Title 10
SECTION 31.11
31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.
§ 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.
(8) Cobalt-57, in units not exceeding 0.37 megabecquerel (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.
(b) A person shall not receive, acquire, possess, use, or transfer byproduct material under the general license established by paragraph (a) of this section unless that person:
(1) Has filed NRC Form 483, “Registration Certificate - In Vitro Testing with Byproduct Material Under General License,” with the Director, Office of Nuclear Material Safety and Safeguards , by an appropriate method listed in § 30.6(a) of this chapter, and has received from the Commission a validated copy of NRC Form 483 with a registration number assigned; or
(2) Has a license that authorizes the medical use of byproduct material that was issued under part 35 of this chapter.
(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, under 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, cobalt-57 and/or iron-59 in excess of 7.4 megabecquerels (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 § 20.2001.
(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, or before November 30, 2007, and the provisions of a specific license issued by a State with comparable provisions to § 32.71 that authorize manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to persons generally licensed by the Agreement State or the State with comparable provisions to § 32.71.
(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1
1 Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.
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, Office 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 NRC-483. 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 §§ 20.2001, 20.2201, and 20.2202.
[33 FR 16553, Nov. 14, 1968] Editorial Note:For Federal Register citations affecting § 31.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.