Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 31.
NUTRITION SERVICES
Subchapter C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)
25 TAC §§31.21, 31.30, 31.32 - 31.37
The Texas Department of Health (department) adopts amendments
to §§31.21, 31.30, and 31.32-31.37 concerning the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC). Sections 31.30,
31.32, 31.33, 31.34, and 31.36 are adopted with changes to the proposed text
as published in the October 5, 2001, issue of the
Texas Register
(26 TexReg 7750). Sections 31.21, 31.35, and 31.37 are
adopted without changes, and therefore the sections will not be republished.
The United States Department of Agriculture (USDA) provides federal grant
funds to the department to administer the WIC Program, provided the department
does so in accordance with federal regulations. The WIC Program is 100% funded
by a combination of federal grant funds and monies received from infant cereal
and formula manufacturers in the form of rebates to the department. Rebate
monies are considered dedicated general revenue and can only be expended to
offset WIC food costs. Costs to the state for implementing these rules will
be paid for by federal funds.
The amendments to §§31.21, 31.30, and 31.32-31.36 are required
to implement new federal regulations governing the WIC Program. The amendment
to §31.37 will enable the program to respond in a more timely, efficient,
and flexible manner to changes in packaging of WIC-issued foods by manufacturers
and to changes in allowable foods requested by vendors and clients.
The department is making the following minor changes to clarify the intent
and improve the accuracy of the section.
Change: Concerning §31.30(a), the conjunction "or" has been added
to improve the clarity of the section.
Change: Concerning §31.30(e), the Investigation section formerly attached
to the Office of General Counsel has been reorganized and redesignated the
department's Office of Criminal Investigations.
Change: Concerning §31.30(f), the Investigation section formerly attached
to the Office of General Counsel has been reorganized and redesignated the
department's Office of Criminal Investigations.
Change: Concerning §31.36(a), the conjunction "and" has been moved
from the beginning of §31.36(a)(3) to the end of §31.36(a)(2).
The following public comments were received concerning the proposed amendments
to the rules. Following each comment is the department's response and any
resulting changes.
Comment: Concerning §31.32(h)(1)(D), one commenter suggested the required
advance notice for a vendor to notify the state agency of the opening of a
new store should be less than 30 days. The commenter added that a 30-day advance
notice was not fair to WIC clients using the services in that area because
a vendor may not always know a new store's opening date 30 days in advance
and may change the date depending on several factors.
Response: The department agrees and has deleted the specific 30-day timeframe
from the advance notice requirement.
Comment: Concerning §31.33(c)(1) and §31.33(c)(2), one commenter
suggested that these sections are already covered in federal WIC regulations
and are therefore unnecessary.
Response: The department agrees and deleted the paragraphs.
Comment: Concerning §31.34, one commenter pointed out that federal
regulations authorize the department to issue warnings to vendors who fail
to meet competitive pricing criteria prior to terminating the vendor's contract,
and suggested that the department should do so.
Response: The department agrees and added language to allow the department
to conduct a preliminary review of a vendor's compliance with competitive
pricing criteria and to issue a warning if the preliminary review indicates
noncompliance. The amended section requires that if a subsequent review indicates
noncompliance, the vendor's contract shall be terminated.
The commenters were the USDA Food and Nutrition Service and the Gulf Coast
Retailers Association. The commenters were not against the rules in their
entirety, but made recommendations for change as discussed in the summary
of comments.
The amendments to the rules are adopted under Health and Safety
Code, §12.001, which provides the Texas Board of Health (board) with
the authority to adopt rules for the performance of every duty imposed by
law on the board, the department, and the commissioner of health; the Texas
Omnibus Hunger Act of 1985, 69th Legislature, Chapter 150, Title II, Human
Resources Code, Chapter 33; the Child Nutrition Act of 1966, 42 USC §1786;
and 7 CFR Part 246.
§31.30.Participant Fraud and Abuse.
(a)
Participants and parents, guardians, client-designated
proxies, state agency- appointed proxies, or caretakers of participants identified
and documented as having abused the WIC Program shall be sanctioned.
(b)
In all cases where it is found by the state agency that
a participant or parent, guardian, client-designated proxy, state agency-appointed
proxy, or caretaker of a participant unlawfully received benefits due to WIC
Program abuse, including but not limited to dual participation, the state
agency has the option to refer the matter for criminal prosecution.
(c)
Program violations means any intentional act of a participant,
parent, guardian or caretaker of an infant or child participant, client-designated
proxy or state agency-designated proxy that violates Federal or State statutes,
regulations, rules, policies or procedures governing the WIC Program. Violations
include, but are not limited to, intentionally making a false or misleading
statement; intentionally misrepresenting, concealing, or withholding facts
to obtain benefits; exchanging food instruments or food for cash, credit,
non-food items, or unauthorized foods, including foods in excess of that authorized;
threatening to harm or physically harming local agency, vendor or state agency
staff; and simultaneous participation in the Program in one or more than one
WIC clinic or participation in the Commodity Supplemental Food Program during
the same period of time
(d)
If prosecution is declined by the appropriate jurisdiction,
the violation does not involve a violation of criminal law, or final disposition
of criminal prosecution has occurred the state agency shall direct the local
agency to initiate sanctions which may include disqualification from the Program
for up to one year.
(e)
Upon a final determination by the department's Office of
Criminal Investigations that a program violation has occurred and that final
disposition of any criminal prosecution has occurred, the following mandatory
disqualifications shall apply.
(1)
For an offense where a claim of $100 or more is assessed,
the participant shall be disqualified for one year.
(2)
For an offense where a participant illegally received benefits
at more than one WIC office and the state agency assesses a claim for such
dual participation, the participant shall be disqualified for one year.
(3)
When the state agency assesses a second or subsequent claim
of any amount, the participant shall be disqualified for one year.
(f)
Upon a final determination by the department's Office of
Criminal Investigations that a program violation which does not warrant a
one year mandatory disqualification has occurred and final disposition of
any criminal prosecution has occurred, the following sanctions shall apply.
(1)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant exchanges
food instruments or food for cash or credit, the participant shall be disqualified
for a period of six months for a first offense and 12 months for a second
or subsequent offense.
(2)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant exchanges
food instruments or food for firearms, explosives, ammunition, controlled
substances, alcohol, or tobacco products, the participant shall be disqualified
for a period of six months for a first offense and 12 months for a second
or subsequent offense.
(3)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant exchanges
food instruments or food for non-food items not listed in §31.30(f)(2),
the participant shall receive a warning for the first offense and shall be
disqualified for a period of 12 months for a second or subsequent offense.
(4)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant exchanges
food instruments or food for unauthorized food including foods in excess of
that authorized, the participant shall receive a warning for the first offense
to and shall be disqualified for a period of 12 months for a second or subsequent
offense.
(5)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant threatens
to harm local agency, vendor, or state agency staff, the participant shall
be disqualified for a period of six months for a first offense and 12 months
for a second or subsequent offense.
(6)
When a participant or a parent, guardian, client-designated
proxy, state agency-appointed proxy, or caretaker of a participant physically
harms local agency, vendor, or state agency staff, the participant shall be
disqualified for a period of 12 months for a first offense and 12 months for
a second or subsequent offense.
(g)
Exceptions to disqualification:
(1)
The state agency may decide not to impose a disqualification
if, for violations which resulted in a claim assessed by the state agency
against the participant, parent, guardian, client designated proxy, state
agency-appointed proxy, or caretaker of a participant, full restitution is
made within 30 days of receipt of a letter demanding repayment or a repayment
schedule is agreed on.
(2)
The state agency may permit a disqualified participant
to reapply for the program before the end of a disqualification period if,
in the case of a violation where a claim was assessed by the state agency
against the participant or parent, guardian, client-designated proxy, state-agency
appointed proxy, or caretaker of a participant, full restitution is made or
a repayment schedule is agreed upon.
(3)
At the recommendation of the local agency's competent professional
authority, the state agency may issue a waiver to appoint a person as a special
proxy to transact food instruments and receive nutrition education for an
infant, child, or participant under age 18 when the infant, child, or participant
under age 18 will incur a serious health risk from the suspension of benefits.
(h)
The state agency shall attempt to recover, in cash, the
value of the benefits received by a participant or the parent, guardian, client-designated
proxy, state agency-appointed proxy or caretaker of a participant as a result
of participant abuse.
(1)
The state agency shall determine the amount of the benefits
improperly received by a participant through an independent review of local
agency records and such other procedures as the state agency considers necessary
under the specific circumstances.
(2)
In cases involving criminal prosecutions for violations
of law, repayment of the cash value of benefits improperly received shall
become a part of any restitution agreement with the prosecutor. In such cases,
the participant shall not have the right to a fair hearing by the department.
(3)
In cases involving an administrative claim but no criminal
prosecution, the state agency shall notify the participant or parent, caretaker,
or guardian of a participant in writing that a financial claim has been established
and shall request repayment of an amount equal to the value of the benefits
improperly received. The written notification shall include the reasons for
the claim, the value of the benefits improperly received, and the participant's
right to a fair hearing.
(i)
Collection of a financial claim assessed against a participant
by offset of future benefits is not authorized.
§31.32.Selection of Vendors for WIC Initial Authorization for Participation.
(a)
A representative from the state agency or the nearest local
agency shall perform an on-site evaluation of a vendor applying for authorization
to redeem WIC food instruments.
(1)
The state or local agency representative shall complete
a vendor evaluation form during the visit to the vendor indicating the type
of WIC-authorized foods in stock and their shelf prices.
(2)
The state or local agency representative shall recommend
approval or disapproval of the vendor's application based on the observations
during the store visit.
(3)
The owner or manager or a store representative shall have
the opportunity to review the information on the vendor evaluation form and
shall sign the form to acknowledge accuracy of shelf prices listed at the
time of the evaluation. The evaluator shall provide a copy of the form, including
the date, local agency number, and the name of the evaluator, to the vendor
at the time of the in-store evaluation.
(b)
The state agency shall base its decision to authorize a
vendor on the following criteria:
(1)
The vendor's shelf prices for approved WIC foods in stock
are competitive for the local agency area.
(2)
The vendor has sufficient quantities of authorized milk,
evaporated milk, cheese, cereal, contract infant formula, contract infant
cereal, eggs, peanut butter, and dried beans.
(A)
pharmacy may elect to provide only the designated contract
milk and soy formulas and special formulas.
(B)
A vendor may elect not to provide infant formula.
(C)
For vendors who elect to provide all authorized foods,
the following amounts of each food type shall constitute sufficient quantities:
(i)
a total of at least 108 ounces of adult cereal, including
36 ounces each of at least three of the following types of cereal: oat, corn,
wheat, rice, and multi-grain;
(ii)
at least six dozen Grade A or AA large, medium, or small
size eggs;
(iii)
a total of at least 18 containers of juice, including
at least two varieties of juice in 46-ounce fluid cans and/or 12-ounce frozen
cans;
(iv)
a total of at least six pounds of cheese;
(v)
a total of at least nine gallons of milk, some of which
must be available in one-half gallon containers;
(vi)
at least three one-pound bags of dry beans;
(vii)
at least three 18-ounce jars of peanut butter;
(viii)
at least eight 12-ounce cans of evaporated milk;
(ix)
at least 31 cans of milk or soy concentrate infant formula
(contract brand) and either eight cans of milk-based powder formula or nine
cans of soy powder formula (contract brand); and
(x)
at least two 8-ounce boxes or one 16-ounce box of infant
cereal.
(3)
The vendor provides milk in gallon and half-gallon containers
and juice in 46-ounce or 12-ounce containers.
(4)
The vendor's shelf prices do not exceed the maximum prices
on WIC food instruments.
(5)
The recommendation by the state or local agency representative
who conducted the on-site evaluation.
(6)
The vendor has a retail food operations permit or food
manufacturer's permit from the applicable city, county, district, or state
health authority.
(7)
The vendor's store is clean, with fresh merchandise (no
expired food items).
(8)
The vendor has no apparent conflict of interest with the
local agency in the vendor's service area or with the state agency.
(9)
The vendor has posted prices for food items.
(10)
If applicable, the vendor's history of WIC Program noncompliance.
(11)
The vendor has business integrity as indicated by a lack
of activities during the past six years including fraud, antitrust violations,
embezzlement, theft, forgery, bribery, falsification or destruction of records,
making false statements, receiving stolen property, making false claims, obstruction
of justice, or tax evasion.
(12)
The vendor is not currently disqualified from the Food
Stamp Program or has not been assessed a civil money penalty for hardship
by the Food Stamp Program and the disqualification period that would otherwise
have been imposed by the Food Stamp Program has not expired unless denying
WIC Program authorization would result in inadequate participant access.
(13)
The vendor operates and will transact food instruments
at a fixed location unless a mobile store is necessary to meet special needs
as described in the state agency's state plan and approved by USDA.
(14)
The vendor has participated in vendor interactive training.
(c)
If the state agency disapproves the application by a vendor
for authorization, the reasons for the disapproval shall be provided to the
vendor in writing.
(d)
Vendors who apply for authorization who have been evaluated
twice within a six-month period and denied approval both times shall not be
evaluated again until at least six months from the last evaluation.
