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March 2006
A more recent version of this guidance issued in March 2007. Below is an earlier version.
This guidance document is being distributed for comment purposes only.
Submit comments and suggestions regarding this draft document by the date provided in the Federal Register notice announcing the availability of the draft guide. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. You should identify all comments with the docket number listed in the notice of availability that published in the Federal Register.
Additional copies of this draft guidance are available from the
Office of Plant and Dairy Foods, Division of Plant Product Safety (HFS-305),
5100 Paint Branch Parkway, College Park, MD 20740, or by calling 1-301-436-1400,
or from the internet at
http://www.cfsan.fda.gov/guidance.html
For questions regarding this document, contact Amy Green (301) 436-2025.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
March 2006
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 may 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 number listed on the title page of this guidance.
Table of Contents
Appendices
Several national campaigns are promoting a healthful diet rich in fresh fruits and vegetables. In response, per capita consumption data show that Americans are eating more fresh produce. With $12 billion in annual sales in the past few years (Ref. 1), the fresh-cut sector of the produce industry is its fastest growing segment.
Since the early 1990s, the number of foodborne illnesses associated with fresh fruits and vegetables has doubled in the United States. From 1998 to 2004, forty foodborne illness outbreaks were associated with the consumption of fresh produce. Of these produce related outbreaks, twenty-five percent implicated fresh-cut produce. An increase in global trade, a longer food chain, exposure to exotic microflora, distribution to a larger population in more geographically dispersed areas, and an aging population that is susceptible to foodborne illness may all play a role in the increased number of foodborne illnesses that implicate fresh produce. As the fresh-cut market continues to grow, the processor is faced with the challenge of processing an increasing variety and volume of products in a manner that ensures their safety to the public.
Processing fresh produce into fresh-cut products increases the risk of bacterial contamination and growth by breaking the natural exterior barrier of the produce. Once surface integrity is broken, bacterial growth can occur if pathogens are present. Processing of fresh produce without proper sanitation procedures in the processing environment enhances the potential for contamination by microbial pathogens. (See Appendix B, "Foodborne Pathogens Associated with Fresh Fruits and Vegetables.") 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. Moreover, 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. 2). 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 during production to eliminate pathogens, and the potential for temperature abuse during processing, storage, transport, and retail display (Ref. 2).
This draft guidance is intended for all fresh-cut produce firms, both domestic 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 is not a set of binding requirements nor does it identify all possible preventive measures to minimize microbial food safety hazards. We recommend that each fresh-cut produce processor assess the recommendations in this draft 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 draft guidance primarily addresses microbiological hazards and appropriate control measures for such hazards. However, some chapters in the draft guidance discuss physical and chemical hazards.
FDA's guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance documents 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 would should in Agency guidance means that something is suggested or recommended, but not required.
Fresh-cut Produce: This guidance covers fresh produce that has been processed by peeling, slicing, chopping, shredding, coring, trimming, or mashing, with or without washing or other treatment, prior to being packaged for consumption. 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 melons, sliced pineapple, and sectioned grapefruit.(2) Fresh-cut produce does not require additional preparation, processing, or cooking before consumption, with the exception of washing or the addition of salad dressing, seasoning, or other accompaniments.
Fresh-cut Produce and Current Good Manufacturing Practices for Foods (CGMPs) (21 CFR Part 110)(3): Fresh-cut produce are processed foods because they are no longer in their natural state. Therefore, the exclusion in CGMPs (21 CFR 110.19) for raw agricultural commodities does not apply to fresh cut produce, and the CGMPS in Part 110 are applicable. Under 21 CFR 110.3, the definitions in section 201 of the Federal Food, Drug, and Cosmetic Act (the Act) apply to Part 110. 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." The conclusion that fresh cut produce are not raw agricultural commodities is consistent with the preamble to the proposed revisions to the Current Good Manufacturing Practices in Manufacturing, Packing or Holding Food (44 FR 33238 at 33239, June 8, 1979), which states, when discussing the exclusion for raw agricultural commodities, 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." FDA believes that the recommendations in this guidance complement the CGMPs (21 CFR Part 110). The CGMPs contain food safety practices applicable to processors who manufacture, process, pack, or hold processed food. This guidance recommends more specific food safety practices relevant to processors of fresh-cut produce.
