W. Va. Code R. § 64-23-6 - Standards for Protection Against Radiation
6.1. Purpose and Scope
6.1.a. Except as specifically provided in
other Sections of this rule, this Section applies to persons registered by the
agency to receive, possess, use, transfer, or dispose of sources of radiation.
The limits in this part do not apply to doses due to background radiation, to
exposure of patients to radiation for the purpose of medical diagnosis or
therapy, or to voluntary participation in medical research programs.
6.1.b. The requirements of this Section are
designed to control the receipt, possession, use, transfer, and disposal of
sources of radiation by any registrant 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.
6.2.
Definitions - As used in this Section, the following definitions apply:
6.2.a. 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 the reference man that would result
in a committed effective dose equivalent of five one-hundredths (0.05) Sv (five
(5) Rem) or a committed dose equivalent of five- tenths (0.5) Sv (fifty (50)
Rem) to any individual organ or tissue. ALI values for intake by ingestion and
by inhalation of selected radionuclides are given in Table 64-23 F, Columns 1
and 2.
6.2.b. 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 applies to a range of clearance half-times: for Class D, days, of less
than ten (10) days, for Class W, weeks, from ten (10) to one hundred (100) days
, and for Class Y, years, of greater than one hundred (100) days. For purposes
of this rule, "lung class" and "inhalation class" are equivalent
terms.
6.2.c. Declared Pregnant
Woman - a woman who has voluntarily informed her employer, in writing, of her
pregnancy and the estimated date of conception.
6.2.d. Derived Air Concentration (DAC) - the
concentration of a given radionuclide in air which, if breathed by the
reference man for a working year of two thousand (2,000) hours under conditions
of light work, results in an intake of one ALI. For purposes of this rule, the
condition of light work is an inhalation rate of one and two-tenths (1.2) cubic
meters of air per hour for two thousand (2,000) hours in a year. DAC values are
given in Table 64-23 F, Table I, Column 3.
6.2.e. 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
registrant may take two thousand (2,000) DAC-hours to represent one ALI,
equivalent to a committed effective dose equivalent of five one-hundredths
(0.05) Sv (five [5] Rem).
6.2.f.
Dosimetry Processor - an individual or an organization that processes and
evaluates individual monitoring devices in order to determine the radiation
dose delivered to the monitoring devices.
6.2.g. Inhalation 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
applies to a range of clearance half-times: for Class D, days, of less than ten
(10) days, for Class W, weeks, from ten (10) to one hundred (100) days , and
for Class Y, years, of greater than one hundred (100) days.
6.2.h. Lung 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 applies to a
range of clearance half-times: for Class D, days, of less than ten (10) days,
for Class W, weeks, from ten (10) to one hundred (100) days , and for Class Y,
years, of greater than one hundred (100) days.
6.2.i. 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 rule, "deterministic effect" is an
equivalent term.
6.2.j. Planned
Special Exposure - an infrequent exposure to radiation, separate from and in
addition to the annual occupational dose limits.
6.2.k. Quarter - a period of time equal to
one-fourth of the year observed by the registrant, approximately thirteen (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.
6.2.l. 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 the reference man is
contained in the International Commission on Radiological Protection Report,
ICRP publication 23, "Report of the Task Group on Reference Man."
6.2.m. Respiratory Protective Equipment - an
apparatus, such as a respirator, used to reduce an individual's intake of
airborne radioactive materials.
6.2.n. 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
registrant.
6.2.o. 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 rule, "probabilistic
effect" is an equivalent term.
6.2.p. Very High Radiation Area - an area,
accessible to individuals, in which radiation levels could result in an
individual receiving an absorbed dose in excess of five (5) Gy (five hundred
[500] Rad) in one (1) hour at one (1) meter from a source of radiation or from
any surface that the radiation
penetrates.1
6.2.q. 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 listed in Table 64-23 C.
6.3. Implementation
6.3.a. Any existing registration condition
that is more restrictive than Section 6. remains in force until there is an
amendment or renewal of the registration.
6.3.b. If a registration condition exempts a
registrant from a provision of Section 6. in effect on or before July 1, 2001,
it also exempts the registrant from the corresponding provision of Section
6.
6.3.c. If a registration
condition cites provisions of Section 6. in effect prior to July 1, 2001, which
do not correspond to any provisions of Section 6., the registration condition
remains in force until there is an amendment or renewal of the registration
that modifies or removes this condition.
6.4. Radiation Protection Programs.
6.4.a. Each registrant shall develop,
document, and implement a radiation protection program sufficient to ensure
compliance with the provisions of Section 6. See Subsection 6.41. for record
keeping requirements relating to these programs.
6.4.b. The registrant 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).
6.4.c. The registrant shall, at intervals not
to exceed twelve (12) months, review the radiation protection program content
and implementation.
6.5.
Occupational Dose Limits for Adults.
6.5.a.
The registrant shall control the occupational dose to individual adults, except
for planned special exposures pursuant to Subsection 6.10. to the following
dose limits:
6.5.a.1. An annual limit, which
is the more limiting of:
6.5.a.1.A. The total
effective dose equivalent being equal to five one-hundredths (0.05) Sv (five
[5] Rem); or
6.5.a.1.B. 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 five-tenths (0.5)
Sv (fifty [50] Rem).
6.5.a.2. The annual limits to the lens of the
eye, to the skin, and to the extremities which are listed in Table 64-23 D.
6.5.a.2.A. An eye dose equivalent of fifteen
one hundredths .15 Sv; and
6.5.a.2.B. A shallow dose equivalent of
five-tenths (0.5) Sv (fifty [50] Rem) to the skin or to any
extremity.
6.5.b. 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 Paragraphs 6.10.f.1. and 2.
6.5.c. The assigned deep dose equivalent and
shallow dose equivalent shall be for the portion of the body receiving the
highest exposure:
6.5.c.1. The deep dose
equivalent, eye 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; or
6.5.c.2. When a protective apron is worn
while working with medical fluoroscopic equipment and monitoring is conducted
as specified in Section 6.17.a.5., the effective dose equivalent for external
radiation shall be determined as follows:
6.5.c.2.A. When only one individual
monitoring device is used and it is located at the neck outside the protective
apron, the reported deep dose equivalent shall be the effective dose equivalent
for external radiation; or
6.5.c.2.B. When only one individual
monitoring device is used and it is located at the neck outside the protective
apron, and the reported dose exceeds twenty-five (25) percent of the limit
specified in Subdivision 6.5.a., the reported deep dose equivalent value
multiplied by three-tenths (0.3) shall be the effective dose equivalent for
external radiation; or
6.5.c.2.C.
When individual monitoring devices are worn, both under the protective apron at
the waist and outside the protective apron at the neck, the effective dose
equivalent for external radiation shall be assigned the value of the sum of the
deep dose equivalent reported for the individual monitoring device located at
the waist under the protective apron multiplied by one and five-tenths (1.5)
and the deep dose equivalent reported for the individual monitoring device
located at the neck outside the protective apron multiplied by four
one-hundredths (0.04).
6.5.d. Derived air concentration (DAC) and
annual limit on intake (ALI) values are specified in Table 64-23 F Table I and
may be used to determine the individual's dose and to demonstrate compliance
with the occupational dose limits. See Subsection 6.46.
6.5.e. Notwithstanding the annual dose
limits, the or registrant shall limit the soluble uranium intake by an
individual to ten (10) milligrams in a week in consideration of chemical
toxicity (footnote c of Table 64-23 F).
6.5.f. The registrant shall reduce the dose
that an individual may be allowed to receive in the current year by the amount
of occupational dose received while employed by any other person during the
current year (Subsection 6.9).
6.6. Compliance with Requirements for
Summation of External and Internal Doses.
6.6.a. If the registrant is required to
monitor pursuant to both Subdivisions 6.17.a. and b., the registrant shall
demonstrate compliance with the dose limits by summing external and internal
doses. If the registrant is required to monitor only pursuant to Subdivision
6.17.a. or only pursuant to Subdivision 6.17.b., then summation is not required
to demonstrate compliance with the dose limits. The registrant may demonstrate
compliance with the requirements for summation of external and internal doses
pursuant to Subdivisions 6.6.b., c. and d. 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.
6.6.b. Intake by Inhalation. 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:
6.6.b.1. The sum of the
fractions of the inhalation ALI or each radionuclide; or
6.6.b.2. The total number of derived air
concentration-hours (DAC-hours) for all radionuclides divided by two thousand
(2,000); or
6.6.b.3. 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 ten (10) percent
of the maximum weighted value of HT,50, that is,
wTHT,50, per unit intake for any
organ or tissue.
6.6.c.
Intake by Oral Ingestion. If the occupationally exposed individual receives an
intake of radionuclides by oral ingestion greater than ten (10) percent of the
applicable oral ALI, the registrant shall account for this intake and include
it in demonstrating compliance with the limits.
6.6.d. Intake through Wounds or Absorption
through Skin. The registrant 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 pursuant to Subsection
6.6.d.
6.6.e. Orders Requiring
Furnishing of Bioassay Services - Where necessary or desirable in order to aid
in determining the extent of an individual's exposure to concentrations of
radioactive material, the agency may incorporate registration provisions or
issue an order requiring a registrant to make available to the individual
appropriate bioassay services and to furnish a copy of the reports of such
services to the agency.
6.7. Determination of External Dose from
Airborne Radioactive Material.
6.7.a.
Registrants 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 Table 64-23-F, footnotes a
and b.
