Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 31.
NUTRITION SERVICES
Subchapter C. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC)
25 TAC §31.37
The Texas Department of Health (department) adopts amendments
to §31.37, concerning selection of allowable foods in the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC), with changes to
the proposed text as published in the December 6, 2002, issue of the
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 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 may be expended only as
offsets to WIC food costs.
The amendments to §31.37 enables the program to respond in a more
timely, efficient, and flexible manner to changes in packaging of WIC-issued
foods by manufacturers and to requests for changes in allowable foods by vendors
and clients. The section has also been streamlined by the removal of redundant
language.
The following comments were received concerning the proposed amendments
to the section. Following each comment is the department's responses and any
resulting change(s).
Comment: Concerning §31.37, one commenter stated that food manufacturers
submitting foods for consideration as a WIC-authorized food should be required
to certify that the food meets the mandated federal requirements for minimum
nutritional content.
Response: Although current procedures for submitting foods for consideration
already require such a certification, the department agrees that this requirement
also should be stated in §31.37. Section 31.37(d) has been amended accordingly.
Comment: Concerning §31.37(k), one commenter asked whether the department's
use of the phrase "may not" means the department has discretion concerning
approval of products that have similar names or package designs.
Response: When reviewing product(s) submitted for approval as WIC-authorized
foods, the department must exercise its informed discretion concerning whether
the product(s) have similar names or package designs. However, if the department
determines that such similarity exists, and therefore might cause substantial
confusion among WIC vendors and/or participants, the department shall not
approve the product(s). The department has amended §31.37(k) by including
the word "shall" in lieu of "may" and adding language to clarify that approval
will not be granted when there is the potential for substantial confusion.
Comment: Concerning §31.37, the commenter endorsed the rules as proposed
with no changes requested.
Response: The department acknowledges the commenter's support. No changes
were necessary as a result of this comment.
The commenters were the USDA Food and Nutrition Service, the WIC Advisory
Committee, and an individual. The commenters were in favor of the rules in
their entirety, and made one recommendation for change as discussed in the
summary of comments.
The amendment is 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.
§31.37.Selection of WIC Program Allowable Foods.
(a)
Criteria for approving products for inclusion in the WIC
Program food package are based on federal regulations, packaging, cost, cultural
acceptability, and nutritive value.
(b)
A product shall meet the federal regulations governing
the WIC Program food package in order to be considered for approval through
the WIC Program.
(c)
The state agency may restrict the number of brands and
types of any products in order to contain the cost of the food package and
minimize the confusion for WIC participants. The state agency is not obligated
to authorize every available food that meets the federal requirements.
(d)
The state agency shall review the WIC Program list of allowable
foods annually to determine the need for adding or deleting food products.
(1)
If the state agency determines that the list of allowable
cereals or juices should be changed, the state agency shall notify both juice
and cereal manufacturers of that intent through a request for information
(RFI).
(2)
Juice and cereal manufacturers may contact the WIC Program
at any time during the year to request that their names and addresses be added
to the mailing list for an RFI.
(3)
Manufacturers of juice and cereal shall certify through
their RFI response that their products meet the requirements for nutritional
content as specified in federal regulations governing the program.
(e)
The state agency may restrict the size of packages and
types of containers of any products for any food type including limiting package
size and container type within brands of products in order to contain the
cost of the food package and minimize the confusion for WIC participant.
(f)
A product for any food type shall be available for retail
purchase in Texas on or before the effective date of the approved food list
or it will not be considered by the state agency for authorization.
(g)
The product form and marketing approach for any product
for any food type shall be consistent with the promotion of good nutrition
and education.
(h)
The state agency reserves the right to solicit rebates
for any eligible foods from manufacturers through a competitive bid process.
(i)
The state agency reserves the right to determine the numbers
and types of foods within a food type to be authorized.
(j)
In determining the number of brands and types of any products
to be approved, the state agency may consider consumer, cultural, and/or ethnic
acceptability, and suitability for children.
(k)
Products having similar names and package designs shall
not be approved if the similarity in name and/or packaging would cause substantial
confusion for vendors and/or participants.
(l)
Additional criteria for each food type are as follows:
(1)
Milk. Milk shall be:
(A)
unflavored, fresh, whole, reduced fat, low-fat or fat-free
(nonfat or skim) milk including cultured buttermilk fortified with vitamins
A and D to meet the federal standards;
(B)
whole or fat-free (nonfat) evaporated cow's milk fortified
with vitamins A and D to meet the federal standards; and/or
(C)
nonfat, dry, powdered milk fortified with vitamins A and
D to meet the federal standards.
(2)
Cheese. Cheese shall be unflavored and pasteurized.
(3)
Cereals.
(A)
Cereal shall contain a minimum of 28 milligrams of iron
per 100 grams of dry cereal, and not more than 21.2 grams of sucrose and other
sugars per 100 grams of dry cereal (6 grams per ounce).
(B)
The state agency reserves the right to determine the number
and brands of cereals, which shall include at least one hot cereal and at
least one corn, wheat, oat, rice, and multi-grain cereal.
(4)
Juice.
(A)
Juices shall be single-strength fluid fruit or vegetable
juices containing a minimum of 30 milligrams of vitamin C per 100 milliliters
and/or concentrated fruit or vegetable juices containing a minimum of 30 milligrams
of vitamin C per 100 milliliters of reconstituted juice.
(B)
Juices shall be 100% juice and shall contain no added sugar,
or other natural or artificial sweeteners.
(C)
Juices packaged in a variety of containers, even though
made by the same manufacturer, shall be evaluated separately.
(5)
Eggs. Eggs shall be fresh grade A or grade AA large, medium,
or small.
(6)
Beans/Peas/Lentils. Beans, peas, and lentils shall be dry
with the exception of canned beans which may be authorized only for the homeless
food package.
(7)
Peanut Butter. Peanut butter shall contain no other ingredients
such as jelly or candy pieces.
(8)
Tuna. Tuna shall be packed in water.
(9)
Carrots. Carrots shall be bagged, fresh, large carrots
without tops and/or canned, sliced carrots.
(10)
Infant formula. Infant formulas shall be registered with
the United States Food and Drug Administration as complying with the legal
definition of infant formula.
(11)
Infant cereal. Infant cereal shall contain a minimum of
45 milligrams of iron per 100 grams of dry cereal in dehydrated flake form.
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 April 9, 2003.
TRD-200302349
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: October 1, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
25 TAC §§103.14 - 103.16, 103.19
The Texas Department of Health (the department) adopts amendments
to §§103.14 - 103.16 and 103.19 concerning injury reporting requirements
to the department. Sections 103.16 and 103.19 are adopted with changes to
the proposed text as published in the January 31, 2003 issue of the
The sections are amended to ensure there will be no change in the information
reported after the federal Health Insurance Portability and Accountability
Act of 1996 (HIPAA) privacy standards (45 Code of Federal Regulations (CFR),
Parts 160 and 164) become effective on April 14, 2003, and to further ensure
that HIPAA covered reporting entities will comply with the letter and the
spirit of the HIPAA privacy standards. The amended sections correct any discrepancies
between the rule and the information the department currently receives. The
section is further amended to clarify the definition of regional registries,
and to clarify the role and guidelines of regional registries.
The HIPAA privacy standards contain sections that allow HIPAA covered entities
to use and disclose protected health information (PHI), which is individually
identifiable health information, without the authorization of the individual,
if the use and disclosure is required by law or rule, the use and disclosure
complies with the law or rule and is limited to the requirements of the law
or rule (45 CFR §164.512(a); or for public health activities (45 CFR §164.512(b)).
To ensure that all the department rules meet the standards established in
these sections, the department conducted a review of the department rules
and the information that is actually received under the authority of the rules.
This review was done to ensure there would be no interruption of information
reported to the department, and to ensure that persons required to report
under the rules would not be confused or uncertain whether they were in compliance
with the HIPAA privacy standards.
The sections correct any discrepancies between the rule and the information
the department currently receives. The sections will make no change in the
information a person is currently required to report to the department. These
sections will ensure that persons required to report will have continuing
authority to disclose PHI to the department after the implementation date
of the federal privacy standards.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning §103.19 (a)(1), three commenters objected to language
deleting reference to regional registries. The commenters requested that regional
registries be categorized as either "entities" or "business associates" in
order to comply with the HIPAA rules and that such language be included in
a "definitions" section of this rule.
Response: The department agrees and has retained mention of regional registries
and has added language to support their use as business associates. A definition
of regional registries currently exists in the rule. A definition of business
associates has also been added to §103.19(a)(3).
Comment: Concerning the rules in general, three commenters requested additional
rules be written to support regional trauma registries and that, in collaboration
with Regional Advisory Councils that have regional registries, the role, function,
and guidelines of regional registries be clearly defined.
Response: The department agrees to work with Regional Advisory Councils
on developing clearly defined guidelines for regional registries, but the
suggested changes go beyond the scope of these amendments. No changes were
made due to the comments.
Comment: One commenter was concerned because neither the specifics nor
the spirit of the recommendation made by the Community Consultation on Injury
Reporting in August 2001 was addressed by the proposed rule. The Community
Consultation on Injury Reporting recommended, in part, that the department
adopt rules that require providers to report names of individuals who sustain
traumatic brain and/or spinal cord injuries.
Response: The department disagrees. The addition of data elements for injury
reporting goes beyond the purpose of the proposed amendments. These amendments
were presented to preserve the reporting status quo ante on April 14, 2003.
Adding name reporting or other data elements would go beyond this. The amendments
to the rule are limited to ensuring compliance with specific provisions of
HIPAA-specifically 45 CFR 164.512(a)-ensuring that there is agreement between
what the agency collects and the rules-therefore maintaining the status quo
for reporting entities. The department did not intend to make any substantive
changes at this time. Because of the limited scope of the amendments stated
in the proposed preamble, the department declines making substantive changes
without providing notice and an opportunity for comment on substantive changes
to the rule. No change was made as a result of the comment.
Comment: Regarding §103.14(e), §103.14(f), §103.15(c), §103.15(d), §103.16(c), §103.16(d),
one commenter was concerned that the rule did not contain any obligation by
the department for public and state agency participation in the development
or oversight of information contained in the various reporting guidelines
referenced in the rule.
Response: The procedure to ensuring public and agency comment and input
to the reporting requirement is contained in Administrative Procedure Act
(APA). These mechanisms include contact with the Governor's EMS and Trauma
Advisory Council, posting on the department's EMS website, and E-mail listserv
mailings. The department has in the past and always will have mechanisms for
stakeholder input. No change was made as a result of the comment.
Comment: Regarding §103.17, one commenter requested that changes be
made to rules to ensure that acute or post-acute rehabilitation facilities
meet the requirements of the HIPAA privacy standards.
Response: The purpose of these rules is not to ensure these facilities
are complying with HIPPA. These amendments serve a more limited purpose, to
make sure that entities are compliant with HIPAA when they report to the department.
The existing rule does this, therefore no change was necessary.
Comment: One commenter suggested that there was inconsistency regarding
reporting information electronically or by paper in §103.14(b)(2), and §103.14(c)(2).
Response: The department disagrees. There is no inconsistency. If a hospital
does not have the ability to report electronically, the hospital may report
by the referenced paper form as referenced in the rules. No change was made
as a result of the comment.
Comment: One commenter identified punctuation errors regarding §103.16(a)(1).
Response: The department agrees and has added a closing parentheses after
the word "Variables."
Comment: One commenter requested adding and defining the term "business
associate" in the rule.
Response: The department agrees and has added suggested language to §103.19(a)(2)
and (3).
The commenters were the Heart of Texas Regional Advisory Council, the Southeast
Texas Trauma Regional Advisory Council, a trauma care coordinator, and the
Texas Traumatic Brain Injury Advisory Council. Three commenters were against
provisions in the rules which deleted references to regional registries. One
commenter requested additional data elements to be incorporated. One commenter
was concerned that the rule did not contain any obligation by the department
for public and state agency participation in the development or oversight
of information contained in the various reporting guidelines referenced in
the rule. One commenter requested that changes be made to rules to ensure
that acute or post-acute rehabilitation facilities meet the requirements of
the HIPAA privacy standards. One commenter suggested that there was inconsistency
between sections. One commenter identified punctuation errors. One commenter
requested adding and defining the term "business associate" in the rule.
The amendments are adopted under the Health and Safety Code, §92.002,
which requires the Board of Health (board) to adopt rules necessary to implement
the reporting of injuries; the Health and Safety Code, §§773.112
and 773.113(a)(3), which require the department to adopt rules necessary to
implement a trauma reporting and analysis system; and Health and Safety Code, §12.001,
which provides the board with the authority to adopt rules for the performance
of each duty imposed by law on the board, the department, and the commissioner.
§103.16.Reporting Requirements for Pre-hospital Providers.
(a)
For submersion injuries and all pre-hospital provider calls:
(1)
The information found in the most current version of the
department's Prehospital Reporting EMS/Trauma Guidelines or Texas EMS/Trauma
Registry Data Dictionary (Prehospital Data Variables).
(2)
The procedure for reporting is described in §103.19
of this title (relating to Electronic Reporting).
(b)
If a pre-hospital provider does not transport any patients
sustaining an injury within any given month, and therefore does not have any
electronic records to transmit for that month, the pre-hospital provider must
complete and submit to the program within ninety days a form prescribed by
the program stating that it did not have any cases to report for that month.
