Final OCSPP Product Performance Test Guidelines for Antimicrobial Pesticides Series 810.2000-2200

EPA announces the availability of final test guidelines for “Series 810 – Product Performance Test Guidelines: Group B – Antimicrobial Efficacy Test Guidelines,” which provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides that work against public health microbial pests.

The three final guidelines are:

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Methods and Guidance for Testing the Efficacy of Antimicrobials against Spores of Clostridium difficile

EPA is announcing the availability of test methods for evaluating the efficacy of antimicrobial pesticides against Clostridum difficile as well as regulatory guidance for pesticidal claims for those products. These test methods and guidance provide a framework for registrants who seek to make a claim for antimicrobial pesticide products to control these spores on hard, non-porous surfaces.

Under the Federal Insecticide, Fungicide, and Rodenticide Act, the registrant of an antimicrobial product with a public health claim is required to submit efficacy data to EPA in support of the product’s registration.   Continue reading

Clostridium difficile – Guidance and Methods for Antimicrobial Efficacy Testing

The Environmental Protection Agency (EPA) is announcing the availability for public comment of two proposed test methods and associated testing guidance for evaluating the effectiveness of antimicrobial pesticides against Clostridium difficile (C. diff).

C. diff is an anaerobic, spore-forming bacterium and a frequent cause of hospital-acquired infections. EPA recognizes the potential public health implications of C. difficile and recommends specific laboratory methodologies to produce and store spores, apply the spores to a hard non-porous surface, and evaluate the effectiveness of antimicrobial products intended to treat these surfaces. Continue reading

EPA Announces Updated Draft Efficacy Protocol for Copper Surface Sanitizer Products

The U.S. Environmental Protection Agency initiated an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products. The testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims. Based on public comments, numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process and product characterization. Continue reading

EPA Revises Antimicrobial Pesticide Data Requirements Guidance–Pesticide Use Site Index

Today, the Environmental Protection Agency is making available a revised Antimicrobial Pesticide Use Site Index (USI). The revised document simplifies and improves EPA guidance to assist applicants for antimicrobial pesticide registration by helping them identify the data requirements necessary to register a pesticide or support their product registrations and will likewise be used by Agency staff evaluating pesticide applications. This document provides guidance about antimicrobial pesticide use sites and general antimicrobial pesticide use patterns and helps registrants determine if labeled uses require the establishment of a tolerance (maximum residue level for food or feed) or exemption from the requirement of a tolerance. Continue reading

EPA develops protocol for testing antimicrobial efficacy of copper surfaces

The U.S. Environmental Protection Agency has released a recommended protocol for testing the antimicrobial efficacy of copper-containing surfaces. The testing described in this protocol is intended to support registration of products bearing non-food contact, surface sanitizer claims. The Agency is accepting comments on the protocol for 60 days. At a later time, EPA expects to issue a Data Call-In to require testing using this protocol for currently registered copper and copper alloy-based surface products.

Under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. The products in question here are hard surface products such as door handles, light switch panels and bed rails that contain copper or copper alloys for their antimicrobial characteristics.

Antimicrobial efficacy testing of copper-containing surface products presents numerous challenges due to the prolonged product use period and the wide variation in potential product forms and use patterns. This protocol is designed to address these issues by including a product characterization component that addresses the product’s physical durability and chemical stability when used as proposed. The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against three pathogenic microorganisms – Staphylococcus aureus, Enterobacter aerogenes, and Pseudomonas aeruginosa. The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.

For more information:

EPA’s Antimicrobial Testing Methods & Procedures

EPA’s Antimicrobial Testing Program