6.7.b. 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.
6.8.
Determination of Internal Exposure.
6.8.a.
For purposes of assessing dose used to determine compliance with occupational
dose equivalent limits, the registrant shall, when required pursuant to
Subsection 6.17., take suitable and timely measurements of:
6.8.a.1. Concentrations of radioactive
materials in air in work areas; or
6.8.a.2. Quantities of radionuclides in the
body; or
6.8.a.3. Quantities of
radionuclides excreted from the body; or
6.8.a.4. Combinations of these
measurements.
6.8.b.
Unless respiratory protective equipment is used, as provided in Section 6.24.,
or the assessment of intake is based on bioassays, the registrant shall assume
that an individual inhales radioactive material at the airborne concentration
in which the individual is present.
6.8.c. 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 registrant may:
6.8.c.1. Use that information to calculate
the committed effective dose equivalent, and, if used, the registrant shall
document that information in the individual's record; and
6.8.c.2. 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
6.8.c.3. 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 Table 64-23 F.
6.8.d. If the registrant chooses
to assess intakes of class y material using the measurements given in Paragraph
6.8.a.2. or 3., the registrant may delay the recording and reporting of the
assessments for periods up to seven (7) months, unless otherwise required by
Subsections 6.42. or 6.43. This delay permits the registrant to make additional
measurements basic to the assessments.
6.8.e. 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:
6.8.e.1. The sum of the ratios of the
concentration to the appropriate DAC value, that is, D, W, or Y, from Table
64-23 F for each radionuclide in the mixture; or
6.8.e.2. The ratio of the total concentration
for all radionuclides in the mixture to the most restrictive DAC value for any
radionuclide in the mixture.
6.8.f. 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.
6.8.g. When a mixture of radionuclides in air
exists, a registrant may disregard certain radionuclides in the mixture if:
6.8.g.1. The registrant uses the total
activity of the mixture in demonstrating compliance with the dose limits in
Subsection 6.5. and in complying with the monitoring requirements in Paragraph
6.17.b.; and
6.8.g.2. The
concentration of any radionuclide disregarded is less than ten (10) percent of
its DAC; and
6.8.g.3. The sum of
these percentages for all of the radionuclides disregarded in the mixture does
not exceed thirty (30) percent.
6.8.h. When determining the committed
effective dose equivalent, the following information may be considered:
6.8.h.1. In order to calculate the committed
effective dose equivalent, the registrant may assume that the inhalation of one
ALI, or an exposure of two thousand (2,000) DAC-hours, results in a committed
effective dose equivalent of five one-hundredths (0.05) Sv (five [5] Rem) for
radionuclides that have their ALIs or DACS based on the committed effective
dose equivalent;
6.8.h.2. For an
ALI and the associated DAC determined by the nonstochastic organ dose limit of
five tenths (0.5) Sv (fifty [50] Rem), the intake of radionuclides that would
result in a committed effective dose equivalent of five one-hundredths (0.05)
Sv (five [5] Rem), that is, the stochastic ALI, is listed in parentheses in
Table I of Table 64-23 F. The registrant may, as a simplifying assumption, use
the stochastic ALI to determine committed effective dose equivalent. However,
if the registrant uses the stochastic ALI, the registrant shall also
demonstrate that the limit in Subparagraph 6.5.a.1.B. is met.
6.9. Determination of
Prior Occupational Dose.
6.9.a. For each
individual who may enter the registrant's restricted area and is likely to
receive, in a year, an occupational dose requiring monitoring pursuant to
Subsection 6.17. the registrant shall:
6.9.a.1. Determine the occupational radiation
dose received during the current year; and
6.9.a.2. Attempt to obtain the records of
lifetime cumulative occupational radiation dose.
6.9.b. Prior to permitting an individual to
participate in a planned special exposure, the registrant shall determine:
6.9.b.1. The internal and external doses from
all previous planned special exposures; and
6.9.b.2. All doses in excess of the limits,
including doses received during accidents and emergencies, received during the
lifetime of the individual.
6.9.c. In complying with the requirements of
Subdivision 6.9.a., a registrant may:
6.9.c.1. 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 most
recent employer for work involving radiation exposure, that discloses the
nature and the amount of any occupational dose that the individual received
during the current year; and
6.9.c.2. Accept, as the record of lifetime
cumulative radiation dose, an up-to-date Agency Form Y 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 registrant; and
6.9.c.3. Obtain reports of the individual's
dose equivalent from the most recent employer for work involving radiation
exposure, or the individual's current employer, if the individual is not
employed by the registrant, by telephone, telegram, facsimile, or letter. The
registrant shall request a written verification of the dose data if the
authenticity of the transmitted report cannot be established.
6.9.d. The registrant shall record
the exposure history, as required by Subdivision 6.9.a., on Agency Form Y, 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
registrant obtains reports, the registrant shall use the dose shown in the
report in preparing Agency Form Y or equivalent. For any period in which the
registrant does not obtain a report, the registrant shall place a notation on
Agency Form Y or equivalent indicating the periods of time for which data are
not available.
6.9.e. Registrants
are not required to partition historical dose between external dose equivalent
and internal committed dose equivalent. Further, occupational exposure
histories obtained and recorded on Agency Form Y or equivalent before July 1,
2001, might not have included effective dose equivalent, but may be used in the
absence of specific information on the intake of radionuclides by the
individual.
6.9.f. If the
registrant is unable to obtain a complete record of an individual's current and
previously accumulated occupational dose, the registrant shall assume:
6.9.f.1. In establishing administrative
controls pursuant to Subdivision 6.5.f. for the current year, that the
allowable dose limit for the individual is reduced by twelve and five tenths
(12.5) mSv (one and twenty five one-hundredths [1.25] Rem) for each quarter for
which records were unavailable and the individual was engaged in activities
that could have resulted in occupational radiation exposure; and
6.9.f.2. That the individual is not available
for planned special exposures.
6.9.g. The registrant shall retain the
records on Agency Form Y or equivalent until the agency terminates each
pertinent registration requiring this record. The registrant shall retain
records used in preparing Agency Form Y or equivalent for three (3) years after
the record is made.
6.10. Planned Special Exposures.
6.10.a. A registrant 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 6.5. provided that each
of the following conditions is satisfied:
6.10.b. The registrant authorizes a planned
special exposure only in an exceptional situation when alternatives that might
avoid the higher exposure are unavailable or impractical;
6.10.c. The registrant, and employer if the
employer is not the registrant, specifically authorizes the planned special
exposure, in writing, before the exposure occurs;
6.10.d. Before a planned special exposure,
the registrant ensures that each individual involved is:
6.10.d.1. Informed of the purpose of the
planned operation; and
6.10.d.2.
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
6.10.d.3. Instructed in
the measures to be taken to keep the dose ALARA considering other risks that
may be present;
6.10.e.
Prior to permitting an individual to participate in a planned special exposure,
the registrant ascertains prior doses as required by subdivision 6.9.b. during
the lifetime of the individual for each individual involved;
6.10.f. Subject to Subdivision 6.5.b., the
registrant 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:
6.10.f.1.
The numerical values of any of the dose limits in Subdivision 6.5.a. in any
year; and
6.10.f.2. Five (5) times
the annual dose limits in Subdivision 6.5.a. during the individual's
lifetime;
6.10.g. The
registrant maintains records of the conduct of a planned special exposure in
accordance with Subsection 6.45. and submits a written report in accordance
with Subsection 6.55.;
6.10.h. The
registrant 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 thirty (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 pursuant
to Subdivision 6.5.a. but shall be included in evaluations required by
Subdivisions 6.10.d. and e.
6.11. Occupational Dose Limits for Minors.
The annual occupational dose limits for minors are ten (10) percent of the
annual occupational dose limits specified for adult workers in Subsection
6.5.
6.12. Dose to an Embryo or
Fetus.
6.12.a. The registrant shall ensure
that the dose to an embryo or fetus during the entire pregnancy, due to
occupational exposure of a declared pregnant woman, does not exceed five (5)
mSv [five-tenths (0.5 Rem)]. See Subsection 6.46. for record keeping
requirements.
6.12.b. The
registrant shall make efforts to avoid substantial variation
2above a uniform monthly
exposure rate to a declared pregnant woman so as to satisfy the limit in
Subdivision 6.12.a.
6.12.c. The
dose to an embryo or fetus shall be taken as the sum of:
6.12.c.1. The dose to the embryo or fetus
from radionuclides in the embryo or fetus and radionuclides in the declared
pregnant woman; and
6.12.c.2. The
dose that is most representative of the dose to the embryo or fetus from
external radiation, that is, in the mother's lower torso region.
6.12.c.2.A. If multiple measurements have not
been made, assignment of the highest deep dose equivalent for the declared
pregnant woman shall be the dose to the embryo or fetus, in accordance with
Subdivision 6.9.c.; or
6.12.c.2.B.
If multiple measurements have been made, assignment of the deep dose equivalent
for the declared pregnant woman from the individual monitoring device which is
most representative of the dose to the embryo or fetus shall be the dose to the
embryo or fetus. Assignment of the highest deep dose equivalent for the
declared pregnant woman to the embryo or fetus is not required unless that dose
is also the most representative deep dose equivalent for the region of the
embryo or fetus.
6.12.d. If by the time the woman declares
pregnancy to the registrant, the dose to the embryo or fetus has exceeded four
and five-tenths (4.5) mSv (forty-five one-hundredths [0.45 Rem]), the or
registrant shall be deemed to be in compliance with Section 6.12.a. if the
additional dose to the embryo or fetus does not exceed five-tenths (0.5) mSv
(five one-hundredths [0.05] Rem) during the remainder of the
pregnancy.