Fresh-cut Produce and HACCP Systems: A Hazard Analysis and Critical Control Points (HACCP) system is a prevention-based food safety system designed to prevent, eliminate, or reduce to acceptable levels the microbial, chemical, and physical hazards associated with food production (Ref. 2). The 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 fresh-cut produce processors, HACCP has been adopted voluntarily by many segments of the fresh-cut produce industry and is recommended by the International Fresh-cut Produce Association (Ref. 1).
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 on 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: (1) water that is safe and sanitary, at suitable temperatures, and under pressure as needed for all uses where water does not become a component of the fresh-cut produce (2) water that is used in a manner such that the water may become a component of the fresh-cut produce, e.g., when such water contacts components, fresh cut produce, or any contact surface, should, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the fresh-cut produce.
Clean: to wash and rinse food or food-contact surfaces with safe and sanitary water and make visually free of dust, dirt, food residues, and other debris.
Disinfect: to treat processing water by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, without adversely affecting the product or its safety for the consumer.
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: fresh fruits and vegetables for human consumption that have been peeled, sliced, chopped, shredded, cored, trimmed, or mashed, with or without washing, prior to being packaged (e.g., pre-cut, packaged, ready-to-eat salad mixes).
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 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 contamination of fresh produce with microbial pathogens is 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 treatments to eliminate contamination after it has occurred.
On the farm, potential contamination avenues include contact with untreated manure used as fertilizer, contaminated water, infected field 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 potentially 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.FDA's 1998 "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide) (Ref. 7), provides recommendations for growers, packers, and shippers to use good agricultural and good manufacturing practices in those areas over which they have control to minimize microbial food safety hazards in fresh produce. The GAPs Guide provides recommendations for growers and packers for preventing the contamination of fresh produce with pathogens. Potential sources of contamination identified in the GAPs Guide are biosolids and manure, water, field workers, equipment, and containers.
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, water supplies, and 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 personnel health and personal 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 active symptoms of infectious diseases; these symptoms are vomiting, nausea, diarrhea, and abdominal cramps. We recommend that employees with symptoms be transferred to work assignments that do not involve direct or indirect contact with fresh or fresh-cut produce, processing equipment, or tools. If an employee is diagnosed with an infectious disease, we recommend that a physician or local health authority determine when this employee may return to work involving direct contact because he or she no longer poses a risk of transmitting the disease. Appendix C has more information on symptoms of infectious diseases.
We recommend that areas of an employee's arms, wrists, or forearms that have an infected wound be covered with a dry, tight fitting, waterproof bandage and an outer covering for the entire bandage. A wound that contains pus, such as an open and draining boil or other infected wound, and is located on a part of the body that could contact fresh 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 firms consider using bandages that are detectable by a metal detector if there is a metal detector in the processing line. Using detectable bandages will alert a worker to remove a bandage that has fallen into the processing line before the product is finished. We also recommend that a worker with a wound that cannot be covered to prevent contact with fresh or fresh-cut produce, processing equipment, or tools not work with any aspect of fresh 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, processing equipment, or tools from becoming contaminated as a result of poor employee hygiene or inappropriate employee conduct:
FDA recommends that employees wash hands before beginning work and after engaging in any activity that may contaminate the 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) 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 it 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. For example, useful materials and information may be found at the Government Food Safety Information website and the Fight BAC!® campaign of the Partnership for Food Safety Education.
Training employees annually and providing short refresher courses during the processing season will help them remember important food protection practices. We recommend that firms consider teaching only a small number of employees at or near their workstation 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 pictoral 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 what the training covered and who has 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 handwashing 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. Handwashing training is particularly important. We recommend that employees be trained in how and when to 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 training aid on how to wash your hands
Use soap and warm running water
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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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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, 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. 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 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 baths, in proper cleaning and sanitizing steps of the equipment and facility, in proper use of equipment such as hoses and tools in the production environment, 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, 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 processing equipment and facilities maintenance and cleaning:
Figure 3. 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 be submerged in water tanks could allow back siphonage of water, contaminating the water distribution system.
Further, we recommend that employees be trained not to use 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.
Anything that touches product may contaminate it. 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 them 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 limited access to the facility and to its processing areas, adequate space for operations, adequate drainage of processing and wash water, food contact surfaces that are easy to clean and maintain, and areas and structures designed 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 cleaned 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.
2. Facility Layout
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 and finished product areas (including separate microbiology laboratories, maintenance, fabrication shop, waste areas, chemical storage, and toilet facilities) and separate processing 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 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 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 10). 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, chlorine injectors, power systems, or alarm systems malfunction. 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 they cannot be maintained in a sanitary condition or if damaged.
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 food contact 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 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. Example of a routine cleaning and sanitizing schedule
| Fresh-cut Produce Processing Areas | Cleaning Frequency | ||
|---|---|---|---|
1) Food contact surfaces
| Clean at a frequency that removes product residue to minimize contamination of your product, which is usually after each equipment or utensil use and at the end of each shift. | ||
2) Non-food contact surfaces/areas |
a) Surfaces with a potential to become a niche for microbial contamination (e.g., where there is a potential for moisture or residue build-up, where employees contact equipment during operation) | Daily | |
| b) Drains and floors (including refrigerator drains) | Daily cleaning. Weekly flush of drains with sanitizer. | ||
| c) Non-wood pallets | Daily | ||
| d) Waste containers | Daily | ||
| e) Refrigerators | Daily
The refrigerator tube should be cleaned daily if using hydrocooling/vacuuming |
||
| f) Cleaning tools (e.g., brooms, brushes) | Daily | ||
| g) Bathrooms and break rooms | Daily (more frequently, if needed) | ||
| h) Overhead piping, outside surfaces of enclosed processing systems and light fixtures | Monthly | ||
| i) Ceiling, walls, windows, doors | Monthly (unless they meet conditions in 2a, then daily) | ||
| j) Fans (fan guards) | Weekly | ||
| k) Condensate drip pans | Weekly when using sanitizer blocks; daily when using other form of sanitizer | ||
| l) Ice machine: | Doors, gaskets, outside surfaces | Daily | |
| Drain reservoir | Monthly | ||
| Flush unit | Monthly | ||
| g) Heating, venting, and air conditioning (HVAC) system | Air intake and output ducts | Weekly | |
| Check filters | Monthly | ||
| Ductwork | Yearly | ||
Premise Areas |
a) Loading dock | Daily:
sweep and scrub floors
Weekly: scrub walls and surrounding areas |
|
| b) Parking lot, curbs, sidewalks, landscaping | Daily: pick up trash
Weekly: scrub entrance to facility |
||
| c) Dumpster and trash areas | Daily | ||
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 we recommend that they be stored in dry areas away from facility traffic and processing operations and traffic and 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.
We recommend that chemical controls be applied by a licensed pest control operator.
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 are equipped with self-closing mechanisms or have a maze-type entrance/exit.
FDA recommends the following practices:
We recommend that these signs be posted near the facility entrance, in restrooms, near all handwashing 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 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 recommend that processors maintain proper positive, negative, and ambient air pressure differentials throughout the processing facility to prevent product contamination. We further recommend that negative air pressures be maintained in raw product areas, microbiology laboratories, and rest rooms to keep air from flowing from those areas into the processing areas. In addition, we recommend that positive air pressures be maintained in areas such as in the processing and packaging area.
We also recommend that fresh-cut processors consider the following:
Water can be a carrier of microorganisms including pathogens. Adequate quality water is critical in a fresh-cut processing facility primarily because of the absence of a step lethal to pathogens (kill step) in processing the product and factors such as the high degree of handling, the damage to the product during cutting or mashing, and the potential for temperature abuse in the 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, e.g., when such water contacts components, fresh cut produce, or any contact surface, we recommend that water, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the fresh-cut produce.
