(Name of manufacturer, assembler, or importer.) '

• The model, serial number, and name of manufacturer, assembler, or importer may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

(b) If the Commission determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (a) of this section, it may waive the requirements of that paragraph and require in lieu thereof that:

(1) A label be affixed to the device identifying:

(i) The manufacturer, assembler, or importer, and

(ii) The type of radioactive material; and

(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(i) The name of the manufacturer, assembler, or importer,

(ii) The type and quantity of radioactive material,

(iii) The model number,

(iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. AEC or of an Agreement State, and

(v) Such other information as may be required by the Commission, including disposal instructions when appropriate.

[33 F.R. 16331, Nov. 7, 1968]

§ 32.55 Same: quality control; prohibition of transfer.

(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any which has an observable

1 Devices distributed prior to Jan. 1, 1969, may bear labels authorized by the regulations in effect on Jan. 1, 1968.

physical defect that could affect containment of the tritium or promethium 147.

(b) Each person licensed under § 32.53 shall subject a number of devices from each production lot, sampled in accordance with § 32.110, to the following quality control procedures:

(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks as evidenced by bubbles emanating from within the device, or water entering the device, shall be rejected.

(2) The immersion test water from the preceding test in subparagraph (1) of this paragraph shall be measured for tritium or promethium 147 content by an apparatus that has been calibrated to measure tritium or promethium 147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium 147 in any device is found to have leaked into the immersion test water, the leaking device shall be rejected.

(3) The levels of radiation from each device containing promethium 147 shall be measured. Any device which has a radiation level in excess of 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, shall be rejected.

(c) An application for a license or for amendment of a license may include a description of quality control procedures proposed as alternatives to those prescribed by paragraph (b) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that they will assure the rejection of any device which has a leakage rate exceeding 0.1 percent of the original quantity of tritium or promethium 147 in any 24-hour period.

(d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter any luminous safety device which has been tested and rejected under the criteria and procedures specified in this section.

§ 32.56 Same: material transfer reports.

Each person licensed under § 32.53 shall file an annual report with the Director, Division of Materials Licensing, United States Atomic Energy Commission, Washington, D.C. 20545, which shall state the total quantity of tritium or promethium 147 transferred to persons generally licensed under § 31.7 of this chapter. The report shall identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium 147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within thirty (30) days thereafter. § 32.57 Calibration or reference sources containing_americium 241: requirements for license to manufacture or import.

An application for a specific license to manufacture or import calibration or reference sources containing americium 241, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if:

(a) The applicant satisfies the general requirements of § 30.33 of this chapter:

(b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of americium 241 in the source;

(2) Details of construction and design;

(3) Details of the method of incorporation and binding of the americium 241 in the source;

(4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium 241, to demonstrate that the americium 241 contained in each source will not be released or be removed from the source under normal conditions of use;

(5) Details of quality control procedures to be followed in manufacture of the source;

(6) Description of labeling to be affixed to the source or the storage container for the source;

(7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the

source.

(c) Each source will contain no more than 5 microcuries of americium 241.

(d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium 241, that:

(1) The method of incorporation and binding of the americium 241 in the source is such that the americium 241 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(2) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.102, Schedule C.

§ 32.58 Same: labeling of devices.

Each person licensed under § 32.57 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:

The receipt, possession, use and transfer of this source, Model Serial No. are subject to a general license and the regulations 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. Do not remove this label. CAUTION

RADIOACTIVE MATERIAL THIS SOURCE CONTAINS AMERICIUM 241. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

(Name of manufacturer or importer) § 32.59 Same: leak testing of each

source.

Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 0.1 microcurie of americium 241 prior to transferring the source to a general licensee under § 31.8 of this chapter. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcurie of americium 241. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing americium 241 and shall not be transferred to a general licensee under § 31.8 of this chapter.

§ 32.60 Same: material transfer reports. Each person licensed under § 32.57 shall file an annual report with the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C., 20545, which shall state the total quantity of americium 241 transferred to persons generally licensed under § 31.8 of this chapter. The report shall identify each general licensee by name and address, state the kinds and numbers of sources transferred, and specify the quantity (in microcuries) of americium 241 in each kind of source. Each report shall cover the calendar year and shall be filed within thirty (30) days after the end of each calendar year.

§ 32.61

Ice detection devices containing strontium 90: requirements for license to manufacture or import.

An application for a specific license to manufacture or import ice detection devices containing strontium 90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if:

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

(b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium 90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Precedures for and results of prototype testing of devices to demonstrate that the strontium 90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device;

(c) Each device will contain no more than 50 microcuries of strontium 90 in an insoluble form.

(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.203 (a) of this chapter, a statement that the device contains strontium 90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices.

(e) The Commission determines that: (1) The method of incorporation and binding of the strontium 90 in the device is such that the strontium 90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium 90 is incorporated or enclosed so as to preclude direct physical conduct by any individual with it and is shielded so that no individual will 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;

(3) The device is so designed that it cannot be easily disassembled;

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.103; and

(5) Quality control procedures have been established to satisfy the requirements of § 32.62.

[30 F.R. 9905, Aug. 10, 1965]

§ 32.62 Same; quality control procedures.

