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(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, Division of Materials Licensing, any changes in the information furnished by him in the "Registration CertificateIn Vitro Testing With Byproduct Material Under General License". Form AEC-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 Part 20 of this chapter with respect to byproduct materials covered by that general license. [33 F.R. 16553, Nov. 14, 1968]

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Byproduct material

Polonium 210 (Po 210). Potassium 42 (K-42) Praseodymium 143 (Pr 143). Promethium 147 (Pm 147)

Samarium 153 (Sm 153) Scandium 46 (Sc 46). Silver 105 (Ag 105). Silver 111 (Ag 111). Sodium 22 (Na 22)

Tellurium 129 (Te 129). Thallium 204 (TI 204) Tin 113 (Sn 113). Tungsten 185 (W 185). Vanadium 48 (V 48). Yttrium 90 (Y 90).

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Rhenium 186 (Re 186).

Rhodium 105 (Rh 105)

Rubidium 86 (Rb 86).

Ruthenium 106-Rhodium 106

(Ru Rh 106)

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Sodium 24 (Na 24)

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Strontium 89 (Sr 89).

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Sec.

32.22

32.23

32.24 32.25

32.26

32.27

32.28

32.29

32.40

32.51

32.52 32.53

32.54 32.55

32.56 32.57

32.58

32.59

32.60 32.61

32.62 32.63 32.70

32.71

Self-luminous products containing tritium, krypton-85 or promethium-147: requirements for license to manufacture, process, produce, import or transfer. Same: safety criteria. Same: table of organ doses.

Conditions of licenses issued under § 32.22: quality control, labeling and reports of transfers. Gas and aerosol detectors containing byproduct material: requirements for license to manufacture, process, produce, import or transfer.

Same: safety criteria.

Same: table of organ doses. Conditions of licenses issued under § 32.26: quality control, labeling, and reports of transfers. Schedule A-Prototype automobile lock illuminators.

tests for

Subpart B-Generally Licensed Items Certain measuring, gauging or controlling devices generally licensed under § 31.5 of this chapter: requirements for license to distribute.

Same: material transfer reports.
Luminous safety devices for use in
aircraft: requirements for license
to manufacture, assemble, repair
or import.

Same: labeling of devices.
Same: quality control; prohibition of
transfer.

Same: material transfer reports.
Calibration or reference sources con-

taining americium 241: require-
ments for license to manufacture
or import.

Same: labeling of devices.
Same: leak testing of each source.
Same: material transfer reports.
Ice detection devices containing

strontium 90; requirements for license to manufacture or import. Same; quality control procedures. Same; material transfer reports. Manufacture and distribution of byproduct materials for medical use under general license. Manufacture and distribution of byproduct materials for certain in vitro clinical or laboratory testing under general license.

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32.110 Quality control sampling procedures under certain specific licenses.

AUTHORITY: The provisions of this Part 32 issued under secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954; 42 U.S.C. 2111, 2201, 2232, 2233.

SOURCE: The provisions of this Part 32 appear at 30 F.R. 8192, June 26, 1965, unless otherwise noted.

§ 32.1 Purpose and scope.

(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture, distribute or import items containing byproduct material for distribution to (1) persons exempted from the licensing requirements of Part 30 of this chapter, or (2) persons generally licensed under Parts 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.

§ 32.2 Definitions.

As used in this part:

(a) "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. [34 F.R. 6653, Apr. 18, 1969] 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

reasonable

assurance

(c) Provides that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in § 30.70, 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 a report in duplicate with the Director, Division of Materials Licensing, United States Atomic Energy Commission, Washington, D.C. 20545, describing 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 owns or possesses the product or material into which byproduct material has been introduced, the type and quantity of byproduct material introduced into each such product or material, and the initial concentrations of byproduct material in the product or material at time of transfer of the byproduct material by the licensee. The report shall be submitted within 30 days after the end of each calendar year in which the licensee introduces byproduct material into a product or material pursuant to a license granted under § 32.11.

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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 import.

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 import 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;

(b) The applicant submits sufficient information regarding the product pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of byproduct material in each product;

(2) Details of construction and design of each product;

(3) The method of containment or binding of the byproduct material in the product;

(4) Procedures for and results of prototype testing to demonstrate that the material will not become detached from the product and that the byproduct material will not be released to the environment under the most severe conditions likely to be encountered in normal use of the product;

(5) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet;

(6) The proposed method of labeling or marking each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container with the identification of the manufacturer or importer of the product and the byproduct material in the product;

(7) For products for which limits on levels of radiation are specified in § 30.15

of this chapter, the radiation level and the method of measurement;

(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the product.

