Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter D. NEWBORN SCREENING PROGRAM
The Texas Department of Health (department) proposes amendments to §§37.51-37.67
and the repeal of §37.69 concerning the newborn screening program.
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). Sections 37.51-37.67 have
been reviewed and the department has determined that reasons for their adoption
continue to exist. However, the sections require revision as described in
this preamble. Section 37.69 has been reviewed, and the department has determined
that reasons for its adoption no longer exist.
The department published a Notice of Intention to Review §§37.51-37.67
and §37.69 as required by Government Code, §2001.039 in the
The amendment to §37.51 corrects a syntax error. Amendments to §37.52
incorporate the definition of "bona fide resident" used by the Children With
Special Health Care Needs Services Program. The amendment to §37.53 improves
syntax by substituting "receive" for "be subjected to." An amendment rewords §37.54
to indicate more accurately that children usually have only a single managing
conservator or guardian. An amendment to §37.55 clarifies the amount
of time specimens must be air-dried by changing "three hours" to "three to
four hours". The amendment to §37.56 clarifies the circumstances under
which newborns must be screened within the first 72 hours of life. The amendment
to §37.57 refers to "department" rather than "Texas Department of Health."
An amendment to §37.58 clarifies that individuals must report to the
department all confirmed cases of conditions for which screening tests are
required, as stated by Health and Safety Code §33.015. Amendments clarify
and update §37.59 by including references to the Children With Special
Health Care Needs Services Program (CSHCN) in lieu of the Chronically Ill
and Disabled Children's Services Program (CIDC), and also refer to the "program"
rather than the "Newborn Screening Program." The amendment to §37.60
also refers to "program" rather than "Newborn Screening Program." Amendments
to §37.61 also include the uniform references to "program" rather than
"Newborn Screening Program", "department" rather than "Texas Department of
Health (department)", and "Children With Special Health Care Needs (CSHCN)"
rather than "Chronically Ill and Disabled Children (CIDC)". The section has
also been updated by addition of the "Children's Health Insurance Plan (CHIP)"
as another benefit which could pay for newborn screening services. The amendments
to §37.62 continue the uniform use of "program" in lieu of "Newborn Screening
Program (program)", include the Bureau of Children's Health as the current
organizational address of the program, and delete a reference to a complete
program application, which is not included in the rules. Amendments to the
financial participation scale in §37.63 clarify income eligibility criteria
and add references to CHIP and CSHCN. The amendment to §37.64 clarifies
that the Newborn Screening Program is part of the department's Bureau of Children's
Health, and the section now refers to the department's fair hearing rules,
rather than to the formal hearing rules. The amendment to §37.65 corrects
a syntax error. Amendments to §37.66 and §37.67 include the uniform
use of "department" for "Texas Department of Health (department)" and "program"
for "Newborn Screening Program (program)". Section 37.69, which refers to
the original effective dates of the program, is being repealed because it
is no longer necessary.
Margaret Drummond-Borg, M.D., Director, Genetic Screening and Case Management
Division, has determined that for each year of the first five years the sections
and repeal are in effect, there are no fiscal implications to state or local
government as a result of enforcing or administering the sections as proposed
because the amendments and repeal make no substantive changes in the sections.
Dr. Drummond-Borg has also determined that for each year of the first five
years the sections and repeal are in effect, the public benefits anticipated
as a result of enforcing or administering the amendments and repeal will be
consistency between the rules and contemporary practice and statutes; clarification
of financial eligibility for services; increased clarity and readability of
the sections; and possible reduction of the number of unsatisfactory specimens
received by the program by increasing the permissible drying time. There will
be no effect on micro-businesses or small businesses. This was determined
because the amendments and repeal make no substantive changes in the rules,
which could impact micro-businesses or small business. 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 on the proposal may be submitted to Margaret Drummond-Borg, M.D.,
Director, Genetic Screening and Case Management Division, Texas Department
of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 458-7443, fax
(512) 458-7350. Comments will be accepted for 30 days following publication
of this proposal in the
Texas Register
.
25 TAC §§37.51 - 37.67
The amendments are proposed under Health and Safety Code, §33.002(b)
which provides the Texas Board of Health (board) with the authority to adopt
rules necessary to carry out the Newborn Screening Program; and Health and
Safety Code, §12.001 which provides the board with authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The amendments affect the Health and Safety Code, Chapter 33, and implement
Government Code, §2001.039.
§37.51.Purpose.
These sections describe the Newborn Screening Program administered
by the Texas Department of Health. Under the authorization of the statutes
listed in these sections, each newborn delivered in the state must be subjected
to a panel of screening tests to identify the newborn that may be at risk
of developing phenylketonuria, other heritable diseases, or hypothyroidism.
These
[
§37.52.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
(No change.)
(2)
Bona fide resident--A person
who:
(A)
is physically present within the geographic
boundaries of the state;
(B)
has an intent to remain within the state;
(C)
maintains an abode within the state (i.e., house
or apartment, not merely a post office box);
(D)
has not come to Texas from another country for
the purpose of obtaining medical care, with the intent to return to the person's
native country;
(E)
does not claim residency in any other state
or country; and
(i)
is a minor child residing in Texas whose parent(s),
managing conservator, or guardian of the child's person is a bona fide resident;
(ii)
is a person residing in Texas who is the legally
dependent spouse of a bona fide resident; or
(iii)
is an adult residing in Texas, including an
adult whose legal guardian is a bona fide resident or who is his/her own guardian.
[
[
[
(3)-(15)
(No change.)
§37.53.Conditions for Which Newborn Screening Tests Are Required.
Except as permitted in §37.54 of this title (relating to Exemption
from Screening), all newborns delivered in Texas shall
receive
[
(1)-(5)
(No change.)
§37.54.Exemption from Screening.
A newborn may not be screened if
either
[
§37.55.Responsibilities of Persons Attending a Newborn.
(a)-(b)
(No change.)
(c)
Specimens must air-dry on a flat surface for at least three
to four
hours and must be mailed to the department within 24 hours after
collection. If multiple specimens are mailed in one envelope, care must be
taken to avoid cross-contamination.
§37.56.Blood Specimen Collection for Required Screening Tests.
(a)-(b)
(No change.)
(c)
Unless delivered in a hospital
[
(d)-(e)
(No change.)
§37.57.Screening Test Procedures To Be Used.
Analysis of the blood specimens for the required screening tests must
be performed by the
department
[
(1)-(3)
(No change.)
§37.58.Follow-up and Recordkeeping on Positive Screens.
(a)-(c)
(No change.)
(d)
Individuals
shall
[
(e)-(f)
(No change.)
§37.59.Coordination with Children With Special Health Care Needs [
(a)
All newborns and other individuals under the age of 21
years who have been screened and have been found to be presumptively positive
through the
program
[
(b)
An individual who is determined to be eligible for
CSHCN
[
§37.60.Scope of Newborn Screening Program Services.
In cooperation with the individual's attending physician and within
the limits of funds appropriated by the legislature for this purpose, the
program is authorized to provide the following services to individuals who
are approved for
program
[
(1)-(2)
(No change.)
§37.61.Eligibility Requirements.
(a)
Except as otherwise provided for in these sections, to
be eligible to receive program services, an individual must:
(1)
have a confirmed diagnosis of a disorder screened by the
program
[
(2)-(7)
(No change.)
(b)
An individual is not eligible to receive services from
the program at no cost or reduced cost to the extent that the individual or
the parent, managing conservator, guardian, or other person with a legal obligation
to support the individual is eligible for some other benefit, such as Medicaid,
Children With Special Health Care Needs (CSHCN)
[
(c)
The
department
[
(1)-(2)
(No change.)
§37.62.Application Process.
(a)
To be considered for
program
[
(b)-(h)
(No change.)
§37.63.Calculation of Financial Participation Obligation.
(a)
(No change.)
(b)
The following financial participation scale lists the copayment
obligation for program services.
Figure: 25 TAC §37.63(b)
(c)-(e)
(No change.)
§37.64.Denial of Application; Modification, Suspension, Termination of Program Services.
(a)
(No change.)
(b)
Procedure for denial, modification, suspension, or termination
do not apply to adjustments made by the program in poverty income guidelines
to conform to federal poverty income guidelines or to adjustments in the type
and amount of program services available when such adjustments are necessary
to conform to budgetary limitations as provided in §37.60 of this title
(relating to Scope of Newborn Screening Program Services.)
(1)-(2)
(No change.)
(3)
Within 30 days after receiving notice as specified in paragraph
(2) of this subsection, the individual or the individual's representative
may appeal the program's decision to deny, suspend, modify, or terminate the
services to the department and request an administrative hearing before the
department. Appeals and request for hearings must be in writing and sent the
following address by certified mail: Administrator, Newborn Screening Program,
Bureau of
Children's Health
[
(4)
Appeals and administrative hearings will be conducted in
accordance with the department's
fair
[
§37.65.Advisory Bodies and Task Forces.
The commissioner may appoint both technical and lay advisory committees
to assist in the administration of this program. The commissioner may also
convene special task forces to assist the program and [
§37.66.Confidentiality of Information.
(a)
All information required by these sections to be submitted
may be verified at the discretion of the
department
[
(b)
(No change.)
§37.67.Nondiscrimination Statement.
The
department
[
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 June 14, 2002.
TRD-200203701
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §37.69
(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, §33.002(b)
which provides the Texas Board of Health (board) with the authority to adopt
rules necessary to carry out the Newborn Screening Program; and Health and
Safety Code, §12.001 which provides the board with authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The repeal affects the Health and Safety Code, Chapter 33, and implements
Government Code, §2001.039.
§37.69.Effective Dates.
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 June 14, 2002.
TRD-200203702
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments of §§91.1,
91.4, 91.6, 91.7, the repeal of §§91.2, 91.3, 91.5, 91.8 - 91.14
and new §§91.2, 91.3, 91.5, 91.8 - 91.12 concerning the cancer registry
and the reporting of cancer incidence data to the department or its authorized
representatives. The amended and new sections specify who is required to report
and has access to records for reporting; what cancer information is to be
reported; when, how and where this information should be reported; a definition
of reporting compliance and a cost-recovery method to access cancer information
from persons failing to report in the prescribed format; quality assurance
activities; confidentiality and disclosure of cancer information; and requests
for and release of statistical and personal cancer data.
Specifically, these amendments, repeals, and new sections are required
by Chapter 82, Texas Health and Safety Code which was revised by Senate Bill
285, 77th Legislature, 2001, to include cancer reporting by health care practitioners
and to clarify and improve cancer incidence reporting. These changes also
are needed to fulfill federal grant requirements for Texas to maintain a statewide
population-based cancer registry that meets national standards. State law
and regulations must support the National Program of Cancer Registries' requirements
(42 U.S.C. §§280e to 280e-4) for receipt of federal funding.
New §91.3 reflects the expanded scope of the law for cancer reporting
to include health care practitioners (physicians and dentists). New §§91.3
and 91.9 address cancer case reporting and data disclosure under the Health
Insurance Portability and Accountability Act of 1996 and the Texas Health
and Safety Code, Chapter 181, Medical Records Privacy. An amendment to §91.4
reflects changes in the reportable conditions and information and requires
electronic reporting with one exception. New §91.5 outlines reporting
timeframes and frequency of reporting for health care facilities, health care
practitioners and clinical laboratories. New §91.12 reflects a new approval
process for release of personal cancer data.
Nancy S. Weiss, Ph.D., Director, Cancer Registry Division has determined
that for the first five-year period the sections are in effect, there will
be fiscal implications as a result of enforcing or administering the sections
as proposed. These sections are necessary for the department to continue to
receive federal grant funds. For FY 2002, those funds are $2.1 million. The
amounts for subsequent years have not yet been determined. It is estimated
that costs to the state to administer the new data collection method will
be offset by the federal funds received. There will be no fiscal implications
for most local governments. Local governments that are providing cancer diagnosis
and/or treatment will incur costs of $8 to $15 per case.
Dr. Weiss 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 will be to have complete and accurate cancer data reported
within six months of initial diagnosis or admission for the diagnosis or treatment
of cancer. This will increase the availability of timely, statewide cancer
incidence data for use in cancer prevention and control efforts in the state
and for securing cancer research funding. The anticipated effect on micro-businesses
or small businesses (as well as large businesses) that do not report will
be the cost of data collection by the department estimated to be $35 to $65
per unreported cancer case. The economic costs to persons who are required
to comply with the sections as proposed will be the staff time to complete
reporting requirements which is estimated to be 15 to 45 minutes per case
(estimated $8 to $15 per case). There will be no impact on local employment.
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 §§91.1 - 91.14 and has determined that reasons for
adopting the sections continue to exist; however §§91.1, 91.4, 91.6,
and 91.7 are being amended, and proposed new §§91.2, 91.3, 91.5,
91.8 - 91.12 are necessary as described in this preamble. Sections 91.2, 91.3,
91.5, 91.8 - 91.14 have been reviewed and the department has determined that
the reasons for adopting these sections no longer continue to exist and the
rules will be repealed.
The department published a Notice of Intention to Review for §§91.1
- 91.14 in the
Texas Register
on January 7,
2000 (25 TexReg 218). No comments were received due to publication of this
notice.
Comments on the proposal may be submitted to Nancy S. Weiss, Ph.D., Director,
Cancer Registry Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas, 78756, (512) 458-7523. Comments will be accepted for 30 days
following publication of this proposal in the
Texas
Register
.
Subchapter A. CANCER REGISTRY
25 TAC §§91.1 - 91.12
The amendments and new sections are proposed under Health
and Safety Code §82.006 which provides the department with the authority
to adopt rules necessary to implement Chapter 82 (Cancer Registry); §81.004
which provides the Texas Board of Health with the authority to administer
Chapter 81 for protecting the public's health and preventing the introduction
of disease in the state; and §12.001, which provides the Texas Board
of Health 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 amendments and new sections affect Health and Safety Code, Chapter
82.
§91.1.Purpose.
These sections implement the Texas Cancer Incidence Reporting Act,
Health and Safety Code, Chapter 82, which authorizes the Texas Board of Health
to adopt rules concerning the reporting of cases [
§91.2.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Act--The Texas Cancer Incidence Reporting Act, Texas Health
and Safety Code, Chapter 82.
(2)
Cancer--Includes a large group of diseases characterized
by uncontrolled growth and spread of abnormal cells; any condition of tumors
having the properties of anaplasia, invasion, and metastasis; a cellular tumor
the natural course of which is fatal, including malignant and benign tumors
of the central nervous system; and malignant neoplasm, other than nonmelanoma
skin cancers such as basal and squamous cell carcinomas.
(3)
Cancer reporting handbook--The division's manual for cancer
reporters that documents reporting procedures and format.
(4)
Clinical laboratory--An accredited facility in which tests
are performed identifying findings of anatomical changes; specimens are interpreted
and pathological diagnoses are made.
(5)
Department--Texas Department of Health.
(6)
Division--Cancer Registry Division of the department.
(7)
Health care facility--A general or special hospital as
defined by the Health and Safety Code, Chapter 241; an ambulatory surgical
center licensed under the Health and Safety Code, Chapter 243; an institution
licensed under the Health and Safety Code, Chapter 242; or any other facility,
including an outpatient clinic, that provides diagnostic or treatment services
to patients with cancer.
(8)
Health care practitioner--A physician as defined by Occupations
Code, §151.002 or a person who practices dentistry as described by the
Occupations Code, §251.003.
(9)
Personal cancer data--Information that includes items that
may identify an individual.
(10)
Quality assurance--Operational procedures by which the
accuracy, completeness, and timeliness of the information reported to the
department can be determined and verified.
(11)
Regional cancer registry-The organization authorized by
the department to receive and collect cancer data for a designated area of
the state and which maintains the system by which the collected information
is reported to the department.
(12)
Regional director--The physician who is the chief administrative
officer of a public health region and is designated by the department under
the Local Public Health Reorganization Act, Health and Safety Code, §121.007.
(13)
Report--Information provided to the department that notifies
the appropriate authority of the occupancy of a specific cancer in a person,
including all information required to be provided to the department.
(14)
Research--A systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to
generalizable knowledge.
(15)
Statistical data--Aggregate presentation of individual
records on cancer cases excluding patient identifying information.
(16)
Texas Cancer Registry--The cancer incidence reporting
system administered by the Cancer Registry Division.
§91.3.Who Reports, Access to Records.
(a)
Each health care facility, clinical laboratory or health
care practitioner shall report to the department, by methods specified in §§91.4
- 91.7 of this title (relating to Cancer Registry), required data from each
medical record pertaining to a case of cancer in its custody or under its
control except for cases to which subsection (d) of this section would apply.
(b)
A health care facility or clinical laboratory providing
screening, diagnostic or therapeutic services to patients with cancer shall
grant the department or its authorized representative access to but not removal
of all medical records which would identify cases of cancer, establish characteristics
or treatment of cancer, or determine the medical status of any identified
cancer patient.
(c)
A health care practitioner providing diagnostic or treatment
services to patients with cancer shall grant the department or its authorized
representative access to but not removal of all medical records which would
identify cases of cancer, establish characteristics or treatment of cancer,
or determine the medical status of any identified cancer patient except for
cases to which subsection (d) of this section would apply.
(d)
The department may not require a health care practitioner
to furnish data or provide access to records if:
(1)
the data or records pertain to cases reported by a health
care facility providing screening, diagnostic, or therapeutic services to
cancer patients that involve patients referred directly to or previously admitted
to the facility; and
(2)
the facility reported the same data the practitioner would
be required to report.
(e)
Health care facilities, clinical laboratories, and health
care practitioners are subject to federal law known as the Health Insurance
Portability and Accountability Act of 1996 found at Title 42 United States
Code §1320d et seq.; the federal privacy rules adopted in Title 45 Code
of Federal Regulations (C.F.R.) Parts 160 and 164; and state law found in
the Health and Safety Code, Chapter 181, Medical Records Privacy, §181.101.
Because state law requires reporting of cancer data, persons subject to this
chapter are permitted to provide the data to the department without patient
consent or authorization under 45 C.F.R. §164.512(a) relating to uses
and disclosures required by law and §164.512(b)(1) relating to disclosures
for public health activities. Both of these exceptions to patient consent
or authorization are recognized in the state law in Health and Safety Code, §181.101.
§91.4.What to Report.
(a)
Reportable conditions.
(1)
The cases
[
(A)
all neoplasms with a behavior code of two or three in the
most current edition of the International Classification on Diseases for Oncology
(ICD-O)
of the World Health Organization
with the exception of
those designated by the division as non-reportable in the cancer reporting
handbook;
and
(B)
all benign and borderline neoplasms of the [
[(C)
cystadenomas of borderline malignancy
of ovary (ICDO-2 codes C56.9 and M83801);]
[(D)
hydatiform mole, malignant (ICDO-2 codes
C58.9 and M91001); and]
[(E)
any neoplasm specified malignant.]
(2)
Codes and taxa of the
most current edition of the
International Classification of Diseases, [
(b)
Reportable information.
(1)
The data required to be
reported
[
(A)
(No change.)
(B)
social security number,
date of birth,
gender
[
(C)
(No change.)
(D)
diagnosis including the cancer site
and laterality
, cell type, tumor
behavior,
grade and size, stage of disease,
date of diagnosis, and diagnostic confirmation method;
(E)
(No change.)
(F)
text information to support cancer diagnosis, stage and
treatment codes,
unless another method acceptable to the division is
used to confirm these codes.
[
(2)
Each report shall:
(A)
be legible and contain all data items required in
paragraph (1) of this
subsection [
(B) - (C)
(No change.)
(D)
in the case of individuals who have more than one form
of cancer, be submitted separately for each primary cancer [
(E)
be submitted to the division electronically, or manually
if electronic means are unavailable; and
the annual cancer caseload of
the health care facility, clinical laboratory or health care practitioner
is 50 or fewer cases; and
(F)
(No change.)
§91.5.When to Report.
(a)
All reports shall be submitted to the department within
six months of the patient's admission, initial diagnosis or treatment for
cancer.
(b)
Data shall be submitted no less than quarterly by health
care facilities with annual caseloads of 400 or less. Monthly submissions
are required for all other health care facilities.
(c)
Data shall be submitted no less than quarterly by health
care practitioners initially diagnosing a patient with cancer and performing
the in-house pathological tests for that patient. Otherwise, data shall be
submitted within 4 months of the request to a health care practitioner by
the department or its authorized representative for a report or subset of
a report on a patient diagnosed or treated elsewhere and for whom the same
cancer data has not been reported.
(d)
Data shall be submitted no less than bi-annually by clinical
laboratories.
§91.6.How to Report.
A report of cancer can be made to the department by any of the following
methods:
(1)
submission of
an original of
a completed Confidential
Cancer Reporting Form (TCR No.1)[
(2)
submission electronically
of a TCR No. 1 or a subset
of data items acceptable to the division
using one of the following
methods:
(A)
(No change.)
(B)
compact disc
[
(C) - (D)
(No change.)
§91.7.Where to Report.
(a)
Forms.
[
[(2)
A map and list of public health regions,
and the addresses of respective regional directors are available from the
Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3199.]
(b)
All electronic data reports should be submitted to the
division as specified in the cancer reporting handbook.
[
§91.8.Compliance.
(a)
Each health care facility, clinical laboratory or health
care practitioner that reports to the department, by methods specified in §§91.4-91.7
of this title (relating to Cancer Registry), is considered compliant.
(b)
A person will be notified in writing if the person has
not reported in compliance with this chapter within 30 days following the
end of the calendar year quarter and will be given an opportunity to take
corrective action within 60 days from the date of the notification letter.
A second notification letter will be sent 30 days after the date of the original
notification letter if no corrective action has been taken.