§103.19.Electronic Reporting.
(a)
Hospitals shall submit reports to the Texas Trauma Registry
within three months of discharge from their facility for the diagnosis or
treatment of traumatic brain injuries, traumatic spinal cord injuries, and
information on trauma patients. Pre-hospital providers shall submit reports
to the Texas Trauma Registry within three months of the treatment and transport
of submersion injuries and all pre-hospital calls. Acute or post-acute rehabilitation
facilities shall submit reports to the program within three months of treatment
of traumatic brain injuries and traumatic spinal cord injuries.
(1)
A hospital or pre-hospital provider that uses the services
of a business associate to transmit an electronic data file to the department
will be considered in compliance with this section when the department receives
the complete electronic data file from the business associate, the hospital
or pre-hospital provider as required by this section.
(2)
A regional registry located in a Trauma Service Area may
be a business associate upon conclusion of a business associate agreement
between the hospital or pre-hospital provider and the regional registry.
(3)
Business associate is defined in 45 CFR §160.103.
(b)
Data shall be transmitted by computer modem or by other
electronic means approved by the program at least quarterly; monthly submissions
are recommended.
(c)
Hospitals shall report the information found in the most
current electronic formatted version of the department's Hospital Reporting
Guidelines or Texas EMS/Trauma Registry Data Dictionary (Hospital Data Variables).
(d)
Pre-hospital providers shall report the information found
in the most current electronic formatted version of the department's Prehospital
Reporting EMS/Trauma Guidelines or Texas EMS/Trauma Registry Data Dictionary
(Prehospital Data Variables).
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 April 9, 2003.
TRD-200302346
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 29, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
Subchapter D. GENERAL
25 TAC §289.201
The Texas Department of Health (department) adopts an amendment
to §289.201, concerning general provisions for radioactive material and
is adopted with changes to the proposed rule text as published in the December
6, 2002 issue of the
Texas Register
(27 TexReg
11413).
Government Code, §2001.039 requires that each state agency conduct
a review of its rules every four years and consider for readoption each rule
adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative
Procedure Act). Section 289.201 has been reviewed and the department has determined
that the reasons for adopting the section continue to exist; however, revisions
to the rule are necessary.
The department published a Notice of Intention to Review for §289.201
in regards to Government Code, §2001.039 in the
Texas Register
(27 TexReg 7997) on August 23, 2002. No comments were
received by the department on this section.
The word "Title" was added to clarify references to the United States Nuclear
Regulatory Commission (NRC) Code of Federal Regulations to properly cite the
references. All references to the Texas Natural Resource Conservation Commission
(TNRCC) were changed to reflect the name change to "Texas Commission on Environmental
Quality (TCEQ)," that became effective September 1, 2002. The words "with
license in good standing" were deleted from the definitions of "Pharmacist,"
"Physician," and "Veterinarian" because an individual is either licensed or
not licensed. The subsection concerning records was reformatted for easier
readability. Additional language was also added to that subsection to specify
that the information maintained in the records of receipt, transfer, and disposal
of all non-exempt sources of radiation shall include as a minimum: a unique
identification of the source of radiation, including manufacturer's name,
isotope, activity, and source serial number, if available; the date of receipt,
transfer, or disposal; for the person transferring the source of radiation,
the number of the transferee's radioactive material license and the regulatory
agency issuing the license to the transferee; and for the person receiving
the source of radiation, the number of the transferor's radioactive material
license and the regulatory agency issuing the license to the transferor. Language
was added to clarify that retention periods are specified in other sections
of this chapter. The words "(becquerel(Bq))" were replaced by the symbol "(Bq)"
because it was spelled out previously in the rule.
Several revisions were made because they are items of compatibility with
NRC. As an agreement state, Texas must adopt these requirements to maintain
compatibility with NRC rules. The compatibility items include the following
revisions. A reference to §289.253(i) was added to specify that energy
compensation sources that meet certain criteria do not have to be tested for
leakage and/or contamination. The words "and at the nearest accessible point
to the sealed source" were added to the description of where leak test samples
should be taken in order to further define the process of obtaining a test
for leakage. Wording was added to require licensees to use leak test kits
or methods to perform tests for leakage or contamination that have been approved
by the agency, NRC, an agreement state, or a licensing state. Also, the word
tritium was added in parentheses after "hydrogen-3" to clarify that the terms
refer to the same radionuclide.
References to other sections of this title were clarified. Other minor
clarifying changes were added to make grammatical corrections and to make
the section consistent with other sections of this title. The graphic in §289.201(m)(2)(A)(ii)
concerning open records was amended for clarification.
This amendment is part of the department's continuing effort to update,
clarify and simplify its rules regarding the control of radiation based upon
technological advances, public concerns, legislative directives, or other
factors..
The department is making the following changes due to staff comments to
clarify the intent and improve the accuracy of the section.
Change: Concerning §289.201(d), the department added the words "non-exempt"
to the proposed language to clarify that the record requirements apply to
all sealed sources that are not otherwise exempted from any licensing requirements
of this chapter.
Change: Concerning §289.201(d)(1)(A)(ii), the department added the
words "transfer, or disposal" to the proposed language after the word "receipt"
to further clarify the records that each licensee shall maintain for all non-exempt
sources of radiation.
Change: Concerning §289.201(g)(1)(B), the department changed the proposed
incorrect reference from §289.252(o)(3) and (4) to §289.252(v).
Change: Concerning §289.201(g)(1)(C), the department changed the proposed
incorrect reference from §289.252(o)(3) and (4) to §289.252(v).
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting change(s).
Comment: Concerning the proposed §289.201(d), a commenter questioned
the reference to "sources of radiation", and whether this term applies to
only "sources" or whether it also applies to "devices containing sources".
Also, the commenter stated that if the requirements are intended to apply
to devices containing sources, then the user (transferee) would not have access
to some of the information, e.g., sealed source serial number. Manufacturers/distributors
routinely do not provide their license number except in the case of general
license distribution.
Response: The department acknowledges the comment. However, by definition,
"source of radiation" is defined as "any radioactive material, or any device
or equipment emitting or capable of producing radiation," in accordance with
25 Texas Administrative Code (TAC) §289.201(b)(99) of this title. The
department added the words "if available" to subsection (d)(1)(A)(i)(IV) to
provide for a situation where the sealed source serial number is not available.
Comment: Concerning the proposed §289.201(d)(1), a commenter questioned
why the word "licensed" was deleted from the first sentence. The commenter
questioned if this was intentionally done by the department to now include
exempt quantity sources, check sources, calibration sources, and etcetera.
If this is the intention of the department, the commenter is concerned that
some of these records simply do not exist, that these type of sources rarely
have a serial number, and there is no requirement on manufacturers or distributors
to maintain records showing the receipt, transfer, and disposal of all sources
of radiation.
Response: The department agrees with the commenter and added the words
"non-exempt" to clarify for which devices a licensee should maintain records
of receipt, transfer, and disposal.
Comment: Concerning §289.201(d)(1)(A)(i)(IV), a commenter stated that
the words "a unique identification of each source of radiation, including;
(IV) sealed source serial number;" does not recognize that sealed sources
such as Au-198, I-125, Pd-103, seeds/grains or Ir-192 wires do not have individual
serial or other unique identification numbers for each discrete seed or wire
source.
Response: The department agrees with the commenter and added the words
"if available" at the end of the sentence to clarify that the sealed source
serial number shall be included in the records of receipt, transfer, and disposal
of all sources of radiation if it is available.
Comment: Concerning §289.201(d)(1)(A)(iv), a commenter stated that
the requirement to keep records of "the person from whom the source of radiation
was received" is simply an additional paperwork burden with no attendant benefit
to public health and safety. Once a source of radiation is received by a duly
licensed entity and recorded in their inventory, it is the property and responsibility
of the licensee and where it came from is totally irrelevant.
Response: The department disagrees. Security of sealed sources is important.
The department is requiring documentation to be able to track sealed sources
from origination, through transfers, to ultimate disposal. No change was made
as a result of the comment.
Comment: Concerning §289.201(g)(1)(E), a commenter stated that by
adding the words "...and at the nearest accessible point to the sealed source..."
would potentially create a situation for increased extremity (hand) exposure.
For example, in the case of devices with exposed shutters, one potentially
would insert the hand more directly into the radiation beam rather than taking
the wipe around the shutter area or at the sides of the beam where contamination,
if any existed, would migrate. The commenter also questioned how the user
is supposed to retract insertion sources to obtain the nearest accessible
point to the sealed source. If this is the case, then both whole body and
extremity doses are increased.
Response: The department acknowledges the comment. However, leak test sampling
should be performed using the principle of "As Low As is Reasonable Achievable
(ALARA)," in accordance with §289.202(e)(2) of this chapter. No change
was made as a result of the comment.
Comment: Concerning §289.201(g)(1)(E), a commenter stated that the
last sentence in this paragraph: "For a sealed source contained in a device,
test samples are obtained when the source is in the "off" position;" simply
is not workable for many operating facilities. The commenter suggested that
even though this statement is in the current version of this section, the
department should consider the following statements:
When a device containing a radioactive source is tied to process control,
closing the shutter (or placing the source in the off position) can be detrimental
to the process. False signals can be received in the control room; a tank
or vessel can be overfilled or underfilled; or the entire process can be shut
down. If the process shuts down, it poses the potential for significant operational
problems, as well as significant economic impact.
Leak test samples can be safely obtained, following instructions from the
leak test kit supplier and good safety practices, with the shutter in the
"on position". The potential for unnecessary whole body of extremity exposure
is minimal. As a matter of fact, one would usually stand at the back or at
the side of a device to take the leak test wipe, and the external radiation
levels at these locations vary hardly at all, whether the shutter is "off"
or "on".
What is a licensee to do if it is time to take the samples in order to
meet other time-based requirements and operationally it would be detrimental
to the process to close a shutter?
Response: The department disagrees. Leak tests may be performed when maintenance
is scheduled or at other times when the process line is halted. Leak test
sampling should be performed using the principle of "As Low As is Reasonable
Achievable (ALARA)," in accordance with §289.202(e)(2) of this chapter.
No change was made as a result of the comment.
Comment: Concerning §289.201(g)(1)(H), a commenter stated that this
requirement is not needed since the department already reviews the licensee's
procedures and instructions in order to obtain authorization to distribute
leak test kits to users on how and where to take wipe samples.
Response: The department disagrees. The requirement is for licensees who
use the leak test kits, not necessarily for those licensees distributing the
kits. The requirement makes clear that the licensee must use an approved leak
test kit or must use an alternate approved leak testing method. No change
was made as a result of the comment.
Comment: Concerning §289.201(g)(5) and (6), a commenter stated that
state regulations do not include the requirement for the licensee to check
the equipment associated with the leaking source for radioactive contamination,
and if contaminated, have it decontaminated or disposed of by an NRC or Agreement
State licensee that is authorized to perform these functions.
Response: The department acknowledges the comment. Section 289.253(i)(3)
requires checking of the associated equipment for contamination at the same
time the sealed source is tested for leakage.
Commenters included representatives from University of Texas M.D. Anderson
Cancer Center, United States Nuclear Regulatory Commission, and Radiation
Technology, Inc. The commenters were neither for nor against the rule in its
entirety; however, they raised questions, expressed concerns, and offered
suggestions for changes to the proposal as discussed in the summary of the
comments.
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 with 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.
§289.201.General Provisions for Radioactive Material.
(a)
Scope. Except as otherwise specifically provided, this
section applies to all persons who receive, possess, use, transfer, or acquire
any radioactive material, provided, however, that nothing in this section
shall apply to any person to the extent such person is subject to regulation
by the United States Nuclear Regulatory Commission (NRC) or to radioactive
material in the possession of federal agencies. Attention is directed to the
fact that regulation by the state of source material, byproduct material,
and special nuclear material in quantities not sufficient to form a critical
mass is subject to the provisions of the agreement between the state and NRC
and to Part 150 of NRC regulations (Title 10, Code of Federal Regulations
(CFR), Part 150). A person who receives, possesses, uses, owns, transfers,
or acquires radioactive material prior to receiving a license is subject to
the requirements of this chapter.
(b)
Definitions. The following words and terms when used in
this chapter shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Absorbed dose--The energy imparted by ionizing radiation
per unit mass of irradiated material. The units of absorbed dose are the gray
(Gy) and the rad.
(2)
Accelerator-produced material--Any material made radioactive
by exposing it to the radiation from a particle accelerator.
(3)
Act--Texas Radiation Control Act, Health and Safety Code,
Chapter 401.
(4)
Activity--The rate of disintegration or transformation
or decay of radioactive material. The units of activity are the becquerel
(Bq) and the curie (Ci).
(5)
Adult--An individual 18 or more years of age.
(6)
Agency--The Texas Department of Health.
(7)
Agreement state--Any state with which NRC has entered into
an effective agreement under §274b of the Atomic Energy Act of 1954,
as amended (73 Stat. 689).
(8)
Airborne radioactive material--Any radioactive material
dispersed in the air in the form of dusts, fumes, particulates, mists, vapors,
or gases.
(9)
Airborne radioactivity area--A room, enclosure, or area
in which airborne radioactive materials exist in concentrations:
(A)
in excess of the derived air concentrations (DACs) specified
in Table I, Column 1 of §289.202(ggg)(2)(F) of this title (relating to
Standards for Protection Against Radiation from Radioactive Material); or
(B)
to such a degree that an individual present in the area
without respiratory protective equipment could exceed, during the hours an
individual is present in a week, an intake of 0.6% of the annual limit on
intake (ALI) or 12 DAC-hours.
(10)
As low as is reasonably achievable (ALARA)--Making every
reasonable effort to maintain exposures to radiation as far below the dose
limits in these regulations as is practical, consistent with the purpose for
which the licensed activity is undertaken, taking into account the state of
technology, the economics of improvements in relation to the state of technology,
the economics of improvements in relation to benefits to the public health
and safety, and other societal and socioeconomic considerations, and in relation
to utilization of ionizing radiation and licensed sources of radiation in
the public interest.
(11)
Background radiation--Radiation from cosmic sources; non-technologically
enhanced naturally occurring radioactive material, including radon, except
as a decay product of source or special nuclear material, and including global
fallout as it exists in the environment from the testing of nuclear explosive
devices or from past nuclear accidents, such as Chernobyl, that contribute
to background radiation and are not under the control of the licensee. "Background
radiation" does not include radiation from sources of radiation regulated
by the agency.
(12)
Becquerel (Bq)--The SI unit of activity. One becquerel
is equal to 1 disintegration or transformation per second (dps or tps).
(13)
Bioassay--The determination of kinds, quantities, or concentrations,
and, in some cases, the locations of radioactive material in the human body,
whether by direct measurement, in vivo counting, or by analysis and evaluation
of materials excreted or removed from the human body. For purposes of this
chapter, "radiobioassay" is an equivalent term.
(14)
Brachytherapy--A method of radiation therapy in which
sealed sources are utilized to deliver a radiation dose at a distance of up
to a few centimeters, by surface, intracavitary, or interstitial application.
(15)
Byproduct material--Byproduct material is defined as:
(A)
any radioactive material (except special nuclear material)
yielded in or made radioactive by exposure to the radiation incident to the
process of producing or utilizing special nuclear material; and
(B)
the tailings or wastes produced by or resulting from the
extraction or concentration of uranium or thorium from any ore processed primarily
for its source material content, including discrete surface wastes resulting
from uranium solution extraction processes.
(16)
Certificate of registration--A form of permission given
by the agency to an applicant who has met the requirements for registration
or mammography system certification set out in the Act and this chapter.
(17)
Certification of mammography systems (state certification)--A
form of permission given by the agency to an applicant who has met the requirements
for mammography system certification set out in the Act and this chapter.
(18)
Collective dose--The sum of the individual doses received
in a given period of time by a specified population from exposure to a specified
source of radiation.
(19)
Commercial--Having financial profit as the primary aim.
(20)
Committed dose equivalent (H T, 50)--The dose equivalent
to organs or tissues of reference (T) that will be received from an intake
of radioactive material by an individual during the 50-year period following
the intake.
(21)
Committed effective dose equivalent (H E, 50)--The sum
of the products of the weighting factors applicable to each of the body organs
or tissues that are irradiated and the committed dose equivalent to each of
these organs or tissues (H E, 50 = SigmawT,H T,50).
(22)
Constraint (dose constraint)--A value above which specified
licensee actions are required.
(23)
Critical group--The group of individuals reasonably expected
to receive the greatest exposure to residual radioactivity for any applicable
set of circumstances.
(24)
Curie (Ci)--A unit of measurement of radioactivity. One
curie (Ci) is that quantity of radioactive material that decays at the rate
of 3.7 x1010 disintegrations per second (dps). Commonly used submultiples
of the curie are the millicurie (mCi) and the microcurie (µCi). One
mCi = 1 x 10-3 Ci = 3.7 x 107 dps. One µCi = 1 x10-6 Ci = 3.7 x 104
dps. One nanocurie (nCi) = 1 x 10-9 Ci = 3.7 x 101 dps. One picocurie (pCi)
= 1 x 10 -12 Ci = 3.7 x 10-2 dps.
(25)
Decommission--To remove a facility or site safely from
service and reduce residual radioactivity to a level that permits the following:
(A)
release of the property for unrestricted use and/or termination
of license; or
(B)
release of the property under alternate requirements for
license termination.
(26)
Deep dose equivalent (H d), that applies to external whole
body exposure--The dose equivalent at a tissue depth of 1 centimeter (cm)
(1,000 milligrams per square centimeter (mg/cm2)).
(27)
Depleted uranium--The source material uranium in which
the isotope uranium-235 is less than 0.711 weight percent of the total uranium
present. Depleted uranium does not include special nuclear material.
(28)
Distinguishable from background--The detectable concentration
of a radionuclide is statistically different from the background concentration
of that radionuclide in the vicinity of the site, or, in the case of structures
or equipment, in similar materials using adequate measurement technology,
survey, and statistical techniques.
(29)
Distribution--The physical conveyance and authorized transfer
of commodities from producers to consumers and any intermediate persons involved
in that conveyance.
(30)
Dose--A generic term that means absorbed dose, dose equivalent,
effective dose equivalent, committed dose equivalent, committed effective
dose equivalent, total organ dose equivalent, or total effective dose equivalent.
For purposes of this chapter, "radiation dose" is an equivalent term.
(31)
Dose equivalent (HT)--The product of the absorbed dose
in tissue, quality factor, and all other necessary modifying factors at the
location of interest. The units of dose equivalent are the sievert (Sv) and
rem.
(32)
Dose limits--The permissible upper bounds of radiation
doses established in accordance with this chapter. For purposes of this chapter,
"limits" is an equivalent term.
(33)
Effective dose equivalent (H E)--The sum of the products
of the dose equivalent to each organ or tissue (HT) and the weighting factor
(wT) applicable to each of the body organs or tissues that are irradiated
(HE = Sigmaw THT).
(34)
Embryo/fetus--The developing human organism from conception
until the time of birth.
(35)
Entrance or access point--Any opening through which an
individual or extremity of an individual could gain access to radiation areas
or to licensed sources of radiation. This includes portals of sufficient size
to permit human access, irrespective of their intended use.
(36)
Exposure--The quotient of dQ by dm where "dQ" is the absolute
value of the total charge of the ions of one sign produced in air when all
the electrons (negatrons and positrons) liberated by photons in a volume element
of air having mass "dm" are completely stopped in air. The SI unit of exposure
is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure.
For purposes of this chapter, this term is used as a noun.
(37)
Exposure rate--The exposure per unit of time.
(38)
External dose--That portion of the dose equivalent received
from any source of radiation outside the body.
(39)
Extremity--Hand, elbow, arm below the elbow, foot, knee,
and leg below the knee. The arm above the elbow and the leg above the knee
are considered part of the whole body.
(40)
Generally applicable environmental radiation standards--Standards
issued by the United States Environmental Protection Agency (EPA) under the
authority of the Atomic energy Act of 1954, as amended, that impose limits
on radiation exposures or levels, or concentrations or quantities of radioactive
material, in the general environment outside the boundaries of locations under
the control of persons possessing or using radioactive material.
(41)
Gray (Gy)--The SI unit of absorbed dose. One gray is equal
to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad.
(42)
High radiation area--An area, accessible to individuals,
in which radiation levels from sources of radiation external to the body could
result in an individual receiving a dose equivalent in excess of 0.1 rem (1
millisievert (mSv)) in one hour at 30 cm from any source of radiation or from
any surface that the radiation penetrates.
(43)
Human use--The internal or external administration of
radiation or radioactive material to human beings for healing arts purposes
or research and/or development specifically authorized by the agency.
(44)
Individual--Any human being.
(45)
Individual monitoring--The assessment of:
(A)
dose equivalent to an individual by the use of individual
monitoring devices; or
(B)
committed effective dose equivalent to an individual by
bioassay or by determination of the time-weighted air concentrations to which
an individual has been exposed, that is, DAC-hours. (See the definition for
DAC-hours in §289.202(c) of this title); or
(C)
dose equivalent to an individual by the use of survey data.
(46)
Individual monitoring devices--Devices designed to be
worn by a single individual for the assessment of dose equivalent. For purposes
of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms.
Examples of individual monitoring devices include, but are not limited to,
film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence
dosimeters (OSLs), pocket ionization chambers (pocket dosimeters), electronic
personal dosimeters, and personal air sampling devices.
(47)
Inspection--An official examination and/or observation
including, but not limited to, records, tests, surveys, and monitoring to
determine compliance with the Act and rules, orders, requirements, and conditions
of the agency.
(48)
Internal dose--That portion of the dose equivalent received
from radioactive material taken into the body.
(49)
Ionizing radiation--Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x rays, alpha and
beta particles, high-speed electrons, neutrons, and other nuclear particles.
(50)
Land disposal facility--The land, buildings, and equipment
that are intended to be used for the disposal of low-level radioactive waste
(LLRW) into the subsurface of the land.
(51)
Lens dose equivalent--The external dose equivalent to
the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm 2).
(52)
License--A form of permission given by the agency to an
applicant who has met the requirements for licensing set out in the Act and
this chapter.
(53)
Licensed material--Radioactive material received, possessed,
used, or transferred under a general or specific license issued by the agency.
(54)
Licensee--Any person who is licensed by the agency in
accordance with the Act and this chapter.
(55)
Licensing state--Any state with rules equivalent to the
Suggested State Regulations for Control of Radiation relating to, and having
an effective program for, the regulatory control of naturally occurring or
accelerator-produced radioactive material (NARM) and has been designated as
such by the Conference of Radiation Control Program Directors, Inc. For the
purposes of evaluation and/or distribution of sealed sources, this includes
Licensing State Status: Product Review Only.
(56)
Lost or missing radioactive material--Radioactive material
whose location is unknown. This definition includes licensed material that
has been shipped but has not reached its planned destination and whose location
cannot be readily traced in the transportation system.
(57)
Low-level radioactive waste (LLRW)--Radioactive material
that meets the following criteria:
(A)
LLRW is radioactive material that is:
(i)
discarded or unwanted and is not exempt by rule adopted
under the Texas Radiation Control Act (Act), Health and Safety Code, §401.106;
(ii)
waste, as that term is defined in Title 10, CFR, Part
61.2; and
(iii)
subject to:
(I)
concentration limits established in Title 10, CFR, Part
61.55, or compatible rules adopted by the agency or the Texas Commission on
Environmental Quality (TCEQ), as applicable; and
(II)
disposal criteria established in Title 10, CFR, or established
by the agency or TCEQ, as applicable.
(B)
LLRW does not include:
(i)
high-level radioactive waste as defined by Title 10, CFR,
Part 60.2;
(ii)
spent nuclear fuel as defined by Title 10, CFR, Part 72.3;
(iii)
byproduct material defined in the Act, Health and Safety
Code, §401.003(3)(B);
(iv)
naturally occurring radioactive material (NORM) waste
that is not oil and gas NORM waste;
(v)
oil and gas NORM waste; or
(vi)
transuranics greater than 100 nanocuries per gram.
(58)
Manufacture--To fabricate or mechanically produce.
(59)
Member of the public--Any individual, except when that
individual is receiving an occupational dose.
(60)
Minor--An individual less than 18 years of age.
(61)
Monitoring--The measurement of radiation, radioactive
material concentrations, surface area activities, or quantities of radioactive
material and the use of the results of these measurements to evaluate potential
exposures and doses. For purposes of this chapter, "radiation monitoring"
and "radiation protection monitoring" are equivalent terms.
(62)
NARM--Any naturally occurring or accelerator-produced
radioactive material except source material or special nuclear material.
(63)
Natural radioactivity--Radioactivity of naturally occurring
nuclides whose location and chemical and physical form have not been altered
by man.
(64)
NRC--The United States Nuclear Regulatory Commission (NRC)
or its duly authorized representatives.
(65)
Occupational dose--The dose received by an individual
in the course of employment in which the individual's assigned duties involve
exposure to sources of radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. Occupational dose does not include dose received from background
radiation, from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released in
accordance with this chapter, from voluntary participation in medical research
programs, or as a member of the public.
(66)
Particle accelerator--Any machine capable of accelerating
electrons, protons, deuterons, or other charged particles in a vacuum and
designed to discharge the resultant particulate or other associated radiation
at energies usually in excess of 1 MeV.
(67)
Person--Any individual, corporation, partnership, firm,
association, trust, estate, public or private institution, group, agency,
local government, any other state or political subdivision or agency thereof,
or any other legal entity, and any legal successor, representative, agent,
or agency of the foregoing, other than NRC, and other than federal government
agencies licensed or exempted by NRC.
(68)
Personnel monitoring equipment (See definition for individual
monitoring devices.)
(69)
Pharmacist--An individual licensed by the Texas State
Board of Pharmacy to compound and dispense drugs, prescriptions, and poisons.
(70)
Physician--An individual licensed by the Texas State Board
of Medical Examiners.
(71)
Principal activities--Activities authorized by the license
that are essential to achieving the purpose(s) for which the license was issued
or amended. Storage during which no licensed material is accessed for use
or disposal and activities incidental to decontamination or decommissioning
are not principal activities.
