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By Lisa M. Campbell and Margaret R. Graham

On January 28, 2016, in docket EPA–HQ–OPP–2015–0302, the U.S. Environmental Protection Agency (EPA) posted its revised Antimicrobial Pesticides Use Site Index (USI).  In the USI, EPA states that it “has developed [the USI] to provide guidance about the antimicrobial pesticide use sites associated with these antimicrobial pesticide use patterns,” and it “is a guidance document to assist applicants in identifying the data that are necessary to support registration of products and to determine if labeled uses necessitate establishment of a tolerance or exemption from the requirement of a tolerance.”  EPA also posted a Response to Public Comments which stated that there have been a number of changes based on comments received, specifically from the American Chemistry Council’s Biocides Panel (ACC or Panel) and the Consumer Specialty Products Association (CSPA).  These changes include:

  • Clarifying that the USI is a guidance document and that the sites in the USI are not intended for use in labeling;
  • Simplifying the USI by organizing example use sites into broader groups;
  • Using a tabular format to provide examples of use sites organized by food use description (i.e., direct food use, indirect food use, and nonfood use) within each major use pattern category to make it easier to follow;
  • Clarifying that “food” is defined under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 321(f), and that definition applies, as appropriate, to all food use descriptions;
  • Revising the description of “nonfood use” to provide better clarity;
  • Deleting from the USI some example use sites that were ambiguous, too vague, too specific, or incorrectly categorized regarding major use pattern category or food use description; and
  • Incorporating many of ACC’s suggestions of specific use sites to include in the materials preservatives and wood preservatives general use pattern categories.

More information regarding the draft USI is available in our blog post EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

 

 


 

By Lisa M. Campbell and Lisa R. Burchi

On July 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice extending the public comment period regarding its proposed Antimicrobial Pesticides Use Site Index (USI) from July 31, 2015 to August 31, 2015.  The initial Federal Register notice announcing the availability of EPA’s guidance on the USI was issued on July 1, 2015.

By way of background, in 2014, EPA issued a final rule on Data Requirements for Antimicrobial Pesticides amending the regulations setting forth the data requirements that support an application to register a pesticide product.  The final rule contains the data requirements specifically applicable to antimicrobial pesticides that were codified in 40 C.F.R. Part 158, subpart W.  The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201.  The data requirements applicable to a pesticide product depend in part on the product’s use pattern.  The general use patterns are broad designations, and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.

EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and to assist EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product.  EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.

The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit. 

In addition to extending the comments, EPA also published in the docket a Question and Answer document on the USI Webinar for questions submitted to EPA prior to the July 14, 2015, webinar.  Additional information regarding the USI is available in EPA Docket EPA-HQ-OPP-2015-0302.