Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 12.
This section prescribes requirements for the issuance of
specific licenses of broad scope for radioactive material and certain
regulations governing holders of such licenses.10/
10/ Authority to transfer
possession or control by the manufacturer, processor or producer of any
equipment, device, commodity or other product containing byproduct material
whose subsequent possession, use, transfer and disposal by all other persons
are exempted from regulatory requirements may be obtained only from the U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555.
(a) The different types of broad licenses are
set forth below:
(1) A "Type A specific
license of broad scope" is a specific license authorizing receipt, acquisition,
ownership, possession, use and transfer of any 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 any chemical or physical form of radioactive
material specified in Schedule D,
410 IAC
5-3-29, for any authorized purpose. The possession
limit for a Type B license of broad scope, if only one radionuclide is
possessed thereunder, is the quantity specified for that radionuclide in
Schedule D,
410 IAC
5-3-29, Column I. If two or more radionuclides are
possessed thereunder, 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 Schedule D,
410 IAC
5-3-29, Column I, 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 any chemical or physical form of
radioactive material specified in Schedule D,
410 IAC
5-3-29, for any authorized purpose. The possession
limit for a Type C license of broad scope, if only one radionuclide is
possessed thereunder, is the quantity specified for that radionuclide in
Schedule D,
410 IAC
5-3-29, Column II. If two or more radionuclides are
possessed thereunder, 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 Schedule D,
410 IAC
5-3-29, Column II, for that radionuclide. The sum of
the ratios for all radionuclides possessed under the license shall not exceed
unity.
(b) An application
for a Type A specific license of broad scope will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(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 provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(i) The establishment of a radiation safety
committee composed of such persons as a radiation safety officer, a
representative of management and persons trained and experienced in the safe
use of radioactive material;
(ii)
The appointment of a radiation safety officer who is qualified by training and
experience in radiation protection, and who is available for advice and
assistance on radiation safety matters; and
(iii) The establishment of appropriate
administrative procedures to assure:
(A)
Control of procurement and use of radioactive material;
(B) Completion of safety evaluations of
proposed uses of radiactive [sic.] material which take into
consideration such matters as the adequacy of facilities and equipment,
training and experience of the user, and the operating or handling procedures;
and
(C) Review, approval, and
recording by the radiation safety committee of safety evaluations of proposed
uses prepared in accordance with 410 IAC
5-3-12(b)(3)(iii)(B) prior to use of
the radioactive material.
(c) An application for a Type B specific
license of broad scope will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10; and
(2) The applicant has established
administrative controls and provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:
(i) The appointment of a radiation safety
officer who is qualified by training and experience in radiation protection,
and who is available for advice and assistance on radiation safety matters, and
(ii) The establishment of
appropriate administrative procedures to assure:
(A) Control of procurement and use of
radioactive material,
(B)
Completion of safety evaluations of proposed uses of radioactive material which
take into consideration such matters as the adequacy of facilities and
equipment, training and experience of the user, and the operating or handling
procedures; and
(C) Review,
approval, and recording by the radiation safety officer of safety evaluations
of proposed uses prepared in accordance with 410 IAC
5-3-12(c)(2)(ii)(B) prior
to use of the radioactive material.
(d) An application for a Type C specific
license of broad scope will be approved if:
(1) The applicant satisfies the general
requirements specified in
410
IAC 5-3-10;
(2) The applicant submits a statement that
radioactive material will be used only by, or under the direct supervision of,
individuals who have received:
(i) A college
degree at the bachelor level, or equivalent training experience, in the
physical or biological sciences or in engineering, and
(ii) At least 40 hours of training and
experience in the safe handling of radioactive material, and in the
characteristics of ionizing radiation, units of radiation dose and quantities,
radiation detection instrumentation, and 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, record keeping, material control and
accounting, and management review necessary to assure safe
operations.
(e) Specific
licenses of broad scope are subject to the following conditions:
(1) Unless specifically authorized, persons
licensed pursuant to 410 IAC
5-3-12 shall not:
(i) Conduct tracer studies in the environment
involving direct release of radioactive material;
(ii) 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;
(iv) Add or cause the addition of radioactive
material to any 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 410 IAC
5-3-12 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 410 IAC
5-3-12 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 410 IAC
5-3-12 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 who satisfy the
requirements of 410 IAC
5-3-12(d).
Notes
410 IAC 5-3-12
Indiana State Department
of Health; Rule HRH-2,PT C,Sec C.27; filed May 26, 1978, 3:30 pm: 1 IR 152;
filed Feb 29, 1984, 10:10 am: 7 IR 861; readopted filed Jul 11, 2001, 2:23
p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.:
20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.:
20131009-IR-410130346RFA
Readopted
filed 11/13/2019, 3:14 p.m.:
20191211-IR-410190391RFA