25 TAC §289.202
The Texas Department of Health (department) adopts the amendment
to §289.202, concerning standards for protection against radiation from
radioactive material with changes to the proposed text published in the December
3, 1999 issue of the
Texas Register
(24 TexReg
10775).
The amendment deletes pertinent references to x-ray radiation, registered
sources of radiation, and radiation machines because the requirements for
the use of radiation machines are being consolidated in a new section. The
amendment includes new definitions that support the changes in the rule. A
requirement for licensees to establish a constraint on air emissions of radioactive
material to the environment was added. Language was added to clarify that
exposure from an individual who has had a medical administration of radioactive
material is not to be included in the dose limits required by this section.
The conditions requiring monitoring of radiation exposures to minors and to
pregnant women were modified. The requirement was also clarified to state
that the dose limit requiring monitoring for a declared pregnant woman is
applicable only for the nine-month gestation period. Additional conditions
were added under which teletherapy rooms may be exempted from posting requirements.
Requirements for notification of certain events were moved from another section
and more appropriately placed in this section. New requirements for decommissioning
that are dose-based rather than concentration-based were added. Several of
the revisions have been designated as items of compatibility by the United
States Nuclear Regulatory Commission (NRC). As an Agreement State, Texas must
adopt these items of compatibility in accordance with that agreement. These
amendments are part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
changes, public concerns, legislative directives, compatibility with NRC,
or other factors.
The department received no public comments during the comment period for
this amendment. However, the department is making the following minor changes
due to staff comments to clarify the intent and improve the accuracy of the
section.
Change: Concerning §289.202, the word "materials" was changed to "material"
in the title of the section to reflect how the word is used throughout the
remaining text of the section.
Change: Concerning §289.202(e)(1), a final sentence was added, "Documentation
of the radiation protection program may be incorporated in the licensee's
operating, safety, and emergency procedures." to clarify how the radiation
protection program may be documented.
Change: Concerning §289.202(j)(2)(A)-(C), the phrase, "prior employers"
was changed to, "prior or other current employers" to clarify that a licensee
may obtain information on an employee's occupational dose for the current
year from a prior employer or other current employer if the employee is concurrently
employed and receiving an occupational dose.
Change: Concerning §289.202(p)(3), electronic personal dosimeters
were added to the individual monitoring devices that do not require processing
and evaluation by a dosimetry processor accredited by the National Voluntary
Laboratory Accreditation Program to clarify the processing requirements for
these devices.
Change: Concerning §289.202(ff)(1)(A), the words, "or in" and "or"
were deleted from the first sentence for grammatical correctness.
Change: Concerning §289.202(yy)(1)(B)(v), the words, "or registration"
were deleted because this section does not apply to the use of radiation machines
authorized by a certificate of registration.
Change: Concerning §289.202(yy)(3), the proposed words, "occupationally
overexposed" were deleted and the word "exposed" was retained after the word,
"individual." The department believes overexposures to members of the public
should be reported as well as overexposures to occupationally exposed individuals.
The phrase, "social security number" was replaced with "identification number"
to reflect the same requirements for reporting of occupational exposures.
Change: Concerning §289.202(ddd)(1)(B)(i) and (ii), the words, "the
effective date of the rule" were deleted and replaced with "October 1, 2000"
to state the specific effective date of the rule.
Change: Concerning §289.202(ddd)(1)(C), the phrase, "only if, based
on new information" was deleted so that the sentence reads, "...the agency
will require additional cleanup if it determines that the requirements of
the subsection were not met..." The department believes the cleanup requirements
should be met and the rule should not limit the department's ability to ensure
such cleanup to situations in which "new information" is discovered.
Change: Concerning §289.202(ddd)(5), the words, "the effective date
of the rule" were deleted and replaced with "October 1, 2000" to state the
specific effective date of the rule.
The amendment is adopted under the Health and Safety Code, Chapter
401, which provides the Texas Board of Health (board) with authority to adopt
rules and guidelines relating to the control of radiation; and Health and
Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for its procedure and for the performance
of each duty imposed by law on the board, the department, or the commissioner
of health.
§289.202.Standards for Protection Against Radiation from Radioactive Material.
(a)
Purpose.
(1)
This section establishes standards for protection against
ionizing radiation resulting from activities conducted in accordance with
licenses issued by the agency.
(2)
The requirements in this section are designed to control
the receipt, possession, use, and transfer of sources of radiation by any
licensee so the total dose to an individual, including doses resulting from
all sources of radiation other than background radiation, does not exceed
the standards for protection against radiation prescribed in this section.
However, nothing in this section shall be construed as limiting actions that
may be necessary to protect health and safety in an emergency.
(b)
Scope.
(1)
Except as specifically provided in other sections of this
chapter, this section applies to persons who receive, possess, use, or transfer
sources of radiation, unless otherwise exempted. No person may use, manufacture,
produce, transport, transfer, receive, acquire, own, possess, process, or
dispose of sources of radiation unless that person has a license or exemption
from the agency. The dose limits in this section do not apply to doses due
to background radiation, to exposure of patients to radiation for the purpose
of medical diagnosis or therapy, to exposure from individuals administered
radioactive material and released in accordance with this chapter, or to voluntary
participation in medical research programs. However, no radiation may be deliberately
applied to human beings except by or under the supervision of an individual
authorized by and licensed in accordance with Texas' statutes to engage in
the healing arts.
(2)
Licensees who are also registered by the agency to
receive, possess, use, and transfer radiation machines must also comply with
the requirements of §289.231 of this title (relating to General Provisions
and Standards for Protection Against Machine-Produced Radiation).
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning, unless the context clearly
indicates otherwise.
(1)
Annual limit on intake (ALI)--The derived limit for the
amount of radioactive material taken into the body of an adult worker by inhalation
or ingestion in a year. ALI is the smaller value of intake of a given radionuclide
in a year by Reference Man that would result in a committed effective dose
equivalent of 5 rems (0.05 sievert (Sv)) or a committed dose equivalent of
50 rems (0.5 Sv) to any individual organ or tissue. ALI values for intake
by ingestion and by inhalation of selected radionuclides are given in Columns
1 and 2 of Table I of subsection (ggg)(2) of this section.
(2)
Class--A classification scheme for inhaled material
according to its rate of clearance from the pulmonary region of the lung.
Materials are classified as D, W, or Y, which apply to a range of clearance
half-times: for Class D, Days, of less than 10 days; for Class W, Weeks, from
10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes
of this section, lung class and inhalation class are equivalent terms.
(3)
Declared pregnant woman--A woman who has voluntarily
informed the licensee, in writing, of her pregnancy and the estimated date
of conception. The declaration remains in effect until the declared pregnant
woman voluntarily withdraws the declaration in writing or is no longer pregnant.
(4)
Derived air concentration (DAC)--The concentration
of a given radionuclide in air that, if breathed by Reference Man for a working
year of 2,000 hours under conditions of light work, results in an intake of
1 ALI. For purposes of this section, the condition of light work is an inhalation
rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values
are given in Column 3 of Table I of subsection (ggg)(2) of this section.
(5)
Derived air concentration-hour (DAC-hour)--The product
of the concentration of radioactive material in air, expressed as a fraction
or multiple of the derived air concentration for each radionuclide, and the
time of exposure to that radionuclide, in hours. A licensee may take 2,000
DAC-hours to represent ALI, equivalent to a committed effective dose equivalent
of 5 rems (0.05 Sv).
(6)
Dosimetry processor--A registrant that processes and
evaluates personnel monitoring devices in order to determine the radiation
dose delivered to the monitoring devices.
(7)
Inhalation class (see definition for Class).
(8)
Lung class (see definition for Class).
(9)
Nonstochastic effect--A health effect, the severity
of which varies with the dose and for which a threshold is believed to exist.
Radiation-induced cataract formation is an example of a nonstochastic effect.
For purposes of this section, deterministic effect is an equivalent term.
(10)
Planned special exposure--An infrequent exposure
to radiation, separate from and in addition to the annual occupational dose
limits.
(11)
Quarter--A period of time equal to one-fourth of
the year observed by the licensee, approximately 13 consecutive weeks, providing
that the beginning of the first quarter in a year coincides with the starting
date of the year and that no day is omitted or duplicated in consecutive quarters.
(12)
Reference man--A hypothetical aggregation of human
physical and physiological characteristics determined by international consensus.
These characteristics may be used by esearchers and public health employees
to standardize results of experiments and to relatebiological insult to a
common base. A description of Reference Man is contained in the International
Commission on Radiological Protection report, ICRP Publication 23, "Report
of the Task Group on Reference Man."
(13)
Respiratory protective equipment--An apparatus, such
as a respirator, used to reduce an individual's intake of airborne radioactive
materials.
(14)
Sanitary sewerage--A system of public sewers for
carrying off waste water and refuse, but excluding sewage treatment facilities,
septic tanks, and leach fields owned or operated by the licensee or registrant.
(15)
Stochastic effect--A health effect that occurs randomly
and for which the probability of the effect occurring, rather than its severity,
is assumed to be a linear function of dose without threshold. Hereditary effects
and cancer incidence are examples of stochastic effects. For purposes of this
section probabilistic effect is an equivalent term.
(16)
Weighting factor w
T
for an organ or tissue (T)--The proportion of the risk of stochastic effects
resulting from irradiation of that organ or tissue to the total risk of stochastic
effects when the whole body is irradiated uniformly. For calculating the effective
dose equivalent, the values of w
T
are:
Figure: 25 TAC §289.202(c)(16)
(d)
Implementation.
(1)
Any existing license condition that is more restrictive
than this section remains in force until there is an amendment or renewal
of the license that modifies or removes this condition.
(2)
If a license condition exempts a licensee from a provision
of this section in effect on or before January 1, 1994, it also exempts the
licensee from the corresponding provision of this section.
(3)
If a license condition cites provisions of this section
in effect prior to January 1, 1994, that do not correspond to any provisions
of this section, the license condition remains in force until there is an
amendment or renewal of the license that modifies or removes this condition.
(e)
Radiation protection programs.
(1)
Each licensee shall develop, document, and implement a
radiation protection program sufficient to ensure compliance with the provisions
of this section. See subsection (mm) of this section for recordkeeping requirements
relating to these programs. Documentation of the radiation protection program
may be incorporated in the licensee's operating, safety, and emergency procedures.
(2)
The licensee shall use, to the extent practicable,
procedures and engineering controls based upon sound radiation protection
principles to achieve occupational doses and public doses that are as low
as is reasonably achievable (ALARA).
(3)
The licensee shall, at intervals not to exceed 12
months, ensure the radiation protection program content and implementation
is reviewed.
(4)
To implement the ALARA requirement in paragraph (2)
of this subsection and notwithstanding the requirements in subsection (n)
of this section, a constraint on air emissions of radioactive material to
the environment, excluding radon-222 and its daughters, shall be established
by licensees such that the individual member of the public likely to receive
the highest dose will not be expected to receive a total effective dose equivalent
in excess of 10 millirems (mrem) (0.1 mSv) per year from these emissions.
If a licensee subject to this requirement exceeds this dose constraint, the
licensee shall report the exceedance as required in subsection (yy) of this
section and promptly take appropriate corrective action.
(f)
Occupational dose limits for adults.
(1)
The licensee shall control the occupational dose to individuals,
except for planned special exposures in accordance with subsection (k) of
this section, to the following dose limits.
(A)
An annual limit shall be the more limiting of:
(i)
the total effective dose equivalent being equal to 5 rems
(0.05 Sv); or
(ii)
the sum of the deep dose equivalent and the committed
dose equivalent to any individual organ or tissue other than the lens of the
eye being equal to 50 rems (0.5 Sv).
(B)
The annual limits to the lens of the eye, to the skin,
and to the extremities shall be:
(i)
a lens dose equivalent of 15 rems (0.15 Sv); and
(ii)
a shallow dose equivalent of 50 rems (0.5 Sv) to the skin
or to any extremity.
(2)
Doses received in excess of the annual limits,
including doses received during accidents, emergencies, and planned special
exposures, shall be subtracted from the limits for planned special exposures
that the individual may receive during the current year and during the individual's
lifetime. See subsection (k)(6)(A) and (B) of this section.
(3)
The assigned deep dose equivalent and shallow dose
equivalent shall be for the portion of the body receiving the highest exposure.
(4)
The deep dose equivalent, lens dose equivalent and
shallow dose equivalent may be assessed from surveys, calculations, or radiation
measurements for the purpose of demonstrating compliance with the occupational
dose limits, if the individual monitoring device was not in the region of
highest potential exposure, or the results of individual monitoring are unavailable.
(5)
Derived air concentration (DAC) and annual limit on
intake (ALI) values are specified in Table I of subsection (ggg)(2) of this
section and may be used to determine the individual's dose and to demonstrate
compliance with the occupational dose limits. See subsection (rr) of this
section.
(6)
Notwithstanding the annual dose limits, the licensee
shall limit the soluble uranium intake by an individual to 10 milligrams (mg)
in a week in consideration of chemical toxicity. See footnote 3 of subsection
(ggg)(2) of this section.
(7)
The licensee shall reduce the dose that an individual
may be allowed to receive in the current year by the amount of occupational
dose received while employed by any other person. See subsection (j)(4) of
this section.
(g)
Compliance with requirements for summation of external
and internal doses.
(1)
If the licensee is required to monitor in accordance with
both subsection (q)(1) and (3) of this section, the licensee shall demonstrate
compliance with the dose limits by summing external and internal doses. If
the licensee is required to monitor only in accordance with subsection (q)(1)
of this section or only in accordance with subsection (q)(3) of this section,
then summation is not required to demonstrate compliance with the dose limits.
The licensee may demonstrate compliance with the requirements for summation
of external and internal doses in accordance with paragraphs (2)-(4) of this
subsection. The dose equivalents for the lens of the eye, the skin, and the
extremities are not included in the summation, but are subject to separate
limits.
(2)
If the only intake of radionuclides is by inhalation,
the total effective dose equivalent limit is not exceeded if the sum of the
deep dose equivalent divided by the total effective dose equivalent limit,
and one of the following, does not exceed unity:
(A)
the sum of the fractions of the inhalation ALI for each
radionuclide; or
(B)
the total number of derived air concentration-hours (DAC-hours)
for all radionuclides divided by 2,000; or
(C)
the sum of the calculated committed effective dose equivalents
to all significantly irradiated organs or tissues (T) calculated from bioassay
data using appropriate biological models and expressed as a fraction of the
annual limit. For purposes of this requirement, an organ or tissue is deemed
to be significantly irradiated if, for that organ or tissue, the product of
the weighting factors, w
T
, and the committed
dose equivalent, H
T,50
, per unit intake is greater
than 10% of the maximum weighted value of H
T,50
,
that is, w
T
H
T,50
,
per unit intake for any organ or tissue.
(3)
If the occupationally exposed individual receives
an intake of radionuclides by oral ingestion greater than 10% of the applicable
oral ALI, the licensee shall account for this intake and include it in demonstrating
compliance with the limits.
(4)
The licensee shall evaluate and, to the extent practical,
account for intakes through wounds or skin absorption. The intake through
intact skin has been included in the calculation of DAC for hydrogen-3 and
does not need to be evaluated or accounted for in accordance with this paragraph.
(h)
Determination of external dose from airborne radioactive
material.
(1)
Licensees shall, when determining the dose from airborne
radioactive material, include the contribution to the deep dose equivalent,
eye dose equivalent, and shallow dose equivalent from external exposure to
the radioactive cloud. See footnotes 1 and 2 of subsection (ggg)(2) of this
section.
(2)
Airborne radioactivity measurements and DAC values
shall not be used as the primary means to assess the deep dose equivalent
when the airborne radioactive material includes radionuclides other than noble
gases or if the cloud of airborne radioactive material is not relatively uniform.
The determination of the deep dose equivalent to an individual shall be based
upon measurements using instruments or individual monitoring devices.
(i)
Determination of internal exposure.
(1)
For purposes of assessing dose used to determine compliance
with occupational dose equivalent limits, the licensee shall, when required
in accordance with subsection (q) of this section, take suitable and timely
measurements of:
(A)
concentrations of radioactive materials in air in work
areas;
(B)
quantities of radionuclides in the body;
(C)
quantities of radionuclides excreted from the body; or
(D)
combinations of these measurements.
(2)
Unless respiratory protective equipment is used,
as provided in subsection (x) of this section, or the assessment of intake
is based on bioassays, the licensee shall assume that an individual inhales
radioactive material at the airborne concentration in which the individual
is present.
(3)
When specific information on the physical and biochemical
properties of the radionuclides taken into the body or the behavior of the
material in an individual is known, the licensee may:
(A)
use that information to calculate the committed effective
dose equivalent, and, if used, the licensee shall document that information
in the individual's record;
(B)
upon prior approval of the agency, adjust the DAC or ALI
values to reflect the actual physical and chemical characteristics of airborne
radioactive material, for example, aerosol size distribution or density; and
(C)
separately assess the contribution of fractional intakes
of Class D, W, or Y compounds of a given radionuclide to the committed effective
dose equivalent. See subsection (ggg)(2) of this section.
(4)
If the licensee chooses to assess intakes of
Class Y material using the measurements given in paragraph (1)(A) or (B) of
this subsection, the licensee may delay the recording and reporting of the
assessments for periods up to seven months, unless otherwise required by subsections
(xx) or (yy) of this section. This delay permits the licensee to make additional
measurements basic to the assessments.
(5)
If the identity and concentration of each radionuclide
in a mixture are known, the fraction of the DAC applicable to the mixture
for use in calculating DAC-hours shall be either:
(A)
the sum of the ratios of the concentration to the appropriate
DAC value, that is, D, W, or Y, from subsection (ggg)(2) of this section for
each radionuclide in the mixture; or
(B)
the ratio of the total concentration for all radionuclides
in the mixture to the most restrictive DAC value for any radionuclide in the
mixture.
(6)
If the identity of each radionuclide in a mixture
is known, but the concentration of one or more of the radionuclides in the
mixture is not known, the DAC for the mixture shall be the most restrictive
DAC of any radionuclide in the mixture.
(7)
When a mixture of radionuclides in air exists, a licensee
may disregard certain radionuclides in the mixture if:
(A)
the licensee uses the total activity of the mixture in
demonstrating compliance with the dose limits in subsection (f) of this section
and in complying with the monitoring requirements in subsection (q)(3) of
this section;
(B)
the concentration of any radionuclide disregarded is less
than 10% of its DAC; and
(C)
the sum of these percentages for all of the radionuclides
disregarded in the mixture does not exceed 30%.
(8)
When determining the committed effective dose
equivalent, the following information may be considered.
(A)
In order to calculate the committed effective dose equivalent,
the licensee may assume that the inhalation of 1 ALI, or an exposure of 2,000
DAC-hours, results in a committed effective dose equivalent of 5 rems (0.05
Sv) for radionuclides that have their ALIs or DACs based on the committed
effective dose equivalent.
(B)
For an ALI and the associated DAC determined by the nonstochastic
organ dose limit of 50 rems (0.5 Sv), the intake of radionuclides that would
result in a committed effective dose equivalent of 5 rems (0.05 Sv), that
is, the stochastic ALI, is listed in parentheses in Table I of subsection
(ggg)(2) of this section. The licensee may, as a simplifying assumption, use
the stochastic ALI to determine committed effective dose equivalent. However,
if the licensee uses the stochastic ALI, the licensee shall also demonstrate
that the limit in subsection (f)(1)(A)(ii) of this section is met.
(j)
Determination of occupational dose for the current year.
(1)
For each individual who is likely to receive, in a year,
an occupational dose requiring monitoring in accordance with subsection (q)
of this section, the licensee shall determine the occupational radiation dose
received during the current year.
(2)
In complying with the requirements of paragraph (1)
of this subsection, a licensee may:
(A)
accept, as a record of the occupational dose that the individual
received during the current year, BRC Form 202-2 from prior or other current
employers, or other clear and legible record, of all information required
on that form and indicating any periods of time for which data are not available;
or
(B)
accept, as a record of the occupational dose that the individual
received during the current year, a written signed statement from the individual,
or from the individual's prior or other current employer(s) for work involving
radiation exposure, that discloses the nature and the amount of any occupational
dose that the individual received during the current year; or
(C)
obtain reports of the individual's dose equivalent from
prior or other current employer(s) for work involving radiation exposure,
or the individual's current employer, if the individual is not employed by
the licensee, by telephone, telegram, facsimile, or letter. The licensee shall
request a written verification of the dose data if the authenticity of the
transmitted report cannot be established.
(3)
The licensee shall record the exposure data for
the current year, as required by paragraph (1) of this subsection, on BRC
Form 202-3, or other clear and legible record, of all the information required
on that form.
(4)
If the licensee is unable to obtain a complete record
of an individual's current occupational dose while employed by any other licensee,
the licensee shall assume in establishing administrative controls in accordance
with subsection (f)(8) of this section for the current year, that the allowable
dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts
(mSv)) for each quarter; or 416 mrem (4.16 mSv) for each month for which records
were unavailable and the individual was engaged in activities that could have
resulted in occupational radiation exposure.
(5)
If an individual has incomplete (e.g., a lost or damaged
personnel monitoring device) current occupational dose data for the current
year and that individual is employed solely by the licensee during the current
year, the licensee shall:
(A)
assume that the allowable dose limit for the individual
is reduced by 1.25 rems (12.5 mSv) for each quarter;
(B)
assume that the allowable dose limit for the individual
is reduced by 416 mrem (4.16 mSv) for each month; or
(C)
assess an occupational dose for the individual during the
period of missing data using surveys, radiation measurements, or other comparable
data for the purpose of demonstrating compliance with the occupational dose
limits.
(6)
Administrative controls established in accordance
with paragraph (4) of this subsection shall be documented and maintained for
inspection by the agency. Occupational dose assessments made in accordance
with paragraph (5) of this subsection and records of data used to make the
assessment shall be maintained for inspection by the agency. The licensee
shall retain the records in accordance with subsection (rr) of this section.
(k)
Planned special exposures. A licensee may authorize an
adult worker to receive doses in addition to and accounted for separately
from the doses received under the limits specified in subsection (f) of this
section provided that each of the following conditions is satisfied.
(1)
The licensee authorizes a planned special exposure only
in an exceptional situation when alternatives that might avoid the doses estimated
to result from the planned special exposure are unavailable or impractical.
(2)
The licensee and employer, if the employer is not
the licensee, specifically authorizes the planned special exposure, in writing,
before the exposure occurs.
(3)
Before a planned special exposure, the licensee ensures
that each individual involved is:
(A)
informed of the purpose of the planned operation;
(B)
informed of the estimated doses and associated potential
risks and specific radiation levels or other conditions that might be involved
in performing the task; and
(C)
instructed in the measures to be taken to keep the dose
ALARA considering other risks that may be present.
(4)
Prior to permitting an individual to participate
in a planned special exposure, the licensee shall determine:
(A)
the internal and external doses from all previous planned
special exposures;
(B)
all doses in excess of the limits, including doses received
during accidents and emergencies, received during the lifetime of the individual;
and
(C)
all lifetime cumulative occupational radiation doses.
(5)
In complying with the requirements of paragraph
(4)(C) of this subsection, a licensee may:
(A)
accept, as the record of lifetime cumulative radiation
dose, an up-to-date BRC Form 202-2 or equivalent, signed by the individual
and countersigned by an appropriate official of the most recent employer for
work involving radiation exposure, or the individual's current employer, if
the individual is not employed by the licensee; and
(B)
obtain reports of the individual's dose equivalent from
prior employer(s) for work involving radiation exposure, or the individual's
current employer, if the individual is not employed by the licensee, by telephone,
telegram, facsimile, or letter. The licensee shall request a written verification
of the dose data if the authenticity of the transmitted report cannot be established.
(6)
Subject to subsection (f)(2) of this section,
the licensee shall not authorize a planned special exposure that would cause
an individual to receive a dose from all planned special exposures and all
doses in excess of the limits to exceed:
(A)
the numerical values of any of the dose limits in subsection
(f)(1) of this section in any year; and
(B)
five times the annual dose limits in subsection (f)(1)
of this section during the individual's lifetime.
(7)
The licensee maintains records of the conduct
of a planned special exposure in accordance with subsection (qq) of this section
and submits a written report to the agency in accordance with subsection (zz)
of this section.
(8)
The licensee records the best estimate of the dose
resulting from the planned special exposure in the individual's record and
informs the individual, in writing, of the dose within 30 days from the date
of the planned special exposure. The dose from planned special exposures shall
not be considered in controlling future occupational dose of the individual
in accordance with subsection (f)(1) of this section but shall be included
in evaluations required by paragraphs (4) and (6) of this subsection.
(9)
The licensee shall record the exposure history, as
required by paragraph (4) of this subsection, on BRC Form 202-2, or other
clear and legible record, of all the information required on that form. The
form or record shall show each period in which the individual received occupational
exposure to radiation or radioactive material and shall be signed by the individual
who received the exposure. For each period for which the licensee obtains
reports, the licensee shall use the dose shown in the report in preparing
BRC Form 202-2 or equivalent.
(l)
Occupational dose limits for minors. The annual occupational
dose limits for minors are 10% of the annual occupational dose limits specified
for adult workers in subsection (f) of this section.
(m)
Dose equivalent to an embryo/fetus.
(1)
If a woman declares her pregnancy, the licensee shall ensure
that the dose equivalent to an embryo/fetus during the entire pregnancy, due
to occupational exposure of a declared pregnant woman, does not exceed 0.5
rem (5 mSv). If a woman chooses not to declare pregnancy, the occupational
dose limits specified in subsection (f)(1) of this section are applicable
to the woman. See subsection (rr) of this section for recordkeeping requirements.
(2)
The licensee shall make efforts to avoid substantial
variation above a uniform monthly exposure rate to a declared pregnant woman
so as to satisfy the limit in paragraph (1) of this subsection. The National
Council on Radiation Protection and Measurements recommended in NCRP Report
No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June
1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received
in any one month.
(3)
The dose equivalent to an embryo/fetus shall be taken
as:
(A)
the dose equivalent to the embryo/fetus from radionuclides
in the embryo/fetus and radionuclides in the declared pregnant woman; and
(B)
the dose equivalent that is most representative of the
dose equivalent to the embryo/fetus from external radiation, that is, in the
mother's lower torso region.
(i)
If multiple measurements have not been made, assignment
of the highest deep dose equivalent for the declared pregnant woman shall
be the dose equivalent to the embryo/fetus.
(ii)
If multiple measurements have been made, assignment of
the deep dose equivalent for the declared pregnant woman from the individual
monitoring device that is most representative of the dose equivalent to the
embryo/fetus shall be the dose equivalent to the embryo/fetus. Assignment
of the highest deep dose equivalent for the declared pregnant woman to the
embryo/fetus is not required unless that dose equivalent is also the most
representative deep dose equivalent for the region of the embryo/fetus.
(4)
If by the time the woman declares pregnancy
to the licensee, the dose equivalent to the embryo/fetus has exceeded 0.45
rem (4.5 mSv), the licensee shall be deemed to be in compliance with paragraph
(1) of this subsection, if the additional dose equivalent to the embryo/fetus
does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
(n)
Dose limits for individual members of the public.
(1)
Each licensee shall conduct operations so that:
(A)
except as provided in subparagraph (B) of this paragraph,
the total effective dose equivalent to individual members of the public from
the licensed and/or registered operation does not exceed 0.1 rem (1 mSv) in
a year, exclusive of the dose contribution from background radiation, from
any medical administration the individual has received, from exposure to individuals
administered radioactive material and released in accordance with this chapter,
from voluntary participation in medical research programs, and from the licensee's
disposal of radioactive material into sanitary sewerage in accordance with
subsection (gg) of this section; and
(B)
the dose in any unrestricted area from licensed and/or
registered external sources, exclusive of the dose contributions from patients
administered radioactive material and released in accordance with this chapter,
does not exceed 0.002 rem (0.02 mSv) in any one hour.
(2)
If the licensee permits members of the public
to have access to restricted areas, the limits for members of the public continue
to apply to those individuals.
(3)
A licensee or an applicant for a license may apply
for prior agency authorization to operate up to an annual dose limit for an
individual member of the public of 0.5 rem (5 mSv). This application shall
include the following information:
(A)
demonstration of the need for and the expected duration
of operations in excess of the limit in paragraph (1) of this subsection;
(B)
the licensee's program to assess and control dose within
the 0.5 rem (5 mSv) annual limit; and
(C)
the procedures to be followed to maintain the dose ALARA.
(4)
In addition to the requirements of this section,
a licensee subject to the provisions of the United States Environmental Protection
Agency's (EPA) generally applicable environmental radiation standards in 40
Code of Federal Regulations (CFR), §190 shall comply with those requirements.
(5)
The agency may impose additional restrictions on radiation
levels in unrestricted areas and on the total quantity of radionuclides that
a licensee may release in effluents in order to restrict the collective dose.
(o)
Compliance with dose limits for individual members of the
public.
(1)
The licensee shall make or cause to be made surveys of
radiation levels in unrestricted areas and radioactive materials in effluents
released to unrestricted areas to demonstrate compliance with the dose limits
for individual members of the public as required in subsection (n) of this
section.
(2)
A licensee shall show compliance with the annual dose
limit in subsection (n) of this section by:
(A)
demonstrating by measurement or calculation that the total
effective dose equivalent to the individual likely to receive the highest
dose from the licensed or registered operation does not exceed the annual
dose limit; or
(B)
demonstrating that:
(i)
the annual average concentrations of radioactive material
released in gaseous and liquid effluents at the boundary of the unrestricted
area do not exceed the values specified in Table II of subsection (ggg)(2)
of this section; and
(ii)
if an individual were continuously present in an unrestricted
area, the dose from external sources of radiation would not exceed 0.002 rem
(0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.
(3)
Upon approval from the agency, the licensee
may adjust the effluent concentration values in Table II, of subsection (ggg)(2)
of this section, for members of the public, to take into account the actual
physical and chemical characteristics of the effluents, such as, aerosol size
distribution, solubility, density, radioactive decay equilibrium, and chemical
form.
(p)
General surveys and monitoring.
(1)
Each licensee shall make, or cause to be made, surveys
that:
(A)
are necessary for the licensee to comply with this section;
and
(B)
are necessary under the circumstances to evaluate:
(i)
the magnitude and extent of radiation levels;
(ii)
concentrations or quantities of radioactive material;
and
(iii)
the potential radiological hazards.
(2)
The licensee shall ensure that instruments
and equipment used for quantitative radiation measurements, for example, dose
rate and effluent monitoring, are operable and calibrated:
(A)
by a person licensed or registered by the agency, another
agreement state, a licensing state, or the United States Nuclear Regulatory
Commission (NRC) to perform such service;
(B)
at intervals not to exceed 12 months unless a different
time interval is specified in another section of this chapter;
(C)
after each instrument or equipment repair;
(D)
for the types of radiation used and at energies appropriate
for use; and
(E)
at an accuracy within 20% of the true radiation level.
(3)
All individual monitoring devices, except for
direct and indirect reading pocket dosimeters, electronic personal dosimeters,
and those individual monitoring devices used to measure the dose to any extremity,
that require processing to determine the radiation dose and that are used
by licensees to comply with subsection (f) of this section, with other applicable
provisions of this chapter, or with conditions specified in a license, shall
be processed and evaluated by a dosimetry processor:
(A)
holding current personnel dosimetry accreditation from
the National Voluntary Laboratory Accreditation Program (NVLAP) of the National
Institute of Standards and Technology;
(B)
approved in this accreditation process for the type of
radiation or radiations included in the NVLAP program that most closely approximates
the type of radiation or radiations for which the individual wearing the dosimeter
is monitored; and
(C)
holding a current certificate of registration from the
agency authorizing dosimetry processing.
(q)
Conditions requiring individual monitoring of external
and internal occupational dose. Each licensee shall monitor exposures from
sources of radiation at levels sufficient to demonstrate compliance with the
occupational dose limits of this section. As a minimum:
(1)
each licensee shall monitor occupational exposure to radiation
and shall supply and require the use of individual monitoring devices by:
(A)
adults likely to receive, in one year from sources external
to the body, a dose in excess of 10% of the limits in subsection (f)(1) of
this section;
(B)
minors likely to receive, in one year from sources of radiation
external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv),
a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose
equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
(C)
declared pregnant women likely to receive during the entire
pregnancy, from sources of radiation external to the body, a deep dose equivalent
in excess of 0.1 rem (1 mSv); and
(D)
individuals entering a high or very high radiation area;
(2)
notwithstanding paragraph (1)(C) of this subsection,
a licensee is exempt from supplying individual monitoring devices to healthcare
personnel who may enter a high radiation area while providing patient care
if:
(A)
the personnel are not likely to receive, in one year from
sources external to the body, a dose in excess of 10% of the limits in subsection
(f)(1) of this section; and
(B)
the licensee complies with the requirements of subsection
(e)(2) of this section; and
(3)
each licensee shall monitor, to determine compliance
with subsection (i) of this section, the occupational intake of radioactive
material by and assess the committed effective dose equivalent to:
(A)
adults likely to receive, in one year, an intake in excess
of 10% of the applicable ALI in Columns 1 and 2 of Table I of subsection (ggg)(2)
of this section;
(B)
minors likely to receive, in one year, a committed effective
dose equivalent in excess of 0.1 rem (1 mSv); and
(C)
declared pregnant women likely to receive, during the entire
pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
(r)
Location and use of individual monitoring devices.
(1)
Each licensee shall ensure that individuals who are required
to monitor occupational doses in accordance with subsection (q)(l) of this
section wear and use individual monitoring devices as follows.
(A)
An individual monitoring device used for monitoring the
dose to the whole body shall be worn at the unshielded location of the whole
body likely to receive the highest exposure. When a protective apron is worn,
the location of the individual monitoring device is typically at the neck
(collar).
(B)
If an additional individual monitoring device is used for
monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance
with subsection (m)(1) of this section, it shall be located at the waist under
any protective apron being worn by the woman.
(C)
An individual monitoring device used for monitoring the
lens dose equivalent, to demonstrate compliance with subsection (f)(1)(B)(i)
of this section, shall be located at the neck (collar) or at a location closer
to the eye, outside any protective apron being worn by the monitored individual.
(D)
An individual monitoring device used for monitoring the
dose to the extremities, to demonstrate compliance with subsection (f)(1)(B)(ii)
of this section, shall be worn on the extremity likely to receive the highest
exposure. Each individual monitoring device, to the extent practicable, shall
be oriented to measure the highest dose to the extremity being monitored.
(E)
An individual monitoring device shall be assigned to and
worn by only one individual.
(F)
An individual monitoring device shall be worn for the period
of time authorized by the dosimetry processor's certificate of registration
or for no longer than three months, whichever is more restrictive.
(2)
Each licensee shall ensure that individual monitoring
devices are returned to the dosimetry processor for proper processing.
(3)
Each licensee shall ensure that adequate precautions
are taken to prevent a deceptive exposure of an individual monitoring device.
(s)
Control of access to high radiation areas.
(1)
The licensee shall ensure that each entrance or access
point to a high radiation area has one or more of the following features:
(A)
a control device that, upon entry into the area, causes
the level of radiation to be reduced below that level at which an individual
might receive a deep dose equivalent of 0.1 rem (1 mSv) in one hour at 30
centimeters (cm) from the source of radiation from any surface that the radiation
penetrates;
(B)
a control device that energizes a conspicuous visible or
audible alarm signal so that the individual entering the high radiation area
and the supervisor of the activity are made aware of the entry; or
(C)
entryways that are locked, except during periods when access
to the areas is required, with positive control over each individual entry.
(2)
In place of the controls required by paragraph
(1) of this subsection for a high radiation area, the licensee may substitute
continuous direct or electronic surveillance that is capable of preventing
unauthorized entry.
(3)
The licensee may apply to the agency for approval
of alternative methods for controlling access to high radiation areas.
(4)
The licensee shall establish the controls required
by paragraphs (1) and (3) of this subsection in a way that does not prevent
individuals from leaving a high radiation area.
(5)
The licensee is not required to control each entrance
or access point to a room or other area that is a high radiation area solely
because of the presence of radioactive materials prepared for transport and
packaged and labeled in accordance with the regulations of the United States
Department of Transportation (DOT) provided that:
(A)
the packages do not remain in the area longer than three
days; and
(B)
the dose rate at 1 meter from the external surface of any
package does not exceed 0.01 rem (0.1 millisievert) per hour.
(6)
The licensee is not required to control entrance
or access to rooms or other areas in hospitals solely because of the presence
of patients containing radioactive material, provided that there are personnel
in attendance who are taking the necessary precautions to prevent the exposure
of individuals to sources of radiation in excess of the established limits
in this section and to operate within the ALARA provisions of the licensee's
radiation protection program.
(t)
Control of access to very high radiation areas. In addition
to the requirements in subsection (s) of this section, the licensee shall
institute measures to ensure that an individual is not able to gain unauthorized
or inadvertent access to areas in which radiation levels could be encountered
at 500 rads (5 grays) or more in one hour at 1 m from a source of radiation
or any surface through which the radiation penetrates at this level.
(u)
Control of access to very high radiation areas for irradiators.
(1)
This subsection applies to licensees with sources of radiation
in non-self-shielded irradiators. This subsection does not apply to sources
of radiation that are used in teletherapy, in industrial radiography, or in
completely self-shielded irradiators in which the source of radiation is both
stored and operated within the same shielding radiation barrier and, in the
designed configuration of the irradiator, is always physically inaccessible
to any individual and cannot create high levels of radiation in an area that
is accessible to any individual.
(2)
Each area in which there may exist radiation levels
in excess of 500 rads (5 grays) in one hour at 1 m from a source of radiation
that is used to irradiate materials shall meet the following requirements.
(A)
Each entrance or access point shall be equipped with entry
control devices that:
(i)
function automatically to prevent any individual from inadvertently
entering a very high radiation area;
(ii)
permit deliberate entry into the area only after a control
device is actuated that causes the radiation level within the area, from the
source of radiation, to be reduced below that at which it would be possible
for an individual to receive a deep dose equivalent in excess of 0.1 rem (1
mSv) in one hour; and
(iii)
prevent operation of the source of radiation if it would
produce radiation levels in the area that could result in a deep dose equivalent
to an individual in excess of 0.1 rem (1 mSv) in one hour.
(B)
Additional control devices shall be provided so that, upon
failure of the entry control devices to function as required by subparagraph
(A) of this paragraph:
(i)
the radiation level within the area, from the source of
radiation, is reduced below that at which it would be possible for an individual
to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour;
and
(ii)
conspicuous visible and audible alarm signals are generated
to make an individual attempting to enter the area aware of the hazard and
at least one other authorized individual, who is physically present, familiar
with the activity, and prepared to render or summon assistance, aware of the
failure of the entry control devices.
(C)
The licensee shall provide control devices so that, upon
failure or removal of physical radiation barriers other than the sealed source's
shielded storage container:
(i)
the radiation level from the source of radiation is reduced
below that at which it would be possible for an individual to receive a deep
dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and
(ii)
conspicuous visible and audible alarm signals are generated
to make potentially affected individuals aware of the hazard and the licensee
or at least one other individual, who is familiar with the activity and prepared
to render or summon assistance, aware of the failure or removal of the physical
barrier.
(D)
When the shield for stored sealed sources is a liquid,
the licensee shall provide means to monitor the integrity of the shield and
to signal, automatically, loss of adequate shielding.
(E)
Physical radiation barriers that comprise permanent structural
components, such as walls, that have no credible probability of failure or
removal in ordinary circumstances, need not meet the requirements of subparagraphs
(C) and (D) of this paragraph.
(F)
Each area shall be equipped with devices that will automatically
generate conspicuous visible and audible alarm signals to alert personnel
in the area before the source of radiation can be put into operation and in
time for any individual in the area to operate a clearly identified control
device, which must be installed in the area and which can prevent the source
of radiation from being put into operation.
(G)
Each area shall be controlled by use of such administrative
procedures and such devices as are necessary to ensure that the area is cleared
of personnel prior to each use of the source of radiation.
(H)
Each area shall be checked by a radiation measurement to
ensure that, prior to the first individual's entry into the area after any
use of the source of radiation, the radiation level from the source of radiation
in the area is below that at which it would be possible for an individual
to receive a deep dose equivalent in excess of 0.1 rem (1 mSv) in one hour.
(I)
The entry control devices required in subparagraph (A)
of this paragraph shall be tested for proper functioning. See subsection (uu)
of this section for recordkeeping requirements.
(i)
Testing shall be conducted prior to initial operation with
the source of radiation on any day, unless operations were continued uninterrupted
from the previous day.
(ii)
Testing shall be conducted prior to resumption of operation
of the source of radiation after any unintentional interruption.
(iii)
The licensee shall submit and adhere to a schedule for
periodic tests of the entry control and warning systems.
(J)
The licensee shall not conduct operations, other than those
necessary to place the source of radiation in safe condition or to effect
repairs on controls, unless control devices are functioning properly.
