Current through Reg. 49, No. 38; September 20, 2024
(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 shall 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)
Air-purifying respirator--A respirator with an air-purifying filter, cartridge,
or canister that removes specific air contaminants by passing ambient air
through the air-purifying element.
(2) 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.
(3) Assigned
protection factor (APF)--The expected workplace level of respiratory protection
that would be provided by a properly functioning respirator or a class of
respirators to properly fitted and trained users. Operationally, the inhaled
concentration can be estimated by dividing the ambient airborne concentration
by the APF.
(4)
Atmosphere-supplying respirator--A respirator that supplies the respirator user
with breathing air from a source independent of the ambient atmosphere and
includes supplied-air respirators (SARs) and self-contained breathing apparatus
(SCBA) units.
(5) 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.
(6)
Debris--The remains of something destroyed, disintegrated, or decayed. Debris
does not include soils, sludges, liquids, gases, naturally occurring
radioactive material regulated in accordance with §
289.259
of this title (relating to Licensing of Naturally Occurring Radioactive
Material (NORM)), or low-level radioactive waste (LLRW) received from other
persons.
(7) 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.
(8) Demand respirator--An
atmosphere-supplying respirator that admits breathing air to the facepiece only
when a negative pressure is created inside the facepiece by
inhalation.
(9) 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.
(10) 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).
(11) Disposable respirator--A respirator for
which maintenance is not intended and that is designed to be discarded after
excessive breathing resistance, sorbent exhaustion, physical damage, or
end-of-service-life renders it unsuitable for use. Examples of this type of
respirator are a disposable half-mask respirator or a disposable escape-only
self-contained breathing apparatus.
(12) Dosimetry processor--A person that
processes and evaluates personnel monitoring devices in order to determine the
radiation dose delivered to the monitoring devices.
(13) Filtering facepiece (dust mask)--A
negative pressure particulate respirator with a filter as an integral part of
the facepiece or with the entire facepiece composed of the filtering medium,
not equipped with elastomeric sealing surfaces and adjustable straps.
(14) Fit factor--A quantitative estimate of
the fit of a particular respirator to a specific individual, and typically
estimates the ratio of the concentration of a substance in ambient air to its
concentration inside the respirator when worn.
(15) Fit test--The use of a protocol to
qualitatively or quantitatively evaluate the fit of a respirator on an
individual.
(16) Helmet--A rigid
respiratory inlet covering that also provides head protection against impact
and penetration.
(17) Hood--A
respiratory inlet covering that completely covers the head and neck and may
also cover portions of the shoulders and torso.
(18) Inhalation class (see definition for
Class).
(19) Loose-fitting
facepiece--A respiratory inlet covering that is designed to form a partial seal
with the face.
(20) Lung class (see
definition for Class).
(21)
Nationally tracked source--A sealed source containing a quantity equal to or
greater than Category 1 or Category 2 levels of any radioactive material listed
in subsection (hhh)(2) of this section. In this context a sealed source is
defined as radioactive material that is sealed in a capsule or closely bonded,
in a solid form and which is not exempt from regulatory control. It does not
mean material encapsulated solely for disposal, or nuclear material contained
in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1
nationally tracked sources are those containing radioactive material at a
quantity equal to or greater than the Category 1 threshold. Category 2
nationally tracked sources are those containing radioactive material at a
quantity equal to or greater than the Category 2 threshold but less than the
Category 1 threshold.
(22) Negative
pressure respirator (tight fitting)--A respirator in which the air pressure
inside the facepiece is negative during inhalation with respect to the ambient
air pressure outside the respirator.
(23) 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.
(24) Planned
special exposure--An infrequent exposure to radiation, separate from and in
addition to the annual occupational dose limits.
(25) Positive pressure respirator--A
respirator in which the pressure inside the respiratory inlet covering exceeds
the ambient air pressure outside the respirator.
(26) Powered air-purifying respirator--An
air-purifying respirator that uses a blower to force the ambient air through
air-purifying elements to the inlet covering.
(27) Pressure demand respirator--A positive
pressure atmosphere-supplying respirator that admits breathing air to the
facepiece when the positive pressure is reduced inside the facepiece by
inhalation.
(28) Qualitative fit
test--A pass/fail fit test to assess the adequacy of respirator fit that relies
on the individual's response to the test agent.
(29) Quantitative fit test--An assessment of
the adequacy of respirator fit by numerically measuring the amount of leakage
into the respirator.
(30)
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.
(31) Reference man--A hypothetical
aggregation of human physical and physiological characteristics determined by
international consensus. These characteristics may be used by researchers and
public health employees to standardize results of experiments and to relate
biological 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."
(32) Respiratory protective equipment--An
apparatus, such as a respirator, used to reduce an individual's intake of
airborne radioactive materials.
(33) 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.
(34) Self-contained
breathing apparatus--An atmosphere-supplying respirator for which the breathing
air source is designed to be carried by the user.
(35) 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.
(36) Supplied-air respirator
or airline respirator--An atmosphere-supplying respirator for which the source
of breathing air is not designed to be carried by the user.
(37) Tight-fitting facepiece--A respiratory
inlet covering that forms a complete seal with the face.
(38) User seal check (fit check)--An action
conducted by the respirator user to determine if the respirator is properly
seated to the face. Examples include negative pressure check, positive pressure
check, irritant smoke check, or isoamyl acetate check.
(39) Weighting factor
wT for an organ or tissue (T)--The proportion of the
risk of stochastic effects resulting from irradiation of that organ or tissue
to the total risk of stochastic effects when the whole body is irradiated
uniformly. For calculating the effective dose equivalent, the values of
wT are:
Attached Graphic
(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. The review shall include a reevaluation of the
assessments made to determine monitoring is not required in accordance with
subsection (q)(1) and (3) of this section in conjunction with the licensee's
current operating conditions.
(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 (TEDE) in
excess of 10 millirems (mrem) (0.1 millisievert (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 to ensure
against recurrence.
(5) If
monitoring is not required in accordance with subsection (q)(1) and (3) of this
section, the licensee shall document assessments made to determine the
requirements of subsection (q)(1) and (3) of this section are not applicable.
The licensee shall maintain the documentation in accordance with subsection
(rr)(5) of this section.
(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 of the whole body, and to the skin of 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 of the whole body or to the skin of
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) When the external
exposure is determined by measurement with an external personal monitoring
device, the deep-dose equivalent shall be used in place of the effective dose
equivalent, unless the effective dose equivalent is determined by a dosimetry
method approved by the agency. The assigned deep dose equivalent shall be for
the portion of the body receiving the highest exposure. The assigned
shallow-dose equivalent shall be the dose averaged over the contiguous 10
square centimeters (cm2) of skin receiving the
highest exposure.
