October 26, 1998
This document summarizes the final steps in the process to develop the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (the guide) and summarizes and responds to the major comments received in response to FDA's request for comments on the proposed guide and for economic data. FDA received about 40 letters containing one or more comments on the proposed guide in addition to many oral comments at the various public meetings. The agency has reviewed all the comments and has modified the guide, as appropriate, in light of those comments. Section B below addresses comments received in response to questions posed in the notice of availability of the draft guide published in the Federal Register of April 13, 1998. In addition, a discussion of several comments that are beyond the specific content of the guide is found in section C. below.
A. Development of the Guide
The guide on minimizing food safety hazards in fresh fruits and vegetables in the agricultural and packinghouse environments was developed in accordance with FDA's Good Guidance Practices, a policy set out in the Federal Register of February 27, 1997 (62 FR 8921). Under that policy, guidance must be developed with appropriate public participation and the resulting guidance document must be readily available to the public. FDA intends to review periodically and update guidance documents, if appropriate, as science and existing policies evolve. Most importantly, the policy recognizes clearly that guidance documents do not themselves establish legally enforceable rights or responsibilities and are not legally binding on the agency or the public.
In keeping with this policy, FDA sought further participation in the development of the guide after availability of the proposed guide was announced in the Federal Register of April 13, 1998. FDA, in cooperation with USDA, held three public meetings between May 19 and May 27, 1998, in Washington, DC, Miami, FL, and San Diego, CA. The purpose of the meetings was to solicit public input on the guide and other pertinent comments from the agricultural community, industry, consumer groups, individuals, and other interested parties. In addition, the agency sought further participation from local, state, and Federal health and agricultural agencies.
A total of more than 160 participants attended the three public meetings. Participants included representatives from farms, food companies, trade associations, retailers, importers, brokers, agricultural consultants, consumer and labor organizations, and representatives from U.S. and foreign governments. Transcripts of the public meetings and all comments received on the proposed guide have been placed on file in the Dockets Management Branch, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, under docket number 97N-0451. The transcripts and comments are also accessible via the FDA home page on the World Wide Web (http://www.fda.gov).
B. Comment on the Federal Register Notice
In the Federal Register Notice of April 13, 1998 (63 FR 18029), FDA announced the availability of the proposed guidance document. In that notice, FDA stated that because of the broad-scope nature of the guide 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), the agency had not attempted to rank the risk factors in order of significance or rank the intervention strategies in order of importance. The notice stated that it might be possible to provide such information as science progresses and as additional, more focused documents (education and outreach materials on specific commodities or practices) are developed. Therefore, FDA requested comment on the following: (1) current industry practices to reduce microbial hazards and comments from small farmers and other industry groups on how the recommendations in the guide might be most effectively applied to farms of various sizes; (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) the 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 to assess cost effective measures.
FDA received one comment that specifically addressed the four items above from Western Growers. With respect to the first query, the comment asserted that the agricultural community is taking steps to reduce microbial hazards in growing, packing, and shipping operations to the greatest extent possible. As an example, the comment mentioned that workers are given mandatory training on sanitary practices in the field and packing house and are expected to follow good sanitary practices; manure, if used, is often tested to ensure that no pathogens survive; the use of biosolids in produce production areas is very infrequent, if at all; and packing sheds are kept as clean as possible. Further, the comment stated that trucks are inspected to insure that they had not been previously used for shipping inappropriate commodities, and with the significant detailed information kept on the origin of produce, traceback efforts could be conducted if needed.
With respect to the second query, the comment stated that costs will be incurred any time a new practice or procedure is added to a production, packing or shipping operation. It stated that new machinery may have to be purchased and employees will have to be trained in appropriate practices. The comment added that it would be impossible to estimate the cost of each change in practices without knowing the specifics of the practice and the size and past experience of each grower, packer, or shipper. Finally, the comment noted that although a detailed cost-benefit analysis could analyze examples of practices and probably assess their cost for different size operations, it would be difficult to obtain a national average. The comment suggested that costs will differ from location to location and from one region of the country to another.