(K)
Entry and exit portals that are used in transporting materials
to and from the irradiation area, and that are not intended for use by individuals,
shall be controlled by such devices and administrative procedures as are necessary
to physically protect and warn against inadvertent entry by any individual
through these portals. Exit portals for irradiated materials shall be equipped
to detect and signal the presence of any loose radioactive material that is
carried toward such an exit and automatically to prevent loose radioactive
material from being carried out of the area.
(3)
Licensees or applicants for licenses for sources
of radiation within the purview of paragraph (2) of this subsection that will
be used in a variety of positions or in locations, such as open fields or
forests, which make it impracticable to comply with certain requirements of
paragraph (2) of this subsection, such as those for the automatic control
of radiation levels, may apply to the Agency for approval of alternative safety
measures. Alternative safety measures shall provide personnel protection at
least equivalent to those specified in paragraph (2) of this subsection. At
least one of the alternative measures shall include an entry-preventing interlock
control based on a measurement of the radiation that ensures the absence of
high radiation levels before an individual can gain access to the area where
such sources of radiation are used.
(4)
The entry control devices required by paragraphs (2)
and (3) of this subsection shall be established in such a way that no individual
will be prevented from leaving the area.
(v)
Use of process or other engineering controls. The licensee
shall use, to the extent practicable, process or other engineering controls,
such as containment or ventilation, to control the concentrations of radioactive
material in air.
(w)
Use of other controls. When it is not practicable to apply
process or other engineering controls to control the concentrations of radioactive
material in air to values below those that define an airborne radioactivity
area, the licensee shall, consistent with maintaining the total effective
dose equivalent ALARA, increase monitoring and limit intakes by one or more
of the following means:
(1)
control of access;
(2)
limitation of exposure times;
(3)
use of respiratory protection equipment; or
(4)
other controls.
(x)
Use of individual respiratory protection equipment.
(1)
If the licensee uses respiratory protection equipment to
limit intakes in accordance with subsection (w) of this section.
(A)
Except as provided in subparagraph (B) of this paragraph,
the licensee shall use only respiratory protection equipment that is tested
and certified or had certification extended by the National Institute for
Occupational Safety and Health (NIOSH) and the Mine Safety and Health Administration
(MSHA).
(B)
If the licensee wishes to use equipment that has not been
tested or certified by the NIOSH and the MSHA, or has not had certification
extended by the NIOSH and the MSHA, or for which there is no schedule for
testing or certification, the licensee shall submit an application for authorized
use of that equipment, including a demonstration by testing, or a demonstration
on the basis of test information, that the material and performance characteristics
of the equipment are capable of providing the proposed degree of protection
under anticipated conditions of use.
(C)
The licensee shall implement and maintain a respiratory
protection program that includes:
(i)
air sampling sufficient to identify the potential hazard,
permit proper equipment selection, and estimate exposures;
(ii)
surveys and bioassays, as appropriate, to evaluate actual
intakes;
(iii)
testing of respirators for operability immediately prior
to each use;
(iv)
written procedures regarding selection, fitting, issuance,
maintenance, and testing of respirators, including testing for operability
immediately prior to each use; supervision and training of personnel; monitoring,
including air sampling and bioassays; and recordkeeping; and
(v)
determination by a physician prior to initial fitting of
respirators, and either every 12 months thereafter or periodically at a frequency
determined by a physician, that the individual user is physically able to
use the respiratory protection equipment.
(D)
The licensee shall issue a written policy statement on
respirator usage covering:
(i)
the use of process or other engineering controls, instead
of respirators;
(ii)
the routine, nonroutine, and emergency use of respirators;
and
(iii)
the length of periods of respirator use and relief from
respirator use.
(E)
The licensee shall advise each respirator user that the
user may leave the area at any time for relief from respirator use in the
event of equipment malfunction, physical or psychological distress, procedural
or communication failure, significant deterioration of operating conditions,
or any other conditions that might require such relief.
(F)
The licensee shall use respiratory protection equipment
within the equipment manufacturer's expressed limitations for type and mode
of use and shall provide proper visual, communication, and other special capabilities,
such as adequate skin protection, when needed.
(2)
When estimating exposure of individuals to airborne
radioactive materials, the licensee may make allowance for respiratory protection
equipment used to limit intakes in accordance with subsection (w) of this
section, provided that the following conditions, in addition to those in paragraph
(1) of this subsection, are satisfied.
(A)
The licensee selects respiratory protection equipment that
provides a protection factor, asspecified in subsection (ggg)(1) of this section,
greater than the multiple by which peak concentrations of airborne radioactive
materials in the working area are expected to exceed the values specified
in Column 3 of Table I of subsection (ggg)(2) of this section. However, if
the election of respiratory protection equipment with a protection factor
greater than the peak concentration is inconsistent with the goal specified
in subsection (w) of this section of keeping the total effective dose equivalent
ALARA, the licensee may select respiratory protection equipment with a lower
protection factor provided that such a selection would result in a total effective
dose equivalent that is ALARA. The concentration of radioactive material in
the air that is inhaled when respirators are worn may be initially estimated
by dividing the average concentration in air, during each period of uninterrupted
use, by the protection factor. If the exposure is later found to be greater
than initially estimated, the corrected value shall be used; if the exposure
is later found to be less than initially estimated, the corrected value may
be used.
(B)
The licensee shall obtain authorization from the agency
before assigning respiratory protection factors in excess of those specified
in subsection (ggg)(1) of this section. The agency may authorize a licensee
to use higher protection factors on receipt of an application that:
(i)
describes the situation for which a need exists for higher
protection factors; and
(ii)
demonstrates that the respiratory protection equipment
provides these higher protection factors under the proposed conditions of
use.
(3)
In an emergency, the licensee shall use
as emergency equipment only respiratory protection equipment that has been
specifically certified or had certification extended for emergency use by
the NIOSH and the MSHA.
(4)
The licensee shall notify the agency in writing at
least 30 days before the date that respiratory protection equipment is first
used in accordance with either paragraphs (1) or (2) of this subsection.
(y)
Security and control of licensed sources of radiation.
(1)
The licensee shall secure radioactive material from unauthorized
removal or access.
(2)
The licensee shall maintain constant surveillance,
using devices and/or administrative procedures to prevent unauthorized use
of radioactive material that is in an unrestricted area and that is not in
storage.
(z)
Caution signs.
(1)
Unless otherwise authorized by the agency, the standard
radiation symbol prescribed shall use the colors magenta, or purple, or black
on yellow background. The standard radiation symbol prescribed is the three-bladed
design as follows:
Figure: 25 TAC §289.202(z)(1) (No change.)
(A)
the cross-hatched area of the symbol is to be magenta,
or purple, or black; and
(B)
the background of the symbol is to be yellow.
(2)
Notwithstanding the requirements of paragraph
(1) of this subsection, licensees are authorized to label sources, source
holders, or device components containing sources of radiation that are subjected
to high temperatures, with conspicuously etched or stamped radiation caution
symbols and without a color requirement.
(aa)
Posting requirements.
(1)
The licensee shall post each radiation area with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION
AREA."
(2)
The licensee shall post each high radiation area with
a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION,
HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
(3)
The licensee shall post each very high radiation area
with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE
DANGER, VERY HIGH RADIATION AREA." If the very high radiation area involves
medical treatment of patients, the licensee may omit the word "GRAVE" from
the sign or signs.
(4)
The licensee shall post each airborne radioactivity
area with a conspicuous sign or signs bearing the radiation symbol and the
words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY
AREA."
(5)
The licensee shall post each area or room in which
there is used or stored an amount of licensed material exceeding 10 times
the quantity of such material specified in subsection (ggg)(3) of this section
with a conspicuous sign or signs bearing the radiation symbol and the words
"CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
(bb)
Exceptions to posting requirements.
(1)
A licensee is not required to post caution signs in areas
or rooms containing sources of radiation for periods of less than 8 hours,
if each of the following conditions is met:
(A)
the sources of radiation are constantly attended during
these periods by an individual who takes the precautions necessary to prevent
the exposure of individuals to sources of radiation in excess of the limits
established in this section; and
(B)
the area or room is subject to the licensee's control.
(2)
Rooms or other areas in hospitals that are occupied
by patients are not required to be posted with caution signs in accordance
with subsection (aa) of this section provided that the patient could be released
from licensee control in accordance with this chapter.
(3)
A room or area is not required to be posted with a
caution sign because of the presence of a sealed source(s) provided the radiation
level at 30 centimeters from the surface of the sealed source container(s)
or housing(s) does not exceed 0.005 rem (0.05 mSv) per hour.
(4)
Rooms in medical facilities that are used for teletherapy
are exempt from the requirement to post caution signs in accordance with subsection
(aa) of this section provided the following conditions are met.
(A)
Access to the room is controlled in accordance with this
chapter; and
(B)
Personnel in attendance take necessary precautions to prevent
the inadvertent exposure of workers, other patients, and members of the public
to radiation in excess of the limits established in this section.
(cc)
Labeling containers.
(1)
The licensee shall ensure that each container of licensed
material bears a durable, clearly visible label bearing the radiation symbol
and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL."
The label shall also provide information, such as the radionuclides present,
an estimate of the quantity of radioactivity, the date for which the activity
is estimated, radiation levels, kinds of materials, and mass enrichment, to
permit individuals handling or using the containers, or working in the vicinity
of the containers, to take precautions to avoid or minimize exposures.
(2)
Each licensee shall, prior to removal or disposal
of empty uncontaminated containers to unrestricted areas, remove or deface
the radioactive material label or otherwise clearly indicate that the container
no longer contains radioactive materials.
(dd)
Exemptions to labeling requirements. A licensee is not
required to label:
(1)
containers holding licensed material in quantities less
than the quantities listed in subsection (ggg)(3) of this section;
(2)
containers holding licensed material in concentrations
less than those specified in Table III of subsection (ggg)(2) of this section;
(3)
containers attended by an individual who takes the
precautions necessary to prevent the exposure of individuals in excess of
the limits established by this section;
(4)
containers when they are in transport and packaged
and labeled in accordance with the rules of the DOT (labeling of packages
containing radioactive materials is required by the DOT if the amount and
type of radioactive material exceeds the limits for an excepted quantity or
article as defined and limited by DOT regulations 49 CFR 173.403(m) and (w)
and 173.424);
(5)
containers that are accessible only to individuals
authorized to handle or use them, or to work in the vicinity of the containers,
if the contents are identified to these individuals by a readily available
written record. Examples of containers of this type are containers in locations
such as water-filled canals, storage vaults, or hot cells. The record shall
be retained as long as the containers are in use for the purpose indicated
on the record; or
(6)
installed manufacturing or process equipment, such
as piping and tanks.
(ee)
Procedures for receiving and opening packages.
(1)
Each licensee who expects to receive a package containing
quantities of radioactive material in excess of a Type A quantity, as defined
in §289.201(b) of this title and specified in §289.257(s)(1) of
this title (relating to Packaging and Transportation of Radioactive Material),
shall make arrangements to receive:
(A)
the package when the carrier offers it for delivery; or
(B)
the notification of the arrival of the package at the carrier's
terminal and to take possession of the package expeditiously.
(2)
Each licensee shall:
(A)
monitor the external surfaces of a labeled package, labeled
with a Radioactive White I, Yellow II, or Yellow III label as specified in
DOT regulations 49 CFR 172.403 and 172.436-440, for radioactive contamination
unless the package contains only radioactive material in the form of gas or
in special form as defined in §289.201(b) of this title; and
(B)
monitor the external surfaces of a labeled package, labeled
with a Radioactive White I, Yellow II, or Yellow III label as specified in
DOT regulations 49 CFR 172.403 and 172.436-440, for radiation levels unless
the package contains quantities of radioactive material that are less than
or equal to the Type A quantity, as defined in §289.201(b) of this title
and specified in §289.257(s)(1) of this title; and
(C)
monitor all packages known to contain radioactive material
for radioactive contamination and radiation levels if there is evidence of
degradation of package integrity, such as packages that are crushed, wet,
or damaged.
(3)
The licensee shall perform the monitoring required
by paragraph (2) of this subsection as soon as practicable after receipt of
the package, but not later than three hours after the package is received
at the licensee's facility if it is received during the licensee's normal
working hours. If a package is received after working hours, the package shall
be monitored no later than three hours from the beginning of the next working
day. If the licensee discovers there is evidence of degradation of package
integrity, such as a package that is crushed, wet, or damaged, the package
shall be surveyed immediately.
(4)
The licensee shall immediately notify the final delivery
carrier and, by telephone and telegram, mailgram, or facsimile, the agency
when removable radioactive surface contamination or external radiation levels
exceed the limits established in subparagraphs (A) and (B) of this paragraph.
(A)
Limits for removable radioactive surface contamination
levels.
(i)
The level of removable radioactive contamination on the
external surfaces of each package offered for shipment shall be ALARA. The
level of removable radioactive contamination may be determined by wiping an
area of 300 square centimeters (cm
2
) of the
surface concerned with an absorbent material, using moderate pressure, and
measuring the activity on the wiping material. Sufficient measurements must
be taken in the most appropriate locations to yield a representative assessment
of the removable contamination levels. Except as provided in clause (iii)
of this subparagraph, the amount of radioactivity measured on any single wiping
material, when averaged over the surface wiped, must not exceed the limits
given in clause (ii) of this subparagraph at any time during transport. If
other methods are used, the detection efficiency of the method used must be
taken into account and in no case may the removable contamination on the external
surfaces of the package exceed 10 times the limits listed in clause (ii) of
this subparagraph.
(ii)
Removable external radioactive contamination wipe limits
are as follows.
Figure: 25 TAC §289.202(ee)(4)(A)(ii) (No change.)
(iii)
In the case of packages transported as exclusive use
shipments by rail or highway only, the removable radioactive contamination
at any time during transport must not exceed 10 times the levels prescribed
in clause (ii) of this subparagraph. The levels at the beginning of transport
must not exceed the levels in clause (ii) of this subparagraph.
(B)
Limits for external radiation levels.
(i)
External radiation levels around the package and around
the vehicle, if applicable, will not exceed 200 millirems per hour (mrem/hr)
(2 millisiverts per hour (mSv/hr)) at any point on the external surface of
the package at any time during transportation. The transport index shall not
exceed 10.
(ii)
For a package transported in exclusive use by rail, highway
or water, radiation levels external to the package may exceed the limits specified
in clause (i) of this subparagraph but shall not exceed any of the following:
(I)
200 mrem/hr (2 mSv/hr) on the accessible external surface
of the package unless the following conditions are met, in which case the
limit is 1,000 mrem/hr (10 mSv/hr):
(-a-)
the shipment is made in a closed transport vehicle;
(-b-)
provisions are made to secure the package so that
its position within the vehicle remains fixed during transportation; and
(-c-)
there are no loading or unloading operations between
the beginning and end of the transportation;
(II)
200 mrem/hr (2 mSv/hr) at any point on the outer surface
of the vehicle, including the upper and lower surfaces, or, in the case of
a flat-bed style vehicle, with a personnel barrier, at any point on the vertical
planes projected from the outer edges of the vehicle, on the upper surface
of the load (or enclosure, if used), and on the lower external surface of
the vehicle (a flat-bed style vehicle with a personnel barrier shall have
radiation levels determined at vertical planes. If no personnel barrier, the
package cannot exceed 200 mrem/hr (2 mSv/hr) at the surface.);
(III)
10 mrem/hr (0.1 mSv/hr) at any point 2 m from the vertical
planes represented by the outer lateral surfaces of the vehicle, or, in the
case of a flat-bed style vehicle, at any point 2 m from the vertical planes
projected from the outer edges of the vehicle; and
(IV)
2 mrem/hr (0.02 mSv/hr) in any normally occupied positions
of the vehicle, except that this provision does not apply to private motor
carriers when persons occupying these positions are provided with special
health supervision, personnel radiation exposure monitoring devices, and training
in accordance with §289.203(c) of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections).
(5)
Each licensee shall:
(A)
establish, maintain, and retain written procedures for
safely opening packages in which radioactive material is received; and
(B)
ensure that the procedures are followed and that due consideration
is given to special instructions for the type of package being opened.
(6)
Licensees transferring special form sources in
vehicles owned or operated by the licensee to and from a work site are exempt
from the contamination monitoring requirements of paragraph (2) of this subsection,
but are not exempt from the monitoring requirement in paragraph (2) of this
subsection for measuring radiation levels that ensures that the source is
still properly lodged in its shield.
(ff)
General requirements for waste management.
(1)
Unless otherwise exempted, a licensee shall discharge,
treat, or decay licensed material or transfer waste for disposal only:
(A)
by transfer to an authorized recipient as provided in subsection
(jj) of this section, §289.252 of this title, §289.254 of this title
(relating to Licensing of Radioactive Waste Processing and Storage Facilities), §289.257
of this title, §289.259 of this title (relating to Licensing of Naturally
Occurring Radioactive Material (NORM)), or to the United States Department
of Energy (DOE);
(B)
by decay in storage with prior approval from the agency;
(C)
by release in effluents within the limits in subsection
(n) of this section; or
(D)
as authorized in accordance with paragraph (2) of this
subsection, and subsections (gg) and (hh) of this section.
(2)
Upon agency approval, emission control dust and
other material from electric arc furnaces or foundries, such as K061 listed
hazardous waste or other listed hazardous waste, contaminated as a result
of inadvertent melting of a cesium-137 source may be transferred for disposal
to a hazardous waste disposal facility authorized by the Texas Natural Resource
Conservation Commission (Commission) or its successor, another state's regulatory
agency with jurisdiction to regulate hazardous waste as classified under Subtitle
C of the Resource Conservation and Recovery Act (RCRA), or the EPA. The material
may be transferred for disposal without regard to its radioactivity if the
following conditions are met.
(A)
Contaminated material described in paragraph (2) of this
subsection, whether packaged or unpackaged (i.e., bulk), must be treated through
stabilization to comply with all waste treatment requirements of the appropriate
state or federal regulatory agency as listed in this paragraph. The treatment
operations must be undertaken by either of the following:
(i)
the owner/operator of the electric arc furnace or foundry
licensed to possess, treat or transfer cesium-137 contaminated incident-related
material; or
(ii)
a service contractor licensed by the agency, NRC, or an
agreement state.
(B)
The emission control dust and other incident-related materials
have been stored (if applicable) and transferred in accordance with operating
and emergency procedures approved by the agency.
(C)
The total cesium-137 activity contained in emission control
dust and other incident-related materials to be transferred to a hazardous
waste disposal facility has been specifically approved by NRC or the appropriate
agreement state(s) and does not exceed the total activity associated with
the inadvertent melting incident.
(D)
The hazardous waste disposal facility operator has been
notified in writing of the impending transfer of the incident-related materials
and has agreed in writing to receive and dispose of the packaged or unpackaged
materials. Copies of the notification and agreement shall be submitted to
the agency.
(E)
The licensee, as listed in subparagraph (A)(i) or (ii)
of this paragraph, notifies the NRC or agreement state(s) in which the transferor
and transferee are located, in writing, of the impending transfer, at least
30 days before the transfer.
(F)
The packaged stabilized material has been packaged for
transportation and disposal in non-bulk steel packaging as defined in DOT
regulations at 49 CFR 173.213.
(G)
The emission control dust and other incident-related materials
that have been stabilized and packaged as described in subparagraph (F) of
this paragraph shall contain pretreatment average concentrations of cesium-137
that do not exceed 130 pCi/g of material, above background.
(H)
The dose rate at 3.28 feet (1 m) from the surface of any
package containing stabilized waste shall not exceed 20 micro;rem per hour
or 0.20 micro;Sv per hour, above background.
(I)
The unpackaged stabilized material shall contain pretreatment
average concentrations of cesium-137 that do not exceed 100 pCi/g of material,
above background.
(gg)
Discharge by release into sanitary sewerage.
(1)
A licensee may discharge licensed material into sanitary
sewerage if each of the following conditions is satisfied:
(A)
the material is readily soluble, or is readily dispersible
biological material, in water;
(B)
the quantity of licensed radioactive material that the
licensee releases into the sewer in one month divided by the average monthly
volume of water released into the sewer by the licensee does not exceed the
concentration listed in Table III of subsection (ggg)(2) of this section;
and
(C)
if more than one radionuclide is released, the following
additional conditions must also be satisfied:
(i)
the fraction of the limit in Table III of subsection (ggg)(2)
of this section represented by discharges into sanitary sewerage determined
by dividing the actual monthly average concentration of each radionuclide
released by the licensee into the sewer by the concentration of that radionuclide
listed in Table III of subsection (ggg)(2) of this section; and
(ii)
the sum of the fractions for each radionuclide required
by clause (i) of this subparagraph does not exceed unity; and
(D)
the total quantity of licensed radioactive material that
the licensee releases into the sanitary sewerage in a year does not exceed
5 curies (Ci) (185 gigabecquerels (GBq)) of hydrogen-3, 1 Ci (37 GBq) of carbon-14,
and 1 Ci (37 GBq) of all other radioactive materials combined.
