[Title 21 CFR 1040.20]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter J - RADIOLOGICAL HEALTH]
[Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS]
[Sec. 1040.20 - Sunlamp products and ultraviolet lamps intended for use in sunlamp products.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01false1040.20Sec. 1040.20FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,RADIOLOGICAL HEALTHPERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Sec. 1040.20  Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

    (a) Applicability. (1) The provisions of this section, as amended, 
are applicable as specified herein to the following products 
manufactured on or after September 8, 1986.
    (i) Any sunlamp product.
    (ii) Any ultraviolet lamp intended for use in any sunlamp product.
    (2) Sunlamp products and ultraviolet lamps manufactured on or after 
May 7, 1980, but before September 8, 1986, are subject to the provisions 
of this section as published in the Federal Register of November 9, 1979 
(44 FR 65357).
    (b) Definitions. As used in this section the following definitions 
apply:
    (1) Exposure position means any position, distance, orientation, or 
location relative to the radiating surfaces of the sunlamp product at 
which the user is intended to be exposed to ultraviolet radiation from 
the product, as recommended by the manufacturer.
    (2) Intended means the same as ``intended uses'' in Sec. 801.4.
    (3) Irradiance means the radiant power incident on a surface at a 
specified location and orientation relative to the radiating surface 
divided by the area of the surface, as the area becomes vanishingly 
small, expressed in units of watts per square centimeter (W/
cm2).
    (4) Maximum exposure time means the greatest continuous exposure 
time interval recommended by the manufacturer of the product.
    (5) Maximum timer interval means the greatest time interval setting 
on the timer of a product.
    (6) Protective eyewear means any device designed to be worn by users 
of a product to reduce exposure of the eyes to radiation emitted by the 
product.
    (7) Spectral irradiance means the irradiance resulting from 
radiation within a wavelength range divided by the wavelength range as 
the range becomes vanishingly small, expressed in units of watts per 
square centimeter per nanometer (W/(cm2/nm)).
    (8) Spectral transmittance means the spectral irradiance transmitted 
through protective eyewear divided by the spectral irradiance incident 
on the protective eyewear.
    (9) Sunlamp product means any electronic product designed to 
incorporate one or more ultraviolet lamps and intended for irradiation 
of any part of the living human body, by ultraviolet radiation with 
wavelengths in air between 200 and 400 nanometers, to induce skin 
tanning.
    (10) Timer means any device incorporated into a product that 
terminates radiation emission after a preset time interval.
    (11) Ultraviolet lamp means any lamp that produces ultraviolet 
radiation in the wavelength interval of 200 to 400 nanometers in air and 
that is intended for use in any sunlamp product.
    (c) Performance requirements--(1) Irradiance ratio limits. For each 
sunlamp product and ultraviolet lamp, the ratio of the irradiance within 
the wavelength range of greater than 200 nanometers through 260 
nanometers to the irradiance within the wavelength range of greater than 
260 nanometers through 320 nanometers may not exceed 0.003 at any 
distance and direction from the product or lamp.

[[Page 616]]

    (2) Timer system. (i) Each sunlamp product shall incorporate a timer 
system with multiple timer settings adequate for the recommended 
exposure time intervals for different exposure positions and expected 
results of the products as specified in the label required by paragraph 
(d) of this section.
    (ii) The maximum timer interval(s) may not exceed the manufacturer's 
recommended maximum exposure time(s) that is indicated on the label 
required by paragraph (d)(1)(iv) of this section.
    (iii) No timer interval may have an error greater than 10 percent of 
the maximum timer interval of the product.
    (iv) The timer may not automatically reset and cause radiation 
emission to resume for a period greater than the unused portion of the 
timer cycle, when emission from the sunlamp product has been terminated.
    (v) The timer requirements do not preclude a product from allowing a 
user to reset the timer before the end of the preset time interval.
    (3) Control for termination of radiation emission. Each sunlamp 
product shall incorporate a control on the product to enable the person 
being exposed to terminate manually radiation emission from the product 
at any time without disconnecting the electrical plug or removing the 
ultraviolet lamp.
    (4) Protective eyewear. (i) Each sunlamp product shall be 
accompanied by the number of sets of protective eyewear that is equal to 
the maximum number of persons that the instructions provided under 
paragraph (e)(1)(ii) of this section recommend to be exposed 
simultaneously to radiation from such product.
    (ii) The spectral transmittance to the eye of the protective eyewear 
required by paragraph (c)(4)(i) of this section shall not exceed a value 
of 0.001 over the wavelength range of greater than 200 nanometers 320 
nanometers and an value of 0.01 over the wavelength range of greater 
than 320 nanometers through 400 nanometers, and shall be sufficient over 
the wavelength greater than 400 nanometers to enable the user to see 
clearly enough to reset the timer.
    (5) Compatibility of lamps. An ultraviolet lamp may not be capable 
of insertion and operation in either the ``single-contact medium screw'' 
or the ``double-contact medium screw'' lampholders described in American 
National Standard C81.10-1976, Specifications for Electric Lamp Bases 
and Holders--Screw-Shell Types, which is incorporated by reference. 
Copies are available from the American National Standards Institute, 
1430 Broadway, New York, NY 10018, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (d) Label requirements. In addition to the labeling requirements in 
part 801 and the certification and identification requirements of 
Secs. 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall 
be subject to the labeling requirements prescribed in this paragraph and 
paragraph (e) of this section.
    (1) Labels for sunlamp products. Each sunlamp product shall have a 
label(s) which contains:
    (i) A warning statement with the words ``DANGER--Ultraviolet 
radiation. Follow instructions. Avoid overexposure. As with natural 
sunlight, overexposure can cause eye and skin injury and allergic 
reactions. Repeated exposure may cause premature aging of the skin and 
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE 
BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may 
increase your sensitivity to the ultraviolet radiation. Consult 
physician before using sunlamp if you are using medications or have a 
history of skin problems or believe yourself especially sensitive to 
sunlight. If you do not tan in the sun, you are unlikely to tan from the 
use of this product.''
    (ii) Recommended exposure position(s). Any exposure position may be 
expressed either in terms of a distance specified both in meters and in 
feet (or in inches) or through the use of markings or other means to 
indicate clearly the recommended exposure position.
    (iii) Directions for achieving the recommended exposure position(s) 
and a warning that the use of other positions may result in 
overexposure.
    (iv) A recommended exposure schedule including duration and spacing 
of

