Page images
PDF
EPUB

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)

pears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1

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.

PART 32-SPECIFIC DOMESTIC LI

CENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

Sec. 32.1 Purpose and scope. 32.2 Definitions.

(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 0 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

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. 32.12 Same: material transfer reports. 32.13 Same: prohibition of introduction. 32.14 Certain items containing byproduct

material; requirements for license to

apply or initially transfer. 32.15 Same: quality assurance, prohibition

of transfer, and labeling. 32.16 Certain items containing byproduct

material: reports of transfer. 32.17 Resins containing scandium-46 and

designed for sand-consolidation in oil wells: requirements for license to manufacture, or initially transfer for sale or

distribution. 32.18 Manufacture, distribution and trans

fer of exempt quantities of byproduct

material: requirements for license. 32.19 Same: conditions of licenses. 32.20 Same: records and material transfer

reports. 32.22 Self-luminous products containing

tritium, krypton-85 or promethium-147: requirements for license to manufacture, process, produce, or initially trans

fer. 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 re

ports 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 re

ports of transfer. 32.40 Schedule A-Prototype tests for

automobile lock illuminators.

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

Subpart B-Generally Licensed Items

32.16, 32.20, 32.25(c), 32.29(c), 32.52, 32.56. 32.60, 32.63 issued under sec. 1610., 68 Stat. 950, as amended; 42 U.S.C. 2201(0), unless otherwise noted.

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

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

Sec. 32.51 Byproduct material contained in de

vices 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 initial

ly 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 con

taining americium-241: requirements for license to manufacture or initially trans

fer. 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 by

product materials for medical use under

general license. 32.71 Manufacture and distribution of by

product material for certain in vitro clinical or laboratory testing under gen

eral license. 32.72 Manufacture and distribution of

radiopharmaceuticals containing byproduct material for medical use under

group licenses. 32.73 Manufacture and distribution of gen

erators or reagent kits for preparation of radiopharmaceuticals containing by

product material. 32.74 Manufacture and distribution of

sources or devices containing byproduct

material for medical use. 32.101 Schedule B--Prototype tests for lu

minous safety devices for use in aircraft. 32.102 Schedule C-Prototype tests for

calibration or reference sources contain:

ing americium-241. 32.103 Schedule D-Prototype tests for ice

detection devices containing strontium 90.

8 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. (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 8192, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978)

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,

8 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.

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

(34 FR 6653, Apr. 18, 1969, as amended at 39 Safeguards, U.S. Nuclear Regulatory FR 22129, June 20, 1974)

Commission, Washington, D.C. 20555,

with a copy of the appropriate NRC Subpart A-Exempt Concentrations Regional Office listed in Appendix D and Items

of Part 20 of this chapter, which shall

identify the type and quantity of each $ 32.11. Introduction of byproduct material product or material into which by.

in exempt concentrations into products product material has been introduced or materials, and transfer of ownership during the reporting period; name and

or possession: requirements for license. address of the person who owned or An application for a specific license possessed the product or material, into authorizing the introduction of by which byproduct material has been inproduct material into a product or ma troduced, at the time of introduction; terial owned by or in the possession of the type and quantity of radionuclide the licensee or another and the trans introduced into each such product or fer of ownership or possession of the material; and the initial concentraproduct or material containing the by tions of the radionuclide in the prodproduct material will be approved if uct or material at time of transfer of the applicant:

the byproduct material by the licens(a) Satisfies the general require ee. If no transfers of byproduct matements specified in § 30.33 of this chap- rial have been made pursuant to ter;

$ 32.11 during the reporting period, (b) Provides a description of the

the report shall so indicate. The product or material into which the by

report shall cover the year ending product material will be introduced,

June 30, and shall be filed within 30 intended use of the byproduct materi

days thereafter. al and the product or material into which it is introduced, method of in- (35 FR 6703, Apr. 28, 1970, as amended at 38 troduction, initial concentration of the FR 1271, Jan. 11, 1973; 41 FR 16446, Apr. 19, byproduct material in the product or 1976) material, control methods to assure that no more than the specified con

