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PROP. 65: HEARING ON REPEAL OF FDA-REGULATED PRODUCTS EXEMPTION

This article was originally published in The Tan Sheet

Executive Summary

PROP. 65: HEARING ON REPEAL OF FDA-REGULATED PRODUCTS EXEMPTION is scheduled for June 24, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) announced in the May 7 California Regulatory Notice Register. The hearing is expected to address the notice of proposed rulemaking on the repeal, effective July 1, 1993, of the exemption for foods, drugs, cosmetics and medical devices from Proposition 65's warning requirements for chemicals listed by the state as carcinogens. The exemption was repealed in a Dec. 23 out-of-court settlement of AFL-CIO, et al. v. George Deukmejian, et al., also called "Duke II." Trade associations representing FDA-regulated industries -- such as the Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry and Fragrance Association, the Grocery Manufacturers Association and the Pharmaceutical Manufacturers Association -- are jointly preparing written comments opposing the repeal. CTFA also said it plans to testify at the hearing. OEHHA is repealing the exemption because it was designed as an interim provision to provide guidance until the state had established numeric "no significant risk" levels for about 50 listed carcinogens. There are currently 216 numeric "no significant risk" levels listed in Prop. 65. OEHHA also noted that the proposition was never intended to provide a "categorical exemption" for FDA-regulated products.
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