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U.S. Department of Health and Human Services

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Produce Safety From Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption

Back to Produce Safety Action Plan Main Page


October 2004

Background | Objectives

 

Background

The Challenge of Foodborne Illness:

Foodborne illness continues to present a public health challenge in the United States (U.S.). The Centers for Disease Control and Prevention (CDC) estimates that, in the U.S. each year, 76 million people become sick, more than 325,000 people are hospitalized, and 5,000 people die from foodborne illness. The estimated economic cost of foodborne illness in terms of pain and suffering, reduced productivity, and medical expenses is substantial, in the range of $10-83 billion each year. Foodborne illness is associated with a range of foods, including fresh produce.

Produce is recognized as an important component of a healthy diet because it is a source of vitamins, minerals, fiber, and antioxidants. Produce can play an important role in weight management as well. Because most produce is grown in a natural environment, it is vulnerable to contamination with pathogens. Factors that may affect the occurrence of such contamination include agricultural water quality, the use of manure as fertilizer, the presence of animals in fields or packing areas, and the health and hygiene of workers handling the produce during production, packing, processing, transportation, distribution, or preparation. The fact that produce is often consumed raw without any type of intervention that would reduce, control, or eliminate pathogens prior to consumption contributes to its potential as a source of foodborne illness.

CDC estimates that, in the 1990's, at least 12 percent of foodborne-outbreak-associated illnesses were linked to fresh produce items. Over the past decade, the federal government has focused significant resources on reducing foodborne illness from all sources. However, despite these efforts, foodborne illness associated with fresh produce continues to be documented. The persistence of foodborne illness associated with fresh produce may be attributable to a number of factors, but many cases are preventable. Given the importance of produce consumption and its central role in a healthy diet, it is imperative that the incidence of foodborne illness cases associated with produce be reduced.

As the federal agency principally responsible for regulating the safety of the majority of the food supply, including produce, the Food and Drug Administration (FDA) is prepared to lead the effort to achieve this reduction. Realistically, however, reducing foodborne illness associated with fresh produce consumption will require a collaborative effort by FDA, its federal food safety partners such as the CDC and the U.S. Department of Agriculture (USDA), FDA's counterparts in foreign governments, state and local agencies, the private sector (including relevant trade associations), academia and consumers.

Goal and Objectives of the Produce Safety Action Plan (Action Plan):

The overarching goal of FDA's Action Plan is to minimize the incidence of foodborne illness associated with the consumption of fresh produce. To achieve this goal, the Action Plan has four general objectives: 1) Prevent Contamination of Fresh Produce with Pathogens; 2) Minimize the Public Health Impact When Contamination of Fresh Produce Occurs; 3) Improve Communication with Producers, Preparers, and Consumers about Fresh Produce; and 4) Facilitate and Support Research Relevant to Fresh Produce. For each objective, FDA's Action Plan identifies steps that could contribute to the achievement of the objective.

FDA believes that the most effective strategy for reducing foodborne illness from fresh produce is one that approaches the problem from several different angles. For this reason, the Action Plan anticipates that FDA's food safety partners in both the public and private sectors will participate in the identified activities. By working both independently and cooperatively, these agencies or groups will ensure maximum progress toward the goal of reducing the incidence of foodborne illness associated with the consumption of fresh produce.

Scope of the Action Plan:

FDA's Action Plan is designed to target microbial food safety hazards (such as bacteria, viruses, and parasites) in or on produce consumed in the U.S., whether produced in the U.S. or abroad. FDA believes that each entity involved in producing, packing, processing, transporting, distributing, or preparing fresh produce has a responsibility to conduct its activities so as to reduce, control, or eliminate microbial contamination of produce. Thus, the Action Plan extends to all parts of the food chain from farm through retail or consumer preparation and consumption and is intended to cover fresh fruits and vegetables, both in their unpeeled, natural form and raw products that have received some minimal processing (such as peeling, chopping, or trimming). The Action Plan is not intended to cover frozen fruits and vegetables, fruit and vegetable juices, or other commodities such as tree nuts that are neither fruits nor vegetables and not typically regarded as produce.