(e)
In the event a vendor purchases or acquires a store location
or business which was in the process of being disqualified or which is disqualified
from the WIC Program at the time of acquisition, the vendor's application
for that store location or business shall not be considered until the state
agency makes a determination that the sale was a bona fide arms-length transaction.
The state agency will make this determination no later than six months from
the date of application. If the state agency determines that the transfer
was not an arms-length transaction, the application shall not be considered
until the disqualification period has been served.
(f)
If the state agency has allowed the vendor agreement for
a previous owner of a store location or business to expire for noncompliance
or notified the previous owner that the vendor agreement for the store location
or business will be allowed to expire for noncompliance, a new owner's application
for that store location or business shall not be considered until at least
six months from the expiration date of the previous owner's last vendor agreement
unless the state agency makes an earlier determination that the sale was a
bona fide arms-length transaction.
(g)
The state agency may waive the requirement for an on-site
evaluation when a grocery chain comprising 20 or more outlets authorized to
participate in the WIC Program purchases or merges with another chain with
20 or more authorized outlets if the merger or purchase does not materially
change the stores' staff or pricing structure
(h)
Upon request, the state agency may provide an applicant
vendor with tentative authorization to redeem WIC food instruments starting
the day the store opens.
(1)
To obtain tentative authorization, the vendor shall comply
with all of the following criteria:
(A)
The owner of the applicant store owns ten or more stores
that have been participating in the WIC Program under the current ownership
for at least the six-month period prior to application for authorization.
(B)
For the six month period prior to application for authorization,
fewer than 20% of the applicant's participating stores' authorizations have
been terminated for exceeding the competitive pricing criteria for either
the woman/child package or the infant food package for their respective local
agency vendor bands.
(C)
None of the participating stores has been disqualified
from program participation for two or more months within the 12-month period
prior to application for authorization.
(D)
The applicant store notifies the state agency prior to
the official opening date.
(E)
The applicant store's manager or assistant manager acknowledges
receipt and understanding of the vendor agreement including its attachments,
training materials and manuals, the allowable foods list, and vendor rules
and policies.
(F)
The applicant store's manager or assistant manager has
scored at least 70% on a written test provided by the state agency and returned
to the state agency no later than five days prior to the applicant store's
opening date.
(2)
If, after evaluation, a store which has received tentative
authorization from the state agency does not meet all authorization criteria,
the store shall be notified of its tentative agreement expiration date and
instructed to discontinue redeeming the WIC Program food instruments. The
state agency shall honor properly redeemed food instruments from the opening
date until the tentative agreement expiration.
(i)
On a temporary basis, the state agency may consider and
approve applications from new vendors for the following reasons:
(1)
the vendor has been authorized to accept Food Stamps;
(2)
the disqualification of an existing authorized vendor in
a local agency service area would create inadequate access for WIC Program
participants;
(3)
a currently-authorized vendor outlet(s) changes ownership;
or
(4)
authorization of a new vendor would result in a significant
cost advantage to the WIC Program.
(j)
The state agency may deny an application to participate
as a vendor if an owner, partner, principal stockholder, officer, director,
manager, or operator of the applicant was an owner, partner, principal stockholder,
officer, director, manager, or operator of another vendor which has been disqualified
or which has violated WIC Program vendor agreement procedures, policies, rules
or regulations.
(k)
The state agency may hold an authorized vendor individually
responsible for previous violations by an owner, partner, manager, or principal
stockholder of the vendor when considering renewal of the vendor's agreement
or future applications for vendor agreements.
(l)
A history of noncompliance with the WIC Program's federal
and state statutes and regulations, rules, policies, and procedures shall
be considered by the state agency when evaluating an authorized vendor's application
for authorization of new outlets. The state agency will not authorize new
outlets for a vendor where 50% of the vendor's outlets are in a disqualification
or termination status at the time of a request to authorize new outlets.
§31.33.Selection of Vendors for Reauthorization for Participation.
(a)
Vendors with a current vendor agreement who seek reauthorization
shall reapply and shall be evaluated for issuance of a subsequent vendor agreement
under WIC Program procedures, policies, rules, and regulations and shall be
reauthorized unless notified in writing by the state agency at least 15 days
before expiration of the vendor agreement.
(b)
Prior to reauthorization, the state agency shall assess
and review the qualifications of all vendors to assure that each continues
to meet the WIC Program's goals. Criteria utilized in assessment and determination
of qualifications for reauthorization include, but are not limited to.
(1)
Competitive prices for the local agency area. A vendor's
prices shall be considered competitive if the combined prices for the items
included in the standard woman/child and/or infant food package do not exceed
108% of the local agency food package averages for the vendor's band.
(2)
Volume of WIC sales. The vendor's volume of WIC sales exceeds
$300 a month. If monthly sales fall below $300 a month for three consecutive
months prior to the time of the vendor agreement reauthorization evaluation,
the vendor agreement may not be renewed.
(3)
Previous compliance with WIC Program procedures, policies,
rules, and regulations. The vendor has satisfactorily complied with food instrument
redemption and submission procedures, policies, rules, and regulations.
(4)
Continuing to meet selection criteria. The vendor continues
to meet the selection criteria as stated in this section and in §31.32
of this title (related to Selection of Vendors for WIC Initial Authorization
for Participation).
(5)
Use of the WIC acronym or WIC logo. If the state agency
determines that the vendor failed to comply with the prohibitions on the use
of the WIC acronym or WIC logo, after having received a written warning, the
state agency shall allow the vendor agreement to expire without renewal.
(6)
Failure to attend training. The vendor agreement shall
not be renewed if a vendor or vendor representative has not attended a WIC
vendor interactive training within three years from the last date a representative
attended a WIC vendor interactive training.
(c)
A history of noncompliance with WIC Program procedures,
policies, rules, and regulations shall be considered by the state agency in
determining if the vendor is eligible for a subsequent contract.
(d)
The state agency may allow a vendor's agreement to expire
and not be renewed if the vendor has a history of noncompliance with provisions
in the vendor agreement or the WIC Program procedures, policies, rules, and/or
regulations.
(1)
Expiration of the vendor agreement is not subject to appeal.
(2)
In the event the vendor's agreement has been allowed to
expire due to previous noncompliance, a vendor's request for reauthorization
shall not be considered until at least six months from the expiration date
of the vendor's last agreement.
(e)
All vendors must have a retail food operation permit or
food manufacturers' permit from the applicable city, county, district, or
state health authority.
§31.34.Calculation and Use of Vendor Competitive Pricing Data.
(a)
The state agency shall use the following calculation to
determine whether a vendor's prices are competitive with those of similar
vendors in the local agency service area.
(1)
The state agency data system calculates by vendor outlet
the average unit costs to the state agency for each food type based on the
food instruments redeemed by that vendor outlet.
(2)
Authorized vendor outlets within a local agency service
area are grouped into volume vendor bands.
(3)
Utilizing food-type averages for each vendor outlet within
a vendor band, the state agency determines the local agency average standard
food package costs for an infant and/or a woman/child participant for each
vendor band.
(4)
A vendor outlet's average standard food package costs are
determined based on the store evaluation for an applicant vendor or actual
WIC redemption data for authorized vendors.
(5)
The state agency compares the vendor outlet's standard
food package costs to the local agency's average standard food package costs
for that vendor band. Local agency averages for a prior period will be used.
An outlet's standard food package costs are considered competitive if they
are less than or equal to 108% of the local agency's average standard food
package costs for that vendor band.
(6)
The state agency may make adjustments to the local agency
averages due to anomalies, such as those caused by sharp wholesale price increases
or crop failures since the prior period in which the averages were calculated.
(7)
The state agency may reassign a vendor to an alternative
comparison group when the vendor, such as a high-volume, national discount
superstore, is not characteristic of other vendors in the band; when the vendor
is the only store in a rural area within the local agency; or when the vendor
is the sole occupant of a band.
(b)
The state agency may perform a preliminary review of the
vendor's compliance with competitive pricing at any time during the term of
the vendor agreement. The state agency shall provide a noncompliant vendor
with written notification of noncompliance determined from the preliminary
review. If, on a subsequent assessment within the term of the vendor agreement,
the noncompliant vendor fails to comply with competitive pricing, the state
agency shall provide a vendor with written notification of noncompliance with
competitive pricing and the vendor agreement shall be terminated.
§31.36.The Right of a Vendor or Local Agency to Appeal.
(a)
A local agency or vendor has the right to appeal when an
application for participation is denied and/or any other adverse action affecting
participation is taken. The only exceptions to this rule are:
(1)
expiration of the vendor agreement or local agency contract;
(2)
disqualification of a vendor as a result of disqualification
from the Food Stamp Program; and
(3)
a determination by the state agency WIC Program concerning
whether disqualification of a vendor would result in inadequate participant
access.
(b)
The state agency shall provide a local agency or vendor
with written notification of an adverse action, the cause(s) for the action,
the effective date of the action, and the right to appeal the adverse action.
(c)
The state agency shall provide a local agency notice of
disqualification at least 60 days prior to the effective date.
(d)
The state agency shall provide a vendor notice of an adverse
action at least 15 days prior to the effective date of the action except when
the adverse action results from conviction for trafficking in food instruments
or selling firearms, ammunition, explosives, or controlled substances in exchange
for food instruments, which is effective on receipt of the notice.
(e)
A local agency or vendor shall provide the state agency
with a written request for a hearing within 15 days of the receipt of the
notice of denial or adverse action. The written request shall, at a minimum,
describe the action being appealed.
(f)
When a participating local agency appeals an adverse action,
the adverse action shall be postponed until a hearing decision is reached.
(g)
When a vendor appeals an adverse action, the adverse action
may be postponed until a hearing decision is reached at the discretion of
the state agency WIC Program.
(h)
Appealing an adverse action does not relieve a local agency
or a vendor permitted to continue participating in the program while an appeal
is pending from the obligation of continued compliance with the terms of the
written agreement or contract with the state agency.
(i)
The state agency shall provide the local agency or vendor
the following:
(1)
at least ten days advance notice of the time and place
for the hearing;
(2)
the opportunity to reschedule the hearing one time;
(3)
the opportunity to review all written case records prior
to the hearing;
(4)
the opportunity to be represented by counsel if desired;
(5)
the opportunity to call witnesses;
(6)
the opportunity to confront and cross-examine adverse witnesses
except that such examination shall be conducted behind a protective screen
or other device when necessary to protect the identity of WIC Program monitors;
(7)
an impartial decision-maker who will prepare a written
decision based solely on whether the state agency has correctly applied federal
and state statutes, regulations, rules, policies and procedures governing
the program according to the evidence presented at the hearing; and
(8)
written notification of the final decision within 90 days
from the date of receipt of the request for a hearing by a vendor and within
60 days from the date of receipt of a local agency's request for a hearing.
These timeframes are only administrative requirements for the state agency
and do not provide a basis for overturning the state agency's adverse action
if a decision is not made within the specified timeframes.
(j)
The state agency is not responsible for losses incurred
by the local agency or vendor as a result of disqualification and/or denial
of an application to participate.
(k)
If the hearing results in a final decision adverse to the
local agency or vendor, the appellant may seek judicial review of the decision
to the extent authorized by state law. The state agency or its legal counsel
shall not provide legal advice to adverse parties concerning judicial review
of final decisions in administrative hearings. Appellants must seek advice
from their own attorneys.
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 February 25, 2002.
TRD-200201173
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 1, 2002
Proposal publication date: November 5, 2001
For further information, please call: (512) 458-7236
Subchapter D. GENERAL
25 TAC §289.202
The Texas Department of Health (department) adopts an amendment
to §289.202 concerning the standards for protection against radiation
from radioactive material with changes to the proposed text as published in
the December 14, 2001, issue of the
Texas Register
(26 TexReg 10217).
The revision allows disposal, without regard to its radioactivity, of certain
concentrations of americium-241 in emission control dust as a result of unintentional
melting of a radioactive source in electric arc furnaces or foundries. When
the specific handling, treatment, transport, and radiation dose conditions
of the proposed amendment are met, the contaminated material is required to
be managed as a hazardous waste rather than a mixed waste. The amendment provides
a safe additional disposal option for a very limited category of material
that would otherwise be considered mixed waste. Language that was adopted
in the July 3, 1998 (23 TexReg 6960) issue of the
Texas Register
and was inadvertently omitted during the 2000 adoption
submission in May 26, 2000, (25 TexReg 4834) issue of the
Texas Register
is being reinstated in §289.202(ff)(2)(J)-(L) and
(3). An additional revision addresses a licensee's responsibility to record
summaries of annual dosimetry information on monitored individuals. The amendment
changes the time frame from within 60 days of the end of the year to April
30 of the following year to complete the records. The revised requirement
will allow companies and facilities with large numbers of monitored employees
a more realistic time frame to comply with the requirement. This amendment
is also part of the department's continuing effort to update, clarify, and
simplify its rules regarding the control of radiation based upon technological
advances, public concerns, legislative directives, or other factors.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.202 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however, revisions to the rule were necessary.
The department published a Notice of Intention to Review for §289.202
as required by Government Code §2001.039 in the
Texas Register
(26 TexReg 8197) on October 12, 2001. No comments were
received by the department on this section.
The department received no public comments during the comment period for
these amendments. However, the department is making the following changes
due to staff comments to clarify the intent and improve the accuracy of the
section.