(4) The deep dose
equivalent, lens dose equivalent and shallow dose equivalent may be assessed
from surveys, or other radiation measurements for the purpose of demonstrating
compliance with the occupational dose limits, if the individual monitoring
device was not in the region of highest potential exposure, or the results of
individual monitoring are unavailable.
(5) Derived air concentration (DAC) and
annual limit on intake (ALI) values are specified in Table I of subsection
(ggg)(2) of this section and may be used to determine the individual's dose and
to demonstrate compliance with the occupational dose limits. See subsection
(rr) of this section.
(6)
Notwithstanding the annual dose limits, the licensee shall limit the soluble
uranium intake by an individual to 10 milligrams (mg) in a week in
consideration of chemical toxicity. See footnote 3 of subsection (ggg)(2) of
this section.
(7) The licensee
shall reduce the dose that an individual may be allowed to receive in the
current year by the amount of occupational dose received while employed by any
other person. See subsection (j)(4) of this section.
(g) Compliance with requirements for
summation of external and internal doses.
(1)
If the licensee is required to monitor in accordance with both subsection
(q)(1) and (3) of this section, the licensee shall demonstrate compliance with
the dose limits by summing external and internal doses. If the licensee is
required to monitor only in accordance with subsection (q)(1) of this section
or only in accordance with subsection (q)(3) of this section, then summation is
not required to demonstrate compliance with the dose limits. The licensee may
demonstrate compliance with the requirements for summation of external and
internal doses in accordance with paragraphs (2) - (4) of this subsection. The
dose equivalents for the lens of the eye, the skin, and the extremities are not
included in the summation, but are subject to separate limits.
(2) If the only intake of radionuclides is by
inhalation, the total effective dose equivalent limit is not exceeded if the
sum of the deep dose equivalent divided by the total effective dose equivalent
limit, and one of the following, does not exceed unity:
(A) the sum of the fractions of the
inhalation ALI for each radionuclide; or
(B) the total number of derived air
concentration-hours (DAC-hours) for all radionuclides divided by 2,000;
or
(C) the sum of the calculated
committed effective dose equivalents to all significantly irradiated organs or
tissues (T) calculated from bioassay data using appropriate biological models
and expressed as a fraction of the annual limit. For purposes of this
requirement, an organ or tissue is deemed to be significantly irradiated if,
for that organ or tissue, the product of the weighting factors,
wT, and the committed dose equivalent,
HT,50, per unit intake is greater than 10% of the
maximum weighted value of HT,50, that is,
wTHT,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, RC 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, facsimile, letter, or
other electronic media transmission. 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
RC 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)(7) of this section for the current year, that the allowable dose limit for
the individual is reduced by 1.25 rems (12.5 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) 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, facsimile, letter, or other electronic media
transmission. The licensee shall request a written verification of the dose
data if the authenticity of the transmitted report cannot be
established.
(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: may:
(A) accept, as the record of lifetime
cumulative radiation dose, an up-to-date RC 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 RC 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 RC 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 (NCRP)
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) 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 §
289.256
of this title (relating to Medical and Veterinary Use of Radioactive Material),
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 §
289.256
of this title, 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.
(6)
Notwithstanding paragraph (1)(A) of this subsection, a licensee may permit
visitors to an individual who cannot be released, in accordance with §
289.256
of this title, to receive a radiation dose greater than 0.1 rem (1 mSv) if:
(A) the radiation dose received does not
exceed 0.5 rem (5 mSv); and
(B) the
authorized user, as defined in §
289.256
of this title, has determined before the visit that it is
appropriate.
(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 of areas, including the subsurface
that:
(A) are necessary for the licensee to
comply with this chapter; and
(B)
are necessary under the circumstances to evaluate:
(i) the magnitude and extent of radiation
levels;
(ii) concentrations or
quantities of residual radioactivity; and
(iii) the potential radiological hazards of
the radiation levels and residual radioactivity detected.
(2) In addition to subsection (nn)
of this section, records from surveys describing the location and amount of
subsurface residual radioactivity identified at the site shall be kept with
records important for decommissioning, and such records shall be maintained and
retained in accordance with §
289.252(gg)
of this title (relating to Licensing of Radioactive Material).
(3) 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, the United States Nuclear Regulatory Commission (NRC), or any agreement
state 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.
(4) 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; and
(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.
(5) All
individual monitoring devices shall be appropriate for the environment in which
they are used.
(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 skin of the extremities, to demonstrate compliance
with subsection (f)(1)(B)(ii) of this section, shall be worn on the skin of 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 skin of 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 (m) from the external surface of any package does not
exceed 0.01 rem (0.1 mSv) 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,
decontamination, or ventilation, to control the concentrations of radioactive
material in air.
(w) Use of other
controls.
(1) 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:
(A) control
of access;
(B) limitation of
exposure times;
(C) use of
respiratory protection equipment; or
(D) other controls.
(2) If the licensee performs an ALARA
analysis to determine whether respirators should be used, the licensee may
consider safety factors other than radiological factors. The licensee shall
also consider the impact of respirator use on workers' industrial health and
safety.
(x) Use of
individual respiratory protection equipment.
(1) If the licensee uses respiratory
protection equipment to limit intakes of radioactive material in accordance
with subsection (w) of this section, the licensee shall do the following.
(A) Except as provided in subparagraph (B) of
this paragraph, the licensee shall use only respiratory protection equipment
that is tested and certified by the National Institute for Occupational Safety
and Health (NIOSH).
(B) If the
licensee wishes to use equipment that has not been tested or certified by the
NIOSH, or for which there is no schedule for testing or certification, the
licensee shall submit an application to the agency 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
doses;
(ii) surveys and bioassays,
as appropriate, to evaluate actual intakes;
(iii) testing of respirators for operability
(user seal check for face sealing devices and functional check for others)
immediately prior to each use;
(iv)
written procedures regarding the following:
(I) monitoring, including air sampling and
bioassays;
(II) supervision and
training of respirator users;
(III)
fit testing;
(IV) respirator
selection;
(V) breathing air
quality;
(VI) inventory and
control;
(VII) storage, issuance,
maintenance, repair, testing, and quality assurance of respiratory protection
equipment;
(VIII) recordkeeping;
and
(IX) limitations on periods of
respirator use and relief from respirator use;
(v) determination by a physician prior to
initial fitting of a face sealing respirator and the first field use of
non-face sealing respirators, and either every 12 months thereafter or
periodically at a frequency determined by a physician, that the individual user
is medically fit to use the respiratory protection equipment; and
(vi) fit testing, with fit factor > 10
times the APF for negative pressure devices, and a fit factor > 500 for any
positive pressure, continuous flow, and pressure-demand devices, before the
first field use of tight fitting, face-sealing respirators and periodically
thereafter at a frequency not to exceed 1 year. Fit testing shall be performed
with the facepiece operating in the negative pressure mode.
