Ariz. Admin. Code § R9-7-310 - Special Requirements for Issuance of Specific Broad Scope Licenses
A. The Department
shall issue three classes of academic and industrial broad scope licenses, and
only a single class A medical broad scope license.
1. The license may authorize the radioactive
materials in multi-curie quantities, and may authorize other radioactive
materials and forms in addition to those listed in subsection (A)(1)(a). A
license is a broad scope class A license if it:
a. Contains the exact wording "Any
radioactive material with Atomic Number 3 through 83" or "Any radioactive
material with Atomic Number 84 through 92" in License Item 6; and
b. Contains the word "any" to authorize the
chemical or physical form of the materials in License Item 7;
2. A broad scope class B license
is any specific license which authorizes the acquisition, possession, use, and
transfer of the radioactive materials specified in Exhibit C of 9 A.A.C. 7,
Article 3 in any chemical or physical form and in quantities determined as
follows:
a. The possession limit, if only one
radionuclide is possessed, is the quantity specified for that radionuclide in
Exhibit C, Column I; or
b. The
possession limit for multiple radionuclides is determined as follows: The sum
of the ratios for all radionuclides possessed under the license shall not
exceed unity (1). The ratio for each radionuclide is determined by dividing the
quantity possessed by the applicable quantity in Exhibit C, Column I.
3. A broad scope class C license
is any specific license authorizing the possession and use of the radioactive
materials specified in Exhibit C of 9 A.A.C. 7, Article 3 in any chemical or
physical form and in quantities determined as follows:
a. The possession limit, if only one
radionuclide is possessed, is the quantity specified for that radionuclide in
Exhibit C, Column II; or
b. The
possession limit for multiple radionuclides is determined as follows: The sum
of the ratios for all radionuclides possessed under the license shall not
exceed unity (1). The ratio for each radionuclide is determined by dividing the
quantity possessed by the applicable quantity in Exhibit C, Column
II.
B. The
Department shall approve:
1. An application
for a class A broad scope license if:
a. The
applicant satisfies the general requirements specified in R9-7-309;
b. The applicant has engaged in a reasonable
number of activities involving the use of radioactive material. For purposes of
this subsection, the requirement of "reasonable number of activities" can be
satisfied by showing that the applicant has five years of experience in the use
of radioactive material. The Department may accept less than five years of
experience if the applicant's qualifications are adequate for the scope of the
proposed license; and
c. The
applicant has established administrative controls and provisions relating to
organization, management, procedures, recordkeeping, material control,
accounting, and management review that are necessary to assure safe operations,
including:
i. Establishment of a radiation
safety committee composed of a radiation safety officer, a representative of
management, and persons trained and experienced in the safe use of radioactive
material;
ii. 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.
Establishment of appropriate administrative procedures to assure:
(1) Control of procurement and use of
radioactive material;
(2)
Completion of safety evaluations 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 operating or handling
procedures; and
(3) 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.
2. An application for a class B broad scope
license if:
a. The applicant satisfies the
general requirements specified in R9-7-309; and
b. The applicant has established
administrative controls and provisions relating to organization, management,
procedures, recordkeeping, material control, accounting, and management review
that are necessary to assure safe operations, including:
i. Appointment of a radiation safety officer
who is qualified by training and experience in radiation protection, and
available for advice and assistance on radiation safety matters; and
ii. Establishment of appropriate
administrative procedures to assure:
(1)
Control of procurement and use of radioactive material;
(2) Completion of safety evaluations 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
(3) Review, approval, and recording by the
radiation safety officer of safety evaluations of proposed uses prepared
according to subsection (B)(2)(b)(ii) prior to use of the radioactive material.
3. An application for a class C broad scope
license if:
a. The applicant satisfies the
general requirements specified in R9-7-309; and
b. 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 and 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, the characteristics of
ionizing radiation, units of 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
c. 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.
C.
Unless specifically authorized, broad-scope licensees shall not:
1. Conduct tracer studies in the environment
involving direct release of radioactive material;
2. Acquire, receive, possess, use, own,
import, or transfer devices containing 3.7 petabecquerels (100,000 curies) or
more of radioactive material in sealed sources used for irradiation of
materials;
3. Conduct activities
for which a specific license is issued under
R9-7-311 and 9 A.A.C. 7, Articles
5, 7, or 17; or
4. 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.
D.
Radioactive material possessed under the class A broad scope license shall only
be used by, or under the direct supervision of, individuals approved by the
licensee's radiation safety committee.
E. Radioactive material possessed under the
class B broad scope license shall only be used by, or under the direct
supervision of, individuals approved by the licensee's radiation safety
officer.
F. Radioactive material
possessed under the class C broad scope license shall only be used by, or under
the direct supervision of, individuals who satisfy the requirements of
R9-7-310(B)(3)(b).
Notes
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No prior version found.