and
U.S. DEPARTMENT OF AGRICULTURE
Washington, D.C.
February 24, 1998
The Honorable William Jefferson Clinton
The White House
Washington, DC 20500
Dear Mr. President:
Attached is our report, as requested in your October 2, 1997 Directive, on progress made on the Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables. The report is a synopsis of the progress we have made in providing Good Agricultural Practices and Good Manufacturing Practices guidance to domestic and international growers, harvesters, handlers, and transporters of fresh fruits and vegetables.
The report also discusses our plans for extending existing programs in order to improve the monitoring of agricultural and manufacturing practices domestically and abroad, to assist domestic and foreign producers to improve those practices, where necessary, to prevent the distribution and importation of unsafe produce, and to accelerate research to support these activities.
| Sincerely, | |
|
Donna E. Shalala Secretary of Health and Human Services |
Dan Glickman Secretary of Agriculture |
Background
American consumers enjoy one of the safest food supplies in the world. However, over the last several years there has been an increase in reported outbreaks of foodborne illness associated with both domestic and imported fresh fruits and vegetables. In May 1997, as part of the President's Food Safety Initiative, the Department of Health and Human Services (DHHS), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) sent to the President a report that identified produce as an area of concern. On October 2, 1997, President Clinton announced a new initiative to ensure that our fruits and vegetables, including those imported from other countries, meet the highest health and safety standards.
The President called on Congress to give the Food and Drug Administration (FDA) the authority to better assure that food imports meet existing United States food safety laws and regulations. Legislation has been introduced in the House of Representatives that would enhance FDA's ability to ensure the safety of all foods imported into the U.S. The legislation would enhance FDA's ability to protect U.S. consumers while being consistent with U.S. trade rights and obligations.
In addition, the President directed the Secretary of Health and Human Services and the Secretary of Agriculture to work together in close cooperation with the agricultural community to develop the first-ever safety guidance for the growing, processing, shipping, and selling of fruits and vegetables. This voluntary guidance will address potential food safety problems throughout the production and distribution system and help ensure the sanitation and safety practices of all those seeking to sell produce in the U.S. market. This second component of the President's Directive -- voluntary guidance -- is an important outreach and education effort, reflecting the Administration's commitment to direct resources toward improving food safety and the availability of food safety technologies.
The President's FY 1999 budget includes funds necessary to expand FDA's international capabilities; full implementation in FY 1999 will be contingent on receiving adequate appropriations.
This Report
The President asked the two Secretaries to report back to him with a plan and schedule for developing this guidance. This report presents the progress made to develop voluntary guidance for the growing, processing, shipping, and selling of fruits and vegetables and the schedule and plans to accomplish these and the other elements of the President's produce initiative. To meet the President's goal that our produce meet the highest health and safety standards, the Departments will develop voluntary Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) guidance for produce (henceforth referred to as guidance). GAPs cover production practices including growing, harvesting, handling, and transportation. GMPs primarily address harvesting and transportation, but also include aspects of manufacturing such as processing and packaging. GAPs and GMPs by necessity, overlap and are interrelated.
This report also describes interdependent activities that will help industry successfully apply the voluntary guidance. For example, the domestic and foreign industry may require technical assistance from U.S. agencies to effectively apply the voluntary guidance. Education and outreach efforts will be provided to the domestic and foreign industry and these activities will be based on a strong underlying, accelerated research program. In the long-term, research and risk assessment on fresh produce will be incorporated in the multi-year Food Safety Initiative research planning process. Development of this interagency research planning process is being facilitated by the White House Office of Science and Technology Policy.
The U.S. produce industry, states, and many countries exporting fresh fruits and vegetables to the U.S. have already taken significant steps to develop and implement improved agricultural practices and guidelines. Activities in this initiative, particularly in developing the voluntary GAP/GMP guidance, recognize this effort and build on it.