Change: Concerning proposed §289.202(ff)(2)(G) and (I), the scientific
notation 3 pCi/g is stated incorrectly. The department changed the notation
from 3 pCi/gm to 3 pCi/g.
Change: Concerning proposed §289.202(ff)(3)-(5), these requirements
specifically concern emission control and should be subparagraphs under paragraph
(2). The paragraphs in this subsection were renumbered. Change is reflected
in §289.202(ff)(2)(J) through §289.202(ff)(3).
The amendment is adopted under the Health and Safety Code, §401.051,
which provides the Texas Board of Health (board) with the authority to adopt
rules and guidelines relating to the control of radiation; and §12.001,
which provides the board the authority to adopt rules for its procedures and
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
§289.202.Standards for Protection Against Radiation from Radioactive Materials.
(a)
Purpose.
(1)
This section establishes standards for protection against
ionizing radiation resulting from activities conducted in accordance with
licenses issued by the agency.
(2)
The requirements in this section are designed to control
the receipt, possession, use, and transfer of sources of radiation by any
licensee so the total dose to an individual, including doses resulting from
all sources of radiation other than background radiation, does not exceed
the standards for protection against radiation prescribed in this section.
However, nothing in this section shall be construed as limiting actions that
may be necessary to protect health and safety in an emergency.
(b)
Scope.
(1)
Except as specifically provided in other sections of this
chapter, this section applies to persons who receive, possess, use, or transfer
sources of radiation, unless otherwise exempted. No person may use, manufacture,
produce, transport, transfer, receive, acquire, own, possess, process, or
dispose of sources of radiation unless that person has a license or exemption
from the agency. The dose 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, to exposure from individuals administered
radioactive material and released in accordance with this chapter, 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.
(2)
Licensees who are also registered by the agency to receive,
possess, use, and transfer radiation machines must also comply with the requirements
of §289.231 of this title (relating to General Provisions and Standards
for Protection Against Machine-Produced Radiation).
(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)
Class--A classification scheme for inhaled material according
to its rate of clearance from the pulmonary region of the lung. Materials
are classified as D, W, or Y, which apply to a range of clearance half-times:
for Class D, Days, of less than 10 days; for Class W, Weeks, from 10 to 100
days, and for Class Y, Years, of greater than 100 days. For purposes of this
section, lung class and inhalation class are equivalent terms.
(3)
Declared pregnant woman--A woman who has voluntarily informed
the licensee, in writing, of her pregnancy and the estimated date of conception.
The declaration remains in effect until the declared pregnant woman voluntarily
withdraws the declaration in writing or is no longer pregnant.
(4)
Derived air concentration (DAC)--The concentration of a
given radionuclide in air that, if breathed by Reference Man for a working
year of 2,000 hours under conditions of light work, results in an intake of
1 ALI. For purposes of this section, the condition of light work is an inhalation
rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values
are given in Column 3 of Table I of subsection (ggg)(2) of this section.
(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)
Dosimetry processor--A registrant that processes and evaluates
personnel monitoring devices in order to determine the radiation dose delivered
to the monitoring devices.
(7)
Inhalation class (see definition for Class).
(8)
Lung class (see definition for Class).
(9)
Nonstochastic effect--A health effect, the severity of
which varies with the dose and for which a threshold is believed to exist.
Radiation-induced cataract formation is an example of a nonstochastic effect.
For purposes of this section, deterministic effect is an equivalent term.
(10)
Planned special exposure--An infrequent exposure to radiation,
separate from and in addition to the annual occupational dose limits.
(11)
Quarter--A period of time equal to one-fourth of the year
observed by the licensee, 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.
(12)
Reference man--A hypothetical aggregation of human physical
and physiological characteristics determined by international consensus. These
characteristics may be used by esearchers and public health employees to standardize
results of experiments and to relatebiological insult to a common base. A
description of Reference Man is contained in the International Commission
on Radiological Protection report, ICRP Publication 23, "Report of the Task
Group on Reference Man."
(13)
Respiratory protective equipment--An apparatus, such as
a respirator, used to reduce an individual's intake of airborne radioactive
materials.
(14)
Sanitary sewerage--A system of public sewers for carrying
off waste water and refuse, but excluding sewage treatment facilities, septic
tanks, and leach fields owned or operated by the licensee or registrant.
(15)
Stochastic effect--A health effect that occurs randomly
and for which the probability of the effect occurring, rather than its severity,
is assumed to be a linear function of dose without threshold. Hereditary effects
and cancer incidence are examples of stochastic effects. For purposes of this
section probabilistic effect is an equivalent term.
(16)
Weighting factor wT for an organ or tissue (T)--The proportion
of the risk of stochastic effects resulting from irradiation of that organ
or tissue to the total risk of stochastic effects when the whole body is irradiated
uniformly. For calculating the effective dose equivalent, the values of wT
are:
Figure: 25 TAC §289.202(c)(16) (No change.)
(d)
Implementation.
(1)
Any existing license condition that is more restrictive
than this section remains in force until there is an amendment or renewal
of the license that modifies or removes this condition.
(2)
If a license condition exempts a licensee from a provision
of this section in effect on or before January 1, 1994, it also exempts the
licensee from the corresponding provision of this section.
(3)
If a license condition cites provisions of this section
in effect prior to January 1, 1994, that do not correspond to any provisions
of this section, the license condition remains in force until there is an
amendment or renewal of the license that modifies or removes this condition.
(e)
Radiation protection programs.
(1)
Each licensee shall develop, document, and implement a
radiation protection program sufficient to ensure compliance with the provisions
of this section. See subsection (mm) of this section for recordkeeping requirements
relating to these programs. Documentation of the radiation protection program
may be incorporated in the licensee's operating, safety, and emergency procedures.
(2)
The licensee shall use, to the extent practicable, procedures
and engineering controls based upon sound radiation protection principles
to achieve occupational doses and public doses that are as low as is reasonably
achievable (ALARA).
(3)
The licensee shall, at intervals not to exceed 12 months,
ensure the radiation protection program content and implementation is reviewed.
(4)
To implement the ALARA requirement in paragraph (2) of
this subsection and notwithstanding the requirements in subsection (n) of
this section, a constraint on air emissions of radioactive material to the
environment, excluding radon-222 and its daughters, shall be established by
licensees such that the individual member of the public likely to receive
the highest dose will not be expected to receive a total effective dose equivalent
in excess of 10 millirems (mrem) (0.1 mSv) per year from these emissions.
If a licensee subject to this requirement exceeds this dose constraint, the
licensee shall report the exceedance as required in subsection (yy) of this
section and promptly take appropriate corrective action.
(f)
Occupational dose limits for adults.
(1)
The licensee shall control the occupational dose to individuals,
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)
a lens 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)
Doses received in excess of the annual limits, including
doses received during accidents, emergencies, and planned special exposures,
shall be subtracted from the limits for planned special exposures that the
individual may receive during the current year and during the individual's
lifetime. See subsection (k)(6)(A) and (B) of this section.
(3)
The assigned deep dose equivalent and shallow dose equivalent
shall be for the portion of the body receiving the highest exposure.
(4)
The deep dose equivalent, lens dose equivalent and shallow
dose equivalent may be assessed from surveys, calculations, or radiation measurements
for the purpose of demonstrating compliance with the occupational dose limits,
if the individual monitoring device was not in the region of highest potential
exposure, or the results of individual monitoring are unavailable.
(5)
Derived air concentration (DAC) and annual limit on intake
(ALI) values are specified in Table I of subsection (ggg)(2) of this section
and may be used to determine the individual's dose and to demonstrate compliance
with the occupational dose limits. See subsection (rr) of this section.
(6)
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.
(7)
The licensee shall reduce the dose that an individual may
be allowed to receive in the current year by the amount of occupational dose
received while employed by any other person. See subsection (j)(4) of this
section.
(g)
Compliance with requirements for summation of external
and internal doses.
(1)
If the licensee is required to monitor in accordance with
both subsection (q)(1) and (3) of this section, the licensee shall demonstrate
compliance with the dose limits by summing external and internal doses. If
the licensee is required to monitor only in accordance with subsection (q)(1)
of this section or only in accordance with subsection (q)(3) of this section,
then summation is not required to demonstrate compliance with the dose limits.
The licensee may demonstrate compliance with the requirements for summation
of external and internal doses in accordance with paragraphs (2)-(4) of this
subsection. The dose equivalents for the lens of the eye, the skin, and the
extremities are not included in the summation, but are subject to separate
limits.
(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)
the sum of the fractions of the inhalation ALI for each
radionuclide; or
(B)
the total number of derived air concentration-hours (DAC-hours)
for all radionuclides divided by 2,000; or
(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, wT, and the committed dose equivalent, H T,50, per
unit intake is greater than 10% of the maximum weighted value of HT,50, that
is, wT HT,50, per unit intake for any organ or tissue.
(3)
If the occupationally exposed individual receives an intake
of radionuclides by oral ingestion greater than 10% of the applicable oral
ALI, the licensee shall account for this intake and include it in demonstrating
compliance with the limits.
(4)
The licensee shall evaluate and, to the extent practical,
account for intakes through wounds or skin absorption. The intake through
intact skin has been included in the calculation of DAC for hydrogen-3 and
does not need to be evaluated or accounted for in accordance with this paragraph.
(h)
Determination of external dose from airborne radioactive
material.
(1)
Licensees shall, when determining the dose from airborne
radioactive material, include the contribution to the deep dose equivalent,
eye dose equivalent, and shallow dose equivalent from external exposure to
the radioactive cloud. See footnotes 1 and 2 of subsection (ggg)(2) of this
section.
(2)
Airborne radioactivity measurements and DAC values shall
not be used as the primary means to assess the deep dose equivalent when the
airborne radioactive material includes radionuclides other than noble gases
or if the cloud of airborne radioactive material is not relatively uniform.
The determination of the deep dose equivalent to an individual shall be based
upon measurements using instruments or individual monitoring devices.
(i)
Determination of internal exposure.
(1)
For purposes of assessing dose used to determine compliance
with occupational dose equivalent limits, the licensee shall, when required
in accordance with subsection (q) of this section, take suitable and timely
measurements of:
(A)
concentrations of radioactive materials in air in work
areas;
(B)
quantities of radionuclides in the body;
(C)
quantities of radionuclides excreted from the body; or
(D)
combinations of these measurements.
(2)
Unless respiratory protective equipment is used, as provided
in subsection (x) of this section, or the assessment of intake is based on
bioassays, the licensee shall assume that an individual inhales radioactive
material at the airborne concentration in which the individual is present.
(3)
When specific information on the physical and biochemical
properties of the radionuclides taken into the body or the behavior of the
material in an individual is known, the licensee may:
(A)
use that information to calculate the committed effective
dose equivalent, and, if used, the licensee shall document that information
in the individual's record;
(B)
upon prior approval of the agency, adjust the DAC or ALI
values to reflect the actual physical and chemical characteristics of airborne
radioactive material, for example, aerosol size distribution or density; and
(C)
separately assess the contribution of fractional intakes
of Class D, W, or Y compounds of a given radionuclide to the committed effective
dose equivalent. See subsection (ggg)(2) of this section.
(4)
If the licensee chooses to assess intakes of Class Y material
using the measurements given in paragraph (1)(A) or (B) of this subsection,
the licensee may delay the recording and reporting of the assessments for
periods up to seven months, unless otherwise required by subsections (xx)
or (yy) of this section. This delay permits the licensee to make additional
measurements basic to the assessments.
(5)
If the identity and concentration of each radionuclide
in a mixture are known, the fraction of the DAC applicable to the mixture
for use in calculating DAC-hours shall be either:
(A)
the sum of the ratios of the concentration to the appropriate
DAC value, that is, D, W, or Y, from subsection (ggg)(2) of this section for
each radionuclide in the mixture; or
(B)
the ratio of the total concentration for all radionuclides
in the mixture to the most restrictive DAC value for any radionuclide in the
mixture.
(6)
If the identity of each radionuclide in a mixture is known,
but the concentration of one or more of the radionuclides in the mixture is
not known, the DAC for the mixture shall be the most restrictive DAC of any
radionuclide in the mixture.
(7)
When a mixture of radionuclides in air exists, a licensee
may disregard certain radionuclides in the mixture if:
(A)
the licensee uses the total activity of the mixture in
demonstrating compliance with the dose limits in subsection (f) of this section
and in complying with the monitoring requirements in subsection (q)(3) of
this section;
(B)
the concentration of any radionuclide disregarded is less
than 10% of its DAC; and
(C)
the sum of these percentages for all of the radionuclides
disregarded in the mixture does not exceed 30%.
(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 shall determine the occupational radiation dose
received during the current year.
(2)
In complying with the requirements of paragraph (1) of
this subsection, a licensee may:
(A)
accept, as a record of the occupational dose that the individual
received during the current year, BRC Form 202-2 from prior or other current
employers, or other clear and legible record, of all information required
on that form and indicating any periods of time for which data are not available;
or
(B)
accept, as a record of the occupational dose that the individual
received during the current year, a written signed statement from the individual,
or from the individual's prior or other current employer(s) for work involving
radiation exposure, that discloses the nature and the amount of any occupational
dose that the individual received during the current year; or
(C)
obtain reports of the individual's dose equivalent from
prior or other current employer(s) for work involving radiation exposure,
or the individual's current employer, if the individual is not employed by
the licensee, by telephone, telegram, facsimile, or letter. The licensee shall
request a written verification of the dose data if the authenticity of the
transmitted report cannot be established.
