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The licensee's operating and emergency procedures shall include instructions in at least the following:

(a) The handling and use of licensed sealed sources and radiographic exposure devices to be employed such that no person is likely to be exposed to radiation doses in excess of the limits established in Part 20 of this chapter "Standards for Protection Against Radiation";

(b) Methods and occasions for conducting radiation surveys;

(c) Methods for controlling access to radiographic areas;

(d) Methods and occasions for locking and securing radiographic exposure devices, storage containers and sealed sources;

(e) Personnel monitoring and the use of personnel monitoring equipment;

(f) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, posting of vehicles and control of the sealed sources during transportation;

(g) Minimizing exposure of persons in the event of an accident;

(h) The procedure for notifying proper persons in the event of an accident; and

(i) Maintenance of records.

§ 34.33

Personnel monitoring control.

(a) The licensee shall not permit any person to act as a radiographer or as a radiographer's assistant unless, at all times during radiographic operations, each such person shall wear a film badge and either a pocket dosimeter or pocket chamber. Pocket dosimeters and pocket chambers shall be capable of measuring doses from zero to at least 200 milliroentgens. A film badge shall be assigned to and worn by only one person.

(b) Pocket dosimeters and pocket chambers shall be read and doses recorded daily. A film badge shall be immediately processed if a pocket chamber or pocket dosimeter is discharged beyond

its range. The film badge reports received from the film badge processor and records of pocket dosimeter and pocket chamber readings shall be maintained for inspection by the Commission.

PRECAUTIONARY PROCEDURES IN
RADIOGRAPHIC OPERATIONS

§ 34.41 Security.

During each radiographic operation the radiographer or radiographer's assistant shall maintain a direct surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in Part 20 of this chapter, except (a) where the high radiation area is equipped with a control device or an alarm system as described in § 20.203 (c) (2) of this chapter, or (b) where the high radiation area is locked to protect against unauthorized or accidental entry. § 34.42 Posting.

Notwithstanding any provisions in § 20.204 (c) of this chapter, areas in which radiography is being performed shall be conspicuously posted as required by § 20.203 (b) and (c) (1) of this chapter.

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(a) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation as described in § 34.24 is available and used at each site where radiographic exposures are made.

(b) A physical radiation survey shall be made after each radiographic exposure during a radiographic operation to determine that the sealed source has been returned to its shielded condition.

(c) A physical radiation survey shall be made to determine that each sealed source is in its shielded condition prior to securing the radiographic exposure device and storage container as specified in § 34.22.

(d) Records shall be kept of the surveys required by paragraph (c) of this section and maintained for inspection by the Commission.

EXEMPTIONS

§ 34.51 Applications for exemptions.

The Commission may, upon application by any licensee or upon its own initiative, grant such exemptions from

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§ 35.1 Purpose and scope.

This part prescribes regulations governing the licensing of byproduct material for human uses. It includes special requirements for issuance of specific licenses authorizing human use of byproduct material general licenses for human use of byproduct material of specified types and forms, and certain regulations governing the holders of such specific and general licenses. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of Part 30 of this chapter apply to applications and licenses subject to this part.

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§ 35.11

SPECIFIC LICENSES

Specific licenses for human use of byproduct material in institutions. An application by an institution for a specific license for human use of byproduct material will be approved if:

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

(b) 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;

(c) The applicant possesses adequate facilities for the clinical care of patients;

(d) 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

(e) 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.

§ 35.12 Specific licenses to individual physicians for human use of byproduct material.

An application by an individual physician for a specific license for human use of byproduct material will be approved if:

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

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

(c) 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.)

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An application for a specific license for use of a sealed source for human use will be approved if:

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

(b) The applicant or, if the application is made by an institution, the individual user (1) 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 (2) is a physician.

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131

(1) Iodine as sodium iodide (NaI11) for measurement of thyroid uptake;

(2) Iodine 131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;

(3) Iodine 125 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume; (4) Cobalt 58 for the measurement of intestinal absorption of cyanocobalamin; (5) Cobalt 60 for the measurement of intestinal absorption of cyanocobalamin;

(6) Chromium 51 as sodium radiochromate for determination of red blood cell volumes and studies of red blood cell survival time.

NOTE: Section 32.70 of this chapter requires manufacturers of radiopharmaceuticals which are under the general license in this paragraph to include the following statement in the label affixed to the container or in the leaflet or brochure which accompanies the radiopharmaceutical:

This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use, and transfer are subject to the regulations and a general license of the United States Atomic Energy Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of manufacturer)

(b) No physician shall receive, possess, use, or transfer byproduct material pursuant to the general license established by paragraph (a) of this section until he his filed Form AEC-482, "Registration Certificate-Medical Use of Byproduct Material Under General License" with the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C. 20545, and received from the Commission a validated copy of the Form AEC-482 with registration number assigned. The registrant shall furnish on Form AEC-482 the fol

lowing information and such other information as may be required by that form:

(1) Name and address of the registrant;

(2) A statement that the registrant is a duly licensed physician authorized to dispense drugs in the practice of medicine, and specifying the license number and the State in which such license is valid; and

(3) A statement that the registrant has appropriate radiation measuring instruments to carry out the diagnostic procedures for which he proposes to use byproduct material under the general license of § 35.31 of this chapter and that he is competent in the use of such instruments.

