Every manufacturer of a product listed under § 78.750, shall submit an initial report to the Director, Bureau of Radiological Health, 5600 Fishers Lane, Rockville, Md. 20852, in accordance with this section. The report shall be submitted within 90 days following the effective date of this subpart or prior to the introduction of such product into commerce, whichever is later. The report shall be distinctly marked "Initial Report of (Name of Manufacturer)" and shall:

(a) State in the report for each model of a listed product whether the report is submitted pursuant to paragraph (a), (b), or (c) of § 78.750.

(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling sufficient to enable the Secretary to determine the date and place of manufacture.

(c) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product.

(d) State the standards or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a Federal standard, if applicable.

(e) For each model, describe the physical or electrical characteristics such as shielding, or electronic circuitry, etc., incorporated into the product in order that the standards or specifications reported pursuant to paragraph (d) of this section are met.

(f) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures.

(g) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining

that such testing and quality control procedures are not necessary.

(h) Provide sufficient results of the testing and measuring of electronic product radiation safety and of the quality control procedures described in accordance with paragraphs (f) and (g) of this section to enable the Secretary to determine the effectiveness of the methods and procedures used to accomplish the stated purposes.

(i) Report for each model, all warning signs, labels and instructions, for installation, operation, and use which relate to electronic product radiation safety.

(j) Provide upon request such other information as the Secretary may reasonably require to enable him to determine whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Secretary to carry out the purposes of the Act. [35 F.R. 8363, May 28, 1970, as amended at 36 F.R. 18646, Sept. 18, 1971]

§ 78.711 Reports of model changes.

Prior to the introduction into commerce of a new or modified model of a product listed in § 78.750 for which an initial report under § 78.710 was required, each manufacturer shall submit a report with respect to such new or modified model containing any changes in the information submitted in the initial report. § 78.712 Annual reports.

(a) Every manufacturer of products listed under § 78.750 (b) and (c) shall submit an annual report summarizing the contents of the records required to be maintained by § 78.720(a).

(b) The first annual report shall be submitted by September 1, 1971, with subsequent reports due annually thereafter. Such reports shall cover the 12month period ending on June 30 preceding the due date of the report.

[35 F.R. 8363, May 28, 1970; 35 F.R. 10855, July 3, 1970]

other officers or employees of the Department and of the other agencies concerned with carrying out the requirements of the Act. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.

RECORDS TO BE MAINTAINED BY MANUFACTURERS OF LISTED ELECTRONIC PRODUCTS

§ 78.720 Records to be maintained by manufacturers.

(a) Manufacturers of products listed under paragraphs (b) and (c) of § 78.750 shall establish and maintain the following records with respect to such products:

(1) Description of the quality control procedures with respect to electronic product radiation safety.

(2) Records of the results of tests for electronic product radiation safety, inIcluding the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.

(3) For those products displaying aging effects which may increase electronic product radiation emission, records of the results of tests for durability and stability of the product, and the basis for selecting these tests.

(4) Copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product.

(b) In addition to the records required by paragraph (a) of this section, manufacturers of products listed in paragraph (c) of § 78.750 shall establish and maintain the following records with respect to such products:

(1) A record of the manufacturer's distribution of products in a form which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers.

(2) Records received from dealers or distributors pursuant to § 78.731.

[35 F.R. 8363, May 28, 1970, as amended at 36 F.R. 18646, Sept. 18, 1971]

(a) Every manufacturer required to maintain records pursuant to this subpart, including records received pursuant to § 78.731, shall preserve such records for a period of 5 years from the date of the record.

(b) Upon reasonable notice by an offcer or employee duly designated by the Department, manufacturers shall permit such officer or employee to inspect appropriate books, records, papers, and documents as are relevant to determining whether the manufacturer has acted or is acting in compliance with Federal standards.

(c) Upon request of the Director, Bureau of Radiological Health, a manufacturer of products listed in paragraph (c) of $78.750 shall submit to the Director, copies of the records required to be maintained by paragraph (b) of § 78.720.

DEALER AND DISTRIBUTOR RECORDS § 78.730

Records to be maintained by dealers and distributors.

(a) Dealers and distributors of electronic products listed in paragraph (c) of § 78.750, for which there are applicable Federal standards under this part, and for which the retail price is not less than $50, shall obtain and preserve for a period of 5 years from the date of the sale, award, or lease of each such product such information as is necessary to permit tracing of specific products to specific purchasers.

(b) Such information shall include:

(1) The name and mailing address of the distributor, dealer, or purchaser to whom the product was transferred.

(2) Identification and brand name of the product.

