4/26/2017 FAQs for EPA's Document: Efficacy Testing Standards for Antimicrobial Product Data Call-In Responses 1. Should data be submitted/cited on both the basic (required) organisms as well as the supplemental (additional) organisms? Yes. Efficacy data should be submitted/cited for all basic (required) and supplemental (additional) organisms supporting public health efficacy claims. The efficacy data to support the basic and additional organisms should be consistent with the data requirements identified in the 810 guidelines. 2. The Efficacy Testing Standards for Product Data Call-In Responses document states that the basic formulation should be used for efficacy testing. What if the basic formulation is not used in commerce and the materials to batch the basic formula are not readily accessible? If the basic formulation cannot be tested, a currently marketed alternate formulation may be used instead. In this situation, however, the Confidential Statements of Formula (CSF) should be revised to identify the tested alternate as the basic CSF. 3. This document states that the product needs to have full test material characterization data. Is a laboratory Certificate of Analysis (COA) sufficient to provide this information? Yes. A laboratory Certificate of Analysis which identifies the active ingredient concentration(s) of the tested product lots is adequate. 4. If cited studies or existing studies do not contain a COA that was performed at the time of the original study, can a new COA be generated and provided to support this data need? Yes, but only if the product lots tested have not expired and have been maintained under appropriate storage conditions. 5. The efficacy data supporting my product for supplemental (additional) bacteria uses minimum carrier counts of 1x10^ and 10 carriers per each of two lots, however the studies were performed prior to the Efficacy Testing Standards for Antimicrobial Product Data Call-in Responses guidance document using a version of the test method in place when the 2012 guidelines were published. Do I need to generate new data for these additional/supplemental bacteria? The Agency recommends submitting previously performed studies that were generated under the test methods in place when the 2012 guidelines were published. However, efficacy studies initiated after posting of the Efficacy Testing Standards for Antimicrobial Product Data Call-in Responses guidance document (7/1/2015) should comply with this updated guidance. ------- 6. Do Staphylococcus aureus or Pseudomonas aeruginosa studies that comply with the product data call-in (DCI) guidance document but were performed under a pre-2013 AOAC use-dilution method need to be regenerated under the new, 2013 use-dilution method? No. Use-dilution data performed prior to the 2013 version of this method may be submitted in response to a reregi strati on data call-in (DCI) as long as the studies conform to the updated standards identified in this guidance document. 7. Can efficacy data performed under the Antimicrobial Testing Program (ATP) be cited to satisfy the DCI requirement? Yes. A product lot tested under the ATP may be cited in response to a reregi strati on data call-in as long as the active ingredient concentration of the lot tested was at or below the nominal concentration. Registrants should provide available information/details regarding the ATP testing data. 8. If a product has multiple active ingredients that are all covered by a single CAS number or trade name, is a single analytical assessment for that material adequate? Yes. Active ingredients with the same CAS number may be combined to determine a total analytical concentration. 9. Why are non-food contact sanitizer requirements not addressed in the Efficacy Testing Standards for Antimicrobial Product Data Call-in Responses guidance document? This Efficacy Testing Standards for Antimicrobial Product Data Call-in Responses guidance document is intended to be a supplement that identifies certain updated standards since the 2012, 810 Series Guidelines (810.2000 - 810.2700). As a result, the document does not repeat all the testing requirements in the current 2012 Guidelines. 10. Is there an acceptable active ingredient concentration range above the nominal concentration for previously-performed efficacy data? For instance, if the analytical method error is +/-2%, will testing on formulas at 2% above nominal be allowed? No. The product lots tested in previously performed (existing) efficacy data that is submitted in response to a reregi strati on product data call-in should be performed with active ingredient concentrations at or below the nominal concentration. 11. If there is a need to repeat data because the previously performed study batches were above the active ingredient nominal concentration (but below the upper certified limit), does the entire efficacy package need to be repeated or can confirmatory data be performed at the LCL for the basic (required) organisms? In the situation described above, confirmatory data performed at the LCL may be used to support the basic (required) test organisms for disinfection claims and/or for food-contact surface sanitization claims (see 810.2200 and 810.2300). When this approach is used, the studies performed with concentrations above the nominal should be in cited in the DCI response along with the confirmatory data performed at the LCL. Note that under the current guidelines, confirmatory testing is not an option for non-food contact surface sanitization. Further, any additional organisms under these base claims should be supported by appropriate, non-confirmatory testing data. ------- 12. Clarification is needed as to whether confirmatory data at the lower certified limit (LCL) can be submitted in support of the DCI. It is not clear if EPA understands that substantial confirmatory data on alternate formulas, performed at the LCL, can be submitted. Confirmatory efficacy data should not be submitted in response to a reregi strati on data call-in except under the scenario described in question number 11, above. Otherwise, only efficacy data meeting the standard (non-confirmatory) data requirements are relevant to reregi strati on. 13. Should claims that are not a part of the 810 guidelines such as non-public health claims be addressed in the DCI response (e.g., non-OIE list veterinary organisms [e.g., canine parvovirus])? Antimicrobial efficacy responses to a reregi strati on product data call-in should address only public health efficacy data requirements. 14. Can efficacy data that supports hospital/health care disinfection be used to support broad-spectrum disinfection as well? Yes. Acceptable efficacy data that supports claims for hospital/health care disinfection may be cited in the DCI response to support broad-spectrum disinfection claims. ------- |