6.13. Dose
Limits for Individual Members of the Public.
6.13.a. Each registrant shall conduct
operations so that:
6.13.a.1. Except as
provided in item 6.13.a.3., the total effective dose equivalent to individual
members of the public from the registered operation does not exceed one (1) mSv
(one-tenth [0.1] Rem) in a year, exclusive of the dose contribution from the
registrant's disposal of radioactive material into sanitary sewerage in
accordance with Subsection 6.35.; and
6.13.a.2. The dose in any unrestricted area
from external sources does not exceed two one-hundredths (0.02) mSv (two
one-thousandths [0.002] Rem) in any one hour; and
6.13.a.3. The total effective dose equivalent
to individual members of the public from infrequent exposure to radiation from
radiation machines does not exceed five (5) mSv (five-tenths [0.5]
Rem).
6.13.b. If the
registrant permits members of the public to have access to restricted areas,
the limits for members of the public continue to apply to those
individuals.
6.13.c. A registrant
or an applicant for registration may apply for prior agency authorization to
operate up to an annual dose limit for an individual member of the public of
five (5) mSv (five-tenths [0.5] Rem). This application shall include the
following information:
6.13.c.1.
Demonstration of the need for and the expected duration of operations in excess
of the limit in 6.13.a.; and
6.13.c.2. The registrant's program to assess
and control dose within the five (5) mSv (five-tenths [0.5] Rem) annual limit;
and
6.13.c.3. The procedures to be
followed to maintain the dose ALARA.
6.13.d. In addition to the requirements of
Section 6., a registrant subject to the provisions of the United States
Environmental Protection Agency's generally applicable Environmental Radiation
Standards in 40 CFR 190 shall comply with those standards.
6.13.e. The agency may impose additional
restrictions on radiation levels in unrestricted areas and on the total
quantity of radionuclides that a registrant may release in effluents in order
to restrict the collective dose.
6.14. Compliance with Dose Limits for
Individual Members of the Public.
6.14.a. The
registrant 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 in Subsection 6.13.
6.14.b. A registrant shall show compliance
with the annual dose limit in Subsection 6.13. by:
6.14.b.1. Demonstrating by measurement or
calculation that the total effective dose equivalent to the individual likely
to receive the highest dose from the registered operation does not exceed the
annual dose limit; or
6.14.b.2.
Demonstrating that:
6.14.b.2.A. 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 Table 64-23 F; and
6.14.b.2.B. If an individual were
continuously present in an unrestricted area, the dose from external sources
would not exceed two one-hundredths (0.02) mSv (two one-thousandths [0.002]
Rem) in an hour and five-tenths (0.5) mSv (five one-hundredths [0.05] Rem) in a
year.
6.14.c.
Upon approval from the agency, the registrant may adjust the effluent
concentration values in Table 64-23 F, or 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.
6.15. Testing for Leakage or Contamination of
Sealed Sources.
6.15.a. The registrant in
possession of any sealed source shall assure that:
6.15.a.1. Each sealed source, except as
specified in Subdivision 6.15.b., is tested for leakage or contamination and
the test results are received before the sealed source is put into use unless
the registrant has a certificate from the transferor indicating that the sealed
source was tested within six (6) months before transfer to the registrant
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);
6.15.a.2. Each sealed source that is not
designed to emit alpha particles is tested for leakage or contamination at
intervals not to exceed 6 months or at alternative intervals approved by the
agency, after evaluation of information specified by of this rule, an agreement
state, a licensing state, or the Nuclear Regulatory Commission;
6.15.a.3. Each sealed source that is designed
to emit alpha particles is tested for leakage or contamination at intervals not
to exceed 3 months or at alternative intervals approved by the agency, after
evaluation of information specified by this rule, an agreement state, a
licensing state, or the Nuclear Regulatory Commission;
6.15.a.4. For each sealed source that is
required to be tested for leakage or contamination, at any other time there is
reason to suspect that the sealed source might have been damaged or might be
leaking, the registrant shall assure that the sealed source is tested for
leakage or contamination before further use;
6.15.a.5. Tests for leakage for all sealed
sources, except brachytherapy sources manufactured to contain radium, shall be
capable of detecting the presence of one hundred eighty-five (185) Bq (five
one-thousandths [0.005] :Ci) of radioactive material on a test sample. Test
samples shall be taken from the sealed source or from the surfaces of the
container in which the sealed source is stored or mounted on which one might
expect contamination to accumulate. For a sealed source contained in a device,
test samples are obtained when the source is in the "off" position;
6.15.a.6. The test for leakage for
brachytherapy sources manufactured to contain radium shall be capable of
detecting an absolute leakage rate of thirty-seven (37) Bq (one one-thousandths
[0.001] :Ci) of Radon-222 in a twenty-four 24 hour period when the collection
efficiency for Radon-222 and its daughters has been determined with respect to
collection method, volume and time;
6.15.a.7. Tests for contamination from radium
daughters shall be taken on the interior surface of brachytherapy source
storage containers and shall be capable of detecting the presence of one
hundred eighty-five (185) Bq (five one-thousandths [0.005] :Ci) of a radium
daughter which has a half-life greater than four (4) days.
6.15.b. A registrant need not perform test
for leakage or contamination on the following sealed sources:
6.15.b.1. Sealed sources containing only
radioactive material with a half-life of less than thirty (30) days;
6.15.b.2. Sealed sources containing only
radioactive material as a gas;
6.15.b.3. Sealed sources containing three and
seven-tenth (3.7) MBq (one hundred [100] :Ci) or less of beta or
photon-emitting material or three hundred seventy (370) kBq (ten [10] :Ci) or
less of alpha-emitting material;
6.15.b.4. Sealed sources containing only
hydrogen-3;
6.15.b.5. Seeds of
Iridium-192 encased in nylon ribbon; and
6.15.b.6. Sealed sources, except teletherapy
and brachytherapy sources, which are stored, not being used and identified as
in storage. The registrant shall, however, test each such sealed source for
leakage or contamination and receive the test results before any use or
transfer unless it has been tested for leakage or contamination within six (6)
months before the date of use or transfer.
6.15.c. Tests for leakage or contamination
from sealed sources shall be performed by persons specifically authorized by
the agency, an agreement state, a licensing state, or the Nuclear Regulatory
Commission to perform such services.
6.15.d. Test results shall be kept in units
of becquerel or microcurie and maintained for inspection by the agency. Records
of test results for sealed sources shall be made pursuant to Subsection
6.43.
6.15.e. The following shall
be considered evidence that a sealed source is leaking:
6.15.e.1. The presence of one hundred
eighty-five (185) Bq (five one-thousandths [0.005] :Ci) or more of removable
contamination on any test sample;
6.15.e.2. Leakage of thirty-seven (37) Bq
(one one-thousandth [0.001] :Ci) of Radon-222 per twenty four (24) hours for
brachytherapy sources manufactured to contain radium;
6.15.e.3. The presence of removable
contamination resulting from the decay of one hundred eighty-five (185) Bq
(five one-thousandths [0.005] :Ci) or more of radium.
6.15.f. The registrant shall immediately
withdraw a leaking sealed source from use and shall take action to prevent the
spread of contamination. The leaking sealed source shall be repaired or
disposed of in accordance with this Section.
6.15.g. Reports of test results for leaking
or contaminated sealed sources shall be made pursuant to Subsection
6.58.
6.16. Surveys and
Monitoring
6.16.a. Each registrant shall
make, or cause to be made, surveys that:
6.16.a.1. Are necessary for the registrant to
comply with Section 6.; and
6.16.a.2. Are necessary under the
circumstances to evaluate:
6.16.a.2.A.
Radiation levels; and
6.16.a.2.B.
Concentrations or quantities of radioactive material; and
6.16.a.2.C. The potential radiological
hazards that could be present.
6.16.b. The registrant shall ensure that
instruments and equipment used for quantitative radiation measurements, for
example, dose rate and effluent monitoring, are calibrated at intervals not to
exceed twelve (12) months for the radiation measured, except when a more
frequent interval is specified in another applicable Section of this
rule.
6.16.c. All personnel
dosimeters, except for direct and indirect reading pocket ionization chambers
and those dosimeters used to measure the dose to any extremity, that require
processing to determine the radiation dose and that are used by registrants to
comply with Subsection 6.5., with other applicable provisions of this rule, or
with conditions specified in a registration shall be processed and evaluated by
a dosimetry processor:
6.16.c.1. Holding
current personnel dosimetry accreditation from the national voluntary
laboratory accreditation program of the national institute of standards and
technology; and
6.16.c.2. Approved
in this accreditation process for the type of radiation or radiations included
in the national voluntary laboratory accreditation program that most closely
approximates the type of radiation or radiations for which the individual
wearing the dosimeter is monitored.
6.16.d. The registrant shall ensure that
adequate precautions are taken to prevent a deceptive exposure of an individual
monitoring device.
6.17.
Conditions Requiring Individual Monitoring of External and Internal
Occupational Dose.
6.17.a. Each registrant
shall monitor exposures from sources of radiation at levels sufficient to
demonstrate compliance with the occupational dose limits of Section 6. As a
minimum:
6.17.a.1. Each registrant shall
monitor occupational exposure to radiation and shall supply and require the use
of individual monitoring devices by:
6.17.a.2. Adults likely to receive, in 1 year
from sources external to the body, a dose in excess of 10 percent of the limits
in Subdivision 6.5.a.;
6.17.a.3.
