Part I.
Texas Department of Health
Chapter 98.
HIV and STD Control
Subchapter C. Medication Program
Medication Pilot Project
25 TAC §§98.131-98.141
The Texas Department of Health (department) by majority vote
of the Texas Board of Health (board) on January 16, 1998, enters this order
finally adopting new §§98.131-98.141, concerning the Human Immunodeficiency
Virus (HIV) Medication Program. Specifically, these sections describe a medication
pilot project; the purpose and scope of the project; criteria for financial
eligibility and specific benefits; medications covered; priority; application
and appeal procedures; confidentiality; the types of payment for approved
medication; participating pharmacies; and prescription fees. The new rules
are adopted without changes to the proposed text as published in the November
7, 1997, issue of the
Texas Register
(22
TexReg 10879) and therefore will not be republished.
Rider 54 to the Texas Department of Health portion of the General Appropriation
Act of the 75th Legislature encouraged the department to develop this pilot
project to expend donated funds for HIV medications and coinsurance payments
for HIV positive persons. The Texas Health and Safety Code, Chapter 85, Subchapter
C, ("HIV Medication Program") requires the department to assist health care
providers and HIV-infected individuals in the purchase of medications approved
by the board that have been shown to be effective in reducing hospitalizations
due to HIV-related conditions. The new rules will implement the goals established
by these laws, in a fair and efficient manner and will encourage and support
the increased participation of persons infected with HIV in the workforce.
No comments were received on the proposed rules.
The new sections are proposed under Texas Health and Safety Code
§85.062 which requires the board to establish by rule, financial eligibility
requirements for participation in the HIV medication program; §85.063
which requires the board to establish application and distribution procedures,
eligibility guidelines, and appeals procedures for the HIV medication program;
§85.016 which allows the board to adopt any rules necessary to implement
the HIV Medication Program; and §12.001 which provides the board with
the authority to adopt rules for the performance of every duty imposed by
law on the board, the department, and the commissioner of health.
Filed with the Office of the Secretary of State on January
21, 1998.
TRD-9800973
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: November 7, 1997
For further information, please call: (512) 458-7236
25 TAC §§128.1-128.9
The Texas Department of Health (department), by majority
vote of the Texas Board of Health (board) on January 16, 1998, enters this
order finally adopting new §§128.1 - 128.9, concerning the regulation
of persons and business entities that sell, deliver, or dispense contact lenses
in Texas. Sections 128.3, 128.4, and 128.6 are adopted with changes to the
proposed text as published in the September 26, 1997, issue of the
Texas Register
(22 TexReg 9602). Sections 128.1, 128.2, 128.5, 128.7,
128.8, and 128.9 are adopted without changes, and therefore the sections will
not be republished.
The new sections implement the applicable provisions of the Texas Contact
Lens Prescription Act, (Act), Texas Civil Statutes, Article 4552-A (House
Bill 196, 75th Legislature, 1997), which establishes that before an optician
may dispense contact lenses to a person in this state, the optician must obtain
a contact lens dispensing permit from the department by January 1, 1998, and
sets an annual permit fee. The sections provide for the regulation and permitting
of contact lens dispensers. The sections cover definitions; permit application
procedures and requirements; renewal of permits; name and address changes;
violations, complaints, and disciplinary actions; petition for rulemaking;
display of permit; and electronic storage of contact lens prescriptions.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning §128.2 (Definitions), one commenter suggested
that the definition of "optician" should include language that is inclusive
of mail order companies that dispense contact lenses.
Response: The department disagrees. The definition is statutory language.
Based on a review of Sections 4(a) and 5(c) of the Act, the department agrees
with the commenter that mail order companies who dispense contact lenses to
persons in Texas are required to obtain a contact lens dispensing permit.
Comment: One commenter stated that the proposed rules accomplish what the
Act envisioned. Concerning §128.3 (Application Requirements and Procedures),
the commenter noted that the proposed section did not reflect the requirement
in the Act that the board may not issue a permit to an applicant who has had
a contact lens dispensing permit revoked or cancelled for cause within the
24-month period preceding the application date.
Response: The department agrees and has added the suggested language in
§128.3(g).
Comment: Concerning §128.3(e)(1), one commenter stated that the board
exceeds its statutory authority if it mandates an applicant to disclose his
or her date of birth and social security number.
Response: The department disagrees. The disclosure of a social security
number is required under the Family Code, §231.302. Social security numbers
are used for identification purposes and are confidential except as to the
Child Support Enforcement Division of the Office of the Attorney General.
The date of birth is required should the department need to stagger permit
renewals at some later date and to ensure accurate identification should applicants
and permit holders report past criminal convictions.
Comment: Concerning §128.3(e)(3), one commenter stated that there
is no basis in the Act to support mandatory disclosure of the names and addresses
of all officers, directors, and major shareholders of a corporation in a permit
application.
Response: The department disagrees. Section 5(b)(2) of the Act mandates
that the board shall not issue a permit to an applicant who has had a contact
lens dispensing permit revoked or cancelled for cause within the 24-month
period preceding the application date. The information is required in order
to identify permit applicants who have previous disciplinary action by the
department.
Comment: Concerning §128.3(e)(3) and (e)(4), one commenter stated
that the paragraphs are ambiguous since (e)(3) does not reference a corporation,
which is a business entity.
Response: The department agrees and has added language to §128.3(e)(3)
that clarifies that the rule applies to corporations and other business entities.
Comment: Concerning §128.4(c)(1), one commenter suggested that a notice
for permit renewal be mailed to a permit holder at least 60 days (instead
of 30 days) prior to the expiration date.
Response: The department agrees and has changed the wording of §128.4(c)(1)
to read "60" days instead of "30" days.
Comment: Concerning §128.4(c)(2), one commenter suggested that the
words "disclosure of" should be added prior to the last phrase of the rule
in order to clarify that a permit holder is required to disclose felony and
misdemeanor convictions at the time of renewal.
Response: The department agrees and has added the suggested language to
§128.4(c)(2).
Comment: Concerning §128.6 (Violations, Complaints, and Disciplinary
Actions), department staff noted that the section does not address whether
criminal convictions of an applicant or a permit holder may be the basis for
the denial of a permit application or a permit renewal application or the
revocation, suspension, or probation of an existing permit.
Response: The department agrees and has added §128.6(f) relating to
eligibility of persons with criminal backgrounds for a contact lens dispensing
permit.
Comment: Concerning §128.6 (Violations, Complaints, and Disciplinary
Actions), department staff recommended editorial changes.
Response: The department agrees. The phrase "these rules" has been changed
to "this chapter" in §§128.6(a), 128.6(b)(1), and 128.6(d)(2). The
phrase "or this chapter" has been added to §128.6(d)(1). These changes
clarify the intent and improve the accuracy of the section. "Thirty" has been
changed to "30" in §128.6(d)(3) to reflect
Texas Register
format.
Comment: Concerning §128.8 (Display of Permit), one commenter suggested
that either a consumer complaint sign be required for display by a permit
holder or that the name, address, and telephone number of the department be
prominently visible on the permit.
Response: The department confirms that the name, address, and telephone
number of the department will be prominently visible on the permit and no
change to §128.8 was made.
Comment: One commenter requested that a standard stamp or imprint be required
for use when an optician partially fills a prescription for disposable contact
lenses, so that the modification of the prescription may be recognized as
a permanent and valid modification.
Response: This matter is not addressed in the proposed rules. However,
§4(g) of the Act sets out a specific procedure that details to opticians,
optometrists, pharmacists, and physicians exactly what information must be
noted on a partially filled prescription. When a notation is made on a prescription
in accordance with that section, the notation is a permanent and valid modification
of the prescription.
The comments on the proposed rules received by the department during the
comment period were submitted by Texas Optometric Association, Texas Optometry
Board, LensCrafters, Inc., and by department staff. The commenters were neither
for nor against the rules in their entirety; however, they raised questions,
offered comments for clarification purposes, and suggested clarifying language
concerning specific provisions in the rules.
The new sections are adopted under Texas Civil Statutes, Article
4552-A, which provides the Board of Health (board) with the authority to adopt
rules; and Health and Safety Code, §12.001, which provides the board
with authority to adopt rules to implement every duty imposed by law on the
board, the department, and the commissioner of health.
§128.3. Application Requirements and Procedures.
(a)
Contact lenses may only be dispensed by the following
persons: a physician, optometrist, or therapeutic optometrist; a pharmacist;
or an optician, a corporation, or other business entity that holds a valid
contact lens dispensing permit issued under the Act.
(b)
An employee of a corporation or business entity with a
permit issued under the Act is not required to obtain a separate permit.
(c)
A corporation or other business entity that dispenses
contact lenses to a person in this state must obtain a contact lens dispensing
permit. A corporation or other business entity that has nine or fewer locations
is required to obtain a permit for each location. A corporation or other business
entity with ten or more locations may obtain a single permit for the entity
and its employees.
(d)
An applicant for a permit must submit all required information
on official application forms prescribed by the department and submit the
required permit fee.
(e)
The application form shall contain the following information:
(1)
specific information regarding personal data, full legal
name, date of birth, social security number, information regarding other licenses,
registrations, permits, and certifications held by applicant, and information
regarding misdemeanor and felony convictions of applicant;
(2)
trade names and addresses of all locations in which
the optician intends to conduct business;
(3)
if applicant is a corporation or other business entity,
specific information regarding type of ownership, registered address, and
names and addresses of all officers, directors, registered agents and major
shareholders;
(4)
if applicant is a corporation, a current letter from
the state comptroller's office stating the corporation is in good standing
or a notarized certification that the tax owed to the state under the Tax
Code, Chapter 171 (relating to Franchise Tax); is not delinquent or that the
corporation is exempt from the payment of the tax and is not subject to the
Tax Code, Chapter 171 (relating to Franchise Tax);
(5)
a statement that the applicant has read the Act and
these rules;
(6)
a statement that the applicant, if issued a permit,
shall return the permit to the board upon revocation or suspension of the
permit or other disciplinary action against the permit holder;
(7)
a statement that the applicant understands that fees
and materials submitted in the permitting process are nonrefundable and nonreturnable;
(8)
a statement that the applicant agrees to comply with
all state and federal laws and regulations regarding the sale, delivery,
or dispensing of contact lenses;
(9)
a statement that the information contained in the
application is truthful and complete; and
(10)
the signature of the applicant which has been dated
and notarized.
(f)
Application processing. The department shall comply with
the following procedures in processing applications for permits and applications
for permit renewal.
(1)
The following periods of time shall apply from the date
of receipt of an application until the date of issuance of a written notice
that the application is complete and accepted for filing or that the application
is deficient and additional specific information is required. The contact
lens dispensing permit may be sent in lieu of the notice of acceptance of
a complete application. The time periods are as follows:
(A)
letter of acceptance of application for a permit - 30
working days;
(B)
issuance of permit renewal after receipt of documentation
of all renewal requirements - 20 working days; and
(C)
letter of denial of permit - 30 working days.
(2)
Reimbursement of fees.
(A)
In the event an application is not processed in the time
periods stated in paragraph (1) of this subsection, the applicant has the
right to request reimbursement of all fees paid in that particular application
process. Application for reimbursement shall be made to the administrator.
If the administrator does not agree that the time period has been violated
or finds that good cause existed for exceeding the time period, the request
will be denied.
(B)
Good cause for exceeding the time period is considered
to exist if the number of applications for permits and permit renewal exceeds
by 15% or more the number of applications processed in the same calendar quarter
the preceding year; another public or private entity relied upon by the board
in the application process caused the delay; or any other condition exists
giving the department good cause for exceeding the time period.
(3)
Appeal. If a request for reimbursement under
paragraph (2) of this subsection is denied by the administrator, the applicant
may appeal to the commissioner for a timely resolution of any dispute arising
from a violation of the time periods. The applicant shall give written notice
to the commissioner at the address of the department that he or she requests
full reimbursement of all fees paid because his or her application was not
processed within the applicable time period. The administrator shall submit
a written report of the facts related to the processing of the application
and of any good cause for exceeding the applicable time period. The program
administrator shall provide written notice of the commissioner's decision
to the applicant. An appeal shall be decided in the applicant's favor if the
applicable time period was exceeded and good cause was not established. If
the appeal is decided in favor of the applicant, full reimbursement of all
fees paid in that particular application process shall be made.
(4)
Contested cases. The time periods for contested cases
related to the denial of permits or permit renewals are not included within
the time periods stated in paragraph (1) of this subsection. The time period
for conducting a contested case hearing runs from the date the department
receives a written request for a hearing and ends when the decision of the
department is final and appealable. A hearing may be completed within one
to four months, but may extend for a longer period of time depending on the
particular circumstances of the hearing.
(g)
The board shall not issue a permit to an applicant who
has had a contact lens dispensing permit revoked or cancelled for cause within
the 24-month period preceding the application date, or has otherwise failed
to comply with the Act or this chapter.
§128.4. Renewal of Permit.
(a)
Purpose. The purpose of this section is to set out the
rules governing permit renewal.
(b)
General.
(1)
When issued, a permit is valid for one year commencing
on the date of issuance of the initial permit.
(2)
A permit holder must renew the permit annually.
(3)
The renewal date of a permit shall be the last day
of the month in which the permit was originally issued.
(4)
Each permit holder is responsible for renewing the
permit before the expiration date and shall not be excused from paying additional
fees or penalties. Failure to receive notification from the department prior
to the expiration date of the permit shall not excuse failure to file for
timely renewal.
(5)
The department shall not renew a permit if renewal
is prohibited by the Education Code, §57.491 (relating to Loan Default
Ground for Nonrenewal of Professional or Occupational License).
(6)
The department shall not renew a permit if renewal
is prohibited by a court order or attorney general's order issued pursuant
to the Family Code, Chapter 232 (relating to Suspension of License for Failure
to Pay Child Support), as set out in §1.301 of this title (relating
to Suspension of License for Failure to Pay Child Support).
(c)
Permit renewal procedures.
(1)
At least 60 days prior to the expiration date of a permit,
the department shall send notice to the permit holder's address in the department's
records a permit renewal form. The renewal form shall give notice of the expiration
date of the permit and the amount of the renewal fee required. The permit
holder must complete and return the renewal form and fee to the department.
(2)
The permit renewal form shall require the applicant
to provide the preferred mailing address, primary employment address and telephone
number, trade names and addresses of all locations in which the optician intends
to conduct business, and the disclosure of misdemeanor or felony convictions.
(3)
A permit holder has renewed the permit when the permit
holder has mailed the fully completed renewal form and the required renewal
fee to the department prior to the expiration date of the permit. The postmark
date shall be considered the date of mailing.
(4)
The department shall issue a renewed permit to a
permit holder who has met all requirements for renewal.
(5)
A permit holder whose check for the renewal fee is
not honored by the financial institution shall remit to the department a money
order or cashier's check within 30 days of the date of the permit holder's
receipt of the department's notice. If proper payment is not received, the
permit shall not be renewed. If a renewed permit has already been issued,
it shall be ineffective.
(6)
If a permit holder fails to timely renew his or her
permit because the permit holder is or was on active duty with the armed forces
of the United States of America serving outside the state of Texas, the permit
holder may renew the permit pursuant to this subsection.
(A)
Renewal of the permit may be requested by the permit holder,
the permit holder's spouse, or an individual having power of attorney from
the permit holder. The renewal form shall include a current address and telephone
number for the individual requesting the renewal.
(B)
Renewal may be requested before or after expiration of
the permit. Permit holders who renew in accordance with this subsection shall
be excused from paying late fees and penalties.
(C)
A copy of the official orders or other official military
documentation showing that the permit holder is or was on active duty serving
outside the state of Texas shall be filed with the department along with the
renewal form.
(D)
A copy of the power of attorney from the permit holder
shall be filed with the department along with the renewal form if the individual
having the power of attorney executes any of the documents required in this
subsection.
(d)
Expiration of permit. A permit holder whose permit has
expired may not fill a contact lens prescription in this state or sell, deliver,
or dispense contact lenses to any person in this state.
§128.6. Violations, Complaints, and Disciplinary Actions.
(a)
Purpose. The purpose of this section is to set out procedures
concerning complaints alleging violations of the Act or this chapter and to
set out the department actions against a permit holder when violations have
occurred.
(b)
Filing of complaints.
(1)
Any person may complain to the department alleging that
a person has violated the Act or this chapter.
(2)
A person wishing to file a complaint against a permit
holder or other person shall notify the department. The initial notification
of a complaint may be in writing, by telephone, or by personal visit to the
administrator's office. The mailing address is Contact Lens Dispensing Permit
Program, 1100 West 49th Street, Austin, Texas 78756-3183, Telephone: (512)
834-4515.
(3)
Upon receipt of a complaint, the administrator shall
send to the complainant an acknowledgment letter and the department's complaint
form, which the complainant must complete and return to the administrator
before further action can be taken. If the complaint is made by a visit to
the administrator's office, the form may be given to the complainant at that
time; however, it must be completed and returned to the department before
further action can be taken.
(4)
Anonymous complaints shall be investigated by the
department provided that the complainant provides sufficient information.
(c)
Investigation of complaints.
(1)
The administrator is responsible for handling complaints.
(2)
The department shall make the initial investigation
and report the findings to the administrator.
(3)
If the administrator determines that the complaint
does not come within the department's jurisdiction, the administrator shall
advise the complainant and, if possible, refer the complainant to the appropriate
governmental agency for handling such a complaint.
(4)
The administrator, on behalf of the board, shall,
at least as frequently as quarterly, notify the complainant and the respondent
of the status of the complaint until its final disposition.
(5)
The administrator may recommend that the permit be
revoked, suspended, or denied or that the permit be placed on probation or
that other appropriate action as authorized by law be taken.
(6)
If the administrator determines that there are insufficient
grounds to support the complaint, the administrator shall dismiss the complaint
and give written notice of the dismissal to the permit holder or person against
whom the complaint has been filed and the complainant.
(d)
Department actions.
(1)
The board may deny a permit application or permit renewal
application or suspend or revoke the permit, or place the permit on probation
for a violation of the Act or this chapter. The board may also impose an administrative
penalty of not more than $1000 for a violation of the Act. Administrative
penalties shall be assessed in accordance with the procedures set forth in
the Opticians' Registry Act, Texas Civil Statutes, Article 4551-1, §10A.
(2)
Prior to institution of formal proceedings to revoke,
suspend, or place on probation or impose an administrative penalty, the department
shall give written notice to the permit holder by certified mail, return receipt
requested, of the facts or conduct alleged to warrant the proposed action,
and the permit holder shall be given an opportunity, as described in the notice,
to show compliance with all requirements of the Act and this chapter.
(3)
If disciplinary action of a permit holder is proposed,
the department shall give written notice by certified mail, return receipt
requested, that the permit holder must request, in writing, a formal hearing
within 30 of receipt of the notice, or the right to a hearing shall be waived
and the action shall be taken.
(e)
Formal hearings.
(1)
A formal hearing shall be conducted in accordance with
the Administrative Procedure Act, Government Code, Chapter 2001, and Chapter
1 of this title (relating to Texas Board of Health).
(2)
Copies of the formal hearing procedures are indexed
and filed in the administrator's office, Professional Licensing and Certification
Division, 1100 West 49th Street, Austin, Texas 78756-3183, and are available
for public inspection during regular working hours.
(f)
Guidelines concerning criminal convictions.
(1)
The purpose of this section is to comply with the requirements
of Texas Civil Statutes, Article 6252-13d (relating to Suspension, Revocation,
or Denial of License to Persons with Criminal Backgrounds; Guidelines and
Application of Law.)
(2)
The department may deny a permit application or a
permit renewal application, or revoke, suspend, or place on probation an existing
permit if an applicant or permit holder has been convicted of a crime (felony
or misdemeanor) according to the following guidelines:
(A)
a person holding a contact lens dispensing permit may
only dispense contact lenses pursuant to an original, unexpired contact lens
prescription and must do so accurately and without modification. Those criminal
convictions which evidence an unwillingness or inability to follow these requirements
may be asserted as a basis to deny a permit or institute disciplinary action
against an existing permit; and
(B)
the factors and evidence listed in Article 6252-13c, §4
(relating to Eligibility of Persons with Criminal Backgrounds for Certain
Occupations, Professions, and Licenses) shall be considered in determining
eligibility for a permit.
Filed with the Office of the Secretary
of State on January 21, 1998.
TRD-9800976
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: September 26, 1997
For further information, please call: (512) 458-7236
Texas Regulations for Control of Radiation
25 TAC §289.123
The Texas Department of Health (department), by majority
vote of the Texas Board of Health (board) on January 16, 1998, enters this
order finally adopting the repeal of §289.123 and new §289.260,
concerning licensing of uranium recovery and byproduct material disposal facilities,
with changes to the proposed text as published in the September 26, 1997,
issue of the
Texas Register
(22 TexReg 9607).
The repeal of §289.123 is adopted without changes and therefore will
not be republished.
The section adopted for repeal adopts by reference Part 43, titled "Licensing
of Uranium Recovery Facilities" of the
Texas Regulations
for Control of Radiation
(TRCR). The new section incorporates language
from Part 43 that has been rewritten in
Texas Register
format and includes addition and revision of several subsections of
the section. The repeal and new section are part of the renumbering phase
in the process of rewriting the department's radiation rules in the
The new section incorporates requirements for expeditious reclamation of
uranium mill tailings impoundments, including reclamation schedules and milestones.
Requirements for decommissioning of licensed facilities are expanded and requirements
for timeliness of decommissioning are added. In addition, the new section
clarifies the need for the licensee to submit an updated closure plan at the
time of decommissioning. These requirements are items of compatibility with
the United States Nuclear Regulatory Commission and as an agreement state,
Texas must adopt them. References to other sections of this chapter are clarified
to reflect the
Texas Register
format. Other
subsections of the section are changed to clarify and more adequately specify
the requirements for uranium recovery and byproduct material disposal facilities.
The revisions are a result of Senate Bill 1857, 75th Legislature, which transferred
the jurisdiction for the regulation of uranium recovery and byproduct material
disposal facilities from the Texas Natural Resource Conservation Commission
(TNRCC) to the department. TNRCC adopted the items of compatibility on May
27, 1997, prior to the transfer of jurisdiction.
No public comments were received during the comment period for the repeal
of §289.123, and new §289.260. However, the department is making
minor editorial changes due to staff comments to clarify the intent and improve
the accuracy of the section.
Change: Concerning §289.260(h)(10), the form was changed from "TRC
Form 12-2L" to "BRC Form 252-1" to state the correct applicable form.
Change: Concerning §289.260(j)(6)(A), the date for submission for
financial security was changed from "six months from the effective date of
the rule" to "September 1, 1998" to state the actual effective date for this
requirement.
Change: Concerning §289.260(s), Figure 1: 25 TAC §289.260(s),
the department realized several values in the table were listed in the wrong
maximum concentration column, and moved the values to the correct column.
The repeal is adopted under the Health and Safety Code, Chapter
401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January
21, 1998.
TRD-9800964
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: September 26, 1997
For further information, please call: (512) 458-7236
25 TAC §289.260
The new section is adopted under the Health and Safety Code,
Chapter 401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
§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 which accept for disposal byproduct
material. No person shall engage in such activities except as authorized in
a specific license issued pursuant to this section unless otherwise provided
for in §289.252 of this title (relating to Licensing of Radioactive Material).
(b)
Scope. In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of §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), §289.202 of this title (relating to Standards for Protection
Against Radiation), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material(s) Licenses, Emergency Planning and
Implementation, and Other Regulatory Services), §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).
(c)
Definitions. The following words and terms when used in
this part shall have the following meaning unless the context clearly indicates
otherwise.
(1)
Aquifer - A geologic formation, group of formations, or
part of a formation capable of yielding a significant amount of groundwater
to wells or springs. Any saturated zone created by uranium or thorium recovery
operations would not be considered an aquifer unless the zone is or potentially
is:
(A)
hydraulically interconnected to a natural aquifer;
(B)
capable of discharge to surface water; or
(C)
reasonably accessible because of migration beyond the
vertical projection of the boundary of the land transferred for long-term
government ownership and care in accordance with subsection (r) of this section.
(2)
As expeditiously as practicable considering
technological feasibility - As quickly as possible considering the physical
characteristics of the byproduct material and the site, the limits of "available
technology" (as defined in this subsection), the need for consistency with
mandatory requirements of other regulatory programs, and "factors beyond the
control of the licensee" (as defined in this subsection). The phrase permits
consideration of the cost of compliance only to the extent specifically provided
for by use of the term "available technology."
(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), (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.
(4)
Byproduct material - Tailings or wastes produced
by or resulting from the extraction or concentration of uranium or thorium
from any ore processed primarily for its source material content, including
discrete surface wastes resulting from uranium solution extraction processes.
Underground ore bodies depleted by such solution extraction operations do
not constitute "byproduct material" within this definition.
(5)
Capable fault - As used in this section, "capable
fault" has the same meaning as defined in Section III(g) of Appendix A of
Title 10 Code of Federal Regulations (CFR) Part 100.
(6)
Closure - The post-operational activities to decontaminate
and decommission the buildings and site used to produce byproduct materials
and reclaim the tailings and/or disposal area, including groundwater restoration,
if needed.
(7)
Closure plan - The plan approved by the agency to
accomplish closure. The closure plan consists of a decommissioning plan and
may also include a reclamation plan.
(8)
Commencement of construction - Any clearing of land,
excavation, or other substantial action that would adversely affect the environment
of a site, but does not include necessary borings to determine site characteristics
or other preconstruction monitoring to establish background information related
to the suitability of a site, or to the protection of the environment.
(9)
Compliance period - The period of time that begins
when the agency sets secondary groundwater protection standards and ends when
the owner or operator's license is terminated and the site is transferred
to the state or federal government for long-term care, if applicable.
(10)
Dike - An embankment or ridge of either natural
or man-made materials used to prevent the movement of liquids, sludges, solids,
or other materials.
(11)
Disposal area - The area containing byproduct materials
to which the requirements of subsection (q)(16)-(q)(27) of this section apply.
(12)
Existing portion - As used in subsection (q)(9)(A)
of this section, "existing portion" is that land surface area of an existing
surface impoundment on which significant quantities of byproduct materials
had been placed prior to September 30, 1983.
(13)
Factors beyond the control of the licensee - Factors
proximately causing delay in meeting the schedule in the applicable reclamation
plan for the timely emplacement of the final radon barrier notwithstanding
the good faith efforts of the licensee to complete the barrier in compliance
with subsection (q)(24) of this section. These factors may include but are
not limited to:
(A)
physical conditions at the site;
(B)
inclement weather or climatic conditions;
(C)
an act of God;
(D)
an act of war;
(E)
a judicial or administrative order or decision, or change
to the statutory, regulatory, or other legal requirements applicable to the
licensee's facility that would preclude or delay the performance of activities
required for compliance;
(F)
labor disturbances;
(G)
any modifications, cessation or delay ordered by state,
federal, or local agencies;
(H)
delays beyond the time reasonably required in obtaining
necessary government permits, licenses, approvals, or consent for activities
described in the reclamation plan proposed by the licensee that result from
government agency failure to take final action after the licensee has made
a good faith, timely effort to submit legally sufficient applications, responses
to requests (including relevant data requested by the agencies), or other
information, including approval of the reclamation plan; and
(I)
an act or omission of any third party over whom the licensee
has no control.
(14)
Final radon barrier - The earthen cover (or
approved alternative cover) over byproduct material constructed to comply
with subsection (q)(16)-(q)(27) of this section (excluding erosion protection
features).
(15)
Fund - The Radiation and Perpetual Care Fund.
(16)
Groundwater - Water below the land surface in a
zone of saturation. For purposes of this section, groundwater is the water
contained within an aquifer as defined in paragraph (1) of this subsection.
(17)
Hazardous constituent - Subject to subsection (q)(10)(E)
of this section, "hazardous constituent" is a constituent which meets all
three of the following tests:
(A)
The constituent is reasonably expected to be in or derived
from the byproduct material in the disposal area;
(B)
The constituent has been detected in the groundwater in
the uppermost aquifer; and
(C)
The constituent is listed in 10 CFR Part 40, Appendix
A, Criterion 13.
(18)
Leachate - Any liquid, including any suspended
or dissolved components in the liquid, that has percolated through or drained
from the byproduct material.
(19)
Licensed site - The area contained within the boundary
of a location under the control of persons generating or storing byproduct
materials under a license.
(20)
Liner - A continuous layer of natural or man-made
materials, beneath or on the sides of a surface impoundment which restricts
the downward or lateral escape of byproduct material, hazardous constituents,
or leachate.
(21)
Maximum credible earthquake - That earthquake 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.
(22)
Milestone - An action or event that is required
to occur by an enforceable date.
(23)
Operation - The period of time during which a byproduct
material disposal area is being used for the continued placement of byproduct
material or is in standby status for such placement. A disposal area is in
operation from the day that byproduct material is first placed in it until
the day final closure begins.
(24)
Point of compliance - The site-specific location
in the uppermost aquifer where the groundwater protection standard 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.
(25)
Principal activities - Activities authorized by
the license 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.
(26)
Reclamation plan - For the purposes of subsection
(q)(16)-(q)(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 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 must
also be addressed in the closure plan. The detailed reclamation plan may be
incorporated into the closure plan.
(27)
Security (surety) - The following are examples of
"security":
(A)
cash deposits;
(B)
surety bonds;
(C)
certificates of deposit;
(D)
deposits of government securities;
(E)
irrevocable letters of credit; or
(F)
other security acceptable to the agency.
(28)
Surface impoundment - A natural topographic
depression, man-made excavation, or diked area, which is designed to hold
an accumulation of liquid wastes or wastes containing free liquids, and which
is not an injection well.
(29)
Unrefined and unprocessed ore - Ore in its natural
form before any processing, such as grinding, roasting, beneficiating, solution
extracting, or refining.
(30)
Uppermost aquifer - The geologic formation nearest
the natural ground surface that is an aquifer, as well as lower aquifers that
are hydraulically interconnected with this aquifer within the facility's property
boundary.
(31)
Uranium recovery - Any uranium extraction or concentration
activity that results in the production of "byproduct material" as it is defined
in this subsection. As used in this definition, "uranium recovery" has the
same meaning as "uranium milling" in 10 CFR 40.4.
(d)
Filing application for specific licenses.
(1)
Applications for specific licenses shall be filed in eight
copies on 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.
(2)
The agency may at any time after the filing of the
original application, 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 whether a license should be granted, modified, or revoked.
(3)
Each application shall be signed by the applicant
or licensee or a person legally authorized to act for and on the applicant's
or licensee's behalf.
(4)
An application for a license may include a request
for one or more activities.
(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.
(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 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 BRC Form
252-1.
(11)
Applications for new licenses shall be processed
in accordance with the following time periods.
(A)
The first period is 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.
(B)
The second period is 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.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by 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.
(A)
In the event the application is not processed in the time
periods as stated in paragraph (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 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,
§1.21-1.34 of this title (relating to the Texas Board of Health).
(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 protect public health and safety
and the environment;
(2)
the applicant's proposed equipment, facilities, and
procedures are adequate to protect public health and safety and the environment;
(3)
the issuance of the license will not be inimical
to public health and safety nor have a long-term detrimental impact on the
environment;
(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.
(f)
Special requirements for 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 to the agency a satisfactory
application as described herein and meets the following other conditions specified.
(1)
An application for a license shall include 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 alternatives.
(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, 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)(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.
(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.
(g)
Issuance of specific licenses.
(1)
Upon a determination that an application meets the requirements
of the Texas Radiation Control Act (Act) and the requirements of the agency,
the agency may issue a specific license authorizing the activity in such form
and containing such conditions and limitations as it deems appropriate or
necessary.
(2)
The agency may incorporate in any license at the
time of issuance or amendment, or thereafter by appropriate requirement or
order, such additional requirements and conditions as it deems appropriate
or necessary in order to:
(A)
protect public health and safety or the environment;
(B)
require such reports and the keeping of such records,
and to provide for such inspections of activities under the license as may
be appropriate or necessary; and
(C)
prevent loss or theft of material subject to this section.
(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, now or hereafter in effect,
and to all applicable rules and orders of the agency.
(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 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, now and hereafter in effect,
and to applicable requirements 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 use and possession of the licensed material
to the locations and purposes authorized in the license.
(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 U.S.C.) by or against:
(A)
a licensee;
(B)
an entity (as that term is defined in 11 U.S.C. 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 U.S.C. 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.
(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:
(A)
any failure in a byproduct material retention system which
results in a release of byproduct material into unrestricted areas;
(B)
any release of radioactive material which exceeds the
concentrations for water listed in Table II, Column 2, of §289.202(ggg)(2)
of this title and which extends beyond the licensed boundary;
(C)
any spill which exceeds 20,000 gallons and which exceeds
the concentrations for water listed in Table II, Column 2, of §289.202(ggg)(2)
of this title; or
(D)
any release of solids which exceeds the contamination
limits in §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:
(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 which exceeds 2,000 gallons and which exceeds
the concentrations for water listed in Table II, Column 2, of §289.202(ggg)(2)
of this title.
(i)
Expiration and termination of licenses and decommissioning
of sites, separate buildings, or outdoor areas.
(1)
Except as provided in paragraph (4) of
this subsection and subsection (j)(2) of this section, each specific license
shall expire at the end of the day, in the month and year stated in the license.
(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.
(4)
Each specific license continues in effect, beyond
the expiration date if necessary, with respect to possession of source material
until the agency notifies the licensee in writing that the license is terminated.
During this time, the licensee shall:
(A)
limit actions involving source material to those related
to decommissioning; and,
(B)
continue to control entry to restricted areas until they
are suitable for release 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)(2) of this section, so that the buildings or outdoor areas
are suitable for release in accordance with agency requirements, if:
(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.
(6)
Coincident with the notification required by
paragraph (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
must be increased, or may be decreased, as appropriate, to cover the detailed
cost estimate for decommissioning established in accordance with paragraph
(12)(F) of this subsection.