With respect to the most appropriate ways to analyze benefits and costs, the comment responded that any analysis would have to look at three criteria: crop, region of the country, and the practice. It explained that once the analysis is initiated, other factors should be included, such as size of the company involved, whether the crop or practice is a known one or a new crop for the company, etc. The comment asserted that this task would be enormous and, therefore, it suggested that FDA analyze the issues in such a way that the task could be broken down into cells that are manageable and ultimately meaningful. The comment cited an example that would be fairly easy to assess - the cost of adding field sanitary facilities, where not already in place, for different size farms in different areas of the country; or assessing the cost of testing manure for possible pathogens in various areas of the country.
With respect to the last query, costs and benefits analysis of existing data, the comment noted that FDA, in cooperation with the National Agricultural Statistics Service (NASS) within USDA, is developing a survey to gather data on a number of practices associated with food safety. The comment stated that although Western Growers has reservations about such a survey, the survey is probably the best method to use as a first step to obtain cost and benefit data. The comment encouraged FDA to work with and draw on the expertise of a number of state departments of agriculture, in addition to other Federal groups, such as the Occupational Safety and Health Administration (OSHA).
FDA and USDA will consider the suggestions of this comment. As noted by the comment, FDA is working with NASS to design and conduct a survey of current 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. Data for such surveys may also serve as a foundation for future assessments, such as cost comparisons or public health impact assessments, as appropriate.
C. Other Comments to the Docket
Some comments were raised that implementation of mandatory regulations may be transformed into non-tariff trade barriers that could be used to limit access for products to U.S. markets. One comment stated that a non-tariff trade barrier might arise by the imposition of requirements for imports that are different or more stringent than those applied to domestically produced commodities. Other comments expressed concern that other countries might use all or portions of the U.S. guidance to erect trade barriers against U.S. produced fruits and vegetables.
As the agency has stated at each of its pubic meetings, and in the document itself, the guide is guidance and it is not a regulation. As guidance and if applied as appropriate and feasible to individual fruit and vegetable production operations, the guide will help to minimize microbial food safety hazards for fresh produce. Because it is guidance, and not a regulation, the guide does not have the force and effect of law and thus, the agency will not "enforce" the guide for either domestic or foreign producers. Furthermore, the agency stated in the addendum to the proposed guide that there should be a "level playing field" for domestic and foreign producers, and the guide can assist both groups to produce safer produce and to increase the likelihood that products of both will comply with U.S. food safety laws.
The agency recognizes the possibility that the guide, or portions of it, may be used voluntarily by the private sector (domestic or international) to ensure food safety through contractual arrangements. Nevertheless, as the guide is guidance and does not establish binding requirements, it does not erect a barrier to trade with the U.S. By the same token, FDA does not believe that the guide will cause other countries to erect barriers to trade for U.S. products.
One comment recommended that future efforts of U.S. food regulatory agencies proceed through internationally recognized mechanisms, such as the Codex Alimentarius Commission (Codex), to assure that U.S. approaches to enhancing food safety are consistent with emerging international standards and do not impose unilateral requirements that might be inappropriately used as non-tariff barriers. Several comments stated that the guide should be consistent with World Trade Organization (WTO) agreements. A few comments suggested that FDA and USDA develop and use harmonized sanitary and phytosanitary measures based on international standards without requiring WTO members to alter their appropriate level of protection for the protection of human, animal, and plant life and health.
FDA agrees that it is critical to bring the general concepts contained in the guide into the ongoing deliberations of international food safety standard setting organizations and to consider incorporating portions of international standards and guidelines as appropriate, and as they are established, into subsequent revisions of the guide. The agency intends to work closely with appropriate Codex committees, other relevant international organizations, and foreign and domestic agencies and producers to promote the principles contained in the guide as effective tools for control of foodborne microbial contaminants and to avoid any use of the guide in a manner that would unfairly restrict international trade.
