GENERAL PROVISIONS

License requirements.

Definitions.

Interpretations.

EXEMPTIONS

Persons operating Commission-owned facilities. Carriers.

Other exemptions.

Exempt Concentrations.

Certain Luminous Timepieces

30.12 Lock Illuminators Installed in Automobile Locks.

§ 30.3 License requirements. No person subject to the regulations in this part shall manufacture, produce, transfer, receive, acquire, own, possess, use, import or export byproduct material except as authorized in a specific or general license issued pursuant to the regulations in this part.

§ 30.4 Definitions. As used in this part:

(a) "Act" means the Atomic Energy Act of 1954, including any amendments thereto;

(b) "Byproduct material" means any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material;

(c) "Commission" means the Atomic Energy Commission and its duly authorized representatives;

(d) "Curie" means that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second;

(e) "Human use" means the internal or external administration of byproduct material, or the radiation therefrom, to human beings;

(f) "License," except where otherwise specified means a license issued pursuant to the regulations in this part;

(g) "Microcurie" means that amount of radioactive material which disintegrates at the rate of 37 thousand atoms per second;

(h) "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;

(i) "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;

(j) "Production facility" means production facility as defined in the regulations contained in Part 50 of this chapter;

(k) "Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into pratical application for experimental and demonstration purposes, including the experimental production and

testing of models, devices, equipment, materials and processes. "Research and development" as used in this part does not include the internal or external administration of byproduct material, or the radiation therefrom, to human beings;

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

(m) "Source material" means source material as defined in the regulations contained in Part 40 of this chapter;

(n) "Special nuclear material" means special nuclear material as defined in the regulations contained in Part 70 of this chapter;

(o) "United States," when used in a geographical sense, includes all territories and possessions of the United States, the Canal Zone and Puerto Rico;

(p) "Utilization facility" means a utilization facility as defined in the regulations contained in Part 50 of this chapter;

(q) Other terms defined in section 11 of the act shall have the same meaning when used in the regulations in this part;

(r) "Radiographer" means any individual who performs or who, in attendance at the site where the sealed source or sources are being used, personally supervises radiographic operations and who is responsible to the licensee for assuring compliance with the requirements of the regulations of this part and the conditions of the license;

(s) "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 survey instruments in radiography;

(t) "Radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of byproduct materials;

(u) "Agreement State" as designated in Part 150 of this chapter means any State with which the Commission has entered into an effective agreement under subsection 274. (b) of the Atomic Energy Act of 1954, as amended. "Nonagreement State" means any other State.

§ 30.5 Interpretations. Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission.

EXEMPTIONS

§ 30.6 Persons operating Commission-owned facilities. Any person is exempt from the requirements for a license set forth in section 81 or 82 of the act and from the regulations in this Part to the extent that such person operates Commissioned-owned plants and laboratories on behalf of the Commission. In any such case, such person's obligations with respect to the byproduct material are covered by the applicable contract between such person and the Commission.

$30.7 Carriers. Common and contract carriers

and the United States Post Office Department are exempt from the regulations in this part and the requirements for a license set forth in section 81 of the act to the extent that they transport byproduct material in the regular course of their business as carriers.

§ 30.8 Other exemptions. The Commission may upon the application of any interested person, or upon its own initiative, exempt certain classes or quantities of byproduct material or kinds of uses or users from the requirements for a license set forth in section 81 of the act and in the regulations in this part, when it makes a finding that the exemption of such classes or quantities of such material or such kinds of uses or users will not constitute an unreasonable risk to the common defense and security and to the health and safety of the public.

§ 30.9 Exempt concentrations. (a) Except as provided in § 30.32 (f), any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing byproduct material in concentrations not in excess of those listed in § 30.73.

(b) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material.

(a) Except

§ 30.10 Certain luminous timepieces. for persons who apply tritium to luminous timepieces or hands or dials and persons who import for sale or distribution luminous timepieces or hands or dials containing tritium, 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 of this chapter to the extent that such person receives, possesses, uses, transfers, exports, owns or acquires luminous timepieces or hands or dials containing tritium.

