§ 30.19 Self-luminous products containing tritium, krypton-85, or promethium147.

(a) Except for persons who manufacture, process, produce or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in paragraph (c) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in Parts 20 and 30 through 35 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to § 32.22 of this chapter, which license authorizes the initial transfer of the product for use under this section.

(b) Any person who desires to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to transfer such products for use pursuant to paragraph (a) of this section, should apply for a license pursuant to § 32.22 of this chapter, which license states that the product may be transferred by the licensee to persons exempt from the regulations pursuant to paragraph (a) of this section or equivalent regulations of an Agreement State.

(c) The exemption in paragraph (a) of this section does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

(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 9026, June 6, 1969, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978]

§ 30.20 Gas and aerosol detectors containing byproduct material.

(a) Except for persons who manufacture, process, produce or initially transfer for sale or distribution gas and aerosol detectors containing by

product material any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in Parts 20 and 30 through 35 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to § 32.26 of this chapter, which license authorizes the initial transfer of the product for use under this section.

(b) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use pursuant to paragraph (a) of this section, should apply for a license pursuant to § 32.26 of this chapter, which license states that the product may be initially transferred by the licensee to persons exempt from the regulations pursuant to paragraph (a) of this section or equivalent regulations of an Agreement State.

(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 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978]

LICENSES

§ 30.31 Types of licenses.

Licenses for byproduct material are of two types: General and specific. Specific licenses are issued to named persons upon applications filed pursuant to the regulations in this part and Parts 32 through 35 of this chapter. General licenses are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons.

(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 8185, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978]

§ 30.32 Application for specific licenses.

(a) Applications for specific licenses should be filed in duplicate on Form NRC-313, “Application for Byproduct Material License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. Applications may be filed in person at the Commission's offices at 1717 H Street, N.W., Washington, D.C., at 7920 Norfolk Avenue, Bethesda, Maryland. Information contained in previous applications, statements or reports filed with the Commission or the Atomic Energy Commission may be incorporated by reference, provided that such references are clear and specific.

(b) The Commission may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked.

(c) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

(d) An application for license filed pursuant to the regulations in this part and Parts 32 through 35 of this chapter will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided that the application specifies the additional activities for which licenses are requested and complies with regulations of the Commission as to applications for such licenses.

(e) Each application for a byproduct material license, other than a license exempted from Part 170 of this chapter, shall be accompanied by the fee prescribed in § 170.31 of this chapter. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in § 170.31 of this chapter.

(f) An application for a license to receive and possess byproduct material for commercial waste disposal by land burial or for the conduct of any other activity which the Commission determines will significantly affect the quality of the environment shall be

filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any Environmental Report required pursuant to Part 51 of this chapter.

(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 8185, June 26, 1965, as amended at 36 FR 145, Jan. 6, 1971; 37 FR 5747, Mar. 21, 1972; 39 FR 26279, July 18, 1974; 40 FR 8785, Mar. 3, 1975; 40 FR 50704, Oct. 31, 1975; 43 FR 6922, Feb. 17, 1978]

§ 30.33 General requirements for issuance of specific licenses.

(a) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by the Act;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;

(3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property;

(4) The applicant satisfies any special requirements contained in Parts 32 through 35; and

(5) In the case of an application for a license to receive and possess byproduct material for commercial waste disposal by land burial or for the conduct of any other activity which the Commission determines will significantly affect the quality of the environment, the Director of Nuclear Material Safety and Safeguards or his designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to Part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion

shall be grounds for denial of a license to receive and possess byproduct material in such plant or facility. As used in this paragraph the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

(b) Upon a determination that an application meets the requirements of the Act, and the regulations of the Commission, the Commission will issue a specific license authorizing the possession and use of byproduct material (Form NRC 374, "Byproduct Material License").

(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); secs. 11.e(2), 81, 83, 84, 161b, 1610, 161x, 274; Pub. L. 83-703 as amended by Title II of Pub. L. 95-604, 68 stat. 919 et seq. 92 stat 3021 et seq (42 U.S.C. 2014e(2), 2111, 2113, 2114, 2201b, 2201x, 2021))

[30 FR 8185, June 26, 1965, as amended at 36 FR 12731, July 7, 1971; 37 FR 5747. Mar. 21, 1972; 39 FR 26279, July 18, 1974; 43 FR 6922, Feb. 17, 1978; 45 FR 65530, Oct. 3, 1980]

§ 30.34 Terms and conditions of licenses.

(a) Each license issued pursuant to the regulations in this part and the regulations in Parts 31 through 35 of this chapter shall be subject to all the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations and orders of the Commission.

(b) No license issued or granted pursuant to the regulations in this part and Parts 31 through 35, nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Commission, shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.

