Current through Register Vol. 39, No. 6, September 16, 2024
(a) All persons
manufacturing or initially transferring items or devices containing exempt
quantities or exempt concentrations of byproduct material, as described in Rule
.0301(a)(11) and .0301(a)(13) of this Chapter, generally licensed and
specifically licensed items or devices containing byproduct material, items or
devices containing byproduct material for medical use in humans, and persons
requesting safety evaluations of sealed sources or devices for registration
with the national Sealed Source and Device Registry shall comply with the
following requirements of 10 CFR 32 :
(1)
10 CFR
32.1(a), (b), and (c)(2),
"Purpose and scope;"
(2)
10 CFR
32.2, "Definitions," the term "initially
transfer" shall mean the "initial commercial transfer of items and devices to
an end user or a commercial or retail reseller;"
(3)
10 CFR
32.3, "Maintenance of
records."
(b) All Persons
manufacturing or initially transferring items or devices containing exempt
quantities of byproduct material shall comply with the following requirements
of Subpart A - Exempt Concentrations and Items:
(1)
10 CFR
32.13, "Same: Prohibition of
introduction;"
(2)
10 CFR
32.24, "Same: Table of organ doses;"
and
(3) applications to
manufacture, process, produce, prepare, package, re-package, or initially
transfer items or devices for commercial distribution containing exempt
concentrations or exempt quantities of byproduct material shall be made to the
United States Nuclear Regulatory Commission (NRC) in lieu of the
agency.
(c) All persons
manufacturing or initially transferring generally licensed devices containing
byproduct material shall comply with Paragraph (g) of this Rule and the
following requirements of Subpart B - Generally Licensed Items:
(1)
10 CFR
32.51, "Byproduct material contained in
devices for use under 10 CFR
31.5; requirements for license to
manufacture, or initially transfer;"
(2)
10 CFR
32.51a, "Same: Conditions of
licenses;"
(3)
10 CFR
32.52, "Same: Material transfer reports and
records;"
(4)
10 CFR
32.53, "Luminous safety devices for use in
aircraft: Requirements for license to manufacture, assemble, repair or
initially transfer;"
(5)
10 CFR
32.54, "Same: Labeling of devices;"
(6)
10 CFR
32.55, "Same: Quality assurance; prohibition
of transfer;"
(7)
10 CFR
32.56, "Same: Material transfer
reports;"
(8)
10 CFR
32.57, "Calibration or reference sources
containing americium-241 or radium- 226: Requirements for license to
manufacture or initially transfer;"
(9)
10 CFR
32.58, "Same: Labeling of devices;"
(10)
10 CFR
32.59, "Same: Leak testing of each
source;"
(11)
10 CFR
32.61, "Ice detection devices containing
strontium-90; requirements for license to manufacture or initially
transfer;"
(12)
10 CFR
32.62, "Same: Quality assurance; prohibition
of transfer;" and
(13)
10 CFR
32.71, "Manufacture and distribution of
byproduct material in certain in vitro clinical or laboratory testing under
general license."
(d)
All persons manufacturing or initially transferring items or devices containing
byproduct material for medical use in humans shall comply with Paragraph (g) of
this Rule and the following requirements of Subpart C - Specifically Licensed
Items:
(1)
10 CFR
32.72, "Manufacture, preparation, or transfer
for commercial distribution of radioactive drugs containing byproduct material
for medical use under part 35;" and
(2)
10 CFR
32.74, "Manufacture and distribution of
sources or devices containing byproduct material for medical
use."
(e) All persons
manufacturing sealed sources containing byproduct material in quantities equal
to or greater than the quantities listed in Appendix E of 10 CFR 20 shall
comply with Paragraph (g) of this Rule and the requirements of
10 CFR
32.201.
(f) All persons manufacturing or initially
transferring sealed sources or devices containing byproduct material under this
Rule for commercial distribution and persons requesting safety evaluations of
sealed sources or devices for registration with the national Sealed Source and
Device Registry shall comply with the following requirements of Subpart D -
Sealed Source and Device Registration:
(1)
10 CFR
32.210, "Registration of product
information;"
(2)
10 CFR
32.211, "Inactivation of certificates of
registration of sealed sources and devices;" and
(3) requests for safety evaluations and
registration of product information under this Paragraph and inactivation of
certificates of registration of sealed sources and devices issued by the agency
shall be submitted to the agency by e-mail at Licensing.RAM@dhhs.nc.gov, or at
the address shown in Rule .0111 of this Chapter in lieu of the
NRC.
(g) Applications
shall be made on forms provided by the agency. One copy of the application and
supporting material shall be submitted to the agency by e-mail at
Licensing.RAM@dhhs.nc.gov, or at the address shown in Rule .0111 of this
Chapter in lieu of the NRC:
(1) Persons
applying for new radioactive materials licenses, or for the renewal of existing
radioactive materials licenses, shall submit an Application for Radioactive
Materials License. The following information shall appear on the application:
(A) legal business name and mailing
address;
(B) physical address(es)
where radioactive material shall be used or possessed. The application shall
indicate if radioactive materials shall be used at temporary
jobsites;
(C) the name, telephone
number, and e-mail address of the Radiation Safety Officer;
(D) the name, telephone number, and e-mail
address of the individual to be contacted about the application. If this
individual is same as the Radiation Safety Officer, the application shall so
state;
(E) the application shall
indicate if the application is for a new license, or for the renewal of an
existing license, by marking the corresponding check box;
(F) if the application is for the renewal of
an existing license, the license number shall be provided on the
application;
(G) applicants shall
indicate the type and category of license as shown on the form by marking the
corresponding check box; and
(H)
the printed name, title, and signature of the certifying official. The
certifying official shall be an individual employed by the business or
licensee, who is authorized by the licensee to sign license applications on
behalf of the business or licensee.
(2) Persons applying for an amendment to an
existing license shall submit an Application for Amendment of Radioactive
Materials and Accelerator Licenses. The following information shall appear on
the application:
(A) the license
number;
(B) amendment number of the
current license;
(C) expiration
date of the license;
(D) licensee
name as it currently appears on the license;
(E) the name, telephone number, and e-mail
address of the Radiation Safety Officer;
(F) the name, telephone number, and e-mail
address of the individual to be contacted about the application. If this
individual is same as the Radiation Safety Officer, item 5b on the application
shall be left blank;
(G) applicants
shall provide a description of the action requested by marking the
corresponding checkbox in item 6a. If the check box next to "Other" is marked
in item 6a, provide a brief description of the action requested in the space
provided in item 6b;
(H)
explanation of the action requested; and
(I) the printed name, title, and signature of
the certifying official. The certifying official shall be an individual
employed by the business or licensee who is authorized by the licensee to sign
license applications on behalf of the business or licensee.
(3) Applications specified in this
Rule are available at: https://radiation.ncdhhs.gov/rms/rmsforms2.ht
m(Rev01).htm.
(h) The
regulations cited in this Rule from 10 CFR Part 32 are hereby incorporated by
reference, including subsequent amendments and editions. Copies of these
regulations are available free of charge at
https://www.nrc.gov/reading-rm/doc-collections/cfr/part032/.
Authority
G.S.
104E-7;
104E-10(b);
104E-20;
10 CFR
30.71;
Eff. February 1,
1980;
Amended Eff. October 1, 2013; May 1, 1993;
Transferred and Recodified from
15A NCAC
11.0304 Eff. February 1, 2015;
Amended Eff. March 1, 2017.
