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February 2008
Additional copies are available from:
Office of Food Safety
Division of Plant and Dairy Food Safety (HFS-317)
5100 Paint Branch
Parkway
College Park, MD 20740
(Tel) 301-436-1700
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 2008
OMB Control No. 0910-0609
Expiration Date: 10/31/2010
See additional PRA statement in section XIII of this
guidance.
Table of Contents
Appendices
Contains Nonbinding Recommendations
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.
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.
Fresh-cut Produce: This guidance covers fresh-cut fruits and vegetables that have been minimally processed (e.g., no lethal kill step), and altered in form, by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melon, sliced pineapple, and sectioned grapefruit.(2) Fresh-cut produce does not require additional preparation, processing, or cooking before consumption, with the possible exception of washing(3) or the addition of salad dressing, seasoning, or other accompaniments. As the fresh-cut produce market continues to evolve, the scope of this guidance may need to be modified to address new or novel types of products.
Fresh-cut Produce and Current Good Manufacturing Practice requirements for foods (CGMPs) (21 CFR Part 110) (4): FDA's regulations in 21 CFR Part 110 establish CGMPs in manufacturing, packing, or holding human food. However, raw agricultural commodities (RACs), as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (the Act), are not subject to the CGMP requirements by virtue of the exclusion in 21 CFR 110.19. Section 201(r) defines a raw agricultural commodity as any food "in its raw or natural state…." Fresh-cut fruits and vegetables are not RACs because they are no longer "in [their] raw or natural state" and instead have become "processed food" as that term is defined in the Act. Section 201(gg) of the Act defines a "processed food" as "any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydrating, or milling." Under 21 CFR 110.3, the definitions in section 201 of the Act apply to Part 110. Thus, fresh-cut fruits and vegetables are appropriately considered "processed foods" and are subject to the CGMPs in Part 110. The conclusion that fresh-cut produce are not RACs is consistent with the preamble to the proposed revisions to the CGMP regulation (44 FR 33238 at 33239, June 8, 1979), which states, when discussing the exclusion for RACs, that such products may be excluded because "food from those commodities is… brought into compliance with the Act at the later stages of manufacturing, processing, packing, or holding." The CGMPs establish food safety practices applicable to processors who manufacture, process, pack, or hold processed food. FDA believes that the recommendations in this guidance complement the CGMPs by suggesting more specific food safety practices for processors of fresh-cut produce.
Fresh-cut Produce and HACCP Systems: A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food safety system designed to prevent, reduce to acceptable levels, or eliminate the microbial, chemical, and physical hazards associated with food production (Ref. 6). One strength of HACCP is its proactive approach to prevent food contamination rather than trying to identify and control contamination after it has occurred.
Although HACCP is not currently required for the processing of fresh-cut produce, the United Fresh Produce Association recommends use of HACCP principles, and according to the association, many segments of the fresh-cut produce industry have adopted HACCP principles.(5)
FDA encourages fresh-cut produce processors to take a proactive role in minimizing microbial food safety hazards potentially associated with fresh-cut produce. We recommend that fresh-cut processors consider a preventive control program to build safety into the processing operations for fresh-cut fruits and vegetables. Awareness of the common risk factors discussed in this guidance and implementation of preventive controls determined by a firm to be appropriate to its individual operations will enhance the safety of fresh-cut fruits and vegetables. FDA also recommends that processors encourage the adoption of safe practices (See Chapter IV) by their partners throughout the supply chain, including produce growers, packers, distributors, transporters, importers, exporters, retailers, food service operators, and consumers, to ensure that the processor's efforts will be enhanced.
This guidance begins with a discussion of primary production and harvesting of fresh produce in Chapter IV and continues with recommendations for fresh-cut processing in four areas-- (1) personnel health and hygiene, (2) training, (3) building and equipment, and (4) sanitation operations. Following this discussion, the guidance covers fresh-cut produce production and processing controls from product specification to storage and transport. The final chapters provide recommendations on recordkeeping and on recalls and tracebacks.
The following definitions apply to this guidance.
Adequate quality water: The determination of adequate quality water is based on its use, where adequate quality water for one purpose is not necessarily adequate for another purpose. (1) Where the water does not become a component of the fresh-cut produce, adequate quality refers to water that is safe and sanitary, at suitable temperatures, and under pressure as needed for all uses; and (2) where the water is used in a manner such that it may become a component of the fresh-cut produce (e.g., when such water contacts components, fresh-cut produce, or any contact surface), adequate quality water refers to water that complies with applicable Federal, State, and local requirements.
Fresh fruits and vegetables: fresh produce that is likely to be sold to consumers in an unprocessed (i.e., raw) form. Fresh produce may be intact, such as whole strawberries, carrots, radishes, or tomatoes, or cut from roots or stems during harvesting, such as celery, broccoli, lettuce, or cauliflower.
Fresh-cut fruits and vegetables or fresh-cut produce: fresh fruits and vegetables for human consumption that have been minimally processed and altered in form by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing, prior to being packaged for use by the consumer or a retail establishment (e.g., pre-cut, packaged, ready-to-eat salad mixes). Fresh-cut produce does not require additional preparation, processing, or cooking before consumption, with the possible exception of washing or the addition of salad dressing, seasoning or other accompaniments.
Food hazard: a biological, chemical, or physical agent that is reasonably likely to cause human illness or injury in the absence of its control.
Pathogen: a microorganism capable of causing human illness or injury.
Processing water: water that is used for post-harvest handling of produce, such as washing, cooling, waxing, or product transport.
Standard Operating Procedures (SOPs): Procedures established by an operator for the day-to-day activities involved in the production of safe and wholesome food.
