To require the Food and Drug Administration to issue a monograph with respect to over-the-counter sunscreen.

SA 1818. Mr. DODD (for himself, Mr. Harkin, Mr. Reed, Mr. Carper, Mr. Biden, and Mr. Lieberman) submitted an amendment intended to be proposed by him to the bill H.R. 2744, making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for the fiscal year ending September 30, 2006, and for other purposes; as follows:

On page 173, after line 24, insert the following:

Sec. 7__. (a) Congress makes the following findings:

(1) Consumers need clear and consistent information about the risks associated with exposure to the sun, and the protection offered by over-the-counter sunscreen products.

(2) The Food and Drug Administration (referred to in this section as the “FDA”) began developing a monograph for over-the-counter sunscreen products in 1978.

(3) In 2002, after 23 years, the FDA issued the final monograph for such sunscreen products.

(4) One of the most critical aspects of sunscreen is how to measure protection against UVA rays, which cause skin cancer.

(5) The final sunscreen monograph failed to address this critical aspect and, accordingly, the monograph was stayed shortly after being issued until issuance of a comprehensive monograph.

(6) Skin cancer rates continue to rise, especially in younger adults and women.

(7) Pursuant to section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r), a Federal rule on sunscreen labeling would preempt any related State labeling requirements.

(8) The absence of a Federal rule could lead to a patchwork of State labeling requirements that would be confusing to consumers and unnecessarily burdensome to manufacturers.

(b) Not later than one year after the date of enactment of this Act, the FDA shall issue a comprehensive final monograph for over-the-counter sunscreen products, which shall include UVA and UVB labeling requirements.