research programs within the scope of the regulations in this part.

§ 37.2 Scope.

The scope of the program set forth in this part extends only to purchases of radioisotopes for use in research in the fields of agriculture and biomedicine, including research in medical therapy and diagnosis, and permits such purchases at 20 percent of the current prices established by the Commission. Discount purchases are not permitted for radioisotopes used in routine clinical treatment, in fixed sources such as strontium applicators, teletherapy units, cobalt-60 needles and applicators, gold 198 colloid, or Y-90 colloid. All discount purchases of radioisotopes are subject to budgetary limitations and the availability of funds, and to the byproduct license requirements of Part 30 of this chapter.

As used in this part: (a) "Applicant" means any domestic user of radioisotopes that is an individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, a State or any political subdivision of, or any political entity within a State, or a legal successor, representative, agent or agency of the foregoing: Provided, however, That the term "applicant" shall not include, for purposes of this part, any agencies of the United States Government or any contractor operated facility, wholly supported by the AEC.

(b) "Commission" means the Atomic Energy Commission or its duly authorized representative.

(c) "Director" means the Director. Division of Biology and Medicine, or his duly authorized representative.

(d) "Distributor" means any AEC facility which produces radioisotopes for sale.

(e) "Purchaser" means any applicant to which the Commission has issued a Discount Certificate.

(f) "Radioisotope" means any byproduct material as defined in section 1 (e) of the Atomic Energy Act of 1954.

(g) "Supplier" means anyone, licensed by the Atomic Energy Commission under the authority of section 81 of the Atomic Energy Act of 1954, engaged in the business of selling radioisotopes.

tation of the meaning of the regulations in this part by any officer or employee of the Commission other than by the General Counsel, in writing, will be recognized to be binding upon the Commission. § 37.5 Communications.

All communications concerning the program established in this part, and applications filed in connection with it, should be addressed to the United States Atomic Energy Commission, Washington, D.C. 20545, Attention: Director, Division of Biology and Medicine. Communications and reports may be delivered in person at the Commission's offices at 1717 H Street NW., Washington, D.C., or its offices at Germantown, Md. [20 F.R. 4712, July 2, 1955, as amended at 23 F.R. 1122, Feb. 21, 1958]

§ 37.6 Applications.

(a) Any applicant desiring to purchase radioisotopes at discount from the AEC established price, pursuant to this part shall file with the Director a Form AEC-372, "Application for Radioisotope Research Support."

(b) Form AEC-372, will require the applicant to: State name and address; agree to limit the use of the radioisotopes purchased at discount solely to the purposes permitted by the program; agree to make the results of the research available either for publication or to the AEC: agree to treat Restricted Data developed in the course of the research in accordance with the security requirements of the Atomic Energy Act of 1954 and the Commission's regulations for the safeguarding of Restricted Data; summarize the nature of the research in connection with which the radioisotopes will be used; state the location at which the research is to be conducted; briefly describe facilities to be used for the particular research proposed; summarize briefly the research experience of the applicant; list its licenses or authorizations permitting the procurement of radioisotopes for use in connection with the research proposed: and state whether or not the contemplated medical research involves human applications and if so. whether or not the applicant is a Doctor of Medicine and licensed to practice in the jurisdiction in which the research will be conducted. § 37.7 Additional information.

The Director may, at any time after the filing of the original application and be

fore the expiration of the Discount Certificate, require additional information in order to enable him to determine whether the Discount Certificate should be granted or denied or whether it should be modified, suspended, or revoked. § 37.8 Requirements for approval.

The applicant must evidence, in its application and any supporting information submitted supplementary thereto, that it is qualified to conduct the research proposed, and that the research proposed constitutes a well considered program justifying an authorization to purchase radioisotopes at a discount. § 37.9 Issuance.

The Director will review each application and, upon making a finding that the applicant satisfies the requirements of § 37.8 will issue to the applicant three original copies of a Discount Certificate. No Discount Certificates will be issued on or after April 5, 1961.

[20 F.R. 4712, July 2, 1955, as amended at 26 F.R. 2821, Apr. 5, 1961]

§ 37.10

Disapproval of applications.

