[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Pages 58055-58056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0451]
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 guide entitled ``Guidance for Industry: Guide to
Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (the guide). The guide is designed to provide voluntary
guidance on good agricultural practices and good management practices
and 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 fresh
[[Page 58056]]
fruits and vegetables. The voluntary guide is intended to assist
growers, packers, and other operators in continuing to improve the
safety of domestic and imported fresh produce.
ADDRESSES: Submit written requests for single copies of the guide to
Lou Carson, Center for Food Safety and Applied Nutrition (HFS-32), 200
C St. SW., Washington, DC 20204, 202-260-8920. Send one self-addressed,
self-adhesive label to assist that office in processing your request.
Requests for copies of the guide should be identified with the docket
number found in brackets in the heading of this document. A copy of the
guide is available for public examination in the Dockets Management
Branch, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through Friday. The guide is also accessible
via the FDA home page on the World Wide Web (WWW) (http://www.fda.gov).
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition, Food and Drug Administration (HFS-32),
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 the Department 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 good
agricultural practices and good manufacturing practices for fresh
fruits and vegetables. FDA is coordinating the effort for DHHS.
Between November 17, 1997, and December 12, 1997, FDA and USDA
held a series of public meetings to provide the details on a broad
approach on how to minimize microbial contamination of produce through
the control of water, manure, worker health and hygiene, field and
facility sanitation, and transportation. A draft guidance document
entitled ``Working Draft: Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruit and Vegetables'' was made available
electronically on FDA's home page on the WWW (http://www.fda.gov) and
at each public meeting.
In the Federal Register notice of April 13, 1998 (63 FR 18029), FDA
announced the availability of a proposed guidance document entitled
``Guidance for Industry: Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables.'' The proposed guidance
document was also made available on FDA's home page and by mail to
interested persons. The proposed guidance document responded to
comments received on the working draft of the guidance document, as
well as to comments received at the public meetings. FDA, in
cooperation with USDA, held three public meetings between May 19, 1997,
and May 27, 1998, to provide an overview of, and to seek additional
public input on, the proposed guidance document. Transcripts of these
meetings and all comments received on the proposed guide are on file in
the Dockets Management Branch (address above) under the docket number
appearing above and are accessible via the FDA home page on the WWW
(http://www.fda.gov/ohrms/dockets).
In the April 13, 1998, notice, the agency asked for comments on the
proposed guide and requested information about current agricultural
practices, the cost of applying good agricultural and management
practices, and ways to analyze costs and benefits to assess cost
effective measures (63 FR 18029 at 18030). In response to that request,
FDA received about 40 letters containing one or more comments in
addition to many oral comments at the three public meetings held in May
1998. FDA has reviewed all of these comments, both oral and written,
and has modified the proposed guide, as appropriate, in light of those
comments. A number of comments were beyond the specific content of the
guide. Therefore, the agency has prepared a written analysis of those
comments, including those that addressed the agency's request for
information about costs/benefits of agricultural practices, and has
placed it in the docket (Docket No. 97N-0451). This analysis is
available for review at the Dockets Management Branch (address above)
or may be obtained via FDA's home page on the WWW (http://www.fda.gov/
ohrms/dockets) under the docket number.
FDA is announcing the availability of the final guide. The guide
responds to comments received on the proposed guidance document and
represents FDA's and USDA's current thinking on strategies to minimize
microbial hazards for fresh produce. The guide does not create or
confer any rights for or on any person and does not operate to bind
FDA, USDA, or the public. The guide is being distributed in accordance
with the FDA's policy for Level 1 guidance documents as set out in the
agency's Good Guidance Practices, published in the Federal Register of
February 27, 1997 (62 FR 8961).
FDA believes that this guidance serves as an important step in
addressing the risks of foodborne illness associated with fresh
produce. There are, at this time, limited data available on current
agricultural practices. To gather better data and provide a foundation
for the agency's future evaluation of the impact of the guidance, FDA
is working with USDA's National Agricultural Statistics Service (NASS)
to design and conduct a survey of current domestic agricultural
production and packing practices for fresh produce. The objective of
the survey is to document the prevalence and variety of practices
currently used in the production of fresh fruits and vegetables in the
United States. The survey will focus on practices that are addressed in
the guide, including practices related to agricultural water quality,
manure management, packinghouse sanitation, and worker hygiene. The
survey development process has included an industry advisory group to
help ensure the effectiveness of the survey. NASS plans to conduct a
pilot test survey of two States and approximately 30 commodities in
fiscal year (FY) 1999 and, depending on resources, to conduct a
nationwide survey in FY 2000.
Dated: October 26, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-29022 Filed 10-26-98; 2:39 pm]
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