Department of Health and Human Services
Food and Drug Administration
21 CFR Part 1040
[Docket No. 82N-0188]
Sunlamp Products; Performance Standard
Agency: Food and Drug Administration.
Action: Final rule.
Summary: The Food and Drug Administration is amending the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products to accommodate new products employing design concepts significantly different from those for which the current standard was developed. Also, FDA’s experience in applying the current standard, which went into effect on May 7, 1980, indicates that some requirements are either inappropriate or inapplicable to some products. The amendments are intended to establish a standard that is appropriate for the present technology of suntanning and new sunlamp product designs.
Dates: Effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. For additional information concerning the applicability of this amended performance standard, see the "EFFECTIVE DATE" paragraph in the preamble of this document. The Director of the Office of the Federal Register approves the incorporation by reference of certain publications in 21 CFR 1040.20 effective Sept. 8, 1986.
For Further Information Contact: Manuel Karos, FDA Office of Compliance, 2098 Gaither Road, Rockville, MD 20850, (301) 594-4654.
Supplementary Information:
In the Federal Register of May 20, 1983 (48 FR 22886) (corrected Oct. 21, 1983; 48 FR 48837), FDA issued a proposed rule to amend the performance standard for sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20). In the preamble to the May 20, 1983, proposal, FDA discussed the history of 1040.20 and the issues that led to the agency’s decision to propose to revise the standard. The preamble also described the changes in the standard that FDA proposed to make based on the agency’s experience in administering the standard. Interested persons were given until July 19, 1983, to provide written data, views or comments concerning the amendments and any associated information on their potential environmental or economic impact.
Comments
Comments were received from an interested member of the public, a medical academy, two manufacturers, an individual who described himself as an association representing suntanning professionals, and a Canadian government agency. A summary of the comments and FDA’s responses to them follows:
