hour instruction
segment. A student who is absent from more than 10% of the course instruction,
including hands-on sessions and field trips, is ineligible to complete the
course.
(10)
An accredited training provider must verify and keep a
written record of any student achieving a minimum score of 70% correct on
each course test. The training provider shall have a written policy concerning
the administration of tests, including allowing only one re-test per student
for each course. The use of the same questions for both the original and re-test
is not allowed. Oral tests are not allowed; however, a training provider may
read the written test questions and possible answers to a student who must
then mark his or her answer on an answer sheet. If a student fails the re-test,
the student must repeat the course and pass a new test.
(11)
Each training provider shall send at least one course
instructor to any meeting held by the department for the purpose of ensuring
quality training. The department shall hold no more than two such meetings
per year.
(12)
An individual instructor shall not train himself/herself
to qualify for a license or a registration.
(c)
Qualification. To qualify for an accreditation, each applicant:
(1)
must have a written policy concerning refunds and cancellations
in all languages in which training is offered. The refund and cancellation
policy must be made available to students prior to payment of fees and shall
include the cancellation procedures;
(2)
shall employ a mold training manager who:
(A)
meets at least one of the following requirements:
(i)
at least two years of experience, education, or training
in teaching workers or adults;
(ii)
a bachelor's or graduate degree in building construction
technology, engineering, industrial hygiene, safety, public health, education,
or business administration or program management; or
(iii)
at least two years of experience in managing an occupational
health and safety training program specializing in environmental hazards;
and
(B)
has demonstrated experience, education, or training in
mold assessment or remediation, lead or asbestos abatement, occupational safety
and health, or industrial hygiene;
(3)
shall provide for each course a qualified principal instructor
who meets the requirements under §295.319 of this title; and
(4)
must develop and implement a plan to maintain and improve
the quality of the training program. This plan shall contain at least the
following elements:
(A)
procedures for periodic revision of training materials
and the course test to reflect innovations in the field; and
(B)
procedures for the training manager's annual review of
instructor competency.
(d)
Fees. The fees for mold training provider accreditation
are:
(1)
$500 for a one-year accreditation issued before January
1, 2006; and
(2)
$1,000 for a two-year accreditation issued on or after
January 1, 2005.
(e)
Applications and renewals. Applications shall be submitted
as required by §295.308(a) of this title (relating to Credentials: Applications
and Renewals). An applicant shall include:
(1)
for an initial accreditation, at least one complete application
for approval of a training course and at least one complete application for
approval of an instructor, as described under §295.319 of this title;
(2)
for a renewal accreditation, a list of all of the training
provider's courses and instructors currently approved by the department; and
(3)
a description of the training provider's organization,
including the address of its central office, the names and business addresses
of its principals, a statement of any affiliation with another mold-related
company doing business in Texas, and a listing of the courses to be offered.
The organization shall designate a staff member as the mold training manager
who meets the qualifications of subsection (c)(2) of this section.
(f)
Responsibilities. In addition to the requirements listed
in §295.306 of this title (relating to Credentials: General Responsibilities),
an accredited mold training provider shall be responsible for:
(1)
confirming, before enrolling a student in a refresher training
course, that the student has successfully completed a previous training course
in the same discipline within 24 months;
(2)
maintaining the hands-on skills assessment to ensure that
it accurately evaluates student performance of the work practices and procedures
associated with the course topics contained in §295.320 of this title
(relating to Training: Required Mold Training Courses);
(3)
maintaining the validity and integrity of the course test
to ensure that it accurately evaluates the student's knowledge and retention
of the course topics;
(4)
furnishing appropriate equipment in good working order
and in sufficient quantities for each training session in which equipment
is required;
(5)
presenting to students all course information and material
approved by the department;
(6)
at the conclusion of each training course, providing to
each student who successfully completes the course and passes the required
test:
(A)
a course-completion certificate as described in §295.319(c)(8)
of this title;
(B)
a wallet-size photo-identification card, indicating the
course completed, the effective date, and a number identifier for the student;
(C)
a current one-inch square photo of the student's face on
a white background taken during the course to be attached by the student to
an application for licensing or registration; and
(D)
a copy of the application and schedule for the state licensing
examination;
(7)
submitting to the department, within 10 working days of
the completion date of each course:
(A)
the names and number identifiers of each student who attended
the course, on a form provided by the department;
(B)
individual one-inch square photos of the face of each student
on a white background taken during the course; and
(C)
a group photo taken at the end of the course that identifies
which students did and did not pass the course. Digital or scanned images
will be accepted. The group photograph must be no smaller than a standard
3 1/2-inch by 4 1/4-inch print;
(8)
documenting that each person who receives a certificate
has successfully completed an initial course in accordance with §295.320
of this title (relating to Training: Required Mold Training Courses) and has
achieved a passing score on the written test. The training provider must maintain
a file for each course that includes the training course name, dates and discipline,
a copy of the course test and each student's name and graded answer sheet,
the date and location where the test was administered, the name of the test
proctor, the names of students receiving certificates, the certificate numbers,
and the expiration date of the training. All information from the training
course and test must correspond to the information on each person's course-completion
certificate. All records under this section shall be available for inspection
by the department immediately upon conclusion of the course and the test;
and
(9)
complying with all requirements under §295.320(d)
of this title if the company provides training to individuals seeking registration
as mold remediation workers and maintaining copies of the required training
documents at a central location at its Texas office.
(g)
Inspections and audits. Training providers shall permit
department representatives to attend, evaluate, and monitor any training course,
without charge or advance notice, to ensure compliance with this subchapter.
The following criteria are grounds for suspending or withdrawing training
provider accreditations or instructor approvals under §295.330 of this
title (relating to Compliance: Reprimand, Suspension, Revocation, Probation)
or for assessing administrative penalties under §295.331 of this title
(relating to Compliance: Administrative Penalty):
(1)
failure to adhere to the training standards and requirements
of this subchapter;
(2)
misrepresentation of the extent of approval of a training
course or instructor;
(3)
falsification of records or submitting false information
to the department;
(4)
failure to submit required information in a timely manner;
or
(5)
failure to comply with these regulations in a manner that
demonstrates a lack of ability, capacity or fitness to perform training duties
and responsibilities.
§295.319.Training: Approval Of Training Courses and Instructors.
(a)
General provisions. The department must approve all training
courses and instructors in advance of the course being offered except as provided
under §295.318(b)(1) of this title (relating to Mold Training Provider:
Accreditation). Applications for approval of courses or instructors submitted
with an application for initial accreditation under §295.318 of this
title will be reviewed at the same time for no additional approval fee. Each
application for course or instructor approval must be made on a separate application
form.
(b)
Fees. The application fee for approval of each initial
or refresher training course is $100 per mold training course, except as provided
in subsection (a) of this section. There is no separate application fee for
approval of an instructor.
(c)
Application for course approval. An application must be
submitted to the department in writing. Within 30 working days after receiving
an application, the department shall acknowledge receipt of the application
and notify the applicant of any deficiency in the application. The department
will approve or deny the application upon receipt of the complete application.
A complete application for training course approval shall include:
(1)
the training program provider's name, business address
and telephone number;
(2)
the discipline and type of course (initial or refresher)
for which approval is being sought, including the course length in training
hours;
(3)
a detailed outline of each course curriculum including
the specific topics taught, the amount of time allotted to each topic, the
amount and type of hands-on training, and the name(s) and qualifications of
the individual(s) teaching the instruction program for each topic;
(4)
a description of the facilities and equipment available
for lecture and hands-on training;
(5)
a copy of the course test blueprint (written documentation
of the proportion of test questions devoted to each major topic in the course);
(6)
a copy of all course materials (student manuals, instructor
notebooks, handouts, and other course-related materials) in all languages
taught;
(7)
the names and qualifications of all course instructors.
Instructors must meet the requirements under subsection (e) of this section;
and
(8)
a description and example of the photo identification cards
and course certificates to be issued to students. Each certificate must have
a unique certificate number and must include:
(A)
the school's name, address, and telephone number;
(B)
the student's name;
(C)
a statement that the student successfully completed the
course and the name and dates of the training course completed;
(D)
an expiration date two years after the date of course completion;
(E)
the signature of the course instructor; and
(F)
the signature of the course director or the principal officer,
owner, or chief executive officer of the training provider.
(d)
Changes to training courses. An accredited training provider
must receive department approval for changes to any of the items in subsections
(c)(2)-(9) of this section. Accredited training providers must submit requests
in writing and shall not offer training courses incorporating any changes
until the department has granted approval.
(e)
Application for instructor approval. Only state-approved
instructors are permitted to provide instruction in courses required under
this subchapter, except that guest speakers are permitted to provide limited
instruction as provided under subsection (f) of this section. A training provider
shall submit for approval a resume or other documentation to show the qualifications
of each instructor conducting mold training courses. The department must approve
all instructors before they are permitted to provide instruction. The training
provider will notify the department of additions and deletions to its instructor
roster within 15 working days of actual occurrence. Department approval of
an instructor or a guest speaker for a discipline applies to that discipline
only and does not convey approval for any other disciplines.
(1)
Instructor qualifications. Instructors shall be qualified
in at least one of the categories in subparagraphs (A)-(D) of this paragraph.
Instructor qualifications must be fully documented and verifiable by the department.
The categories include:
(A)
at least two years of actual hands-on experience in mold-related
activities for the subject that the instructor will teach, and a high school
diploma and completion of at least one teacher education course in vocational
or industrial teaching;
(B)
graduation from an accredited college or university with
a bachelor's degree or advanced degree in natural or physical sciences or
a related field, with one year's hands-on experience in mold-related activities;
(C)
at least three years teaching experience and completion
of one or more teacher education courses in vocational or industrial teaching
from an accredited two or four year college; or
(D)
a vocational teacher with certification from the Texas
Education Agency with one year's hands-on experience in mold-related activities.
(2)
Instructor training. Each instructor shall meet the training
requirements under §295.305(e)(1)-(2) of this title (relating to Credentials:
General Conditions) for each discipline in which the instructor seeks department
approval to teach. Instructors are not required to be separately licensed
or registered.
(3)
Professional references. Each instructor application shall
include three professional references attesting to teaching experience and
mold-related qualifications of the applicant. No more than two references
will be accepted from an applicant's current company. References must be submitted
on a form provided by the department and must be mailed directly to the department
by the author.
(4)
Complete applications. The department shall consider only
complete applications for instructor approval including sufficient, verifiable
references.
(f)
Guest speakers. Training providers may utilize guest speakers
to present training who have documentable and verifiable professional expertise
on the subject about which they are speaking. Training providers are not required
to obtain department approval for guest speakers but must maintain proof of
each guest speaker's qualifications as described under §295.326 of this
title (relating to Recordkeeping).
(g)
Suspension and revocation of approval. The following criteria
are grounds for suspending or withdrawing approval from a training course
or instructor under §295.330 of this title (relating to Compliance: Reprimand,
Suspension, Revocation, Probation):
(1)
failure of an instructor or guest speaker to adhere to
the standards and requirements of this subchapter;
(2)
failure of a training course, instructor, or guest speaker
to provide training that meets the requirements of the department or this
subchapter;
(3)
falsification or misrepresentation by an instructor of
his/her qualifications;
(4)
submittal by an accredited training provider to the department
of false information for training course or instructor approval;
(5)
misrepresentation by an accredited training provider of
the extent of a department approved training course or instructor; and
(6)
violation by an approved training course instructor or
a guest speaker of other mold-related activity regulations in a manner that
indicates a lack of ability, capacity or fitness to perform training duties
and responsibilities.
§295.320.Training: Required Mold Training Courses.
(a)
General provisions. Individual applicants for licensing
or renewal must submit evidence acceptable to the department of fulfillment
of specific training requirements.
(b)
Assessment technician training. The assessment technician
course shall consist of at least 24 training hours that includes lectures,
demonstrations, audio-visuals and hands-on training, course review, and a
written test of 100 multiple-choice questions. The course requirements in
paragraphs (3), (5)-(8), and (10) of this subsection require hands-on training
as an integral part of the course. The assessment technician course shall
include:
(1)
sources of indoor mold and conditions necessary for indoor
mold growth;
(2)
potential health effects;
(3)
workplace hazards and safety, including personal protective
equipment, and respirators;
(4)
technical and legal considerations for mold assessment,
including applicable regulatory requirements, the role of the mold assessment
technician, and the roles of other professionals (including an assessment
consultant);
(5)
performance of visual inspections where mold might be present
and determining sources of moisture problems, including exterior spaces (including
crawlspaces and attics), interior components (including windows, plumbing,
walls, and ceilings) and heating, ventilation, and air-conditioning (HVAC)
systems (including return air and supply ducts);
(6)
utilization of physical measurement equipment and tools,
including moisture meters, humidity meters, particle counters, data-logging
equipment, and visual and robotic inspection equipment;
(7)
biological sampling strategies and methodologies, including
sampling locations and techniques, and minimizing cross-contamination;
(8)
sampling methodologies, including bulk, surface (including
tape, swab, and vacuum sampling), and air sampling (including the differences
between culturable and particulate sampling, sampling times, calibrating pumps,
selecting media for culturable samples, and sampling for fungal volatile organic
compounds);
(9)
state-of-the-art work practices and new technologies;
(10)
proper documentation for reports, including field notes,
measurement data, photographs, structural diagrams, and chain-of-custody forms;
(11)
an overview of mold remediation projects and requirements,
including containment and air filtration; and
(12)
clearance testing and procedures, including review of
mold remediation protocols, work plans, visual inspections, and sampling strategies.
(c)
Assessment consultant training. The assessment consultant
course shall consist of at least 40 training hours that includes lectures,
demonstrations, audio-visuals and hands-on training, course review, and a
written test of 100 multiple-choice questions. The assessment consultant course
shall include:
(1)
all topics listed under subsection (b) of this section,
including appropriate hands-on activities;
(2)
workplace safety, including development of respiratory
protection plans and programs, workplace safety plans, and medical surveillance
programs;
(3)
technical and legal considerations for mold assessment,
including applicable regulatory requirements, the role of the assessment consultant,
the roles of other professionals, recordkeeping and notification requirements,
insurance, and legal liabilities;
(4)
an overview of building construction, building sciences,
moisture control, and water intrusion events;
(5)
prevention of indoor air quality problems, including avoiding
design and construction defects and improving maintenance and housekeeping;
(6)
basics of HVAC systems and their relationship to indoor
air quality (including pyschrometrics, filtration, ventilation and humidity
control), HVAC inspection and assessment, and remediation of HVAC systems;
(7)
survey protocols for effective assessment, covering the
areas described under subsection (b)(5)-(8) of this section;
(8)
interpretation of data and sampling results;
(9)
interviewing building occupants, minimum requirements for
questionnaires, and interpreting results;
(10)
writing mold management plans and mold remediation protocols,
including format and contents (including structural components, HVAC systems,
and building contents), defining affected areas (including floor plans), identifying
and repairing moisture sources and their causes, developing a scope of work
analysis, specifying containment and air filtration strategies, determining
post-remediation assessment criteria, and clearance criteria;
(11)
post-remediation clearance testing and procedures, including
review of mold remediation plans, visual inspections, sampling strategies,
and quality assurance; and
(12)
case studies.
(d)
Remediation worker training. Remediation worker training
shall consist of at least four training hours that includes lectures, demonstrations,
audio-visuals, and hands-on training. The training shall include all course
information and material required under this subsection. An individual must
successfully complete worker training and submit an application for registration
as a mold remediation worker prior to performing any work on a mold remediation
project.
(1)
The training must be provided by either:
(A)
the licensed mold remediation contractor or company employing
the individual receiving the training; or
(B)
a mold training provider accredited by the department.
(2)
The principal instructor for the training must be either:
(A)
a licensed mold remediation contractor; or
(B)
an individual who is approved by the department under §295.319
of this title to teach mold-related courses.
(3)
The training shall adequately address the following areas
and shall include hands-on training in the areas described in subparagraphs
(C) and (E)-(F) of this paragraph:
(A)
sources of indoor mold and conditions necessary for indoor
mold growth;
(B)
potential health effects and symptoms from mold exposure;
(C)
workplace hazards and safety, personal protective equipment
including respirators, personal hygiene, personal decontamination, confined
spaces, and water, structural, and electrical hazards;
(D)
technical and legal considerations for mold remediation,
including applicable regulatory requirements, the role of the worker, and
the roles of other professionals;
(E)
an overview of how mold remediation projects are conducted,
including containment and air filtration; and
(F)
work practices for removing, cleaning, and treating mold.
(4)
The person providing the training shall submit to the department,
within five working days of a training session:
(A)
the following items, on a form provided by the department:
(i)
the name, address, telephone number, and license number
of the person listed under paragraph (1) of this subsection who provided the
training;
(ii)
the date of the training;
(iii)
the printed name, address, telephone number, number identifier,
and signature of each individual who attended the training; and
(iv)
the printed name and signature of the principal instructor;
(B)
a group photo, taken at the end of the training, that identifies
each individual who attended the training. Digital or scanned images will
be accepted. The group photograph must be no smaller than a standard 3 1/2-inch
by 4 1/4-inch print; and
(C)
a statement indicating which individuals successfully completed
the training and which individuals did not.