Sanitation Standard Operating Procedures (SSOPs): Procedures established by an operator for the day-to-day sanitation activities involved in the production of safe and wholesome food.
In general, anything that comes into contact with fresh produce has the potential to contaminate it. Fresh produce may become contaminated at any point along the farm-to-table continuum. The major source of microbial contamination of fresh produce is indirect or direct contact with animal or human feces. Once fresh produce has been contaminated, removing or killing the microbial pathogens is very difficult. Prevention of microbial contamination at all steps in the farm-to-table continuum is preferable to treatment to eliminate contamination after it has occurred.
On the farm, potential contamination avenues include contact with untreated manure used as a soil amendment, contaminated water, infected workers, or conditions in the field or packing facility such as unclean containers and tools used in harvesting and packing, and the presence of animals. In transport, conditions such as unclean floors and walls of the transport vehicle and unclean containers can contribute to contamination with pathogens. Thus, it is important that fresh-cut produce processors be aware of the conditions under which their fresh produce is grown, harvested, packed, and transported. Furthermore, knowing your suppliers and what they are doing to minimize risk of contamination is prudent.
To reduce potential contamination, the 1998 "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide) (Ref. 15) provides recommendations for growers, packers, and shippers to use good agricultural and good manufacturing practices in those areas over which they have control to prevent or minimize microbial food safety hazards in fresh produce. Potential sources of contamination identified in the GAPs Guide are biosolids and manure, water, field workers, equipment, and containers.
We recommend the following practices to ensure that incoming fresh produce is safe and suitable for processing into fresh-cut product:
This section provides recommendations regarding personnel of an establishment that processes fresh-cut produce. The recommendations address two major areas: worker health and hygiene, and training.
Workers can carry microbial pathogens on their skin, in their hair, on their hands, and in their digestive systems or respiratory tracts. Unless workers understand and follow basic food protection principles, they may unintentionally contaminate fresh produce and fresh-cut produce, food contact surfaces, water supplies, or other workers, and thereby, create the opportunity to transmit foodborne illness. Basic food protection practices related to worker health and hygiene fall into two categories, disease control and cleanliness.
FDA recommends that employees with direct access (such as processing, storage, and transport workers) and indirect access (such as equipment operators, buyers, and pest control operators) to the production areas of fresh-cut fruits and vegetables follow good hygienic practices for maintaining personal health and hygiene in order to protect the product from contamination.
FDA recommends the following practices to prevent food, food contact surfaces, and food packaging materials from becoming contaminated with microbial pathogens from an employee with an infectious illness or wound:
We recommend that firms train employees to report to their supervisor any information about personal health status or activities relating to diseases transmitted through food. Such information would include reporting an active case of illness. FDA recommends that supervisors be trained to recognize the symptoms of active infectious disease; these symptoms are vomiting, nausea, diarrhea, and abdominal cramps. We recommend that employees with these symptoms be excluded from any operations which may be expected to result in contamination of fresh or fresh-cut produce or food contact surfaces, including equipment and utensils, until the medical condition is resolved.
We recommend that firms maintain an adequate supply of bandages that provide protection from any wound. A wound containing pus (such as an open and draining boil or other infected wound) that is located on a part of the body that could contact fresh produce or fresh-cut produce, processing equipment, or tools, presents a risk of contaminating fresh-cut produce. When a worker in the processing area needs a bandage, we recommend that the firm consider using a bandage that is detectable by a metal detector if there is a metal detector in the processing line. Using detectable bandages will allow the facility to detect when a bandage has fallen into the processing line so that corrective action can be taken.We also recommend that a worker with a wound that cannot be covered to prevent contact with fresh produce or fresh-cut produce, processing equipment, or tools not work with any aspect of fresh produce or fresh-cut produce, processing equipment or tools until the wound has healed.
FDA recommends that employees use the following food protection practices to prevent fresh or fresh-cut produce or food contact surfaces including equipment or utensils from becoming contaminated as a result of poor employee hygiene or inappropriate employee conduct:
FDA recommends that employees wash their hands before beginning work and after engaging in any activity that may contaminate their hands. FDA’s recommendations regarding when employees should wash their hands are reflected in the following list
Improperly used gloves may become a vehicle for spreading pathogens. The use of gloves does not lessen the need for, or importance of, hand-washing and other proper hygiene practices. We recommend that if gloves are used in a facility, the firm develop guidelines for their safe use, sanitation, and changing.
FDA recommends that employees wear clean clothes and any additional outer items (e.g., hairnets and beard covers, lab coats, aprons, and appropriate footwear) that will help protect fresh and fresh-cut produce from inadvertent contamination during processing.
FDA recommends that employees in food processing areas not engage in activities that could contaminate food, such as eating, using tobacco, chewing gum, or spitting.
Training every employee about the CGMPs and preventive controls will help to eliminate or minimize contamination of fresh-cut produce. We recommend that education and training programs be designed to help employees understand what is expected of them and why what is expected is important. We also recommend that company expectations for proper employee hygiene and food protection techniques be clearly communicated to new employees before starting employment and reaffirmed during periodic training programs. There are many materials available to firms to support employee training. We recommend that firms consider whether the language of the training and training materials is appropriate for the employees. Useful materials and information may be found at the Fight BAC!® campaign of the Partnership for Food Safety Education, and Gateway to Government Food Safety Information (http://www.FoodSafety.gov/).
Training employees before they begin work with fresh or fresh-cut produce, at regular intervals, and at a minimum annually provides employees with important information about food safety best practices and company policies. We recommend that firms consider teaching, in the same training session, only a small number of employees at or near their workstation, if the environment permits it, for short periods of time, such as 10-15 minutes per session. The sessions could cover only one topic at a time and could be targeted to specific food safety concerns of that workstation. For example, washing station employees could be trained about appropriate antimicrobial chemical usage, and packaging station employees could be trained about proper handling and cleanliness of boxes and totes. We recommend refresher or follow-up training to reinforce the initial training. Training a few employees at a time can be an effective way to provide refresher training with the least disruption to work.