(72)
Public dose--The dose received by a member of the public
from exposure to sources of radiation released by a licensee, or to any other
source of radiation under the control of a licensee/registrant. It does not
include occupational dose or doses received from background radiation, from
any medical administration the individual has received, from exposure to individuals
administered radioactive material and released in accordance with this chapter,
or from voluntary participation in medical research programs.
(73)
Quality factor (Q)--The modifying factor listed in subsection
(n)(1) and (2) of this section that is used to derive dose equivalent from
absorbed dose.
(74)
Quarter (calendar 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.
(75)
Rad--The special unit of absorbed dose. One rad is equal
to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 gray).
(76)
Radiation--One or more of the following:
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
emission of radiation from any electronic device to such
energy density levels as to reasonably cause bodily harm; or
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(77)
Radiation area--Any area, accessible to individuals, in
which radiation levels could result in an individual receiving a dose equivalent
in excess of 0.005 rem (0.05 mSv) in one hour at 30 cm from the source of
radiation or from any surface that the radiation penetrates.
(78)
Radiation machine--Any device capable of producing ionizing
radiation except those devices with radioactive material as the only source
of radiation.
(79)
Radiation safety officer (RSO)--An individual who has
a knowledge of and the authority and responsibility to apply appropriate radiation
protection rules, standards, and practices, who must be specifically authorized
on a radioactive material license, and who is the primary contact with the
agency.
(80)
Radioactive material--Any material (solid, liquid, or
gas) that emits radiation spontaneously.
(81)
Radioactive waste--As used in §289.254 of this title
(relating to Licensing of Radioactive Waste Processing and Storage Facilities),
this term is equivalent to LLRW.
(82)
Radioactivity--The disintegration of unstable atomic nuclei
with the emission of radiation.
(83)
Radiobioassay (See definition for bioassay.)
(84)
Registrant--Any person issued a certificate of registration
by the agency in accordance with the Act and this chapter.
(85)
Regulation (See definition for rule.)
(86)
Regulations of the United States Department of Transportation
(DOT)--The requirements in Title 49, CFR, Parts 100-189.
(87)
Rem--The special unit of any of the quantities expressed
as dose equivalent. The dose equivalent in rem is equal to the absorbed dose
in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)).
(88)
Research and development - Research and development is
defined as:
(A)
theoretical analysis, exploration, or experimentation;
or
(B)
the extension of investigative findings and theories of
a scientific or technical nature into practical application for experimental
and demonstration purposes, including the experimental production and testing
of models, devices, equipment, materials, and processes.
(89)
Residual radioactivity--The radioactivity in structures,
materials, soils, groundwater, and other media at a site resulting from activities
under the licensee's control. This includes radioactivity from all licensed
and unlicensed sources used by the licensee, but excludes background radiation.
It also includes radioactive materials remaining at the site as a result of
routine or accidental releases of radioactive material at the site and previous
burials at the site, even if those burials were made in accordance with the
provisions of Title 30, Texas Administrative Code, §336.334.
(90)
Restricted area--An area, access to which is limited by
the licensee for the purpose of protecting individuals against undue risks
from exposure to sources of radiation. Restricted area does not include areas
used as residential quarters, but separate rooms in a residential building
may be set apart as a restricted area.
(91)
Roentgen (R)--The specia unit of exposure. One roentgen
(R) equals 2.58 x 10-4C/kg of air. (See definition for exposure.)
(92)
Rule (as defined in the Government Code, Chapters 2001
and 2002, as amended)--Any agency statement of general applicability that
implements, interprets, or prescribes law or policy, or describes the procedure
or practice requirements of an agency. The term includes the amendment or
repeal of a prior section but does not include statements concerning only
the internal management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as "regulation."
(93)
Sealed source--Radioactive material that is permanently
bonded or fixed in a capsule or matrix designed to prevent release and dispersal
of the radioactive material under the most severe conditions that are likely
to be encountered in normal use and handling.
(94)
Shallow dose equivalent (H
s
)
(that applies to the external exposure of the skin or an extremity)--The dose
equivalent at a tissue depth of 0.007 cm (7 mg/cm
2
)
averaged over an area of 1 square centimeter (cm
2
).
(95)
SI--The abbreviation for the International System of Units.
(96)
Sievert--The SI unit of any of the quantities expressed
as dose equivalent. The dose equivalent in sievert is equal to the absorbed
dose in gray multiplied by the quality factor (1 SV = 100 rem).
(97)
Site boundary--That line beyond which the land or property
is not owned, leased, or otherwise controlled by the licensee.
(98)
Source material--Source material is defined as:
(A)
uranium or thorium, or any combination thereof, in any
physical or chemical form; or
(B)
ores that contain by right 0.05% or more of uranium, thorium,
or any combination thereof; and
(C)
does not include special nuclear material.
(99)
Source of radiation--Any radioactive material, or any
device or equipment emitting or capable of producing radiation.
(100)
Special form radioactive material--Radioactive material
that satisfies the following conditions.
(A)
It is either a single solid piece or is contained in a
sealed capsule that can be opened only by destroying the capsule;
(B)
The piece or capsule has at least one dimension not less
than 5 millimeters (mm) (0.2 inch); and
(C)
It satisfies the requirements specified by NRC. A special
form encapsulation designed in accordance with NRC requirements in effect
on June 30, 1983, and constructed prior to July 1, 1985, may continue to be
used. A special form encapsulation designed in accordance with NRC requirements
in effect on March 31, 1996, and constructed prior to April 1, 1998, may continue
to be used. A special form encapsulation either designed or constructed after
April 1, 1998, must meet the requirements of this definition applicable at
the time of its design or construction.
(101)
Special nuclear material--Special nuclear material is
defined as:
(A)
plutonium, uranium-233, uranium enriched in the isotope
233 or in the isotope 235, and any other material that NRC, in accordance
with the provisions of the Atomic Energy Act of 1954, §51 as amended,
determines to be special nuclear material, but does not include source material;
or
(B)
any material artificially enriched by any of the foregoing,
but does not include source material.
(102)
Special nuclear material in quantities not sufficient
to form a critical mass--Uranium enriched in the isotope 235 in quantities
not exceeding 350 grams (g) of contained uranium-235; uranium-233 in quantities
not exceeding 200 g; plutonium in quantities not exceeding 200 g; or any combination
of them in accordance with the following formula.
(A)
For each kind of special nuclear material, determine the
ratio between the quantity of that special nuclear material and the quantity
specified above for the same kind of special nuclear material. The sum of
such ratios for all of the kinds of special nuclear material in combination
shall not exceed "1" (i.e., unity).
(B)
For example, the following quantities in combination would
not exceed the limitation and are within the formula:
Figure: 25 TAC §289.201(b)(102)(B) (No change.)
(103)
Special units--The conventional units historically used
by licensees, for example, curie (activity), rad (absorbed dose), and rem
(dose equivalent).
(104)
Survey--An evaluation of the radiological conditions
and potential hazards incident to the production, use, transfer, release,
disposal, and/or presence of sources of radiation. When appropriate, such
survey includes, but is not limited to, tests, physical examination of location
of materials and equipment, measurements of levels of radiation or concentration
of radioactive material present, and evaluation of administrative and/or engineered
controls.
(105)
Termination--A release by the agency of the obligations
and authorizations of the licensee under the terms of the license. It does
not relieve a person of duties and responsibilities imposed by law.
(106)
Test--A method of determining the characteristics or
condition of sources of radiation or components thereof.
(107)
Texas Regulations for Control of Radiation (TRCR)--All
sections of Title 25 Texas Administrative Code (TAC), Chapter 289.
(108)
Total effective dose equivalent (TEDE)--The sum of the
deep dose equivalent for external exposures and the committed effective dose
equivalent for internal exposures.
(109)
Total organ dose equivalent (TODE)--The sum of the deep
dose equivalent and the committed dose equivalent to the organ receiving the
highest dose as described in §289.202(rr)(1)(F) of this title.
(110)
Transport index--The dimensionless number (rounded up
to the next tenth) placed on the label of a package, to designate the degree
of control to be exercised by the carrier during transportation. The transport
index is determined as follows:
(A)
For non-fissile material packages, the number determined
by multiplying the maximum radiation level in millisievert per hour (mSv/hr)
at 1 meter (m) (3.3 feet) from the external surface of the package by 100
(equivalent to the maximum radiation level in millirem per hour (mrem/hr)
at 1 m (3.3 feet); or
(B)
For fissile material packages, the number determined by
multiplying the maximum radiation level in mSv/hr at 1 m (3.3 feet) from the
external surface of the package by 100 (equivalent to the maximum radiation
level in mrem/hr at 1 m (3.3 feet), or, for criticality control purposes,
the number obtained as described in 10 CFR 71.59, whichever is larger.
(111)
Type A quantity--A quantity of radioactive material,
the aggregate radioactivity of which does not exceed A1 for special form radioactive
material or A2 for normal form radioactive material, where A1 and A2 are given
in §289.257(s)(2) of this title (relating to Packaging and Transportation
of Radioactive Material) or may be determined by procedures described in §289.257(s)(1)-(4)
of this title.
(112)
Type B quantity--A quantity of radioactive material greater
than a type A quantity.
(113)
Unrefined and unprocessed ore--Ore in its natural form
prior to any processing, such as grinding, roasting, beneficiating, or refining.
(114)
Unrestricted area (uncontrolled area)--An area, or access
to, which is neither limited nor controlled by the licensee. For purposes
of this chapter, "uncontrolled area" is an equivalent term.
(115)
Very high radiation area--An area, accessible to individuals,
in which radiation levels from sources of radiation external to the body could
result in an individual receiving an absorbed dose in excess of 500 rads (5
grays) in one hour at 1 meter (m) from a source of radiation or from any surface
that the radiation penetrates. At very high doses received at high dose rates,
units of absorbed dose, gray and rad, are appropriate, rather than units of
dose equivalent, Sv and rem.
(116)
Veterinarian--An individual licensed by the Texas Board
of Veterinary Medical Examiners.
(117)
Week--Seven consecutive days starting on Sunday.
(118)
Whole body--For purposes of external exposure, head,
trunk including male gonads, arms above the elbow, or legs above the knee.
(119)
Worker--An individual engaged in work under a license
or certificate of registration issued by the agency and controlled by a licensee
or registrant, but does not include the licensee or registrant.
(120)
Working level (WL)--Any combination of short-lived radon
daughters in 1 liter of air that will result in the ultimate emission of 1.3
x 105 million electron volts (MeV) of potential alpha particle energy. The
short-lived radon daughters are - for radon-222: polonium-218, lead-214, bismuth-214,
and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212,
and polonium-212.
(121)
Working level month (WLM)--An exposure to one working
level for 170 hours - 2,000 working hours per year divided by 12 months per
year is approximately equal to 170 hours per month.
(122)
Year--The period of time beginning in January used to
determine compliance with the provisions of this chapter. The licensee may
change the starting date of the year used to determine compliance by the licensee
provided that the change is made at the beginning of the year and that no
day is omitted or duplicated in consecutive years.
(c)
Exemptions.
(1)
General provision. The agency may, upon application therefor
or upon its own initiative, exempt a source of radiation or a kind of use
or user from the requirements of this chapter if the agency determines that
the exemption is not prohibited by law and will not result in a significant
risk to public health and safety and the environment. In determining such
exemptions, the agency will consider:
(A)
state of technology;
(B)
economic considerations in relation to benefits to the
public health and safety; and
(C)
other societal, socioeconomic, or public health and safety
considerations.
(2)
United States Department of Energy (DOE) contractors and
NRC contractors. Any DOE contractor or subcontractor and any NRC contractor
or subcontractor of the following categories operating within Texas is exempt
from this chapter, with the exception of §289.204 of this title (relating
to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services), to the extent
that such contractor or subcontractor under that individual's contract receives,
possesses, uses, transfers, or acquires sources of radiation:
(A)
prime contractors performing work for DOE at United States
government-owned or controlled sites, including the transportation of sources
of radiation to or from such sites and the performance of contract services
during temporary interruptions of such transportation;
(B)
prime contractors of DOE performing research in, or development,
manufacture, storage, testing, or transportation of, atomic weapons or components
thereof;
(C)
prime contractors of DOE using or operating nuclear reactors
or other nuclear devices in a United States government-owned vehicle or vessel;
and
(D)
any other prime contractor or subcontractor of DOE or of
NRC when the state and NRC jointly determine that:
(i)
the exemption of the prime contractor or subcontractor
is authorized by law; and
(ii)
in accordance with the terms of the contract or subcontract,
there is adequate assurance that the work thereunder can be accomplished without
undue risk to the public health and safety and the environment.
(d)
Records.
(1)
Each licensee shall maintain records showing the receipt,
transfer, and disposal of all non-exempt sources of radiation.
(A)
Records of receipt, transfer, and disposal of sources of
radiation shall include as a minimum, the following information:
(i)
a unique identification of each source of radiation, including:
(I)
manufacturer's name;
(II)
isotope;
(III)
activity; and
(IV)
if available, sealed source serial number;
(ii)
the date of receipt, transfer, or disposal of each source
of radiation;
(iii)
for the person transferring the source of radiation,
the name of the transferee, the number of the transferee's radioactive material
license authorizing possession of the material, and the regulatory agency
issuing the license to the transferee; and
(iv)
for the person receiving the source of radiation, the
name of the transferor, the number of the transferor's radioactive material
license authorizing possession of the material, and the regulatory agency
issuing the license to the transferor.