(5)
The person providing the training shall provide the following
to each individual who successfully completes the training:
(A)
a training certificate. Each certificate must include:
(i)
the name, address, telephone number, and license number
of the person listed under paragraph (1) of this subsection who provided the
training;
(ii)
the date of the training;
(iii)
the name, address, telephone number and number identifier
of the individual;
(iv)
the printed name and signature of the principal instructor;
and
(v)
a statement that the individual successfully completed
the training;
(B)
a current one-inch square photo of the individual's face
on a white background, taken during the course, to be attached by the individual
to an application for registration; and
(C)
a copy of the registration application.
(6)
The person providing the training must maintain a file
for each training session that includes the date, the certificate numbers,
and the names, addresses, and telephone numbers of students receiving training
certificates. All information from the training must correspond to the information
on each certificate.
(e)
Remediation contractor training. The remediation contractor
course shall consist of at least 40 training hours that includes lectures,
demonstrations, audio-visuals and hands-on training, course review, and a
written test of 100 multiple-choice questions. The course requirements in
paragraphs (3) and (7)-(8) of this subsection require hands-on training as
an integral part of the training. The course shall adequately address:
(1)
sources of indoor mold and conditions necessary for indoor
mold growth;
(2)
potential health effects;
(3)
workplace hazards and safety, personal protective equipment
including respirators, personal hygiene, personal decontamination, confined
spaces, and water, structural, and electrical hazards;
(4)
worker protection, including development of respiratory
protection plans and programs, workplace safety plans, and medical surveillance
programs;
(5)
technical and legal considerations for mold remediation,
including applicable regulatory requirements, the role of the mold remediation
contractor, the role of the mold remediation worker, the roles of other professionals,
insurance, legal liabilities, and recordkeeping and notification requirements;
(6)
building sciences, moisture control, and water intrusion
events;
(7)
an overview of how mold remediation projects are conducted
and requirements thereof, including containment, and air filtration;
(8)
work practices for removing, cleaning, and treating mold,
including state-of-the-art work practices and new technologies;
(9)
development of a mold remediation work plan from a protocol,
including writing the work plan, detailing remediation techniques for the
building structure, HVAC system, and contents, delineating affected areas
from floor plans, developing appropriate containment designs, determining
HEPA air filtration requirements, and determining dehumidification requirements;
(10)
clearance testing and procedures, including a review of
typical clearance criteria, visual inspection of the work area prior to clearance,
and achieving clearance;
(11)
contract specifications, including estimating job costs
from a protocol and determining insurance and liability issues; and
(12)
protecting the public and building occupants from mold
exposures.
(f)
Refresher training. The refresher courses for mold assessment
technicians, mold assessment consultants, and mold remediation contractors
shall be at least eight training hours in length. Refresher training for mold
remediation workers shall be at least four training hours in length and shall
be provided by a person specified under subsection (d)(1) of this section.
Refresher training shall include a review of state regulations, state-of-the-art
developments, and key aspects of the initial training course. All disciplines
shall receive refresher training every two years.
(g)
Course tests. Each training provider shall administer a
closed-book written test consisting of 100 multiple-choice questions to students
who have completed an initial or refresher training course, except that no
examination is required of students in remediation worker training. Training
providers may include demonstration testing as part of the test. A student
must answer correctly at least 70% of the questions to receive a course-completion
certificate. Training providers shall use tests provided or approved by the
department.
§295.321.Minimum Work Practices and Procedures for Mold Assessment.
(a)
Purpose. The purpose of a mold assessment is to determine
the sources, locations and extent of mold growth in a building, to determine
the condition(s) that caused the mold growth, and to enable the consultant
to prepare a mold remediation protocol.
(b)
Building occupants. A mold assessment consultant shall
consider whether to recommend to a client that, before remediation begins,
the client should inform building occupants of mold-related activities that
will disturb or will have the potential to disturb areas of mold contamination.
(c)
Sampling and data collection. If samples for laboratory
analysis are collected during the assessment:
(1)
sampling must be performed according to nationally accepted
methods;
(2)
preservation methods shall be implemented for all samples
where necessary;
(3)
proper sample documentation, including the sampling method,
the sample identification code, each location and material sampled, the date
collected, the name of the person who collected the samples, and the project
name or number must be recorded for each sample;
(4)
proper chain of custody procedures must be used; and
(5)
samples must be analyzed by a laboratory licensed under §295.317
of this title (relating to Mold Analysis Laboratory: Licensing Requirements).
(d)
Mold remediation protocol. An assessment consultant shall
prepare a mold remediation protocol for each project and provide the protocol
to the client before the remediation begins. The mold remediation protocol
must specify:
(1)
the rooms or areas where the work will be performed;
(2)
the estimated quantities of materials to be cleaned or
removed;
(3)
the proposed methods for each type of remediation in each
type of area;
(4)
the proposed types of containment to be used during the
project in each type of area; and
(5)
the proposed clearance procedures and criteria for each
type of remediation in each type of area.
§295.322.Minimum Work Practices and Procedures for Mold Remediation.
(a)
Scope. These general work practices are minimum requirements
and do not constitute complete or sufficient specifications for a mold remediation
project. More detailed requirements developed by a remediation contractor
for a particular project shall take precedence over the provisions of this
section.
(b)
Remediation work plan. A remediation contractor shall prepare
a mold remediation work plan based on a mold remediation protocol and shall
provide the mold remediation work plan to the client before the mold remediation
begins.
(c)
Personal protective equipment (PPE) requirements. An employer
shall provide PPE, including respirators, to all employees who engage in remediation
activities who will, or are anticipated to, disturb or remove mold contamination.
Each employee who is provided PPE must receive training on the appropriate
use and care of the provided PPE. The employer must document successful completion
of the training before the employee performs regulated activities.
(1)
When the mold affects a total surface area of 25 to 100
contiguous square feet for the project, the required minimum PPE is an N-95
respirator, gloves, and goggles/eye protection.
(2)
When the mold affects a total surface area of more than
100 contiguous square feet, the required minimum PPE is a full-face respirator
with high-efficiency particulate air (HEPA) filter, gloves, disposable full
body clothing, headgear, and foot coverings.
(d)
Containment requirements. Containment must be used on a
mold remediation project when the mold affects a total surface area of 25
contiguous square feet or more for the project. Containment is not required
if no person who is not licensed or registered under this subchapter occupies
the building in which the remediation takes place at any time between the
start date and stop date for the project as specified on the notification
required under §295.325 of this subchapter (relating to Notifications).
The containment, when constructed as described in the remediation work plan
and under normal conditions of use, must prevent the spread of mold to areas
outside the containment. If walk-in containment is used, supply and return
air vents must be blocked, and air pressure within the walk-in containment
must be lower than the pressure in building areas adjacent to the containment.
(e)
Warning signs. Warning signs advising that a mold remediation
project is in progress shall be displayed at all entrances to remediation
areas adjacent to occupied areas of a building.
(f)
Removal of containment. No person shall remove or dismantle
any walk-in containment structures or materials from a project site prior
to receipt by the licensed mold remediation contractor or remediation company
overseeing the project of a written notice from a licensed mold assessment
consultant that the project has achieved clearance as described under §295.324
of this title (relating to Post-Remediation Assessment and Clearance).
(g)
Biocides. Biocides may be used only if they are registered
by the United States Environmental Protection Agency (EPA) for the intended
use and if the use is consistent with the manufacturer's labeling instructions.
A person who applies a biocide to wood to control a wood-infesting organism
must be licensed by the Texas Structural Pest Control Board as provided under
the Texas Occupations Code, Chapter 1951 (relating to Structural Pest Control)
unless exempt under the Texas Occupations Code, Chapter 1951, Subchapter B
(relating to Exemptions).
(h)
Anti-microbial agents. Anti-microbial agents may be used
only if they are registered by the EPA for the intended use and if the use
is consistent with the manufacturer's labeling instructions. A decision by
a consultant or contractor to use such products must take into account the
potential for occupant sensitivities and possible adverse reactions to chemicals
that have the potential to be off-gassed from surfaces coated with such products.
§295.323.Mold Remediation of Heating, Ventilation and Air Conditioning (HVAC) Systems.
(a)
Disinfectants, biocides and antimicrobial coatings. A licensee
under this subchapter may apply a disinfectant, biocide or antimicrobial coating
in an HVAC system only if it is registered by the EPA for the intended use
and if the use is consistent with the manufacturer's labeling instructions.
The licensee shall apply the product only after the building owner or manager
has been provided a material safety data sheet for the product, has agreed
to the application, and has notified building occupants prior to the application.
The licensee shall follow all manufacturer's label directions when using the
product.
(b)
Other license requirements. Persons who perform air conditioning
and refrigeration contracting (including the repair, maintenance, service,
or modification of equipment or a product in an environmental air conditioning
system, a commercial refrigeration system, or a process cooling or heating
system) must be licensed by the Texas Department of Licensing and Registration,
as provided under the Texas Occupations Code, Chapter 1302 (relating to Air
Conditioning and Refrigeration Contractors). A person who performs biomedical
remediation as defined under 16 TAC, §75.10(5) (relating to Definitions)
must be licensed by the Texas Department of Licensing and Regulation in accordance
with 16 TAC, Chapter 75 (relating to Air Conditioning and Refrigeration Contractor
License Law) unless exempt under 16 TAC, §75.30 (relating to Exemptions)
or 16 TAC, §75.100 (relating to Technical Requirements).
§295.324.Post-Remediation Assessment and Clearance.
(a)
Clearance criteria. For a remediation project to achieve
clearance, a licensed mold assessment consultant shall conduct a post-remediation
assessment to determine that:
(1)
the work area is free from all visible mold and wood rot;
and
(2)
all work has been completed in compliance with the remediation
protocol and remediation work plan and meets clearance criteria specified
in the protocol.
(b)
Moisture sources. Post-remediation assessment shall, to
the extent feasible, verify that all moisture sources previously identified
as causes of the mold that necessitated the remediation project have been
corrected.
(c)
Sampling within containment. If walk-in containment is
used at a project site, the post-remediation assessment shall be conducted
while the walk-in containment is in place. Any air filtration equipment must
be deactivated for at least four hours prior to the post-remediation assessment.
(d)
Analytical methods. The assessment consultant shall either
use direct microscopic examination or shall use a swab, a tape lift, or an
equivalent methodology to collect one representative sample within each remediated
area in order to determine whether the remediation project passes clearance.
Where visual inspection reveals visible mold, or other deficiencies sufficient
to fail clearance, analytical sampling need not be conducted. For an acceptable
clearance, the fungal structures (including hyphae and conidia) and spores
present in a sample shall not exceed 30 counts per square inch of surface
sampled.
(1)
If all remediated material has been removed from a project
or containment area and is not available to sample, an adjacent area shall
be examined or sampled to confirm that contamination was not spread during
the remediation.
(2)
If direct microscopic examination is used, the consultant
shall retain in the project file, for each field counted, a printed copy of
a photograph of the field and a record of the area of the field, to confirm
that the total number of fungal structures and spores counted for a sample
did not exceed 30. Digital photographs are acceptable for purposes of this
paragraph.
(e)
Passed clearance report. An assessment consultant who determines
that remediation has been successful shall issue a written passed clearance
report to the client at the conclusion of each mold remediation project. The
report must include the following:
(1)
a description of relevant worksite observations;
(2)
all data collected at the worksite including temperature,
humidity, and material moisture readings;
(3)
the type, location, and results of samples collected;
(4)
copies of all photographs the consultant took, including
copies of photographs from any direct microscopic examinations; and
(5)
a clear statement that clearance has been achieved.
(f)
Final status report. If the mold assessment consultant
determines that remediation has not been successful and ceases to be involved
with the project before the project achieves clearance, the consultant shall
issue a written final status report to the client and to the remediation contractor
or company performing the project. The status report must include the items
listed in subsection (e)(1)-(4) of this section and any conclusions that the
consultant has drawn.
§295.325.Notifications.
(a)
General provision. A contractor or company shall notify
the department of a mold remediation project when mold contamination affects
a total surface area of 25 contiguous square feet or more. Notification shall
be received by the department no less than five working days (not calendar
days) prior to the anticipated start date of the activity and shall be submitted
by United States Postal Service, commercial delivery service, hand-delivery,
electronic mail (E-mail), or facsimile on a form specified by the department.
The form must be filled out completely and properly. Blanks that do not apply
shall be marked "N/A". The designation of "N/A" will not be accepted for identification
of the work site, building description, building owner, individuals required
to be identified on the notification form, or start and stop dates. A signature
of the responsible person is required on each notification form. The contractor
or company shall retain a confirmation that the notification was received
by the department.
(b)
Start-date change to later date. When mold remediation
activity begins later than the date contained in the notice, the department
shall be notified by telephone as soon as possible but prior to the original
start date. A written amended notification is required immediately following
the telephone notification and shall be faxed or overnight mailed to the department.
(c)
Start-date change to earlier date. When mold remediation
activities begin on a date earlier than the date contained in the notice,
the department shall be provided with written notice of the new start date
at least five working days before the start of work unless the provisions
of subsection (e) of this section apply. The licensee shall confirm that the
notice is received five working days before the start of work.
(d)
Start-date/stop-date (completion date) requirement. In
no event shall mold remediation begin or be completed on a date other than
the date contained in the written notice except for operations covered under
subsection (e) of this section. Amendments to start date changes must be submitted
as required in subsections (b) and (c) of this section. An amendment is required
for any stop dates that change by more than one workday for each week (seven
calendar day period). The contractor or company shall provide schedule changes
to the department no less than 24 hours prior to the new stop date. Changes
less than five days in advance shall be confirmed with the appropriate department
regional office by telephone, facsimile, or e-mail and followed up in writing
to the department's central office at 1100 West 49th Street, Austin, Texas,
78756.
(e)
Provision for emergency. In an emergency, notification
to the department shall be made as soon as practicable but not later than
the following business day after the license holder identifies the emergency.
Initial notification shall be made to the department's central office either
immediately by telephone, followed by formal notification on the department's
notification form, or immediately by facsimile on the department's notification
form. The contractor or company shall retain a confirmation that the notification
was received by the department. Emergencies shall be documented. An emergency
exists if a delay in mold remediation services in response to a water damage
occurrence would increase mold contamination.
(f)
Notification fees.
(1)
The contractor or company shall remit to the department
a fee of $100 for each initial notification of a mold remediation project.
Amendments to a notification shall not require a separate fee.
(2)
The department shall send an invoice for the required fee
to the contractor or company after the department has received the notification.
Payment must be remitted in the manner instructed on the invoice no later
than 60 working days following the date on the notification invoice. Failure
to pay the required fee after an invoice has been sent is a violation, and
the department may seek administrative penalties as listed in §295.331
of this title (relating to Compliance: Administrative Penalty).
§295.326.Recordkeeping.
(a)
Record retention. Records and documents required by this
section shall be retained for a period of three years from the date of project
completion unless otherwise stated. Such records and documents shall be made
available for inspection by the department or any law enforcement agency immediately
upon request. Licensees and accredited training providers who cease to do
business shall notify the department in writing 30 days prior to such event
to advise how they will maintain all records during the minimum three-year
retention period. The department, upon receipt of such notification and at
its option, may provide instructions for how the records shall be maintained
during the required retention period. A licensee or accredited person shall
notify the department that it has complied with the department's instructions
within 30 days of their receipt or make other arrangements approved by the
department. Failure to comply may result in disciplinary action against individual
licensees.
(b)
Mold remediation companies and contractors. A licensed
mold remediation company shall maintain the records listed in paragraphs (1)
and (2) of this subsection for each mold remediation project performed by
the company and the records listed in paragraph (3) of this subsection for
each remediation worker training session provided by the company. A licensed
mold remediation contractor not employed by a company shall personally maintain
the records listed in paragraphs (1) and (2) of this subsection for each mold
remediation project performed by the contractor and the records listed in
paragraph (3) of this subsection for each remediation worker training session
provided by the contractor.
(1)
A licensed mold remediation contractor shall maintain the
following records and documents on-site at a project for its duration:
(A)
a current copy of the mold remediation work plan and all
mold remediation protocols used in the preparation of the work plan; and
(B)
a listing of the names and license/registration numbers
of all individuals working on the remediation project.
(2)
A licensed mold remediation company shall maintain the
following records and documents at a central location at its Texas office
for three years following the stop date of each project that the company performs.
A licensed mold remediation contractor not employed by a company shall maintain
the following records and documents at a central location at his or her Texas
office for three years following the stop date of each project that the contractor
performs:
(A)
all records and documents listed in paragraph (1) of this
subsection;
(B)
photographs of the scene of the mold remediation taken
before and after the remediation;
(C)
the written contract between the mold remediation company
or remediation contractor and the client, and any written contracts related
to the mold remediation project between the company or contractor and any
other party;
(D)
all invoices issued regarding the mold remediation;
(E)
copies of all regulatory agency correspondence concerning
a mold-related activity, including letters, notices, citations received and
notifications; and
(F)
copies of all certificates of mold remediation issued by
the company or contractor.
(3)
A licensed mold remediation contractor or remediation company
who trains employees to meet the requirements under §295.320(d) of this
title (relating to Training: Required Mold Training Courses) shall maintain
copies of the required training documents at a central location at its Texas
office.
(c)
Mold assessment companies and consultants.
