June 17, 2011 Attachment 2 Examples of Testing Guidelines Inapplicable to Antimicrobial Use Patterns

 Post - Application Exposure, Descriptions of Human Activity , 875.2800 The guideline is d escribed as relevant only for determining reentry

interv als foll owing crop treatments. See generally

Appendix G, page 5 - 10. Also see Appendix G, page 8 regarding the data requirement associated with this testing guideline .  Environmental Fate, laboratory studies (currentl y proposed as required for all uses) Ready Bio degradabilit y, 835.3100; Porous Pot Test, 835.3220 At the dosing level necessary to see CO 2 evolution caused b y the compound above background evolution, many biocides will be toxic to the microbial community . Also may not be suitable or practical for ant imicrobial testing, including biodegradability testing with inorganic chemicals or chemical elements. See Appendix H, page 4 and 5

 Environmental Fate, Transformation in Water and Soil Aerobic Soil Metabolism, Anaerobic Soil Metabolism, Aerobic Aquatic Metabolism, Anaerobic Aquatic Metabolism (OPPTS 835.4100 through 835.4400) These are clearl y identified as designed for terrestrial applications to crops and non - crop areas and provide no guidance for antimicrobial pesticides uses. They also depend on ma intenance of an appropriate microbial population in the soils. Since antimicrobial pesticides are designed to control microorganisms, the relevance of these testing protocols is questionable, particularl y given what likely are significant limitations on the dosing levels to avoid toxicity to the microorganisms. See Appendix H, page 5 - 6.

 Mutagenicity

Testing, particularl y 870.5100 (Ames assay) In clusion is inconsistent with the Agency ’s prior conclusions on the relevance of assay for antimicrobial pestic ides. Itwould be more appropriate to provide other options and allow the registrant to conduct the appropriate study for the compound of concern. See Appendix E, page 18Steven Bradbury , Ph.D. and Joan Harrigan - Farrelly

Attachment 2 June 17, 2011 Page 2 of 2

- 2 -  Companion Animal Safety Testing 870.7200 Application of antimicrobials to companion animals removes those uses from the definition of pesticide, as such uses would be considered as animal drugs. This testing guidance is not applicable to antimicrobial pesticides.

 Residue Chemistry Residues in Meat/Milk/Poultry /Eggs 860.1480 Addre sses direct application to livestock or addition to livestock feed. If there is such an application of an antimicrobial pesticide, it would be exempt from FIFRA because it would be regulated as an animal drug. Similarl y, direct application of an antimicr obial pesticide to livestock feed is not subject to FIFRA, but instead is regulated by FD A as an animal feed additive. Plant Metabolism (860.1300) Crop Field Trials (860.1500), Processed Food or Feed (860.1520) Data requirements c u rrently proposed to be required or conditionally required are for agricultural prem ises, indirect food contact uses, ‘direct’ food contact uses, and aquatic uses. Direct application to edible crops removes the product from the definition of an antimicrobial pesticide; the use then would be regulated as a conventional chemical by the Registr ation Division. See generally

Appendix A, pages 1 - 4 and Appendix I , pages 2 - 3.