Current through Register No. 40, October 3, 2024
(a) An application for specific license to
distribute byproduct material other than source or byproduct material to
persons exempted from licensing pursuant to
He-P
4030.08 may be approved if:
(1) The byproduct material is not contained
in any food, beverage, cosmetic, drug, or other commodity designed for
ingestion or inhalation by, or application to, a human being;
(2) The byproduct material is in the form of
processed chemical elements, compounds, or mixtures, tissue samples, bioassay
samples, counting standards, plated or encapsulated sources, or similar
substances, identified as radioactive and to be used for its radioactive
properties, but is not incorporated into any manufactured or assembled
commodity, product, or device intended for commercial distribution;
and
(3) The applicant submits
copies of prototype labels and brochures and DHHS/RHS approves such labels and
brochures.
(b) The
license for exempt quantities issued under
He-P
4032.09 shall be subject to the following conditions:
(1) No more than 10 exempt quantities as
listed in He-P 4092.01, which may be
composed of fractional parts, shall be sold or transferred in a single
transaction, provided that the sum of the fractional parts shall not exceed
one;
(2) Each exempt quantity shall
be separately and individually packaged;
(3) No more than 10 packaged exempt
quantities shall be contained in any outer package for transfer to persons
exempt pursuant to He-P 4030.03;
(4) The outer package shall be such that the
dose rate at the external surface of the package does not exceed 0.5 millirem
per hour;
(5) The immediate
container of each quantity or separately packaged fractional quantity of
radioactive material shall bear a durable, legible label which:
a. Identifies the radionuclide and the
quantity of radioactivity; and
b.
Bears the words "Radioactive Material"; and
(6) In addition to the labeling information
required by He-P 4032.09, the label affixed
to the immediate container, or an accompanying brochure, shall:
a. State that the contents are exempt from
licensing state requirements;
b.
Bear the words "Radioactive Material - Not for Human Use - Introduction into
Foods, Beverages, Cosmetics, Drugs, or Medicinal, or into Products Manufactured
for Commercial Distribution is Prohibited - Exempt Quantities Should Not be
Combined"; and
c. Set forth
additional radiation safety precautions and instructions relating to the
handling, use, storage, and disposal of the byproduct material.
(c) Each person
licensed under He-P 4032.09 shall maintain
records identifying, by name and address, each person to whom byproduct
material is transferred for use under
He-P
4030.03 or the equivalent regulations of the Nuclear
Regulatory Commission or an agreement state or licensing state, and the kinds
and quantities of byproduct material transferred.
(d) An annual summary report shall be filed
with DHHS/RHS, as follows:
(1) Each report
shall state the total quantity of each radionuclide transferred under the
specific license;
(2) Each report
shall cover the year ending June 30;
(3) Each report shall be filed within 30 days
after the end of the quarter; and
(4) If no transfers of byproduct material
have been made pursuant to this section during the reporting period, the report
shall so indicate.
(See Revision Note at part heading for He-P 4032) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff
8-7-07