A firm may wish to post signs and pictorial representations of good practices covered in training as an additional way to reinforce training. We recommend that signs be multilingual and posted in areas close to where the practice is performed. We also recommend that the training provided to employees be documented so there is a record of the training topics covered and which employees completed it.
A well-designed training program provides information to help employees apply CGMPs while on the job. We recommend that a fresh-cut produce firm's training program for employees (including temporary, seasonal, and full time employees) include training on the CGMPs for production, maintenance, quality assurance, and quality control with an emphasis on worker health and hygiene; employee roles and responsibilities; and sanitation principles and sanitary practices.
We recommend that employees be trained to follow good personal hygiene practices, including the use of proper hand washing techniques, wearing clean clothes and any additional outer coverings (e.g., hairnets and beard covers, disposable gloves, aprons), and appropriate conduct on the job. FDA also recommends that employees be trained on how, when, and to whom to report illness. Hand washing training is particularly important. We recommend that employees be trained about how, when, and why they must properly wash their hands and exposed portions of their arms. We also recommend that employees be taught to wash and sanitize their hands before entering areas where fresh or fresh-cut produce is present.
Figure 1 is an example of an aid that could be used to train employees on the proper technique to use in washing hands:
Figure 1. Example of a training aid on how to wash your hands
Use soap and warm running water
↓
Wet hands
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Apply soap
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Vigorously rub hands up to elbows for 20 seconds
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Rinse Hands
↓
Turn off running water with a paper towel, not bare hands
↓
Dry hands with a paper towel or air dry. Do not share towels
Soap combined with scrubbing helps dislodge and remove dirt and germs.
We recommend that employees be trained consistent with the level of complexity of their jobs and that additional training be provided as needed to ensure current knowledge of equipment and process technology.
One goal of a training program is to help workers understand the importance of the tasks for which they are responsible, particularly those tasks that are important to minimizing microbial food safety hazards (such as monitoring the disinfectant level in wash water). We recommend that employees be trained about how to perform these tasks; to be aware of the microbial food safety hazards associated with them; to understand the procedures for monitoring conditions such as the disinfectant level, pH, and the temperature of the wash water, and any associated recordkeeping that the firm chooses to implement; to know the actions that are needed to minimize contamination of the product; and to consult with their supervisors if the established limits (such as the appropriate level of disinfectant in the wash water) are not met.
We recommend that personnel responsible for maintaining equipment that may have an impact on food safety be trained to understand the importance of their role in the production of safe food. Equipment maintenance jobs that may have an impact on food safety include changing water filters, maintaining refrigeration units, treating processing water, and calibrating equipment. We recommend that employees be trained to identify deficiencies that could affect product safety, to take the appropriate corrective actions (e.g., in-house repairs, contract repairs), and to be able to understand how indirect cross-contamination may occur when proper equipment controls are not maintained.
We recommend that employees with cleaning and sanitation duties be trained to understand the principles and methods required for effective cleaning and sanitation, especially as those methods relate to food safety. We recommend that supervisors be trained to identify and promote good sanitary practices.
We also recommend that employees be trained in the proper use of sanitizing agents (sanitizers) and foot foam, foot baths, or spray systems, in proper cleaning and sanitizing steps of the equipment and facility, in proper use of equipment in the production environment, such as hoses and tools, and in the proper use, handling, and storage of chemicals used in sanitation.
Figure 2 is an example of an aid that could be used to train employees on the proper use of sanitizers:
Figure 2. Example of a training aid on proper use of sanitizers
Equipment (whether fixed or free standing), fixtures, floors, walls, and other structures in a processing facility can become a source of microbial contamination if not adequately maintained in sanitary condition. The high humidity and structural niches in a fresh-cut produce processing facility encourage microbial build-up. To prevent fresh-cut produce from becoming contaminated by equipment or other structures in the facility, we recommend that employees be trained on proper cleaning and sanitizing steps within the processing areas.
Figure 3 is an example of an aid that could be used to train employees on the cleaning and maintenance of processing equipment and facilities:
Figure 3. An example of a training aid on cleaning and sanitizing steps within processing areas
* Work from top down for cleaning and sanitizing activities. Some equipment may need to be disassembled before cleaning and sanitizing followed by reassembly.
In addition to using sanitizers appropriately and cleaning and sanitizing the equipment and facility regularly, proper use of equipment, such as hoses, can also reduce the risk of contamination of fresh and fresh-cut produce. For example, keeping hose nozzles off the floor can help prevent nozzles and employee hands from becoming a source of contamination. We recommend that sections of hose that touch the floor or other unclean surface not make contact with fresh produce, food-contact surfaces, or packaging materials. A retractable hose suspended from the ceiling may help to prevent such contamination. In addition, allowing hose ends to sit in standing water or to be submerged in water tanks could allow back siphonage of water, thereby contaminating the water distribution system.
Further, we recommend that employees be trained to avoid use of high-pressure water hoses to clean floors, walls, and equipment in the processing and packaging areas during production or after production equipment has been cleaned. This practice will help prevent aerosols from contacting processing equipment and food-contact surfaces, product, or packaging materials. Therefore, we recommend that employees be trained on the proper use of cleaning equipment.
FDA recommends that the processing facility and its structures (such as walls, ceilings, floors, windows, doors, vents, and drains) be designed to be easy to clean and maintain and to protect the product from microbial, physical, and chemical contamination. For example, designing food contact surfaces to be smooth, nonabsorbent, smoothly bonded, without niches, and sealed would make these surfaces easier to clean and thus, would prevent the harborage of microbial pathogens.