If the Director determines that the applicant does not satisfy the requirements of § 37.8, he will so notify the applicant and include in the notice a statement of the reasons for that determination. The Director's determination shall be final. § 37.11

Discount Certificate.

A Discount Certificate:

(a) Is merely evidence that its holder may purchase radioisotopes at the discount specified thereon;

(b) Does not, in any way, affect any limitations imposed by or abrogate any requirements of byproduct licenses or radioisotope authorizations issued or required pursuant to the Atomic Energy Act of 1954;

(c) Apart from any requirements or limitations pursuant to paragraph (b) of this section, sets no limits on the types or quantities or radioisotopes purchased;

(d) Is non-transferable and nonassignable:

(e) Is valid only during the fiscal year (July 1-June 30) in which it is issued but may be reissued for the ensuing fiscal year upon the submission and approval of a new application;

(f) May be modified from time to time, as the Director deems necessary, in accordance with Commission regulations and pursuant to established Commission policy; and

(g) May be suspended or revoked by the Director,

(1) If budgetary or fiscal limitations necessitate the discontinuance of the program; or

(2) For cause, including, but not limited to, a material false statement in the application, revealed conditions or facts which would have warranted a disapproval of the application in the first instance, failure to fulfill the obligations undertaken in the application, or violation of or failure to observe any of the requirements, terms, or conditions of the Atomic Energy Act of 1954 or Commission regulations. The Certificate holder shall be notified promptly of a suspension or revocation for cause and the reasons therefor.

been issued to the undersigned by the Director, Division of Biology and Medicine, U.S. Atomic Energy Commission, authorizing the purchase of radioisotopes at 20% of AEC established price; that isotopes purchased under this authority will be used only for agricultural and biomedical research, including research in medical therapy and diagnosis; that the undersigned 18 inthorized, pursuant to the regulations in Title 10. Part 30. Code of Federal Regulations, Radioisotope Distribution, to procure such radioisotopes; and, that all of the information set forth and the statements made herein are to the best of (its) (my) knowledge true and correct.

(Signature)

(b) By forwarding to the supplier or distributor, along with the first purchase order placed with it during the fiscal year then current, a copy of the purchaser's Discount Certificate as furnished by the Commission, or a certified true copy thereof.

(c) Discount purchases may not be made with respect to radioisotopes not shipped by the supplier or distributor, at the case may be, on or before June 30, 1961.

[20 F.R. 6605, Sept. 9. 1955, as amended at 26 F.R. 2821, Apr. 5, 1961]

§ 37.13 Procedures for suppliers.

(a) Suppliers that receive requests for discount purchases are, before honoring such requests, responsible for obtaining a certified purchase order and a copy of a Discount Certificate as required by § 37.12.

(b) A supplier that has honored a discount purchase request for radioisotopes shall, within 45 days from the date of the discount sale, submit to the distributor from which the radioisotopes were obtained, a request for a credit, against the supplier's further purchases of radioisotopes, in the dollar amount of the discounts the supplier has allowed under and in accordance with the regulations in this part.

(c) Such a request for credit submitted to a distributor shall summarize the total of the credit requested for the period covered and shall be accompanied by supporting documents, such as shipping memoranda, shipping tabulations, or receipted purchase orders, which include the following pertinent information with respect to each sale or shipment and such additional information as may be required by the distributor: (1) Name of purchaser in the same manner as it appears on the purchaser's Discount Certificate;

(2) Number of the purchaser's Discount Certificate;

(3) Type and quantity of radioisotopes

sold and delivered;

(4) Date of shipment;

(5) Evidence of the amount of the discount given to the purchaser.

(d) The distributor shall, within a reasonable time after receipt of a request for credit, require any supplementary supporting data that may be necessary and notify the supplier of the credit granted.

(e) No credit shall be requested, and none will be given, with respect to any shipments of radioisotopes after June 30, 1961.

