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Guidance on the Processing of Applications for Registration
of Antimicrobial Products Intended to Mitigate Food Borne
Pathogens

(9/20/01)

Purpose

To establish firm time frames under which the Agency will review applications for registration of antimicrobial products intended to decrease the incidence of food borne pathogens.

Introduction

As part of an interagency Food Safety Initiative, in January, 1999, the U.S. Food and Drug Administration (FDA) announced that it would expedite its review of petitions for certain food additive uses that are intended to significantly increase the safety of the food supply (see "Food Additive Petition Expedited Review - Guidance for Industry and Center for Food safety and Applied Nutrition Staff" at http://vm.cfsan.fda.gov). Specifically, the FDA Office of Premarket Approval (OPA) indicated that it would consider expedited review of petitions for food additives that are (a) intended to significantly decrease human pathogens or their toxins in/on food and (b) complete in terms of 21 CFR 171.1 and appear to contain sufficient data and information to support a decision whether to approve the additive.

Some of the products that meet FDA's criteria for expedited review are subject to "dual jurisdiction." That is, antimicrobial products that are added to raw agricultural commodities prior to processing are reviewed by FDA under section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) while the same products are reviewed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). For example, an antimicrobial product intended to control Salmonella and E. coli on raw fruits and vegetables in a food processing plant would be subject to review and approval by both the FDA and EPA.

For these "dual jurisdiction" products, it is clear that the two agencies need to focus on a common goal with respect to food safety. In addition, the EPA believes that such goals should extend to products over which EPA holds sole jurisdiction (e.g., food contact surface sanitizers). Thus, EPA intends to speed up its review process for all antimicrobial products intended to control food-borne pathogens by establishing and following standard time frames for reviewing these types of products. This step should provide an incentive to the development of these kinds of products and should ultimately benefit the public as well.

The Agency has not been required by law to set or meet deadlines for applications for registration of antimicrobial products used on or around food. That is, although the Food Quality Protection Act (FQPA) of 1996 mandated deadlines for the Agency to complete its reviews of applications for "antimicrobial pesticides," food-use related pesticides are excluded from the definition of "antimicrobial pesticides" [FIFRA sec. 2(mm)(1)]. The basic rationale for this exclusion is that, in general, certain toxicology and exposure data must be submitted and a full risk assessment must be conducted for food uses of pesticides in order to assure that the new requirements of FQPA have been met.

Notwithstanding the lack of a legal mandate, the Agency has decided to voluntarily process applications for registration of antimicrobials intended to control food-borne pathogens (such as new food contact surface sanitizers) in accordance with the deadlines mandated the FQPA for other antimicrobial pesticides. EPA believes that it is in the public interest to speed up the processing of such applications. Moreover, as a matter of good management and responsiveness to its "customers," the Agency believes that it should set and meet reasonable deadlines for processing applications for food-safety related uses of antimicrobials. Based on its experience with reviewing these applications, the Agency is confident that it can meet the target deadlines and still conduct the full assessment of exposure and risks to humans as required by FQPA to assure that human health and safety is fully protected.

Procedure

The Antimicrobials Division, Office of Pesticide Programs, intends to follow and meet the same deadlines for food-safety related uses of antimicrobials as for "antimicrobial pesticides." Examples of such uses are food-related uses that bear claims for sanitization, disinfection, control of specific food borne pathogens, or other public health-related claims. The categories and time frames that AD will use are:

  1. New active ingredient = 540 days.
  2. New product or amendment bearing major new use = 270 days.
  3. Major new use amendment = 270 days.
  4. Substantive amendment = 90-180 days.
  5. Identical or substantially similar product = 90 days.
  6. Minor amendment = 90 days.

AD staff will insert these standard review times with FQPA action codes into the Pesticides Regulatory Action Tracking System (PRATS) and establish due dates for each food-use related application, as applicable. These time frames are described in FQPA section 3(h)(2) as well as in proposed regulations for 40 CFR 152.457 (see 64 FR 50720, 9/17/99).

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