Both direct contamination and cross-contamination of produce can be minimized by giving proper attention to physical design, emphasizing proper product flow, using appropriate construction materials, managing facility traffic, and ensuring proper airflow. We recommend that facilities and staging areas be designed to facilitate maintenance and good sanitation practices so that contamination may be controlled throughout receiving, cooling, processing, packing, and storage operations. We also recommend that buildings, fixtures, and equipment be maintained in a condition that will protect fresh-cut produce from potential microbial, chemical, and physical contamination.
In general, we recommend limiting access to the facility and to its processing areas, providing adequate space for operations, ensuring adequate drainage of processing and wash water, installing food contact surfaces that are easy to clean and maintain, and designing areas and structures to protect the product and equipment from contamination.
In addition, we recommend the following practices:
We recommend against the use of a floor flume transfer from the produce cooling and packing operation into or across an area housing fresh-cut produce operations.
Where overhead condensate cannot be prevented, we recommend that catch pans be utilized, and be cleaned and sanitized on a regular basis.
If wooden equipment is used (including pallets), we recommend that the equipment be in good condition and well maintained so it is not a source of physical or microbial contamination. Non-wooden construction materials, such as plastic or stainless steel, are preferable for use in processing areas because they reduce the risk of microbial harborage and cross-contamination of final product.
We recommend that a fresh-cut fruit or vegetable processing facility be designed so that incoming raw products never cross paths with or are commingled with finished fresh-cut produce products. Similarly, we recommend maintaining separate raw incoming product, in process, and finished product areas so as to prevent the potential for microbial cross-contamination. Adequate food safety controls, operating practices, and facility design can reduce the potential for contamination by using location and/or flow of humans, product, equipment, and air.
We recommend the following practices that use location to reduce the potential for contamination:
We recommend the following practices that use flow of personnel, product, equipment, or air to reduce the potential for contamination:
(Figure 7 in Appendix E is an example of product and personnel flow patterns in a fresh-cut processing plant.)
We also recommend that air intake for the facility be located to minimize contamination of the intake air by:
Color coding bins, totes, clothing, cleaning implements, maintenance tools, and other items (e.g., blue aprons for receiving zones and red aprons for processing and packaging areas) may help achieve separation of traffic and thereby, minimize cross-contamination.
We recommend that the processing equipment be designed and constructed to be easy to clean and maintain and to avoid microbial contamination of the fresh-cut product.
We recommend the following to facilitate cleaning and to help ensure that fresh–cut produce is not contaminated during the processing operation:
Food contact surfaces include items such as knives, conveyors, belts, chutes, product totes, gloves, tools including shovels and racks, cutting boards, tables, dryers and spinner baskets, and packing scales. We recommend that all food contact surfaces be smoothly bonded (e.g., free of pits, folds, cracks, crevices, open seams, cotter pins, exposed threads, and piano hinges) to avoid harboring pathogens. Where two food contact surfaces meet, we recommend use of a cover over the juncture to prevent food debris from collecting in the crevice and creating an area that is difficult to clean.
We suggest cautious use of hollow structures, such as catwalk framework, table legs, conveyor rollers, and racks, because they may collect water and debris, and thus, harbor pathogens.
Establishing a preventive maintenance program helps to ensure that all equipment functions as intended. Equipment failure requiring maintenance activities during production may increase the risk of microbial contamination, particularly from L. monocytogenes (Ref. 16). Preventive maintenance includes periodic examination and maintenance of equipment such as valves, gaskets, o-rings, pumps, screens, filters, and heat exchanger plates. We recommend that a firm develop appropriate plans of action in case important equipment, such as refrigeration equipment, disinfectant delivery systems, power systems, or alarm systems, malfunctions. We also recommend the following practices:
We recommend that maintenance personnel who work in the processing or packaging areas comply with the hygiene requirements for production employees.
We recommend that knives be replaced if damaged or if they cannot otherwise be maintained in a sanitary condition.
We recommend that blades be removed and cleaned separately, and remaining equipment parts disassembled (if possible) and cleaned on a regular basis.
We recommend that procedures be in place, such as a the use of metal detectors during packaging operations, to minimize the possibility that metal ends up in finished product packages.
Pathogenic microorganisms may be found on floors, in drains, and on the surfaces of sorting, grading, processing, and packaging equipment. Without appropriate sanitation practices, these surfaces may be a source of microbial contamination.
We recommend the use of a comprehensive sanitation program developed by a trained employee such as a certified sanitarian to avoid microbial contamination of the product in a fresh-cut processing facility.
We recommend that fresh-cut processors consider using the following practices for their sanitation program:
An example of such a schedule is included in Figure 4. When visual inspection or environmental monitoring results for equipment or the facility reveal dirt, food residues, or other debris, we recommend a more frequent cleaning and sanitizing schedule relative to what is shown in Figure 4.
