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 ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 97N-0451 Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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