(1)
A licensed mold assessment company shall maintain the following
records and documents at a central location at its Texas office for the time
period required under paragraph (2) of this subsection for each project that
the company performs. A licensed mold assessment consultant not employed by
a company shall maintain the following records and documents at a central
location at his or her Texas office for the time period required under paragraph
(2) of this subsection for each project that the contractor performs:
(A)
the name and mold certificate number of each of its employees
who worked on the project and a description of each employee's involvement
with the project;
(B)
the written contract between the mold assessment company
or consultant and the client;
(C)
all invoices issued regarding the mold assessment;
(D)
copies of all regulatory agency correspondence concerning
a mold-related activity, including letters, notices, and citations received;
(E)
copies of all laboratory reports and sample analyses;
(F)
Copies of all photographs required under §295.324
of this title (relating to Post-Remediation Assessment and Clearance);
(G)
copies of all mold assessment reports, mold management
plans, and protocols and changes prepared as a result of mold assessment activities;
(H)
copies of all final status reports issued by the company
or consultant;
(I)
copies of all passed clearance reports issued by the company
or consultant; and
(J)
copies of any signed certificates of mold remediation provided
to a mold remediation company or contractor by the mold assessment company
or consultant.
(2)
For each project, a licensed mold assessment company or
consultant shall maintain all the records listed in paragraph (1) of this
subsection for:
(A)
three years from the date of the mold assessment report,
management plan, or remediation protocol, if the company or consultant performs
only the initial assessment for the project;
(B)
three years from the date of the final status report, if
a final status report is issued; or
(C)
three years from the date on the signed certificate of
mold remediation, if a certificate of mold remediation is signed.
(d)
Mold analysis laboratories. A licensed mold analysis laboratory
shall maintain copies of the results, including the sample identification
number, of all analyses performed as part of a mold assessment or mold remediation
for three years from the date of the sample analysis.
(e)
Training providers. Accredited training providers shall
comply with the following record-keeping requirements. The training provider
shall maintain the records in a manner that allows verification of the required
information.
(1)
Training course materials. An accredited training provider
must retain one copy of each instructional aid used in classroom training,
including student manuals, instructor notebooks and handouts for three years
from the date last used.
(2)
Training records. The training provider shall maintain
records for at least three years from the date of the class in accordance
with §295.318(f)(8) and (9) of this title (relating to Mold Training
Provider: Accreditation).
(3)
Courses, instructors and guest speakers. An accredited
training provider must retain for at least three years copies of resumes or
other documentation to prove the qualifications of all instructors and guest
speakers and the course and instructor approval documents issued by the department.
Records must accurately identify the instructors and guest speakers that taught
each particular course for each date that a course is offered together with
the course student roster.
§295.327.Photographs; Certificate of Mold Remediation; Duty of Property Owner.
(a)
Not later than one week after completion of a mold remediation
project, the licensed mold remediation contractor or company shall provide
the property owner with copies of required photographs of the scene of the
mold remediation taken before and after the remediation.
(b)
Not later than the 10th day after the project stop date,
the licensed mold remediation contractor or company shall provide a certificate
of mold remediation to the property owner on a form adopted by the Texas Commissioner
of Insurance. The certificate must include the following:
(1)
a statement by a licensed mold assessment consultant (not
the licensed mold remediator) that based on visual, procedural, and analytical
evaluation, the mold contamination identified for the project has been remediated
as outlined in the mold remediation protocol; and
(2)
a statement on the certificate that the underlying cause
of the mold has been remediated, if the licensed mold assessment consultant
determines that the underlying cause of the mold has been remediated so that
it is reasonably certain that the mold will not return from that same cause.
(c)
Copies of the completed certificate shall be retained in
the business files of the assessment consultant/company and the remediation
contractor/company.
(d)
If a property owner sells the property, the property owner
shall provide to the buyer a copy of each remediation certificate that has
been issued for the property under this section.
§295.328.Complaints.
A person who believes that any provision of the Act or this subchapter
has been violated may file a written complaint with the department. The department
shall conduct an investigation, including for an anonymous complaint if the
complainant provides sufficient information.
§295.329.Compliance: Inspections and Investigations.
(a)
The department may inspect or investigate the business
practices of any persons involved with mold-related activity for compliance
with this subchapter.
(b)
A department representative, upon presenting a department
identification card, shall have the right to enter at all reasonable times
any area or environment, including but not limited to any containment area,
building, construction site, storage or office area, or vehicle to review
records, to question any person, or to locate, identify, or assess areas of
mold growth for the purpose of inspection and investigation for compliance
with this subchapter.
(c)
A department representative in pursuance of official duties
is not required to notify or seek permission to conduct inspections or investigations.
It is a violation for any person to interfere with, deny, or delay an inspection
or investigation conducted by a department representative. A department representative
shall not be impeded or refused entry in the course of official duties by
reason of any regulatory or contractual specification.
§295.330.Compliance: Reprimand, Suspension, Revocation, Probation.
(a)
After notice of the opportunity for a hearing in accordance
with subsection (d) of this section, the department may take any of the disciplinary
actions outlined in subsection (c) of this section. If the department suspends
a credential on an emergency basis, the department shall provide an opportunity
for a hearing in accordance with subsection (d) of this section within 20
days.
(b)
A person who is denied a credential for failure to meet
the qualifications under this subchapter is ineligible to reapply until all
qualifications are met. A suspension shall be for a period of not more than
two years. A person whose application or credential has been revoked shall
be ineligible to reapply for any mold-related credential for up to three years.
(c)
The department may issue an administrative penalty as described
in §295.331 of this title (relating to Compliance: Administrative Penalty),
deny an application, suspend, suspend on an emergency basis, suspend with
probationary terms, or revoke a credential of a person who:
(1)
fails to comply with this subchapter;
(2)
has fraudulently or deceptively obtained or attempted to
obtain the credential, ID card or approval, including engaging in misconduct
or dishonesty during the state licensing examination, such as cheating or
having another person take or attempt to take the examination for that person;
(3)
duplicates or allows another person to duplicate a credential,
ID card or approval;
(4)
uses a credential issued to another person or allows any
other person to use a credential, ID card or approval not issued to that other
person;
(5)
falsifies records for mold-related activities that the
department requires the person to create, submit, or maintain;
(6)
is convicted of a felony or misdemeanor arising from mold-related
activity.
(d)
The contested-case hearing provisions of the Administrative
Procedure Act (Texas Government Code, Chapter 2001) and the formal hearing
procedures of the department in Chapter 1 of this title (relating to the Board
of Health) shall apply to any enforcement action under this section. A person
charged with a violation shall be notified of the alleged violation, the grounds
upon which any disciplinary action is based, the proposed penalty, and the
opportunity to request a hearing.
§295.331.Compliance: Administrative Penalty.
(a)
If a person violates the Act, this subchapter or an order,
the department may assess an administrative penalty.
(b)
The penalty shall not exceed $5,000 per violation except
as indicated. Each day a violation continues will be considered a separate
violation for violations listed in subsection (d)(1)(A)-(B) and (d)(2)(A)-(B)
of this section. The department may reduce or enhance penalties as warranted.
(c)
In assessing administrative penalties, including reductions
or enhancements, the department shall consider:
(1)
whether the violation was committed knowingly, intentionally,
or fraudulently;
(2)
the seriousness of the violation;
(3)
any hazard created to the public health and safety;
(4)
the person's history of previous violations; and
(5)
any other matter that justice may require, including demonstrated
good faith.
(d)
Violations shall be placed in one of the following severity
levels.
(1)
Critical violation. Severity Level I violations have or
may have a direct negative impact on public health and safety. This category
includes fraud and misrepresentation. The penalty for a Level I violation
may be up to $5,000 per violation. Violations listed in subparagraphs (A)
and (B) of this paragraph may be assessed at up to $5,000 per violation per
day. Examples include but are not limited to:
(A)
working without a valid credential, ID card or approval
or with a credential or ID card that has been expired for more than one month;
(B)
engaging in a conflict of interest as described in §295.307(a)(1)-(2)
of this title (relating to Conflict of Interest);
(C)
engaging in misconduct or dishonesty during the state licensing
examination;
(D)
submitting a forged or altered training certificate;
(E)
offering training required under this subchapter without
valid department approval of the course, instructor(s) or guest speaker(s);
and
(F)
providing training certificates for a course required by
the department to persons who have not successfully completed the course.
(2)
Serious violation. Severity Level II violations could compromise
public health and safety. The maximum penalty for Level II violations is $2,500
per violation. Violations listed in subparagraphs (A) and (B) of this paragraph
may be assessed at up to $2,500 per violation per day. Examples include but
are not limited to:
(A)
working with a credential or ID card that has been expired
for one month or less;
(B)
failing to disclose an ownership interest as required in §295.307(b)
of this title;
(C)
failing to submit a timely notification;
(D)
failure to conduct a training course as specified under §295.320
of this title (relating to Training: Required Mold Training Courses); and
(E)
failure of a credentialed person to maintain current required
training.
(3)
Significant violation. Severity Level III violations, while
not having a direct negative impact on health and safety, could lead to more
serious circumstances. The maximum penalty for Level III violations is $1,000
per violation. Examples include but are not limited to:
(A)
failure to provide the department Consumer Mold Information
Sheet as required under §295.306 of this title (relating to Credentials:
General Responsibilities);
(B)
failure to have a department-issued identification card
at a job site;
(C)
submitting an incorrect or improper notification;
(D)
failure of a training provider to submit information to
the department regarding training course schedules or to notify the department
of cancellations within the specified time periods;
(E)
failure of a training provider to submit course completion
information within the time period specified in §295.319(f)(7) of this
title (relating to Mold Training Provider: Accreditation);
(F)
failure of a remediation company, remediation contractor,
or training provider to submit worker training information within the time
period specified in §295.320(d) of this title (relating to Mold Training
Provider: Accreditation); and
(G)
failure of a training provider to maintain the required
trainee-instructor ratio in a training course.
§295.332.Compliance: Exception to the Administrative Penalty.
(a)
The commissioner may choose not to impose an administrative
penalty under §295.331 of this title (relating to Compliance: Administrative
Penalty) if, not later than the 10th day after the date on a written notice
of a violation as provided under §295.333 of this title (relating to
Compliance: Notice; Opportunity for Hearing; Order), the person charged with
the violation provides conclusive evidence satisfactory to the department
that the circumstances giving rise to the violation have been corrected and
all actual damages are paid.
(b)
This section does not apply to a violation alleged under:
(1)
the Texas Occupations Code, Chapter 1958, §1958.101
(relating to License Required; Rules);
(2)
§295.305(a)-(b) of this title (relating to Credentials:
General Conditions);
(3)
the Texas Occupations Code, Chapter 1958, §1958.155
(relating to Conflict of Interest; Disclosure Required); or
(4)
§295.307 of this title (relating to Conflict of Interest
and Disclosure Requirement).
§295.333.Compliance: Notice; Opportunity for Hearing; Order.
(a)
The commissioner shall impose an administrative penalty
under this subchapter only after a person is given written notice of the opportunity
for a hearing conducted in accordance with the Administrative Procedure Act
(Texas Government Code, Chapter 2001) and the department's formal hearing
procedures in Chapter 1 of this title (relating to the Board of Health).
(b)
The written notice of violation must state the facts that
constitute the alleged violation, the law or rule that has been violated,
the proposed penalty, and the opportunity for a hearing.
(c)
If a hearing is held, the commissioner shall make findings
of fact and issue a written decision as to the occurrence of the violation
and the amount of any penalty that is warranted.
(d)
If a person fails to exercise the opportunity for a hearing,
the commissioner, after determining that a violation occurred and the amount
of penalty warranted, is authorized to impose a penalty and issue an order
requiring the person to pay.
(e)
Not later than the 30th day after the date the commissioner
issues an order, the commissioner shall inform the person of the amount of
any penalty imposed.
(f)
The commissioner is authorized to consolidate a hearing
under this section with another proceeding.
§295.334.Compliance: Options Following Administrative Order.
(a)
Not later than the 30th day after the date the commissioner's
decision or order concerning an administrative penalty assessed under §295.331
of this title (relating to Compliance: Administrative Penalty) becomes final
as provided by the Texas Government Code, Chapter 2001, §2001.144, (relating
Decisions; When Final) to the person against whom the penalty is assessed
either shall pay the administrative penalty or shall file a petition for judicial
review.
(b)
A person who files a petition for judicial review can stay
enforcement of the penalty either by paying the penalty to the commissioner
for placement in an escrow account or by giving the commissioner a bond, in
a form approved by the commissioner, that is for the amount of the penalty
and that is effective until judicial review of the commissioner's decision
or order is final.
§295.335.Compliance: Collection of Administrative Penalty; Judicial Review.
(a)
At the request of the commissioner, the Texas Attorney
General is authorized to bring a civil action to recover an administrative
penalty imposed under §295.331 of this title (relating to Compliance:
Administrative Penalty).
(b)
Judicial review of a decision or order of the commissioner
imposing a penalty is instituted by filing a petition with a district court
in Travis County and is under the substantial evidence rule as provided by
the Texas Government Code, Chapter 2001, Subchapter G (relating to Contested
Cases: Judicial Review).
(c)
If, after judicial review, the administrative penalty is
reduced or is not upheld by the court, not later than the 30th day after the
date of the determination, the commissioner shall:
(1)
remit the appropriate amount, plus accrued interest, to
a person who paid the penalty as provided under §295.334 of this title
(relating to Compliance: Options Following Administrative Order); or
(2)
execute a release of a bond provided under §295.334(b)
of this title to the person who gave the bond.
§295.336.Compliance: Civil Penalty.
A person who violates the Act or this subchapter is liable for a civil
penalty in an amount not to exceed $2,000 for the first violation or $10,000
for a second or later violation. The commissioner may request the Texas Attorney
General or the district, county, or city attorney having jurisdiction to bring
an action to collect a civil penalty under this section.
§295.337.Compliance: Injunctive Relief.
The commissioner may request the Texas Attorney General or the district,
county, or city attorney having jurisdiction to bring an action for a restraining
order, injunction, or other relief the court determines is appropriate if
it appears to the department that a person is violating or has violated the
Act or this subchapter.
§295.338.Civil Liability Exemption for Certain Property Owners or Governmental Entities.
(a)
A property owner is not liable for damages related to mold
remediation on a property if a certificate of mold remediation has been issued
under §295.327 of this title (relating to Photographs; Certificate of
Mold Remediation; Duty of Property Owner) for that property and the damages
accrued on or before the date of the issuance of the certificate.
(b)
A person is not liable in a civil lawsuit for damages related
to a decision to allow occupancy of a property after mold remediation has
been performed on the property if a certificate of mold remediation has been
issued §295.327 of this title for the property, the property is owned
or occupied by a governmental entity, including a school, and the decision
was made by the owner, the occupier, or any person authorized by the owner
or occupier to make the decision.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the
Office of the Secretary of State on January 16, 2004.
TRD-200400344
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: February 29, 2004
For further information, please call: (512) 458-7236
Chapter 405.
CLIENT (PATIENT) CARE
Subchapter H. BEHAVIOR MANAGEMENT - FACILITIES SERVING PERSONS WITH MENTAL RETARDATION
Chapter 61.
CHRONIC DISEASES
diabetics
] to detect
retinopathy before vision is compromised. Unfortunately, many
people
[
persons
] with diabetes are not presently being referred
to ophthalmic specialists to receive these annual examinations. While several
factors contribute to the problem, lack of resources is a significant factor.
The
[
It also happens that the
] prevalence of diabetes is
greater among minority populations [
who historically have been financially
disadvantaged
]. Specifically, the prevalence of diabetes is
higher
[
three to five times greater
] among
Hispanics/Latinos
American Indians, Asian Americans and African Americans
[
Mexican
Americans
] than non-Hispanic whites. [
Blacks also have a 33% higher
prevalence of diabetes than non-Hispanic whites.
]
Existing evidence
also
[
There is also evidence which
] indicates that minority
populations suffer disproportionately higher rates of complications from diabetes.
For these reasons, the Texas Department of Health (TDH), through Texas Diabetes
Program/
Council funds,
supports
[
is supporting
]
diabetic eye disease screening activities. [
The diabetic eye disease
detection initiative is an attempt to provide needed eye examinations to many
persons with diabetes who might otherwise not receive services because of
a lack of resources.
]
Detection Initiative
] is to provide dilated funduscopic
examinations to
eligible
persons with diabetes
who might otherwise
not receive services
so that vision-threatening conditions, such as
retinopathy, can be identified and treated.
These
[
Diabetes
Control Program (DCP)
] services are provided to Texas residents who
are at high risk for vision loss due to diabetes, and who meet
the program's
[
TDH
] income eligibility criteria for services.
Persons
] providing
DEDP
services [
under
the DCP
] must have a current Texas license to practice
ophthalmology
[
medicine
] or optometry and must be in good standing with
the Texas Board of Medical Examiners or Texas Board of Optometry, whichever
is applicable. Persons wishing to
become
[
be
] providers
should
complete
[
furnish
] the information requested
on the department's fee-for-service contract and return the completed contract
to the
Texas Diabetes
[
Chronic Disease Prevention
] Program,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.
(d)
Civil rights. Providers of services under
the DCP are subject to the provisions of the Federal Civil Rights Act of 1964,
Public Law 88-532, and Texas Civil Statutes, Article 6252-16, so that no person
will be excluded from participation in the DCP or otherwise subjected to discrimination
on the grounds of race, color, or national origin.