(3) Model number and serial or other identification number of the product. (4) Date of sale, award, or lease. § 78.731 Records furnished to manufac turers by dealers and distributors. (a) Information obtained by dealers and distributors pursuant to § 78.730 shall immediately be forwarded to the appropriate manufacturer unless:

(1) The dealer or distributor elects to hold and preserve such information and to immediately furnish it to the manufacturer when advised by the manufacturer or the Director, Bureau of Radiological Health, that such informa

tion is required for purposes of section 359 of the Act; and

(2) The dealer or distributor, upon making the election under subparagraph (1) of this paragraph, promptly notifies the manufacturer and the Director, Bureau of Radiological Health, of such election; such notification shall be in writing and shall identify the dealer or distributor and the electronic product or products for which the information is being accumulated and preserved.

(b) Every dealer or distributor obtaining information pursuant to this subpart shall take such steps as are necessary to insure that such information is furnished to the manufacturer prior to the time the dealer or distributor discontinues the dealing in or distribution of electronic products.

§ 78.740 Special exemptions.

(a) Manufacturers of electronic products listed under paragraphs (b) and (c) of 78.750 may submit to the Director, Bureau of Radiological Health, with or subsequent to the submission of the initial report required by § 78.710, a request, together with accompanying justification, that a product be exempted from the annual reporting and recordkeeping requirements. In addition to other information which may be required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested:

(1) Cannot emit electronic product radiation in sufficient intensity or of such quality under any conditions of use or product failure to be hazardous; or

(2) Is produced in such small numbers as to negate the need for continuous recordkeeping and reporting, and is to be used by trained individuals who are knowledgable of the hazards involved in such use.

(b) The Director, Bureau of Radiological Health, may exempt manufacturers from all or part of the record and reporting requirements of this subpart

on the basis of information submitted in accordance with paragraph (a) of this section or such other information which he may possess or may require of the manufacturer if he determines that such exemption is in keeping with the purposes of the Act.

§ 78.741

Exemptions for manufacturers of products intended for the U.S. Government.

Upon application therefore by the manufacturer, the Director, Bureau of Radiological Health, may exempt from the provisions of this subpart a manufacturer of any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.

[35 F.R. 8363, May 28, 1970, as amended at 36 F.R. 18646, Sept. 18, 1971]

LISTED ELECTRONIC PRODUCTS § 78.750 List of specific product groups.

(a) Group A. (1) Lasers and products containing lasers which have a reporting index number N, less than one (1). Reporting index numbers shall be calculated in accordance with Appendix A. (2) Ultrasonic products.

(3) Microwave heating equipment not listed in paragraph (c) of this section.

(4) High voltage vacuum switches, high voltage rectifier tubes, shunt regulator tubes, and cathode ray tubes which are intended to be operated at voltages greater than 5,000 volts but less than 15,000 volts.

(b) Group B. (1) Television receivers which, on or after the effective date of this subpart, meets the Federal standard in effect on June 1, 1971, provided also that the voltage on the cathode ray tube and any other vacuum tube component cannot exceed 15,000 volts under the test conditions required by the Federal standard at that time.

(2) High voltage vacuum switches, high voltage rectifier tubes, shunt regulator tubes, and cathode ray tubes, which are intended to operate at voltages of 15,000 volts or greater.

(c) Group C. (1) Products subject to Federal standards prescribed under subpart C of this Part 78 except for televi

sion receivers described in paragraph (b) (1) of this section.

(2) Products which are intended to produce x radiation.

(3) Microwave ovens intended to be used in homes, restaurants, food vending or service establishments, on interstate carriers and in similar locations.

(4) Microwave diathermy machines.

(5) Lasers and products or devices containing lasers which have a reporting index number of N, equal to or greater than one (1). Reporting index numbers shall be calculated in accordance with Appendix A.

APPENDIX A-LASER REPORTING INDEX NUMBER

(a) For laser products, the reporting index number N, shall be calculated using the relation N=BU/A. The appropriate value of B may be determined from Table 1 for a given wave-length. U is the radiant energy in joules (J). For continuous operation, U is the radiant energy per second in the laser emission. For single pulse operation, U is the true radiant energy per pulse. For repetitively pulsed lasers, reporting index numbers will be computed using both energy per pulse and energy per second. When computing the reporting index number using energy per pulse, that value of B corresponding to the pulse duration of the laser emission in Table 1 will be used. When computing the reporting index number using energy per second, that value of B found in the column "continuous to 0.1 sec" of Table 1 will be used.

(b) A, as used in the relation above, is the actual beam area in square centimeters. For

parallel or divergent beams, A is measured at 30 centimeters (cm) from the permanent instrument housing1 at the points of closest approach to the exit port or ports of the laser beam; for convergent beams, A is measured at that distance from the permanent instrument housing which results in a value of N which is maximal.

(c) If more than one value of N can be determined for a given product, the largest value shall be used for reporting purposes. When simultaneous emission of more than one wavelength occur, an individual reporting index number shall be calculated for each wavelength. The sum of the individual reporting index numbers shall be used as the reporting index number for the product. Where N cannot be calculated, a reporting index number of 1,000 shall be used.