(B)
Records of receipt, transfer, and disposal shall be maintained
by the licensee until disposal is authorized by the agency.
(2)
Additional record requirements and retention periods are
specified elsewhere in this chapter.
(3)
All records required by this chapter shall be accurate
and factual.
(4)
Records are only valid if stamped, initialed, or signed
and dated by authorized personnel or otherwise authenticated.
(5)
Each record required by this chapter must be legible throughout
the retention period specified by the agency. The record may be the original
or a reproduced copy or a microform provided that the copy or microform is
authenticated by authorized personnel and that the microform is capable of
producing a clear copy throughout the required retention period. The record
may also be stored in electronic media with the capability for producing legible,
accurate, and complete records during the required retention period. Records,
such as letters, drawings, or specifications, must include all pertinent information
such as stamps, initials, and signatures. The licensee shall maintain adequate
safeguards against tampering with and loss of records.
(e)
Inspections.
(1)
The agency may enter public or private property at reasonable
times to determine whether, in a matter under the agency's jurisdiction, there
is compliance with the Act, the agency's rules, license conditions, and orders
issued by the agency.
(2)
Each licensee shall afford the agency, at all reasonable
times, opportunity to inspect sources of radiation and the premises and facilities
wherein such sources of radiation are used or stored.
(3)
Each licensee shall make available to the agency for inspection,
upon reasonable notice, records maintained in accordance with this chapter.
(f)
Tests.
(1)
Each licensee shall perform, upon instructions from the
agency, or shall permit the agency to perform such reasonable tests as the
agency deems appropriate or necessary including, but not limited to, tests
of:
(A)
sources of radiation;
(B)
facilities wherein sources of radiation are used or stored;
(C)
radiation detection and monitoring instruments; and
(D)
other equipment and devices used in connection with utilization
or storage of licensed sources of radiation.
(2)
Each licensee is required to accept from the agency, samples
collected from its facility(ies) or from areas that are radioactive as a result
of its licensed activities.
(g)
Tests for leakage and/or contamination of sealed sources.
(1)
The licensee in possession of any sealed source shall assure
that:
(A)
each sealed source, except as specified in paragraph (2)
of this subsection and §289.253(i) of this title (relating to Radiation
Safety Requirements for Well Logging Service Operations and Tracer Studies),
is tested for leakage or contamination and the test results are received before
the sealed source is put into use unless the licensee has a certificate from
the transferor indicating that the sealed source was tested within six months
before transfer to the licensee;
(B)
each sealed source that is not designed to emit alpha particles
is tested for leakage or contamination at intervals not to exceed six months
or at alternative intervals approved by the agency, or by NRC, an agreement
state, or a licensing state after evaluation of information specified in §289.252(v)
of this title (relating to Licensing of Radioactive Material);
(C)
each sealed source that is designed to emit alpha particles
is tested for leakage or contamination at intervals not to exceed three months
or at alternative intervals approved by the agency, after evaluation of information
specified in §289.252(v) of this title, or by NRC, an agreement state,
or a licensing state;
(D)
for each sealed source that is required to be tested for
leakage or contamination, at any other time there is reason to suspect that
the sealed source might have been damaged or might be leaking, the licensee
shall assure that the sealed source is tested for leakage or contamination
before further use;
(E)
tests for leakage for all sealed sources, except brachytherapy
sources manufactured to contain radium, shall be capable of detecting the
presence of 0.005 µCi (185 Bq) of radioactive material on a test sample.
Test samples shall be taken from the sealed source or from the surfaces of
the container in which the sealed source is stored or mounted and at the nearest
accessible point to the sealed source where contamination might accumulate.
For a sealed source contained in a device, test samples are obtained when
the source is in the "off" position;
(F)
the test for leakage for brachytherapy sources manufactured
to contain radium shall be capable of detecting an absolute leakage rate of
0.001 µCi (37 Bq) of radon-222 in a 24-hour period when the collection
efficiency for radon-222 and its daughters has been determined with respect
to collection method, volume, and time;
(G)
tests for contamination from radium daughters shall be
taken on the interior surface of brachytherapy source storage containers and
shall be capable of detecting the presence of 0.005 µCi (185 Bq) of
a radium daughter that has a half-life greater than four days; and
(H)
tests for leakage or contamination shall be performed using
a leak test kit or method approved by the agency, NRC, an agreement state,
or a licensing state.
(2)
A licensee need not perform tests for leakage or contamination
on the following sealed sources:
(A)
sealed sources containing only radioactive material with
a half-life of less than 30 days;
(B)
sealed sources containing only radioactive material as
a gas;
(C)
sealed sources containing 100 µCi (3.7 megabecquerels
(MBq)) or less of beta or gamma-emitting material or 10 µCi (370 kilobecquerels
(kBq)) or less of alpha or neutron-emitting material;
(D)
sealed sources containing only hydrogen-3 (tritium);
(E)
seeds of iridium-192 encased in nylon ribbon; and
(F)
sealed sources, except teletherapy and brachytherapy sources,
which are stored, not being used, and identified as in storage. The licensee
shall, however, test each such sealed source for leakage or contamination
and receive the test results before any use or transfer unless it has been
tested for leakage or contamination within six months before the date of use
or transfer.
(3)
Analysis of tests for leakage or contamination from sealed
sources shall be performed by persons specifically authorized by the agency,
NRC, an agreement state, or a licensing state, to perform such services.
(4)
Test results shall be kept in units of microcurie or becquerel
and maintained for inspection by the agency.
(5)
The following shall be considered evidence that a sealed
source is leaking:
(A)
the presence of 0.005 µCi (185 becquerels Bq) or
more of removable contamination on any test sample;
(B)
leakage of 0.001 µCi (37 Bq) of radon-222 per 24
hours for brachytherapy sources manufactured to contain radium; or
(C)
the presence of removable contamination resulting from
the decay of 0.005 µCi (185 Bq) or more of radium.
(6)
The licensee shall immediately withdraw a leaking sealed
source from use and shall take action to prevent the spread of contamination.
The leaking sealed source shall be repaired or transferred for disposal in
accordance with §289.202 of this title.
(7)
Reports of test results for leaking or contaminated sealed
sources shall be made in accordance with §289.202(bbb) of this title.
(h)
Additional requirements. The agency may, by rule, order,
or condition of license or general license acknowledgment, impose upon any
licensee such requirements in addition to those established in this chapter
as it deems appropriate or necessary to minimize danger to public health and
safety or property or the environment.
(i)
Violations. An injunction or other court order may be obtained
prohibiting any violation of any provision of the Act or any rule or order
issued thereunder. Any person who willfully violates any provision of the
Act or any rule or order issued thereunder may be guilty of a misdemeanor
and upon conviction, may be punished by fine or imprisonment or both, as provided
by law.
(j)
Impounding. Sources of radiation shall be subject to impounding
in accordance with §401.068 of the Act and §289.205 of this title
(relating to Hearing and Enforcement Procedures).
(k)
Communications.
(1)
Except where otherwise specified, all communications and
reports concerning this chapter and applications filed under them should be
addressed to the Bureau of Radiation Control, Texas Department of Health,
1100 West 49th Street, Austin, Texas, 78756-3189. Communications, reports,
and applications may be delivered in person to the agency's office located
at 8407 Wall Street, Austin, Texas.
(2)
Documents transmitted to the agency will be deemed submitted
on the date of the postmark, telegram, telefacsimile, or electronic media
transmission.
(l)
Interpretations. Except as specifically authorized by the
agency in writing, no interpretation of the meaning of this chapter by any
officer or employee of the agency other than a written interpretation by the
Office of General Counsel, Texas Department of Health, will be considered
binding upon the agency.
(m)
Open records.
(1)
Subject to the limitations provided in the Texas Public
Information Act, Government Code, Chapter 552, all information and data collected,
assembled, or maintained by the agency are public records open to inspection
and copying during regular office hours.
(2)
Any person who submits written information or data to the
agency and requests that the information be considered confidential, privileged,
or otherwise not available to the public under the Texas Public Information
Act, shall justify such request in writing, including statutes and cases where
applicable, addressed to the agency.
(A)
Documents containing information that is claimed to fall
within an exception to the Texas Public Information Act shall be marked to
indicate that fact. Markings shall be placed on the document on origination
or submission.
(i)
The words "NOT AN OPEN RECORD" shall be placed conspicuously
at the top and bottom of each page containing information claimed to fall
within one of the exceptions.
(ii)
The following wording shall be placed at the bottom of
the front cover and title page, or first page of text if there is no front
cover or title page:
Figure: 25 TAC §289.201(m)(2)(A)(ii)
(B)
The agency requests, whenever possible, that all information
submitted under the claim of an exception to the Texas Public Information
Act be extracted from the main body of the application and submitted as a
separate annex or appendix to the application.
(C)
Failure to comply with any of the procedures described
in subparagraphs (A) and (B) of this paragraph may result in all information
in the agency file being disclosed upon an open records request.
(3)
The agency will determine whether information falls within
one of the exceptions to the Texas Public Information Act. The Office of General
Counsel will be queried as to whether or not there has been a previous determination
that the information falls within one of the exceptions to the Texas Public
Information Act. If there has been no previous determination and the agency
believes that the information falls within one of the exceptions, an opinion
of the Attorney General will be requested. If the agency agrees in writing
to the request, the information shall not be open for public inspection unless
the Attorney General's office subsequently determines that it does not fall
within an exception.
(4)
Requests for information.
(A)
All requests for open records information must be in writing
and refer to documents currently in possession of the agency.
(B)
The agency will ascertain whether the information may be
released or whether it falls within an exception to the Texas Public Information
Act.
(i)
The agency may take a reasonable period of time to determine
whether information falls within one of the exceptions to the Texas Public
Information Act.
(ii)
If the information is determined to be public, it will
be presented for inspection and/or copies of documents will be furnished within
a reasonable period of time. A fee will be charged to recover agency costs
for copies.
(C)
Original copies of public records may not be removed from
the agency. Under no circumstances shall material be removed from existing
records.
(n)
Mean quality factors and absorbed dose equivalencies.
(1)
As used in this chapter, the quality factors for converting
absorbed dose to dose equivalent are shown in the following table:
Figure: 25 TAC §289.201(n)(1) (No change.)
(2)
If it is more convenient to measure the neutron fluence
rate than to determine the neutron dose equivalent rate in sievert per hour
or rem per hour, as provided in paragraph (1) of this subsection, 1 rem (0.01
Sv) of neutron radiation of unknown energies may, for purposes of this section,
be assumed to result from a total fluence of 25 million neutrons per square
centimeter incident upon the body. If sufficient information exists to estimate
the approximate energy distribution of the neutrons, the licensee may use
the fluence rate per unit dose equivalent or the appropriate Q value from
the following table to convert a measured tissue dose in rad (gray) to dose
equivalent in rem (Sv).
Figure: 25 TAC §289.201(n)(2) (No change.)
(o)
Units of activity. For purposes of this chapter, activity
is expressed in the special unit of curie (Ci) (Bq), or its multiples, or
disintegrations or transformations per second (dps or tps).
(1)
1 Ci = 3.7 x 1010 dps or tps = 3.7 x 1010 (Bq) = 2.22 x
10 12 disintegrations or transformations per minute (dpm or tpm).
(2)
1 Bq = 1 dps or tps.
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 April 9, 2003.
TRD-200302347
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 29, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
25 TAC §289.253
The Texas Department of Health (department) adopts an amendment
to §289.253, concerning radiation safety requirements for well logging
service operations and tracer studies with changes to the proposed text as
published in the December 6, 2002 issue of the
Texas
Register
(27 TexReg 11417).
Government Code, §2001.039 requires that each state agency conduct
a review of its rules every four years and consider for readoption each rule
adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative
Procedure Act). Section 289.253 has been reviewed and the department has determined
that the reasons for adopting the section continue to exist; however, revisions
to the rule are necessary.
The department published a Notice of Intention to Review for §289.253
in regards to Government Code, §2001.039 in the
Texas Register
(27 TexReg 1537) on March 1, 2002. No comments were
received by the department on this section.
Definitions for energy compensation source and tritium neutron generator
target source were added. These definitions have been designated as items
of compatibility by the United States Nuclear Regulatory Commission (NRC)
and as an agreement state, Texas must adopt these items of compatibility in
accordance with that agreement. The following revisions were also items of
compatibility with NRC. The subsection on leak testing of sealed sources was
reformatted and language was added to require leak testing of energy compensation
sources at intervals not to exceed three years, if such sources are not exempt
from the leak testing requirement. Language was added to require a check of
equipment associated with a leaking source for contamination and to take appropriate
action if it is contaminated. Language was added to the requirements concerning
design and performance criteria for sealed sources used in well logging operations
to allow sources manufactured prior to July 14, 1989, to meet United States
of America Standards Institute (USASI) criteria, American National Standard
Institute (ANSI) criteria, or specified prototype testing. Sealed sources
manufactured after July 14, 1989, must comply with ANSI criteria or specified
prototype testing. Wording was added to specify that the requirements concerning
design and performance criteria do not apply to energy compensation devices
in this section because these requirements are already specified in §289.252
of this chapter. Language requiring sources that have not had prototype testing
to be certified to meet specified prototype testing, and that the certification
must be performed by persons authorized to do so, and that certification documentation
be maintained was deleted. The language was deleted because it is not applicable
with the addition of the revised wording that allows sources to meet USASI
criteria, ANSI criteria, or specified prototype testing. Wording requiring
the use of specified individual monitoring devices was deleted and replaced
with wording requiring use of individual monitoring devices that are processed
and evaluated by an accredited National Laboratory Accreditation Program (NVLAP)
processor. The revised language allows the flexibility to incorporate new
monitoring technologies and maintains the standard established by requiring
processing and evaluation by a NVLAP processor. Language was added to specify
the requirements that energy compensation sources and tritium neutron generator
target sources are subject to, including those used in wells without surface
casing. Wording that was deleted in the proposed revision was added again
to clarify what is meant by the terminology, "a means to prevent inadvertent
intrusion on the source." The revised requirement states the intent of the
requirement, but does not limit the options for accomplishing that intent.