]
(e)
] Procedures for eligible persons
receiving services from the
DEDP
[
DCP
]. Individuals
must be referred
by
[
to
] the staff of TDH regions, local
health departments, or others
who have been
approved as nominators
by the
program
[
DCP, TDH
]. The nominator's responsibility
is to assess whether a prospective client with diabetes meets
DEDP
[
DCP
] eligibility criteria, and to [
obtain approval from the TDH
regional dental office to
] refer the client to a
participating
provider. Nominators
should
[
may
] also assist
in follow-up with clients and providers regarding missed appointments and
any
need for subsequent treatment for eye disease. [
The regional
office will confirm (usually by phone) the client's eligibility and authorize
the nominator to refer the client to the participating provider of the client's
choice.
] The nominator will then refer the client and send a tracking
form to the provider. This form is the written authorization for the provider
to perform services. Upon completion of
the
client's examination,
the provider will forward a copy of the tracking form to the
DEDP
[
appropriate regional
] office and retain a copy for the provider's record.
If treatment is recommended and the client is to be referred to another facility
for treatment, then the provider will forward
a copy
[
the
remaining copies
] of the tracking form to the treatment facility. If
the provider is also performing treatment, the results of the treatment will
be documented on the tracking form and sent to the
Texas Diabetes Program
[
DCP
] in Austin.
However, the DEDP will pay only for
the funduscopic eye exam and is not authorized to pay for eyeglasses, contact
lenses, any additional examinations, or any indicated follow-up care.
Patient ] Eligibility.
.
]
(1)
]
[
Eligible persons
] include individuals
with diabetes who:
(A)
] meet the
DEDP
[
Diabetes Control Program (DCP)
] criteria (i.e., [
being
] at
high risk for developing diabetic eye disease);
(B)
] are not covered for
funduscopic
examinations from any other third-party payer; [
and
]
(C)
] have been certified by
a program nominator to have a family income at or below 150% of the TDH-HHS
poverty guidelines
[
the TDH regional office as meeting eligibility
requirements for DCP
]
; and
(2)
To be eligible for services, the prospective
patient must meet the basic income criteria established by the Texas Department
of Health and participating local health departments as described in the department's
guidelines for clinical health services in §1.91(b)(1) of this title
(relating to Fees for Clinical Health Services).
]
Persons
] at high risk for
diabetic eye disease.
People
[
Persons
] considered to
be at high risk for diabetic eye disease include:
Type I (insulin
dependent) diabetics who are 18 years of age or older and
] who have
had
the disease
[
diabetes
] for five years or longer;
and
Type II (non-insulin dependent) diabetics
].
$40
] per examination for a complete dilated funduscopic
examination on both eyes.
, and blood pressure measurement
].
patient
] per year are limited to one annual
screening examination. In instances where eye disease (retinopathy, maculopathy)
is detected in the initial exam,
a maximum of
two additional follow-up
exams may be administered
within any given twelve month period
if
needed. [
Total benefits are not to exceed $120 per patient per year
],
unless written approval is obtained from the
DEDP
[
Diabetes
Control Program (DCP)
].
for
] treatment of eye disease.
Control
] Program [
DCP
]
in Austin. A form may be obtained from the Chronic Disease
and Tobacco
Prevention Program, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756.
DCP
]
will pay providers only for approved services
that
[
which
] have been authorized by the
nominator
[
TDH regional
dental office
] prior to the performance of
such
services.
Payment for any service will be made only after the delivery of the service.
Providers must agree to accept program fees as payment in full for service
rendered, although such fee may be
less than
[
below
]
usual and customary charges.
DCP
] within 75 days of the date
service was authorized.
department
]-developed
publication titled Manual for Providers of Services.
DCP
];
DCP
] (duplicate claims).
DCP
] will be reconsidered
for payment if:
DCP
] within 30 days from receipt
of the notice of denial; and
DCP
] notice of denial.
which
] exceed
time limit. Eye examinations must be completed within 60 days from the date
services were approved and the tracking form must be forwarded to the TDH
Texas Diabetes Program
[
regional dental office
] within 75
days of the date
that
service was authorized. If special or extenuating
circumstances exist
that
[
which
] make it impossible
or impractical for the provider to complete services within that time period,
such claims will be evaluated by the [
chief,
] Bureau of [
Dental and
] Chronic Disease
and Tobacco
Prevention, Texas
Department of Health, on an individual basis, with due consideration given
to the circumstances.
Dental and
] Chronic Disease
and Tobacco
Prevention,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, within
10 days from the provider's receipt of notice of termination, suspension,
or denial of claim for payment.
Chapter 100.
IMMUNIZATION REGISTRY
Chapter 117.
END STAGE RENAL DISEASE FACILITIES
Subchapter B. APPLICATION AND ISSUANCE OF A LICENSE
Subchapter B. FACILITY LICENSING
a temporary
]
initial license [
and first annual license
] is complete when the
department has received, reviewed, and found acceptable the information described
in §117.12 of this title (relating to Application and Issuance of [
Temporary
] Initial License [
and First Annual License
]).
Annual
] Renewal License).
(4)
An application for a change
of ownership license is complete when the department has received, reviewed,
and found acceptable the information described in §117.14 of this title
(relating to Change of Ownership or Services).]
a temporary
] initial license [
and a first annual
license
] or
a
[
an annual
] renewal license shall
be processed in accordance with the following time periods.
time periods in §1.34 of this title (relating
to Time Periods for Conducting Contested Case Hearings) are applicable
].
(3)
An inspection conducted by
the department shall be in accordance with the procedures set out in subsection
(i) of this section.]
first annual
] license. A department surveyor
may
[
shall
] conduct an initial inspection after the date of issuance of the
[
temporary
] initial license to determine if the facility meets
the requirements of the statute and this chapter [
for licensing
].
The initial inspection is an evaluation of compliance with all requirements
of the statute and this chapter.
, at a minimum, each of the requirements
in:
]
(A)
§117.32 of this title
(relating to Equipment);]
(B)
§117.33 of this title
(relating to Water Treatment, Dialysate Concentrates and Reuse);]
(C)
§117.34 of this title
(relating to Sanitary Conditions and Hygienic Practices);]
(D)
§117.41 of this title
(relating to Quality Assurance for Patient Care);]
(E)
§117.43 of this title
(relating to Provision and Coordination of Treatment and Services);]
(F)
§117.44 of this title
(relating to Qualifications of Staff);]
(G)
§117.45 of this title
(relating to Clinical Records);]
(H)
§117.46 of this title
(relating to Reports to the Director);]
(I)
§117.61 of this title
(relating to General Requirements);]
(J)
§117.62 of this title
(relating to Training Curricula and Instructors);]
(K)
§117.63 of this title
(relating to Competency Evaluation);]
(L)
§117.64 of this title
(relating to Documentation of Competency); and]
(M)
§117.65 of this title
(relating to Prohibited Acts).]
Disciplinary Action
]).
Subchapter F. CORRECTIVE ACTION PLAN AND ENFORCEMENT Disciplinary Action ].
or
]
.
]
Civil Statutes, Article 6252-13c
].
Civil
Statutes, Article 6252-13c
].
Chapter 157.
EMERGENCY MEDICAL CARE
categorization
] of EMS vehicles; emergency suspension,
reprimand,
suspension,
probation, revocation, or denial of an EMS provider license;
first responder
organizations;
EMS personnel certification and licensure; interstate
reciprocity for EMS certification; EMS personnel recertification or relicensure;
continuing education requirements; course coordinator and program instructor
certification; disciplinary action for EMS personnel, course coordinators
and program instructors; EMS training courses and course approval; Emergency
Medical Information Operator training, instructor training, course approval
and certification; certification or licensure of persons with criminal backgrounds;
Out-of-Hospital Do-Not-Resuscitate orders;
automated external defibrillators;
requests for emergency care attendant training; fees; the establishment
of trauma service areas; the establishment of regional EMS/trauma systems;
requirements for trauma facility designation; and disciplinary actions for
designated trauma facilities.
Subchapter B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
an
] fee) to the department.
The nonrefundable fee shall be $150 for each EMS vehicle to be
operated unless the license is issued for less than 12 months in which case
the nonrefundable fee shall be $75 for each vehicle.
]
A rotor-wing air ambulance
provider from New Mexico, Oklahoma, Arkansas, or Louisiana may apply for reciprocal
issuance of a provider license. A nonrefundable administrative fee of $250
shall accompany the application in addition to the nonrefundable fee in subsection
(a)(2) of this section.
]
$25
]. One provisional license,
valid for not more than 60 days, may be granted only to prevent probable adverse
impact to the health and safety of the service community. Without a provisional
license, a provider may not operate if there is a lapse in time between license
expiration and license renewal.
$25
],
if applicable.
$50
] application fee.
If the registration is issued for less than 12 months in which case the nonrefundable
fee shall be
$30
[
$25
]. The FRO's personnel are not
exempt from the payment of certification application fees.
Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL
$25
] for review of a basic self-study,
except that this nonrefundable fee may be waived if the program receives no
remuneration for providing training;
$75
] for conducting a basic
site visit;
$50
] for review of an advanced
self-study, except that this nonrefundable fee may be waived if the program
receives no remuneration for providing training;
$200
] for conducting an advanced
site visit;
$25
] for processing a basic
course notification or approval application, except that this nonrefundable
fee may be waived if the program receives no remuneration for providing training;
and
$50
] for processing an advanced
course notification or approval application, except that this nonrefundable
fee may be waived if the program receives no remuneration for providing training.
$25
] for a Basic Course (ECA
or EMT);
$50
] for an Advanced Course
(EMT-Intermediate or Paramedic);
$25
] for an EMS Instructor Course;
and
$50
] for an Emergency Medical
Information Operator Instructor Course.
;
]
$50
] for emergency care attendant
(ECA) or emergency medical technician (EMT);
$75
] for EMT-intermediate (EMT-I)
or EMT-paramedic (EMT-P); and
$12.50
] per each year remaining in the certification. The nonrefundable
fee for EMT-I or EMT-P shall be
$22.50
[
$18.75
] per
each year remaining in the certification. Any portion of a year will count
as a full year; and
$25
], if applicable.
$25
], if applicable.
$5
].
$25
] in addition to the
regular nonrefundable application fee.
$100
].
$50
] for Emergency Care Attendant
(ECA) or Emergency Medical Technician (EMT);
$75
] for EMT-Intermediate (EMT-I)
or EMT-Paramedic (EMT-P); and
$12.50
] per each year remaining in the certification. The non-refundable
fee for EMT-I or EMT-P shall be
$22.50
[
$18.75
] per
each year remaining in the certification. Any portion of a year will count
as a full year.
$25
] for each attempt.
$100;
]
. EMS volunteer--no fee; however,
if the applicant later receives compensation during the renewed licensure
period, the exemption ceases and the individual shall pay a prorated fee to
the department based upon the number of years remaining in the licensure period
when employment begins. The non-refundable fee shall be $30 per each year
remaining in the license. Any portion of a year that the licensed paramedic
receives compensation for his or her paramedic service will count as a full
year.
license and
] wallet-sized
license
[
copy
] may be issued, by the department to replace
lost credentials for a fee of
$10
[
$5.00
].
$100
] with the application;
.
]
however
[
However
], if the applicant later receives compensation
during the renewed licensure period, the exemption ceases and the individual
shall pay a prorated fee to the department based on the number of years remaining
in the licensure period when employment begins. The non-refundable fee shall
be
$30
[
$25
] per each year remaining in the licensure.
Any portion of a year that the licensed paramedic receives compensation for
his paramedic service will count as a full year.
(h)
Applying for inactive status
after expiration of active or inactive licensure status. A candidate seeking
to achieve inactive licensure after expiration of active or inactive licensure
status shall apply within the department's record retention requirements for
the prior license, which is no later than three years past the license expiration.]
(i)
] Reciprocity. A person currently
certified by the National Registry and/or certified or licensed as a paramedic
in another state and who meets all the requirements of this section may apply
for licensure by submitting an application along with a nonrefundable fee
of
$120
[
$100
] and meeting the requirements set forth
in subsection (a)(1) and
(a)
(2)(B) of this section. After the department
evaluates the application, verifies the licensure and assures that the requirements
in subsection (a) of this section have been met, the candidate will be licensed
in Texas for four years from the issuance date of the current Texas licensure.
(j)
] Equivalency.
$150
];
$100
]; and
(k)
] Military personnel. A licensee
who fails to renew a license within three months of the expiration date because
of active duty in the United States military outside the State of Texas shall
have one year from the date of discharge or the date of reassignment to Texas
(whichever is first) to complete all requirements for relicensure.
(l)
] Conversion from inactive paramedic
certification to inactive paramedic licensure. A certified paramedic currently
on inactive status who meets all other criteria as defined in subsection (a)(1)
of this section may apply for inactive licensure status.
$100
]; and
Subchapter D. EMERGENCY MEDICAL SERVICES PERSONNEL CERTIFICATION
$75
] to the
Texas Department of Health (department) except a fee shall not be required
if compensation is not received for coordinating training courses or programs;
$25
], except a fee shall not be required if compensation is not received
for coordinating training courses or programs. If requirements are not completed
within one year after course completion date, the candidate must meet the
requirements of subsection (d) of this section including the completion of
another initial course to be certified.
$75
] to the
department; except a fee shall not be required if compensation is not received
for coordinating training courses or programs;
$25
], except a fee shall not be required if compensation is not received
for coordinating training courses or programs. If requirements are not completed
within one year after course completion date, the candidate must meet the
requirements of subsection (e) of this section including the completion of
another initial course to be certified; and
$1,000
] per day per violation of the Health and Safety Code or the rules adopted
thereunder.
$50
] to the department, except a fee shall
not be required if compensation is not received for instructing training courses
or programs; and a course completion document from a department-approved instructor
course; and
(c)
] Currently certified instructors
shall be considered to have met the qualifications in this section.
(d)
] Period of certification. After
verification by the department of the information submitted by the candidate,
the candidate who meets the requirements of subsection (b) of this section
shall be certified as an instructor for two years commencing on the date of
issuance of the certificate.
(e)
] Responsibilities. An instructor
shall have the following responsibilities:
(f)
] Recertification.
$50
].
(g)
] Late recertification.
(h)
] Recertification. To be eligible
for recertification, the candidate shall meet the following:
(i)
] Disciplinary action.
(e)
] of this section;
$50
], except a fee shall not be required if the EMS information
operator instructor is not to be compensated for providing EMS information
operator training;
$50
], except a fee shall not be required
if the candidate is not to be compensated for providing EMS information operator
training; and
$50
], except a fee shall not be required if the candidate
is not to be compensated for providing EMS information operator training;
and
$25
], if applicable.
$50
], except a fee shall not be required
if the candidate is not to be compensated for providing EMS information operator
instructor training; and
Subchapter G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
by December 31, 2000,
] or the bureau may
re-align the counties in that TSA to other TSAs which have such a facility;
Mitchell,
] Motley, Scurry, Terry, Yoakum;
$3.00
] per licensed
bed with an upper limit of
$5,000
[
$3000
] and a lower
limit of
$4,000
[
$100
];
$2.00
] per licensed bed with an upper
limit of
$2,500
[
$2000
] and a lower limit of
$1,500
[
$100
]; and
$1.00
] per licensed bed with an upper
limit of
$1,000
[
$1000
] and a lower limit of
$500
[
$100
].
Chapter 289.
RADIATION CONTROL
(d)
Exemptions. No application or annual fee
shall be required for a general license issued in accordance with §289.251
of this title that does not require a general license acknowledgment.
]
(e)
] Payment of fees.
(f), (h),
or (i)
] of this section shall be accompanied by a nonrefundable fee
equal to the appropriate [
annual
] fee. Each request for evaluation
of a sealed source and/or device shall be accompanied by a nonrefundable fee
[
equal to the appropriate fee as
] prescribed in subsection
(f)
[
(g)
] of this section.
Each application for accreditation
of a mammography facility shall be accompanied by a nonrefundable fee prescribed
in subsection (h) of this section. Each application for an industrial radiographer
certification and an industrial radiographer examination shall be accompanied
by a nonrefundable fee prescribed in subsection (i) of this section.
or general license category
]
shall be accompanied by the prescribed fee for the highest category and 25%
of the applicable prescribed fee for each additional requested category.
base
] fee for the highest category [
of use plus the prescribed
machine or service fee for each category of use
].
(f)
] of this section shall be paid [
annually
] for each radioactive material license and/or for each general license
acknowledgement.
The fee shall be for the two-year term of the license
or general license acknowledgement.
The fee shall be paid in full [
each year
] on or before the last day of the expiration month
and
year
of the license or general license acknowledgement. [
For example,
if the license or general license acknowledgement expires May 31, 2010, annual
fees are due on or before May 31 of each calendar year.
] In the case
of a single license that authorizes more than one category of use, the [
annual
] fee shall be the prescribed fee for the highest license category
plus 25% of the applicable prescribed fee for each additional license category
authorized.
subsections (f) or (i)
] of this section, shall be paid
[
annually
] for each certificate of registration for radiation machines
and/or services, or sources of laser radiation.
The fee shall be for
the two-year term of the certificate of registration.
[
The fee
consists of a base fee for all registrants plus a fee where specified for
each machine possessed or registrable service offered.
]
(i)
] of this section and assigned
the higher [
of the
] fee [
or base fee plus corresponding machine/service
fee, as applicable,
] will be used.
