[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1040.30]

[Page 657-659]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1040_PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--Table of Contents
 
Sec. 1040.30  High-intensity mercury vapor discharge lamps.

    (a) Applicability. The provisions of this section apply to any high-
intensity mercury vapor discharge lamp that is designed, intended, or 
promoted for illumination purposes and is manufactured or assembled 
after March 7, 1980, except as described in paragraph (d)(1)(ii) of this 
section.
    (b) Definitions. (1) High-intensity mercury vapor discharge lamp 
means any lamp including any ``mercury vapor'' and ``metal halide'' 
lamp, with the exception of the tungsten filament self-ballasted mercury 
vapor lamp, incorporating a high-pressure arc discharge tube that has a 
fill consisting primarily of mercury and that is contained within an 
outer envelope.
    (2) Advertisement means any catalog, specification sheet, price 
list, and any other descriptive or commercial brochure and literature, 
including videotape and film, pertaining to high-intensity mercury vapor 
discharge lamps.
    (3) Packaging means any lamp carton, outer wrapping, or other means 
of containment that is intended for the storage, shipment, or display of 
a high-intensity mercury vapor lamp and is intended to identify the 
contents or recommend its use.
    (4) Outer envelope means the lamp element, usually glass, 
surrounding a high-pressure arc discharge tube, that, when intact, 
attenuates the emission of shortwave ultraviolet radiation.
    (5) Shortwave ultraviolet radiation means ultraviolet radiation with 
wavelengths shorter than 320 nanometers.
    (6) Cumulative operating time means the sum of the times during 
which electric current passes through the high-pressure arc discharge.
    (7) Self-extinguishing lamp means a high-intensity mercury vapor 
discharge lamp that is intended to comply with the requirements of 
paragraph (d)(1) of this section as applicable.
    (8) Reference ballast is an inductive reactor designed to have the 
operating characteristics as listed in Section 7 in the American 
National Standard Specifications for High-Intensity Discharge Lamp 
Reference Ballasts (ANSI C82.5-1977) \1\ or its equivalent.
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    \1\Copies are available from American National Standards Institute, 
1430 Broadway, New York, NY 10018.
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    (c) General requirements for all lamps. (1) Each high-intensity 
mercury vapor discharge lamp shall:
    (i) Meet the requirements of either paragraph (d) or paragraph (e) 
of this section; and
    (ii) Be permanently labeled or marked in such a manner that the name 
of the manufacturer and the month and year of manufacture of the lamp 
can be determined on an intact lamp and after the outer envelope of the 
lamp is broken or removed. The name of the manufacturer and month and 
year of manufacture may be expressed in code or symbols, provided the 
manufacturer has previously supplied the Director, Center for Devices 
and Radiological Health, with the key to the code or symbols and the 
location

[[Page 658]]

of the coded information or symbols on the lamp.
    (2) In lieu of permanently affixing or inscribing tags or labels on 
the product as required by Sec. Sec. 1010.2(b) and 1010.3(a) of this 
chapter, the manufacturer of any high-intensity mercury vapor discharge 
lamp may permanently affix or inscribe such required tags or labels on 
the lamp packaging uniquely associated with the applicable lamp.
    (d) Requirements for self-extinguishing lamps--(1) Maximum 
cumulative operating time. (i) Each self-extinguishing lamp manufactured 
after March 7, 1980 shall cease operation within a cumulative operating 
time not to exceed 15 minutes following complete breakage or removal of 
the outer envelope (with the exception of fragments extending 50 
millimeters or less from the base shell); and
    (ii) Each self-extinguishing lamp manufactured after September 7, 
1981, shall cease operation within a cumulative operating time not to 
exceed 15 minutes following breakage or removal of at least 3 square 
centimeters of contiguous surface of the outer envelope.
    (2) Lamp labeling. Each self-extinguishing lamp shall be clearly 
marked with the letter ``T'' on the outer envelope and on another part 
of the lamp in such a manner that it is visible after the outer envelope 
of the lamp is broken or removed.
    (3) Lamp packaging. Lamp packaging for each self-extinguishing lamp 
shall clearly and prominently display:
    (i) The letter ``T''; and
    (ii) The words ``This lamp should self-extinguish within 15 minutes 
after the outer envelope is broken or punctured. If such damage occurs, 
TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous 
shortwave ultraviolet radiation.''
    (e) Requirements for lamps that are not self-extinguishing lamps--
(1) Lamp labeling. Any high-intensity mercury vapor discharge lamp that 
does not comply with paragraph (d)(1) of this section shall be clearly 
and legibly marked with the letter ``R'' on the outer envelope and on 
another part of the lamp in such a manner that it is visible after the 
outer envelope of the lamp is broken or removed.
    (2) Lamp packaging. Lamp packaging for each high-intensity mercury 
vapor discharge lamp that does not comply with paragraph (d)(1) of this 
section shall clearly and prominently display:
    (i) The letter ``R''; and
    (ii) The words ``WARNING: This lamp can cause serious skin burn and 
eye inflammation from shortwave ultraviolet radiation if outer envelope 
of the lamp is broken or punctured. Do not use where people will remain 
for more than a few minutes unless adequate shielding or other safety 
precautions are used. Lamps that will automatically extinguish when the 
outer envelope is broken or punctured are commercially available.''
    (3) Lamp advertisement. Advertising for any high-intensity mercury 
vapor discharge lamp that does not comply with paragraph (d)(1) of this 
section shall prominently display the following wording: ``WARNING: This 
lamp can cause serious skin burn and eye inflammation from shortwave 
ultraviolet radiation if outer envelope of the lamp is broken or 
punctured. Do not use where people will remain for more than a few 
minutes unless adequate shielding or other safety precautions are used. 
Lamps that will automatically extinguish when the outer envelope is 
broken or punctured are commercially available.''
    (f) Test conditions. Any high-intensity mercury vapor discharge lamp 
under test for compliance with the requirements set forth in paragraph 
(d)(1) of this section shall be started and operated under the following 
conditions as applicable:
    (1) Lamp voltage, current, and orientation shall be those indicated 
or recommended by the manufacturer for operation of the intact lamp.
    (2) The lamp shall be operated on a reference ballast.
    (3) The lamp shall be started in air that has a temperature of 25 
5 [deg]C. Heating and movement of the air 
surrounding the lamp shall be that produced by the lamp and ballast 
alone.
    (4) If any test is performed in an enclosure, the enclosure shall be 
not less than 0.227 cubic meter (8 cubic feet).
    (5) Any lamp designed to be operated only in a specific fixture or 
luminaire that the lamp manufacturer supplies or

[[Page 659]]

specifies shall be tested in that fixture or luminaire. Any other lamp 
shall be tested with no reflector or other surrounding material.

[44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988]