Status: FDA, working with the USDA, is preparing a general GAP/GMP guidance document. FDA plans to publish the document as proposed voluntary guidance with opportunity for public comments. This guidance, titled "Guide to Minimizing Microbial Food Safety Hazards for Fresh Fruits and Vegetables", describes science-based good agricultural practices that farmers and producers may use for water quality, manure management, sanitation (both field and facility sanitation, as well as worker hygiene), and handling and transportation. The guidance also describes use of producer identification and information on the flow of the product through distribution channels. This information can facilitate source identification, should a commodity be associated with a foodborne illness outbreak. This guidance can be used by both domestic and foreign fresh fruit and vegetable producers to help ensure the safety of their produce. The guidance, which is a science-based evaluation of risks, will be consistent with World Trade Organization obligations and will not impose unnecessary or unequal restrictions or barriers on either domestic or foreign producers. The agencies recognize that appropriate use of pesticides and related antimicrobial agents play an important role in controlling microbial contamination, but caution that excessive or inappropriate use of these substances does not take the place of GAPs/GMPs.
FDA and USDA sponsored, with states, a series of public meetings from mid-November to mid-December, 1997, in which the agricultural community, the international trade community, consumers, and the scientific community participated. The purpose of these meetings was to give participants the opportunity to offer their perspective on the working draft guidance and provide comments, technical information, and suggested modifications to the draft guidance. The National Advisory Committee on Microbiological Criteria for Foods' Fresh Produce Subcommittee (a USDA/FDA advisory committee) was present at the first public meeting. Based on information exchanged at that first public meeting and Subcommittee members' expertise, the Subcommittee provided recommendations that were incorporated into the working draft guidance document. This revised working draft document was subsequently used as the basis of discussion at a series of meetings for the agricultural community. These "grassroots" meetings were held at six regional locations around the country during December. The agencies also presented the draft guidance to representatives of embassies and individuals associated with importing produce into the U.S. at an international meeting in December. Feedback from the agricultural community through the "grassroots" meetings and other fora is essential to be sure that the guidance being developed is practical and applicable. Development of the final guidance will draw on scientific data and other information that describes the fresh fruit and vegetable industry domestically and in countries exporting products to the U.S.
FDA, with USDA, will oversee a task force (with representation from other federal agencies and states) to assist in developing additional guidance if sound science, risk, or experience with general guidance indicate a need. The additional guidance may be tailored to reduce the potential for microbial contamination with specific pathogens (e.g., E. coli O157:H7, Cyclospora) and to reduce contamination associated with particular hazards (e.g., microbially-derived toxins) and commodities. This type of guidance can also be designed to minimize microbial contamination through particular pathways, such as control of water quality, worker sanitation and health, field and facility sanitation, and transportation and handling of produce. Options are being explored to determine the most efficient ways to provide industry with effective guidance that yields the most benefit for the resources expended. Any additional guidance will be developed through an open process involving industry, consumers, academia, states, and public health professionals, including the FDA public review and comment process.
The general guidance may be augmented as information about scientific advances and risks associated with fresh produce received from a variety of sources, (e.g., foodborne illness outbreaks and research) indicates the need for targeted guidance or refinement of the general guidance.
Timeline:
Supporting Information: To complement data and information being developed domestically, comparable data and country information, such as epidemiologic data on human health and food safety legislation and regulations affecting production, handling, and storage of produce for selected countries that export produce to the U.S. will be compiled by mid-July, 1998.
Timeline:
Technical Assistance:
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. If a foreign government is interested in learning more about the U.S. guidelines and systems for assuring the safety of domestically produced and imported fresh fruits and vegetables, overseas personnel from USDA and State Department will collaborate as necessary to facilitate these visits. Likewise, in order to provide technical assistance or followup to foodborne illness outbreaks, these overseas personnel will facilitate visits of FDA and/or Centers for Disease Control and Prevention (CDC) investigators or scientists to foreign operations to ascertain the source of problems that may pose a safety hazard in produce exported to the U.S.
USDA and FDA plan to work with a broad spectrum of representatives from the public and private sector in foreign countries and in the U.S. to promote appropriate application of the guidance and improve production and processing practices. These include officials from the health and agriculture agencies in foreign countries, the Food and Agriculture Organization, the World Health Organization, and subsidiary organizations (e.g., Pan American Health Organization), as well as exporter associations and multinational banks. In the U.S., the agencies will work with appropriate land grant colleges and universities, state agencies, and industry associations. In working with domestic and foreign groups, it is critical that in addition to technical assistance, we provide clear guidance on the legal requirements for offering fresh food for sale in the U.S. With this understanding, the foreign and domestic government, industry, and academic groups can guide producers' decisions about what, if any, modifications of current practices are appropriate for industry to satisfy U.S. legal requirements for foods. As part of this effort, USDA and FDA will share new technologies as they are developed to enhance the safety of fresh fruits and vegetables, such as improved manure treatment methods, more sensitive analytical methods, and post-harvest treatments to reduce levels of or eliminate pathogens on produce.
Timeline:
Education and Outreach: Education and outreach programs are essential to foster appropriate application of the guidance by the domestic and international fresh fruit and vegetable industry. These programs are pivotal to industry's understanding of the essential principles of the guidance, as well as the scientific and practical reasons for application of the guidance as everyday production and processing practice. Others in the distribution chain from the fruit and vegetable producers to the final user-- the consumer -- must be reached by these programs in order to assure that the care taken to prevent microbial contamination in growing, harvesting, processing, and transporting is not thwarted by later mishandling.
USDA, through its partnership with State Cooperative Extension Services in the United States, will provide leadership for the Directive's producer outreach and educational strategy. USDA, FDA and CDC will plan a national food safety scientific and education conference in 1998 to share current scientific and educational information on food safety risks that can further enhance the microbiological safety of fresh fruits and vegetables, to apprise scientific experts and extension professionals of the voluntary general guidance document, and to discuss methods for promoting appropriate application of the guidance. The guidance will be incorporated into extension programs focused on the best management practices in fruit and vegetable production. It will also serve as a basis for directing program resources to help assure appropriate application of production practices which minimize contamination of fruits and vegetables. State and local extension agents can play a vital role in the successful application of the guidance, since they are knowledgeable about on-farm production practices and can provide expert advice on how producers can incorporate interventions recommended in the guidance to reduce the risk of microbial contamination at the farm level.
To reach the domestic produce industry workforce, the guidance and associated educational materials must be available in native languages and must use terms understood by this diverse community. Multi-lingual materials are also needed for use in foreign countries. To meet these needs, FDA and USDA will work with industry and foreign governments to provide translations of the guidance documents, as well as associated training and information materials, as the documents are finalized.
We anticipate that education and outreach activities will reach beyond the immediate needs of the growers, harvesters, processors, and distributors of fresh produce to the wholesale and retail segments of the industry and to the consumer. Expanded education efforts will be directed to increasing awareness of how to enhance the safety of fresh fruits and vegetables, as well as about use of safe practices for handling and storing fresh produce.
The information provided at the grassroots and international meetings will help the agencies prioritize outreach activities and preparation of materials. FDA and USDA anticipate drawing on the resources and expertise of other agencies and industry groups to provide outreach and education, particularly targeted to specific regional needs in the U.S. The agencies have met with representatives of state agriculture departments and the industry to begin discussions of how best to make available needed training and information. We anticipate that industry itself will be a primary vehicle for outreach and education activities.
In the international arena, USDA will be instrumental in facilitating the development of education and training programs. The USDA's International Cooperation and Development staff can facilitate development of cooperative training programs on the guidance, in collaboration with other agencies capable of providing funding for these activities. The State Department will facilitate FDA and USDA contacts with foreign governments and industry groups to inform them of the guidance and provide technical assistance. USDA will also explore mechanisms to obtain the resources and expertise from other international organizations, such as the Food and Agriculture Organization and the Inter-American Institute for Cooperation on Agriculture, in order to facilitate discussions on produce safety issues. FDA and USDA will evaluate the scope of GAP/GMP education programs and materials needed to educate foreign governments and organizations, factoring in information provided at the international meeting.
Timeline:
Inspection and Testing: Inspections of fresh fruit and vegetable operations in combination with sampling and testing provides FDA and USDA with scientific information about the microbial quality of both domestic and imported products. Identification of microbiological problems allows implementation of prevention or intervention measures before illness occurs. It also aids in targeting educational outreach and technical assistance.
FDA will expand its fresh fruit and vegetable inspection and testing program for domestic and imported produce. Additional resources will be focused particularly on sampling products from areas, in the U.S. and abroad, where there is evidence that a potential hazard exists and preventive measures are lacking.