(5)
] Each application for reciprocal
recognition of an out-of-state license in accordance with §289.252(s)
of this title, an out-of-state registration in accordance with §289.226
of this title, or an out-of-state laser registration in accordance with §289.301
of this title
,
shall be accompanied by the applicable [
annual
] fee, provided that no such fee has been submitted within 24 [
12
] months of the date of commencement of the proposed activity.
(6)
] Each holder of a fixed nuclear
facility construction permit or operating license or an operator of any other
fixed nuclear facility shall submit an annual fee for services received. This
fee shall recover for the State of Texas the actual expenses arising from
environmental surveillance and emergency planning and implementation activities.
Payment shall be made within 90 days following the date of invoice.
(7)
] Fee payments shall be in cash
or by check or money order made payable to the Texas Department of Health.
The payments may be made by personal delivery to the central office, Bureau
of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin,
Texas, or mailed to the Bureau of Radiation Control, Texas Department of Health,
1100 West 49th Street, Austin, Texas, 78756-3189.
(8)
] Any applicant requesting authorization
for any of the categories in subsection
(e)
[
(f)
] of
this section for veterinary use will be assessed the [
annual
] fee
for the corresponding category.
(f)
] Schedule of [
annual
]
fees for radioactive material licenses. The following schedule contains the
[
annual
] fees for radioactive material licenses:
Figure: 25 TAC §289.204(f)]
(g)
] Fee for
evaluation
[
Evaluation
] of a
sealed source
[
Sealed Source
]
and/or
device
[
Device
].
(h)
] Fees for certification of
mammography systems.
(i)
] Schedule of [
annual
]
fees for certificates of registration for radiation machines, lasers, and
services.
The fee for certificates of registration for dental radiation
machines is specified in §289.232 of this title. The fee for certificates
of registration for radiation machines used in veterinary medicine is specified
in §289.233 of this title.
The following schedule contains the
[
annual
] fees for certificates of registration for radiation machines,
lasers, and services:
Figure: 25 TAC §289.204(i)]
(j)
] Annual fees for environmental
surveillance and emergency planning and implementation. Fees shall be set
annually by the agency for each facility. Fees for fixed nuclear facilities
shall be the actual expenses for environmental surveillance and emergency
planning and implementation activities. Costs of activities benefiting more
than one facility shall be prorated.
(k)
] Failure to pay prescribed
fees.
(2)
In any case where the agency finds that
a licensee or registrant has failed to pay a fee prescribed by this section
by the due date, the licensee or registrant shall pay an annual late payment
fee of 20% of the annual fee prescribed in subsections (f), (h), (i) and (l)
of this section, in addition to the annual license and registration fee. The
annual late payment fee shall not exceed $10,000 for each licensee or registrant
who fails to pay the fees prescribed by this section.
]
(3)
] In any case where the agency
finds that a licensee or registrant has failed to pay a fee prescribed by
this section by the due date,
the license or certificate of registration
expires and
the agency may implement compliance procedures as provided
in §289.205 of this title (relating to Hearing and Enforcement Procedures).
(4)
] In any case where the agency
finds that a fixed nuclear facility has failed to pay fees for environmental
surveillance or emergency planning and implementation within 90 days following
date of invoice, the agency may issue an order to show cause why those services
should not be terminated.
(l)
] Schedule of fees for uranium
recovery and byproduct material disposal facility licenses. The following
schedule contains the fees for uranium recovery and byproduct material disposal
facility licenses:
Figure: 25 TAC §289.204(l)]
(m)
] Adjustments to [
annual
] fees for uranium recovery and byproduct material disposal facility
licenses.
annual
]
fee shall be increased by 25% for each additional site for an operational
year and 50% for closure only.
annual
] fee shall be increased
by 25%.
(n)
] One-time fee adjustments for
uranium recovery and byproduct material disposal facility licenses. For the
addition of the following items after an environmental assessment has been
completed on a facility, a one-time fee corresponding to the item shall be
paid:
Subchapter E. REGISTRATION REGULATIONS
and Veterinary Medicine ].
and in veterinary medicine
].
for human use or licensed veterinarian for veterinary
use
].
(q)(1)
] of this section.
The
use of radiation machines for veterinary medicine is subject to the requirements
in §289.233 of this title (relating to Radiation Control Regulations
for Radiation Machines for Veterinary Medicine).
§289.226(j)(1)
] of this title; and
§289.226(j)(2)
] of this title.
(2)
Veterinary facilities are exempt from
the following requirements:
]
(A)
entrance exposure limits for fluoroscopy
in subsection (o)(3) and (4) of this section;
]
(B)
aural communication requirements for computed
tomography (CT) in subsection (p)(2)(A) of this section; and
]
(C)
CT dose measurements in subsection (p)(3)
and (4) of this section.
]
(3)
] Individuals who are sole practitioners
and sole operators and the only occupationally exposed individual are exempt
from the following requirements:
(4)
] Registrants are exempt from
the posting of the radiation area requirements in §289.231(x)(1) of this
title provided that the operator has continuous surveillance and access control
of the radiation area.
(5)
Facilities with CT x-ray systems producing
digital images only are exempt from subsections (r), (s), and (t)(1)(O) and
(P) of this section.
]
(13)
Calibration of machines--The measurement
and specification of absorbed dose to a medium, or exposure in air, at a defined
point in a radiation beam.
]
(14)
] Central axis of the beam--A
line passing through the virtual source and the center of the plane figure
formed by the edge of the first beam-limiting device.
(15)
] Certified equipment--Equipment
that has been certified in accordance with Title 21, Code of Federal Regulations
(CFR).
(16)
] Coefficient of variation
or C--The ratio of the standard deviation to the mean value of a population
of observations. It is estimated using the following equation:
Figure: 25 TAC §289.227(e)(16)]
(17)
] Collimator--A device or
mechanism by which the x-ray beam is restricted in size.
(18)
] Computed tomography (CT)--The
production of a tomogram by the acquisition and computer processing of x-ray
transmission data.
(19)
Continuous pressure type switch--A switch
so constructed that a circuit closing contact can be maintained only by continuous
pressure on the switch by the operator.
]
(20)
Contrast scale (CS)--The change in the
linear attentuation coefficient per CT number (CTN) relative to water; that
is:
]
Figure: 25 TAC §289.227(e)(20)]
(21)
] Control panel--The part
of the radiation machine control upon which are mounted the switches, knobs,
push buttons, and other hardware necessary for manually setting the technique
factors.
(22)
] CT conditions of operation--All
selectable parameters governing the operation of a CT x-ray system including,
but not limited to, nominal tomographic section thickness, filtration, and
the technique factors as defined in this subsection.
(23)
] CT gantry--The tube housing
assemblies, beam-limiting devices, detectors, and the supporting structures
and frames that hold these components.
(24)
CT number (CTN)--The number used to represent
the x-ray attenuation associated with each elemental area of the CT image,
that is:
]
Figure: 25 TAC §289.227(e)(24)
]
(25)
] Diagnostic source assembly--The
tube housing assembly with a beam-limiting device attached.
(26)
] Diagnostic x-ray system--An
x-ray system designed for irradiation of any part of the human body [
or any animal
] for the purpose of diagnosis or visualization.
(27)
Diaphragm--A device or mechanism by which
the x-ray beam is restricted in size.
]
(28)
] Entrance exposure--The exposure
expressed in roentgens (R), measured in air with the specified technique,
calculated or adjusted to represent the exposure at the point where the center
of the useful beam enters the patient.
(29)
] Entrance exposure rate--The
exposure per unit time at the point where the center of the useful beam enters
the patient.
(30)
] Field emission equipment--Equipment
that uses an x-ray tube in which electron emission from the cathode is due
solely to the action of an electric field.
(31)
] Field size--The dimensions
along the major axes of an area in a plane perpendicular to the central axis
of the beam at the normal treatment or examination source to image distance
and defined by the intersection of the major axes and the 50% isodose line.
(32)
] Filter--Material placed
in the useful beam to preferentially absorb selected radiations.
(33)
] Fluoroscopic imaging assembly--A
subsystem in which x-ray photons produce a fluoroscopic image. It includes
the image receptors such as the image intensifier and spot-film device, electrical
interlocks, if any, and structural material providing linkage between the
image receptor and diagnostic source assembly.
(34)
] Focal spot--The area projected
on the anode of the x-ray tube bombarded by the electrons accelerated from
the cathode and from which the useful beam originates.
(35)
Gantry--That part of the system supporting
and allowing possible movement of the radiation source.
]
(36)
] General purpose x-ray system--Any
radiographic x-ray system that is not limited by design to radiographic examinations
of specific anatomical regions.
37
] Gonadal shield--A protective
barrier for the testes or ovaries.
(38)
] Half-value layer (HVL)--The
thickness of a specified material that attenuates the beam of radiation to
an extent such that the exposure rate is reduced to one-half of its original
value.
(39)
] Healing arts--Any system,
treatment, operation, diagnosis, prescription, or practice for the ascertainment,
cure, relief, palliation, adjustment, or correction of any human disease,
ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.
(40)
] Healing arts screening--The
testing of asymptomatic human beings using radiation machines for the detection
or evaluation of health indications when such tests are not specifically and
individually ordered by a licensed practitioner of the healing arts legally
authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
(41)
] High level control for fluoroscopy--Any
selected mode having an entrance exposure rate above 10 roentgens per minute
(R/min). This mode shall meet the high level requirements in subsection
(m)(3)(A)(i)(II), (ii)(II), or (iii)(II)
[
(o)(3)(A)(i)(II), (ii)(II),
or (iii)(II)
] of this section.
(42)
] Image intensifier--A device,
installed in its housing, that instantaneously converts an x-ray pattern into
a corresponding light image of higher energy density.
(43)
] Image receptor--Any device,
such as a fluorescent screen or radiographic film, that transforms incident
x-ray photons either into a visible image or into another form that can be
made into a visible image by further transformations.
(44)
] Irradiation--The exposure
of matter to ionizing radiation.
(45)
] kV--Kilovolt.
(46)
] kVp--Kilovolt peak (See
definition for peak tube potential).
(47)
] kWs--Kilowatt-second. It
is equivalent to 10 E 3 watt-second, where 1 watt-second = 1 kV x 1 milliampere
(mA) x 1 second.
(48)
] Lead equivalent--The thickness
of lead affording the same attenuation, under specified conditions, as the
material in question.
(49)
] Leakage radiation--Radiation
emanating from the diagnostic [
or therapeutic
] source assembly
except for the useful beam and radiation produced when the exposure switch
or timer is not activated.
(50)
] Leakage technique factors--The
technique factors associated with the diagnostic source assembly that are
used in measuring leakage radiation. They are defined as follows:
(51)
] Licensed medical physicist--An
individual holding a current Texas license under the Medical Physics Practice
Act, Texas Occupations Code, Chapter 602
, with a specialty in diagnostic
radiological physics
.
(52)
Linear attenuation coefficient (u)--The
quotient of dN/N by dl when dN/N is the fraction of uncharged ionizing radiation
that experiences interactions in traversing a distance dl in a specified material.
]
(53)
] mA--Milliampere.
(54)
] mAs--Milliampere-second.
(55)
] Medical research--The investigation
of various health risks and diseases [
using radiation machines as part
of the evaluation process
].
(56)
] Mobile
service operation
[
services
]--
The provision of radiation machines and
personnel at temporary sites for limited time periods. The radiation machines
may be fixed inside a motorized vehicle or may be a portable radiation machine
that may be removed from the vehicle and taken into a facility for use.
[
The utilization of radiation machines in temporary locations for limited time
periods. The radiation machines may be fixed inside a mobile van or transported
to temporary locations.
]
(57)
Mobile x-ray equipment--(See definition
for x-ray equipment).
]
(58)
] Multiple
slice
tomogram
system--A computed tomography x-ray system that obtains x-ray transmission
data simultaneously during a single scan to produce more than one tomogram.
(59)
] Nominal tomographic section
thickness--The full-width at half-maximum of the sensitivity profile taken
at the center of the cross sectional volume over which x-ray transmission
data are collected.
(60)
] Non-certified
radiographic
equipment--Equipment manufactured and assembled prior to certification
requirements of Title 21, CFR, effective as specified in Title 21, CFR, Part
1020.30(a).
(61)
] Patient--An individual subjected
to healing arts examination, diagnosis, or treatment.
(62)
] Peak tube potential--The
maximum value of the potential difference in kilovolts across the x-ray tube
during an exposure.
(63)
] Phantom--A volume of material
behaving in a manner that can be related to tissue with respect to the attenuation
and scattering of radiation.
(64)
] Phototimer--A method for
controlling exposures to image receptors by the amount of radiation that reaches
a radiation monitoring device. The radiation monitoring device is part of
an electronic circuit that controls the duration of time the tube is activated
(See definition for automatic exposure control).
(65)
] Portable x-ray equipment
(See definition for x-ray equipment).
(66)
] Practitioner of the healing
arts (practitioner)--A person licensed to practice healing arts by either
the Texas State Board of Medical Examiners as a physician, the Texas Board
of Chiropractic Examiners, or the Texas State Board of Podiatry Examiners.
(67)
] Primary protective barrier--(See
definition for protective barrier).
(68)
] Protective apron--An apron
made of radiation
attenuating
[
absorbing
] materials
used to reduce radiation exposure.
(69)
] Protective barrier--A barrier
of radiation absorbing materials used to reduce radiation exposure. The types
of protective barriers are as follows:
(70)
] Protective glove--A glove
made of radiation
attenuating
[
absorbing
] materials
used to reduce radiation exposure.
(71)
] Radiograph--An image receptor
on which the image is created directly or indirectly by an x-ray exposure
and results in a permanent record.
(72)
] Reference plane--A plane
that is displaced from and parallel to the tomographic plane.
(73)
] Scan--The complete process
of collecting x-ray transmission data for the production of a tomogram. Data
can be collected simultaneously during a single scan for the production of
one or more tomograms.
(74)
] Scan increment--The amount
of relative displacement of the patient with respect to the CT x-ray system
between successive scans measured along the direction of such displacement.
(75)
] Scan sequence--A preselected
set of two or more scans performed consecutively under preselected CT conditions
of operation.
(76)
] Scan time--The period of
time between the beginning and end of x-ray transmission data accumulation
for a single scan.
(77)
] Scattered radiation--
Radiation
[
radiation
] that has been deviated in direction
during passage through matter.
(78)
] Secondary protective barrier
(See definition for protective barrier).
(79)
] Shutter--A device attached
to the tube housing assembly that can totally intercept the useful beam and
that has a lead equivalency not less than that of the tube housing assembly.
(80)
] Single tomogram system--CT
x-ray system that obtains x-ray transmission data during a scan to produce
a single tomogram.
(81)
] Source--The focal spot of
the x-ray tube.
(82)
] Source-to-image receptor
distance (SID)--The distance from the source to the center of the input surface
of the image receptor.
(83)
] Source-to-skin distance
(SSD)--The distance from the source to the skin of the patient.
(84)
Spacer--A device designed to limit the
target to skin distance.
]
(85)
] Special purpose x-ray system--Any
radiographic x-ray system that is limited by design to radiographic examinations
of specific anatomical regions. Special purpose x-ray systems include, but
are not limited to, dedicated chest units, cystography units, and head and
skull units.
(86)
] Special procedures--The
application of special x-ray equipment and specialized techniques to obtain
required diagnostic information. [
This usually provides enhanced detail
of a given anatomical structure but with reduced visualization of others.
] Special procedures include, but are not limited to, angiography, cardiac
catheterization, myelogram, and surgery.
(87)
] Spot film--A radiograph
that is made during a fluoroscopic examination to permanently record conditions
that exist during that fluoroscopic procedure.
(88)
] Spot film device--A device
intended to transport and/or position a radiographic image receptor between
the x-ray source and fluoroscopic image receptor. It includes a device intended
to hold a cassette over the input end of an image intensifier for the purpose
of making a radiograph.
(89)
] Stationary x-ray equipment--(See
definition for x-ray equipment).
(90)
] Stray radiation--The sum
of leakage and scattered radiation.
(91)
] Supervision--The delegating
, by the practitioner,
of the task of applying radiation [
in accordance
with this section
] to persons [
not licensed in the healing arts
or veterinary medicine,
] who
perform tasks
[
provide
services
] under the practitioner's control
and who are certified
under the Medical Radiologic Technologist Act, Texas Occupations Code, Chapter
601
. The [
licensed
] practitioner [
or veterinarian
]
assumes full responsibility for these tasks and shall assure that the tasks
will be administered correctly.
(92)
] Target--The part of a radiation
machine
head that by design intercepts a beam of accelerated particles
with subsequent emission of other radiation.
(93)
] Technique chart--A chart
that provides all necessary generator control settings and geometry needed
to make clinical radiographs when the radiography system is in manual mode.
(94)
] Technique factors--The conditions
of operation that are specified as follows:
(95)
] Tomogram--The depiction
of the x-ray attenuation properties of a section through the body.
(96)
] Tomographic plane--The geometric
plane that is identified as corresponding to the output.
(97)
] Tomographic section--The
volume of an object whose x-ray attenuation properties are imaged in a tomogram.
(98)
] Traceable to a national
standard--This indicates that a quantity or a measurement has been compared
to a national standard, for example, the National Institute of Standards and
Technology, directly or indirectly through one or more intermediate steps
and that all comparisons have been documented.
(99)
] Tube--An x-ray tube, unless
otherwise specified.
(100)
] Tube housing assembly--The
tube housing with tube installed. It includes high-voltage and/or filament
transformers and other appropriate elements when such are contained within
the tube housing.
(101)
] Useful beam--Radiation
that passes through the window, aperture, cone, or other collimating device
of the source housing. Also referred to as the primary beam.
(102)
Veterinarian--An individual licensed
by the Texas Board of Veterinary Medical Examiners.
]
(103)
] X-ray control--A device
that controls input power to the x-ray high-voltage generator and/or the x-ray
tube. It includes equipment such as timers, phototimers, automatic brightness
stabilizers, and similar devices that control the technique factors of an
x-ray exposure.
(104)
] X-ray equipment--An x-ray
system, subsystem, or component thereof.
For the purposes of this rule,
types
[
Types
] of x-ray equipment are as follows:
mobile x-ray
equipment
]--x-ray equipment mounted on a permanent base with wheels
and/or casters for moving while completely assembled
. Portable x-ray
equipment may also include equipment designed to be hand-carried; or
[
;
]
(B)
portable x-ray equipment--x-ray equipment
designed to be hand-carried; or
]
(C)
] stationary x-ray equipment--x-ray
equipment that is installed in a fixed location.
(105)
] X-ray field--That area
of the intersection of the useful beam and any one of the set of planes parallel
to and including the plane of the image receptor, whose perimeter is the locus
of points at which the exposure rate is one-fourth of the maximum in the intersection.
(106)
] X-ray high-voltage generator--A
device that transforms electrical energy from the potential supplied by the
x-ray control to the tube operating potential. The device may also include
means for transforming alternating current to direct current, filament transformers
for the x-ray tubes, high-voltage switches, electrical protective devices,
and other appropriate elements.
(107)
] X-ray system--An assemblage
of components for the controlled production of x rays. It includes minimally
an x-ray high-voltage generator, an x-ray control, a tube housing assembly,
a beam-limiting device, and the necessary supporting structures. Additional
components that function with the system are considered integral parts of
the system.
(108)
] X-ray subsystem--Any combination
of two or more components of an x-ray system.
(109)
] X-ray tube--Any electron
tube that is designed to be used primarily for the production of
x-rays
[
x rays
].
(f)
Educational facilities. Facilities conducting
training using non-humans shall comply with all the requirements of this section
except for subsection (i)(5) of this section concerning operator credentialing,
subsection (k) of this section concerning radiographic entrance exposure limits,
subsections (r) and (s) of this section concerning film processing, and subsection
(q) of this section concerning equipment performance evaluation.
]
§289.226(j)
] of this title;
(5)
exemptions in accordance with subsection
(d)(1),(3), and (4) of this section;
]
(6)
] definitions in accordance
with subsection (e) of this section, as applicable;
(7)
] operating and safety procedures
in accordance with subsection (i)(2) of this section;
(8)
] operator credentialing in
accordance with subsection (i)(5) of this section;
(9)
] gonadal shielding in accordance
with subsection
(i)(13)
[
(j)(3)
] of this section;
(10)
] warning labels in accordance
with subsection
(k)(1)
[
(l)(1)
] of this section;
(11)
] record requirements for
authorized use locations and authorized records locations for mobile services
in accordance with subsection
(s)(1)(A)-(D), (G)-(J), (R), and (s)(2)
[
(t)(1)(A)-(D), (G)-(I), (J), (Q), and (t)(2)
] of this section;
and
(12)
] record requirements for
mobile services in accordance with subsection
(s)(1)(A)-(D), (H), and
(J)
[
(t)(1)(A)-(D), (H), and (J)
] of this section. These
records shall be maintained with the bone densitometer authorized to be used
for mobile services.
for chiropractic, medical, and
podiatric facilities
]. [
This subsection does not apply to veterinary
facilities.
] In addition to the requirements of this chapter, the registrant
shall not make, nor cause to be made, any modification of components or installations
of components certified in accordance with the United States Food and Drug
Administration (FDA) Title 21, CFR, Part 1020, "Performance Standards for
Ionizing Radiation Emitting Products," as amended, in any manner that could
cause the installations or the components to fail to meet the requirements
of the applicable parts of the standards specified in Title 21, CFR, Part
1020, except where a variance has been granted by the Director, Center for
Devices and Radiological Health, FDA. A copy of the variance shall be maintained
by the registrant in accordance with subsection
(s)(1)
[
(t)(1)
] of this section for inspection by the agency.
for chiropractic, medical, podiatric, and veterinary facilities.
]
(2)
Operating and safety procedures. Each
registrant shall have and implement written operating and safety procedures.
These procedures shall be made available to each individual operating a radiation
machine, including any restrictions of the operating technique required for
the safe operation of the particular x-ray system. These procedures shall
include, but are not limited to, the items in subsection (u) of this section.
]
(o)(8)
] of this section.
(t)(1)
] of this section for inspection by the agency.
Windows, mirrors, closed circuit television, or a method shall be provided
to permit the operator to continuously observe the patient during irradiation.
]
(j)
Requirements specifically for chiropractic,
medical, and podiatric facilities.
]
(1)
] Patient protection. Notwithstanding
the provisions of subsection (i)(7) of this section, other patients who are
in line with the primary beam and who cannot be removed from the room shall
be protected by whole body protective barriers of a minimum of 0.25 mm lead
equivalent material or so positioned that the nearest portion of their body
is at least six feet from both the tube head and the nearest edge of the image
receptor.
(2)
Contact with the patient. The operator
shall be able to maintain verbal, visual, and aural contact with the patient.
]
(3)
] Gonadal shielding. Gonadal
shielding shall be used on patients when the gonads are in or within 5 cm
of the useful beam. This requirement does not apply if the shielding will
interfere with the diagnostic procedure. Gonadal shielding shall be of at
least 0.5 mm lead equivalent material.
(k)
] Radiographic entrance exposure
limits
.
[
for chiropractic, medical, and podiatric facilities.
This subsection does not apply to veterinary facilities.
] The in-air
exposure determined for the technique used
by the registrant
for
the specified average human adult patient thickness for routine medical radiography
shall not exceed the entrance exposure limits in the following
Table
II
[
Table I
].
Figure: 25 TAC §289.227(k)
]
(l)
]
Machine
[
General
] requirements for [
all diagnostic
]
general radiographic
and fluoroscopic
x-ray systems
.
[
for chiropractic, medical,
podiatric, and veterinary facilities.
]
(4)
Radiation from components other than the
diagnostic source assembly. The radiation emitted by a component other than
the diagnostic source assembly shall not exceed 2 milliroentgens (mR) in one
hour at 5 cm from any accessible surface of the component when it is operated
in an assembled x-ray system under any conditions for which it was designed.
Measurement is averaged over an area of 100 square centimeters (cm
2
) with no linear dimension greater than 20 cm.
]
(5)
] Beam quality. The following
requirements apply to beam quality.
Figure: 25 TAC §289.227(k)(5)(A)(i)
]
(5)
] of this subsection
shall be determined with the maximum quantity of charge per exposure.
(6)
] Multiple tubes. Where two
or more radiographic tubes are controlled by one exposure switch, the tube
or tubes that have been selected shall be clearly indicated prior to initiation
of the exposure. This indication shall be both on the x-ray control panel
and at or near the tube housing assembly that has been selected.
(7)
] Technique and exposure indicators.
(m)
] Additional
machine
requirements
for radiographic x-ray systems,
[
specifically for chiropractic,
medical, and podiatric x-ray systems.
] This subsection does not apply
to fluoroscopic[
, veterinary,
] or CT x-ray systems.
Mobile x-ray systems. Mobile x-ray systems
] shall comply
with the requirements in subparagraph
(A)
[
(A)(i)-(iii)
]
of this paragraph
, as applicable, based on manufacturer's design
.
(A)
X-ray control. An x-ray control shall
be incorporated into each x-ray system such that an exposure can be terminated
by the operator at any time except for an exposure of 0.5 seconds or less
or during serial radiography when means shall be provided to permit completion
of any single exposure of the series in process. The exposure switch shall
be of the continuous pressure type.
]
(B)
] Timers. Means shall be provided
to terminate the exposure at a preset time interval, a preset product of current
and time, a preset number of pulses, or a preset radiation exposure to the
image receptor. In addition, it shall not be possible to make an exposure
when the timer is set to a "zero" or "off" position if either position is
provided.
(C)
] AEC. When [
an
]
AEC is provided, the following shall occur.
(D)
] Exposure interval reproducibility.
When all technique factors are held constant, including control panel selections
associated with AEC systems, the coefficient of variation of exposure interval
for both manual and AEC systems shall not exceed 0.05. This requirement applies
to clinically used techniques.
Figure: 25 TAC §289.227(m)(5)
]
(n)
Additional requirements specifically for
veterinary x-ray systems.
]
(1)
The x-ray control shall provide visual
or audible indication of the production of x-rays observable at or from the
operator's protected position whenever x-rays are produced.
]
(2)
Beam limiting devices shall do the following:
]
(A)
provide the same degree of protection
as is required of the housing;
]
(B)
restrict the useful beam to the area of
clinical interest; and
]
(C)
limit the x-ray field such that the x-ray
field shall not exceed:
]
(i)
2.0% of the SID for the length or width
of the rectangular image receptor; or
]
(ii)
2.0% of the SID for the diagonal of the
image receptor for circular image receptors.
]
(3)
A means shall be provided to center the
primary beam to the image receptor within 2.0% of the SID.
]
(4)
A means shall be provided to terminate
the exposure at the following:
]
(A)
a preset time interval;
]
(B)
a preset product of current and time;
]
(C)
a preset number of pulses; or
]
(D)
a preset radiation exposure to the image
receptor.
]
(5)
The radiation machine shall not be able
to make an exposure when the timer is set to a "zero" or "off" position if
either position is provided.
]
(6)
All stationary, mobile, or portable x-ray
systems used for veterinary x rays shall be provided with the following:
]
(A)
a continuous pressure type exposure switch;
and
]
(B)
either a six and one-half foot high protective
barrier for operator protection during exposures; or
]
(C)
a means for the operator to be at least
six feet from the tube housing assembly.
]
(7)
Operators using portable radiation machines
designed to be hand-held are exempt from the requirements of paragraph (6)
of this subsection. The hand-held portable radiation machine shall be held
by the tube housing support or handle. The operator shall wear protective
devices in accordance with subsection (i)(4) of this section.
]
(8)
When all technique factors are held constant,
including control panel selections associated with AEC systems, the coefficient
of variation of exposure for both manual and AEC systems shall not exceed
0.05. This requirement applies to clinically used techniques.
]
(9)
The technique factors to be used during
an exposure shall be indicated before the exposure begins. If AECs are used,
the technique factors that are set prior to the exposure shall be indicated.
]
(10)
For machines having fixed technique factors,
the requirements of paragraph (9) of this subsection may be met by permanent
markings on the equipment. Indication of technique factors shall be visible
from the operator's position except in the case of spot films made by the
fluoroscopist.
]
(11)
Fluoroscopic and CT units used in veterinary
facilities shall meet the requirements of subsections (o) and (p) of this
section. Therapy systems used in veterinary facilities shall meet the requirements
of §289.229 of this title.
]
(12)
Portable machines shall be used in a
manner that complies with this section.
]
(13)
All exams and retakes shall be ordered
by the veterinarian.
]
(o)
] Fluoroscopic x-ray systems
and spot-film devices for all facilities.
with a specialty
in diagnostic radiological physics
].
(t)(1)
] of this section for inspection by the agency. The measurement results
shall be stated in R/min and include the technique factors used in determining
such results. The name of the person performing the measurements and the date
the measurements were performed shall be included in the results.
(6)
SSD. The SSD shall not be less than the
following:
]
(A)
38 cm on stationary fluoroscopes installed
after March 1, 1989;
]
(B)
35.5 cm on stationary fluoroscopes that
were in operation prior to March 1, 1989;
]
(C)
30 cm on all mobile and portable fluoroscopes;
]
(D)
20 cm for C-arm fluoroscopes used for
specific applications that would require a shorter source to skin distance
than that specified in subparagraph (C) of this paragraph. The written operating
and safety procedures shall provide precautionary measures to be adhered to
during the use of the shorter source to skin distance. The procedures shall
provide instructions to restore the unit to a minimum SSD of 30 cm prior to
performing any procedure other than those specified in the operating and safety
procedures; and
]
(E)
]
The SSD shall not be
less than
the FDA approved variance for a specific manufacturer of a
hand-held fluoroscope.
(p)
] CT x-ray systems.
(A)
] Tomographic plane indication
and alignment.
(B)
] Indication of CT conditions
of operation. The CT x-ray system shall be designed such that the CT conditions
of operation to be used during a scan or a scan sequence are indicated prior
to the initiation of a scan or a scan sequence. On equipment having all or
some of these conditions of operation at fixed values, this requirement may
be met by permanent markings. Indication of CT conditions of operation shall
be visible from any position from which scan initiation is possible.
(C)
] Initiation of operation.
(D)
] Termination of exposure.
(E)
] Additional requirements applicable
to CT x-ray systems. Additional requirements applicable to CT x-ray systems
containing a gantry manufactured after September 3, 1985, are as follows.
Dose measurements
]
of the radiation output of the CT x-ray system
, using the computed tomography
dose index (CTDI) as recommended by the American Association of Physicists
in Medicine (AAPM) and the International Council on Radiation Protection (ICRP),
shall be performed [
as follows
] by a licensed medical physicist
[
with a specialty in diagnostic radiological physics
].
(t)(1)
] of this section for inspection by the agency.
and
]
. The registrant
shall maintain either of the following in accordance with subsection (t)(1)
of this section for inspection by the agency:
]
(i)
photographic copies of the images obtained
from the image display device; or
]
(ii)
images stored in digital form.
]
(q)
] Equipment performance evaluation
.
[
for chiropractic, medical, and podiatric facilities. This subsection
does not apply to veterinary facilities.
]
For all x-ray systems listed in
paragraphs (5)-(7) of this subsection, the registrant shall perform, or cause
to be performed, tests necessary to assure proper function of equipment with
the indicated standard for each item specified. Such tests shall be performed
at the frequency listed in the following table.
]
Figure: 25 TAC §289.227(q)(1)
]
(t)(1)
] of this section for inspection by the agency.
(t)(1)
] of this section for inspection by the agency.
Measurements
] of the radiation output of an x-ray system
are
[
shall be
] performed with a calibrated dosimetry system. The dosimetry
system shall have been calibrated within the preceding 24 months and the calibration
shall be traceable to a national standard. During the calendar year in which
the dosimetry system is not calibrated, an intercomparison to a system calibrated
within the previous 12 months shall be performed.
The registrant shall
make and maintain a record of the dosimetry system calibration. If the registrant
has caused the tests to be performed by a licensed medical physicist, registered
in accordance with §289.226(b)(10) of this title, that licensed medical
physicist shall make the record.
(m)(4)
]
of this section.
(m)(5)
] of this section.
(m)(1)
] of this section:
(o)
] of
this section.
(p)
] of this section.
(r)
] Automatic and manual film
processing for [
chiropractic, medical, podiatric, and veterinary
]
facilities and mobile services.
(t)(1)
] of this section for inspection by the agency.
(t)(1)
] of this section for inspection by the agency.
(s)
] Alternative processing systems.
Users of daylight processing systems, laser processors, self-processing film
units, or other alternative processing systems shall follow manufacturer's
recommendations for image processing. Documentation that the registrant is
following manufacturer's recommendations shall include the date and initials
of the individual completing the document and shall be maintained at the site
where performed in accordance with subsection
(s)(1)
[
(t)(1)
] of this section for inspection by the agency.
(t)
] Record/document requirements
for mobile services and authorized use locations [
for chiropractic, medical,
podiatric, and veterinary facilities
].
Figure: 25 TAC §289.227(t)(1)
]
paragraph (1)(F), (Q), and (R)
] of this subsection
shall include the following:
from
the control panel of the radiation machine or from the survey instrument
];
(B)
dates of receipt, transfer, and disposal
for records required by paragraph (1)(Q) of this subsection; and
]
paragraph
(1)(A)-(D), (H), (J), and (N)-(P)
] of this subsection shall be kept
with radiation machines authorized to be used for mobile services. Mobile
services with on-board film processors shall maintain the records in
items (1)(O)-(Q) of the figure in paragraph 1
[
paragraph (1)(O)
and/or (P)
] of this subsection, as applicable, with the processor
or system
for a period of no less than one year.
(u)
] Appendices. The registrant's
operating and safety procedures shall include, but are not limited to, the
following procedures as applicable:
(j)(3)
] of this section;
(14)
use of 20 cm SSD (spacers) in accordance
with subsection (o)(6)(D) of this section;
]
(15)
] control of scattered radiation
in accordance with subsection
(m)(8)
[
(o)(8)
] of this
section; and
(16)
] film processing program
or digital image processing protocols
in accordance with subsections
(p), (q), and (r)
[
(r) and (s)
] of this section.
(2)
] Adult - An individual 18 or
more years of age.
(3)
] Agency - The Texas Department
of Health.
(4)
] Agreement State - Any state
with which the United States Nuclear Regulatory Commission (NRC) has entered
into an effective agreement under Section 274b. of the Atomic Energy Act of
1954, as amended (73 Stat. 689).