(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.
(7)
In addition to the provisions of paragraph (6)
of this subsection, each licensee shall submit an updated closure plan to
the agency within 12 months of the notification required by paragraph (5)
of this subsection. The updated closure plan shall meet the requirements of
subsections (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 public health and safety and is otherwise
in the public interest. The request must be submitted no later than 30 days
before notification in accordance with paragraph (5) of this subsection. The
schedule for decommissioning set forth in paragraph (5) of this subsection
may not commence until the agency has made a determination on the request.
(9)
A decommissioning plan 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;
(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.
(10)
The agency may approve an alternate schedule
for submittal of a decommissioning plan required in accordance with paragraph
(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 public health and safety and is otherwise
in the public interest.
(11)
The procedures listed in paragraph (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 must include:
(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)
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 therein 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.
(14)
Except as provided in paragraph (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 (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 area, and the license termination if appropriate, if the agency
determines that the alternative is warranted by the 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;
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.
(17)
As the final step in decommissioning, the licensee
shall:
(A)
certify the disposition of all licensed material, including
accumulated byproduct material;
(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 some other manner. The licensee shall, as appropriate;
(i)
report levels of gamma radiation in units of microroentgen
per hour (µR/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 (µCi) (megabecquerels
(MBq)) per 100 square centimeters (cm
2
) removable
and fixed for surfaces, µCi (MBq) per milliliter for water, and picocuries
(pCi) (becquerels (Bq)) per gram (g) for solids such as soils or concrete;
and
(ii)
specify the survey instrument(s) used and certify that
each instrument is properly calibrated and tested.
(18)
Specific licenses, including expired licenses,
will be terminated by license amendment when the agency determines that:
(A)
source material and byproduct 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 which demonstrates
that the premises are suitable for release in accordance with agency requirements;
(D)
other information submitted by the licensee is sufficient
to demonstrate that the premises are suitable for release in accordance with
agency requirements;
(E)
records required by §289.251(l)(4)(C) of this title
have been received;
(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.
(19)
Specific licenses for uranium recovery are
exempt from paragraphs (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 must be submitted and approved
in accordance with subsection (q)(16)-(q)(27) of this section.
(20)
The agency may terminate a specific license upon
written request submitted by the licensee to the agency in accordance with
this subsection.
(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 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 §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.
(j)
Renewal of license.
(1)
Request for renewal of specific licenses shall be filed
in accordance with subsection (d) of this section with the exception of subsection
(d)(9) of this section.
(2)
In any case in which a licensee, not less than 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.
(k)
Amendment of licenses at request of licensee. Requests
for amendment of a license shall be filed in accordance with subsection (d)
of this section, except that the requirements of subsection (d)(1), (d)(7),
and (d)(8) of this section may be waived at the discretion of the agency.
Such requests shall also specify how the licensee desires the license to be
amended and the basis for such amendment.
(l)
Agency action on applications to renew or amend. In considering
a request by a licensee to renew or amend the license, the agency will apply
the appropriate criteria set forth in subsections (e) and (f) of this section.
(m)
Transfer of material.
(1)
No licensee shall transfer radioactive material except
as authorized in accordance with this section.
(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)
to the agency after receiving prior approval from the
agency;
(B)
to the United States Department of Energy;
(C)
to any person exempt from the licensing requirements of
the Act and these requirements or exempt from the licensing requirements of
the NRC or an agreement state, to the extent permitted by these exemptions;
(D)
to any person authorized to receive such material under
terms of a general license or its equivalent, or a specific license or equivalent
licensing documents, issued by the agency, any agreement state, or to any
person otherwise authorized to receive such material by the federal government
or any agency thereof, the agency, or any agreement state;
(E)
to any person abroad pursuant to an export license issued
under Title 10, Chapter 1, CFR Part 110; or
(F)
as otherwise authorized by the agency in writing.
(3)
Before transferring radioactive material to
a specific licensee of the agency, the NRC, an agreement state, or to a general
licensee who is required to register with the agency, the NRC, or an agreement
state prior to receipt of the radioactive material, the licensee transferring
the material shall verify that the transferee's license authorizes the receipt
of the type, form, and quantity of radioactive material to be transferred.
(4)
The following methods for the verification of paragraph
(3) of this subsection are acceptable:
(A)
the transferor may possess and have read a current copy
of the transferee's specific license or registration certificate;
(B)
the transferor may possess a written certification by
the transferee that the transferee is authorized by the license or certificate
of registration to receive the type, form, and quantity of radioactive material
to be transferred, specifying the license or registration certificate number,
issuing agency, and expiration date;
(C)
for emergency shipments, the transferor may accept oral
certification by the transferee that the transferee is authorized by license
or registration certificate to receive the type, form, and quantity of radioactive
material to be transferred, specifying the license or registration certificate
number, issuing agency, and expiration date, provided that the oral certification
is confirmed in writing within ten days; or
(D)
when none of the methods of verification described in
subparagraphs (A)-(C) of this paragraph are readily available or when a transferor
desires to verify that information received by one of these methods is correct
or up-to-date, the transferor may obtain and record confirmation from the
agency, or the NRC, that the transferee is licensed to receive the radioactive
material.
(5)
Preparation for shipment and transport of radioactive
material shall be in accordance with the provisions of §289.257 of this
title.
(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, or by reason of rules or orders issued
by the agency.
(2)
Any license may be revoked, suspended, or modified,
in whole or in part:
(A)
for any material false statement in the application or
any statement of fact required under provisions of the Act; or
(B)
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
(C)
for violation of, or failure to observe applicable terms
and conditions of the Act, or of the license, or of any requirement or order
of the agency.
(3)
Except in cases of willful violation of the
Act or these requirements or cases in which protection of the 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.
(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.
(5)
Each specific license revoked by the agency expires
at the end of the day on the date of the Agency's final determination to revoke
the license, or on the expiration date stated in the determination, or as
otherwise provided by agency order.
(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 must be based on agency-approved cost estimates in an
agency-approved closure plan for:
(A)
decontamination and decommissioning of buildings and the
site to levels which allow unrestricted use of these areas upon decommissioning;
and
(B)
the reclamation of byproduct material disposal areas in
accordance with technical criteria delineated in subsection (q) of this section.
(2)
The licensee shall submit this plan in conjunction
with an environmental report that addresses the expected environmental impacts
of the licensee's operation, decommissioning and reclamation, and evaluates
alternatives for mitigating these impacts.
(3)
The security 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.
(4)
In establishing specific security arrangements, the
licensee's cost estimates must take into account total costs that would be
incurred if an independent contractor were hired to perform the decommissioning
and reclamation work. In order to avoid unnecessary duplication and expense,
the agency may accept financial securities that have been consolidated with
financial or security arrangements established to meet requirements of other
federal or state agencies and/or local governing bodies for such decommissioning,
decontamination, reclamation, and long-term site surveillance and control,
provided such arrangements are considered adequate to satisfy these requirements
and that the portion of the security that covers the decommissioning and reclamation
of the buildings, site, and byproduct material disposal areas, and the long-term
funding charge is clearly identified and committed for use in accomplishing
these activities.
(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 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 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 (e.g., five years) yet which must be automatically
renewed unless the security notifies the agency and the licensee some reasonable
time (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 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
must be agreed by all parties.
(8)
Self-insurance, or any arrangement that essentially
constitutes self insurance (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.
(p)
Long-term care and maintenance requirements.
(1)
Unless otherwise provided by the agency, each licensee
licensed in accordance with this part for disposal of byproduct material shall
make payments into the Radiation and Perpetual Care Fund in amounts specified
by the agency. The agency shall make such determinations on a case-by-case
basis.
(2)
The final disposition of byproduct material should
be such that the need for ongoing active maintenance is eliminated to the
maximum extent practicable.
(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 (e.g., if fencing or monitoring is determined to be necessary), the
agency may specify a higher charge. The total charge 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.
(4)
The requirements of this subsection shall apply only
to those sites whose ownership is subject to being transferred to the state
or the federal government. The total amount of funds collected by the agency
in accordance with this subsection shall be transferred to the federal government
if title and custody of the byproduct material disposal site is transferred
to the federal government upon termination of the license.
(q)
Technical requirements.
(1)
Byproduct material handling and disposal systems shall
be designed to accommodate full-capacity production over the lifetime of the
facility. When later expansion of systems or operations may be likely, capability
of the disposal system to be modified to accommodate increased quantities
without degradation in long-term stability and other performance factors shall
be evaluated.
(2)
In selecting among alternative byproduct material
disposal sites or judging the adequacy of existing sites, the following site
features which would assure meeting the broad objective of isolating the tailings
and associated contaminants without ongoing active maintenance shall be considered:
(A)
remoteness from populated areas;
(B)
hydrogeologic and other environmental conditions conducive
to continued immobilization and isolation of contaminants from usable groundwater
sources; and
(C)
potential for minimizing erosion, disturbance, and dispersion
by natural forces over the long term.
(3)
The site selection process must be an optimization
to the maximum extent reasonably achievable in terms of these site features.
(4)
In the selection of disposal sites, primary emphasis
shall be given to isolation of the byproduct material, a matter having long-term
impacts, as opposed to consideration only of short-term convenience or benefits
(e.g., minimization of transportation of land acquisition costs). While isolation
of byproduct material will also be a function of both site and engineering
design, overriding consideration shall be given to siting features.
(5)
Byproduct material should be disposed of in a manner
such that no active maintenance is required to preserve conditions of the
site.
(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 must be demonstrated that an above grade disposal
program will provide reasonably equivalent isolation of the byproduct material
from natural erosional forces.
(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 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.
(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 must be minimized
to decrease erosion potential by flooding which could erode or wash out sections
of the byproduct material disposal area;
(B)
the topographic features shall provide good wind protection;
(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 which are as close as possible to those 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 which make such slopes acceptable
shall be identified;
(D)
a full self-sustaining vegetative cover shall be established
or rock cover employed to reduce wind and water erosion to negligible levels;
(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 which
may exist on the top of the pile;
(F)
the following factors shall be considered in establishing
the final rock cover design to avoid displacement of rock particles by human
and animal traffic or by natural processes, and to preclude undercutting and
piping:
(i)
shape, size, composition, gradation of rock particles
(excepting bedding material, average particles size shall be at least cobble
size or greater);
(ii)
rock cover thickness and zoning of particles by size;
and
(iii)
steepness of underlying slopes.
(G)
individual rock fragments shall be dense, sound, and resistant
to abrasion, and 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;
(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; and there is negligible
drainage catchment area upstream of the pile, and there is good wind protection;
(I)
all impoundment surfaces shall be contoured to avoid areas
of concentrated surface runoff or abrupt or sharp changes in slope gradient.
In addition to rock cover on slopes, areas toward which surface runoff might
be directed shall be well protected with substantial rock cover (riprap).
In addition to providing for stability of the impoundment system itself, overall
stability, erosion potential, and geomorphology of surrounding terrain shall
be evaluated to assure that there are no ongoing or potential processes, such
as gully erosion, which would lead to impoundment instability;
(J)
the impoundment shall not be located near a capable fault
that could cause a maximum credible earthquake larger than that which the
impoundment could reasonably be expected to withstand; and
(K)
the impoundment should be designed to incorporate features
that will promote deposition. Design features that promote deposition of sediment
suspended in any runoff which flows into the impoundment area might be utilized.
The object of such a design feature would be to enhance the thickness of cover
over time.
(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)
The primary groundwater protection standard is a design
standard for surface impoundments used to manage byproduct material. Unless
exempted under paragraph (9)(C) of this subsection, surface impoundments (except
for an existing portion) shall have a liner that is designed, constructed,
and installed to prevent any migration of wastes out of the impoundment to
the adjacent subsurface soil, groundwater, or surface water at any time during
the active life (including the closure period) of the impoundment. If the
liner is constructed of materials that may allow wastes to migrate into the
liner during the active life of the facility, impoundment closure shall include
removal or decontamination of all waste residues, contaminated containment
system components (liners, etc.), contaminated subsoils, and structures and
equipment contaminated with waste and leachate. For impoundments that will
be closed with the liner material left in place, the liner shall be constructed
of materials that can prevent wastes from migrating into the liner during
the active life of the facility.
(B)
The liner required by subparagraph (A) of this paragraph
shall be:
(i)
constructed of materials that have appropriate chemical
properties and sufficient strength and thickness to prevent failure due to
pressure gradients (including static head and external hydrogeologic forces),
physical contact with the waste or leachate to which they are exposed, climatic
conditions, the stress of installation, and the stress of daily operation;
(ii)
placed upon a foundation or base capable of providing
support to the liner and resistance to pressure gradients above and below
the liner to prevent failure of the liner due to settlement, compression,
or uplift; and
(iii)
installed to cover all surrounding earth likely to be
in contact with the wastes or leachate.
(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)
the nature and quantity of the wastes;
(ii)
the proposed alternate design and operation;
(iii)
the hydrogeologic setting of the facility, including
the attenuative capacity and thickness of the liners and soils present between
the impoundment and groundwater or surface water; and
(iv)
all other factors which would influence the quality and
mobility of the leachate produced and the potential for it to migrate to groundwater
or surface water.
(D)
A surface impoundment shall be designed, constructed,
maintained, and operated to prevent overtopping resulting from normal or abnormal
operations, overfilling, wind and wave actions, rainfall, or run-off; from
malfunctions of level controllers, alarms, and other equipment; and from human
error.
(E)
When dikes are used to form the surface impoundment, the
dikes shall be designed, constructed, and maintained with sufficient structural
integrity to prevent massive failure of the dikes. In ensuring structural
integrity, it shall not be presumed that the liner system will function without
leakage during the active life of the impoundment.
(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 must not exceed
the specified concentration limits in the uppermost aquifer beyond the point
of compliance during the compliance period.
(B)
specified concentration limits are those limits established
by the agency as indicated in subparagraph (G) of this paragraph.
(C)
the agency will also establish the point of compliance
and compliance period on a site-specific basis through license conditions
and orders.
(D)
when the detection monitoring established under paragraphs
(28) and (29) of this section indicates leakage of hazardous constituents
from the disposal area, the agency will perform the following:
(i)
identify hazardous constituents;
(ii)
establish concentration limits;
(iii)
set the compliance period; and
(iv)
may adjust the point of compliance if needed in accordance
with developed data and site information regarding the flow of groundwater
or contaminants.
(E)
even when constituents meet all three tests in the definition
of hazardous constituent, the agency may exclude a detected constituent from
the set of hazardous constituents on a site-specific basis if it finds that
the constituent is not capable of posing a substantial present or potential
hazard to human health or the environment. In deciding whether to exclude
constituents, the agency will consider the following:
(i)
potential adverse effects on groundwater quality, considering
the following:
(I)
physical and chemical characteristics of the waste in
the licensed site, including its potential for migration;
(II)
hydrogeological characteristics of the licensed site
and surrounding land;
(III)
quantity of groundwater and the direction of groundwater
flow;
(IV)
proximity of groundwater users and groundwater withdrawal
rates;
(V)
current and future uses of groundwater in the area;
(VI)
existing quality of groundwater, including other sources
of contamination and cumulative impact on the groundwater quality;
(VII)
potential for human health risks caused by human exposure
to waste constituents;
(VIII)
potential damage to wildlife, crops, vegetation, and
physical structures caused by exposure to waste constituents; and
(IX)
persistence and permanence of potential adverse effects.
(ii)
potential adverse effects on quality of hydraulically-
connected surface water, considering the:
(I)
volume and physical and chemical characteristics of the
byproduct material in the licensed site;
(II)
hydrogeological characteristics of the licensed site
and surrounding land;
(III)
quantity and quality of groundwater and the direction
of groundwater flow;
(IV)
patterns of rainfall in the region;
(V)
proximity of the licensed site to surface waters;
(VI)
current and future uses of surface waters in the area
and any water quality standards established for those surface waters;
(VII)
existing quality of surface water, including potential
impacts from other sources of contamination and the cumulative impact on surface
water quality;
(VIII)
potential for human health risks caused by human exposure
to waste constituents;
(IX)
potential damage to wildlife, crops, vegetation, and
physical structures caused by exposure to waste constituents; and
(X)
persistence and permanence of the potential adverse effects.
(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 Environmental Protection
Agency and the Texas Natural Resource Conservation Commission (Commission).
(G)
At the point of compliance, the concentration of a hazardous
constituent shall not exceed the following:
(i)
the agency approved background concentration in the groundwater
of the constituents listed in 10 CFR 40, Appendix A, Criterion 13;
(ii)
the respective value given in subsection (s) of this
section if the constituent is listed in the table and if the background level
of the constituent is below the value listed; or
(iii)
an alternate concentration limit established by the
agency.
(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 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.
(11)
If the groundwater protection standards established
under subparagraph (D) of this paragraph are exceeded at a licensed site,
a corrective action program 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 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.
(12)
In developing and conducting groundwater protection
programs, applicants and licensees shall also consider the following:
(A)
where synthetic liners are used, a leakage-detection system
shall be installed immediately below the liner to ensure detection of any
major failures. This is in addition to the groundwater monitoring program
conducted as provided in paragraph (29) of this subsection. Where clay liners
are proposed or relatively thin, in situ clay soils are to be relied upon
for seepage control, tests shall be conducted with representative tailings
solutions and clay materials to confirm that no significant deterioration
of permeability or stability properties will occur with continuous exposure
of clay to byproduct material solutions. Tests shall be run for a sufficient
period of time to reveal any effects that may occur;
(B)
mill process designs which provide the maximum practicable
recycle of solutions and conservation of water to reduce the net input of
liquid to the byproduct material impoundment;
(C)
dewatering of byproduct material solutions by process
devices and/or in situ drainage systems. At new sites, byproduct material
solutions shall be dewatered by a drainage system installed at the bottom
of the impoundment to lower the phreatic surface and reduce the driving head
of seepage, unless tests show byproduct material solutions are not amenable
to such a system. Where in situ dewatering is to be conducted, the impoundment
bottom shall be graded to assure that the drains are at a low point. The drains
shall be protected by suitable filter materials to assure that drains remain
free-running. The drainage system shall also be adequately sized to assure
good drainage; and
(D)
neutralization to promote immobilization of hazardous
constituents.
(13)
Technical specifications shall be prepared
for installation of seepage control systems. A quality assurance, testing,
and inspection program, which includes supervision by a qualified engineer
or scientist, shall be established to assure that specifications are met.
If adverse groundwater impacts or conditions conducive to adverse groundwater
impacts occur due to seepage, action shall be taken to alleviate the impacts
or conditions and restore groundwater quality to levels consistent with those
before operations began. The specific seepage control and groundwater protection
method, or combination of methods, to be used shall be worked out on a site-specific
basis.
(14)
In support of a byproduct material disposal system
proposal, the applicant/licensee shall supply the following information:
(A)
the chemical and radioactive characteristics of the waste
solutions;
(B)
the characteristics of the underlying soil and geologic
formations particularly as they will control transport of contaminants and
solutions. This shall include detailed information concerning extent, thickness,
uniformity, shape, and orientation of underlying strata. Hydraulic gradients
and conductivities of the various formations shall be determined. This information
shall be gathered by borings and field survey methods taken within the proposed
impoundment area and in surrounding areas where contaminants might migrate
to groundwater. The information gathered on boreholes shall include both geologic
and geophysical logs in sufficient number and degree of sophistication to
allow determining significant discontinuities, fractures, and channeled deposits
of high hydraulic conductivity. If field survey methods are used, they should
be in addition to and calibrated with borehole logging. Hydrologic parameters
such as permeability shall not be determined on the basis of laboratory analysis
of samples alone. A sufficient amount of field testing (e.g., pump tests)
shall be conducted to assure actual field properties are adequately understood.
Testing shall be conducted to make possible estimates of chemisorption attenuation
properties of underlying soil and rock; and
(C)
location, extent, quality, capacity, and current uses
of any groundwater at and near the site.
(15)
If ore is stockpiled, methods shall be used
to minimize penetration of radionuclides and other substances into underlying
soils.
(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
which provides reasonable assurance of control of radiological hazards to
the following:
(A)
be effective for 1,000 years to the extent reasonably
achievable and, in any case, for at least 200 years; and
(B)
limit releases of radon-222 from uranium byproduct materials
and radon-220 from thorium byproduct materials to the atmosphere so as not
to exceed an average release rate of 20 picocuries per square meter per second
(pCi/m
2
s) to the extent practicable throughout
the effective design life determined in accordance with subparagraph (A) of
this paragraph. This average applies to the entire surface of each disposal
area over a period of at least one year, but a period short compared to 100
years. Radon will come from both byproduct materials and cover materials.
Radon emissions from cover materials should be estimated as part of developing
a closure plan for each site. The standard, however, applies only to emissions
from byproduct materials to the atmosphere.
(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 which
contain elevated levels of radium. Soils used for near-surface cover 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.
(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 20
pCi/m
2
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.
(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 must be conducted for each portion of the pile or
impoundment as the final radon barrier for that portion is emplaced.
(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
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.
(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 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.
(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
), that, as a result
of byproduct material, does not exceed the background level by more than:
(A)
5 picocuries per gram (pCi/g) of radium-226, or in the
case of thorium byproduct material, radium-228, averaged over the first 15
centimeters (cm) below the surface; and
(B)
15 pCi/g of radium-226, or in the case of thorium byproduct
material, radium-228, averaged over 15-cm thick layers more than 15 cm below
surface.
(23)
The licensee shall also address the nonradiological
hazards associated with the waste in planning and implementing closure. The
licensee shall ensure that disposal areas are closed in a manner that minimizes
the need for further maintenance. To the extent necessary to prevent threats
to human health and the environment, the licensee shall control, minimize,
or eliminate post-closure escape of nonradiological hazardous constituents,
leachate, contaminated rainwater, or waste decomposition products to groundwater
or surface waters or to the atmosphere.
(24)
For impoundments containing uranium byproduct materials,
the final radon barrier 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 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 must also be completed in a timely manner in accordance
with a written reclamation plan approved by the agency by license amendment.
(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. If the delay
is approved on the basis that the radon releases do not exceed 20 pCi/m
(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 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
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, 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.
(27)
The licensee's closure plan shall provide reasonable
assurance that institutional control will be provided for the length of time
found necessary by the agency to ensure the requirements of paragraph (16)
of this subsection are met.
(28)
Prior to any major site construction, a preoperational
monitoring program shall be conducted for one full year to provide complete
baseline data on the site and its environs. Throughout the construction and
operating phases of the project, an operational monitoring program shall be
conducted to measure or evaluate compliance with applicable standards and
rules; to evaluate performance of control systems and procedures; to evaluate
environmental impacts of operation; and to detect potential long-term effects.
(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 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 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.
(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 must
be kept as low as is reasonably achievable.
(B)
Checks shall be made and logged hourly of all parameters
which determine the efficiency of emission control equipment operation. It
shall be determined whether or not conditions are within a range prescribed
to ensure that the equipment is operating consistently near peak efficiency.
Corrective action shall be taken when performance is outside of prescribed
ranges. Effluent control devices shall be operative at all times during drying
and packaging operations and whenever air is exhausting from the uranium dryer
stack. Drying and packaging operations shall terminate when controls are inoperative.
When checks indicate the equipment is not operating within the range prescribed
for peak efficiency, actions shall be taken to restore parameters to the prescribed
range. When this cannot be done without shutdown and repairs, drying and packaging
operations shall cease as soon as practicable. Operations may not be restarted
after cessation due to off-normal performance until needed corrective actions
have been identified and implemented. All such cessations, corrective actions,
and re-starts shall be reported to the agency in writing within ten days of
the subsequent restart.
(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 which will be utilized.
(D)
Uranium recovery facility operations producing or involving
thorium byproduct material shall be conducted in such a manner as to provide
reasonable assurance that the annual dose equivalent does not exceed 25 millirems
(mrem) to the whole body, 75 mrem to the thyroid, and 25 mrem to any other
organ of any member of the public as a result of exposures to the planned
discharge of radioactive materials to the general environment, radon-220 and
its daughters excepted.
(E)
Byproduct materials must be managed so as to conform to
the applicable provisions of 40 CFR 440, as codified on January 1, 1983.
(31)
Licensees/applicants may propose alternatives
to the specific requirements in subsections (o)-(r) of this section. The alternative
proposals may take into account local or regional conditions including geology,
topography, hydrology, and meteorology.
(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 which would be
achieved by the requirements of subsections (o)-(r) of this section and the
standards promulgated by the Environmental Protection Agency in 40 CFR Part
192, Subparts D and E.
(33)
All site-specific licensing decisions based on the
criteria in subsections (o)-(r) of this section, or alternatives proposed
by licensees/applicants shall take into account the risk to the public health
and safety and the environment with due consideration to the economic costs
involved and any other factors the agency determines to be appropriate.
(34)
Any proposed alternatives to the specific requirements
in subsections (o)-(r) of this section must meet the requirements of 10 CFR
150.31(d).
(35)
No new site shall be located in a 100-year floodplain
or wetland as defined in "Floodplain Management Guidelines for Implementing
Executive Order 11988."
(r)
Land ownership of byproduct material disposal sites.
(1)
These criteria relating to ownership of byproduct material
and their disposal sites apply to all licenses terminated, issued, or renewed
after November 8, 1981.
(2)
Unless exempted by the NRC, title to land (including
any affected interests therein) which is used for the disposal of byproduct
material or 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 such land and interests therein, and the ability
of a licensee to transfer title and custody thereof to the State.
(3)
Any uranium recovery facility license 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.
(4)
For surface impoundments only, the applicant/licensee
shall demonstrate a serious effort to obtain severed mineral rights and shall,
in the event that fee simple title including all mineral rights cannot be
obtained, provide notification in local public land records of the fact that
the land is being used for the disposal of radioactive material and is subject
to a NRC license prohibiting the disruption and disturbance of the tailings.
(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 such use of such land, it will provide
the person who transferred such land with the first refusal with respect to
such use of such land.
(s)
Maximum values for use in groundwater protection. The
following is a list of the maximum concentration values to be used for groundwater
protection.
Figure 1: 25 TAC §289.260(s)
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January
21, 1998.
TRD-9800963
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: September 26, 1997
For further information, please call: (512) 458-7236
25 TAC §289.126
The Texas Department of Health (department), by majority
vote of the Texas Board of Health (board) on January 16, 1998, enters this
order finally adopting the repeal of §289.126 and new §289.204,
concerning fees for certificates of registration, radioactive material(s)
licenses, emergency planning and implementation, and other regulatory services,
without changes to the proposed text as published in the September 26, 1997,
issue of the
Texas Register
(22 TexReg 9622),
and therefore the sections will not be republished.
The section adopted for repeal adopts by reference Part 12, titled "Fees
for Certificates of Registration, Radioactive Material(s) Licenses, Emergency
Planning and Implementation, and Other Regulatory Services" of the
Texas Regulations for Control of Radiation
(TRCR). The new section
incorporates language from Part 12 that has been rewritten in
Texas Register
format and includes addition and revision of several
subsections of the section. The repeal and new section are part of the renumbering
phase in the process of rewriting the department's radiation rules in the
New definitions are added to §289.204(c) to clarify terms used in
the schedule of fees for uranium recovery and byproduct disposal facility
licenses. The revision to §289.204(k) implements the provisions of House
Bill 2170, 75th Legislature, 1997, which changed the amount a licensee or
registrant is required to pay for a late fee to 20% of the amount of the annual
license or registration fee, not to exceed $10,000 annually for each licensee
or registrant. New §289.204(l), (m), and (n) are added to specify the
annual fees, adjustments to annual fees, and one-time fee adjustments for
uranium recovery and byproduct disposal facility licenses. The fees are necessary
to recover the costs of regulating these licenses. The revision of §289.204(c)
and addition of §289.204(l), (m), and (n) are as a result of Senate Bill
1857, 75th Legislature, 1997, which transferred the jurisdiction for the regulation
of uranium recovery and byproduct material disposal facilities from the Texas
Natural Resource Conservation Commission (TNRCC) to the department.
The department received no public comments during the comment period for
the repeal of §289.126 and new §289.204.
The repeal is adopted under the Health and Safety Code, Chapter
401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health. §289.126 Fees for Certificates
or Registration, Radioactive Material(s), Emergency Planning and Implementation,
and Other Regulatory Services.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January
21, 1998.
TRD-9800954
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: September 26, 1997
For further information, please call: (512) 458-7236
25 TAC §289.204
The new section is adopted under the Health and Safety Code,
Chapter 401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January
21, 1998.
TRD-9800953
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 10, 1998
Proposal publication date: September 26, 1997
For further information, please call: (512) 458-7236
25 TAC §§289.201, §289.202
The Texas Department of Health (department), by majority
vote of the Texas Board of Health (board) on January 16, 1998, enters this
order finally adopting amendments to §§289.201, 289.202, 289.252,
and 289.254, concerning general provisions, standards for protection against
radiation, licensing of radioactive material, and licensing of radioactive
waste processing and storage facilities, with changes to the proposed text
as published in the October 3, 1997, issue of the
Texas Register
(22 TexReg 9804), as a result of comments received during
the 30-day comment period.
The amendment to §289.201 includes addition of a definition of radioactive
waste, which is moved from §289.254 to a more appropriate location in
§289.201; deletion of requirements for transport groups, which are moved
to a more appropriate location in §289.254; and addition of a requirement
for licensees to accept from the department samples collected from the licensees'
facilities or from areas that are radioactive as a result of licensed activities.
Section 289.202 is amended to clarify the radiation units that are to be used
on records and to clarify decommissioning standards to be used by a licensee
prior to vacating facilities or land. The amendment to §289.252 adds
decommissioning timeliness and recordkeeping requirements and criteria relating
to use of financial tests and self guarantees for providing reasonable assurance
of funds for decommissioning. In §289.254, references to transport groups
are changed to waste processing and storage categories to reflect that use
of this term is unique to this section. Definitions and other requirements
concerning packaging and transportation of radioactive material are deleted
from §§289.201, 289.202, 289.252, and 289.254 and are moved to a
more appropriate location in new §289.257. The amendments to §§289.202
and 289.252 are items of compatibility with the United States Nuclear Regulatory
Commission (NRC) and as an agreement state, Texas must adopt them.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the section.
Change: Concerning §289.201(b), the department added a definition
for "filing timeframes" to clarify document submission requirements in this
chapter.
Change: Concerning §289.201(c)(2)(D), the department deleted the word
"commission" and replaced this with "NRC" because the Texas Radiation Control
Act, Chapter 401, Health and Safety Code, defines "commission" as the Texas
Natural Resource Conservation Commission rather than the NRC.
Change: Concerning §289.201(q)(1), the department replaced the incorrect
figure which was published in the October 3, 1997 issue of the
Texas Register
(22 TexReg 9804) with the correct figure.
Change: Concerning §289.202, the department changed "1" to "one" throughout
the section to comply with
Texas Register
format.
Change: Concerning §289.252(d)(7), the department changed "TRC Form
12-2L" to "BRC Form 252-1" to state the correct applicable form.
Change: Concerning §289.252(q)(2), the department changed the end
of the last sentence to read, "...of the terms and conditions of the Act,
this chapter, or of the license, or order of the agency." for clarification
and consistency with other sections in this chapter.
Change: Concerning §289.252(t), the department deleted the existing
text and replaced the text with a sentence to read "Requirements for the preparation
of radioactive material for transport are specified in §289.257 of this
title." to clarify which section of this chapter contains the appropriate
requirements for transport of radioactive material.
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting change(s). Other
minor editorial changes were made for clarification purposes.
Comment. Concerning §289.201(b)(57) now located in §289.201(b)(58),
one commenter suggested changing the word "individual" to read "worker" as
in: "Any individual, except a worker who is receiving an occupational dose...".
Response. The department agrees that this wording would clarify the specified
subsection; however, this section is an item of compatibility with the United
States Nuclear Regulatory Commission (NRC), and as an agreement state, Texas
must adopt this section as comparable to NRC's regulations. Therefore, the
definition cannot be amended at this time. No change was made as a result
of the comment.
Comment. Concerning §289.201(b)(65) now located in §289.201(b)(66),
one commenter suggested changing the word "individual" to read "worker" as
in: "The dose received by a worker in the course of employment in which the
workers assigned duties involve exposure to sources of radiation from licensed/registered...".
.
Response. The department agrees that this wording would clarify the specified
subsection; however, this section is an item of compatibility with the United
States Nuclear Regulatory Commission, and as an agreement state, Texas must
adopt this section as comparable to NRC's regulations. Therefore, the definition
cannot be amended at this time. No change was made as a result of the comment.
Comment. Concerning §289.201(d)(2), one commenter stated that the
section appears to require all records to contain the signature and date by
"authorized personnel". However, who "authorized personnel" are is unclear.
The commenter suggested further clarification of the term "authorized personnel."
Response. The department disagrees with the commenter because the "authorized
personnel" will vary from licensee to licensee and registrant to registrant
based on the scope of operation, therefore the subsection as stated allows
for necessary flexibility. No change was made as a result of the comment.
Comment. Concerning §289.201(g)(1)(E), one commenter stated that this
new requirement specifies: "For sealed sources contained in a device, test
samples are obtained when the source is in the "off" position." This requirement
would require that a fixed gauging device have the shutter closed (be in the
"off" position) before it could be leak tested. The commenter suggested clarification
to exclude "fixed gauging devices in operation at the time of leak testing."
Response. The department disagrees with the commenter because the subsection
as stated does not imply that a fixed gauging device has to have the shutter
closed before it can be leak tested. No change was made as a result of the
comment.
Comment. Concerning §289.252 (l)(15) and (16), one commenter questioned
whether the reference in these paragraphs should be to paragraph (17) instead
of "this paragraph."
Response. The department agrees and has corrected the references in question.
Comment. Concerning §289.252(l)(19)(A), one commenter suggested the
words "source material" be replaced with "radioactive material".
