902 KAR 100:052.
Broad scope licenses.
RELATES TO: KRS
211.842-211.852, 211.990(4)
STATUTORY
AUTHORITY: KRS 194.050, 211.090, 211.844
NECESSITY,
FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS
211.844 to provide by administrative regulation for the registration and
licensing of the possession or use of sources of ionizing or electronic product
radiation and the handling and disposal of radioactive waste. This
administrative regulation prescribes requirements for the issuance of specific
licenses of broad scope for radioactive material.
Section 1.
Applicability. This administrative regulation establishes requirements for
specific licensees to possess, use or transfer radioactive material for
licenses of broad scope.
Section 2. Types
of Specific Licenses of Broad Scope. (1) A "Type A specific license of
broad scope" is a specific license authorizing receipt, acquisition,
ownership, possession, use and transfer of a chemical or physical form of the
radioactive material specified in the license, but not exceeding quantities
specified in the license, for any authorized purpose. The quantities specified
are usually in the multicurie range.
(2) A "Type
B specific license of broad scope" is a specific license authorizing
receipt, acquisition, ownership, possession, use and transfer of a chemical or
physical form of radioactive material specified in 902 KAR 100:090, relating to
broad license quantities, for any authorized purpose. The possession limit for
a Type B broad license, if only one (1) radionuclide is possessed, is the
quantity specified for that radionuclide in Column I of the table in Section 2
of 902 KAR 100:090. If two (2) or more radionuclides are possessed, the
possession limit for each is determined as follows: for each radionuclide,
determine the ratio of the quantity possessed to the applicable quantity
specified in Column I of the table in Section 2 of 902 KAR 100:090 for that
radionuclide. The sum of the ratios for all radionuclides possessed under the
license shall not exceed unity.
(3) A "Type
C specific license of broad scope" is a specific license authorizing
receipt, acquisition, ownership, possession, use and transfer of a chemical or
physical form of radioactive material specified in 902 KAR 100:090, relating to
broad licensed quantities, for any authorized purpose. The possession limit for
a Type C broad license, if only one (1) radionuclide is possessed, is the
quantity specified for that radionuclide in Column II of the table in Section 2
of 902 KAR 100:090. If two (2) or more radionuclides are possessed, the
possession limit is determined for each as follows: for each radionuclide
determine the ratio of the quantity possessed to the applicable quantity
specified in Column II of the table in Section 2 of 902 KAR 100:090 for that
radionuclide. The sum of the ratios for all radionuclides possessed under the
license shall not exceed unity.
Section 3.
Requirements for the Issuance of a Type A Specific License of Broad Scope. An
application for a Type A specific license of broad scope will be approved if:
(1) The
applicant satisfies the general requirements specified in 902 KAR 100:040;
(2) The
applicant has engaged in a reasonable number of activities involving the use of
radioactive material; and
(3) The
applicant has established administrative controls and requirements relating to
organization, management, procedures, recordkeeping, material control and
accounting, and management review that are necessary to assure safe operations,
including:
(a) The establishment
of a radiation safety committee composed of persons, such as a radiation safety
officer, a representative of management, and persons trained and experienced in
the safe use of radioactive materials;
(b) The
appointment of a radiation safety officer who is qualified by training and
experienced in radiation protection, who is available for advice and assistance
on radiological safety matters; and
(c) The
establishment of appropriate administrative procedures to assure control of
procurement and use of radioactive material; completion of safety evaluation of
proposed uses of radioactive material which take into consideration matters,
such as the adequacy of facilities and equipment, training and experience of
the user, and the operating or handling procedures; and review, approval, and
recording by the radiation safety committee of safety evaluations of proposed
uses prepared in accordance with this subsection prior to use of the
radioactive material.
Section 4.
Requirements for the Issuance of a Type B Specific License of Broad Scope. An
application for a Type B specific license of broad scope will be approved if:
(1) The
applicant satisfies the general requirements specified in 902 KAR 100:040; and
(2) The
applicant has established administrative controls and provisions relating to
organization, management, procedures, recordkeeping, material control and
accounting, and management review that are necessary to assure safe operations,
including:
(a) The
appointment of a radiation safety officer who is qualified by training and
experience in radiation protection, who is available for advice and assistance
on radiological safety matters; and
(b) The
establishment of appropriate administrative procedures to assure control of
procurement and use of radioactive material; completion of safety evaluations
or proposed uses of radioactive materials which take into consideration such
matters as the adequacy of facilities and equipment, training and experience of
the user, the operating or handling procedures; and review, approval and
recording by the radiation safety officer of safety evaluations of proposed
uses prepared in accordance with this subsection prior to use of the
radioactive material.
Section 5.
Requirements for the Issuance of a Type C Specific License of Broad Scope. An
application for a Type C specific license of broad scope shall be approved if:
(1) The
applicant satisfies the general requirements specified in 902 KAR 100:040;
(2) The
applicant submits a statement that radioactive material will be used only by,
or under the direct supervision of, individuals who have received:
(a) A college
degree at the bachelor level, or equivalent training and experience, in the
physical or biological sciences or in engineering;
(b) At least
forty (40) hours of training and experience in the safe handling of radioactive
materials, characteristics of ionizing radiation, units of radiation dose and
quantities, radiation detection instrumentation, biological hazards of exposure
to radiation appropriate to the type and forms of radioactive material to be
used; and
(3) The
applicant has established administrative controls and provisions relating to
procurement of radioactive material, procedures, recordkeeping, material
control and accounting, and management review necessary to assure safe
operations.
Section 6.
Prohibited Acts and Conditions for Specific Licenses of Broad Scope. (1) Unless
otherwise specifically authorized by these administrative regulations, persons
licensed under this administrative regulation shall not:
(a) Conduct
tracer studies in the environment involving direct release of radioactive
material;
(b) Receive,
acquire, own, possess, use, or transfer, devices containing 100,000 curies or
more of radioactive material in sealed sources used for irradiation of
materials;
(c) Conduct
activities for which a specific license issued by the cabinet under 902 KAR
100:051 or 902 KAR 100:058 is required; or
(d) Add or cause
the addition of radioactive material to a food, beverage, cosmetic, drug, or
other product designed for ingestion or inhalation by, or application to, a
human being.
(2) Each Type A
specific license of broad scope issued under this administrative regulation
shall be subject to the condition that radioactive material possessed under the
license may only be used by, or under the direct supervision of, individuals
approved by the licensee's radiation safety committee.
(3) Each Type B
specific license of broad scope issued under this administrative regulation
shall be subject to the condition that radioactive material possessed under the
license may only be used by, or under the direct supervision of, individuals
approved by the licensee's radiation safety officer.
(4) Each Type C
specific license of broad scope issued under this administrative regulation
shall be subject to the condition that radioactive material possessed under
this license may only be used by, or under the direct supervision of,
individuals who satisfy the requirements of Section 5 of this administrative
regulation. (6 Ky.R. 219; eff. 12-5-79; Am. 12 Ky.R. 1033; eff. 1-3-86; 18
Ky.R. 1513; eff. 1-10-92.)