October 15, 2019

October 15, 2019

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October 14, 2019

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Results of EPA OIG’s Review of EPA’s Antimicrobial Testing Program

On September 19, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (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.”  OIG found that the ATP “does not assure that hospital-level disinfectant products continue to be effective after they are registered,”  specifically that:

  • Once the EPA tests a product and it passes, it is listed as Agency Confirmed Efficacy on the agency’s website and is typically not tested again; the long-term efficacy of the product cannot be assured.

  • EPA relies on manufacturers to voluntarily submit product samples for testing. In the last three years, out of the approximately 300 registered hospital disinfectant products that have not been tested, manufacturers submitted only 12 samples to EPA for ATP efficacy testing.

Importantly, however, OIG concludes: “Although the program as currently designed and conducted does not assure that most hospital disinfectant products continue to be effective, at this point it is redundant and unnecessary to make adjustments, since the EPA is concurrently having the products re-registered.”

OIG makes two major recommendations:

  1. EPA should suspend administering the current Antimicrobial Testing Program until completion of the one-time re-registration process.

  2. EPA should develop a risk-based antimicrobial testing strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace. At a minimum, OIG states, the strategy should:

  • Include a framework for periodic testing to assure products continue to be effective after registration.

  • Define a program scope that is flexible and responsive to current and relevant public health risks.

  • Identify risk factors for selecting products to test.

  • Identify the method to be used for obtaining samples for testing.

  • Designate a date to commence risk-based post-registration testing.

In its response, EPA agreed with OIG’s recommendations, and stated it will develop a plan to coordinate and implement the discontinuation of the present-day program, with the closure of the ATP program to take place by November 2017.  EPA also stated that by December 2018 it plans to develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  

Registrants of the affected products should monitor closely the development of EPA’s plans both to discontinue the program and to establish this new risk-based strategy for assuring product efficacy.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
Partner

Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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Lisa R. Burchi, Toxic Substances Control Act Attorney, FIFRA Lawyer, Bergeson and Campbell, Law firm
Of Counsel

Lisa Burchi's work involves Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulatory matters. She has particular expertise in data compensation matters under FIFRA, the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Biocide Product Regulation (BPR), and Plant Protection Product (PPP) Regulation, and also counsels on matters related to California law, including Proposition 65 and the recent Green Chemistry Initiative/Safer Consumer Products Regulations. She delivers more than 18 years of experience in highly specialized fields. Though she works for Washington, DC-based Bergeson & Campbell, P.C. (B&C®), she lives in and is licensed in the State of California.

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Timothy Backstrom, Bergeson Campbell PC, Endangered Species Act attorney, EPA litigation, FIFRA lawyer, Clean Air regulation legal counsel, FOIA law
Of Counsel

Timothy Backstrom spent some 25 years in the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel (OGC) working on pesticide, toxic substances, and air quality issues before coming to Bergeson & Campbell, P.C. (B&C®). He offers an extraordinary understanding of how EPA operates, as well as established relationships with many key players at EPA. He brings substantial litigation experience in both federal courts and administrative adjudications. He served for many years as the OGC’s designated administrative law...

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