International Congress BIOLOGICAL PRODUCTS - Gruppo di ...
International Congress BIOLOGICAL PRODUCTS - Gruppo di ...
International Congress BIOLOGICAL PRODUCTS - Gruppo di ...
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BIOPESTICIDES AND THEIR REGISTRATION IN THE UNITED STATE<br />
Sheryl K. Reilly<br />
Chief, Biochemical Pesticides Branch<br />
Biopesticides and Pollution Prevention Division<br />
Office of Pesticides Programs<br />
U.S. Environmental Protection Agency<br />
Biopesticides play an important role in organic crop production. Their proper use can significantly enhance the quality<br />
and production of crops targeted to address specific “niche market” needs. Biopesticides are regulated by the U.S.<br />
Environmental Protection Agency (USEPA) as pesticides and the cost of commercial development can be significant.<br />
Of the two broad classes of pesticides currently recognized by the USEPA, namely conventional chemicals and<br />
biological pesticides (or biopesticides), a substantial number belong to the biopesticide class, specifically the<br />
biochemical category. By definition, a biochemical pesticide is classified as such if it can be shown to possess a nontoxic<br />
mode of action on the target pest, and if it is naturally occurring or structurally similar and functionally identical to<br />
a naturally occurring substance. Biochemical pesticides are generally active at low concentrations and fairly specific in<br />
terms of their effects on a pest. USEPA is required by law to assure that any pesticide use in commerce will not result<br />
in unreasonable adverse effects to humans or the environment. In order to make this assessment, data requirements<br />
(e.g., mammalian toxicology, product identification and analytical methods, non-target plant and animal toxicology,<br />
fate, etc.) have been established for pesticide product registration. Registrants must address each data requirement,<br />
either by submitting a valid study or a request for a waiver of those requirements, prior to receiving formal product<br />
registration by the USEPA. Waivers of required data are based on scientific rationale or information that is known in<br />
the publically available, peer-reviewed scientific literature. For biochemical pesticides, the acceptability of data and/or<br />
waivers, as well as any proposed label uses, are reviewed by the Biopesticides and Pollution Prevention Division<br />
(BPPD) in the Office of Pesticide Programs of the USEPA. This <strong>di</strong>vision of the USEPA was formed in 1994 to facilitate<br />
the development of biopesticide products which are important tools in an integrated pest management program and<br />
offer alternatives to conventional chemical pesticides. Given the time and expense associated with product<br />
development, commercialization, and registration, registrants should work closely with the USEPA, grower groups,<br />
university and extension personnel, trade group(s) and others to ensure a successful product development process.<br />
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