as a basis for initiating a proceeding to make a device a banned device in accordance with § 895.21(d) and when appropriate to establish a special effective date in accordance with § 895.30.

§ 895.30 Special effective date.

(a) The Commissioner may declare a proposed regulation under § 895.21(d) to be effective upon its publication in the FEDERAL REGISTER and until the efiective date of any final action taken respecting the regulation if:

(1) The Commissioner determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with use of the device that is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and

(2) Before the date of the publication of such regulation, the Commissioner notifies the domestic manufacturer and importer, if any, of the device that the regulation is to be made so effective. If necessary, the Commissioner may also notify the distributor or any other responsible person(s). In addition, the Commissioner will attempt to notify any foreign manufacturer when the name and address of the foreign manufacturer are readily available.

(b) This procedure may be used when the Commissioner determines that the potential or actual injury involved is a serious one that the Commissioner believes will endanger the health of individuals who have been, or will be, exposed to the device. In assessing the degree of danger, the Commissioner need not find that the danger is immediate, and it shall be sufficient for the Commissioner to determine that the danger may involve a serious long-term risk.

(c) If the Commissioner makes a proposed regulation effective in accordance with this section, the Commissioner will, as expeditiously as possible, give interested persons prompt

notice of this action in the FEDERAL REGISTER and will provide an opportunity for an informal hearing in accordance with Part 16 of this chapter.

(d) After the hearing, if any, and after considering any written comments submitted on the proposal and any additional available information and data, the Commissioner will as expeditiously as possible either affirm, modify, or revoke the proposed regulation making the device a banned device. If the Commissioner decides to affirm or modify the proposed regulation to make a device a banned device, the Commissioner will amend Subpart B by adding the name or description of the device, or both, to the list of banned devices. If the Commissioner decides to revoke a proposed regulation making a device a banned device, a notice of termination of rulemaking proceedings and reasons therefor will be published in the FEDERAL REGISTER.

(e) The Commissioner may declare the special effective date provided by this section to be in effect after the publication of a proposed regulation under § 895.21(d), if, based on new information, or upon reconsideration of previously available information, the Commissioner makes the determination and provides the appropriate notices and an opportunity for a hearing in accordance with paragraphs (a) and (c) of this section.

(f) Those devices that have been named banned devices under § 895.30 and that have already been sold to the public may be subject to relabeling by the manufacturer, distributor, importer, or any other person(s) responsible for the labeling of the device or may be subject to the provisions of section 518(a) or (b) of the act.

Subpart B-Listing of Banned Devices § 895.101 Prosthetic hair fibers.

Prosthetic hair fibers are devices intended for implantation into the

human scalp to simulate natural hair or conceal baldness. Prosthetic hair fibers may consist of various materials; for example, synthetic fibers, such as modacrylic, polyacrylic, and polyester; and natural fibers, such as processed human hair. Excluded from the banned device are natural hair trans

plants, in which a person's hair and its surrounding tissue are surgically removed from one location on the person's scalp and then grafted onto another area of the person's scalp.

[48 FR 25136, June 3, 1983, and 49 FR 1177, Jan. 10, 1984]

energy to produce ionization or atomic or electron excitation by collision.

(d) "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.

(e) "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 which is intended for use as a component, part, or accessory of a product described in paragraph (e)(1) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.

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

(g) "Commerce" means (1) commerce between any place in any State and any place outside thereof, and (2) commerce wholly within the District of Columbia.

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

(i) "Act" means the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602, 42 U.S.C. 263b et seq.). (j) "Secretary" means the Secretary of the Department of Health and Human Services.

(k) "Federal standard" means a performance standard issued pursuant to section 358 of the Act.

such person is or has been primarily or customarily engaged in such business.

(n) The term "purchaser” means the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and also includes a person who leases an electronic product for purposes other than subleasing.

(0) The term "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.

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.

jectives of the examination to protect the germinal tissue of patients from radiation exposure that may cause genetic mutations during many medical X-ray procedures in which the gonads lie within or are in close proximity to the x-ray field. Such shielding should be provided when the following conditions exist:

(a) The gonads will lie within the primary x-ray field, or within close proximity (about 5 centimeters), despite proper beam limitation. Except as provided in paragraph (b) or (c) of this section:

(1) Specific area testicular shielding should always be used during those examinations in which the testes usually are in the primary x-ray field, such as examinations of the pelvis, hip, and upper femur;

(2) Specific area testicular shielding may also be warranted during other examinations of the abdominal region in which the testes may lie within or in close proximity to the primary xray field, depending upon the size of the patient and the examination techniques and equipment employed. Some examples of these are: Abdominal, lumbar spine and lumbosacral spine examinations, intravenous pyelograms, and abdominal scout film for barium enemas and upper GI series. Each x-ray facility should evaluate its procedures, techniques, and equipment and compile a list of such examinations for which specific area testicular shielding should be routinely considered for use. As a basis for judgment, specific area testicular shielding should be considered for all examinations of male patients in which the pubic symphysis will be visualized on the film;

(3) Specific area gonad shielding should never be used as a substitute for careful patient positioning, the use of correct technique factors and film processing, or proper beam limitation (confinement of the x-ray field to the area of diagnostic interest), because this could result in unnecessary doses to other sensitive tissues and could adversely affect the quality of the radiograph; and

(4) Specific area gonad shielding should provide attenuation of x-rays