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PROPOSITION 65 FEDERAL WORKING GROUP TO CONSIDER FEDERAL PREEMPTION

Executive Summary

PROPOSITION 65 FEDERAL WORKING GROUP TO CONSIDER FEDERAL PREEMPTION of California's "Safe Drinking Water and Toxic Enforcement Act." FDA Commissioner Frank Young chairs the group, which was set up under the auspices of the White House Domestic Policy Council in July. The group is scheduled to report on its findings and recommendations, with a focus on Proposition 65's "clear and reasonable" consumer warning label requirements, before the Reagan Administration leaves office on Jan. 20. The 30-member task force consists of representatives from each domestic department of the government. In addition to Young, the group includes FDA Chief Counsel Tom Scarlett and HHS Assistant Secretary of Planning and Evaluation Bob Helms. Other interested parties include the departments of Justice, Commerce, Interior, Agriculture, Treasury and the Office of Management & Budget as well as the Domestic Policy Council staff and the Council of Economic Advisors. A six-member subgroup of the task force, formed to examine the economic impact of Proposition 65, is expected to report to the working group by the end of November. Proposition 65, which went into effect Feb. 27, requires consumer products containing chemicals listed by the state as "known to cause cancer" to provide a clear warning about exposure. Products affected include ethylene oxide, which has been identified as a carcinogen and reproductive toxicant under the law. California, at the end of October, re-issued interim emergency regulations for 120 days that exempt products regulated by FDA from the carcinogen warning label requirement; reproductive toxicants, however, are not exempt. FDA has not taken any action to date on Proposition 65. The agency's only formal statement on the issue was in an Aug. 28, 1987 letter from Young to California Governor George Deukmejian urging the preemption of those products that have been found by FDA to present "no significant risk" under the provisions of the Food, Drug & Cosmetic Act. Young's letter followed petitions to California's Health & Welfare Agency by the Health Industry Manufacturers Association and Cosmetic, Toiletry and Fragrance Association (CTFA), as well as a petition to FDA by the Proprietary Association (PA) seeking federal preemption.

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