(c) Each person licensed by the Commission pursuant to the regulations in this part and Parts 31 through 35 shall confine his possession and use of the byproduct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the regulations in this part and Parts 31 through 35 of this chapter shall carry with it the right to receive, acquire, own, and possess byproduct material. Preparation for shipment and transport of byproduct material shall be in accordance with the provisions of Part 71 of this chapter.

(d) Each license issued pursuant to the regulations in this part and Parts 31 through 35 shall be deemed to contain the provisions set forth in section 183b.-d., inclusive, of the Act, whether or not these provisions are expressly set forth in the license.

(e) The Commission may incorporate, in any license issued pursuant to the regulations in this part and Parts 31 through 35, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of byproduct material as it deems appropriate or necessary in order to:

(1) Promote the common defense and security;

(2) Protect health or to minimize danger to life or property;

(3) Protect restricted data;

(4) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

(f) Each licensee shall notify the Commission in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license. This notification requirement applies to all specific licenses issued under this part and Parts 32 through 35 of this chapter.

(g) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m gen

(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); secs 81, 161b, Pub. L. 83-703, 68 Stat. 935-948 (42 U.S.C. 2111, 2201); sec. 201 as amended, Pub. L. 93-438, 88 Stat. 1242 as amended by Pub. L. 94-79, 89 Stat. 413 (42 U.S.C. 5841))

[30 FR 8185, June 26, 1965, as amended at 38 FR 33969, Dec. 10, 1973; 43 FR 6922, Feb. 17, 1978; 44 FR 17480, Mar. 22, 1979; 45 FR 41394, June 19, 1980]

§ 30.36 Expiration of licenses.

Except as provided in § 30.37(b), each specific license shall expire at the end of the day, in the month and year stated therein.

§ 30.37 Applications for renewal of li

censes.

(a) Applications for renewal of a specific license shall be filed in accordance with § 30.32.

(b) In any case in which a licensee, not less than thirty (30) days prior to the expiration of his existing license, has filed an application in proper form for renewal or for a new license, such existing license shall not expire until the application has been finally determined by the Commission.

§ 30.38 Applications for amendment of li

censes.

Applications for amendment of a license shall be filed in accordance with § 30.32 and shall specify the respects in which the licensee desires his license to be amended and the grounds for such amendment.

§ 30.39 Commission action on applications to renew or amend.

In considering an application by a licensee to renew or amend his license the Commission will apply the applicable criteria set forth in § 30.33 and Parts 32 through 35 of this chapter.

(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 8185, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978]

§ 30.41 Transfer of byproduct material.

(a) No licensee shall transfer byproduct material except as authorized pursuant to this section.

(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer byproduct material:

(1) To the Department;

(2) To the agency in any Agreement State which regulates radioactive material pursuant to an agreement under section 274 of the Act;

(3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption;

(4) To any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption;

(5) To any person authorized to receive such byproduct material under terms of a specific license or a general license or their equivalents issued by the Atomic Energy Commission, the Commission, or an Agreement State;

(6) To a person abroad pursuant to an export license issued under Part 110 of this chapter; or

(7) As otherwise authorized by the Commission in writing.

(c) Before transferring byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred.

(d) The following methods for the verification required by paragraph (c) of this section are acceptable:

(1) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;

(2) The transferor may have in his possession a written certification by the transferee that he is authorized by

license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;

(3) for emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date: Provided, That the oral certification is confirmed in writing within 10 days;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registration; or

(5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of such methods is correct or upto-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the byproduct material.

(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))

[38 FR 33969, Dec. 10, 1973, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6922, Feb. 17, 1978]

for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, such records shall be maintained until the Commission authorizes their disposition.

(c)(1) Records of receipt of byproduct material which must be maintained pursuant to paragraph (a) of this section shall be maintained as long as the licensee retains possession of the byproduct material and for two years following transfer, or disposal of the byproduct material.

(2) [Reserved]

(3) Records of transfer of byproduct material shall be maintained by the licensee who transferred the material for five years after such transfer.

(4) Records of disposal of byproduct material shall be maintained in accordance with § 20.401(c) of this chapter.

(d)(1) Records which must be maintained pursuant to this part and Parts 31 through 35 of this chapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations.

(2) If there is a conflict between the Commission's regulations in this part and Parts 31 through 35 of this chapter, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part and Parts 31 through 35 of this chapter for such records shall apply unless the Commission, pursuant to § 30.11, has granted a specific exemption from the record retention requirements specified in the regulations in this part or Parts 31 through 35 of this chapter.

(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))

[41 FR 18301, May 5, 1976, as amended at 43 FR 6922, Feb. 17, 1978]