Response. The department agrees and has replaced the words "source material"
with "radioactive material."
Comment. Concerning §289.252(u), one commenter stated that language
equivalent to 10 Code of Federal Regulations (CFR) 30.35(c)(4) needed to be
added to meet NRC compatibility requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(c)(4)
language to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.252(u)(2)(B), one commenter stated that language
equivalent to 10 CFR 30.35(b)(2) needed to be added to meet NRC compatibility
requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(b)(2)
language to comply with NRC compatibility requirements because as an agreement
state with the NRC, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.252(u)(5), one commenter stated that language
equivalent to 10 CFR 30.35(e) needed to be added to meet NRC compatibility
requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(e)
language to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.252(u)(6)(B), one commenter stated that the
second "subsection (w)(3) of this section" reference is incorrect and should
be "subsection (w)(7) of this section."
Response. The department agrees and has corrected the reference in question.
Comment. Concerning §289.254(h), one commenter stated that language
equivalent to 10 CFR 30.35(c)(4) needed to be added to meet NRC compatibility
requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(c)(4)
language to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.254(h)(2)(B), one commenter stated that language
equivalent to 10 CFR 30.35(b)(2) needed to be added to meet NRC compatibility
requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(b)(2)
language to comply with NRC compatibility requirements because as an agreement
state with the NRC, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.254(h)(5), one commenter stated that language
equivalent to 10 CFR 30.35(e) needed to be added to meet NRC compatibility
requirements.
Response. The department agrees and has added the equivalent 10 CFR 30.35(e)
language to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.254(h)(6)(B), one commenter stated that the
second "§289.254(w)(3) of this section" reference is incorrect and should
be "§289.254(w)(7) of this section".
Response. The department agrees and has corrected the reference in question.
Commenters included a representative from the United States Nuclear Regulatory
Commission and Herb Dushane. The two commenters were generally in favor of
the proposal; however, they presented comments and suggestions for changes
to the proposal as previously discussed.
The amendments are adopted under the Health and Safety Code,
Chapter 401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
§289.201. General Provisions.
(a)
Scope. Except as otherwise specifically provided, this
section applies to all persons who receive, possess, use, transfer, or acquire
any source of radiation, provided, however, that nothing in this section shall
apply to any person to the extent such person is subject to regulation by
the United States Nuclear Regulatory Commission (NRC) or to sources of radiation
in the possession of federal agencies. Attention is directed to the fact that
regulation by the state of source material, byproduct material, and special
nuclear material in quantities not sufficient to form a critical mass is subject
to the provisions of the agreement between the state and the NRC and to Part
150 of the NRC regulations (10 Code of Federal Regulations (CFR) Part 150).
(b)
Definitions. The following words and terms when used in
this chapter shall have the following meanings, unless the context clearly
indicates otherwise.
(1)-(8)
(No change.)
(9)
Airborne radioactivity area - A room, enclosure,
or area in which airborne radioactive materials exist in concentrations:
(A)
in excess of the derived air concentrations (DACs) specified
in Table I, Column 1 of §289.202(ggg)(2)(F) (relating to Standards for
Protection Against Radiation) of this title; or
(B)
(No change.)
(10)-(11)
(No change.)
(12)
Becquerel (Bq) - The SI unit of activity. One becquerel
is equal to one disintegration or transformation per second (dps or tps).
(13)-(14)
(No change.)
(15)
Byproduct material - Byproduct material is defined
as:
(A)
(No change.)
(B)
the tailings or wastes produced by or resulting from the
extraction or concentration of uranium or thorium from any ore processed primarily
for its source material content, including discrete surface wastes resulting
from uranium solution extraction processes.
(16)-(19)
(No change.)
(20)
Commission - The Texas Natural Resource Conservation
Commission.
(21)-(22)
(No change.)
(23)
Curie (Ci) - A unit of measurement of radioactivity.
One curie (Ci) is that quantity of radioactive material that decays at the
rate of 3.7 x 10
10
disintegrations per second
(dps). Commonly used submultiples of the curie are the millicurie (mCi) and
the microcurie (µCi). One mCi = 1 x 10
-3
Ci = 3.7 x 10
7
dps. One µCi = 1 x 10
(24)
(No change.)
(25)
Deep dose equivalent (H
d
),
that applies to external whole body exposure - The dose equivalent at a tissue
depth of 1 centimeter (cm) (1000 milligrams per square centimeter (mg/cm
(26)-(37)
(No change.)
(38)
Eye dose equivalent - The external dose equivalent
to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm
2
).
(39)
Filing timeframes - Documents transmitted to the
agency will be deemed submitted on the date of the postmark, telegram, telefacsimile
or electronic media transmission.
(40)
Generally applicable environmental radiation standards
- Standards issued by the United States Environmental Protection Agency (EPA)
under the authority of the Atomic Energy Act of 1954, as amended, that impose
limits on radiation exposures or levels, or concentrations or quantities of
radioactive material, in the general environment outside the boundaries of
locations under the control of persons possessing or using radioactive material.
(41)
Gray (Gy) - The SI unit of absorbed dose. One gray
is equal to an absorbed dose of one joule per kilogram (J/kg) (100 rad).
(42)
High radiation area - An area, accessible to individuals,
in which radiation levels could result in an individual receiving a dose equivalent
in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any
source of radiation or from any surface that the radiation penetrates.
(43)
Human use - The internal or external administration
of radiation or radioactive material to human beings for healing arts purposes
or research and/or development specifically authorized by the agency.
(44)
Individual - Any human being.
(45)
Individual monitoring - The assessment of:
(A)
dose equivalent by the use of individual monitoring devices;
or
(B)
committed effective dose equivalent by bioassay or by
determination of the time-weighted air concentrations to which an individual
has been exposed, that is, DAC-hours. (See the definition for DAC-hours in
§289.202(c) of this title); or
(C)
dose equivalent by the use of survey data.
(46)
Individual monitoring devices - Devices designed
to be worn by a single individual for the assessment of dose equivalent. For
purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent
terms. Examples of individual monitoring devices are film badges, thermoluminescent
dosimeters (TLDs), pocket ionization chambers, and personal air sampling devices.
(47)
Inspection - An official examination and/or observation
including, but not limited to, records, tests, surveys, and monitoring to
determine compliance with the Act and rules, orders, requirements, and conditions
of the agency.
(48)
Internal dose - That portion of the dose equivalent
received from radioactive material taken into the body.
(49)
Ionizing radiation - Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x rays, alpha and
beta particles, high speed electrons, neutrons, and other nuclear particles.
(50)
Land disposal facility - The land, buildings, and
equipment that are intended to be used for the disposal of radioactive wastes
into the subsurface of the land.
(51)
License - A form of permission given by the agency
to an applicant who has met the requirements for licensing set out in the
Act and this chapter.
(52)
Licensed material - Radioactive material received,
possessed, used, or transferred under a general or specific license issued
by the agency.
(53)
Licensee - Any person who is licensed by the agency
in accordance with this chapter and the Act.
(54)
Licensing state - Any state with rules equivalent
to the
Suggested State Regulations for Control of
Radiation
relating to, and having an effective program for, the regulatory
control of naturally occurring or accelerator-produced radioactive material
(NARM) and has been designated as such by the Conference of Radiation Control
Program Directors, Inc. For the purposes of evaluation and/or distribution
of sealed sources, this includes Licensing State Status: Product Review Only.
(55)
Lost or missing source of radiation - A source of
radiation whose location is unknown. This definition includes licensed material
that has been shipped but has not reached its planned destination and whose
location cannot be readily traced in the transportation system.
(56)
Mammography system certification - An authorization
for the use of a mammography system.
(57)
Manufacture - To fabricate or mechanically produce.
(58)
Member of the public - Any individual, except when
that individual is receiving an occupational dose.
(59)
Minimal threat - That during the operation of electronic
devices capable of generating or emitting fields of radiation:
(A)
no deliberate exposure of an individual occurs;
(B)
the radiation is not emitted in an open beam configuration;
and
(C)
no known physical injury to an individual has occurred.
(60)
Minor - An individual less than 18 years of
age.
(61)
Misadministration - The administration of:
(A)
a radiopharmaceutical or radiation from a sealed source
other than the one intended;
(B)
a radiopharmaceutical or radiation from a sealed source
to the wrong patient;
(C)
a radiopharmaceutical or radiation from a sealed source
by a route of administration other than that intended by the prescribing physician;
(D)
a diagnostic dosage of a radiopharmaceutical differing
from the prescribed dosage by more than 50%;
(E)
a therapeutic dosage of a radiopharmaceutical differing
from the prescribed dosage by more than 10%; or
(F)
a therapeutic radiation dose from a sealed source such
that errors in the source calibration, time of exposure, and treatment geometry
result in a calculated total treatment dose differing from the final prescribed
total treatment dose by more than 10%.
(62)
Monitoring - The measurement of radiation,
radioactive material concentrations, surface area activities, or quantities
of radioactive material and the use of the results of these measurements to
evaluate potential exposures and doses. For purposes of this chapter, "radiation
monitoring" and "radiation protection monitoring" are equivalent terms.
(63)
NARM - Any naturally occurring or accelerator-produced
radioactive material except source material or special nuclear material.
(64)
Natural radioactivity - Radioactivity of naturally
occurring nuclides whose location and chemical and physical form have not
been altered by man.
(65)
NRC - The United States Nuclear Regulatory Commission
(NRC) or its duly authorized representatives.
(66)
Occupational dose - The dose received by an individual
in the course of employment in which the individual's assigned duties involve
exposure to sources of radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. Occupational dose does not include dose received from background
radiation, as a patient from medical practices, from voluntary participation
in medical research programs, or as a member of the public.
(67)
Particle accelerator - Any machine capable of accelerating
electrons, protons, deuterons, or other charged particles in a vacuum and
designed to discharge the resultant particulate or other associated radiation
into a medium at energies usually in excess of 1 MeV.
(68)
Person - Any individual, corporation, partnership,
firm, association, trust, estate, public or private institution, group, agency,
local government, any other state or political subdivision or agency thereof,
or any other legal entity, and any legal successor, representative, agent,
or agency of the foregoing, other than the NRC, and other than federal government
agencies licensed or exempted by the NRC.
(69)
Personnel monitoring equipment (See definition for
individual monitoring devices.)
(70)
Pharmacist - An individual licensed by the Texas
State Board of Pharmacy, and with license in good standing, to compound and
dispense drugs, prescriptions, and poisons.
(71)
Physician - An individual licensed by the Texas
State Board of Medical Examiners, with license in good standing.
(72)
Principal activities - Activities authorized by
the license that are essential to achieving the purpose(s) for which the license
was 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.
(73)
Public dose - The dose received by a member of the
public from exposure to sources of radiation released by a licensee, or to
any other source of radiation under the control of a licensee/registrant.
It does not include occupational dose or doses received from background radiation,
as a patient from medical practices, or from voluntary participation in medical
research programs.
(74)
Quality factor (Q) - The modifying factor listed
in subsection (o)(3) and (4) of this section that is used to derive dose equivalent
from absorbed dose.
(75)
Quarter (calendar quarter) - A period of time equal
to one-fourth of the year observed by the licensee or registrant, approximately
13 consecutive weeks, providing that the beginning of the first quarter in
a year coincides with the starting date of the year and that no day is omitted
or duplicated in consecutive quarters.
(76)
Rad - The special unit of absorbed dose. One rad
is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01
gray).
(77)
Radiation - One or more of the following:
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
stimulated emission of radiation from any electronic device
to such energy density levels as to reasonably cause bodily harm; or
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(78)
Radiation area - Any area, accessible to individuals,
in which radiation levels could result in an individual receiving a dose equivalent
in excess of 0.005 rem (0.05 mSv) in one hour at 30 cm from the source of
radiation or from any surface that the radiation penetrates.
(79)
Radiation machine - Any device capable of producing
ionizing radiation except those devices with radioactive material as the only
source of radiation.
(80)
Radiation safety officer (RSO) - An individual who
has a knowledge of and the authority and responsibility to apply appropriate
radiation protection rules, standards, and practices, and who must be specifically
authorized on a certificate of registration or radioactive material license.
(81)
Radioactive material - Any material (solid, liquid,
or gas) that emits radiation spontaneously.
(82)
Radioactive waste - Any discarded or unwanted radioactive
material, unless exempted by agency rule or any radioactive material that
would require processing before it could be put to a beneficial reuse. The
term does not include byproduct material as defined in paragraph (15) (B)
of this subsection, or uranium ore, naturally occurring radioactive material
(NORM) waste, or oil and gas NORM waste.
(83)
Radioactivity - The disintegration of unstable atomic
nuclei with the emission of radiation.
(84)
Radiobioassay (See definition for bioassay.)
(85)
Registrant - Any person issued a certificate of
registration by the agency in accordance with this chapter and the Act.
(86)
Regulation (See definition for rule.)
(87)
Regulations of the United States Department of Transportation
(DOT) - The requirements in 49 CFR Parts 100-189.
(88)
Rem - The special unit of any of the quantities
expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed
dose in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)).
(89)
Research and development - Research and development
is defined as:
(A)
theoretical analysis, exploration, or experimentation;
or
(B)
the extension of investigative findings and theories of
a scientific or technical nature into practical application for experimental
and demonstration purposes, including the experimental production and testing
of models, devices, equipment, materials, and processes.
(90)
Restricted area - An area, access to which
is limited by the licensee or registrant for the purpose of protecting individuals
against undue risks from exposure to sources of radiation. Restricted area
does not include areas used as residential quarters, but separate rooms in
a residential building may be set apart as a restricted area.
(91)
Roentgen (R) - The special unit of exposure. One
roentgen (R) equals 2.58 x 10
-4
C/kg of air.
(See definition for exposure.)
(92)
Rule (as defined in the Government Code, Chapters
2001 and 2002, as amended) - Any agency statement of general applicability
that implements, interprets, or prescribes law or policy, or describes the
procedure or practice requirements of an agency. The term includes the amendment
or repeal of a prior section but does not include statements concerning only
the internal management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as "regulation."
(93)
Sealed source - Radioactive material that is permanently
bonded or fixed in a capsule or matrix designed to prevent release and dispersal
of the radioactive material under the most severe conditions that are likely
to be encountered in normal use and handling.
(94)
Shallow dose equivalent (H
s
), (that applies to the external exposure of the skin or an extremity)
- The dose equivalent at a tissue depth of 0.007 cm (7 mg/cm
2
) averaged over an area of 1 square centimeter (cm
2
).
(95)
SI - The abbreviation for the International System
of Units.
(96)
Sievert - The SI unit of any of the quantities expressed
as dose equivalent. The dose equivalent in sievert is equal to the absorbed
dose in gray multiplied by the quality factor (1 Sv = 100 rem).
(97)
Site boundary - That line beyond which the land
or property is not owned, leased, or otherwise controlled by the licensee
or registrant.
(98)
Source material - Source material is defined as:
(A)
uranium or thorium, or any combination thereof, in any
physical or chemical form; or
(B)
ores that contain by weight 0.05% or more of uranium,
thorium, or any combination thereof; and
(C)
does not include special nuclear material.
(99)
Source of radiation - Any radioactive material,
or any device or equipment emitting or capable of producing radiation.
(100)
Special form radioactive material - Radioactive
material that satisfies the following conditions:
(A)
It is either a single solid piece or is contained in a
sealed capsule that can be opened only by destroying the capsule;
(B)
The piece or capsule has at least one dimension not less
than 5 millimeters (mm) (0.2 inch (in)); and
(C)
It satisfies the requirements specified by the NRC. A
special form encapsulation designed in accordance with the NRC requirements
in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue
to be used. A special form encapsulation designed in accordance with the NRC
requirements in effect on March 31, 1996, and constructed prior to April 1,
1998, may continue to be used. A special form encapsulation either designed
or constructed after April 1, 1998, must meet the requirements of this definition
applicable at the time of its design or construction.
(101)
Special nuclear material - Special nuclear
material is defined as:
(A)
plutonium, uranium-233, uranium enriched in the isotope
233 or in the isotope 235, and any other material that the NRC, in accordance
with the provisions of the Atomic Energy Act of 1954, §51 as amended,
determines to be special nuclear material, but does not include source material;
or
(B)
any material artificially enriched by any of the foregoing,
but does not include source material.
(102)
Special nuclear material in quantities not
sufficient to form a critical mass - Uranium enriched in the isotope 235 in
quantities not exceeding 350 grams (g) of contained uranium-235; uranium-233
in quantities not exceeding 200 g; plutonium in quantities not exceeding 200
g; or any combination of them in accordance with the following formula.
(A)
For each kind of special nuclear material, determine the
ratio between the quantity of that special nuclear material and the quantity
specified above for the same kind of special nuclear material. The sum of
such ratios for all of the kinds of special nuclear material in combination
shall not exceed "1" (i.e., unity).
(B)
For example, the following quantities in combination would
not exceed the limitation and are within the formula:
Figure 1: 25 TAC §289.201(b)(102)(B)
(103)
Special units - The conventional units historically
used by licensees and registrants, i.e., curie (activity), rad (absorbed dose),
and rem (dose equivalent).
(104)
Survey - An evaluation of the radiological conditions
and potential hazards incident to the production, use, transfer, release,
disposal, and/or presence of sources of radiation. When appropriate, such
evaluation includes, but is not limited to, tests, physical examination of
location of materials and equipment, and measurements of levels of radiation
or concentration of radioactive material present.
(105)
Termination - A release by the agency of the obligations
and authorizations of the licensee or registrant under the terms of the license
or certificate of registration. It does not relieve a person of duties and
responsibilities imposed by law.
(106)
Test - A method of determining the characteristics
or condition of sources of radiation or components thereof.
(107)
These rules - All sections of the
Texas Regulations for Control of Radiation
(TRCR).
(108)
Total effective dose equivalent (TEDE) - The sum
of the deep dose equivalent for external exposures and the committed effective
dose equivalent for internal exposures.
(109)
Total organ dose equivalent (TODE) - The sum of
the deep dose equivalent and the committed dose equivalent to the organ receiving
the highest dose as described in §289.202(rr)(1)(F) of this title.
(110)
Transport index - The dimensionless number (rounded
up to the next tenth) placed on the label of a package, to designate the degree
of control to be exercised by the carrier during transportation. The transport
index is determined as follows:
(A)
For non-fissile material packages, the number determined
by multiplying the maximum radiation level in millisievert per hour (mSv/hr)
at 1 meter (m) (3.3 feet) from the external surface of the package by 100
(equivalent to the maximum radiation level in millirem per hour (mrem/hr)
at 1 m (3.3 feet); or
(B)
For fissile material packages, the number determined by
multiplying the maximum radiation level in mSv/hr at 1 m (3.3 feet) from the
external surface of the package by 100 (equivalent to the maximum radiation
level in mrem/hr at 1 m (3.3 feet), or, for criticality control purposes,
the number obtained as described in 10 CFR 71.59, whichever is larger.
(111)
Type A quantity - A quantity of radioactive
material, the aggregate radioactivity of which does not exceed A
1
for special form radioactive material or A
2
for normal form radioactive material, where A
1
and A
2
are given in §289.257(s)(2)
of this title (relating to Packaging and Transportation of Radioactive Material)
or may be determined by procedures described in §289.257(s)(1)-(4) of
this title.
(112)
Type B quantity - A quantity of radioactive material
greater than a type A quantity.
(113)
Unrefined and unprocessed ore - Ore in its natural
form prior to any processing, such as grinding, roasting, beneficiating, or
refining.
(114)
Unrestricted area (uncontrolled area) - An area,
access to which is neither limited nor controlled by the licensee or registrant.
For purposes of this chapter, "uncontrolled area" is an equivalent term.
(115)
Veterinarian - An individual licensed by the Texas
Board of Veterinary Medical Examiners, with license in good standing.
(116)
Week - Seven consecutive days starting on Sunday.
(117)
Whole body - For purposes of external exposure,
head, trunk including male gonads, arms above the elbow, or legs above the
knee.
(118)
Worker - An individual engaged in work under a
license or certificate of registration issued by the agency and controlled
by a licensee or registrant, but does not include the licensee or registrant.
(119)
Working level (WL) - Any combination of short-lived
radon daughters in 1 liter of air that will result in the ultimate emission
of 1.3 x 10
5
million electron volts (MeV) of
potential alpha particle energy. The short-lived radon daughters are -- for
radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for
radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.
(120)
Working level month (WLM) - An exposure to one
working level for 170 hours - - 2,000 working hours per year divided by 12
months per year is approximately equal to 170 hours per month.
(121)
Year - The period of time beginning in January
used to determine compliance with the provisions of this chapter. The licensee
or registrant may change the starting date of the year used to determine compliance
by the licensee or registrant provided that the change is made at the beginning
of the year and that no day is omitted or duplicated in consecutive years.
(c)
Exemptions.
(1)
General provision. The agency may, upon application therefor
or upon its own initiative, grant exemptions from the requirements of this
chapter as it determines will not result in undue hazard to public health
and safety or property. In determining such exemptions, the agency will consider:
(A)
state of technology,
(B)
economic considerations in relation to benefits to the
public health and safety; and
(C)
other societal, socioeconomic, or public health and safety
considerations.
(2)
United States Department of Energy (DOE) contractors
and NRC contractors. Any DOE contractor or subcontractor and any NRC contractor
or subcontractor of the following categories operating within Texas is exempt
from this chapter, with the exception of §289.204 of this title (relating
to Fees for Certificates of Registration, Radioactive Material(s) Licenses,
Emergency Planning and Implementation, and Other Regulatory Services), to
the extent that such contractor or subcontractor under that individual's contract
receives, possesses, uses, transfers, or acquires sources of radiation:
(A)
prime contractors performing work for the DOE at United
States government-owned or controlled sites, including the transportation
of sources of radiation to or from such sites and the performance of contract
services during temporary interruptions of such transportation;
(B)
prime contractors of the DOE performing research in, or
development, manufacture, storage, testing, or transportation of, atomic weapons
or components thereof;
(C)
prime contractors of the DOE using or operating nuclear
reactors or other nuclear devices in a United States government-owned vehicle
or vessel; and
(D)
any other prime contractor or subcontractor of the DOE
or of the NRC when the state and the NRC jointly determine that:
(i)
the exemption of the prime contractor or subcontractor
is authorized by law; and
(ii)
in accordance with the terms of the contract or subcontract,
there is adequate assurance that the work thereunder can be accomplished without
undue risk to the public health and safety and the environment.
(d)
Records.
(1)
Each licensee and registrant shall maintain records showing
the receipt, transfer, and disposal of all licensed or registered sources
of radiation. These records shall be maintained by the licensee or registrant
until disposal is authorized by the agency. Additional record requirements
are specified elsewhere in this chapter. All records required by this chapter
shall be accurate and factual.
(2)
Records are only valid if stamped, initialed, or
signed and dated by authorized personnel or otherwise authenticated.
(3)
Each record required by this chapter must be legible
throughout the retention period specified by the agency. The record may be
the original or a reproduced copy or a microform provided that the copy or
microform is authenticated by authorized personnel and that the microform
is capable of producing a clear copy throughout the required retention period.
The record may also be stored in electronic media with the capability for
producing legible, accurate, and complete records during the required retention
period. Records, such as letters, drawings, or specifications, must include
all pertinent information such as stamps, initials, and signatures. The licensee
shall maintain adequate safeguards against tampering with and loss of records.
(e)
Inspections.
(1)-(2)
(No change.)
(3)
Routine inspection of radiation machines and services.
(A)
Routine inspections by agency personnel will be made no
more frequently than the intervals specified in subsection (q)(1) of this
section. Registrants having certificates of registration authorizing multiple
uses will be inspected at the most frequent interval specified for the uses
authorized.
(B)
Notwithstanding the provisions of subparagraph (A) of
this paragraph, for those radiation machines determined by the agency to constitute
a minimal threat to human health and safety, the routine inspection interval
will be five years. The applicable categories are listed in subsection (q)(2)
of this section.
(C)
(No change.)
(4)
Training for agency inspectors of electronic
products.
(A)-(B)
(No change.)
(C)
A person performing inspections of electronic products
for the uses described in subparagraph (A) of this paragraph will receive
training specified in subsection (q)(3) of this section.
(f)
Tests.
(1)
Each licensee and registrant shall perform, upon instructions
from the agency, or shall permit the agency to perform such reasonable tests
as the agency deems appropriate or necessary including, but not limited to,
tests of:
(A)
sources of radiation;
(B)
facilities wherein sources of radiation are used or stored;
(C)
radiation detection and monitoring instruments; and
(D)
other equipment and devices used in connection with utilization
or storage of licensed or registered sources of radiation.
(2)
Each licensee is required to accept from the
agency, samples collected from its facility(ies) or from areas that are radioactive
as a result of its licensed activities.
(g)
Tests for leakage and/or contamination of sealed sources.
(1)
The licensee in possession of any sealed source shall
assure that:
(A)
(No change.)
(B)
each sealed source that is not designed to emit alpha
particles is tested for leakage or contamination at intervals not to exceed
six months or at alternative intervals approved by the agency, or by the NRC,
an agreement state, or a licensing state after evaluation of information specified
in §289.252(h)(7)(D) and (E) of this title (relating to Licensing of
Radioactive Material);
(C)
each sealed source that is designed to emit alpha particles
is tested for leakage or contamination at intervals not to exceed three months
or at alternative intervals approved by the agency, after evaluation of information
specified in §289.252(h)(7)(D) and
(E)
of this title, or by the NRC, an agreement state, or a
licensing state.
(D)
(No change.)
(E)
tests for leakage for all sealed sources, except brachytherapy
sources manufactured to contain radium, shall be capable of detecting the
presence of 0.005 µCi (185 becquerels (Bq)) of radioactive material
on a test sample. Test samples shall be taken from the sealed source or from
the surfaces of the container in which the sealed source is stored or mounted
where contamination might accumulate. For a sealed source contained in a device,
test samples are obtained when the source is in the "off" position;
(F)
the test for leakage for brachytherapy sources manufactured
to contain radium shall be capable of detecting an absolute leakage rate of
0.001 µCi (37 Bq) of radon-222 in a 24-hour period when the collection
efficiency for radon-222 and its daughters has been determined with respect
to collection method, volume, and time; and
(G)
tests for contamination from radium daughters shall be
taken on the interior surface of brachytherapy source storage containers and
shall be capable of detecting the presence of 0.005 µCi (185 Bq) of
a radium daughter that has a half-life greater than four days.
(2)
A licensee need not perform tests for leakage
or contamination on the following sealed sources:
(A)-(B)
(No change.)
(C)
sealed sources containing 100 µCi (3.7 megabecquerels
(MBq)) or less of beta or photon-emitting material or 10 µCi (370 kilobecquerels
(kBq)) or less of alpha-emitting material;
(D)-(F)
(No change.)
(3)
Analysis of tests for leakage or contamination
from sealed sources shall be performed by persons specifically authorized
by the agency, the NRC, an agreement state, or a licensing state, to perform
such services.
(4)
(No change.)
(5)
The following shall be considered evidence that a
sealed source is leaking:
(A)
the presence of 0.005 µCi (185 becquerels Bq) or
more of removable contamination on any test sample;
(B)
leakage of 0.001 µCi (37 Bq) of radon-222 per 24
hours for brachytherapy sources manufactured to contain radium; or
(C)
the presence of removable contamination resulting from
the decay of 0.005 µCi (185 Bq) or more of radium.
(6)
(No change.)
(7)
Reports of test results for leaking or contaminated
sealed sources shall be made in accordance with §289.202(bbb) of this
title.
(h)-(i)
(No change.)
(j)
Impounding. Sources of radiation shall be subject to impounding
in accordance with §401.068 of the Act and §289.112 of this title
(relating to Hearing and Enforcement Procedures).
(k)
Prohibited uses.
(1)
A hand-held fluoroscopic screen shall not be used with
x-ray equipment unless it has been listed in the Registry of Sealed Sources
and Devices maintained by the agency or the NRC, or accepted for certification
by the United States Food and Drug Administration (FDA), Center for Devices
and Radiological Health.
(2)
(No change.)
(l)-(n)
(No change.)
(o)
Units of exposure and dose.
(1)
As used in this chapter, the unit of exposure is the coulomb
per kilogram (C/kg) of air. One roentgen (R) is equal to 2.58 x 10
-4
C/kg.
(2)
As used in this chapter, the units of dose are as
follows:
(A)
Rad is the special unit of absorbed dose. One rad is equal
to an absorbed dose of 100 erg/g or 0.01 J/kg (0.01 gray). Gray (Gy) is the
SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 J/kg
(100 rads).
(B)
(No change.)
(C)
Sievert (Sv) is the SI unit of any of the quantities expressed
as dose equivalent. The dose equivalent in sievert is equal to the absorbed
dose in gray multiplied by the quality factor (1 Sv = 100 rems).
(3)
(No change.)
(4)
If it is more convenient to measure the neutron fluence
rate than to determine the neutron dose equivalent rate in sievert per hour
or rem per hour, as provided in subsection (o)(3) of this section, 1 rem (0.01
Sv) of neutron radiation of unknown energies may, for purposes of this section,
be assumed to result from a total fluence of 25 million neutrons per square
centimeter incident upon the body. If sufficient information exists to estimate
the approximate energy distribution of the neutrons, the licensee or registrant
may use the fluence rate per unit dose equivalent or the appropriate Q value
from the following table to convert a measured tissue dose in rad (gray) to
dose equivalent in rem (Sv).
Figure 4: 25 TAC §289.201(o)(4)
(p)
Units of activity. For purposes of this chapter, activity
is expressed in the special unit of curie (Ci) (becquerel (Bq)), or its multiples,
or disintegrations or transformations per second (dps or tps).
(1)
One Ci = 3.7 x 10
10
dps or
tps = 3.7 x 10
10
(Bq) = 2.22 x 10
12
disintegrations or transformations per minute (dpm or tpm).
(2)
One Bq = 1 dps or tps.
(q)
Appendices.
(1)
Routine inspection intervals for registrants.
Figure 5: 25 TAC §289.201(q)(1)
(2)
Minimal threat radiation machines. The following
radiation machines are considered to be of minimal threat:
(A)
electron microscope;
(B)
x-ray fluorescence (machine);
(C)
x-ray gauges radiography - certified cabinet x-ray only;
(D)
particle size analyzer (x-ray);
(E)
baggage or package x-ray;
(F)
electron beam welding;
(G)
ion implantation devices; and
(H)
cathodoluminescence devices;
(3)
Training for agency inspectors of electronic
products.
(A)
Objectives. Training of agency inspectors of electronic
products will be conducted by the agency. Upon completion of training, the
inspector will be able to:
(i)
select and operate the necessary testing equipment used
to perform an inspection of electronic products;
(ii)
utilize radiation protection principles;
(iii)
operate radiation detection instruments;
(iv)
define basic regulatory terminology;
(v)
apply this section regarding electronic products;
(vi)
perform routine agency inspections of electronic products;
(vii)
complete agency inspection documentation;
(viii)
demonstrate knowledge of agency ethics, professional,
and technical policies; and
(ix)
successfully achieve the objectives in this subparagraph.
(B)
Initial training program.
(i)
Initial training will be conducted during a six month
period.
(ii)
All training evaluation instruments will be developed
by the agency.
(iii)
Instruments to be used in determining a proficiency
level are as follows:
(I)
evaluation of each inspectors training needs prior to
initial training;
(II)
evaluation of knowledge obtained and verification of
tasks performed by each inspector subsequent to training received by the agency;
and
(III)
evaluation of each inspector's task performance by the
agency.
(C)
Continuing education.
(i)
The agency inspector of electronic products will accumulate
24 hours of continuing education regarding electronic products, at intervals
not to exceed 24 months. These hours of continuing education may be acquired
as follows:
(I)
documented continuing education earned in an agency-accepted
training format; and
(II)
agency staff meetings.
(ii)
Failure to obtain 24 hours of continuing education within
each 24 month interval may result in a reassessment by the agency of an agency
inspector's proficiency level.
(iii)
After the initial training period, each inspector of
electronic products will be evaluated by the agency, at intervals not to exceed
12 months.
(D)
Agency proficiency standards. The agency proficiency standards
for agency inspectors of electronic products are as follows.
(i)
Level I. The agency inspector has not successfully achieved
the objectives in subparagraph (A) of this paragraph after the initial training
period. Additional training is required. Unsupervised inspections will not
be performed.
(ii)
Level II. The agency inspector has partially achieved
the objectives in subparagraph (A) of this paragraph, but has not achieved
the objective in subparagraph (A)(ix) of this paragraph after the initial
training period. Additional training is required. Unsupervised inspections
are not permitted for the type of electronic products for which the objectives
of subparagraph (A)(ix) of this paragraph have not been achieved. Unsupervised
inspections may be performed for the type of electronic products for which
the objectives in subparagraph (A)(ix) of this paragraph have been successfully
achieved.
(iii)
Level III. The agency inspector has successfully achieved
the objectives in subparagraph (A) of this paragraph. Supervision is not required
for routine inspections.
§289.202. Standards for Protection Against Radiation.
(a)
(No change.)
(b)
Scope. Except as specifically provided in other sections
of this chapter, this section applies to persons licensed or registered by
the agency to receive, possess, use, or transfer sources of radiation. The
limits in this section do not apply to doses due to background radiation,
to exposure of patients to radiation for the purpose of medical diagnosis
or therapy, or to voluntary participation in medical research programs. However,
no radiation may be deliberately applied to human beings except by or under
the supervision of an individual authorized by and licensed in accordance
with Texas' statutes to engage in the healing arts.
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning, unless the context clearly
indicates otherwise.
(1)
Annual limit on intake (ALI) - The derived limit for the
amount of radioactive material taken into the body of an adult worker by inhalation
or ingestion in a year. ALI is the smaller value of intake of a given radionuclide
in a year by Reference Man that would result in a committed effective dose
equivalent of 5 rems (0.05 sievert (Sv)) or a committed dose equivalent of
50 rems (0.5 Sv) to any individual organ or tissue. ALI values for intake
by ingestion and by inhalation of selected radionuclides are given in Columns
1 and 2 of Table I of subsection (ggg)(2) of this section.
