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June 19, 2015

EPA Announces Availability for Comment of OCSPP Harmonized Test Guidelines

Bergeson & Campbell, P.C.

On June 17, 2015, the Environmental Protection Agency (EPA) published a notice announcing the availability for comment of three draft revised 810 series test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP).  These test guidelines will provide updated guidance on antimicrobial efficacy testing to the regulated community.

EPA states that when these guidelines were published in final in 2012, they drew criticism as confusing and inaccurate.  EPA states that the guidelines have been reformatted, corrected and updated to reflect policy and technical changes during the intervening three years.  The draft revised guidelines include expanded upfront summaries and appear more accessible with bolded titles for sections and subsections.  Recent policy and technical changes that are incorporated into the draft revised test guideline include the following:  a requirement that certain product efficacy testing must be conducted at the active ingredient’s (AI) lower certified limit (LCL) concentration; and the updated test methodology for Clostridium difficile (C. diff).  In 2013, EPA specified in separate guidance that specific efficacy testing must be conducted on products with the AI at the LCL concentration.  In 2014, EPA announced the revised C. diff test methodology.  The substance of these two guidance documents is now incorporated into the draft revised test guideline. 

EPA is inviting public comment on the three draft revised 810 Series test guidelines, available at the below links:

Comments must be received on or before August 17, 2015.