(D) 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.
(E) The licensee shall use
respiratory protection equipment within the equipment manufacturer's expressed
limitations for type and mode of use and shall provide for vision correction,
adequate communication, low-temperature work environment, and the concurrent
use of other safety or radiological protection equipment. The licensee shall
use equipment in such a way as not to interfere with the proper operation of
the respirator.
(F) Standby rescue
persons are required whenever one-piece atmosphere-supplying suits, or any
combination of supplied air respiratory protection device and personnel
protective equipment are used from which an unaided individual may have
difficulty extricating himself or herself. The standby persons shall be
equipped with respiratory protection devices or other apparatus appropriate for
the potential hazards. The standby rescue persons shall observe or otherwise
maintain continuous communication with the workers (visual, voice, signal line,
telephone, radio, or other suitable means), and be immediately available to
assist them in case of a failure of the air supply or for any other reason that
requires relief from distress. A sufficient number of standby rescue persons
must be immediately available to assist all users of this type of equipment and
to provide effective emergency rescue if needed.
(G) Atmosphere-supplying respirators shall be
supplied with respirable air of grade D quality or better as defined by the
Compressed Gas Association in publication G-7.1, "Commodity Specification for
Air," 1997 and included in the regulations of the Occupational Safety and
Health Administration (Title 29, CFR, §1910.134(i)(1)(ii)(A) through (E).
Grade D quality air criteria include:
(i)
oxygen content (volume/volume) of 19.5-23.5%;
(ii) hydrocarbon (condensed) content of 5 mg
per cubic meter of air or less;
(iii) carbon monoxide (CO) content of 10
parts per million (ppm) or less;
(iv) carbon dioxide content of 1,000 ppm or
less; and
(v) lack of noticeable
odor.
(H) The licensee
shall ensure that no objects, materials or substances, such as facial hair, or
any conditions that interfere with the face-facepiece seal or valve function,
and that are under the control of the respirator wearer, are present between
the skin of the wearer's face and the sealing surface of a tight-fitting
respirator facepiece.
(I) In
estimating the dose to individuals from intake of airborne radioactive
materials, the concentration of radioactive material in the air that is inhaled
when respirators are worn is initially assumed to be the ambient concentration
in air without respiratory protection, divided by the assigned protection
factor. If the dose is later found to be greater than the estimated dose, the
corrected value shall be used. If the dose is later found to be less than the
estimated dose, the corrected value may be used.
(2) The agency may impose restrictions in
addition to those in paragraph (1) of this subsection, subsection (w) of this
section, and subsection (ggg)(1) of this section, in order to:
(A) ensure that the respiratory protection
program of the licensee is adequate to limit doses to individuals from intakes
of airborne radioactive materials consistent with maintaining total effective
dose equivalent ALARA; and
(B)
limit the extent to which a licensee may use respiratory protection equipment
instead of process or other engineering controls.
(3) 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:
(A) describes the situation
for which a need exists for higher protection factors; and
(B) demonstrates that the respiratory
protection equipment provides these higher protection factors under the
proposed conditions of use.
(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 access to use of radioactive material that is in an unrestricted
area and that is not in storage.
(3) Each portable gauge licensee shall use a
minimum of two independent physical controls that form tangible barriers to
secure portable gauges from unauthorized removal, whenever portable gauges are
not under the control and constant surveillance of the licensee.
(4) Utilization records shall be maintained
for portable and mobile devices which contain radioactive material, and which
are transported from a licensed site temporarily for use by the licensee and
then returned to the licensed site of origin. The information required by
subparagraphs (A) - (D) of this paragraph shall be recorded when a device is
removed from the licensed site. The information in subparagraph (E) of this
paragraph shall be recorded when a device is returned to the licensed site:
(A) the manufacturer, model, and serial
number of the device;
(B) the name
of the individual(s) transporting and using the device;
(C) the location(s) where each device is
used;
(D) the date each device is
removed from storage; and
(E) the
date each device is returned to storage.
(5) Utilization records shall be maintained
at the licensed site where the devices are stored for inspection by the agency
in accordance with subsection (ggg)(5) of this section.
(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:
Attached Graphic
(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 cm 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 Title
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 (relating to General Provisions for Radioactive Material) and
specified in §
289.257(ee)
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 Title 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;
(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 Title 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(ee)
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, facsimile, or other electronic media
transmission, the agency when removable radioactive surface contamination or
external radiation levels exceed the limits established in subparagraphs (A)
and (B) of this paragraph.
(A) Limits for
removable radioactive surface contamination levels.
(i) The level of removable radioactive
contamination on the external surfaces of each package offered for shipment
shall be ALARA. The level of removable radioactive contamination may be
determined by wiping an area of 300 square centimeters
(cm2) of the surface concerned with an absorbent
material, using moderate pressure, and measuring the activity on the wiping
material. Sufficient measurements shall 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, shall 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 shall 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.
Attached Graphic
(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 millisieverts 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, §
289.257
of this title, §
289.259
of this title, or to the United States Department of Energy (DOE);
(B) by decay in storage with prior approval
from the agency, except as authorized in §
289.256(ee)
of this title;
(C) by release in
effluents within the limits in subsection (n) of this section in accordance
with the applicable requirements of the Texas Commission on Environmental
Quality (TCEQ) or the Railroad Commission of Texas (RRC);
(D) as authorized in accordance with
paragraph (2) of this subsection, and subsections (gg), (hh), and (fff) of this
section; or
(E) by transfer of
residual radiopharmaceutical waste for decay in storage only to persons who
manufactured, compounded, and supplied the radiopharmaceutical and who
otherwise meet the requirements for exemption under Title 30, Texas
Administrative Code (TAC), §336.1209.
(2) Upon agency approval, emission control
dust and other material from electric arc furnaces or foundries contaminated as
a result of inadvertent melting of cesium-137 or americium-241 sources may be
transferred for disposal to a hazardous waste disposal facility authorized by
TCEQ or its successor, another state's regulatory agency with jurisdiction to
regulate hazardous waste as classified under Subtitle C of the Resource
Conservation and Recovery Act (RCRA), or the EPA. The material may be
transferred for disposal without regard to its radioactivity if the following
conditions are met.
