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March 19, 2012

EPA Announces Availability of Final Test Guidelines for Antimicrobial Products

The ACTA Group

On March 16, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of the long-awaited final test guidelines for Series 810 — Product Performance Test Guidelines, specifically public health uses of antimicrobial agents (OCSPP 810.2000), sterilants (OCSPP 810.2100), disinfectants (OCSPP 810.2200), and sanitizers (OCSPP 810.2300). These test guidelines are part of a series established by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Section 408 of the Federal Food, Drug, and Cosmetic (FFDCA). Studies conducted according to these test guidelines may be used for satisfying FIFRA data requirements in 40 C.F.R. Parts 158 and 161, data-call-ins issued pursuant to FIFRA Section 3(c)(2)(B), as needed to satisfy data requirements appropriate for specific pesticide registration applications, or for satisfying data requirements to demonstrate the safety of a tolerance or tolerance exemption under FFDCA Section 408. EPA notes that, as guidance documents, the test guidelines are not binding on either EPA or any outside parties. The test guidelines are available online.

The following final test guidelines for Group B — Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents in OCSPP Series 810 — Product Performance Test Guidelines are available:

  1. General Considerations for Public Health Uses of Antimicrobial Agents (OCSPP 810.2000);
  2. Sterilants — Efficacy Data Recommendations (OCSPP 810.2100);
  3. Disinfectants for Use on Hard Surfaces — Efficacy Data Recommendations (OCSPP Guideline 810.2200); and
  4. Sanitizers for Use on Hard Surfaces — Efficacy Data Recommendations (OCSPP 810.2300).

These final test guidelines address efficacy testing for antimicrobial agents intended to be used on hard, inanimate, environmental surfaces and that bear label claims as sterilants, disinfectants, and sanitizers. EPA notes that, at places in this guidance, it uses the word “should.” According to EPA, in this guidance, use of “should” with regard to an action means that the action is recommended rather than mandatory. EPA states that while the procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, “EPA recognizes that departures may be appropriate in specific situations.” Alternatives to the recommendations described in the test guidelines may be proposed, and EPA will assess them for appropriateness on a case-by-case basis.

EPA last updated the product performance guidelines for antimicrobial agents in 1982 under the “Pesticide Assessment Guidelines — Subdivision G, Product Performance.” Since then, EPA has presented several issues at two separate meetings of the FIFRA Scientific Advisory Panel (SAP) related to the conduct of studies for antimicrobial agents. The first meeting was held September 9-10, 1997, and included discussion of efficacy testing issues concerning public health antimicrobial pesticides. Information regarding the meeting, including the final report, is available online. The second meeting, to discuss guidance on test methods for demonstrating the efficacy of antimicrobial products for inactivating Bacillus anthracis spores on environmental surfaces, was held July 17-19, 2007. Information regarding the meeting is available online. EPA also published the test guidelines for comment in January 2010, and revised them based on comments received from industry. Select revisions are highlighted below.

To the Overview document (OCSPP 810.2000), EPA makes the following revisions:

  • Clarifies that not all disinfectants are considered to be human health-related, regardless of claims, by revising the text to state:An antimicrobial pesticide is considered to make a public health claim if the pesticide product bears a claim to control pest microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including but not limited to, microorganisms infectious to man in any area of the environment.
  • Adds definitions for slime, volatile, non-volatile, and revises the definition of biofilm.
  • Acknowledges that there may be situations in which it may not be technically feasible to test a product at the lowest certified limit (LCL); EPA states that testing should be conducted as close to the LCL as possible and a rationale for why the testing cannot be conducted at the LCL should be provided to EPA.
  • Revises the document to state that shorter contact times than those listed in the standard methods are allowed without obtaining EPA review prior to conducting the study. Resulting claims would reflect reduced contact time.

To the Sterilants Guideline (OCSPP 810.2100), EPA makes the following revisions:

  • Adds data recommendations for testing against the spore formers Bacillus anthracis and Clostridium difficile.
  • Adds language addressing porous carriers as the more stringent test standard, on which claims for efficacy on non-porous surfaces could also be based.
  • Explains the term “failures” in the “Evaluation of Sterilant Success” section to mean, “growth of test organism after carrier treatment.”

To the Disinfectants Guideline (OCSPP 810.2200), EPA makes the following revisions:

  • Includes the carrier counts for each test organism for the Hard Surface Carrier Test.
  • States that it will post all cited test methods, such as for Sanitizer for Urinal and Toilet Bowl Water and In-tank Sanitizers, on the Antimicrobial Division’s website.

Finally, to the Sanitizer Guideline (OCSPP 810.2300), EPA makes the following revisions:

  • Expands the test information guidance for food contact surface towelettes and residual self-sanitizing testing.
  • Updates the name for Salmonella typhi (ATCC 6359) to Salmonella enterica (ATCC 6359).