Equivalent metric measurements were parenthetically added to the specified
measurements of the plaque that is required to be posted on the well or wellbore
containing an abandoned source. The revised and additional requirements concerning
energy compensation sources are intended to recognize the use of the low activity
sources. Without specified requirements for these sources, licensees would
have to comply with overly burdensome requirements intended for higher activity
sources, including those for leak testing, design and performance criteria
for sealed sources, and well abandonment.
In addition to revisions that are compatibility items with NRC, language
was added to clarify that a licensee must immediately notify the agency by
telephone prior to beginning source recovery operations if the sealed source
is separated from the logging tool and lost downhole and when commencing abandonment
procedures for a lost or stuck source. References to other subsections of
this section were changed because of renumbering of the section. Other minor
clarifying changes were added to make grammatical corrections and to make
the section consistent with other sections of this title. This amendment is
part of the department's continuing effort to update, clarify and simplify
its rules regarding the control of radiation based upon technological advances,
public concerns, legislative directives, or other factors.
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting change(s).
Comment: Concerning §289.253(i), a commenter stated that the regulations
do not include the requirement for the licensee to check the equipment associated
with the leaking source for radioactive contamination and if contaminated,
have it decontaminated or disposed of by an NRC or agreement state licensee
that is authorized to perform these functions. Furthermore, the state must
include this requirement in order to meet the essentials objectives of Title
10, CFR §39.35, as per the agreement between Texas and NRC.
Response: The department agrees and added new language in §289.253(i)(3)
to require licensees to check equipment associated with leakage or contamination
of sealed sources of radiation.
Comment: Concerning §289.253(l)(3), a commenter stated that the regulations
do not include the requirement that energy compensation sources (ECS) must
be registered with the agency or with NRC. Furthermore, the state must include
this requirement in order to meet the essential objectives of Title 10, CFR §39.41(f),
as per the agreement between Texas and NRC.
Response: The department disagrees. This requirement is contained in §289.252
of this title (relating to Licensing of Radioactive Material). No change was
made as a result of the comment.
Comment: Concerning §289.253(y), a commenter stated that the state
did not specify the requirements on procedures for protecting fresh water
aquifers from licensees that use energy compensation source(s) (ECS) in wells
without surface casing. Furthermore, the state should include this requirement
in order to meet all the essential objectives of Title 10, CFR §39.53(b).
Response: The department agrees and added language to clarify the requirements
for establishing procedures for licensees that use energy compensation source(s)
in wells without surface casing for protecting fresh water aquifers.
Comment: Concerning §289.253(z), a commenter stated that the state
did not specify that licensees who use tritium neutron generator sources in
uncased wells are subject to state requirements equivalent to Title 10, Chapter
1, CFR Part 39, except for 10 CFR §39.41. Furthermore, the state should
include this requirement in order to meet all the essential objectives of
Title 10, CFR §39.55(b).
Response: The department agrees and added wording in §289.253(z)(2)
to clarify requirements for the use of tritium neutron generator target source
in wells without a surface casing to protect fresh water aquifers.
Comment: Concerning §289.253(cc)(5), a commenter stated that the state
omitted the requirement for obtaining approval prior to commencing abandonment
procedures for a lost or stuck source as per Title 10, CFR §39.77. Furthermore,
the state needs to include this requirement to meet the compatibility requirements.
Response: The department agrees and added new language in §289.253(cc)(5)(A)
to clarify the requirements for obtaining approval prior to commencing abandonment
procedures for a lost or stuck source of radiation.
Comment: Concerning proposed §289.253(cc)(5)(A)(ii), now renumbered
as §289.253(cc)(5)(B)(ii), a commenter stated that it is important to
provide some form of guidance in order to establish, as a minimum, a baseline
performance-based example of what the standard is about.
Response: The department agrees and added the words "such as the setting
of a whipstock or other deflection device," as an example of a method to prevent
inadvertent intrusion on a source lost downhole.
Commenters included representatives from the American College of Medical
Physics and United States Nuclear Regulatory Commission. The commenters were
neither for nor against the rule in its entirety; however, they raised questions,
expressed concerns, and offered suggestions for changes to the proposal as
discussed in the summary of the comments.
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.
§289.253.Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies.
(a)
Purpose. This section establishes radiation safety requirements
for persons using sources of radiation for well logging service operations,
including radioactive markers, mineral exploration and tracer studies.
(b)
Scope. This section applies to all licensees or registrants
who use sources of radiation for well logging service operations, radioactive
markers, mineral exploration and tracer studies. In addition to the requirements
of this section, licensees and registrants are subject to the requirements
of §289.201 of this title (relating to General Provisions for Radioactive
Material), §289.202 of this title (relating to Standards for Protection
Against Radiation from Radioactive Material), §289.203 of this title
(relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), §289.226 of this title (relating to Registration of Radiation
Machine Use and Services), §289.229 of this title (relating to Radiation
Safety Requirements for Accelerators, Therapeutic Radiation Machines, and
Simulators), §289.231 of this title (relating to General Provisions and
Standards for Protection Against Machine-Produced Radiation), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive Material).
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning unless the context clearly indicates
otherwise.
(1)
Energy compensation source (ECS)--A small sealed source
with an activity not exceeding 100 microcurie (µCi)(3.7 megabecquerel
(MBq)), used within a logging tool or other tool components, to provide a
reference standard to maintain the tools calibration when in use.
(2)
Field station (additional authorized use/storage location)--A
facility where sources of radiation may be stored or used and from which equipment
is dispatched to temporary job sites.
(3)
Injection tool--A device used for subsurface or downhole
controlled injection of radioactive tracer material.
(4)
Logging assistant (equipment operator)--Any individual
who, under the personal supervision of a logging supervisor, handles sealed
sources or tracers that are not in logging tools or shipping containers or
who performs surveys required by subsection (aa) of this section.
(5)
Logging supervisor (field engineer)--The individual who
provides personal supervision of the use of sources of radiation at temporary
job sites.
(6)
Logging tool--A device used subsurface to perform well
logging.
(7)
Mineral logging--Any logging performed for the purpose
of mineral exploration other than oil or gas.
(8)
Personal supervision--Guidance and instruction by the supervisor,
who is physically present at the job site and in such proximity that visual
contact can be maintained and immediate assistance given as required.
(9)
Radiation safety officer--An individual named by the licensee
or registrant and listed on the license or certificate of registration who
has a knowledge of, responsibility for, and authority to enforce appropriate
radiation protection rules, standards, and practices on behalf of the licensee
and/or registrant; and who meets the requirements of subsection (r) of this
section.
(10)
Radioactive marker--Radioactive material placed subsurface
or upon a structure intended for subsurface use for the purpose of depth determination
or direction orientation.
(11)
Residential location--Any area where structures in which
people lodge or live are located, and the grounds on which these structures
are located including, but not limited to, houses, apartments, condominiums,
and garages.
(12)
Service company--Any contracted or subcontracted company
that is present at the temporary job site, specifically, that company to which
the licensee's equipment is connected and that is exposed to radioactive material.
(13)
Source holder--A housing or assembly into which a radioactive
source is placed for the purpose of facilitating the handling and use of the
source.
(14)
Storage container--A container designed to provide radiation
safety and security when sources of radiation are being stored.
(15)
Temporary job site--A location where well logging or tracer
studies are performed other than the specific location(s) listed on a license
or certificate of registration.
(16)
Tracer study--The release of a substance tagged with radioactive
material for the purpose of tracing the movement or position of the tagged
substance in the wellbore, at the wellhead, or adjacent formation.
(17)
Transport container--A container that meets the requirements
of the United States Department of Transportation (DOT) and is designed to
provide radiation safety and security when sources of radiation are being
transported.
(18)
Tritium neutron generator target source--A tritium source
used within a neutron generator tube to produce neutrons for use in well logging
applications.
(19)
Uranium sinker bar--A weight containing depleted uranium
used to aid in the descent of a logging tool down toward the bottom of a wellbore.
(20)
Wellbore--A drilled hole in which wireline service operations
are performed.
(21)
Well logging--All operations involving the lowering and
raising of measuring devices or logging tools (that may or may not contain
sources of radiation) into wellbores or cavities for the purpose of obtaining
information about the well and/or adjacent formations.
(22)
Wireline--An armored steel cable containing one or more
electrical conductors used to lower and raise logging tools in the wellbore.
(23)
Wireline service operation--Any mechanical service that
is performed in the wellbore using devices that are lowered into the well
on a wireline for purposes of evaluation.
(d)
Prohibitions.
(1)
No licensee shall perform well logging service operations
with a sealed source(s) in any well or wellbore unless, prior to commencement
of the operation, the licensee has a written agreement with the well operator,
well owner, drilling contractor, or land owner that specifies who will be
responsible for ensuring the following requirements are met:
(A)
a reasonable effort at recovery will be made in the event
a sealed source is lost or lodged downhole;
(B)
a person shall not attempt to recover a sealed source in
a manner that, in the licensee's opinion, could result in a source rupture;
(C)
in the event the environment, any equipment, or personnel
are contaminated with radioactive material, decontamination to levels specified
in §289.202(f), (n), and (eee) of this title shall be performed; and
(D)
the requirements of subsection (cc)(4) of this section
shall be met in the event a decision is made to abandon the sealed source
downhole.
(2)
No licensee shall perform tracer study operations with
a substance tagged with radioactive material in any well or wellbore unless,
prior to commencement of the operation, the licensee has a written agreement
with the well operator, well owner, drilling contractor or land owner, and
the service company to which the licensee's equipment is connected, as applicable,
that specifies who will be responsible for ensuring the following requirements
are met:
(A)
in the event the service company's personnel or equipment
are contaminated with radioactive material, they shall be decontaminated in
accordance with §289.202(n) or (eee) of this title before release from
the job site or release for unrestricted use;
(B)
in the event the well head or job site is contaminated
with radioactive material, it shall be decontaminated in accordance with §289.202(eee)
of this title; and
(C)
in the event radioactive material is to be reversed from
the well or the well screens out, the licensee shall have established procedures
and equipment or facilities to do the following:
(i)
reverse material into a preconstructed pit that is specifically
established in the event of a screen out; or
(ii)
reverse material into suitable transport container(s)
in the event of a screen out.
(3)
The licensee shall maintain, in accordance with subsection
(dd)(5) of this section, a copy of the written agreement specified in paragraphs
(1) or (2) of this subsection.
(e)
Limits on levels of radiation. Sources of radiation shall
be used, stored, and transported in such a manner that the requirements of §289.202
of this title, §289.231 of this title, and §289.257 of this title,
as applicable, are met.
(f)
Storage precautions.
(1)
Each source of radiation, except accelerators, shall be
provided with a storage and/or transport container. Each container shall have
a lock (or tamper seal for calibration sources) to prevent unauthorized removal
of, or exposure to, the source of radiation.
(2)
Each area or room in which sources of radiation are stored
shall be posted in accordance with §289.202(aa)(5) or §289.231(x)
of this title, as applicable.
(3)
Sources of radiation shall be stored downhole or in a bunker
in order to minimize the danger from explosion and/or fire.
(4)
Sources of radiation may not be stored in residential locations.
This section does not apply to storage of radioactive material in a vehicle
in transit for use at temporary job sites, if the licensee complies with subsection
(aa)(2) of this section.
(5)
Sources of radiation in storage shall be secured to prevent
tampering, or removal by unauthorized individuals.
(g)
Transport precautions. Transport containers shall be locked
and physically secured to the transporting vehicle to prevent shifting during
transport, accidental loss, tampering, or unauthorized removal.
(h)
Radiation survey instruments.
(1)
The licensee or registrant shall maintain a sufficient
number of calibrated and operable radiation survey instruments at each location
where sources of radiation are stored or used to make physical radiation surveys
as required by this section and by §289.202(p) or §289.231(s), of
this title, as applicable. Instrumentation shall be capable of measuring 0.1
milliroentgen per hour (mR/hr) (1 microsievert per hour (µSv/hr)) through
at least 50 mR/hr (500 µSv/hr). (Instrumentation capable of measuring
0.1 mR/hr (1 µSv/hr) through 50 mR/hr (500 µSv/hr) may not be
sufficient to determine compliance with DOT requirements.)