(A) Contaminated material
described in paragraph (2) of this subsection, whether packaged or unpackaged
(i.e., bulk), must be treated through stabilization to comply with all waste
treatment requirements of the appropriate state or federal regulatory agency as
listed in this paragraph. The treatment operations must be undertaken by either
of the following:
(i) the owner/operator of
the electric arc furnace or foundry licensed to possess, treat or transfer
cesium-137 or americium-241 contaminated incident-related material;
or
(ii) a service contractor
licensed by the agency, NRC, or an agreement state to possess, treat, or
transfer cesium-137 or americium-241 contaminated incident-related
material.
(B) The
emission control dust and other incident-related materials have been stored (if
applicable) and transferred in accordance with operating and emergency
procedures approved by the agency.
(C) The total cesium-137 or americium-241
activity contained in emission control dust and other incident-related
materials to be transferred to a hazardous waste disposal facility has been
specifically approved by NRC or the appropriate agreement state(s) and does not
exceed the total activity associated with the inadvertent melting
incident.
(D) The hazardous waste
disposal facility operator has been notified in writing of the impending
transfer of the incident-related materials and has agreed in writing to receive
and dispose of the packaged or unpackaged materials. Copies of the notification
and agreement shall be submitted to the agency.
(E) The licensee, as listed in subparagraph
(A)(i) or (ii) of this paragraph, notifies the NRC or agreement state(s) in
which the transferor and transferee are located, in writing, of the impending
transfer, at least 30 days before the transfer.
(F) The packaged stabilized material has been
packaged for transportation and disposal in non-bulk steel packaging as defined
in DOT regulations at Title 49, CFR, §173.213.
(G) The emission control dust and other
incident-related materials that have been stabilized and packaged as described
in subparagraph (F) of this paragraph shall contain pretreatment average
concentrations of cesium-137 that do not exceed 130 pCi/g of material, above
background, or pretreatment average concentrations of americium-241 that do not
exceed 3 pCi/g of material, above background.
(H) The dose rate at 3.28 feet (1 m) from the
surface of any package containing stabilized waste shall not exceed 20
µrem per hour or 0.20 µSv per hour, above background.
(I) The unpackaged stabilized material shall
contain pretreatment average concentrations of cesium-137 that do not exceed
100 pCi/g of material, above background, or pretreatment average concentrations
of americium-241 that do not exceed 3 pCi/g of material, above
background.
(J) The licensee
transferring the cesium-137 or americium-241 contaminated incident-related
material shall consult with the agency, the TCEQ or its successor, another
state's regulatory agency with jurisdiction to regulate hazardous waste as
classified under RCRA, or the EPA and other authorized parties, including state
and local governments, and obtain all necessary approvals, in addition to those
of the NRC and/or any agreement state, for the transfers described in paragraph
(2) of this subsection.
(K) Nothing
in this subsection shall be or is intended to be construed as a waiver of any
RCRA permit condition or term, of any state or local statute or regulation, or
of any federal RCRA regulation.
(L)
The total incident-related cesium-137 activity described in paragraph (2) of
this subsection received by a facility over its operating life shall not exceed
1 Ci (37 gigabequerels (GBq)). The total incident-related americium-241
activity described in paragraph (2) of this subsection received by a facility
over its operating life shall not exceed 30 mCi (1.11 GBq). The agency will
maintain a record of the total incident-related cesium-137 or americium-241
activity shipped by a person licensed by the agency. Upon consultation with the
TCEQ, the agency will determine if the total incident-related activity received
by a hazardous waste disposal facility over its operating life has reached 1 Ci
(37 GBq) of cesium-137 or 30 mCi (1.11 GBq) of americium-241. The agency will
not approve shipments of cesium-137 or americium-241 contaminated
incident-related material that will cause this limit to be exceeded.
(3) Radioactive waste exempted by
TCEQ for disposal in a hazardous waste disposal facility that holds a TCEQ
permit issued under Subtitle C of the RCRA may be transferred for disposal as
authorized by TCEQ.
(4) A person
shall be specifically licensed to receive waste containing licensed material
from other persons for:
(A) treatment prior
to disposal;
(B) treatment by
incineration;
(C) decay in
storage;
(D) disposal at an
authorized land disposal facility; or
(E) storage until transferred to a storage or
disposal facility authorized to receive the waste.
(5) Byproduct material as defined in §
289.201(b)(19)(C)
- (E) of this title may be disposed of in accordance with Title 10, CFR, Part
61, even though it is not defined as low level radioactive waste. Therefore,
any byproduct material being disposed of at a facility, or transferred for
ultimate disposal at a facility licensed under Title 10, CFR, Part 61, shall
meet the requirements of this chapter.
(6) A licensee may dispose of byproduct
material, as defined in §
289.201(b)(19)(C)
- (E) of this title, at a disposal facility authorized to dispose of such
material in accordance with any Federal or State solid or hazardous waste
law.
(7) Any licensee shipping
byproduct material as defined in §
289.201(b)(19)(C)
- (E) of this title intended for ultimate disposal at a land disposal facility
licensed under Title 10, CFR, Part 61, shall document the information required
on the NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this
recorded manifest information to the intended consignee in accordance with
§
289.257(gg)
of this title.
(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 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(ff)
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(ff)
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
International System of Units (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
subsections (ee)(4) and (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 SI units 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) and (ss) - (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 make, maintain, and
retain the records required by paragraphs (1)(A) and (1)(B) of this subsection
for inspection by the agency in accordance with subsection (ggg)(5) of this
section.
(nn) Records
of surveys.
(1) Each licensee shall make,
maintain, and retain records documenting the results of surveys and
calibrations required by subsections (p) and (ee)(2) of this section and
include a unique identification of survey instrument(s). The licensee shall
maintain these records for inspection by the agency in accordance with
subsection (ggg)(5) of this section.
(2) Record of the calibration shall include:
(A) the manufacturer's name, model and serial
number of each calibrated source and/or device;
(B) the complete date of the calibration;
and
(C) the name of the individual
recording the information.
(3) The licensee shall make, maintain, and
retain each of the following records for inspection by the agency in accordance
with subsection (ggg)(5) of this section:
(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) the results of measurements and
calculations used to determine individual intakes of radioactive material and
used in the assessment of internal dose; and
(C) the results of air sampling, surveys, and
bioassays required in accordance with subsection (x)(1)(C)(i) and (ii) of this
section; and
(D) the 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 maintained
and retained for inspection by the agency in accordance with subsection
(ggg)(5) of this section.
