Draft 810 Series Guidelines Posted

EPA Posts Three New Draft 810s

The Series 810 documents, often called the “810s,” are harmonized test guidelines from EPA covering a broad range of antimicrobial product types. For disinfectant developers, the Series 810 documents are an invaluable guide to the testing that is required to get various label claims.  Links to the existing, historical 810s follow:

  • 810.2000 – General Considerations (2012) 
  • 810.2100 – Sterilants (2012) 
  • 810.2200 – Disinfectants (2012) 
  • 810.2300 – Sanitizers (September 2012) 
  • 810.2400 – Fabric Sanitizers (2013) 
  • 810.2500 – Air Sanitizers (2013)
  • 810.2600 – Water Disinfectants (2013)
  • 810.2700 – Prion Products (2012)

The existing guidelines for antimicrobial efficacy have been in place for 2-3 years, last updated in March of 2013. 

 

EPA just posted three new draft Series 810 documents.  Links to the new documents are provided below:

  • 810.2000 – General Considerations (2015)
  • 810.2100 – Sterilants & Sporicides (2015)
  • 810.2200 – Disinfectants (2015)

These new documents will post to the Federal Register soon.  Once posted to the Federal Register, they will be open to comment.  Continue reading for ATL’s initial observations with regard to the “new 810s.”

Interesting Changes Noted by

Scientists at Antimicrobial Test Laboratories have begun studying the draft 810 series documents and have observed several interesting changes.

The following caught our attention upon initial review:

  • Clear guidance is provided for confirmatory testing.
  • All virus claims from liquid disinfectants may be bridged to towelettes by testing just the most difficult viruses.
  • A second lab, or a second set of scientists and QA staff at the original lab, must test quat-based tuberculocides to ensure efficacy.
  • Clear guidance on testing at the Lower Certified Limit (LCL) is provided.
  • If a test is contaminated and the product fails, the failure “counts.”

We will continue to review these draft guidelines and update our clients as new information becomes available.