Guidance for Industry and FDA 

Staff 

Applicability of the Performance 

Standard for High-Intensity 

Mercury Vapor Discharge 

Lamps (21 CFR 1040.30) 

 
Document issued on November 6, 2005 
 
 
 
 
For questions regarding this document contact Jerome E. Dennis, 301-796-5710, 
jerome.dennis@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Electronic Products Devices Branch 
Division of Mammography Quality and Radiation Programs 
Office of Communication, Education, and Radiation Programs 
 
 
  Contains Nonbinding Recommendations 
Preface  
 
 
 
Public Comment  
 
Written comments and suggestions may be submitted at any time for Agency consideration 
to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 
 
When submitting comments, please refer to the exact title of this guidance document.  
Comments may not be acted upon by the Agency until the document is next revised or  
updated. 
 
 
 
Additional Copies 
 
Additional copies are available from the Internet at:  
http://www.fda.gov/cdrh/ocer/guidance/1565.pdf, or to receive this document by fax, send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request 
to 301-847-8149 to receive a hard copy. Please use the document number (1565) to identify 
the guidance you are requesting. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  Contains Nonbinding Recommendations 
Guidance for Industry and FDA Staff 

 
Applicability of the Performance 

Standard for High-Intensity Mercury 

Vapor Discharge Lamps (21 CFR 

1040.30) 

 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.  You can use an alternative approach if the 
approach satisfies the requirements of the applicable statutes and regulations.  If you  
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
Introduction 
This document is intended to provide guidance to manufacturers and importers of high-
intensity mercury vapor discharge lamps (HID) and to FDA import staff.  The guidance 
clarifies that FDAs intent is to apply the performance standard at 21 CFR 1040.30 for 
HID lamps only to those lamps used for general purpose lighting. General purpose 
lighting includes lighting in gymnasia, auditoriums, and stores.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
 
Background 
 
What is a high-intensity mercury vapor discharge lamp?  
 
A high-intensity mercury vapor discharge lamp consists of a quartz discharge tube 
enclosed within a hard glass outer envelope.  The glass outer envelope blocks the 
transmission of short wavelength ultraviolet radiation from the discharge tube and also 
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protects the tube and interior structural and electrical elements.  These lamps can 
continue operating when the outer envelope becomes partially or completely broken 
away, allowing ultraviolet radiation to escape.   
 
How can exposure to this ultraviolet radiation affect health? 
 
Exposure to ultraviolet radiation can cause painful injuries such as photokeratitis and 
erythema, also known as snow-blindness and sunburn.  Because of numerous incidents 
involving scores of people requiring emergency room treatment, FDA issued a radiation 
safety performance standard that became  effective in 1980. The overwhelming majority 
of these incidents occurred in school gymnasia after the outer envelope of a lamp in an 
open fixture was broken by a ball or other projectile.  The injured people were usually 
spectators at a sporting event who sat beneath the broken lamp for many minutes to a few 
hours before they felt the symptoms of ultraviolet exposure.  
 
Performance Standard 
 
What does the performance standard say? 
 
The entire performance standard can be found at 21 CFR 1040.30.  The text we are 
addressing in this guidance document is 21 CFR 1040.30(a), which reads as follows: 
 
  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. 
 
FDA issued the performance standard to establish performance criteria for self-
extinguishing (T Type) lamps.  The standard also requires packaging for non-self 
extinguishing (R Type) lamps that warns they should not be used in locations where 
people congregate for more than a few minutes.  The public health goal was to preclude 
the injuries that were occurring to people who gathered and remained in locations lighted 
by potentially broken HID lamps, such as gymnasia and auditoriums.   
 
Issue 
 
Why are some manufacturers and importers of high-intensity mercury vapor 
discharge lamps, which are not used for general purpose lighting, experiencing 
import delays? 
  
As explained above, FDA intended the performance standard to apply only to HID lamps 
used for general purpose lighting, such as gymnasia (see the preambles to the proposed* 
and final** rules authorizing the standard), and FDA has been interpreting the regulation 
to apply only to those products since it was promulgated. However, the standard uses the 
term illumination rather than general purpose lighting. This has recently caused some  
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confusion because in its broadest sense, illumination can mean casting light on 
anything. Some FDA import officers have been applying this broad interpretation and 
detaining importations of lamps designed and intended for applications other than general 
purpose lighting. As the preambles to the proposed and final rule indicate, this is not the 
intent of the standard. 
 
*  The proposed rule can be found in the Federal Register of April  21, 1978 (43 FR  16997). 
** The final  rule can be found in the Federal Register of September 7, 1979 (44 FR  52195). 
 
FDA interprets 21 CFR 1040.30 to be applicable only to the high-intensity mercury vapor 
discharge lamps that are intended for use in fixtures for general purpose lighting. This 
lighting is to aid vision within rooms such as gymnasia, auditoriums, or industrial 
locations where people are present for sports, entertainment, or work. 
 
What is an example of a high-intensity mercury vapor discharge lamp that is 
 
outside the scope of the performance standard? 
 
Large size projection televisions use high-intensity mercury vapor discharge lamp 
assemblies for illumination of the images that are projected on the screen.  In this type of 
application, the lamps are installed inside the television so they are not subject to impact 
from external projectiles, unlike lamps in open fixtures in gymnasia.  Additionally, the 
lamp assemblies for large size projection televisions are in precision mountings to ensure 
correct positioning when installed.   
 
We do not consider HID lamps for specialized applications and for installation within 
products, such as large size projection televisions, to be within the scope of the standard. 
 
What are the intended results of this guidance? 
 
FDA import officers should refrain from asking for import papers, including FD Form  
2877, for HID lamps other than those for general purpose lighting. 
 
This restatement of the intent of the standard should result in expedited clearance of 
imports of HID lamps other than those for general purpose lighting.   Importers may refer 
to this guidance in responding to questions from import officers. 
 
Getting More Information 
 
You can get more information about our requirements for high-intensity mercury vapor 
discharge lamps from our electronic products radiation control web page at 
http://www.fda.gov/cdrh/radhlth/mercury-vapor.html. 
 
If you have questions about this guidance, contact Jerome Dennis, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993. 
 
 
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