(5)
] As low as is reasonably achievable
(ALARA) - Making every reasonable effort to maintain exposures to radiation
as far below the dose limits in this chapter as is practical, consistent with
the purpose for which the registered activity is undertaken, taking into account
the state of technology, the economics of improvements in relation to the
state of technology, the economics of improvements in relation to benefits
to the public health and safety, and other societal and socioeconomic considerations,
and in relation to utilization of ionizing radiation and radiation machines
in the public interest.
(6)
] Background radiation - Radiation
from cosmic sources; non-technologically enhanced naturally occurring radioactive
material, including radon, except as a decay product of source or special
nuclear material, and including global fallout as it exists in the environment
from the testing of nuclear explosive devices or from past nuclear accidents,
such as Chernobyl, that contribute to background radiation and are not under
the control of the registrant. "Background radiation" does not include radiation
from sources of radiation regulated by the agency.
(7)
] Certificate of registration
- A form of permission given by the agency to an applicant who has met the
requirements for registration or mammography system certification set out
in the
Texas Radiation Control Act (Act)
[
Act
] and this
chapter.
(8)
] Certification of mammography
systems (state certification) - A form of permission given by the agency to
an applicant who has met the requirements for mammography system certification
set out in the Act and this chapter.
(9)
] Chiropractor - An individual
licensed by the Texas State Board of Chiropractic Examiners [
, with license
in good standing
].
(10)
] Collective dose - The sum
of the individual doses received in a given period of time by a specified
population from exposure to a specified source of radiation.
(11)
] Declared pregnant woman
- A woman who has voluntarily informed the registrant, in writing, of her
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant woman voluntarily withdraws the declaration
in writing or is no longer pregnant.
(12)
] Deep dose equivalent (DDE),
that applies to external whole body exposure - The
dose equivalent (DE)
[
DE
] at a tissue depth of 1 centimeter (cm) (1,000 milligrams
per square centimeter
(mg/cm
2
))
[
(mg/cm2))
].
(13)
] Dentist - An individual
licensed by the Texas State Board of Dental Examiners[
, with license
in good standing
].
(14)
] Dose - For external exposure
to x-ray radiation from radiation machines, a generic term that means absorbed
dose, DE, or total effective dose equivalent. For purposes of this chapter,
"radiation dose" is an equivalent term.
(15)
] Dose equivalent (DE) - The
product of the absorbed dose in tissue, quality factor, and all other necessary
modifying factors at the location of interest. The units of DE are the sievert
(Sv) and rem.
(16)
] Dose limits - The permissible
upper bounds of radiation doses established in accordance with this chapter.
For purposes of this chapter, "limits" is an equivalent term.
(17)
] Dosimetry processor - A
person
[
registrant
] that processes and evaluates personnel
monitoring devices in order to determine the radiation dose delivered to the
monitoring devices.
(18)
] Embryo/fetus - The developing
human organism from conception until the time of birth.
(19)
] Entrance or access point
- Any opening through which an individual or extremity of an individual could
gain access to radiation areas or to radiation machines. This includes portals
of sufficient size to permit human access, irrespective of their intended
use.
(20)
] Exposure - The quotient
of dQ by dm where "dQ" is the absolute value of the total charge of the ions
of one sign produced in air when all the electrons (negatrons and positrons)
liberated by photons in a volume element of air having mass "dm" are completely
stopped in air. The
International System of Units (SI)
[
SI
] unit of exposure is the coulomb per kilogram (C/kg). The roentgen
is the special unit of exposure. For purposes of this chapter, this term is
used as a noun.
(21)
] Exposure rate - The exposure
per unit of time.
(22)
] External dose - That portion
of the DE received from any source of radiation outside the body.
(23)
] Extremity - Hand, elbow,
arm below the elbow, foot, knee, and leg below the knee. The arm above the
elbow and the leg above the knee are considered part of the whole body.
(24)
] Gray (Gy) - The SI unit
of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram
(J/kg) or 100 rad.
(25)
] High radiation area - An
area, accessible to individuals, in which radiation levels from sources of
radiation external to the body could result in an individual receiving a DE
in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any
source of radiation or from any surface that the radiation penetrates.
(26)
] Human use - For exposure
to x-ray radiation from radiation machines, the external administration of
radiation to human beings for healing arts purposes or research and/or development
specifically authorized by the agency.
(27)
] Individual - Any human being.
(28)
] Individual monitoring -
The assessment of DE to an individual by the use of:
(29)
] Individual monitoring devices
- Devices designed to be worn by a single individual for the assessment of
DE. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are
equivalent terms. Examples of individual monitoring devices include, but are
not limited to, film badges, thermoluminescence dosimeters (TLDs), optically
stimulated luminescence dosimeters (OSLs), pocket ionization chambers (pocket
dosimeters), and electronic personal dosimeters.
(30)
] Inspection - An official
examination and/or observation including, but not limited to, records, tests,
surveys, and monitoring to determine compliance with the Act and rules, orders,
requirements, and conditions of the agency.
(31)
] Ionizing radiation - Any
electromagnetic or particulate radiation capable of producing ions, directly
or indirectly, in its passage through matter. Ionizing radiation includes
gamma rays and x rays, alpha and beta particles, high speed electrons, neutrons,
and other nuclear particles.
(32)
] Lens dose equivalent (LDE)
- The external DE to the lens of the eye at a tissue depth of 0.3 cm (300
mg/cm
2
[
2
]).
(33)
] License - A form of permission
given by the agency to an applicant who has met the requirements for licensing
set out in the Act and this chapter.
(34)
] Licensed material - Radioactive
material received, possessed, used, or transferred under a general or specific
license issued by the agency.
(35)
] Licensee - Any person who
is licensed by the agency in accordance with the Act and this chapter.
(36)
] Licensing state - Any state
with rules equivalent to the Suggested State Regulations for Control of Radiation
relating to, and having an effective program for, the regulatory control of
naturally occurring or accelerator-produced radioactive material (NARM) and
has been designated as such by the Conference of Radiation Control Program
Directors, Inc.
(37)
] Lost or missing radiation
machine(s) - A radiation machine(s) whose location is unknown.
(38)
] Machine-produced radiation
- A stimulated emission of radiation from a manufactured product or device
or component part of a manufactured product or device that has an electronic
circuit that during operation can generate or emit a physical field of radiation.
(39)
] Manufacture - To fabricate
or mechanically produce.
(40)
] Member of the public - Any
individual, except when that individual is receiving an occupational dose.
(41)
] Minimal threat radiation
machines - Those radiation machines capable of generating or emitting fields
of radiation that, during the operation of which:
(42)
] Minor - An individual less
than 18 years of age.
(43)
] Monitoring - The measurement
of radiation and the use of the results of these measurements to evaluate
potential exposures and doses. For purposes of this chapter, "radiation monitoring"
and "radiation protection monitoring" are equivalent terms.
(44)
] Occupational dose - The
dose received by an individual in the course of employment in which the individual's
assigned duties involve exposure to sources of radiation from licensed/registered
and unlicensed/unregistered sources of radiation, whether in the possession
of the licensee/registrant or other person. Occupational dose does not include
dose received from background radiation, from any medical administration the
individual has received, from exposure to individuals administered radioactive
material and released in accordance with this chapter, from voluntary participation
in medical research programs, or as a member of the public.
(45)
] Particle accelerator - Any
machine capable of accelerating electrons, protons, deuterons, or other charged
particles in a vacuum and designed to discharge the resultant particulate
or other associated radiation at energies usually in excess of 1 MeV.
(46)
] Person - Any individual,
corporation, partnership, firm, association, trust, estate, public or private
institution, group, agency, local government, any other state or political
subdivision or agency thereof, or any other legal entity, and any legal successor,
representative, agent, or agency of the foregoing, other than the NRC, and
other than federal government agencies licensed or exempted by the NRC.
(47)
] Personnel monitoring equipment
(See definition for individual monitoring devices.)
(48)
] Physician - An individual
licensed by the Texas State Board of Medical Examiners [
, with license
in good standing
].
(49)
] Podiatrist - An individual
licensed by the Texas State Board of Podiatric Examiners [
, with license
in good standing
].
(50)
] Public dose - The dose received
by a member of the public from exposure to sources of radiation released by
a licensee, or to any other source of radiation under the control of a licensee/registrant.
It does not include occupational dose or doses received from background radiation,
from any medical administration the individual has received, from exposure
to individuals administered radioactive material and released in accordance
with this chapter, or from voluntary participation in medical research programs.
(51)
] Quarter - A period of time
equal to one-fourth of the year observed by the registrant, approximately
13 consecutive weeks, providing that the beginning of the first quarter in
a year coincides with the starting date of the year and that no day is omitted
or duplicated in consecutive quarters.
(52)
] Rad - The special unit of
absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram (erg/g)
or 0.01 J/kg (0.01 gray).
(53)
] Radiation - One or more
of the following:
stimulated
emission of radiation from any electronic device to such energy density levels
as to reasonably cause bodily harm
]; or
(54)
] Radiation area - Any area,
accessible to individuals, in which radiation levels could result in an individual
receiving a DE in excess of 0.005 rem (0.05 mSv) in one hour at 30 cm from
the radiation machine or from any surface that the radiation penetrates.
(55)
] Radiation machine - Any
device capable of producing ionizing radiation except those devices with radioactive
material as the only source of radiation.
(56)
] Radiation safety officer
(RSO) - An individual who has a knowledge of and the authority and responsibility
to apply appropriate radiation protection rules, standards, and practices,
who must be specifically authorized on a certificate of registration, and
who is the primary contact with the agency.
(57)
] Registrant - Any person
issued a certificate of registration by the agency in accordance with the
Act and this chapter.
(58)
] Regulation (See definition
for rule.)
(59)
] Rem - The special unit of
any of the quantities expressed as DE. The DE in rem is equal to the absorbed
dose in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)).
(60)
] Research and development
- Research and development is defined as:
(61)
] Restricted area - An area,
access to which is limited by the registrant for the purpose of protecting
individuals against undue risks from exposure to radiation. Restricted area
does not include areas used as residential quarters, but separate rooms in
a residential building may be set apart as a restricted area.
(62)
] Roentgen (R) - The special
unit of exposure. One roentgen (R) equals 2.58 x 10
-4
[
-4
]C/kg of air. (See definition for exposure.)
(63)
] Rule (as defined in the
Government Code, Chapters 2001 and 2002, as amended) - Any agency statement
of general applicability that implements, interprets, or prescribes law or
policy, or describes the procedure or practice requirements of an agency.
The term includes the amendment or repeal of a prior section but does not
include statements concerning only the internal management or organization
of any agency and not affecting private rights or procedures. The word "rule"
was formerly referred to as "regulation."
(64)
] Shallow dose equivalent
(SDE) - The DE at a tissue depth of 0.007 cm (7 mg/cm
2
[
2
])
that applies to the external exposure of
the skin of the whole body or the skin of an extremity.
[
averaged
over an area of 1 square centimeter (cm2) (applies to the external exposure
of the skin or an extremity).
]
(65)
] SI - The abbreviation for
the International System of Units.
(66)
] Sievert (Sv) - The SI unit
of any of the quantities expressed as DE. The DE in sievert is equal to the
absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).
(67)
] Site boundary - That line
beyond which the land or property is not owned, leased, or otherwise controlled
by the registrant.
(68)
] Source of radiation - Any
radioactive material, or any device or equipment emitting or capable of producing
radiation.
(69)
] Special units - The conventional
units historically used by registrants,
for example
[
i.e.
], rad (absorbed dose), and rem (DE).
(70)
] Survey - An evaluation of
the radiological conditions and potential hazards incident to the production,
use, transfer, disposal, and/or presence of sources of radiation. When appropriate,
such survey includes, but is not limited to, tests, physical examination of
location of equipment, measurements of levels of radiation present, and evaluation
of administrative and/or engineered controls.
(71)
] Termination - A release
by the agency of the obligations and authorizations of the registrant under
the terms of the certificate of registration. It does not relieve a person
of duties and responsibilities imposed by law.
(72)
] Texas Regulations for Control
of Radiation (TRCR) - All sections of Title 25 Texas Administrative Code (TAC),
Chapter 289.
(73)
] Total effective dose equivalent
(TEDE) - For external exposures only to x-ray radiation from radiation machines,
the TEDE is equal to the DDE. If an individual receives an occupational dose
from both radiation machines and radioactive materials, the TEDE is the sum
of the DDE for external exposures and the committed effective dose equivalent
for internal exposures as defined in §289.201(b) of this title.
(74)
] Unrestricted area (uncontrolled
area) - An area, access to which is neither limited nor controlled by the
registrant. For purposes of this chapter, "uncontrolled area" is an equivalent
term.
(75)
] Very high radiation area
- An area, accessible to individuals, in which radiation levels from sources
of radiation external to the body could result in an individual receiving
an absorbed dose in excess of 500 rads (5 grays) in one hour at 1 meter (m)
from a radiation machine or from any surface that the radiation penetrates.
At very high doses received at high dose rates, units of absorbed dose, gray
and rad, are appropriate, rather than units of DE, Sv and rem.
(76)
]Veterinarian - An individual
licensed by the Texas Board of Veterinary Medical Examiners [
, with license
in good standing
].
(77)
] Week - Seven consecutive
days starting on Sunday.
(78)
] Whole body - For purposes
of external exposure, head, trunk including male gonads, arms above the elbow,
or legs above the knee.
(79)
] Worker - An individual engaged
in work under a certificate of registration issued by the agency and controlled
by a registrant, but does not include the registrant.
(80)
] Year - The period of time
beginning in January used to determine compliance with the provisions of this
chapter. The registrant may change the starting date of the year used to determine
compliance by the registrant provided that the change is made at the beginning
of the year and that no day is omitted or duplicated in consecutive years.
An
] injunction
or
agency
[
other court
] order may be
issued
[
obtained
] prohibiting any violation of any provision of the Act or any
rule or order issued thereunder. Any person who willfully violates any provision
of the Act or any rule or order issued thereunder may be subject to civil
and/or administrative penalties. Such person may also be guilty of a misdemeanor
and upon conviction, may be punished by fine or imprisonment or both, as provided
by law.
Office of General Counsel, Texas Department
of Health,
] will be considered binding upon the agency.
and SDE
] shall be for the
portion of the body receiving the highest exposure.
The assigned SDE
shall be the dose averaged over the contiguous 10 square centimeters of skin
receiving the highest exposure.
, calculations,
] or radiation measurements for the purpose of demonstrating
compliance with the occupational dose limits, if the individual monitoring
device was not in the region of highest potential exposure, or the results
of individual monitoring are unavailable.
(ll)(2)
] of this section.
(F)
An individual monitoring device shall
be worn for the period of time authorized by the dosimetry processor's certificate
of registration or for no longer than three months, whichever is more restrictive.
]
e.g.,
] a lost or damaged personnel monitoring device) current occupational
dose data for the current year and that individual is employed solely by the
registrant during the current year, the registrant shall:
(ll)(5)
]
of this section.
or with conditions specified in a certificate of registration,
] shall be processed and evaluated by a dosimetry processor:
; and
]
(C)
holding a current certificate of registration
from the agency authorizing dosimetry processing.
]
, §289.119 of this
title (relating to Radiation Safety Requirements for Particle Accelerators),
] §289.227 of this title (relating to Use of Radiation Machines
in the Healing Arts [
and Veterinary Medicine
]),
§289.229
of this title (relating to Radiation Safety for Accelerators, Therapeutic
Radiation Machines, and Simulators),
and §289.255 of this title
(relating to Radiation Safety Requirements and Licensing and Registration
Procedures for Industrial Radiography).
, §289.119
of this title,
] §289.227 of this title,
§289.229 of this
title,
and §289.255 of this title.
or
] purple, or black; and
Office of General Counsel
] will
determine
[
be queried as to
] whether or not there has been a previous determination
that the information falls within one of the exceptions to the Texas Public
Information Act. If there has been no previous determination and the agency
believes that the information falls within one of the exceptions, an opinion
of the Attorney General will be requested. If the agency agrees in writing
to the request, the information shall not be open for public inspection unless
the Attorney General's office subsequently determines that it does not fall
within an exception.
(1)
Each registrant shall make and maintain
records showing the receipt, transfer, and disposal of all radiation machines.
These records shall be maintained by the registrant in accordance with subsection
(ll)(5) of this section. Additional record requirements are specified elsewhere
in this chapter. All records required by this chapter shall be accurate and
factual.
]
paragraph (1)
of this subsection, and
] subsections (cc)-(ee) of this section shall
include the date and the identification of individual(s) making the record,
and, as applicable, a unique identification of survey instrument(s) used,
and an exact description of the location of the survey. [
Records of receipt,
transfer, and disposal shall uniquely identify the radiation machine(s).
]
paragraph
(1) of this subsection, and
] subsections (cc)-(ee) of this section,
and by certificate of registration conditions that are relevant to operations
at an additional authorized use/storage site shall be maintained at that site
in addition to the main site specified on a certificate of registration in
accordance with subsection
(ll)(6)
[
(ll)(5)
] of this
section.
(ll)(5)
] of this section.
(ll)(5)
]
of this section.
60
] days of the end of the year.
(ll)(5)
] of this section. [
The registrant shall retain records
used in preparing BRC Form 231-3 or equivalent in accordance with subsection
(ll)(5) of this section.
]
(ll)(5)
] of this section.
Routine inspection
] of
radiation machines and services.