(2)
A licensee using tracer material shall have available at
each additional authorized use/storage location and temporary job site additional
calibrated and operable radiation survey instruments sensitive enough to detect
the radioactive surface contamination limits specified in §289.202(eee)
of this title.
(3)
Each radiation survey instrument shall be calibrated:
(A)
by a person specifically licensed or registered by the
agency, another agreement state or licensing state or the United States Nuclear
Regulatory Commission (NRC) to perform such service;
(B)
at intervals not to exceed six months and after each survey
instrument repair;
(C)
for the types of radiation used and at energies appropriate
for use; and
(D)
at an accuracy within ±20% of the true radiation
level at each calibration point.
(4)
The licensee or registrant shall maintain calibration records
in accordance with subsection (dd)(5) of this section.
(i)
Leak testing of sealed sources.
(1)
Testing and record keeping. Sealed sources shall be tested
for leakage and contamination in accordance with this section and §289.201(g)
of this title. The licensee shall maintain records of leak tests in accordance
with subsection (dd)(5) of this section.
(2)
Each energy compensation source that is not exempt from
testing in accordance with §289.201(g)(2) of this title must be tested
at intervals not to exceed three years. In the absence of a certificate from
a transferor that a test has been made within the three years before the transfer,
the energy compensation source may not be used until tested in accordance
with §289.201(g) of this title.
(3)
If a sealed source is found to be leaking in accordance
with §289.201(g) of this title, the licensee shall check the equipment
associated with the leaking source for radioactive contamination and, if contaminated,
have it decontaminated or disposed of by persons specifically authorized by
the agency, the NRC, an agreement state, or a licensing state, to perform
such services.
(j)
Quarterly inventory. Each licensee or registrant shall
conduct a physical inventory to account for all sources of radiation received
or possessed at intervals not to exceed three months. The licensee or registrant
shall make and maintain records of inventories in accordance with subsection
(dd)(5) of this section and shall include the following:
(1)
the quantities and kinds of sources of radiation;
(2)
the location where sources of radiation are assigned;
(3)
a unique identification of each source of radiation;
(4)
the date of the inventory; and
(5)
the name of the individual conducting the inventory.
(k)
Utilization records. Utilization records shall be maintained
by each licensee or registrant in accordance with subsection (dd)(5) of this
section and shall include the following information for each source of radiation:
(1)
identification of each source of radiation to include:
(A)
the make and model number and/or serial number (or if absent,
a description) of each sealed source used; or
(B)
the radionuclide and activity of tracer materials and radioactive
markers used at a particular well site and the disposition of any unused tracer
materials.
(2)
the identity of the logging supervisor or individual who
is responsible for receiving sources of radiation, to whom assigned; and
(3)
the locations where used and dates of use.
(l)
Design and performance criteria for sealed sources used
in well logging operations.
(1)
Each sealed source used in well logging applications shall
meet the following minimum criteria.
(A)
The sealed source is of doubly encapsulated construction.
(B)
The sealed source contains radioactive material with a
chemical/physical form as insoluble and nondispersible as practicable.
(C)
The sealed source meets one of the following requirements:
(i)
for a sealed source manufactured on or before July 14,
1989, the requirements from the United States of America Standards Institute
(USASI) N5.10-1968, "Classification of Sealed Radioactive Sources," or the
requirements in clause (ii) or (iii) of this subparagraph;
(ii)
for a sealed source manufactured after July 14, 1989,
the oil-well logging requirements from the American National Standard Institute/Health
Physics Society (ANSI/HPS) N43.6-1997, "Sealed Radioactive Sources-Classification;"
or
(iii)
for a sealed source manufactured after July 14, 1989,
the sealed source's prototype has been tested and found to maintain its integrity
after each of the following tests:
(I)
Temperature. The test source shall be held at -40 degrees
Celsius for 20 minutes, 600 degrees Celsius for one hour, and then be subjected
to a thermal shock test with a temperature drop from 600 degrees Celsius to
20 degrees Celsius within 15 seconds.
(II)
Impact. A 5 kilogram (kg) steel hammer, 2.5 centimeters
(cm) in diameter, shall be dropped from a height of 1 meter (m) onto the test
source.
(III)
Vibration. The test source shall be subjected to a vibration
from 25 Hertz (Hz) to 500 Hz with a peak amplitude of five times the acceleration
of gravity for 30 minutes.
(IV)
Puncture. A 1 gram (gm) hammer and pin, 0.3 cm pin diameter,
shall be dropped from a height of 1 m onto the test source.
(V)
Pressure. The test source shall be subjected to an external
pressure of 24,600 pounds per square inch absolute (1.695 x 10
7
pascals) without leakage.
(2)
The requirements in paragraph (1) of this subsection do
not apply to sealed sources that contain radioactive material in gaseous form.
(3)
The requirements in this subsection do not apply to energy
compensation sources.
(m)
Labeling.
(1)
Each source, source holder, or logging tool containing
radioactive material in other than an exempt quantity, shall bear a durable,
legible, and clearly visible marking or label that has, as a minimum, the
standard radiation caution symbol with no color requirement, and the wording
DANGER (or CAUTION), RADIOACTIVE--DO NOT HANDLE, NOTIFY CIVIL AUTHORITIES
(OR NAME OF COMPANY).
(2)
The labeling specified in paragraph (1) of this subsection
shall be on the smallest component, source, source holder, or logging tool,
that is transported as a separate piece of equipment.
(3)
Each transport container shall have permanently attached
to it a durable, legible, and clearly visible label that has, as a minimum,
the standard radiation caution symbol and the wording DANGER (or CAUTION),
RADIOACTIVE, NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY).
(4)
Each transport container shall have attached to it a durable,
legible, and clearly visible label(s) that has, as a minimum, the licensee's
name, address, and telephone number, the radionuclide, its activity, and assay
date.
(n)
Inspection and maintenance.
(1)
Each licensee or registrant shall conduct, at intervals
not to exceed six months, a program of visual inspection and maintenance of
source holders (or sealed source, if there is no source holder), logging tools,
source handling tools, storage containers, transport containers, and injection
tools to assure proper labeling and physical condition. The inspection program
may be performed concurrently with routine leak testing of sealed sources.
Records of inspection and maintenance shall be made and maintained by the
licensee or registrant in accordance with subsection (dd)(5) of this section.
(2)
If any inspection conducted in accordance with paragraph
(1) of this subsection reveals damage to labeling or components critical to
radiation safety, the device shall be removed from service at the time the
damage is discovered and until repairs have been made.
(3)
Any operation, such as drilling, cutting, or chiseling
on a source holder containing a sealed source, shall be performed on the source
holder only by persons specifically licensed to do so by the agency, another
agreement or licensing state, or the NRC. The provisions of this paragraph
do not apply to logging tool recovery (fishing) operations conducted in accordance
with the provisions of subsection (cc)(3) of this section.
(4)
The repair, opening, or modification of any sealed source
shall be performed only by persons specifically licensed to do so by the agency,
another agreement or licensing state, or the NRC.
(o)
Training requirements.
(1)
No licensee or registrant shall permit any individual to
act as a logging supervisor until such individual has met the following requirements:
(A)
successfully completed an agency-accepted course or a course
recognized by another agreement or licensing state, or the NRC, including
at least 24 hours of formal training in the subjects outlined in subsection
(dd)(1) of this section;
(B)
received copies of and instruction in the following:
(i)
the requirements contained in this section and the applicable
subsections of §§289.201, 289.202, 289.203, and 289.231 of this
title or their equivalent;
(ii)
the conditions of the appropriate license or certificate
of registration; and
(iii)
the licensee's or registrant's operating, safety, and
emergency procedures;
(C)
demonstrated understanding of the requirements in subparagraph
(A) and (B) of this paragraph by successfully completing a written examination
administered by the licensee or registrant;
(D)
completed two months of on-the-job training under the supervision
of a logging supervisor; and
(E)
demonstrated through a field evaluation, competence in
the use of sources of radiation, related handling tools, and the type of radiation
survey instruments that will be used in the job assignment.
(2)
No licensee or registrant shall permit any individual to
act as a logging assistant until such individual has met the following requirements:
(A)
received copies of and instruction in the applicable subsections
of §§289.201, 289.202, 289.203, and 289.231 of this title or their
equivalent, and the licensee's or registrant's operating, safety, and emergency
procedures;
(B)
demonstrated understanding of the requirements in subparagraph
(A) of this paragraph by successfully completing a written examination administered
by the licensee or registrant; and
(C)
demonstrated competence to use, under the personal supervision
of the logging supervisor, the sources of radiation, related handling tools,
and radiation survey instruments that will be used in the job assignment.
(3)
The licensee or registrant shall provide an annual radiation
safety review for logging supervisors and logging assistants.
(4)
Each licensee or registrant shall maintain records that
document that the requirements of paragraphs (1)-(3) of this subsection are
met. Such records shall be maintained in accordance with subsection (dd)(5)
of this section.
(p)
Operating, safety, and emergency procedures. The licensee
or registrant shall maintain written operating, safety, and emergency procedures
that include descriptions of and directions in at least the items listed in
subsection (dd)(4) of this section.
(q)
Personnel monitoring.
(1)
In addition to the requirements of §289.202(p)(3)
and (q) of this title or §289.231(n) and (s)(3) of this title, as applicable,
no licensee or registrant shall permit any individual to act as a logging
supervisor or logging assistant unless that individual wears an individual
monitoring device that is processed and evaluated by an accredited National
Laboratory Accreditation Program (NVLAP) processor, at all times during well
logging service operations and/or tracer studies utilizing sources of radiation.
Each individual monitoring device shall be assigned to and worn by only one
individual. Film badges shall be replaced at least monthly. Other individual
monitoring devices shall be replaced at least quarterly. After replacement,
each individual monitoring device shall be returned to the supplier for processing
within 14 calendar days or as soon as practicable. In circumstances that make
it impossible to return each individual monitoring device to the supplier
for processing within 14 calendar days, such circumstances shall be documented
and available for review by the agency.
(2)
When necessary in order to aid in determining the extent
of an individual's exposure to concentrations of radioactive material, the
agency may require a licensee or registrant to make available to the individual
appropriate bioassay services and to furnish a copy of the reports of such
services to the agency.
(3)
Personnel monitoring records shall be maintained by the
licensee or registrant in accordance with subsection (dd)(5) of this section.
(r)
Radiation safety officer.
(1)
A radiation safety officer (RSO) shall be designated for
every license and certificate of registration issued by the agency.
(2)
The RSO's documented qualifications shall include:
(A)
possession of a high school diploma or a certificate of
high school equivalency based on the GED test;
(B)
completion of the training and testing requirements of
subsection (o)(1) of this section; and
(C)
two years of experience as a logging supervisor to include
knowledge of well logging service operations and tracer studies.
(3)
The duties of the RSO include, but are not limited to,
the following:
(A)
establishing and overseeing operating, safety, and emergency,
and as low as reasonably achievable (ALARA) procedures, and to review them
regularly to ensure that the procedures are current and conform with this
chapter;
(B)
overseeing and approving all phases of the training program
for well logging service operations and/or tracer studies personnel so that
appropriate and effective radiation protection practices are taught;
(C)
ensuring that required radiation surveys and leak tests
are performed and documented in accordance with this chapter, including any
corrective measures when levels of radiation exceed established limits;
(D)
ensuring that personnel monitoring is used properly by
occupationally-exposed personnel, that records are kept of the monitoring
results, and that timely notifications are made as required by §289.203
of this title;
(E)
investigating and reporting to the agency each known or
suspected case of radiation exposure to an individual or radiation level detected
in excess of limits established by this chapter and each theft or loss of
source(s) of radiation, to determine the cause, and to take steps to prevent
its recurrence;
(F)
having a thorough knowledge of management policies and
administrative procedures of the licensee or registrant;
(G)
assuming control and having the authority to institute
corrective actions including shutdown of operations when necessary in emergency
situations or unsafe conditions;
(H)
maintaining records as required by this chapter (see subsection
(dd)(5) of this section);
(I)
ensuring the proper storing, labeling, transport, and use
of sources of radiation, storage, and/or transport containers;
(J)
ensuring that inventories are performed in accordance with
subsection (j) of this section;
(K)
ensuring that personnel are complying with this chapter,
the conditions of the license or the registration, and the operating, safety,
and emergency procedures of the licensee or registrant; and
(L)
serving as the primary contact with the agency.
(s)
Security. During each well logging or tracer application,
the logging supervisor or other employee who is authorized by the specific
licensee for that activity, is responsible for protecting against unauthorized
and/or unnecessary entry into a restricted area, as defined in §289.201(b)
of this title, or §289.231 of this title, as applicable.
(t)
Handling tools. The licensee shall provide and require
the use of tools that will assure remote handling of sealed sources other
than low activity calibration sources.
(u)
Tracer studies.
(1)
Appropriate protective clothing and equipment shall be
used by all personnel handling radioactive tracer material. Precautions shall
be taken to avoid ingestion or inhalation of radioactive material and to avoid
contamination of field stations, temporary job sites, vehicles, associated
equipment, and clothing.
(2)
No licensee shall permit the injection of radioactive material
into usable quality groundwater (3,000 parts per million (ppm) total dissolved
solids or less) without prior written authorization from the agency.
