[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: ``[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 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]
BILLING CODE 4160-01-F