Verification: Verifying the application of the guidance, particularly in segments of the industry where microbial foodborne illnesses have occurred, is integral to determining its effectiveness in reducing the risk associated with fresh fruits and vegetables. The USDA and FDA will use evaluation of risks and survey techniques, such as USDA's Fruit Survey and Vegetable Survey and FDA field surveys of processors, to determine the extent of application of the guidance by both the domestic and foreign industry and the effectiveness of the GAP/GMP program in reducing the occurrence of pathogenic microorganisms and the incidence of produce-associated illnesses. The first survey will be conducted to determine current practices, specifically those practices that have the most impact on public health and those that are covered in the general guidance. This baseline information will be augmented with information from other sources, such as foreign governments and state agencies, on current practices. A second, more extensive, survey on practices will be conducted at a later date. This information -- from the surveys and other sources -- will be used to evaluate application of the guidance and to make necessary adjustments in the GAP/GMP program, including refinements of the guidance.
Timeline:
Successful implementation of this initiative relies on scientific research and characterization of the risks to public health posed by microbial contamination. The overall research goal identified in this initiative is development of cost-effective intervention and prevention strategies to reduce the incidence of foodborne illness. Research will also support development of improved detection methods useful in a variety of environments and targeted to sources of contamination. These methods will be used to support long-term surveillance and monitoring of both domestic and imported produce at the point of production and harvest (e.g., methods for detection of Cyclospora and Hepatitis A on produce) and to support development of control and prevention strategies that augment use of general and additional GAP/GMP guidance.
FDA and USDA both have vigorous research programs in areas related to development of pathogen detection and quantification methodology, as well as development of control and prevention interventions. EPA and USDA research would be conducted to assess the significance of pathogen concentrations in natural (free-flowing) and agricultural water supplies and potential subsequent contamination of fruits and vegetables through irrigation practices.
FDA and USDA are individually and collectively reviewing their respective FY 1998 research projects related to fresh fruits and vegetables to identify specific research that can be accelerated. USDA and FDA have held research planning meetings with other agencies conducting food safety related research, including the CDC, EPA, Department of Defense, Department of Energy, National Science Foundation, and National Institutes of Health (NIH). In addition, the agencies have met with industry and consumer representatives to determine what food safety research is currently ongoing or in the developmental stages outside the government and to identify research needs from this outside perspective.
The agencies are developing a coordinated research plan for reducing microbial risk in produce. The research plan is scheduled to be available in early 1998. Four specific areas for research focus have been identified as: improved detection methods, resistance to traditional preservation techniques, antibiotic resistance, and development of intervention strategies. Research is currently underway in all these areas. Among the areas to be further investigated are: packaging, storage, and preservation technologies; production practices; and use of post-harvest treatments to reduce levels of unavoidable microbial contamination. NIH research on pathogenicity and clinical human disease will support both development of detection methods and the risk assessments necessary to evaluate control strategies for the target pathogens.
Research and characterization of risks is a high priority. Research on preventive technologies and intervention strategies to reduce or eliminate microbial contamination is a specific priority. Work will be conducted on manure treatment or composting techniques to assure that the manure is acceptable for application to a specific commodity. Post-harvest chemical (such as use of antimicrobial agents in wash water) and physical treatments will be investigated for fruits and vegetables, as will methods of preventing the persistence and growth of pathogens on both whole and minimally processed produce during storage and transportation. Another area of research that will be accelerated is methods development, specifically methods to detect Cyclospora and Hepatitis A on produce. Studies of chemical pattern recognition (trace-element fingerprints) to identify where specific foods were grown or processed will also aid in tracebacks to determine both the source of foods and the pathogens implicated in foodborne illness outbreaks.
Timeline:
The following agencies are contributing to this initiative: the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention in the Department of Health and Human Services; the Agricultural Marketing Service, the Agricultural Research Service, the Animal and Plant Health Inspection Service, the Cooperative State Research, Education, and Extension Service, the Economic Research Service, the Foreign Agricultural Service, the Food Safety and Inspection Service, the National Agricultural Statistics Service, the Natural Resources Conservation Service, and the Office of Risk Assessment and Cost Benefit Analysis in the U.S. Department of Agriculture; the Environmental Protection Agency; the Department of Labor's Occupational Safety and Health Administration; and the Department of Defense's U.S. Army-Natick Research Development and Engineering Center are also working on segments of the initiative.