(2)
Excreta from individuals undergoing medical diagnosis
or therapy with radioactive material are not subject to the limitations contained
in paragraph (1) of this subsection.
(hh)
Treatment by incineration. A licensee may treat licensed
material by incineration only in the form and concentration specified in subsection
(fff)(1) of this section or as authorized by the agency.
(ii)
Discharge by release into septic tanks. No licensee shall
discharge radioactive material into a septic tank system except as specifically
approved by the agency.
(jj)
Transfer for disposal and manifests.
(1)
The control of transfers of LLRW intended for disposal
at a licensed low-level radioactive waste disposal facility, the establishment
of a manifest tracking system, and additional requirements concerning transfers
and recordkeeping for those wastes are found in §289.257(s)(5) of this
title.
(2)
Each person involved in the transfer of waste for
disposal including the waste generator, waste collector, and waste processor,
shall comply with the requirements specified in §289.257(s)(5) of this
title.
(kk)
Compliance with environmental and health protection regulations.
Nothing in subsections (ff), (gg), (hh), or (jj) of this section relieves
the licensee from complying with other applicable federal, state, and local
regulations governing any other toxic or hazardous properties of materials
that may be disposed of in accordance with subsections (ff), (gg), (hh), or
(jj) of this section.
(ll)
General provisions for records.
(1)
Each licensee shall use the SI units becquerel, gray, sievert,
and coulomb per kilogram, or the special units curie, rad, rem, and roentgen,
including multiples and subdivisions, and shall clearly indicate the units
of all quantities on records required by this section. Disintegrations per
minute may be indicated on records of surveys performed to determine compliance
with subsection (ggg)(6) of this section. To ensure compatibility with international
transportation standards, all limits in this section are given in terms of
dual units: The International System of Units (SI) followed or preceded by
United States (U.S.) standard or customary units. The U.S. customary units
are not exact equivalents, but are rounded to a convenient value, providing
a functionally equivalent unit. For the purpose of this section, either unit
may be used.
(2)
Notwithstanding the requirements of paragraph (1)
of this subsection, when recording information on shipment manifests, as required
in §289.257 of this title, information must be recorded in SI units or
in SI and units as specified in paragraph (1) of this subsection.
(3)
The licensee shall make a clear distinction among
the quantities entered on the records required by this section, such as, total
effective dose equivalent, total organ dose equivalent, shallow dose equivalent,
lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.
(4)
Records required in accordance with §289.201(d)
of this title, and subsections (mm)-(oo), (tt), and (uu) of this section shall
include the date and the identification of individual(s) making the record,
and, as applicable, a unique identification of survey instrument(s) used,
and an exact description of the location of the survey. Records of receipt,
transfer, and disposal of sources of radiation shall uniquely identify the
source of radiation.
(5)
Copies of records required in accordance with §289.201(d)
of this title, and subsections (mm)-(uu) of this section, and by license condition
that are relevant to operations at an additional authorized use/storage site
shall be maintained at that site in addition to the main site specified on
a license.
(mm)
Records of radiation protection programs.
(1)
Each licensee shall maintain records of the radiation protection
program, including:
(A)
the provisions of the program; and
(B)
audits and other reviews of program content and implementation.
(2)
The licensee shall retain the records required
by paragraph (1)(A) of this subsection until the agency terminates each pertinent
license requiring the record. The licensee shall retain the records required
by paragraph (1)(B) of this subsection for three years after the record is
made.
(nn)
Records of surveys.
(1)
Each licensee shall maintain records showing the results
of surveys and calibrations required by subsections (p) and (ee)(2) of this
section. The licensee shall retain these records for three years after the
record is made.
(2)
The licensee shall retain each of the following records
until the agency terminates each pertinent license requiring the record:
(A)
the results of surveys to determine the dose from external
sources of radiation used, in the absence of or in combination with individual
monitoring data, in the assessment of individual dose equivalents; and
(B)
results of measurements and calculations used to determine
individual intakes of radioactive material and used in the assessment of internal
dose; and
(C)
results of air sampling, surveys, and bioassays required
in accordance with subsection (x)(1)(C)(i) and (ii) of this section; and
(D)
results of measurements and calculations used to evaluate
the release of radioactive effluents to the environment.
(oo)
Records of tests for leakage or contamination of sealed
sources. Records of tests for leakage or contamination of sealed sources required
by §289.201(g) of this title shall be kept in units of becquerel or microcurie
and retained for inspection by the agency for five years after the records
are made.
(pp)
Records of lifetime cumulative occupational radiation
dose. The licensee shall retain the records of lifetime cumulative occupational
radiation dose as specified in subsection (k) of this section on BRC Form
202-2 or equivalent until the agency terminates each pertinent license requiring
this record. The licensee shall retain records used in preparing BRC Form
202-2 or equivalent for three years after the record is made.
(qq)
Records of planned special exposures.
(1)
For each use of the provisions of subsection (k) of this
section for planned special exposures, the licensee shall maintain records
that describe:
(A)
the exceptional circumstances requiring the use of a planned
special exposure;
(B)
the name of the management official who authorized the
planned special exposure and a copy of the signed authorization;
(C)
what actions were necessary;
(D)
why the actions were necessary;
(E)
what precautions were taken to assure that doses were maintained
ALARA;
(F)
what individual and collective doses were expected to result;
and
(G)
the doses actually received in the planned special exposure.
(2)
The licensee shall retain the records until the
agency terminates each pertinent license requiring these records.
(rr)
Records of individual monitoring results.
(1)
Each licensee shall maintain records of doses received
by all individuals for whom monitoring was required in accordance with subsection
(q) of this section, and records of doses received during planned special
exposures, accidents, and emergency conditions. Assessments of dose equivalent
and records made using units in effect before January 1, 1994, need not be
changed. These records shall include, when applicable:
(A)
the deep dose equivalent to the whole body, lens dose equivalent,
shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;
(B)
the estimated intake of radionuclides, see subsection (g)
of this section;
(C)
the committed effective dose equivalent assigned to the
intake of radionuclides;
(D)
the specific information used to calculate the committed
effective dose equivalent in accordance with subsection (i)(1) and (3) of
this section and when required by subsection (q)(1) of this section;
(E)
the total effective dose equivalent when required by subsection
(g) of this section;
(F)
the total of the deep dose equivalent and the committed
dose to the organ receiving the highest total dose; and
(G)
the data used to make occupational dose assessments in
accordance with subsection (j)(5) of this section.
(2)
The licensee shall make entries of the records
specified in paragraph (1) of this subsection at intervals not to exceed 1
year and within 60 days of the end of the year.
(3)
The licensee shall maintain the records specified
in paragraph (1) of this subsection on BRC Form 202-3, in accordance with
the instructions for BRC Form 202-3, or in clear and legible records containing
all the information required by BRC Form 202-3.
(4)
The licensee shall maintain the records of dose to
an embryo/fetus with the records of dose to the declared pregnant woman. The
declaration of pregnancy, including the estimated date of conception, shall
also be kept on file, but may be maintained separately from the dose records.
(5)
The licensee shall retain each required form or record
until the agency terminates each pertinent license requiring the record. The
licensee shall retain records used in preparing BRC Form 202-3 or equivalent
for three years after the record is made.
(ss)
Records of dose to individual members of the public.
(1)
Each licensee shall maintain records sufficient to demonstrate
compliance with the dose limit for individual members of the public. See subsection
(n) of this section.
(2)
The licensee shall retain the records required by
paragraph (1) of this subsection until the agency terminates each pertinent
license requiring the record.
(tt)
Records of discharge, treatment, or transfer for disposal.
(1)
Each licensee shall maintain records of the discharge or
treatment of licensed materials made in accordance with subsection (gg) and
(hh) of this section and of transfers for disposal made in accordance with
subsection (jj) of this section and §289.257 of this title.
(2)
The licensee shall retain the records required by
paragraph (1) of this subsection until the agency terminates each pertinent
license requiring the record.
(uu)
Records of testing entry control devices for very high
radiation areas.
(1)
Each licensee shall maintain records of tests made in accordance
with subsection (u)(2)(I) of this section on entry control devices for very
high radiation areas. These records must include the date, time, and results
of each such test of function.
(2)
The licensee shall retain the records required by
paragraph (1) of this subsection for three years after the record is made.
(vv)
Form of records. Each record required by this chapter
shall be legible throughout the specified retention period. The record shall
be the original or a reproduced copy or a microform, provided that the copy
or microform is authenticated by authorized personnel and that the microform
is capable of producing a clear copy throughout the required retention period
or the record may also be stored in electronic media with the capability for
producing legible, accurate, and complete records during the required retention
period. Records, such as letters, drawings, and specifications, shall include
all pertinent information, such as stamps, initials, and signatures. The licensee
shall maintain adequate safeguards against tampering with and loss of records.
(ww)
Reports of stolen, lost, or missing licensed sources of
radiation.
(1)
Each licensee shall report to the agency by telephone as
follows:
(A)
immediately after its occurrence becomes known to the licensee,
stolen, lost, or missing licensed radioactive material in an aggregate quantity
equal to or greater than 1,000 times the quantity specified in subsection
(ggg)(3) of this section, under such circumstances that it appears to the
licensee that an exposure could result to individuals in unrestricted areas;
or
(B)
within 30 days after its occurrence becomes known to the
licensee, lost, stolen, or missing licensed radioactive material in an aggregate
quantity greater than 10 times the quantity specified in subsection (ggg)(3)
of this section that is still missing.
(2)
Each licensee required to make a report in accordance
with paragraph (1) of this subsection shall, within 30 days after making the
telephone report, make a written report to the agency setting forth the following
information:
(A)
a description of the licensed source of radiation involved,
including, for radioactive material, the kind, quantity, and chemical and
physical form;
(B)
a description of the circumstances under which the loss
or theft occurred;
(C)
a statement of disposition, or probable disposition, of
the licensed source of radiation involved;
(D)
exposures of individuals to radiation, circumstances under
which the exposures occurred, and the possible total effective dose equivalent
to persons in unrestricted areas;
(E)
actions that have been taken, or will be taken, to recover
the source of radiation; and
(F)
procedures or measures that have been, or will be, adopted
to ensure against a recurrence of the loss or theft of licensed sources of
radiation.
(3)
Subsequent to filing the written report, the
licensee shall also report additional substantive information on the loss
or theft within 30 days after the licensee learns of such information.
(4)
The licensee shall prepare any report filed with the
agency in accordance with this subsection so that names of individuals who
may have received exposure to radiation are stated in a separate and detachable
portion of the report.
(xx)
Notification of incidents.
(1)
Notwithstanding other requirements for notification, each
licensee shall immediately report each event involving a source of radiation
possessed by the licensee that may have caused or threatens to cause:
(A)
an individual to receive:
(i)
a total effective dose equivalent of 25 rems (0.25 Sv)
or more;
(ii)
a lens dose equivalent of 75 rems (0.75 Sv) or more; or
(iii)
a shallow dose equivalent to the skin or extremities
or a total organ dose equivalent of 250 rads (2.5 grays) or more; or
(B)
the release of radioactive material, inside or outside
of a restricted area, so that, had an individual been present for 24 hours,
the individual could have received an intake five times the occupational ALI.
This provision does not apply to locations where personnel are not normally
stationed during routine operations, such as hot-cells or process enclosures.
(2)
Each licensee shall, within 24 hours of discovery
of the event, report to the agency each event involving loss of control of
a licensed source of radiation possessed by the licensee that may have caused,
or threatens to cause:
(A)
an individual to receive, in a period of 24 hours:
(i)
a total effective dose equivalent exceeding 5 rems (0.05
Sv);
(ii)
a lens dose equivalent exceeding 15 rems (0.15 Sv); or
(iii)
a shallow dose equivalent to the skin or extremities
or a total organ dose equivalent exceeding 50 rems (0.5 Sv); or
(B)
the release of radioactive material, inside or outside
of a restricted area, so that, had an individual been present for 24 hours,
the individual could have received an intake in excess of one occupational
ALI. This provision does not apply to locations where personnel are not normally
stationed during routine operations, such as hot-cells or process enclosures.
(3)
Licensees shall make the initial notification
reports required by paragraphs (1) and (2) of this subsection by telephone
to the agency and shall confirm the initial notification report within 24
hours by telegram, mailgram, or facsimile to the agency.
(4)
The licensee shall prepare each report filed with
the agency in accordance with this section so that names of individuals who
have received exposure to sources of radiation are stated in a separate and
detachable portion of the report.
(5)
The provisions of this section do not apply to doses
that result from planned special exposures, provided such doses are within
the limits for planned special exposures and are reported in accordance with
subsection (zz) of this section.
(6)
Each licensee shall notify the agency as soon as possible
but not later than four hours after the discovery of an event that prevents
immediate protective actions necessary to avoid exposures to radioactive materials
that could exceed regulatory limits or releases of radioactive materials that
could exceed regulatory limits (events may include fires, explosions, toxic
gas releases, etc.).
(7)
Each licensee shall notify the agency within 24 hours
after the discovery of any of the following events involving radioactive material:
(A)
an unplanned contamination event that:
(i)
requires access to the contaminated area, by workers or
the public, to be restricted for more than 24 hours by imposing additional
radiological controls or by prohibiting entry into the area;
(ii)
involves a quantity of material greater than five times
the lowest annual limit on intake specified in subsection (ggg)(2) of this
section for the material; and
(iii)
has access to the area restricted for a reason other
than to allow isotopes with a half-life of less than 24 hours to decay prior
to decontamination.
(B)
an event in which equipment is disabled or fails to function
as designed when:
(i)
the equipment is required by rule or license condition
to prevent releases exceeding regulatory limits, to prevent exposures to radioactive
materials exceeding regulatory limits, or to mitigate the consequences of
an accident;
(ii)
the equipment is required to be available and operable
when it is disabled or fails to function; and
(iii)
no redundant equipment is available and operable to perform
the required safety function;
(C)
an event that requires unplanned medical treatment at a
medical facility of an individual with spreadable radioactive contamination
on the individual's clothing or body; or
(D)
an unplanned fire or explosion damaging any radioactive
material or any device, container, or equipment containing radioactive material
when:
(i)
the quantity of material involved is greater than five
times the lowest annual limit on intake specified in subsection (ggg)(2) of
this section for the material; and
(ii)
the damage affects the integrity of the radioactive material
or its container.
(8)
Preparation and submission of reports. Reports
made by licensees in response to the requirements of paragraphs (6) and (7)
of this subsection shall be made as follows.
(A)
Licensees shall make reports required by paragraphs (6)
and (7) of this subsection by telephone to the agency. To the extent that
the information is available at the time of notification, the information
provided in these reports shall include:
(i)
the caller's name and call back telephone number;
(ii)
a description of the event, including date and time;
(iii)
the exact location of the event;
(iv)
the isotopes, quantities, and chemical and physical form
of the radioactive material involved; and
(v)
any personnel radiation exposure data available.
(B)
Each licensee who makes a report required by paragraphs
(6) and (7) of this subsection shall submit to the agency a written follow-up
report within 30 days of the initial report. Written reports prepared in accordance
with other requirements of this chapter may be submitted to fulfill this requirement
if the reports contain all of the necessary information and the appropriate
distribution is made. The reports must include the following:
(i)
a description of the event, including the probable cause
and the manufacturer and model number (if applicable) of any equipment that
failed or malfunctioned;
(ii)
the exact location of the event;
(iii)
the isotopes, quantities, and chemical and physical form
of the radioactive material involved;
(iv)
date and time of the event;
(v)
corrective actions taken or planned and the results of
any evaluations or assessments; and
(vi)
the extent of exposure of individuals to radioactive materials
without identification of individuals by name.
(yy)
Reports of exposures, radiation levels, and concentrations
of radioactive material exceeding the limits.
(1)
In addition to the notification required by subsection
(xx) of this section, each licensee shall submit a written report within 30
days after learning of any of the following occurrences:
(A)
incidents for which notification is required by subsection
(xx) of this section;
(B)
doses in excess of any of the following:
(i)
the occupational dose limits for adults in subsection (f)
of this section;
(ii)
the occupational dose limits for a minor in subsection
(l) of this section;
(iii)
the limits for an embryo/fetus of a declared pregnant
woman in subsection (m) of this section;
(iv)
the limits for an individual member of the public in subsection
(n) of this section;
(v)
any applicable limit in the license; or
(vi)
the ALARA constraints for air emissions as required by
subsection (e)(4) of this section;
(C)
levels of radiation or concentrations of radioactive material
in:
(i)
a restricted area in excess of applicable limits in the
license; or
(ii)
an unrestricted area in excess of 10 times the applicable
limit set forth in this section or in the license, whether or not involving
exposure of any individual in excess of the limits in subsection (n) of this
section; or
(D)
for licensees subject to the provisions of the EPA's generally
applicable environmental radiation standards in 40 CFR 190, levels of radiation
or releases of radioactive material in excess of those standards, or of license
conditions related to those requirements.
(2)
Each report required by paragraph (1) of this
subsection shall describe the extent of exposure of individuals to radiation
and radioactive material, including, as appropriate:
(A)
estimates of each individual's dose;
(B)
the levels of radiation and concentrations of radioactive
material involved;
(C)
the cause of the elevated exposures, dose rates, or concentrations;
and
(D)
corrective steps taken or planned to ensure against a recurrence,
including the schedule for achieving conformance with applicable limits, ALARA
constraints, generally applicable environmental standards, and associated
license conditions.
(3)
Each report filed in accordance with paragraph
(1) of this subsection shall include for each individual exposed: the name,
identification number, and date of birth. With respect to the limit for the
embryo/fetus in subsection (m) of this section, the identifiers should be
those of the declared pregnant woman. The report shall be prepared so that
this information is stated in a separate and detachable portion of the report.
(4)
All licensees who make reports in accordance with
paragraph (1) of this subsection shall submit the report in writing to the
agency.
(zz)
Reports of planned special exposures. The licensee shall
submit a written report to the agency within 30 days following any planned
special exposure conducted in accordance with subsection (k) of this section,
informing the agency that a planned special exposure was conducted and indicating
the date the planned special exposure occurred and the information required
by subsection (qq) of this section.
(aaa)
Notifications and reports to individuals.
(1)
Requirements for notification and reports to individuals
of exposure to sources of radiation are specified in §289.203 of this
title.
(2)
When a licensee is required in accordance with subsection
(yy) or (zz) of this section to report to the agency any exposure of an identified
occupationally exposed individual, or an identified member of the public,
to sources of radiation, the licensee shall also notify the individual and
provide a copy of the report submitted to the agency, to the individual. Such
notice shall be transmitted at a time not later than the transmittal to the
agency, and shall comply with the provisions of §289.203(d)(1) of this
title.
(bbb)
Reports of leaking or contaminated sealed sources. The
licensee shall immediately notify the agency if the test for leakage or contamination
required in accordance with §289.201(g) of this title indicates a sealed
source is leaking or contaminated. A written report of a leaking or contaminated
source shall be submitted to the agency within five days. The report shall
include the equipment involved, the test results and the corrective action
taken.
(ccc)
Vacating premises.
(1)
Each licensee or person possessing non-exempt sources of
radiation shall, no less than 30 days before vacating and relinquishing possession
or control of premises, notify the agency, in writing, of the intent to vacate.
(2)
The licensee or person possessing non-exempt radioactive
material shall decommission the premises to a degree consistent with subsequent
use as an unrestricted area and in accordance with the requirements of subsection
(ddd) of this section or, for uranium recovery and byproduct material disposal
facilities licensed in accordance with §289.260 of this title, subsection
(eee) of this section.
(ddd)
Radiological requirements for license termination.
(1)
General provisions and scope.
(A)
The requirements in this section apply to the decommissioning
of facilities licensed in accordance with §289.252 of this title (relating
to Licensing of Radioactive Material), §289.254 of this title (relating
to Licensing of Radioactive Waste Processing and Storage Facilities), §289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography), and §289.258 of
this title (relating to Licensing and Radiation Safety Requirements for Irradiators).
The requirements do not apply to uranium recovery and byproduct material disposal
facilities already subject to the requirements of §289.260 of this title
(relating to Licensing of Uranium Recovery and Byproduct Material Disposal
Facilities).
(B)
The requirements in this section do not apply to the following:
(i)
sites that have been decommissioned prior to October 1,
2000, in accordance with requirements identified in this section and in §289.252
of this title; or
(ii)
sites that have previously submitted and received approval
on a decommissioning plan by October 1, 2000.
