Supplemental Efficacy: Sterilizers
EFFICACY DATA REQUIREMENTS
A "sterilizer" is an antimicrobial pesticide that destroys or eliminates all forms of microbial life in the inanimate environment, including bacterial spores. The term "sporicide" is deemed to be synonymous with "sterilizer". Since sterilization includes eradication of all living microorganisms, such claims are intrinsically related to protection of human health. The following apply to all products represented in labeling as sterilizing or sporicidal agents.
- Test requirements.
The AOAC Sporicidal Test is required for substantiating sterilizing claims. Sixty carriers-representing each of two types of surfaces (porcelain penicylinders and silk suture loops) are required to be tested against spores of both Bacillus subtilis ATCC 19659 and Clostridium sporogenes ATCC 3584 on three product samples representing three different batches, one of which is at least 60 days old (240 carriers per sample; a total of 720 carriers). Any sterilizing agent (liquid, vapor, or gas) which is recommended for use in a specific device must be tested by the AOAC Sporicidal Test in that specific device and according to the directions for use.
- Performance requirements.
Killing on all of the 720 carriers is required. No failures are permitted. Data to support sterilizing claims must be confirmed by tests conducted by the Agency's Microbiology Laboratory before the data submitted for registration will be considered acceptable.
*Note: Due to curtailment of laboratory operations at the EPA microbiology laboratory at Beltsville, MD, the required confirmatory validation data for a product as a sterilizer should be conducted by a second, independent laboratory of your choice (other than the laboratory which developed the original data). The following minimal confirmatory data must be developed on one sample of the product: Thirty carriers with each of the two types of surfaces (silk suture loops and porcelain penicylinders) against spores-of both Bacillus subtilis and Clostridium sporogenes (a total of 120 carriers) by the AOAC Sporicidal Test.