Supplemental Efficacy: Sterilizers
DIS/TSS-9
EFFICACY DATA REQUIREMENTS
Supplemental Efficacy
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.
(1) 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.
(2) 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.
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