(C)
After a site has been decommissioned and the license terminated
in accordance with the requirements in the subsection, the agency will require
additional cleanup if it determines that the requirements of the subsection
were not met and residual radioactivity remaining at the site could result
in significant threat to public health and safety.
(D)
When calculating TEDE to the average member of the critical
group, the licensee shall determine the peak annual TEDE dose expected within
the first 1,000 years after decommissioning.
(2)
Radiological requirements for unrestricted use.
A site will be considered acceptable for unrestricted use if the residual
radioactivity that is distinguishable from background radiation results in
a TEDE to an average member of the critical group that does not exceed 25
mrem (0.25 mSv) per year, including that from groundwater sources of drinking
water, and the residual radioactivity has been reduced to levels that are
ALARA. Determination of the levels that are ALARA must take into account consideration
of any detriments, such as deaths from transportation accidents, expected
to potentially result from decontamination and waste disposal.
(3)
Alternate requirements for license termination.
(A)
The agency may terminate a license using alternate requirements
greater than the dose requirements specified in paragraph (2) of this subsection
if the licensee does the following:
(i)
provides assurance that public health and safety would
continue to be protected, and that it is unlikely that the dose from all man-made
sources combined, other than medical, would be more than the 1 mSv per year
(100 mrem per year) limit specified in subsection (o) of this section, by
submitting an analysis of possible sources of exposure;
(ii)
reduces doses to ALARA levels, taking into consideration
any detriments such as traffic accidents expected to potentially result from
decontamination and waste disposal; and
(iii)
has submitted a decommissioning plan to the agency indicating
the licensee's intent to decommission in accordance with the requirements
in §289.252(l)(7) of this title, and specifying that the licensee proposes
to decommission by use of alternate requirements. The licensee shall document
in the decommissioning plan how the advice of individuals and institutions
in the community who may be affected by the decommissioning has been sought
and addressed, as appropriate, following analysis of that advice. In seeking
such advice, the licensee shall provide for the following:
(I)
participation by representatives of a broad cross section
of community interests who may be affected by the decommissioning;
(II)
an opportunity for a comprehensive, collective discussion
on the issues by the participants represented; and
(III)
a publicly available summary of the results of all such
discussions, including a description of the individual viewpoints of the participants
on the issues and the extent of agreement and disagreement among the participants
on the issues.
(B)
The use of alternate requirements to terminate a license
requires the approval of the agency after consideration of the agency's recommendations
that will address any comments provided by the EPA and any public comments
submitted in accordance with paragraph (4) of this subsection.
(4)
Public notification and public participation.
Upon receipt of a decommissioning plan from the licensee, or a proposal from
the licensee for release of a site in accordance with paragraph (3) of this
subsection, or whenever the agency deems such notice to be in the public interest,
the agency will do the following:
(A)
notify and solicit comments from the following:
(i)
local and state governments in the vicinity of the site
and any Indian Nation or other indigenous people that have treaty or statutory
rights that could be affected by the decommissioning; and
(ii)
the EPA for cases where the licensee proposes to release
a site in accordance with paragraph (3) of this subsection; and
(B)
publish a notice in the
Texas
Register
and a forum, such as local newspapers, letters to state of
local organizations, or other appropriate forum, that is readily accessible
to individuals in the vicinity of the site, and solicit comments from affected
parties.
(5)
Minimization of contamination. Applicants for
licenses, other than renewals, after October 1, 2000, shall describe in the
application how facility design and procedures for operation will minimize,
to the extent practical, contamination of the facility and the environment,
facilitate eventual decommissioning, and minimize, to the extent practical,
the generation of LLRW.
(eee)
Limits for contamination of soil, surfaces of facilities
and equipment, and vegetation.
(1)
No licensee shall possess, receive, use, or transfer radioactive
material in such a manner as to cause contamination of surfaces of facilities
or equipment in unrestricted areas to the extent that the contamination exceeds
the limits specified in subsection (ggg)(6) of this section.
(2)
No licensee shall possess, receive, use, or transfer
radioactive material in such a manner as to cause contamination of soil in
unrestricted areas, to the extent that the contamination exceeds, on a dry
weight basis, the concentration limits specified in:
(A)
subsection (ggg)(8) of this section; or
(B)
the effluent concentrations in Table II, Column 2 of subsection
(ggg)(2)(F) of this section, with the units changed from microcuries per milliliter
to microcuries per gram, for radionuclides not specified in subsection (ggg)(8)
of this section or paragraph (4) of this subsection.
(3)
Where combinations of radionuclides are involved,
the sum of the ratios between the concentrations present and the limits specified
in paragraph (2) of this subsection shall not exceed one.
(4)
Notwithstanding the limits specified in paragraph
(2) of this subsection, no licensee shall cause the concentration of radium-226
or radium-228 in soil in unrestricted areas, averaged over any 100 square
meters (m
2
), to exceed the background level by
more than:
(A)
5 picocuries per gram (pCi/g) (0.185 becquerel per gram
(Bq/g)), averaged over the first 15 cm of soil below the surface; and
(B)
15 pCi/g (0.555 Bq/g), averaged over 15 cm thick layers
of soil more than 15 cm below the surface.
(5)
No licensee shall possess, receive, use, or transfer
radioactive material in such a manner as to cause contamination of vegetation
in unrestricted areas to exceed 5 pCi/g (0.185 Bq/g), based on dry weight,
for radium-226 or radium-228.
(6)
Notwithstanding the limits specified in paragraph
(2) of this subsection, no licensee shall cause the concentration of natural
uranium with no daughters present, based on dry weight and averaged over any
100 m
2
of area, to exceed the following limits:
(A)
30 pCi/g (1.11 Bq/g), averaged over the top 15 cm of soil
below the surface; and
(B)
150 pCi/g (5.55 Bq/g), average concentration at depths
greater than 15 centimeters below the surface so that no individual member
of the public will receive an effective dose equivalent in excess of 100 mrem
(1 mSv) per year.
(fff)
Exemption of specific wastes.
(1)
A licensee may discard the following licensed material
without regard to its radioactivity:
(A)
0.05 microcurie (micro;Ci) (1.85 kilobecquerels (kBq)),
or less, of hydrogen-3, carbon-14, or iodine-125 per gram of medium used for
liquid scintillation counting or in vitro clinical or in vitro laboratory
testing; and
(B)
0.05 micro;Ci (1.85 kBq), or less, of hydrogen-3, carbon-14,
or iodine-125, per gram of animal tissue, averaged over the weight of the
entire animal.
(2)
A licensee shall not discard tissue in accordance
with paragraph (1)(B) of this subsection in a manner that would permit its
use either as food for humans or as animal feed.
(3)
The licensee shall maintain records in accordance
with subsection (tt) of this section.
(4)
Any licensee may, upon agency approval of procedures
required in paragraph (6) of this subsection, discard licensed material included
in subsection (ggg)(7) of this section, provided that it does not exceed the
concentration and total curie limits contained therein, in a Type I municipal
solid waste site as defined in the Municipal Solid Waste Regulations of the
authorized regulatory agency (31 Texas Administrative Code Chapter 330), unless
such licensed material also contains hazardous waste, as defined in Section
3(15) of the Solid Waste Disposal Act, Health and Safety Code, Chapter 361.
Any licensed material included in subsection (ggg)(7) of this section and
which is a hazardous waste as defined in the Solid Waste Disposal Act may
be discarded at a facility authorized to manage hazardous waste by the authorized
regulatory agency.
(5)
Each licensee who discards material described in paragraphs
(1) or (4) of this subsection shall:
(A)
make surveys adequate to assure that the limits of paragraphs
(1) or (4) of this subsection are not exceeded; and
(B)
remove or otherwise obliterate or obscure all labels, tags,
or other markings that would indicate that the material or its contents is
radioactive.
(6)
Prior to authorizations in accordance with paragraph
(4) of this subsection, a licensee shall submit procedures to the agency for:
(A)
the physical delivery of the material to the disposal site;
(B)
surveys to be performed for compliance with paragraph (5)(A)
of this subsection;
(C)
maintaining secure packaging during transportation to the
site; and
(D)
maintaining records of any discards made under paragraph
(4) of this subsection.
(7)
Nothing in this section relieves the licensee
of maintaining records showing the receipt, transfer, and discard of such
radioactive material as specified in §289.201(d) of this title.
(8)
Nothing in this section relieves the licensee from
complying with other applicable federal, state, and local regulations governing
any other toxic or hazardous property of these materials.
(9)
Licensed material discarded under this section is
exempt from the requirements of §289.252(t) of this title.
(ggg)
Appendices.
(1)
Protection factors for respirators. The following table
contains protection factors for respirators
a
:
Figure: 25 TAC §289.202(ggg)(1)
(2)
Annual limits on intake (ALI) and derived air concentrations
(DAC) of radionuclides for occupational exposure; effluent concentrations;
concentrations for release to sanitary sewerage.
(A)
Introduction.
(i)
For each radionuclide, Table I of subparagraph (F) of this
paragraph indicates the chemical form that is to be used for selecting the
appropriate ALI or DAC value. The ALIs and DACs for inhalation are given for
an aerosol with an activity median aerodynamic diameter (AMAD) of 1 micron,
and for three classes (D, W, Y) of radioactive material, which refer to their
retention (approximately days, weeks, or years) in the pulmonary region of
the lung. This classification applies to a range of clearance half-times for
D if less than 10 days, for W from 10 to 100 days, and for Y greater than
100 days. Table II of subparagraph (F) of this paragraph provides concentration
limits for airborne and liquid effluents released to the general environment.
Table III of subparagraph (F) of this paragraph provides concentration limits
for discharges to sanitary sewerage.
(ii)
The values in Tables I, II, and III of subparagraph (F)
of this paragraph are presented in the computer "E" notation. In this notation
a value of 6E-02 represents a value of 6 x 10
-2
or 0.06, 6E+2 represents 6 x 10
2
or 600, and
6E+0 represents 6 x 10
0
or 6.
(B)
Occupational values.
(i)
Note that the columns in Table I of subparagraph (F) of
this paragraph captioned "Oral Ingestion ALI," "Inhalation ALI," and "DAC,"
are applicable to occupational exposure to radioactive material.
(ii)
The ALIs in subparagraph (F) of this paragraph are the
annual intakes of given radionuclide by "Reference Man" that would result
in either a committed effective dose equivalent of 5 rems (0.05 Sv), stochastic
ALI, or a committed dose equivalent of 50 rems (0.5 Sv) to an organ or tissue,
non-stochastic ALI. The stochastic ALIs were derived to result in a risk,
due to irradiation of organs and tissues, comparable to the risk associated
with deep dose equivalent to the whole body of 5 rems (0.05 Sv). The derivation
includes multiplying the committed dose equivalent to an organ or tissue by
a weighting factor, w
T
. This weighting factor
is the proportion of the risk of stochastic effects resulting from irradiation
of the organ or tissue, T, to the total risk of stochastic effects when the
whole body is irradiated uniformly. The values of w
T
are listed under the definition of "weighting factor" in subsection
(c) of this section. The non-stochastic ALIs were derived to avoid non-stochastic
effects, such as prompt damage to tissue or reduction in organ function.
(iii)
A value of w
T
= 0.06 is
applicable to each of the five organs or tissues in the "remainder" category
receiving the highest dose equivalents, and the dose equivalents of all other
remaining tissues may be disregarded. The following portions of the GI tract;
stomach, small intestine, upper large intestine, and lower large intestine,
are to be treated as four separate organs.
(iv)
The dose equivalents for an extremity, skin, and lens
of the eye are not considered in computing the committed effective dose equivalent,
but are subject to limits that must be met separately.
(v)
When an ALI is defined by the stochastic dose limit, this
value alone is given. When an ALI is determined by the non-stochastic dose
limit to an organ, the organ or tissue to which the limit applies is shown,
and the ALI for the stochastic limit is shown in parentheses. Abbreviated
organ or tissue designations are used as follows:
(I)
LLI wall = lower large intestine wall;
(II)
St. wall = stomach wall;
(III)
Blad wall = bladder wall; and
(IV)
Bone surf = bone surface.
(vi)
Figure: 25 TAC §289.202(ggg)(2)(B)(vi) (No change.)
(vii)
The dose equivalents for an extremity, skin, and lens
of the eye are not considered in computing the committed effective dose equivalent,
but are subject to limits that must be met separately.
(viii)
The DAC values are derived limits intended to control
chronic occupational exposures. The relationship between the DAC and the ALI
is given by:
Figure: 25 TAC §289.202(ggg)(2)(B)(viii) (No change.)
(ix)
The DAC values relate to one of two modes of exposure:
either external submersion or the internal committed dose equivalents resulting
from inhalation of radioactive materials. DACs based upon submersion are for
immersion in a semi-infinite cloud of uniform concentration and apply to each
radionuclide separately.
(x)
The ALI and DAC values include contributions to exposure
by the single radionuclide named and any in-growth of daughter radionuclides
produced in the body by decay of the parent. However, intakes that include
both the parent and daughter radionuclides should be treated by the general
method appropriate for mixtures.
(xi)
The values of ALI and DAC do not apply directly when the
individual both ingests and inhales a radionuclide, when the individual is
exposed to a mixture of radionuclides by either inhalation or ingestion or
both, or when the individual is exposed to both internal and external irradiation.
See subsection (g) of this section. When an individual is exposed to radioactive
materials which fall under several of the translocation classifications of
the same radionuclide, such as, Class D, Class W, or Class Y, the exposure
may be evaluated as if it were a mixture of different radionuclides.
(xii)
It should be noted that the classification of a compound
as Class D, W, or Y is based on the chemical form of the compound and does
not take into account the radiological half-life of different radionuclides.
For this reason, values are given for Class D, W, and Y compounds, even for
very short-lived radionuclides.
(C)
Effluent concentrations.
(i)
The columns in Table II of subparagraph (F) of this paragraph
captioned "Effluents," "Air," and "Water" are applicable to the assessment
and control of dose to the public, particularly in the implementation of the
provisions of subsection (o) of this section. The concentration values given
in Columns 1 and 2 of Table II of subparagraph (F) of this paragraph are equivalent
to the radionuclide concentrations which, if inhaled or ingested continuously
over the course of a year, would produce a total effective dose equivalent
of 0.05 rem (0.5 mSv).
(ii)
Consideration of non-stochastic limits has not been included
in deriving the air and water effluent concentration limits because non-stochastic
effects are presumed not to occur at or below the dose levels established
for individual members of the public. For radionuclides, where the non-stochastic
limit was governing in deriving the occupational DAC, the stochastic ALI was
used in deriving the corresponding airborne effluent limit in Table II of
subparagraph (F) of this paragraph. For this reason, the DAC and airborne
effluent limits are not always proportional as they were in the previous radiation
protection standards.
(iii)
The air concentration values listed in Column I of Table
II of subparagraph (F) of this paragraph were derived by one of two methods.
For those radionuclides for which the stochastic limit is governing, the occupational
stochastic inhalation ALI was divided by 2.4 x 10
9
,
relating the inhalation ALI to the DAC, as explained in subparagraph (B)(viii)
of this paragraph, and then divided by a factor of 300. The factor of 300
includes the following components:
(I)
a factor of 50 to relate the 5 rems (0.05 Sv) annual occupational
dose limit to the 0.1 rem limit for members of the public;
(II)
a factor of 3 to adjust for the difference in exposure
time and the inhalation rate for a worker and that for members of the public;
and
(III)
a factor of 2 to adjust the occupational values, derived
for adults, so that they are applicable to other age groups.
(iv)
For those radionuclides for which submersion, that is
external dose, is limiting, the occupational DAC in Column 3 of Table I of
subparagraph (F) of this paragraph was divided by 219. The factor of 219 is
composed of a factor of 50, as described in clause (iii) of this subparagraph,
and a factor of 4.38 relating occupational exposure for 2,000 hours per year
to full-time exposure (8,760 hours per year). Note that an additional factor
of 2 for age considerations is not warranted in the submersion case.
(v)
The water concentrations were derived by taking the most
restrictive occupational stochastic oral ingestion ALI and dividing by 7.3
x 10
7
. The factor of 7.3 x 10
7
milliliters (ml) includes the following components:
(I)
the factors of 50 and 2 described in clause (iii) of this
subparagraph; and
(II)
a factor of 7.3 x 10
5
(ml)
which is the annual water intake of "Reference Man."
(vi)
Note 2 of subparagraph (F) of this paragraph provides
groupings of radionuclides that are applicable to unknown mixtures of radionuclides.
These groupings, including occupational inhalation ALIs and DACs, air and
water effluent concentrations, and releases to sewer, require demonstrating
that the most limiting radionuclides in successive classes are absent. The
limit for the unknown mixture is defined when the presence of one of the listed
radionuclides cannot be definitely excluded as being present either from knowledge
of the radionuclide composition of the source or from actual measurements.
(D)
Releases to sewers. The monthly average concentrations
for release to sanitary sewerage are applicable to the provisions in subsection
(gg) of this section. The concentration values were derived by taking the
most restrictive occupational stochastic oral ingestion ALI and dividing by
7.3 x 10
6
(ml). The factor of 7.3 x 10
6
(ml) is composed of a factor of 7.3 x 10
5
(ml), the annual water intake by "Reference Man," and a factor of 10, such
that the concentrations, if the sewage released by the licensee were the only
source of water ingested by a "Reference Man" during a year, would result
in a committed effective dose equivalent of 0.5 rem.
(E)
List of elements.
Figure: 25 TAC §289.202(ggg)(2)(E) (No change.)
(F)
Tables--Values for annual limits. The following tables
contain values for annual limits on intake (ALI) and derived air concentrations
(DAC) of radionuclides for occupational exposure; effluent concentrations;
concentrations for release to sanitary sewerage:
Figure: 25 TAC §289.202(ggg)(2)(F) (No change.)
(3)
Quantities of licensed material requiring labeling.
The following tables contain quantities of licensed material requiring labeling:
Figure: 25 TAC §289.202(ggg)(3) (No change.)
(4)
Classification and characteristics of low-level radioactive
waste (LLRW).
(A)
Classification of radioactive waste for land disposal.
(i)
Considerations. Determination of the classification of
LLRW involves two considerations. First, consideration must be given to the
concentration of long-lived radionuclides (and their shorter-lived precursors)
whose potential hazard will persist long after such precautions as institutional
controls, improved waste form, and deeper disposal have ceased to be effective.
These precautions delay the time when long-lived radionuclides could cause
exposures. In addition, the magnitude of the potential dose is limited by
the concentration and availability of the radionuclide at the time of exposure.
Second, consideration must be given to the concentration of shorter-lived
radionuclides for which requirements on institutional controls, waste form,
and disposal methods are effective.
(ii)
Classes of waste.
(I)
Class A waste is waste that is usually segregated from
other waste classes at the disposal site. The physical form and characteristics
of Class A waste must meet the minimum requirements set forth in subparagraph
(B)(i) of this paragraph. If Class A waste also meets the stability requirements
set forth in subparagraph (B)(ii) of this paragraph, it is not necessary to
segregate the waste for disposal.
(II)
Class B waste is waste that must meet more rigorous requirements
on waste form to ensure stability after disposal. The physical form and characteristics
of Class B waste must meet both the minimum and stability requirements set
forth in subparagraph (B) of this paragraph.
(III)
Class C waste is waste that not only must meet more rigorous
requirements on waste form to ensure stability but also requires additional
measures at the disposal facility to protect against inadvertent intrusion.
The physical form and characteristics of Class C waste must meet both the
minimum and stability requirements set forth in subparagraph (B) of this paragraph.
(iii)
Classification determined by long-lived radionuclides.
If the radioactive waste contains only radionuclides listed in subclause (V)
of this clause, classification shall be determined as follows.
(I)
If the concentration does not exceed 0.1 times the value
in subclause (V) of this clause, the waste is Class A.
(II)
If the concentration exceeds 0.1 times the value in Table
I, but does not exceed the value in subclause (V) of this clause, the waste
is Class C.
(III)
If the concentration exceeds the value in subclause (V)
of this clause, the waste is not generally acceptable for land disposal.
(IV)
For wastes containing mixtures of radionuclides listed
in subclause (V) of this clause, the total concentration shall be determined
by the sum of fractions rule described in clause (vii) of this subparagraph.
(V)
Classification table for long-lived radionuclides.
Figure: 25 TAC §289.202(ggg)(4)(A)(iii)(V) (No change.)
(iv)
Classification determined by short-lived radionuclides.
If the waste does not contain any of the radionuclides listed in clause (iii)(V)
of this subparagraph, classification shall be determined based on the concentrations
shown in subclause (VI) of this clause. However, as specified in clause (vi)
of this subparagraph, if radioactive waste does not contain any nuclides listed
in either clause (iii)(V) of this subparagraph or subclause (VI) of this clause,
it is Class A.