(3)
The licensee shall record the exposure data for the current
year, as required by paragraph (1) of this subsection, on BRC Form 202-3,
or other clear and legible record, of all the information required on that
form.
(4)
If the licensee is unable to obtain a complete record of
an individual's current occupational dose while employed by any other licensee,
the licensee 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 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 during the current
year, the licensee 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)
assess an occupational dose for the individual during the
period of missing data using surveys, radiation measurements, or other comparable
data for the purpose of demonstrating compliance with the occupational dose
limits.
(6)
Administrative controls established in accordance with
paragraph (4) of this subsection shall be documented and maintained for inspection
by the agency. Occupational dose assessments made in accordance with paragraph
(5) of this subsection and records of data used to make the assessment shall
be maintained for inspection by the agency. The licensee shall retain the
records in accordance with subsection (rr) of this section.
(k)
Planned special exposures. A licensee may authorize an
adult worker to receive doses in addition to and accounted for separately
from the doses received under the limits specified in subsection (f) of this
section provided that each of the following conditions is satisfied.
(1)
The licensee authorizes a planned special exposure only
in an exceptional situation when alternatives that might avoid the doses estimated
to result from the planned special exposure are unavailable or impractical.
(2)
The licensee and employer, if the employer is not the licensee,
specifically authorizes the planned special exposure, in writing, before the
exposure occurs.
(3)
Before a planned special exposure, the licensee ensures
that each individual involved is:
(A)
informed of the purpose of the planned operation;
(B)
informed of the estimated doses and associated potential
risks and specific radiation levels or other conditions that might be involved
in performing the task; and
(C)
instructed in the measures to be taken to keep the dose
ALARA considering other risks that may be present.
(4)
Prior to permitting an individual to participate in a planned
special exposure, the licensee shall determine:
(A)
the internal and external doses from all previous planned
special exposures;
(B)
all doses in excess of the limits, including doses received
during accidents and emergencies, received during the lifetime of the individual;
and
(C)
all lifetime cumulative occupational radiation doses.
(5)
In complying with the requirements of paragraph (4)(C)
of this subsection, a licensee may:
(A)
accept, as the record of lifetime cumulative radiation
dose, an up-to-date BRC Form 202-2 or equivalent, signed by the individual
and countersigned by an appropriate official of the most recent employer for
work involving radiation exposure, or the individual's current employer, if
the individual is not employed by the licensee; and
(B)
obtain reports of the individual's dose equivalent from
prior employer(s) for work involving radiation exposure, or the individual's
current employer, if the individual is not employed by the licensee, by telephone,
telegram, facsimile, or letter. The licensee shall request a written verification
of the dose data if the authenticity of the transmitted report cannot be established.
(6)
Subject to subsection (f)(2) of this section, the licensee
shall not authorize a planned special exposure that would cause an individual
to receive a dose from all planned special exposures and all doses in excess
of the limits to exceed:
(A)
the numerical values of any of the dose limits in subsection
(f)(1) of this section in any year; and
(B)
five times the annual dose limits in subsection (f)(1)
of this section during the individual's lifetime.
(7)
The licensee maintains records of the conduct of a planned
special exposure in accordance with subsection (qq) of this section and submits
a written report to the agency in accordance with subsection (zz) of this
section.
(8)
The licensee records the best estimate of the dose resulting
from the planned special exposure in the individual's record and informs the
individual, in writing, of the dose within 30 days from the date of the planned
special exposure. The dose from planned special exposures shall not be considered
in controlling future occupational dose of the individual in accordance with
subsection (f)(1) of this section but shall be included in evaluations required
by paragraphs (4) and (6) of this subsection.
(9)
The licensee shall record the exposure history, as required
by paragraph (4) of this subsection, on BRC Form 202-2, or other clear and
legible record, of all the information required on that form. The form or
record shall show each period in which the individual received occupational
exposure to radiation or radioactive material and shall be signed by the individual
who received the exposure. For each period for which the licensee obtains
reports, the licensee shall use the dose shown in the report in preparing
BRC Form 202-2 or equivalent.
(l)
Occupational dose limits for minors. The annual occupational
dose limits for minors are 10% of the annual occupational dose limits specified
for adult workers in subsection (f) of this section.
(m)
Dose equivalent to an embryo/fetus.
(1)
If a woman declares her pregnancy, the licensee shall ensure
that the dose equivalent 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 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
one month.
(3)
The dose equivalent to an embryo/fetus shall be taken as:
(A)
the dose equivalent to the embryo/fetus from radionuclides
in the embryo/fetus and radionuclides in the declared pregnant woman; and
(B)
the dose equivalent that is most representative of the
dose equivalent to the embryo/fetus from external radiation, that is, in the
mother's lower torso region.
(i)
If multiple measurements have not been made, assignment
of the highest deep dose equivalent for the declared pregnant woman shall
be the dose equivalent to the embryo/fetus.
(ii)
If multiple measurements have been made, assignment of
the deep dose equivalent for the declared pregnant woman from the individual
monitoring device that is most representative of the dose equivalent to the
embryo/fetus shall be the dose equivalent to the embryo/fetus. Assignment
of the highest deep dose equivalent for the declared pregnant woman to the
embryo/fetus is not required unless that dose equivalent is also the most
representative deep dose equivalent for the region of the embryo/fetus.
(4)
If by the time the woman declares pregnancy to the licensee,
the dose equivalent to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the
licensee shall be deemed to be in compliance with paragraph (1) of this subsection,
if the additional dose equivalent 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 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 background radiation, from
any medical administration the individual has received, from exposure to individuals
administered radioactive material and released in accordance with this chapter,
from voluntary participation in medical research programs, and from the licensee's
disposal of radioactive material into sanitary sewerage in accordance with
subsection (gg) of this section; and
(B)
the dose in any unrestricted area from licensed and/or
registered external sources, exclusive of the dose contributions from patients
administered radioactive material and released in accordance with this chapter,
does not exceed 0.002 rem (0.02 mSv) in any one hour.
(2)
If the licensee permits members of the public to have access
to restricted areas, the limits for members of the public continue to apply
to those individuals.
(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)
demonstration of the need for and the expected duration
of operations in excess of the limit in paragraph (1) of this subsection;
(B)
the licensee's program to assess and control dose within
the 0.5 rem (5 mSv) annual limit; and
(C)
the procedures to be followed to maintain the dose ALARA.
(4)
In addition to the requirements of this section, a licensee
subject to the provisions of the United States Environmental Protection Agency's
(EPA) generally applicable environmental radiation standards in 40 Code of
Federal Regulations (CFR), §190 shall comply with those requirements.
(5)
The agency may impose additional restrictions on radiation
levels in unrestricted areas and on the total quantity of radionuclides that
a licensee may release in effluents in order to restrict the collective dose.
(o)
Compliance with dose limits for individual members of the
public.
(1)
The licensee shall make or cause to be made surveys of
radiation levels in unrestricted areas and radioactive materials in effluents
released to unrestricted areas to demonstrate compliance with the dose limits
for individual members of the public as required in subsection (n) of this
section.
(2)
A licensee shall show compliance with the annual dose limit
in subsection (n) of this section by:
(A)
demonstrating by measurement or calculation that the total
effective dose equivalent to the individual likely to receive the highest
dose from the licensed or registered operation does not exceed the annual
dose limit; or
(B)
demonstrating that:
(i)
the annual average concentrations of radioactive material
released in gaseous and liquid effluents at the boundary of the unrestricted
area do not exceed the values specified in Table II of subsection (ggg)(2)
of this section; and
(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)
Upon approval from the agency, the licensee may adjust
the effluent concentration values in Table II, of subsection (ggg)(2) of this
section, for members of the public, to take into account the actual physical
and chemical characteristics of the effluents, such as, aerosol size distribution,
solubility, density, radioactive decay equilibrium, and chemical form.
(p)
General surveys and monitoring.
(1)
Each licensee shall make, or cause to be made, surveys
that:
(A)
are necessary for the licensee to comply with this section;
and
(B)
are necessary under the circumstances to evaluate:
(i)
the magnitude and extent of radiation levels;
(ii)
concentrations or quantities of radioactive material;
and
(iii)
the potential radiological hazards.
(2)
The licensee 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)
at intervals not to exceed 12 months unless a different
time interval is specified in another section of this chapter;
(C)
after each instrument or equipment repair;
(D)
for the types of radiation used and at energies appropriate
for use; and
(E)
at an accuracy within 20% of the true radiation level.
(3)
All individual monitoring devices, except for direct and
indirect reading pocket dosimeters, electronic personal dosimeters, and those
individual monitoring devices used to measure the dose to any extremity, that
require processing to determine the radiation dose and that are used by licensees
to comply with subsection (f) of this section, with other applicable provisions
of this chapter, or with conditions specified in a license, shall be processed
and evaluated by a dosimetry processor:
(A)
holding current personnel dosimetry accreditation from
the National Voluntary Laboratory Accreditation Program (NVLAP) of the National
Institute of Standards and Technology;
(B)
approved in this accreditation process for the type of
radiation or radiations included in the NVLAP program that most closely approximates
the type of radiation or radiations for which the individual wearing the dosimeter
is monitored; and
(C)
holding a current certificate of registration from the
agency authorizing dosimetry processing.
(q)
Conditions requiring individual monitoring of external
and internal occupational dose. Each licensee 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)
each licensee shall monitor occupational exposure to radiation
and shall supply and require the use of individual monitoring devices by:
(A)
adults likely to receive, in one year from sources external
to the body, a dose in excess of 10% of the limits in subsection (f)(1) of
this section;
(B)
minors likely to receive, in one year from sources of radiation
external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv),
a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose
equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
(C)
declared pregnant women likely to receive during the entire
pregnancy, from sources of radiation external to the body, a deep dose equivalent
in excess of 0.1 rem (1 mSv); and
(D)
individuals entering a high or very high radiation area;
(2)
notwithstanding paragraph (1)(C) of this subsection, a
licensee is exempt from supplying individual monitoring devices to healthcare
personnel who may enter a high radiation area while providing patient care
if:
(A)
the personnel are not likely to receive, in one year from
sources external to the body, a dose in excess of 10% of the limits in subsection
(f)(1) of this section; and
(B)
the licensee complies with the requirements of subsection
(e)(2) of this section; and
(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)
adults likely to receive, in one year, an intake in excess
of 10% of the applicable ALI in Columns 1 and 2 of Table I of subsection (ggg)(2)
of this section;
(B)
minors likely to receive, in one year, a committed effective
dose equivalent in excess of 0.1 rem (1 mSv); and
(C)
declared pregnant women likely to receive, during the entire
pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
(r)
Location and use of individual monitoring devices.
(1)
Each licensee shall ensure that individuals who are required
to monitor occupational doses in accordance with subsection (q)(l) of this
section wear and use individual monitoring devices as follows.
(A)
An individual monitoring device used for monitoring the
dose to the whole body shall be worn at the unshielded location of the whole
body likely to receive the highest exposure. When a protective apron is worn,
the location of the individual monitoring device is typically at the neck
(collar).
(B)
If an additional individual monitoring device is used for
monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance
with subsection (m)(1) of this section, it shall be located at the waist under
any protective apron being worn by the woman.
(C)
An individual monitoring device used for monitoring the
lens dose equivalent, to demonstrate compliance with subsection (f)(1)(B)(i)
of this section, shall be located at the neck (collar) or at a location closer
to the eye, outside any protective apron being worn by the monitored individual.
(D)
An individual monitoring device used for monitoring the
dose to the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii)
of this section, shall be worn on the extremity likely to receive the highest
exposure. Each individual monitoring device, to the extent practicable, shall
be oriented to measure the highest dose to the extremity being monitored.
(E)
An individual monitoring device shall be assigned to and
worn by only one individual.
(F)
An individual monitoring device shall be worn for the period
of time authorized by the dosimetry processor's certificate of registration
or for no longer than three months, whichever is more restrictive.
(2)
Each licensee shall ensure that individual monitoring devices
are returned to the dosimetry processor for proper processing.
(3)
Each licensee shall ensure that adequate precautions are
taken to prevent a deceptive exposure of an individual monitoring device.
(s)
Control of access to high radiation areas.
(1)
The licensee 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)
a control device that energizes a conspicuous visible or
audible alarm signal so that the individual entering the high radiation area
and the supervisor of the activity are made aware of the entry; or
(C)
entryways that are locked, except during periods when access
to the areas is required, with positive control over each individual entry.
(2)
In place of the controls required by paragraph (1) of this
subsection for a high radiation area, the licensee may substitute continuous
direct or electronic surveillance that is capable of preventing unauthorized
entry.
(3)
The licensee may apply to the agency for approval of alternative
methods for controlling access to high radiation areas.
(4)
The licensee shall establish the controls required by paragraphs
(1) and (3) of this subsection in a way that does not prevent individuals
from leaving a high radiation area.
