Guidance for Industry: Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

I. Introduction

The Federal Government provides advice on healthful eating, including consuming a diet rich in a variety of fruits and vegetables, through the Dietary Guidelines for Americans and the related MyPyramid food guidance system (Ref. 1, 2). In response, per capita consumption data show that Americans are eating more fresh produce (Ref. 3). With $12 billion in annual sales in the past few years (Ref. 4), the fresh-cut sector of the produce industry is its fastest growing segment. As the fresh-cut produce market continues to grow, the processors of such produce are faced with the challenge of processing an increasing variety and volume of products in a manner that ensures the safety of this produce. From 1996 to 2006, seventy-two foodborne illness outbreaks were associated with the consumption of fresh produce. Of these produce related outbreaks, 25 percent (18 outbreaks) implicated fresh-cut produce (Ref. 5). Many factors may play a role in the incidence and reporting of foodborne illness outbreaks that implicate fresh produce, such as an aging population that is susceptible to foodborne illness, an increase in global trade, a more complex supply chain, improved surveillance and detection of foodborne illness, improvements in epidemiological investigation, and increasingly better methods to identify pathogens (Refs. 6 thru 12).

Processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination by breaking the natural exterior barrier of the produce (Ref. 6).The release of plant cellular fluids when produce is chopped or shredded provides a nutritive medium in which pathogens, if present, can survive or grow (Ref. 6). Thus, if pathogens are present when the surface integrity of the fruit or vegetable is broken, pathogen growth can occur and contamination may spread. The processing of fresh produce without proper sanitation procedures in the processing environment increases the potential for contamination by pathogens (see Appendix B, “Foodborne Pathogens Associated with Fresh Fruits and Vegetables.”). In addition, the degree of handling and product mixing common to many fresh-cut processing operations can provide opportunities for contamination and for spreading contamination through a large volume of product. The potential for pathogens to survive or grow is increased by the high moisture and nutrient content of fresh-cut fruits and vegetables, the absence of a lethal process (e.g., heat) during production to eliminate pathogens, and the potential for temperature abuse during processing, storage, transport, and retail display (Ref. 6). Importantly, however, fresh-cut produce processing has the capability to reduce the risk of contamination by placing the preparation of fresh-cut produce in a controlled, sanitary facility.

This guidance is intended for all fresh-cut produce processing firms, both domestic firms and firms importing or offering fresh-cut product for import into the U.S., to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. This guidance does not set binding requirements or identify all possible preventive measures to minimize microbial food safety hazards. We recommend that each fresh-cut produce processor assess the recommendations in this guidance and then tailor its food safety practices to the processor’s particular operation. Alternative approaches that minimize microbial food safety hazards may be used so long as they are consistent with applicable laws and regulations.

This guidance primarily addresses microbiological hazards and appropriate control measures for such hazards. However, some chapters in the guidance discuss physical and chemical hazards.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Table of Contents

  1. Introduction
  2. Scope and Use
  3. Definitions
  4. Primary Production and Harvesting of Fresh Fruits and Vegetables
  5. Personnel
  6. Building and Equipment
  7. Sanitation Operations
  8. Production and Process Controls
  9. Documentation and Records
  10. Traceback and Recall
  11. Additional Information
  12. References
  13. Paperwork Reduction Act of 1995


  1. Notifying FDA of a Recall
  2. Foodborne Pathogens Associated with Fresh Fruits and Vegetables
  3. Pathogens Often Transmitted by Food That Has Been Contaminated by Infected Employees
  4. Sources of Microbial Contamination
  5. An Example of Product/personnel Flow Patterns in a Fresh-cut Processing Plant (Figure 7)