(c)
If a person is non-compliant and takes no corrective action
within 60 days of the original notification letter, the department or its
authorized representative may access the information from the health care
facility, clinical laboratory or health care practitioner as provided in §91.3
of this title (relating to Who Reports, Access to Records) and report it in
the appropriate format.
(1)
The health care facility, clinical laboratory or health
care practitioner shall be notified at least two weeks in advance before a
scheduled arrival for collection of the information.
(2)
A health care facility, clinical laboratory or health care
practitioner that knowingly or in bad faith fails to furnish data as required
by this chapter shall reimburse the department or its authorized representative
for its cost to access and report the information. The costs must be reasonable,
based on the actual costs incurred by the department or by its authorized
representative in the collection of the data and may include salary and travel
expenses. It is presumed that a health care facility, clinical laboratory
or health care practitioner acted knowingly or in bad faith if it failed to
take corrective action within 60 days of the date of the original notification
letter.
(3)
A health care facility, clinical laboratory or health care
practitioner may request the department to conduct a hearing under the department's
fair hearing rules to determine whether reimbursement to the department is
appropriate.
(d)
Any health care facility, clinical laboratory or health
care practitioner which is required to reimburse the department or its authorized
representative for the cost to access and report the information pursuant
to subsection (c)(2) of this section shall provide payment to the department
or its authorized representative within 60 days of the day this payment is
demanded. In the event any health care facility, clinical laboratory or health
care practitioner fails to make payment to the department or its authorized
representative within 60 days of the day the payment is demanded, the department
or its authorized representative may, at its discretion, assess a late fee
not to exceed 1-1/2 % per month of the outstanding balance.
§91.9.Confidentiality and Disclosure.
(a)
Pursuant to the Act, Chapter 82, §82.009, all data
obtained is for the confidential use of the department and the persons or
public or private entities that the department determines are necessary to
carry out the intent of the Act.
(b)
Limited release of the data is allowed by the Act, §82.008(h)
and §82.009(b).
(c)
Any requests for confidential or statistical data shall
be made in accordance with §§91.11 or 91.12 of this title (relating
to Cancer Registry).
(d)
The Texas Cancer Registry is subject to the Health and
Safety Code, Chapter 181, Medical Records Privacy, §181.101 that requires
compliance with portions of the federal law and regulations cited in §91.3(e)
of this title (relating to Who Reports, Access to Records). The department
is authorized to use and disclose, for purposes described in the Act, cancer
data without patient consent or authorization under 45 C.F.R §164.512(a)
relating to uses and disclosures required by law, §164.512(b)(1) and
(2) relating to uses and disclosures for publish health activities, and §164.512(i)
relating to uses and disclosures for research purposes.
§91.10.Quality Assurance.
The department shall cooperate and consult with persons required to
comply with this chapter so that such persons may provide timely, complete
and accurate data. The department will provide:
(1)
reporting training, on-site case-finding studies, and reabstracting
studies;
(2)
quality assessment reports to ascertain that the computerized
data utilized for statistical information and data compilation is accurate;
and
(3)
educational information on cancer morbidity and mortality
statistics available from the Texas Cancer Registry and the department.
§91.11.Requests for Statistical Cancer Data.
(a)
Statistical cancer data previously analyzed and printed
are available upon written or oral request to the division. All other requests
for statistical data shall be in writing and directed to: Cancer Registry
Division, Texas Department of Health, 1100 West 49th Street, Austin Texas
78756-3199.
(b)
To ensure that the proper data are provided, the request
shall include, but not be limited to, the following information:
(1)
name, address, and telephone number of the person requesting
the information;
(2)
type of data needed and for what years (e.g. lung cancer
incidence rates, Brewster County, 1992-1995); and
(3)
name and address of person(s) to who data and billings
are to be sent (if applicable).
§91.12.Requests and Release of Personal Cancer Data.
(a)
Data requests for research.
(1)
Requests for personal cancer data shall be in writing and
directed to: Texas Department of Health, Institutional Review Board (IRB),
1100 West 49th Street, Austin, Texas 78756-3199.
(2)
Written requests for personal data shall meet the submission
requirements of the department's IRB before release.
(3)
The division may release personal cancer data to state,
federal, local, and other public agencies and organizations if approved by
the IRB.
(4)
The division may release personal cancer data to private
agencies, organizations, and associations if approved by the IRB.
(5)
The division may release personal cancer data to any other
individual or entities for reasons deemed necessary by the department to carry
out the intent of the Act if approved by the IRB.
(b)
Data requests for non-research purposes.
(1)
The division may provide reports containing personal data
back to the respective reporting entity from records previously submitted
to the division from each respective reporting entity for the purposes of
case management and administrative studies. These reports will not be released
to any other entity.
(2)
The division may release personal data to other bureaus
of the department, provided that the disclosure is required or authorized
by law. All communications of this nature shall be clearly labeled "Confidential"
and will follow established departmental internal protocols and procedures.
(3)
The division may release personal data to the department's
Cancer Registry Program personnel headquartered in public health regions or
public health departments to facilitate the collection, editing, and analysis
of cancer registry data for the respective geographic area. All communications
of this nature shall be clearly labeled "Confidential" and will follow established
departmental internal protocols and procedures.
(4)
The division may release personal cancer data to state,
federal, local, and other public agencies and organizations in accordance
with subsection (a) of this section.
(5)
The division may release personal cancer data to any other
individual or entities for reasons deemed necessary by the board to carry
out the intent of the Act and in accordance with subsection (a) of this section.
(6)
A person who submits a valid authorization for release
of an individual cancer record shall have access to review or obtain copies
of the information described in the authorization for release.
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 June 14, 2002.
TRD-200203710
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §§91.2 - 91.3, 91.5, 91.8 - 91.14
(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 §82.006 which provides the department with the authority to adopt
rules necessary to implement Chapter 82 (Cancer Registry); §81.004 which
provides the Texas Board of Health with the authority to administer Chapter
81 for protecting the public's health and preventing the introduction of disease
in the state; and §12.001, which provides the Texas Board of Health 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 Health and Safety Code, Chapter 82.
§91.2.Definitions.
§91.3.Who Reports.
§91.5.When To Report.
§91.8.Compliance.
§91.9.Immunity from Liability.
§91.10.Confidentiality and Disclosure.
§91.11.Quality Assurance.
§91.12.Requests for Statistical Cancer Data.
§91.13.Requests and Release of Personal Cancer Data.
§91.14.Statistical Reports.
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 June 14, 2002.
TRD-200203711
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes amendments to §§97.91-97.92
concerning consent for immunizations required for delegation of authority
to give informed consent for immunizations of a minor. The department also
proposes amendments to §§97.101-97.102 concerning statewide immunization
of children by hospitals, physicians, and other health care providers.
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 Subchapter C, §§97.91-97.92 and Subchapter D, §§97.101-97.102
and determined that reasons for adopting the sections continue to exist; however,
clarification on terminology is necessary to make the rules more accessible,
understandable, and usable.
The department published a Notice of Intention to Review Subchapter C, §§97.91-97.92
and Subchapter D, §§97.101-97.102 as required by Government Code, §2001.039
in the
Texas Register
on January 14, 2000
(25 TexReg 275). No comments were received due to publication of this notice.
The Delegation of Authority form in §97.91(d) was revised to state
Delegation of Authority to Give Consent for Immunizations of a Minor. Also,
the Documentation of Failure to Contact form in §97.92(d) was revised
to state Documentation of Failure to Contact Parent, Managing Conservator,
Guardian, or Other Person for Consent for Immunizations of a Minor.
The amendments to §§97.101 and 97.102 updated the area of the
department where to obtain required immunizations schedules for minors.
Linda S. Linville, M.S., R. N., Chief, Bureau Immunization and Pharmacy
Support, has determined that for the first five-year-period that the sections
will be in effect there will be no fiscal implications for state or local
governments as a result of enforcing and administering the sections as proposed.
Ms. Linville has also determined that for each year of the first five years
the sections are in effect the impact on hospitals, physicians, clinics and
parents will remain unchanged. The proposed changes are simply for clarification
so the proposed revisions shall have no fiscal impact on small businesses
or micro-businesses or persons who are required to comply with the sections.
No impact on local employment is expected.
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
.
Subchapter C. CONSENT FOR IMMUNIZATION
25 TAC §97.91, §97.92
These amendments are proposed under the authority of Health
and Safety Code, §81.023, which gives the board the right to develop
immunization requirements for children; 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 the commissioner of health.
The amendments affect the Health and Safety Code, Chapters 12 and 81.
§97.91.Delegation of Authority To Give Informed Consent for Immunizations of a Minor.
(a)-(c)
(No change.)
(d)
The delegation of authority statement must contain the
information in subsection (c) of this section and could resemble the following.
Figure: 25 TAC §97.91(d)
§97.92.Recommendations for Documentation of Reason(s) Parent, Managing Conservator, Guardian, or Other Person Could Not Be Contacted.
(a)
(No change.)
(b)
The reason the parent, managing conservator, guardian,
or other authorized person cannot be contacted should [
(c)
(No change.)
(d)
The documentation of failure to contact the parent, managing
conservator, guardian, or other authorized person should contain at least
the information in subsections (b) and (c) of this section and could resemble
the following.
Figure: 25 TAC §97.92(d)
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 June 14, 2002.
TRD-200203695
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §97.101, §97.102
These amendments are proposed under the authority of Health
and Safety Code, §81.023, which gives the board the right to develop
immunization requirements for children; 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 the commissioner of health.
The amendments affect the Health and Safety Code, Chapters 12 and 81.
§97.101.Statewide Immunization of Children.
(a)
Every person less than 18 years old shall be immunized
against vaccine-preventable diseases [
(b)
The
vaccine requirements
[
(c)-(g)
(No change.)
§97.102.Immunizations Required upon Admission of a Child to the Texas Department of Criminal Justice, Texas Department of Mental Health and Mental Retardation, or the Texas Youth Commission.
(a)
On admission of a child to a facility of the Texas Department
of Mental Health and Mental Retardation, the Texas Department of Criminal
Justice, or the Texas Youth Commission, the facility physician shall review
the immunization history of the child and administer any needed immunization(s)
or refer the child for immunization(s) to another health care provider. Required
immunizations are those set out in §97.63 of this title (relating to
Required Immunizations). Copies
of Immunization Requirements in Texas
Elementary and Secondary Schools and Institutions of Higher Education
may be obtained from [
(b)-(d)
(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 June 14, 2002.
TRD-200203696
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
Subchapter B. MEAT AND POULTRY INSPECTION
25 TAC §221.11, §221.14
The Texas Department of Health (department) proposes amendments
to §§221.11 and 221.14 concerning meat and poultry inspection. Proposed
changes to §221.11 adopt United States Department of Agriculture (USDA)
regulations to limit the amount of water retained by raw, single-ingredient,
meat and poultry products as a result of post-evisceration processing. Proposed
changes to §221.14 clarify conditions under which processing of hunter
killed exotic animals or hunter killed feral swine may be carried out without
benefit of a grant of Custom Exemption.
Under the proposed changes to §221.11, raw livestock and poultry carcasses
and parts will not be permitted to retain water resulting from post-evisceration
processing, such as carcass washing and chilling, unless the establishment
preparing those carcasses and parts demonstrates to the department, with data
collected in accordance with a written protocol, that any water retained in
the carcasses and parts is an inevitable consequence of the process used to
meet applicable food safety requirements. In addition, the establishment will
be required to disclose on the labeling of the meat or poultry products the
maximum percentage of retained water in the raw product. The required labeling
statement will help consumers of raw meat and poultry products to make informed
purchasing decisions.
Establishments having data demonstrating that there is no retained water
in their products can choose not to label the products with the retained-water
statement or to make a no-retained-water claim on the product label. The proposed
rule also revises the poultry chilling regulations to improve consistency
with the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP)
regulations; eliminates "command-and-control" features; and reflects current
technological capabilities and good manufacturing practices. The rule allows
the department to continue to meet the statutory requirement for rules to
equal federal meat and poultry inspection regulations.
The proposed changes to §221.14 will clarify the fact that persons
engaged in processing hunter killed exotic animals and hunter killed feral
swine may not use the same facilities to engage in the receipt, storage, processing,
or distribution of other amenable meat and/or poultry food products, as those
used for processing hunter killed exotic animals and hunter killed feral swine,
without benefit of a grant of Custom Exemption.
Tom J. Sidwa, D.V.M., Meat Safety Assurance Division, has determined that
for each year of the first five-year period the sections are in effect there
will be no fiscal implications to state or local government as a result of
enforcing or administering the rules as proposed. There will be no impact
on local employment.
Dr. Sidwa has also determined that for each year of the first five years
the sections are in effect, the public benefit anticipated will be to retain
compatibility with federal regulations, to provide consumers with more information
regarding their meat and poultry purchases, and to clarify for industry the
requirements of a grant of Custom Exemption. Dr. Sidwa has also estimated
that there will be a cost to micro businesses, small businesses or individuals
who are required to comply with §221.11. The requirement to prohibit
retained water in raw meat would not appear to have a significant impact on
the meat industry because it is already achieving zero retained water. It
is estimated that five or fewer establishments will have difficulty meeting
pathogen reduction standards and will be required to conduct water retention
tests to establish unavoidable levels. The total industry cost for the testing
required is estimated to be $23,500. The total industry cost for the labeling
requirement is estimated to be $50,000. The proposed changes to §221.14
would result in no additional costs for any entity currently operating in
compliance with the current rules in 25 Texas Administrative Code (TAC), Chapter
221, and Chapter 229.
Comments on the proposal may be submitted to Tom J. Sidwa, D.V.M., Meat
Safety Assurance Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0205. Comments will be accepted for 30 days
following publication of the proposal in the
Texas
Register
.
The amendments are proposed under the Health and Safety Code,
Chapter 433, which provides the department with the authority to adopt necessary
regulations pursuant to the enforcement of Chapter 433; and §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.
The amendments affect the Health and Safety Code, Chapter 433 and Chapter
12.
§221.11.Federal Regulations on Meat and Poultry Inspection.
(a)
The Texas Department of Health (TDH) adopts by reference
the following federal requirements in the Code of Federal Regulations (CFR),
as amended:
(1)-(32)
(No change.)
(33)
9 CFR, Part 417, "Hazard Analysis and Critical Control
Point (HACCP) Systems"; [
(34)
9 CFR, Part 424, "Preparation and Processing Operations[
(35)
9 CFR, Part 441 "Consumer Protection
Standards: Raw Products."
(b)
(No change.)
§221.14.Custom Slaughter and Processing; Very Low Volume Poultry/Rabbit Slaughter Operations.
(a)
Custom slaughter requirements. The requirements of this
section shall apply to the custom slaughter by any person of livestock, as
defined in §221.12(b) of this title (relating to Meat and Poultry Inspection),
delivered by or for the owner thereof for such slaughter, not for sale to
the public and exclusively for use, in the household of such owner, by him
and members of his household and nonpaying guests. The requirements of this
section do not apply to
processing of
hunter killed game animals,
as defined in §221.12(b) of this title.
The requirements of
this section do not apply to processing of
hunter killed exotic animals,
or
[
(1)-(10)
(No change.)
(b)
Custom processing requirements. The requirements of this
section shall apply to the custom processing by any person of uninspected
livestock carcasses or parts, delivered by or for the owner thereof for such
processing, not for sale to the public and exclusively for use, in the household
of such owner, by him and members of his household and nonpaying guests. The
requirements of this section shall not apply to processing
of
hunter
killed game animals,
as defined in §221.12(b) of this title.
The requirements of this section do not apply to processing of
hunter
killed exotic animals,
or
[
(1)-(11)
(No change.)
(c)
(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 June 14, 2002.
TRD-200203698
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §230.1
The Texas Department of Health (department) proposes new §230.1,
concerning the average manufacture price and purchase price reporting for
pharmaceuticals.
Specifically, the new section covers definitions; exemptions; reporting
procedures; confidentiality and enforcement. New subsection (a) will define
the terms necessary to use in order to correctly request and receive accurate
pricing information. New subsection (b) provides that certain businesses and
entities that are required to be licensed by Health and Safety Code, Chapter
431, will be exempt from reporting pricing information since they do not sell
pharmaceuticals to the state. New subsection (c) provides for requesting pricing
information from manufacturers and wholesale distributors and for reporting
that information back to be retrieved by the designee(s) of the Interagency
Council on Pharmaceuticals Bulk Purchasing. New subsection (d) provides confidentiality
provisions in compliance with House Bill 915, 77th Legislative Session (2001),
as codified in the Health and Safety Code, Chapter 110. New subsection (e)
provides for a confidential opportunity to correct inaccurate or missing information,
answer questions, and discuss reports prior to referral to the Office of the
Attorney General for enforcement.
Susan E. Tennyson, J.D., Chief, Bureau of Food and Drug Safety, has determined
that for the first five-year period the section is in effect, there will be
fiscal implications as a result of administering the rule as proposed. The
effect on state government will mean increased revenue to the state estimated
by the Legislative Budget Board to be $8,978,506 in FY03, $9,319,667 in FY04,
$9,675,671 in FY05, and $10,044,032 in FY06. It is estimated that the costs
to the department to administer the new provisions will be a one-time cost
of $76,000. There will be no impact on local government.
Ms. Tennyson has also determined that for each of the first five years
the section is in effect, the public benefit anticipated as a result of enforcing
the section will be to enable the state to negotiate a lower price for pharmaceuticals
and to increase the state's purchasing power. There are anticipated costs
to micro-businesses, small businesses or persons who comply with the rule.
The costs cannot be determined, but the process will involve receiving an
electronic request for pricing information from the department, calculating
the cost information for the report, filling in the report, and electronically
submitting it to the department, where it will be entered into the appropriate
database. It has been estimated that the cost to large wholesale drug distributors
may be approximately $108,400 per year for each large wholesale drug distributor.
Comments on the proposed rule may be submitted to Susan E. Tennyson, Bureau
of Food and Drug Safety, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0222, e-mail address: Susan.Tennyson@tdh.state.tx.us.
Comments will be accepted for 60 days from the date of publication of this
proposal in the
Texas Register
.
The new section is proposed under the Health and Safety Code, §431.208,
which provides the department with the authority to adopt necessary regulations
to implement the reporting of purchase prices; and §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.
The new section affects the Health and Safety Code, Chapter 431 and Chapter
12.
§230.1.Average Manufacturer Price and Purchase Price Reporting for Pharmaceuticals.
(a)
Definitions. The following words and terms when used in
this chapter shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Actual price--The weighted median invoice price at which
a wholesale distributor sells a drug to a Texas retail pharmacy from the first
day of the month through the last day of the calendar month prior to the date
of the request.
(2)
Average manufacturer price--The average price paid to the
manufacturer for the drug in the United States by wholesalers for drugs distributed
to the retail pharmacy class of trade, after deducting customary prompt pay
discounts, calculated for the most recent required quarterly report to the
Secretary of Health and Human Services.
(3)
BFDS--The Bureau of Food and Drug Safety within the Texas
Department of Health.
(4)
Council--The Interagency Council on Pharmaceuticals Bulk
Purchasing.
(5)
Department--The Texas Department of Health.
(6)
Drug manufacturer--A person subject to licensure in Chapter
229 of this title who manufactures, prepares, propagates, compounds, processes,
packages, repackages, or changes the container, wrapper, or labeling of any
drug product.
(7)
Retail pharmacy, for the purpose of actual price--Any Class
A pharmacy or community pharmacy authorized to dispense a drug or device to
the public under a prescription drug order. It does not, however, include
long-term care pharmacies, physicians' offices, closed-door pharmacies, or
outpatient pharmacies affiliated with health systems.
(8)
Wholesale drug distributor--A person subject to licensure
in Chapter 229 of this title to engage in the wholesale distribution of prescription
drugs to retail pharmacies in Texas including, but not limited to: manufacturers;
repackers; own-label distributors; private-label distributors; jobbers; brokers;
warehouses, including manufacturers' and distributors' warehouses, chain drug
warehouses, and wholesale drug warehouses; independent wholesale drug traders;
and retail pharmacies that conduct wholesale distributions.
(b)
Exemptions. The following entities, upon furnishing affirmative
proof, are exempted from the reporting requirements of this section.
(1)
Manufacturers or wholesale drug distributors of only:
(A)
veterinary drugs or medical equipment;
(B)
durable medical equipment;
(C)
oxygen and oxygen USP;
(D)
salvaged drugs or devices;
(E)
dental equipment; and/or
(F)
cosmetics.
(2)
Manufacturers or wholesale drug distributors who are:
(A)
health care clinics;
(B)
hospitals or hospital districts;
(C)
university health care systems and/or pharmacy schools;
(D)
blood and tissue centers; or
(E)
other non-profit health care systems.
(c)
Reporting procedures.
(1)
Requests. No later than the 25th day of each month, the
council's designee(s) shall submit a list of drugs about which pricing information
is desired, to the BFDS. The list from the council will be in a standardized
format, which identifies each drug by the National Drug Code (NDC) for the
drug, the name of the drug, the unit dosage and the count, and the name of
the manufacturer. The BFDS will then submit the request electronically to
each manufacturer and wholesale drug distributor by the 5th day of the next
month.
Figure: 25 TAC §230.1(c)(1)
(2)
Reports. Each manufacturer and wholesale sale distributor
shall report to BFDS on a standardized electronic format no later than the
30th day after receipt of the request. The manufacturer shall report the average
manufacturer price and the wholesale drug distributor shall report the actual
price for the drug.
Figure: 25 TAC §230.1(c)(2)
(3)
The BFDS will provide direct access to all reports to the
council designee(s) on a file transfer protocol. BFDS will provide the council
with a monthly report of those manufacturers and wholesale drug distributors
not filing the required report. BFDS will not have direct access to pricing
information.
