Federal Register: April 13, 1998 (Volume 63, Number 70)
Notices
Page 18029-18030
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr13ap98-67
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
Docket No. 97N-0451
 
 
Draft Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and Vegetables; Availability
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notice.
 
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a proposed guide entitled ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables (the proposed guide).'' The document provides guidance on
good agricultural practices (GAP's) and good manufacturing practices
(GMP's). The GAP's and GMP's are designed to minimize microbial food
safety hazards common to the growing, harvesting, packing, and
transport of most fruits and vegetables sold to consumers in an
unprocessed or minimally processed (i.e., raw) form. This action is in
response to the Presidential initiative to ensure the safety of
imported and domestic fruits and vegetables. The proposed guide is
intended to assist growers, packers, and other operators in continuing
to improve the safety of domestic and imported produce.
 
DATES: Written comments by June 29, 1998.
ADDRESSES: Submit written comments on the proposed guide to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written requests
for single copies of the proposed guide entitled ``Guidance for
Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables'' to Lou Carson, Center for Food Safety and
Applied Nutrition, 200 C St. SW., rm. 3812, Washington, DC 20204, 202-
260-8920. Send one self-adhesive address label to assist that office in
processing your request. Comments and requests for copies should be
identified with the docket number found in brackets in the heading of
this document. A copy of the proposed guidance and received comments
are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
 
FOR FURTHER INFORMATION CONTACT:
    Joyce J. Saltsman, Center for Food Safety and Applied Nutrition
(HFS-165), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-5916, FAX 202-260-9653, e-mail:
jsaltsma@bangate.fda.gov, or
    Michelle A. Smith, Center for Food Safety and Applied Nutrition
(HFS-306), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-2975, FAX 202-205-4422, e-mail: msmith1@bangate.fda.gov.
 
SUPPLEMENTARY INFORMATION:  On October 2, 1997, the President announced
the ``Initiative to Ensure the Safety of Imported and Domestic Fruits
and Vegetables'' (fresh produce safety initiative). As part of the
fresh produce safety initiative, the President directed the Secretary
of Health and Human Services (DHHS) and the Secretary of the U.S.
Department of Agriculture (USDA), in cooperation with the agricultural
community, to issue, within 1 year, guidance on GAP's and GMP's for
fresh fruits and vegetables. FDA is coordinating the effort for DHHS.
    As part of this effort, FDA and USDA held a series of public
meetings between November 17, 1997, and December 12, 1997, to provide
the details on a broad approach on how to minimize microbial
contamination through the control of water, manure, worker health and
hygiene, field and facility sanitation, and transportation. A draft
guide entitled ``Working Draft: Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruit and Vegetables'' (the working draft) was made
available on FDA's World Wide Web (WWW) home page (http://www.fda.gov)
and at each public meeting. The Fresh Produce Subcommittee of the
National Advisory Committee for Microbiological Criteria for Food also
reviewed and commented on sections of a working draft at the November
1997, meeting. Transcripts of these meetings and all comments received
on the working draft of the proposed guide are on file in the Dockets
Management Branch (address above) under the docket number appearing in
brackets in the heading of this document and are accessible via the FDA
home page on the WWW (http://www.fda.gov/dockets/dockets.htm).
    With this notice, FDA is announcing the availability of the
proposed guide. The proposed guide responds to comments received on the
draft guidance document and represents the agencies' current thinking
on strategies to minimize microbial hazards for fresh fruits and
vegetables. The proposed guide does not create or confer any rights for
or on any person and does not operate to bind FDA, USDA, or the public.
An alternative approach may be used if such approach would effectively
serve to reduce the microbial contaminants that could result in
foodborne illnesses and if such approach satisfies applicable statutes
and regulations. The proposed guide is being distributed for comment
purposes, in accordance with the FDA's policy for Level 1 Good Guidance
Practices documents as set out in the Federal Register of February 27,
1997 (62 FR 8961).
    Because the guide is voluntary guidance, and not a regulation
imposing binding requirements, FDA is not required to perform an
economic impact analysis of the recommendations contained therein.
However, the agency recognizes that, to reduce microbial hazards, the
industry will want to select good agricultural and manufacturing
practices that are most cost-effective, appropriate to their individual
operations.
 
Page 18030
 
    The guide represents the best effort of FDA, USDA, and other
technical experts to identify practices that are feasable and that are
likely to reduce microbial hazards. However, because of the broad-scope
nature of the guide (such as covering all fresh fruits and vegetables
grown in all regions of the US and overseas) and the current state of
science (such as the need for additional research on pathogen survival
under varying field conditions and the impact of various treatments to
eliminate or reduce pathogens on the surface of crops with different
physical characteristics), FDA has not attempted to rank the risk
factors in order of significance or rank the intervention strategies in
order of importance. It may, however, be possible to provide such
information as science progresses and as additional, more focused
documents (such as education and outreach materials on specific
commodities or practices) are developed. To this end, FDA is requesting
comment on the following:
    (1) Current industry practices to reduce microbial hazards and
how the recommendations in the guide might be most effectively
applied to farms of various sizes. The agency specifically requests
comments from small farmers and other industry groups currently
employing these or other practices to reduce microbial hazards from
fresh produce;
    (2) Mechanisms used by growers and packers as part of good
agricultural and good management practices programs and cost of
application of such mechanisms;
    (3) Most appropriate ways to analyze benefits and costs, such as
by crop group (e.g., berries, tree fruit, vegetable row crops), by
region, or by practice (e.g., manure management, water use in
packing houses); and
    (4)How to best draw on existing resources and expertise to
assemble existing data and analyze costs and benefits (such as
industry partnerships or pilot programs) to assess cost effective
measures.
    Interested persons may, on or before June 29, 1998, submit written
comments to the Dockets Management Branch (address above) on the
proposed guide. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The proposed guide may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday. An electronic version of this
draft guidance is available on the Internet using the WWW (http://
www.fda.gov/dockets/dockets.htm) or (http://vm.cfsan.fda.gov/
<difference>dms/fs-toc.html).
 
    Dated: April 3, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
FR Doc. 98-9636 Filed 4-10-98; 8:45 am
BILLING CODE 4160-01-F