[30 FR 8189, June 26, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978]

§ 31.9 General license to own byproduct material.

A general license is hereby issued to own byproduct material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export byproduct material, except as authorized in a specific li

cense.

§ 31.10

General license for strontium 90 in ice detection devices.

(a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices, provided each device contains not more than fifty microcuries of strontium 90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to § 32.61 of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufacture of the ice detection devices for distribution to persons generally licensed by the Agreement State.

(b) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in paragraph (a) of this section:

(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to Part 30 or 32 of this chapter or from an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of § 20.301 of this chapter;

(2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;

(3) Are exempt from the requirements of Parts 19, 20, and 21, of this chapter except that such persons shall comply with the provisions of §§ 20.301, 20.402, and 20.403 of this chapter.

(c) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices.

(Sec. 202, Pub. L. 93-438, 88 Stat. 1244 (42 U.S.C. 5842) sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))

[30 FR 9905, Aug. 10, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978]

§ 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.

(a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units:

(1) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(2) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(3) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material,

or the radiation therefrom, to human beings or animals.

(5) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings, or animals.

(6) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(b) No person shall receive, acquire, possess, use, or transfer byproduct material pursuant to the general license established by paragraph (a) of this section until he has filed form NRC483, "Registration Certificate-In Vitro Testing with Byproduct Material Under General License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, and received from the Commission a validated copy of Form NRC-483 with registration number assigned or until he has been authorized pursuant to § 35.14(c) of this chapter to use byproduct material under the general license in this § 31.11. The registrant shall furnish on Form NRC-483 the following information and such other information as may be required by that form:

(1) Name and address of the registrant;

(2) The location of use; and

(3) A statement that the registrant has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with byproduct materials as authorized under the general license in paragraph (a) of this section, and that such tests will be performed only by personnel competent in the use of such instruments and in

the handling of the byproduct materials.

(c) A person who receives, acquires, possesses, or uses byproduct material pursuant to the general license established by paragraph (a) of this section shall comply with the following:

(1) The general licensee shall not possess at any one time, pursuant to the general license in paragraph (a) of this section, at any one location of storage or use, a total amount of iodine 125, iodine 131, selenium-75, and/or iron-59 in excess of 200 microcuries.

(2) The general licensee shall store the byproduct material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(3) The general licensee shall use the byproduct material only for the uses authorized by paragraph (a) of this section.

(4) The general licensee shall not transfer the byproduct material except by transfer to a person authorized to receive it by a license pursuant to this chapter or from an Agreement State, nor transfer the byproduct material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(5) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in paragraph (a)(7) of this section as required by § 20.301 of this chapter.

(d) The general licensee shall not receive, acquire, possess, or use byproduct material pursuant to paragraph (a) of this section:

(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of § 32.71 of this chapter or in accordance with the provisions of a specific license issued by an Agreement State that authorizes manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, or Mock Iodine-125 for distribution to persons generally licensed by the Agreement State.

(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, ap

This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)

(e) The registrant possessing or using byproduct materials under the general license of paragraph (a) of this section shall report in writing to the Director of Nuclear Material Safety and Safeguards, any changes in the information furnished by him in the "Registration Certificate-In Vitro Testing With Byproduct Material Under General License". Form NRC483. The report shall be furnished within 30 days after the effective date of such change.

(f) Any person using byproduct material pursuant to the general license of paragraph (a) of this section is exempt from the requirements of Parts 19, 20, and 21, of this chapter with respect to byproduct materials covered by that general license, except that such persons using the Mock Iodine-125 described in paragraph (a)(7) of this section shall comply with the provisions of §§ 20.301, 20.402, and 20.403 of this chapter.

NOTE: The reporting and record keeping requirements contained in this part have been approved by the General Accounting Office under B-180225 (R0088), (R0160).

(Secs. 201 and 202, Pub. L. 93-438, 88 Stat. 1242, 1244 (42 U.S.C. 5841, 5842))

[33 FR 16553, Nov. 14, 1968, as amended at 38 FR 1271, Jan. 11, 1973; 38 FR 34110, Dec. 11, 1973; 39 FR 26147, July 17, 1974; 40 FR

'Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

8785, Mar. 3, 1975; 41 FR 16446, Apr. 19, 1976; 42 FR 21604, Apr. 28, 1977; 42 FR 25721, May 19, 1977; 42 FR 26987, May 26, 1977; 42 FR 28896, June 6, 1977; 44 FR 50325, Aug. 28, 1979]

32.22 Self-luminous

products containing tritium, krypton-85 or promethium-147: requirements for license to manufacture, process, produce, or initially transfer.