(pp)
Records of lifetime cumulative occupational radiation dose. The licensee shall
make, maintain, and retain the records of lifetime cumulative occupational
radiation dose as specified in subsection (k) of this section on RC Form 202-2
or equivalent and the records used in preparing RC Form 202-2 or equivalent for
inspection by the agency in accordance with subsection (ggg)(5) of this
section.
(qq) Records of planned
special exposures.
(1) For each use of the
provisions of subsection (k) of this section for planned special exposures, the
licensee shall maintain records that describe:
(A) the exceptional circumstances requiring
the use of a planned special exposure;
(B) the name of the management official who
authorized the planned special exposure and a copy of the signed
authorization;
(C) what actions
were necessary;
(D) why the actions
were necessary;
(E) what
precautions were taken to assure that doses were maintained ALARA;
(F) what individual and collective doses were
expected to result; and
(G) the
doses actually received in the planned special exposure.
(2) The licensee shall retain the records
until the agency terminates each pertinent license requiring these
records.
(rr) Records of
individual monitoring results.
(1) Each
licensee shall maintain records of doses received by all individuals for whom
monitoring was required in accordance with subsection (q) of this section, and
records of doses received during planned special exposures, accidents, and
emergency conditions. Assessments of dose equivalent and records made using
units in effect before January 1, 1994, need not be changed. These records
shall include, when applicable:
(A) the deep
dose equivalent to the whole body, lens dose equivalent, shallow dose
equivalent to the skin, and shallow dose equivalent to the
extremities;
(B) the estimated
intake of radionuclides, see subsection (g) of this section;
(C) the committed effective dose equivalent
assigned to the intake of radionuclides;
(D) the specific information used to
calculate the committed effective dose equivalent in accordance with subsection
(i)(1) and (3) of this section and when required by subsection (q)(1) of this
section;
(E) the total effective
dose equivalent when required by subsection (g) of this section;
(F) the total of the deep dose equivalent and
the committed dose to the organ receiving the highest total dose; and
(G) the data used to make occupational dose
assessments in accordance with subsection (j)(5) of this section.
(2) The licensee shall make
entries of the records specified in paragraph (1) of this subsection at
intervals not to exceed 1 year and by April 30 of the following year.
(3) The licensee shall maintain the records
specified in paragraph (1) of this subsection on RC Form 202-3, in accordance
with the instructions for RC Form 202-3, or in clear and legible records
containing all the information required by RC 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 RC 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,
chemical and physical form, source and/or device manufacturer, model number,
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 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, except a patient
administered radiation for purposes of medical diagnosis or therapy, 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 facsimile or other electronic
media transmission 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;
(v) any personnel
radiation exposure data available; and
(vi) the source and/or device manufacturer,
model, and serial number.
(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, chemical and physical form of the radioactive material involved,
and the source and/or device manufacturer, model number, and serial
number;
(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 Title 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, dose limit exceeded, concentrations of radioactive
material involved, and the source and/or device manufacturer, model number, and
serial number;
(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 5 days. The report shall include the equipment involved, including the
device manufacturer, model and serial number; the test results; the date of the
test; model and serial number; if assigned, of the leaking source, the
radionuclide and its estimated activity; 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.
(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, §
289.253
of this title (relating to Radiation Safety Requirements for Well Logging
Service Operations and Tracer Studies), §
289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography), §
289.258
of this title (relating to Licensing and Radiation Safety Requirements for
Irradiators), and §
289.259
of this title (relating to Licensing of Naturally Occurring Radioactive
Material).
(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 shall take into account
consideration of any detriments, such as deaths from transportation accidents,
expected to potentially result from decontamination and waste
disposal.
(3) Criteria for
license termination under restricted conditions. A site will be considered
acceptable for license termination under restricted conditions if:
(A) the licensee can demonstrate that further
reductions in residual radioactivity necessary to comply with the requirements
of paragraph (2) of this subsection would result in net public or environmental
harm or were not being made because the residual levels associated with
restricted conditions are ALARA. Determination of the levels which are ALARA
shall take into account consideration of any detriments, such as traffic
accidents, expected to potentially result from decontamination and waste
disposal;
(B) the licensee has made
provisions for legally enforceable institutional controls that provide
reasonable assurance that the TEDE from residual radioactivity distinguishable
from background to the average member of the critical group will not exceed 25
mrem (0.25 mSv) per year;
(C) the
licensee has provided sufficient financial assurance to enable an independent
third party, including a governmental custodian of a site, to assume and carry
out responsibilities for any necessary control and maintenance of the site.
Acceptable financial assurance mechanisms are:
(i) funds placed into a trust segregated from
the licensee's assets and outside the licensee's administrative control, and in
which the adequacy of the trust funds is to be assessed based on an assumed
annual 1% real rate of return on investment;
(ii) a statement of intent in the case of
federal, state, or local government licensees, as described in §
289.252(gg)
of this title; or
(iii) when a
governmental entity is assuming custody and ownership of a site, an arrangement
that is deemed acceptable by such governmental entity.
(D) the licensee has submitted a
decommissioning plan or License Termination Plan (LTP) to the agency indicating
the licensee's intent to decommission in accordance with §
289.252(y)
of this title, and specifying that the licensee intends to decommission by
restricting use of the site. The licensee shall document in the LTP or
decommissioning plan how the advice of individuals and institutions in the
community who may be affected by the decommissioning has been sought and
incorporated, as appropriate, following analysis of that advice.
(i) Licensees proposing to decommission by
restricting use of the site shall seek advice from such affected parties
regarding the following matters concerning the proposed decommissioning:
(I) whether provisions for institutional
controls proposed by the licensee;
(-a-) will
provide reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical group
will not exceed 25 mrem (0.25 mSv) TEDE per year;
(-b-) will be enforceable; and
(-c-) will not impose undue burdens on the
local community or other affected parties; and
(II) whether the licensee has provided
sufficient financial assurance to enable an independent third party, including
a governmental custodian of a site, to assume and carry out responsibilities
for any necessary control and maintenance of the site.