(I)
If the concentration does not exceed the value in Column
1 of subclause (VI) of this clause, the waste is Class A.
(II)
If the concentration exceeds the value in Column 1 of
subclause (VI) of this clause but does not exceed the value in Column 2 of
subclause (VI) of this clause, the waste is Class B.
(III)
If the concentration exceeds the value in Column 2 of
subclause (VI) of this clause but does not exceed the value in Column 3 of
subclause (VI) of this clause, the waste is Class C.
(IV)
If the concentration exceeds the value in Column 3 of
subclause (VI) of this clause, the waste is not generally acceptable for near-surface
disposal.
(V)
For wastes containing mixtures of the radionuclides listed
in subclause (VI) of this clause, the total concentration shall be determined
by the sum of fractions rule described in clause (vii) of this subparagraph.
(VI)
Classification table for short-lived radionuclides.
Figure: 25 TAC §289.202(ggg)(4)(A)(iv)(VI) (No change.)
(v)
Classification determined by both long- and short-lived
radionuclides. If the radioactive waste contains a mixture of radionuclides,
some of which are listed in clause (iii)(V) of this subparagraph and some
of which are listed in clause (iv)(VI) of this subparagraph, classification
shall be determined as follows:
(I)
If the concentration of a radionuclide listed in clause
(iii)(V) of this subparagraph is less than 0.1 times the value listed in clause
(iii)(V) of this subparagraph, the class shall be that determined by the concentration
of radionuclides listed in clause (iv)(VI) of this subparagraph.
(II)
If the concentration of a radionuclide listed in clause
(iii)(V) of this subparagraph exceeds 0.1 times the value listed in clause
(iii)(V) of this subparagraph, but does not exceed the value listed in clause
(iii)(V) of this subparagraph, the waste shall be Class C, provided the concentration
of radionuclides listed in clause (iv)(VI) of this subparagraph does not exceed
the value shown in Column 3 of clause (iv)(VI) of this subparagraph.
(vi)
Classification of wastes with radionuclides other than
those listed in clauses (iii)(V) and (iv)(VI) of this subparagraph. If the
waste does not contain any radionuclides listed in either clauses (iii)(V)
and (iv)(VI) of this subparagraph, it is Class A.
(vii)
The sum of the fractions rule for mixtures of radionuclides.
For determining classification for waste that contains a mixture of radionuclides,
it is necessary to determine the sum of fractions by dividing each radionuclide's
concentration by the appropriate limit and adding the resulting values. The
appropriate limits must all be taken from the same column of the same table.
The sum of the fractions for the column must be less than 1.0 if the waste
class is to be determined by that column. Example: A waste contains Sr-90
in a concentration of 50 curies per cubic meter (Ci/m
3
) (1.85 terabecquerels per cubic meter (TBq/m
3
)) and Cs-137 in a concentration of 22 Ci/m
3
(814 gigabecquerels per cubic meter (GBq/m
3
)). Since the concentrations both exceed the values in Column 1 of
clause (iv)(VI) of this subparagraph, they must be compared to Column 2 values.
For Sr-90 fraction, 50/150 = 0.33, for Cs-137 fraction, 22/44 = 0.5; the sum
of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class
B.
(viii)
Determination of concentrations in wastes. The concentration
of a radionuclide may be determined by indirect methods such as use of scaling
factors, which relate the inferred concentration of one radionuclide to another
that is measured, or radionuclide material accountability, if there is reasonable
assurance that the indirect methods can be correlated with actual measurements.
The concentration of a radionuclide may be averaged over the volume of the
waste, or weight of the waste if the units are expressed as nanocurie (becquerel)
per gram.
(B)
Radioactive waste characteristics.
(i)
The following are minimum requirements for all classes
of waste and are intended to facilitate handling and provide protection of
health and safety of personnel at the disposal site.
(I)
Wastes shall be packaged in conformance with the conditions
of the license issued to the site operator to which the waste will be shipped.
Where the conditions of the site license are more restrictive than the provisions
of this section, the site license conditions shall govern.
(II)
Wastes shall not be packaged for disposal in cardboard
or fiberboard boxes.
(III)
Liquid waste shall be packaged in sufficient absorbent
material to absorb twice the volume of the liquid.
(IV)
Solid waste containing liquid shall contain as little
free-standing and non-corrosive liquid as is reasonably achievable, but in
no case shall the liquid exceed 1.0% of the volume.
(V)
Waste shall not be readily capable of detonation or of
explosive decomposition or reaction at normal pressures and temperatures,
or of explosive reaction with water.
(VI)
Waste shall not contain, or be capable of generating,
quantities of toxic gases, vapors, or fumes harmful to persons transporting,
handling, or disposing of the waste. This does not apply to radioactive gaseous
waste packaged in accordance with subclause (VIII) of this clause.
(VII)
Waste must not be pyrophoric. Pyrophoric materials contained
in wastes shall be treated, prepared, and packaged to be nonflammable.
(VIII)
Wastes in a gaseous form shall be packaged at an absolute
pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total
activity shall not exceed 100 Ci (3.7 terabecquerels (TBq)) per container.
(IX)
Wastes containing hazardous, biological, pathogenic, or
infectious material shall be treated to reduce to the maximum extent practicable
the potential hazard from the non-radiological materials.
(ii)
The following requirements are intended to provide stability
of the waste. Stability is intended to ensure that the waste does not degrade
and affect overall stability of the site through slumping, collapse, or other
failure of the disposal unit and thereby lead to water infiltration. Stability
is also a factor in limiting exposure to an inadvertent intruder, since it
provides a recognizable and nondispersible waste.
(I)
Waste shall have structural stability. A structurally stable
waste form will generally maintain its physical dimensions and its form, under
the expected disposal conditions such as weight of overburden and compaction
equipment, the presence of moisture, and microbial activity, and internal
factors such as radiation effects and chemical changes. Structural stability
can be provided by the waste form itself, processing the waste to a stable
form, or placing the waste in a disposal container or structure that provides
stability after disposal.
(II)
Notwithstanding the provisions in clause (i)(III) and
(IV) of this subparagraph, liquid wastes, or wastes containing liquid, shall
be converted into a form that contains as little free-standing and non-corrosive
liquid as is reasonably achievable, but in no case shall the liquid exceed
1.0% of the volume of the waste when the waste is in a disposal container
designed to ensure stability, or 0.5% of the volume of the waste for waste
processed to a stable form.
(III)
Void spaces within the waste and between the waste and
its package shall be reduced to the extent practicable.
(C)
Labeling. Each package of waste shall be clearly labeled
to identify whether it is Class A, Class B, or Class C waste, in accordance
with subparagraph (A) of this paragraph.
(5)
Time requirements for record keeping.
Figure: 25 TAC §289.202(ggg)(5) (No change.)
(6)
Acceptable surface contamination levels.
Figure: 25 TAC §289.202(ggg)(6) (No change.)
(7)
Concentration and activity limits of nuclides for
disposal in a Type I municipal solid waste site or a hazardous waste facility
(for use in subsection (fff) of this section). The following table contains
concentration and activity limits of nuclides for disposal in a Type I municipal
solid waste site or a hazardous waste facility.
Figure: 25 TAC §289.202(ggg)(7)
(8)
Soil contamination limits for selected radionuclides
(for use in subsection (ddd) of this section).
Figure: 25 TAC §289.202(ggg)(8) (No change.)
(9)
Cumulative occupational exposure form. The following,
BRC Form 202-2, is to be used to document cumulative occupational exposure
history: (Please find BRC Form 202-2 at the end of this section.)
Figure: 25 TAC §289.202(ggg)(9)
(10)
Occupational exposure form. The following, BRC Form
202-3, is to be used to document occupational exposure record for a monitoring
period: (Please find BRC Form 202-3 at the end of this section.)
Figure: 25 TAC §289.202(ggg)(10)
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 May 15, 2000.
TRD-200003359
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: October 1, 2000
Proposal publication date: December 3, 1999
For further information, please call: (512) 458-7236
Subchapter E. REGISTRATION REGULATIONS
25 TAC §289.231
The Texas Department of Health (department) adopts new §289.231,
concerning general provisions and standards for protection against machine-produced
radiation with changes to the proposed text published in the December 3, 1999,
issue of the
Texas Register
(24 TexReg 10756).
The new section consolidates general provisions and standards for protection
against machine- produced radiation that are currently combined with similar
requirements for radioactive material in §289.201 of this title (relating
to General Provisions for Radioactive Material) and §289.202 of this
title (relating to Standards for Protection Against Radiation from Radioactive
Material). The similar requirements for radioactive material are much lengthier
and more complex. Therefore, separating and consolidating these requirements
for machine-produced radiation provides for a more efficient rule and less
burden on the registrants required to comply with these requirements. In addition
to consolidation of requirements, the new section includes clarification of
several definitions. Language was added to clarify that persons who receive,
possess, use, or acquire radiation machines prior to receiving a certificate
of registration are also subject to the requirements in this chapter. The
language that allows the department to make exemptions to the requirements
of this chapter was revised to reflect changes made as a result of House Bill
1172 passed by the 76th Legislature. Language that specifies the department
may enter public or private property to determine compliance with department
rules and orders was added. Several of the routine inspection intervals were
modified based upon the department's evaluation of compliance history. Training
requirements for department inspectors of lasers was added. The condition
requiring monitoring of radiation exposures to minors is modified. The condition
requiring monitoring of radiation exposures to a declared pregnant woman was
modified and clarified to state that the dose limit requiring monitoring for
a declared pregnant woman is applicable only for the nine-month gestation
period. Other minor grammatical changes were made to the section for clarification.
This section is part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
changes, public concerns, legislative directives, or other factors.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the section.
Change: Concerning §289.231(b)(2), a comma was added after the word
"receive" in the first sentence for grammatical correctness. In addition,
the words "for Radioactive Material" were added after the word "Provisions"
and the words "from Radioactive Material" were added after the word "Radiation"
to state the correct title of the rules.
Change: Concerning §289.231(c)(6), commas were added to the sentence,
"...from past nuclear accidents, such as Chernobyl, that contribute to background
radiation..." for grammatical correctness and ease in reading.
Change: Concerning §289.231(c)(29), the third sentence was changed
to, "Examples of individual monitoring devices include, but are not limited
to, film badges, ..." to provide an allowance for newly developed technologies
in individual monitoring devices.
Change: Concerning §289.231(c)(72), the acronym "TAC" was added after
the title, "Texas Administrative Code" for consistency with the way the title
and acronym are used in this and other sections of this title.
Change: Concerning §289.231(r)(2)(A) - (C), the phrase, "prior employers"
was changed to, "prior or other current employers" to clarify that a registrant
may obtain information on an employee's occupational dose for the current
year from a prior employer or other current employer if the employee is concurrently
employed and receiving an occupational dose.
Change: Concerning §289.231(s)(3), electronic personal dosimeters
were added to the individual monitoring devices that do not require processing
and evaluation by a dosimetry processor accredited by the National Voluntary
Laboratory Accreditation Program to clarify the processing requirements for
these devices.
The following comments were received concerning the proposed section. Following
the comment is the department's responses and any resulting change(s).
Comment: Concerning §289.231(p)(2)(B), the commenter noted that the
rule states a need to demonstrate that a total dose equivalent not exceed
0.050 rem for continuous occupation and questioned if this shouldn't be 0.500
rem in accordance with §289.231(o)(1)(A).
Response: The department disagrees in part with the commenter. This requirement
was extracted from the similar requirement for exposures from radioactive
materials. Licensees using radioactive materials have two options in determining
how to demonstrate compliance with the dose limits to members of the public.
The first option allows evaluation of the total effective dose equivalent
from both internal and external exposure and allows the use of occupancy factors.
The second option requires the evaluation of internal and external dose separately
and does not allow the use of occupancy factors. Therefore, allowance is made
for only 0.050 rem from external exposures, half of the 0.100 rem annual dose
limit for members of the public. However, since there is no internal exposure
component from radiation machines, the requirement citing the separate limit
for external exposures was erroneously extracted from another section. The
department changed the requirement by deleting the proposed §289.231(p)(2)(B).
The requirement, §289.132(p)(2) now reads, "A registrant shall show compliance
with the annual dose limit in subsection (o) of this section by demonstrating
by measurement or calculation that the TEDE to the individual likely to receive
the highest dose from the registered operation does not exceed the annual
dose limit."
Comment: Concerning §289.231(x)(3), the commenter urged the department
to eliminate both the words "grave" and "danger" from signs that are required
to be posted in medical facilities. The commenter suggested that the word,
"caution" on a sign is sufficient and that a danger sign of any kind can cause
significant consternation for patients who are being asked to enter these
rooms, but don't understand the meaning of the signage.
Response: The department disagrees with the commenter. The rule requires
such signage to be posted at very high radiation areas. The rule also allows
the word "grave" to be omitted from signs at very high radiation areas that
involve medical treatment of patients. The department believes such very high
radiation areas should be posted with signs containing the word "danger" as
a signal of the potential radiation exposure levels to workers and other members
of the public.
The individual commenter was generally in favor of the rule, but had a
question and a suggestion for change.
The new section is adopted under the Health and Safety Code,
Chapter 401, which provides the Texas Board of Health (board) with authority
to adopt rules and guidelines relating to the control of radiation; and Health
and Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for its procedure and for the performance
of each duty imposed by law on the board, the department, or the commissioner
of health.
§289.231.General Provisions and Standards for Protection Against Machine-Produced Radiation.
(a)
Purpose.
(1)
This section establishes standards for protection against
ionizing radiation resulting from the use of radiation machines.
(2)
The requirements in this section are designed to control
the receipt, possession, use, and transfer of radiation machines by any person
so the total dose to an individual, including doses resulting from all sources
of radiation other than background radiation, does not exceed the standards
for protection against radiation prescribed in this section. However, nothing
in this section shall be construed as limiting actions that may be necessary
to protect health and safety in an emergency. A person who receives, possesses,
uses, owns, or acquires radiation machines prior to receiving a certificate
of registration is subject to the requirements of this chapter.
(b)
Scope.
(1)
Except as specifically provided in other sections of this
chapter, this section applies to persons who receive, possess, use, or transfer
radiation machines. The dose limits in this section do not apply to doses
due to background radiation, to exposure of patients to radiation for the
purpose of medical diagnosis or therapy, to exposure from individuals administered
radioactive material and released in accordance with this chapter, or to voluntary
participation in medical research programs. However, no radiation may be deliberately
applied to human beings except by or under the supervision of an individual
authorized by and licensed in accordance with Texas' statutes to engage in
the healing arts.
(2)
Registrants who are also licensed by the agency to
receive, possess, use, and transfer radioactive materials must also comply
with the requirements of §289.201 of this title (relating to General
Provisions for Radioactive Material) and §289.202 of this title (relating
to Standards for Protection Against Radiation from 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)
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)
Adult - An individual 18 or more years of age.
(3)
Agency - The Texas Department of Health.
(4)
Agreement State - Any state with which the United
States Nuclear Regulatory Commission (NRC) has entered into an effective agreement
under Section 274b. of the Atomic Energy Act of 1954, as amended (73 Stat.
689).
(5)
As low as is reasonably achievable (ALARA) - Making
every reasonable effort to maintain exposures to radiation as far below the
dose limits in this chapter as is practical, consistent with the purpose for
which the registered activity is undertaken, taking into account the state
of technology, the economics of improvements in relation to the state of technology,
the economics of improvements in relation to benefits to the public health
and safety, and other societal and socioeconomic considerations, and in relation
to utilization of ionizing radiation and radiation machines in the public
interest.
(6)
Background radiation - Radiation from cosmic sources;
non-technologically enhanced naturally occurring radioactive material, including
radon, except as a decay product of source or special nuclear material, and
including global fallout as it exists in the environment from the testing
of nuclear explosive devices or from past nuclear accidents, such as Chernobyl,
that contribute to background radiation and are not under the control of the
registrant. "Background radiation" does not include radiation from sources
of radiation regulated by the agency.
(7)
Certificate of registration - A form of permission
given by the agency to an applicant who has met the requirements for registration
or mammography system certification set out in the Act and this chapter.
(8)
Certification of mammography systems (state certification)
- A form of permission given by the agency to an applicant who has met the
requirements for mammography system certification set out in the Act and this
chapter.
(9)
Chiropractor - An individual licensed by the Texas
State Board of Chiropractic Examiners, with license in good standing.
(10)
Collective dose - The sum of the individual doses
received in a given period of time by a specified population from exposure
to a specified source of radiation.
(11)
Declared pregnant woman - A woman who has voluntarily
informed the registrant, in writing, of her pregnancy and the estimated date
of conception. The declaration remains in effect until the declared pregnant
woman voluntarily withdraws the declaration in writing or is no longer pregnant.
(12)
Deep dose equivalent (DDE), that applies to external
whole body exposure - The DE at a tissue depth of 1 centimeter (cm) (1,000
milligrams per square centimeter (mg/cm
2
)).
(13)
Dentist - An individual licensed by the Texas State
Board of Dental Examiners, with license in good standing.
(14)
Dose - For external exposure to x-ray radiation from
radiation machines, a generic term that means absorbed dose, DE, or total
effective dose equivalent. For purposes of this chapter, "radiation dose"
is an equivalent term.
(15)
Dose equivalent (DE) - The product of the absorbed
dose in tissue, quality factor, and all other necessary modifying factors
at the location of interest. The units of DE are the sievert (Sv) and rem.
(16)
Dose limits - The permissible upper bounds of radiation
doses established in accordance with this chapter. For purposes of this chapter,
"limits" is an equivalent term.
(17)
Dosimetry processor - A registrant that processes
and evaluates personnel monitoring devices in order to determine the radiation
dose delivered to the monitoring devices.
(18)
Embryo/fetus - The developing human organism from
conception until the time of birth.
(19)
Entrance or access point - Any opening through which
an individual or extremity of an individual could gain access to radiation
areas or to radiation machines. This includes portals of sufficient size to
permit human access, irrespective of their intended use.
(20)
Exposure - The quotient of dQ by dm where "dQ" is
the absolute value of the total charge of the ions of one sign produced in
air when all the electrons (negatrons and positrons) liberated by photons
in a volume element of air having mass "dm" are completely stopped in air.
The SI unit of exposure is the coulomb per kilogram (C/kg). The roentgen is
the special unit of exposure. For purposes of this chapter, this term is used
as a noun.
(21)
Exposure rate - The exposure per unit of time.
(22)
External dose - That portion of the DE received from
any source of radiation outside the body.
(23)
Extremity - Hand, elbow, arm below the elbow, foot,
knee, and leg below the knee. The arm above the elbow and the leg above the
knee are considered part of the whole body.
(24)
Gray (Gy) - The SI unit of absorbed dose. One gray
is equal to an absorbed dose of 1 joule per kilogram (J/kg) or 100 rad.
(25)
High radiation area - An area, accessible to individuals,
in which radiation levels from sources of radiation external to the body could
result in an individual receiving a DE in excess of 0.1 rem (1 millisievert
(mSv)) in one hour at 30 cm from any source of radiation or from any surface
that the radiation penetrates.
(26)
Human use - For exposure to x-ray radiation from
radiation machines, the external administration of radiation to human beings
for healing arts purposes or research and/or development specifically authorized
by the agency.
(27)
Individual - Any human being.
(28)
Individual monitoring - The assessment of DE to an
individual by the use of:
(A)
individual monitoring devices; or
(B)
survey data.
(29)
Individual monitoring devices - Devices designed
to be worn by a single individual for the assessment of DE. For purposes of
this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms.
Examples of individual monitoring devices include, but are not limited to,
film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence
dosimeters (OSLs), pocket ionization chambers (pocket dosimeters), and electronic
personal dosimeters.
(30)
Inspection - An official examination and/or observation
including, but not limited to, records, tests, surveys, and monitoring to
determine compliance with the Act and rules, orders, requirements, and conditions
of the agency.
(31)
Ionizing radiation - Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x rays, alpha and
beta particles, high speed electrons, neutrons, and other nuclear particles.
(32)
Lens dose equivalent (LDE) - The external DE to the
lens of the eye at a tissue depth of 0.3 cm (300 mg/cm
2
).
(33)
License - A form of permission given by the agency
to an applicant who has met the requirements for licensing set out in the
Act and this chapter.
(34)
Licensed material - Radioactive material received,
possessed, used, or transferred under a general or specific license issued
by the agency.
(35)
Licensee - Any person who is licensed by the agency
in accordance with the Act and this chapter.
