Current through Register Vol. 35, No. 6, March 26, 2024
A. Except where otherwise determined by the
department, applications for specific licenses shall be filed in duplicate on a
form prescribed by the department (application for a radioactive
material license) in accordance with the instructions to the form.
Additional copies of the application may be required by the department.
Information contained in previous application, statements or reports filed with
the department may be incorporated by reference, provided that the reference is
clear and specific.
B. The
department may at any time after the filing of the original application, and
before the expiration of the license, require further statements in order to
enable the department to determine whether the application shall be granted or
denied or whether a license shall be modified or revoked.
C. Each application shall be signed by the
applicant or licensee or a person duly authorized to act for and on their
behalf.
D. An application for a
license may include a request for a license authorizing more than one activity,
provided that the application specifies the additional activities for which
licenses are requested and complies with the requirements in this chapter as to
applications for such licenses. In such cases, annual fees for all types of
activities authorized by the license may be charged as determined by 20.3.16
NMAC.
E. An application for a
specific license of category 1 and category 2 quantities of radioactive
material shall comply with 10 CFR 37. The licensee shall
comply with 10 CFR
37 except as follows:
(1) any reference to the commission or NRC
shall be deemed a reference to the department;
(2)
10 CFR
37.5 definitions of agreement state,
byproduct material, commission and person shall not be applicable;
(3)
10 CFR
37.7,
10 CFR
37.9,
10 CFR
37.11(a) and (b),
10 CFR
37.13,
10 CFR
37.27(c),
10 CFR
37.105, and
10 CFR
37.107 shall not be applicable; and
(4) the license required report of events or
notification in 10 CFR
37.45,
10 CFR
37.57,
10 CFR
71,
10 CFR
37.77(a) through (d), and
10 CFR
37.81 shall use the following address when
applicable: New Mexico Environment Department/RCB, P.O. Box 5469, Santa Fe, NM
87502-5469.
F. 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 identify the
source and (or) the device by manufacturer name and model number as registered
with the sealed source and device registry.
(1) Except as provided in Paragraph (2), (3)
and (4) of this Subsection, an application for a specific license to use
byproduct material in the form of a sealed source or in a device that contains
the sealed source must either:
(a) identify
the source or device by manufacturer and model number registered with the NRC
pursuant to 10 CFR
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
10 CFR
32.210; or
(b) contain the information identified in
10 CFR
32.210(c).
(2) For sources or devices manufactured
before October 23, 2012 that are not registered with the NRC under
10 CFR
32.210 or with an agreement state, and for
which the applicant is unable to provide all categories of information
specified in 10 CFR
32.210(c), the application
must include:
(a) all available information
identified in 10 CFR
32.210(c) concerning the
source, and, if applicable, the device; and
(b) 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. Such 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.
(3) For sealed
sources and devices allowed to be distributed without registration of safety
information in accordance with
10 CFR
32.210(g)(1), the applicant
may supply only the manufacturer, model number, and radionuclide and
quantity.
(4) 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.
G. As provided by
20.3.3.311 NMAC, certain
applications for a new or renewal specific license must contain a proposed
decommissioning funding plan or a certification of financial assurance for
decommissioning.
H. An application
for a license to receive and possess radioactive material for the conduct of
any activity which the department has determined pursuant to Subpart A of
10 CFR
51 will significantly affect the quality of
the environment shall be filed at least nine months prior to commencement of
construction of the plant or facility in which the activity will be conducted
and shall be accompanied by an environmental impact report required pursuant to
Subpart A of 10 CFR
51.
I. None of the following applications shall
be accepted for review unless it is accompanied by an environmental impact
report, submitted by the applicant, that specifically addresses the short-term
and long-term environmental, radiological and public health and safety aspects
of the applications and alternatives to the proposed action:
(1) an initial application for a radioactive
material license for a commercial radioactive waste disposal site
license;
(2) the first renewal of
any such license not previously accompanied by an environmental impact
report;
(3) an application for an
amendment to an existing license that may result in additional significant
impacts from radiation on the environment or public health or safety beyond
those impacts addressed in the existing license and accompanying documents;
and
(4) any other application that
the secretary determines may have significant impacts from radiation on the
environment or public health or safety.