Figure 4. An Example of a Processing Plant Environmental Sanitation Master Schedule(6),(7)
| Area | Cleaning/Sanitation Method | Tools | Cleaning Materials | Frequency |
|---|---|---|---|---|
| Walls | Foam, brush, rinse | Soft nylon brush and High Pressure Hose (when appropriate) | Chlorine-Quaternary ammonium ("quat")-based cleaner | Once/Month Walls adjacent to processing equipment should be cleaned daily |
| Ceiling | Foam, brush, rinse | Nylon brush, high pressure machine | Chlorine-quat-based cleaner | Once/Month |
| Floors | Wash, rinse | Hard bristle broom (not straw), floor scrubbers, low pressure hose | Chlorine-quat-or iodine based cleaner | Daily |
| Doors | Foam, scrub, rinse | Scouring pad, cloth | Chlorine-quat-based cleaner | Once/Week |
| Plastic curtains | Foam, rinse | Foam and Rinse | Chlorine-quat-based cleaner | Once/Week |
| Overhead pipes, electrical conduits, structural beams | Foam, brush | Brush, bucket, high water pressure machine | Chlorine-quat-based cleaner | Once/Month |
| Hoist, overhead light fixtures | Wipe, clean | Cleaning pad | Water, light detergent | Once/Quarter |
| Refrigeration coils | Rinse, sanitize | High pressure hose | Water, sanitize with quat | Once/Quarter |
| Chillers | Scouring | Scouring pad | Acid cleaner | As Needed/Audit |
| Air distribution filters | Soak | Plastic bins | Chlorine-alkaline detergent | Once/Quarter |
| Drains, trench | Clean, flood, rinse | Soft Nylon brush, 50 gallon container | Chlorine-alkaline detergent, quat or iodine based sanitizer | Daily |
| Grids | Brush, rinse | Nylon brush, high water pressure machine | Chlorine-alkaline detergent | Daily |
| Waste, dumpster areas | Foam, brush, rinse | Nylon brush, high water pressure machine | Heavy duty chlorine-based cleaner | Daily |
| Employee break rooms/bathrooms | Wash, rinse | Nylon brush, sanitary brushes | Chlorine-based soap or quat | Frequently throughout the day |
| Maintenance areas | Scrub, rinse | Nylon brush | Degreasing agent | Once/Month |
For cleaning drains, we recommend using dedicated utensils (color coded and used for cleaning drains only) to minimize the potential for contamination. We also recommend that floor drains not be cleaned during processing operations and that the person who cleaned drains not clean fresh-cut produce food contact surfaces without changing outer garments, and washing and sanitizing his or her hands.
We recommend replacing a tool if it cannot be fixed so that it can be adequately cleaned.
Cleaning and sanitizing chemicals may be toxic, and should be stored in dry, secure, and ventilated areas away from facility traffic and processing operations. They should be handled by employees trained in the use of such chemicals.
We recommend the following practices in using cleaning and sanitizing chemicals:
We recommend a pest control program be implemented throughout the entire processing facility to eliminate pests (such as rodents, birds, reptiles, and insects) that may harbor or be a vector for a variety of pathogens. As part of the plant's pest control program, consider frequent monitoring of affected and treated areas to assess accurately the effectiveness of the program. Some helpful physical and chemical controls are recommended below:
Chemical controls should be applied by a licensed pest control operator or according to local regulations.
We recommend that changing facilities and restrooms be adequate and located in proximity to processing areas, but not so close that they could be a source of contamination. We recommend that restrooms not open directly into processing areas and doors be equipped with self-closing mechanisms or have a maze-type entrance/exit.
FDA recommends the following practices for employee hand washing facilities:
We recommend that these signs be posted near the facility entrance, in restrooms, near all hand washing stations, and wherever employees may handle produce, food packaging materials, or food-contact surfaces. We further recommend that these signs be multilingual where some of the workers in the facility are not native English speakers or pictorial where literacy is a concern.
Air inside a processing plant can be a vehicle for contamination of food by mold, yeast, dust, or pathogens if not properly controlled. Where fresh and fresh-cut fruits and vegetables are exposed to open air, we recommend that air quality be monitored to ensure that it is of suitable quality.
We also recommend that fresh-cut processors consider the following to maintain appropriate air quality:
Water can be a carrier of microorganisms including pathogens. Adequate quality water is critical in a fresh-cut processing facility because of the absence of a step lethal to pathogens (kill step) in processing the product as well as the presence of factors such as the high degree of product handling, the damage to product during cutting, shredding, etc., and the potential for temperature abuse in processing and storage. We recommend that the water supply in a food processing plant be sufficient for the operations intended and be derived from an adequate source. We recommend that water for operations in the processing facility, such as cleaning and sanitizing the facility and equipment as well as preparing the product for processing, processing the product, and manufacturing ice, be of adequate quality. Where water does not become a component of the fresh-cut produce, we recommend that water be safe and sanitary, at suitable temperatures, and under pressure as needed for all uses. For water that is used in a manner such that the water may become a component of the fresh-cut produce (such as when such water contacts components, fresh-cut produce, or any contact surface), we recommend that water comply with applicable Federal, State, and local requirements.
See Section VIII.C., which provides our recommendations for maintaining water quality used from preparation for processing through processing operations.
We recommend the following practices regarding the water used in a processing facility:
We recommend that processors protect sources of water and ice from contamination and that ice be manufactured, transported, and stored under sanitary conditions.
FDA recommends an environmental monitoring program designed to detect areas of pathogen harborage and to verify the effectiveness of cleaning and sanitizing programs in preventing cross-contamination. We recommend the following practices:
We recommend that the appropriate target pathogen be the most resistant microorganism of public health significance that is likely to occur in fresh-cut produce.
To minimize the potential for the growth of microorganisms and for the contamination of fresh-cut produce, FDA recommends that control measures be in place to prepare, process, package, and store the product.
We recommend that food processors consider developing specifications and controls for all ingredients and components (including raw fruits and vegetables, packaging materials, and gases) that are necessary for production of safe finished product. Specifications provide standards by which a food processor can assess the acceptability of ingredients and components and thus, minimize microbial, chemical, and physical hazards. We recommend, for example, that the fresh-cut processor know as much as possible about the production practices and conditions for the firm's incoming product. The "Guide to Minimize Microbial Food Safety Hazards in Fresh Fruits and Vegetables" (Ref .15) provides useful guidance when reviewing primary production practices.
Opportunities for contamination of fresh produce occur from the field to the processing facility. Loading, transporting, and unloading produce may introduce contaminants. Damaged produce, soil, debris, and pests may all arrive with the produce when it is delivered to the facility. To help ensure the quality of incoming fresh produce, we recommend that the processor carefully inspect the produce upon receipt at the processing facility. We also recommend the following practices:
This information will be useful in the event a traceback is conducted. See section X in this guide for more information on tracebacks.
Appropriate preprocessing of incoming produce can help minimize microbial, chemical, and physical hazards. We recommend that fresh-cut produce processors consider the following activities to help minimize microbial, chemical, and physical hazards in in-coming produce:
We recommend, when appropriate, washing incoming RACs prior to further processing (such as cutting or chopping) to reduce the overall potential for microbial contamination from the surface of intact fruits and vegetables.
Water is used extensively in almost all aspects of processing fresh-cut fruits and vegetables, including during cooling, washing, and conveying of produce. Although water may be a useful tool for reducing potential contamination, it may also introduce or spread contaminants. When used for washing, cooling, rinsing, or conveying food, we recommend that water comply with applicable Federal, State, and local requirements.
In a fresh-cut processing operation, water quality changes as the water is used and, thus, maintaining the quality of processing water should be considered. Reusing processing water may present a risk of new or increased number of microbial populations, including human pathogens.
We recommend the following practices:
We recommend that ice used on fresh or fresh-cut produce be included in routine water quality testing.
When used appropriately with adequate quality water, antimicrobial chemicals help minimize the potential for microbial contamination of processing water and subsequent cross contamination of the product. The effectiveness of an antimicrobial agent, as well as the amount that should be used, depends on the treatment conditions, such as water temperature, acidity [pH], water hardness, contact time, amount and rate of product throughput, type of product, water to product ratio, amount of organic material, and the resistance of pathogens to the particular antimicrobial agent. For example, the antimicrobial activity of a chlorine-based disinfectant depends on the amount of hypochlorous acid (also called "free chlorine") present in the water. The amount of hypochlorous acid in the water depends upon the pH of the water, the amount of organic material in the water, and, to some extent, the temperature of the water. If the amount of hypochlorous acid is not maintained when the amount of organic material increases, the antimicrobial agent may lose effectiveness in maintaining water quality. If a fresh-cut processor uses a chlorine containing compound as a disinfectant, we recommend that the processor monitor the processing water for free chlorine or hypochlorous acid concentrations. As another example, the measurement of Oxidation-Reduction Potential (ORP) is used as an indicator of the activity of any antimicrobial agent that is an oxidizer and as a measure of the agent's effectiveness during processing. Variables that affect antimicrobial activity during processing directly affect the ORP value and may also be used to determine the effectiveness of these oxidizers such as hypoorous acid, hypobromous acid, chlorine dioxide, ozone, and peroxides.
We recommend that fresh-cut processors consider options for maintaining the quality of water most appropriate for their individual operations. Producers may wish to contact a local agricultural extension agent, their chemical supplier, or a food safety consultant for help in deciding what water treatment chemicals to use. In addition, processors may refer to 21 CFR 173.315, "Chemicals used in washing or to assist in the peeling of fruits and vegetables," for additional information about chemicals approved for use in wash water.
We recommend that fresh-cut processors also consider the following regarding water quality maintenance:
Manufacturers' suggested or allowable levels of antimicrobial chemicals in wash water should not be exceeded.
Test strips or test kits may be useful for monitoring some disinfectant levels.
For some operations, filtering recirculating water or using a net to scoop plant material or other debris from tanks may help reduce the build up of organic material.
Prior to arriving at the processing facility, RACs may be washed in the field or in a place such as a cooling facility. RACs may also go directly from the field to the processing facility to be washed after receipt. Regardless of where the initial washing of the produce takes place, washing produce can reduce the overall potential for microbial food safety hazards because most microbial contamination is on the surface of the produce. If pathogens are not removed, inactivated, or otherwise controlled at this initial stage, they can potentially spread the contamination to additional produce during processing. Washing RACs before any processing of the produce occurs may reduce potential surface contamination. However, washing, even with disinfectants, can only reduce, not eliminate, pathogens, if present. Washing has little or no effect on pathogens that have been internalized in the produce.
A number of post harvest processes, such as hydrocooling, use of dump tanks, and flume transport utilize a high degree of water-to-produce contact. We recommend that fresh-cut processors use practices to maximize the cleaning potential during these processes and to minimize the potential for cross-contamination.
We recommend the following practices:
For some operations, a series of washes may be more effective than a single wash. An initial wash treatment may be used to remove the bulk of field soil from produce followed by an additional wash or washes containing an antimicrobial chemical.
Vigorous washing of produce not easily bruised or injured increases the likelihood of pathogen removal. Different methods may be used to wash different types of produce, including submersion, spray, or both. Regardless of the method used, maintaining the quality of the wash water (see section 2.a. above) is important in order to minimize the potential for contamination.
Produce is susceptible to infiltration of wash water if warm produce is placed in water that is cooler than the produce. Such infiltration occurs when the temperature difference creates a pressure differential causing air spaces inside the fruit or vegetable to contract, thereby allowing water to be pulled into the fruit or vegetable. If pathogens are present in the cooling/wash water, they may infiltrate the produce, and subsequent washing will not reduce levels of these pathogens (Refs. 6, 14). Therefore, water used for washing or cooling produce should contain sufficient levels of disinfectant to reduce the potential for pathogens to persist in such water. When it is not practical to reduce the temperature differential between the wash/cooling water and the produce, it is especially important that processors follow practices to minimize pathogens in the water or on the surface of produce. Such practices may include using antimicrobial chemicals in the wash water or using spray type wash treatments instead of submerging produce. Alternatively, produce may be cooled by means other than hydrocooling and then washed with water that is warmer than the produce.