(5)
The licensee is not required to control each entrance or
access point to a room or other area that is a high radiation area solely
because of the presence of radioactive materials prepared for transport and
packaged and labeled in accordance with the regulations of the United States
Department of Transportation (DOT) provided that:
(A)
the packages do not remain in the area longer than three
days; and
(B)
the dose rate at 1 meter from the external surface of any
package does not exceed 0.01 rem (0.1 millisievert) per hour.
(6)
The licensee is not required to control entrance or access
to rooms or other areas in hospitals solely because of the presence of patients
containing radioactive material, provided that there are personnel in attendance
who are taking the necessary precautions to prevent the exposure of individuals
to sources of radiation in excess of the established limits in this section
and to operate within the ALARA provisions of the licensee's radiation protection
program.
(t)
Control of access to very high radiation areas. In addition
to the requirements in subsection (s) of this section, the licensee 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.
(u)
Control of access to very high radiation areas for irradiators.
(1)
This subsection applies to licensees with sources of radiation
in non-self-shielded irradiators. This subsection does not apply to sources
of radiation that are used in teletherapy, in industrial radiography, or in
completely self-shielded irradiators in which the source of radiation is both
stored and operated within the same shielding radiation barrier and, in the
designed configuration of the irradiator, is always physically inaccessible
to any individual and cannot create high levels of radiation in an area that
is accessible to any individual.
(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)
function automatically to prevent any individual from inadvertently
entering a very high radiation area;
(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)
conspicuous visible and audible alarm signals are generated
to make an individual attempting to enter the area aware of the hazard and
at least one other authorized individual, who is physically present, familiar
with the activity, and prepared to render or summon assistance, aware of the
failure of the entry control devices.
(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)
conspicuous visible and audible alarm signals are generated
to make potentially affected individuals aware of the hazard and the licensee
or at least one other individual, who is familiar with the activity and prepared
to render or summon assistance, aware of the failure or removal of the physical
barrier.
(D)
When the shield for stored sealed sources is a liquid,
the licensee shall provide means to monitor the integrity of the shield and
to signal, automatically, loss of adequate shielding.
(E)
Physical radiation barriers that comprise permanent structural
components, such as walls, that have no credible probability of failure or
removal in ordinary circumstances, need not meet the requirements of subparagraphs
(C) and (D) of this paragraph.
(F)
Each area shall be equipped with devices that will automatically
generate conspicuous visible and audible alarm signals to alert personnel
in the area before the source of radiation can be put into operation and in
time for any individual in the area to operate a clearly identified control
device, which must be installed in the area and which can prevent the source
of radiation from being put into operation.
(G)
Each area shall be controlled by use of such administrative
procedures and such devices as are necessary to ensure that the area is cleared
of personnel prior to each use of the source of radiation.
(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)
The entry control devices required in subparagraph (A)
of this paragraph shall be tested for proper functioning. See subsection (uu)
of this section for recordkeeping requirements.
(i)
Testing shall be conducted prior to initial operation with
the source of radiation on any day, unless operations were continued uninterrupted
from the previous day.
(ii)
Testing shall be conducted prior to resumption of operation
of the source of radiation after any unintentional interruption.
(iii)
The licensee shall submit and adhere to a schedule for
periodic tests of the entry control and warning systems.
(J)
The licensee shall not conduct operations, other than those
necessary to place the source of radiation in safe condition or to effect
repairs on controls, unless control devices are functioning properly.
(K)
Entry and exit portals that are used in transporting materials
to and from the irradiation area, and that are not intended for use by individuals,
shall be controlled by such devices and administrative procedures as are necessary
to physically protect and warn against inadvertent entry by any individual
through these portals. Exit portals for irradiated materials shall be equipped
to detect and signal the presence of any loose radioactive material that is
carried toward such an exit and automatically to prevent loose radioactive
material from being carried out of the area.
(3)
Licensees or applicants for licenses for sources of radiation
within the purview of paragraph (2) of this subsection that will be used in
a variety of positions or in locations, such as open fields or forests, which
make it impracticable to comply with certain requirements of paragraph (2)
of this subsection, such as those for the automatic control of radiation levels,
may apply to the Agency for approval of alternative safety measures. Alternative
safety measures shall provide personnel protection at least equivalent to
those specified in paragraph (2) of this subsection. At least one of the alternative
measures shall include an entry-preventing interlock control based on a measurement
of the radiation that ensures the absence of high radiation levels before
an individual can gain access to the area where such sources of radiation
are used.
(4)
The entry control devices required by paragraphs (2) and
(3) of this subsection shall be established in such a way that no individual
will be prevented from leaving the area.
(v)
Use of process or other engineering controls. The licensee
shall use, to the extent practicable, process or other engineering controls,
such as containment or ventilation, to control the concentrations of radioactive
material in air.
(w)
Use of other controls. When it is not practicable to apply
process or other engineering controls to control the concentrations of radioactive
material in air to values below those that define an airborne radioactivity
area, the licensee shall, consistent with maintaining the total effective
dose equivalent ALARA, increase monitoring and limit intakes by one or more
of the following means:
(1)
control of access;
(2)
limitation of exposure times;
(3)
use of respiratory protection equipment; or
(4)
other controls.
(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)
Except as provided in subparagraph (B) of this paragraph,
the licensee shall use only respiratory protection equipment that is tested
and certified or had certification extended by the National Institute for
Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration
(MSHA).
(B)
If the licensee wishes to use equipment that has not been
tested or certified by the NIOSH and the MSHA, or has not had certification
extended by the NIOSH and the MSHA, or for which there is no schedule for
testing or certification, the licensee shall submit an application for authorized
use of that equipment, including a demonstration by testing, or a demonstration
on the basis of test information, that the material and performance characteristics
of the equipment are capable of providing the proposed degree of protection
under anticipated conditions of use.
(C)
The licensee shall implement and maintain a respiratory
protection program that includes:
(i)
air sampling sufficient to identify the potential hazard,
permit proper equipment selection, and estimate exposures;
(ii)
surveys and bioassays, as appropriate, to evaluate actual
intakes;
(iii)
testing of respirators for operability immediately prior
to each use;
(iv)
written procedures regarding selection, fitting, issuance,
maintenance, and testing of respirators, including testing for operability
immediately prior to each use; supervision and training of personnel; monitoring,
including air sampling and bioassays; and recordkeeping; and
(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)
The licensee shall issue a written policy statement on
respirator usage covering:
(i)
the use of process or other engineering controls, instead
of respirators;
(ii)
the routine, nonroutine, and emergency use of respirators;
and
(iii)
the length of periods of respirator use and relief from
respirator use.
(E)
The licensee shall advise each respirator user that the
user may leave the area at any time for relief from respirator use in the
event of equipment malfunction, physical or psychological distress, procedural
or communication failure, significant deterioration of operating conditions,
or any other conditions that might require such relief.
(F)
The licensee shall use respiratory protection equipment
within the equipment manufacturer's expressed limitations for type and mode
of use and shall provide proper visual, communication, and other special capabilities,
such as adequate skin protection, when needed.
(2)
When estimating exposure of individuals to airborne radioactive
materials, the licensee may make allowance for respiratory protection equipment
used to limit intakes in accordance with subsection (w) of this section, provided
that the following conditions, in addition to those in paragraph (1) of this
subsection, are satisfied.
(A)
The licensee selects respiratory protection equipment that
provides a protection factor, asspecified in subsection (ggg)(1) of this section,
greater than the multiple by which peak concentrations of airborne radioactive
materials in the working area are expected to exceed the values specified
in Column 3 of Table I of subsection (ggg)(2) of this section. However, if
the election of respiratory protection equipment with a protection factor
greater than the peak concentration is inconsistent with the goal specified
in subsection (w) of this section of keeping the total effective dose equivalent
ALARA, the licensee may select respiratory protection equipment with a lower
protection factor provided that such a selection would result in a total effective
dose equivalent that is ALARA. The concentration of radioactive material in
the air that is inhaled when respirators are worn may be initially estimated
by dividing the average concentration in air, during each period of uninterrupted
use, by the protection factor. If the exposure is later found to be greater
than initially estimated, the corrected value shall be used; if the exposure
is later found to be less than initially estimated, the corrected value may
be used.
(B)
The licensee shall obtain authorization from the agency
before assigning respiratory protection factors in excess of those specified
in subsection (ggg)(1) of this section. The agency may authorize a licensee
to use higher protection factors on receipt of an application that:
(i)
describes the situation for which a need exists for higher
protection factors; and
(ii)
demonstrates that the respiratory protection equipment
provides these higher protection factors under the proposed conditions of
use.
(3)
In an emergency, the licensee shall use as emergency equipment
only respiratory protection equipment that has been specifically certified
or had certification extended for emergency use by the NIOSH and the MSHA.
(4)
The licensee shall notify the agency in writing at least
30 days before the date that respiratory protection equipment is first used
in accordance with either paragraphs (1) or (2) of this subsection.
(y)
Security and control of licensed sources of radiation.
(1)
The licensee shall secure radioactive material from unauthorized
removal or access.
(2)
The licensee shall maintain constant surveillance, using
devices and/or administrative procedures to prevent unauthorized use of radioactive
material that is in an unrestricted area and that is not in storage.
(z)
Caution signs.
(1)
Unless otherwise authorized by the agency, the standard
radiation symbol prescribed shall use the colors magenta, or purple, or black
on yellow background. The standard radiation symbol prescribed is the three-bladed
design as follows:
Figure: 25 TAC §289.202(z)(1) (No change.)
(A)
the cross-hatched area of the symbol is to be magenta,
or purple, or black; and
(B)
the background of the symbol is to be yellow.
(2)
Notwithstanding the requirements of paragraph (1) of this
subsection, licensees are authorized to label sources, source holders, or
device components containing sources of radiation that are subjected to high
temperatures, with conspicuously etched or stamped radiation caution symbols
and without a color requirement.
(aa)
Posting requirements.
(1)
The licensee shall post each radiation area with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION
AREA."
(2)
The licensee shall post each high radiation area with a
conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
(3)
The licensee shall post each very high radiation area with
a conspicuous sign or signs bearing the radiation symbol and words "GRAVE
DANGER, VERY HIGH RADIATION AREA." If the very high radiation area involves
medical treatment of patients, the licensee may omit the word "GRAVE" from
the sign or signs.
(4)
The licensee shall post each airborne radioactivity area
with a conspicuous sign or signs bearing the radiation symbol and the words
"CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY
AREA."
(5)
The licensee shall post each area or room in which there
is used or stored an amount of licensed material exceeding 10 times the quantity
of such material specified in subsection (ggg)(3) of this section with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE
MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
(bb)
Exceptions to posting requirements.
(1)
A licensee is not required to post caution signs in areas
or rooms containing sources of radiation for periods of less than 8 hours,
if each of the following conditions is met:
(A)
the sources of radiation are constantly attended during
these periods by an individual who takes the precautions necessary to prevent
the exposure of individuals to sources of radiation in excess of the limits
established in this section; and
(B)
the area or room is subject to the licensee's control.
(2)
Rooms or other areas in hospitals that are occupied by
patients are not required to be posted with caution signs in accordance with
subsection (aa) of this section provided that the patient could be released
from licensee control in accordance with this chapter.
(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.
(4)
Rooms in medical facilities that are used for teletherapy
are exempt from the requirement to post caution signs in accordance with subsection
(aa) of this section provided the following conditions are met.
(A)
Access to the room is controlled in accordance with this
chapter; and
(B)
Personnel in attendance take necessary precautions to prevent
the inadvertent exposure of workers, other patients, and members of the public
to radiation in excess of the limits established in this section.
(cc)
Labeling containers.
(1)
The licensee shall ensure that each container of licensed
material bears a durable, clearly visible label bearing the radiation symbol
and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL."
The label shall also provide information, such as the radionuclides present,
an estimate of the quantity of radioactivity, the date for which the activity
is estimated, radiation levels, kinds of materials, and mass enrichment, to
permit individuals handling or using the containers, or working in the vicinity
of the containers, to take precautions to avoid or minimize exposures.
(2)
Each licensee shall, prior to removal or disposal of empty
uncontaminated containers to unrestricted areas, remove or deface the radioactive
material label or otherwise clearly indicate that the container no longer
contains radioactive materials.
(dd)
Exemptions to labeling requirements. A licensee is not
required to label:
(1)
containers holding licensed material in quantities less
than the quantities listed in subsection (ggg)(3) of this section;
(2)
containers holding licensed material in concentrations
less than those specified in Table III of subsection (ggg)(2) of this section;
(3)
containers attended by an individual who takes the precautions
necessary to prevent the exposure of individuals in excess of the limits established
by this section;
(4)
containers when they are in transport and packaged and
labeled in accordance with the rules of the DOT (labeling of packages containing
radioactive materials is required by the DOT if the amount and type of radioactive
material exceeds the limits for an excepted quantity or article as defined
and limited by DOT regulations 49 CFR §§173.403(m) and (w) and 173.424);
(5)
containers that are accessible only to individuals authorized
to handle or use them, or to work in the vicinity of the containers, if the
contents are identified to these individuals by a readily available written
record. Examples of containers of this type are containers in locations such
as water-filled canals, storage vaults, or hot cells. The record shall be
retained as long as the containers are in use for the purpose indicated on
the record; or
(6)
installed manufacturing or process equipment, such as piping
and tanks.
