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Pesticide News Story: EPA Proposes Efficacy Data Requirements for Prion Products: Comment Period Opens for Proposed Amendment to Clarify Product Performance Data for Products with Prion-Related Claims and Draft Test Guidelines

For Release: November 17, 2011

EPA is proposing to amend its product performance data requirements to clarify that efficacy data are required for all products with prion-related claims. In addition, EPA is announcing the availability for public review and comment of draft efficacy test guidelines on generating the product performance data for prion-related products.

This is a supplement to the January 2011 Notice of Proposed Rulemaking to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend EPA’s regulations to expressly include prion within the regulatory definition of pest. The intent of issuing the supplemental rule and draft efficacy test guidelines now for public comment is so that they can be issued final at the same time that the prion rule is issued final in late 2012. That way, the final test requirement and efficacy test guidelines can be issued final at simultaneously with the final prion rule that declares a prion to be a pest and amends the current regulations to include prion in the definition of pest.

Prions are abnormally shaped infectious proteins that may occur in the central nervous system tissues of animals and humans. Prions can cause neurodegenerative diseases known collectively as transmissible spongiform encephalopathies (TSE). TSE’s include scrapie disease in sheep, bovine spongiform encephalopathy in cattle, chronic wasting disease in deer and elk, kuru and variant Creutzfeld-Jakob Disease in humans, and similar diseases in other animals. These diseases are always fatal in humans and animals alike, and there are no known treatments or cures.

The Federal Register notice announcing these actions provides interested parties 60 days to comment on both the proposed amendment to EPA’s product performance data requirements to add products with prion-related claims and EPA’s draft test guidelines concerning the generation of product performance data for prion-related products.

Comments can be submitted at www.regulations.gov in docket number EPA-HQ-OPP-2010-0427 until January 17, 2012.

The Notice of Proposed Rulemaking (NPRM) can be found at www.regulations.gov in Docket ID # EPA-HQ-OPP-2010-0427.

The Federal Register Notice of this action was published on November 17, 2011, and is available at http://www.regulations.gov/#!documentDetail;D=EPA_FRDOC_0001-11373.

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