October 23, 2017

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EPA Releases Final Methods and Guidance for Testing the Efficacy of Antimicrobials against Public Health Biofilms

On August 1, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus):

EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically Guidance for Testing the Efficacy of Antimicrobial Products Against Biofilms on Hard, Non-Porous Surfaces.  Drafts of the SOPs and the guidance were initially released in October 2016 for comment.  EPA received comments from nine entities and revised the drafts to incorporate suggested changes.  EPA posted its response to those comments in Docket EPA-HQ-OPP-2016-0357

EPA states that the two methods are adapted from ASTM International (ASTM) standard methods.  EPA MLB SOP MB-19 is used to generate the P. aeruginosa or S. aureus biofilm on coupons.  EPA MLB SOP MB-20, the Single Tube Method, then is used to determine the effectiveness of an antimicrobial product in reducing bacteria in biofilm on the coupons. 

Notable aspects of the test criteria and claims guidelines include:

  • The mean log density for the test organisms of 8.0 to 9.5 for P. aeruginosa and 7.5 to 9.0 for S. aureus; and

  • Product performance criterion of a minimum 6-log reduction.

The guidance lists several examples of claims for efficacy against public health biofilm that EPA states are acceptable.

EPA MLB SOP MB-20 is designed to evaluate the efficacy of antimicrobial products that are water soluble powders or liquid formulations.  If a company wishes to test a different type of product formulation, or test different target microorganisms, or make any other proposed modifications, it would be well advised to submit proposed alternatives to EPA for review and approval.  EPA specifically cautions that the current methodologies are intended for data development to support claims for products registered for use on hard, non-porous surfaces and are not suitable for use sites associated with water systems.

The EPA’s Office of Pesticide Programs’ (OPP) regulation of biofilms has been the subject of increasingly intense commercial interest for years and the availability of this testing guidance is welcome news.  While not all will agree with the approach, the new guidance is a helpful addition to OPP’s testing guidance portfolio.  

More information on antimicrobial pesticides is available on our blog under key phrase Antimicrobial Pesticide.  More information on the methods and guidance is available on EPA’s website and in Docket No. EPA-HQ-OPP-2016-0357.

©2017 Bergeson & Campbell, P.C.

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About this Author

Sheryl Dolan, Senior Regulatory Consultant, Toxic Substance Control Act, Nanoscale Chemicals, Bergeson and Campbell Law Firm
Senior Regulatory Consultant

Sheryl Dolan is an excellent asset to clients who have issues in chemical regulation, registration, and compliance management matters. She works with manufacturers of conventional and nanoscale chemicals, and industrial and consumer products, including intergeneric microorganisms, for compliance with requirements under the Toxic Substances Control Act (TSCA). She also works with registrants of agricultural and other conventional pesticides, antimicrobial products, biopesticides, and plant regulators to register and manage compliance with requirements under the Federal...

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

202-557-3815