(2)-(4)
(No change.)
(5)
Derived air concentration-hour (DAC-hour) - The product
of the concentration of radioactive material in air, expressed as a fraction
or multiple of the derived air concentration for each radionuclide, and the
time of exposure to that radionuclide, in hours. A licensee may take 2,000
DAC-hours to represent ALI, equivalent to a committed effective dose equivalent
of 5 rems (0.05 Sv).
(6)-(15)
(No change.)
(16)
Very high radiation area - An area, accessible to
individuals, in which radiation levels could result in an individual receiving
an absorbed dose in excess of 500 rads (5 grays) in one hour at 1 meter (m)
from a source of radiation or from any surface that the radiation penetrates.
At very high doses received at high dose rates, units of absorbed dose, gray
and rad, are appropriate, rather than units of dose equivalent, Sv and rem.
(17)
(No change.)
(d)-(e)
(No change.)
(f)
Occupational dose limits for adults.
(1)
The licensee or registrant shall control the occupational
dose to individual adults, except for planned special exposures in accordance
with subsection (k) of this section, to the following dose limits.
(A)
An annual limit shall be the more limiting of:
(i)
the total effective dose equivalent being equal to 5 rems
(0.05 Sv); or
(ii)
the sum of the deep dose equivalent and the committed
dose equivalent to any individual organ or tissue other than the lens of the
eye being equal to 50 rems (0.5 Sv).
(B)
The annual limits to the lens of the eye, to the skin,
and to the extremities shall be:
(i)
an eye dose equivalent of 15 rems (0.15 Sv); and
(ii)
a shallow dose equivalent of 50 rems (0.5 Sv) to the
skin or to any extremity.
(2)-(6)
(No change.)
(7)
Notwithstanding the annual dose limits, the licensee
shall limit the soluble uranium intake by an individual to 10 milligrams (mg)
in a week in consideration of chemical toxicity. See footnote 3 of subsection
(ggg)(2) of this section.
(8)
(No change.)
(g)
Compliance with requirements for summation of external
and internal doses.
(1)
(No change.)
(2)
If the only intake of radionuclides is by inhalation,
the total effective dose equivalent limit is not exceeded if the sum of the
deep dose equivalent divided by the total effective dose equivalent limit,
and one of the following, does not exceed unity:
(A)-(B)
(No change.)
(C)
the sum of the calculated committed effective dose equivalents
to all significantly irradiated organs or tissues (T) calculated from bioassay
data using appropriate biological models and expressed as a fraction of the
annual limit. For purposes of this requirement, an organ or tissue is deemed
to be significantly irradiated if, for that organ or tissue, the product of
the weighting factors, w
T
, and the committed
dose equivalent, H
T,50
, per unit intake is greater
than 10% of the maximum weighted value of H
T,50
,
that is, w
T
H
T,50
,
per uxnit intake for any organ or tissue.
(3)-(4)
(No change.)
(h)
(No change.)
(i)
Determination of internal exposure.
(1)-(7)
(No change.)
(8)
When determining the committed effective dose equivalent,
the following information may be considered.
(A)
In order to calculate the committed effective dose equivalent,
the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000
DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05
Sv) for radionuclides that have their ALIs or DACs based on the committed
effective dose equivalent.
(B)
For an ALI and the associated DAC determined by the nonstochastic
organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would
result in a committed effective dose equivalent of 5 rems (0.05 Sv), that
is, the stochastic ALI, is listed in parentheses in Table I of subsection
(ggg)(2) of this section. The licensee may, as a simplifying assumption, use
the stochastic ALI to determine committed effective dose equivalent. However,
if the licensee uses the stochastic ALI, the licensee shall also demonstrate
that the limit in subsection (f)(1)(A)(ii) of this section is met.
(j)
Determination of occupational dose for the current year.
(1)
For each individual who is likely to receive, in a year,
an occupational dose requiring monitoring in accordance with subsection (q)
of this section, the licensee or registrant shall determine the occupational
radiation dose received during the current year.
(2)-(3)
(No change.)
(4)
If the licensee or registrant is unable to obtain
a complete record of an individual's current occupational dose while employed
by any other licensee or registrant, the licensee or registrant shall assume
in establishing administrative controls in accordance with subsection (f)(8)
of this section for the current year, that the allowable dose limit for the
individual is reduced by 1.25 rems (12.5 millisieverts (mSv)) for each quarter;
or 416 millirems (mrem) (4.16 mSv) for each month for which records were unavailable
and the individual was engaged in activities that could have resulted in occupational
radiation exposure.
(5)
If an individual has incomplete (e.g., a lost or
damaged personnel monitoring device) current occupational dose data for the
current year and that individual is employed solely by the licensee or registrant
during the current year, the licensee or registrant shall:
(A)
assume that the allowable dose limit for the individual
is reduced by 1.25 rems (12.5 mSv) for each quarter;
(B)
assume that the allowable dose limit for the individual
is reduced by 416 mrem (4.16 mSv) for each month; or
(C)
(No change.)
(6)
(No change.)
(k)-(1)
(No change.)
(m)
Dose to an embryo/fetus.
(1)
If a woman declares her pregnancy, the licensee or registrant
shall ensure that the dose to an embryo/fetus during the entire pregnancy,
due to occupational exposure of a declared pregnant woman, does not exceed
0.5 rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational
dose limits specified in subsection (f)(1) of this section are applicable
to the woman. See subsection (rr) of this section for recordkeeping requirements.
(2)
The licensee or registrant shall make efforts to
avoid substantial variation above a uniform monthly exposure rate to a declared
pregnant woman so as to satisfy the limit in paragraph (1) of this subsection.
The National Council on Radiation Protection and Measurements recommended
in NCRP Report No. 91 "Recommendations on Limits for Exposure to Ionizing
Radiation" (June 1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus
be received in any 1 month.
(3)
(No change.)
(4)
If by the time the woman declares pregnancy to the
licensee or registrant, the dose to the embryo/fetus has exceeded 0.45 rem
(4.5 mSv), the licensee or registrant shall be deemed to be in compliance
with paragraph (1) of this subsection, if the additional dose to the embryo/fetus
does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
(n)
Dose limits for individual members of the public.
(1)
Each licensee or registrant shall conduct operations so
that:
(A)
except as provided in subparagraph (B) of this paragraph,
the total effective dose equivalent to individual members of the public from
the licensed and/or registered operation does not exceed 0.1 rem (1 mSv) in
a year, exclusive of the dose contribution from the licensee's disposal of
radioactive material into sanitary sewerage in accordance with subsection
(gg) of this section, background radiation, exposure of patients to radiation
for the purpose of medical diagnosis or therapy, or to voluntary participation
in medical research programs;
(B)
the total effective dose equivalent to individual members
of the public from exposure to radiation from radiation machines does not
exceed 0.5 rem (5 mSv) in a year; and
(C)
the dose in any unrestricted area from licensed and/or
registered external sources does not exceed 0.002 rem (0.02 mSv) in any one
hour.
(2)
(No change.)
(3)
A licensee or an applicant for a license may apply
for prior agency authorization to operate up to an annual dose limit for an
individual member of the public of 0.5 rem (5 mSv). This application shall
include the following information:
(A)
(No change.)
(B)
the licensee's program to assess and control dose within
the 0.5 rem (5 mSv) annual limit; and
(C)
(No change.)
(4)-(5)
(No change.)
(o)
Compliance with dose limits for individual members of
the public.
(1)
(No change.)
(2)
A licensee or registrant shall show compliance with
the annual dose limit in subsection (n) of this section by:
(A)
(No change.)
(B)
demonstrating that:
(i)
(No change.)
(ii)
if an individual were continuously present in an unrestricted
area, the dose from external sources of radiation would not exceed 0.002 rem
(0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
(3)-(4)
(No change.)
(p)
General surveys and monitoring.
(1)
(No change.)
(2)
The licensee or registrant shall ensure that instruments
and equipment used for quantitative radiation measurements, for example, dose
rate and effluent monitoring, are operable and calibrated:
(A)
by a person licensed or registered by the agency, another
agreement state, a licensing state, or the United States Nuclear Regulatory
Commission (NRC) to perform such service;
(B)-(E)
(No change.)
(3)-(5)
(No change.)
(q)
Conditions requiring individual monitoring of external
and internal occupational dose. Each licensee or registrant shall monitor
exposures from sources of radiation at levels sufficient to demonstrate compliance
with the occupational dose limits of this section. As a minimum:
(1)-(2)
(No change.)
(3)
each licensee shall monitor, to determine compliance
with subsection (i) of this section, the occupational intake of radioactive
material by and assess the committed effective dose equivalent to:
(A)
(No change.)
(B)
minors and declared pregnant women likely to receive,
in one year, a committed effective dose equivalent in excess of 0.05 rem (0.5
mSv).
(r)
(No change.)
(s)
Control of access to high radiation areas.
(1)
The licensee or registrant shall ensure that each entrance
or access point to a high radiation area has one or more of the following
features:
(A)
a control device that, upon entry into the area, causes
the level of radiation to be reduced below that level at which an individual
might receive a deep dose equivalent of 0.1 rem (1 mSv) in one hour at 30
centimeters (cm) from the source of radiation from any surface that the radiation
penetrates;
(B)-(C)
(No change.)
(2)-(7)
(No change.)
(t)
Control of access to very high radiation areas.
(1)
In addition to the requirements in subsection (s) of this
section, the licensee or registrant shall institute measures to ensure that
an individual is not able to gain unauthorized or inadvertent access to areas
in which radiation levels could be encountered at 500 rads (5 grays) or more
in one hour at 1 m from a source of radiation or any surface through which
the radiation penetrates at this level. This requirement does not apply to
rooms or areas in which diagnostic x-ray systems are the only source of radiation.
(2)
(No change.)
(u)
Control of access to very high radiation areas for irradiators.
(1)
(No change.)
(2)
Each area in which there may exist radiation levels
in excess of 500 rads (5 grays) in one hour at 1 m from a source of radiation
that is used to irradiate materials shall meet the following requirements.
(A)
Each entrance or access point shall be equipped with entry
control devices that:
(i)
(No change.)
(ii)
permit deliberate entry into the area only after a control
device is actuated that causes the radiation level within the area, from the
source of radiation, to be reduced below that at which it would be possible
for an individual to receive a deep dose equivalent in excess of 0.1 rem (1
mSv) in one hour; and
(iii)
prevent operation of the source of radiation if it would
produce radiation levels in the area that could result in a deep dose equivalent
to an individual in excess of 0.1 rem (1 mSv) in one hour.
(B)
Additional control devices shall be provided so that,
upon failure of the entry control devices to function as required by subparagraph
(A) of this paragraph:
(i)
the radiation level within the area, from the source of
radiation, is reduced below that at which it would be possible for an individual
to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour;
and
(ii)
(No change.)
(C)
The licensee shall provide control devices so that, upon
failure or removal of physical radiation barriers other than the sealed source's
shielded storage container:
(i)
the radiation level from the source of radiation is reduced
below that at which it would be possible for an individual to receive a deep
dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
(ii)
(No change.)
(D)-(G)
(No change.)
(H)
Each area shall be checked by a radiation measurement
to ensure that, prior to the first individual's entry into the area after
any use of the source of radiation, the radiation level from the source of
radiation in the area is below that at which it would be possible for an individual
to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour.
(I)-(K)
(No change.)
(3)-(4)
(No change.)
(v)-(w)
(No change.)
(x)
Use of individual respiratory protection equipment.
(1)
If the licensee uses respiratory protection equipment
to limit intakes in accordance with subsection (w) of this section.
(A)-(B)
(No change.)
(C)
The licensee shall implement and maintain a respiratory
protection program that includes:
(i)-(iv)
(No change.)
(v)
determination by a physician prior to initial fitting
of respirators, and either every 12 months thereafter or periodically at a
frequency determined by a physician, that the individual user is physically
able to use the respiratory protection equipment.
(D)-(F)
(No change.)
(2)-(4)
(No change.)
(y)-(aa)
(No change.)
(bb)
Exceptions to posting requirements.
(1)-(2)
(No change.)
(3)
A room or area is not required to be posted with
a caution sign because of the presence of a sealed source(s) provided the
radiation level at 30 centimeters from the surface of the sealed source container(s)
or housing(s) does not exceed 0.005 rem (0.05 mSv) per hour.
(cc)-(dd)
(No change.)
(ee)
Procedures for receiving and opening packages.
(1)
Each licensee who expects to receive a package containing
quantities of radioactive material in excess of a Type A quantity, as defined
in §289.201(b) of this title and specified in §289.257(s)(1) of
this title (relating to Packaging and Transportation of Radioactive Material),
shall make arrangements to receive:
(A)-(B)
(No change.)
(2)
Each licensee shall:
(A)
(No change.)
(B)
monitor the external surfaces of a labeled package, labeled
with a Radioactive White I, Yellow II, or Yellow III label as specified in
DOT regulations 49 CFR 172.403 and 172.436-440, for radiation levels unless
the package contains quantities of radioactive material that are less than
or equal to the Type A quantity, as defined in §289.201(b) of this title
and specified in §289.257(s)(1) of this title; and
(C)
(No change.)
(3)
(No change.)
(4)
The licensee shall immediately notify the final delivery
carrier and, by telephone and telegram, mailgram, or facsimile, the agency
when removable radioactive surface contamination or external radiation levels
exceed the limits established in subparagraphs (A) and (B) of this paragraph.
(A)
Limits for removable radioactive surface contamination
levels.
(i)
The level of removable radioactive contamination on the
external surfaces of each package offered for shipment shall be ALARA. The
level of removable radioactive contamination may be determined by wiping an
area of 300 square centimeters (cm
2
) of the
surface concerned with an absorbent material, using moderate pressure, and
measuring the activity on the wiping material. Sufficient measurements must
be taken in the most appropriate locations to yield a representative assessment
of the removable contamination levels. Except as provided in clause (iii)
of this subparagraph, the amount of radioactivity measured on any single wiping
material, when averaged over the surface wiped, must not exceed the limits
given in clause (ii) of this subparagraph at any time during transport. If
other methods are used, the detection efficiency of the method used must be
taken into account and in no case may the removable contamination on the external
surfaces of the package exceed ten times the limits listed in clause (ii)
of this subparagraph.
(ii)-(iii)
(No change.)
(B)
Limits for external radiation levels.
(i)
External radiation levels around the package and around
the vehicle, if applicable, will not exceed 200 millirems per hour (mrem/hr)
(2 millisiverts per hour (mSv/hr)) at any point on the external surface of
the package at any time during transportation. The transport index shall not
exceed 10.
(ii)
For a package transported in exclusive use by rail, highway
or water, radiation levels external to the package may exceed the limits specified
in clause (i) of this subparagraph but shall not exceed any of the following:
(I)
200 mrem/hr (2 mSv/hr) on the accessible external surface
of the package unless the following conditions are met, in which case the
limit is 1,000 mrem/h (10 mSv/hr):
(-a-)-(-c-)
(No change.)
(II)
200 mrem/hr (2 mSv/hr) at any point on the outer surface
of the vehicle, including the upper and lower surfaces, or, in the case of
a flat-bed style vehicle, with a personnel barrier, at any point on the vertical
planes projected from the outer edges of the vehicle, on the upper surface
of the load (or enclosure, if used), and on the lower external surface of
the vehicle (a flat-bed style vehicle with a personnel barrier shall have
radiation levels determined at vertical planes. If no personnel barrier, the
package cannot exceed 200 mrem/hr (2 mSv/hr) at the surface.);
(III)
10 mrem/hr (0.1 mSv/h) at any point 2 m from the vertical
planes represented by the outer lateral surfaces of the vehicle, or, in the
case of a flat-bed style vehicle, at any point 2 m from the vertical planes
projected from the outer edges of the vehicle; and
(IV)
2 mrem/hr (0.02 mSv/hr) in any normally occupied positions
of the vehicle, except that this provision does not apply to private motor
carriers when persons occupying these positions are provided with special
health supervision, personnel radiation exposure monitoring devices, and training
in accordance with 22.12 of Texas Regulations for Control of Radiation (TRCR)
Part 22 as adopted by reference in §289.114 of this title (relating
to Notices, Instructions, and Reports to Workers; Inspections).
(5)-(6)
(No change.)
(ff)
General requirements for waste management.
(1)
Unless otherwise exempted, a licensee shall discharge,
treat, or decay licensed material or transfer waste for disposal only:
(A)
by transfer to an authorized recipient as provided in
subsection (jj) of this section or in, §289.127 of this title (relating
to Licensing of Naturally Occurring Radioactive Material (NORM)), §289.252
of this title, or §289.254 of this title (relating to Licensing of Radioactive
Waste Processing and Storage Facilities), §289.257 of this title, or
to the United States Department of Energy (DOE);
(B)-(D)
(No change.)
(2)
(No change.)
(gg)
Discharge by release into sanitary sewerage.
(1)
A licensee may discharge licensed material into sanitary
sewerage if each of the following conditions is satisfied:
(A)-(C)
(No change.)
(D)
the total quantity of licensed radioactive material that
the licensee releases into the sanitary sewerage in a year does not exceed
5 curies (Ci) (185 gigabecquerels (GBq)) of hydrogen-3, 1 Ci (37 GBq) of
carbon-14, and 1 Ci (37 GBq) of all other radioactive materials combined.
(2)
(No change.)
(hh)-(ii)
(No change.)
(jj)
Transfer for disposal and manifests.
(1)
The control of transfers of low-level radioactive waste
intended for disposal at a licensed low-level radioactive waste disposal facility,
the establishment of a manifest tracking system, and additional requirements
concerning transfers and recordkeeping for those wastes are found in §289.257(s)(5)
of this title.
(2)
Each person involved in the transfer of waste for
disposal including the waste generator, waste collector, and waste processor,
shall comply with the requirements specified in §289.257(s)(5) of this
title.
(kk)
Compliance with environmental and health protection regulations.
Nothing in subsections (ff), (gg), (hh), or (jj) of this section relieves
the licensee from complying with other applicable federal, state, and local
regulations governing any other toxic or hazardous properties of materials
that may be disposed of in accordance with subsections (ff), (gg), (hh), or
(jj) of this section.
(ll)
General provisions for records.
(1)
Each licensee or registrant shall use the SI units becquerel,
gray, sievert, and coulomb per kilogram, or the special units curie, rad,
rem, and roentgen, including multiples and subdivisions, and shall clearly
indicate the units of all quantities on records required by this section.
Disintegrations per minute may be indicated on records of surveys performed
to determine compliance with subsection (ggg)(6) of this section. To ensure
compatibility with international transportation standards, all limits in this
section are given in terms of dual units: The International System of Units
(SI) followed or preceded by United States (U.S.) standard or customary units.
The U.S. customary units are not exact equivalents, but are rounded to a convenient
value, providing a functionally equivalent unit. For the purpose of this section,
either unit may be used.
(2)
Notwithstanding the requirements of paragraph (1)
of this subsection, when recording information on shipment manifests, as required
in §289.257 of this title, information must be recorded in SI units or
in SI and units as specified in paragraph (1) of this subsection.
(3)
The licensee or registrant shall make a clear distinction
among the quantities entered on the records required by this section, such
as, total effective dose equivalent, total organ dose equivalent, shallow
dose equivalent, eye dose equivalent, deep dose equivalent, or committed effective
dose equivalent.
(4)
Records required in accordance with §289.201(d)
of this title, and subsections (mm), (nn), (oo), (tt), and (uu) of this section
shall include the date and the identification of individual(s) making the
record, and, as applicable, a unique identification of survey instrument(s)
used, and an exact description of the location of the survey. Records of receipt,
transfer, and disposal of sources of radiation shall uniquely identify the
source of radiation.
(5)
Copies of records required in accordance with §289.201(d)
of this title, and subsections (mm) through (uu) of this section, and by license
or certificate of registration condition that are relevant to operations at
an additional authorized use/storage site shall be maintained at that site
in addition to the main site specified on a license or certificate of registration.
(mm)-(ss)
(No change.)
(tt)
Records of discharge, treatment, or transfer for disposal.
(1)
Each licensee shall maintain records of the discharge
or treatment of licensed materials made in accordance with subsection (gg)
and (hh) of this section and of transfers for disposal made in accordance
with subsection (jj) of this section and §289.257 of this title.
(2)
(No change.)
(uu)
(No change.)
(vv)
Form of records. Each record required by this chapter
shall be legible throughout the specified retention period. The record shall
be the original or a reproduced copy or a microform, provided that the copy
or microform is authenticated by authorized personnel and that the microform
is capable of producing a clear copy throughout the required retention period
or the record may also be stored in electronic media with the capability for
producing legible, accurate, and complete records during the required retention
period. Records, such as letters, drawings, and specifications, shall include
all pertinent information, such as stamps, initials, and signatures. The licensee
or registrant shall maintain adequate safeguards against tampering with and
loss of records.
(ww)
(No change.)
(xx)
Notification of incidents.
(1)
Notwithstanding other requirements for notification, each
licensee or registrant shall immediately report each event involving a source
of radiation possessed by the licensee or registrant that may have caused
or threatens to cause:
(A)
an individual to receive:
(i)
a total effective dose equivalent of 25 rems (0.25 Sv)
or more;
(ii)
an eye dose equivalent of 75 rems (0.75 Sv) or more;
or
(iii)
(No change.)
(B)
(No change.)
(2)
Each licensee or registrant shall, within 24
hours of discovery of the event, report to the agency each event involving
loss of control of a licensed or registered source of radiation possessed
by the licensee or registrant that may have caused, or threatens to cause:
(A)
an individual to receive, in a period of 24 hours:
(i)
a total effective dose equivalent exceeding 5 rems (0.05
Sv);
(ii)
an eye dose equivalent exceeding 15 rems (0.15 Sv); or
(iii)
a shallow dose equivalent to the skin or extremities
or a total organ dose equivalent exceeding 50 rems (0.5 Sv); or
(B)
(No change.)
(3)-(5)
(No change.)
(yy)-(zz)
(No change.)
(aaa)
Notifications and reports to individuals.
(1)
Requirements for notification and reports to individuals
of exposure to sources of radiation are specified in §289.114 of this
title.
(2)
When a licensee or registrant is required in accordance
with subsection (yy) or (zz) of this section to report to the agency any exposure
of an identified occupationally exposed individual, or an identified member
of the public, to sources of radiation, the licensee or registrant shall also
notify the individual and provide a copy of the report submitted to the agency,
to the individual. Such notice shall be transmitted at a time not later than
the transmittal to the agency, and shall comply with the provisions of 22.13(a)
of TRCR Part 22 as adopted by reference in §289.114 of this title.
(bbb)
(No change.)
(ccc)
Vacating premises.
(1)
Each licensee, registrant, or person possessing non-exempt
sources of radiation shall, no less than 30 days before vacating or relinquishing
possession or control of premises, notify the agency, in writing, of the intent
to vacate.
(2)
The licensee or person possessing non-exempt radioactive
material shall decommission the premises to a degree consistent with subsequent
use as an unrestricted area and in accordance with the requirements of subsections
(ddd) and (eee) of this section.
(3)
Notwithstanding the limits set forth in subsections
(ddd) and (eee) of this section, contamination levels must be maintained in
unrestricted areas so that no individual member of the public will receive
an effective dose equivalent in excess of 100 mrem (1 mSv) above background
per year.
(4)
No licensee shall vacate a facility or land, or release
a facility or land for unrestricted use, until the annual total effective
dose equivalent to a member of the public resulting from radioactive material
remaining from licensed activities (excluding radium and its decay products)
does not exceed 25 mrem (0.25 mSv) per year above background. The concentration
for radium in soil shall be equivalent to or below the limits in subsection
(eee) of this section. Notwithstanding the limits in this paragraph, each
licensee shall make every reasonable effort to maintain any contamination
of soil or vegetation ALARA. The licensee shall conduct all necessary radiation
surveys and modeling and shall provide reports and documentation to demonstrate
that the requirements for release for unrestricted use have been met. The
Agency may require the licensee to provide any other information necessary
to demonstrate that the facilities and land are suitable for release for unrestricted
use.
(ddd)
Soil contamination limits.
(1)
No licensee shall possess, receive, use, or transfer radioactive
material in such a manner as to cause contamination of soil in unrestricted
areas, to the extent that the contamination exceeds, on a dry weight basis,
the concentration limits specified in:
(A)
subsection (ggg)(8) of this section; or
(B)
the effluent concentrations in Table III of subsection
(ggg)(2) of this section, with the units changed from microcuries per milliliter
to microcuries per gram, for radionuclides not specified in subsection (ggg)(8)
of this section or paragraph (3) of this subsection.
(2)
(No change.)
(3)
Except for the requirements in §289.127 of this
title and notwithstanding the limits imposed by paragraph (1) of this subsection,
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:
(A)
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
(B)
15 pCi/g (0.555 Bq/g), averaged over 15 cm thick layers
of soil more than 15 cm below the surface.
(4)
5 pCi/g (0.185 Bq/g), based on dry weight, for
radium-226 or radium-228 in vegetation; and
(5)
the following limits, based on dry weight, averaged
over any 100 m
2
of area for natural uranium with
no daughters present:
(A)
30 pCi/g (1.11 Bq/g), averaged over the top 15 cm of soil
below the surface; and
(B)
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.
(eee)
Surface contamination limits for facilities and equipment.
(1)
Prior to vacating any facility or releasing areas or equipment
for unrestricted use, each licensee shall ensure that radioactive contamination
has been removed to ALARA levels. In no case shall the licensee vacate a facility
or release areas or equipment for unrestricted use until radioactive surface
contamination levels are below the limits specified in subsection (ggg)(6)
of this section.
(2)
In addition to meeting the surface contamination
limits of paragraph (1) of this subsection, porous materials (e.g., concrete),
that are to be released for unrestricted use, shall be evaluated to determine
whether radioactive materials have penetrated to the interior of the material.
If radioactive contamination has penetrated into the material, analysis of
the average concentration, in pCi/g, shall be made. The material may be released
for unrestricted use if the radionuclide concentrations do not exceed the
limits specified for soil in subsection (ddd) of this section.
(fff)
Exemption of specific wastes.
(1)
A licensee may discard the following licensed material
without regard to its radioactivity:
(A)
0.05 microcurie (µCi) (1.85 kilobecquerels (kBq)),
or less, of hydrogen-3, carbon-14, or iodine-125 per gram of medium used for
liquid scintillation counting or
in vitro
clinical or
in vitro
laboratory testing; and
(B)
0.05 µCi (1.85 kBq), or less, of hydrogen-3, carbon-14,
or iodine-125, per gram of animal tissue, averaged over the weight of the
entire animal.
(2)-(3)
(No change.)
(4)
Any licensee may, upon agency approval of procedures
required in paragraph (6) of this subsection, discard licensed material included
in subsection (ggg)(7) of this section, provided that it does not exceed the
concentration and total curie limits contained therein, in a Type I municipal
solid waste site as defined in the Municipal Solid Waste Regulations of the
authorized regulatory agency (31 TAC Chapter 330), unless such licensed material
also contains hazardous waste, as defined in Section 3(15) of the Solid Waste
Disposal Act, Health and Safety Code, Chapter 361. Any licensed material included
in subsection (ggg)(7) of this section and which is a hazardous waste as defined
in the Solid Waste Disposal Act may be discarded at a facility authorized
to manage hazardous waste by the authorized regulatory agency.
(5)-(9)
(No change.)
(ggg)
Appendices.
(1)
(No change.)
(2)
Annual limits on intake (ALI) and derived air concentrations
(DAC) of radionuclides for occupational exposure; effluent concentrations;
concentrations for release to sanitary sewerage.
(A)
(No change.)
(B)
Occupational values.
(i)
(No change.)
(ii)
The ALIs in subparagraph (F) of this paragraph are the
annual intakes of given radionuclide by "Reference Man" that would result
in either a committed effective dose equivalent of 5 rems (0.05 Sv), stochastic
ALI, or a committed dose equivalent of 50 rems (0.5 Sv) to an organ or tissue,
non-stochastic ALI. The stochastic ALIs were derived to result in a risk,
due to irradiation of organs and tissues, comparable to the risk associated
with deep dose equivalent to the whole body of 5 rems (0.05 Sv). The derivation
includes multiplying the committed dose equivalent to an organ or tissue by
a weighting factor, w
T
. This weighting factor
is the proportion of the risk of stochastic effects resulting from irradiation
of the organ or tissue, T, to the total risk of stochastic effects when the
whole body is irradiated uniformly. The values of w
T
are listed under the definition of "weighting factor" in subsection
(c) of this section. The non-stochastic ALIs were derived to avoid non-stochastic
effects, such as prompt damage to tissue or reduction in organ function.
(iii)-(xii)
(No change.)
(C)
Effluent concentrations.
(i)
The columns in Table II of subparagraph (F) of this paragraph
captioned "Effluents," "Air," and "Water" are applicable to the assessment
and control of dose to the public, particularly in the implementation of the
provisions of subsection (o) of this section. The concentration values given
in Columns 1 and 2 of Table II of subparagraph (F) of this paragraph are equivalent
to the radionuclide concentrations which, if inhaled or ingested continuously
over the course of a year, would produce a total effective dose equivalent
of 0.05 rem (0.5 mSv).
(ii)
(No change.)
(iii)
The air concentration values listed in Column I of Table
II of subparagraph (F) of this paragraph were derived by one of two methods.
For those radionuclides for which the stochastic limit is governing, the occupational
stochastic inhalation ALI was divided by 2.4 x 10
9
,
relating the inhalation ALI to the DAC, as explained in subparagraph (B)(viii)
of this paragraph, and then divided by a factor of 300. The factor of 300
includes the following components:
(I)
a factor of 50 to relate the 5 rems (0.05 Sv) annual occupational
dose limit to the 0.1 rem limit for members of the public;
(II)-(III)
(No change.)
(iv)
(No change.)
(v)
The water concentrations were derived by taking the most
restrictive occupational stochastic oral ingestion ALI and dividing by 7.3
x 10
7
. The factor of 7.3 x 10
7
milliliters (ml) includes the following components:
(I)-(II)
(No change.)
(vi)
(No change.)
(D)-(F)
(No change.)
(3)
(No change.)
(4)
Classification and characteristics of low-level radioactive
waste (LLRW).
(A)
Classification of radioactive waste for land disposal.
(i)
Considerations. Determination of the classification of
LLRW involves two considerations. First, consideration must be given to the
concentration of long-lived radionuclides (and their shorter-lived precursors)
whose potential hazard will persist long after such precautions as institutional
controls, improved waste form, and deeper disposal have ceased to be effective.
These precautions delay the time when long-lived radionuclides could cause
exposures. In addition, the magnitude of the potential dose is limited by
the concentration and availability of the radionuclide at the time of exposure.
Second, consideration must be given to the concentration of shorter-lived
radionuclides for which requirements on institutional controls, waste form,
and disposal methods are effective.
(ii)
Classes of waste.
(I)
Class A waste is waste that is usually segregated from
other waste classes at the disposal site. The physical form and characteristics
of Class A waste must meet the minimum requirements set forth in subparagraph
(B)(i) of this paragraph. If Class A waste also meets the stability requirements
set forth in subparagraph (B)(ii) of this paragraph, it is not necessary to
segregate the waste for disposal.
(II)
Class B waste is waste that must meet more rigorous requirements
on waste form to ensure stability after disposal. The physical form and characteristics
of Class B waste must meet both the minimum and stability requirements set
forth in subparagraph (B) of this paragraph.
(III)
Class C waste is waste that not only must meet more
rigorous requirements on waste form to ensure stability but also requires
additional measures at the disposal facility to protect against inadvertent
intrusion. The physical form and characteristics of Class C waste must meet
both the minimum and stability requirements set forth in subparagraph (B)
of this paragraph.
(iii)
Classification determined by long-lived radionuclides.
If the radioactive waste contains only radionuclides listed in subclause (V)
of this clause, classification shall be determined as follows.
(I)
If the concentration does not exceed 0.1 times the value
in subclause (V) of this clause, the waste is Class A.
(II)
If the concentration exceeds 0.1 times the value in Table
I, but does not exceed the value in subclause (V) of this clause, the waste
is Class C.
(III)
If the concentration exceeds the value in subclause
(V) of this clause, the waste is not generally acceptable for land disposal.
(IV)
For wastes containing mixtures of radionuclides listed
in subclause (V) of this clause, the total concentration shall be determined
by the sum of fractions rule described in clause (vii) of this subparagraph.
(V)
Classification table for long-lived radionuclides.
Figure 10: 25 TAC §289.202(ggg)(4)(A)(iii)(V)
(iv)
Classification determined by short-lived radionuclides.
If the waste does not contain any of the radionuclides listed in clause (iii)(V)
of this subparagraph, classification shall be determined based on the concentrations
shown in subclause (VI) of this clause. However, as specified in clause (vi)
of this subparagraph, if radioactive waste does not contain any nuclides listed
in either clause (iii)(V) of this subparagraph or subclause (VI) of this clause,
it is Class A.
(I)
If the concentration does not exceed the value in Column
1 of subclause (VI) of this clause, the waste is Class A.
(II)
If the concentration exceeds the value in Column 1 of
subclause (VI) of this clause but does not exceed the value in Column 2 of
subclause (VI) of this clause, the waste is Class B.
(III)
If the concentration exceeds the value in Column 2 of
subclause (VI) of this clause but does not exceed the value in Column 3 of
subclause (VI) of this clause, the waste is Class C.
(IV)
If the concentration exceeds the value in Column 3 of
subclause (VI) of this clause, the waste is not generally acceptable for near-surface
disposal.
(V)
For wastes containing mixtures of the radionuclides listed
in subclause (VI) of this clause, the total concentration shall be determined
by the sum of fractions rule described in clause (vii) of this subparagraph.
