Prions; Proposed Amendment To Clarify Product Performance Data for Products With Prion-Related Claims and Availability of Draft Test Guidelines

As a supplement to the proposed rule to declare a prion (i.e., proteinaceous infectious particle) a "pest" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest, EPA is now proposing to amend its product performance data requirements to clarify that efficacy data are required for all products with prion-related claims. The existing product performance data requirements already require efficacy data to be submitted when the "pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment. * * *" Since this general requirement applies to products with prion-related claims, EPA is proposing to amend the regulation to specifically identify that efficacy data are required for products with prion- related claims. In addition, EPA is announcing the availability for public review and comment of draft test guidelines concerning the generation of product performance data for prion-related products.