(v)
Particle accelerators. No licensee or registrant shall
permit above-ground testing of particle accelerators that results in the production
of radiation except in areas or facilities controlled or shielded to meet
the requirements of §289.202(f) or (n) of this title, or §289.231(m)
or (o) of this title, as applicable.
(w)
Radioactive markers. The licensee may use radioactive markers
in wells only if the individual markers contain quantities of radioactive
material not exceeding the quantities specified in §289.251(q)(2) of
this title. The use of markers is subject only to the provisions of this subsection
and subsection (j) of this section.
(x)
Uranium sinker bars. The licensee may use a depleted uranium
sinker bar in well logging service operations only if it is legibly impressed
with the wording "DANGER (or CAUTION), RADIOACTIVE-DEPLETED URANIUM, NOTIFY
CIVIL AUTHORITIES (OR NAME OF COMPANY) IF FOUND".
(y)
Energy compensation source.
(1)
The licensee may use an energy compensation source that
is contained within a logging tool or other tool components.
(2)
For well logging applications with a surface casing for
protecting fresh water aquifers, use of the ECS is only subject to the requirements
of subsections (i), (j), and (k) of this section.
(3)
For well logging applications without a surface casing
for protecting fresh water aquifers, use of the ECS is only subject to the
requirements of subsections (d), (i), (j), (k), (bb)(4)(A), and (cc) of this
section.
(z)
Tritium neutron generator target source.
(1)
Use of a tritium neutron generator target source, containing
quantities not exceeding 30 curie (Ci) (1,110 MBq) and in a well with a surface
casing to protect fresh water aquifers, is subject to the requirements of
this section, except subsections (d), (l), and (cc) of this section.
(2)
Use of a tritium neutron generator target source, containing
quantities exceeding 30 Ci (1,110 MBq) or in a well without a surface casing
to protect fresh water aquifers, is subject to the requirements of this section,
except subsection (l) of this section.
(aa)
Radiation surveys.
(1)
Radiation surveys (and calculations for neutron sources)
shall be made and recorded for each area where radioactive materials are stored.
(2)
Radiation surveys (and calculations for neutron sources)
of the radiation levels in occupied positions and on the exterior of each
vehicle used to transport radioactive materials shall be made and recorded.
Such surveys (and calculations for neutron sources) shall include all sources
of radiation transported in the vehicle.
(3)
If the sealed source assembly is removed from the logging
tool before departing the job site, a survey of the tool to verify that the
logging tool is free of contamination shall be made and recorded.
(4)
If the encapsulation of the sealed source has been damaged
by an operation or is likely to have been damaged by an operation, the licensee
shall immediately conduct a radiation survey and make a record of that survey,
including a contamination survey, during and after the operation.
(5)
Radiation surveys shall be made and recorded at the job
site and/or well head for each tracer operation except for those utilizing
hydrogen-3, carbon-14, sulfur-35, or krypton-85. These surveys shall include
measurements of radiation levels before and after the operation.
(6)
Records required in accordance with paragraphs (1)-(5)
of this subsection shall also include the dates, the identification of individual(s)
making the survey, the unique identification of survey instrument(s) used,
radiation measurements in milliroentgen per hour (mR/hr), calculations in
millirem per hour (mrem/hr) (microsievert per hour (µSv/hr)), and an
exact description of the location of the survey. Each licensee or registrant
shall make and maintain records of these surveys in accordance with subsection
(dd)(5) of this section.
(bb)
Records/documents for inspection by the agency.
(1)
Each licensee or registrant shall maintain the records/documents
specified in subsection (dd)(5) of this section for inspection by the agency.
(2)
Each licensee or registrant maintaining additional authorized
use/storage locations from which well logging service operations are conducted
shall have copies of the records/documents specified in subsection (dd)(5)(B)-(E)
and (G)-(O) of this section that are specific to the site available at each
site for inspection by the agency.
(3)
Records/documents required in accordance with paragraph
(2) of this subsection shall be maintained in accordance with subsection (dd)(5)
of this section.
(4)
Each licensee or registrant conducting well logging service
operations at a temporary job site shall have copies of the records/documents
specified in subsection (dd)(5)(B), (C), (I), (K), (L), and (N) of this section
available at that site for inspection by the agency.
(5)
Records/documents required by paragraph (4) of this subsection
shall be maintained at the temporary job site for the period of operation
at that site for inspection by the agency.
(cc)
Notification of incidents and lost sources; abandonment
procedures for irretrievable sources.
(1)
Notification of incidents and sources lost in other than
downhole well logging operations shall be made in accordance with appropriate
provisions of §289.202 of this title, or §289.231 of this title,
as applicable.
(2)
Whenever a sealed source or a device containing radioactive
material has been ruptured or is likely to have been ruptured, the licensee
shall notify the agency immediately by telephone and submit written notification
within 30 days. The written notification shall designate the following:
(A)
the well or other location;
(B)
a description of the magnitude and extent of the escape
of radioactive material;
(C)
an assessment of the consequences of the rupture; and
(D)
an explanation of the efforts planned or being taken to
mitigate these consequences.
(3)
Whenever a sealed source is separated from the logging
tool and is lost downhole, the licensee shall notify the agency immediately
by telephone prior to beginning source recovery operations.
(4)
Whenever a sealed source or device containing radioactive
material is lost downhole, the licensee shall do the following:
(A)
consult with the well operator, well owner, drilling contractor,
or land owner regarding methods to retrieve the source or device that may
reduce the likelihood that the source or device will be damaged or ruptured
during the logging tool recovery (fishing) operations;
(B)
monitor with a radiation survey instrument (or logging
tool adjusted to detect gamma emissions from source(s) lost downhole), at
the surface for the presence of radioactive contamination during logging tool
recovery (fishing) operations; and
(C)
notify the agency immediately by telephone and submit written
notification within 30 days if radioactive contamination is detected at the
surface or if the source appears to be damaged.
(5)
When efforts to recover the radioactive source are not
successful, the licensee shall do the following:
(A)
notify the agency by telephone of the circumstances that
resulted in the inability to retrieve the source and obtain agency approval
to implement abandonment procedures, or that the licensee implemented abandonment
before receiving agency approval because the licensee believed there was an
immediate threat to public health and safety; and
(B)
advise the well operator of the Texas Railroad Commission
requirements regarding abandonment and an appropriate method of abandonment,
that shall include the following:
(i)
the immobilization and sealing in place of the radioactive
source with a cement plug;
(ii)
a means to prevent inadvertent intrusion on the source,
such as the setting of a whipstock or other deflection device, unless the
source is not accessible to any subsequent drilling operations; and
(iii)
the mounting of a permanent identification plaque, containing
information required by paragraph (5) of this subsection, at the surface of
the well;
(C)
notify the agency by telephone giving the circumstances
of the loss; and
(D)
file a written report with the agency within 30 days of
the abandonment, providing the following information:
(i)
date of occurrence;
(ii)
a description of the radioactive source involved, including
radionuclide, activity, chemical and physical form, and serial number;
(iii)
surface location and identification of well;
(iv)
results of efforts to immobilize and seal the source in
place;
(v)
depth of the radioactive source;
(vi)
depth of the top of the cement plug;
(vii)
depth of the well; and
(viii)
information contained on the permanent identification
plaque.
(6)
Whenever a sealed source containing radioactive material
is abandoned downhole, the licensee shall provide a permanent plaque (an example
of a suggested plaque is shown in subsection (dd)(3) of this section) for
posting on the well or wellbore. This plaque shall meet the following requirements:
(A)
be constructed of long-lasting material such as stainless
steel, brass, bronze, or monel. The size of the plaque should be convenient
for use on active or inactive wells; for example, a 7-inch (17 cm) square.
Letter size of the word "CAUTION" should be approximately twice the letter
size of the rest of the information; for example, 1/2 inch (1.27 cm) and 1/4
inch (0.63 cm) letter size, respectively; and
(B)
contain the following engraved information on its face:
(i)
the word "CAUTION;"
(ii)
the radiation symbol (color not required);
(iii)
the date of abandonment;
(iv)
the name of the well operator or well owner;
(v)
the well name and well identification number(s) or other
designation;
(vi)
radionuclide(s) and activity(ies) of the source(s);
(vii)
the source depth and the plug back depth (depth to the
top of the plug); and
(viii)
an appropriate warning, depending on the specific circumstances
of each abandonment, such as the following:
(I)
"Do not drill below plug back depth;"
(II)
"Do not enlarge casing;" or
(III)
"Do not re-enter hole before contacting Bureau of Radiation
Control, Texas Department of Health."
(7)
The licensee shall immediately notify the agency by telephone
and confirming letter if the licensee knows or has reason to believe that
radioactive material has been lost in or to an underground potable water source.
Such notice shall designate well location and describe the magnitude and extent
of loss of radioactive material, consequences of such loss and efforts taken
or planned to mitigate these consequences.
(8)
In the event of an uncontrolled release of radioactive
tracer material to the environment, the licensee shall notify the agency by
telephone within 24 hours and submit written notification within 30 days.
(dd)
Appendices.
(1)
Subjects to be included in training courses for well logging
service operations and/or tracer studies are as follows:
(A)
fundamentals of radiation safety that include:
(i)
characteristics of radiation;
(ii)
units of radiation dose (rem) and activity;
(iii)
significance of radiation dose specifying radiation protection
standards and biological effects of radiation;
(iv)
levels of radiation from sources of radiation;
(v)
methods of controlling radiation dose specifying time,
distance, and shielding;
(vi)
radiation safety practices, specifying prevention of contamination
and methods of decontamination; and
(vii)
discussion of ingestion, inhalation pathways.
(B)
radiation detection instrumentation to be used that includes:
(i)
use of radiation survey instruments specifying operation,
calibration, and limitations;
(ii)
survey techniques; and
(iii)
use of individual monitoring devices;
(C)
equipment to be used that specifies;
(i)
handling equipment and remote handling tools;
(ii)
sources of radiation;
(iii)
storage control, disposal, and transport of equipment
and sources of radiation;
(iv)
operation and control of equipment; and
(v)
maintenance of equipment.
(D)
pertinent federal and state requirements;
(E)
the licensee's or registrant's written operating, safety,
and emergency procedures;
(F)
the licensee's or registrant's record keeping procedures;
and
(G)
case histories and potential consequences of accidents
in well logging service operations and tracer studies.
(2)
In addition to the subjects for training courses required
in paragraph (1) of this subsection, individuals performing tracer studies
must also complete training in the following subjects:
(A)
sources of contamination;
(B)
contamination detection and control;
(C)
decontamination techniques and limits;
(D)
survey techniques for tracer materials; and
(E)
packaging requirements for transportation of radioactive
materials, especially residual materials from tracer studies.
(3)
The following is an example of a plaque for identifying
wells containing sealed sources of radioactive material abandoned downhole:
Figure: 25 TAC §289.253(dd)(3)
(4)
The licensee's or registrant's operating, safety, and emergency
procedures shall include descriptions of and instructions in at least the
following:
(A)
the handling and use of sources of radiation in wells without
surface casing for protecting fresh water aquifers, if appropriate;
(B)
the handling and use of sources of radiation to be employed
so that no individual is likely to be exposed to radiation doses in excess
of the limits established in §289.202 of this title, or §289.231
of this title, as applicable. Every reasonable effort shall be made to keep
radiation exposures and releases of radioactive material in soils and effluents
to unrestricted areas as low as is reasonably achievable;
(C)
methods and occasions for conducting radiation surveys;
(D)
methods and occasions for locking and securing sources
of radiation;
(E)
personnel monitoring, including bioassays, and the use
of individual monitoring devices;
(F)
removal of radioactive material from storage, transportation
of radioactive material to field locations and temporary job sites, including
packaging of sources of radiation in the vehicles, placarding of vehicles,
securing sources of radiation during transportation, and return to storage;
(G)
minimizing exposure of individuals during routine use and
in the event of an accident;
(H)
procedures for notifying proper personnel in the event
of an accident or well excursion;
(I)
maintenance of records;
(J)
use, inspection, and maintenance of source holders, logging
tools, source handling tools, storage containers, transport containers, and
injection tools;
(K)
procedures to be followed in the event a sealed source
is lost or lodged downhole;
(L)
procedures to be used for picking up, receiving, handling,
and opening packages containing radioactive material;
(M)
procedures to be used for surveys of temporary job sites
and equipment, and decontamination of vehicles, associated equipment, and
clothing following tracer studies;
(N)
storage and disposal of radioactive waste;
(O)
procedures for laundering contaminated clothing, if applicable;
(P)
licensee's or registrant's management structure;
(Q)
posting of radiation areas and labeling radioactive material
containers;
(R)
procedures to be followed in the event of an uncontrolled
release of radioactive tracer material to the environment; and
(S)
actions to be taken if a sealed source is ruptured, including
actions to prevent the spread of contamination and minimize inhalation and
ingestion of radioactive material, and actions to obtain suitable radiation
survey instruments as required by subsection (h) of this section.
(5)
The following records/documents shall be maintained by
the licensee or registrant for inspection by the agency.
Figure: 25 TAC §289.253(dd)(5)
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 April 9, 2003.
TRD-200302348
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 29, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
Chapter 103.
INJURY PREVENTION AND CONTROL
Chapter 289.
RADIATION CONTROL
Subchapter F. LICENSE REGULATIONS