[Federal Register Volume 63, Number 70 (Monday, April 13, 1998)]
[Notices]
[Pages 18029-18030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9636]


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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Draft Guidance for Industry: Guide to Minimize Microbial Food 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: 
[email protected], 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: [email protected].

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/
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