(d)
Confidentiality. Information provided by a manufacturer
and a wholesale drug distributor pursuant to these rules and the Health and
Safety Code, Chapter 110, may only be disclosed pursuant to the Health and
Safety Code, Chapter 110, and the procedures of the council.
(e)
Enforcement.
(1)
The BFDS will provide electronic notice of a failure to
report to a manufacturer or wholesale drug distributor from whom the council
did not receive a requested report. The manufacturer or wholesale drug distributor
must submit the report within 15 days after receipt of the notice of failure
to report.
(2)
If the council disputes the accuracy of the information
on a particular NDC or NDCs provided by the manufacturer or wholesale drug
distributor, then a confidential settlement conference with the manufacturer
or wholesale drug distributor, a member of the council, and BFDS may be held.
(3)
If a manufacturer or wholesale drug distributor fails to
file the requested report after being provided the 15-day opportunity to cure,
or if the accuracy of the report cannot be reconciled, BFDS shall consider
the manufacturer's or wholesale drug distributor's demonstration of good faith
prior to any referral to the Office of the Attorney General for investigation
and/or action.
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 June 14, 2002.
TRD-200203697
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
Subchapter F. LICENSE REGULATIONS
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.
The proposed rule adds requirements for applicants for licensure, and licensees
upon renewal, to submit documentation of financial qualification, as required
by House Bill 1099 (77th Legislature 2001). The revision increases the specified
amounts of financial assurance for decommissioning for certain quantities
of radioactive materials authorized on the license, to adjust for inflation.
The revision adds a requirement for persons who receive, possess, or process
sealed sources as radioactive waste from other persons and who are exempt
from §289.254 of this title (relating to Licensing of Radioactive Waste
Processing and Storage Facilities) to submit a decommissioning funding plan
and financial assurance. In Figure: 25 TAC, §289.252(ii)(2), the "Ca-45"
radionuclide was deleted after the "K-40" radionuclide within the second group
of radionuclides, as this radionuclide was incorrectly included within this
group. The revision also clarifies that if a person stores sealed sources
of radioactive material received from other persons for recycle or beneficial
reuse for longer than two years, that person is then considered to be receiving
the sealed sources of radioactive material as radioactive waste from other
persons. Other minor clarifying changes are added to make corrections and
to make the section consistent with other sections of this title. 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.
The department published a Notice of Intention to Review for §289.252
as required by Government Code §2001.039 in the
Texas Register
(27 TexReg 1189) on February 15, 2002. No comments were
received by the department on this section.
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 increase in the specified amounts of financial
assurance for decommissioning will be held in the Radiation and Perpetual
Care Security Trust Account in the event that funds are needed to decommission
a site.
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 applicants/licensees are financially qualified to conduct
the licensed activities. The proposed section also ensures funds required
of licensees for financial assurance are adequate to decommission licensed
facilities. There will be no fiscal impact from the financial qualification
requirement on applicants/licensees that are small businesses, micro-businesses
or other persons not required to submit financial assurance. There will not
be a fiscal impact because those licensees not required to submit financial
assurance may submit attestation of financial qualification. There will also
be no fiscal impact from the financial qualification requirement on applicants/licensees
that are small businesses, micro-businesses, or other persons required to
submit financial assurance. There will not be a fiscal impact because licensees
required to submit financial assurance may submit the same types of documentation
used to obtain the financial assurance instrument in order to comply with
the financial qualification requirement. Licensees that are small businesses,
micro-businesses, or other persons required to comply with the section as
proposed and choose to submit the financial assurance amount specified in
rule, will incur an increase in financial assurance for decommissioning ranging
from $10,000 to $100,000 over the lifetime of the license. If a licensee's
site is adequately decommissioned, the financial assurance is returned to
the licensee at that time. There is no anticipated impact on local employment.
Comments on the proposal may be presented 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 1:30 p.m., Tuesday,
July 9, 2002, in Conference Room N218, 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, §401.301,
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, Chapter 401, Chapter 12,
and 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)
(No change.)
(2)
Each application shall be signed by
the chief executive
officer or other individual delegated the authority to manage, direct, or
administer the licensee's activities
[
(3)-(5)
(No change.)
(6)
Each applicant shall demonstrate to the
agency that the applicant is financially qualified to conduct the activity
requested for licensure, including any required decontamination, decommissioning,
reclamation, and disposal before the agency issues a license. Each licensee
shall demonstrate to the agency that it remains financially qualified to conduct
the licensed activity before a license is renewed. Methods for demonstrating
financial qualifications are specified in subsection (ii)(8) of this section.
The requirement for demonstration of financial qualification is separate from
the requirement specified in subsection (gg) of this section for certain applicants
or licensees to provide financial assurance in conjunction with a decommissioning
funding plan.
(7)
If facility drawings submitted in conjunction
with the application for a license are prepared by a professional engineer
or engineering firm, those drawings shall be final and shall be signed, sealed
and dated in accordance with the requirements of the Texas Board of Professional
Engineers, 22 Texas Administrative Code, Chapter 131.
(8)
[
(A)
The first period is the time from receipt of an application
by the Division of Licensing, Registration and Standards to the date of issuance
or denial of the license or a written notice outlining why the application
is incomplete or unacceptable. This time period is 60 days.
(B)
The second period is the time from receipt of the last
item necessary to complete the application to the date of issuance or denial
of the license. This time period is 30 days.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by the Government Code, Chapter
2001.
(9)
[
(A)
In the event the application is not processed in the time
periods stated in paragraph
(8)
[
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(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 the Formal Hearing Procedures,
§§1.21, 1.23, 1.25, 1.27
[
(10)
[
(A)
any material false statement in the application or any
statement of fact required under provisions of the Texas Radiation Control
Act (Act); [
(B)
conditions revealed by the 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 application
; or
[
(C)
failure to clearly demonstrate how these
requirements have been addressed.
(e)
General requirements for the issuance of specific licenses.
A license application will be approved if the agency determines that:
(1)-(8)
(No change.)
(9)
the owner of the property is aware that radioactive material
is stored [
(10)
there is no reason to deny the license
as specified in subsection (d)(10) of this section.
(f)-(n)
(No change.)
(o)
Specific licenses for the manufacture and commercial distribution
of sealed sources or devices containing radioactive material for medical use.
In addition to the requirements in subsection (e) of this section, a specific
license to manufacture and commercially distribute sealed sources and devices
containing radioactive material to persons licensed for use of sealed sources
in the healing arts for use as a calibration or reference source will be issued
if the agency approves the following information submitted by the applicant:
(1)
an evaluation of the radiation safety of each type of sealed
source or device including the following:
(A)-(G)
(No change.)
(H)
procedures for disposition of unwanted or unused radioactive
material; [
(2)-(4)
(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(k)(2) of this
title will be issued if the agency approves the following information submitted
by the applicant:
(1)
(No change.)
(2)
that each prepackaged unit bears a durable, clearly visible
label:
(A)
(No change.)
(B)
displaying the radiation caution symbol in accordance with §289.202(z)
of this title and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for
Internal or External Use in Humans or Animals
;"
[
(3)-(4)
(No change.)
(q)-(r)
(No change.)
(s)
Specific licenses for the manufacture and commercial distribution
of products containing depleted uranium for mass-volume applications.
(1)-(3)
(No change.)
(4)
Each person licensed in accordance with paragraph (1) of
this subsection shall:
(A)-(B)
(No change.)
(C)
assure that before being installed in each product or device,
the depleted uranium has been impressed with the following legend clearly
legible through any plating or other covering: "Depleted Uranium
;"
[
(D)
furnish a copy of the following:
(i)
the general license in §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(g)(5)
of this title
;
[
(ii)-(iii)
(No change.)
(E)-(G)
(No change.)
(t)-(v)
(No change.)
(w)
Issuance of specific licenses.
(1)-(2)
(No change.)
(3)
The agency may also request additional
information after the license has been issued to enable the agency to determine
whether the license should be modified.
(x)
(No change.)
(y)
Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.
(1)-(2)
(No change.)
(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 (6) of this subsection, and begin decommissioning upon approval
of that plan
if
:
(A)
the license has expired in accordance with this subsection
or subsection (dd)(3) of this section; [
(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)-(D)
(No change.)
(4)
Coincident with the notification required by paragraph
(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 (9)(E) of this subsection.
(5)-(13)
(No change.)
(14)
As the final step in decommissioning, the licensee shall
do the following:
(A)
(No change.)
(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)
(No change.)
(15)
The agency will provide written notification to specific
licensees
[
(A)-(B)
(No change.)
(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
,
[
(D)
(No change.)
(16)
(No change.)
(z)
Renewal of license.
(1)
Requests for renewal of specific licenses shall be filed
in accordance with subsection (d)(1)-(3) and
(5)-(7)
[
(2)
(No change.)
(aa)-(cc)
(No change.)
(dd)
Modification and revocation of licenses.
(1)
The terms and conditions of all licenses shall be subject
to amendment, revision, or modification. A license may be suspended or revoked
by reason of amendments to the Act, [
(2)
Any license may be revoked, suspended, or modified, in
whole or in part, for any of the following:
(A)-(B)
(No change.)
(C)
violation of, or failure to observe any of the terms and
conditions of the Act, this chapter, [
(3)
Each specific license revoked by the agency ends at the
end of the day on the date of he agency's final determination to revoke the
license, 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 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.
(ee)
Reciprocal recognition of licenses.
(1)
Subject to this section, any person who holds a specific
license from the 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 of Texas provided that:
(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)
the exact location, start date, duration, and type
of
activity to be conducted;
(ii)-(vi)
(No change.)
(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 the NRC, an
agreement state, or a licensing state authorizing the holder to manufacture,
transfer, install, or service the device described in §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 of Texas provided that:
(A)-(B)
(No change.)
(C)
the person assures that any labels required to be affixed
to the device in accordance with requirements of the authority that licensed
manufacture of the device bear a statement that "Removal of this label is
prohibited
;"
[
(D)
(No change.)
(3)
(No change.)
(ff)
(No change.)
(gg)
Financial assurance and record keeping for decommissioning.
(1)
The applicant for
or holder of
each specific
license authorizing the possession and use of unsealed radioactive material
with a half-life greater than 120 days and in quantities exceeding 10
(2)
The applicant for
or holder of
each specific
license authorizing possession and use of radioactive material of half-life
greater than 120 days and in quantities specified in paragraph
(3)
[
(A)
submit a decommissioning funding plan as described in paragraph
(4)
[
(B)
submit [
[(3)
The holder of each specific license issued:]
[(A)
on or after January 1, 1995, that is of a type described
in paragraph (2) of this subsection shall provide financial assurance for
decommissioning in accordance with the criteria specified in this section;]
[(B)
before January 1, 1995, and of a type described in paragraph
(1) of this subsection, shall submit on or before January 1, 1995, a decommissioning
funding plan or a certification of financial assurance for decommissioning
in an amount at least equal to $750,000, in accordance with the criteria specified
in this section. If the licensee submits the certification of financial assurance
rather than a decommissioning funding plan at this time, the licensee shall
include a decommissioning funding plan in any application for license renewal;]
[(C)
before January 1, 1995, and of a type described in paragraph
(2) of this subsection, shall submit on or before January 1, 1995, a certification
of financial assurance for decommissioning or a decommissioning funding plan
in accordance with the criteria specified in this section.]
(3)
[
(A)
$850,000
[
(B)
$170,000
[
(C)
$85,000
[
(4)
[
(5)
[
(A)
Prepayment. Prepayment is the deposit prior to
issuance
of the license
[
(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)
The surety method or insurance shall be open-ended or,
if written for a specified term, such as five years, shall be renewed automatically
unless 90 days or more prior to the renewal date, the issuer notifies the
agency, the beneficiary, and the licensee of its intention not to renew. The
surety method or insurance shall also provide that the full face amount be
paid to the beneficiary automatically prior to the expiration without proof
of forfeiture if the licensee fails to provide a replacement acceptable to
the agency within 30 days after receipt of notification of cancellation.
(ii)
The surety method or insurance shall be payable
in the state of Texas
to
the Radiation and Perpetual Care Fund.
[
(iii)
The surety method or insurance shall remain in effect
until the agency has terminated the license.
(C)
An external sinking fund in which deposits are made at
least annually, coupled with a surety method or insurance, the value of which
may decrease by the amount being accumulated in the sinking fund. An external
sinking fund is a fund established and maintained by setting aside funds periodically
in an account segregated from licensee assets and outside the licensee's administrative
control in which the total amount of funds would be sufficient to pay decommissioning
costs at the time termination of operation is expected. An external sinking
fund may be in the form of a trust, escrow account, government fund, certificate
of deposit, or deposit of government securities. The surety or insurance provisions
shall be in accordance with subparagraph (B) of this paragraph.
(D)
In the case of federal, state, or local government licensees,
a statement of intent containing a cost estimate for decommissioning or an
amount in accordance with paragraph (4) of this subsection, and indicating
that funds for decommissioning will be obtained when necessary.
(E)
When a governmental entity is assuming custody and ownership
of a site, there shall be an arrangement that is deemed acceptable by such
governmental entity.
(6)
[
(A)
records of spills or other unusual occurrences involving
the spread of contamination in and around the facility, equipment, or site.
These records may be limited to instances when contamination remains after
any cleanup procedures or when there is reasonable likelihood that contaminants
may have spread to inaccessible areas, as in the case of possible seepage
into porous materials such as concrete. These records shall include any known
information on identification of involved nuclides, quantities, forms, and
concentrations;
(B)
as-built drawings and modifications of structures and equipment
in restricted areas where radioactive materials are used and/or stored, and
of locations of possible inaccessible contamination such as buried pipes that
may be subject to contamination. If required drawings are referenced, each
relevant document need not be indexed individually. If drawings are not available,
the licensee shall substitute appropriate records of available information
concerning these areas and locations;
(C)
except for areas containing only sealed sources (provided
the sealed sources have not leaked or no contamination remains after any leak)
or byproduct materials having only half-lives of less than 65 days, a list
contained in a single document and updated every two years, of the following:
(i)
all areas designated and formerly designated as restricted
areas as defined in §289.201(b) of this title;
(ii)
all areas outside of restricted areas that require documentation
under subparagraph (A) of this paragraph; and
(iii)
all areas outside of restricted areas where current and
previous wastes have been buried as documented in accordance with §289.202(tt)
of this title; and
(D)
records of the cost estimate performed for the decommissioning
funding plan or of the amount certified for decommissioning, and records of
the funding method used for assuring funds if either a funding plan or certification
is used.
(7)
[
(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)
(No change.)
(B)
Financial test.
(i)
(No change.)
(ii)
In addition, to pass the financial test, a company shall
meet all of the following requirements:
(I)
the company's independent certified public accountant shall
have compared the data used by the company in the financial test,
that
[
(II)-(III)
(No change.)
(C)
(No change.)
(6)
Criteria relating to use of financial tests and
self-guarantees
[
(A)
(No change.)
(B)
Financial test.
(i)
To pass the financial test, a college or university shall
meet the criteria of subclause (I) or (II) of this clause. The college or
university shall meet one of the following:
(I)
for applicants or licensees that issue bonds, a current
rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A as issued by Standard and
Poor's
[
(II)
(No change.)
(ii)-(iii)
(No change.)
(C)
Self-guarantee. The terms of a self-guarantee that an applicant
or licensee furnishes shall provide the following:
(i)-(iv)
(No change.)
(v)
If, at any time, the licensee's most recent bond issuance
ceases to be rated in any category of "A" or above by either Standard and
Poor's
[
(7)
(No change.)
(8)
Requirements for Demonstrating Financial
Qualifications.
(A)
If an applicant or licensee is not required
to submit financial assurance in accordance with subsection (gg) of this section,
that applicant or licensee shall demonstrate financial qualification by submitting
attestation that the applicant or licensee is financially qualified to conduct
the activity requested for licensure, including any required decontamination,
decommissioning, reclamation, and disposal before the agency issues a license.
(B)
If an applicant or licensee is required
to submit financial assurance in accordance with subsection (gg) of this section,
that applicant or licensee shall:
(i)
submit one of the following:
(I)
the bonding company report or equivalent
(from which information can be obtained to calculate a ratio as described
in clause (ii) of this subparagraph) that was used to obtain the financial
assurance instrument used to meet the financial assurance requirement specified
in subsection (gg) of this section. However, if the applicant or licensee
posted collateral to obtain the financial instrument used to meet the requirement
for financial assurance specified in subsection (gg) of this section, the
applicant or licensee shall demonstrate financial qualification by one of
the methods specified in subclause (II) or (III) of this clause;
(II)
SEC documentation (from which information
can be obtained to calculate a ratio as described in clause (ii) of this subparagraph,
if the applicant or licensee is a publicly-held company; or
(III)
a self-test (for example, an annual
audit report certifying a company's assets and liabilities and resulting ratio
as described in clause (ii) of this subparagraph or, in the case of a new
company, a business plan specifying expected expenses versus capitalization
and anticipated revenues).
(ii)
declare its Standard Industry Classification
(SIC) code. Several companies publish lists, on an annual basis, of acceptable
assets-to liabilities (assets divided by liabilities) ratio ranges for each
type of SIC code. If an applicant or licensee submits documentation of its
current assets and current liabilities or, in the case of a new company, a
business plan specifying expected expenses versus capitalization and anticipated
revenues, and the resulting ratio falls within an acceptable range as published
by generally recognized companies (for example, Almanac of Business and Industrial
Financial Ratios, Industry NORM and Key Business Ratios, Dunn and Bradstreet
Industry publications, and Manufacturing USA: Industry Analyses, Statistics,
and Leading Companies), the agency will consider that applicant or licensee
financially qualified to conduct the requested or licensed activity.
(C)
If the applicant or licensee is a state
or local government entity, a statement of such will suffice as demonstration
that the government entity is financially qualified to conduct the requested
or licensed activities.
(D)
The agency will consider other types of
documentation if that documentation provides an equivalent measure of assurance
of the applicant's or licensee's assets and liabilities and the resulting
ratio.
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 June 14, 2002.
TRD-200203716
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of §289.254
and new §289.254, concerning the licensing of radioactive waste processing
and storage facilities.
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 289.254 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.
The new rule adds requirements for applicants for licensure, and licensees
upon renewal, to submit documentation of financial qualification, as required
by House Bill 1099 (77th Legislature 2001). The revision increases the specified
amounts of financial assurance for decommissioning for certain quantities
of radioactive materials authorized on the license, to adjust for inflation.
Wording is added to exempt persons who, under certain conditions, receive,
possess, or process sealed sources of radioactive material from other persons
for recycle or beneficial reuse from the requirements of this section. The
new rule also clarifies that if a person stores sealed sources of radioactive
material received from other persons for recycle or beneficial reuse for longer
than two years, that person is then considered to be receiving the sealed
sources of radioactive material as radioactive waste from other persons. Other
minor clarifying changes are added to make corrections and to make the section
consistent with other sections of this title. The repeal and new rule 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.
The department published a Notice of Intention to Review for §289.254
as required by Government Code §2001.039 in the
Texas Register
(26 TexReg 6737) on August 31, 2001. No comments were
received by the department on this section.
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 sections will be in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the sections as proposed. The increase in the specified amounts of financial
assurance for decommissioning will be held in the Radiation and Perpetual
Care Security Trust Account in the event that funds are needed to decommission
a site. There is no anticipated impact on local employment.
Mrs. McBurney has also determined that for each year of the first five
years the proposed sections will be in effect, the public benefit anticipated
as a result of enforcing the sections will be to ensure continued protection
of the public, workers, and the environment from unnecessary exposure to radiation
by ensuring that applicants/licensees are financially qualified to conduct
the licensed activities. The proposed sections also ensures funds required
of licensees for financial assurance are adequate to decommission licensed
facilities. There will be no fiscal impact from the financial qualification
requirement on applicants/licensees that are small businesses, micro-businesses
or other persons not required to submit financial assurance. There will not
be a fiscal impact because those licensees not required to submit financial
assurance may submit attestation of financial qualification. There will also
be no fiscal impact from the financial qualification requirement on applicants/licensees
that are small businesses, micro-businesses, or other persons required to
submit financial assurance. There will not be a fiscal impact because licensees
required to submit financial assurance may submit the same types of documentation
used to obtain the financial assurance instrument in order to comply with
the financial qualification requirement. Licensees that are small businesses,
micro-businesses, or other persons required to comply with the section as
proposed and choose to submit the financial assurance amount specified in
rule, will incur an increase in financial assurance for decommissioning ranging
from $10,000 to $100,000 over the lifetime of the license. If a licensee's
site is adequately decommissioned, the financial assurance is returned to
the licensee at that time.
Comments on the proposal may be presented 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 2:30 p.m., Tuesday,
July 9, 2002, in Conference Room N218, Texas Department of Health, Bureau
of Radiation Control, located at the Exchange Building, 8407 Wall Street,
Austin, Texas.
Subchapter F. LICENSE REGULATIONS
25 TAC §289.254
(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, §401.301, 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, Chapter 401, Chapter 12, and
implements Government Code, §2001.039.
§289.254.Licensing of Radioactive Waste Processing and Storage Facilities.
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 June 14, 2002.
TRD-200203721
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §289.254
The new section is proposed under the Health and Safety Code, §401.301,
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, Chapter 401, Chapter 12,
and implements Government Code, §2001.039.
§289.254.Licensing of Radioactive Waste Processing and Storage Facilities.
(a)
Purpose and scope.
(1)
This section establishes the requirements for management
of commercial radioactive waste processing and storage facilities, the procedures
and criteria for the issuance of licenses to receive, possess, transport,
store, and process radioactive waste from other persons, and the terms and
conditions upon which the agency will issue such licenses.