(VI)
Classification table for short-lived radionuclides.
Figure 11: 25 TAC §289.202(ggg)(4)(A)(iv)(VI)
(v)
Classification determined by both long- and short-lived
radionuclides. If the radioactive waste contains a mixture of radionuclides,
some of which are listed in clause (iii)(V) of this subparagraph and some
of which are listed in clause (iv)(VI) of this subparagraph, classification
shall be determined as follows:
(I)
If the concentration of a radionuclide listed in clause
(iii)(V) of this subparagraph is less than 0.1 times the value listed in clause
(iii)(V) of this subparagraph, the class shall be that determined by the concentration
of radionuclides listed in clause (iv)(VI) of this subparagraph.
(II)
If the concentration of a radionuclide listed in clause
(iii)(V) of this subparagraph exceeds 0.1 times the value listed in clause
(iii)(V) of this subparagraph, but does not exceed the value listed in clause
(iii)(V) of this subparagraph, the waste shall be Class C, provided the concentration
of radionuclides listed in clause (iv)(VI) of this subparagraph does not exceed
the value shown in Column 3 of clause (iv)(VI) of this subparagraph.
(vi)
Classification of wastes with radionuclides other than
those listed in clauses (iii)(V) and (iv)(VI) of this subparagraph. If the
waste does not contain any radionuclides listed in either clauses (iii)(V)
and (iv)(VI) of this subparagraph, it is Class A.
(vii)
The sum of the fractions rule for mixtures of radionuclides.
For determining classification for waste that contains a mixture of radionuclides,
it is necessary to determine the sum of fractions by dividing each radionuclide's
concentration by the appropriate limit and adding the resulting values. The
appropriate limits must all be taken from the same column of the same table.
The sum of the fractions for the column must be less than 1.0 if the waste
class is to be determined by that column. Example: A waste contains Sr-90
in a concentration of 50 curies per cubic meter (Ci/m
3
) (1.85 terabecquerels per cubic meter (TBq/m
3
)) and Cs-137 in a concentration of 22 Ci/m
3
(814 gigabecquerels per cubic meter (GBq/m
3
)). Since the concentrations both exceed the values in Column 1 of
clause (iv)(VI) of this subparagraph, they must be compared to Column 2 values.
For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum
of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class
B.
(viii)
Determination of concentrations in wastes. The concentration
of a radionuclide may be determined by indirect methods such as use of scaling
factors, which relate the inferred concentration of one radionuclide to another
that is measured, or radionuclide material accountability, if there is reasonable
assurance that the indirect methods can be correlated with actual measurements.
The concentration of a radionuclide may be averaged over the volume of the
waste, or weight of the waste if the units are expressed as nanocurie (becquerel)
per gram.
(B)
Radioactive waste characteristics.
(i)
The following are minimum requirements for all classes
of waste and are intended to facilitate handling and provide protection of
health and safety of personnel at the disposal site.
(I)
Wastes shall be packaged in conformance with the conditions
of the license issued to the site operator to which the waste will be shipped.
Where the conditions of the site license are more restrictive than the provisions
of this section, the site license conditions shall govern.
(II)
Wastes shall not be packaged for disposal in cardboard
or fiberboard boxes.
(III)
Liquid waste shall be packaged in sufficient absorbent
material to absorb twice the volume of the liquid.
(IV)
Solid waste containing liquid shall contain as little
free-standing and non-corrosive liquid as is reasonably achievable, but in
no case shall the liquid exceed 1.0% of the volume.
(V)
Waste shall not be readily capable of detonation or of
explosive decomposition or reaction at normal pressures and temperatures,
or of explosive reaction with water.
(VI)
Waste shall not contain, or be capable of generating,
quantities of toxic gases, vapors, or fumes harmful to persons transporting,
handling, or disposing of the waste. This does not apply to radioactive gaseous
waste packaged in accordance with subclause (VIII) of this clause.
(VII)
Waste must not be pyrophoric. Pyrophoric materials contained
in wastes shall be treated, prepared, and packaged to be nonflammable.
(VIII)
Wastes in a gaseous form shall be packaged at an absolute
pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total
activity shall not exceed 100 Ci (3.7 terabecquerels (TBq)) per container.
(IX)
Wastes containing hazardous, biological, pathogenic,
or infectious material shall be treated to reduce to the maximum extent practicable
the potential hazard from the non-radiological materials.
(ii)
The following requirements are intended to provide stability
of the waste. Stability is intended to ensure that the waste does not degrade
and affect overall stability of the site through slumping, collapse, or other
failure of the disposal unit and thereby lead to water infiltration. Stability
is also a factor in limiting exposure to an inadvertent intruder, since it
provides a recognizable and nondispersible waste.
(I)
Waste shall have structural stability. A structurally
stable waste form will generally maintain its physical dimensions and its
form, under the expected disposal conditions such as weight of overburden
and compaction equipment, the presence of moisture, and microbial activity,
and internal factors such as radiation effects and chemical changes. Structural
stability can be provided by the waste form itself, processing the waste to
a stable form, or placing the waste in a disposal container or structure that
provides stability after disposal.
(II)
Notwithstanding the provisions in clause (i)(III) and
(IV)
of this subparagraph, liquid wastes, or wastes containing
liquid, shall be converted into a form that contains as little free-standing
and non-corrosive liquid as is reasonably achievable, but in no case shall
the liquid exceed 1.0% of the volume of the waste when the waste is in a disposal
container designed to ensure stability, or 0.5% of the volume of the waste
for waste processed to a stable form.
(III)
Void spaces within the waste and between the waste and
its package shall be reduced to the extent practicable.
(C)
Labeling. Each package of waste shall be clearly labeled
to identify whether it is Class A, Class B, or Class C waste, in accordance
with subparagraph (A) of this paragraph.
(5)
Time requirements for record keeping.
Figure 12: 25 TAC §289.202(ggg)(5)
(6)
Acceptable surface contamination levels.
Figure 13: 25 TAC §289.202(ggg)(6)
(7)
Concentration and activity limits of nuclides for
disposal in a Type I municipal solid waste site or a hazardous waste facility
(for use in subsection (fff) of this section).
Figure 14: 25 TAC §289.202(ggg)(7)
(8)
Soil contamination limits for selected radionuclides
(for use in subsection
(ddd)
of this section).
Figure 15: 25 TAC §289.202(ggg)(8)
(9)
The following, TRC Form 21-2, is to be used to document
cumulative occupational exposure history:
Figure 16: 25 TAC §289.202(ggg)(9)
(10)
The following, TRC Form 21-3, is to be used to document
occupational exposure record for a monitoring period:
Figure 17: 25 TAC §289.202(ggg)(10)
Filed with the Office of the Secretary of
State on January 23, 1998.
TRD-9801069
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 1, 1998
Proposal publication date: October 3, 1997
For further information, please call: (512) 458-7236
25 TAC §289.252, §289.254
The amendments are adopted under the Health and Safety Code,
Chapter 401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; and §12.001, which authorizes the
board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
§289.252. Licensing of Radioactive Material.
(a)
Purpose. This section and §289.115 of this title
(relating to Radiation Safety, Requirements and Licensing and Registration
Procedures for Industrial Radiography), §289.127 of this title (relating
to Licensing of Naturally Occurring Radioactive Material (NORM)), §289.251
of this title (relating to Exemptions, General Licenses, and General License
Acknowledgements), §289.254 of this title (relating to Licensing of Radioactive
Waste Processing and Storage Facilities), and §289.260 of this title
(relating to Licensing of Uranium Recovery and Byproduct Material Disposal
Facilities) provide for the licensing of radioactive material. Unless otherwise
exempted, no person shall receive, possess, use, transfer, own, or acquire
radioactive material except as authorized in a specific license issued in
accordance with this section, or as otherwise provided in this section, in
a specific license issued in accordance with §§289.115, 289.127,
289.254, or §289.260 of this title, or in a general license or general
license acknowledgement issued in accordance with §289.251 of this title.
(b)
Scope. In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of §289.112 of this title (relating to Hearing and Enforcement Procedures),
§289.114 of this title (relating to Notices, Instructions, and Reports
to Workers), §289.202 of this title (relating to Standards for Protection
Against Radiation), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material(s) Licenses, Emergency Planning and
Implementation, and Other Regulatory Services), and §289.257 of this
title (relating to Packaging and Transportation of Radioactive Material).
Licensees engaged in industrial radiographic operations are subject to the
requirements of §289.115 of this title; licensees using sealed sources
in the healing arts are subject to the requirements of §289.256 of this
title (relating to Use of Sealed Radioactive Sources in the Healing Arts);
and licensees engaged in well logging service operations and tracer studies
are subject to the requirements of §289.253 of this title (relating to
Radiation Safety Requirements for Well Logging Service Operations and Tracer
Studies).
(c)
(No change.)
(d)
Filing application for specific licenses.
(1)-(5)
(No change.)
(6)
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.
(7)
Each application shall be accompanied by BRC Form
252-1.
(8)
(No change.)
(9)
Notwithstanding the provisions of §289.204(e)(1)
of this title, reimbursement of application fees may be granted in the following
manner.
(A)-(B)
(No change.)
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with the Formal Hearing Procedures,
§§1.21 - 1.34 of this title (relating to the Texas Board of Health).
(e)
(No change.)
(f)
Special requirements for issuance of certain specific
licenses for radioactive material by specific groups.
(1)
(No change.)
(2)
Specific licenses for medical uses of radioactive
material.
(A)
(No change.)
(B)
Any licensee who is authorized to use one or more of the
medical use groups of radioactive material in accordance with subparagraph
(A) of this paragraph and subsection (w)(2) of this section is subject to
the following conditions.
(i)
For Groups I and II of subsection (w)(2) of this section,
no licensee shall receive, possess, or use radioactive material except as
a radiopharmaceutical manufactured in the form to be administered to the patient,
labeled, packaged, and distributed in accordance with a specific license issued
by the agency in accordance with subsection (h)(10) of this section or by
the United States Nuclear Regulatory Commission (NRC), another agreement state,
or a licensing state.
(ii)
For Group III of subsection (w)(2) of this section, no
licensee shall receive, possess, or use generators or reagent kits containing
radioactive material except those that are manufactured, labeled, packaged,
and distributed in accordance with a specific license issued by the agency
in accordance with subsection (h)(11) of this section or a specific license
issued by the NRC, an agreement state, or a licensing state in accordance
with equivalent regulations.
(iii)
For Group III of subsection (w)(2) of this section,
any licensee who uses generators or reagent kits shall:
(I)
elute the generator or process radioactive material with
the reagent kit in accordance with instructions that are approved by the agency,
the NRC, an agreement state, or a licensing state, and furnished by the manufacturer
on the label attached to or in the leaflet or brochure that accompanies the
generator or reagent kit;
(II)
(No change.)
(III)
prohibit the administration to patients of technetium-99m
containing more than 0.15 microcurie (µCi) of molybdenum-99 per millicurie
(mCi) of technetium-99m; and
(IV)
(No change.)
(C)
(No change.)
(D)
Any licensee who is licensed in accordance with subparagraph
(A) of this paragraph for one or more of the medical use groups in subsection
(w)(2) of this section is also authorized, subject to the provisions of this
subparagraph and subparagraph (E) of this paragraph, to receive, possess,
and use for calibration and reference standards:
(i)
any radioactive material listed in Group I, II, or III
of subsection (w)(2) of this section with a half-life not longer than 100
days, in amounts not to exceed 15 mCi total;
(ii)
any radioactive material listed in Group I, II, or III
of subsection (w)(2) of this section with half-life greater than 100 days
in amounts not to exceed 200 µCi total;
(iii)
technetium-99m in amounts as required for calibration
and testing of laboratory instruments; and
(iv)
any radioactive material, in amounts not to exceed 6
mCi per source, contained in calibration or reference sources that have been
manufactured, labeled, packaged, and distributed in accordance with a specific
license issued by the agency in accordance with subsection (h)(7) of this
section, a specific license issued by the NRC in accordance with 10 Code of
Federal Regulations (CFR) 32.74, or a specific license issued to the manufacturer
by an agreement state or a licensing state in accordance with equivalent regulations.
(E)
Any licensee who possesses and uses calibration and reference
sources in accordance with subparagraph (D)(iv) of this paragraph shall:
(i)
follow the radiation safety and handling instructions
approved by the agency, the NRC, an agreement state, or a licensing state,
and furnished by the manufacturer on the label attached to the source, or
permanent container thereof, or in the leaflet or brochure that accompanies
the source, and maintain such instruction in a legible and conveniently available
form; and
(ii)
conduct a physical inventory at intervals not to exceed
six months to account for all sources received and possessed. Records of the
inventories shall be maintained for inspection by the agency and shall include
the quantities and kinds of radioactive material, source identification numbers,
location of sources, the date of the inventory, and the identification of
the individual(s) making the record.
(F)-(G)
(No change.)
(H)
Any licensee who processes and prepares radiopharmaceuticals
for human use shall do so according to:
(i)
instructions that are approved by the agency, the NRC,
an agreement state, or a licensing state that are furnished by the manufacturer
on the label attached to or in the FDA-accepted instructions in the leaflet
or brochure that accompanies the generator or reagent kit;
(ii)-(iii)
(No change.)
(I)
If the authorized nuclear pharmacist elutes generators
or processes radioactive material with the reagent kit in a manner that deviates
from instructions furnished by the manufacturer on the label attached to or
in the leaflet or brochure that accompanies the generator or reagent kit or
in the accompanying leaflet or brochure, a complete description of the deviation
shall be made and maintained for inspection by the agency for a period of
three years.
(3)
Release of patients containing radiopharmaceuticals,
temporary implants, or permanent implants.
(A)
Any individual to whom more than 30 mCi of a radiopharmaceutical
is administered shall be confined to an agency-approved inpatient facility
and shall not be released from confinement until the activity of the administered
radiopharmaceutical in the patient is less than 30 mCi, or until the measured
dose rate from the patient is less than five millirems per hour (mrem/hr)
at a distance of one meter (m).
(B)
(No change.)
(C)
Any individual containing permanent implant sources shall
remain hospitalized and shall not be released from confinement until the exposure
rate from the patient is less than 5 milliroentgens per hour at a distance
of 1 m from the implant location.
(4)-(6)
(No change.)
(g)
(No change.)
(h)
Special requirements for a specific license to manufacture,
assemble, repair, or commercially distribute commodities, products, or devices
that contain radioactive material.
(1)
(No change.)
(2)
Commercial distribution of radioactive material in
exempt quantities.
(A)-(B)
(No change.)
(C)
The license issued in accordance with subparagraph (B)
of this paragraph is subject to the following conditions.
(i)
(No change.)
(ii)
Each exempt quantity shall be separately and individually
packaged. No more than ten such packaged exempt quantities shall be contained
in any other package for commercial distribution to persons exempt from this
chapter in accordance with §289.251(d)(2) of this title. The outer package
shall be such that the dose rate at the external surface of the package does
not exceed 0.5 mrem/hr.
(iii)-(iv)
(No change.)
(D)
(No change.)
(3)
Incorporation of naturally occurring or accelerator-produced
radioactive material (NARM) into gas and aerosol detectors. In addition to
the requirements set forth in subsection (e) of this section, an application
for a specific license authorizing the incorporation of NARM into gas and
aerosol detectors to be distributed to persons exempt from this chapter in
accordance with §289.251(d)(3)(C) of this title will be approved if the
application satisfies requirements equivalent to those contained in 10 CFR
32.26. The maximum quantity of radium-226 in each device shall not exceed
0.1 µCi.
(4)
Licensing the manufacture and commercial distribution
of devices to persons generally licensed in accordance with §289.251(j)(1)
of this title.
(A)
An application for a specific license to manufacture or
commercially distribute devices containing radioactive material to persons
generally licensed in accordance with §289.251(g)(1)(C) and (j)(1) of
this title or equivalent regulations of the NRC, an agreement state, or a
licensing state will be approved if:
(i)
(No change.)
(ii)
the applicant submits sufficient information relating
to the design, manufacture, prototype testing, quality control, labels, proposed
uses, installation, servicing, leak testing, operating and safety instructions,
and potential hazards of the device to provide reasonable assurance that:
(I)
(No change.)
(II)
under ordinary conditions of handling, storage, and use
of the device, the radioactive material contained in the device will not be
released or inadvertently removed from the device, and it is unlikely that
any person will receive in any period of one year a dose in excess of 10%
of the limits specified in §289.202(f) of this title; and
(III)
under accident conditions (such as fire and explosion)
associated with handling, storage, and use of the device, it is unlikely that
any person would receive an external radiation dose or dose commitment in
excess of the following organ doses:
(-a-)
(No change.)
(-b-)
200 rems to the hands and forearms; feet and ankles;
localized areas of skin averaged over areas no larger than one square centimeter
(cm
2
);
(-c-)
(No change.)
(iii)
each device bears a durable, legible, clearly visible
label or labels approved by the agency, which contain in a clearly identified
and separate statement:
(I)-(II)
(No change.)
(III)
the information called for in one of the following statements,
as appropriate, in the same or substantially similar form:
(-a-)
For radioactive materials other than NARM, the following
statement is appropriate:
Figure 1: 25 TAC §289.252(h)(4)(A)(iii)(III)(-a-)
(-b-)-(-c-)
(No change.)
(B)
In the event the applicant desires that the device be
required to be tested at intervals longer than six months, either for proper
operation of the "on-off" mechanism and indicator, if any, or for leakage
of radioactive material or for both, the applicant shall include in the application
sufficient information to demonstrate that such longer interval is justified
by performance characteristics of the device or similar devices and by design
features that have a significant bearing on the probability or consequences
of radioactive material leakage from the device or failure of the "on-off"
mechanism and indicator. In determining the acceptable interval for the test
for radioactive material leakage, the agency will consider information that
includes, but is not limited to:
(i)-(x)
(No change.)
(C)
In the event the applicant desires that the general licensee
in accordance with §289.251(g)(1)(C) and (j)(1) of this title or in accordance
with equivalent regulations of the NRC, an agreement state, or a licensing
state be authorized to mount the device, collect the sample to be analyzed
by a specific licensee for radioactive material leakage, perform maintenance
of the device consisting of replacement of labels, rust and corrosion prevention,
and for fixed gauges, repair and maintenance of source holder mounting brackets,
test the "on-off" mechanism and indicator, or remove the device from installation,
the applicant shall include in the application written instructions to be
followed by the general licensee, estimated annual doses associated with such
activity or activities, and bases for such estimates. The submitted information
shall demonstrate that performance of such activity or activities by an individual
untrained in radiological protection, in addition to other handling, storage,
and use of devices in accordance with the general license, is unlikely to
cause that individual to receive an annual dose in excess of 10% of the limits
specified in §289.202(f) of this title.
(D)
Each person licensed in accordance with this subparagraph
to commercially distribute devices to generally licensed persons shall:
(i)
(No change.)
(ii)
furnish a copy of the general license in the NRC's, agreement
state's, or licensing state's regulation equivalent to §289.251(g)(1)(C)
and (j)(1) of this title, or alternatively, furnish a copy of the general
license in §289.251(g)(1)(C) and (j)(1) of this title to each person
to whom the licensee directly or through an intermediate person commercially
distributes radioactive material in a device for use in accordance with the
general license of the NRC, the agreement state, or the licensing state. If
a copy of the general license in §289.251(g)(1)(C) and (j)(1) of this
title is furnished to such a person, it shall be accompanied by an explanation
that the use of the device is regulated by the NRC, agreement state, or licensing
state in accordance with requirements substantially the same as those in §289.251(g)(1)(C)
and (j)(1) of this title;
(iii)
(No change.)
(iv)
report to the NRC all commercial distributions of such
devices to persons for use in accordance with the NRC general license in 10
CFR 31.5;
(v)-(vi)
(No change.)
(vii)
report to the NRC information indicating no commercial
distributions have been made to the NRC licensees during the reporting period
if no such commercial distributions have been made; and
(viii)
keep records showing the name, address, and the point
of contact for each general licensee to whom the licensee directly or through
an intermediate person commercially distributes radioactive material in devices
for use in accordance with the general license provided in §289.251(g)(1)(C)
and (j)(1) of this title, or equivalent regulations of the NRC, an agreement
state, or a licensing state. The records should show the date of each commercial
distribution, the isotope and the quantity of radioactivity in each device
commercially distributed, the identity of any intermediate person, and compliance
with the reporting requirements of this subparagraph.
(5)-(6)
(No change.)
(7)
Manufacture and commercial distribution of sources
or devices containing radioactive material for medical use. An application
for a specific license to manufacture and commercially distribute sources
and devices containing radioactive material to persons licensed for use of
sealed sources in the healing arts or in accordance with subsection (f)(2)
of this section for use as a calibration or reference source will be approved
if:
(A)-(B)
(No change.)
(C)
the label affixed to the source or device, or to the permanent
storage container for the source or device, contains information on the radionuclide,
quantity, and date of assay, and a statement that the name of the source or
device is licensed by the agency for commercial distribution to persons licensed
for use of sealed sources in the healing arts or in accordance with subsection
(f)(2) of this section or equivalent licenses of the NRC, an agreement state,
or a licensing state, provided that such labeling for sources that do not
require long-term storage may be on a leaflet or brochure that accompanies
the source;
(D)-(E)
(No change.)
(8)
Manufacture and commercial distribution of radioactive
material for certain
in vitro
clinical or
laboratory testing in accordance with the general license. An application
for a specific license to manufacture or commercially distribute radioactive
material for use in accordance with the general license in §289.251(j)(2)
of this title will be approved if:
(A)
(No change.)
(B)
the radioactive material is to be prepared for distribution
in prepackaged units of:
(i)
iodine-125 in units not exceeding 10 µCi each;
(ii)
iodine-131 in units not exceeding 10 µCi each;
(iii)
carbon-14 in units not exceeding 10 µCi each;
(iv)
hydrogen-3 (tritium) in units not exceeding 50 µCi
each;
(v)
iron-59 in units not exceeding 20 µCi each;
(vi)
cobalt-57 in units not exceeding 10 µCi each;
(vii)
selenium-75 in units not exceeding 10 µCi each;
or
(viii)
mock iodine-125 in units not exceeding 0.05 µCi
of iodine-129 and 0.005 µCi of americium-241 each;
(C)
each prepackaged unit bears a durable, clearly visible
label:
(i)
identifying the radioactive contents as to chemical form
and radionuclide, and indicating that the amount of radioactivity does not
exceed 10 µCi of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75;
50 µCi of hydrogen-3 (tritium); 20 µCi of iron-59; or mock iodine-125
in units not exceeding 0.05 µCi of iodine-129 and 0.005 µCi of
americium-241; and
(ii)
displaying the radiation caution symbol in accordance
with §289.202(ee)(1) and (ee)(2) of this title and the words, "CAUTION,
RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or
Animals";
(D)
one of the following statements, as appropriate, or a
substantially similar statement that contains the information called for in
one of the following statements, appears on a label affixed to each prepackaged
unit or appears in a leaflet or brochure that accompanies the package:
(i)
option 1:
Figure 3: 25 TAC §289.252(h)(8)(D)(i)
(ii)
(No change.)
(E)
the label affixed to the unit, or the leaflet or brochure
that accompanies the package, contains adequate information as to the precautions
to be observed in handling and storing such radioactive material. In the case
of a mock iodine-125 reference or calibration source, the information accompanying
the source must also contain directions to the licensee regarding the waste
disposal requirements of §289.202(ff)of this title.
(9)-(10)
(No change.)
(11)
Manufacture and commercial distribution of generators
or reagent kits for preparation of radiopharmaceuticals containing radioactive
material.
(A)
An application for a specific license to manufacture and
commercially distribute generators or reagent kits containing radioactive
material for preparation of radiopharmaceuticals by persons licensed in accordance
with subsection (f)(2) of this section for the medical uses listed in Group
III defined in subsection (w)(2) of this section will be approved if:
(i)-(iv)
(No change.)
(v)
the label affixed to the generator or reagent kit, or
the leaflet or brochure that accompanies the generator or reagent kit contains:
(I)
(No change.)
(II)
a statement that this generator or reagent kit (as appropriate)
is approved for use by persons licensed by the agency in accordance with
subsection (f)(2) of this section and for the medical uses listed in Group
III defined in subsection (w)(2) of this section or in accordance with equivalent
licenses of the NRC, an agreement state, or a licensing state.
(B)
(No change.)
(12)
Manufacture and commercial distribution of
products containing depleted uranium for mass-volume applications.
(A)
An application for a specific license to manufacture products
and devices containing depleted uranium for use in accordance with §289.251(f)(5)
of this title or equivalent regulations of the NRC or an agreement state,
will be approved if:
(i)
(No change.)
(ii)
the applicant submits sufficient information relating
to the design, manufacture, prototype testing, quality control procedures,
labeling or marking, proposed uses, and potential hazards of the product
or device to provide reasonable assurance that possession, use, or commercial
distribution of the depleted uranium in the product or device is not likely
to cause any individual to receive in any period of one year a radiation
dose in excess of 10% of the limits specified in §289.202(f) of this
title; and
(iii)
(No change.)
(B)-(C)
(No change.)
(D)
Each person licensed in accordance with subparagraph (A)
of this paragraph shall:
(i)
(No change.)
(ii)
label or mark each unit to:
(I)
(No change.)
(II)
state that the receipt, possession, use, and commercial
distribution of the product or device are subject to a general license or
the equivalent and the regulations of the NRC or of an agreement state;
(iii)
(No change.)
(iv)
furnish a copy of the general license in:
(I)
(No change.)
(II)
the NRC's or agreement state's regulation equivalent
to the general license in §289.251(f)(5) of this title and a copy of
the NRC's or agreement state's certificate, or alternatively, furnish a copy
of the general license in §289.251(f)(5) of this title to each person
to whom the licensee commercially distributes depleted uranium in a product
or device for use in accordance with the general license of the NRC or an
agreement state;
(v)
(No change.)
(vi)
report to the NRC and each responsible agreement state
agency all commercial distributions of industrial products or devices to persons
for use in accordance with the general license in the NRC's or agreement state's
equivalent rule to §289.251(f)(5) of this title. Such report shall meet
the provisions of clause (v) of this subparagraph; and
(vii)
keep records showing the name, address, and point of
contact for each general licensee to whom the licensee commercially distributes
depleted uranium in products or devices for use in accordance with the general
license provided in §289.251(f)(5) of this title or equivalent regulations
of the NRC or of an agreement state. The records shall be maintained for a
period of two years and shall show the date of each commercial distribution,
the quantity of depleted uranium in each product or device commercially distributed,
and compliance with the report requirements of this section.
(13)-(14)
(No change.)
(i)
Sealed source or device evaluation. No sealed source or
device containing radioactive material shall be authorized on a specific license
or general license until radiation safety information for that sealed source
or device has been evaluated by the agency, the NRC, another agreement state,
or a licensing state.
(1)-(6)
(No change.)
(j)
Issuance of specific licenses.
(1)
Upon a determination that an application meets the requirements
of the Texas Radiation Control Act (Act) and the rules of the agency, the
agency will issue a specific license authorizing the proposed activity in
such form and containing such conditions and limitations as it deems appropriate
or necessary.
(2)
(No change.)
(k)
(No change.)
(l)
Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.
(1)-(3)
(No change.)
(4)
If a licensee does not submit an application for
license renewal in accordance with subsection (m) of this section, the licensee
shall on or before the expiration date specified in the license:
(A)-(B)
(No change.)
(C)
submit a record of disposal of radioactive material and
radiation survey(s) of the licensee's permanent location(s) of use and/or
storage. Levels of radiation shall be reported in units as required by §289.202(ddd)
and (eee) of this title. The survey or measurement instrument(s) used for
conducting the survey shall be specified; and
(D)
pay any outstanding fees in accordance with §289.204
of this title and resolve any outstanding notices of violations of this chapter
or of license conditions.
(5)
(No change.)
(6)
If radiation levels or radioactive material in excess
of the limits of §289.202(ddd) and/or (eee) of this title are found,
the license continues in effect beyond the expiration date, if necessary,
with respect to possession of residual radioactive material until the agency
notifies the licensee in writing that the license is terminated. During this
time, the licensee is subject to the provisions of paragraph (13) of this
subsection. In addition to the information submitted in accordance with paragraph
(4)(C) of this subsection, the licensee shall submit a plan, if appropriate,
for decontaminating the location(s).
(7)
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(ddd) and/or (eee)
of this title, or submit within 12 months of notification a decommissioning
plan, if required by paragraph (10) of this subsection, and begin decommissioning
upon approval of that plan:
(A)
the license has expired in accordance with subsection
(l) of this section or subsection (q)(3) of this section; or
(B)
the licensee has decided to permanently cease principal
activities, as defined in §289.201(b)(70) of this title, at the entire
site or in any separate building or outdoor area; or
(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(ddd) and/or (eee) of this title.
(8)
Coincident with the notification required by
paragraph (7) of this subsection, the licensee shall maintain in effect all
decommissioning financial assurances established by the licensee in accordance
with subsection (u) of this section in conjunction with a license issuance
or renewal or as required by this section. The amount of the financial assurance
must be increased, or may be decreased, as appropriate, to cover the detailed
cost estimate for decommissioning established in accordance with paragraph
(13)(D) 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 (the effective date of this section).
(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.
(9)
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 public health and safety and is otherwise
in the public interest. The request must be submitted no later than 30 days
before notification in accordance with paragraph (7) of this subsection. The
schedule for decommissioning set forth in paragraph (7) of this subsection
may not commence until the agency has made a determination on the request.
(10)
A decommissioning plan 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:
(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.
(11)
The agency may approve an alternate schedule
for submittal of a decommissioning plan required in accordance with paragraph
(7) 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 public health and safety and is otherwise
in the public interest.
(12)
The procedures listed in paragraph (10) of this
subsection may not be carried out prior to approval of the decommissioning
plan.
(13)
The proposed decommissioning plan for the site or
separate building or outdoor area must 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 (15) of this subsection.
(14)
The proposed decommissioning plan will be approved
by the agency if the information therein 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.
(15)
Except as provided in paragraph (17) 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.
(16)
Except as provided in paragraph (17) 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.
(17)
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 which the agency may consider
appropriate on a case-by-case basis, such as the regulatory requirements of
other government agencies, lawsuits, ground-water 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.
(18)
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 some other manner. The licensee shall do the following, as appropriate:
(i)
report levels of gamma radiation in units of millisieverts
per hour (mSv/hr) (microroentgen per hour (µR/hr)) at 1 m 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
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
(ii)
specify the make and model number of survey instrument(s)
used and certify that each instrument is properly calibrated and tested.
(19)
Specific licenses, including expired licenses,
will be terminated by written notice to the licensee 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; and
(C)
a radiation survey has been performed which demonstrates
that the premises are suitable for release in accordance with §289.202(ddd)
and/or (eee) of this title or other information submitted by the licensee
is sufficient to demonstrate that the premises are suitable for release in
accordance with §289.202 (ddd) and/or (eee) of this title.
(20)
If the licensee does not submit an application
for license renewal in accordance with subsection (m) of this section, in
addition to the information required in accordance with paragraph (4)(C) of
this subsection, the licensee shall submit a plan for completion of decommissioning
if the procedures necessary to carry out decommissioning have not been previously
approved by the agency and 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.
(21)
Procedures with potential health and safety
impacts may not be carried out prior to approval of the decommissioning plan
by the agency.
(22)
The proposed decommissioning plan, if required by
paragraph (20) of this subsection or by license condition, must include:
(A)
a description of planned decommissioning activities;
(B)
a description of methods used to assure protection of
workers and the environment against radiation hazards during decommissioning;
(C)
a description of the planned final radiation survey; and
(D)
an updated, detailed cost estimate for decommissioning,
comparison of that estimate with present funds set aside for decommissioning,
and plan for assuring the availability of adequate funds for completion of
decommissioning.
(23)
The proposed decommissioning plan will be approved
by the agency if the information therein demonstrates that the decommissioning
will be completed as soon as is reasonable and that the health and safety
of workers and the public will be adequately protected.
(24)
Upon approval of the decommissioning plan by the
agency, the licensee shall complete decommissioning in accordance with the
approved plan. As a final step in decommissioning, the licensee shall again
submit the information required in paragraph (4)(C) of this subsection.
(25)
If the information submitted in accordance with
paragraphs (4)(C) or (24) of this subsection does not adequately demonstrate
that the premises are suitable for release for unrestricted use, the agency
will inform the license of the appropriate further actions required for termination
of license.
(26)
Each licensee who possesses residual radioactive
material in accordance with paragraph (6) of this subsection, following the
expiration date specified in the license, shall:
(A)
be limited to actions, involving radioactive material,
related to preparing the location(s) for release for unrestricted use; and
(B)
continue to control entry to restricted areas until the
location(s) are suitable for release for unrestricted use and the agency notifies
the licensee in writing that the license is terminated.
(27)
Each licensee shall submit to the agency all
records required by §289.202(nn)(2) of this title before the license
is terminated.
(m)
Renewal of license.
(1)
(No change.)
(2)
In any case in which a licensee, not less than 30
days prior to expiration of an 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 request has been finally determined
by the agency. In any case in which a licensee, not more than 90 days after
the expiration of an existing license, has filed a request in proper form
for renewal or for a new license authorizing the same activities, the agency
may reinstate the license and extend the expiration until the request has
been finally determined by the agency.
(n)-(o)
(No change.)
(p)
Transfer of material.
(1)
(No change.)
(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 the terms of a general license or its equivalent, or a specific license
or equivalent licensing document, issued by the agency, the NRC, any agreement
state, or any licensing state, or to any person otherwise authorized to receive
such material by the Federal government or any agency thereof, the agency,
any agreement state, or any licensing state; or
(E)
(No change.)