Minors and declared pregnant women likely to receive, in 1 year from sources
external to the body, a dose in excess of ten (10) percent of any of the
applicable limits in Subsection 6.11. or Subsection 6.12.;
6.17.a.4. Individuals entering a high or very
high radiation area; and
6.17.a.5.
Individuals working with medical fluoroscopic equipment;
6.17.a.5.A. An individual monitoring device
used for the dose to an embryo or fetus of a declared pregnant woman, pursuant
to Subdivision 6.12.a., shall be located under the protective apron at the
waist;
6.17.a.5.B. An individual
monitoring device used for eye dose equivalent shall be located at the neck, or
an unshielded location closer to the eye, outside the protective apron;
and
6.17.a.5.C. When only 1
individual monitoring device is used to determine the effective dose equivalent
for external radiation pursuant to Paragraph 6.5.c.2., it shall be located at
the neck outside the protective apron. When a second individual monitoring
device is used, for the same purpose, it shall be located under the protective
apron at the waist. The second individual monitoring device is required for a
declared pregnant woman.
6.17.b. Each registrant shall monitor, to
determine compliance with Subsection 6.8., the occupational intake of
radioactive material by and assess the committed effective dose equivalent to:
6.17.b.1. Adults likely to receive, in one
(1) year, an intake in excess of ten (10) percent of the applicable ALI in
Table I, Columns 1 and 2, of Table 64-23 F; and
6.17.b.2. Minors and declared pregnant women
likely to receive, in one(1) year, a committed effective dose equivalent in
excess of five tenths (0.5) mSv (five one-hundredths [0.05] Rem).
6.18. Location of
Individual Monitoring Devices.
6.18.a. Each
registrant shall ensure that individuals who are required to monitor
occupational doses in accordance with Subdivision 6.17.a. wear individual
monitoring devices as follows:
6.18.a.1. 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);
6.18.a.2. An individual monitoring device
used for monitoring the dose to an embryo or fetus of a declared pregnant
woman, pursuant to Subdivision 6.12.a., shall be located at the waist under any
protective apron being worn by the woman;
6.18.a.3. An individual monitoring device
used for monitoring the eye dose equivalent, to demonstrate compliance with
Subparagraph 6.5.a.2.A., shall be located at the neck (collar), outside any
protective apron being worn by the monitored individual, or at an unshielded
location closer to the eye;
6.18.a.4. An individual monitoring device
used for monitoring the dose to the extremities, to demonstrate compliance with
Paragraph 6.5.a.2., shall be worn on the extremity likely to receive the
highest exposure. Each individual monitoring device shall be oriented to
measure the highest dose to the extremity being monitored;
6.18.a.5. An individual monitoring device
used for monitoring the dose to an embryo or fetus of a declared pregnant
woman, pursuant to Subdivision 6.12.a., shall be located at the waist under any
protective apron being worn by the woman;
6.18.a.6. An individual monitoring device
used for monitoring the eye dose equivalent, to demonstrate compliance with
Subparagraph 6.5.a.2.A., shall be located at the neck (collar), outside any
protective apron being worn by the monitored individual, or at an unshielded
location closer to the eye;
6.18.a.7. An individual monitoring device
used for monitoring the dose to the extremities, to demonstrate compliance with
Subparagraph 6.5.a.2.B., shall be worn on the extremity likely to receive the
highest exposure. Each individual monitoring device shall be oriented to
measure the highest dose to the extremity being monitored.
6.19. Control of Access to High
Radiation Areas.
6.19.a. The registrant shall
ensure that each entrance or access point to a high radiation area has one or
more of the following features:
6.19.a.1. 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 one (1) mSv (one-tenth [0.1] Rem) in one (1) hour at thirty (30)
centimeters from the source of radiation or from any surface that the radiation
penetrates; or
6.19.a.2. 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
6.19.a.3. Entryways that are locked, except
during periods when access to the areas is required, with positive control over
each individual entry.
6.19.b. In place of the controls required by
Subdivision 6.19.a. for a high radiation area, the registrant may substitute
continuous direct or electronic surveillance that is capable of preventing
unauthorized entry.
6.19.c. The
registrant may apply to the agency for approval of alternative methods for
controlling access to high radiation areas.
6.19.d. The registrant shall establish the
controls required by Subdivisions 6.19.a. and c. in a way that does not prevent
individuals from leaving a high radiation area.
6.19.e. The registrant 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 rules of the
Department of Transportation provided that:
6.19.e.1. The packages do not remain in the
area longer than three (3) days; and
6.19.e.2. The dose rate at 1 meter from the
external surface of any package does not exceed one tenth (0.1) mSv (one
one-hundredth [0.01] Rem) per hour.
6.19.f. The registrant 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 radiation or radioactive material in
excess of the established limits in Section 6. and to operate within the ALARA
provisions of the registrant's radiation protection program.
6.19.g. The registrant is not required to
control entrance or access to rooms or other areas containing sources of
radiation capable of producing a high radiation area as described in Subsection
6.19. if the registrant has met all the specific requirements for access and
control specified in other applicable Sections of this rule, such as, Section
7. for x-rays in the healing arts, Section 9. for industrial radiography, and
Section 10. for particle accelerators.
6.20. Control of Access to Very High
Radiation Areas.
6.20.a. In addition to the
requirements in Subsection 6.19., the registrant shall institute measures to
ensure that an individual is not able to gain unauthorized or inadvertent
access to areas in which radiation levels could be encountered at five (5) Gy
(five hundred [500] Rad) or more in one (1) hour at one (1) meter from a source
of radiation or any surface through which the radiation penetrates. This
requirement does not apply to rooms or areas in which diagnostic x-ray systems
are the only source of radiation, or to non-self-shielded
irradiators.
6.20.b. The registrant
is not required to control entrance or access to rooms or other areas
containing sources of radiation capable of producing a very high radiation area
as described in Subdivision 6.20.a. if the registrant has met all the specific
requirements for access and control specified in other applicable Sections of
this rule, such as, Section 7. for x- rays in the healing arts, Section 9. for
industrial radiography, and Section 10. for particle accelerators.
6.21. Control of Access to Very
High Radiation Areas -- Irradiators.
6.21.a.
Subsection 6.21. applies to registrants with sources of radiation in
non-self-shielded irradiators. Subsection 6.21. 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.
6.21.b. Each area in which there may exist
radiation levels in excess of five (5) Gy (five hundred [500] Rad) in one (1)
hour at one (1) meter from a source of radiation that is used to irradiate
materials shall meet the following requirements:
6.21.b.1. Each entrance or access point shall
be equipped with entry control devices which:
6.21.b.1.A. Function automatically to prevent
any individual from inadvertently entering a very high radiation area;
and
6.21.b.1.B. 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 one (1) mSv (one tenth [0.1] Rem) in one (1) hour;
and
6.21.b.1.C. 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 one
(1) mSv (one tenth [0.1] Rem) in one (1) hour.
6.21.b.2. Additional control devices shall be
provided so that, upon failure of the entry control devices to function as
required by Paragraph 6.21.b.1.:
6.21.b.2.A.
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 one (1) mSv (one tenth [0.1] Rem) in one (1) hour;
and
6.21.b.2.B. 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.
6.21.b.3. The
registrant shall provide control devices so that, upon failure or removal of
physical radiation barriers other than the sealed source's shielded storage
container:
6.21.b.3.A. 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 one
(1) mSv (one tenth [0.1] Rem) in 1 hour; and
6.21.b.3.B. Conspicuous visible and audible
alarm signals are generated to make potentially affected individuals aware of
the hazard and the registrant 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.
6.21.b.4. When the shield for stored sealed
sources is a liquid, the registrant shall provide means to monitor the
integrity of the shield and to signal, automatically, loss of adequate
shielding.
6.21.b.5. 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 Paragraphs 6.21.b.3. and
4.
6.21.b.6. 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.
6.21.b.7. 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.
6.21.b.8. 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 one
(1) mSv (one tenth [0.1] Rem) in 1 hour.
6.21.b.9. The entry control devices required
in Paragraph 6.21.b.1. shall be tested for proper functioning. See Subsection
6.42. for recordkeeping requirements.
6.21.b.9.A. 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; and
6.21.b.9.B. Testing shall be conducted prior
to resumption of operation of the source of radiation after any unintentional
interruption; and
6.21.b.9.C. The
registrant shall submit and adhere to a schedule for periodic tests of the
entry control and warning systems.
6.21.b.10. The registrant 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.
6.21.b.11.
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.
6.21.c. Registrants, or applicants for
registrations for sources of radiation within the purview of Subdivision
6.21.b. which will be used in a variety of positions or in locations, such as
open fields or forests, that make it impracticable to comply with certain
requirements of Subdivision 6.21.b., 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 Subdivision 6.21.b. 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.
6.21.d. The
entry control devices required by Subdivisions 6.21.b. and c. shall be
established in such a way that no individual will be prevented from leaving the
area.
6.22. Use of
Process or Other Engineering Controls. The registrant shall use, to the extent
practicable, process or other engineering controls, such as, containment or
ventilation, to control the concentrations of radioactive material in
air.