(2)
Except as otherwise provided, this section applies to all
persons who transport, receive, possess, store, or process radioactive waste
from other persons. In addition to the requirements of this section, all licensees,
unless otherwise specified, are subject to the requirements §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 Material), §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), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material).
(b)
Definitions. The following words and terms when used in
this section shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Commencement of major construction--Any major structural
erection or major alterations to existing structures, or other substantial
action that would change the facility design or site for the purpose of establishing
a radioactive waste processing or storage facility. The term does not mean
the acquisition of existing structures or minor changes thereto.
(2)
Decommissioning--The final activities carried out at a
radioactive waste processing or storage site after completion of processing
operations to remove safely from service and reduce residual radioactivity
to a level that permits release of the property for unrestricted use and/or
termination of the license. Such activities shall include:
(A)
disposing of all radioactive waste at a licensed radioactive
waste disposal site;
(B)
dismantling or decontaminating site structures;
(C)
decontaminating site surfaces and remaining equipment;
and
(D)
conducting final closure surveys, decontamination, and
reclamation of the site.
(3)
Disposal--Isolation or removal of radioactive wastes from
mankind and his environment. The term does not include emissions and discharges
under rules of the agency.
(4)
Engineered barriers--Man-made devices to contain or limit
the potential movement of radioactive material, which might result from spills
or other accidents.
(5)
Floodplain--The lowland and relatively flat areas adjoining
inland and coastal waters, including flood prone areas of off-shore islands.
(6)
Local government--A county, an incorporated city or town,
a special district, or other political subdivision of the state.
(7)
Major aquifer--An aquifer that yields large quantities
of water in a comparatively large area of the state. Major aquifers are located
in the following formations: Ogallala, Alluvium and Bolsom Deposits, Edwards-Trinity
(Plateau), Edwards (Balcones Fault Zone - San Antonio Region), Edwards (Balcones
Fault Zone - Austin Region), Trinity Group, Carrizo-Wilcox, and Gulf Coast.
(8)
Natural barriers--The natural characteristics of a site
or surface and subsurface composition that serves to impede the movement of
radioactive material. Natural barriers may include, for example, the location
of a facility remote from an aquifer, or the sorptive capability of the soil
surrounding a facility.
(9)
Person affected--A person:
(A)
who is a resident of a county, or a county adjacent to
the county, in which radioactive materials subject to the Texas Radiation
Control Act (Act) are/or will be located, including any person who is doing
business or who has a legal interest in land in the county or adjacent county,
and any local government in the county; and
(B)
who shall demonstrate that he has suffered or will suffer
actual injury or economic damage.
(10)
Processing--The storage, extraction of materials, transfer,
volume reduction, compaction, incineration, solidification, or other separation
and preparation of radioactive waste from other persons for reuse or disposal,
including any treatment or activity that renders the waste less hazardous,
safer for transport, or amenable to recovery, storage, or disposal.
(11)
Radioactive waste processing facility--A facility where
radioactive waste received from other persons is processed and repackaged
according to United States Department of Transportation (DOT) regulations.
(12)
Radioactive waste storage facility--A facility where radioactive
waste received from other persons and packaged according to DOT regulations
is stored while awaiting shipment to a licensed radioactive waste processing
or disposal facility.
(13)
Reconnaissance level information--Any information or analysis
that can be retrieved or generated without the performance of new comprehensive
site-specific investigations. Reconnaissance level information includes, but
is not limited to, relevant published scientific literature; drilling records
required by state agencies, such as the Railroad Commission of Texas, the
Texas Environmental Quality Commission (Commission), and the Texas Natural
Resources Information System; and reports of governmental agencies.
(14)
Site--The real property, including the buffer zone, on
which a radioactive waste processing or storage facility may be located.
(15)
Site monitoring--The procedures for the monitoring of
the site and environment to assess quality of site operations and performance
and to detect and quantify levels and types of radioactivity and chemicals
in the environment. It includes preoperational, operational, and license termination
phases.
(16)
Site operations--The routine day-to-day activities carried
out at the site for the receipt, processing, and storage of radioactive waste.
(17)
Site suitability--The capability of the various characteristics
of a processing or storage facility or site to safely contain the radioactive
waste expected to be present at the site.
(18)
Sole source aquifer--The aquifer that is the sole or principal
source of drinking water for an area designated under the Safe Drinking Water
Act of 1974, 42 United States Codes Annotated 300f, et seq.
(19)
Waste processing and storage categories--Radionuclides
classified as follows:
(A)
any one of seven groups into which radionuclides in normal
form are classified, according to their toxicity and their relative potential
hazard in transport, as specified in subsection (v) of this section; and
(B)
any radionuclide not specifically listed in one of the
categories in subsection (v) of this section shall be assigned to one of the
categories in accordance with subsection (v)(2) of this section.
(20)
Wetlands--Areas that are inundated or saturated by surface
or groundwater at a frequency and duration sufficient to support and that,
under normal circumstances, do support a prevalence of vegetation typically
adapted for life in saturated soil conditions. Wetlands generally include
playa lakes, swamps, marshes, bogs, and similar areas.
(c)
Activities requiring license. Except for persons exempted
by this section, no person shall receive, possess, and store or process radioactive
waste from another person except as authorized in a specific license issued
in accordance with this section.
(d)
Radioactive waste processing and storage facility classification.
(1)
Classification of radioactive waste processing and storage
facilities. Radioactive waste processing and storage facilities are classified
according to the radionuclides, other than sealed sources, received, possessed,
or processed in each of the waste processing and storage categories, as defined
in subsection (b) of this section with all applicable provisions, except that,
for the purposes of this section which apply to processing and storage of
radioactive waste, Category IV shall include waste processing and storage
categories IV-VII. The total possession limit of each category of unsealed
(dispersible) radionuclides for each class of facility is as follows:
Figure: 25 TAC §289.254(d)(1)
(2)
Class III storage facilities are those in which the applicable
possession limit of radioactive waste exceeds any limit of Class II storage
facilities.
(3)
Class III processing facilities are those in which the
applicable possession limit of radioactive waste exceeds any limit of Class
II processing facilities.
(e)
Exemptions.
(1)
Sealed sources.
(A)
Persons who receive, possess, or process sealed sources
of radioactive material as radioactive waste from other persons are exempt
from this section, provided that:
(i)
encapsulated sources are tested upon receipt and determined
to have less than 0.005 microcurie of removable contamination; and
(ii)
sealed sources of radioactive material remain in sealed
form after receipt.
(B)
Persons who receive, possess, or process sealed sources
of radioactive material from other persons for recycle or beneficial reuse
are exempt from this section, provided that:
(i)
encapsulated sources are tested upon receipt and determined
to have less than 0.005 microcurie of removable contamination; and
(ii)
sealed sources of radioactive material remain in sealed
form after receipt.
(C)
Persons exempt from the requirements of this section in
accordance with subparagraph (A) of this paragraph, shall meet the requirements
for financial assurance and record keeping for decommissioning in accordance
with §289.252(gg) of this title. Persons who store sealed sources of
radioactive material, in accordance with subparagraph (B) of this paragraph,
for longer than two years, are considered to be receiving, possessing, or
processing sealed sources of radioactive material as radioactive waste from
other persons and shall meet the requirements for financial assurance and
record keeping for decommissioning in accordance with §289.252(gg) of
this title.
(2)
Unsealed sources.
(A)
Persons who receive, possess, or process sources of radioactive
material in unsealed form as radioactive waste from other persons are exempt
from this section provided that:
(i)
the total radioactivity of all radioactive waste possessed
at any one time does not exceed the applicable limits for Class I processing
or storage facilities as described in subsection (d) of this section; and
(ii)
the total volume of radioactive waste processed in any
one year does not exceed 50 cubic feet.
(B)
Persons who receive, possess, and store radioactive material
in unsealed form as radioactive waste from other persons are exempt from this
section provided that:
(i)
the radioactive waste consists only of radiopharmaceutical
residues resulting from radiopharmaceuticals manufactured, compounded, and
supplied by those persons receiving the radiopharmaceutical residues as radioactive
waste;
(ii)
the radioactive waste is held in storage for decay to
background radiation levels; and
(iii)
the radioactive waste is not shipped to a radioactive
waste processing or disposal facility.
(3)
Radioactive material. A person who receives, possesses,
and stores radioactive material as radioactive waste from sites owned and
controlled by that same person is not considered to have received waste from
other persons.
(f)
Filing application for a specific license.
(1)
The applicant for a license to receive, possess, or process
radioactive waste from other persons shall submit, on BRC Form 252-2, "Application
for Radioactive Material License," seven copies of each license application
or application for amendment and any supporting documents. Applications for
issuance of licenses shall include all general and specific technical requirements,
financial information, and environmental requirements, if applicable, described
in this section.
(2)
The agency may at any time after the submission of the
original application, require further statements or data to enable the agency
to determine whether the application should be denied or the license should
be issued.
(3)
Each application shall be signed by the chief executive
officer or other individual delegated the authority to manage, direct, or
administer the licensee's activities.
(4)
An application for a license may include a request for
one or more of the activities specified in paragraph (1) of this subsection.
The agency may require the issuance of separate licenses for those activities.
(5)
Each application for a license shall be accompanied by
the fee prescribed in §289.204 of this title.
(6)
If facility drawings submitted in conjunction with the
application for a license are prepared by a professional engineer or engineering
firm, those drawings shall be final and shall be signed, sealed and dated
in accordance with the requirements of the Texas Board of Professional Engineers,
22 Texas Administrative Code, Chapter 131.
(7)
Each application shall clearly demonstrate how the requirements
of this subsection and subsections (g), (h), (i), and (j) of this section
have been addressed.
(8)
Each application shall be accompanied by a completed BRC
Form 252-1, (Business Information Form).
(9)
Applications for licenses shall be processed in accordance
with the following time periods.
(A)
The first period is the time from receipt of an application
by the Division of Licensing, Registration and Standards to the date of issuance
or denial of the license or a written notice outlining why the application
is incomplete or unacceptable. This time period is 90 days.
(B)
The second period is the time from receipt of the last
item necessary to complete the application to the date of issuance or denial
of the license. This time period is 90 days.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by Government Code, Chapters
2001 and 2002.
(10)
Notwithstanding the provisions of §289.204(e)(1)
of this title, reimbursement of application fees may be granted in the following
manner.
(A)
In the event the application is not processed in the time
periods as stated in paragraph (9) of this subsection, the applicant has the
right to request of the director of the Radiation Control Program full reimbursement
of all application fees paid in that particular application process. If the
director does not agree that the established periods have been violated or
finds that good cause existed for exceeding the established periods, the request
will be denied.
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(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 the Formal Hearing Procedures, §§1.21,
1.23, 1.25, and 1.27 of this title (relating to the Texas Board of Health).
(11)
Applications for licenses may be denied for the following
reasons:
(A)
any material false statement in the application or any
statement of fact required under provisions of the Act;
(B)
conditions revealed by the 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 application; or
(C)
failure to clearly demonstrate how the requirements of
this section have been addressed.
(g)
Additional requirements. An applicant for a license under
this section shall include the following information in the application to
the agency:
(1)
identity of the applicant including the full name, address,
telephone number, and description of the business(es) or occupation(s) of
the applicant;
(2)
the organizational structure of the applicant, both off-site
and on-site, including a description of lines of authority and assignments
of responsibilities, whether in the form of administrative directives, contract
provisions, or otherwise;
(3)
a description of past operations that the applicant has
been involved in including any license limitations, suspensions or revocations
of such licenses, and any other information that will allow the agency to
assess the applicant's past operating history;
(4)
the technical qualifications, including training and experience,
of the applicant and members of the applicant's staff to engage in the proposed
activities; and minimum training and experience requirements for personnel;
(5)
a description of the personnel training and retraining
program;
(6)
a statement of need and a description of the proposed activities
identifying:
(A)
the location of the proposed site;
(B)
the character of the proposed activities;
(C)
the types, chemical and/or physical forms and quantities
of radioactive waste to be received, possessed, and processed; and
(D)
the plans for use of the facility for purposes other than
processing of radioactive waste;
(7)
proposed time schedules for construction and receipt and
processing of radioactive waste at the proposed facility;
(8)
description of the site and accurate drawings of the facility
including, but not limited to:
(A)
construction;
(B)
foundation details;
(C)
ventilation;
(D)
plumbing and fire suppression systems;
(E)
physical security system;
(F)
storage areas;
(G)
radioactive waste handling or processing areas;
(H)
proximity to creeks or culverts; and
(I)
soil types under the facility with respect to compatibility
with foundation and structural design;
(9)
a description that demonstrates that the site suitability
characteristics will meet the following requirements:
(A)
the overall hydrogeologic environment of the site, in combination
with engineering design, shall act to minimize and control potential radioactive
waste migration into surface water and groundwaters;
(B)
no new site shall be located in a 100-year floodplain,
as designated by the Commission, or a wetland; and
(C)
no new site shall be located in the recharge area of a
sole source aquifer or a major aquifer unless it can be demonstrated with
reasonable assurance that the new site will be designed, constructed, operated,
and closed without an unreasonable risk to the aquifer.
(10)
minimum criteria for facility design and operation to
include:
(A)
the building used for processing radioactive wastes shall
have a minimum classification of Type II (111) in accordance with National
Fire Protection Association 220 titled, "Standards Types of Building Construction";
(i)
buildings used for processing or storage of radioactive
wastes shall have ventilation and fire protection systems to minimize the
release of radioactive materials into the soils, waters, and the atmosphere;
and
(ii)
facilities and equipment for repackaging leaking and/or
damaged containers shall be provided.
(B)
the design and operation of the radioactive waste processing
or storage facility shall be such that:
(i)
releases of non-radiological noxious materials from the
facility are minimized; and
(ii)
radiation levels, concentrations, and potential exposures
off-site due to airborne releases during operations are within the limits
established in §289.202 of this title and are maintained as low as reasonably
achievable.
(C)
the design and operation of the radioactive waste processing
or storage facility shall be compatible with the objectives of the site closure
and decommissioning funding plan;
(D)
the facility shall be designed to confine spills. Independent
and diverse engineered barriers shall be provided, as necessary, to complement
natural barriers in minimizing potential releases from the facility and in
complying with this section;
(E)
the location and construction of any new radioactive waste
processing facility shall have a buffer zone adequate to permit emergency
measures to be implemented following accidents and to address airborne plume
dispersions and, as a minimum, shall be such that:
(i)
the active components of a Class II facility are located
at least 30 meters from the nearest residence as of the date of the license
application; and
(ii)
the active components of a Class III facility are located
at least 30 meters from the nearest property not owned or occupied by the
licensee.
(11)
a flow diagram of radioactive waste processing operations;
(12)
a description and accurate drawings of processing equipment
and any required special handling techniques to be employed;
(13)
a description of personnel monitoring methods, training,
and procedures to be followed to keep employees from ingesting and inhaling
radioactive materials, including a description of methods to keep the radiation
exposure to levels as low as reasonably achievable;
(14)
a description of the site monitoring program to include
prelicense data and proposed operational monitoring programs for direct gamma
radiation measurements and radioactive and chemical characteristics of the
soils, groundwater, surface waters, and vegetation, as applicable;
(A)
for radioactive waste storage facilities, the applicant
shall address on-site air quality; and
(B)
for radioactive waste processing facilities, the applicant
shall address on-site and off-site air quality;
(15)
spill detection and cleanup plans for the licensed site
and for associated transportation of radioactive material;
(16)
an operating, safety, and emergency procedures manual
that shall provide detailed procedures for receiving, handling, storing, processing,
and shipping radioactive waste;
(17)
for radioactive waste processing facilities, a description
of the equipment to be installed to maintain control over maximum concentrations
of radioactive materials in gaseous and liquid effluents produced during normal
operations and the means to be employed for keeping levels of radioactive
material in effluents to unrestricted areas as low as reasonably achievable
and within the limits listed in §289.202 of this title;
(18)
methods of ultimate disposal and decommissioning;
(19)
the system for maintaining inventory of receipt, storage,
and transfer of radioactive waste; and
(20)
demonstration to the agency that the applicant is financially
qualified to conduct the licensed activity requested for licensure, including
any required decontamination, decommissioning, reclamation, and disposal,
before the department issues a license. Each licensee shall demonstrate to
the agency that it remains financially qualified to conduct the licensed activity
before a license is renewed. Methods for demonstrating financial qualifications
are specified in §289.252(ii)(8) of this title. The requirement for demonstration
of financial qualification is separate from the requirement specified in subsection
(n) of this section for certain applicants or licensees to provide financial
assurance in conjunction with a decommissioning funding plan.
(h)
Additional environmental requirements for Class III facilities.
An application for a license for a class III processing or storage facility
shall include environmental information that may be based on reconnaissance
level information when appropriate and addresses the following:
(1)
description of present land uses and population distribution
in the vicinity of the site:
(A)
for radioactive waste storage facilities, the description
shall address properties adjacent to the site; and
(B)
for radioactive waste processing facilities, the description
shall address properties adjacent to the site and shall include population
distribution within a one-mile radius of the site;
(2)
area/site suitability including geology, hydrology, and
natural hazards. For radioactive waste processing facilities, area meteorology
also shall be addressed;
(3)
site and project alternatives including alternative siting
analysis;
(4)
socioeconomic effects on surrounding communities of operation
of the licensed activity and of associated transportation of radioactive material;
and
(5)
environmental effects of postulated accidents.
(i)
Issuance of license.
(1)
A license for a radioactive waste processing or storage
facility will be issued if the agency finds reasonable assurance that:
(A)
the proposed radioactive waste facility will be sited,
designed, operated, decommissioned, and closed in accordance with this section;
(B)
the issuance of the license will not be inimical to the
health and safety of the public or the environment; and
(C)
there is no reason to deny the license as specified in
subsection (f)(11) of this section.
(2)
The agency may also request additional information after
the license has been issued to enable the agency to determine whether the
license should be modified.
(j)
Commencement of major construction. Commencement of major
construction is prohibited until 30 days after the agency has given notice
that a license is to be granted or renewed, and the environmental analysis
is available. If a hearing is requested, the commencement of major construction
is prohibited until notice of the contested case hearing is noticed in accordance
with the Act. Commencement of major construction subsequent to issuance of
the notices is at the economic risk of the applicant.
(k)
Commencement of operations. No licensee issued a license
under this section may commence operations until the licensee has obtained
licenses or permits from other agencies as required by law.
(l)
Specific terms and conditions to license.
(1)
Each license issued in accordance with this section shall
be subject to all the provisions of the Act and applicable rules in this chapter,
now or hereafter in effect, and orders of the agency.
(2)
No license issued or granted under this section and no
right to possess or utilize radioactive material granted by any license issued
in accordance with this section shall be transferred, assigned, or in any
manner disposed of, either voluntarily or involuntarily, directly or indirectly,
through transfer of control of any license to any person unless the agency
shall, after securing full information, find that the transfer is in accordance
with the provisions of the Act and to applicable rules in this chapter, now
and hereafter in effect, and orders of the agency, and shall give its consent
in writing.
(3)
Each person licensed by the agency in accordance with this
section shall confine his use and possession of the radioactive material to
the locations and purposes authorized in the license.
(4)
A license issued under this section shall include license
conditions derived from the evaluations of the application and analyses performed
by the agency, including amendments and changes made before a license is issued.
License conditions may include, but are not limited to, items in the following
categories:
(A)
restrictions as to the total radioactive inventory of radioactive
waste to be received;
(B)
restrictions as to size, shape, and materials and methods
of construction of radioactive waste packaging and maximum number of package
units stored, at any one time;
(C)
restrictions as to the physical and chemical form and radioisotopic
content and concentration of radioactive waste;
(D)
controls to be applied to restrict access to the site;
(E)
controls to be applied to maintain and protect the health
and safety of the public and site employees and the environment;
(F)
administrative controls, which are the provisions relating
to organization, management, and operating procedures; record-keeping, review
and audit; and reporting necessary to assure that activities at the facility
are conducted in a safe manner and in conformity with agency rules and license
conditions; and
(G)
maximum retention time for radioactive waste received at
the facility.
(5)
Each licensee shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy.
(6)
The notification in paragraph (5) 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.
(7)
A copy of the petition for bankruptcy shall be submitted
to the agency along with the written notification.
(m)
Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.
(1)
Except as provided in subsection (p)(2) of this section,
each specific license expires at the end of the day, in the month and year
stated in the license.
(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:
(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.
(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 (6) of this subsection, and begin decommissioning upon approval
of that plan:
(A)
the license has expired in accordance with this subsection
or subsection (s)(3) of this section;
(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.
(4)
Coincident with the notification required by paragraph
(3) of this subsection, the licensee shall maintain in effect all decommissioning
financial assurances established by the licensee in accordance with subsection
(n) 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
(9)(E) of this subsection.
(A)
Any licensee who has not provided financial assurance to
cover the detailed cost estimate submitted with the decommissioning plan shall
do so by March 1, 1998.
(B)
Following approval of the decommissioning plan, a licensee
may reduce the amount of the financial assurance as decommissioning proceeds
and radiological contamination is reduced at the site with the approval of
the agency.
(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 (3) of this subsection. The
schedule for decommissioning set forth in paragraph (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:
(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.
(7)
The agency may approve an alternate schedule for submittal
of a decommissioning plan required in accordance with paragraph (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 (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:
(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 (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 (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 (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:
(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.
(14)
As the final step in decommissioning, the licensee shall
do the following:
(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.
(15)
The agency will provide written notification to specific
licenses, including former licenses with provisions continued in effect beyond
the expiration date in accordance with paragraph (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:
(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.
(16)
Each licensee shall submit to the agency all records required
by §289.202(nn)(2) of this title before the license is terminated.
(n)
Financial assurance and record keeping for decommissioning.
