May 21, 2018

May 21, 2018

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May 18, 2018

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Aligning CA Prop 65 and FIFRA Pesticides Labeling Requirements

The California Office of Environmental Health Hazard Assessment (OEHHA) has proposed to amend the California Proposition 65 Clear and Reasonable Warnings requirements to provide an exception to the safe harbor provisions for listed chemicals in pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

  • As we previously reported on this blog, OEHHA published a final rule concerning “clear and reasonable warnings” required under Proposition 65 in September 2016. The new regulations, which become effective on August 30, 2018, provide guidance on the manner and content for providing warnings. Proposition 65 requires companies to provide warning statements where their products cause an “exposure” to listed chemicals. The warning requirements do not apply when an exposure falls within the “safe harbor.”

  • By way of background, most pesticides sold or distributed in the United States must be registered by the Environmental Protection Agency (EPA) under FIFRA. As part of the review and approval process, EPA evaluates each pesticide label. All label language must be approved by EPA before a pesticide can be marketed in the United States. Each pesticide label must use the signal word reflecting the Toxicity Category that the product is assigned by EPA. The signal words used under FIFRA include: “Danger,” “Warning,” and “Caution.” In addition, pesticides sold in California must be registered by the California Department of Pesticide Regulation (DPR), which has its own statutory and regulatory requirements for pesticide product labeling.

  • OEHHA proposed to allow the use of an alternate signal word in the “narrow circumstance” where the EPA and DPR signal word and the Proposition 65 signal word conflict. More specifically, a new subsection (d) would be added to the consumer product exposure warning content set forth in Section 25603. The alternate signal words, “ATTENTION” or “NOTICE,” in capital letters and bold print would be allowed instead of the word “WARNING” when the pesticide label is regulated by EPA pursuant to FIFRA and DPR and its implementing regulations. This exception would only apply when EPA or DPR require the use of a signal word other than “WARNING.” Comments on the proposal must be submitted to OEHHA by June 11, 2018. Information on how to submit comments can be found on OEHHA’s website.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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