(36)
Licensing state - Any state with rules equivalent
to the Suggested State Regulations for Control of Radiation relating to, and
having an effective program for, the regulatory control of naturally occurring
or accelerator-produced radioactive material (NARM) and has been designated
as such by the Conference of Radiation Control Program Directors, Inc.
(37)
Lost or missing radiation machine(s) - A radiation
machine(s) whose location is unknown.
(38)
Machine-produced radiation - A stimulated emission
of radiation from a manufactured product or device or component part of a
manufactured product or device that has an electronic circuit that during
operation can generate or emit a physical field of radiation.
(39)
Manufacture - To fabricate or mechanically produce.
(40)
Member of the public - Any individual, except when
that individual is receiving an occupational dose.
(41)
Minimal threat radiation machines - Those radiation
machines capable of generating or emitting fields of radiation that, during
the operation of which:
(A)
no deliberate exposure of an individual occurs;
(B)
the radiation is not emitted in an open beam configuration;
and
(C)
no known physical injury to an individual has occurred.
(42)
Minor - An individual less than 18 years of
age.
(43)
Monitoring - The measurement of radiation and the
use of the results of these measurements to evaluate potential exposures and
doses. For purposes of this chapter, "radiation monitoring" and "radiation
protection monitoring" are equivalent terms.
(44)
Occupational dose - The dose received by an individual
in the course of employment in which the individual's assigned duties involve
exposure to sources of radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. Occupational dose does not include dose received from background
radiation, from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released in
accordance with this chapter, from voluntary participation in medical research
programs, or as a member of the public.
(45)
Particle accelerator - Any machine capable of accelerating
electrons, protons, deuterons, or other charged particles in a vacuum and
designed to discharge the resultant particulate or other associated radiation
at energies usually in excess of 1 MeV.
(46)
Person - Any individual, corporation, partnership,
firm, association, trust, estate, public or private institution, group, agency,
local government, any other state or political subdivision or agency thereof,
or any other legal entity, and any legal successor, representative, agent,
or agency of the foregoing, other than the NRC, and other than federal government
agencies licensed or exempted by the NRC.
(47)
Personnel monitoring equipment (See definition for
individual monitoring devices.)
(48)
Physician - An individual licensed by the Texas State
Board of Medical Examiners, with license in good standing.
(49)
Podiatrist - An individual licensed by the Texas
State Board of Podiatric Examiners, with license in good standing.
(50)
Public dose - The dose received by a member of the
public from exposure to sources of radiation released by a licensee, or to
any other source of radiation under the control of a licensee/registrant.
It does not include occupational dose or doses received from background radiation,
from any medical administration the individual has received, from exposure
to individuals administered radioactive material and released in accordance
with this chapter, or from voluntary participation in medical research programs.
(51)
Quarter - A period of time equal to one-fourth of
the year observed by the registrant, approximately 13 consecutive weeks, providing
that the beginning of the first quarter in a year coincides with the starting
date of the year and that no day is omitted or duplicated in consecutive quarters.
(52)
Rad - The special unit of absorbed dose. One rad
is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01
gray).
(53)
Radiation - One or more of the following:
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
stimulated emission of radiation from any electronic device
to such energy density levels as to reasonably cause bodily harm; or
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(54)
Radiation area - Any area, accessible to individuals,
in which radiation levels could result in an individual receiving a DE in
excess of 0.005 rem (0.05 mSv) in one hour at 30 cm from the radiation machine
or from any surface that the radiation penetrates.
(55)
Radiation machine - Any device capable of producing
ionizing radiation except those devices with radioactive material as the only
source of radiation.
(56)
Radiation safety officer (RSO) - An individual who
has a knowledge of and the authority and responsibility to apply appropriate
radiation protection rules, standards, and practices, who must be specifically
authorized on a certificate of registration, and who is the primary contact
with the agency.
(57)
Registrant - Any person issued a certificate of registration
by the agency in accordance with the Act and this chapter.
(58)
Regulation (See definition for rule.)
(59)
Rem - The special unit of any of the quantities expressed
as DE. The DE in rem is equal to the absorbed dose in rad multiplied by the
quality factor (1 rem = 0.01 sievert (Sv)).
(60)
Research and development - Research and development
is defined as:
(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.
(61)
Restricted area - An area, access to which is
limited by the registrant for the purpose of protecting individuals against
undue risks from exposure to radiation. Restricted area does not include areas
used as residential quarters, but separate rooms in a residential building
may be set apart as a restricted area.
(62)
Roentgen (R) - The special unit of exposure. One
roentgen (R) equals 2.58 x 10
-4
C/kg of air.
(See definition for exposure.)
(63)
Rule (as defined in the Government Code, Chapters
2001 and 2002, as amended) - Any agency statement of general applicability
that implements, interprets, or prescribes law or policy, or describes the
procedure or practice requirements of an agency. The term includes the amendment
or repeal of a prior section but does not include statements concerning only
the internal management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as "regulation."
(64)
Shallow dose equivalent (SDE) - The DE at a tissue
depth of 0.007 cm (7 mg/cm
2
) averaged over an
area of 1 square centimeter (cm
2
) (applies to
the external exposure of the skin or an extremity).
(65)
SI - The abbreviation for the International System
of Units.
(66)
Sievert (Sv) - The SI unit of any of the quantities
expressed as DE. The DE in sievert is equal to the absorbed dose in gray multiplied
by the quality factor (1 Sv = 100 rem).
(67)
Site boundary - That line beyond which the land or
property is not owned, leased, or otherwise controlled by the registrant.
(68)
Source of radiation - Any radioactive material, or
any device or equipment emitting or capable of producing radiation.
(69)
Special units - The conventional units historically
used by registrants, i.e., rad (absorbed dose), and rem (DE).
(70)
Survey - An evaluation of the radiological conditions
and potential hazards incident to the production, use, transfer, disposal,
and/or presence of sources of radiation. When appropriate, such survey includes,
but is not limited to, tests, physical examination of location of equipment,
measurements of levels of radiation present, and evaluation of administrative
and/or engineered controls.
(71)
Termination - A release by the agency of the obligations
and authorizations of the registrant under the terms of the certificate of
registration. It does not relieve a person of duties and responsibilities
imposed by law.
(72)
Texas Regulations for Control of Radiation (TRCR)
- All sections of Title 25 Texas Administrative Code (TAC), Chapter 289.
(73)
Total effective dose equivalent (TEDE) - For external
exposures only to x- ray radiation from radiation machines, the TEDE is equal
to the DDE. If an individual receives an occupational dose from both radiation
machines and radioactive materials, the TEDE is the sum of the DDE for external
exposures and the committed effective dose equivalent for internal exposures
as defined in §289.201(b) of this title.
(74)
Unrestricted area (uncontrolled area) - An area,
access to which is neither limited nor controlled by the registrant. For purposes
of this chapter, "uncontrolled area" is an equivalent term.
(75)
Very high radiation area - An area, accessible to
individuals, in which radiation levels from sources of radiation external
to the body could result in an individual receiving an absorbed dose in excess
of 500 rads (5 grays) in one hour at 1 meter (m) from a radiation machine
or from any surface that the radiation penetrates. At very high doses received
at high dose rates, units of absorbed dose, gray and rad, are appropriate,
rather than units of DE, Sv and rem.
(76)
Veterinarian - An individual licensed by the Texas
Board of Veterinary Medical Examiners, with license in good standing.
(77)
Week - Seven consecutive days starting on Sunday.
(78)
Whole body - For purposes of external exposure, head,
trunk including male gonads, arms above the elbow, or legs above the knee.
(79)
Worker - An individual engaged in work under a certificate
of registration issued by the agency and controlled by a registrant, but does
not include the registrant.
(80)
Year - The period of time beginning in January used
to determine compliance with the provisions of this chapter. The registrant
may change the starting date of the year used to determine compliance by the
registrant provided that the change is made at the beginning of the year and
that no day is omitted or duplicated in consecutive years.
(d)
Exemptions. 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:
(1)
state of technology;
(2)
economic considerations in relation to benefits to
the public health and safety; and
(3)
other societal, socioeconomic, or public health and
safety considerations.
(e)
Prohibited uses.
(1)
A hand-held fluoroscopic screen shall not be used unless
accepted for certification by the United States Food and Drug Administration
(FDA), Center for Devices and Radiological Health.
(2)
A shoe-fitting fluoroscopic device shall not be used.
(f)
Additional requirements. The agency may, by rule, order,
or condition of certificate of registration, impose upon any registrant such
requirements in addition to those established in this chapter as it deems
appropriate or necessary to minimize danger to public health and safety or
property or the environment.
(g)
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 subject to civil and/or
administrative penalties. Such person may also be guilty of a misdemeanor
and upon conviction, may be punished by fine or imprisonment or both, as provided
by law.
(h)
Impounding. Radiation machines 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).
(i)
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.
(j)
Interpretations. Except as specifically authorized by the
agency in writing, no interpretation of the meaning of this chapter by any
officer or employee of the agency other than a written interpretation by the
Office of General Counsel, Texas Department of Health, will be considered
binding upon the agency.
(k)
Mean quality factors and absorbed dose equivalencies.
(1)
As used in this chapter, the quality factors for converting
absorbed dose to DE are shown in the following table:
Figure: 25 TAC §289.231(k)(1)
(2)
If it is more convenient to measure the neutron fluence
rate than to determine the neutron dose equivalent rate in sievert per hour
or rem per hour, as provided in paragraph (1) of this subsection, 1 rem (0.01
Sv) of neutron radiation of unknown energies may, for purposes of this section,
be assumed to result from a total fluence of 25 million neutrons per square
centimeter incident upon the body. If sufficient information exists to estimate
the approximate energy distribution of the neutrons, the licensee or registrant
may use the fluence rate per unit DE or the appropriate Q value from the following
table to convert a measured tissue dose in rad (gray) to DE in rem (Sv).
Figure: 25 TAC §289.231(k)(2)
(l)
As low as reasonably achievable (ALARA). The registrant
shall use, to the extent practical, procedures and engineering controls based
upon sound radiation protection principles to achieve occupational doses and
public doses that are ALARA.
(m)
Occupational dose limits.
(1)
The registrant shall control the occupational dose to individuals
to the following dose limits.
(A)
An annual limit shall be the TEDE being equal to 5 rems
(0.05 Sv).
(B)
The annual limits to the lens of the eye, to the skin,
and to the extremities shall be:
(i)
an LDE of 15 rems (0.15 Sv); and
(ii)
an SDE of 50 rems (0.5 Sv) to the skin or to any extremity.
(C)
The annual limits for a minor shall be 10% of the annual
occupational dose limits specified in subparagraphs (A) and (B) of this paragraph.
(D)
If a woman declares her pregnancy, the registrant shall
ensure that the DE to an embryo/fetus during the entire pregnancy, due to
occupational exposure of a declared pregnant woman, does not exceed 0.5 rem
(5 mSv). If a woman chooses not to declare pregnancy, the occupational dose
limits specified in paragraph (1)(A) and (B) of this subsection are applicable
to the woman.
(i)
The registrant shall make efforts to avoid substantial
variation above a uniform monthly exposure rate to a declared pregnant woman
so as to satisfy the limit in paragraph (1) of this subsection. The National
Council on Radiation Protection and Measurements recommended in NCRP Report
No. 91 "Recommendations on Limits for Exposure to Ionizing Radiation" (June
1, 1987) that no more than 0.05 rem (0.5 mSv) to the embryo/fetus be received
in any one month.
(ii)
If by the time the woman declares pregnancy to the registrant,
the DE to the embryo/fetus has exceeded 0.45 rem (4.5 mSv), the registrant
shall be deemed to be in compliance with paragraph (1) of this subsection,
if the additional DE to the embryo/fetus does not exceed 0.05 rem (0.5 mSv)
during the remainder of the pregnancy.
(iii)
The DE to an embryo/fetus shall be taken as the DE that
is most representative of the DE to the embryo/fetus from external radiation,
that is, in the mother's lower torso region.
(iv)
If multiple measurements have been made, assignment of
the DDE for the declared pregnant woman from the individual monitoring device
that is most representative of the DE to the embryo/fetus shall be the DE
to the embryo/fetus. Assignment of the highest DDE for the declared pregnant
woman to the embryo/fetus is not required unless that dose is also the most
representative DDE for the region of the embryo/fetus.
(v)
If multiple measurements have not been made, assignment
of the highest DDE for the declared pregnant woman shall be the DE to the
embryo/fetus.
(2)
The assigned DDE and SDE shall be for the
portion of the body receiving the highest exposure.
(3)
When a protective apron is worn while working with
fluoroscopic equipment used for clinical diagnostic or research purposes,
the effective dose equivalent (EDE) for external radiation shall be determined
as follows.
(A)
When only one individual monitoring device is used and
it is located at the neck (collar) outside the protective apron, the reported
DDE shall be the EDE for external radiation; or
(B)
When only one individual monitoring device is used and
it is located at the neck (collar) outside the protective apron, and the reported
dose exceeds 25% of the limit specified in paragraph (1) of this subsection,
the reported DDE value multiplied by 0.3 shall be the EDE for external radiation;
or
(C)
When individual monitoring devices are worn, both under
the protective apron at the waist and outside the protective apron at the
neck (collar), the EDE for external radiation shall be assigned the value
of the sum of the DDE reported for the individual monitoring device located
at the waist under the protective apron multiplied by 1.5 and the DDE reported
for the individual monitoring device located at the neck (collar) outside
the protective apron multiplied by 0.04.
(4)
The DDE, LDE, and SDE may be assessed from surveys,
calculations, or radiation measurements for the purpose of demonstrating compliance
with the occupational dose limits, if the individual monitoring device was
not in the region of highest potential exposure, or the results of individual
monitoring are unavailable.
(5)
The registrant shall reduce the dose that an individual
may be allowed to receive in the current year by the amount of occupational
dose received from radiation machines or radioactive materials while employed
by any other person. See subsection (r)(4) of this section.
(n)
Conditions requiring individual monitoring of occupational
dose.
(1)
Each registrant shall monitor exposures from radiation
machines at levels sufficient to demonstrate compliance with the occupational
dose limits of this section. As a minimum, each registrant shall monitor occupational
exposure to radiation from radiation machines and shall supply and require
the use of individual monitoring devices by:
(A)
adults likely to receive, in one year from sources external
to the body, a dose in excess of 10% of the limits in subsection (m)(1) of
this section;
(B)
minors likely to receive, in one year from sources of radiation
external to the body, a DDE in excess of 0.1 rem (1 mSv), an LDE in excess
of 0.15 rem (1.5 mSv), or an SDE to the skin or to the extremities in excess
of 0.5 rem (5 mSv);
(C)
declared pregnant women likely to receive during the entire
pregnancy, from sources of radiation external to the body, a DDE in excess
of 0.1 rem (1 mSv); and
(D)
individuals entering a high or very high radiation area.
(2)
Notwithstanding the requirements of paragraph
(1)(A) of this subsection, no personnel monitoring shall be required for personnel
operating only minimal threat radiation machines as specified in subsection
(ll)(2) of this section.
(o)
Dose limits for individual members of the public.
(1)
Each registrant shall conduct operations so that:
(A)
the TEDE to individual members of the public from exposure
to radiation from radiation machines does not exceed 0.5 rem (5 mSv) in a
year, exclusive of the dose contribution from background radiation, exposure
of patients to radiation for the purpose of medical diagnosis or therapy,
or to voluntary participation in medical research programs; and
(B)
the dose in any unrestricted area from registered external
sources does not exceed 0.002 rem (0.02 mSv) in any one hour.
(2)
If the registrant permits members of the public
to have access to restricted areas, the limits for members of the public continue
to apply to those individuals.
(3)
The agency may impose additional restrictions on radiation
levels in unrestricted areas in order to restrict the collective dose.
(p)
Compliance with dose limits for individual members of the
public.
(1)
The registrant shall make or cause to be made surveys of
radiation levels in unrestricted areas to demonstrate compliance with the
dose limits for individual members of the public as required in subsection
(o) of this section.
(2)
A registrant shall show compliance with the annual
dose limit in subsection (o) of this section by demonstrating by measurement
or calculation that the TEDE to the individual likely to receive the highest
dose from the registered operation does not exceed the annual dose limit.
(3)
Registrants exempt from individual monitoring requirements
in accordance with subsection (n)(2) of this section are exempt from the requirements
of paragraphs (1) and (2) of this subsection.
(q)
Location and use of individual monitoring devices.
(1)
Each registrant shall ensure that individuals who are required
to monitor occupational doses in accordance with subsection (n)(l) of this
section wear and use individual monitoring devices as follows.
(A)
An individual monitoring device shall be assigned to and
worn by only one individual.
(B)
An individual monitoring device used for monitoring the
dose to the whole body shall be worn at the unshielded location of the whole
body likely to receive the highest exposure. When a protective apron is worn,
the location of the individual monitoring device is typically at the neck
(collar).
(C)
If an additional individual monitoring device is used for
monitoring the dose to an embryo/fetus of a declared pregnant woman, in accordance
with subsection (n)(1)(C) of this section, it shall be located at the waist
under any protective apron being worn by the woman.
(D)
An individual monitoring device used for monitoring the
LDE, to demonstrate compliance with subsection (m)(1)(B)(i) of this section,
shall be located at the neck (collar) or at a location closer to the eye,
outside any protective apron being worn by the monitored individual.
(E)
An individual monitoring device used for monitoring the
dose to the extremities, to demonstrate compliance with subsection (m)(1)(B)(ii)
of this section, shall be worn on the extremity likely to receive the highest
exposure. Each individual monitoring device, to the extent practicable, shall
be oriented to measure the highest dose to the extremity being monitored.
(F)
An individual monitoring device shall be worn for the period
of time authorized by the dosimetry processor's certificate of registration
or for no longer than three months, whichever is more restrictive.
(2)
Each registrant shall ensure that individual
monitoring devices are returned to the dosimetry processor for proper processing.
(3)
Each registrant shall ensure that adequate precautions
are taken to prevent a deceptive exposure of an individual monitoring device.
(r)
Determination of occupational dose for the current year.
(1)
For each individual who is likely to receive, in a year,
an occupational dose requiring monitoring in accordance with subsection (n)
of this section, the registrant shall determine the occupational radiation
dose received during the current year. Occupational dose includes doses received
from exposure to registered/licensed or unregistered/unlicensed sources of
radiation as defined in subsection (c) of this section.
(2)
In complying with the requirements of paragraph (1)
of this subsection, a registrant may:
(A)
accept, as a record of the occupational dose that the individual
received during the current year, BRC Form 231-3 from prior or other current
employers, or other clear and legible record, of all information required
on that form and indicating any periods of time for which data are not available;
or
(B)
accept, as a record of the occupational dose that the individual
received during the current year, a written signed statement from the individual,
or from the individual's prior or other current employer(s) for work involving
radiation exposure, that discloses the nature and the amount of any occupational
dose that the individual received during the current year; or
(C)
obtain reports of the individual's DE from prior or other
current employer(s) for work involving radiation exposure, or the individual's
current employer, if the individual is not employed by the registrant, by
telephone, telegram, facsimile, or letter. The registrant shall request a
written verification of the dose data if the authenticity of the transmitted
report cannot be established.
(3)
The registrant shall record the exposure data
for the current year, as required by paragraph (1) of this subsection, on
BRC Form 231-3, or other clear and legible record, of all the information
required on BRC Form 231-3.
(4)
If the registrant is unable to obtain a complete record
of an individual's current occupational dose while employed by any other registrant
or licensee, the registrant shall assume in establishing administrative controls
in accordance with subsection (m)(5) of this section for the current year,
that the allowable dose limit for the individual is reduced by 1.25 rems (12.5
millisieverts (mSv)) for each quarter; or 416 millirems (mrem) (4.16 mSv)
for each month for which records were unavailable and the individual was engaged
in activities that could have resulted in occupational radiation exposure.
(5)
If an individual has incomplete (e.g., a lost or damaged
personnel monitoring device) current occupational dose data for the current
year and that individual is employed solely by the registrant during the current
year, the registrant shall:
(A)
assume that the allowable dose limit for the individual
is reduced by 1.25 rems (12.5 mSv) for each quarter;
(B)
assume that the allowable dose limit for the individual
is reduced by 416 mrem (4.16 mSv) for each month; or
(C)
assess an occupational dose for the individual during the
period of missing data using surveys, radiation measurements, or other comparable
data for the purpose of demonstrating compliance with the occupational dose
limits.
(6)
Administrative controls established in accordance
with paragraph (4) of this subsection shall be documented and maintained for
inspection by the agency. Occupational dose assessments made in accordance
with paragraph (5) of this subsection and records of data used to make the
assessment shall be maintained for inspection by the agency. The registrant
shall retain the records in accordance with subsection (ll)(5) of this section.
