(a)(1) 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:

(i) Persons exempted from the licensing requirements of part 30 of this chapter, or equivalent regulations of an Agreement State, or

(ii) Persons generally licensed under part 31 of this chapter or equivalent regulations of an Agreement State.

(iii) Persons licensed under part 35 of this chapter.

(2) 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 a licensee or another, and regulations governing holders of such licenses.

(3) This part prescribes certain requirements governing holders of licenses to manufacture or distribute items containing byproduct material.

(4) This part describes procedures and prescribes requirements for the issuance of certificates of registration (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources.

(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, licenses and certificates of registration subject to this part, and the provisions of part 37 of this chapter apply to applications and licenses subject to this part.

(c)(1) The requirements in this part, including provisions that are specific to licensees, shall apply to Government agencies and Federally recognized Indian Tribes with respect to accelerator-produced radioactive material or discrete sources of radium-226 on November 30, 2007 except that the agency or Tribe may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and radioactive drugs and sources and devices to medical use licensees, until the date of the NRC's final licensing determination, provided that the agency or Tribe submits a new license application for these activities on or before December 1, 2008 or an amendment application for these activities on or before June 2, 2008.

(2) The requirements in this part, including provisions that are specific to licensees, shall apply to all persons other than those included in paragraph (c)(1) of this section with respect to accelerator-produced radioactive material or discrete sources of radium-226 on August 8, 2009, or earlier as noticed by the NRC, except that these persons may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and to sell or manufacture radioactive drugs and sources and devices to medical use licensees until the date of the NRC's final licensing determination, provided that the person submits a license application within 12 months from the waiver expiration date of August 7, 2009 or within 12 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever is earlier; or that the person submits an amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

[30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 FR 1896, Jan. 13, 1998; 72 FR 55928, Oct. 1, 2007; 77 FR 43690, July 25, 2012; 78 FR 17006, Mar. 19, 2013; 80 FR 74979, Dec. 1, 2015]

As used in this part:

Committed dose for the purposes of this part means the radiation dose that will accumulate over time as a result of retention in the body of radioactive material. Committed dose is a generic term for internal dose and must be calculated by summing the projected dose over the 50 years after intake for all irradiated organs or tissues multiplying the doses to individual organs and tissues by applicable tissue weighting factors.

Dose commitment means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

Lot Tolerance Percent Defective means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

Nationally tracked source is a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix E to part 20 of this Chapter. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both the NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974; 71 FR 65708, Nov. 8, 2006; 77 FR 43690, July 25, 2012]

Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy of a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

[53 FR 19246, May 27, 1988]

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0001.

(b) The approved information collection requirements contained in this part appear in §§ 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, 32.210, and 32.211.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 32.11, NRC Form 313 is approved under control number 3150-0120.

(2) [Reserved]

[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997; 62 FR 63640, Dec. 2, 1997; 71 FR 65708, Nov. 8, 2006; 72 FR 58486, Oct. 16, 2007; 77 FR 43691, July 25, 2012]