On January 27, 2016, the U.S. Environmental Protection Agency (EPA) issued an Antimicrobial Pesticide Use Site Index (USI) to provide guidance to pesticide applicants and registrants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on identifying specific uses associated with the twelve antimicrobial use patterns codified by EPA in 2013 at 40 CFR Section 158.2201(a).
Although neither binding nor exhaustive, EPA intends the USI to serve as a guide to the general types of use sites commonly listed on antimicrobial product labels. The USI’s organization follows EPA’s twelve antimicrobial use patterns:
- Agricultural premises and equipment (including irrigation systems as well as many indirect food uses such as animal drinking water, food/feed storage premises, and greenhouses);
- Food-handling/storage establishments, premises, and equipment (including food processing equipment and water systems);
- Commercial, institutional and industrial premises and equipment (including nonfood contact areas of commercial sites, such as laundry equipment and HVAC systems);
- Residential and public access premises (including mostly nonfood areas, as well as food-handling areas in homes);
- Medical premises and equipment (including ambulances, hospitals, and nursing homes);
- Human drinking water systems (including any methods used to provide potable water from raw water supplies, such as public water systems, water purifier units, and private water systems);
- Material preservatives (including antimicrobial chemicals added to crops, paints, coatings, adhesives, textiles, and paper);
- Industrial processes and water systems (including microbiocides used to control the growth of bacteria, fungi, and algae in circulating water systems);
- Antifoulant paints and coatings (including coatings and paints applied to control the growth of freshwater or marine fouling organisms, as well as ballast water);
- Wood preservatives (including containers made from treated wood, as well as treated wood intended for use in furniture, decking, fencing, utility poles, and other structures);
- Swimming pools (including products used to prevent or control the growth of bacteria or algae in swimming pools, Jacuzzis and hot tubs); and
- Aquatic areas (including products designed to control or kill slime-forming bacteria, fungi or algae in lakes, ponds, streams, drainage ditches, or other bodies of water).
After identifying the use pattern(s) applicable to its proposed uses according to the USI, the guidance suggests that applicants refer to the antimicrobial data requirements tables at 40 CFR Part 158, Subpart W, to determine the EPA guideline data requirements generally applicable to the product. Although EPA always reserves the right to impose additional requirements on any pesticide product, applicants may use the USI as a tool to identify the minimum set of data necessary to register their products.
Within each use pattern, EPA has further organized the representative sites into three food use categories: direct food uses, indirect food uses, and nonfood uses, and the USI provides guidance on whether a particular use site on an antimicrobial product label may require establishment of a tolerance or tolerance exemption (or, in some circumstances, a food additive regulation or food contact notification) consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA). As noted by EPA, any pesticide product with label directions for use on food must have the necessary FFDCA clearances in place to obtain FIFRA registration. Similarly, EPA will require all necessary FFDCA clearances before FIFRA approval of a pesticide with indirect food uses (for example, antimicrobial pesticides intended for use on food-contact utensils or countertops, or incorporated into cutting boards or food containers to protect those articles from bacterial degradation).
By contrast, EPA will not require FFDCA clearances if an applicant can demonstrate that the uses of a product do not have a reasonable expectation of resulting in residues of food (for example, fuel tanks, footwear, or non-food areas of eating establishments). The USI acknowledges but does not address the threshold analysis required to determine whether residues of an antimicrobial substance are subject to tolerance requirements administered by EPA or food additive regulations administered by FDA, which turns on whether a particular residue meets the FFDCA’s definition of “pesticide chemical residue.”