California and International Regulations

California EPA's Department of Pesticide Regulation (DPR) regulates biopesticides. Currently, biopesticides are given favorable "fast track'' treatment. A biopesticide application submitted concurrently to the U.S. EPA and DPR may be approved by both agencies at the same time, or DPR approval may come before the EPA approval. Sales cannot occur until there is federal approval, however. California currently requires efficacy data for approval. The EPA may ask for efficacy data, but typically does not.

Canada has coordinated its biopesticide regulations with the U.S. so that biopesticides can be registered concurrently in the U.S. and Canada if a registrant chooses to submit the applications at the same time. Otherwise, a Canadian registration will take one year or more for approval after submitting a separate application. In Mexico registration can take six months to years after U.S. approval, although there is currently a NAFTA (North American Free Trade Association) harmonization initiative. In Japan there is an EPA-like tiered system, which takes approximately 12 months after registration submission for approval. In Europe, the European Union is harmonizing biopesticide regulations, and the regulations for biopesticides are becoming more favorable, but registration still takes several years. Most countries outside the U.S. require two years of official field trials conducted by government entities, making the timeline longer than the U.S. process.

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