(ii) In seeking advice on the issues
identified in clause (i) of this subparagraph, the licensee shall provide for:
(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; and
(E) residual radioactivity at the site has
been reduced so that if the institutional controls were no longer in effect,
there is reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical group is
ALARA and would not exceed either:
(i) 100
mrem (1 mSv) per year; or
(ii) 500
mrem (5 mSv) per year provided the licensee:
(I) demonstrates that further reductions in
residual radioactivity necessary to comply with the 100 mrem/y (1 mSv/y) value
of clause (i) of this subparagraph are not technically achievable, would be
prohibitively expensive, or would result in net public or environmental
harm;
(II) makes provisions for
durable institutional controls; and
(III) provides sufficient financial assurance
to enable a responsible government entity or independent third party, including
a governmental custodian of a site, both to carry out periodic rechecks of the
site no less frequently than every 5 years to assure that the institutional
controls remain in place as necessary to meet the criteria of paragraph (2) of
this subsection and to assume and carry out responsibilities for any necessary
control and maintenance of those controls. Acceptable financial assurance
mechanisms are those in subparagraph (C) of this paragraph.
(4)
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;
(iii) has submitted a decommissioning plan to
the agency indicating the licensee's intent to decommission in accordance with
the requirements in §
289.252(y)
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; and
(iv) has provided sufficient
financial assurance in the form of a trust fund to enable an independent third
party, including a governmental custodian of a site, to assume and carry out
responsibilities for any necessary control and maintenance of the
site.
(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 (5) of this subsection.
(5) 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 pursuant to paragraphs (3) and
(4) 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 (4) of
this subsection; and
(B)
publish a notice in the Texas Register and a forum, such as
local newspapers, letters to state or local organizations, or other appropriate
forum, that is readily accessible to individuals in the vicinity of the site,
and solicit comments from affected parties.
(6) Minimization of contamination.
(A) 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.
(B) Licensees shall, to the
extent practical, conduct operations to minimize the introduction of residual
radioactivity into the site, including the subsurface, in accordance with the
existing radiation protection requirements and radiological criteria for
license termination in this subsection.
(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 (ddd) 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 paragraph (4) of this subsection.
(3) Where combinations of
radionuclides are involved, the sum of the ratios between the concentrations
present and the limits specified in paragraph (2) of this subsection shall not
exceed one.
(4) Notwithstanding the
limits specified in paragraph (2) of this subsection, no licensee shall cause
the concentration of radium-226 or radium-228 in soil in unrestricted areas,
averaged over any 100 square meters (m2), to exceed
the background level by more than:
(A) 5
picocuries per gram (pCi/g) (0.185 becquerel per gram (Bq/g)), averaged over
the first 15 cm of soil below the surface; and
(B) 15 pCi/g (0.555 Bq/g), averaged over 15
cm thick layers of soil more than 15 cm below the surface.
(5) No licensee shall possess, receive, use,
or transfer radioactive material in such a manner as to cause contamination of
vegetation in unrestricted areas to exceed 5 pCi/g (0.185 Bq/g), based on dry
weight, for radium-226 or radium-228.
(6) Notwithstanding the limits specified in
paragraph (2) of this subsection, no licensee shall cause the concentration of
natural uranium with no daughters present, based on dry weight and averaged
over any 100 m2 of area, to exceed the following
limits:
(A) 30 pCi/g (1.11 Bq/g), averaged
over the top 15 cm of soil below the surface; and
(B) 150 pCi/g (5.55 Bq/g), average
concentration at depths greater than 15 centimeters below the surface so that
no individual member of the public will receive an effective dose equivalent in
excess of 100 mrem (1 mSv) per year.
(fff) Exemption of specific wastes.
(1) A licensee may discard the following
licensed material without regard to its radioactivity:
(A) 0.05 microcurie (µCi) (1.85
kilobecquerels (kBq)), or less, of hydrogen-3, carbon-14, or iodine-125 per
gram of medium used for liquid scintillation counting or in vitro clinical or
in vitro laboratory testing; and
(B) 0.05 µCi (1.85 kBq), or less, of
hydrogen-3, carbon-14, or iodine-125, per gram of animal tissue, averaged over
the weight of the entire animal.
(2) A licensee shall not discard tissue in
accordance with paragraph (1)(B) of this subsection in a manner that would
permit its use either as food for humans or as animal feed.
(3) The licensee shall maintain records in
accordance with subsection (tt) of this section.
(4) Any licensee may, upon agency approval of
procedures required in paragraph (6) of this subsection, discard licensed
material included in subsection (ggg)(7) of this section, provided that it does
not exceed the concentration and total curie limits contained therein, in a
Type I municipal solid waste site as defined in the Municipal Solid Waste
Regulations of the authorized regulatory agency (Title 30, Texas Administrative
Code, Chapter 330), unless such licensed material also contains hazardous
waste, as defined in §361.003(12) 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(ff)
of this title.
(ggg)
Appendices.
(1) Assigned protection factors
for respirators. The following table contains assigned protection factors for
respiratorsa:
Attached Graphic
(2) Annual limits on intake (ALI)
and derived air concentrations (DAC) of radionuclides for occupational
exposure; effluent concentrations; concentrations for release to sanitary
sewerage.
(A) Introduction.
(i) For each radionuclide, Table I of
subparagraph (F) of this paragraph indicates the chemical form that is to be
used for selecting the appropriate ALI or DAC value. The ALIs and DACs for
inhalation are given for an aerosol with an activity median aerodynamic
diameter (AMAD) of 1 micron, and for three classes (D, W, Y) of radioactive
material, which refer to their retention (approximately days, weeks, or years)
in the pulmonary region of the lung. This classification applies to a range of
clearance half-times for D if less than 10 days, for W from 10 to 100 days, and
for Y greater than 100 days. Table II of subparagraph (F) of this paragraph
provides concentration limits for airborne and liquid effluents released to the
general environment. Table III of subparagraph (F) of this paragraph provides
concentration limits for discharges to sanitary sewerage.
(ii) The values in Tables I, II, and III of
subparagraph (F) of this paragraph are presented in the computer "E" notation.
In this notation a value of 6E-02 represents a value of 6 x
10-2 or 0.06, 6E+2 represents 6 x
102 or 600, and 6E+0 represents 6 x
100 or 6.
(B) Occupational values.
(i) Note that the columns in Table I of
subparagraph (F) of this paragraph captioned "Oral Ingestion ALI," "Inhalation
ALI," and "DAC," are applicable to occupational exposure to radioactive
material.
(ii) The ALIs in
subparagraph (F) of this paragraph are the annual intakes of given radionuclide
by "Reference Man" that would result in either a committed effective dose
equivalent of 5 rems (0.05 Sv), stochastic ALI, or a committed dose equivalent
of 50 rems (0.5 Sv) to an organ or tissue, non-stochastic ALI. The stochastic
ALIs were derived to result in a risk, due to irradiation of organs and
tissues, comparable to the risk associated with deep dose equivalent to the
whole body of 5 rems (0.05 Sv). The derivation includes multiplying the
committed dose equivalent to an organ or tissue by a weighting factor,
wT. This weighting factor is the proportion of the risk
of stochastic effects resulting from irradiation of the organ or tissue, T, to
the total risk of stochastic effects when the whole body is irradiated
uniformly. The values of wT are listed under the
definition of "weighting factor" in subsection (c) of this section. The
non-stochastic ALIs were derived to avoid non-stochastic effects, such as
prompt damage to tissue or reduction in organ function.
