relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(1) The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(2) The establishment of appropriate administrative procedures to assure: (i) Control of procurement and use of byproduct material;

(ii) Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(iii) Review, approval, and recording by the radiological safety officer of safety evaluations of proposed uses prepared in accordance with paragraph (b)(2)(ii) of this section prior to use of the byproduct material.

§ 33.15 Requirements for the issuance of a Type C specific license of broad scope. An application for a Type C specific license of broad scope will be approved if:

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

(b) The applicant submits a statement that byproduct material will be used only by, or under the direct supervision of, individuals who have received:

(1) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

(2) At least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of byproduct material to be used; and

(c) The applicant has established administrative controls and provisions relating to procurement of byproduct

material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

§ 33.16 Application for other specific li

censes.

An application filed pursuant to Part 30 of this chapter for a specific license other than one of broad scope will be considered by the Commission as an application for a specific license of broad scope under this part if the requirements of the applicable sections of this part are satisfied.

§ 33.17 Conditions of specific licenses of broad scope.

(a) Unless specifically authorized pursuant to other parts of this chapter, persons licensed under this part shall not: (1) Conduct tracer studies in the environment involving direct release of byproduct material; (2) receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of byproduct material in sealed sources used for irradiation of materials; (3) conduct activities for which a specific license issued by the Commission under Part 32, 34, or 35 of this chapter is required; or (4) add or cause the addition of byproduct material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each Type A specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(c) Each Type B specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiological safety officer.

(d) Each Type C specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or

(Sec. 201, Pub. L. 93-438; 88 Stat. 1242 (42 U.S.C. 5841))

[33 FR 14579, Sept. 28, 1968]

PART 34-LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS

Sec.

34.1 Purpose and scope.

34.2 Definitions.

34.3 Applications for specific licenses. 34.8 Information collection requirements: OMB approval.

Subpart A-Specific Licensing Requirements 34.11 Issuance of specific licenses for use of sealed sources in radiography.

34.51 Applications for exemptions. APPENDIX A

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended; 42 U.S.C. 2111, 2201, 2232, 2233. For the purposes of sec. 223, 68 Stat. 958, as amended, 42 U.S.C. 2273, §§ 34.11(d), 34.25(c), 34.26, 34.27, 34.28(b), 34.29(c), 34.31(c), 34.33(b), 34.33(e), and 34.43(c) issued under sec. 1610, 68 Stat. 950, as amended, 42 U.S.C. 2201(o), unless otherwise noted.

SOURCE: 30 FR 8198, June 26, 1965, unless otherwise noted.

§ 34.1 Purpose and scope.

This part prescribes requirements for the issuance of licenses for the use of sealed sources containing byproduct material and radiation safety requirements for persons using such sealed sources in radiography. The provisions and requirements of this part are in

(c)

"Radiographer's assistant" means any individual who under the personal supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in radiography;

(d) "Radiographic exposure device" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure;

(e) "Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material;

(f) "Storage container" means device in which sealed sources transported or stored.

a

are

(g) "Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources;

(h) "Permanent radiographic installation" means a shielded installation or structure designed or intended for radiography and in which radiography is regularly performed.

ments: OMB approval.

(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 of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number 31500007.

(b) The approved information collection requirements contained in this part appear in §§ 34.11, 34.24, 34.25, 34.26, 34.27, 34.28, 34.29, 34.31, 34.32, 34.33, and 34.43.

(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 § 34.3, Form NRC-313R is approved under control number 31500023.

[49 FR 19626, May 9, 1984]

Subpart A-Specific Licensing Requirements

§ 34.11 Issuance of specific licenses for use of sealed sources in radiography. An application for a specific license for use of sealed sources in radiography will be approved if: