(ii) Offers an expected benefit to public health which is so great that the time required for the processing of an amendment to the standard would present an unjustifiable risk to public health, and

(3) The granting of the alternative is in keeping with the purposes of the Mammography Quality Standards Act of 1992.

(b) Applicants for alternatives. (1) Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of § 900.12.

(2) State governments that are not accrediting bodies may apply for alternatives to the standards of § 900.12(a).

(3) Manufacturers and assemblers of equipment used for mammography may apply for alternatives to the standards of § 900.12 (b), (c), and (d).

(c) Application for approval of an alternative standard. An application for approval of an alternative standard or for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Director, Division of Mammography Quality and Radiation Programs, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. The application for approval of an alternative standard shall include the following information:

(1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why it is believed necessary to propose the alternative;

(2) A description of the manner in which the alternative is proposed to deviate from the original standard;

(3) A description, supported by data, of the advantages to be derived from such deviation;

(4) An explanation, supported by data, of how such a deviation would assure equal or greater quality of production, processing, or interpretation of mammograms than the original stand

ard;

(5) The suggested period of time that the proposed alternative standard would be in effect; and

(6) Such other information required by the Director to evaluate and act on the application.

(d) Ruling on applications. (1) The Director may approve or deny, in whole or in part, a request for approval of an alternative standard or any amendment or extension thereof, and shall inform the applicant in writing of this action. The written notice will state the manner in which the requested alternative standard differs from the agency standard and a summary of the reasons for approval or denial of the request. If the request is approved, the written notice will also include the effective date and the termination date of the approval, a summary of the limitations and conditions attached to the approval, and any other information that may be relevant to the approved request. Each approved alternative standard will be assigned an identifying number.

(2) Notice of an approved request for an alternative standard or any amendment or extension thereof will be placed in the public docket file in the office of the Dockets Management Branch and may also be in the form of a notice published in the FEDERAL REGISTER. The notice will state the name of the applicant, a description of the published agency standard, and a description of the approved alternative standard, including limitations and conditions attached to approval of the alternative standard.

(3) Summaries of approved alternative standards, including information on their nature and number, will be provided to the National Mammography Quality Assurance Advisory Committee.

(4) All applications for approval of alternative standards and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications will be available for public disclosure in the Dockets Management Branch, excluding patient identifiers and confidential commercial information.

(e) Amendment or extension of an alternative standard. An application for amending or extending approval of an alternative standard shall include the following information:

(1) The approval number and the expiration date of the alternative standard;

(2) The amendment or extension requested and the basis for the amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or extension would assure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.

(f) Applicability of the alternative standards. Any approval of an alternative standard, amendment, or extension may be implemented only by the entity to which it was granted and under the terms under which it was granted, except that when an alternative standard is approved for a manufacturer of equipment, any facility using that equipment will also be covered by the alternative standard. Other

entities interested in similar or identical approvals must file their own application by following the provisions of § 900.18(c).

(g) Withdrawal of approval of alternative standards. The Director shall amend or withdraw approval of an alternative standard whenever the Director determines that this action is necessary to protect the public health or otherwise is justified by §900.12. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification of the applicant when the Director determines that such action is necessary to prevent an imminent health hazard. [59 FR 49812, Sept. 30, 1994]

Sec.

PART 1000-GENERAL

Subpart A-General Provisions

Subpart B-Statements of Policy and
Interpretation

1000.15 Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

Subpart C-Radiation Protection
Recommendations

1000.50 Recommendation for the use of speIcific area gonad shielding on patients during medical diagnostic x-ray procedures.

1000.55 Recommendation for quality assurance programs in diagnostic radiology facilities.

1000.60 Recommendation on administra

tively required dental x-ray examinations.

AUTHORITY: Secs. 530-542 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh-360ss).

SOURCE: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.

Subpart A-General Provisions

§ 1000.1 General.

References in this Subchapter J to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.

[50 FR 33688, Aug. 20, 1985]

§ 1000.3 Definitions.

As used in this Subchapter J:

(a) Accidental radiation occurrence means a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.

(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh-360ss).

(c) Chassis family means a group of one or more models with all of the following common characteristics:

(1) The same circuitry in the high voltage, horizontal oscillator, and power supply sections;

(2) The same worst component failures;

(3) The same type of high voltage hold-down or safety circuits; and

(4) The same design and installation. (d) Commerce means:

(1) Commerce between any place in any State and any place outside thereof, and

(2) Commerce wholly within the District of Columbia.