Section VIII.C 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 that includes sampling for pathogens to detect areas of harborage and to verify the effectiveness of cleaning and sanitizing programs in preventing cross-contamination. We recommend that an environmental monitoring program be part of the fresh-cut produce operations and recommend the following practices:
We recommend that environmental sampling be done on both food contact and non-food contact surfaces (e.g., drains).
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 their incoming product. The "Guide to Minimize Microbial Food Safety Hazards in Fresh Fruits and Vegetables" (Ref. 7) 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.
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:
We recommend washing incoming produce 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
We recommend that metal detectors be set up to reject product from the normal product flow if a problem is detected.
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, rinsing, or conveying food, we recommend that water, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate fresh-cut produce.
In a fresh-cut processing operation, water quality needs may vary depending on how the water is used and whether a particular process is followed by additional cleaning processes. Reusing processing water may present a risk of new or increased number of microbial populations, including human pathogens.
We also recommend the following practices:
We recommend including ice used on fresh or fresh-cut produce in routine water 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 finished 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 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.
We recommend that fresh-cut processors consider options for maintaining the safety 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:
We recommend that the manufacturer's suggested or allowable levels of antimicrobial chemicals in wash water 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.
Washing fresh 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, they can potentially spread the contamination to additional produce during processing. However, washing, even with disinfectants, can only reduce the number of pathogens, if present. Washing has little effect on pathogens that have been internalized.
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.
For many types of produce, removing field heat is a primary consideration in maintaining quality. However, some types of produce such as cantaloupe, mangoes, and tomatoes are 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. Thus pathogens that may be present on the surface of the produce or in the water may be drawn into the produce. If pathogens are pulled into the produce, subsequent washing will not reduce levels of these pathogens (Refs. 2, 4). For products that may be susceptible to pathogen internalization, the recommended temperature differential (i.e., temperature difference between the wash water and the temperature of the fresh produce) may be achieved by cooling produce before immersion.
When it is not practical to reduce the temperature differential between the 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.
If product is washed or cooled in a submersion system, we recommend that care be taken to control the rate of product flow to minimize the amount of product that is submerged at a greater depth as well as the time sufficient to accomplish the process.
Proper precooling and storage of unprocessed and processed fresh produce is important in reducing the risk of microbial contamination and growth. 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
We recommend that finished fresh-cut produce be stored at 40°F or lower. L. monocytogenes, for example, survives at refrigeration temperatures, but grows more slowly at lower temperatures, so we recommend the processors consider using the lowest practical temperature for refrigerating finished product.
We recommend that temperature monitoring devices be located in the warm area of the refrigerator unit (e.g., near the door) and calibrated on a regular basis, and that all refrigeration units be inspected and kept in good operating condition (Ref. 8).
Final washing of fresh produce after cutting, slicing, shredding, and similar fresh-cut processes helps to remove some of the cellular fluids that could serve as nutrients for microbial growth. Monitoring water quality and replacing water at an appropriate frequency as indicated by such monitoring may help prevent the build up of organic material and reduce or prevent cross-contamination of processed produce. We have the following additional recommendations for use after the final wash:
Anything that touches fresh-cut produce has the potential to contaminate it. This includes the materials used in packaging the product.
We recommend the following practices:
For example, we recommend against using a carton designated for holding fresh-cut produce to hold tools.
To help achieve proper rotation of inventory, we recommend that all pallets be dated upon receipt.
Deviation from the packaging criteria could result in the survival and growth of microbial pathogens in the fresh-cut produce because microorganisms are affected by the levels of O2 and CO2 in MAP packaging.
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. 2). 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. 2). It is generally believed, however, that fresh-cut produce will spoil before the toxin becomes a concern (Ref. 2). 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. If refrigeration temperatures are not maintained during distribution of the products or while they are held by retailers or consumers, we recommend that controls be in place to either prevent increases in temperature 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. We also recommend that food processors using MAP adhere to strict temperature controls and appropriate shelf-life parameters.
Another potential source of contamination in using MAP packaging for fresh-cut produce occurs when the gases, equipment, and 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 or the packaging materials themselves do not cause the product to become contaminated.
Fresh-cut fruits and vegetables can potentially cause illness due to contamination with a variety of microorganisms because there is no processing for these products to ensure the total elimination of microorganisms should they be present. Some packaging and storage techniques for fresh-cut produce (e.g., modified atmosphere packaging, refrigerated storage) may slow the rate of physical deterioration by slowing respiration of the produce. However, if the 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 the shelf-life of the product, which means that a higher respiration rate decreases shelf-life (Ref. 2). Fresh fruits and vegetables that have been cut or otherwise physically altered will have increased respiration, and thus, a shorter shelf-life. 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 procts be stored and transported under conditions that will protect the food against physical, chemical, and microbiological contamination. We recommend 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 areas where inconsistencies occur in operations and further employee training may be needed. Maintaining adequate documentation and records of processing operations is also 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 may be kept for most food processing operations such as 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 being 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 effecting 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 in 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 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 violative of 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 what 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:
1) FDA/Center for Food Safety and Applied Nutrition
2) Fight Bac!®
3) Gateway to Government Food Safety Information
4) Center for Disease Control and Prevention (CDC)
5) USDA/Food Safety and Inspections Service (FSIS)
Other resources:
7) Ednet: a monthly electronic newsletter for food safety educators. To subscribe, send an email message to . Send the message: Subscribe EDNET-L first name last name.
8) FDA's Outreach and Information Center: 1.888.SAFEFOOD
1) International Fresh-cut Produce Association (IFPA).
2) Institute of Food Technologists and the Food and Drug Administration. "Analysis and Evaluation of Preventative Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce." September 2001.
3) FDA, "Reducing Microbial Food Safety Hazards for Sprouted Seeds," 1998.
4) FDA, "Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production," 1999.
5) Environmental Protection Agency. Drinking water quality standards.
6) Environmental Protection Agency. Maximum contaminant levels (MCLs) for microbiological contaminants. 40 CFR Part 141.63.
7) FDA, "Guide to Minimize Microbial Food Safety Hazards in Fresh Fruits and Vegetables," 1998 October.
8) Technical Institute of Food Safety. "Engineering for Food Safety and Sanitation: A Guide to the Sanitary Design of Food Plants and Food Plant Equipment," T.J. Inholte, 1984.
9) U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Foodborne Pathogenic Microorganisms and Natural Toxins Handbook, Escherichia coli O157:H7, (Bad Bug Book), January 2001.
10) Department of Health and Human Services and the United States Department of Agriculture. Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-eat Foods. September 2003.
11) FDA and the Centers for Disease Control and Prevention, "Reducing the Risk of Listeria monocytogenes, FDA/CDC 2003 Update of the Listeria Action Plan," November 2003.
In the event of a firm-initiated recall, if a firm believes its product is violative of the Act, we request that the firm immediately notify the appropriate FDA district office in the state where the processing facility is located and that the notification include:
For further FDA guidance on recalls, see 21 CFR 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 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.(5)
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 |
| 6. Streptococcus puogenes | fever, sore throat with fever |
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
Figure 7. An Example of Product/personnel Flow Patterns in a Fresh-cut Processing Plant[7]
(1) This draft guidance has been prepared by the Center for Food Safety and Applied Nutrition (CFSAN) 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 CGMPs. 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. 3) and "Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production" (Ref. 4).
(3) A copy of the CGMPs in 21 CFR Part 110 may be accessed on the internet.
(4) The percent efficiency is the percent of particles at the specific micron size that will be retained on the filter.
(5) More information about these and other microbiological pathogens can be found in FDA's Bad Bug Book.
(6) 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. 11) and a Listeria risk assessment (Ref. 10).
(7) With permission from IFPA, Food Safety Guidelines for the Fresh-cut Produce Industry, 4th Edition, 2001.
March 1, 2006: FDA Issues Draft Guidance for the Safe Production of Fresh-Cut Fruits and Vegetables
Federal Register Notice of Availability March 6, 2006
A more recent version of this guidance issued in March 2007. Above is an earlier version.