(c) Each product will contain no more than the quantity of byproduct material specified for that product in § 30.15 of this chapter. The levels of radiation from each product containing byproduct material will not exceed the limits specified for that product in § 30.15 of this chapter.

(d) The Commission determines that:

(1) The method of containment or binding of the byproduct material in the product is such that the radioactive material will not be released or be removed from the product under the most severe conditions which are likely to be encountered in normal use and handling. Tritium will be considered to be properly bound to dials, hands, and pointers if there is no visible flaking or chipping and the total loss of tritium does not exceed 5 percent of the total tritium when prototype dials, hands, and pointers are subjected to the following tests in the order specified below.

(i) Attachment of dials to a vibrating fixture and vibration at a rate of not less than 26 cycles per second and a vibration acceleration of not less than 2G for a period of not less than one hour; and

(ii) Attachment of the hub ends of the hands or pointers to a clamp and bending of hands or pointers over a 1-inch diameter cylinder; and

(iii) Total immersion of the dials, hands and pointers used in the tests described in subdivisions (i) and (ii) of this subparagraph in 100 milliliters of water at room temperature for a period of 24 consecutive hours and analysis of the test water for its radioactive material content by liquid scintillation counting or other equally sensitive method.

(2) The product has been subjected to and meets the requirements of the prototype tests. Prototype tests for automobile lock illuminators are prescribed by § 32.40, Schedule A.

[31 F.R. 5316, Apr. 2, 1966, as amended at 34 F.R. 6652, Apr. 18, 1969]

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the installation of the part into the product;

(b) Subject production lots to such quality control tests as may be required as a condition of the license issued under § 32.14 sampled in accordance with § 32.110 and accept or reject production lots in accordance with the directions of § 32.110; and

(c) Visually inspect each unit, except electron tubes containing byproduct material, in production lots and reject any unit which has an observable physical defect that could affect containment of the byproduct material.

(d) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or importer of the product and the byproduct material in the product can be identified. [31 F.R. 5317, Apr. 2, 1966, as amended at 34 F.R. 6652, Apr. 18, 1969]

§ 32.16 Certain items containing byproduct material: material transfer reports.

Each person licensed under § 32.14 or § 32.17 shall file an annual report with the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C. 20545, which shall state the total quantity of byproduct material imported for sale or distribution, or transferred to other persons under § 30.15 or § 30.16 of this chapter during the reporting period. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter.

[32 F.R. 4241, Mar. 18, 1967]

§ 32.17 Resins containing scandium 46 and designed for sand-consolidation in oil wells-requirements for license to manufacture, or import for sale or distribution.

An application for a specific license to manufacture, or import for sale or distribution, synthetic plastic resins containing scandium 46 for use pursuant to § 30.16 of this chapter will be approved if:

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

(b) The product is designed to be used only for sand-consolidation in oil wells; (c) The applicant submits the following information:

(1) The general description of the product to be manufactured or imported.

(2) A description of control procedures to be used to assure that the concentration of scandium 46 in the final product at the time of distribution will not exceed 1.4 x 10-3μc/ml.

(d) Each container of such product will bear a durable, legible label approved by the Commission, which contains the following information:

(1) The product name;

(2) A statement that the product contains radioactive scandium and is designed and manufactured only for sandconsolidation in oil wells;

(3) Instructions necessary for proper use; and

(4) The manufacturer's name. [32 F.R. 4241, Mar. 18, 1967]

§ 32.22

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

(a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to import or to transfer such products for use pursuant to § 30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33 (a) (2) and (3) do not apply to an application for a license to transfer tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, or produced pursuant to a license issued by an Agreement State.

(2) 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 self-luminous product to demonstrate that the product will meet the safety criteria set forth in § 32.23. The information should include:

(i) A description of the product and its intended use or uses.

(ii) The type and quantity of byproduct material in each unit.

(iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product.

(iv) Solubility in water and body fluids of the forms of the byproduct ma

terial identified in subdivisions (iii) and (xii) of this subparagraph.

(v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product.

(vi) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement.

(vii) Degree of access of human beings to the product during normal handling and use.

(viii) Total quantity of byproduct material expected to be distributed in the product annually.

(ix) The expected useful life of the product.

(x) The proposed method of labeling or marking each unit with identification of the manufacturer or importer of the product and the byproduct material in the product.

(xi) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product.

(xii) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features.

(xiii) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.23 and the basis for such estimates.

(xiv) A determination that the probabilities with respect to the doses referred to in § 32.23 (d) meet the criteria of that paragraph.

(xv) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet.

(xvi) Any additional information, including experimental studies and tests, required by the Commission.

(b) Notwithstanding the provisions of paragraph (a) of this section, the Commission may deny an application for a specific license under this section if the

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