6.23. Use of Other Controls.
When it is not practicable to apply process or other engineering controls to
control the concentrations of radioactive material in air to values below those
that define an airborne radioactivity area, the registrant shall, consistent
with maintaining the total effective dose equivalent ALARA, increase monitoring
and limit intakes by one or more of the following means:
6.23.a. Control of access; or
6.23.b. Limitation of exposure times;
or
6.23.c. Use of respiratory
protection equipment; or
6.23.d.
Other controls.
6.24.
Use of Individual Respiratory Protection Equipment.
6.24.a. If the registrant uses respiratory
protection equipment to limit intakes pursuant to Subsection 6.23:
6.24.a.1. Except as provided in Paragraph
6.24.a.2., the registrant shall use only respiratory protection equipment that
is tested and certified or had certification extended by the National Institute
for Occupational Safety and Health and the Mine Safety and Health
Administration;
6.24.a.2. The
registrant may use equipment that has not been tested or certified by the
National Institute for Occupational Safety and Health and the Mine Safety and
Health Administration has not had certification extended by the National
Institute for Occupational Safety and Health and the Mine Safety and Health
Administration, or for which there is no schedule for testing or certification,
provided the registrant has submitted to the agency and the agency has approved
an application for authorized use of that equipment, including a demonstration
by testing, or a demonstration on the basis of test information, that the
material and performance characteristics of the equipment are capable of
providing the proposed degree of protection under anticipated conditions of
use;
6.24.a.3. The registrant shall
implement and maintain a respiratory protection program that includes:
6.24.a.3.A. Air sampling sufficient to
identify the potential hazard, permit proper equipment selection, and estimate
exposures; and
6.24.a.3.B. Surveys
and bioassays, as appropriate, to evaluate actual intakes; and
6.24.a.3.C. Testing of respirators for
operability immediately prior to each use; and
6.24.a.3.D. Written procedures regarding
selection, fitting, issuance, maintenance, and testing of respirators,
including testing for operability immediately prior to each use; supervision
and training of personnel; monitoring, including air sampling and bioassays;
and record keeping; and
6.24.a.3.E.
Determination by a physician prior to initial fitting of respirators, and at
least every twelve (12) months thereafter, that the individual user is
physically able to use the respiratory protection equipment;
6.24.a.4. The registrant shall
issue a written policy statement on respirator usage covering:
6.24.a.4.A. The use of process or other
engineering controls, instead of respirators; and
6.24.a.4.B. The routine, nonroutine, and
emergency use of respirators; and
6.24.a.4.C. The length of periods of
respirator use and relief from respirator use;
6.24.a.5. The registrant 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;
6.24.a.6. The registrant
shall use respiratory protection equipment within the equipment manufacturer's
expressed limitations for Type And mode of use and shall provide proper visual,
communication, and other special capabilities, such as adequate skin
protection, when needed.
6.24.b. When estimating exposure of
individuals to airborne radioactive materials, the registrant may make
allowance for respiratory protection equipment used to limit intakes pursuant
to Subsection 6.23., provided that the following conditions, in addition to
those in Subdivision 6.24.a., are satisfied:
6.24.b.1. The registrant selects respiratory
protection equipment that provides a protection factor, specified in Table
64-23 E, greater than the multiple by which peak concentrations of airborne
radioactive materials in the working area are expected to exceed the values
specified in Table 64-23 F, Table I, column 3. However, if the selection of
respiratory protection equipment with a protection factor greater than the peak
concentration is inconsistent with the goal specified in Subsection 6.23. of
keeping the total effective dose equivalent ALARA, the registrant may select
respiratory protection equipment with a lower protection factor provided that
such a selection would result in a total effective dose equivalent that is
ALARA. The concentration of radioactive material in the air that is inhaled
when respirators are worn may be initially estimated by dividing the average
concentration in air, during each period of uninterrupted use, by the
protection factor. If the exposure is later found to be greater than initially
estimated, the corrected value shall be used; if the exposure is later found to
be less than initially estimated, the corrected value may be used;
6.24.b.2. The registrant shall obtain
authorization from the agency before assigning respiratory protection factors
in excess of those specified in Table 64-23 E. The agency may authorize a
registrant to use higher protection factors on receipt of an application that:
6.24.b.2.A. Describes the situation for which
a need exists for higher protection factors; and
6.24.b.2.B. Demonstrates that the respiratory
protection equipment provides these higher protection factors under the
proposed conditions of use.
6.24.c. In an emergency, the registrant shall
use as emergency equipment only respiratory protection equipment that has been
specifically certified or had certification extended for emergency use by the
National Institute for Occupational Safety and Health and the Mine Safety and
Health Administration.
6.24.d. The
registrant shall notify the agency in writing at least thirty (30) days before
the date that respiratory protection equipment is first used pursuant to either
Paragraph 6.24.a. or b.
6.25. Storage and Control of Registered
Sources of Radiation.
6.25.a. The registrant
shall secure registered radioactive material from unauthorized removal or
access.
6.25.b. The registrant
shall maintain constant surveillance, and use devices or administrative
procedures to prevent unauthorized use of registered radioactive material that
is in an unrestricted area and that is not in storage.
6.25.c. The registrant shall secure
registered radiation machines from unauthorized removal.
6.25.d. The registrant shall use devices or
administrative procedures to prevent unauthorized use of registered radiation
machines.
6.25.e. Sources of
radiation shall be secured against unauthorized removal from the place of
storage and shall be provided with reasonable protection against loss, leakage,
or dispersion be the effects of fire or water.
6.26. Caution Signs
6.26.a. Standard Radiation Symbol. Unless
otherwise authorized by the agency, the symbol prescribed by Subsection 6.26.
shall use the colors magenta, or purple, or black on yellow background. The
symbol prescribed is the three-bladed design as follows:
1. Cross-hatched area is to be magenta, or
purple, or black, and
2. The
background is to be yellow.
Radiation Symbol
6.26.b. Exception ot Color Requirements for
Standard Radiation Symbol. Notwithstanding the requirements of Subdivision
6.26.a., registrants 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.
6.26.c. Additional Information on Signs and
Labels. In addition to the contents of signs and labels prescribed in Section
6., the registrant may provide, on or near the required signs and labels,
additional information, as appropriate, to make individuals aware of potential
radiation exposures and to minimize the exposures.
6.27. Posting Requirements.
6.27.a. Posting of Radiation Areas. The
registrant shall post each radiation area with a conspicuous sign or signs
bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
6.27.b. Posting of High Radiation Areas. The
registrant shall post each high radiation area with a conspicuous sign or signs
bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or
"DANGER, HIGH RADIATION AREA."
6.27.c. Posting of Very High Radiation Areas.
The registrant shall post each very high radiation area with a conspicuous sign
or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH
RADIATION AREA."
6.27.c.1. Each entrance or
access point to a high radiation area shall be:
6.27.c.1.A. Equipped with a control device
which shall cause the level of radiation to be reduced below that at which an
individual might receive a dose of one hundred (100) milliRems in one (1) hour
upon entry into the area; or
6.27.c.1.B. Equipped with a control device
which shall energize a conspicuous visible or audible alarm signal in such a
manner that the individual entering the high radiation area and the registrant
or a supervisor of the activity are made aware of the entry; or
6.27.c.1.C. Maintained locked except during
periods when access to the area is required, with positive control over each
individual entry.
6.27.c.1.D. The
controls required by Paragraph 6.27.c.1. shall be established in such a way
that no individual will be prevented from leaving a high radiation
area.
6.27.c.2. In the
case of a high radiation area established for a period of thirty (30) days or
less, direct surveillance to prevent unauthorized entry may be substituted for
the controls required by Paragraph 6.21.b.1.
6.27.c.3. Any registrant may apply to the
agency for approval of methods not included in Subdivisions 6.21.b. and c. for
controlling access to high radiation areas. The agency will approve the
proposed alternatives if the registrant demonstrates that the alternative
methods of control will prevent unauthorized entry into a high radiation area,
and that the requirement of Subdivision 6.21.b. is met.
6.27.d. Posting of Airborne Radioactivity
Areas. The registrant 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."
6.27.e. Posting of Areas or
Rooms in Which Registered Material is Used or Stored. The registrant shall post
each area or room in which there is used or stored an amount of registered
material exceeding 10 times the quantity of such material specified in Table
64-23 G with a conspicuous sign or signs bearing the radiation symbol and the
words "CAUTION, RADIOACTIVE MATERIALS" or "DANGER, RADIOACTIVE
MATERIALS."
6.28.
Exceptions to Posting Requirements.
6.28.a. A
registrant 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:
6.28.a.1. 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 Section 6.;
and
6.28.a.2. The area or room is
subject to the registrant's control.
6.28.b. Rooms or other areas in hospitals
that are occupied by patients are not required to be posted with caution signs
pursuant to Subsection 6.27. provided that the requirements of Paragraphs
11.38.b.2. or 11.44.b.3. of this rule are met.
6.28.c. Rooms or other areas in hospitals
that are occupied by patients are not required to be posted with caution signs,
provided that:
6.28.c.1. A patient being
treated with a permanent implant could be released from confinement pursuant to
Subsection 11.26. of this rule; or
6.28.c.2. A patient being treated with a
therapeutic radiopharmaceutical could be released from confinement pursuant to
Subdivision 11.38.c. of this rule.
6.28.d. A room or area is not required to be
posted with a caution sign because of the presence of a sealed source provided
the radiation level at thirty (30) centimeters from the surface of the sealed
source container or housing does not exceed five one-hundredths (0.05) mSv
(five one-thousandths [0.005] Rem) per hour.