(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)
the package when the carrier offers it for delivery; or
(B)
the notification of the arrival of the package at the carrier's
terminal and to take possession of the package expeditiously.
(2)
Each licensee shall:
(A)
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 radioactive
contamination unless the package contains only radioactive material in the
form of gas or in special form as defined in §289.201(b) of this title;
and
(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)
monitor all packages known to contain radioactive material
for radioactive contamination and radiation levels if there is evidence of
degradation of package integrity, such as packages that are crushed, wet,
or damaged.
(3)
The licensee shall perform the monitoring required by paragraph
(2) of this subsection as soon as practicable after receipt of the package,
but not later than three hours after the package is received at the licensee's
facility if it is received during the licensee's normal working hours. If
a package is received after working hours, the package shall be monitored
no later than three hours from the beginning of the next working day. If the
licensee discovers there is evidence of degradation of package integrity,
such as a package that is crushed, wet, or damaged, the package shall be surveyed
immediately.
(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 (cm2) 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 10 times the
limits listed in clause (ii) of this subparagraph.
(ii)
Removable external radioactive contamination wipe limits
are as follows.
Figure: 25 TAC §289.202(ee)(4)(A)(ii) (No change.)
(iii)
In the case of packages transported as exclusive use
shipments by rail or highway only, the removable radioactive contamination
at any time during transport must not exceed 10 times the levels prescribed
in clause (ii) of this subparagraph. The levels at the beginning of transport
must not exceed the levels in clause (ii) of this subparagraph.
(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/hr (10 mSv/hr):
(-a-)
the shipment is made in a closed transport vehicle;
(-b-)
provisions are made to secure the package so that its
position within the vehicle remains fixed during transportation; and
(-c-)
there are no loading or unloading operations between
the beginning and end of the transportation;
(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/hr) 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 §289.203(c) of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections).
(5)
Each licensee shall:
(A)
establish, maintain, and retain written procedures for
safely opening packages in which radioactive material is received; and
(B)
ensure that the procedures are followed and that due consideration
is given to special instructions for the type of package being opened.
(6)
Licensees transferring special form sources in vehicles
owned or operated by the licensee to and from a work site are exempt from
the contamination monitoring requirements of paragraph (2) of this subsection,
but are not exempt from the monitoring requirement in paragraph (2) of this
subsection for measuring radiation levels that ensures that the source is
still properly lodged in its shield.
(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, §289.252 of this title, §289.254 of this title
(relating to Licensing of Radioactive Waste Processing and Storage Facilities), §289.257
of this title, §289.259 of this title (relating to Licensing of Naturally
Occurring Radioactive Material (NORM)), or to the United States Department
of Energy (DOE);
(B)
by decay in storage with prior approval from the agency;
(C)
by release in effluents within the limits in subsection
(n) of this section; or
(D)
as authorized in accordance with paragraph (2) of this
subsection, and subsections (gg) and (hh) of this section.
(2)
Upon agency approval, emission control dust and other material
from electric arc furnaces or foundries contaminated as a result of inadvertent
melting of cesium-137 or americium-241 sources may be transferred for disposal
to a hazardous waste disposal facility authorized by the Texas Natural Resource
Conservation Commission (Commission) or its successor, another state's regulatory
agency with jurisdiction to regulate hazardous waste as classified under Subtitle
C of the Resource Conservation and Recovery Act (RCRA), or the EPA. The material
may be transferred for disposal without regard to its radioactivity if the
following conditions are met.
(A)
Contaminated material described in paragraph (2) of this
subsection, whether packaged or unpackaged (i.e., bulk), must be treated through
stabilization to comply with all waste treatment requirements of the appropriate
state or federal regulatory agency as listed in this paragraph. The treatment
operations must be undertaken by either of the following:
(i)
the owner/operator of the electric arc furnace or foundry
licensed to possess, treat or transfer cesium-137 or americium-241 contaminated
incident-related material; or
(ii)
a service contractor licensed by the agency, NRC, or an
agreement state to possess, treat, or transfer cesium-137 or americium-241
contaminated incident-related material.
(B)
The emission control dust and other incident-related materials
have been stored (if applicable) and transferred in accordance with operating
and emergency procedures approved by the agency.
(C)
The total cesium-137 or americium-241 activity contained
in emission control dust and other incident-related materials to be transferred
to a hazardous waste disposal facility has been specifically approved by NRC
or the appropriate agreement state(s) and does not exceed the total activity
associated with the inadvertent melting incident.
(D)
The hazardous waste disposal facility operator has been
notified in writing of the impending transfer of the incident-related materials
and has agreed in writing to receive and dispose of the packaged or unpackaged
materials. Copies of the notification and agreement shall be submitted to
the agency.
(E)
The licensee, as listed in subparagraph (A)(i) or (ii)
of this paragraph, notifies the NRC or agreement state(s) in which the transferor
and transferee are located, in writing, of the impending transfer, at least
30 days before the transfer.
(F)
The packaged stabilized material has been packaged for
transportation and disposal in non-bulk steel packaging as defined in DOT
regulations at 49 CFR §173.213.
(G)
The emission control dust and other incident-related materials
that have been stabilized and packaged as described in subparagraph (F) of
this paragraph shall contain pretreatment average concentrations of cesium-137
that do not exceed 130 pCi/g of material, above background, or pretreatment
average concentrations of americium-241 that do not exceed 3 pCi/g of material,
above background.
(H)
The dose rate at 3.28 feet (1 m) from the surface of any
package containing stabilized waste shall not exceed 20 µrem per hour
or 0.20 µSv per hour, above background.
(I)
The unpackaged stabilized material shall contain pretreatment
average concentrations of cesium-137 that do not exceed 100 pCi/g of material,
above background, or pretreatment average concentrations of americium-241
that do not exceed 3 pCi/g of material, above background.
(J)
The licensee transferring the cesium-137 or americium -241
contaminated incident-related material must consult with the agency, the Commission
or its successor, another state's regulatory agency with jurisdiction to regulate
hazardous waste as classified under RCRA, or the EPA and other authorized
parties, including state and local governments, and obtain all necessary approvals,
in addition to those of NRC and/or appropriate agreement states, for the transfers
described in paragraph (2) of this subsection.
(K)
Nothing in this subsection shall be or is intended to be
construed as a waiver of any RCRA permit condition or term, of any state or
local statute or regulation, or of any federal RCRA regulation.
(L)
The total incident-related cesium-137 activity described
in paragraph (2) of this subsection received by a facility over its operating
life shall not exceed 1 Ci (37 GBq). The total incident-related americium-241
activity described in paragraph (2) of this subsection received by a facility
over its operating life shall not exceed 30 mCi (1.11MBq). The agency will
maintain a record of the total incident-related cesium-137 or americium-241
activity shipped by a person licensed by the agency. Upon consultation with
the Commission, the agency will determine if the total incident-related activity
received by a hazardous waste disposal facility over its operating life has
reached 1 Ci (37 GBq) of cesium-137 or 30 mCi (1.11MBq) of americium-241.
The agency will not approve shipments of cesium-137 or americium-241 contaminated
incident-related material that will cause this limit to be exceeded.
(3)
A person shall be specifically licensed to receive waste
containing licensed material from other persons for:
(A)
treatment prior to disposal;
(B)
treatment by incineration;
(C)
decay in storage;
(D)
disposal at an authorized land disposal facility; or
(E)
storage until transferred to a storage or disposal facility
authorized to receive the waste.
(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)
the material is readily soluble, or is readily dispersible
biological material, in water;
(B)
the quantity of licensed radioactive material that the
licensee releases into the sewer in one month divided by the average monthly
volume of water released into the sewer by the licensee does not exceed the
concentration listed in Table III of subsection (ggg)(2) of this section;
and
(C)
if more than one radionuclide is released, the following
additional conditions must also be satisfied:
(i)
the fraction of the limit in Table III of subsection (ggg)(2)
of this section represented by discharges into sanitary sewerage determined
by dividing the actual monthly average concentration of each radionuclide
released by the licensee into the sewer by the concentration of that radionuclide
listed in Table III of subsection (ggg)(2) of this section; and
(ii)
the sum of the fractions for each radionuclide required
by clause (i) of this subparagraph does not exceed unity; and
(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)
Excreta from individuals undergoing medical diagnosis or
therapy with radioactive material are not subject to the limitations contained
in paragraph (1) of this subsection.
(hh)
Treatment by incineration. A licensee may treat licensed
material by incineration only in the form and concentration specified in subsection
(fff)(1) of this section or as authorized by the agency.
(ii)
Discharge by release into septic tanks. No licensee shall
discharge radioactive material into a septic tank system except as specifically
approved by the agency.
(jj)
Transfer for disposal and manifests.
(1)
The control of transfers of LLRW 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 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 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, lens
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)-(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)-(uu) of this section, and by license 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.
(mm)
Records of radiation protection programs.
(1)
Each licensee shall maintain records of the radiation protection
program, including:
(A)
the provisions of the program; and
(B)
audits and other reviews of program content and implementation.
(2)
The licensee shall retain the records required by paragraph
(1)(A) of this subsection until the agency terminates each pertinent license
requiring the record. The licensee shall retain the records required by paragraph
(1)(B) of this subsection for three years after the record is made.
(nn)
Records of surveys.
(1)
Each licensee shall maintain records showing the results
of surveys and calibrations required by subsections (p) and (ee)(2) of this
section. The licensee shall retain these records for three years after the
record is made.
(2)
The licensee shall retain each of the following records
until the agency terminates each pertinent license requiring the record:
(A)
the results of surveys to determine the dose from external
sources of radiation used, in the absence of or in combination with individual
monitoring data, in the assessment of individual dose equivalents; and
(B)
results of measurements and calculations used to determine
individual intakes of radioactive material and used in the assessment of internal
dose; and
(C)
results of air sampling, surveys, and bioassays required
in accordance with subsection (x)(1)(C)(i) and (ii) of this section; and
(D)
results of measurements and calculations used to evaluate
the release of radioactive effluents to the environment.
(oo)
Records of tests for leakage or contamination of sealed
sources. Records of tests for leakage or contamination of sealed sources required
by §289.201(g) of this title shall be kept in units of becquerel or microcurie
and retained for inspection by the agency for five years after the records
are made.
(pp)
Records of lifetime cumulative occupational radiation
dose. The licensee shall retain the records of lifetime cumulative occupational
radiation dose as specified in subsection (k) of this section on BRC Form
202-2 or equivalent until the agency terminates each pertinent license requiring
this record. The licensee shall retain records used in preparing BRC Form
202-2 or equivalent for three years after the record is made.
(qq)
Records of planned special exposures.
(1)
For each use of the provisions of subsection (k) of this
section for planned special exposures, the licensee shall maintain records
that describe:
(A)
the exceptional circumstances requiring the use of a planned
special exposure;
(B)
the name of the management official who authorized the
planned special exposure and a copy of the signed authorization;
(C)
what actions were necessary;
(D)
why the actions were necessary;
(E)
what precautions were taken to assure that doses were maintained
ALARA;
(F)
what individual and collective doses were expected to result;
and
(G)
the doses actually received in the planned special exposure.
(2)
The licensee shall retain the records until the agency
terminates each pertinent license requiring these records.
(rr)
Records of individual monitoring results.
(1)
Each licensee shall maintain records of doses received
by all individuals for whom monitoring was required in accordance with subsection
(q) of this section, and records of doses received during planned special
exposures, accidents, and emergency conditions. Assessments of dose equivalent
and records made using units in effect before January 1, 1994, need not be
changed. These records shall include, when applicable:
(A)
the deep dose equivalent to the whole body, lens dose equivalent,
shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;
(B)
the estimated intake of radionuclides, see subsection (g)
of this section;
(C)
the committed effective dose equivalent assigned to the
intake of radionuclides;
(D)
the specific information used to calculate the committed
effective dose equivalent in accordance with subsection (i)(1) and (3) of
this section and when required by subsection (q)(1) of this section;
(E)
the total effective dose equivalent when required by subsection
(g) of this section;
(F)
the total of the deep dose equivalent and the committed
dose to the organ receiving the highest total dose; and
(G)
the data used to make occupational dose assessments in
accordance with subsection (j)(5) of this section.
(2)
The licensee shall make entries of the records specified
in paragraph (1) of this subsection at intervals not to exceed 1 year and
by April 30 of the following year.
(3)
The licensee shall maintain the records specified in paragraph
(1) of this subsection on BRC Form 202-3, in accordance with the instructions
for BRC Form 202-3, or in clear and legible records containing all the information
required by BRC Form 202-3.
(4)
The licensee shall maintain the records of dose to an embryo/fetus
with the records of dose to the declared pregnant woman. The declaration of
pregnancy, including the estimated date of conception, shall also be kept
on file, but may be maintained separately from the dose records.
(5)
The licensee shall retain each required form or record
until the agency terminates each pertinent license requiring the record. The
licensee shall retain records used in preparing BRC Form 202-3 or equivalent
for three years after the record is made.
(ss)
Records of dose to individual members of the public.
(1)
Each licensee shall maintain records sufficient to demonstrate
compliance with the dose limit for individual members of the public. See subsection
(n) of this section.
(2)
The licensee shall retain the records required by paragraph
(1) of this subsection until the agency terminates each pertinent license
requiring the record.