J. The application for a radioactive material
license for a commercial radioactive waste disposal site, or for any renewal
thereof, or for an amendment thereto as described in Paragraph (3) of
Subsection H of this section, shall demonstrate that the activity for which
such license is requested will comply with all laws and regulations enforceable
by the department.
K. An
application from a medical facility or educational institution to produce PET
radioactive drugs for noncommercial transfer to licensees in its consortium
authorized for medical use under 20.3.7 NMAC shall include:
(1) a request for authorization for the
production of PET radionuclides or evidence of an existing license issued under
20.3.3 NMAC or under equivalent NRC or agreement state requirements for a PET
radionuclide production facility within its consortium from which it receives
PET radionuclides;
(2) evidence
that the applicant is qualified to produce radioactive drugs for medical use by
meeting one of the criteria in Subparagraph (b) of Paragraph (1) of Subsection
J of 20.3.3.315 NMAC;
(3) identification of individual(s)
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 Subparagraph (b) of Paragraph (2) of
Subsection J of
20.3.3.315 NMAC; and
(4) information identified in Subparagraph
(c) of Paragraph (1) of Subsection J of
20.3.3.315 NMAC on the PET drugs
to be non-commercially transferred to members of its
consortium.
L. An
application for a specific license to transfer source material under this
section.
(1) An application for a specific
license to initially transfer source material for use under
20.3.3.307 NMAC, will be approved
if:
(a) the applicant satisfies the general
requirements specified in this section; and
(b) the applicant submits adequate
information on, and the department approves the methods to be used for quality
control, labeling, and providing safety instructions to recipients.
(2) Each person licensed under
this section shall label the immediate container of each quantity of source
material with the type of source material and quantity of material and the
words, "radioactive material."
(3)
Each person licensed under this section shall ensure that the quantities and
concentrations of source material are as labeled and indicated in any transfer
records.
(4) Each person licensed
under this section shall provide the information specified in this paragraph to
each person to whom source material is transferred for use under this section.
This information must be transferred before the source material is transferred
for the first time in each calendar year to the particular recipient. The
required information includes:
(a) a copy of
Subsection B of 20.3.3.304.B NMAC and
10 CFR
40.51 or equivalent regulations under
Subsection L of
20.3.3.307 NMAC; and
(b) appropriate radiation safety precautions
and instructions relating to handling, use, storage, and disposal of the
material.
(5) Each person
licensed under this section shall report transfers as follows:
(a) File a report with the department under
20.3.1.116 NMAC. The report shall
include the following information:
(i) The
name, address, and license number of the person who transferred the source
material; and
(ii) For each general
licensee under 10 CFR
40.22 or
20.3.3.304 NMAC to whom greater
than 50 grams (0.11 lb) of source material has been transferred in a single
calendar quarter, the name and address of the general licensee to whom source
material is distributed; a responsible agent, by name and/or position and phone
number, of the general licensee to whom the material was sent; and the type,
physical form, and quantity of source material transferred; and
(iii) The total quantity of each type and
physical form of source material transferred in the reporting period to all
such generally licensed recipients.
(b) File a report with each responsible
agreement state agency that identifies all persons, operating under the
provisions equivalent to 10
CFR 40.22, to whom greater than 50 grams
(0.11 lb) of source material has been transferred within a single calendar
quarter. The report shall include the following information specific to those
transfers made to the agreement state:
(i) The
name, address, and license number of the person who transferred the source
material;
(ii) The name and address
of the general licensee to whom source material was distributed; a responsible
agent, by name and/or position and phone number, of the general licensee to
whom the material was sent; and the type, physical form, and quantity of source
material transferred; and
(iii) The
total quantity of each type and physical form of source material transferred in
the reporting period to all such generally licensed recipients within the
Agreement State.
(c)
Submit each report by January 31 of each year covering all transfers for the
previous calendar year. If no transfers were made to persons generally licensed
under 10 CFR
40.22 or equivalent agreement state
provisions during the current period, a report shall be submitted to the NRC
indicating so. If no transfers have been made to general licensees in a
particular agreement state during the reporting period, this information shall
be reported to the responsible agreement state agency upon request of the
agency.
(d) Each person licensed
under 20.3.3.304 NMAC shall maintain all
information that supports the reports required by this section concerning each
transfer to a general licensee for a period of one year after the event is
included in a report to the NRC or to an agreement state
agency.