(b) Any person who desires to apply tritium to luminous timepieces or hands or dials for sale or distribution, or desires to import for sale or distribution luminous timepieces or hands or dials containing tritium, should apply for a specific license, pursuant to § 30.24 (i), which license states that the luminous timepieces or hands or dials may be distributed by the licensee to persons exempt from the regulations pursuant to paragraph (a) of this section.

§ 30.12 Lock illuminators installed in automobile locks. Any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in Part 20 of this chapter and this part to the extent that he receives, possesses, uses, transfers, exports, owns or acquires lock illuminators each containing not more that 15 millicuries of tritium installed in an automobile lock. The manufacture, installation into automobile locks, or importation for sale or distribution of lock illuminators whether or not installed in automobile locks, is not included in this exemption, but may be authorized by a specific license under the provisions of this part.

GENERAL LICENSES; APPLICATIONS FOR LICENSES

§ 30.20 Types of licenses. (a) Licenses for byproduct material are of two types: general and specific. The general licenses provided in § 30.21 are effective without the filing of applications with the Commission or the issuance of licensing documents to particular persons. Specific licenses are issued to named persons upon applications filed pursuant to the regulations in this part.

§ 30.21 General licenses. (a) A general license is hereby issued:

(1) To transfer, receive, acquire, own, possess and use byproduct material incorporated in a device or equipment which is listed in § 30.71 and has been manufactured pursuant to a specific license issued by the Commission.

(2) To transfer, receive, acquire, own, possess, use and import the quantities of byproduct materials listed in § 30.72, provided that no person shall at any one time possess or use, pursuant to the general licensing provisions of this paragraph, more than a total of ten such scheduled quantities.

(b) The general licenses provided in this section are subject to the provisions of § § 30.32 to 30.72, inclusive of the regulations in this part and are subject to the regulations contained in Part 20 of this chapter.1 In addition, persons who transfer, receive, acquire, own, possess, use or import scheduled items and quantities of byproduct material pursuant to the general licenses provided in paragraph (a) of this section.

(1) Shall not effect an increase in the radioactivity of said scheduled items or quantities by adding other radioactive material thereto, by combining byproduct material from two or more such items or quantities, or by altering them in any other manner so as to increase thereby the rate of radiation therefrom;

(2) Shall not administer externally or internally, or direct the administration of, said scheduled items or quantities or any part thereof to a human being for any purpose, including, but not limited to, diagnostic, therapeutic, and research purposes;

(3) Shall not add, or direct the addition of, said scheduled items or quantities or any part thereof to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being;

(4) Shall not include said scheduled items or quantities or any part thereof in any device, instrument, apparatus (including component parts and accessories thereto) intended for use in diagnosis, treatment or prevention of disease in human beings or animals or otherwise intended to affect the structure or any function of the body of human beings or animals.1

(c) (1) Subject to the provisions of subparagraphs (2) to (6) of this paragraph (c), a general license is hereby issued to own, receive, acquire, possess and use byproduct material when contained in devices designed and manufactured for the purpose of detect

iAttention is directed particularly to the provisions of the regulations in Part 20 of this chapter which relate to the labelling of containers.

ing, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(2) The general license contained in subparagraph (1) of this paragraph (c) applies only to devices which have been:

(i) Manufactured in accordance with the specifications contained in a specific license issued by the Commission to the manufacturer of the device pursuant to § 30.24 (f), or, in accordance with the specifications contained in a specific license issued to the manufacturer by an agreement State; and

(ii) Installed on the premises of the general licensee by a person authorized to install such devices under a specific license issued to the installer by the Commission pursuant to this part or by an agreement State, provided that the specific license referred to in subdivision (i) of this subparagraph (2) contains provisions authorizing the transfer of such devices to, and the installation of such devices in the premises of, general licensees.

