the preset time. Means shall also be incorporated to enable termination of emission at any time. Means shall be incorporated to indicate the magnitude of the duration of emission (expressed in minutes) to within 0.5 minute of the preset duration of emission for setting less than 5 minutes, to within 10 percent of the preset duration of emission for settings of from 5 minutes to 10 minutes, and to within 1 minute of the preset duration of emission for settings greater than 10 minutes.

(3) Pulse duration and repetition rate. A means shall be incorporated for indicating the magnitudes of pulse duration and pulse repetition rate of the emitted ultrasonic radiation, if there are operation controls for varying these quantities.

(4) Ultrasonic frequency. A means shall be incorporated for indicating the magnitude of the ultrasonic frequency of the emitted ultrasonic radiation, if there is an operation control for varying this quantity.

(5) Visual indicator. A means shall be incorporated to provide a clear, distinct, and readily understood visual indicator when and only when electrical energy of appropriate ultrasonic frequency is being applied to the ultrasonic transducer(s).

(d) Labeling requirements. In addition to the labeling requirements in part 801 and the requirements of §§ 1010.2 and 1010.3 of this chapter, each ultrasonic therapy product shall be subject to the applicable labeling requirements this paragraph.

of

(1) Operation controls. Each operation control shall be clearly labeled identifying the function controlled and, where appropriate, the units of measure of that function. If a separate control and indicator are associated with the same function, then labeling the appropriate units of measure of that function is required for the indicator but not for the control.

(2) Service controls. Each service control that is accessible without displacement or removal of any part of the ultrasonic therapy product shall be clearly labeled identifying the function controlled and shall include the phrase "for service adjustment only."

(3) Generators. (i) Each generator shall bear a label that states: The

brand name, model designation, and unique serial number or other unique identification so that it is individually identifiable; ultrasonic frequency (unless there is an operation control for varying this quantity); and type of waveform (continuous wave or amplitude modulated).

(ii) Generators employing amplitudemodulated waveforms shall also bear a label that provides the following information: Pulse duration and pulse repetition rate (unless there are operation controls for varying these quantities), an illustration of the amplitude-modulated waveform, and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. (If this ratio is a function of any operation control setting, then the range of the ratio shall be specified, and the waveform illustration shall be provided for the maximum value of this ratio.)

(4) Applicators. Each applicator shall bear a label that provides the following information:

(i) The brand name, model designation, and unique serial number or other unique identification so the applicator is individually identifiable;

(ii) A designation of the generator(s) for which the applicator is intended; and

(iii) The ultrasonic frequency, effective radiating area, maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and for a focusing applicator the focal length and focal area.

(5) Label specification. Labels required by this paragraph shall be permanently affixed to or inscribed on the ultrasonic therapy product; they shall be legible and clearly visible. If the size, configuration, or design of the ultrasonic therapy product would preclude compliance with the requirements of this paragraph, the Director, Center for Devices and Radiological Health, may approve alternate means of providing such labels).

(e) Tests for determination of compliance (1) Tests for certification. Tests on which certification pursuant to §1010.2 of this chapter is based shall account for all measurement errors and uncertainties. Such tests shall also account

for increases in emission and degradation in radiation safety that occur with age.

(2) Test conditions. Except as provided in §1010.13 of this chapter, tests for compliance with each of the applicable requirements of this section shall be made:

(i) For all possible combinations of adjustments of the controls listed in the operation instructions.

(ii) With the ultrasonic radiation emitted into the equivalent of an infinite medium of distilled, degassed water at 30 °C for measurements concerning the ultrasonic radiation.

(iii) With line voltage variations in the range of ±10 percent of the rated value specified by the manufacturer.

(3) Measurement parameters. Measurements for determination of the spatial distribution of the ultrasonic radiation field shall be made with a detector having dimensions of less than one wavelength in water or an equivalent measurement technique.

requirements—(1)

(f) Informational Servicing information. The manufacturer of an ultrasonic therapy product shall provide or cause to be provided to servicing dealers and distributors, and to others upon request, at a cost not to exceed the cost of preparation and distribution adequate instructions for operations, service, and calibration, including a description of those controls and procedures that could be used to increase radiation emission levels, and a schedule of maintenance necessary to keep equipment in compliance with this section. The instructions shall include adequate safety precautions that may be necessary regarding ultrasonic radiation exposure.

