2. An application for a specific
license to manufacture and/or initially transfer products or materials
containing NORM to persons exempted from these regulations pursuant to
1.11.4(2), will be approved if:
a. The NORM
is not contained in any food, beverage, cosmetic, drug, or other commodity
designed for ingestion or inhalation by, or application to, a human being;
and
b. The applicant submits
sufficient information relating to the design, manufacture, prototype testing,
quality control procedures, labeling or marking, and conditions of handling,
storage, use, and disposal of the NORM material or product to demonstrate that
the material or product will meet the safety criteria set forth in 1.11.16. The
information shall include:
i. A description of
the material or product and its intended use or uses;
ii. The type, quantity, and concentration of
NORM in each material or product;
iii. The chemical and physical form of the
NORM in the material or product, and changes in chemical and physical form that
may occur during the useful life of the material or product;
iv. An analysis of the solubility in water
and body fluids of the NORM in the material or product;
v. The details of manufacture and design of
the material or product relating to containment and shielding of the NORM and
other safety features under normal and severe conditions of handling, storage,
use, reuse, and disposal of the material or product;
vi. The degree of access of human beings to
the material or product during normal handling, use, and disposal;
vii. The total quantity of NORM expected to
be distributed annually in the material or product;
viii. The expected useful life of the
material or product;
ix. The
proposed method of labeling or marking each unit of the material or product
with identification of the manufacturer and/or initial transferor of the
product and the radionuclide(s) and quantity of NORM in the material or
product;
x. The procedures for
prototype testing of the material or product to demonstrate the effectiveness
of the containment, shielding, and other safety features under both normal and
severe conditions of handling, storage, use, reuse, and disposal;
xi. The results of the prototype testing of
the material or product, including any change in the form of the NORM contained
in it, the extent to which the NORM may be released to the environment, any
change in radiation levels, and any other changes in safety features;
xii. The estimated external radiation doses
and dose commitments relevant to the safety criteria in 1.11.16 and the basis
for such estimates;
xiii. A
determination that the probabilities with respect to doses referred to 1.11.16
meet the safety criteria;
xiv. The
quality control procedures to be followed in the production of production lots
of the material or product, and the quality control standards the material or
product will be required to meet; and
xv. Any additional information, including
experimental studies and tests, required by the Agency to facilitate a
determination of the radiation safety of the material or
product.