(e) Component, for the purposes of this part, means an essential functional part of a subassembly or of an assembled electronic product, and which may affect the quantity, quality, direction, or radiation emission of the finished product.

(f) Dealer means a person engaged in the business of offering electronic products for sale to purchasers, without regard to whether such person is or has been primarily engaged in such business, and includes persons who offer such products for lease or as prizes or awards.

(g) Director means the Director of the Center for Devices and Radioloical Health.

(h) Distributor means a person engaged in the business of offering electronic products for sale to dealers, without regard to whether such person is or has been primarily or customarily engaged in such business.

(i) Electromagnetic radiation includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in Figure 1 includes, but is not limited to, gamma rays, x-rays, ultra-violet, visible, infrared, microwave, radiowave, and low frequency radiation.

(j) Electronic product means:

(1) Any manufactured or assembled product which, when in operation: (i) Contains or acts as part of an electronic circuit and

(ii) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (2) Any manufactured or assembled article that is intended for use as a component, part, or accessory of a product described in paragraph (j)(1) of this section and which, when in operation, emits (or in the absence of effective shielding or other controls would emit) such radiation.

(k) Electronic product radiation means: (1) Any ionizing or nonionizing electromagnetic or particulate radiation,

or

(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

(1) Federal standard means a performance standard issued pursuant to sec

tion 534 of the Federal Food, Drug, and Cosmetic Act.

(m) Infrasonic, sonic (or audible) and ultrasonic waves refer to energy transmitted as an alteration (pressure, particle displacement or density) in a property of an elastic medium (gas, liquid or solid) that can be detected by an instrument or listener.

(n) Manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products.

(0) Model means any identifiable, unique electronic product design, and refers to products having the same structural and electrical design characteristics and to which the manufacturer has assigned a specific designation to differentiate between it and other products produced by that manufacturer.

(p) Model family means products having similar design and radiation characteristics but different manufacturer model numbers.

(q) Modified model means a product that is redesigned so that actual or potential radiation emission, the manner of compliance with a standard, or the manner of radiation safety testing is affected.

or

(r) Particulate radiation is defined as: (1) Charged particles, such as protons, electrons, alpha particles, heavy particles, which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions or electrical repulsion; or

(2) Uncharged particles, such as neutrons, which can initiate a nuclear transformation or liberate charged particles having sufficient kinetic energy to produce ionization or atomic or electron excitation.

(8) Phototherapy product means any ultraviolet lamp, or product containing such lamp, that is intended for irradiation of any part of the living human body by light in the wavelength range of 200 to 400 nanometers, in order to perform a therapeutic function.

(t) Purchaser means the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and includes a person who leases an electronic product for purposes other than subleasing.

(u) State means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.

[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996]

Subpart B-Statements of Policy and Interpretation

§ 1000.15 Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which the regulations of this part apply.

(a) Examples of electronic products which may emit x-rays and other ionizing electromagnetic radiation, electrons, neutrons, and other particulate radiation include:

Ionizing electromagnetic radiation:

Television receivers.

Accelerators.

X-ray machines (industrial, medical, research, educational).

Particulate radiation and ionizing electro-
magnetic radiation:
Electron microscopes.
Neutron generators.

(b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio and low frequency electromagnetic radiation include:

Ultraviolet:

Biochemical and medical analyzers. Tanning and therapeutic lamps. Sanitizing and sterilizing devices. Black light sources. Welding equipment. Visible:

White light devices.
Infrared:

Alarm systems.
Diathermy units.

Dryers, ovens, and heaters.

Microwave:

Alarm systems.

Diathermy units.

Dryers, ovens, and heaters.
Medico-biological heaters.

Microwave power generating devices.
Radar devices.

Remote control devices.

Signal generators.

Radio and low frequency:
Cauterizers.

Diathermy units.

Power generation and transmission equipment.

Signal generators.

Electromedical equipment.

(c) Examples of electronic products which may emit coherent electromagnetic radiation produced by stimulated emission include:

Laser:

Art-form, experimental and educational devices.

Biomedical analyzers.

Cauterizing, burning and welding devices. Cutting and drilling devices. Communications transmitters. Rangefinding devices.

Maser:

Communications transmitters.

(d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include:

Infrasonic: