The latest version of this document issued in October 2004. Below is an earlier version.

---

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

Background | Objectives | Public Meeting

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 rate 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, or preparation. The fact that produce is often consumed raw without any type of intervention to 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 illness 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,¹ but many cases are preventable. Given the importance of produce consumption and its central role in a healthy diet, it is imperative that the number 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 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), and consumers.

Goal and Objectives of the Proposed Action Plan:

The overarching goal of FDA’s proposed Action Plan is to minimize foodborne illness associated with the consumption of fresh produce. To achieve this goal, the proposed Action Plan has four general objectives: Prevent Contamination of Fresh Produce; Minimize the Public Health Impact When Contamination of Fresh Produce Occurs; Improve Communication with Producers, Preparers, and Consumers about Fresh Produce, and Facilitate and Support Research Relevant to Fresh Produce. For each objective, FDA’s proposed 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 likely to be one that approaches the problem from several different angles. For this reason, the proposed Action Plan contemplates 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 foodborne illness associated with the consumption of fresh produce.

Scope of the Proposed Action Plan:

FDA’s proposed 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, 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 proposed 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 proposed 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. FDA welcomes suggestions as to how to determine, after the Action Plan is implemented, whether the Plan has had a concrete, positive effect on the public health risks presented by the consumption of fresh produce.

 

Objectives of the Proposed Action Plan

Objective 1: Prevent Contamination of Fresh Produce With Pathogens

FDA believes that this objective could be achieved by steps such as the following:

• Promoting 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
• Promoting the application of other guidance relevant to fresh produce production (such as FDA’s two guidance documents relating to growing sprouts, Reducing Microbial Food Safety Hazards For Sprouted Seeds and Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production)
• Developing additional guidance, either commodity-specific or general guidance, applicable to the production of fresh produce, such as guidance for preparation of fresh-cut (minimally processed) produce
• Developing guidance to promote improved hygiene and better preparation practices in the retail environment
  

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

FDA believes that this objective could be achieved by steps such as the following:

• Expanding surveillance of fresh produce, improving pathogen detection methods, increasing the speed and accuracy of trace-backs, and, where necessary, ensuring prompt regulatory follow-up
• Increasing focused surveillance and sampling of produce with a history of an association with illness outbreaks
• Increasing routine monitoring of all parts of the fresh produce production chain, including farms, packing facilities, and distribution centers
• Preparing training or guidance for on-farm investigations by federal, state, and local investigators
• Developing closer ties between all federal, state, and local food safety agencies that conduct epidemiological investigations of foodborne illness outbreaks and thereby ensure the prompt utilization of the results of such investigations
• Enhancing PulseNet capacity to expedite identification and comparison of foodborne pathogens likely to be transmitted by produce
• Collaborating with international organizations, such as the World Health Organization and the Pan American Health Organization, to develop and sustain PulseNet capacity in countries that export fresh produce to the U.S.

Objective 3: Improve Communication with Producers, Preparers, and Consumers about Fresh Produce

FDA believes that this objective could be achieved by steps such as the following:

• Establishing a protocol to ensure that consumers are informed as quickly as possible about a foodborne illness outbreak involving an FDA-regulated product
• Establishing a mechanism 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 commodity group
• Raising and maintaining consumer awareness about how to handle fresh produce safely through periodic distribution of information through the media (print and non-print)
• Developing commodity-specific handling advice and sharing the advice with state and local food safety agencies for communication to preparers of fresh produce such as retailers, restaurants, and food service operations
• Utilizing 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

Objective 4: Facilitate and Support Research Relevant to Fresh Produce

FDA believes that this objective could be achieved by steps such as the following:

• Identifying research likely to make the most significant contribution to reducing the public health risk from contaminated fresh produce, with a focus on approaches that provide practical information
• Clarifying specific areas of concern for fresh produce (such as agricultural water quality, human and animal vectors, and use of manure in production) and mechanisms of contamination under commercial conditions
• Elucidating approaches directed at preventing contamination of fresh produce or addressing and rectifying contamination that has occurred
• Developing 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
• Developing 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
• Leveraging 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
  

¹ These factors include increased consumption of fresh produce, globalization of the sources of produce, demographic changes (including a larger immuno-compromised population), and the availability of new, minimally processed products that may require different handling techniques to ensure safety.

---

Public Meeting on the 2004 Produce Safety Action Plan; June 29, 2004 Federal Register Notice June 15, 2004

The latest version of this document issued in October 2004.