[20 F.R. 4712, July 2, 1955, as amended at 20 F.R. 6605, Sept. 9, 1955; 26 F.R. 2821. Apr. 5, 1961]

§ 37.14 Expiration of Radioisotope Research Support Program. Discount Certificates will not be issued on or after April 5, 1961, and credits will not be given with respect to any shipments subsequent to June 30, 1961 of radioisotopes ordered on the discount

AUTHORITY: The provisions of this Part 40 issued under secs. 62, 63, 64, 65, 161, 182, 183, 68 Stat. 932, 933, 948, 953, 954, as amended; 42 U.S.C. 2092, 2093, 2094, 2095, 2201, 2232, 2233, unless otherwise noted. Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended; 42 U.S.C. 2234. For the purposes of sec. 223, 68 Stat. 958, as amended; 42 U.S.C. 2273, § 40.41(c) issued under sec. 161b., 68 Stat. 948; 42 U.S.C. 2201 (b) and §§ 40.23 (e) (3), 40.61 and 40.62 issued under sec. 1610., 68 Stat. 950, as amended; 42 U.S.C. 2201 (0). SOURCE: The provisions of this Part 40 appear at 26 F.R. 284, Jan. 14, 1961, unless otherwise noted.

(b) "Commission" means the Atomic Energy Commission or its duly authorized representatives;

(c) "Government agency" means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government;

(d) "License", except where otherwise specified, means a license issued pursuant to the regulations in this part; (e) "Person" means (1) any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission, any State or any political subdivision of, or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent or agency of the foregoing;

(f) "Pharmacist" means an individual registered by a state or territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to compound and dispense drugs, prescriptions and poisons.

(g) "Physician" means an individual licensed by a state or territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico to dispense drugs in the practice of medicine.

(h) "Source Material” means (1) uranium or thorium, or any combination thereof, in any physical or chemical form or (2) ores which contain by weight one-twentieth of one percent (0.05%) or more of (i) uranium, (ii) thorium or (iii) any combination thereof. Source material does not include special nuclear material.

(1) "Special nuclear material" means (1) plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material; or (2) any material artificially enriched by any of the foregoing;

(j) "United States," when used in a geographical sense, includes all ter

39-053 0-75-18

ritories and possessions of the United States, the Canal Zone and Puerto Rico;

(k) "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting or beneficiating, or refining;

(1) Other terms defined in section 11 of the Act shall have the same meaning when used in the regulations in this part.

(m) "Agreement State" means any State with which the Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended.

(n) "Commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the natural environment of a site but does not include changes desirable for the temporary use of the land for public recreational uses, necessary borings to determine site characteristics or other preconstruction monitoring to establish background information related to the suitability of a site or to the protection of environmental values.

[26 F.R. 284, Jan. 14, 1961, as amended at 30 F.R. 15285, Dec. 10, 1965; 31 F.R. 15145, Dec. 2, 1966; 37 F.R. 5747, Mar. 21, 1972]

Except where otherwise specified in this part, all communications and reports concerning the regulations in this part, and applications filed under them, should be addressed to the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C. 20545. Communications, reports, and applications may be delivered in person at the Commission's offices at 1717 H Street NW., Washington, D.C.; at 7920 Norfolk Avenue, Bethesda, Md.; or at Germantown, Md.

[31 F.R. 4669, Mar. 19, 1966, as amended at 34 FR 19546, Dec. 11, 1969; 38 FR 1272, Jan. 11, 1973]

EXEMPTIONS

§ 40.11 Persons using source material under certain Atomic Energy Commission contracts.

Any prime contractor of the Commission is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Commission, receives, possesses, uses, transfers, delivers, or imports into or exports from the United States source material for: (a) The performance of work for the Commission at a United States Government-owned or controlled site, including the transportation of source material to or from such site and the performance of contract services during temporary interruptions of such transportation; (b) research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or (c) the use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel. In addition to the foregoing exemptions, any prime contractor or subcontractor of the Commission is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor receives, possesses, uses, transfers, delivers, or imports into or exports from the United States source material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety. Any person exempt from licensing under this part prior to the effective date of this amendment who would otherwise be required by virtue of this section to obtain a license shall continue to be so exempt on an interim basis. Such interim exemption shall expire 60 days from the effective date of this amendment, unless within said 60-day period either an application for a license covering the activity or an application for an appropriate exemption under this