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Regulating Biopesticides

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Before a pesticide can be marketed and used in the United States, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that EPA evaluate the proposed pesticide to assure that its use will not pose unreasonable risks of harm to human health and the environment. This regulation involves an extensive review of health and safety information.

Biopesticides include naturally occurring substances that control pests (biochemical pesticides), microorganisms that control pests (microbial pesticides), and pesticidal substances produced by plants containing added genetic material (plant-incorporated protectants) or PIPs.

The Pesticide Registration Manual (Blue Book) and Biopesticide Registration Tools provide links to information tools to assist applicants. The Fact Sheets sections provides links to information about each of the biopesticide active ingredients. The Product Lists section provides various lists of individual biopesticide products to assist the public in identifying appropriate biopesticide product for pest problems. Finally, the PIPs section provides extensive information regarding the regulation of genetically engineered plants.

Biopesticide Registration Tools

The federal pre-marketing approval of pesticides - termed registration -- is a complex process. The documents linked from this page augment the general registration process as they relate specifically to the registration of biopesticides. The e-mail address bppdconsistency@epa.gov has been created to respond to issues concerning biopesticide registration inconsistency that affect processing of submissions.

Biopesticide Regulatory Action Leaders will meet to discuss these issues and provide an answer usually within two to three weeks. Resolution of these issues will be posted to this site.

Since this e-mail address is only for the submission of generic issues regarding consistency in the regulation of biopesticides. Other questions regarding biopesticides should be directed to the appropriate biopesticide Regulatory Action Leader or the Biopesticide Communications and Registration Liaison, Nicole Berckes (berckes.nicole@epa.gov). If you have questions about conventional pesticides or antimicrobials, please contact the Ombudsman for the Registration Division or the Antimicrobial Division.

Biopesticide Active Ingredient Fact Sheets

This collection of fact sheets contains chemical specific information about biopesticide active ingredients. Additionally, some of the fact sheets include a detailed technical document, bibliographies, regulatory history, Federal Register notices, and/or registrant and product lists.

Biopesticide Ingredient & Product Lists

Lists of EPA registered (approved) biopesticide ingredients & products are provided, including a listing by active ingredient, and lists of biopesticide active ingredients by year first approved.

Plant Incorporated Protectants (PIPs)

Plant-Incorporated Protectants are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. For example, scientists can take the gene for a specific Bt pesticidal protein, and introduce the gene into the plant's genetic material. Then the plant manufactures the pesticidal protein that controls the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA; the plant itself is not regulated.

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