(1)
The applicant for or holder of each specific license authorizing
the receipt, possession, transport, storage, and processing of radioactive
waste from other persons with a half-life greater than 120 days and in quantities
exceeding 10
5
times the applicable quantities
set forth in §289.252(ii)(2) of this title shall submit a decommissioning
funding plan as described in paragraph (4) of this subsection in an amount
sufficient to allow the agency to engage a third party to decommission the
site(s) specified on the license. The decommissioning funding plan shall also
be submitted when a combination of isotopes is involved if R divided by 10
(2)
The applicant for or holder of each specific license authorizing
receipt, possession, transport, storage, and processing of radioactive waste
from other persons with a half-life greater than 120 days and in quantities
specified in paragraph (3) of this subsection shall:
(A)
submit a decommissioning funding plan as described in paragraph
(4) of this subsection in an amount sufficient to allow the agency to engage
a third party to decommission the site(s) specified on the license; or
(B)
submit financial assurance for decommissioning in the amount
in accordance with paragraph (3) of this subsection using one of the methods
described in paragraph (5) of this subsection in an amount sufficient to allow
the agency to engage a third party to decommission the site(s) specified on
the license. Upon renewal, the holder of a specific license shall certify
that the current financial assurance is adequate to meet the requirements
of this subparagraph or submit financial assurance that meets the requirements
of this subparagraph. For an applicant, the financial assurance will be obtained
after the application has been approved and the license issued, but prior
to the receipt of radioactive waste. If the applicant defers execution of
the financial instrument until after the license has been issued, a signed
original of the financial instrument obtained to satisfy the requirements
of paragraph (5) of this subsection shall be submitted to the agency before
receipt of radioactive waste. If the applicant does not defer execution of
the financial instrument, a signed original of the financial instrument obtained
to satisfy the requirements of paragraph (5) of this subsection is to be submitted
to the agency.
(3)
Required amounts of financial assurance. The required amount
of financial assurance for decommissioning is determined by quantity of material
authorized on the license and is determined as follows:
(A)
$850,000 for quantities of material greater than 10
(B)
$170,000 for quantities of material greater than 10
(C)
$85,000 for quantities of material greater than 10
(4)
Each decommissioning funding plan shall contain a cost
estimate for decommissioning in an amount sufficient to allow the agency to
engage a third party to decommission the site(s) specified on the license
and a description of the method of assuring funds for decommissioning from
paragraph (5) of this subsection, including means of adjusting cost estimates
and associated funding levels periodically over the life of the facility.
The required amount of financial assurance for decommissioning is determined
by the quantity of material authorized by the license. The applicant for or
holder of the specific license shall submit with the decommissioning funding
plan a signed original of the financial instrument obtained to satisfy the
requirements of paragraph (5) of this subsection. Upon approval of the decommissioning
funding plan by the agency, the amount of financial assurance shall be adjusted
and posted in conformance with agency approval.
(5)
Financial assurance for decommissioning shall be provided
by one or more of the following methods and shall be reviewed and approved
by the agency. The financial instrument obtained shall be continuous for the
term of the license.
(A)
Prepayment. Prepayment is the deposit prior to issuance
of the license into an account segregated from licensee assets and outside
the licensee's administrative control of cash or liquid assets such that the
amount of funds would be sufficient to pay decommissioning costs. Prepayment
may be in the form of a trust, escrow account, government fund, certificate
of deposit, or deposit of government securities.
(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 §289.252(ii)(3)
of this title. 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 §289.252(ii)(4) of this title. 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 §289.252(ii)(5) of this title. 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 §289.252(ii)(6) of this title. 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)
The surety method or insurance shall be open-ended or,
if written for a specified term, such as five years, shall be renewed automatically
unless 90 days or more prior to the renewal date, the issuer notifies the
agency, the beneficiary, and the licensee of its intention not to renew. The
surety method or insurance shall also provide that the full face amount be
paid to the beneficiary automatically prior to the expiration without proof
of forfeiture if the licensee fails to provide a replacement acceptable to
the agency within 30 days after receipt of notification of cancellation.
(ii)
The surety method or insurance shall be payable in the
state of Texas to the Radiation and Perpetual Care Fund.
(iii)
The surety method or insurance shall remain in effect
until the agency has terminated the license.
(C)
External sinking fund. An external sinking fund in which
deposits are made at least annually, coupled with a surety method or insurance,
the value of which may decrease by the amount being accumulated in the sinking
fund. An external sinking fund is a fund established and maintained by setting
aside funds periodically in an account segregated from licensee assets and
outside the licensee's administrative control in which the total amount of
funds would be sufficient to pay decommissioning costs at the time termination
of operation is expected. An external sinking fund may be in the form of a
trust, escrow account, government fund, certificate of deposit, or deposit
of government securities. The surety or insurance provisions shall be in accordance
with subparagraph (B) of this paragraph.
(D)
Statement of intent. In the case of federal, state, or
local government licensees, a statement of intent containing a cost estimate
for decommissioning or an amount in accordance with paragraph (4) of this
subsection, and indicating that funds for decommissioning will be obtained
when necessary.
(E)
When a governmental entity is assuming custody and ownership
of a site, there shall be an arrangement that is deemed acceptable by such
governmental entity.
(6)
Each person licensed under this section shall keep records
of information important to the safe and effective decommissioning of the
facility in an identified location until the license is terminated by the
agency. If records of relevant information are kept for other purposes, reference
to these records and their locations may be used. Information the agency considers
important to decommissioning consists of the following:
(A)
records of spills or other unusual occurrences involving
the spread of contamination in and around the facility, equipment, or site.
These records may be limited to instances when contamination remains after
any cleanup procedures or when there is reasonable likelihood that contaminants
may have spread to inaccessible areas, as in the case of possible seepage
into porous materials such as concrete. These records shall include any known
information on identification of involved nuclides, quantities, forms, and
concentrations;
(B)
as-built drawings and modifications of structures and equipment
in restricted areas where radioactive waste is processed and/or stored, and
of locations of possible inaccessible contamination such as buried pipes that
may be subject to contamination. If required drawings are referenced, each
relevant document need not be indexed individually. If drawings are not available,
the licensee shall substitute appropriate records of available information
concerning these areas and locations;
(C)
except for areas containing only sealed sources (provided
the sources have not leaked or no contamination remains after any leak) or
byproduct materials having only half-lives of less than 65 days, a list contained
in a single document and updated every two years, of the following:
(i)
all areas designated and formerly designated as restricted
areas as defined in §289.201(b) of this title;
(ii)
all areas outside of restricted areas that require documentation
under subparagraph (A) of this paragraph; and
(iii)
all areas outside of restricted areas where current and
previous wastes have been buried as documented under §289.202(tt) of
this title; and
(D)
records of the cost estimate performed for the decommissioning
funding plan or of the amount certified for decommissioning, and records of
the funding method used for assuring funds if either a funding plan or certification
is used.
(7)
Any licensee who has submitted an application before January
1, 1995, for renewal of license in accordance with this section shall provide
financial assurance for decommissioning in accordance with paragraphs (1)
and (2) of this subsection. This assurance shall be submitted when this section
becomes effective March 1, 1998.
(o)
Emergency plan for responding to a release.
(1)
A new or renewal application for each specific license
authorizing the receipt, possession, transport, storage, and processing of
radioactive waste from other persons in excess of the quantities in §289.252(ii)(7)
of this title shall contain either:
(A)
an evaluation showing that the maximum dose to a person
offsite due to a release of radioactive materials would not exceed 1 rem effective
dose equivalent or 5 rems to the thyroid; or
(B)
an emergency plan for responding to a release of radioactive
waste.
(2)
One or more of the following factors may be used to support
an evaluation submitted in accordance with paragraph (1)(A) of this subsection:
(A)
the radioactive waste is physically separated so that only
a portion could be involved in an accident;
(B)
all or part of the radioactive waste is not subject to
release during an accident because of the way it is stored or packaged;
(C)
the release fraction in the respirable size range would
be lower than the release fraction shown in §289.252(ii)(7) of this title
due to the chemical or physical form of the waste;
(D)
the solubility of the radioactive waste would reduce the
dose received;
(E)
facility design or engineered safety features in the facility
would cause the release fraction to be lower than shown in §289.252(ii)(7)
of this title;
(F)
operating restrictions or procedures would prevent a release
fraction as large as that shown in §289.252(ii)(7) of this title; or
(G)
other factors appropriate for the specific facility.
(3)
An emergency plan for responding to a release of radioactive
waste submitted in accordance with paragraph (1)(B) of this subsection shall
include the following information:
(A)
a brief description of the licensee's facility and area
near the site;
(B)
an identification of each type of radioactive waste accident
for which protective actions may be needed;
(C)
a classification system for classifying accidents as alerts
or site area emergencies;
(D)
identification of the means of detecting each type of accident
in a timely manner;
(E)
a brief description of the means and equipment for mitigating
the consequences of each type of accident, including those provided to protect
workers onsite, and a description of the program for maintaining the equipment;
(F)
a brief description of the methods and equipment to assess
releases of radioactive waste;
(G)
a brief description of the responsibilities of licensee
personnel should an accident occur, including identification of personnel
responsible for promptly notifying offsite response organizations and the
agency; also, responsibilities for developing, maintaining, and updating the
plan;
(H)
a commitment to and a brief description of the means to
promptly notify offsite response organizations and request offsite assistance,
including medical assistance for the treatment of contaminated injured onsite
workers when appropriate. A control point shall be established. The notification
and coordination must be planned so that unavailability of some personnel,
parts of the facility, and some equipment will not prevent the notification
and coordination. The licensee shall also commit to notify the agency immediately
after notification of the appropriate offsite response organizations and not
later than one hour after the licensee declares an emergency. These reporting
requirements do not supersede or release licensees of complying with the requirements
under the Emergency Planning and Community Right-to-Know Act of 1986, Title
III, Publication L. 99-499 or other state or federal reporting requirements;
(I)
a brief description of the types of information on facility
status, radioactive releases, and recommended protective actions, if necessary,
to be given to offsite response organizations and to the agency;
(J)
a brief description of the frequency, performance objectives,
and plans for the training that the licensee will provide workers on how to
respond to an emergency, including any special instructions and orientation
tours the licensee would offer to fire, police, medical, and other emergency
personnel. The training shall familiarize personnel with site-specific emergency
procedures. Also, the training shall thoroughly prepare site personnel for
their responsibilities in the event of accident scenarios postulated as most
probable for the specific site, including the use of team training for such
scenarios;
(K)
a brief description of the means of restoring the facility
to a safe condition after an accident;
(L)
provisions for conducting quarterly communications checks
with offsite response organizations and biennial onsite exercises to test
response to simulated emergencies. Quarterly communications checks with offsite
response organizations shall include the check and update of all necessary
telephone numbers. The licensee shall invite offsite response organizations
to participate in the biennial exercises. Participation of offsite response
organizations in biennial exercises, although recommended, is not required.
Exercises shall use accident scenarios postulated as most probable for the
specific site and the scenarios shall not be known to most exercise participants.
The licensee shall critique each exercise using individuals not having direct
implementation responsibility for the plan. Critiques of exercises shall evaluate
the appropriateness of the plan, emergency procedures, facilities, equipment,
training of personnel, and overall effectiveness of the response. Deficiencies
found by the critiques shall be corrected; and
(M)
a certification that the applicant has met its responsibilities
under the Emergency Planning and Community Right-to-Know Act of 1986, Title
III, Publication L. 99-499, if applicable to the applicant's activities at
the proposed place of processing and/or storage of radioactive waste.
(4)
The licensee shall allow the offsite response organizations
expected to respond in case of an accident 60 days to comment on the licensee's
emergency plan before submitting it to the agency. The licensee shall provide
any comments received within the 60 days to the agency with the emergency
plan.
(p)
Renewal of license.
(1)
Application for renewal of specific licenses shall be filed
in accordance with subsection (f) of this section. In any application for
renewal, the applicant may incorporate drawings by reference.
(2)
In any case in which a licensee, not less than 30 days
prior to expiration of the existing license, has filed an application in proper
form for renewal or for a new license authorizing the same activities, such
existing license shall not expire until the agency has made a final determination
on the application.
(3)
The licensee is responsible for decommissioning the facility
and continued safe storage of any radioactive waste whether an application
for continued receipt of wastes is filed or not.
(q)
Amendment of license at request of licensee. Applications
for amendment of a license shall be filed in accordance with subsection (f)
of this section, except that the requirements of subsection (f)(5) of this
section may be waived at the discretion of the agency. Such applications shall
also specify how the licensee desires his license to be amended and the basis
for such amendment.
(r)
Agency action on application to renew or amend. In considering
a request by a licensee to renew or amend a license, the agency will apply
the criteria in subsection (i) of this section.
(s)
Modification and revocation of licenses.
(1)
The terms and conditions of all licenses shall be subject
to amendment, revision, or modification. A license 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 license 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 license on an original application; or
(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.
(3)
Each specific license revoked by the agency ends at the
end of the day on the date of the agency's final determination to revoke the
license, or on the revocation date stated in the determination, or as otherwise
provided by the agency order.
(4)
Except in cases in which occupational and public health
and safety or the environment require 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.
(t)
Waste processing and packaging requirements. All processed
radioactive waste offered for transport or disposal shall meet:
(1)
all applicable transportation requirements of the agency,
the United States Nuclear Regulatory Commission, and of the DOT; and
(2)
all applicable disposal facility license conditions.
(u)
Environmental assessment. A written analysis of the impact
on the human environment will be prepared or secured by the agency for any
license for a class III processing or storage facility and shall be available
to the public for written comment at least 30 days prior to the beginning
of a hearing, if any, on the issuance or renewal of the license.
(v)
Waste processing and storage categories of radionuclides.
(1)
The following table contains waste processing and storage
categories of radionuclides.
Figure: 25 TAC §289.254(v)(1)
(2)
Any radionuclide not specifically listed in paragraph (1)
of this section shall be assigned to one of the categories in accordance with
the following table.
Figure: 25 TAC §289.254(v)(2)
(3)
For mixtures of radionuclides, the following shall apply.
(A)
If the identity and respective activity of each radionuclide
are known, the permissible activity of each radionuclide shall be such that
the sum, for all categories present, of the ratio between the total activity
for each category to the permissible activity for each category will not be
greater than unity.
(B)
If the categories of the radionuclides are known but the
amount in each category cannot be reasonably determined, the mixture shall
be assigned to the most restrictive category present.
(C)
If the identity of all or some of the radionuclides cannot
be reasonably determined, each of those unidentified radionuclides shall be
considered as belonging to the most restrictive category that cannot be positively
excluded.
(D)
Mixtures consisting of a single radioactive decay chain
where the radionuclides are in the naturally occurring proportions shall be
considered as consisting of a single radionuclide. The category and activity
shall be that of the first member present in the chain, except that if radionuclide
"X" has a half-life longer than that of that first member and an activity
greater than that of any other member, including the first, at any time during
processing, the waste processing and storage category shall be that of nuclide
"X" and the activity of the mixture shall be the maximum activity of nuclide
"X" during processing.
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 June 14, 2002.
TRD-200203720
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
25 TAC §289.260
The Texas Department of Health (department) proposes an amendment
to §289.260, concerning the licensing of uranium recovery and byproduct
material disposal facilities.
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 289.260 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.
Language is added to clarify methods by which an applicant or licensee
shall show financial qualification to conduct the requested/licensed activity.
The conditions under which a license application may be denied and the minimum
qualifications for a radiation safety officer are included for clarification
and for consistency with other licensing sections in this chapter. Language
is added requiring facility drawings submitted with an application to be prepared
by a professional engineer or engineering firm to ensure accuracy of the drawings.
References are updated and minor clarifying language is added/deleted throughout
the rule to include
Texas Register
coding
errors in the Texas Administrative Code. 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.
The department published a Notice of Intention to Review for §289.260
as required by Government Code §2001.039 in the
Texas Register
(26 TexReg 5449) on July 20, 2001. No comments were
received by the department on this section.
Mrs. 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. There will be no impact on small businesses, micro-businesses,
or other persons required to comply with the section as proposed. The requirement
to demonstrate financial qualification existed previously and the proposed
language clarifies the methods by which to demonstrate financial qualification.
There is no anticipated impact on local employment 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 applicants/licensees are financially qualified to conduct
the licensed activities. There will be no fiscal impact on entities required
to comply with the section as proposed. The requirement to demonstrate financial
qualification existed previously and the proposed language clarifies the methods
by which to demonstrate financial qualification. Other proposed language clarifies
what the department has historically accepted as radiation safety officer
qualifications and facility drawings and language is being added for consistency
with other licensing sections in this chapter.
Comments on the proposal may be presented 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 10 a.m., Tuesday,
July 9, 2002, in Conference Room N218, 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 the performance of
each duty imposed by law on the board, the department, and the commissioner
of health.
The amendment affects Health and Safety Code, Chapter 401, Chapter 12,
and implements Government Code §2001.039.
§289.260.Licensing of Uranium Recovery and Byproduct Material Disposal Facilities.
(a)
Purpose. This section provides for the specific licensing
of the receipt, possession, use, or disposal of radioactive material in uranium
recovery facilities and other operations
that
[
(b)
Scope. In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of [
(c)
Definitions. The following words and terms when used in
this
section
[
(1)-(2)
(No change.)
(3)
Available technology--Technologies and methods for emplacing
a final radon barrier on byproduct material piles or impoundments. This term
shall not be construed to include extraordinary measures or techniques that
would impose costs that are grossly excessive as measured by practice within
the industry (or one that is reasonably analogous), (
for example,
[
(4)-(16)
(No change.)
(17)
Hazardous constituent--Subject to subsection (q)(10)(E)
of this section, "hazardous constituent" is a constituent
that
[
(A)
the
[
(B)
the
[
(C)
the
[
(18)-(19)
(No change.)
(20)
Liner--A continuous layer of natural or man-made materials,
beneath or on the sides of a surface impoundment
that
[
(21)
Maximum credible earthquake--That earthquake
that
[
(22)-(23)
(No change.)
(24)
Point of compliance--The site-specific location in the
uppermost aquifer where the groundwater protection standard
shall
[
(25)
Principal activities--Activities authorized by the license
that
[
(26)
Reclamation plan--For the purposes of subsection (q)(16)-(27)
of this section, "reclamation plan" is the plan detailing activities to accomplish
reclamation of the byproduct material disposal area in accordance with the
technical criteria of this section. The reclamation plan
shall
[
(27)
Security (surety)--The following are examples of
security:
[
(A)-(F)
(No change.)
(28)-(31)
(No change.)
(d)
Filing application for specific licenses.
(1)
Applications for specific licenses shall be filed in
seven
[
(2)
The agency may
,
at any time after the filing
of the original application, [
(3)
Each application shall be signed by
the chief executive
officer or other individual delegated the authority to manage, direct, or
administer the licensee's activities.
[
(4)
An application for a license may include a request for
one or more activities.
The agency may require the issuance of separate
licenses for those activities.
(5)
The applicant shall demonstrate to the
agency that the applicant is financially qualified to conduct the licensed
activity, including any required decontamination, decommissioning, reclamation,
and disposal, before the agency issues or renews a license. The requirement
is different from those in subsection (o) of this section for financial security.
(A)
An applicant or licensee shall show financial
qualification by submitting one of the following:
(i)
the bonding company report or equivalent
(from which information can be obtained to calculate a ratio as described
in subparagraph (B) of this paragraph) that was used to obtain the financial
security instrument used to meet the financial security requirement specified
in subsection (o) of this section. However, if the applicant or licensee posted
collateral to obtain the financial instrument used to meet the requirement
for financial security specified in subsection (o) of this section, the applicant
or licensee shall demonstrate financial qualification by one of the methods
specified in clause (ii) or (iii) of this subparagraph;
(ii)
SEC documentation (from which information
can be obtained to calculate a ratio as described in subparagraph (B) of this
paragraph), if the applicant or licensee is a publicly-held company; or
(iii)
a self-test (for example, an annual
audit report, certifying a company's assets and liabilities and resulting
ratio (as described in subparagraph (B) of this paragraph) or, in the case
of a new company, a business plan specifying expected expenses versus capitalization
and anticipated revenues).
(B)
Each applicant or licensee must declare
its Standard Industry Classification (SIC) code. Several companies publish
lists, on an annual basis, of acceptable assets-to-liabilities (assets divided
by liabilities) ratio ranges for each type of SIC code. If an applicant or
licensee submits documentation of its current assets and current liabilities
or, in the case of a new company, a business plan specifying expected expenses
versus capitalization and anticipated revenues, and the resulting ratio falls
within an acceptable range as published by generally recognized companies
(for example, Almanac of Business and Industrial Financial Ratios, Industry
NORM and Key Business Ratios, Dunn and Bradstreet Industry publications, and
Manufacturing USA: Industry Analyses, Statistics, and Leading Companies),
the agency will consider that applicant or licensee financially qualified
to conduct the requested or licensed activity.
(C)
The agency will consider other types of
documentation if that documentation provides an equivalent measure of assurance
of the applicant's or licensee's assets and liabilities and the resulting
ratio.
[(5)
In any application, the applicant may
incorporate by reference, information contained in previous applications,
statements, or reports filed with the agency, provided that the reference
is clear and specific.]
[(6)
Applications and documents submitted
to the agency will be made available for public inspection except that the
agency may withhold any document or part thereof from public inspection if
the applicant or licensee states in writing that disclosure of its content
is not required in the public interest and would adversely affect the interest
of a person concerned. Exceptions to agency decisions regarding disclosure
are subject to the Texas Public Information Act, Government Code, Chapter
552.]