(3)
Before transferring radioactive material to
a specific licensee of the agency, the NRC, an agreement state, or a licensing
state, or to a general licensee who is required to register with the agency,
the NRC, an agreement state, or a licensing state prior to receipt of the
radioactive material, the licensee transferring the material shall verify
that the transferee's license authorizes the receipt of the type, form, and
quantity of radioactive material to be transferred.
(4)
The following methods for the verification required
by paragraph (3) of this subsection are acceptable.
(A)-(C)
(No change.)
(D)
The transferor may obtain other sources of information
compiled by a reporting service from official records of the agency, the NRC,
or the licensing agency of an agreement state or a licensing state as to the
identity of licensees and the scope and expiration dates of licenses and registrations.
(E)
When none of the methods of verification described in
subparagraphs (A)-(D) of this paragraph are readily available or when a transferor
desires to verify that information received by one of such methods is correct
or up-to-date, the transferor may obtain and record confirmation from the
agency, the NRC, or the licensing agency of an agreement state or a licensing
state that the transferee is licensed to receive the radioactive material.
(5)
(No change.)
(q)
Modification and revocation of licenses.
(1)
(No change.)
(2)
Any license may be revoked, suspended, or modified,
in whole or in part, for any material false statement in the application or
any statement of fact required in accordance with 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 grant a license on an original application, or for violation
of, or failure to observe applicable terms and conditions of the Act, this
chapter, or of the license, or order of the agency.
(3)
Each specific license revoked by the agency expires
at the end of the day on the date of the agency's final determination to revoke
the license, or on the expiration date stated in the determination, or as
otherwise provided by the agency order.
(4)
Except in cases of willfulness or those in which
the 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
accorded an opportunity to demonstrate or achieve compliance with all lawful
requirements.
(r)
Notification of incidents.
(1)
Immediate report. Each licensee shall notify the agency
as soon as possible but not later than four hours after the discovery of an
event that prevents immediate protective actions necessary to avoid exposures
to radioactive materials that could exceed regulatory limits or releases of
radioactive materials that could exceed regulatory limits (events may include
fires, explosions, toxic gas releases, etc.).
(2)
Twenty-four hour report. Each licensee shall notify
the agency within 24 hours after the discovery of any of the following events
involving radioactive material:
(A)
an unplanned contamination event that:
(i)
(No change.)
(ii)
involves a quantity of material greater than five times
the lowest annual limit on intake specified in §289.202(ggg)(2) of this
title for the material; and
(iii)
(No change.)
(B)-(C)
(No change.)
(D)
an unplanned fire or explosion damaging any radioactive
material or any device, container, or equipment containing radioactive material
when:
(i)
the quantity of material involved is greater than five
times the lowest annual limit on intake specified in §289.202(ggg)(2)
of this title for the material; and
(ii)
(No change.)
(3)
(No change.)
(s)
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 hereby 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)-(v)
(No change.)
(vi)
an annual fee as specified in §289.204(e)(7) of
this title.
(C)-(D)
(No change.)
(E)
the out-of-state licensee shall not transfer or dispose
of radioactive material possessed or used in accordance with the general license
provided in this section except by transfer to a person:
(i)
specifically licensed by the agency, the NRC, another
agreement state, or another licensing state to receive such material, or
(ii)
(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 a device described in §289.251
(g)(1)(C) and (j)(1) of this title, within areas subject to the jurisdiction
of the licensing body, is hereby granted a general license to install, transfer,
demonstrate, or service such a device in the state of Texas provided that:
(A)-(D)
(No change.)
(3)
(No change.)
(t)
Preparation of radioactive material for transport. Requirements
for the preparation of radioactive material for transport are specified in
§289.257 of this title.
(u)
Financial assurance and record keeping for decommissioning.
(1)
(No change.)
(2)
The applicant for each specific license authorizing
possession and use of radioactive material of half-life greater than 120 days
and in quantities specified in paragraph (4) of this subsection shall either:
(A)
(No change.)
(B)
submit a certification that financial assurance for decommissioning
has been provided in the amount in accordance with paragraph (4) of this subsection
using one of the methods described in paragraph (6) of this subsection. For
an applicant, 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 (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
(6) of this subsection is to be submitted to the agency.
(3)-(4)
(No change.)
(5)
Each decommissioning funding plan must contain a
cost estimate for decommissioning and a description of the method of assuring
funds for decommissioning from paragraph (6) of this subsection, including
means of adjusting cost estimates and associated funding levels periodically
over the life of the facility. The decommissioning funding plan shall also
contain a certification by the licensee that financial assurance for decommissioning
has been provided in the amount of the cost estimate for decommissioning and
a signed original of the financial instrument obtained to satisfy the requirements
of paragraph (6) of this subsection.
(6)
Financial assurance for decommissioning must be provided
by one or more of the following methods.
(A)
(No change.)
(B)
A surety method, insurance, or other guarantee method.
These methods guarantee that decommissioning costs will be paid. A surety
method may be in the form of a surety bond, letter of credit, or line of credit.
A parent company guarantee of funds for decommissioning costs based on a financial
test may be used if the guarantee and test are as contained in subsection
(w)(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.
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 (w)(7) 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 must contain the following conditions.
(i)
The surety method or insurance must be open-ended or,
if written for a specified term, such as five years, must 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 must 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)-(iii)
(No change.)
(C)-(D)
(No change.)
(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:
(A)
(No change.)
(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 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 outside of restricted areas that require documentation
under subparagraph (A) of this paragraph; and
(ii)
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.
(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.
(v)
Emergency plan for responding to a release.
(1)
A new or renewal application for each specific license
to possess radioactive materials in unsealed form, on foils or plated sources,
or sealed in glass in excess of the quantities in subsection (w)(4) of this
section must contain either:
(A)-(B)
(No change.)
(2)-(4)
(No change.)
(w)
Appendices.
(1)-(2)
(No change.)
(3)
Criteria relating to use of financial tests and parent
company guarantees for providing reasonable assurance of funds for decommissioning.
(A)
(No change.)
(B)
Financial test.
(i)
To pass the financial test, the parent company must meet
the criteria of either subclause (I) or (II) of this clause.
(I)
The parent company must have:
(-a-)-(-c)
(No change.)
(-d-)
assets located in the United States amounting to
at least 90% of total assets or at least six times the current decommissioning
cost estimates (or prescribed amount if a certification is used.)
(II)
The parent company must have:
(-a-)-(-c-)
(No change.)
(-d-)
assets located in the United States amounting to
at least 90% of total assets or at least six times the current decommissioning
cost estimates (or prescribed amount if certification is used).
(ii)-(iv)
(No change.)
(C)
(No change.)
(4)
Quantities of radioactive materials requiring
consideration of the need for an emergency plan for responding to a release.
Figure 5: 25 TAC §289.252(w)(4)
(5)
Acceptable training and experience for medical uses
of radioactive material.
(A)
Training for uptake, dilution, and excretion studies.
(i)
The licensee shall require the authorized user of a radiopharmaceutical
listed in Group I of subsection (w)(2) of this section, to be a physician
who:
(I)
(No change.)
(II)
has successfully completed classroom and laboratory training
in basic radioisotope handling techniques applicable to the use of prepared
radiopharmaceuticals and supervised clinical experience as follows:
(-a-)-(-b-)
(No change.)
(-c-)
has successfully completed a six-month training
program in nuclear medicine as part of a residency program that has been accredited
by the Accreditation Council for Graduate Medical Education (ACGME) or the
Council on Postdoctoral Training of the American Osteopathic Association (COPT-AOA)
and that included classroom and laboratory training, work experience, and
supervised clinical experience in all the topics identified in this subclause.
(ii)-(iii)
(No change.)
(B)
Training for imaging and localization studies.
(i)
The licensee shall require the authorized user of a radiopharmaceutical,
generator, or reagent kit listed in Groups II and III of paragraph (2)(B)
and (C) of this subsection, to be a physician who:
(I)
(No change.)
(II)
has successfully completed classroom and laboratory training
in basic radioisotope handling techniques applicable to the use of prepared
radiopharmaceuticals, generators, and reagent kits, supervised work experience,
and supervised clinical experience as follows:
(-a-)-(-c-)
(No change.)
(-d-)
has successfully completed a six-month training
program in nuclear medicine as part of a residency program that has been accredited
by the ACGME or the COPT-AOA and that included classroom and laboratory training,
work experience, and supervised clinical experience in all the topics identified
in this subclause.
(ii)
(No change.)
(iii)
Classroom and laboratory training identified in clause
(i)(II)(-a-) of this subparagraph that was initiated before October 1, 1995,
and completed by October 1,
1997, will be accepted if it is obtained in an accredited medical school,
a federal teaching hospital,
or a training program for medical use of radioactive material that has been
accepted by the agency,
NRC, or another agreement state.
(iv)
(No change.)
(C)
Training for the therapeutic use of radiopharmaceuticals.
(i)
The licensee shall require the authorized user of radiopharmaceuticals
for therapeutic use to be a physician who:
(I)
(No change.)
(II)
has classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of therapeutic radiopharmaceuticals
and supervised clinical experience as follows:
(-a-)
(No change.)
(-b-)
supervised clinical experience under the supervision
of an authorized physician user for the type of therapy authorization requested
from the following list:
(-1-)-(-6-)
(No change.)
(-7-)
has successfully completed a six-month training program
in nuclear medicine as part of a residency program that has been accredited
by the ACGME or the COPT-AOA and that included classroom and laboratory training,
work experience and supervised clinical experience in all the topics identified
in this subclause.
(ii)
(No change.)
(D)
Training for use of brachytherapy sources (except for
beta applicators - See subparagraph (E) of this paragraph).
(i)
The licensee shall require the authorized user of a brachytherapy
source to be a physician who:
(I)
(No change.)
(II)
is in the active practice of therapeutic radiology, has
had classroom training in radioisotope handling techniques applicable to the
therapeutic use of brachytherapy sources, and supervised clinical experience
as follows:
(-a-)-(-c-)
(No change.)
(ii)
(No change.)
(E)
(No change.)
(F)
Training for use of sealed sources for diagnosis.
(i)
The licensee shall require the authorized user of a sealed
source in the devices listed in clause (ii) of this subparagraph, to be a
physician, dentist, or podiatrist who:
(I)
(No change.)
(II)
has had eight hours of classroom and laboratory training
in radioisotope handling techniques specifically applicable to the use of
the device that includes:
(-a-)-(-d-)
(No change.)
(ii)-(iii)
(No change.)
(G)
Training for teletherapy.
(i)
The licensee shall require the authorized user of a sealed
source in a teletherapy unit to be a physician who:
(I)
(No change.)
(II)
is in the active practice of therapeutic radiology, and
has had classroom and laboratory training in basic radioisotope techniques
applicable to the use of a sealed source in a teletherapy unit, supervised
work experience, and supervised clinical experience as follows:
(-a-)-(-c-)
(No change.)
(ii)
(No change.)
(H)
Training for experienced authorized users. Physicians,
dentists, or podiatrists identified as authorized users for the medical, dental,
or podiatric use of radioactive material on a NRC or agreement state license
issued before September 1, 1993, and those issued by the agency before October
1, 1995, who perform only those methods of use for which they were authorized
on that date need not comply with the training requirements in this paragraph.
(I)
Recentness of training.
(i)-(ii)
(No change.)
(6)
(No change.)
(7)
Criteria relating to use of financial tests and self
guarantees for providing reasonable assurance of funds for decommissioning.
(A)
Introduction. An applicant or licensee may provide reasonable
assurance of the availability of funds for decommissioning based on furnishing
its own guarantee that funds will be available for decommissioning costs and
on a demonstration that the company passes a financial test of subparagraph
(B) of this paragraph. Subparagraph (B) of this paragraph establishes criteria
for passing the financial test for the self guarantee and establishes the
terms for a self guarantee.
(B)
Financial test.
(i)
To pass the financial test, a company must meet all of
the following criteria:
(I)
tangible net worth at least ten times the total current
decommissioning cost estimate (or the current amount required if certification
is used for all decommissioning activities for which the company is responsible
as self guaranteeing licensee and as parent-guarantor);
(II)
assets located in the United States amounting to at least
90% of total assets or at least ten times the total current decommissioning
cost estimate (or the current amount required if certification is used for
all decommissioning activities for which the company is responsible as self-guaranteeing
licensee and as parent-guarantor); and
(III)
a current rating for its most recent bond issuance of
AAA, AA, A as issued by Standard and Poor's, or Aaa, Aa, A as issued by Moody's.
(ii)
To pass the financial test, a company must meet all of
the following additional requirements:
(I)
the company must have at least one class of equity securities
registered under the Securities Exchange Act of 1934.
(II)
the company's independent certified public accountant
must have compared the data used by the company in the financial test which
is derived from the independently audited, year-end financial statements for
the latest fiscal year, with the amounts in such financial statement. In connection
with that procedure, the licensee shall inform the agency within 90 days of
any matters coming to the auditor's attention that 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; and
(III)
after the initial financial test, the company must repeat
the passage of the test within 90 days after the close of each succeeding
fiscal year.
(iii)
If the licensee no longer meets the requirements of
clause (i) of this subparagraph, the licensee must send immediate notice to
the agency of its intent to establish alternate financial assurance as specified
in the NRC's regulations within 120 days of such notice.
(C)
Company self guarantee. The terms of a self guarantee
which an applicant or licensee furnishes must provide that:
(i)
the company guarantee will remain in force unless the
licensee sends notice of cancellation by certified mail to the agency. Cancellation
may not occur, however, during the 120 days beginning on the date of receipt
of the notice of cancellation by the agency, as evidenced by the return receipt;
(ii)
the licensee shall provide alternate financial assurance
as specified in the agency's regulations within 90 days following receipt
by the agency of a notice of cancellation of the guarantee;
(iii)
the guarantee and financial test provisions must remain
in effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the licensee;
(iv)
the licensee will promptly forward to the agency and
the licensee's independent auditor all reports covering the latest fiscal
year filed by the licensee with the Securities and Exchange Commission in
accordance with the requirements of the Securities and Exchange Act of 1934,
§13;
(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 or Moody's, the licensee will provide notice in writing of such fact
to the agency within 20 days after publication of the change by the rating
service. If the licensee's most recent bond issuance ceases to be rated in
any category of A or above by both Standard and Poor's and Moody's, the licensee
no longer meets the requirements of subparagraph (B)(i) of this paragraph;
and
(vi)
the applicant or licensee must provide to the agency
a written guarantee (a written commitment by a corporate officer) which states
that the licensee will fund and carry out the required decommissioning activities
or, upon issuance of an order by the agency, the licensee will set up and
fund a trust in the amount of the current cost estimates for decommissioning.
§289.254. Licensing of Radioactive Waste Processing And Storage Facilities.
(a)
Purpose and scope.
(1)
(No change.)
(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
of §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), §289.202 of this title (relating to Standards for Protection
Against Radiation), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material(s) Licenses, Emergency Planning and
Implementation, and Other Regulatory Services), §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 which 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 Natural Resource Conservation 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 which 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 (x) of this section.
(B)
Any radionuclide not specifically listed in one of the
categories in subsection (x) of this section shall be assigned to one of the
categories in accordance with subsection (x)(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 1: 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)
(No change.)
(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)
(No change.)
(B)
(No change.)
(3)
(No change.)
(f)
Filing application for specific license.
(1)-(6)
(No change.)
(7)
Applications or documents submitted to the agency
in connection with licensing actions shall be made available for public inspection
in accordance with provisions of the Texas Public Information Act, Government
Code, Chapter 552. If the application contains information of the type described
in the Texas Public Information Act which, the applicant wishes withheld from
public disclosure, such information shall be submitted with the application
under separate cover, along with a justification for withholding the information.
(8)-(10)
(No change.)
(11)
Notwithstanding the provisions of §289.204(e)(1)
of this title, reimbursement of application fees may be granted in the following
manner.
(A)-(B)
(No change.)
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with the Formal Hearing Procedures,
§1.21-1.34 of this title (relating to the Texas Board of Health).
(g)
Application requirements. An applicant for a license under
this section shall include the following information in the application to
the agency:
(1)-(14)
(No change.)
(15)
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; and
(16)
(No change.)
(h)
Financial assurance and record keeping for decommissioning.
(1)
(No change.)
(2)
The applicant for 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 (4) of this subsection shall either:
(A)
(No change.)
(B)
submit a certification that financial assurance for decommissioning
has been provided in the amount prescribed by paragraph (4) of this subsection
using one of the methods described in paragraph (6) of this subsection. For
an applicant, 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 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 (6) 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, as part of the certification, a signed original
of the financial instrument obtained to satisfy the requirements of paragraph
(6) of this subsection is to be submitted to the agency.
(3)-(4)
(No change.)
(5)
Each decommissioning funding plan must contain a
cost estimate for decommissioning and a description of the method of assuring
funds for decommissioning from paragraph (6) of this subsection, including
means of adjusting cost estimates and associated funding levels periodically
over the life of the facility. The decommissioning funding plan shall also
contain a certification by the licensee that financial assurance for decommissioning
has been provided in the amount of the cost estimate for decommissioning and
a signed original of the financial instrument obtained to satisfy the requirements
of paragraph (6) of this subsection.
(6)
Financial assurance for decommissioning must be provided
by one or more of the following methods.
(A)
(No change.)
(B)
A surety method, insurance, or other guarantee method.
These methods guarantee that decommissioning costs will be paid. A surety
method may be in the form of a surety bond, letter of credit, or line of credit.
A parent company guarantee of funds for decommissioning costs based on a financial
test may be used if the guarantee and test are as contained in §289.252(w)(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. 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(w)(7)
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
must contain the following conditions.
(i)
The surety method or insurance must be open-ended or,
if written for a specified term, such as five years, must 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 must 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)-(iii)
(No change.)
(C)-(D)
(No change.)
(7)
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 must 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 outside of restricted areas that require documentation
under subparagraph (A) of this paragraph; and
(ii)
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.
(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.
(i)
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(w)(4)
of this title must contain either:
(A)-(B)
(No change.)
(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)-(G)
(No change.)
(3)
An emergency plan for responding to a release
of radioactive waste submitted in accordance with paragraph (1)(B) of this
subsection must include the following information:
(A)-(M)
(No change.)
(4)
(No change.)
(j)
Additional environmental requirements for class III facilities.
An application for a license for a class III processing or storage facility
shall include environmental information which may be based on reconnaissance
level information when appropriate and addresses the following:
(1)-(5)
(No change.)
(k)-(m)
(No change.)
(n)
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, now or hereafter in effect, and
to all rules, regulations, 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 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 material licensed
to the locations and purposes authorized in the license.
(4)-(6)
(No change.)
(o)-(s)
(No change.)
(t)
Site suitability criteria. The following requirements
specify the characteristics which a new site must have to be acceptable for
licensure.
(1)
(No change.)
(2)
No new site shall be located in a 100-year floodplain,
as designated by the Commission, or a wetland.
(3)
(No change.)
(u)
Minimum criteria for facility design and operation.
(1)
(No change.)
(2)
The design and operation of the radioactive waste
processing or storage facility shall be such that:
(A)
(No change.)
(B)
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.
(3)-(4)
(No change.)
(5)
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:
(A)
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
(B)
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.
(v)
Waste processing and packaging requirements. All processed
radioactive waste offered for transport or disposal must meet:
(1)
all applicable transportation requirements of the agency,
the United States Nuclear Regulatory Commission, and of the DOT; and
(2)
(No change.)
(w)
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.
(x)
Waste processing and storage categories of radionuclides.
(1)
The following table contains waste processing and storage
categories of radionuclides.
Figure 2: 25 TAC §289.254(x)(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 3: 25 TAC §289.254(x)(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 which 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.
Filed with the Office of the Secretary
of State on January 23, 1998.
TRD-9801070
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 1, 1998
Proposal publication date: October 3, 1997
For further information, please call: (512) 458-7236
25 TAC §289.257
The Texas Department of Health (department), by majority
vote of the Texas Board of Health (board) on January 16, 1998, enters this
order finally adopting new §289.257, concerning the packaging and transportation
of radioactive material, including radioactive waste, with changes to the
proposed text as published in the October 3, 1997, issue of the
Texas Register
(22 TexReg 9839), as a result of comments received during
the 30-day comment period.
Specifically, the section defines terms that are used in the packaging
and interstate transport of radioactive material and establishes minimum requirements
for packaging and transport of radioactive material, related records, special
modes of transportation, and the use of a uniform waste manifest. These requirements
are similar to the packaging and transportation requirements of the United
States Department of Transportation and are items of compatibility with the
United States Nuclear Regulatory Commission. As an agreement state, Texas
must adopt the items of compatibility. For shipments of low-level radioactive
waste (LLRW), the section establishes requirements for emergency plans, quality
control plans, inspections of LLRW shipments, and fees for shipments of LLRW.
These requirements are specified in Health and Safety Code, Chapters 401 and
402. The fee of $10 per cubic foot of shipped LLRW is to be assessed on shipments
to a Texas LLRW disposal facility and is therefore contingent upon the licensure,
construction, and operation of a Texas LLRW disposal facility.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the section.
Change: Concerning §289.257(d), the department added a definition
for "industrial packaging" to provide additional information concerning industrial
packaging of radioactive material. Change is reflected in §289.257(d)(18).
Change: Concerning §289.257(d)(19)(A)(iv), the department deleted
the word "bulk" to more accurately reflect the definition in accordance with
the United States Department of Transportation (DOT) 49 Code of Federal Regulations
(CFR) 173.403. Change is reflected in §289.257(d)(20)(A)(iv).
Change: Concerning §289.257(d)(19)(C)(i), the department deleted the
words "essentially uniformly" in the first line of the definition since this
language was redundant. Change is reflected in §289.257(d)(20)(C)(i).
Change: Concerning §289.257(d)(25), the department added the phrase
"service equipment for filling, emptying, venting, and pressure relief," prior
to the words "and devices" to the definition of "packaging" to more accurately
reflect the definition in accordance with DOT's 49 CFR 173.403. Change is
reflected in §289.257(d)(26).
Change: Concerning §289.257(d)(28), the department added a sentence
"This definition applies only to shipments of LLRW shipped to the Texas LLRW
disposal facility." to clarify the applicability of the definition. Change
is reflected in §289.257(d)(29).
Change: Concerning §289.257(d)(29), the department deleted the definition
of "shipping paper" because this term was redundant of the definition in §289.257(d)(33).
Change: Concerning §289.257(d)(33), the department revised the definition
to read "BRC Forms 540, 540A, 541, 541A, 542, and 542A - Official agency forms
referenced in subsection (s)(5) of this section which includes the information
required by DOT in 49 CFR Part 172. BRC Form 541B contains additional information
for LLRW shipments to the Texas LLRW disposal facility." to incorporate deleted
text from §289.257(d)(29) and clarify the intent of BRC Form 541B.
Change: Concerning §289.257(f), the department added §289.257(f)(5)
"Licensed material discarded in accordance with §289.202(fff) of this
title is exempt from all requirements of this section" to provide an exemption
for materials that are addressed in another section of this chapter.
Change: Concerning §289.257(g)(2)(A) and (B), the department corrected
the reference "subsection (a) of this section" to read "paragraph (1) of this
subsection" to state the correct reference.
Change: Concerning §289.257(m)(2), the department revised the sentence
to read "Advance notification....of radioactive waste when the following three
conditions are met:" to prevent the perception that all radioactive waste
must be carried in a Type B container.
Change: Concerning §289.257(s)(5)(A), the department added the phrase
"or their equivalent" to the end of the first sentence to clarify allowing
the use of the waste manifest forms of choice. The department also changed
"TRC Form" to "BRC Form" to state the correct applicable form.
Change: Concerning the entire section, the department changed "TRC Form"
to "BRC Form" to state the correct applicable form.
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting change(s). Other
minor editorial changes were made for clarification purposes.
Comment. Concerning the section in general, the commenter stated that the
phrase "this subsection" is vague when reading the proposed rules. It is impossible
to tell which parts of the rules are being referred to when the phrase is
used without referring to the subsection by number and number designation.
Response. The department responds that for rule publication, the
Comment. Concerning §289.257(d), one commenter suggested that a statement
be added to clarify that shipment of industrial packagings for low specific
activity materials will be permitted.
Response. The department agrees and added a definition for "industrial
packaging".
Comment. Concerning §289.257(f)(2)(C), one commenter stated that language
equivalent to 10 Code of Federal Regulations (CFR) 71.10(b)(3) needed to be
added to meet NRC compatibility requirements.
Response. The department agrees and has added the equivalent 10 CFR 71.10(b)(3)
language to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.257(g), one commenter questioned the department's
general license requirement for a "quality assurance program approval" from
the NRC. The commenter has received information stating that the NRC has terminated
its quality assurance program.
Response. The department responds that in accordance with 10 CFR 71.101(g),
a program for transport container inspection and maintenance limited to radiographic
exposure devices, source changers, or packages transporting these devices
and meeting the requirements of 10 CFR 34.31(b) or equivalent agreement state
requirments, is deemed to satisfy the requirements of 10 CFR 71.12(b) and
71.101(b). No change was made as a result of the comment.
Comment. Concerning §289.257(g)(2)(B)(i), one commenter noted that
the date "April 1, 1996" should be "April 1, 1999" as an item of compatibility.
Response. The department agrees and has changed the incorrect date to "April
1, 1999" to comply with NRC compatibility requirements because as an agreement
state, Texas must adopt this section as comparable to NRC's regulations.
Comment. Concerning §289.257(o), one commenter asked if it is necessary
that Texas inspect every shipment of waste to a low level waste disposal site.
Response. The department responds that the Texas Low-Level Radioactive
Waste Disposal Authority Act, Chapter 402, Health and Safety Code, §402.221(b)
states that an inspector employed by the department shall inspect all packaged
radioactive waste before it is transported to a permanent disposal site in
this state. No change was made as a result of the comment.
Comment. Concerning §289.257(r), one commenter questioned the $10
per cubic foot charge for waste shipped to the proposed Texas LLRW disposal
facility. The commenter states that the department can not justify charging
that kind of fee to send an inspector to the generator's site to look at the
load and review the paperwork.
Response. The department responds that the Texas Radiation Control Act,
Chapter 401, Health and Safety Code, §401.052(b)(5) states that the department
shall assess a fee on shippers for shipments to a Texas LLRW disposal facility
of radioactive waste originating in Texas and out-of-state. The department
has assessed a $10 per cubic foot of shipped radioactive waste fee in order
to establish the $500,000 maximum contribution to the radiation and perpetual
care fund from shipment of radioactive waste to the Texas LLRW disposal facility.
Commenters included a representative from Chevron Research and Technology
Co., the United States Nuclear Regulatory Commission, Frank Malek and Associates,
and Gammatron. The commenters were generally in favor of the proposal; however,
they presented comments and suggestions for changes to the proposal as previously
discussed.
The new section is adopted under the Health and Safety Code,
Chapter 401, which provides the board with authority to adopt rules and guidelines
relating to the control of radiation; under the Health and Safety Code, Chapter
402, which provides the board with authority to adopt rules and guidelines
relating to the packaging of radioactive waste; and §12.001, which authorizes
the board rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
§289.257. Packaging and Transportation of Radioactive Material.
(a)
Purpose.
(1)
This section establishes requirements for packaging, preparation
for shipment, and transportation of radioactive material including radioactive
waste.
(2)
The packaging and transport of radioactive material
are also subject to the requirements of §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), §289.202 of this title
(relating to Standards for Protection Against Radiation), §289.204 of
this title (relating to Fees for Certificates of Registration, Radioactive
Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.251 of this title (relating to Exemptions, General Licenses,
and General License Acknowledgements), §289.252 of this title (relating
to Licensing of Radioactive Material), and §289.254 of this title (relating
to Licensing of Radioactive Waste Processing and Storage Facilities) and to
the regulations of other agencies (e.g., the United States Department of Transportation
(DOT) and the United States Postal Service) having jurisdiction over means
of transport. The requirements of this section are in addition to, and not
in substitution for, other requirements.
(b)
Scope.
(1)
The requirements in this section apply to any licensee
authorized by a specific or general license issued by the agency to receive,
possess, use, or transfer radioactive material, if the licensee delivers that
material to a carrier for transport, transports the material outside the site
of usage as specified in the agency license, or transports that material on
public highways. No provision of this section authorizes possession of radioactive
material.
(2)
Exemptions from the requirements for a license in
subsection (c) of this section are specified in subsection (f) of this section.
The general license in subsection (g) of this section requires that a United
States Nuclear Regulatory Commission (NRC) certificate of compliance or other
package approval be issued for the package to be used under the general license.
The transport of radioactive material or delivery of radioactive material
to a carrier for transport is subject to the operating controls and procedural
requirements of subsections (h)-(m) of this section and to the general provisions
of subsections (a)-(e) of this section, including DOT regulations referenced
in subsection (e) of this section.
(c)
Requirement for license. Except as authorized in a general
or specific license issued by the agency, or as exempted in this section,
no licensee may transport radioactive material or deliver radioactive material
to a carrier for transport.
(d)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise. To ensure compatibility with international transportation standards,
all limits in this section are given in terms of dual units: The International
System of Units (SI) followed or preceded by United States (U.S.) standard
or customary units. The U.S. customary units are not exact equivalents, but
are rounded to a convenient value, providing a functionally equivalent unit.
For the purpose of this section, SI units shall be used.
(1)
A
1
- The maximum activity
of special form radioactive material permitted in a Type A package.
(2)
A
2
- The maximum activity
of radioactive material, other than special form, low specific activity (LSA)
and surface contaminated object (SCO) material, permitted in a Type A package.
These values are either listed in subsection (s)(2) of this section, or may
be derived in accordance with the procedure prescribed in subsection (s)(1)
of this section.
(3)
Authority - The Texas Low-Level Radioactive Waste
Disposal Authority (TLLRWDA).
(4)
Carrier - A person engaged in the transportation
of passengers or property by land or water as a common, contract, or private
carrier, or by civil aircraft.
(5)
Certificate holder - A person who has been issued
a certificate of compliance or other package approval by the agency.
(6)
Chelating agent - Amine polycarboxylic acids (e.g.,
EDTA, DTPA), hydroxy-carboxylic acids, and polycarboxylic acids (e.g., citric
acid, carbolic acid, and glucinic acid).
(7)
Chemical description - A description of the principal
chemical characteristics of a low-level radioactive waste (LLRW).
(8)
Consignee - The designated receiver of the shipment
of low-level radioactive waste.
(9)
Containment system - The assembly of components of
the packaging intended to retain the radioactive material during transport.
(10)
Conveyance - For transport on:
(A)
public highway or rail by transport vehicle or large freight
container;
(B)
water by vessel, or any hold, compartment, or defined
deck area of a vessel including any transport vehicle on board the vessel;
and
(C)
aircraft.
(11)
Decontamination facility - A facility operating
under a NRC, agreement state, or agency license whose principal purpose is
decontamination of equipment or materials to accomplish recycle, reuse, or
other waste management objectives, and, for purposes of this section, is not
considered to be a consignee for LLRW shipments.
(12)
Disposal container - A transport container principally
used to confine LLRW during disposal operations at a land disposal facility
(also see definition for high integrity container). Note that for some shipments,
the disposal container may be the transport package.
(13)
Environmental Protection Agency (EPA) identification
number - The number received by a transporter following application to the
administrator of EPA as required by 40 Code of Federal Regulations (CFR) Part
263.
(14)
Exclusive use - The sole use by a single consignor
of a conveyance for which all initial, intermediate, and final loading and
unloading are carried out in accordance with the direction of the consignor
or consignee. The consignor and the carrier must ensure that any loading or
unloading is performed by personnel having radiological training and resources
appropriate for safe handling of the consignment. The consignor must issue
specific instructions, in writing, for maintenance of exclusive use shipment
controls, and include them with the shipping paper information provided to
the carrier by the consignor.
(15)
Fissile material - Plutonium-238, plutonium-239,
plutonium-241, uranium-233, uranium-235, or any combination of these radionuclides.
Unirradiated natural uranium and depleted uranium, and natural uranium or
depleted uranium that has been irradiated in thermal reactors only are not
included in this definition. Agency jurisdiction extends only to "special
nuclear material in quantities not sufficient to form a critical mass" as
defined in §289.201(b) of this title.
(16)
Generator - A licensee operating under a NRC, agreement
state, or agency license who:
(A)
is a waste generator as defined in this section; or
(B)
is the licensee to whom waste can be attributed within
the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985
(e.g., waste generated as a result of decontamination or recycle activities).
(17)
High integrity container (HIC) - A container
commonly designed to meet the structural stability requirements of 10 CFR
61.56, and to meet DOT requirements for a Type A package.
(18)
Industrial package (IP) - A packaging that, together
with its low specific activity (LSA) material or surface contaminated object
(SCO) contents, meets the requirements of 49 CFR 173.410 and 173.411. Industrial
packages are categorized in 49 CFR 173.411 as either:
(A)
Industrial package Type 1 (IP-1);
(B)
Industrial package Type 2 (IP-2); or
(C)
Industrial package Type 3 (IP-3).
(19)
Low-level radioactive waste (LLRW) - Waste
containing radioactive material that:
(A)
is acceptable for disposal in a LLRW disposal facility;
(B)
is subject to the disposal criteria and concentration
limits established by the agency or the commission;
(C)
is discarded or unwanted and is not exempt by agency rule
adopted under Section 401.106; and
(D)
does not include:
(i)
irradiated reactor fuel, high level radioactive waste,
or spent nuclear fuel as defined by 10 CFR Part 61;
(ii)
the tailings or wastes produced by or resulting from
the extraction or concentration of uranium or thorium from any ore processed
primarily for its source material content, including discrete surface wastes
resulting from uranium solution extraction processes; or
(iii)
NORM waste or oil and gas NORM waste.
(20)
Low specific activity (LSA) material -
Radioactive material with limited specific activity that satisfies the following
descriptions and limits. Shielding materials surrounding the LSA material
may not be considered in determining the estimated average specific activity
of the package contents. LSA material must be in one of the following three
groups:
(A)
LSA-I.