[[Page 617]]

sequential exposures and maximum exposure time(s) in minutes.
    (v) A statement of the time it may take before the expected results 
appear.
    (vi) Designation of the ultraviolet lamp type to be used in the 
product.
    (2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a 
label which contains:
    (i) The words ``Sunlamp--DANGER--Ultraviolet radiation. Follow 
instructions.''
    (ii) The model identification.
    (iii) The words ``Use ONLY in fixture equipped with a timer.''
    (3) Label specifications. (i) Any label prescribed in this paragraph 
for sunlamp products shall be permanently affixed or inscribed on an 
exterior surface of the product when fully assembled for use so as to be 
legible and readily accessible to view by the person being exposed 
immediately before the use of the product.
    (ii) Any label prescribed in this paragraph for ultraviolet lamps 
shall be permanently affixed or inscribed on the product so as to be 
legible and readily accessible to view.
    (iii) If the size, configuration, design, or function of the sunlamp 
product or ultraviolet lamp would preclude compliance with the 
requirements for any required label or would render the required wording 
of such label inappropriate or ineffective, or would render the required 
label unnecessary, the Director, Office of Compliance (HFZ-300), Center 
for Devices and Radiological Health, on the Center's own initiative or 
upon written application by the manufacturer, may approve alternate 
means of providing such label(s), alernate wording for such label(s), or 
deletion, as applicable.
    (iv) In lieu of permanently affixing or inscribing tags or labels on 
the ultraviolet lamp as required by Secs. 1010.2(b) and 1010.3(a), the 
manfacturer of the ultraviolet lamp may permanently affix or inscribe 
such required tags or labels on the lamp packaging uniquely associated 
with the lamp, if the name of the manufacturer and month and year of 
manufacture are permanently affixed or inscribed on the exterior surface 
of the ultraviolet lamp so as to be legible and readily accessible to 
view. The name of the manufacturer and month and year of manufacture 
affixed or inscribed on the exterior surface of the lamp may be 
expressed in code or symbols, if the manufacturer has previously 
supplied the Director, Office of Compliance (HFZ-300), Center for 
Devices and Radiological Health, with the key to such code or symbols 
and the location of the coded information or symbols on the ultraviolet 
lamp. The label or tag affixed or inscribed on the lamp packaging may 
provide either the month and year of manufacture without abbreviation, 
or information to allow the date to be readily decoded.
    (v) A label may contain statements or illustrations in addition to 
those required by this paragraph if the additional statements are not 
false or misleading in any particular; e.g., if they do not diminish the 
impact of the required statements; and are not prohibited by this 
chapter.
    (e) Instructions to be provided to users. Each manufacturer of a 
sunlamp product and ultraviolet lamp shall provide or cause to be 
provided to purchasers and, upon request, to others at a cost not to 
exceed the cost of publication and distribution, adequate instructions 
for use to avoid or to minimize potential injury to the user, including 
the following technical and safety information as applicable:
    (1) Sunlamp products. The users' instructions for a sunlamp product 
shall contain:
    (i) A reproduction of the label(s) required in paragraph (d)(1) of 
this section prominently displayed at the beginning of the instructions.
    (ii) A statement of the maximum number of people who may be exposed 
to the product at the same time and a warning that only that number of 
protective eyewear has been provided.
    (iii) Instructions for the proper operation of the product including 
the function, use, and setting of the timer and other controls, and the 
use of protective eyewear.
    (iv) Instructions for determining the correct exposure time and 
schedule for persons according to skin type.
    (v) Instructions for obtaining repairs and recommended replacement 
components and accessories which are compatible with the product, 
including

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compatible protective eyewear, ultraviolet lamps, timers, reflectors, 
and filters, and which will, if installed or used as instructed, result 
in continued compliance with the standard.
    (2) Ultraviolet lamps. The users' instructions for an ultraviolet 
lamp not accompanying a sunlamp product shall contain:
    (i) A reproduction of the label(s) required in paragraphs (d)(1)(i) 
and (2) of this section, prominently displayed at the beginning of the 
instructions.
    (ii) A warning that the instructions accompanying the sunlamp 
product should always be followed to avoid or to minimize potential 
injury.
    (iii) A clear identification by brand and model designation of all 
lamp models for which replacement lamps are promoted, if applicable.
    (f) Test for determination of compliance. Tests on which 
certification pursuant to Sec. 1010.2 is based shall account for all 
errors and statistical uncertainties in the process and, wherever 
applicable, for changes in radiation emission or degradation in 
radiation safety with age of the product. Measurements for certification 
purposes shall be made under those operational conditions, lamp voltage, 
current, and position as recommended by the manufacturer. For these 
measurements, the measuring instrument shall be positioned at the 
recommended exposure position and so oriented as to result in the 
maximum detection of the radiation by the instrument.

(The information collection requirements contained in paragraphs (d) and 
(e) were approved by the Office of Management and Budget under control 
number 0910-0195)

[50 FR 36550, Sept. 6, 1985]