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(A)
The first period is
the
[
(B)
The second period is
the
[
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by [
(11)
[
(A)
In the event the application is not processed in the time
periods as stated in paragraph
(10)
[
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for licenses to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(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 the Formal Hearing Procedures,
§
§1.21-1.34 of this title (relating to the Texas Board of
Health).
(12)
Applications for licenses may be denied
for the following reasons:
(A)
any material false statement in the application
or any statement of fact required under provisions of the Texas Radiation
Control Act (Act);
(B)
conditions revealed by the 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 application;
or
(C)
failure to clearly demonstrate how these
requirements have been addressed.
(e)
General requirements for the issuance of specific licenses.
A license application will be approved if the agency determines that:
(1)
the applicant and all personnel who will be handling the
radioactive material are qualified by reason of training and experience to
use the material in question for the purpose requested in accordance with
these requirements in such a manner as to
minimize danger to occupational
and
[
(2)
the applicant's proposed equipment, facilities, and procedures
are adequate to
minimize danger to occupational and
[
(3)
the issuance of the license will not be inimical to
occupational and
public health and safety nor have a long-term detrimental
impact on the environment;
(4)
qualifications of the designated radiation
safety officer (RSO) are adequate for the purpose requested in the application
and include as a minimum:
(A)
possession of a high school diploma or
a certificate of high school equivalency based on the GED test;
(B)
completion of the training and testing
requirements specified in this chapter for the activities for which the license
application is submitted; and
(C)
training and experience necessary to supervise
the radiation safety aspects of the licensed activity;
[(4)
the applicant has demonstrated financial
capability to conduct the proposed activity including all costs associated
with decommissioning, decontamination, disposal, reclamation, and long-term
care and maintenance; and]
(5)
the applicant satisfies all applicable special requirements
in this section
; and
[
(6)
there is no reason to deny the license
as specified in subsection (d)(12) of this section.
(f)
Special requirements for
a
[
(1)
An application for a license shall include [
(A)
for new licenses, an environmental report
that includes the results of a one-year preoperational monitoring program
and for renewal of licenses, an environmental report containing the results
of the operational monitoring program. Both shall also include the following:
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(vi)
[
(B)
[
[
(C)
[
(D)
[
(E)
[
(F)
[
(2)
Unless otherwise exempted, the applicant
shall not begin construction at the site until the agency has issued the license.
Commencement of construction prior to issuance of the license shall be grounds
for denial of a license.
(3)
Facility drawings submitted in conjunction
with the application for a license shall be prepared by a professional engineer
or engineering firm. Those drawings shall be final and shall be signed, sealed
and dated in accordance with the requirements of the Texas Board of Professional
Engineers, 22 Texas Administrative Code, Chapter 131.
(g)
Issuance of specific licenses.
(1)
When the agency determines
[
(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
[
(A)
minimize danger to occupational and
[
(B)
require [
(C)
prevent loss or theft of
radioactive
material
subject to this
chapter.
[
(3)
The agency may also request additional
information after the license has been issued to enable the agency to determine
whether the license should be modified.
(h)
Specific terms and conditions of license.
(1)
Each license issued in accordance with this section shall
be subject to the applicable provisions of the Act
and to applicable
rules
, now or hereafter in effect, [
(2)
No license issued in accordance with this section and no
right to possess or utilize radioactive material authorized by any license
issued in accordance with this
section
[
(3)
Each person licensed by the agency in accordance with this
section shall confine use and possession of the
radioactive
[
(4)
Each licensee shall notify the agency,
in writing, immediately following the filing of a voluntary or involuntary
petition for bankruptcy.
(5)
The notification in paragraph (4) 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.
(6)
A copy of the petition for bankruptcy
shall be submitted to the agency along with the written notification.
[(4)
Each licensee shall notify the agency,
in writing, immediately following the filing of a voluntary or involuntary
petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the
United States Code (11 USC) by or against:]
[(A)
a licensee;]
[(B)
an entity (as that term is defined in 11 USC 101(14))
controlling a licensee or listing the license or licensee as property of the
estate; or]
[(C)
an affiliate (as that term is defined in 11 USC 101(2))
of the licensee.]
[(5)
The notification required by paragraph
(4) of this subsection must indicate:]
[(A)
the bankruptcy court in which the petition for bankruptcy
was filed;]
[(B)
a copy of the bankruptcy petition; and]
[(C)
the date of filing of the petition.]
(7)
[
(8)
[
(A)
any failure in a byproduct material retention system
that
[
(B)
any release of radioactive material
that
[
(C)
any spill
that
[
(D)
any release of solids
that
[
(9)
[
(A)
any spill that extends:
(i)
beyond the wellfield monitor well ring;
(ii)
more than 400 feet from an injection or production well
pipe artery to or from a recovery plant; or
(iii)
more than 200 feet from a recovery plant; or
(B)
any spill
that
[
(10)
A licensee shall submit to the agency
at five year intervals from the issuance of the license or at the time of
renewal, if renewal and reevaluation occur in the same year, continued proof
of the licensee's financial qualifications.
(i)
Expiration and termination of licenses and decommissioning
of sites, separate buildings, or outdoor areas.
(1)
Except as provided in paragraph
(2)
[
[(2)
Each licensee shall notify the agency
immediately, in writing, and request termination of the license when the licensee
decides to terminate all activities involving materials authorized under the
license. This notification and request for termination of the license must
include the reports and information specified in paragraphs (6) and (17) of
this subsection. The licensee is subject to the provisions of paragraphs (4)-(18)
of this subsection, as applicable.]
[(3)
No less than 90 days before the expiration
date specified in a specific license, the licensee shall either:
[(A)
submit an application for license renewal under subsection
(j) of this section; or]
[(B)
notify the agency in writing, under paragraph (2) of this
subsection, if the licensee decides to discontinue all activities involving
radioactive material.]
(2)
[
(A)
be limited to actions involving radioactive material
that are related to decommissioning;
[
(B)
continue to control entry to restricted areas until
the location(s) is
[
(3)
[
(A)
the license has expired in accordance with paragraph (1)
of this subsection; or
(B)
the licensee has decided to permanently cease principal
activities, as defined in subsection (c)(25) of this section, at the entire
site or in any separate building or outdoor area; or
(C)
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 agency requirements.
(4)
Outdoor areas are considered suitable
for release for unrestricted use if the following limits are not exceeded.
(A)
The concentration of radium-226 or radium-228
in soil, averaged over any 100 square meters (m
2
),
shall not exceed the background level by more than:
(i)
5 picocuries per gram (pCi/g) (0.185 becquerel
per gram (Bq/g)), averaged over the first 15 cm of soil below the surface;
and
(ii)
15 pCi/g (0.555 Bq/g), averaged over
15 cm thick layers of soil more than 15 cm below the surface.
(B)
The contamination of vegetation shall
not exceed 5 pCi/g (0.185 Bq/g), based on dry weight, for radium-226 or radium-228.
(C)
The concentration of natural uranium in
soil, with no daughters present, averaged over any 100 m
2
, shall not exceed the background level by more than:
(i)
30 pCi/g (1.11 Bq/g), averaged over the
top 15 cm of soil below the surface; and
(ii)
150 pCi/g (5.55 Bq/g), average concentration
at depths greater than 15 centimeters below the surface so that no individual
member of the public will receive an effective dose equivalent in excess of
100 mrem (1 mSv) per year.
(5)
[
(A)
Any licensee who has not provided financial security to
cover the detailed cost estimate submitted with the closure plan shall do
so on or before September 1, 1998.
(B)
Following approval of the closure plan, a licensee may
reduce the amount of the financial security, with the approval of the agency,
as decommissioning proceeds and radiological contamination is reduced at the
site.
(6)
[
(7)
[
(8)
[
(A)
procedures
[
(B)
workers
[
(C)
procedures
[
(D)
procedures
[
(9)
[
(10)
[
(11)
[
(A)
a description of the conditions of the site, separate buildings,
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 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) of this subsection.
[
(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;
and
(C)
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 groundwater 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
radioactive
[
(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 paragraph (4) of this subsection.
[
(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
[(i)
report levels of gamma radiation in units
of microroentgen per hour (micro;R/hr) (millisieverts per hour (mSv/hr)) at
1 meter (m) from surfaces, and report levels of radioactivity, including alpha
and beta, in units of disintegrations per minute (dpm) or microcuries (micro;Ci)
(megabecquerels (MBq)) per 100 square centimeters (cm[sup]2[/sup]) removable
and fixed for surfaces, micro;Ci (MBq) per milliliter for water, and 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
[
(B)
reasonable effort has been made to eliminate residual radioactive
contamination, if present;
(C)
a radiation survey has been performed
that
[
(D)
other information submitted by the licensee is sufficient
to demonstrate that the premises are suitable for release in accordance with
the requirements of paragraph (4) of this subsection;
[
(E)
all records required by §289.202(nn)(2) of this
title have been submitted to the agency;
[
(F)
the licensee has paid any outstanding fees required by §289.204
of this title and has resolved any outstanding notice(s) of violation issued
to the licensee;
(G)
the licensee has met the applicable technical and other
requirements for closure and reclamation of a byproduct material disposal
site; and
(H)
the United States Nuclear Regulatory Commission (NRC) has
made a determination that all applicable standards and requirements have been
met.
(18)
[
[(20)
The agency may terminate a specific
license upon written request submitted by the licensee to the agency in accordance
with this subsection.]
(19)
[
(j)
Renewal of license.
(1)
Request for renewal of specific licenses shall be filed
in accordance with
subsections (d)(1)-(8) and (10), and (f)(1) of this
section.
[
(2)
In any case in which a licensee, not less than
30
[
(k)
(No change.)
(l)
Agency action on applications to renew or amend. In considering
a request by a licensee to renew or amend
a
[
(m)
Transfer of material.
(1)
No licensee shall transfer radioactive material except
as authorized in accordance with this
chapter.
[
(2)
Except as otherwise provided in a license and subject to
the provisions of paragraphs (3) and (4) of this subsection, any licensee
may transfer radioactive material:
(A)-(C)
(No change.)
(D)
to any person authorized to receive such material
in accordance with
[
(E)-(F)
(No change.)
(3)
Before transferring radioactive material to a specific
licensee of the agency, the NRC, an agreement state,
a licensing state,
or to a general licensee who is required to register with the agency,
[
(4)-(5)
(No change.)
(n)
Modification and revocation of licenses.
(1)
The terms and conditions of all licenses shall be subject
to amendment, revision, or modification. A license may be suspended or revoked
by reason of amendments to the Act, [
(2)
Any license may be revoked, suspended, or modified, in
whole or in part
for any of the following
:
(A)
[
(B)
[
(C)
[
(3)
Except in cases [
[(4)
The agency may terminate a specific license
upon written request submitted by the licensee to the agency in accordance
with subsection (i) of this section.]
(4)
[
(o)
Financial security requirements.
(1)
Financial security for decontamination, decommissioning,
reclamation, restoration, disposal, and any other requirements of the agency
shall be established by each licensee prior to the commencement of operations
to assure that sufficient funds will be available to carry out the decontamination
and decommissioning of buildings and the site and for the reclamation of any
byproduct material disposal areas. The amount of funds to be ensured by such
security arrangements
shall
[
(A)
decontamination and decommissioning of buildings and the
site to levels
that
[
(B)
(No change.)
(2)
(No change.)
(3)
The security
shall
[
(4)
(No change.)
(5)
The security shall be continuous for the
term of the license and shall be payable in the state of Texas to the Radiation
and Perpetual Care Fund.
(6)
[
(7)
[
(8)
[
(9)
[
(p)
Long-term care and maintenance requirements.
(1)-(2)
(No change.)
(3)
A minimum charge of $250,000 (1978 dollars) or more, if
demonstrated as necessary by the agency, shall be paid into the Radiation
and Perpetual Care Fund to cover the costs of long-term care and maintenance.
The total charge shall be paid prior to the termination of a license. With
agency approval, the charge may be paid in installments. The total or unpaid
portion of the charge shall be covered during the term of the license by additional
security meeting the requirements of subsection (o) of this section. If site
surveillance, control, or maintenance requirements at a particular site are
determined, on the basis of a site-specific evaluation, to be significantly
greater (
for example,
[
(4)
(No change.)
(q)
Technical requirements.
(1)-(2)
(No change.)
(3)
The site selection process
shall
[
(4)-(5)
(No change.)
(6)
The applicant's environmental report shall evaluate alternative
sites and disposal methods and shall consider disposal of byproduct material
by placement below grade. Where full below grade burial is not practicable,
the size of retention structures, and size and steepness of slopes associated
with exposed embankments shall be minimized by excavation to the maximum extent
reasonably achievable or appropriate given the geologic and hydrologic conditions
at a site. In these cases, it
shall
[
(7)
To avoid proliferation of small waste disposal sites and
thereby reduce perpetual surveillance obligations, byproduct material from
in situ extraction operations, such as residues from solution evaporation
or contaminated control processes, and wastes from small remote above ground
extraction operations
shall
[
(8)
The following site and design requirements shall be adhered
to whether byproduct material is disposed of above or below grade:
(A)
the upstream rainfall catchment areas
shall
[
(B)
(No change.)
(C)
the embankment and cover slopes shall be relatively flat
after final stabilization to minimize erosion potential and to provide conservative
factors of safety assuring long term stability. The objective should be to
contour final slopes to grades
that
[
(D)
(No change.)
(E)
where a full vegetative cover is not likely to be self-sustaining
due to climatic conditions, such as in semi-arid and arid regions, rock cover
shall be employed on slopes of the impoundment system. The agency will consider
relaxing this requirement for extremely gentle slopes, such as those
that
[
(F)
(No change.)
(G)
individual rock fragments shall be dense, sound, and resistant
to abrasion, and
shall
[
(H)
rock covering of slopes may not be required where top covers
are very thick (on the order of 10 m or greater); impoundment slopes are very
gentle (on the order of 10h:1v or less); bulk cover materials have inherently
favorable erosion resistance characteristics; [
(I)-(K)
(No change.)
(9)
Groundwater protection. The following groundwater protection
requirements and those in paragraphs (10) and (11) of this subsection and
subsection (s) of this section apply during operations and until closure is
completed. Groundwater monitoring to comply with these standards is required
by paragraphs (28) and (29) of this subsection.
(A)-(B)
(No change.)
(C)
The applicant or licensee will be exempted from the requirements
of subparagraph (A) of this paragraph if the agency finds, based on a demonstration
by the applicant or licensee, that alternate design and operating practices,
including the closure plan, together with site characteristics will prevent
the migration of any hazardous constituents into groundwater or surface water
at any future time. In deciding whether to grant an exemption, the agency
will consider:
(i)-(iii)
(No change.)
(iv)
all other factors
that
[
(D)-(E)
(No change.)
(10)
Byproduct materials shall be managed to conform to the
following secondary groundwater protection requirements:
(A)
hazardous constituents, as defined in subsection (c)(17)
of this section, entering the groundwater from a licensed site
shall
[
(B)-(E)
(No change.)
(F)
In making any determinations under subparagraphs (E) and
(H) of this paragraph about the use of groundwater in the area around the
facility, the agency will consider any identification of underground sources
of drinking water and exempted aquifers made by the
United States
Environmental Protection Agency
(EPA)
and the Texas Natural Resource
Conservation Commission (Commission).
(G)
(No change.)
(H)
Alternate concentration limits to background concentration
or to the drinking water limits in subsection (s) of this section that present
no significant hazard may be proposed by licensees for agency consideration.
Licensees shall provide the basis for any proposed limits including consideration
of practicable corrective actions, evidence that limits are as low as reasonably
achievable, and information on the factors the agency
shall
[
(11)
If the groundwater protection standards established under
subparagraph (D) of this paragraph are exceeded at a licensed site, a corrective
action program
shall
[
(12)
In developing and conducting groundwater protection programs,
applicants and licensees shall also consider the following:
(A)
(No change.)
(B)
mill process designs
that
[
(C)-(D)
(No change.)
(13)-(15)
(No change.)
(16)
In disposing of byproduct material, licensees shall place
an earthen cover over the byproduct material at the end of the facility's
operations and shall close the waste disposal area in accordance with a design
that
[
(A)-(B)
(No change.)
(17)
In computing required byproduct material cover thicknesses,
moisture in soils in excess of amounts found normally in similar soils in
similar circumstances shall not be considered. Direct gamma exposure from
the byproduct material should be reduced to background levels. The effects
of any thin synthetic layer shall not be taken into account in determining
the calculated radon exhalation level. Cover shall not include materials
that
[
(18)
As soon as reasonably achievable after emplacement of
the final cover to limit releases of radon-222 from uranium byproduct material
and prior to placement of erosion protection barriers of other features necessary
for long-term control of the tailings, the licensee shall verify through appropriate
testing and analysis that the design and construction of the final radon barrier
is effective in limiting releases of radon-222 to a level not exceeding
20pCi/m
2
s
[
(19)
When phased emplacement of the final radon barrier is
included in the applicable reclamation plan, as defined in subsection (c)(26)
of this section, the verification of radon-222 release rates required in paragraph
(30) of this subsection
shall
[
(20)
Within 90 days of the completion of all testing and analysis
relevant to the required verification in paragraphs (30)(C) and (30)(D) of
this subsection, the uranium recovery licensee shall report to the agency
the results detailing the actions taken to verify that levels of release of
radon-222 do not exceed
20 pCi/m
2
s
[
(21)
Near-surface cover materials may not include waste, rock,
or other materials that contain elevated levels of radium. Soils used for
near-surface cover
shall
[
(22)
The design requirements for longevity and control of radon
releases apply to any portion of a licensed and/or disposal site unless such
portion contains a concentration of radium in land averaged over areas of
100 square meters
(m
2
)
[
(A)-(B)
(No change.)
(23)
(No change.)
(24)
For impoundments containing uranium byproduct materials,
the final radon barrier
shall
[
(25)
The agency may approve by license amendment a licensee's
request to extend the time for performance of milestones related to emplacement
of the final radon barrier if, after providing an opportunity for public participation,
the agency finds that the licensee has adequately demonstrated in the manner
required in paragraph (18) of this subsection that releases of radon-222 do
not exceed an average of
20 pCi/m
2
s
.
[
(26)
The agency may authorize by license amendment, upon licensee
request, a portion of the impoundment to accept uranium byproduct material,
or such materials that are similar in physical, chemical, and radiological
characteristics to the uranium mill tailings and associated wastes already
in the pile or impoundment, from other sources during the closure process.
No such authorization will be made if it results in a delay or impediment
to emplacement of the final radon barrier over the remainder of the impoundment
in a manner that will achieve levels of radon-222 releases not exceeding
20 pCi/m
2
s
[
(27)-(28)
(No change.)
(29)
The licensee shall establish a detection monitoring program
needed for the agency to set the site-specific groundwater protection standards
in paragraph (10)(D) of this subsection. For all monitoring under this paragraph,
the licensee or applicant will propose, as license conditions for agency approval,
which constituents are to be monitored on a site-specific basis. The data
and information shall provide a sufficient basis to identify those hazardous
constituents
that
[
(30)
Systems shall be designed and operated so that all airborne
effluent releases are as low as is reasonably achievable. The primary means
of accomplishing this shall be by means of emission controls. Institutional
controls, such as extending the site boundary and exclusion area, may be employed
to ensure that offsite exposure limits are met, but only after all practicable
measures have been taken to control emissions at the source.
(A)
During operations and prior to closure, radiation doses
from radon emissions from surface impoundments of byproduct materials
shall
[
(B)
(No change.)
(C)
To control dusting from byproduct material, that portion
not covered by standing liquids shall be wetted or chemically stabilized to
prevent or minimize blowing and dusting to the maximum extent reasonably achievable.
This requirement may be relaxed if byproduct material are effectively sheltered
from wind, as in the case of below-grade disposal. Consideration shall be
given in planning byproduct material disposal programs to methods for phased
covering and reclamation of byproduct material impoundments. To control dusting
from diffuse sources, applicants/licensees shall develop written operating
procedures specifying the methods of control
that
[
(D)
(No change.)
(E)
Byproduct materials
shall
[
(31)
(No change.)
(32)
The agency may find that the proposed alternatives meet
the agency's requirements if the alternatives will achieve a level of stabilization
and containment of the sites concerned and a level of protection for the public
health and safety and the environment from radiological and nonradiological
hazards associated with the sites, which is equivalent to, to the extent practicable,
or more stringent than the level
that
[
(33)
(No change.)
(34)
Any proposed alternatives to the specific requirements
in subsections (o)-(r) of this section
shall
[
(35)
(No change.)
(r)
Land ownership of byproduct material disposal sites.
(1)
(No change.)
(2)
Unless exempted by the NRC, title to land (including any
affected interests therein)
that
[
(3)
Any uranium recovery facility license
shall
[
(4)
(No change.)
(5)
If the NRC, subsequent to title transfer, determines that
use of the surface or subsurface estates, or both, of the land transferred
to the state or federal government will not endanger the public health and
safety or the environment, the NRC may permit the use of the surface or subsurface
estates, or both, of such land in a manner consistent with the provisions
of this section. If the NRC permits
the
[
(s)
(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 June 14, 2002.
TRD-200203715
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: July 28, 2002
For further information, please call: (512) 458-7236
Chapter 411.
STATE AUTHORITY RESPONSIBILITIES
Subchapter B. INTERAGENCY AGREEMENTS
The
] sections also identify program services which
are available to individuals who have a confirmed diagnosis of a heritable
disease or hypothyroidism and establish eligibility criteria, financial participation
requirements and procedures for the orderly provision of the identified services
to eligible individuals.