32.23 Same: safety criteria.

32.24 Same: table of organ doses. 32.25 Conditions of licenses issued under § 32.22: quality control, labeling, and reports of transfer.

32.26 Gas and aerosol detectors containing byproduct material: requirements for license to manufacture, process, produce, or initially transfer.

32.27 Same: safety criteria. 32.28 Same: table of organ doses. 32.29 Conditions of licenses issued under § 32.26: quality control, labeling, and reports of transfer.

32.40 Schedule A-Prototype tests for automobile lock illuminators.

Sec.

Subpart B-Generally Licensed Items

32.51 Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture or initially transfer.

32.51a Same: conditions of licenses.

32.52 Same: material transfer reports and records.

32.53 Luminous safety devices for use in aircraft: requirements for license to manufacture, assemble, repair or initially transfer.

32.54 Same: labeling of devices. 32.55 Same: quality assurance; prohibition of transfer.

32.56 Same: material transfer reports. 32.57 Calibration or reference sources containing americium-241: requirements for license to manufacture or initially transfer.

32.58 Same: labeling of devices.

32.59 Same: leak testing of each source. 32.60 [Reserved]

32.61 Ice detection

devices containing strontium-90; requirements for license to manufacture or initially transfer. 32.62 Same: quality assurance; prohibition of transfer.

32.70 Manufacture and distribution of byproduct materials for medical use under general license.

32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license. 32.72 Manufacture and distribution of radiopharmaceuticals containing byproduct material for medical use under group licenses.

32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing byproduct material.

32.74 Manufacture and

distribution

of

sources or devices containing byproduct material for medical use. 32.101 Schedule B-Prototype tests for luminous safety devices for use in aircraft. 32.102 Schedule C-Prototype tests for calibration or reference sources containing americium-241.

32.103 Schedule D-Prototype tests for ice detection devices containing strontium 90.

Subpart C-Quality Control Sampling

Procedures

32.110 Acceptance sampling procedures under certain specific licenses.

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954; 42 U.S.C. 2111, 2201, 2232, 2233. For the purposes of sec. 223, 68 Stat. 958, as amended; 42 U.S.C. 2273, §§ 32.12.

32.16, 32.20, 32.25(c), 32.29(c), 32.52, 32.56. 32.60, 32.63 issued under sec. 161o., 68 Stat. 950, as amended; 42 U.S.C. 2201(o), unless otherwise noted.

SOURCE: 30 FR 8192, June 26, 1965, unless otherwise noted.

NOMENCLATURE CHANGES: 40 FR 8785, 8786, Mar. 3, 1975.

§ 32.1 Purpose and scope.

(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture, or initially transfer items containing byproduct material for sale or distribution to (1) persons exempted from the licensing requirements of Part 30 of this chapter, or (2) persons generally licensed under Part 31 or 35 of this chapter. This part also prescribes certain regulations governing holders of such licenses. In addition, this part prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material into a product or material owned by or in the possession of the licensee or another and regulations governing holders of such licenses.

(b) The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of Part 30 of this chapter apply to applications and licenses subject to this part.

[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974]

Subpart A-Exempt Concentrations and Items

§ 32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: requirements for license. An application for a specific license authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material will be approved if the applicant:

(a) Satisfies the general requirements specified in § 30.33 of this chapter;

(b) Provides a description of the product or material into which the byproduct material will be introduced, intended use of the byproduct material and the product or material into which it is introduced, method of introduction, initial concentration of the byproduct material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and

assurance

(c) Provides reasonable that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in § 30.70 of this chapter, that reconcentration of the byproduct material in concentrations exceeding those in § 30.70 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

§ 32.12 Same: material transfer reports.

Each person licensed under § 32.11 shall file an annual report with the Director of Nuclear Material Safety and

Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, with a copy of the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter, which shall identify the type and quantity of each product or material into which byproduct material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which byproduct material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the byproduct material by the licensee. If no transfers of byproduct material have been made pursuant to § 32.11 during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.

[35 FR 6703, Apr. 28, 1970, as amended at 38 FR 1271, Jan. 11, 1973; 41 FR 16446, Apr. 19, 1976]

§ 32.13 Same: prohibition of introduction.

No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under § 30.14 of this chapter or equivalent regulations of an Agreement State, except in accordance with a license issued pursuant to § 32.11 or the general license provided in § 150.20 of this chapter.

§ 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer. An application for a specific license to apply byproduct material to, or to incorporate byproduct material into, the products specified in § 30.15 of this chapter or to initially transfer for sale or distribution such products containing byproduct material for use pursuant to § 30.15 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;