(iii) A value of wT=
0.06 is applicable to each of the five organs or tissues in the "remainder"
category receiving the highest dose equivalents, and the dose equivalents of
all other remaining tissues may be disregarded. The following portions of the
GI tract; stomach, small intestine, upper large intestine, and lower large
intestine, are to be treated as four separate organs.
(iv) The dose equivalents for an extremity,
skin, and lens of the eye are not considered in computing the committed
effective dose equivalent, but are subject to limits that shall 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.
(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:
Attached Graphic
(ix) The DAC values relate to one
of two modes of exposure: either external submersion or the internal committed
dose equivalents resulting from inhalation of radioactive materials. DACs based
upon submersion are for immersion in a semi-infinite cloud of uniform
concentration and apply to each radionuclide separately.
(x) The ALI and DAC values include
contributions to exposure by the single radionuclide named and any in-growth of
daughter radionuclides produced in the body by decay of the parent. However,
intakes that include both the parent and daughter radionuclides should be
treated by the general method appropriate for mixtures.
(xi) The values of ALI and DAC do not apply
directly when the individual both ingests and inhales a radionuclide, when the
individual is exposed to a mixture of radionuclides by either inhalation or
ingestion or both, or when the individual is exposed to both internal and
external irradiation. See subsection (g) of this section. When an individual is
exposed to radioactive materials which fall under several of the translocation
classifications of the same radionuclide, such as, Class D, Class W, or Class
Y, the exposure may be evaluated as if it were a mixture of different
radionuclides.
(xii) It should be
noted that the classification of a compound as Class D, W, or Y is based on the
chemical form of the compound and does not take into account the radiological
half-life of different radionuclides. For this reason, values are given for
Class D, W, and Y compounds, even for very short-lived radionuclides.
(C) Effluent concentrations.
(i) The columns in Table II of subparagraph
(F) of this paragraph captioned "Effluents," "Air," and "Water" are applicable
to the assessment and control of dose to the public, particularly in the
implementation of the provisions of subsection (o) of this section. The
concentration values given in Columns 1 and 2 of Table II of subparagraph (F)
of this paragraph are equivalent to the radionuclide concentrations which, if
inhaled or ingested continuously over the course of a year, would produce a
total effective dose equivalent of 0.05 rem (0.5 mSv).
(ii) Consideration of non-stochastic limits
has not been included in deriving the air and water effluent concentration
limits because non-stochastic effects are presumed not to occur at or below the
dose levels established for individual members of the public. For
radionuclides, where the non-stochastic limit was governing in deriving the
occupational DAC, the stochastic ALI was used in deriving the corresponding
airborne effluent limit in Table II of subparagraph (F) of this paragraph. For
this reason, the DAC and airborne effluent limits are not always proportional
as they were in the previous radiation protection standards.
(iii) The air concentration values listed in
Column I of Table II of subparagraph (F) of this paragraph were derived by one
of two methods. For those radionuclides for which the stochastic limit is
governing, the occupational stochastic inhalation ALI was divided by 2.4 x
109, relating the inhalation ALI to the DAC, as
explained in subparagraph (B)(viii) of this paragraph, and then divided by a
factor of 300. The factor of 300 includes the following components:
(I) a factor of 50 to relate the 5 rems (0.05
Sv) annual occupational dose limit to the 0.1 rem limit for members of the
public;
(II) a factor of 3 to
adjust for the difference in exposure time and the inhalation rate for a worker
and that for members of the public; and
(III) a factor of 2 to adjust the
occupational values, derived for adults, so that they are applicable to other
age groups.
(iv) For
those radionuclides for which submersion, that is external dose, is limiting,
the occupational DAC in Column 3 of Table I of subparagraph (F) of this
paragraph was divided by 219. The factor of 219 is composed of a factor of 50,
as described in clause (iii) of this subparagraph, and a factor of 4.38
relating occupational exposure for 2,000 hours per year to full-time exposure
(8,760 hours per year). Note that an additional factor of 2 for age
considerations is not warranted in the submersion case.
(v) The water concentrations were derived by
taking the most restrictive occupational stochastic oral ingestion ALI and
dividing by 7.3 x 107. The factor of 7.3 x
107 milliliters (ml) includes the following
components:
(I) the factors of 50 and 2
described in clause (iii) of this subparagraph; and
(II) a factor of 7.3 x
105 ml which is the annual water intake of
"Reference Man."
(vi)
Note 2 of subparagraph (F) of this paragraph provides groupings of
radionuclides that are applicable to unknown mixtures of radionuclides. These
groupings, including occupational inhalation ALIs and DACs, air and water
effluent concentrations, and releases to sewer, require demonstrating that the
most limiting radionuclides in successive classes are absent. The limit for the
unknown mixture is defined when the presence of one of the listed radionuclides
cannot be definitely excluded as being present either from knowledge of the
radionuclide composition of the source or from actual measurements.
(D) Releases to sewers. The
monthly average concentrations for release to sanitary sewerage are applicable
to the provisions in subsection (gg) of this section. The concentration values
were derived by taking the most restrictive occupational stochastic oral
ingestion ALI and dividing by 7.3 x 106 ml. The
factor of 7.3 x 106 ml is composed of a factor of
7.3 x 105 ml, the annual water intake by "Reference
Man," and a factor of 10, such that the concentrations, if the sewage released
by the licensee were the only source of water ingested by a "Reference Man"
during a year, would result in a committed effective dose equivalent of 0.5
rem.
(E) List of elements.
Attached Graphic
(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:
Attached Graphic
(3) Quantities of
licensed material requiring labeling. The following tables contain quantities
of licensed material requiring labeling:
Attached Graphic
(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.
Attached Graphic
(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.
Attached Graphic
(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 shall all be
taken from the same column of the same table. The sum of the fractions for the
column shall 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/m3 (1.85 terabecquerels per cubic
meter (TBq/m3)) and Cs-137 in a concentration of 22
Ci/m3 (814 gigabecquerels per cubic meter
(GBq/m3)). Since the concentrations both exceed the
values in Column 1 of clause (iv)(VI) of this subparagraph, they shall 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.