(2)
Bona fide resident--An individual
who:]
(A)
is physically present within the geographic
boundaries of Texas; has an intent to remain within the state, either permanently
or for an indefinite period; actually maintains an abode (e.g., house, apartment,
etc., but not merely a post office box) within this state; and]
(B)
does not claim residency in any other state
or country; is a minor child, residing in Texas, of a bona fide resident;
is a legal dependent spouse, residing in Texas, of a bona fide resident; is
an adult residing in Texas and his/her legal guardian is a bona fide resident.]
be subjected to
] two screening tests for the following conditions:
the
]
parent,
the
managing conservator, or guardian objects to the screening
tests because the screening tests conflict with the religious tenets or practices
of
either of
the parents,
the
managing
conservator
[
conservators
], or
guardian
[
guardians
].
Newborns
delivered outside of hospitals
] or birthing
center licensed by
the department
[
centers, e.g., home deliveries
],
a newborn
must be screened within the first 72 hours of life. The second screen
must be done between one and two weeks of age.
Texas Department of Health
(department)
]. The department is responsible for identifying and implementing
proper laboratory procedures for the screening tests required in §37.53
of this title (relating to Conditions for Which Screening Tests Are Required).
are requested to
]
report to the department all confirmed cases of the conditions for which
required
screening tests are
performed
[
required
]
that have been detected by other mechanisms.
Chronically Ill and Disabled Children's ] Services Program.
Newborn Screening Program (program)
]
may be referred, if financially eligible, to the
department's
[
Texas Department of Health's (department's)
]
Children With Special
Health Care Needs (CSHCN) Program
[
Chronically Ill and Disabled
Children's Services Program (CIDC)
].
CIDC
] services shall be given approved services through
that program, including special dietary formula for individuals who have phenylketonuria
and homosystinuria [
through CIDC
]. An individual who does not meet
CSHCN
[
that
] eligibility criteria shall be referred to the
program
[
Newborn Screening Program
] for a determination of
eligibility for
program
[
Newborn Screening Program
] services.
Newborn Screening Program
]
services:
Newborn Screening Program (program)
];
Chronically Ill
and Disabled Children (CIDC)
],
Children's Health Insurance Plan
(CHIP)
or private insurance, that would pay for all or part of the services.
Texas Department of Health
(department)
] may waive ineligibility if the department finds that:
Newborn Screening
Program (program)
] services, a complete application [
(copy attached)
] for admission to the program must be filed annually with the program
administrator by mailing to the following address: Newborn Screening Program,
Bureau of
Children's Health
[
Women and Children
], Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756.
Women and Children
], Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756-3190. Failure
to respond will be deemed a waiver of the appeal and of the opportunity for
a hearing.
formal
] hearing
rules,
§§1.41, 1.51-1.55
[
§§1.21-1.32
] of this title (relating to
Fair
[
Formal
] Hearing
Procedures).
the
] advisory
committees with special technical expertise or to address special emotional,
social, educational, financial, or other problems which arise in families
having a family member with a confirmed diagnosis of phenylketonuria, other
heritable disease, or hypothyroidism.
Texas
Department of Health (department)
] with or without notice to any individual
applying for or recipient of
program
[
Newborn Screening Program
(program)
] benefits, or to the providers of program services. Except
as necessary for timely and effective referral for diagnostic services or
to ensure appropriate management for individuals with confirmed diagnosis,
the information received by the program in the administration of the program
is confidential to the extent authorized by law.
Texas Department of Health
] operates
in compliance with Civil Rights Act of 1964 Title VI (Public Law 88-352) and
Part 80 of Title 45, Code of Federal Regulations, so that no person will be
excluded from participation in the
program
[
Newborn Screening
Program (program)
], be denied benefits of the program, or be otherwise
subjected to discrimination on the grounds of race, color, national origin,
sex, creed, disability, or age.
Chapter 91.
CANCER
of precancerous and
tumorous diseases and
] cancer for the recognition, prevention, cure,
or control of those diseases, and
to
facilitate participation in
the national program of cancer registries established by 42 United States
Code §§280e to 280e-4. Nothing in these sections shall preempt the
authority of facilities or individuals providing diagnostic or treatment services
to patients with cancer to maintain their own
cancer
[
facility
based tumor
] registries.
Cases
] of cancer [
or those precancerous or tumorous diseases
] to be reported to the division
are as follows:
brain
and
] central nervous system[
;
]
.
Ninth Revision,
]
Clinical Modification
of the World Health Organization
which correspond
to the division's reportable list are specified in the cancer reporting handbook.
produced
or furnished
] shall include, but not be limited to:
sex
], race and [
Spanish
] ethnicity,
marital status,
and birthplace, to the extent such information is available
from the medical record;
to be provided by facilities without
a documented data quality program such as one approved by the American College
of Surgeons.
]
(b)(1) of this section relating
to reporting requirements and complete documentation
];
or precancerous
or tumorous disease
] diagnosed;
;
]
if electronic means are
unavailable and the annual cancer caseload of the health care facility, clinical
laboratory or health care practitioner is 50 or fewer cases; or
magnetic tape
];
(1)
]
All counties shall be assigned
by the
division
to a [
designated
] regional cancer registry
.
[
of a public health region.
] Completed forms shall be submitted
to the regional director or his designee at the
regional cancer registry
[
public health region
] designated to receive data from
the county
where the person with cancer [
or precancerous or tumorous
disease
] is
admitted,
diagnosed or treated.
central
office of the division to the Cancer Registry Division, Texas Department of
Health, 1100 West 49th Street, Austin, Texas 78756-3199.
]
Chapter 97.
COMMUNICABLE DISEASES
be written or
typed and
] contain the name of the consenting adult, name of the minor
child, the relationship of the consenting adult to the minor child, the date
of the interview, the initials of the clinician conducting the interview of
the consenting adult, and the reason the parent, managing conservator, guardian,
or other authorized person could not be contacted.
Subchapter D. STATEWIDE IMMUNIZATION OF CHILDREN BY HOSPITALS, PHYSICIANS, AND OTHER HEALTH CARE PROVIDERS
caused by infectious agents
]
in accordance with the immunization schedule adopted by the Board of Health.
The immunization requirements are also adopted as a statewide "control measure"
for communicable diseases as that term is used in the Health and Safety Code, §81.081
and §81.082, and as an "instruction of the department" as that term is
used in the Health and Safety Code, §81.007.
required immunization
schedule
] shall be
those required
[
based upon the immunization
requirements
] for children and students under §§97.61-97.77
of this title (relating to Immunization Requirements in Texas Elementary and
Secondary Schools and Institutions of Higher Education). Additional copies
of Immunization Requirements in Texas Elementary and Secondary Schools and
Institutions of Higher Education
may be obtained from [
Literature
and Forms,
] Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756-3180, (512) 458-7284.
: Literature and Forms,
] Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3180, (512) 458-7284.
Chapter 221.
MEAT SAFETY ASSURANCE
and
]
.
]"
; and
and
] hunter killed feral swine, as defined in §221.12(b)
of this title[
.
]
, provided persons engaged in such processing
do not utilize the same facilities to engage in the receipt, storage, processing,
or distribution of other meat and/or poultry food products.
and
] hunter killed feral
swine
,
as defined in §221.12(b) of this title[
.
]
, provided persons engaged in such processing do not utilize the same facilities
to engage in the receipt, storage, processing, or distribution of other meat
and/or poultry food products.
Chapter 230.
AVERAGE MANUFACTURE PRICE AND PURCHASE PRICE REPORTING FOR PHARMACEUTICALS
Chapter 289.
RADIATION CONTROL
management
].
(6)
] Applications for licenses shall
be processed in accordance with the following time periods.
(7)
] Notwithstanding the provisions
of §289.204(e)(1) of this title, reimbursement of application fees may
be granted in the following manner.
(6)
] of this subsection,
the applicant has the right to request of the director of the Radiation Control
Program full reimbursement of all application fees paid in that particular
application process. If the director does not agree that the established periods
have been violated or finds that good cause existed for exceeding the established
periods, the request will be denied.
§§1.21-1.34
]
of this title (relating to the Texas Board of Health).
(8)
] Applications for licenses
may be denied for the following reasons:
and
]
.
]
and/or used
] on the property, if the proposed storage
facility is not owned by the applicant. The applicant shall provide a written
statement from the owner
, or from the owner's agent,
indicating
such. This paragraph does not apply to property owned or held by a government
entity
or to property on which radioactive material is used under an
authorization for temporary job site use
.
and
]
";
]
";
]
, or
]
or
]
or
]
(i)
report levels of gamma radiation in units
of millisieverts per hour (mSv/hr) (microroentgen per hour (µR/hr))
at 1 meter from surfaces, and report levels of radioactivity, including alpha
and beta, in units of megabecquerels (MBq) (disintegrations per minute (dpm)
or µCi per 100 cm
2
for both removable and
fixed for surfaces, MBq (µCi) per milliliter (ml) for water, and becquerels
(Bq) (picocuries (pCi)) per gram (g) for solids such as soils or concrete;
and
]
licenses
], including former
licensees
[
licenses
] with provisions continued in effect beyond the expiration
date in accordance with
paragraph (2) of this
subsection [
(y)(2) of this section
], that the provisions of the license are no longer
binding. The agency will provide such notification when the agency determines
that:
.
] 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
(5)
] of this section.
In any application for renewal, the applicant
may incorporate drawings by reference.
or
] by reason of rules in
this chapter
, or
[
and
] orders issued by the agency.
or of
] the license, or order
of the agency.
";
] and
(5)
] of this subsection in an amount
sufficient to allow the agency to engage a third party to decommission the
site(s) specified on the
license. The decommissioning funding plan shall
also be submitted when a combination of isotopes is involved if R divided
by 10
5
is greater than 1 (unity rule), where
R is defined as the sum of the ratios of the quantity of each isotope to the
applicable value in subsection (ii)(2) of this section.
Those persons
who receive, possess, or process sealed sources as radioactive waste from
other persons and who are exempt from §289.254 of this title shall submit
a decommissioning funding plan as described in paragraph (4) of this subsection
in an amount sufficient to allow the agency to engage a third party to decommission
the site(s) specified on the license. Persons who receive, possess, or process
sealed sources of radioactive material from other persons for recycle or beneficial
reuse and store the sealed sources of radioactive material for longer than
two years, are considered to be receiving, possessing, or processing sealed
sources of radioactive material as radioactive waste from other persons and
shall submit a decommissioning funding plan as described in paragraph (4)
of this subsection in an amount sufficient to allow the agency to engage a
third party to decommission the site(s) specified on the license.
(4)
] of this subsection shall either:
(5)
] of this subsection in an amount sufficient to allow
the agency to engage a third party to decommission the
site(s) specified
on the
license; or
a certification that
] financial assurance
for decommissioning [
has been provided
] in the amount in accordance
with paragraph
(3)
[
(4)
] of this subsection using one
of the methods described in paragraph
(5)
[
(6)
] of this
subsection in an amount sufficient to allow the agency to engage a third party
to decommission the
site(s) specified on the
license.
Upon
renewal, the holder of a specific license shall certify that the current financial
assurance is adequate to meet the requirements of this subparagraph or submit
financial assurance that meets the requirements of this subparagraph.
For an applicant,
the financial
[
this certification may state
that the appropriate
] assurance will be obtained after the application
has been approved and the license issued, but prior to the receipt of licensed
material. If the applicant defers execution of the financial instrument until
after the license has been issued, a signed original of the financial instrument
obtained to satisfy the requirements of paragraph
(5)
[
(6)
] of this subsection shall be submitted to the agency before receipt
of licensed material. If the applicant does not defer execution of the financial
instrument, [
as part of the certification,
] a signed original of
the financial instrument obtained to satisfy the requirements of paragraph
(5)
[
(6)
] of this subsection shall be submitted to the agency.
(4)
] The required
amount
[
amounts
] of financial assurance for decommissioning
is
[
are
] determined by
the
quantity of material
authorized
by the license and is determined
[
and are
] as follows:
$750,000
] for quantities
of material greater than 10
4
but less than or
equal to 10
5
times the applicable quantities
in subsection (ii)(2) of this section in unsealed form. (For a combination
of radionuclides, if R, as defined in paragraph (1) of this subsection, divided
by 10
4
is greater than 1 but R divided by 10
$150,000
] for quantities
of material greater than 10
3
but less than or
equal to 10
4
times the applicable quantities
in subsection (ii)(2) of this section in unsealed form. (For a combination
of radionuclides, if R, as defined in paragraph (1) of this subsection, divided
by 10
3
is greater than 1 but R divided by 10
$75,000
] for quantities
of material greater than 10
10
times the applicable
quantities in subsection (ii)(2) of this section in sealed sources or plated
foils. (For a combination of radionuclides, if R, as defined in paragraph
(1) of this subsection, divided by 10
10
is greater
than one.)
(5)
] Each decommissioning funding
plan shall contain a cost estimate for decommissioning in an amount sufficient
to allow the agency to engage a third party to decommission the
site(s)
specified on the
license and a description of the method of assuring
funds for decommissioning from paragraph
(5)
[
(6)
] of
this subsection, including means of adjusting cost estimates and associated
funding levels periodically over the life of the facility.
The required
amount of financial assurance for decommissioning is determined by the quantity
of material authorized by the license. The applicant for or holder of the
specific license shall submit with the decommissioning funding plan
[
The decommissioning funding plan shall also contain a certification
by the licensee that financial assurance for decommissioning has been provided
in an amount sufficient to allow the agency to engage a third party to decommission
the license and
] a signed original of the financial instrument obtained
to satisfy the requirements of paragraph
(5)
[
(6)
] of
this subsection.
Upon approval of the decommissioning funding plan by
the agency, the amount of financial assurance shall be adjusted and posted
in conformance with agency approval.
(6)
] Financial assurance for decommissioning
shall be provided by one or more of the following methods and shall be reviewed
and approved by the agency.
The financial instrument obtained shall be
continuous for the term of the license.
the start of operation
] into an account segregated
from licensee assets and outside the licensee's administrative control of
cash or liquid assets such that the amount of funds would be sufficient to
pay decommissioning costs. Prepayment may be in the form of a trust, escrow
account, government fund, certificate of deposit, or deposit of government
securities.
a trust established for decommissioning costs. The trustee and
trust shall be acceptable to the agency. An acceptable trustee includes an
appropriate state or federal government agency or an entity that has the authority
to act as a trustee and whose trust operations are regulated and examined
by a federal or state agency.
]
(7)
] Each person licensed in accordance
with this section shall keep records of information important to the safe
and effective decommissioning of the facility in an identified location until
the license is terminated by the agency. If records of relevant information
are kept for other purposes, reference to these records and their locations
may be used. Information the agency considers important to decommissioning
consists of the following:
(8)
] Any licensee who has submitted
an application before January 1, 1995, for renewal of license in accordance
with this section shall provide financial assurance for decommissioning in
accordance with paragraphs (1) and (2) of this subsection. This assurance
shall be submitted when this section becomes effective March 1, 1998.
which
] is required to be derived from the independently
audited year end financial statement based on United States generally accepted
accounting practices for the latest fiscal year, with the amounts in the financial
statement. In connection with that procedure, the licensee shall inform the
agency within 90 days of any matters that may cause the auditor to believe
that the data specified in the financial test should be adjusted and that
the company no longer passes the test;
self-guarantee
] for providing reasonable assurance of funds
for decommissioning by nonprofit entities, such as colleges, universities,
and nonprofit hospitals.
Poors
] or Aaa, Aa, or A as issued by
Moody's
[
Moodys
].
Poors
] or
Moody's
[
Moodys
],
the licensee shall provide notice in writing of the fact to the agency within
20 days after publication of the change by the rating service.
Chapter 289.
RADIATION CONTROL
which
]
accept
byproduct material
for disposal [
byproduct material
]. No person shall engage in such activities except as authorized in
a specific license issued
in accordance with
[
pursuant to
] this section unless otherwise provided for in §289.252 of this
title (relating to Licensing of Radioactive Material).
§289.112 of this title (relating to Hearing and Enforcement
Procedures) §289.114 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections),
] §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 Material
),
§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
[
Material(s)
] Licenses, Emergency Planning and Implementation,
and Other Regulatory Services),
§289.205 of this title (relating
to Hearing and Enforcement Procedures),
§289.251 of this title
(relating to Exemptions, General Licenses, and General License Acknowledgements), §289.252
of this title, and §289.257 of this title (relating to Packaging and
Transportation of Radioactive Material).
part
] shall have the following meaning
unless the context clearly indicates otherwise.
e.g.,
] by way of illustration only, unreasonable overtime, staffing,
or transportation requirements, etc., considering normal practice in the industry;
laser fusion of soils; etc.), provided there is reasonable progress toward
emplacement of the final radon barrier. To determine grossly excessive costs,
the relevant baseline against which costs shall be compared is the cost estimate
for tailings impoundment closure contained in the licensee's approved reclamation
plan, but costs beyond these estimates shall not automatically be considered
grossly excessive.
which
] meets all three of the following tests:
The
] constituent is reasonably
expected to be in or derived from the byproduct material in the disposal area;
The
] constituent has been detected
in the groundwater in the uppermost aquifer; and
The
] constituent is listed in
10 CFR Part 40, Appendix A, Criterion 13.
which
] restricts the downward or lateral escape of byproduct material, hazardous
constituents, or leachate.
which
] would cause the maximum vibratory ground motion
based upon an evaluation of earthquake potential considering the regional
and local geology and seismology and specific characteristics of local subsurface
material.
must
] be met. The objective in selecting the point of compliance
is to provide the earliest practicable warning that an impoundment is releasing
hazardous constituents to the groundwater. The point of compliance is selected
to provide prompt indication of groundwater contamination on the hydraulically
downgradient edge of the disposal area.
which
] are essential to achieving the purpose(s) for
which the license is issued or amended. Storage during which no licensed material
is accessed for use or disposal and activities incidental to decontamination
or decommissioning are not principal activities.
must
] include a schedule for reclamation milestones that are key
to the completion of the final radon barrier, including as appropriate, but
not limited to, wind blown tailings retrieval and placement on the pile, interim
stabilization (including dewatering or the removal of freestanding liquids
and recontouring), and final radon barrier construction. Reclamation of byproduct
material
shall
[
must
] also be addressed in the closure
plan. The detailed reclamation plan may be incorporated into the closure plan.
"security":
]
eight
] copies on
BRC Form 252-2, "Application
for Radioactive Material License."
[
a form prescribed by the agency.
Applications for issuance of licenses shall include an environmental report
that includes the results of a one-year preoperational monitoring program.
Applications for renewal of licenses shall include an environmental report
that includes the results of the operational monitoring program.
]
and before the expiration of the license,
] require further statements or data to enable the agency to determine
whether the application should be denied or
the
[
whether a
] license should be
issued.
[
granted, modified, or revoked.
]
the applicant or licensee
or a person legally authorized to act for and on the applicant's or licensee's
behalf.
]
(7)
] An application for a license
shall contain written specifications relating to the uranium recovery facility
operations [
,
] and the disposition of the byproduct material.
(8)
] Each application
shall
[
must
] clearly demonstrate how the requirements of subsections
(d)-(h) and (o)-(r) of this section have been addressed. [
Failure to
clearly demonstrate how these requirements have been addressed shall be grounds
for refusing to accept an application for filing.
]
(9)
] Each application for a [
specific
] license[
, other than a license exempted from §289.204
of this title,
] shall be accompanied by the fee prescribed in §289.204
of this title.
(10)
] Each application shall be
accompanied by
a completed
BRC Form 252-1
, (Business Information
Form)
.
(11)
] Applications for new licenses
shall be processed in accordance with the following time periods.
a
] time
from receipt of an application by the Division of Licensing, Registration
and Standards to the date of issuance or denial of the license or a written
notice outlining why the application is incomplete or unacceptable. This time
period is 180 days.
a
] time
from receipt of the last item necessary to complete the application to the
date of issuance or denial of the license. This time period is 180 days.
the
] Government
Code, Chapters 2001 and 2002.
(12)
] Notwithstanding the provisions
of §289.204(e)(1) of this title, reimbursement of application fees may
be granted in the following manner.
(11)
] of this subsection,
the applicant has the right to request of the Director of the Radiation Control
Program full reimbursement of all application fees paid in that particular
application process. If the
director
[
Director
] does
not agree that the established periods have been violated or finds that good
cause existed for exceeding the established periods, the request will be denied.
protect
] public health and safety and the environment;
protect
] public health and safety and the environment;
.
]
specific
]
license application for uranium recovery and byproduct material disposal facilities.
In addition to the requirements [
set forth
] in subsection (e) of
this section, a [
specific
] license will be issued if the applicant
submits
the items in paragraph (1) of this subsection for agency approval
and meets the conditions in paragraphs (2) and (3) of this subsection
[
to the agency a satisfactory application as described herein and meets
the following other conditions specified.
]
an environmental
report that addresses
] the following:
(A)
] description of the proposed
project or action;
(B)
] area/site characteristics
including ecology, geology, topography, hydrology, meteorology, historical
and cultural landmarks, and archaeology;
(C)
] radiological and nonradiological
impacts of the proposed project or action, including waterway and groundwater
impacts and any long-term impacts;
(D)
] environmental effects of
accidents;
(E)
] byproduct material disposal,
decommissioning, decontamination, and reclamation and impacts of these activities;
and
(F)
] site and project alternative;
(2)
] [
The applicant shall provide
] a closure plan for decontamination, decommissioning, restoration,
and reclamation of buildings and the site to levels that would allow unrestricted
use and for reclamation of the byproduct material disposal areas in accordance
with the technical requirements of subsection (q) of this section
;
[
.
]
(3)
]
[
Unless otherwise exempted, the applicant
shall not commence construction at the site until the agency has issued the
license. Commencement of construction prior to issuance of the license shall
be grounds for denial of a license.
]
(4)
] [
Prior to issuance of
the license, the applicant shall propose, for approval by the agency,
]
proposal of
an acceptable form and amount of financial security consistent
with the requirements of subsection (o) of this section
;
[
.