(i)
Ores containing only naturally occurring radionuclides
(e.g., uranium, thorium) and uranium or thorium concentrates of such ores;
or
(ii)
Solid unirradiated natural uranium or depleted uranium
or natural thorium or their solid or liquid compounds or mixtures; or
(iii)
Radioactive material, other than fissile material, for
which the A
2
value is unlimited; or
(iv)
Mill tailings, contaminated earth, concrete, rubble,
other debris, and activated material in which the radioactive material is
essentially uniformly distributed, and the average specific activity does
not exceed 10
-6
A
2
per gram (A
2
/g).
(B)
LSA-II.
(i)
Water with tritium concentration up to 0.8 terabecquerel
per liter (TBq/l) (20.0 curies per liter (Ci/l)); or
(ii)
Material in which the radioactive material is uniformly
distributed throughout, and the average specific activity does not exceed
10
-4
A
2
/g for solids
and gases, and 10
-5
A
2
/g for liquids.
(C)
LSA-III. Solids (e.g., consolidated wastes, activated
materials) in which:
(i)
the radioactive material is distributed throughout a solid
or a collection of solid objects, or is essentially uniformly distributed
in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);
and
(ii)
the radioactive material is relatively insoluble, or
it is intrinsically contained in a relatively insoluble material, so that,
even under loss of packaging, the loss of radioactive material per package
by leaching, when placed in water for seven days, would not exceed 0.1 A
(iii)
the average specific activity of the solid does not
exceed 2 x 10
-3
A
2
/g.
(21)
Low toxicity alpha emitters - Natural
uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232,
thorium-228 or thorium-230 when contained in ores or physical or chemical
concentrates or tailings; or alpha emitters with a half-life of less than
ten days.
(22)
Maximum normal operating pressure - The maximum
gauge pressure that would develop in the containment system in a period of
one year under the heat condition specified in 10 CFR 71.71(c)(1), in the
absence of venting, external cooling by an ancillary system, or operational
controls during transport.
(23)
Natural thorium - Thorium with the naturally occurring
distribution of thorium isotopes (essentially 100 weight percent thorium-232).
(24)
Normal form radioactive material - Radioactive material
that has not been demonstrated to qualify as special form radioactive material.
(25)
Package - The packaging together with its radioactive
contents as presented for transport.
(A)
Fissile material package - A fissile material packaging
together with its fissile material contents.
(B)
Type A package - A packaging that, together with its radioactive
contents limited to A
1
or A
2
as appropriate, meets the requirements of 49 CFR 173.410 and 173.412
and is designed to retain the integrity of containment and shielding under
normal conditions of transport as demonstrated by the tests set forth in 49
CFR 173.465 or 173.466, as appropriate.
(C)
Type B package - A Type B packaging together with its
radioactive contents. On approval by the NRC, a Type B package design is designated
by NRC as B(U) unless the package has a maximum normal operating pressure
of more than 700 kilopascals (kPa) (100 pounds per square inch (lb/in
(26)
Packaging - The assembly of components necessary
to ensure compliance with the packaging requirements of this section. It may
consist of one or more receptacles, absorbent materials, spacing structures,
thermal insulation, radiation shielding, service equipment for filling, emptying,
venting, and pressure relief, and devices for cooling or absorbing mechanical
shocks. The vehicle, tie-down system, and auxiliary equipment may be designated
as part of the packaging.
(27)
Physical description - The items called for on BRC
Form 541 to describe a LLRW.
(28)
Residual waste - LLRW resulting from processing
or decontamination activities that cannot be easily separated into distinct
batches attributable to specific waste generators. This waste is attributable
to the processor or decontamination facility, as applicable.
(29)
Shipper - The licensed entity (i.e., the waste generator,
waste collector, or waste processor) who offers LLRW for transportation, typically
consigning this type of waste to a licensed waste collector, waste processor,
or land disposal facility operator. This definition applies only to shipments
of LLRW shipped to the Texas LLRW disposal facility.
(30)
Site of usage - The licensee's facility, including
all buildings and structures between which radioactive material is transported
and all roadways that are not within the public domain on which radioactive
material can be transported.
(31)
Specific activity of a radionuclide - The radioactivity
of the radionuclide per unit mass of that nuclide. The specific activity of
a material in which the radionuclide is essentially uniformly distributed
is the radioactivity per unit mass of the material.
(32)
Surface contaminated object (SCO) - A solid object
that is not itself classed as radioactive material, but which has radioactive
material distributed on any of its surfaces. A SCO must be in one of the following
two groups with surface activity not exceeding the following limits:
(A)
SCO-I: A solid object on which:
(i)
the non-fixed contamination on the accessible surface
averaged over 300 square centimeters (cm
2
) (or
the area of the surface if less than 300 cm
2
)
does not exceed 4 becquerels per square centimeter (Bq/cm
2
) (10
-4
microcurie per square centimeter
(µCi/cm
2
)) for beta and gamma and low
toxicity alpha emitters, or 4 x 10
-1
Bq/cm
(ii)
the fixed contamination on the accessible surface averaged
over 300 cm
2
(or the area of the surface if less
than 300 cm
2
) does not exceed 4 x 10
4
Bq/cm
2
(1 µCi/cm
2
) for beta and gamma and low toxicity alpha emitters, or 4 x 10
(iii)
the non-fixed contamination plus the fixed contamination
on the inaccessible surface averaged over 300 cm
2
(or the area of the surface if less than 300 cm
2
)
does not exceed 4 x 10
4
Bq/cm
2
(1 µCi/cm
2
) for beta and gamma
and low toxicity alpha emitters, or 4 x 10
3
Bq/cm
(B)
SCO-II: A solid object on which the limits for SCO-I are
exceeded and on which the following limits are not exceeded:
(i)
the non-fixed contamination on the accessible surface
averaged over 300 cm
2
(or the area of the surface
if less than 300 cm
2
) does not exceed 400 Bq/cm
(ii)
the fixed contamination on the accessible surface averaged
over 300 cm
2
(or the area of the surface if less
than 300 cm
2
) does not exceed 8 x 10
5
Bq/cm
2
(20 µCi/cm
2
) for beta and gamma and low toxicity alpha emitters, or 8 x 10
(iii)
the non-fixed contamination plus the fixed contamination
on the inaccessible surface averaged over 300 cm
2
(or the area of the surface if less than 300 cm
2
)
does not exceed 8 x 10
5
Bq/cm
2
(20 µCi/cm
2
)for beta and gamma
and low toxicity alpha emitters, or 8 x 10
4
Bq/cm
(33)
BRC Forms 540, 540A, 541, 541A, 542, and
542A - Official agency forms referenced in subsection (s)(5) of this section
which includes the information required by DOT in 49 CFR Part 172. BRC Form
541B contains additional information for LLRW shipments to the Texas LLRW
disposal facility. Licensees need not use originals of these forms as long
as any substitute forms are equivalent to the original documentation in respect
to content, clarity, size, and location of information. Upon agreement between
the shipper and consignee, BRC Forms 541 (and 541A and 541B) and BRC Forms
542 (and 542A) may be completed, transmitted, and stored in electronic media.
The electronic media must have the capability for producing legible, accurate,
and complete records in the format of the uniform manifest.
(34)
Uniform Low-Level Radioactive Waste Manifest or
uniform manifest - The combination of BRC Forms 540, 541, and, if necessary,
542, and their respective continuation sheets as needed, or equivalent.
(35)
Uranium - Natural, depleted, enriched:
(A)
Natural uranium - Uranium with the naturally occurring
distribution of uranium isotopes (approximately 0.711 weight percent uranium-235,
and the remainder by weight essentially uranium-238).
(B)
Depleted uranium - Uranium containing less uranium-235
than the naturally occurring distribution of uranium isotopes.
(C)
Enriched uranium - Uranium containing more uranium-235
than the naturally occurring distribution of uranium isotopes.
(36)
Waste collector - An entity, operating under
a NRC, agreement state, or agency license, whose principal purpose is to collect
and consolidate waste generated by others, and to transfer this waste, without
processing or repackaging the collected waste, to another licensed waste collector,
licensed waste processor, or licensed land disposal facility.
(37)
Waste description - The physical, chemical and radiological
description of a LLRW as called for on BRC Form 541.
(38)
Waste generator - An entity, operating under a NRC,
agreement state, or agency license, who:
(A)
possesses any material or component that contains radioactivity
or is radioactively contaminated for which the licensee foresees no further
use; and
(B)
transfers this material or component to a licensed land
disposal facility or to a licensed waste collector or processor for handling
or treatment prior to disposal. A licensee performing processing or decontamination
services may be a waste generator if the transfer of LLRW from its facility
is defined as residual waste.
(39)
Waste processor - An entity, operating under
a NRC or agreement state license, whose principal purpose is to process, repackage,
or otherwise treat LLRW or waste generated by others prior to eventual transfer
of waste to a licensed LLRW land disposal facility.
(40)
Waste type - A waste within a disposal container
having a unique physical description (i.e., a specific waste descriptor code
or description; or a waste sorbed on or solidified in a specifically defined
media).
(e)
Transportation of radioactive material.
(1)
Each licensee who transports radioactive material outside
the site of usage as specified in the agency license, transports on public
highways, or delivers radioactive material to a carrier for transport, shall
comply with the applicable requirements of the DOT regulations in 49 CFR Parts
170-189 appropriate to the mode of transport. The licensee shall comply with
the following, particularly noting DOT regulations as applicable in the following
areas:
(A)
Packaging - 49CFR Part173: Subparts A, B, and I.
(B)
Marking and labeling - 49 CFR Part 172: Subpart D, §§172.400
- 172.407, §§172.436 - 172.440, and Subpart E.
(C)
Placarding - 49CFR Part172: Subpart F, especially §§172.500-
172.519, §172.556, and Appendices B andC.
(D)
Accident reporting - 49 CFR Part 171:§171.15 and
§171.16.
(E)
Shipping papers and emergency information - 49 CFR Part
172: Subparts C and G.
(F)
Hazardous material employee training - 49 CFR Part 172:
Subpart H.
(G)
Hazardous material shipper/carrier registration - 49 CFR
Part 107: Subpart G.
(2)
If DOT regulations are not applicable to a shipment
of radioactive material, the licensee shall conform to DOT standards and requirements
specified in paragraph (1) of this subsection to the same extent as if the
shipment or transportation were subject to DOT regulations. A request for
modification, waiver, or exemption from those requirements must be filed and
approved by the agency. Any notification referred to in those requirements,
must be submitted to the agency.
(f)
Exemption for low-level radioactive materials.
(1)
A licensee is exempt from all requirements of this section
with respect to shipment or carriage of a package containing radioactive material
having a specific activity not greater than 70 becquerels per gram (Bq/g)
(0.002 microcuries per gram (µCi/g)).
(2)
A licensee is exempt from all requirements of this
section, other than subsections (e) and (i) of this section, with respect
to shipment or carriage of the following packages, provided the packages contain
no fissile material, or the fissile material exemption standards of 10 CFR
71.53 are satisfied:
(A)
a package containing no more than a Type A quantity of
radioactive material;
(B)
a package in which the only radioactive material is LSA
material or SCO, provided the external radiation level at 3 m from the unshielded
material or objects does not exceed 10 millisieverts per hour (mSv/hr) (1
rem per hour (rem/hr)); or
(C)
a package transported within locations within the United
States which contains only americium or plutonium in special form with an
aggregate radioactivity not to exceed 20 Ci.
(3)
A licensee is exempt from all requirements of
this section, other than subsections (e) and (i) of this section, with respect
to shipment or carriage of LSA material in group LSA-I, or SCOs in group SCO-I.
(4)
Common and contract carriers, freight forwarders,
and warehousemen, who are subject to the rules and regulations of the DOT
or the United States Postal Service (39 CFR Parts 14 and 15), are exempt from
these regulations to the extent that they transport or store sources of radiation
in the regular course of their carriage for another or storage incident thereto.
Private carriers who are subject to the rules and regulations of the DOT are
exempted from these regulations to the extent that they transport sources
of radiation. Common, contract, and private carriers who are not subject to
the rules and regulations of the DOT or the United States Postal Service are
subject to applicable sections of these regulations.
(5)
Persons who discard licensed material in accordance
with §289.202(fff) of this title are exempt from all requirements of
this section.
(g)
General license.
(1)
NRC-approved package.
(A)
A general license is hereby issued to any licensee of
the agency to transport, or to deliver to a carrier for transport, radioactive
material in a package for which a license, certificate of compliance, or other
approval has been issued by the NRC.
(B)
This general license applies only to a licensee who has
a quality assurance program approved by the NRC as satisfying the provisions
of 10 CFR 71.
(C)
This general license applies only to a licensee who meets
the following requirements:
(i)
has a copy of the specific license, certificate of compliance,
or other approval by the NRC of the package, and has the drawings and other
documents referenced in the approval relating to the use and maintenance of
the packaging and to the actions to be taken before shipment; and
(ii)
complies with the terms and conditions of the specific
license, certificate, or other approval by the NRC, as applicable, and the
applicable requirements of 10 CFR 71;
(2)
Previously approved package.
(A)
A Type B package previously approved by the NRC, but not
designated as B(U) or B(M) in the identification number of the NRC certificate
of compliance, may be used under the general license of paragraph (1) of this
subsection with the following additional conditions:
(i)
fabrication of the packaging was satisfactorily completed
before August 31, 1986, as demonstrated by application of its model number
in accordance with NRC regulations at 10 CFR 71.85(c);
(ii)
a package used for a shipment to a location outside the
United States is subject to multilateral approval, as defined in DOT regulations
at 49 CFR 173.403; and
(iii)
a serial number that uniquely identifies each packaging
which conforms to the approved design is assigned to, and legibly and durably
marked on, the outside of each packaging.
(B)
A Type B(U) package, a Type B(M) package, a LSA material
package or a fissile material package, previously approved by the NRC but
without the designation "-85" in the identification number of the NRC certificate
of compliance, may be used under the general license of paragraph (1) of this
subsection with the following additional conditions:
(i)
fabrication of the package is satisfactorily completed
by April 1, 1999, as demonstrated by application of its model number in accordance
with NRC regulations at 10 CFR 71.85(c);
(ii)
a package used for a shipment to a location outside the
United States is subject to multilateral approval except approved under special
arrangement in accordance with DOT regulations at 49 CFR 173.403; and
(iii)
a serial number which uniquely identifies each packaging
which conforms to the approved design is assigned to and legibly and durably
marked on the outside of each packaging.
(3)
DOT specification container.
(A)
A general license is issued to any licensee to transport,
or to deliver to a carrier for transport, licensed material in a specification
container for fissile material or for a Type B quantity of radioactive material
as specified in 49 CFR Parts 173 and 178.
(B)
This general license applies only to a licensee who:
(i)
has a copy of the specification;
(ii)
complies with the terms and conditions of the specification
and the applicable requirements of this section; and
(iii)
has a quality assurance program required by 10 CFR 71.105.
(C)
The general license in subparagraph (A) of this paragraph
is subject to the limitation that the specification container may not be used
for a shipment to a location outside the United States except by multilateral
approval as defined in 49 CFR 173.403.
(4)
Use of foreign approved package.
(A)
A general license is issued to any licensee to transport,
or to deliver to a carrier for transport, licensed material in a package the
design of which has been approved in a foreign national competent authority
certificate which has been revalidated by the DOT as meeting the applicable
requirements of 49 CFR 171.12.
(B)
This general license applies only to international shipments.
(C)
This general license applies only to a licensee who:
(i)
has a copy of the applicable certificate, the revalidation,
and the drawings and other documents referenced in the certificate relating
to the use and maintenance of the packaging and to the actions to be taken
prior to shipment;
(ii)
complies with the terms and conditions of the certificate
and revalidation, and with the applicable requirements of this section; and
(iii)
the licensee has a quality assurance program approved
by the NRC.
(h)
Routine determinations. Before each shipment of radioactive
material, the licensee shall ensure that the package with its contents satisfies
the applicable requirements of this section and of the license. The licensee
shall determine that:
(1)
the package is proper for the contents to be shipped;
(2)
the package is in unimpaired physical condition except
for superficial defects such as marks or dents;
(3)
each closure device of the packaging, including any
required gasket, is properly installed, secured, and free of defects;
(4)
any system for containing liquid is adequately sealed
and has adequate space or other specified provision for expansion of the liquid;
(5)
any pressure relief device is operable and set in
accordance with written procedures;
(6)
the package has been loaded and closed in accordance
with written procedures;
(7)
any structural part of the package that could be
used to lift or tie down the package during transport is rendered inoperable
for that purpose, unless it satisfies the design requirements of 10 CFR 71.45;
(8)
the level of non-fixed (removable) radioactive contamination
on the external surfaces of each package offered for shipment is as low as
reasonably achievable (ALARA), and within the limits specified in DOT regulations
in 49 CFR 173.443;
(9)
external radiation levels around the package and
around the vehicle, if applicable, will not exceed the following limits at
any time during transportation:
(A)
Except as provided in subparagraph (B) of this paragraph,
each package of radioactive materials offered for transportation must be designed
and prepared for shipment so that under conditions normally incident to transportation
the radiation level does not exceed 2 mSv/hr (200 mrem/hr) at any point on
the external surface of the package, and the transport index does not exceed
10.
(B)
A package that exceeds the radiation level limits specified
in subparagraph (A) of this paragraph must be transported by exclusive use
shipment only, and the radiation levels for such shipment must not exceed
the following during transportation:
(i)
2 mSv/hr (200 mrem/hr) on the accessible external surface
of the package, unless the following conditions are met, in which case the
limit is 10 mSv/hr (1,000 mrem/hr):
(I)
the shipment is made in a closed transport vehicle;
(II)
the package is secured within the vehicle so that its
position remains fixed during transportation; and
(III)
there are no loading or unloading operations between
the beginning and end of the transportation;
(ii)
2 mSv/hr (200 mrem/hr) at any point on the outer surface
of the vehicle, including the top and underside of the vehicle; or in the
case of a flat-bed style vehicle, at any point on the vertical planes projected
from the outer edges of the vehicle, on the upper surface of the load or enclosure,
if used, and on the lower external surface of the vehicle; and
(iii)
0.1 mSv/hr (10 mrem/hr) at any point 2 meters (m) (6.6
feet (ft)) from the outer lateral surfaces of the vehicle (excluding the
top and underside of the vehicle); or in the case of a flat-bed style vehicle,
at any point 2 m (6.6 ft) from the vertical planes projected by the outer
edges of the vehicle (excluding the top and underside of the vehicle); and
(iv)
0.02 mSv/hr (2 mrem/hr) in any normally occupied space,
except that this provision does not apply to private carriers, if exposed
personnel under their control wear radiation dosimetry devices in conformance
with §289.202(q) of this title;
(10)
a package must be designed, constructed,
and prepared for transport so that in still air at 38 degrees Celsius (100
degrees Fahrenheit) and in the shade, no accessible surface of a package would
have a temperature exceeding 50 degrees Celsius (122 degrees Fahrenheit) in
a nonexclusive use shipment, or 85 degrees Celsius (185 degrees Fahrenheit)
in an exclusive use shipment. Accessible package surface temperatures shall
not exceed these limits at any time during transportation; and
(11)
a package must not incorporate a feature intended
to allow continuous venting during transport.
(i)
Air transport of plutonium.
(1)
Notwithstanding the provisions of any general licenses
and notwithstanding any exemptions stated directly in this section or included
indirectly by citation of 49 CFR Chapter 1, as may be applicable, the licensee
shall assure that plutonium in any form, whether for import, export, or domestic
shipment, is not transported by air or delivered to a carrier for air transport
unless:
(A)
the plutonium is contained in a medical device designed
for individual human application; or
(B)
the plutonium is contained in a material in which the
specific activity is not greater than 0.002 µCi/g (70 Bq/g) of material
and in which the radioactivity is essentially uniformly distributed; or
(C)
the plutonium is shipped in a single package containing
no more than an A
2
quantity of plutonium in any
isotope or form, and is shipped in accordance with subsection (e) of this
section; or
(D)
the plutonium is shipped in a package specifically authorized
for the shipment of plutonium by air in the Certificate of Compliance for
that package issued by the NRC.
(2)
Nothing in paragraph (1) of this subsection
is to be interpreted as removing or diminishing the requirements of 10 CFR
73.24.
(3)
For a shipment of plutonium by air which is subject
to paragraph (1) of this subsection, the licensee shall, through special arrangement
with the carrier, require compliance with 49 CFR 175.704, DOT regulations
applicable to the air transport of plutonium.
(j)
Opening instructions. Before delivery of a package to
a carrier for transport, the licensee shall ensure that any special instructions
needed to safely open the package have been sent to, or otherwise made available
to, the consignee for the consignee's use in accordance with §289.202(ee)(5)
of this title.
(k)
Records. Each licensee shall maintain, for a period of
three years after shipment, a record of each shipment of radioactive material
showing the following where applicable:
(1)
identification of the packaging by model number and serial
number;
(2)
verification that there are no significant defects
in the packaging, as shipped;
(3)
type and quantity of radioactive material in each
package, and the total quantity of each shipment;
(4)
date of the shipment;
(5)
for fissile packages and for Type B packages, any
special controls exercised;
(6)
name and address of the transferee;
(7)
address to which the shipment was made; and
(8)
surveys performed to determine compliance with subsection
(h)(8) and (9) of this section.
(l)
Reports. The shipper shall immediately report by telephone,
telegram, mailgram, or facsimile, all radioactive waste transportation accidents
to the agency and the local emergency planning committees in the county where
the radioactive waste accident occurs. All other accidents involving radioactive
material shall be reported in accordance with §289.202(xx) and (yy) of
this title.
(m)
Advance notification of transport of certain radioactive
waste.
(1)
As specified in paragraphs (2)-(4) of this subsection,
each licensee shall provide advance notification to the governor of a state,
or the governor's designee, of the shipment of radioactive waste, through,
or across the boundary of the state, before the transport, or delivery to
a carrier, for transport, of radioactive waste outside the confines of the
licensee's facility or other place of use or storage.
(2)
Advance notification is required under this section
for shipment of radioactive waste when the following three conditions are
met:
(A)
the radioactive waste is required by this section to be
in Type B packaging for transportation;
(B)
the radioactive waste is being transported to or across
a state boundary en route to a disposal facility or to a collection point
for transport to a disposal facility; and
(C)
the quantity of radioactive waste in a single package
exceeds the least of the following:
(i)
3000 times the A
1
value of
the radionuclides as specified in subsection (vv)(2) of this section for special
form radioactive material;
(ii)
3000 times the A
2
value of
the radionuclides as specified in subsection (vv)(2) of this section for normal
form radioactive material; or
(iii)
1,000 terabecquerels (TBq) (27,000 curies (Ci)).
(3)
The following are procedures for submitting
advance notification:
(A)
The notification must be made in writing to the office
of each appropriate governor or governor's designee and to the agency.
(B)
A notification delivered by mail must be postmarked at
least seven days before the beginning of the seven-day period during which
departure of the shipment is estimated to occur.
(C)
A notification delivered by messenger must reach the office
of the governor or of the governor's designee at least four days before the
beginning of the seven-day period during which departure of the shipment is
estimated to occur.
(i)
A list of the names and mailing addresses of the governors'
designees receiving advance notification of transportation of radioactive
waste was published in the Federal Register on June 30, 1995 (60 FR 34306).
(ii)
The list will be published annually in the Federal Register
on or about June 30 to reflect any changes in information.
(iii)
A list of the names and mailing addresses of the governors'
designees is available on request from the Director, Office of State Programs,
United States Nuclear Regulatory Commission, Washington, DC 20555.
(D)
The licensee shall retain a copy of the notification as
a record for three years.
(4)
Each advance notification of shipment of radioactive
waste must contain the following information:
(A)
the name, address, and telephone number of the shipper,
carrier, and receiver of the radioactive waste shipment;
(B)
a description of the radioactive waste contained in the
shipment, as specified in the regulations of DOT in 49 CFR Part 172, §172.202
and §172.203(d);
(C)
the point of origin of the shipment and the seven-day
period during which departure of the shipment is estimated to occur;
(D)
the seven-day period during which arrival of the shipment
at state boundaries is estimated to occur;
(E)
the destination of the shipment, and the seven-day period
during which arrival of the shipment is estimated to occur; and
(F)
a point of contact, with a telephone number, for current
shipment information.
(5)
A licensee who finds that schedule information
previously furnished to a governor or governor's designee, in accordance with
this section, will not be met, shall telephone a responsible individual in
the office of the governor of the state or of the governor's designee and
inform that individual of the extent of the delay beyond the schedule originally
reported. The licensee shall maintain a record of the date, time, and name
of the individual contacted for three years.
(6)
The following are procedures for a cancellation notice.
(A)
Each licensee who cancels a radioactive waste shipment
for which advance notification has been sent shall send a cancellation notice
to the governor of each state or to the governor's designee previously notified,
and to the agency.
(B)
The licensee shall state in the notice that it is a cancellation
and identify the advance notification that is being canceled. The licensee
shall retain a copy of the notice as a record for three years.
(n)
Emergency plan. Each shipper and transporter of radioactive
waste shall adopt an emergency plan approved by the agency for responding
to transportation accidents.
(o)
Inspections. Each shipment of LLRW to a licensed land
disposal facility in Texas shall be inspected by the agency prior to shipment.
The waste shipper shall notify the agency no less than 72 hours prior to the
scheduled shipment of the intent to transport waste to the licensed land disposal
facility.
(p)
Quality control program. Each shipper shall adopt a quality
control program to include verification of the following to ensure that shipping
containers are suitable for shipments to a licensed disposal facility:
(1)
identification of appropriate container(s);
(2)
container testing documentation is adequate;
(3)
appropriate container used;
(4)
container packaged appropriately;
(5)
container labeled appropriately;
(6)
manifest filled out appropriately; and
(7)
documentation maintained of each step.
(q)
Transfer for disposal and manifests.
(1)
The requirements of this section and subsection (s)(5)
of this section are designed to:
(A)
control transfers of LLRW by any waste generator, waste
collector, or waste processor licensee, as defined in this section, who ships
LLRW either directly, or indirectly through a waste collector or waste processor,
to a licensed LLRW land disposal facility, as defined in §289.201(b)
of this title;
(B)
establish a manifest tracking system; and
(C)
supplement existing requirements concerning transfers
and recordkeeping for those wastes.
(2)
Beginning March 1, 1998, all affected licensees
must use subsection (s)(5) of this section.
(3)
Each shipment of LLRW intended for disposal at a
licensed land disposal facility must be accompanied by a shipment manifest
in accordance with subsection (s)(5)(A) of this section.
(4)
Any licensee shipping LLRW intended for ultimate
disposal at a licensed land disposal facility must document the information
required on the uniform manifest and transfer this recorded manifest information
to the intended consignee in accordance with subsection (s)(5) of this section.
(5)
Each shipment manifest must include a certification
by the waste generator as specified in subsection (s)(5)(J) of this section,
as appropriate.
(6)
Each person involved in the transfer for disposal
and disposal of LLRW, including the waste generator, waste collector, waste
processor, and disposal facility operator, shall comply with the requirements
specified in subsection (s)(5)(K) of this section, as appropriate.
(7)
Any licensee shipping LLRW to a licensed Texas LLRW
disposal facility shall comply with the waste acceptance criteria in 31 TAC
§§451.21-451.29.
(r)
Fees.
(1)
Each shipper shall be assessed a fee for shipments of
LLRW originating in Texas or out-of-state being shipped to a licensed Texas
LLRW disposal facility and these fees shall be:
(A)
$10 per cubic foot of shipped LLRW;
(B)
collected by the Authority and deposited to the credit
of the radiation and perpetual care fund; and
(C)
used exclusively by the agency for emergency planning
for and response to transportation accidents involving LLRW.
(2)
Fee assessments under this section shall be
suspended when the amount of fees collected reaches $500,000, except that
if the balance of fees collected is reduced to $350,000 or less, the assessments
shall be reinstituted to bring the balance of fees collected to $500,000.
(3)
Money expended from the radiation and perpetual care
fund to respond to accidents involving LLRW must be reimbursed to the radiation
and perpetual care fund by the responsible shipper or transporter according
to rules adopted by the board.
(s)
Appendices.
(1)
Determination of A
1
and A
(A)
Values of A
1
and A
2
for individual radionuclides, which are the bases for many activity
limits elsewhere in these rules are given in paragraph (2) of this subsection.
The curie (Ci) values specified are obtained by converting from the terabecquerel
(TBq) figure. The curie values are expressed to three significant figures
to assure that the difference in the TBq and Ci quantities is one tenth of
1.0% or less. Where values of A
1
or A
2
are unlimited, it is for radiation control purposes only. For nuclear
criticality safety, some materials are subject to controls placed on fissile
material.
(B)
For individual radionuclides whose identities are known,
but which are not listed in paragraph (2) of this subsection, the determination
of the values of A
1
and A
2
requires NRC approval, except that the values of A
1
and A
2
in paragraph (3) of this subsection
may be used without obtaining NRC approval.
(C)
In the calculations of A
1
and A
2
for a radionuclide not in paragraph (2)
of this subsection, a single radioactive decay chain, in which radionuclides
are present in their naturally occurring proportions, and in which no daughter
nuclide has a half-life either longer than ten days, or longer than that of
the parent nuclide, shall be considered as a single radionuclide, and the
activity to be taken into account and the A
1
or A
2
value to be applied shall be those corresponding
to the parent nuclide of that chain. In the case of radioactive decay chains
in which any daughter nuclide has a half-life either longer than ten days,
or greater than that of the parent nuclide, the parent and those daughter
nuclides shall be considered as mixtures of different nuclides.
(D)
For mixtures of radionuclides whose identities and respective
activities are known, the following conditions apply.
(i)
For special form radioactive material, the maximum quantity
transported in a Type A package:
Figure 1: 25 TAC §289.257(s)(1)(D)(i)
(ii)
For normal form radioactive material, the maximum quantity
transported in a Type A package:
Figure 2: 25 TAC §289.257(s)(1)(D)(ii)
(iii)
Alternatively, an A
1
value
for mixtures of special form material may be determined as follows:
Figure 3: 25 TAC §289.257(s)(1)(D)(iii)
(iv)
An A
2
value for mixtures
of normal form material may be determined as follows:
Figure 4: 25 TAC §289.257(s)(1)(D)(iv)
(E)
When the identity of each radionuclide is known, but the
individual activities of some of the radionuclides are not known, the radionuclides
may be grouped and the lowest A
1
or A
2
value, as appropriate, for the radionuclides in each group may be
used in applying the formulas in subparagraph (D) of this paragraph. Groups
may be based on the total alpha activity and the total beta/gamma activity
when these are known, using the lowest A
1
or
A
2
values for the alpha emitters and beta/gamma
emitters.
(2)
A
1
and A
2
values for radionuclides. The following table contains A
1
and A
2
values for radionuclides:
Figure 5: 25 TAC §289.257(s)(2)
(3)
General values for A
1
and A
2
. The following table contains general
values for A
1
and A
2
:
Figure 6: 25 TAC §289.257(s)(3)
(4)
Activity-mass relationships for uranium. The following
table contains activity-mass relationships for uranium:
Figure 7: 25 TAC §289.257(s)(4)
(5)
Requirements for transfers of LLRW intended for disposal
at licensed land disposal facilities and manifests.
(A)
Manifest. A waste generator, collector, or processor who
transports, or offers for transportation, LLRW intended for ultimate disposal
at a licensed LLRW land disposal facility must prepare a manifest reflecting
information requested on applicable BRC Forms 540 (Uniform Low-Level Radioactive
Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste
Manifest (Container and Waste Description)) and, if necessary, on an applicable
BRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index
and Regional Compact Tabulation)) or their equivalent. BRC Forms 540 and 540A
must be completed and must physically accompany the pertinent LLRW shipment.
Upon agreement between shipper and consignee, BRC Forms 541, 541A and 541B,
and 542 and 542A may be completed, transmitted, and stored in electronic media
with the capability for producing legible, accurate, and complete records
on the respective forms. Licensees are not required by the agency to comply
with the manifesting requirements of this section when they ship:
(i)
LLRW for processing and expect its return (i.e., for storage
under their license) prior to disposal at a licensed land disposal facility;
(ii)
LLRW that is being returned to the licensee who is the
waste generator or generator, as defined in this section; or
(iii)
radioactively contaminated material to a waste processor
that becomes the processor's residual waste.
(B)
Form instructions. For guidance in completing these forms,
refer to the instructions that accompany the forms. Copies of manifests required
by this subsection may be legible carbon copies, photocopies, or computer
printouts that reproduce the data in the format of the uniform manifest.
(C)
Forms. BRC Forms 540, 540A, 541, 541A, 541B, 542 and 542A,
and the accompanying instructions, in hard copy, may be obtained from the
agency.
(D)
Information requirements of the DOT. This subsection includes
information requirements of the DOT, as codified in 49 CFR Part 172. Information
on hazardous, medical, or other waste, required to meet EPA regulations, as
codified in 40 CFR Parts 259, 261 or elsewhere, is not addressed in this section,
and must be provided on the required EPA forms. However, the required EPA
forms must accompany the uniform manifest required by this section.
(E)
General information. The shipper of the LLRW, shall provide
the following information on the uniform manifest:
(i)
the name, facility address, and telephone number of the
licensee shipping the waste;
(ii)
an explicit declaration indicating whether the shipper
is acting as a waste generator, collector, processor, or a combination of
these identifiers for purposes of the manifested shipment; and
(iii)
the name, address, and telephone number, or the name
and EPA identification number for the carrier transporting the waste.