Ice detection devices containing strontium 90 which are manufactured or imported under a license pursuant to § 32.61 shall be subjected to the following quality control procedures:

(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could effect containment of the strontium 90.

(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium 90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping

the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(c) Each person licensed under § 32.61 shall subject a number of devices from each production lot, sampled in accordance with the procedures in § 32.110, to the following quality control procedures, and shall accept or reject production lots in accordance with the directions of § 32.110.

(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of physical contact between the water and the strontium 90. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks, as evidenced by physical contact between the water and the strontium 90, shall be rejected.

(2) The immersion test water from the preceding test (1) of this paragraph shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 percent of the original amount of strontium 90 in any device, the device shall be rejected.

(d) An application for a license or for amendment of a license may include a description of quality control procedures proposed as alternatives to those prescribed by paragraph (c) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that they will assure the rejection of any device which has a leakage rate exceeding 0.1 percent of the original quantity of strontium 90 in any 24-hour period.

(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter any device which has been tested and rejected under the criteria and procedures specified in this § 32.62. [30 F.R. 9905, Aug. 10, 1965]

§ 32.63 Same; material transfer reports. Each person licensed under § 32.61 shall file an annual report with the Di

rector, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C., 20545, which shall state the total quantity of strontium 90 transferred to persons generally licensed under § 31.10 of this chapter. The report shall identify each general licensee by name and address, state the kinds and numbers of devices transferred, and specify the quantity (in microcuries) of strontium 90 in each kind of device. Each report shall cover the calendar year and shall be filed within thirty (30) days after the end of each calendar year. [30 F.R. 9905, Aug. 10, 1965]

§ 32.70

Manufacture and distribution of byproduct materials for medical use under general license.

An application for a specific license to distribute byproduct material for use by physicians under the general license of § 35.31 of this chapter will be approved if:

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

(b) The applicant submits evidence that the byproduct material is to be manufactured, labeled, and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration. has approved, or in accordance with a license for a biologic product issued by the Secretary, Department of Health, Education, and Welfare;

(c) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package:

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.

material for use under the general license of § 31.11 of this chapter will be approved if:

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

(b) The byproduct material is to be prepared for distribution in prepackaged units of:

(1) Iodine-125 in units not exceeding 10 microcuries each.

(2) Iodine-131 in units not exceeding 10 microcuries each.

(c) Each prepackaged unit bears a durable, clearly visible label:

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries; and

(2) Displaying the radiation caution symbol described in § 20.203(a)(1) of this chapter and the words, "Caution, Radioactive Material", and "Not for Internal or External Use in Humans or Animals."

(d) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

This radioactive material may be received, acquired, possessed, and used only by physicians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. 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

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material.

[33 F.R. 16553, Nov. 14, 1968]

§ 32.101 Schedule B-Prototype tests for luminous safety devices for use in aircraft.

An applicant for a license pursuant to § 32.53 shall conduct prototype tests on each of five prototype luminous safety devices for use in aircraft as follows:

(a) Temperature-altitude test. The device shall be placed in a test chamber as it would be used in service. A temperature-altitude condition schedule shall be followed as outlined in the following steps:

Step 1. The internal temperature of the test chamber shall be reduced to -62° C. (-80° F.) and the device shall be maintained for at least 1 hour at this temperature at atmospheric pressure.

Step 2. The internal temperature of the test chamber shall be raised to 54° C. (-65°F.) and maintained until the temperature of the device has stabilized at -54° C. at atmospheric pressure.

Step 3. The atmospheric pressure of the chamber shall be reduced to 83 millimeters of mercury absolute pressure while the chamber temperature is maintained at -54° C.

Step 4. The internal temperature of the chamber shall be raised to -10° C. (+14°F.) and maintained until the temperature of the device has stabilized at -10° C., and the internal pressure of the chamber shall then be adjusted to atmospheric pressure. The test chamber door shall then be opened in order that frost will form on the device, and shall remain open until the frost has melted but not long enough to allow the moisture to evaporate. The door shall then be closed.

Step 5. The internal temperature of the chamber shall be raised to +85° C. (185° F.) at atmospheric pressure. The temperature of the device shall be stabilized at +85° C. and maintained for 2 hours. The device shall then be visually inspected to determine the extent of any deterioration.

Step 6. The chamber temperature shall be reduced to +71° C. (160° F.) at atmospheric pressure. The temperature of the device shall be stabilized at+71° C. for a period of 30 minutes.

Step 7. The chamber temperature shall be reduced to +55° C. (130° F.) at atmospheric pressure. The temperature of the device shall be stabilized at this temperature for a period of 4 hours.

Step 8. The internal temperature of the chamber shall be reduced to +30° C. (86° F.) and the pressure to 138 millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of 4 hours.

Step 9. The temperature of the test chamber shall be raised to +35° C. (95° F.) and the pressure reduced to 83 millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of 30 minutes.

Step 10. The internal pressure of the chamber shall be maintained at 83 millimeters of mercury absolute pressure and the temperature reduced to +20° C. (68° F.) and stabilized. The device shall be maintained under these conditions for a period of 4 hours.