The agency notes that there is nothing in the guide that conflicts with provisions of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement). Further, the guide is not intended to affect in any way a country's rights and obligations as specified in the SPS agreement.
A few comments stated that U.S. agencies should have authority to enter into agreements with governments or industries of exporting countries whereby the U.S. would recognize through a certification arrangement that a foreign country's fruit and/or vegetable industry, in whole or in part, is capable of meeting U.S. requirements. One comment encouraged the agency to implement a third-party verification and certification system to demonstrate that a country or "Safety Zones" within a country are meeting the principles contained in the guide. One comment suggested that the U.S. government establish protocols to recognize regions within a country and groups of growers that meet or exceed all U.S. requirements and standards. Another comment noted that the guide does not contain specific language that would require verification that foreign producers were adhering to the same strict standards as U.S. producers.
As previously noted, the guide is not a regulation and neither the U.S. or foreign produce industries are required to adhere to the entire guide or to specific portions of it. Although FDA does not envision "agreements" with foreign governments aimed specifically at certifying or verifying another country's adherence to the principles contained in the guide, FDA does have authority to enter into such arrangements with foreign government agencies on matters related to food safety, and could do so, as warranted. Although FDA recognizes that "regionalization" is a concept whereby a defined area (either within a country or crossing national borders) may be considered low risk or risk free for animal and plant diseases and pests, the agency has not as yet considered this concept as it might pertain to foodborne pathogens.
With regard to the guide, the agency again stresses the fact that neither U.S. nor foreign producers are obligated to comply with provisions of the guide. Therefore, an agency list of regions or producers that "comply" with the guide is not appropriate.
One comment encouraged the development of equivalent standards for domestic and imported products.
The agency notes that under current law, domestically produced foods and those imported into the U.S. are required to meet the same food safety standards. These standards are defined by U.S. statutes and regulations as promulgated by U.S. agencies.
One comment noted that the well-intended guide should not result inadvertently in an undermining of U.S. agricultural production of fruits and vegetables and a concomitant transfer of production to foreign countries where production controls may be less stringent than in the U.S. The comment urged FDA to encourage retention of fruit and vegetable production in the U.S.
The guide is intended to assist production systems in the U.S. and in other countries in improving the safety of fresh produce and is not intended to adversely affect any fruit or vegetable producer in the U.S. or any other country.
One comment stated that exporters of produce and food products from the Caribbean to the U.S. and Europe should not be required to implement dual systems. Exporters of Caribbean produce to Europe need to conform to Codex Alimentarius HACCP regulations, and eventually to develop and implement overall quality management systems.
The guide is neither a U.S. regulation nor is there a requirement that producers outside of the U.S. comply with the guidance. If the guidance is implemented where feasible and practicable, it will help to minimize microbial food safety hazards for fruits and vegetables that are ready-to-eat or that are minimally processed.
The agency actively participates in the Codex Alimentarius to better ensure global food safety and harmonization of standards to facilitate trade. FDA intends to regularly examine the guide to determine whether changes are appropriate to conform with evolving Codex documents. Regardless of whether modifications are made, the guide is consistent with U.S. trade rights and obligations.
The Caribbean countries would appreciate information and technical and financial assistance that may be forthcoming to assist in implementing provisions contained in the guide.
In a status report on the Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables to the President (Ref. 1), the Secretaries of Health and Human Services (Department of Health and Human Services) and Agriculture (USDA) stated that "technical expertise and resources must complement the voluntary guidance to achieve improvement in the safety of fresh fruits and vegetables. The guidance will be most effective when safety is bolstered at every step in the process, from in-field operations through distribution to the consumer. U.S. government agencies, FDA and USDA in particular, will work with appropriate U.S. and foreign government public health and agricultural agencies, as well as with industry groups, to provide technical assistance needed to support appropriate application of the guidance by the produce industry."
FDA and USDA are examining options for providing technical assistance.
1. Shalala, D.E. and D. Glickman, Letter to President William Clinton, February 24, 1998.