§ 32.25 Conditions of licenses issued under § 32.22: quality control, labeling, and reports of transfer.

Each person licensed under § 32.22 shall:

(a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission;

(b) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the byproduct material in the product can be identified; and

(c) 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 to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter, which shall include the following information on products transferred to other persons for use under § 30.19 of this chapter or equivalent regulations of

an Agreement State: (1) A description or identification of the type of each product; (2) for each radionuclide in each type of product, the total quantity of the radionuclide; and (3) the number of units of each type of product during the reporting period. If no transfers of byproduct material have been made pursuant to § 32.22 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))

[34 FR 9027, June 6, 1969, as amended at 35 FR 6703, Apr. 28, 1970; 38 FR 1271, Jan. 11, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6923, Feb. 17, 1978]

§ 32.26

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

An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect life or property from fires and airborne hazards, or to initially transfer such products for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if:

(a) 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 byproduct material in gas and aerosol detectors manufactured, processed or produced pursuant to a license issued by an Agreement State.

(b) 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 gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in § 32.27. The information should include:

(1) A description of the product and its intended use or uses;

(2) The type and quantity of byproduct material in each unit;

(3) 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;

(4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section;

(5) 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;

(6) 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;

(7) Degree of access of human beings to the product during normal handling and use;

(8) Total quantity of byproduct material expected to be distributed in the product annually;

(9) The expected useful life of the product;

(10) The proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of § 32.29(b);

(11) 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;

(12) 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;

(13) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.27 and the basis for such estimates;

(14) A determination that the probabilities with respect to the doses re

ferred to in § 32.27(c) meet the criteria of that paragraph;

(15) 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; and

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

(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))

[34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980]

§ 32.27 Same: safety criteria.

An applicant for a license under § 32.26 shall demonstrate that the product is designed and will be manufactured so that:

(a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.28.

(b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

(c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation

'It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria:

Low-not more than one such failure per year for each 10,000 exempt units distributed.

Negligible-not more than one such failure per year for each one million exempt units distributed.

the external surface of the detector containing:

(i) The following statement: "CONTAINS RADIOACTIVE MATERIAL"; (ii) The name of the radionuclide and quantity of activity; and

(iii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State.

(2) The labeling or marking specified in paragraph (b)(1) of this section is located where its will be readily visible when the detector is removed from its mounting.

(3) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:

(i) The name of the radionuclide and quantity of activity;

(ii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State; and

(iii) The following or a substantially similar statement: "THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS."

(4) Each detector and point-of-sale package is provided with such other information as may be required by the Commission; and

(c) 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 to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter, which shall include the following information on products transferred to other persons for use under § 30.20 of this chapter or equivalent regulations of an Agreement State: (1) A description or identification of the type of each product; (2) for each radionuclide in each type of product, the total quantity of the radionuclide; and (3) the number of units of each type of product during the reporting period. If no transfers of byproduct material have

been made pursuant to § 32.26 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))

[34 FR 6654, Apr. 18, 1969, as amended at 35 FR 6703, Apr. 28, 1970; 38 FR 1271, Jan. 11, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9,. 1980]

§ 32.40 Schedule A-Prototype tests for automobile lock illuminators.

An applicant for a license pursuant to § 32.14 to install lock illuminators into automobile locks, or to initially transfer lock illuminators in automobile locks for use pursuant to § 30.15 of this chapter shall conduct the following prototype tests on each of five prototype devices, consisting of the automobile lock with the installed illuminator in the following order:

(a) The device shall be subjected to 100 hours of accelerated weathering in a suitable weathering machine which simulates the most severe conditions of normal use;

(b) The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to an equivalent treatment in a test device simulating such a fall. The drop test shall be repeated 100 times from random orientations;

(c) The device shall be attached to a vibratory fixture and vibrated at a rate of not less than 26 cycles per second and a vibration acceleration of not less than 2 G for a period of not less than 1 hour;

(d) On completion of the foregoing tests, the device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry into the lock illuminator. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any evidence of bubbles emanating from within the

lock illuminator, or water entering the lock illuminator, shall be considered leakage;

(e) After each of the tests prescribed by this section, each device shall be examined for evidence of physical damage and for loss of tritium or promethium-147. Any evidence of damage to or failure of any device which could affect the containment of the tritium or promethium-147 in such devices shall be cause for rejection of the design on which such prototype devices were constructed or manufactured if the damage or failure is attributable to design defect. Loss of tritium or promethium-147 from each tested device shall be measured both by sampling the immersion test water used in paragraph (d) of this section and by wiping with filter paper the entire accessible area of the lock illuminator. Measurements of tritium or promethium-147 shall be made in an apparatus calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in the device is found in the immersion test water of the test in paragraph (d) of this section, or if more than 2,200 disintegrations per minute of tritium or promethium-147 on the filter paper is measured after any of the tests in paragraphs (a) to (d) of this section the device shall be rejected.

(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 31 FR 5317, Apr. 2, 1966; 43 FR 6923, Feb. 17, 1978]

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.

(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if:

(1) The applicant satisfies the general requirements of § 30.33 of this chapter;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(i) The device can be safety operated by persons not having training in radiological protection;

(ii) Under ordinary conditions of handling, storage and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits specified in the table in § 20.101(a) of this chapter; and

(iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24.

(3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly identified and separate statement:

(i) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(ii) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(iii) The information called for in the following statement in the same or substantially similar form: 1

The receipt, possession, use, and transfer of this device Model ▬▬▬▬▬▬▬▬▬▬▬▬ 2 Serial No. -2, are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION-RADIOACTIVE MATERIAL

(Name of manufacturer, or initial transferor)

(b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Commission will consider information which includes, but is not limited to:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment; (4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype tests;

'Devices licensed under § 32.51 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

2 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.