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Antimicrobial Product Evaluation Program (APEP) for Products with Public Health Claims in the Marketplace

On June 21, 2018, during the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) webinar, EPA discussed the new draft risk-based strategy for ensuring the performance of public health antimicrobial products and announced the intended replacement of the former Antimicrobial Testing Program (ATP) with the new Antimicrobial Product Evaluation Program (APEP).  Comments on the draft risk-based strategy may be submitted to EPA until July 16, 2018.

Public health antimicrobial products are those products that bear a claim to control microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including microorganisms infectious to people in any area of the inanimate environment.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires product performance (i.e., efficacy) data to support registration of antimicrobial products bearing a public health claim. 

EPA began the webinar with an overview of the Office of Inspector General (OIG) Report entitled “EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants.”  Report #16-P-0316 (Sept. 19, 2016).  OIG conducted a review of EPA’s ATP to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.”  See Bergeson & Campbell, P.C.’s article dated September 21, 2016, “Results of EPA OIG’s Review of EPA’s Antimicrobial Testing Program” for a full summary of the OIG report.  In the 2016 report, OIG recommends OPP suspend administering the current ATP and develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  EPA agreed with OIG’s recommendations.

EPA provided that “[t]he intent of the [APEP] is to ensure continued effectiveness of antimicrobial products with public health claims (hospital disinfectants, tuberculocides, and other health care claims) in the marketplace.  The maintenance and development of technically-sound test methods, quality improvement tools (e.g., peer review of new protocols), and outreach and stewardship activities will further support the program.” 

The risk-based testing strategy will ensure the effectiveness of public health pesticides used in hospital settings by:

  • Establishing a framework for periodic testing after registration;
  • Defining a program that is responsive to current public health risks;
  • Identifying risk factors for selecting products to test;
  • Establishing a process to be used for obtaining samples for testing; and
  • Setting a date to begin risk-based post-registration testing.

Risk-based factors under consideration by EPA include:

  • Use of healthcare-associated infection data reports;
  • Claims against microorganisms of greatest concern to healthcare-associated infections (e.g., Clostridium difficile, MRSA,VRE);
  • Emerging pathogens and homeland security considerations;
  • Trends in previous ATP compliance history (e.g., claims against Mycobacterium bovis BCG);
  • Atypical label claims (e.g., very short contact times, use sites and surfaces, new product delivery and application procedures); 
  • Claims not evaluated under the previous ATP;
  • New and unusual active ingredients;
  • Formulation chemistry-related issues (e.g., shelf-life/stability once prepared, lack of expiration dates);
  • Use of new or procedurally-revised test methods;
  • Tips and complaints;
  • Issues identified during reregistration (e.g., frequency of repeat testing, acceptance criteria not met); and
  • Link to other federal initiatives.

OIG recommends a functional program begin after registration review is completed in 2022.  According to OIG, the development of a solid, acceptable testing strategy is key -- the strategy must be finalized and communicated to regulated and public health communities.  OIG specified other EPA outreach activities for the testing program that must be considered, e.g., setting and clearly communicating goals and establishing the baseline reporting mechanisms.

EPA expects to release this final strategy in November 2018 and seeks public input prior to implementation.  Please submit your comments on this topic by July 16, 2018, to the Office of Pesticide Programs Docket, EPA-HQ-OPP-2018-0265 at https://www.regulations.gov.

For additional information, please visit https://www.epa.gov/pesticide-registration/antimicrobial-testing-program or https://www.epa.gov/pesticide-registration/webinar-risk-based-strategy-ensure-continued-effectiveness-hospital.

©2019 Bergeson & Campbell, P.C.

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About this Author

Healther Collins, Regulatory Consultant, Bergeson and Campbell, health and safety compliance
Regulatory Consultant

Heather F. Collins, M.S., Regulatory Consultant with Bergeson & Campbell, P.C. has nearly two decades of experience developing, implementing, and managing environmental, health, and safety (EH&S) compliance for global chemical and chemical product companies.  Her prodigious skills in developing biocide and pesticide registration and compliance strategies, safety data sheet authoring, and dangerous goods management, coupled with her keen awareness of the financial and temporal pressures of the marketplace make her an excellent resource for clients...

724-524-1860
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 Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Ms. Dolan helps reduce enforcement risk and improves product stewardship practices for Bergeson & Campbell, P.C. (B&C®) clients by assisting them in assessing and improving compliance practices. She also can assist in bringing new and/or improved products to market by obtaining timely regulatory approvals of new chemicals and products. She has worked with several clients to leverage environmentally preferable and bio-based product attributes into sales opportunities.

202-557-3804