(ll)(1)
] of this section. Registrants having certificates of registration
authorizing multiple uses will be inspected at the most frequent interval
specified for the uses authorized.
(B)
Notwithstanding the provisions of subparagraph
(A) of this paragraph, for those radiation machines determined by the agency
to constitute a minimal threat to human health and safety, the routine inspection
interval will be five years. The applicable categories are listed in subsection
(ll)(2) of this section.
]
(C)
] Notwithstanding the inspection
intervals specified in this section, the agency may inspect registrants more
frequently due to:
(D)
] The agency will conduct inspections
of [
medical, podiatric medical, veterinary, and chiropractic
] radiation
machines or lasers in a manner designed to cause as little disruption of a
healing arts
[
medical, podiatric medical, veterinary, or chiropractic
] practice as is practicable.
, podiatric medical,
veterinary, or chiropractic
] radiation machines or lasers will have
training in the design and uses of the
machines
[
products
] and will receive training specified in subsection
(ll)(4) and/or
(5)
[
(ll)(3) and/or (4)
] of this section.
wherein
] radiation
machines are used or stored;
Routine inspection intervals for registrants.
]
Figure: 25 TAC §289.231(ll)(1)
]
(2)
] Minimal threat radiation machines.
Minimal threat radiation machines include, but are not limited to, the following:
(A)
electron microscope;
]
(B)
] x-ray fluorescence (machine);
(C)
] x-ray gauges;
(D)
] particle size analyzer (x-ray);
(E)
airport baggage x-ray;
]
(F)
] electron beam welding;
(G)
] ion implantation devices;
(H)
] cathodoluminescence devices;
(I)
] package x-ray; and
(J)
] certified cabinet x-ray.
(3)
] Training for agency inspectors
of radiation machines
for human use
.
inspectors of
] radiation machines
for
human use
will be conducted by the agency. Upon completion of training,
the inspector will be able to:
(4)
] Training for agency inspectors
of lasers. Initial training will include an introduction to the requirements
in this chapter and inspection forms. Inspections of two medical and two entertainment
lasers, conducted by an inspector having completed the requirements of this
paragraph, shall be observed before unsupervised inspection of lasers is permitted.
(5)
] Time requirements for record
keeping. The following are time requirements for record keeping.
Figure: 25 TAC §289.231(ll)(5)
]
(6)
] Occupational exposure form.
The following, BRC Form 231-3, is to be used to document occupational exposure
record for a monitoring period
.
[
: (Please find BRC Form 231-3
at the end of this section).
]
Figure: 25 TAC §289.231(ll)(6)
]
Subchapter F. LICENSE REGULATIONS
§289.204(e)(1)
] of this title, reimbursement of application
fees may be granted in the following manner.
(L)
] to ensure that personnel are
complying with this chapter, the conditions of the license, and the operating,
safety, and emergency procedures of the licensee; and
(M)
] to serve as the primary contact
with the agency.
§289.251(q)(1)
] of this title;
§289.251(q)(1)
] of this title will not occur;
§289.251(h)(1)(C) and (k)(1)
] of this title.
§289.251(h)(1)(C) and (k)(1)
] of this title or equivalent requirements of the NRC, an agreement
state, or a licensing state will be issued if the agency approves the following
information submitted by the applicant:
§289.251(h)(1)(C)
and (k)(1)
] of this title or in accordance with equivalent regulations
of the NRC, an agreement state, or a licensing state, be authorized to mount
the device, collect the sample to be analyzed by a specific licensee for radioactive
material leakage, perform maintenance of the device consisting of replacement
of labels, rust and corrosion prevention, and for fixed gauges, repair and
maintenance of sealed source holder mounting brackets, test the "on-off" mechanism
and indicator, or remove the device from installation, the applicant shall
include in the application written instructions to be followed by the general
licensee, estimated annual doses associated with such activity or activities,
and bases for such estimates. The submitted information shall demonstrate
that performance of such activity or activities by an individual untrained
in radiological protection, in addition to other handling, storage, and use
of devices in accordance with the general license, is unlikely to cause that
individual to receive an annual dose in excess of 10% of the limits specified
in §289.202(f) of this title.
§289.251(h)(1)(C) and (k)(1)
] of this title to each
person to whom the licensee directly commercially distributes radioactive
material in a device for use in accordance with the general license in
§289.251(f)(4)(H)
[
§289.251(h)(1)(C) and (k)(1)
]
of this title;
§289.251(h)(1)(C) and (k)(1)
] of this title, or alternatively,
a copy of the general license in
§289.251(f)(4)(H)
[
§289.251(h)(1)(C) and (k)(1)
] of this title to each person to whom
the licensee directly commercially distributes radioactive material in a device
for use in accordance with the general license of the NRC, the agreement state,
or the licensing state.
If certain requirements of the regulations do
not apply to the particular device, those requirements may be omitted.
If
a copy of the general license in
§289.251(f)(4)(H)
[
§289.251(h)(1)(C) and (k)(1)
] of this title is furnished to such
a person, it shall be accompanied by an explanation that the use of the device
is regulated by the NRC, agreement state, or licensing state in accordance
with requirements substantially the same as those in
§289.251(f)(4)(H)
[
§289.251(h)(1)(C) and (k)(1)
] of this title;
§289.251(h)(1)(C)
and (k)(1)
] of this title;
and
]
.
]
(5)
] In the case of a transfer
through an intermediate person, each licensee who commercially distributes
radioactive material in a device for use in accordance with the general license
in
§289.251(f)(4)(H)
[
§289.251(h)(1)(C) and (k)(1)
] of this title, shall furnish the information in paragraph (4) of this
subsection to the intended user prior to the initial transfer to the intermediate
person.
(6)
] Each person licensed in accordance
with this subsection to commercially distribute devices to generally licensed
persons shall:
§289.251(h)(1)(C) and (k)(1)
] of this title
and all receipts of devices from general licensees licensed in accordance
with §289.251(f)(4)(H) of this title
.
,
]
shall
] be filed within 30 days
thereafter
;
[
, and shall include:
]
(I)
]
identify
[
identity of
] each general licensee by name and
mailing
address
for the location of use; if there is no mailing address for the location of
use, an alternate address for the general licensee shall be submitted along
with information on the actual location of use
;
(II)
]
identify
[
identity of
] an individual by name
,
[
and/or position
]
title, and phone number
who
has knowledge of and authority
to take required actions to ensure compliance with the appropriate regulations
and requirements
[
may constitute a point of contact between the
agency and the general licensee
];
(III)
]
identify
the
type, model and serial number of device, and serial number of sealed source
commercially distributed; [
and
]
(IV)
]
identify
the
quantity and type of radioactive material contained in the device
; and
[
.
]
identification
of
] each intermediate person
and clearly designate the intermediate
person(s)
[
by name, address, contact, and relationship to the intended
user
].
§289.251(h)(1)(C) and (k)(1)
] of this title during the reporting
period, the report shall so indicate.
(II)
identity of an individual
by name and/or position who may constitute a point of contact between the
agency and the general licensee;]
(III)
] the type, model and serial
number of device, and serial number of sealed source commercially distributed;
[
and
]
(IV)
] the quantity and type of
radioactive material contained in the device; [
or
]
(ii)
] if no commercial distributions
have been made to the NRC licensees during the reporting period; the report
shall so indicate; and
§289.251(h)(1)(C) and (k)(1)
] of this title
and all receipts
of devices from general licensees
.
and shall include the following:
]
(I)
]
identify
[
identity of
] each general licensee by name and
mailing
address
for the location of use; if there is no mailing address for the location of
use an alternate address for the licensee shall be submitted along with the
information on the actual location of use
;
(II)
]
identify
[
identity of
] an individual by name
,
[
and/or
] position
, and phone number
who
has knowledge of and authority to take required
actions to ensure compliance with the appropriate regulations and requirements
[
may constitute a point of contact between the agency and the
general licensee
];
(III)
] the type, model and serial
number of the device, and serial number of sealed source commercially distributed;
[
and
]
(IV)
] the quantity and type of
radioactive material contained in the device
; and
[
.
]
identification of
] each intermediate person
, and clearly designate the intermediate person(s)
[
by name, address,
contact, and relationship to the intended user
]; and
§289.251(h)(1)(C) and (k)(1)
] of this title, or equivalent
requirements of the NRC, an agreement state, or a licensing state.
§289.251(h)(1)(C) and (k)(1)
] of this title during the reporting
period, the records shall so indicate.
(7)
] If a notification of bankruptcy
has been made in accordance with subsection (x)(4) of this section or the
license is to be terminated, each person licensed under this subsection shall
provide, upon request to the NRC and to any appropriate agreement state or
licensing state, records of final disposition required under subsection
(y)(16)(A)
[
(y)(14)(A)
] of this section.
§289.251(h)(4)
] of this title. In addition to the
requirements in subsection (e) of this section, a specific license to manufacture,
assemble, or repair luminous safety devices containing tritium or promethium-147
for use in aircraft, for commercial distribution to persons generally licensed
in accordance with
§289.251(f)(4)(B)
[
§289.251(h)(4)
] of this title, will be issued if the agency approves the information
submitted by the applicant. The information shall satisfy the requirements
of Title 10, CFR, §§32.53, 32.54, 32.55, 32.56, and 32.101 or their
equivalent.
§289.251(h)(6)
] of this title. In addition to the
requirements in subsection (e) of this
section
[
title
],
a specific license to manufacture calibration sources containing americium-241,
plutonium, or radium-226 to persons generally licensed in accordance with
§289.251(f)(4)(D)
[
§289.251(h)(6)
] of this title
will be issued if the agency approves the information submitted by the applicant.
The information shall satisfy the requirements of Title 10, CFR, §§32.57,
32.58, 32.59, and 32.102, and 10 CFR 70.39 or their equivalent.
§289.251(k)(2)
] of this title will be issued if the agency approves
the following information submitted by the applicant:
§289.251(h)(5)
] of this title
will be issued if the agency approves the information submitted by the applicant.
This information shall satisfy the requirements of Title 10, CFR, §§32.61,
32.62, and 32.103.
§289.251(g)(5)
] of this title or equivalent regulations of the
NRC or an agreement state, will be issued if the agency approves the following
information submitted by the applicant:
§289.251(g)(5)
] of this title to each person to whom the licensee
commercially distributes depleted uranium in a product or device for use in
accordance with the general license in
§289.251(f)(3)(D)
[
§289.251(g)(5)
] of this title;
§289.251(g)(5)
] of this title and a copy of the NRC's or agreement state's certificate;
or
§289.251(g)(5)
] of this title to each person to whom
the licensee commercially distributes depleted uranium in a product or device
for use in accordance with the general license of the NRC or an agreement
state;
§289.251(g)(5)
] of this title.
§289.251(g)(5)
] of this title during the reporting period, the
report shall so indicate;
§289.251(g)(5)
] of this title. The report shall meet the provisions of subparagraph
(E)(i) and (ii) of this paragraph; and
§289.251(g)(5)
]
of this title or equivalent requirements of the NRC or of an agreement state.
The records shall be maintained for a period of two years for inspection by
the agency and shall show the date of each commercial distribution, the quantity
of depleted uranium in each product or device commercially distributed, and
compliance with the report requirements of this section.
it
] deems
appropriate or necessary.
it
]
deems appropriate or necessary in order to:
and
] decommissioning of sites and separate buildings
or outdoor areas.
(2)
] of this subsection and subsection (z)(2) of this section, each
specific license expires at the end of the day, in the month and year stated
in the license.
Upon payment of the fee required by §289.204 of
this title and if the agency does not deny the renewal in accordance with
subsection (x)(7) of this section, the specific license will be administratively
renewed.
(2)
] All license provisions continue
in effect beyond the expiration date, with respect to possession of radioactive
material until the agency notifies the former licensee in writing that the
provisions of the license are no longer binding. During this time, the former
licensee shall:
(3)
] Within 60 days of the occurrence
of any of the following, each licensee shall provide notification to the agency
in writing and either begin decommissioning its site, or any separate building
or outdoor area that contains residual radioactivity, so that the building
and/or outdoor area is suitable for release in accordance with §289.202(eee)
of this title, or submit within 12 months of notification a decommissioning
plan, if required by paragraph
(8)
[
(6)
] of this subsection,
and begin decommissioning upon approval of that plan if:
(dd)(3)
] of this section;
(4)
] Coincident with the notification
required by paragraph
(5)
[
(3)
] of this subsection,
the licensee shall maintain in effect all decommissioning financial assurances
established by the licensee in accordance with subsection (gg) of this section
in conjunction with a license issuance or renewal or as required by this section.
The amount of the financial assurance shall be increased, or may be decreased,
as appropriate, with agency approval, to cover the detailed cost estimate
for decommissioning established in accordance with paragraph
(11)(E)
[
(9)(E)
] of this subsection.
(5)
] The agency may grant a request
to delay or postpone initiation of the decommissioning process if the agency
determines that such relief is not detrimental to the occupational and public
health and safety and is otherwise in the public interest. The request shall
be submitted no later than 30 days before notification in accordance with
paragraph
(5)
[
(3)
] of this subsection. The schedule
for decommissioning set forth in paragraph
(5)
[
(3)
]
of this subsection may not commence until the agency has made a determination
on the request.
(6)
] A decommissioning plan shall
be submitted if required by license condition or if the procedures and activities
necessary to carry out decommissioning of the site or separate building or
outdoor area have not been previously approved by the agency and these procedures
could increase potential health and safety impacts to workers or to the public,
such as in any of the following cases:
(7)
] The agency may approve an
alternate schedule for submittal of a decommissioning plan required in accordance
with paragraph
(5)
[
(3)
] of this subsection if the agency
determines that the alternative schedule is necessary to the effective conduct
of decommissioning operations and presents no undue risk from radiation to
the occupational and public health and safety and is otherwise in the public
interest.
(8)
] The procedures listed in
paragraph
(8)
[
(6)
] of this subsection may not be carried
out prior to approval of the decommissioning plan.
(9)
] The proposed decommissioning
plan for the site or separate building or outdoor area shall include the following:
(13)
] of this subsection.
(10)
] The proposed decommissioning
plan will be approved by the agency if the information in the plan demonstrates
that the decommissioning will be completed as soon as practicable and that
the health and safety of workers and the public will be adequately protected.
(11)
] Except as provided in paragraph
(15)
[
(13)
] of this subsection, licensees shall complete
decommissioning of the site or separate building or outdoor areas as soon
as practicable but no later than 24 months following the initiation of decommissioning.
(12)
] Except as provided in paragraph
(15)
[
(13)
] of this subsection, when decommissioning involves
the entire site, the licensee shall request license termination as soon as
practicable but no later than 24 months following the initiation of decommissioning.
(13)
] The agency may approve a
request for an alternate schedule for completion of decommissioning of the
site or separate building or outdoor area, and license termination if appropriate,
if the agency determines that the alternative is warranted by consideration
of the following:
(14)
] As the final step in decommissioning,
the licensee shall do the following:
(15)
] The agency will provide
written notification to specific licensees, including former licensees with
provisions continued in effect beyond the expiration date in accordance with
paragraph
(4)
[
2
] of this subsection, that the provisions
of the license are no longer binding. The agency will provide such notification
when the agency determines that:
(16)
] Each licensee shall submit
to the agency all records required by §289.202(nn)(2) of this title before
the license is terminated.
Renewal
of license
].
Requests
] for
a technical
renewal of specific licenses shall be filed in accordance
with subsection (d)(1)-(3) and (5)-(7) of this section.
An application
for a technical renewal of a specific license shall be filed by the date specified
in the existing license condition. If the licensee fails to apply and pay
the fee required by §289.204 of this title, the license expires and the
licensee shall comply with the requirements of subsection (y) of this section.
In any application for renewal, the applicant may incorporate drawings
by clear and specific reference (for example, title, date and unique number
of drawing), if no modifications have been made since previously submitted.
not less than 30
days
] prior to expiration of an existing license, has filed a request
in proper form for
a technical
renewal or for a new license authorizing
the same activities, such existing license shall not expire until the request
has been finally determined by the agency. In any case in which a licensee,
not more than
30
[
90
] days after the expiration of an
existing license, has filed
an application for technical renewal in entirety
and paid the fee required by §289.204 of this title
[
a request
in proper form for renewal
] or for a new license authorizing the same
activities, the agency may reinstate the license and extend the expiration
until the request has been finally determined by the agency.
amendment,
] revision[
,
] or modification. A license
may be
modified,
suspended or revoked by reason of amendments to
the Act, by reason of rules in this chapter, or orders issued by the agency.
or
]
.
]
, interest
] or safety requires otherwise, no license shall be [
modified,
] suspended[
,
] or revoked unless, prior to the institution
of proceedings therefore, facts or conduct that may warrant such action shall
have been called to the attention of the licensee in writing and the licensee
shall have been afforded an opportunity to demonstrate compliance with all
lawful requirements.
state
] of Texas provided that:
an annual
] fee as specified in §289.204
of this title.
§289.251 (h)(1)(C) and (k)(1)
] of this title, within areas subject
to the jurisdiction of the licensing body, is granted a general license to
install, transfer, demonstrate, or service the device in the
State
[
state
] of Texas provided that:
§289.251 (h)(1)(C) and (k)(1)
] of this title.
state
] of Texas to the Radiation and Perpetual Care
Account
[
Fund
].
)
]
Chapter 295.
OCCUPATIONAL HEALTH
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION