March 2006
 Guidance for IndustryGuide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
VegetablesDraft Guidance
This guidance document is being distributed for comment
purposes only.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Additional copies of this draft guidance are available from the Office of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/~dms/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
Guidance for IndustryGuide to Minimize Microbial Food Safety Hazards of Fresh-cut
Fruits and VegetablesDraft Guidance
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
- Introduction
- Scope and
Use
- Definitions
- Primary
Production and Harvesting of Fresh Fruits and Vegetables
- Personnel
- Worker Health and Hygiene
- Disease Control
- Cleanliness
- Training.
- Worker Health and Hygiene
- Employee Roles and Responsibilities
- Sanitation Principles and Sanitary Practices
- Building and
Equipment
- Building
- External/Internal Structures
- Facility Layout
- Equipment Design, Construction and Maintenance
- Equipment Design and Construction.
- Equipment Maintenance
- Sanitation
Operations
- Sanitation Program
- Cleaning and Sanitizing Chemicals
- Pest Control
- Sanitary Facilities and Controls
- Employee Changing Facilities and Toilets
- Hand Washing Facilities
- Air Quality
- Water Supply
- Environmental Monitoring
- Production and
Process Controls
- Product Specifications
- Receipt and Inspection of Ingredients
- Specific Process Steps
- Preparation for Processing
- Processing Water
- Maintaining Water Quality
- Washing Fresh Produce
- Precooling and Cold Storage
- Washing Fresh-cut Produce:Post-processing Controls.
- Packaging
- Modified Atmosphere Packaging (MAP)
- Shelf-life
- Transportation and Storage
- Documentation
and Records
- Traceback and
Recall
- Additional
Information
- References
Appendices
- Notifying FDA
of a Recall
- Foodborne
Pathogens Associated with Fresh Fruits and Vegetables
- Pathogens Often
Transmitted by Food That Has Been Contaminated by Infected Employees
- Sources of
Microbial Contamination
- Potential Sources of Microbial Contamination (Figure 5)
- Examples of Scenarios That May Cause Microbial Contamination of the
Product (Figure 6)
- An Example of
Product/personnel Flow Patterns in a Fresh-cut Processing Plant (Figure 7)
I. Introduction
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.
II. Scope and Use
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.
III. Definitions
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.
IV. Primary Production and Harvesting of Fresh Fruits and Vegetables
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.
V. Personnel
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.
A. Worker Health and Hygiene
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.
1. Disease Control
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:
- Establishing a company policy that requires that employees report any
active case of illness to supervisors before beginning work
- Training supervisors to know the typical signs and symptoms of infectious
disease
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.
- Maintaining an adequate supply of bandages that provide protection from
any wound
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.
2. Cleanliness
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:
- Maintaining adequate personal cleanliness
- Washing hands frequently and effectively and sanitizing hands if needed
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:
- Before beginning work, especially if the employee has direct contact
with fresh produce
- Before putting on a new pair of disposable or non-disposable gloves and
after removing the gloves
- After touching human body parts or anything else except food and food
contact surfaces
- After using the toilet; after coughing, sneezing, using a handkerchief
or tissue
- After using tobacco, eating, or drinking
- After engaging in any activity that may contaminate hands, such as
taking out the garbage, handling cleaning chemicals, handling incoming
produce that is, as yet, unwashed
- After caring for or touching animals
- Before returning to a workstation
- Washing and sanitizing non-disposable gloves before starting work, and as
needed
- Changing disposable gloves whenever contamination is a possibility
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.
- Wearing appropriate attire on the job
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.
- Not engaging in certain activities where food may be exposed or utensils
are washed
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.
B. Training
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.
1. Training for Worker Health and Hygiene
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
How to wash your hands
Use soap and warm running water
▼
Wet hands
▼
Apply soap
▼
Vigorously rub hands up to elbows for 20 seconds
▼
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.
2. Training on Employee Roles and Responsibilities
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.
3. Training on Sanitation Principles and Sanitary Practices
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
Use sanitizers properly
Hand
sanitizing stations
- After hand washing, sanitize your clean hands with a sanitizer solution
- Allow hands to air dry
- Wash and sanitize nondisposable gloves before wearing
- Re-sanitize your hands after touching non-food contact surfaces
Foot baths and sanitizer sprays
- When entering any area where fresh produce or fresh-cut produce is
present, walk through a foot bath containing sanitizer
- All carts, forklifts, and other equipment entering the processing area
should be passed through the sanitizer bath.
Sanitizer
maintenance
- Maintain effectiveness of chemical concentrations in hand sanitizing units
and foot baths.
- Change hand sanitizing solutions at least once per shift. (Your monitoring
program will tell you if more frequent changes are needed.)
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
Cleaning and sanitizing steps*
- Remove heavy debris from floors with brooms or shovels and dry clean
processing equipment, if needed
- Pre-rinse the equipment with adequate quality water
- Foam and scrub the equipment with an effective cleaner
- Rinse the equipment with adequate quality water
- Clean debris from floor
- Rinse floor and drains with adequate quality water using a low
pressure/low volume hose
- Use dedicated brushes to scrub floor and drain with an effective cleaner,
applying adequate quality water as needed
- Thoroughly rinse floors and drain using a low pressure/low volume hose
with adequate quality water
- Remove excess water from floors
- Sanitize (according to manufacturer directions) the equipment and floors*
* 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.
VI. Building and 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.
A. Building
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.
1. External/Internal Structures
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:
- Adequately screening open windows, vents, fans, and similar features to
prevent pest (insect, bird, rodent, reptile) entry
- Closing all exterior doors and entrances when not in use and forming an
adequate seal when exterior doors and entrances are closed
- Properly constructing all walls, ceilings, windows, doors, floors, and
overheads (e.g., pipes, air vents, and lights) and maintaining them in good
condition (e.g., no cracks, rust, breakage, missing parts, or dips allowing
puddles to form) so that they do not harbor pests or pathogens
- Designing properly sloping floors to drains (¼ inch per foot), and sealing
and keeping them in good repair so as to provide for adequate drainage
- Designing floor drains to prevent the accumulation of water in or around
the drain, and making drains accessible for cleaning
- Fitting floor drains with seals and grates capable of preventing insect
and rodent entry
- Using floor flumes with caution due to the potential for water aerosol
contamination of the room air and nearby equipment surfaces
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.
- Constructing trench drains for automatic flushing
- Using under-floor drains in fresh-cut produce processing areas
- Designing collection areas for waste stream water to prevent product and
equipment contamination
- Designing pipelines to avoid pipe and wall condensation from becoming a
source of contamination
Where overhead condensate cannot be prevented, we recommend that catch pans
be utilized and cleaned on a regular basis.
- Avoiding wood construction materials wherever possible
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.
- Using protective guards for light fixtures to prevent broken glass from
falling into 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:
- Using different equipment cleaning rooms for raw produce equipment and for
fresh-cut produce equipment
- Having rest rooms that open into a location other than the processing area
- Locating the door to the outside in an area other than into a processing
area
- Having a microbiology lab that opens into an area other than into a
processing area
- Storing in-process and raw produce materials in different rooms
- Establishing dedicated cold rooms for raw product and processed product
- Locating hand washing and sanitizing facilities to facilitate regular and
appropriate use by employees
- Locating footbaths and foot mats containing disinfectant at all entrances
and exits to all production and finished product storage areas.
We recommend the following practices that use flow of personnel,
product, equipment, or air to reduce the potential for contamination:
We also recommend that air intake for the facility be located to minimize
contamination of the intake air by:
- Keeping the number of entrances and exits to the processing areas to a
minimum
- Restricting the movement of lift trucks, bins, totes, maintenance tools,
cleaning implements, clothing, and people from receiving and storage zones to
processing and packaging areas
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.
B. Equipment Design, Construction, and Maintenance
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.
1. Equipment Design and Construction
We recommend the following to facilitate cleaning and help ensure that
fresh-cut produce is not contaminated during the processing operation:
- Using smooth, non-absorbent, sealed, and easily cleanable food contact
surfaces that are sloped to drain freely and made of durable, non-corrosive
nontoxic materials
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.
- Constructing catwalks with open grating and locating the catwalks so they
do not pass over areas of exposed fresh or fresh-cut produce or
food-contact surfaces
- Designing equipment in the processing area to prevent water collection
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.
- Elevating food-contact surfaces sufficiently above the floor (with
accessibility for cleaning) to prevent contamination from floor splashes
- Installing stationary equipment away from floor drains to allow
accessibility to drains for cleaning and to prevent contamination of the
equipment
2. Equipment Maintenance
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:
- Having appropriately trained personnel perform maintenance and calibration
of equipment
We recommend that maintenance personnel who work in the processing or
packaging areas comply with the hygiene requirements for production
employees.
- Installing, calibrating, and maintaining temperature measuring or
recording devices as necessary to ensure accuracy
- Frequently sharpening knives, if used, including retractable knives, and
disinfecting before use
We recommend that knives be replaced if they cannot be maintained in a
sanitary condition or if damaged.
- Frequently inspecting cutting blades and belts during processing
operations for damage, product residue build up, or cleaning needs
We recommend that blades be removed and cleaned separately, and remaining
equipment parts disassembled (if possible) and cleaned on a regular basis.
- Operating metal detectors in accordance with the manufacturer's
instructions and checking for proper functioning at least daily to ensure
effective detection of metal and removal of affected product
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.
- Calibrating flow meters, such as chlorine feed rate meters and gas
pressure meters, daily to ensure accuracy
- Examining air filters for plant air (intake air) and compressed air and
changing at least as often as the manufacturer specifies, or more frequently
if there is an indication of a problem, such as a positive result from routine
microbiological monitoring
VII. Sanitation Operations
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.
A. Sanitation Program
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:
- Establishing sanitation standard operating procedures (SSOPs), including a
cleaning procedure and schedule for all equipment, storage areas, fresh and
fresh-cut produce production areas, air systems, and water storage areas
- Developing regular cleaning and sanitizing schedules
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
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 |
- Including as part of the sanitation schedule the name of the employee (or
alternate when primary employee is absent) responsible for the activity, the
equipment to be cleaned and how to disassemble it, the frequency of cleaning,
procedures for cleaning (including type and concentration of cleaning compound
and sanitizer), time and temperature requirements, cleaning solution flow rate
(pressure) if applicable, and the name of an employee responsible for
verifying the program effectiveness by inspection
- Cleaning the condenser unit, drip pans, and hoses of refrigerators
- Keeping cold storage as dry as possible
- After cleaning and sanitizing, visually inspecting the area cleaned for
product residue and conducting routine microbiological tests (conventional or
rapid microbiological methods, such as total count or bioluminescence) to
verify effectiveness of the cleaning and sanitizing program
- When reassembling sanitized equipment, placing the equipment parts on a
sanitary mat and not on the floor
- Cleaning and sanitizing all processing equipment, facility utilities
(e.g., air system, water system), and food-contact surfaces after maintenance
work and prior to use in production
- Cleaning and sanitizing processing equipment and food-contact surfaces
between the processing of different commodities
- Cleaning and sanitizing equipment during processing operations, if needed,
to prevent contamination (e.g., if there is residue build up on the equipment)
- Using floor drain brushes ¼ inch smaller than the diameter of the drain
opening or a splash guard to help prevent splashing during cleaning
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.
- Regularly inspecting tools for cutting, slicing, and shredding for damage
that could impair cleaning and sanitizing them
We recommend replacing a tool if it cannot be fixed so that it can be
adequately cleaned.
1. Cleaning and Sanitizing Chemicals
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:
- Using adequate quality water for cleaning and sanitizing at temperatures
appropriate for the chemicals used
- Using toxic chemicals for cleaning operations in accordance with the
manufacturer's instructions and in accordance with relevant Federal, State,
and local government regulations
- Clearly labeling toxic chemicals
- Storing toxic chemicals and pesticides in a manner that protects against
contamination of food, food-contact surfaces, and food-packaging materials and
in accordance with relevant Federal, State, and local government regulations
- Monitoring the effectiveness of cleaning and sanitizing chemicals by
visual inspection and environmental testing (especially grooves and niches)
for microbial growth
2. Pest Control
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.
B. Sanitary Facilities and Controls
1. Employee Changing Facilities and Toilets
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.
2. Hand Washing Facilities
FDA recommends the following practices:
- Providing a sink, hot and cold adequate quality water, effective hand
cleaning preparations (e.g., liquid soap), sanitary hand drying devices (such
as disposable paper towels), and a waste container
- Installing water control devices (such as knee, foot, or elbow faucet
controls) that will protect against recontamination of clean hands
- Posting signs that show proper hand washing instructions
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.
3. Air Quality
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:
- Filtering air coming into the plant using at a minimum, a final filter (if
more than one air filter is used) with an efficiency(4) of 90-95% at 1 micron
- Using air flow barriers (such as air curtains) to isolate receiving and
shipping areas that may be open to the outside environment
- Filtering compressed air (such as oxygen, N2, and
CO2 used in modified atmospheric packaging) when such air contacts
fresh produce and in packaging contact areas using a 0.3 micron filter (with
an efficiency of approximately 75%)
4. Water Supply
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:
5. Environmental Monitoring
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:
VIII. Production and Process Controls
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.
A. Product Specifications
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.
B. Receipt and Inspection of Ingredients
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:
C. Specific Processing Steps
1. Preparation for Processing
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:
- Inspecting fresh produce for field contaminants that may not have been
noticed during the incoming produce inspection
- Removing from the processing stream damaged or decomposed produce,
extraneous matter, and produce that appears to be contaminated by animal
feces, fuels, machine grease, or oil
- Removing as much dirt as possible from incoming produce
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
- Using metal detectors or magnets to detect any metal fragments, such as
broken knife blades or machinery nuts and bolts, in incoming produce
We recommend that metal detectors be set up to reject product from the
normal product flow if a problem is detected.
2. Processing Water
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:
a. Maintaining Water Quality
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:
- Following the manufacturer's directions for correct mixing of
antimicrobial agents to obtain effective concentrations and to minimize safety
hazards
We recommend that the manufacturer's suggested or allowable levels of
antimicrobial chemicals in wash water not be exceeded.
- Monitoring disinfectant levels frequently in water used for various
processing operations to ensure appropriate concentrations are maintained
Test strips or test kits may be useful for monitoring some disinfectant
levels.
- Minimizing the build up of organic material in wash water
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.
- Following contact between produce and processing water containing
antimicrobial chemicals with a clean water rinse to remove any treatment
residues where appropriate and according to and consistent with the
manufacturer's directions
b. Washing Fresh Produce
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:
- Using a series of washes
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.
- Using appropriate wash methods
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.
- Maintaining the efficacy of wash treatments
- Using wash water of an appropriate temperature
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.
3. Precooling and Cold Storage
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:
- Preventing condensate and defrost water from evaporator-type cooling
systems (e.g., vacuum cooling, cold storage) from dripping onto fresh and
fresh-cut produce
- Designing and maintaining forced air cooling to avoid contaminating fresh
produce
In most instances, vacuum cooling or use of fans poses the lowest risk of
microbial contamination
- After cooling, holding produce in cold storage (≤ 40°F (≤ 4°C)) or at a temperature that will promote
quality and minimize microbial growth until processed and shipped
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.
- Monitoring and maintaining temperatures in cold storage rooms at 40°F or
lower
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).
- Storing similar commodities together (unprocessed product next to
unprocessed product and finished product next to finished product) to avoid
cross-contamination
- Using an appropriate inventory system to ensure first in first out (FIFO)
use and shipment of raw materials and finished products
4. Washing Fresh-cut Produce: Post-processing Controls
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:
- Removing as much excess water as possible from processed produce through
draining methods such as spin drying
- Keeping containers used to hold produce (e.g., spin baskets) from direct
contact with the floor and away from containers that have had direct contact
with the floor (e.g., in cold storage)
- Keeping containers of produce dripping wash water from passing over other
produce
D. Packaging
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:
- Maintaining an effective system to prevent the use of contaminated,
damaged, or defective cartons and totes in order to prevent microbial
contamination of the fresh-cut produce during packing operations
- Establishing specifications for all product packaging
- Overseeing incoming materials and gases used in packaging to confirm that
they meet those specifications
- Rejecting packaging materials that are damaged or contaminated
- Determining the appropriate gas mixtures for products
- Using containers and cartons for their intended purpose only
For example, we recommend against using a carton designated for holding
fresh-cut produce to hold tools.
- Using an effective cleaning system where all containers, especially reused
containers, are cleaned and sanitized, as necessary, immediately before use
- Storing packaging containers and other packaging materials in a manner so
as to protect them from contamination, such as away from pests, dirt, cleaning
chemicals, and water condensation from overhead equipment and structures
- Using an appropriate inventory system to ensure FIFO use of packaging
containers and other packaging materials
To help achieve proper rotation of inventory, we recommend that all pallets
be dated upon receipt.
- Establishing and controlling important packaging criteria, such as the
fill weight of fresh-cut produce, gas mixture, flushing time, and package
sealing
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.
- Maintaining a program to identify and correct situations where damage to
containers may potentially occur
- Labeling all finished fresh-cut produce products with recommended storage
instructions (e.g., "Keep Refrigerated") or storage temperature to inform all
persons handling the product of the recommended storage conditions
1. Modified Atmosphere Packaging (MAP)
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.
2. Shelf-life
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:
E. Transportation and Storage
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:
- Keeping finished products at refrigeration temperatures (≤ 40°F (≤ 40°C)) during storage,
transportation, and display for sale to minimize the potential for growth of
microbial pathogens
- Equipping refrigerated transportation vehicles and storage rooms with
accurate temperature measuring devices, preferably including a recording
device
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.
- Shipping fresh-cut produce products on a FIFO basis to minimize storage
time
- Ensuring that for refrigerated vehicles, the refrigeration equipment is
designed to circulate cold air uniformly throughout the vehicle, taking the
load layout into consideration
- Placing fresh-cut produce products in storage facilities and
transportation vehicles in a manner that allows for proper air circulation
- Transporting and storing fresh-cut produce products in vehicles and
containers that are dedicated to carrying food products and have been treated
by a process that is effective in destroying vegetative cells of the
microorganism of public health significance
- Inspecting transportation vehicles and containers for debris, soil, and
off-odors prior to loading to ensure that they are suitable for the
transportation of fresh-cut produce
- Loading and unloading fresh-cut produce in a manner that minimizes damage
and microbial contamination
IX. Documentation and Records
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:
- Water quality and supply records
- Water treatment and monitoring records
- Employee training records
- Temperature control records
- Equipment monitoring and maintenance records
- Calibration records
- Sanitation records
- Product processing batch records
- Corrective action records
- Pest control records
- Distribution records
X. Traceback and Recall
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.
XI. Additional Information
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)
6) NACMCF HACCP
guidelines
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
XII. References
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.
Appendices
- Notifying FDA of a Recall
- Foodborne Pathogens Associated with Fresh Fruits and Vegetables
- Pathogens Often Transmitted by Food That Has Been Contaminated by Infected
Employees
- Sources of Microbial Contamination
- Potential Sources of Microbial Contamination
- Scenarios That May Cause Microbial Contamination of the Product
- An Example of Product/personnel Flow Patterns in a Fresh-cut Processing
Plant
Appendix A
Notifying FDA of 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 and that the notification include:
- the identity of the product involved (i.e., an adequate description of the
type of food to include brand name and specific variety, date of releasing the
food, the lot or code number or other identifier of the implicated product,
the quantity and how the food is packaged);
- the reason for the recall and the date and circumstances under which the
product deficiency or possible deficiency was discovered;
- an evaluation of the risk associated with the product; the total amount of
implicated product units processed and the time span of processing;
- the total amount of product in inventory and the total amount of product
distributed; the distribution information including the number of direct
accounts and, where necessary, the identity of the direct accounts;
- a copy of the firm's recall communication if any has issued, or the
proposed communication if none has issued, the proposed strategy for
conducting the recall; and
- the name and telephone number of the firm official who should be contacted
concerning the recall
For further FDA guidance on recalls, see 21 CFR 7.40-7.59.
Appendix B
Foodborne Pathogens Associated with Fresh Fruits and Vegetables
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)
- Cyclospora infections (cyclosporiasis) are caused by the
protozoan Cyclospora cayetanensis. The infections are spread by
ingestion of food or water contaminated with infected stool. Direct
person-to-person transmission is unlikely because excreted oocysts require
days to weeks under favorable environmental conditions to become infectious
(i.e., sporulate). The natural host for this parasite has not been identified;
however, contaminated water used for irrigation and pesticide application and
poor worker hygiene have been suggested as the most likely routes of
contamination. The infection (cyclosporiasis) is commonly characterized by
watery diarrhea, loss of appetite, weight loss, abdominal bloating and
cramping, low-grade fever, nausea, vomiting, and fatigue. Relapses and
asymptomatic infections can occur. Outbreaks of cyclosporiasis have been
linked to fresh raspberries, mesclun lettuce, and basil or basil-containing
products. (For more information: Bad Bug Book, Cyclospora
cayetanensis)
- E. coli O157:H7 is one of the enterovirulent
strains of Escherichia coli. It is one of a minority of E. coli strains capable of causing human illness. Most E. coli strains are
nonpathogenic, found in the intestines of all animals, including humans, and
function by suppressing harmful bacterial growth. However, there are a
minority of strains such as serotype O157:H7 that may cause human illness. E. coli O157:H7 is a life-threatening bacterium that produces large
quantities of potent toxins that can cause severe damage to the lining of the
intestines. Human illness associated with E. coli O157:H7 infection may
include nonbloody diarrhea, hemorrhagic colitis, hemolytic uremic syndrome
(HUS), or thrombotic thrombocytopenic purpura (TTP). Hemorrhagic colitis
progresses from abdominal cramps to nonbloody diarrhea to bloody diarrhea. HUS
largely affects young children and is the leading cause of acute renal failure
in children. TTP is a rare syndrome of E. coli O157:H7 infection, which
largely affects adults and resembles HUS histology. E. coli O157:H7
outbreaks have been associated with meat (especially undercooked or raw
hamburger), fresh produce, raw milk, unpasteurized apple juice, coleslaw, and
contaminated water (Ref. 9).
- Hepatitis A virus may cause a serious, and sometimes
fatal, disease. Hepatitis attributed to hepatitis A virus is characterized by
sudden onset of fever, malaise, nausea, anorexia, and abdominal discomfort,
followed after several days by jaundice. Hepatitis A virus is excreted in
fecal material and is transmitted by the fecal-oral route (including by
consumption of contaminated food). The most common food sources of Hepatitis A
are shellfish and salads. Hepatitus A may also be transmitted through drinking
water. (For more information: Bad Bug Book, Hepatitis A Virus)
- Listeria monocytogenes[6] is a bacterium that causes listeriosis, a serious
disease in pregnant women, the elderly, and those with weakened immune
systems. L. monocytogenesis widespread in the environment (i.e., in
soil, water, and decaying vegetation) and has been isolated from domestic
animals, humans, raw produce, food processing environments (particularly cool
damp areas), and home refrigerators. Outbreaks of listeriosis in the United
States have been associated with the consumption of hot dogs, deli or luncheon
meats, pate, salami, Mexican-style soft cheeses and butter made with raw milk,
and raw vegetables (Ref. 10). (For
more information: "Quantitative Assessment of
Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods")
- Norovirus causes a non-fatal disease manifested by
gastrointestinal upset, headache, low grade fever, nausea, vomiting, and
diarrhea. Norovirus is transmitted by the fecal-oral route most commonly via
contaminated water or contaminated foods. Shellfish and salad ingredients are
the foods most often implicated in norovirus outbreaks. (For more information: Bad Bug Book, The
Norwalk virus family)
- Salmonella is the second most common cause of foodborne
illness (salmonellosis) in the United States and is responsible for millions
of cases of illness each year. Typical symptoms of salmonellosis are nausea,
vomiting, abdominal cramps, fever, mild diarrhea, and headache; these symptoms
usually last 6-48 hours. Salmonella outbreaks have been associated with the
consumption of raw and undercooked eggs, undercooked poultry and meat, dairy
products made with unpasteurized milk, shrimp, fresh produce, and
unpasteurized fruit juice. (For more information: Bad Bug Book, Salmonella spp.
- Shigella spp. Humans are a natural reservoir for Shigella spp. The primary means of transmission of the shigellae
organism is by the fecal-oral route. Most cases of foodborne shigellosis are
attributed to the ingestion of food or water contaminated with fecal matter.
Contamination has often been associated with poor personal hygiene of food
workers. Typical symptoms include abdominal pain, cramps, diarrhea, fever,
vomiting, and blood, pus, or mucus in stools. Shigellosis outbreaks have been
associated with shredded lettuce, potato salad, green onions, parsley, cheese,
seafood, and poultry (Ref. 11). (For
more information: Bad Bug Book, Shigella spp.)
Appendix C
Pathogens Often Transmitted by Food that Has Been Contaminated
by Infected Employees*
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: *.
Appendix D
Figure 5. Potential sources of microbial contamination
- Ingredients
- Raw produce
- Fresh-cut produce
- Packaging materials
- Containers, films, lids, trays
- Processing aids
- Compressed air
- Untreated or inadequately treated wash water
- Ice
- Reused processing water
- Facility environment
- Ceilings, overhead structures, catwalks
- Rubber seals around doors (especially coolers)
- Drains
- Walls
- Standing water
- Wet insulation in walls or around pipes and cooling units
- Condensate
- Vacuum cleaner contents
- Hand washing areas (sinks) and restrooms
- Food contact surfaces
- Fibrous or porous type conveyor belts
- Filling or packaging equipment
- Equipment cleaning tools
- Slicers, dicers, shredders, blenders,
- Belts, peelers, collators
- Containers, bins, tubs, or baskets
- Hands, gloves, and outerwear
- Ice makers
- Utensils
- Nonfood-contact surfaces
- In-floor weighing equipment
- Hollow rollers for conveyors
- Trash cans and other such ancillary items
- Visible bearings within equipment
- Condensate drip pans
- Maintenance tools (wrenches, screw drivers, etc.)
- On/off switches
- Cracked hoses
- Equipment framework
- Wet rusting or hollow framework
- Poorly maintained compressed air filters
- Motor housing
- Forklifts, hand trucks, trolleys, racks
- Vacuum cleaners and floor scrubbers
Figure 6. Examples of Scenarios That May Cause Microbial Contamination of
the Product
- A processing line is moved or modified significantly.
- Used equipment is brought in from storage or another plant and installed
into the process flow.
- An equipment breakdown occurs.
- Construction or major modifications are made to a fresh-cut produce
processing area (e.g., replacing refrigeration units or floors, replacing or
building walls, modifications to sewer lines).
- An employee unfamiliar with the operation and microbial controls has been
hired or assigned to work or clean equipment in the processing areas.
- Personnel who handle fresh produce and fresh-cut produce touch surfaces or
equipment that are likely to be contaminated (e.g., floor, trash cans) and do
not change gloves or follow other recommended procedures before handling
product.
- Periods of heavy production make it difficult to change processing water
or clean food contact surfaces at the facility as scheduled.
- A drain backs up.
- Product is caught or hung up on equipment. Stagnant product in a system
can be a major source of microbial growth during production. FDA recommends
that equipment be modified to eliminate areas where product stops moving along
or through a processing line.
- There are frequent product changes on a packaging line which necessitate
changing packaging film, labels, forming pockets or molds, line speeds, etc.
- Personnel are used interchangeably for handling unprocessed produce and
finished fresh-cut product.
- There is increased production requiring wet cleaning of down lines in the
same room as lines running product.
- Equipment parts, tubs, screens, etc. are cleaned on the floor.
- Waste bins in the processing areas are not properly maintained, cleaned,
and sanitized. Personnel handling product may come into contact with these
items and then contaminate product and/or product contact surfaces.
Appendix E
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
FDA/Center for Food Safety & Applied Nutrition |
