Current through Register Vol. 49, No. 13, September 23, 2024
Subpart
1.
General requirements.
A. Applications for specific licenses must be
filed in duplicate on an application for radioactive material license form
prescribed by the commissioner.
B.
An application must be signed by the applicant or licensee or a person duly
authorized to act for and on behalf of the applicant or licensee.
C. The commissioner may at any time after the
filing of the original application, and before the expiration of the license,
require further statements to enable the commissioner to determine whether the
application should be granted or denied or whether a license should be modified
or revoked.
D. An application must
be accompanied by the fee prescribed under Minnesota Statutes, section
144.1205.
E. An application for a license to receive
and possess radioactive material that the commissioner has determined will
significantly affect the quality of the environment must be filed at least nine
months prior to commencement of construction of the plant or facility in which
the activity will be conducted and must be accompanied by any environmental
report as required under Code of Federal Regulations, title 10, part 51,
subpart A.
Subp. 2.
Sealed source requirements.
A.
Except as provided in items B, C, and D, an application for a specific license
to use radioactive material in the form of a sealed source or in a device that
contains the sealed source must:
(1) identify the source or device by
manufacturer and model number as registered with the NRC under Code of Federal
Regulations, title 10, section 32.210, with an agreement state, or for a source
or a device containing radium-226 or accelerator-produced radioactive material
with a state under provisions comparable to
Code of Federal
Regulations, title 10, section 32.210; or
(2) contain the
information identified in
Code of Federal Regulations, title
10, section 32.210(c).
B. For sources or
devices manufactured prior to October 23, 2012, that are not registered with
the NRC under Code of Federal Regulations, title 10, section 32.210, or with an
agreement state, and for which the applicant is unable to provide all
categories of information specified in Code of Federal Regulations, title 10,
section 32.210(c), the applicant must provide:
(1) all available information identified in
Code of Federal Regulations, title 10, section 32.210(c) and
this chapter concerning the source, and, if applicable, the device;
and
(2) sufficient additional
information to demonstrate that there is reasonable assurance that the
radiation safety properties of the source or device are adequate to protect
health and minimize danger to life and property. This information must include
a description of the source or device, a description of radiation safety
features, the intended use and associated operating experience, and the results
of a recent leak test.
C. For sealed sources and devices allowed to
be distributed without registration of safety information according to Code of
Federal Regulations, title 10, section 32.210(g)(1), the applicant may supply
only the manufacturer, model number, and radionuclide and quantity.
D. If it is not feasible to identify each
sealed source and device individually, the applicant may propose constraints on
the number and type of sealed sources and devices to be used and the conditions
under which they will be used, in lieu of identifying each sealed source and
device.
Subp. 3.
Decommissioning requirements.
As provided under part 4731.3080, certain applications for
specific licenses filed under parts 4731.3000 to 4731.3175 and 4731.3300 to
4731.4527 must contain a proposed decommissioning funding plan or a
certification of financial assurance for decommissioning.
Subp. 4.
Additional
requirements.
A. An application to
possess radioactive materials in unsealed form, on foils or plated sources, or
sealed in glass in excess of the quantities in part 4731.3150 must contain:
(1) an evaluation showing that the maximum
dose to a person off-site due to a release of radioactive material would not
exceed one rem effective dose equivalent or five rems to the thyroid;
or
(2) an emergency plan for
responding to a release of radioactive material.
B. One or more of the following factors may
be used to support an evaluation submitted under item A, subitem (1):
(1) the radioactive material is physically
separated so that only a portion could be involved in an accident;
(2) all or part of the radioactive material
is not subject to release during an accident because of the way it is stored or
packaged;
(3) the release fraction
in the respirable size range would be lower than the release fraction shown in
part 4731.3150 due to the chemical or physical form of the material;
(4) the solubility of the radioactive
material would reduce the dose received;
(5) facility design or engineered safety
features in the facility would cause the release fraction to be lower than
shown in part 4731.3150;
(6)
operating restrictions or procedures would prevent a release fraction as large
as that shown in part 4731.3150; or
(7) other factors appropriate for the
specific facility.
Subp.
5.
Emergency plan.
An emergency plan submitted under subpart 4, item A, subitem
(2), must include:
A. a brief
description of the licensee's facility and area near the site;
B. identification of each type of radioactive
materials accident for which protective actions may be needed;
C. a classification system for classifying
accidents as alert or site area emergencies;
D. identification of the means of detecting
each type of accident in a timely manner;
E. a brief description of the means and
equipment for mitigating the consequences of each type of accident, including
those provided to protect workers on-site, and a description of the program for
maintaining the equipment;
F. a
brief description of the methods and equipment to assess releases of
radioactive materials;
G. a brief
description of the responsibilities of licensee personnel should an accident
occur, including identification of personnel responsible for promptly notifying
off-site response organizations and the commissioner, and the responsibilities
for developing, maintaining, and updating the plan;
H. a commitment to and a brief description of
the means to promptly notify off-site response organizations and request
off-site assistance, including medical assistance for the treatment of
contaminated injured on-site workers when appropriate. A control point must be
established. The notification and coordination must be planned so that
unavailability of some personnel, parts of the facility, and some equipment
does not prevent notification and coordination. The licensee must also commit
to notifying the commissioner immediately after the licensee has notified the
appropriate off-site response organizations and not later than one hour after
the licensee declares an emergency. These reporting requirements do not
supersede or release a licensee's responsibility to comply with the Emergency
Planning and Community Right-to-Know Act of 1986, title III, Public Law 99-499,
or other state or federal reporting requirements;
I. a brief description of the types of
information on facility status, radioactive releases, and recommended
protective actions, if necessary, to be given to off-site response
organizations and to the commissioner;
J. a brief description of the frequency,
performance objectives, and plans for the training that the licensee will
provide workers on how to respond to an emergency, including any special
instructions and orientation tours the licensee would offer to fire, police,
medical, and other emergency personnel. The training must:
(1) familiarize personnel with site-specific
emergency procedures;
(2)
thoroughly prepare site personnel for their responsibilities in the event of an
accident, using accident scenarios postulated as the most probable for the
specific site; and
(3) use team
training for accident scenarios postulated as the most probable for the
specific site;
K. a
brief description of the means of restoring the facility to a safe condition
after an accident;
L. provisions
for conducting quarterly communications checks with off-site response
organizations and biennial on site exercises to test response to simulated
emergencies. Quarterly communications checks with off-site response
organizations must include checking and updating all necessary telephone
numbers. The licensee must invite off-site response organizations to
participate in the biennial exercises. Participation of off-site response
organizations in biennial exercises, although recommended, is not required.
Exercises must use accident scenarios postulated as most probable for the
specific site and the scenarios must not be known to most exercise
participants. The licensee must critique the exercises using individuals not
having direct implementation responsibility for the plan. Critiques of
exercises must evaluate the appropriateness of the plan, emergency procedures,
facilities, equipment, training of personnel, and overall effectiveness of the
response. Deficiencies found by the critiques must be corrected; and
M. a certification that the applicant has met
its responsibilities under the Emergency Planning and Community Right-to-Know
Act of 1986, title III, Public Law 99-499, if applicable to the applicant's
activities at the proposed place of use of the radioactive material.
Subp. 6.
Comments.
A licensee must:
A.
allow the off-site response organizations expected to respond in case of an
accident 60 days to comment on the licensee's emergency plan before submitting
it to the commissioner; and
B.
provide any comments received within the 60 days to the commissioner along with
the emergency plan.
Subp.
7.
Application to produce PET radioactive drugs.
An application from a medical facility, educational
institution, or federal facility to produce positron emission tomography (PET)
radioactive drugs for noncommercial transfer to licensees in its consortium
authorized for medical use under NRC, or equivalent agreement state
requirements must include:
A. a
request for authorization for the production of PET radionuclides or evidence
of an existing license issued by the NRC, or an agreement state with
requirements for a PET radionuclide production facility within its consortium
from which it receives PET radionuclides;
B. evidence that the applicant is qualified
to produce radioactive drugs for medical use by meeting one of the criteria in
part 4731.3395, subpart 1;
C.
identification of individuals authorized to prepare the PET radioactive drugs
if the applicant is a pharmacy, and documentation that each individual meets
the requirements of an authorized nuclear pharmacist as specified in part
4731.3395, subpart 2; and
D.
information identified in part 4731.3395, subpart 1, on the PET drugs to be
noncommercially transferred to members of its consortium.