6.28.e. A room or area is not required to be
posted with a caution sign because of the presence of radiation machines used
solely for diagnosis in the healing arts.
6.29. Labeling Containers and Radiation
Machines.
6.29.a. The registrant shall ensure
that each container of registered 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.
6.29.b. Each registrant 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.
6.29.c. Each registrant shall ensure that
each radiation machine is labeled in a conspicuous manner which cautions
individuals that radiation is produced when it is energized.
6.30. Exemptions to Labeling
Requirements.
6.30.a. A registrant is not
required to label:
6.30.a.1. Containers
holding registered material in quantities less than the quantities listed in
Table 64-23 G ; or
6.30.a.2.
Containers holding registered material in concentrations less than those
specified in Table III of Table 64-23 F; or
6.30.a.3. Containers attended by an
individual who takes the precautions necessary to prevent the exposure of
individuals in excess of the limits established by Section 6.; or
6.30.a.4. Containers when they are in
transport and packaged and labeled in accordance with the rules of the
Department of
Transportation3;
or
6.30.a.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
6.30.a.6. Installed manufacturing or process
equipment, such as piping and tanks.
6.31. Procedures for Receiving and Opening
Packages.
6.31.a. Each registrant who expects
to receive a package containing quantities of radioactive material in excess of
a Type A quantity, as defined in Section 14. and Table 64-23 Ee of this rule,
shall make arrangements to receive:
6.31.a.1.
The package when the carrier offers it for delivery; or
6.31.a.2. The notification of the arrival of
the package at the carrier's terminal and to take possession of the package
expeditiously.
6.31.b.
Each registrant shall:
6.31.b.1. Monitor the
external surfaces of a
labeled4 package for
radioactive contamination unless the package contains only radioactive material
in the form of gas or in special form as defined in Section 3. of this rule;
and
6.31.b.2. Monitor the external
surfaces of a labeled package 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 Section 3. and Table Ee of this rule; and
6.31.b.3. 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.
6.31.c. The registrant shall perform the
monitoring required by Subdivision 6.31.b. as soon as practicable after receipt
of the package, but not later than three (3) hours after the package is
received at the registrant's facility if it is received during the registrant's
normal working hours or if there is evidence of degradation of package
integrity, such as a package that is crushed, wet, or damaged. If a package is
received after working hours, and has no evidence of degradation of package
integrity, the package shall be monitored no later than three (3) hours from
the beginning of the next working day.
6.31.d. The registrant shall immediately
notify the final delivery carrier and, by telephone and either telegram, or
facsimile, the agency when:
6.31.d.1.
Removable radioactive surface contamination exceeds the limits of Subdivision
14.14.h. of this rule; or
6.31.d.2.
External radiation levels exceed the limits of Subdivisions 14.14.j. and k. of
this rule.
6.31.e. Each
registrant shall:
6.31.e.1. Establish,
maintain, and retain written procedures for safely opening packages in which
radioactive material is received; and
6.31.e.2. Ensure that the procedures are
followed and that due consideration is given to special instructions for the
type of package being opened.
6.31.f. Registrants transferring special form
sources in vehicles owned or operated by the registrant to and from a work site
are exempt from the contamination monitoring requirements of Subsection
6.31.b., but are not exempt from the monitoring requirement in Subdivision
6.31.b. for measuring radiation levels that ensures that the source is still
properly lodged in its shield.
6.32. Waste Disposal
6.32.a. General Requirements - No registrant
shall dispose of any registered radioactive material except:
6.32.a.1. By transfer to an authorized
recipient as provided in Subsection 6.39. or in Section 11. of this rule or to
the Department of Energy; or
6.32.a.2. By release in effulents within
limits of Subsection 6.13.; or
6.32.a.3. As authorized pursuant to
Subsection 6.33., Subsection 6.34., Subsection 6.35., or Subsection 6.36.;
or
6.32.a.4. By decay in
storage.
6.32.b. A
person shall be specifically registered to receive waste containing registered
material from other persons for:
6.32.b.1.
Treatment prior to disposal; or
6.32.b.2. Treatment or disposal by
incineration; or
6.32.b.3. Decay in
storage; or
6.32.b.4. Disposal at a
land disposal facility; or
6.32.b.5. Storage until transferred to a
storage or disposal facility authorized to receive the waste.
6.33. Methods of
Obtaining Approval of Proposed Disposal Procedures
6.33.a. Any registrant or applicant for
registration may apply to the agency for approval of proposed procedures to
dispose of radioactive material in a manner not otherwise authorized in this
Section.
6.33.b. Each application
shall include a description of the radioactive material, including the
quantities and kinds of radioactive material and levels of radioactivity
involved, and the proposed manner and conditions of disposal.
6.33.c. The application, where appropriate
should also include an analysis and evaluation of pertinent information as to
the nature of the environment, including topographical, geological,
meteorological and hydrological characteristics; usage of ground and surface
waters in the general area; the nature and location of other potentially
affected facilities; and procedures to be observed to minimize the risk of
unexpected or hazardous exposures.
6.33.d. The agency will not approve any
application for a registration to receive radioactive material from other
persons for disposal on land not owned by a state or the federal
government.
6.34.
Disposal by Release Into Sanitary Sewerage Systems
6.34.a. No registrant shall dispose of
radioactive material into a sanitary sewerage system unless:
6.34.a.1. It is readily soluble or
dispersible in water;
6.34.a.2. The
quantity of any registered radioactive material released into the system by the
registrant in any one day does not exceed the larger of the
following:
6.34.a.3. The quantity
of registered radioactive material that the registrant releases into the sewer
in one (1) month divided by the average monthly volume of water released into
the sewer by the registrant does not exceed the concentration listed in Table
III of Table 64-23 F; and
6.34.a.4.
If more than one radionuclide is released, the following conditions must also
be satisfied:
6.34.a.4.A. The registrant shall
determine the fraction of the limit in Table III of Table 64-23 F represented
by discharges into sanitary sewerage by dividing the actual monthly average
concentration of each radionuclide released by the registrant into the sewer by
the concentration of that radionuclide listed in Table III of Table 64-23 F;
and
6.34.a.4.B. The sum of the
fractions for each radionuclide required by Section 6.34.a.iii. does not exceed
unity; and
6.34.a.4.C. The total
quantity of registered radioactive material that the registrant releases into
the sanitary sewerage in a year does not exceed one hundred eighty five (185)
GBq (five [5] Ci) of Hydrogen-3, thirty seven (37) GBq (one [1] Ci) of
Carbon-14, and thirty seven (37) GBq (one [1] Ci) of all other radioactive
materials combined.
6.34.b. Excreta from individuals undergoing
medical diagnosis or therapy with radioactive material are not subject to the
limitations contained in Subdivision 6.34.a.
6.35. Treatment or Disposal by Incineration.
A registrant may treat or dispose of registered material by incineration only
in the form and concentration specified in Subsection 6.36. or as specifically
approved by the agency pursuant to Subsection 6.33.
6.36. Disposal of Specific Wastes.
6.36.a. A registrant may dispose of the
following registered material as if it were not radioactive:
6.36.a.1. One and eighty five one-hundredths
(1.85) kBq (five one-hundredths [0.05] [PHI]Ci), or less, of Hydrogen-3 or
Carbon-14 per gram of medium used for liquid scintillation counting;
and
6.36.a.2. One and eighty five
one-hundredths (1.85) kBq (five one-hundredths [0.05] [PHI]Ci), or less, of
Hydrogen-3 or Carbon-14 per gram of animal tissue, averaged over the weight of
the entire animal.
6.36.b. A registrant shall not dispose of
tissue pursuant to Paragraph 6.36.a.2. in a manner that would permit its use
either as food for humans or as animal feed.
6.36.c. The registrant shall maintain records
in accordance with Subsection 6.48.
6.37. Transfer of Material
6.37.a. No registrant shall transfer
radioactive material except as authorized pursuant to this Section.
6.37.b. Any registrant may transfer
radioactive material:
6.37.b.1. To the U.S.
Nuclear Regulatory Commission;
6.37.b.2. To any person authorized to receive
such material under terms of a general license or its equivalent, or a specific
license or equivalent licensing document, issued by the U.S. Nuclear Regulatory
Commission, or any agreement state, or to any person otherwise authorized to
receive such material by the federal government or any agency thereof, or any
agreement state; or,
6.37.b.3. As
otherwise authorized by the agency in writing.
6.38. Transfer for Disposal and Manifests.
6.38.a. The requirements of Subsection 6.38.
and Table 64-23 H are designed to control transfers of low-level radioactive
waste intended for disposal at a licensed low-level radioactive waste disposal
facility, establish a manifest tracking system, and supplement existing
requirements concerning transfers and recordkeeping for those wastes.
6.38.b. Each shipment of radioactive waste
designated for disposal at a licensed low-level radioactive waste disposal
facility shall be accompanied by a shipment manifest as specified in Table
64-23 H i.
6.38.c. Each shipment
manifest shall include a certification by the waste generator as specified in
Table 64-23 H ii.
6.38.d. Each
person involved in the transfer of waste for disposal or in the disposal of
waste, including the waste generator, waste collector, waste processor, and
disposal facility operator, shall comply with the requirements specified in
Table 64-23 H iii.
6.39.
Compliance with Environmental and Health Protection Rules.
6.39.a. Nothing in Subsections 6.32., 6.33.,
6.34., 6.35., 6.36. or 6.37. relieves the registrant from complying with other
applicable federal, state and local rules governing any other toxic or
hazardous properties of materials that may be disposed of to Subsections 6.32.,
6.33., 6.34., 6.35., 6.36. or 6.37.