(3) The general license contained in subparagraph (1) of this paragraph (c) applies only to devices which (i) are labeled in accordance with the provisions of the specific license which authorizes the distribution of the device to general licensees, and (ii) bear a label containing the following or a substantially similar statement which contains the information called for in the following statement:

(4) Persons who own, receive, acquire, possess or use a device pursuant to the general license contained in subparagraph (1) of this paragraph (c):

(i) Shall not transfer, abandon or dispose of the device, except by transfer to a person authorized by a specific license from the Commission or an agreement State to receive such device;

(ii) Shall assure that all labels affixed to the device at the time of receipt and bearing the statement, "Removal of this label is prohibited by regulations of the Atomic Energy Commission", are maintained thereon and shall comply with all instructions contained in such labels;

(iii) Shall have the device tested for leakage of radioactive material and proper operation of the onoff mechanism and indicator, if any, at no longer than six-month intervals; provided that devices containing only krypton need not be tested for leakage, and devices containing only tritium need not be tested for any purpose;

(iv) Shall have the tests required by subdivision (iii) of this subparagraph and all other services involving the radio-active material, its shielding and containment, performed by the supplier or other person holding a specific license from the Commission or

an agreement State to manufacture, install or service such devices;

(v) Shall maintain records of all tests performed on the devices as required under this section, including the dates and results of the tests and the names of the persons conducting the tests;

(vi) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding or containment of the radioactive material or the on-off mechanism or indicator, shall immediately suspend operation of the device until it has been repaired by the supplier or other person holding a specific license from the Commission or an agreement State to manufacture, install or service such devices, or disposed of by transfer to a person authorized to receive the byproduct material contained in the device; and

(vii) Shall be exempt from the requirements of Part 20 of this chapter, except that such persons shall comply with the provisions of § § 20.402 and 20.403 of this chapter.

(5) The general license provided in subparagraph (1) of this paragraph (c) is subject to the provisions of § § 30.32 to 30.72, inclusive: Provided, That persons who possess byproduct material pursuant to this general license shall not export such byproduct material without a specific license from the Commission authorizing such export.

(6) Any person who holds a specific license issued by an agreement State authorizing the holder to manufacture, install or service a device described in subparagraph (1) of this paragraph (c) within such agreement State is hereby granted a general license to install and service such device in any non-agreement State; Provided, That:

(i) Such person shall file a report with the Director, Division of Licensing and Regulation, Atomic Energy Commission, Washington 25, D.C., within 30 days after the end of each calendar quarter in which any device is transferred or installed. Each such report shall identify each general licensee by name and address, the type of device transferred, and the quantity and type of byproduct material contained in the device.

(ii) The device has been manufactured, labelled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the agreement State;

(iii) Such person assures that any labels required to be affixed to the device under regulations of the agreement State which licensed manufacture of the device bear a statement that "Removal of this label is prohibited by the regulations of the Atomic Energy Commission".

(iv) Shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in § 30.21 (c).

(d) (1) A general license is hereby issued to own, receive, acquire, possess and use tritium contained in luminous safety devices for use in aircraft, provided each device contains not more than four curies

of tritium and that each device has been manufactured, assembled or imported in accordance with a license issued under the provisions of § 30.24 (j). (2) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in subparagraph (1) of this paragraph are exempt from the requirements of Part 20 of this chapter, except that they shall comply with the provisions of § § 20.402 and 20.403 of this chapter.

(3) This general license does not authorize the manufacture, assembly, repair or import of luminous safety devices containing tritium.

(4) This general license does not authorize the export of luminous safety devices containing tritium except in accordance with the provisions of § 30.33.

§ 30.22 Applications for specific licenses. (a) Applications for specific licenses shall be filed on Form AEC-313, "Application for Byproduct Material License", with the United States Atomic Energy Commission, Division of Licensing and Regulation, Washington 25, D.C., Attention: Isotopes Branch and shall set forth the information called for by the form. Information contained in previous applications, statements or reports filed with the 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 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.