(2) User information. The manufacturer of an ultrasonic therapy product shall provide as an integral part of any user instruction or operation manual that is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each ultrasonic therapy product, and to others upon request, at a cost not to exceed the cost of preparation and distribution:

(i) Adequate instructions concerning assembly, operation, safe use, any safe

ty procedures and precautions that may be necessary regarding the use of ultrasonic radiation, and a schedule of maintenance necessary to keep the equipment in compliance with this section. The operation instructions shall include a discussion of all operation controls, and shall describe the effect of each control.

(ii) Adequate description of the spatial distribution of the ultrasonic radiation field and the orientation of the field with respect to the applicator. This will include a textual discussion with diagrams, plots, or photographs representative of the beam pattern. If there is more than one ultrasonic transducer in an applicator and their positions are not fixed relative of each other, then the description must specify the spatial distribution of the ultrasonic radiation field emitted by each ultrasonic transducer and present adequate examples of the combination field of the ultrasonic tranducers with regard to safe use. The description of the ultrasonic radiation field shall state that such description applies under conditions specified in paragraph (e)(2)(ii) of this section.

(iii) Adequate description, as appropriate to the product, of the uncertainties in magnitude expressed in terms of percentage error, of the ultrasonic frequency effective radiating area, and, where applicable, the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity, pulse duration, pulse repetition rate, focal area, and focal length. The errors in indications specified in paragraphs (c)(1) and (c)(2) of this section shall be stated in the instruction manual.

(iv) A listing of controls, adjustments, and procedures for operation and maintenance, including the warning "Caution-use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy."

[43 FR 7166. Feb. 17, 1978, as amended at 45 FR 16483, Mar. 14, 1980; 53 FR 11255, Apr. 6. 1988]

1210.30 Hearing procedure for permit denial, suspension, and revocation. 1210.31 Hearing before prosecution.

AUTHORITY: 21 U.S.C. 141-149.

CROSS REFERENCES: For Animal and Plant Health Inspection Service regulations concerning tubercular cattle, see 9 CFR parts 50 and 77. For Animal and Plant Health Inspection Service regulations, see 9 CFR chapter I. For customs regulations concerning importation of milk and cream, see 19 CFR 12.7. For regulations of the Agricultural Marketing Service (Marketing Agreements and Orders) covering marketing areas for milk, see 7 CFR chapter X.

(a) Secretary. Secretary means the Secretary of Health and Human Services.

(b) Commissioner. Commissioner means the Commissioner of Food and Drugs.

(c) Milk. For the purposes of the act and of the regulations in this part: Milk is the whole, fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within 15 days before and 5 days after calving, or such longer period as may be necessary to render the milk practically colostrum free.

(d) Condensed milk. Condensed milk, as the term is used in section 3, paragraph 2, of the Federal Import Milk Act, includes evaporated milk in the manufacture of which sterilization of the milk and cream is a necessary and usual process; it includes sweetened condensed milk only if it is prepared by a process which insures sterilization of the milk and cream. Condensed milk, as the term is used in section 3, paragraph 3, of the Federal Import Milk Act, means sweetened condensed milk.

(e) Sweetened condensed milk. Sweetened condensed milk conforms to the definition and standard of identity for such food as set out in § 131.120 of this chapter.

(f) Evaporated milk. Evaporated milk conforms to the definition and standard of identity for such food as set out in § 131.130 of this chapter.

(g) Cream. Cream is that portion of the milk, rich in milk fat, which rises to the surface of milk on standing or is separated from it by centrifugal force. (See §§ 131.150 through 131.157 of this chapter).

(h) Pasteurization. Pasteurization is the process of heating every particle of milk or cream to at least 143 °F., and holding it at such temperature continuously for at least 30 minutes, or to at least 161 °F., and holding it at such temperature continuously for at least 15 seconds.

(i) Shipper. A shipper is anyone, other than a common carrier, who ships, transports, or causes to be shipped or transported into the United States milk or cream owned by him.