(c) A physician who receives, possesses, or uses a pharmaceutical containing byproduct material pursuant to the general license established by paragraph (a) of this section shall comply with the following:

(1) He shall not possess at any one time, pursuant to the general license in paragraph (a) of this section, more than:

(i) 200 microcuries of iodine 131, (ii) 200 microcuries of iodine 125, (iii) 5 microcuries of cobalt 58, (iv) 5 microcuries of cobalt 60, and (v) 200 microcuries of chromium 51. (2) He shall store the pharmaceutical until administered in the original shipping container or a container providing equivalent radiation protection;

(3) He shall use the pharmaceutical only for the uses authorized by paragraph (a) of this section;

(4) He shall not administer the pharmaceutical to a woman with confirmed pregnancy or to a person under 18 years of age;

(5) He shall not transfer the byproduct material to a person who is not authorized to receive it pursuant to a license issued by the Commission or an agreement State, or in any manner other than in the unopened, labeled shipping container as received from the supplier, except by administering it to a patient.

(d) The registrant possessing or using byproduct material under the general license of paragraph (a) shall report in duplicate to the Director, Division of Materials Licensing, any changes in the information furnished by him in the "Registration Certificate-Medical Use of Byproduct Material Under General License," Form AEC-482. The report

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AUTHORITY: The provisions of this Part 36 issued under secs. 81, 82, 161, 182, 183, 68 Stat. 935, 948, 953, 954; 42 U.S.C. 2111, 2112, 2201, 2232, 2233.

SOURCE: The provisions of this Part 36 appear at 30 F.R. 8201, June 26, 1965, unless otherwise noted.

§ 36.1 Purpose and scope.

This part prescribes regulations governing specific licenses for the export of byproduct material and establishes certain general licenses for the export from and import into the United States of byproduct material. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of Part 30 of this chapter apply to applications and licenses subject to this part.

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(b) All communications and reports concerning the regulations in this part with regard to import should be addressed to the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C. 20545.

(c) Communications and reports may be delivered in person at the Commission's offices at 1717 H Street NW., Washington, D.C.; at 4915 St. Elmo Avenue, Bethesda, Md.; or at Germantown, Md. § 36.3

License requirements for export of byproduct material.

(a) No person shall export byproduct material from the United States except as authorized pursuant to the regulations in this part and Part 30.

(b) No person shall export byproduct material from the United States knowing or having reason to believe that it is to be reexported directly or indirectly, in whole or in part, from the country of ultimate destination shown on the export license, shipper's export declaration, bill of lading, or commercial invoice, unless either:

(1) The reexport has been authorized by the Commission; or

(2) At the time of export, the material may be exported directly from the United States to the new country of ultimate destination under the terms of one of the general licenses established in this part.

SPECIFIC LICENSES

§ 36.11 Applications for specific li

censes.

Applications for specific licenses for export of byproduct material from the United States shall be filed in triplicate on Form AEC-7 with the Director, Division of State and Licensee Relations, U.S. Atomic Energy Commission, Washington, D.C. 20545. Applications may also be filed in person at the Commission's offices at 1717 H Street NW., Washington, D.C.; at 4915 St. Elmo Avenue, Bethesda, Md.; or at Germantown, Md.

§ 36.12 Issuance of specific licenses for export of byproduct material.

The Commission may, upon application by an interested person, issue a license authorizing the export of byproduct material to a country or destination listed in § 36.50, Schedule A, for the export of byproduct material in quantities or forms not authorized for export under general license if, in the

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opinion of the Commission, the proposed export would not be inimical to the common defense and security.

§ 36.21

GENERAL LICENSES

Export of certain byproduct material to countries other than Schedule A countries.

(a) A general license designated AECGL-3621 is hereby issued authorizing any licensee of the Commission or of an agreement State to export from the United States byproduct material covered by his license having an atomic number from 3 to 83, inclusive, or tritium when contained in luminous safety dveices installed in aircraft as generally licensed items pursuant to § 31.7 of this chapter, to any foreign country except Southern Rhodesia or countries or destinations listed in § 36.50, Schedule A.

(b) A general license designated AECGL-MED is hereby issued authorizing any licensee of the Commission or of an agreement State to export from the U.S. byproduct material covered by his license having an atomic number from 3 to 83, inclusive, to Southern Rhodesia to the extent that the byproduct material is contained in medicinals or pharmaceutical preparations or in devices, applicators or appliances designed for use in medical diagnosis or therapy. [30 F.R. 15285, Dec. 10, 1965, as amended at 31 F.R. 7959, June 4, 1966; 31 F.R. 8417, June 16, 1966]

§ 36.22 Export of certain quantities of tritium and polonium 210.

(a) A general license designated AECGL-3622 is hereby issued authorizing any licensee of the Commission or of an agreement State to export from the United States to any foreign country except Southern Rhodesia, Poland or Rumania or countries or destinations listed in 36.50, Schedule A, 5,000 curies of tritium and 5,000 curies of polonium 210 in a calendar quarter. Not more than 1,000 curies of tritium may be exported by any person to any one country or destination in a calendar quarter and not more than 100 curies of tritium may be exported by any person in a single shipment under this general license. Exports under this general license may be in one or more of the following forms or products only:

(1) Tritium activated luminous paint; (2) Tritium labeled organic compounds;

(3) Tritiated accelerator targets;

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