| (II) identity of an individual by name and position
who may constitute a point of contact between the department and the
general licensee;
(III) the type and model number of devices commercially
distributed; and
(IV) the quantity of depleted uranium contained in
the product or device.
(ii) If no commercial distributions have been made
to persons generally licensed in accordance with §289.251(f)(3)(D)
of this title during the reporting period, the report shall so indicate;
(F) report to the NRC and each responsible agreement
state agency all commercial distributions of industrial products or
devices to persons for use in accordance with the general license
in the NRC's or agreement state's equivalent requirements to §289.251(f)(3)(D)
of this title. The report shall meet the provisions of subparagraph
(E)(i) and (ii) of this paragraph; and
(G) make, maintain, and retain records including the
name, address, and point of contact for each general licensee to whom
the licensee commercially distributes depleted uranium in products
or devices for use in accordance with the general license provided
in §289.251(f)(3)(D) of this title or equivalent requirements
of the NRC or any agreement state. The records shall be maintained
for inspection by the department in accordance with subsection (mm)
of this section and shall include the date of each commercial distribution,
the quantity of depleted uranium in each product or device commercially
distributed, and compliance with the report requirements of this section.
(t) Specific licenses for the processing of loose radioactive
material for manufacture and commercial distribution. In addition
to the requirements in subsection (e) of this section, a license to
process loose radioactive material for manufacture and commercial
distribution of radioactive material to persons authorized to possess
such radioactive material in accordance with this chapter will be
issued if the department approves the following information submitted
by the applicant:
(1) radionuclides to be used, including the chemical
and physical form and the maximum activity of each radionuclide;
(2) intended use of each radionuclide and the sealed
sources or other products to be manufactured that includes:
(A) receipt of radioactive material;
(B) chemical or physical preparations;
(C) sealed source construction;
(D) final assembly or processing;
(E) quality assurance testing;
(F) quality control program;
(G) leak testing;
(H) American National Standards Institute (ANSI) testing
procedures;
(I) transportation containers;
(J) shipping procedures; and
(K) disposition of unwanted or unused radioactive material;
(3) scaled drawings of the facility to include:
(A) air filtration;
(B) ventilation system;
(C) plumbing; and
(D) radioactive material handling systems and, when
applicable, remote handling hot cells;
(4) details of the environmental monitoring program;
and
(5) documentation of training as specified in subsection
(jj)(1) of this section for all personnel who will be handling radioactive
materials.
(u) Specific licenses for other manufacture and commercial
distribution of radioactive material. In addition to the requirements
in subsection (e) of this section, a license to manufacture and commercially
distribute radioactive material to persons authorized to possess such
radioactive material in accordance with these requirements will be
issued if the department approves the following information submitted
by the applicant:
(1) the radionuclides to be used, including the chemical
and physical form and the maximum activity of each radionuclide;
(2) the intended use of each radionuclide and the sealed
sources or other products to be manufactured that includes:
(A) receipt of radioactive material;
(B) chemical or physical preparations;
(C) sealed source construction;
(D) final assembly or processing;
(E) quality assurance testing;
(F) quality control program;
(G) leak testing;
(H) ANSI testing procedures;
(I) transportation containers;
(J) shipping procedures; and
(K) disposition of unwanted or unused radioactive material;
(3) scaled drawings of radioactive material handling
systems; and
(4) documentation of training as specified in subsection
(jj)(1) of this section for all personnel who will be handling radioactive
material.
(v) Sealed source or device evaluation.
(1) Any manufacturer or initial distributor of a sealed
source or device containing a sealed source may submit a request to
the department for evaluation of radiation safety information about
its product and for its registration.
(2) The request for review shall be sent to the department
in accordance with §289.201(k) of this title and shall be submitted
in duplicate accompanied by the appropriate fee specified in §289.204
of this title.
(3) In order to provide reasonable assurance that the
radiation safety properties of the source or device are adequate to
protect health and minimize danger to life and property, the request
for evaluation of a sealed source or device shall include sufficient
information about the:
(A) design;
(B) manufacture;
(C) prototype testing;
(D) quality control program;
(E) labeling;
(F) proposed uses; and
(G) leak testing.
(4) The request for evaluation of a device shall also
include sufficient information about:
(A) installation;
(B) service and maintenance;
(C) operating and safety instructions; and
(D) its potential hazards.
(5) The department normally evaluates a sealed source
or a device using radiation safety criteria in accepted industry standards.
If these standards and criteria do not readily apply to a particular
case, the department formulates reasonable standards and criteria
with the help of the manufacturer or distributor. The department shall
use criteria and standards sufficient to ensure that the radiation
safety properties of the device or sealed source are adequate to protect
health and minimize danger to life and property. Section 289.251(e)(1)
- (3) of this title includes specific criteria that apply to certain
exempt products and §289.251(f) of this title includes specific
criteria applicable to certain generally licensed devices. This section
includes specific provisions that apply to certain specifically licensed
items.
(6) After completion of the evaluation, the department
issues a sealed source and device (SS & D) certificate of registration
to the person making the request. The SS & D certificate of registration
acknowledges the availability of the submitted information for inclusion
in an application for a specific license proposing use of the product,
or concerning use under an exemption from licensing or general license
as applicable for the category of SS & D certificate of registration.
(7) The person submitting the request for evaluation
and SS & D certificate of registration of safety information about
the product shall manufacture and distribute the product in accordance
with:
(A) the statements and representations, including quality
control program, contained in the request; and
(B) the provisions of the SS & D certificate of
registration.
(8) Authority to manufacture or initially distribute
a sealed source or device to specific licensees shall be provided
in the license without the issuance of a SS & D certificate of
registration in the following cases:
(A) calibration and reference sources shall contain
no more than:
(i) 1 mCi (37 MBq) for beta and/or gamma emitting radionuclides;
or
(ii) 10 µCi (0.37 MBq) for alpha emitting radionuclides;
or
(B) the intended recipients are qualified by training
and experience and have sufficient facilities and equipment to safely
use and handle the requested quantity of radioactive material in any
form in the case of unregistered sources or, for registered sealed
sources contained in unregistered devices, are qualified by training
and experience and have sufficient facilities and equipment to safely
use and handle the requested quantity of radioactive material in unshielded
form, as Cont'd... |