6.40. Intrastate Transportation of
Radioactive Material
6.40.a. The provisions
of this part apply to transportation of radioactive material, or the delivery
of radioactive material to a carrier for transportation, which is not subject
to the rules and rules of the U.S. Department of Transportation, the U.S.
Postal Service and other federal agencies.
6.40.b. No registrant shall transport any
radioactive material outside of the confines of his plant or other authorized
location of use, or deliver any radioactive material to a carrier for
transportation, unless the registrant complies with all requirements,
appropriate to the mode of transportation, relating to the packaging of the
radioactive material, and to the marking and labeling of the package and
transporting vehicle, of the rules and regulations, as amended of the U.S.
Department of Transportation and other federal agencies regulating the
transportation of radioactive material.
6.41. Records
6.41.a. Each registrant shall use 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 Section
6.
6.41.b. The registrant shall
make a clear distinction among the quantities entered on the records required
by Section 6., such as, total effective dose equivalent, total organ dose
equivalent, shallow dose equivalent, eye dose equivalent or committed effective
dose equivalent.
6.41.c. Upon
termination of employment of an individual, the individual or agency shall,
upon request, be supplied with a summary statement of that individual's
radiation dose. This record shall include statements of any circumstances
wherein the dose to the employee from any source of radiation, exceeded those
specified in this rule. Employee records must be kept available for inspection
by the agency during the tenure of employment of an employee and for a period
of five years thereafter.
6.41.d.
Each registrant shall maintain records in the same units used in this rule,
showing the results of surveys and calibrations required to comply with this
rule and disposals made under Subsections 6.32. - 6.36. The registrant shall
retain these records for three years after the record is made.
6.41.e. Records of individual exposure to
radiation and to radioactive material which must be maintained pursuant to the
provisions of Subsection 6.46. and records of bioassays, including results of
whole body counting examinations, made pursuant to Subdivision 6.6.e. shall be
preserved indefinitely or until the agency authorizes their disposal. (Records
which must be maintained pursuant to this part may be maintained in the form of
microfilms.)
6.41.f. An accurate
accounting for all radioactive materials shall be maintained for a radiation
installation. Such records shall show radioactive materials received, produced,
transferred and disposed, the amounts and form of the radioactive materials,
and such information as may be necessary to account for the difference between
the amount of radioactive materials, received or produced and the amount on
hand. Such records shall be retained for at least five years after the final
disposition of any radioactive material.
6.41.g. Copies of all records required under
this rule shall be transferred to the agency in the event of termination of the
registrant's business operations and at such other times as the agency may
direct.
6.42. Records of
Surveys.
6.42.a. Each registrant shall
maintain records showing the results of surveys and calibrations required by
Subsections 6.16. and 6.31.b. The registrant shall retain these records for
three (3) years after the record is made.
6.42.b. The registrant shall retain each of
the following records until the agency terminates each pertinent registration
requiring the record:
6.42.b.1. Records of
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
6.42.b.2. Records of the results of
measurements and calculations used to determine individual intakes of
radioactive material and used in the assessment of internal dose; and
6.42.b.3. Records showing the results of air
sampling, surveys, and bioassays required pursuant to Subparagraphs 6.24.a.3.A.
and B.; and
6.42.b.4. Records of
the results of measurements and calculations used to evaluate the release of
radioactive effluents to the environment.
6.42.c. Upon termination of the registration,
the registrant shall permanently store records on Agency Form Y or equivalent,
or shall make provision with the agency for transfer to the agency.
6.43. Records of Tests for Leakage
or Contamination of Sealed Sources. Records of tests for leakage or
contamination of sealed sources [required by Subsection 6.15.] shall be kept in
units of becquerel or microcurie and maintained for inspection by the agency
for five (5) years after the records are made.
6.44. Records of Prior Occupational Dose.
6.44.a. The registrant shall retain the
records of prior occupational dose and exposure history as specified in
Subsection 6.9. on agency form y or equivalent until the agency terminates each
pertinent registration requiring this record. The registrant shall retain
records used in preparing agency form y or equivalent for three (3) years after
the record is made.
6.44.b. Upon
termination of the registration, the registrant shall permanently store records
on Agency Form Y or equivalent, or shall make provision with the agency for
transfer to the agency.
6.45. Records of Planned Special Exposures.
6.45.a. For each use of the provisions of
Subsection 6.10. for planned special exposures, the registrant shall maintain
records that describe:
6.45.a.1. The
exceptional circumstances requiring the use of a planned special
exposure;
6.45.a.2. The name of the
management official who authorized the planned special exposure and a copy of
the signed authorization;
6.45.a.3.
What actions were necessary;
6.45.a.4. Why the actions were
necessary;
6.45.a.5. What
precautions were taken to assure that doses were maintained ALARA;
6.45.a.6. What individual and collective
doses were expected to result; and
6.45.a.7. The doses actually received in the
planned special exposure.
6.45.b. The registrant shall retain the
records until the agency terminates each pertinent registration requiring these
records.
6.46. Records
of Individual Monitoring Results.
6.46.a.
Recordkeeping Requirement. Each registrant shall maintain records of doses
received by all individuals for whom monitoring was required pursuant to
Subsection 6.17., 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 July 1, 2001. need not be
changed. These records shall include, when applicable:
6.46.a.1. The deep dose equivalent to the
whole body, eye dose equivalent, shallow dose equivalent to the skin, and
shallow dose equivalent to the extremities; and
6.46.a.2. The estimated intake of
radionuclides, see Subsection 6.6.;
6.46.a.3. The committed effective dose
equivalent assigned to the intake of radionuclides;
6.46.a.4. The specific information used to
calculate the committed effective dose equivalent pursuant to Subsection
6.8.c.;
6.46.a.5. The total
effective dose equivalent when required by Subsection 6.6.; and
6.46.a.6. The total of the deep dose
equivalent and the committed dose to the organ receiving the highest total
dose.
6.46.b.
Recordkeeping Frequency. The registrant shall make entries of the records
specified in Subdivision 6.46.a. at intervals not to exceed one (1)
year.
6.46.c. Recordkeeping Format.
The registrant shall maintain the records specified in Subdivision 6.46.a. on
Agency Form Z, in accordance with the instructions for Agency Form Z, or in
clear and legible records containing all the information required by Agency
Form Z.
6.46.d. The registrant
shall maintain the records of dose to an embryo or 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.
6.46.e. The registrant shall retain each
required form or record until the agency terminates each pertinent registration
requiring the record.
6.47. Records of Dose to Individual Members
of the Public.
6.47.a. Each registrant shall
maintain records sufficient to demonstrate compliance with the dose limit for
individual members of the public. See Subsection 6.13.
6.47.b. The registrant shall retain the
records required by Subdivision 6.47.a. until the agency terminates each
pertinent registration requiring the record.
6.48. Records of Waste Disposal.
6.48.a. Each registrant shall maintain
records of the disposal of registered materials made pursuant to Subsections
6.33., 6.34., 6.35. and 6.36., of this rule.
6.48.b. The registrant shall retain the
records required by Subdivision 6.48.a. until the agency terminates each
pertinent registration requiring the record.
6.49. Records of Testing Entry Control
Devices for Very High Radiation Areas.
6.49.a.
Each registrant shall maintain records of tests made pursuant to Paragraph
6.21.b.9. on entry control devices for very high radiation areas. These records
must include the date, time, and results of each such test of
function.
6.49.b. The registrant
shall retain the records required by Subdivision 6.49.a. for three (3) years
after the record is made.
6.50. Form of Records. Each record required
by Section 6. 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 registrant shall maintain adequate safeguards
against tampering with and loss of records.
6.51. Reports
6.51.a. Report to Employees and Others of
Radiation Dosage - Each registrant, at the request of any individual employed
or associated with him, shall advise such individual annually of the
individual's exposure to radiation as shown in records maintained by the
registrant pursuant to Subsection 6.46.
6.51.b. Report to Former Employees and Others
of Exposure to Radiation
6.51.b.1. A
registrant, at the request of any individual formerly employed or associated
with him (i.e., student, craftsman, etc.) shall furnish to such individual a
report of his exposure to radiation as shown in records maintained pursuant to
Subsection 6.46. Such report shall be furnished within thirty (30) days from
the time the request is made and shall cover each calendar quarter of the
individual's employment or association involving exposure to radiation, or such
lesser period as may be requested by the individual. The report shall also
include the results of any calculations and analysis of radioactive material
deposited in the body of the individual and made pursuant to the provisions of
Subdivision 6.6.e. The report shall be in writing and contain the following
statement:
"This report is furnished to you under the provisions of the West Virginia Bureau for Public Health's rule entitled, Radiological Health Rules. You should preserve this report for future reference."
6.51.b.2. The individual's request should
include appropriate identifying data, such as social security number and dates
and locations of employment of association.
6.52. Reports of Stolen, Lost, or Missing
Registered Sources of Radiation.
6.52.a.
Telephone Reports. Each registrant shall report to the agency by telephone as
follows:
6.52.a.1. Immediately after its
occurrence becomes known to the registrant, stolen, lost, or missing registered
radioactive material in an aggregate quantity equal to or greater than one
thousand (1,000) times the quantity specified in Appendix C under such
circumstances that it appears to the registrant that an exposure could result
to individuals in unrestricted areas; or
6.52.a.2. Within thirty (30) days after its
occurrence becomes known to the registrant, lost, stolen, or missing registered
radioactive material in an aggregate quantity greater than ten (10) times the
quantity specified in Table 64-23 G that is still missing;
6.52.a.3. Immediately after its occurrence
becomes known to the registrant, a stolen, lost, or missing radiation
machine.