Measuring the Success of the Action Plan:

FDA recognizes that developing this Action Plan is only one of many steps required to achieve the overall goal of reducing foodborne illness associated with the consumption of fresh produce. Implementation is, of course, critical to the success of any action plan. Likewise, it is essential to evaluate the effects of implementation. Thus, FDA intends to measure the effects of the Action Plan. An overall measure of the success of the Action Plan would be a decrease in the number of foodborne illness outbreaks, and the number of illnesses per outbreak associated with fresh produce. FDA will work closely with CDC to monitor the incidence of foodborne illnesses associated with fresh produce consumption. The agency acknowledges, however, that this is not a completely reliable indicator because of many factors. The success of each individual objective in the plan can be measured by the following:

  • Objective 1 can be measured by the issuance of guidance, regulations and tools to assist implementation and an assessment of the adoption of guidance or adherence to regulations by relevant producers, and by the incidence of contaminated produce identified during sampling surveys.
  • Objective 2 can be measured by the speed and accuracy of epidemiological, traceback, and environmental investigations, and the information gained from such investigations.
  • Objectives 3 and 4 can be measured by whether the action items have been successfully accomplished.

 

 

Objectives of the Action Plan

Objective 1: Prevent Contamination of Fresh Produce with Pathogens

This objective can be achieved by steps such as the following:

Guidance and Regulations

  • Periodically review FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" and revise to reflect advances in science or technology and findings from foodborne illness outbreaks and other investigations
  • Develop, and assist in the development of, additional guidance, e.g., commodity-specific and practice-specific guidance relevant to producing, packing, processing, transporting, distributing, or preparing fresh produce (such as guidance for safe processing of fresh-cut produce)
  • Develop guidance to promote improved hygiene and better preparation practices in the retail environment
  • Develop commodity-specific handling advice for preparers of fresh produce, such as retailers, restaurants, food service operations, and consumers, and share the advice with state and local food safety agencies for further dissemination
  • Initiate rulemaking to minimize foodborne illness associated with the consumption of sprouted seeds
  • Add language to the FDA Food Code, as needed, to address produce safety at retail
  • Assess the extent of the adoption of guidance and adherence to regulations by relevant sectors in the fresh produce supply chain

Education Outreach

  • Promote the application of Good Agricultural Practices and Good Manufacturing Practices (GAPs and GMPs) to fresh produce production, using FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" or comparable guidance emphasizing producers that have not been previously reached
  • Promote the application of other guidance for fresh produce production (such as FDA's two guidance documents about growing sprouts, "Reducing Microbial Food Safety Hazards For Sprouted Seeds and Sampling" and "Microbial Testing Of Spent Irrigation Water During Sprout Production")
  • Raise and maintain consumer awareness about how to handle fresh produce safely by periodic distribution of information through community outreach programs, in the media (print and non-print), and by other means
  • Share educational outreach and consumer advisory materials with federal, state, and local agencies, foreign governments, and the private sector for broad dissemination
  • Use the internet, such as the federal government's food safety website (www.foodsafety.gov), to promote ready access to educational materials for fresh produce producers, distributors, retailers, food workers, and consumers

Facilitating Implementation

  • Develop, support, and promote tools (e.g., fact sheets, model forms, Standard Operating Procedures (SOPs), checklists) to assist in the implementation of guidance and regulations that cover segments in the fresh produce supply chain
  • Identify and promote requirements of other legal authorities that support practices and conditions to prevent the microbial contamination of fresh produce (e.g., Occupational Safety and Health Act and 29 CFR 1928.110, field sanitation laws and regulations that establish the minimum ratio of toilets to workers and proper hand washing facilities, maximum worker to restroom distance and maintenance of facility cleanliness)
  • Identify and seek solutions to requirements of other legal authorities that could inadvertently increase the risk of microbial contamination of fresh produce (e.g., state water conservation requirements)

Objective 2: Minimize the Public Health Impact When Contamination of Fresh Produce Occurs

This objective can be achieved by steps such as the following:

  • Use tools such as facility inspections and surveys, increase routine monitoring of practices and conditions in the fresh produce supply chain, including farms, packing facilities, and distribution centers, to identify practices that could lead to the spread of contamination in produce
  • Expand surveillance of fresh produce, including both focused sampling of fresh produce with a history of association with illness outbreaks and expanded sampling of a broader range of produce items to obtain baseline data on the incidence of contamination
  • Continue to improve and refine appropriate regulatory follow up when insanitary conditions are identified or contamination of fresh produce is found
  • Increase the speed of epidemiological, traceback, and environmental investigations and the quality of the information obtained through such investigations
  • Review and revise, as appropriate, the criteria for initiating traceback and farm investigations and the composition of investigative teams
  • Prepare training or guidance as needed for epidemiological, traceback, and environmental investigations by federal, state, and local investigators to promote consistency of investigations and identification of potential sources of contamination and to promote preventive measures to ensure produce safety
  • Support the collection and analysis of outbreak surveillance data by CDC to help assess the impact of the Action Plan
  • Develop systems for exchange and prompt use of data between all federal, state, and local food safety agencies that conduct epidemiological investigations of foodborne illness outbreaks and to ensure the prompt utilization of the results of such investigations
  • Enhance PulseNet capacity to expedite identification and comparison of foodborne pathogens likely to be transmitted by produce
  • Collaborate with international organizations, such as the World Health Organization and the Pan American Health Organization, to develop and sustain PulseNet capacity in other countries that export fresh produce to the U.S.

Objective 3: Improve Communication with Producers, Packers, Processors, Transporters, Distributors, Preparers, Consumers, and Other Government Entities about Fresh Produce

This objective can be achieved by steps such as the following:

  • Promote improved lines of communication between federal, state, and local food safety agencies, foreign governments, the public and the private sector on an ongoing basis and in response to a specific event, such as a foodborne illness outbreak or other crisis associated with fresh produce
  • Promote transparency in the development of guidance, regulations, and other protocols designed to address fresh produce safety
  • Encourage the two-way exchange of information between FDA and all stakeholders throughout the supply chain on surveys, research, investigational findings, and industry practices throughout the supply chain
  • Collaborate with appropriate stakeholders to gain information on industry practices associated with implicated product in order to focus traceback, facilitate investigations, and maintain consumer confidence in the food supply
  • Establish a protocol, with stakeholder input, to ensure that consumers are informed as quickly as possible about a foodborne illness outbreak involving an FDA-regulated product and share the protocol with stakeholders
  • Establish mechanisms to ensure prompt communication between federal, state, and local food safety agencies, foreign governments, and the private sector when there is a concern about a particular region, practice, or produce commodity group

Objective 4: Facilitate and Support Research Relevant to the Contamination of Fresh Produce

This objective can be achieved by steps such as the following:

  • Identify research likely to make the most significant contributions to reducing the public health risk from contaminated fresh produce, with a focus on approaches that provide practical information
  • Develop risk-based approaches directed at preventing contamination of fresh produce or identify effective interventions to address contamination that has occurred
  • Assess relative risk for specific areas of concern for fresh produce (such as agricultural and processing water quality, environmental contamination during production, unsafe handling practices, insanitary equipment, employee health and hygiene, and the practices that hinder traceback) and clarify mechanisms of contamination under commercial conditions in produce supply chain settings
  • Develop additional sampling protocols, as needed, to facilitate efficient and reliable detection of pathogens in or on fresh produce and in the fresh produce production environment
  • Develop revised or new analytical methods for improving the timely detection of pathogens in or on fresh produce and in the fresh produce production environment, with a focus on the commodity/pathogen combinations of greatest public health concern
  • Leverage research resources aimed at developing sampling and pathogen detection methods for fresh produce through cooperative efforts between federal agencies, state and local offices, academic institutions, and the private sector
  • Assess the efficacy of guidance, educational outreach, and training materials and validate the efficacy of industry practices and interventions
  • Identify barriers to implementing best practices in the production, processing, and preparation of fresh produce to assist in the development of effective intervention strategies
  • Promote the technology transfer of research findings