Sanitary cold storage of RACs and fresh-cut produce is important to reduce the risk of microbial contamination and potential for subsequent growth. However, most current temperature recommendations for both whole and fresh produce are based on temperatures that maintain quality attributes.(8) Although we recognize that more research needs to be done to identify the types of whole and fresh-cut produce that will support the growth of human pathogens and the temperatures at which this pathogen growth will occur, certain practices can reduce the potential for pathogen growth and contamination during precooling and cold storage.We recommend the following practices to reduce this risk:
In most instances, vacuum cooling or use of fans poses the lowest risk of microbial contamination
Final washing of fresh produce after cutting, slicing, shredding, and similar fresh-cut processes helps remove some of the cellular fluids that could serve as nutrients for microbial growth. Monitoring the quality of water used in such operations and replacing it at an appropriate frequency as indicated by such monitoring may help prevent the build up of organic material in the water and reduce or prevent cross-contamination of processed produce. We have the following additional recommendations for use after the final wash of processed produce:
Anything that touches fresh-cut produce has the potential to contaminate it, including the materials used in packaging the finished product.
We recommend the following practices:
Some packaging controls used for fresh-cut produce affect the environment within the package by reducing the levels of oxygen. Low oxygen levels help maintain the quality of fresh produce and extend shelf-life by slowing respiration and senescence in plant tissues. Oxygen can be reduced passively by using gas permeable films in packaging that result in the natural development of the desired atmosphere; the desired atmosphere is a consequence of the products' respiration as gas diffuses through the film (Ref. 6). Oxygen can also be reduced actively by displacing the mixture of gases in a package with a gas mixture that has a low concentration of oxygen (1-5%). Microorganisms respond differently to the surrounding gases depending on their tolerance. While reduced oxygen and elevated carbon dioxide retard the growth of spoilage microorganisms such as Pseudomonas spp., the same gas conditions may provide growth opportunities for pathogenic microorganisms. At extremely low oxygen levels (< 1%), anaerobic respiration can occur, resulting in tissue destruction that affects product quality and creating the potential for growth of foodborne pathogens such as Clostridium botulinum (Ref. 6). It is generally believed, however, that fresh-cut produce will spoil before the toxin becomes a concern (Ref. 6). Non-pathogenic aerobic and facultative microorganisms are present at the time of packaging and persist after packaging.
MAP is only effective in extending shelf-life if used in conjunction with good refrigeration. Elevated temperatures can promote the growth of spoilage organisms and pathogens that may be present. Thus, we recommend that food processors using MAP adhere to strict temperature controls and appropriate shelf-life parameters. Because refrigeration temperatures may not be maintained during distribution of the products or while they are held by retailers or consumers, we also recommend that controls be in place to either prevent increases in temperature, as feasible, or to alert the processor, retailer, or consumer that the product may not be safe to consume. Processors may wish to consider providing product handling guidelines on temperature control and washing to the distributor, retailer, and consumer. Another potential source of contamination of fresh cut produce packed in MAP occurs when the gases, equipment, or packaging materials are not properly maintained. As with any type of packaging, we recommend that controls be put in place to ensure that the process of packaging the product and the packaging materials themselves do not cause the product to become contaminated.
Fresh-cut fruits and vegetables can cause illness due to contamination with a variety of microorganisms because these products do not undergo any processing to ensure the total elimination of microorganisms that might be present. Some packaging and storage techniques for fresh-cut produce (e.g., MAP, refrigerated storage) may slow the rate of physical deterioration by slowing respiration of the produce. However, if packaging and storage are not properly controlled, pathogens may grow to levels that could render the product unsafe for human consumption. The rate of respiration of fresh produce is inversely related to product shelf-life, which means that a higher respiration rate decreases shelf-life (Ref. 6). Fresh fruits and vegetables that have been cut or otherwise physically altered will have increased respiration, and thus, a shorter shelf-life. To address the risks of increased respiration, we recommend the following practices:
We recommend that records of these data and studies be maintained to document the reliability of the "use by" labeling.
We recommend that finished fresh-cut product be stored and transported under conditions that will protect the food against physical, chemical, and microbiological contamination. We recommend, if feasible, that raw whole produce not be stored with finished product and finished product be transported in clean, sanitary vehicles. We also recommend the following practices:
If a recording temperature device is not used, we recommend that a min/max thermometer, i.e., a thermometer that shows the range of temperatures attained over a set time period, be used.
We recommend as a general practice that food processors maintain records sufficient to reflect important product information and practices. Such documentation can be helpful to the processor in several ways. First, such records help ensure consistency of processing operations and end-product quality and safety. They are more reliable than human memory, and they are a useful tool to identify operational areas where inconsistencies occur and further employee training may be needed. Second, maintaining adequate documentation and records of processing operations is important if a traceback investigation of product is ever needed. We recommend that records be retained at the processing plant for at least six months after the date that the products were prepared unless a longer retention time is required under a relevant law or regulation. Records are most useful when they begin by including the date and time, name of person(s) who completed the record, and the activity or production station being recorded.
Records that may be kept for most food processing operations include the following:
Traceback is the process of tracking food items, such as fresh-cut produce, back to their source (growers, packers, processor, field and when harvested). The ability to identify the source of a product can serve as an important complement to food safety programs intended to prevent the occurrence of microbial contamination. Information gained from a traceback investigation may also be useful in limiting the impact of an outbreak of foodborne illness and in identifying and eliminating conditions that may have resulted in the produce becoming contaminated. We recommend that fresh-cut processors establish and maintain written traceback procedures to respond to food safety hazard problems when they arise.