6.52.b. Written
Reports. Each registrant required to make a report pursuant to Subsection
6.51.a. shall, within thirty (30) days after making the telephone report, make
a written report to the agency setting forth the following information:
6.52.b.1. A description of the registered
source of radiation involved, including, for radioactive material, the kind,
quantity, and chemical and physical form; and, for radiation machines, the
manufacturer, model and serial number, Type And maximum energy of radiation
emitted;
6.52.b.2. A description of
the circumstances under which the loss or theft occurred;
6.52.b.3. A statement of disposition, or
probable disposition, of the registered source of radiation involved;
6.52.b.4. Exposures of individuals to
radiation, circumstances under which the exposures occurred, and the possible
total effective dose equivalent to persons in unrestricted areas;
6.52.b.5. Actions that have been taken, or
will be taken, to recover the source of radiation; and
6.52.b.6. Procedures or measures that have
been, or will be, adopted to ensure against a recurrence of the loss or theft
of registered sources of radiation.
6.52.c. Subsequent to filing the written
report, the registrant shall also report additional substantive information on
the loss or theft within thirty (30) days after the registrant learns of such
information.
6.52.d. The registrant
shall prepare any report filed with the agency pursuant to Subsection 6.51. so
that names of individuals who may have received exposure to radiation are
stated in a separate and detachable portion of the report.
6.53. Notification of Incidents
6.53.a. Immediate Notification- Each
registrant shall immediately notify the agency by telephone or facsimile of any
incident involving any sources of radiation possessed by him and which may have
caused or threatens to cause an individual to receive:
6.53.a.1. A total effective dose equivalent
exceeding twenty five one-hundredths (0.25) Sv (twenty five [25] Rem) or more;
or
6.53.a.2. An eye dose equivalent
exceeding seventy five one-hundredths (0.75) Sv (seventy-five [75]Rem) or more;
or
6.53.a.3. A shallow dose
equivalent to the skin or extremities or a total organ dose equivalent of two
and five-tenths (2.5) Gy (two hundred fifty [250] Rad) or more; or
6.53.a.4. The release of radioactive
material, inside or outside of a restricted area, so that, had an individual
been present for twenty-four (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.
6.53.a.5. A loss of one working week or more
of the operation of any facilities affected; or
6.53.a.6. Damage to property to property in
excess of one hundred thousand dollars ($100,000).
6.53.b. Twenty-four (24) Hour Notification -
Each registrant shall within twenty four (24) hours of discovery of the event,
notify the agency by telephone or facsimile of any incident involving any
sources of radiation possessed by him and which may have caused or threatens to
cause an individual to receive, in a period of twenty four (24) hours:
6.53.b.1. A total dose equivalent exceeding
five one-hundredths (0.05) Sv (five [5] Rem); or
6.53.b.2. An eye dose equivalent exceeding
fifteen one-hundredths (0.15) Sv (fifteen [15] Rem); or
6.53.b.3. A shallow dose equivalent to the
skin or extremities or a total organ dose equivalent exceeding five tenths
(0.5) Sv (fifty [50] Rem); or
6.53.c. The release of radioactive material,
inside or outside of a restricted area, so that, had an individual been present
for twenty four (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; or
6.53.d. A loss of one day or more on the
operation of any facilities affected; or
6.53.e. Damage to property in excess of one
thousand dollars ($1,000).
6.53.f.
Any report filed with the agency pursuant to this part shall be prepared in
such a manner that names of individuals who have received exposure to radiation
will be stated in a separate part of the report.
6.53.g. Registrants shall make the reports
required by Subdivisions 6.52.a and b. by initial contact by telephone to the
agency and shall confirm the initial facsimile to the agency.
6.53.h. The registrant shall prepare each
report filed with the agency pursuant to Subsection 6.52. so that names of
individuals who have received exposure to sources of radiation are stated in a
separate and detachable portion of the report.
6.53.i. The provisions of Subsection 6.52. 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
pursuant to Subsection 6.54.
6.54. Reports of Exposures, Radiation Levels,
and Concentrations of Radioactive Material Exceeding Limits.
6.54.a. In addition to any notification
required by Subsection 6.52., each registrant shall make a report in writing
within thirty (30) days to the agency after learning of any of the following
occurrences:
6.54.a.1. Incidents for which
notification is required by Subsection 6.52.;
6.54.a.2. Doses in excess of any of the
following:
6.54.a.2.A. The occupational dose
limits for adults in Subsection 6.5.;
6.54.a.2.B. The occupational dose limits for
a minor in Subsection 6.11.;
6.54.a.2.C. The limits for an embryo or fetus
of a declared pregnant woman in Subsection 6.12.;
6.54.a.2.D. The limits for an individual
member of the public in Subsection 6.13.;or
6.54.a.2.E. Any applicable limit in the
registration;
6.54.a.3.
Levels of radiation or concentrations of radioactive material in:
6.54.a.3.A. A restricted area in excess of
applicable limits in the registration;
6.54.a.3.B. An unrestricted area in excess of
ten (10) times the applicable limit set forth in Section 6. or in the
registration, whether or not involving exposure of any individual in excess of
the limits in Subsection 6.13.; or
6.54.a.3.C. For registrants subject to the
provisions of the Environmental Protection Agency's generally applicable
Environmental Radiation Standards in 40 CFR 190, levels of radiation or
releases of radioactive material in excess of those standards, or of
registration conditions related to those standards.
6.54.b. In any case where a
registrant is required pursuant to the provisions of this Section to report to
the agency any exposure of an individual to radiation or concentrations of
radioactive material, the registrant shall no later than the making of such
report to the agency also notify such individual of the nature and extent of
exposure. Such notice shall be in writing and shall contain the following
statement:
"This report is furnished to you under the provisions of the West Virginia Bureau for Public Health rule entitled, Radiological Health Rules. You should preserve this report for future reference."
6.54.c. Contents of Reports.
6.54.c.1. Each report required by Subdivision
6.53.a. shall describe the extent of exposure of individuals to radiation and
radioactive material, including, as appropriate:
6.54.c.1.A. Estimates of each individual's
dose;
6.54.c.1.B. The levels of
radiation and concentrations of radioactive material involved;
6.54.c.1.C. The cause of the elevated
exposures, dose rates, or concentrations; and
6.54.c.1.E. Corrective steps taken or planned
to ensure against a recurrence, including the schedule for achieving
conformance with applicable limits, generally applicable environmental
standards, and associated registration conditions.
6.54.d. Each report filed pursuant
to Subdivision 6.53.a. shall include for each individual exposed the name,
social security account number, and date of birth. With respect to the limit
for the embryo or fetus in Subsection 6.12., 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.
6.54.e. All registrants who
make reports pursuant to Subdivision 6.53.a. shall submit the report in writing
to the agency.
6.55.
Reports of Planned Special Exposures. The registrant shall submit a written
report to the agency within thirty (30) days following any planned special
exposure conducted in accordance with Subsection 6.10., 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
6.38.
6.56. Reports of Individual
Monitoring.
6.56.a. This Section applies to
each person registered by the agency to:
6.56.a.1. Possess or use sources of radiation
for purposes of industrial radiography pursuant to Sections 9. and 11. of this
rule; or
6.56.a.2. Possess or use
at any time, for processing or manufacturing for distribution pursuant to
Sections 11. or 12. of this rule, radioactive material in quantities exceeding
any one of the quantities listed in Table 64-23 D.
6.56.b. Each registrant in a category listed
in Subdivision 6.55.a. shall submit an annual report of the results of
individual monitoring carried out by the registrant for each individual for
whom monitoring was required by Subsection 6.17. during that year. The
registrant may include additional data for individuals for whom monitoring was
provided but not required. The registrant shall use Agency Form Z or equivalent
or electronic media containing all the information required by Agency Form Z.
6.56.c. The registrant shall file
the report required by Subsection 6.55., covering the preceding year, on or
before April 30 of each year. The registrant shall submit the report to the
agency.
6.57.
Notifications and Reports to Individuals.
6.57.a. Requirements for notification and
reports to individuals of exposure to radiation or radioactive material are
specified in Subsection 13.4. of this rule.
6.57.b. When a registrant is required
pursuant to Subsection 6.53. to report to the agency any exposure of an
individual to radiation or radioactive material, the registrant shall also
notify 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
Subdivision 13.4.a. of this rule.
6.58. Reports of Leaking or Contaminated
Sealed Sources. The registrant shall file a report within five (5) days with
the agency if the test for leakage or contamination (required pursuant to
Subsection 6.15.) indicates a sealed source is leaking or contaminated. The
report shall include the equipment involved, the test results and the
corrective action taken.
6.59.
Vacating Premises
6.59.a. Each registrant
shall, no less than thirty (30) days before vacating or relinquishing
possession or control of premises in which radioactive material has been stored
or used, notify the agency in writing of intent to vacate and afford the agency
the opportunity to survey the premises for contamination. When deemed necessary
by the agency the registrant shall decontaminate said premises in such a manner
as the agency may authorize and shall not vacate or relinquish possession or
control of said premises without written consent of the agency. Quantities to
be used in decommissioning are listed in Table 64-23 L.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.