Updates to EPA 810 Product Performance Test Guidelines

Posted on: March 19, 2018

On February 28, 2018, the Environmental Protection Agency released final 810 guidelines for 810.2000, 810.2100 and 810.2200. Documents pertaining to the revision of the product performance guidelines, including public comments, and the agency’s response to the comments are available in docket EPA-HQ-OPP-2015-0276.  The following provides a summary of critical changes made to the 810 guidelines.

810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides

Diluent for concentrates

There are three hard water options for diluting products. (Note: the use of distilled water, as the diluent, needs to be discussed with the agency.)

  • Unsoftened tap water with a minimum of 200 ppm calcium carbonate
  • AOAC Synthetic hard water of 400 ppm calcium carbonate
  • OECD hard water of 375 ppm calcium carbonate
Repeat testing guidance

The agency has provided guidance on how to address repeat testing. This section of the guidance is important for Accuratus because it proscribes how to execute testing to the EPA’s specification. Our business development and study director teams are fully trained on these new requirements and will ensure testing is completed within the specifications of the guidelines.

Lower Certified Limit (LCL) guidance

This was an expected change that replaced the need to test an aged batch. Clarification was provided that fungicidal products need to be tested at the LCL. Additionally, the EPA stated the requirements for Certificate of Analyses content.

Confirmatory testing

Confirmatory testing is needed when an identical product formulation is not produced by the same manufacturer using the same production process and minor inert formulation changes that do not affect the active ingredient.

810.2100: Sterilants, Sporicides and Decontaminants

  • Confirmatory testing requirements were added.
  • Verification testing requirements were added. This involves testing with a separate study director, technical staff and quality assurance. Accuratus has ample staff to execute the verification testing, with multiple teams available for testing.
  • Aseptic packing testing parameters were updated to increase exposure time and include an exposure temperature range.
  • Clostridium difficile sporicidal claims requirements was added.

810.2200: Disinfectants for Use on Environmental Surfaces

Additional Bacteria

Control carrier counts have been updated to include an upper limit. In anticipation of this change, Accuratus has performed extensive work to ensure we can achieve this new requirement.

Virucidal Claims

The requirement for completion inactivation has been removed and only a ≥3 Log reduction is required. In addition, the minimum dried virus target is now 4.80 Log10 per carrier.

Fungicidal Activity Test

An inoculum upper limit has been added.

Tuberculocidal Claims

The EPA is allowing test cultures to be prepared following the EPA SOP MB-16, which included agitation.

Quantitative Tuberculocidal Claims

Requirement to follow EPA SOP MB-16 has been added.

Towelettes

A recommendation has been added to follow the QPM method (ASTM E2896-12)

If you have questions about the revised guidelines, please contact Dave Rottjakob, Accuratus Director of Business Development, at [email protected] or (612) 379-5519.