(F)
Shipment information. The shipper of the LLRW shall provide
the following information regarding the waste shipment on the uniform manifest:
(i)
the date of the waste shipment;
(ii)
the total number of packages/disposal containers;
(iii)
the total disposal volume and disposal weight in the
shipment;
(iv)
the total radionuclide activity in the shipment;
(v)
the activity of each of the radionuclides hydrogren-3,
carbon-14, technetium-99, iodine-129, chlorine-36, nickel-63, strontium-90,
cesium-137, radium-226, and any other isotopes with a half-life greater than
35 years contained in the shipment; and
(vi)
the total masses of uranium-233, uranium-235, and plutonium
in special nuclear material, and the total mass of uranium and thorium in
source material.
(G)
Disposal container and waste information. The shipper
of the LLRW shall provide the following information on the uniform manifest
regarding the waste and each disposal container of waste in the shipment:
(i)
an alphabetic or numeric identification that uniquely
identifies each disposal container in the shipment;
(ii)
a physical description of the disposal container, including
the manufacturer and model of any high integrity container;
(iii)
the volume displaced by the disposal container;
(iv)
the gross weight of the disposal container, including
the waste;
(v)
for waste consigned to a disposal facility, the maximum
radiation level at the surface of each disposal container;
(vi)
a physical and chemical description of the waste;
(vii)
the total weight percentage of chelating agent for any
waste containing more than 0.1% chelating agent by weight, plus the identity
of the principal chelating agent;
(viii)
the approximate volume of waste within a container;
(ix)
the sorbing or solidification media, if any, and the
identity of the solidification media vendor and brand name;
(x)
the identities and activities of individual radionuclides
contained in each container, the masses of uranium-233, uranium-235, and plutonium
in special nuclear material, and the masses of uranium and thorium in source
material. For discrete waste types (i.e., activated materials, contaminated
equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization
media), the identities and activities of individual radionuclides associated
with or contained on these waste types within a disposal container shall be
reported;
(xi)
the total radioactivity within each container; and
(xii)
for wastes consigned to a disposal facility, the classification
of the waste in accordance with §289.202(ggg)(4)(A) of this title. Waste
not meeting the structural stability requirements of §289.202(ggg)(4)(B)(ii)
of this title must be identified.
(H)
Uncontainerized waste information. The shipper of the
LLRW shall provide the following information on the uniform manifest regarding
a waste shipment delivered without a disposal container:
(i)
the approximate volume and weight of the waste;
(ii)
a physical and chemical description of the waste;
(iii)
the total weight percentage of chelating agent if the
chelating agent exceeds 0.1% by weight, plus the identity of the principal
chelating agent;
(iv)
for waste consigned to a disposal facility, the classification
of the waste in accordance with §289.202(ggg)(4)(A) of this title. Waste
not meeting the structural stability requirements of §289.202(ggg)(4)(B)(ii)
of this title must be identified;
(v)
the identities and activities of individual radionuclides
contained in the waste, the masses of uranium-233, uranium-235, and plutonium
in special nuclear material, and the masses of uranium and thorium in source
material; and
(vi)
for wastes consigned to a disposal facility, the maximum
radiation levels at the surface of the waste.
(I)
Multi-generator disposal container information. This subparagraph
applies to disposal containers enclosing mixtures of waste originating from
different generators. (Note: The origin of the LLRW resulting from a processor's
activities may be attributable to one or more generators (including waste
generators) as defined in this section). It also applies to mixtures of wastes
shipped in an uncontainerized form, for which portions of the mixture within
the shipment originate from different generators.
(i)
For homogeneous mixtures of waste, such as incinerator
ash, provide the waste description applicable to the mixture and the volume
of the waste attributed to each generator.
(ii)
For heterogeneous mixtures of waste, such as the combined
products from a large compactor, identify each generator contributing waste
to the disposal container, and, for discrete waste types (i.e., activated
materials, contaminated equipment, mechanical filters, sealed source/devices,
and wastes in solidification/stabilization media), the identities and activities
of individual radionuclides contained on these waste types within the disposal
container. For each generator, provide the following:
(I)
the volume of waste within the disposal container;
(II)
a physical and chemical description of the waste, including
the solidification agent, if any;
(III)
the total weight percentage of chelating agents for
any disposal container containing more than 0.1% chelating agent by weight,
plus the identity of the principal chelating agent;
(IV)
the sorbing or solidification media, if any, and the
identity of the solidification media vendor and brand name if the media is
claimed to meet stability requirements in §289.202(ggg)(4)(B)(ii) of
this title; and
(V)
radionuclide identities and activities contained in the
waste, the masses of uranium-233, uranium-235, and plutonium in special nuclear
material, and the masses of uranium and thorium in source material if contained
in the waste.
(J)
Certification. An authorized representative of the waste
generator, processor, or collector shall certify by signing and dating the
shipment manifest that the transported materials are properly classified,
described, packaged, marked, and labeled and are in proper condition for transportation
according to the applicable regulations of the DOT and the agency. A collector
in signing the certification is certifying that nothing has been done to the
collected waste which would invalidate the waste generator's certification.
(K)
Control and tracking.
(i)
Any licensee who transfers LLRW to a land disposal facility
or a licensed waste collector shall comply with the requirements in subclauses
(I)-(IX) of this clause. Any licensee who transfers waste to a licensed waste
processor for waste treatment or repackaging shall comply with the requirements
of subclauses (IV)-(IX) of this clause. A licensee shall:
(I)
prepare all wastes so that the waste is classified according
to §289.202(ggg)(4)(A) of this title and meets the waste characteristic
requirements in §289.202(ggg)(4)(B) of this title;
(II)
label each disposal container (or transport package if
potential radiation hazards preclude labeling of the individual disposal container)
of waste to identify whether it is Class A waste, Class B waste, Class C waste,
or greater then Class C waste, in accordance with §289.202(ggg)(4)(A)
of this title;
(III)
conduct a quality assurance program to assure compliance
with §289.202(ggg)(4)(A) and (B) of this title;
(IV)
prepare the uniform manifest as required by this subsection;
(V)
forward a copy or electronically transfer the uniform
manifest to the intended consignee so that either:
(-a-)
receipt of the manifest precedes the LLRW shipment;
or
(-b-)
the manifest is delivered to the consignee with
the waste at the time the waste is transferred to the consignee. Using both
items (-a-) and (-b-) of this subclause is also acceptable;
(VI)
include the uniform manifest with the shipment regardless
of the option chosen in subclause (V) of this clause;
(VII)
receive acknowledgement of the receipt of the shipment
in the form of a signed copy of the uniform manifest;
(VIII)
retain a copy of or electronically store the uniform
manifest and documentation of acknowledgement of receipt as the record of
transfer of radioactive material as required by §289.251 of this title,
§289.252 of this title, and §289.254 of this title; and
(IX)
for any shipments or any part of a shipment for which
acknowledgement of receipt has not been received within the times set forth
in this subsection, conduct an investigation in accordance with clause (v)
of this subparagraph.
(ii)
Any waste collector licensee who handles only prepackaged
waste shall:
(I)
acknowledge receipt of the waste from the shipper within
one week of receipt by returning a signed copy of the uniform manifest;
(II)
prepare a new uniform manifest to reflect consolidated
shipments that meet the requirements of this subsection. The waste collector
shall ensure that, for each container of waste in the shipment, the uniform
manifest identifies the generator of that container of waste;
(III)
forward a copy or electronically transfer the uniform
manifest to the intended consignee so that either:
(-a-)
receipt of the uniform manifest precedes the LLRW shipment;
or
(-b-)
the uniform manifest is delivered to the consignee
with the waste at the time the waste is transferred to the consignee. Using
both items (-a-) and (-b-) of this subclause is also acceptable;
(IV)
include the uniform manifest with the shipment regardless
of the option chosen in subclause (III) of this clause;
(V)
receive acknowledgement of the receipt of the shipment
in the form of a signed copy of the uniform manifest;
(VI)
retain a copy of or electronically store the uniform
manifest and documentation of acknowledgement of receipt as the record of
transfer of radioactive material as required by §289.251 of this title,
§289.252 of this title, and §289.254 of this title;
(VII)
for any shipments or any part of a shipment for which
acknowledgement of receipt has not been received within the times set forth
in this clause, conduct an investigation in accordance with clause (v) of
this subparagraph; and
(VIII)
notify the shipper and the agency when any shipment,
or part of a shipment, has not arrived within 60 days after receipt of an
advance uniform manifest, unless notified by the shipper that the shipment
has been cancelled.
(iii)
Any licensed waste processor who treats or repackages
waste shall:
(I)
acknowledge receipt of the waste from the shipper within
one week of receipt by returning a signed copy of the uniform manifest;
(II)
prepare a new uniform manifest that meets the requirements
of this subsection. Preparation of the new uniform manifest reflects that
the processor is responsible for meeting these requirements. For each container
of waste in the shipment, the manifest shall identify the waste generators,
the preprocessed waste volume, and the other information as required in subparagraph
(I) of this paragraph;
(III)
prepare all wastes so that the waste is classified according
to §289.202(ggg)(4)(A) of this title and meets the waste characteristics
requirements in §289.202(ggg)(4)(B) of this title;
(IV)
label each package of waste to identify whether it is
Class A waste, Class B waste, or Class C waste, in accordance with §289.202(ggg)(4)(A)
and (C) of this title;
(V)
conduct a quality assurance program to assure compliance
with §289.202(ggg)(4)(A) and (B) of this title;
(VI)
forward a copy or electronically transfer the uniform
manifest to the intended consignee so that either:
(-a-)
receipt of the uniform manifest precedes the LLRW shipment;
or
(-b-)
the uniform manifest is delivered to the consignee
with the waste at the time the waste is transferred to the consignee. Using
both items (-a-) and (-b-) of this subclause is also acceptable;
(VII)
include the uniform manifest with the shipment regardless
of the option chosen in subclause (VI) of this clause;
(VIII)
receive acknowledgement of the receipt of the shipment
in the form of a signed copy of the uniform manifest;
(IX)
retain a copy of or electronically store the uniform
manifest and documentation of acknowledgement of receipt as the record of
transfer of radioactive material as required by §289.251 of this title,
§289.252 of this title, and §289.254 of this title;
(X)
for any shipment or any part of a shipment for which acknowledgement
of receipt has not been received within the times set forth in this clause,
conduct an investigation in accordance with clause (v) of this subparagraph;
and
(XI)
notify the shipper and the agency when any shipment,
or part of a shipment, has not arrived within 60 days after receipt of an
advance uniform manifest, unless notified by the shipper that the shipment
has been cancelled.
(iv)
The land disposal facility operator shall perform the
following:
(I)
acknowledge receipt of the waste within one week of receipt
by returning, as a minimum, a signed copy of the uniform manifest to the shipper.
The shipper to be notified is the licensee who last possessed the waste and
transferred the waste to the operator. If any discrepancy exists between materials
listed on the uniform manifest and materials received, copies or electronic
transfer of the affected forms must be returned indicating the discrepancy;
(II)
maintain copies of all completed uniform manifests and
electronically store the information required by §289.202(ggg)(4)(C)(iv)(II)
of this title until the agency terminates the license; and
(III)
notify the shipper and the agency when any shipment,
or part of a shipment, has not arrived within 60 days after receipt of an
advance uniform manifest, unless notified by the shipper that the shipment
has been cancelled.
(v)
Any shipment or part of a shipment for which acknowledgement
is not received within the times set forth in this section must undergo the
following:
(I)
be investigated by the shipper if the shipper has not
received notification or receipt within 20 days after transfer; and
(II)
be traced and reported. The investigation shall include
tracing the shipment and filing a report with the agency. Each licensee who
conducts a trace investigation shall file a written report with the agency
within two weeks of completion of the investigation.
This agency hereby certifies that the
adoption has been reviewed by legal counsel and found to be a valid exercise
of the agency's legal authority.
Filed with the Office of the Secretary of State on January
22, 1998.
TRD-9801017
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: March 1, 1998
Proposal publication date: October 3, 1997
For further information, please call: (512) 458-7236
Chapter 405.
Client (Patient) Care
Subchapter E. Electroconvulsive Therapy
25 TAC §§405.108, 405.112, 405.117
The Texas Department of Mental Health and Mental Retardation
(department) adopts amendments to §405.108 and §405.112 of Chapter
405, Subchapter E, concerning electroconvulsive therapy, with changes to the
text as proposed in the November 28, 1997, issue of the
Texas Register
(22 TexReg 11636). New §405.117 is adopted without
changes to the proposed text.
The amendments to §405.108 implement provisions of Senate Bill 1309
of the 75th Legislature, which revised the Texas Health and Safety Code, §578.003.
The amendments provide additional protections in §405.108(d) and new
(h) for patients aged 65 years of age or older for whom electroconvulsive
therapy (ECT) is recommended, and also delete the adjective "remote" as a
modifier of "death" in §405.108(e)(3)(D), which describes a requirement
that the written consent must clearly and explicitly state certain risks and
consequences of ECT.
The amendments to §405.112 respond to confusion expressed by some
hospitals and physicians by clarifying the quarterly deadlines for reporting
ECT data in subsection (b)(1)(B).
New §405.117 lists three exhibits described in §405.108 and
§405.112.
Minor revisions to language in §405.108(d) and §405.112(b)(1)
clarify references to the three exhibits listed in new §405.117. Language
has been revised in §405.108(d)(5) to be consistent with the provisions
of SB 1309; specifically, an "a" is substituted for "the" in the phrase "a
patient 65 years of age or older; "known" is inserted before "current medical
conditions"; and "two physicians" is added to clarify that the statement of
medical necessity for persons 65 years of age or older must be signed by two
physicians. In §405.108(h), the term "supplemental statement" is substituted
for "written supplement" in two places to be consistent with usage elsewhere
in the section. Also in §405.108(h), "stating" is substituted for "attesting"
and "and" for "or" to more accurately reflect the language of SB 1309. Language
in §405.112(b)(1) which had been proposed for deletion has been restored.
The language requires the collection of clinical data based upon the physician's
assessment of degrees of severity before and after ECT of memory impairment
and symptomatology. Exhibit C titled "Report of ECT and Other Therapies" has
been revised accordingly.
A hearing to accept oral and written testimony from the public concerning
the proposed amendments and new section was held on Friday, December 19, 1997,
in the department's Central Office auditorium in Building 2, 909 West 45th
Street in Austin. Testimony was presented by Advocacy, Inc., Austin; two physicians
in private practice, Austin; Restoring and Educating People Effected by ECT,
(RESPECT), Houston; and an individual speaking on behalf of three advocacy
organizations, Psychee, Committee for Truth in Psychiatry (CTIP), and Christians
United to Ban Electroshock Therapy (CUBES), Giddings. Written comments were
received from the following members of the public: a consumer/advocate, Austin;
Advocacy Inc., Austin; Texas Hospital Association (THA), Austin; Texas Medical
Association (TMA), Austin; Texas Mental Health Consumers (TMHC), Austin; and
Texas Society of Psychiatric Physicians (TSPP), Austin.
One commenter, in addressing testimony offered during the public hearing,
expressed concern that much of the testimony was misinformation promulgated
by a small number of individuals and groups who wish to discredit psychiatry
and psychiatric treatments and who do not represent the vast numbers of patients,
consumers, or professionals. He stated that the activities of these individuals
and groups perpetuate myths of psychiatric treatment and the stigma of mental
illness. Another commenter presented rebuttal testimony to statements of others
who had testified earlier in the hearing. The department responds that the
comments are outside the scope of the proposed amendments and new section.
One commenter suggested that information about advance directives for
mental health treatment be presented to consumers at a time when they are
stabilized and able to consult with other people and conduct research about
electroshock therapy. This would allow consumers to make an unhurried, dispassionate
decision. The department agrees that providing educational material concerning
advance directives for mental health treatment is a good idea. The commenter
is invited to submit this recommendation for consideration when the subchapter
is comprehensively revised as part of the rules sunset review process required
by Section 167 of Article IX of the current Appropriations Act. The department
also notes that in an information bulletin "For Your Information" (FYI) dated
September 22, 1997, information concerning advance directives for mental health
treatment was distributed; statutory provision for the directives was added
by SB 972 of the 75th Legislature to the Texas Civil Practice and Remedies
Code, Chapter 137.
The same commenter also recommended that laws concerning the disclosure
of side effects be strengthened, but provided no specifics. The department
responds that it continues to dialogue interested parties concerning the state's
ECT statutes.
A commenter stated that laws regarding safeguards for patients who receive
ECT are not being enforced as intended by the legislature and recommended
that they be more stringently followed. The department responds that specific
concerns about compliance with, and enforcement of, laws governing ECT should
be reported to the Texas Department of Health (TDH) at 1/800-228-1570. TDH
is the state agency with responsibility for investigating allegations of
violations of laws and rules governing ECT.
The commenter also recommended that magnetic resonance imaging (MRI) be
used before and after ECT treatment, that cognitive skill testing be conducted
before and after ECT, and that memory testing be conducted before ECT, immediately
after in two-week intervals, and in four-month intervals after final ECT
treatments. The department responds that studies in which attempts have been
made to detect brain damage resulting from ECT using MRI indicate that MRI
of extremely limited or negligible value for that purpose. The American Psychiatric
Association (APA) guidelines for ECT recommend that MRI should only be considered
if other data suggest that an abnormality may be present. The expense and
rigor required to obtain reliable data from cognitive skills testing and
memory testing suggests that such an approach, while possibly appropriate
for a limited research study, is not feasible as a statewide requirement.
A commenter recommended that ECT be performed only on an inpatient basis
and that if ECT is performed as maintenance treatment, the patient should
remain in the hospital for at least 48 hours. The department responds that
the standard of professional care and practice for any medical procedure is
that the physician will evaluate the patient's clinical needs and support
system and prescribe care accordingly.
A second commenter requested the addition of language to ensure that prior
to discharging a patient, a physician has assessed the individual and determined
that the individual is capable of addressing daily activities or has a support
system to address these needs. The department declines to add the language
as requested and notes again that doctors are expected to comply with the
accepted standard of professional care and practice for any medical procedure,
which includes evaluating the patient's clinical needs and support system
before authorizing the patient's discharge.
One commenter recommended that physical examinations of patients recommended
for ECT be conducted by a physician other than a psychiatrist, and that a
physical examination be conducted both before and after an ECT treatment.
Two other commenters recommended that the second physician required in §405.108(d)
and (h) not be a psychiatrist but rather a "physical medical doctor" who is
"familiar with cardiovascular, musculoskeletal, neurologic and other complications."
The department responds that a psychiatrist who performs or recommends ECT
is more likely to be sensitive to the physiological affects of the treatment
and is qualified to address the issue of medical conditions which may increase
the possibility of injury or death as a result of ECT.
A commenter recommended that ECT be recommended only for the treatment
of depression and only as a last means of treatment when other methods of
treatment have proven ineffective. The department responds that the APA guidelines
for ECT recognize its effectiveness of all subtypes of bipolar disorder major
depression, all types of mania, and for psychotic schizophrenic exacerbations
in certain situations. The APA guidelines also recognize that ECT may be appropriate
as a first line of treatment in certain situations prior to a trial of psychoactive
medications, such as when a need for rapid, definitive response exists for
medical or psychiatric reasons, when the risks of other treatments outweigh
the risk of ECT, or when a history of poor drug response and/or good ECT response
exists for previous episodes of the illness, or when the patient expresses
a preference for ECT.
A commenter expressed concern that health insurance companies, particularly
health maintenance organizations (HMOs), are pushing for the use of ECT as
a rapid response treatment so patients can be discharged from inpatient settings
quickly. The commenter urged that adequate protections be developed to prevent
patients from being dismissed without necessary and appropriate post-treatment
care. The department responds that the corporate policies of health insurers
vary widely, but all health insurers in Texas, excluding ERISA insurers, are
regulated by the Texas Department of Insurance (TDI). TDI rules require that
insurers provide mechanisms by which consumers can appeal the insurer's decisions.
Consumers can also complain directly to TDI (1-800-252-3439) which investigates
complaints and has authority to enforce rules governing health insurance.
Six commenters recommended the retention of a provision proposed for deletion
in §405.112(b)(1) concerning the collection of clinical data concerning
memory loss and symptomology from before, during, and 30 days after ECT is
performed. Two commenters recommended that the department develop a consumer-driven
system for reporting occurrences of memory loss similar to the system used
by California. One commenter stated that while subjective, the information
which has been collected has proven useful and that the a physician's assessment
of the patient's degree and scope of memory loss is practical and already
is routinely done. The department has restored the language in §405.112(b)(1)
and in Exhibit C.
With regard to §405.108, concerning informed consent to ECT, a commenter
recommended adding language specifying that if a patient receiving psychoactive
medications under court order is recommended for ECT, the issue of the patient's
capacity to consent to ECT must be submitted to the court for consideration.
The department responds that the statutory provisions concerning a patient's
capacity to provide consent to the administration of psychoactive medications
are narrowly drawn and no statutory authority exists for the department to
petition a court for permission to perform ECT.
A commenter recommended that the initial consent for ECT or series of
ECT be videotaped as a safeguard for both the department and the patient.
The department responds that videotaping currently is not a standard of practice
when obtaining consent for medical procedures. In addition, such a requirement
could be expected to carry a significant fiscal impact.
A commenter expressed concern that patients are being asked to sign consent
for second and subsequent treatments while still confused and suffering memory
loss from the previous treatments. The commenter requested that time intervals
between signatures on the consent form be researched and the information shared
with the commenter. The department responds that the time intervals between
treatments in a series are driven by clinical considerations specific to each
patient.
Concerning the provision in §405.108(g), which permits a patient's
guardian to authorize both the series and each individual treatment via a
faxed or mailed signature sheet, a commenter recommended adding language requiring
the patient to be provided with the signed consent form well in advance of
the initial treatment and to have the information explained orally. The department
responds that §405.108(f)(1) already requires both patient and guardian
to be provided with a copy of the completed consent form and supplemental
statement and (f)(2) requires the information in the consent form and supplemental
statement to be explained orally in simple, nontechnical terms to both the
patient and guardian. The department also notes that the length of time between
the presentation of the consent form and performance of ECT is dictated by
clinical considerations. The commenter also requested that when multiple signatures
are recorded simultaneously by the guardian on the consent form, the patient
still must be presented with the document and have the information explained
orally. The department responds that neither statute nor rule permits the
simultaneous recording of multiple signatures on the consent form. Both statute
(§578.003(c)(4)) and rule (§405.108(c)) require that the consent
form be signed before each treatment in a series.
A commenter requested that the "or" in new §405.108(h) be replaced
by an "and" consistent with SB 1309, which requires both patient and guardian
to be presented with the completed consent forms. The department agrees that
this change conforms to the intent of the statute amended by SB 1309 and has
revised the language accordingly.
A commenter stated that the requirement in §405.108(d) and (h) that
two physicians sign the supplemental statement for patients over 65 places
an undue burden and cost on hospitals and physicians who perform ECT, especially
in rural areas where finding a second physician may be difficult and could
delay administration of necessary treatment. In addition, the commenter said,
it is likely that obtaining the second signature would involve a second evaluation
and thus a second charge to the patient. In this way, the patient in need
of ECT would be greatly disserviced by having to wait for this unnecessary
step and by having to pay for an additional consultation, if necessary, to
obtain the second signature. The department responds that the provision is
required by SB 1309.
A commenter requested that the designation of "treating" and "consulting"
be deleted for the two signature for physicians on the portion of the supplemental
statement (Exhibit B) dealing with patients 65 years of age or older. The
commenter stated that SB 1309 specifies only that two physicians sign the
form, without specifying "treating" and "consulting." The department responds
that requiring this information is consistent with statutory intent.
A commenter recommended that Exhibit C (Report of ECT and Other Therapies)
not include the date of the most recent ECT or the names of the physician
who performed ECT or the psychiatrist who ordered ECT because the statute
does not require this information be submitted in the quarterly reports. The
commenter stated that identifying the names of the physician and psychiatrist
is a breach of confidentiality. A second commenter also raised the issue of
breach of confidentiality if the name of a psychiatrist who orders ECT is
included in the form. The second commenter also said that if the department
decides to retain the requirement, the name should not be disclosed except
for agency analysis in any copy of, or report generated from the data submitted
on the form. The department responds that while the statute does not specifically
require that the information in question be reported, §578.007(b)(9)
of the Texas Health and Safety Code permits the department to ask for other
information on the quarterly reports. As the state regulatory agency for ECT,
the department needs this information if issues should arise about the treatments
covered in the quarterly reports. Concerning the second commenter's request
that the name of the psychiatrist ordering the ECT not be disclosed, the department
explains that the report required in THSC §578.008(b) to be filed with
the governor and the presiding officer of each house of the legislature does
not include the names of any physicians. The statute, in fact, requires that
the names of private physicians performing ECT on an outpatient basis not
be included in the report.
A commenter recommended Exhibit C (Report of ECT and Other Therapies)
not include "DSM diagnosis" and "type of stimulus equipment used" because
the THSC, §578.007, does not require this information be submitted in
the quarterly reports. The commenter also recommended that deaths not be considered
reportable events to be included in the quarterly report since the statute
requires reporting "the number of fractures, reported memory losses, incidents
of apnea, and cardiac arrests without death." The commenter noted that the
statute requires that autopsy findings be reported "if death followed within
14 days after the date" of treatment. The department responds that although
the statute does not specifically require that the information in question
be reported, THSC, §578.007(b)(9), permits the department to ask for
other information on the quarterly reports. Also the department believes that
requiring that deaths be reported on Exhibit C is not inconsistent with the
statutory requirement of submitting autopsy findings for deaths occurring
within 14 days after an ECT treatment.
The sections are adopted under the Texas Health and Safety Code,
§532.015, which provides the Texas Mental Health and Mental Retardation
Board with broad rulemaking authority; with §571.006, which provides
for the adoption of rules as necessary for the proper and efficient treatment
of persons with mental illness; and with §578.003 which provides for
the adoption of rules related to the standard written consent form.
§405.108. Informed Consent to ECT.
(a)
Consent under this section is not valid unless the person
giving consent understands the information presented and consents voluntarily
and without coercion or undue influence.
(b)
A person who gives consent may revoke consent for any
reason at any time, with revocation effective immediately.
(c)
Prior to each individual ECT treatment, consent to electroconvulsive
therapy must be obtained. Unless the person consents in accordance with this
subchapter, ECT may not be administered to:
(1)
a patient who is 16 years or older and voluntarily receiving
services;
(2)
an involuntary patient who is 16 years or older and
who has not been adjudicated incompetent to manage his or her own personal
affairs;
(3)
an involuntary patient who is 16 years or older and
who has been adjudicated incompetent to manage his or her own personal affairs,
unless:
(A)
the patient has an appointed guardian of the person of
the patient;
(B)
the guardian of the person consents to treatment in accordance
with this section; and
(C)
the consent of the guardian is based on knowledge of what
the patient would desire, if known.
(d)
Consent shall be documented by the signature of the person
giving consent on the form entitled "Disclosure and Consent for Electroconvulsive
Therapy" which is referenced as Exhibit A of §405.117 of this title (relating
to Exhibits), and which shall include a supplemental statement about the individual
patient containing the information in the form entitled "Supplemental Statement"
which is referenced as Exhibit B of §405.117 of this title (relating
to Exhibits), including:
(1)
indications for therapy for the patient;
(2)
medical evaluation results;
(3)
contraindications to therapy;
(4)
results of psychiatric and other medical consultation(s)
relevant to ECT; and
(5)
for a patient 65 years of age or older:
(A)
known current medical conditions that may increase the
possibility of injury or death as a result of ECT; and
(B)
statement by two physicians that the treatment is medically
necessary.
(e)
The consent form shall be fully completed to explicitly
state the following information:
(1)
the nature and seriousness of the mental condition requiring
ECT;
(2)
the nature of the procedures to be followed, including
anesthesia, and their purposes, including the identification of any procedures
which are experimental;
(3)
the nature, degree, duration, and probability of
significant risks and/or side effects and/or adverse effects resulting from
ECT commonly known by the medical profession, including:
(A)
memory changes of events prior to, during, and immediately
following the treatment;
(B)
fractures and dislocations of bones;
(C)
the probability of significant temporary post-treatment
confusion requiring special care; and
(D)
the possibility of permanent memory dysfunction, especially
noting the possible degree and duration of memory loss, the possibility of
permanent, irrevocable memory loss, the remote possibility of seizures, and
the possibility of death;
(4)
that there is a division of opinion as to the
efficacy of the procedure;
(5)
the benefits reasonably to be expected;
(6)
the probable degree or duration of improvement or
remission expected with or without the procedure;
(7)
a disclosure of any appropriate alternative procedures
that might be advantageous for the patient;
(8)
an offer to answer any inquiries concerning the procedures;
(9)
an instruction that the consenting party is free
to withdraw consent and to discontinue an individual treatment or a series
of treatments at any time without prejudice to the care of the individual;
(10)
an instruction that consent is for one individual
treatment, and that additional treatments shall require renewed written informed
consent; and
(11)
the side effects of anesthesia shall also be explained.
(f)
Before a patient receives ECT, the hospital, facility,
or physician administering the therapy shall ensure that:
(1)
the patient and the patient's guardian of the person,
if any, receive a copy of the completed consent form, a written supplement
containing related information concerning the individual patient, in the patient's
primary language, if possible;
(2)
the consent form and supplement are orally explained
to the patient and the patient's guardian of the person, if any, in simple,
nontechnical terms in the patient's primary language, if possible, or by means
reasonably calculated to communicate with a hearing-impaired or visually-impaired
person, if applicable;
(3)
the patient or the patient's guardian of the person,
as appropriate, signs the consent form, which states that the person has read
and understood the consent form and written supplement; and
(4)
the signed consent form is made a part of the patient's
permanent medical record.
(g)
In cases in which the individual giving consent is the
guardian of the person, the requirements of the consent process may be fulfilled
through a phone conversation that includes all of the elements that would
be discussed in person, witnessed by one individual who is not the physician
who will be administering ECT. A copy of the consent form and written supplement
must be mailed or faxed to the individual giving consent prior to obtaining
the initial informed consent. The consent must be obtained for each individual
treatment.
(h)
For a patient 65 years of age or older, before each treatment
series begins the hospital, facility, or physician administering the procedure
shall:
(1)
ensure two physicians sign the appropriate section of
the supplemental statement described in subsection (d)(5) of this section
stating that the treatment is medically necessary; and
(2)
inform the patient and the patient's guardian of
the person, if any, orally and in the supplemental statement described in
subsection (d)(5) of this section, of any known current medical condition
the patient has that may increase the possibility of injury or death as a
result of the treatment.
§405.112. Report of ECT.
(a)
Reporting requirements for state facilities and community
centers.
(1)
A report of each individual ECT administered to a patient
shall be entered into the patient's medical record and shall include, but
not be limited to, the following:
(A)
diagnosis for which ECT given;
(B)
date of treatment;
(C)
type of ECT machine used;
(D)
duration and strength of electrical stimulation;
(E)
all medications administered; and
(F)
any complications or adverse effects.
(2)
A report of all ECT treatments will be provided
at the end of each month to the chief executive officer. The report shall
include the following:
(A)
name, age, gender, and identification number of patient;
(B)
diagnosis for which ECT given;
(C)
dates and number of treatments given; and
(D)
any complications or adverse effects.
(b)
Reporting requirements for all providers.
(1)
On a quarterly basis, the chief executive officer of a
mental hospital or other facility that administers ECT, psychosurgery, "prefrontal
sonic treatment," or any other convulsive or coma-producing therapy to treat
mental illness and any physician who administers ECT on an outpatient basis
shall make a written report to the TXMHMR medical director containing the
information requested on the form entitled "Report of ECT/Other Therapies"
which is referenced as Exhibit C of §405.117 of this title (relating
to Exhibits). The reporting format requires clinical data from before, after,
and 30 days after treatment.
(A)
The facility and/or its medical staff shall require that
the treating physician(s) provide complete, accurate, and timely information
to the CEO for this purpose.
(B)
Reports must submitted to be received by the TXMHMR medical
director not later than 30 days following the end of each state fiscal year
quarter. For treatments administered in September, October, and November,
the deadline is December 31; for December, January, and February, the deadline
is March 31; for March, April, and May, the deadline is June 30; and for June
July, and August, the deadline is September 30.
(2)
The report will include, but may not be limited
to, the following information for the quarter:
(A)
the number of persons who received the therapy, including:
(i)
the number of persons receiving voluntary mental health
services who consented to the therapy;
(ii)
the number of involuntary patients who consented to the
therapy; and
(iii)
the number of involuntary patients for whom a guardian
of the person consented to the therapy;
(B)
the age, gender, and race of the persons receiving therapy;
(C)
the general source of the treatment payment;
(D)
the number of non-electroconvulsive treatments listed
in paragraph (1) of this subsection;
(E)
the number of electroconvulsive treatments administered
for each complete series of treatments, excluding maintenance treatments;
(F)
the number of maintenance electroconvulsive treatments
administered;
(G)
the number of fractures, reported memory losses, incidents
of apnea, and cardiac arrests without death;
(H)
autopsy findings if death followed within 14 days after
the date of the administration of the therapy; and
(I)
other information that may be required by the department.
(c)
Reporting requirements for the department.
(1)
Annually the department shall compile the information
reported under subsection (b) of this section by mental hospital, other facility,
and private physician administering ECT on an outpatient basis. Private physicians
and individual patients shall not be named or otherwise identified.
(2)
A copy of the report shall be filed with the governor
and presiding officer of each house of the legislature.
(3)
The department shall use this information to analyze,
audit, and monitor the use of ECT and other reportable procedures.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of the Secretary of State on January
22, 1998.
TRD-9801022
Ann Utley
Chair, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: February 11, 1998
Proposal publication date: November 28, 1997
For further information, please call: (512) 206-4516
Subchapter C. Use and Maintenance of
Chapter 128.
Permits for Contact Lens Dispensers
Chapter 289.
Radiation Control
License Regulations
Texas Regulations for Control of Radiation
General
General
License Regulations
License Regulations
Part II.
Texas Department of Mental Health and Mental Retardation
Chapter 415.
Provider Clinical Responsibilities