Biotech pesticides in the United States are regulated under the Coordinated Framework for Biotechnology. You can read more about that here on their website.
The U.S. Government agencies responsible for oversight of the products of agricultural biotechnology are the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services’ Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to review by one or more of these agencies.
When pesticidal traits are installed into plants using recombinant technology they are regulated by USDA and EPA. If the plant may be used as food or feed, they are also regulated by FDA.
EPA refers to such plants as Plant-Incorporated Protectants (PIPs). PIPs have their own special regulations apart from either traditional chemical pesticides or regular Biopesticides. Rules for PIPs are found in Title 40, Section 174 of the Code of Federal Regulations (CFR).
AgCens is uniquely qualified to help you with your regulatory needs concerning biotech products and PIPs in particular. We have been involved with the regulation of biotech pesticides since the beginning of the Coordinated Framework for Biotechnology and were intimately involved with the writing of the EPA rules for PIPs. At AgCens we stay up to date on all the issues affecting biotech regulations.