§ 32.13 Same: prohibition of introduction. centration is introduced into the prod No person may introduce byproduct uct or material, estimated time inter

material into a product or material val between introduction and transfer knowing or having reason to believe of the product or material, and esti

that it will be transferred to persons mated concentration of the radioiso

exempt under $ 30.14 of this chapter topes in the product or material at the

or equivalent regulations of an Agreetime of transfer; and

ment State, except in accordance with (c) Provides reasonable assurance

a license issued pursuant to $ 32.11 or that the concentrations of byproduct

the general license provided in $ 150.20 material at the time of transfer will not exceed the concentrations in

of this chapter. $ 30.70 of this chapter, that reconcen

8 32.14 Certain items containing byprodtration of the byproduct material in

uct material; requirements for license concentrations exceeding those in

to apply or initially transfer. § 30.70 is not likely, that use of lower concentrations is not feasible, and that

An application for a specific license the product or material is not likely to to apply byproduct material to, or to be incorporated in any food, beverage, incorporate byproduct material into, cosmetic, drug or other commodity or the products specified in § 30.15 of this product designed for ingestion or inha chapter or to initially transfer for sale lation by, or application to, a human

or distribution such products containbeing.

ing byproduct material for use pursu

ant to $ 30.15 of this chapter will be 8 32.12 Same: material transfer reports. approved if:

Each person licensed under $ 32.11 (a) The applicant satisfies the genershall file an annual report with the Di- al requirements specified in § 30.33 of rector of Nuclear Material Safety and 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 initial transferor 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 1inch diameter cylinder; and

(iii) Total immersion of the dials, hands and pointers used in the tests described in paragraphs (d)(1)(i) and (ii) of this section 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. (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)) (31 FR 5316, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 43 FR 6922, Feb. 17. 1978)

8 32.15 Same: quality assurance, prohibi.

tion of transfer, and labeling. (a) Each person licensed under $ 32.14 shall:

(1) Maintain quality assurance practices in the manufacture of the part or product, or the installation of the part into the product;

(2) Subject inspection lots to such testing as may be required as a condition of the license issued under $ 32.14 taking a random sample of the size required by the tables in $ 32.110, and for Lot Tolerance Percent Defective of 5.0 percent, accept or reject inspection (31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922. Feb. 17, 1978)

lots in accordance with the directions of $ 32.110; and

(3) Visually inspect each unit, except electron tubes containing byproduct material, in inspection lots. Any unit which has an observable physical defect that could affect containment of the byproduct material shall be considered as a defective unit.

(b) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (a)(2) of this part, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that the operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.

(c) No person licensed under $ 32.14 shall transfer to other persons for use under $ 30.15 of this chapter or equivalent regulations of an Agreement State:

(1) Any part or product which has been tested and found defective under the criteria and procedures specified in the license issued under $ 32.14, unless the defective units have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under $ 32.14; or

(2) Any inspection lot which has been rejected as a result of the procedures in $ 32.110 or alternative procedures in paragraph (b) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met such criteria as may be required as a condition of the license issued under $ 32.14.

(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 initial transferor of the product and the byproduct material in the product can be identified. (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))

8 32.16 Certain items containing byprod

uct material: reports of transfer. Each person licensed under $ 32.14 or $ 32.17 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 include the following information on items transferred to other persons for use under $ 30.15 or § 30.16 of this chapter or equivalent regulations of an Agreement State: (a) A description or identification of the type of each product; (b) for each radionuclide in each type of product, the total quantity of the radionuclide; and (c) the number of units of each type of product during the reporting period. If no transfers of byproduct material have been made pursuant to § 32.14 or $ 32.17 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. (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)) (35 FR 6703, Apr. 28, 1970, as amended at 38 FR 1271, Jan. 11, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6922, Feb. 17, 1978)

$ 32.17 Resins containing scandium-46

and designed for sand-consolidation in oil wells: requirements for license to manufacture, or initially transfer for

sale or distribution. An application for a specific license to manufacture, or initially transfer 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:

[blocks in formation]
« PreviousContinue »