[38 FR 32104, Nov. 20, 1973, as amended at 42 FR 14091, Mar. 15, 1977]

Subpart B-Inspection and Testing

§ 1210.10 Availability for examination and inspection.

Dairy farms and plants from which milk or cream is shipped or transported into the United States shall be open at all reasonable times to authorized agents for necessary examinations and inspections. Failure to permit such examinations and inspections may be considered cause for the suspension or revocation of the permit.

§ 1210.11 Sanitary inspection of dairy farms.

The sanitary conditions of any dairy farm producing milk or cream to be shipped or transported into the United States or to a plant from which milk or cream is to be shipped or transported into the United States must score at least 50 points out of 100 points, according to the methods for scoring as provided by the score card for sanitary inspection of dairy farms in the form prescribed by the Secretary.

(a) Physical examination of any and all cows in herds producing milk or cream which is to be shipped or transported into the United States shall be made by an authorized veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced to determine whether such cow or cows are in a healthy condition. Such examination shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within one year previous to the time of the importation.

(b) The result of the physical examination shall be set forth in the form prescribed by the Secretary.

§ 1210.13 Tuberculin test.

(a) Except as provided in § 1210.27 any and all animals in herds producing milk or cream which is to be shipped or transported raw into the United States shall be free from tuberculosis, as determined by a tuberculin test applied by an official veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced. Such test shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within 1 year previous to the time of the importation. All animals showing positive or suspicious reactions to the tuberculin test must be permanently removed from the herd.

(b) The results of the tuberculin test and all facts concerning the disposal of reacting or suspected animals shall be set forth in the form prescribed by the Secretary.

§ 1210.14 Sanitary inspection of plants. The sanitary conditions of any plant handling milk or cream any part of which is to be shipped or transported into the United States shall score at least 50 points out of 100 points according to the methods for scoring as provided by the score card for sanitary inspection of such plants in the form prescribed by the Secretary.

All dairy farms and plants at which any milk or cream is pasteurized for shipment or transportation into the United States shall employ adequate pasteurization machinery of a type easily cleaned and of sanitary construction capable of holding every portion of the milk or cream at the required temperature for the required time. Such pasteurizing machinery shall be properly equipped with accurate time and temperature recording devices, which shall be kept at all times in good working order. The temperature at the time of heating and holding must invariably be recorded on thermograph charts, initialed, numbered, and dated by the official having jurisdiction over such farms and plants. All thermograph charts shall be held for a period of 2 years unless within that period they have been examined and released by such authorized agents as are designated by the Secretary.

§ 1210.16 Method of bacterial count.

The bacterial count of milk and cream refers to the number of viable bacteria as determined by the standard plate method of the American Public Health Association in use at the time of the examination.

§ 1210.17 Authority to sample and inspect.

Inspectors engaged in the enforcement of the Federal Import Milk Act are empowered to test for temperature, to take samples of milk or cream, and to use such means as may be necessary for these purposes.

§ 1210.18 Scoring.

Scoring of sanitary conditions required by §§ 1210.11, 1210.14 shall be done by an official inspector of the United States or of any State or municipality thereof or of the country in which the dairy farm or plant is located.

Subpart C-Permit Control

§ 1210.20 Application for permit.

Application for a permit to ship or transport milk or cream into the United States shall be made by the ac

tual shipper upon forms prescribed by the Secretary. The request for forms of applications for permits should be addressed to Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857.

§ 1210.21 Permit number.

Each permit issued under the Federal Import Milk Act, including each temporary permit, shall bear an individual number. The right to the use of such number is restricted solely to the permittee.

§ 1210.23 Permits granted on certificates.

In the discretion of the Secretary, a permit may be granted on a duly certified statement signed by a duly accredited official of an authorized department of any foreign government or of any State of the United States or any municipality thereof. Such statement shall be in the form of a certificate prescribed by the Secretary, and shall have attached thereto, as a part thereof, signed copies of reports prescribed by §§ 1210.12, 1230.13, and also by §§ 1210.11, 1210.14, as applicable. The necessary inspections and examinations upon which the reports are based