#Spore testing requirements update

difficile outlined in the most current version of the Product Performance Test Guidelines – OCSPP 810.2100: Sterilants, Sporicides, and Decontaminants – Guidance for Efficacy Testing or Product Performance Test Guideline, –OCSPP 810.2200: Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing.

difficile claims may be added to liquid, spray, and towelette formulations of a sterilant, sporicide, or hospital disinfectant product provided that the product meets the performance criteria for testing against C. difficile spores to be public health claims for which the Agency must receive, review, and approve appropriate efficacy data. The Agency recognizes the potential public health implications of these spores in healthcare settings and the importance of having antimicrobial products with demonstrated efficacy against C. difficile is an anaerobic spore-forming bacterium and a frequent cause of hospital-acquired infections. difficile Spores and Their Public Health SignificanceĬ. Data submission procedures for efficacy dataĬ.Test procedures for developing efficacy data supporting C.difficile spores and their public health significance This guidance may be updated in the future and incorporated in the OCSPP Product Performance Test Guideline 810.2200. The Agency will evaluate any proposed method modifications for appropriateness on a case-by-case basis. Registrants and applicants may propose and submit alternative practices (e.g., modifications to the recommended test methodology) to the Agency for assessment. This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice. This guidance supersedes the Agency’s previous guidance for the efficacy evaluation of antimicrobial pesticides registered or proposed for use against C. difficile spores on hard, non-porous surfaces. These test methods and guidance provide a framework for registrants who seek to make a claim for antimicrobial pesticide products to control C.

difficile), as well as regulatory guidance for pesticidal claims for those products. This webpage provides test methods for evaluating the efficacy of antimicrobial pesticides against spores of Clostridioides difficile ( C.

#Spore testing requirements update

This update reflects revised nomenclature for Clostridioides difficile (formerly Clostridium), revised carrier specifications, and revised verification testing.