]
(5)
] [
The applicant shall
provide
] procedures describing the means employed to meet the requirements
of subsections
(h)(7) and (8)
[
(h)(6), (h)(7),
] and
(q)(15) of this section during the operational phase of any project
;
[
.
]
(6)
][
An application for a
license shall contain
] specifications for the emissions control and
disposition of the byproduct material
; and
[
.
]
(7)
][
An application
]
for disposal of byproduct material from others
,
[
shall include
] information on the chemical and radioactive characteristics of the
wastes to be received, detailed procedures for receiving and documenting incoming
waste shipments, and detailed waste acceptance criteria.
Upon a determination
] that an application meets the requirements of the
Act
[
Texas Radiation Control Act (Act)
] and the requirements of the agency,
the agency
will
[
may
] issue a [
specific
]
license authorizing the
proposed
activity in such form and containing
the
[
such
] conditions and limitations as it deems appropriate
or necessary.
or thereafter
by appropriate requirement or order, such additional requirements and conditions
] as it deems appropriate or necessary in order to:
protect
] public health and safety or the environment;
such
] reports and the keeping of [
such
] records, and to provide for [
such
] inspections of activities
in accordance with
[
under
] the license as may be appropriate
or necessary; and
section.
]
and to all applicable rules
] and orders of the agency.
part
] shall
be transferred, assigned, or in any manner disposed of, either voluntarily
or involuntarily, directly or indirectly, through transfer of control of any
license to any person unless the agency shall, after securing full information,
find that the transfer is in accordance with the provisions of the Act
and to applicable rules,
now and hereafter in effect, [
and to applicable
requirements
] and orders of the agency, and shall give its consent in
writing.
licensed
] material to the locations and purposes authorized in the license.
(6)
] Daily inspection of any byproduct
material retention systems shall be conducted by the licensee. General qualifications
for [
such
] individuals conducting [
such
] inspections
shall be approved by the agency. Records of the inspections shall be maintained
for review by the agency.
(7)
] In addition to the applicable
requirements of §289.202(ww)-(yy) of this title
,
[
and §289.252(r)
of this title,
] the licensee shall immediately notify the agency of
the following:
which
] results in a release of byproduct material into
unrestricted areas;
which
] exceeds the concentrations for water listed in Table II, Column
2, of §289.202(ggg)(2) of this title and
that
[
which
] extends beyond the licensed boundary;
which
] exceeds 20,000
gallons and
that
[
which
] exceeds the concentrations
for water listed in Table II, Column 2, of §289.202(ggg)(2) of this title;
or
which
]
exceeds the [
contamination
] limits in
subsection (i)(4) of
this section
[
§289.202)(ddd) of this title
] and that
extends beyond the licensed boundary.
(8)
] In addition to the applicable
requirements of §289.202(ww)-(yy) of this title
,
[
and §289.252(r)
of this title,
] the licensee shall notify the agency within 24 hours
of the following:
which
] exceeds 2,000
gallons and
that
[
which
] exceeds the concentrations
for water listed in Table II, Column 2, of §289.202(ggg)(2) of this title.
(4)
] of this subsection and subsection (j)(2) of this section, each specific
license
expires
[
shall expire
] at the end of the day,
in the month and year stated in the license.
]
(4)
]
All license provisions
continue
[
Each specific license continues
] in effect[
,
] beyond the expiration date [
if necessary,
] with respect
to possession of
radioactive
[
source
] material until
the agency notifies the
former
licensee in writing that the
provisions of the license are no longer binding.
[
license is terminated.
] During this time, the
former
licensee shall:
limit actions involving source
material to those related to decommissioning;
] and[
,
]
they are
] suitable for release
for unrestricted use in accordance with the requirements of paragraph (4)
of this subsection.
[
in accordance with agency requirements.
]
(5)
] 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
buildings or outdoor areas that contain residual radioactivity in accordance
with the closure plan in subsection
(f)(1)(B)
[
(f)(2)
]
of this section, so that the buildings or outdoor areas are suitable for release
in accordance with
paragraph (4) of this subsection
[
agency
requirements,
] if:
(6)
] Coincident with the notification
required by paragraph
(3)
[
(5)
] of this subsection,
the licensee shall maintain in effect all decommissioning financial security
established by the licensee in accordance with subsection (o) of this section
in conjunction with a license issuance or renewal or as required by this section.
The amount of the financial security
shall
[
must
] 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)
[
(12)(F)
] of this
subsection.
(7)
] In addition to the provisions
of paragraph
(5)
[
(6)
] of this subsection, each licensee
shall submit an updated closure plan to the agency within 12 months of the
notification required by paragraph
(3)
[
(5)
] of this
subsection. The updated closure plan shall meet the requirements of subsections
(f)(1)(B)
[
(f)(2)
] and (o) of this section. The updated closure
plan shall describe the actual conditions of the facilities and site and the
proposed closure activities and procedures.
(8)
] 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
[
must
] be submitted no later than 30 days
before notification in accordance with paragraph
(3)
[
(5)
] of this subsection. The schedule for decommissioning [
set forth
] in paragraph
(3)
[
(5)
] of this subsection may
not
begin
[
commence
] until the agency has made a determination
on the request.
(9)
] A decommissioning plan
shall
[
must
] 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:
Procedures
] would involve
techniques not applied routinely during cleanup or maintenance operations;
Workers
] would be entering
areas not normally occupied where surface contamination and radiation levels
are significantly higher than routinely encountered during operation;
Procedures
] could result
in significantly greater airborne concentrations of radioactive materials
than are present during operation; or
Procedures
] could result
in significantly greater releases of radioactive material to the environment
than those associated with operation.
(10)
] The agency may approve an
alternate schedule for submittal of a decommissioning plan required in accordance
with paragraph
(3)
[
(5)
] 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.
(11)
] The procedures listed in
paragraph
(8)
[
(9)
] of this subsection may not be carried
out prior to approval of the decommissioning plan.
(12)
] The proposed decommissioning
plan for the site or separate building or outdoor area
shall
[
must
] include:
a justification for the delay based on the criteria in paragraph
(16) of this subsection for decommissioning plans calling for completion of
decommissioning later than 24 months after plan approval.
]
(13)
] The proposed decommissioning
plan will be approved by the agency if the information
in the plan
[
therein
] demonstrates that the decommissioning will be completed
as soon as practicable and that the
occupational
health and safety
of workers and the public will be adequately protected.
(14)
] Except as provided in paragraph
(15)
[
(16)
] of this subsection, licensees shall complete decommissioning
of the site or separate building or outdoor area as soon as practicable but
no later than 24 months following the initiation of decommissioning.
(15)
] Except as provided in paragraph
(15)
[
(16)
] 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.
(16)
] The agency may approve a
request for an alternate schedule for completion of decommissioning of the
site or separate buildings or outdoor
areas
[
area
], and
the license termination if appropriate, if the agency determines that the
alternative is warranted by the consideration of the following:
(17)
] As the final step in decommissioning,
the licensee shall:
licensed
] material, including accumulated byproduct material;
in some other
manner.
] The licensee shall, as appropriate;
(18)
]
The agency will provide
written notification to specific licensees, including former licensees with
license provisions continued in effect beyond the expiration date in accordance
with paragraph (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:
[
Specific licenses, including expired licenses,
will be terminated by license amendment when the agency determines that:
]
source material and
byproduct material
] has been properly disposed;
which
] demonstrates that the premises are suitable for release in accordance
with agency requirements;
agency requirements;
]
records required by §289.251(l)(4)(C)
of this title have been received;
]
(19)
]
Licenses
[
Specific licenses
] for uranium recovery
and byproduct material
disposal
are exempt from paragraphs
(3)(C), (6), and (7)
[
(5)(C), (7), and (8)
] of this subsection with respect to reclamation
of byproduct material impoundments and/or disposal areas. Timely reclamation
plans for byproduct material disposal areas
shall
[
must
]
be submitted and approved in accordance with subsection (q)(16)-(27) of this
section.
(21)
] A licensee may request that
a subsite or a portion of a licensed site be released for unrestricted use
before full license termination as long as release of the area of concern
will not adversely impact the remaining unaffected areas and will not be recontaminated
by ongoing authorized activities. When the licensee is confident that the
area of concern will be acceptable to the agency for release for unrestricted
use, a written request for release for unrestricted use and agency confirmation
of closeout work performed
shall
[
must
] be submitted
to the agency. The request should include a comprehensive report, accompanied
by survey and sample results that show contamination is less than the limits
specified in
paragraph (4) of this subsection
[
§289.202(ddd)
of this title
] and an explanation of how ongoing authorized activities
will not adversely affect the area proposed to be released. Upon confirmation
by the agency that the area of concern is releasable for unrestricted use,
the licensee may apply for a license amendment, if required.
subsection (d) of this section with the exception of
subsection (d)(9) of this section.
]
In any application for renewal,
the applicant may incorporate drawings by reference.
90
] days prior to expiration of the existing license, has
filed a request in proper form for renewal or for a new license authorizing
the same activities, such existing license shall not expire until the application
has been finally determined by the agency.
the
] license,
the agency will apply the appropriate criteria [
set forth
] in subsections
(e) and (f) of this section.
section.
]
under
] terms of a general license or
its equivalent, [
or
] a specific license or equivalent licensing
document
[
documents,
] issued by the agency,
the NRC,
any agreement state,
any licensing state,
or to any person
otherwise authorized to receive such material by the federal government or
any agency
of the federal government,
[
thereof,
]
or
the agency
;
[
, or any agreement state;
]
the NRC, or an agreement state prior to receipt of the radioactive material,
] the licensee transferring the
radioactive
material shall
verify that the transferee's license authorizes the receipt of the type, form,
and quantity of radioactive material to be transferred.
or
] by reason of rules
in this chapter,
or orders issued by the agency.
for
] any material false statement in the application
or any statement of fact required under provisions of the Act; [
or
]
because of
] 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 issue a license on an original
application; or
for
] violation of, or failure to observe
any of the
[
applicable
] terms and conditions of the Act,
this chapter,
[
or of
] the license, [
or of any requirement
] or order of the agency.
of willful violation of the Act or
these requirements or cases
] in which [
protection of the
]
occupational and
public health and safety or the environment require
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 [
or achieve
] compliance with all lawful requirements.
(5)
] Each specific license revoked
by the agency expires at the end of the day on the date of the
agency's
[
Agency's
] final determination to revoke the license, or
on the
revocation
[
expiration
] date stated in the determination,
or as otherwise provided by agency order.
must
] be based on agency-approved
cost estimates in an agency-approved closure plan for:
which
] allow unrestricted use of
these areas upon decommissioning; and
must
] also cover
the payment of the charge for long-term surveillance and control for byproduct
material disposal areas required by subsection (p)(3) of this section.
(5)
] The licensee's security mechanism
will be reviewed annually by the agency to assure that sufficient funds would
be available for completion of the reclamation plan if the work had to be
performed by an independent contractor. The amount of security liability should
be adjusted to recognize any increases or decreases resulting from inflation,
changes in engineering plans, activities performed, and any other conditions
affecting costs.
(6)
] Regardless of whether reclamation
is phased through the life of the operation or takes place at the end of operations,
an appropriate portion of security liability
shall
[
must
]
be retained until final compliance with the reclamation plan is determined.
This will yield a security that is at least sufficient at all times to cover
the costs of decommissioning and reclamation of the areas that are expected
to be disturbed before the next license renewal. The term of the security
mechanism
shall
[
must
] be open ended
.
[
unless it can be demonstrated that another arrangement would provide an equivalent
level of assurance.
] This assurance would be provided with a security
instrument that is written for a specified period of time (
for example,
[
e.g.,
] five years) yet which
shall
[
must
] be automatically renewed unless the security notifies the agency and
the licensee some reasonable time (
for example,
[
e.g.,
]
90 days) prior to the renewal date of their intention not to renew. In such
a situation the security requirement still exists and the licensee would be
required to submit an acceptable replacement security within a brief period
of time to allow at least 60 days for the agency to collect.
(7)
] Proof of forfeiture
shall
[
must
] not be necessary to collect the security so that
in the event that the licensee could not provide an acceptable replacement
security within the required time, the security shall be automatically collected
prior to its expiration. The conditions described above would have to be clearly
stated on any security instrument
,
[
which is not open-ended,
] and
shall
[
must
] be agreed
upon
by
all parties.
(8)
] Self-insurance, or any arrangement
that essentially constitutes self insurance (
for example,
[
e.g.,
] a contract with a state or federal agency), will not satisfy
the security requirement since this provides no additional assurance other
than that which already exists through license requirements.
e.g.,
] if fencing or monitoring
is determined to be necessary), the agency may specify a higher charge. The
total charge
shall
[
must
] be such that, with an assumed
1.0% annual real interest rate, the collected funds will yield interest in
an amount sufficient to cover the annual costs of site care, surveillance,
and where necessary, maintenance. Prior to actual payment, the total charge
will be adjusted annually for inflation. The inflation rate to be used is
that indicated by the change in the Consumer Price Index published by the
United States Department of Labor, Bureau of Labor Statistics.
must
] be an optimization to the maximum extent reasonably achievable in
terms of these site features.
must
] be demonstrated
that an above grade disposal program will provide reasonably equivalent isolation
of the byproduct material from natural erosional forces.
must
] be disposed of at
existing large mill tailings disposal sites; unless, considering the nature
of the wastes, such as their volume and specific activity, and the costs and
environmental impacts of transporting the wastes to a large disposal site,
such offsite disposal is demonstrated to be impracticable or the advantages
of onsite burial clearly outweigh the benefits of reducing the perpetual surveillance
obligations.
must
] be minimized to decrease erosion potential by flooding
that
[
which
] could erode or wash out sections of the byproduct
material disposal area;
which
] are as close
as possible to those
that
[
which
] would be provided
if byproduct material was disposed of below grade. Slopes shall not be steeper
than 5 horizontal to 1 vertical (5h:1v), except as specifically authorized
by the agency. Where steeper slopes are proposed, reasons why a slope steeper
than 5h:1v would be as equally resistant to erosion shall be provided, and
compensating factors and conditions
that
[
which
] make
such slopes acceptable shall be identified;
which
] may exist on the top of the pile;
must
] be free from cracks, seams,
and other defects that would tend to unduly increase their destruction by
erosion and weathering action. Local rock materials are permissible provided
the characteristics under local climatic conditions indicate similar long-term
performance as a protective layer. Weak, friable, or laminated aggregate may
not be used;
and
] there is negligible
drainage catchment area upstream of the pile
;
[
,
] and
there is good wind protection;
which
] would
influence the quality and mobility of the leachate produced and the potential
for it to migrate to groundwater or surface water.
must
] not exceed the specified concentration limits in
the uppermost aquifer beyond the point of compliance during the compliance
period.
must
] consider. The agency will establish a site-specific alternate
concentration limit for a hazardous constituent, as provided in subparagraph
(G) of this paragraph, if it finds that the proposed limit is as low as reasonably
achievable, after considering practicable corrective actions, and that the
constituent will not pose a substantial present or potential hazard to human
health or the environment as long as the alternate concentration limit is
not exceeded. In making the present and potential hazard finding, the agency
will consider the factors listed in subparagraph (D) of this paragraph.
must
] be put into operation as
soon as is practicable, and in no event later than 18 months after the agency
finds that the standards have been exceeded. The licensee shall submit the
proposed corrective action program and supporting rationale for agency approval
prior to putting the program into operation, unless otherwise directed by
the agency. The licensee's proposed program
shall
[
must
]
address removing or treating in place any hazardous constituents that exceed
concentration limits in groundwater between the point of compliance and downgradient
licensed site boundary. The licensee shall continue corrective action measures
to the extent necessary to achieve and maintain compliance with the groundwater
protection standard. The agency will determine when the licensee may terminate
corrective action measures based on data from the groundwater monitoring program
and other information that provides reasonable assurance that the groundwater
protection standard will not be exceeded.
which
]
provide the maximum practicable recycle of solutions and conservation of water
to reduce the net input of liquid to the byproduct material impoundment;
which
] provides reasonable assurance of control of
radiological hazards to the following:
which
] contain elevated levels of radium. Soils used
for near-surface cover
shall
[
must
] be essentially the
same, as far as radioactivity is concerned, as that of surrounding surface
soils. If non-soil materials are proposed as cover materials, the licensee
shall demonstrate that such materials will not crack or degrade by differential
settlement, weathering, or other mechanisms over the long term.
20 pCi/m[sup]2[/sup]s
]
averaged over the entire pile or impoundment using the procedures described
in Appendix B, method 115 of 40 CFR Part 61, or another method of verification
approved by the agency as being at least as effective in demonstrating the
effectiveness of the final radon barrier.
must
] be conducted for
each portion of the pile or impoundment as the final radon barrier for that
portion is emplaced.
20 pCi/m[sup]2[/sup]s
] when averaged over the entire pile or impoundment.
The licensee shall maintain records documenting the source of input parameters,
including the results of all measurements on which they are based, the calculations
and/or analytical methods used to derive values for input parameters, and
the procedure used to determine compliance. These records shall be maintained
until termination of the license and shall be kept in a form suitable for
transfer to the custodial agency at the time of transfer of the site to the
state or federal government in accordance with subsection (r) of this section.
must
] be essentially the same,
as far as radioactivity is concerned, as surrounding surface soils. This is
to ensure that surface radon exhalation is not significantly above background
because of the cover material itself.
(m[sup]2[/sup])
], that, as a result of byproduct material, does not exceed the background
level by more than:
must
] be completed as
expeditiously as practicable considering technological feasibility after the
pile or impoundment ceases operation in accordance with a written reclamation
plan, as defined in subsection (c)(26) of this section, approved by the agency,
by license amendment. (The term "as expeditiously as practicable considering
technological feasibility" includes "factors beyond the control of the licensee.")
Deadlines for completion of the final radon barrier and applicable interim
milestones
shall
[
must
] be established as license conditions.
Applicable interim milestones may include, but are not limited to, the retrieval
of windblown byproduct material and placement on the pile and the interim
stabilization of the byproduct material (including dewatering or the removal
of freestanding liquids and recontouring). The placement of erosion protection
barriers or other features necessary for long-term control of the byproduct
material
shall
[
must
] also be completed in a timely
manner in accordance with a written reclamation plan approved by the agency
by license amendment.
20 pCi/m[sup]2[/sup]s
] If the delay is approved on the basis that
the radon releases do not exceed
20 pCi/m
2
s
, [
20 pCi/m[sup]2[/sup]s
] a verification of radon levels,
as required by paragraph (18) of this subsection,
shall
[
must
] be made annually during the period of delay. In addition, once
the agency has established the date in the reclamation plan for the milestone
for completion of the final radon barrier, the agency may by license amendment
extend that date based on cost if, after providing an opportunity for public
participation, the agency finds that the licensee is making good faith efforts
to emplace the final radon barrier, the delay is consistent with the definition
of "available technology," and the radon releases caused by the delay will
not result in a significant incremental risk to the public health.
20 pCi/m[sup]2[/sup]s
] averaged over the entire impoundment. The verification required in
paragraph (18) of this subsection may be completed with a portion of the impoundment
being used for further disposal if the agency makes a final finding that the
impoundment will continue to achieve a level of radon-222 release not exceeding
20 pCi/m
2
s
[
20 pCi/m[sup]2[/sup]s
] averaged over the entire impoundment. After the final radon barrier
is complete except for the continuing disposal area, only byproduct material
will be authorized for disposal, and the disposal will be limited to the specified
existing disposal area. This authorization by license amendment will only
be made after providing opportunity for public participation. Reclamation
of the disposal area, as appropriate,
shall
[
must
] be
completed in a timely manner after disposal operations cease in accordance
with paragraph (16) of this subsection. These actions are not required to
be complete as part of meeting the deadline for final radon barrier construction.
which
] require concentration limit
standards and to enable the agency to set the limits for those constituents
and compliance period. They may provide the basis for adjustments to the point
of compliance. The detection monitoring program
shall
[
must
] be in place when specified by the agency in orders or license conditions.
Once groundwater protection standards have been established in accordance
with paragraph (10)(D) of this subsection, the licensee shall establish and
implement a compliance monitoring program. In conjunction with a corrective
action program, the licensee shall establish and implement a corrective action
monitoring program to demonstrate the effectiveness of the corrective actions.
Any monitoring program required by this paragraph may be based on existing
monitoring programs to the extent the existing programs can meet the stated
objective for the program.
must
] be kept as low as is reasonably achievable.
which
]
will be utilized.
must
]
be managed so as to conform to the applicable provisions of 40 CFR 440, as
codified on January 1, 1983.
which
] would
be achieved by the requirements of subsections (o)-(r) of this section and
the standards promulgated by the
EPA
[
Environmental Protection
Agency
] in 40 CFR Part 192, Subparts D and E.
must
]
meet the requirements of 10 CFR 150.31(d).
which
] is used for
the disposal of byproduct material or
that
[
which
] is
essential to ensure the long-term stability of the disposal site and title
to the byproduct material shall be transferred to the State of Texas or the
United States prior to the termination of the license. Material and land transferred
shall be transferred without cost to the State of Texas or the United States.
In cases where no ongoing site surveillance will be required, surface land
ownership transfer requirements may be waived. For licenses issued before
November 8, 1981, the NRC may take into account the status of the ownership
of
the
[
such
] land and interests therein, and the ability
of a licensee to transfer title and custody thereof to the State.
must
] contain [
such
] terms and conditions as the agency
determines necessary to assure that, prior to termination of the license,
the licensee will comply with ownership requirements of this subsection for
sites used for tailings disposal.
such
] use of
such land, it will provide the person who transferred
the
[
such
] land with the first refusal with respect to
the
[
such
] use of such land.
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION