Method and Proposed Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms

The American Chemistry Council Biocides Panel asks that the Draft Guidance be revised to state that EPA will evaluate whether a claim to control biofilm is a public health claim by determining whether the claim meets the public health claim criteria established under EPA's regulations at 40 CFR 158.2204. The Agency also should clearly state that the term "biofilm" is not a per se public health claim and can be used without implicating a public health claim when the criteria established under 40 CFR 158.2204 do not apply. If EPA remains committed to defining "biofilm" as a public health claim, then the Panel believes formal rulemaking is required, as the new definition will be contrary to the definition of a public health claim as established by the criteria under 40 CFR 158.2204.