[Federal Register: October 29, 1998 (Volume 63, Number 209)] [Notices] [Page 58055-58056] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr29oc98-90] ----------------------------------------------------------------------- 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: ``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] BILLING CODE 4160-01-F
Proposed Guide - April 13, 1998
Analysis of Comments to the Proposed Guide - October 26, 1998
Final Guide - October 26, 1998