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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