(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)
The licensee shall retain the records required by paragraph
(1) of this subsection until the agency terminates each pertinent license
requiring the record.
(uu)
Records of testing entry control devices for very high
radiation areas.
(1)
Each licensee shall maintain records of tests made in accordance
with subsection (u)(2)(I) of this section on entry control devices for very
high radiation areas. These records must include the date, time, and results
of each such test of function.
(2)
The licensee shall retain the records required by paragraph
(1) of this subsection for three years after the record is made.
(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
shall maintain adequate safeguards against tampering with and loss of records.
(ww)
Reports of stolen, lost, or missing licensed sources of
radiation.
(1)
Each licensee shall report to the agency by telephone as
follows:
(A)
immediately after its occurrence becomes known to the licensee,
stolen, lost, or missing licensed radioactive material in an aggregate quantity
equal to or greater than 1,000 times the quantity specified in subsection
(ggg)(3) of this section, under such circumstances that it appears to the
licensee that an exposure could result to individuals in unrestricted areas;
or
(B)
within 30 days after its occurrence becomes known to the
licensee, lost, stolen, or missing licensed radioactive material in an aggregate
quantity greater than 10 times the quantity specified in subsection (ggg)(3)
of this section that is still missing.
(2)
Each licensee required to make a report in accordance with
paragraph (1) of this subsection shall, within 30 days after making the telephone
report, make a written report to the agency setting forth the following information:
(A)
a description of the licensed source of radiation involved,
including, for radioactive material, the kind, quantity, and chemical and
physical form;
(B)
a description of the circumstances under which the loss
or theft occurred;
(C)
a statement of disposition, or probable disposition, of
the licensed source of radiation involved;
(D)
exposures of individuals to radiation, circumstances under
which the exposures occurred, and the possible total effective dose equivalent
to persons in unrestricted areas;
(E)
actions that have been taken, or will be taken, to recover
the source of radiation; and
(F)
procedures or measures that have been, or will be, adopted
to ensure against a recurrence of the loss or theft of licensed sources of
radiation.
(3)
Subsequent to filing the written report, the licensee shall
also report additional substantive information on the loss or theft within
30 days after the licensee learns of such information.
(4)
The licensee shall prepare any report filed with the agency
in accordance with this subsection so that names of individuals who may have
received exposure to radiation are stated in a separate and detachable portion
of the report.
(xx)
Notification of incidents.
(1)
Notwithstanding other requirements for notification, each
licensee shall immediately report each event involving a source of radiation
possessed by the licensee 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)
a lens dose equivalent of 75 rems (0.75 Sv) or more; or
(iii)
a shallow dose equivalent to the skin or extremities
or a total organ dose equivalent of 250 rads (2.5 grays) or more; or
(B)
the release of radioactive material, inside or outside
of a restricted area, so that, had an individual been present for 24 hours,
the individual could have received an intake five times the occupational ALI.
This provision does not apply to locations where personnel are not normally
stationed during routine operations, such as hot-cells or process enclosures.
(2)
Each licensee shall, within 24 hours of discovery of the
event, report to the agency each event involving loss of control of a licensed
source of radiation possessed by the licensee 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)
a lens 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)
the release of radioactive material, inside or outside
of a restricted area, so that, had an individual been present for 24 hours,
the individual could have received an intake in excess of one occupational
ALI. This provision does not apply to locations where personnel are not normally
stationed during routine operations, such as hot-cells or process enclosures.
(3)
Licensees shall make the initial notification reports required
by paragraphs (1) and (2) of this subsection by telephone to the agency and
shall confirm the initial notification report within 24 hours by telegram,
mailgram, or facsimile to the agency.
(4)
The licensee shall prepare each report filed with the agency
in accordance with this section so that names of individuals who have received
exposure to sources of radiation are stated in a separate and detachable portion
of the report.
(5)
The provisions of this section do not apply to doses that
result from planned special exposures, provided such doses are within the
limits for planned special exposures and are reported in accordance with subsection
(zz) of this section.
(6)
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.).
(7)
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)
requires access to the contaminated area, by workers or
the public, to be restricted for more than 24 hours by imposing additional
radiological controls or by prohibiting entry into the area;
(ii)
involves a quantity of material greater than five times
the lowest annual limit on intake specified in subsection (ggg)(2) of this
section for the material; and
(iii)
has access to the area restricted for a reason other
than to allow isotopes with a half-life of less than 24 hours to decay prior
to decontamination.
(B)
an event in which equipment is disabled or fails to function
as designed when:
(i)
the equipment is required by rule or license condition
to prevent releases exceeding regulatory limits, to prevent exposures to radioactive
materials exceeding regulatory limits, or to mitigate the consequences of
an accident;
(ii)
the equipment is required to be available and operable
when it is disabled or fails to function; and
(iii)
no redundant equipment is available and operable to perform
the required safety function;
(C)
an event that requires unplanned medical treatment at a
medical facility of an individual with spreadable radioactive contamination
on the individual's clothing or body; or
(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 subsection (ggg)(2) of
this section for the material; and
(ii)
the damage affects the integrity of the radioactive material
or its container.
(8)
Preparation and submission of reports. Reports made by
licensees in response to the requirements of paragraphs (6) and (7) of this
subsection shall be made as follows.
(A)
Licensees shall make reports required by paragraphs (6)
and (7) of this subsection by telephone to the agency. To the extent that
the information is available at the time of notification, the information
provided in these reports shall include:
(i)
the caller's name and call back telephone number;
(ii)
a description of the event, including date and time;
(iii)
the exact location of the event;
(iv)
the isotopes, quantities, and chemical and physical form
of the radioactive material involved; and
(v)
any personnel radiation exposure data available.
(B)
Each licensee who makes a report required by paragraphs
(6) and (7) of this subsection shall submit to the agency a written follow-up
report within 30 days of the initial report. Written reports prepared in accordance
with other requirements of this chapter may be submitted to fulfill this requirement
if the reports contain all of the necessary information and the appropriate
distribution is made. The reports must include the following:
(i)
a description of the event, including the probable cause
and the manufacturer and model number (if applicable) of any equipment that
failed or malfunctioned;
(ii)
the exact location of the event;
(iii)
the isotopes, quantities, and chemical and physical form
of the radioactive material involved;
(iv)
date and time of the event;
(v)
corrective actions taken or planned and the results of
any evaluations or assessments; and
(vi)
the extent of exposure of individuals to radioactive materials
without identification of individuals by name.
(yy)
Reports of exposures, radiation levels, and concentrations
of radioactive material exceeding the limits.
(1)
In addition to the notification required by subsection
(xx) of this section, each licensee shall submit a written report within 30
days after learning of any of the following occurrences:
(A)
incidents for which notification is required by subsection
(xx) of this section;
(B)
doses in excess of any of the following:
(i)
the occupational dose limits for adults in subsection (f)
of this section;
(ii)
the occupational dose limits for a minor in subsection
(l) of this section;
(iii)
the limits for an embryo/fetus of a declared pregnant
woman in subsection (m) of this section;
(iv)
the limits for an individual member of the public in subsection
(n) of this section;
(v)
any applicable limit in the license; or
(vi)
the ALARA constraints for air emissions as required by
subsection (e)(4) of this section;
(C)
levels of radiation or concentrations of radioactive material
in:
(i)
a restricted area in excess of applicable limits in the
license; or
(ii)
an unrestricted area in excess of 10 times the applicable
limit set forth in this section or in the license, whether or not involving
exposure of any individual in excess of the limits in subsection (n) of this
section; or
(D)
for licensees subject to the provisions of the EPA's generally
applicable environmental radiation standards in 40 CFR §190, levels of
radiation or releases of radioactive material in excess of those standards,
or of license conditions related to those requirements.
(2)
Each report required by paragraph (1) of this subsection
shall describe the extent of exposure of individuals to radiation and radioactive
material, including, as appropriate:
(A)
estimates of each individual's dose;
(B)
the levels of radiation and concentrations of radioactive
material involved;
(C)
the cause of the elevated exposures, dose rates, or concentrations;
and
(D)
corrective steps taken or planned to ensure against a recurrence,
including the schedule for achieving conformance with applicable limits, ALARA
constraints, generally applicable environmental standards, and associated
license conditions.
(3)
Each report filed in accordance with paragraph (1) of this
subsection shall include for each individual exposed: the name, identification
number, and date of birth. With respect to the limit for the embryo/fetus
in subsection (m) of this section, the identifiers should be those of the
declared pregnant woman. The report shall be prepared so that this information
is stated in a separate and detachable portion of the report.
(4)
All licensees who make reports in accordance with paragraph
(1) of this subsection shall submit the report in writing to the agency.
(zz)
Reports of planned special exposures. The licensee shall
submit a written report to the agency within 30 days following any planned
special exposure conducted in accordance with subsection (k) of this section,
informing the agency that a planned special exposure was conducted and indicating
the date the planned special exposure occurred and the information required
by subsection (qq) of this section.
(aaa)
Notifications and reports to individuals.
(1)
Requirements for notification and reports to individuals
of exposure to sources of radiation are specified in §289.203 of this
title.
(2)
When a licensee 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 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 §289.203(d)(1) of this
title.
(bbb)
Reports of leaking or contaminated sealed sources. The
licensee shall immediately notify the agency if the test for leakage or contamination
required in accordance with §289.201(g) of this title indicates a sealed
source is leaking or contaminated. A written report of a leaking or contaminated
source shall be submitted to the agency within five days. The report shall
include the equipment involved, the test results and the corrective action
taken.
(ccc)
Vacating premises.
(1)
Each licensee or person possessing non-exempt sources of
radiation shall, no less than 30 days before vacating and 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 subsection
(ddd) of this section or, for uranium recovery and byproduct material disposal
facilities licensed in accordance with §289.260 of this title, subsection
(eee) of this section.
(ddd)
Radiological requirements for license termination.
(1)
General provisions and scope.
(A)
The requirements in this section apply to the decommissioning
of facilities licensed in accordance with §289.252 of this title (relating
to Licensing of Radioactive Material), §289.254 of this title (relating
to Licensing of Radioactive Waste Processing and Storage Facilities), §289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography), and §289.258 of
this title (relating to Licensing and Radiation Safety Requirements for Irradiators).
The requirements do not apply to uranium recovery and byproduct material disposal
facilities already subject to the requirements of §289.260 of this title
(relating to Licensing of Uranium Recovery and Byproduct Material Disposal
Facilities).
(B)
The requirements in this section do not apply to the following:
(i)
sites that have been decommissioned prior to October 1,
2000, in accordance with requirements identified in this section and in §289.252
of this title; or
(ii)
sites that have previously submitted and received approval
on a decommissioning plan by October 1, 2000.
(C)
After a site has been decommissioned and the license terminated
in accordance with the requirements in the subsection, the agency will require
additional cleanup if it determines that the requirements of the subsection
were not met and residual radioactivity remaining at the site could result
in significant threat to public health and safety.
(D)
When calculating TEDE to the average member of the critical
group, the licensee shall determine the peak annual TEDE dose expected within
the first 1,000 years after decommissioning.
(2)
Radiological requirements for unrestricted use. A site
will be considered acceptable for unrestricted use if the residual radioactivity
that is distinguishable from background radiation results in a TEDE to an
average member of the critical group that does not exceed 25 mrem (0.25 mSv)
per year, including that from groundwater sources of drinking water, and the
residual radioactivity has been reduced to levels that are ALARA. Determination
of the levels that are ALARA must take into account consideration of any detriments,
such as deaths from transportation accidents, expected to potentially result
from decontamination and waste disposal.
(3)
Alternate requirements for license termination.
(A)
The agency may terminate a license using alternate requirements
greater than the dose requirements specified in paragraph (2) of this subsection
if the licensee does the following:
(i)
provides assurance that public health and safety would
continue to be protected, and that it is unlikely that the dose from all man-made
sources combined, other than medical, would be more than the 1 mSv per year
(100 mrem per year) limit specified in subsection (o) of this section, by
submitting an analysis of possible sources of exposure;
(ii)
reduces doses to ALARA levels, taking into consideration
any detriments such as traffic accidents expected to potentially result from
decontamination and waste disposal; and
(iii)
has submitted a decommissioning plan to the agency indicating
the licensee's intent to decommission in accordance with the requirements
in §289.252(l)(7) of this title, and specifying that the licensee proposes
to decommission by use of alternate requirements. The licensee shall document
in the decommissioning plan how the advice of individuals and institutions
in the community who may be affected by the decommissioning has been sought
and addressed, as appropriate, following analysis of that advice. In seeking
such advice, the licensee shall provide for the following:
(I)
participation by representatives of a broad cross section
of community interests who may be affected by the decommissioning;
(II)
an opportunity for a comprehensive, collective discussion
on the issues by the participants represented; and
(III)
a publicly available summary of the results of all such
discussions, including a description of the individual viewpoints of the participants
on the issues and the extent of agreement and disagreement among the participants
on the issues.
(B)
The use of alternate requirements to terminate a license
requires the approval of the agency after consideration of the agency's recommendations
that will address any comments provided by the EPA and any public comments
submitted in accordance with paragraph (4) of this subsection.