We also recommend that fresh-cut processors establish and maintain a current written contingency plan for use in initiating and carrying out a recall. Having procedures in place will enable the recall of any lot of product that may have been implicated in an outbreak or that tested positive for a pathogen and help provide detailed information to assist the investigation of any foodborne illness associated with the product. Recall procedures usually include the name of the contact persons responsible at all times; the roles and responsibilities for the coordination of a recall; the methods to identify (e.g., use of lot codes), locate, and control recalled products; requirements to investigate other possibly affected products which could subsequently be included in the recall; and procedures for monitoring the effectiveness of the recall.
Because a recall may extend to more than one lot of product, we recommend that processors develop a coding system to help identify incoming product sources, individual production lots and to whom each lot is distributed. Use of package and date codes can help link product packages with production times, equipment, and raw ingredient sources and may facilitate recovery of products during a recall.
In the event of a firm-initiated recall, if a firm believes its product is adulterated or otherwise violates the Act, we request that the firm immediately notify the appropriate FDA district office in the state where the processing facility is located. District office locations are provided in 21 CFR 5.115. (See Appendix A for information to include in the notification.)
Produce growers and packers, fresh-cut produce processors, and shippers are encouraged to work with their partners in growing, transporting, distributing, packing, and processing, and with retail sectors to develop technologies that allow identification of fresh-cut produce from the grower to your operation, to the retailer, and to the consumer.
The following are additional resources for information on how to handle food products safely.
On the web:
Other resources:
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 0.067 hour per record for SOP & SSOP maintenance, 40 hours per record for traceback maintenance, 0.067 hour per record for system implementation of a preventive control program comparable to a HACCP system, and 4 hours per record for implementation review of that preventive control program, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to: Office of Food Safety, Division of Plant and Dairy Food Safety (HFS-317), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0609 (expires 10/31/2010).
In the event of a firm-initiated recall, if a firm believes its product is adulterated or otherwise violates the Act, we request that the firm immediately notify the appropriate FDA district office and that the notification include:
For further FDA guidance on recalls, see 21 CFR sections 7.40-7.59.
The U.S. Public Health Service has identified a number of microorganisms associated with foodborne illness that are notable either because of the severity or because of the prevalence of the illness they cause. Foodborne microbial pathogens associated with the consumption of fresh fruits and vegetables include Cyclospora cayetanensis, Escherichia coli O157:H7, hepatitis A virus, Listeria monocytogenes, Norovirus, Salmonella spp., and Shigella spp.(9)
A wide range of communicable diseases may be transmitted by infected employees to consumers through contaminated food or food utensils. We recommend that fresh-cut produce firms establish an ongoing program to identify employees who present a risk of transmitting foodborne pathogens to fresh produce or to other employees. Below is a list of the most common pathogens that may be transmitted through food and their associated symptoms.
| Pathogen | Symptoms |
|---|---|
| 1. Hepatitis A virus | fever, jaundice |
| 2. Salmonella typhi | fever |
| 3. Shigella species | diarrhea, fever, vomiting |
| 4. Norwalk and Norwalk-like viruses | diarrhea, fever, vomiting |
| 5. Staphylococcus aureus | diarrhea, vomiting |
Diarrhea, fever, and vomiting are also symptoms of several other pathogens that could be transmitted by food contaminated by infected employees.
Please refer to the CDC web site for further information on foodborne diseases, pathogens, and toxins: *.
Figure 5. Potential sources of microbial contamination
Figure 6. Examples of Scenarios That May Cause Microbial Contamination of the Product
(1) This guidance has been prepared by the Division of Plant and Dairy Food Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
(2) Fresh sprouts are raw agricultural commodities and thus, their production is not governed by 21 CFR Part 110. FDA does, however, recommend that sprouting firms employ current good manufacturing practices. Also, FDA has published specific guidance for the production of sprouts. We recommend that producers of sprouts refer to this guidance, "Reducing Microbial Food Safety Hazards for Sprouted Seeds" (Ref. 13) and "Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production" (Ref. 14).
(3) For information regarding re-washing of fresh-cut produce, California Department of Health Services Food and Drug Branch "Recommendations from Fresh-cut Produce Re-wash Panel, April 4, 2006." (available in PDF).
(4) A copy of the CGMPs in 21 CFR Part 110 may be accessed on the internet.
(5) United Fresh Produce Association: http://www.unitedfresh.org/.
(6)Used with permission from the United Fresh Produce Association (UFPA), Food Safety Guidelines for the Fresh-cut Produce Industry, 4th Edition, 2001.
(7) Also, as noted previously in section V.B.3., we recommend that employees be trained to avoid use of high-pressure water hoses to clean floors, walls, and equipment in the processing and packaging areas during production or after production equipment has been cleaned. This practice will help prevent aerosols from contacting processing equipment and food-contact surfaces, product, or packaging materials.
(8) An exception is Chapter 1 of the FDA Food Code (2005), which defines potentially hazardous food (PHF) and identifies specific fresh produce (among other foods) that is considered PHF and therefore requires refrigeration at 41°F. Cut melons are considered a PHF.
(9) More information about these and other microbiological pathogens can be found in FDA's Bad Bug Book. See Ref. 17.
(10) For additional information, FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture (USDA) have developed a Listeria Action Plan (Ref. 18) and a Listeria risk assessment (Ref. 16).
(11) Used with permission from UFPA, Food Safety Guidelines for the Fresh-cut Produce Industry, 4th Edition, 2001.
The above guidance supercedes the previous version issued March 2007.
Federal Register Notice of Availability February 25, 2008