Attached Graphic
(6) Acceptable surface
contamination levels.
Attached Graphic
(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.
Attached Graphic
(8) Cumulative occupational
exposure form. RC Form 202-2, found in the attached graphic, Figure: 25 TAC
§289.202(ggg)(8), or other equivalent clear and legible record of all the
information required on that form, must be used to document cumulative
occupational exposure history:
Attached
Graphic
(9)
Occupational exposure form. RC Form 202-3, found in the attached graphic,
Figure: 25 TAC §289.202(ggg)(9), or other equivalent clear and legible
record of all the information required on that form, must be used to document
occupational exposure record for a monitoring period:
Attached
Graphic
(hhh) Requirements for nationally tracked
sources.
(1) Reports of transactions involving
nationally tracked sources. Each licensee who manufactures, transfers,
receives, disassembles, or disposes of a nationally tracked source shall
complete and submit to NRC a National Source Tracking Transaction Report as
specified in the following subparagraphs for each type of transaction.
(A) Each licensee who manufactures a
nationally tracked source shall complete and submit to NRC a National Source
Tracking Transaction Report. The report shall include the following
information:
(i) the name, address, and
license number of the reporting licensee;
(ii) the name of the individual preparing the
report;
(iii) the manufacturer,
model, and serial number of the source;
(iv) the radioactive material in the
source;
(v) the initial source
strength in becquerels (curies) at the time of manufacture; and
(vi) the manufacture date of the
source.
(B) Each
licensee that transfers a nationally tracked source to another person shall
complete and submit to NRC a National Source Tracking Transaction Report. A
source transfer transaction does not include transfers to a temporary domestic
job site. Domestic transactions in which the nationally tracked source remains
in the possession of the licensee do not require a report to the National
Source Tracking System. The report shall include the following information:
(i) the name, address, and license number of
the reporting licensee;
(ii) the
name of the individual preparing the report;
(iii) the name and license number of the
recipient facility and the shipping address;
(iv) the manufacturer, model, and serial
number of the source or, if not available, other information to uniquely
identify the source;
(v) the
radioactive material in the source;
(vi) the initial or current source strength
in becquerels (curies);
(vii) the
date for which the source strength is reported;
(viii) the shipping date;
(ix) the estimated arrival date;
and
(x) for nationally tracked
sources transferred as waste under a Uniform Low-Level Radioactive Waste
Manifest, the waste manifest number and the container identification of the
container with the nationally tracked source.
(C) Each licensee that receives a nationally
tracked source shall complete and submit to NRC a National Source Tracking
Transaction Report. The report shall include the following information:
(i) the name, address, and license number of
the reporting licensee;
(ii) the
name of the individual preparing the report;
(iii) the name, address, and license number
of the person that provided the source;
(iv) the manufacturer, model, and serial
number of the source or, if not available, other information to uniquely
identify the source;
(v) the
radioactive material in the source;
(vi) the initial or current source strength
in becquerels (curies);
(vii) the
date for which the source strength is reported;
(viii) the date of receipt; and
(ix) for material received under a Uniform
Low-Level Radioactive Waste Manifest, the waste manifest number and the
container identification with the nationally tracked source.
(D) Each licensee that
disassembles a nationally tracked source shall complete and submit to NRC a
National Source Tracking Transaction Report. The report shall include the
following information:
(i) the name, address,
and license number of the reporting licensee;
(ii) the name of the individual preparing the
report;
(iii) the manufacturer,
model, and serial number of the source or, if not available, other information
to uniquely identify the source;
(iv) the radioactive material in the
source;
(v) the initial or current
source strength in becquerels (curies);
(vi) the date for which the source strength
is reported; and
(vii) the
disassemble date of the source.
(E) Each licensee who disposes of a
nationally tracked source shall complete and submit to NRC a National Source
Tracking Transaction Report. The report shall include the following
information:
(i) the name, address, and
license number of the reporting licensee;
(ii) the name of the individual preparing the
report;
(iii) the waste manifest
number;
(iv) the container
identification with the nationally tracked source;
(v) the date of disposal; and
(vi) the method of disposal.
(F) The reports discussed in
subparagraphs (A) - (E) of this paragraph shall be submitted to NRC by the
close of the next business day after the transaction. A single report may be
submitted for multiple sources and transactions. The reports shall be submitted
to the National Source Tracking System by using the following:
(i) the on-line National Source Tracking
System;
(ii) electronically using a
computer-readable format;
(iii) by
facsimile;
(iv) by mail to the
address on the National Source Tracking Transaction Report Form (NRC Form 748);
or
(v) by telephone with follow-up
by facsimile or mail.
(G) Each licensee shall correct any error in
previously filed reports or file a new report for any missed transaction within
5 business days of the discovery of the error or missed transaction. Such
errors may be detected by a variety of methods such as administrative reviews
or by physical inventories required by regulation. In addition, each licensee
shall reconcile the inventory of nationally tracked sources possessed by the
licensee against that licensee's data in the National Source Tracking System.
The reconciliation shall be conducted during the month of January in each year.
The reconciliation process shall include resolving any discrepancies between
the National Source Tracking System and the actual inventory by filing the
reports identified by subparagraphs (A) - (E) of this paragraph. By January 31
of each year, each licensee shall submit to the National Source Tracking System
confirmation that the data in the National Source Tracking System is
correct.
(H) Each licensee that
possesses Category 1 or Category 2 nationally tracked sources listed in
paragraph (2) of this subsection shall report its initial inventory of Category
1 or Category 2 nationally tracked sources to the National Source Tracking
System by January 31, 2009. The information may be submitted to NRC by using
any of the methods identified by subparagraph (F)(i) - (iv) of this paragraph.
The initial inventory report shall include the following information:
(i) the name, address, and license number of
the reporting licensee;
(ii) the
name of the individual preparing the report;
(iii) the manufacturer, model, and serial
number of each nationally tracked source or, if not available, other
information to uniquely identify the source;
(iv) the radioactive material in the sealed
source;
(v) the initial or current
source strength in becquerels (curies); and
(vi) the date for which the source strength
is reported.
(2) Nationally tracked source thresholds. The
Terabecquerel (TBq) values are the regulatory standards. The curie (Ci) values
specified are obtained by converting from the TBq value. The curie values are
provided for practical usefulness only and are rounded after conversion.
Attached Graphic
(3) Serialization of nationally
tracked sources. Each licensee who manufactures a nationally tracked source
after February 6, 2007, shall assign a unique serial number to each nationally
tracked source. Serial numbers shall be composed only of alpha-numeric
characters.