(4)
Public notification and public participation. Upon receipt
of a decommissioning plan from the licensee, or a proposal from the licensee
for release of a site in accordance with paragraph (3) of this subsection,
or whenever the agency deems such notice to be in the public interest, the
agency will do the following:
(A)
notify and solicit comments from the following:
(i)
local and state governments in the vicinity of the site
and any Indian Nation or other indigenous people that have treaty or statutory
rights that could be affected by the decommissioning; and
(ii)
the EPA for cases where the licensee proposes to release
a site in accordance with paragraph (3) of this subsection; and
(B)
publish a notice in the
Texas
Register
and a forum, such as local newspapers, letters to state of
local organizations, or other appropriate forum, that is readily accessible
to individuals in the vicinity of the site, and solicit comments from affected
parties.
(5)
Minimization of contamination. Applicants for licenses,
other than renewals, after October 1, 2000, shall describe in the application
how facility design and procedures for operation will minimize, to the extent
practical, contamination of the facility and the environment, facilitate eventual
decommissioning, and minimize, to the extent practical, the generation of
LLRW.
(eee)
Limits for contamination of soil, surfaces of facilities
and equipment, and vegetation.
(1)
No licensee shall possess, receive, use, or transfer radioactive
material in such a manner as to cause contamination of surfaces of facilities
or equipment in unrestricted areas to the extent that the contamination exceeds
the limits specified in subsection (ggg)(6) of this section.
(2)
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 II, Column 2 of subsection
(ggg)(2)(F) 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 (4) of this subsection.
(3)
Where combinations of radionuclides are involved, the sum
of the ratios between the concentrations present and the limits specified
in paragraph (2) of this subsection shall not exceed one.
(4)
Notwithstanding the limits specified in paragraph (2) of
this subsection, no licensee shall cause the concentration of radium-226 or
radium-228 in soil in unrestricted areas, averaged over any 100 square meters
(m2), to 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.
(5)
No licensee shall possess, receive, use, or transfer radioactive
material in such a manner as to cause contamination of vegetation in unrestricted
areas to exceed 5 pCi/g (0.185 Bq/g), based on dry weight, for radium-226
or radium-228.
(6)
Notwithstanding the limits specified in paragraph (2) of
this subsection, no licensee shall cause the concentration of natural uranium
with no daughters present, based on dry weight and averaged over any 100 m2
of area, to exceed the following limits:
(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.
(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)
A licensee shall not discard tissue in accordance with
paragraph (1)(B) of this subsection in a manner that would permit its use
either as food for humans or as animal feed.
(3)
The licensee shall maintain records in accordance with
subsection (tt) of this section.
(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 Texas Administrative Code Chapter 330), unless
such licensed material also contains hazardous waste, as defined in §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)
Each licensee who discards material described in paragraphs
(1) or (4) of this subsection shall:
(A)
make surveys adequate to assure that the limits of paragraphs
(1) or (4) of this subsection are not exceeded; and
(B)
remove or otherwise obliterate or obscure all labels, tags,
or other markings that would indicate that the material or its contents is
radioactive.
(6)
Prior to authorizations in accordance with paragraph (4)
of this subsection, a licensee shall submit procedures to the agency for:
(A)
the physical delivery of the material to the disposal site;
(B)
surveys to be performed for compliance with paragraph (5)(A)
of this subsection;
(C)
maintaining secure packaging during transportation to the
site; and
(D)
maintaining records of any discards made under paragraph
(4) of this subsection.
(7)
Nothing in this section relieves the licensee of maintaining
records showing the receipt, transfer, and discard of such radioactive material
as specified in §289.201(d) of this title.
(8)
Nothing in this section relieves the licensee from complying
with other applicable federal, state, and local regulations governing any
other toxic or hazardous property of these materials.
(9)
Licensed material discarded under this section is exempt
from the requirements of §289.252(t) of this title.
(ggg)
Appendices.
(1)
Protection factors for respirators. The following table
contains protection factors for respiratorsa:
Figure: 25 TAC §289.202(ggg)(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)
Introduction.
(i)
For each radionuclide, Table I of subparagraph (F) of this
paragraph indicates the chemical form that is to be used for selecting the
appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for
an aerosol with an activity median aerodynamic diameter (AMAD) of 1 micron,
and for three classes (D, W, Y) of radioactive material, which refer to their
retention (approximately days, weeks, or years) in the pulmonary region of
the lung. This classification applies to a range of clearance half-times for
D if less than 10 days, for W from 10 to 100 days, and for Y greater than
100 days. Table II of subparagraph (F) of this paragraph provides concentration
limits for airborne and liquid effluents released to the general environment.
Table III of subparagraph (F) of this paragraph provides concentration limits
for discharges to sanitary sewerage.
(ii)
The values in Tables I, II, and III of subparagraph (F)
of this paragraph are presented in the computer "E" notation. In this notation
a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6
x 102 or 600, and 6E+0 represents 6 x 100 or 6.
(B)
Occupational values.
(i)
Note that the columns in Table I of subparagraph (F) of
this paragraph captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC,"
are applicable to occupational exposure to radioactive material.
(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, wT. 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)
A value of wT = 0.06 is applicable to each of the five
organs or tissues in the "remainder" category receiving the highest dose equivalents,
and the dose equivalents of all other remaining tissues may be disregarded.
The following portions of the GI tract; stomach, small intestine, upper large
intestine, and lower large intestine, are to be treated as four separate organs.
(iv)
The dose equivalents for an extremity, skin, and lens
of the eye are not considered in computing the committed effective dose equivalent,
but are subject to limits that must be met separately.
(v)
When an ALI is defined by the stochastic dose limit, this
value alone is given. When an ALI is determined by the non-stochastic dose
limit to an organ, the organ or tissue to which the limit applies is shown,
and the ALI for the stochastic limit is shown in parentheses. Abbreviated
organ or tissue designations are used as follows:
(I)
LLI wall = lower large intestine wall;
(II)
St. wall = stomach wall;
(III)
Blad wall = bladder wall; and
(IV)
Bone surf = bone surface.
(vi)
Figure: 25 TAC §289.202(ggg)(2)(B)(vi) (No change.)
(vii)
The dose equivalents for an extremity, skin, and lens
of the eye are not considered in computing the committed effective dose equivalent,
but are subject to limits that must be met separately.
(viii)
The DAC values are derived limits intended to control
chronic occupational exposures. The relationship between the DAC and the ALI
is given by:
Figure: 25 TAC §289.202(ggg)(2)(B)(viii) (No change.)
(ix)
The DAC values relate to one of two modes of exposure:
either external submersion or the internal committed dose equivalents resulting
from inhalation of radioactive materials. DACs based upon submersion are for
immersion in a semi-infinite cloud of uniform concentration and apply to each
radionuclide separately.
(x)
The ALI and DAC values include contributions to exposure
by the single radionuclide named and any in-growth of daughter radionuclides
produced in the body by decay of the parent. However, intakes that include
both the parent and daughter radionuclides should be treated by the general
method appropriate for mixtures.
(xi)
The values of ALI and DAC do not apply directly when the
individual both ingests and inhales a radionuclide, when the individual is
exposed to a mixture of radionuclides by either inhalation or ingestion or
both, or when the individual is exposed to both internal and external irradiation.
See subsection (g) of this section. When an individual is exposed to radioactive
materials which fall under several of the translocation classifications of
the same radionuclide, such as, Class D, Class W, or Class Y, the exposure
may be evaluated as if it were a mixture of different radionuclides.
(xii)
It should be noted that the classification of a compound
as Class D, W, or Y is based on the chemical form of the compound and does
not take into account the radiological half-life of different radionuclides.
For this reason, values are given for Class D, W, and Y compounds, even for
very short-lived radionuclides.
(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)
Consideration of non-stochastic limits has not been included
in deriving the air and water effluent concentration limits because non-stochastic
effects are presumed not to occur at or below the dose levels established
for individual members of the public. For radionuclides, where the non-stochastic
limit was governing in deriving the occupational DAC, the stochastic ALI was
used in deriving the corresponding airborne effluent limit in Table II of
subparagraph (F) of this paragraph. For this reason, the DAC and airborne
effluent limits are not always proportional as they were in the previous radiation
protection standards.
(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 109, 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)
a factor of 3 to adjust for the difference in exposure
time and the inhalation rate for a worker and that for members of the public;
and
(III)
a factor of 2 to adjust the occupational values, derived
for adults, so that they are applicable to other age groups.
(iv)
For those radionuclides for which submersion, that is
external dose, is limiting, the occupational DAC in Column 3 of Table I of
subparagraph (F) of this paragraph was divided by 219. The factor of 219 is
composed of a factor of 50, as described in clause (iii) of this subparagraph,
and a factor of 4.38 relating occupational exposure for 2,000 hours per year
to full-time exposure (8,760 hours per year). Note that an additional factor
of 2 for age considerations is not warranted in the submersion case.
(v)
The water concentrations were derived by taking the most
restrictive occupational stochastic oral ingestion ALI and dividing by 7.3
x 107. The factor of 7.3 x 10 7 milliliters (ml) includes the following components:
(I)
the factors of 50 and 2 described in clause (iii) of this
subparagraph; and
(II)
a factor of 7.3 x 105 (ml) which is the annual water intake
of "Reference Man."
(vi)
Note 2 of subparagraph (F) of this paragraph provides
groupings of radionuclides that are applicable to unknown mixtures of radionuclides.
These groupings, including occupational inhalation ALIs and DACs, air and
water effluent concentrations, and releases to sewer, require demonstrating
that the most limiting radionuclides in successive classes are absent. The
limit for the unknown mixture is defined when the presence of one of the listed
radionuclides cannot be definitely excluded as being present either from knowledge
of the radionuclide composition of the source or from actual measurements.
(D)
Releases to sewers. The monthly average concentrations
for release to sanitary sewerage are applicable to the provisions in subsection
(gg) of this section. The concentration values were derived by taking the
most restrictive occupational stochastic oral ingestion ALI and dividing by
7.3 x 106 (ml). The factor of 7.3 x 10 6(ml) is composed of a factor of 7.3
x 105 (ml), the annual water intake by "Reference Man," and a factor of 10,
such that the concentrations, if the sewage released by the licensee were
the only source of water ingested by a "Reference Man" during a year, would
result in a committed effective dose equivalent of 0.5 rem.
(E)
List of elements.
Figure: 25 TAC §289.202(ggg)(2)(E) (No change.)
(F)
Tables--Values for annual limits. The following tables
contain values for annual limits on intake (ALI) and derived air concentrations
(DAC) of radionuclides for occupational exposure; effluent concentrations;
concentrations for release to sanitary sewerage:
Figure: 25 TAC §289.202(ggg)(2)(F) (No change.)
(3)
Quantities of licensed material requiring labeling. The
following tables contain quantities of licensed material requiring labeling:
Figure: 25 TAC §289.202(ggg)(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: 25 TAC §289.202(ggg)(4)(A)(iii)(V) (No change.)
(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: 25 TAC §289.202(ggg)(4)(A)(iv)(VI) (No change.)
(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: 25 TAC §289.202(ggg)(5) (No change.)
(6)
Acceptable surface contamination levels.
Figure: 25 TAC §289.202(ggg)(6) (No change.)
(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). The following table contains concentration
and activity limits of nuclides for disposal in a Type I municipal solid waste
site or a hazardous waste facility.
Figure: 25 TAC §289.202(ggg)(7) (No change.)
(8)
Soil contamination limits for selected radionuclides (for
use in subsection (ddd) of this section).
Figure: 25 TAC §289.202(ggg)(8) (No change.)
(9)
Cumulative occupational exposure form. The following, BRC
Form 202-2, is to be used to document cumulative occupational exposure history:
(Please find BRC Form 202-2 at the end of this section.)
Figure: 25 TAC §289.202(ggg)(9) (No change.)
(10)
Occupational exposure form. The following, BRC Form 202-3,
is to be used to document occupational exposure record for a monitoring period:
(Please find BRC Form 202-3 at the end of this section.)
Figure: 25 TAC §289.202(ggg)(10) (No change.)
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 February 26, 2002.
TRD-200201188
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 1, 2002
Proposal publication date: December 14, 2001
For further information, please call: (512) 458-7236
Chapter 403.
OTHER AGENCIES AND THE PUBLIC
Subchapter B. CHARGES FOR COMMUNITY-BASED SERVICES
25 TAC §§403.41 - 403.53
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) adopts the repeals of §§403.41 - 403.53 of Chapter 403,
Subchapter B, concerning charges for community-based services, without changes
to the proposal as published in the December 28, 2001, issue of the
The repeals allow for the adoption of new sections governing the same matters.
No comment on the proposal was received.
These sections are repealed under the Texas Health and Safety
Code, §532.015, which provides the Texas Board of Mental Health and Mental
Retardation (board) with broad rulemaking authority, and §534.067, which
requires TDMHMR to establish a uniform fee collection policy for all local
authorities that is equitable, provides for collections, and maximizes contributions
to local revenue.
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 February 28, 2002.
TRD-200201256
Andrew Hardin
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: September 1, 2002
Proposal publication date: December 28, 2001
For further information, please call: (512) 206-5216
Subchapter C. CHARGES FOR COMMUNITY SERVICES
Chapter 289.
RADIATION CONTROL
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION
Chapter 412.
LOCAL AUTHORITY RESPONSIBILITIES