(s)
General surveys and monitoring.
(1)
Each registrant shall make, or cause to be made, surveys
that:
(A)
are necessary for the registrant to comply with this section;
and
(B)
are necessary under the circumstances to evaluate:
(i)
the magnitude and extent of radiation levels; and
(ii)
the potential radiological hazards.
(2)
The registrant shall ensure that instruments
and equipment used for quantitative radiation measurements, for example, dose
rate, are operable and calibrated:
(A)
by a person licensed or registered by the agency, another
agreement state, a licensing state, or the NRC to perform such service;
(B)
at intervals not to exceed 12 months unless a different
time interval is specified in another section of this chapter;
(C)
after each instrument or equipment repair;
(D)
for the types of radiation used and at energies appropriate
for use; and
(E)
at an accuracy within 20% of the true radiation level.
(3)
All individual monitoring devices, except for
direct and indirect reading pocket dosimeters, electronic personal dosimeters,
and those individual monitoring devices used to measure the dose to any extremity,
that require processing to determine the radiation dose and that are used
by registrants to comply with subsection (m) of this section, with other applicable
provisions of this chapter, or with conditions specified in a certificate
of registration, shall be processed and evaluated by a dosimetry processor:
(A)
holding current personnel dosimetry accreditation from
the National Voluntary Laboratory Accreditation Program (NVLAP) of the National
Institute of Standards and Technology;
(B)
approved in this accreditation process for the type of
radiation or radiations included in the NVLAP program that most closely approximates
the type of radiation or radiations for which the individual wearing the dosimeter
is monitored; and
(C)
holding a current certificate of registration from the
agency authorizing dosimetry processing.
(t)
Control of access to high radiation areas.
(1)
The registrant shall ensure that each entrance or access
point to a high radiation area has one or more of the following features:
(A)
a control device that, upon entry into the area, causes
the level of radiation to be reduced below that level at which an individual
might receive a DDE of 0.1 rem (1 mSv) in one hour at 30 cm from the source
of radiation from any surface that the radiation penetrates;
(B)
a control device that energizes a conspicuous visible or
audible alarm signal so that the individual entering the high radiation area
and the supervisor of the activity are made aware of the entry; or
(C)
entryways that are locked, except during periods when access
to the areas is required, with positive control over each individual entry.
(2)
In place of the controls required by paragraph
(1) of this subsection for a high radiation area, the registrant may substitute
continuous direct or electronic surveillance that is capable of preventing
unauthorized entry.
(3)
The registrant may apply to the agency for approval
of alternative methods for controlling access to high radiation areas.
(4)
The registrant shall establish the controls required
by paragraphs (1) and (3) of this subsection in a way that does not prevent
individuals from leaving a high radiation area.
(5)
The registrant is not required to control entrance
or access to rooms or other areas containing radiation machines capable of
producing a high radiation area as described in this subsection if the registrant
has met all the specific requirements for access and control specified in
other applicable sections of this chapter, such as, §289.119 of this
title (relating to Radiation Safety Requirements for Particle Accelerators), §289.227
of this title (relating to Use of Radiation Machines in the Healing Arts and
Veterinary Medicine), and §289.255 of this title (relating to Radiation
Safety Requirements and Licensing and Registration Procedures for Industrial
Radiography).
(u)
Control of access to very high radiation areas.
(1)
In addition to the requirements in subsection (t) of this
section, the registrant shall institute measures to ensure that an individual
is not able to gain unauthorized or inadvertent access to areas in which radiation
levels could be encountered at 500 rads (5 grays) or more in one hour at 1
m from a radiation machine or any surface through which the radiation penetrates
at this level.
(2)
The registrant is not required to control entrance
or access to rooms or other areas containing radiation machines capable of
producing a very high radiation area as described in paragraph (1) of this
subsection if the registrant has met all the specific requirements for access
and control specified in other applicable sections of this chapter, such as, §289.119
of this title, §289.227 of this title, and §289.255 of this title.
(3)
The entry control devices required by paragraphs (1)
and (2) of this subsection shall be established in such a way that no individual
will be prevented from leaving the area.
(v)
Security and control of radiation machines.
(1)
The registrant shall secure radiation machines from unauthorized
removal.
(2)
The registrant shall use devices and/or administrative
procedures to prevent unauthorized use of radiation machines.
(w)
Caution signs. Unless otherwise authorized by the agency,
the standard radiation symbol prescribed shall use the colors magenta, or
purple, or black on yellow background. The standard radiation symbol prescribed
is the three-bladed design as follows:
Figure: 25 TAC §289.231(w)
(1)
the cross-hatched area of the symbol is to be magenta,
or purple, or black; and
(2)
the background of the symbol is to be yellow.
(x)
Posting requirements.
(1)
The registrant shall post each radiation area with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION
AREA."
(2)
The registrant shall post each high radiation area
with a conspicuous sign or signs bearing the radiation symbol and the words
"CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
(3)
The registrant shall post each very high radiation
area with a conspicuous sign or signs bearing the radiation symbol and words
"GRAVE DANGER, VERY HIGH RADIATION AREA." If the very high radiation area
involves medical treatment of patients, the registrant may omit the word "GRAVE"
from the sign or signs.
(y)
Exceptions to posting requirements. A registrant is not
required to post caution signs in areas or rooms containing radiation machines
for periods of less than 8 hours, if each of the following conditions is met:
(1)
the radiation machines are constantly attended during these
periods by an individual who takes the precautions necessary to prevent the
exposure of individuals to radiation in excess of the limits established in
this section; and
(2)
the area or room is subject to the registrant's control.
(z)
Labeling radiation machines. Each registrant shall ensure
that each radiation machine is labeled in a conspicuous manner that cautions
individuals that radiation is produced when it is energized. This label shall
be affixed in a clearly visible location on the face of the control unit.
(aa)
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 §289.231(aa)(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.
(bb)
General provisions for records.
(1)
Each registrant shall make and maintain records showing
the receipt, transfer, and disposal of all radiation machines. These records
shall be maintained by the registrant in accordance with subsection (ll)(5)
of this section. Additional record requirements are specified elsewhere in
this chapter. All records required by this chapter shall be accurate and factual.
(2)
Records are only valid if stamped, initialed, or signed
and dated by authorized personnel or otherwise authenticated.
(3)
Each registrant shall use the SI units gray, sievert,
and coulomb per kilogram, or the special units rad, rem, and roentgen, including
multiples and subdivisions, and shall clearly indicate the units of all quantities
on records required by this chapter.
(4)
The registrant shall make a clear distinction among
the quantities entered on the records required by this section, such as TEDE,
SDE, LDE, or DDE.
(5)
Records required in accordance with paragraph (1)
of this subsection, and subsections (cc)-(ee) of this section shall include
the date and the identification of individual(s) making the record, and, as
applicable, a unique identification of survey instrument(s) used, and an exact
description of the location of the survey. Records of receipt, transfer, and
disposal shall uniquely identify the radiation machine(s).
(6)
Copies of records required in accordance with paragraph
(1) of this subsection, and subsections (cc)-(ee) of this section, and by
certificate of registration conditions that are relevant to operations at
an additional authorized use/storage site shall be maintained at that site
in addition to the main site specified on a certificate of registration in
accordance with subsection (ll)(5) of this section.
(cc)
Records of surveys.
(1)
Each registrant shall make and maintain records showing
the results of surveys and calibrations required by subsection (s) of this
section. The registrant shall retain these records in accordance with subsection
(ll)(5) of this section.
(2)
The registrant shall retain the results of surveys
to determine the dose from external sources of radiation used, in the absence
of or in combination with individual monitoring data, in the assessment of
individual DEs in accordance with subsection (ll)(5) of this section.
(dd)
Records of individual monitoring results.
(1)
Each registrant shall make and maintain records in accordance
with subsection (r) of this section of the doses received by all individuals
for whom monitoring was required in accordance with subsection (n) of this
section, and records of doses received during accidents, and emergency conditions.
Assessments of DE and records made using units in effect before January 1,
1994, need not be changed. These records shall include, when applicable:
(A)
the DDE to the whole body, LDE, SDE to the skin, and SDE
to the extremities;
(B)
the data used to make occupational dose assessments in
accordance with subsection (r)(5) of this section.
(2)
The registrant shall make entries of the records
specified in paragraph (1) of this subsection at intervals not to exceed one
year and within 60 days of the end of the year.
(3)
The registrant shall maintain the records specified
in paragraph (1) of this subsection on BRC Form 231-3, in accordance with
the instructions for BRC Form 231-3, or in clear and legible records containing
all the information required by BRC Form 231-3.
(4)
The registrant shall maintain the records of dose
to an embryo/fetus with the records of dose to the declared pregnant woman.
The declaration of pregnancy, including the estimated date of conception,
shall also be kept on file, but may be maintained separately from the dose
records.
(5)
The registrant shall retain each required form or
record required by this subsection in accordance with subsection (ll)(5) of
this section. The registrant shall retain records used in preparing BRC Form
231-3 or equivalent in accordance with subsection (ll)(5) of this section.
(ee)
Records of dose to individual members of the public.
(1)
Each registrant shall maintain records sufficient to demonstrate
compliance with the dose limit for individual members of the public. See subsections
(o) and (p) of this section.
(2)
The registrant shall retain the records required by
paragraph (1) of this subsection in accordance with subsection (ll)(5) of
this section.
(ff)
Form of records.
(1)
Each record required by this chapter shall be legible throughout
the specified retention period.
(2)
The record shall be the original or a reproduced copy
or a microform, provided that the copy or microform is authenticated by authorized
personnel and that the microform is capable of producing a clear copy throughout
the required retention period.
(3)
The record may also be stored in electronic media
with the capability for producing legible, accurate, and complete records
during the required retention period.
(4)
Records, such as letters, drawings, and specifications,
shall include all pertinent information, such as stamps, initials, and signatures.
(5)
The registrant shall maintain adequate safeguards
against tampering with and loss of records.
(gg)
Reports of stolen, lost, or missing radiation machines.
(1)
Each registrant shall report to the agency by telephone
a stolen, lost, or missing radiation machine immediately after its occurrence
becomes known to the registrant.
(2)
Each registrant required to make a report in accordance
with paragraph (1) of this subsection shall, within 30 days after making the
telephone report, make a written report to the agency that includes the following
information:
(A)
a description of the radiation machine involved, including,
the manufacturer, model and serial number;
(B)
a description of the circumstances under which the loss
or theft occurred;
(C)
a statement of disposition, or probable disposition, of
the radiation machine involved;
(D)
exposures of individuals to radiation, circumstances under
which the exposures occurred, and the possible TEDE to persons in unrestricted
areas;
(E)
actions that have been taken, or will be taken, to recover
the radiation machine; and
(F)
procedures or measures that have been, or will be, adopted
to ensure against a recurrence of the loss or theft of radiation machines.
(3)
Subsequent to filing the written report, the
registrant shall also report additional substantive information on the loss
or theft within 30 days after the registrant learns of such information.
(4)
The registrant shall prepare any report filed with
the agency in accordance with this subsection so that names of individuals
who may have received exposure to radiation are stated in a separate and detachable
portion of the report.
(hh)
Notification of incidents.
(1)
Notwithstanding other requirements for notification, each
registrant shall immediately report each event involving a radiation machine
possessed by the registrant that may have caused or threatens to cause an
individual to receive:
(A)
a TEDE of 25 rems (0.25 Sv) or more;
(B)
an LDE of 75 rems (0.75 Sv) or more; or
(C)
an SDE to the skin or extremities of 250 rads (2.5 grays)
or more.
(2)
Each registrant shall, within 24 hours of discovery
of the event, report to the agency each event involving loss of control of
a radiation machine possessed by the registrant that may have caused, or threatens
to cause an individual to receive, in a period of 24 hours:
(A)
a TEDE exceeding 5 rems (0.05 Sv);
(B)
an LDE exceeding 15 rems (0.15 Sv); or
(C)
an SDE to the skin or extremities exceeding 50 rems (0.5
Sv).
(3)
Registrants shall make the initial notification
reports required by paragraphs (1) and (2) of this subsection by telephone
to the agency and shall confirm the initial notification report within 24
hours by telegram, mailgram, or facsimile to the agency.
(4)
The registrant shall prepare each report filed with
the agency in accordance with this section so that names of individuals who
have received exposure to radiation are stated in a separate and detachable
portion of the report.
(ii)
Reports of exposures and radiation levels exceeding the
limits.
(1)
In addition to the notification required by subsection
(hh) of this section, each registrant shall submit a written report within
30 days after learning of any of the following occurrences:
(A)
incidents for which notification is required by subsection
(hh) of this section;
(B)
doses in excess of any of the following:
(i)
the occupational dose limits for adults in subsection (m)(1)(A)
of this section;
(ii)
the occupational dose limits for a minor in subsection
(m)(1)(C) of this section;
(iii)
the limits for an embryo/fetus of a declared pregnant
woman in subsection (m)(1)(D) of this section;
(iv)
the limits for an individual member of the public in subsection
(o) of this section; or
(v)
any applicable limit in the registration;
(C)
levels of radiation in:
(i)
a restricted area in excess of applicable limits in the
certificate of registration; or
(ii)
an unrestricted area in excess of 10 times the applicable
limit set forth in this section or in the registration, whether or not involving
exposure of any individual in excess of the limits in subsection (o) of this
section.
(2)
Each report required by paragraph (1) of
this subsection shall describe the extent of exposure of individuals to radiation,
including, as appropriate:
(A)
estimates of each individual's dose;
(B)
the levels of radiation involved;
(C)
the cause of the elevated exposures, dose rates; and
(D)
corrective steps taken or planned to ensure against a recurrence,
including the schedule for achieving conformance with applicable limits, and
associated registration conditions.
(3)
Each report filed in accordance with paragraph
(1) of this subsection shall include for each individual exposed: the name,
social security number, and date of birth. With respect to the limit for the
embryo/fetus in subsection (m)(1)(D) of this section, the identifiers should
be those of the declared pregnant woman. The report shall be prepared so that
this information is stated in a separate and detachable portion of the report.
(4)
All registrants who make reports in accordance with
paragraph (1) of this subsection shall submit the report in writing to the
agency.
(jj)
Notifications and reports to individuals.
(1)
Requirements for notification and reports to individuals
of exposure to radiation are specified in §289.203 of this title (relating
to Notices, Instructions and Reports to Workers; Inspections).
(2)
When a registrant is required in accordance with subsection
(ii) of this section to report to the agency any exposure of an identified
occupationally exposed individual, or an identified member of the public,
to radiation, the registrant shall also notify the individual and provide
a copy of the report submitted to the agency, to the individual. Such notice
shall be transmitted at a time not later than the transmittal to the agency,
and shall comply with the provisions of §289.203 of this title.
(kk)
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, certificate of registration
conditions, and orders issued by the agency.
(2)
Each registrant 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 registrant shall make available to the agency
for inspection, upon reasonable notice, records made and maintained in accordance
with this chapter.
(4)
Routine inspection of radiation machines and services.
(A)
Routine inspections by agency personnel will be made no
more frequently than the intervals specified in subsection (ll)(1) of this
section. Registrants having certificates of registration authorizing multiple
uses will be inspected at the most frequent interval specified for the uses
authorized.
(B)
Notwithstanding the provisions of subparagraph (A) of this
paragraph, for those radiation machines determined by the agency to constitute
a minimal threat to human health and safety, the routine inspection interval
will be five years. The applicable categories are listed in subsection (ll)(2)
of this section.
(C)
Notwithstanding the inspection intervals specified in this
section, the agency may inspect registrants more frequently due to:
(i)
the persistence or severity of violations found during
an inspection;
(ii)
investigation of an incident or complaint concerning the
facility;
(iii)
a request for an inspection by a worker(s) in accordance
with §289.203 of this title;
(iv)
any change in a facility or equipment that might cause
a significant increase in radiation output or hazard; or
(v)
a mutual agreement between the agency and registrant.
(D)
The agency will conduct inspections of medical, podiatric
medical, veterinary, and chiropractic radiation machines or lasers in a manner
designed to cause as little disruption of a medical, podiatric medical, veterinary,
or chiropractic practice as is practicable.
(5)
A person who inspects medical, podiatric medical,
veterinary, or chiropractic radiation machines or lasers will have training
in the design and uses of the products and will receive training specified
in subsection (ll)(3) and/or (4) of this section.
(6)
Each registrant shall perform, upon instructions from
the agency, or shall permit the agency to perform such reasonable surveys
as the agency deems appropriate or necessary including, but not limited to,
surveys of:
(A)
radiation machines;
(B)
facilities wherein radiation machines are used or stored;
(C)
radiation detection and monitoring instruments; and
(D)
other equipment and devices used in connection with utilization
or storage of radiation machines.
(ll)
Appendices.
(1)
Routine inspection intervals for registrants.
Figure: 25 TAC §289.231(ll)(1)
(2)
Minimal threat radiation machines. Minimal threat
radiation machines include, but are not limited to, the following:
(A)
electron microscope;
(B)
x-ray fluorescence (machine);
(C)
x-ray gauges;
(D)
particle size analyzer (x-ray);
(E)
airport baggage x-ray;
(F)
electron beam welding;
(G)
ion implantation devices;
(H)
cathodoluminescence devices;
(I)
package x-ray; and
(J)
certified cabinet x-ray.
(3)
Training for agency inspectors of radiation machines.
(A)
Objectives. Training of agency inspectors of radiation
machines will be conducted by the agency. Upon completion of training, the
inspector will be able to:
(i)
select and operate the necessary testing equipment used
to perform an inspection of radiation machines;
(ii)
utilize radiation protection principles;
(iii)
operate radiation detection instruments;
(iv)
define basic regulatory terminology;
(v)
apply this section regarding radiation machines;
(vi)
perform routine agency inspections of radiation machines;
(vii)
complete agency inspection documentation;
(viii)
demonstrate knowledge of agency ethics, professional,
and technical policies; and
(ix)
successfully achieve the objectives in this subparagraph.
(B)
Initial training program.
(i)
Initial training will be conducted during a six-month period.
(ii)
All training evaluation instruments will be developed
by the agency.
(iii)
Instruments to be used in determining a proficiency level
are as follows:
(I)
evaluation of each inspector's training needs prior to
initial training;
(II)
evaluation of knowledge obtained and verification of tasks
performed by each inspector subsequent to training received by the agency;
and
(III)
evaluation of each inspector's task performance by the
agency.
(C)
Continuing education.
(i)
The agency inspector of radiation machines will accumulate
24 hours of continuing education regarding radiation machines, at intervals
not to exceed 24 months. These hours of continuing education may be acquired
as follows:
(I)
documented continuing education earned in an agency-accepted
training format; and
(II)
agency staff meetings.
(ii)
Failure to obtain 24 hours of continuing education within
each 24 month interval may result in a reassessment by the agency of an agency
inspector's proficiency level.
(iii)
After the initial training period, each inspector of
radiation machines will be evaluated by the agency, at intervals not to exceed
12 months.
(D)
Agency proficiency standards. The agency proficiency standards
for agency inspectors of radiation machines are as follows.
(i)
Level I. The agency inspector has not successfully achieved
the objectives in subparagraph (A) of this paragraph after the initial training
period. Additional training is required. Unsupervised inspections will not
be performed.
(ii)
Level II. The agency inspector has partially achieved
the objectives in subparagraph (A) of this paragraph, but has not achieved
the objective in subparagraph (A)(ix) of this paragraph after the initial
training period. Additional training is required. Unsupervised inspections
are not permitted for the type of radiation machines for which the objectives
of subparagraph (A)(ix) of this paragraph have not been achieved. Unsupervised
inspections may be performed for the type of radiation machines for which
the objectives in subparagraph (A)(ix) of this paragraph have been successfully
achieved.
(iii)
Level III. The agency inspector has successfully achieved
the objectives in subparagraph (A) of this paragraph. Supervision is not required
for routine inspections.
(4)
Training for agency inspectors of lasers.
Initial training will include an introduction to the requirements in this
chapter and inspection forms. Inspections of two medical and two entertainment
lasers, conducted by an inspector having completed the requirements of this
paragraph, shall be observed before unsupervised inspection of lasers is permitted.
(5)
Time requirements for record keeping. The following
are time requirements for record keeping.
Figure: 25 TAC §289.231(ll)(5)
(6)
Occupational exposure form. The following, BRC Form
231-3, is to be used to document occupational exposure record for a monitoring
period: (Please find BRC Form 231-3 at the end of this section).
Figure: 25 TAC §289.231(ll)(6)
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 May 15, 2000.
TRD-200003361
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: October 1, 2000
Proposal publication date: December 3, 1999
For further information, please call: (512) 458-7236