§ 30.23 General requirements for issuance of specific licenses. An application for a specific license will be approved if:

(a) The application is for a purpose authorized by the act; and

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

(c) 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; and

(d) The applicant satisfies any applicable special requirements contained in § 30.24.

§ 30.24 Special requirements for issuance of specific licenses (a) Human use in institutions. An application by an institution for a specific license for human use will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant has appointed a medical isotopes committee of at least three members to evaluate all proposals for research, diagnosis, and therapeutic use of radioisotopes within that institution. Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in assay of radioisotopes and protection against ionizing radiations; and (3) The applicant possesses adequate facilities for the clinical care of patients; and

(4) The physician designated on the application as the individual user has substantial experience in the proposed use, the handling and administration of radioisotopes and, where applicable, the clinical management of radioactive patients; and

(5) If the application is for a license to use unspecified quantities or multiple types of byproduct material, the applicant has previously received a reasonable number of licenses for a variety of byproduct materials for a variety of human uses.

use.

(b) Licensing of individual physicians for human An application by an individual physician for a specific license for human use will be approved if the applicant:

(1) Satisfies the general requirements specified in § 30.23;

(2) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable; and

(3) The applicant has extensive experience in the proposed use, the handling and administration of radioisotopes, and where applicable, the clinical management of radioactive patients. (The physician shall furnish suitable evidence of such experience with his application. A statement from the medical isotope committee in the institution where he acquired his experience, indicating its amount and nature, may be submitted as evidence of such experience.)

(c) "Human use" of sealed sources. An application for a specific license for use of a sealed source for human use will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant or, if the application is made by an institution, the individual user (i) has specialized training in the therapeutic use of the radioactive device considered (teletherapy unit, beta applicator, etc.) or has experience equivalent to such training; and (ii) is a physician.

(d) Multiple quantities or types of byproduct material for use in research and development. An application for a specific license for multiple quantities or types of byproduct material for use in research and development will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant has received a reasonable number of licenses for a variety of radioisotopes for a variety of research and development uses; and

(3) The applicant has established an isotope committee (composed of such persons as a radiological safety officer, a representative of the business office, and one or more persons trained or experienced in the safe use of radioactive materials) which will review and approve, in advance of purchase of radioisotopes, proposals for such uses; and

(4) The applicant has appointed a radiological safety officer who will advise on or be available for advice and assistance on radiological safety problems.

(e) Multiple quantities or types of byproduct material for use in processing. An application for a specific license for multiple quantities or types of byproduct material for use in processing for distribution to other authorized persons will be approved if: (1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant has received a reasonable number of licenses for processing and distribution of a variety of radioisotopes; and

(3) The applicant has appointed a radiological safety officer who will advise on or be available for advice and assistance on radiological safety problems.

(f) Distribution of devices to persons generally licensed under § 30.21 (c). An application for a specific license to distribute certain devices of the types enumerated in § 30.21 (c) to persons generally licensed under § 30.21 (c) will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labelling, proposed uses and potential hazards of the device to provide reasonable assurance that:

(i) The byproduct material contained in the device will not be lost;

(ii) That no person would receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;

(iii) The device can be safely operated by persons not having training in radiological protection; and (iv) The byproduct material within the device would not be accessible to unauthorized persons.

(3) In describing the label or labels and contents thereon to be affixed to the device, the applicant should separately indicate those instructions and precautions which are necessary to assure safe operation of the device. Such instructions and precautions must be contained on labels bearing the statement, "Removal of this label prohibited by regulations of the Atomic Energy Commission."

(g) Use of sealed sources in radiography. An application for a specific license for use of sealed sources in radiography will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.23; and

(2) The applicant will have an adequate program for training radiographers and radiographers' assistants and submits to the Commission a schedule or description of such program which specifies the: