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Appendix II - Proposed Draft Code of Hygienic Practice for the Primary Production, Harvesting and Packing of Fresh Fruits and Vegetables (at Step 5 of the Procedure)


INTRODUCTION
1. OBJECTIVES OF THE CODE
2. SCOPE, USE AND DEFINITIONS
3. PRIMARY PRODUCTION
4. PACKING ESTABLISHMENT: DESIGN AND FACILITIES
5. CONTROL OF OPERATION
6. PACKING ESTABLISHMENT: MAINTENANCE AND SANITATION
7. PACKING ESTABLISHMENT: PERSONNEL HYGIENE
8. TRANSPORTATION
9. PRODUCT INFORMATION AND CONSUMER AWARENESS
10. TRAINING
Annex I - Proposed Draft Annex for Sprout Production
Annex II - Proposed Draft Annex for Ready-to-Eat Fresh Pre-cut Fruits and Vegetables

INTRODUCTION

Scientific research over the last decades has shown that a diet rich in fruits and vegetables is protective against many cancers and lowers the occurrence of coronary heart disease. This recognition of the importance of routine consumption of fresh fruits and vegetables, together with a marked increase in the year-round availability of fresh fruits and vegetables from a global market, has contributed to the substantial increase in consumption of fresh fruits and vegetables over the past two decades. However, the recent increase in reports of food borne illness associated with fresh fruits and vegetables has raised concerns from public health agencies and consumers about the safety of these products.

1. OBJECTIVES OF THE CODE

This code addresses good agricultural practices (GAPs) and good manufacturing practices (GMPs) that will help control microbial, chemical and physical hazards associated with all stages of the production of fresh fruits and vegetables from primary production to packing. Particular attention is given to minimizing microbial hazards. The code provides a general framework of recommendations to allow uniform adoption by this sector rather than providing detailed recommendations for specific agricultural practices, operations or commodities. The fresh fruit and vegetable industry is very complex. Fresh fruits and vegetables are produced and packed under diverse environmental conditions. It is recognized that some of the provisions in this code may be difficult to implement in areas where primary production is conducted in small holdings, in both developed and developing countries and also in areas where traditional farming is practised. Therefore, the code is, of necessity, a flexible one to allow for different systems of control and prevention of contamination for different groups of commodities.

2. SCOPE, USE AND DEFINITIONS


2.1 SCOPE
2.2 USE
2.3 DEFINITIONS

2.1 SCOPE

This draft code of practice covers general hygienic practices for the primary production and packing of fresh fruits and vegetables cultivated for human consumption in order to produce a safe and wholesome product: particularly for those intended to be consumed raw. Specifically, this draft code is applicable to fresh fruits and vegetables grown in the field (with or without cover) or in protected facilities (hydroponic systems, greenhouses). It concentrates on microbial hazards and addresses physical and chemical hazards only in so far as these relate to GAPs and GMPs.

The Proposed Annex for Sprout Production is a supplement to this code and includes additional recommendations to cover the hygienic practices that are specific for the primary production of seeds for sprouting and the production of sprouts for human consumption.

The code does not provide recommendations for handling practices to maintain the safety of fresh fruits and vegetables at retail, food services or in the home. It excludes food products for which there is a specific Codex Alimentarius Code of Hygienic Practices.

2.2 USE

This document follows the format of the Codex Recommended International Code of Practice - General Principles of Food Hygiene- CAC/RCP 1-1969, Rev 3 (1997) and should be used in conjunction. It focuses upon hygienic issues that are specific to the primary production and packing of fresh fruits and vegetables. The major issues are covered in section 3. In other sections, the General Principles of Food Hygiene have been expanded where there are issues specific to primary production and packing. The Proposed Annex for Sprout Production provides additional recommendations specific for the primary production of seeds for sprouting and the production of sprouts for human consumption.

2.3 DEFINITIONS

Definitions of general expressions are included in the General Principles of Food Hygiene. For the purpose of this code, the following terms have the definition stated:

Agricultural inputs - any incoming material (e.g. seeds, fertilizers, water, agricultural chemicals, plant support, etc.) used for the primary production of fresh fruits and vegetables.

Agricultural worker - any person that undertakes cultivation, packing and/or harvesting of fresh fruits and vegetables.

Biological control - the use of competing biologicals (such as insects, microorganisms and/or microbial metabolites) for the control of mites, pests, plant pathogens and spoilage organisms.

Biosolids - Sludge and other residue deposits obtained from residual water treatment plants and from treatment applied to urban and industrial wastes (food industries or other types of industry).

Composting - a managed process in which organic materials are digested aerobically or anaerobically by microbial action.

Cultivation- any agriculture action or practise used by growers to allow and improve the growing conditions of fresh fruits or vegetables grown in the field (with of without cover) or in protected facilities (hydroponic systems, greenhouses).

Farm - any premise or establishment in which fresh fruits and/or vegetables are grown and harvested and the surroundings under the control of the same management.

Grower - the person responsible for the management of the primary production of fresh fruits and vegetables.

Harvester - the person responsible for the management of the harvesting of fresh fruits and vegetables.

Hazardous material - any compound which, at specific levels, has the potential to cause adverse health effects.

Hydroponics - a general term for the production of plants without soil in a water medium.

Manure - Animal excrement which may be mixed with litter or other material, and which may be fermented or otherwise treated.

Microbial hazards -pathogenic or other microorganisms at levels that have the potential to cause an adverse health effect.

Microorganisms -include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective, the term “microbial” is used.

Packer - the person responsible for the management of post-harvest processing and packing of fresh fruits and vegetables.

Packing -the action of putting fresh fruits and vegetables in a package. This may take place in a field or in an establishment.

Packing establishment - any indoor establishment in which fresh fruits and vegetables receive post-harvest treatment and are packaged.

Primary production - those steps involved in the growing and harvesting of fresh fruits and vegetables such as planting, irrigation, application of fertilizers, application of agricultural chemicals, etc.

Definitions of Water:
Clean water - water that does not compromise food safety in the circumstances of its use.

Potable water - water which meets the quality standards of drinking water such as described in the WHO Guidelines for Drinking Water Quality.

[Re-used irrigation water]

[Recycled water]

3. PRIMARY PRODUCTION


3.1 ENVIRONMENTAL HYGIENE
3.2 HYGIENIC PRIMARY PRODUCTION OF FRESH FRUITS AND VEGETABLES
3.3 HANDLING, STORAGE AND TRANSPORT
3.4 CLEANING, MAINTENANCE AND SANITATION

Fresh fruits and vegetables are grown and harvested under a wide range of climatic conditions, using various agricultural inputs and technologies, and on farms of varying sizes. Biological, chemical and physical hazards may therefore vary significantly from one type of production to another. In each primary production area, it is necessary to consider the particular agricultural practices that promote the production of safe fresh fruits and vegetables, taking into account the conditions specific to the primary production area, type of products, and methods used. Procedures associated with primary production should be conducted under hygienic conditions and should minimize potential hazards to health due to the contamination of fresh fruits and vegetables.

3.1 ENVIRONMENTAL HYGIENE

Where possible, potential sources of contamination from the environment should be identified. In particular, primary production should not be carried out in areas where the presence of potentially harmful substances would lead to an unacceptable level of such substances in or on fresh fruits and vegetables after harvest.

Where possible, growers should evaluate the previous uses of the sites (indoor and outdoor) as well as adjoining sites in order to identify potential microbial, chemical and physical hazards. The potential for other types of contamination (e.g., from agricultural chemicals, hazardous wastes, etc.) should also be considered. The evaluation process should include the following:

If previous uses cannot be identified, or the examination of the growing or adjoining sites leads to the conclusion that potential hazards exist, the sites should be analysed for contaminants of concern. If the contaminants are at excessive levels and corrective or preventative actions have not been taken to minimize potential hazards, the sites should not be used until correction/control measures are applied.

3.2 HYGIENIC PRIMARY PRODUCTION OF FRESH FRUITS AND VEGETABLES


3.2.1 Agricultural input requirements
3.2.2 Indoor facilities associated with growing and harvesting
3.2.3 Personnel health, hygiene and sanitary facilities
3.2.4 Equipment associated with growing and harvesting

3.2.1 Agricultural input requirements

Agricultural inputs should not contain microbial or chemical contaminants at levels that may adversely affect the safety of fresh fruits and vegetables and taking into consideration the WHO guidelines on the safe use of wastewater and excreta in agriculture and aquaculture as appropriate.

3.2.1.1 Water for primary production

3.2.1.1.1 Water for irrigation and harvesting

Water used for agricultural purposes (e.g. irrigation, pest control, application of chemical products) should be of suitable quality for its intended use. Special attention to water quality should be considered for the following situations:

3.2.1.1.2 Water for fertilizers, pest control and other agricultural chemicals

Water used for the application of water-soluble fertilizers and agricultural chemicals in the field and indoors should not contain microbial contaminants at levels that may adversely affect the safety of fresh fruits and vegetables. Special attention to the water quality should be considered when using fertilizer and agricultural chemical delivery techniques (e.g. sprinklers) that expose the edible portion of fresh fruits and vegetables directly to water especially close to harvest time.

3.2.1.1.3 Hydroponic water

Plants grown in hydroponic systems absorb nutrients and water at varying rates, constantly changing the composition of the re-circulated nutrient solution. Because of this:

3.2.1.2 Manure, biosolids and other natural fertilizers

The use of manure, biosolids and other natural fertilizers in the production of fresh fruits and vegetables should be managed to limit the potential for microbial, chemical and physical contamination. Manure, biosolids and other natural fertilizers contaminated with heavy metals or other chemicals at levels that may affect the safety of fresh fruits and vegetables should not be used. Where necessary, in order to minimize microbial contamination the following practices should be considered:

3.2.1.3 Soil

Soils should be evaluated for the occurrence of levels of hazards that may compromise the safety of crops. If the evaluation concludes that such levels exist, control measures should be implemented to reduce hazards to acceptable levels. If this cannot be achieved by available control measures, growers should not use these soils for primary production.

3.2.1.4 Agricultural chemicals

3.2.1.5 Biological control

Environmental and consumer safety should be considered when using competing biological organisms and/or their metabolites applied for the control of pests, mites, plant pathogens and spoilage organisms in fresh fruits and vegetables.

Growers should use only biological controls which are authorized for the cultivation of the specific fruit or vegetable and should use them according to the manufacturer’s instructions for the intended purpose.

3.2.2 Indoor facilities associated with growing and harvesting

For operations where fresh fruits and vegetables are grown indoors (greenhouses, hydroponic culture, etc.) suitable premises should be used.

3.2.2.1 Location, design and layout

3.2.2.2 Water supply

Where appropriate an adequate supply of potable water with appropriate facilities for its storage and distribution should be available in indoor primary production facilities. Non-potable water should have a separate system. Non-potable water systems should be identified and should not connect with, or allow reflux into, potable water systems.

3.2.2.3 Drainage and waste disposal

Adequate drainage and waste disposal systems and facilities should be provided. These systems should be designed and constructed so that the risk of contaminating fresh fruits and vegetables, agricultural inputs or the potable water supply is avoided.

3.2.3 Personnel health, hygiene and sanitary facilities

Hygiene and health requirements should be followed to ensure that personnel who come directly [or indirectly] into contact with fresh fruits and vegetables during or after harvesting are not likely to contaminate them. Visitors should, where appropriate, wear protective clothing and adhere to the other personal hygiene provisions in this section.

3.2.3.1 Personnel hygiene and sanitary facilities

Personnel hygiene and sanitary facilities should be available to ensure that an appropriate degree of personal hygiene can be maintained. [As far as possible,] such facilities should:

3.2.3.2 Health status

People known, or suspected, to be suffering from, or to be a carrier of a disease or illness likely to be transmitted through fresh fruits and vegetables, should not be allowed to enter any food handling area if there is a likelihood of their contaminating fresh fruits and vegetables. Any person so affected should immediately report illness or symptoms of illness to the management.

3.2.3.3 Personal cleanliness

Agricultural workers who have direct contact with fresh fruits and vegetables should maintain a high degree of personal cleanliness and, where appropriate, wear suitable protective clothing and footwear. Cuts and wounds should be covered by suitable waterproof dressings when personnel are permitted to continue working.

Personnel should wash their hands when handling fresh fruits and vegetables or other material that comes in contact with them. Personnel should wash their hands before starting work involving the handling of fruits and vegetables, each time they return to handling areas after a break, immediately after using the toilet or after handling any contaminated material where this could result in contamination of fresh fruits and vegetables.

3.2.3.4 Personal behaviour

Agricultural workers should refrain from behaviour which could result in the contamination of food, for example: smoking, spitting, chewing gum or eating, or sneezing or coughing over fresh, unprotected fresh fruits and vegetables.

Personal effects such as jewellery, watches, or other items should not be worn or brought into fresh fruit and vegetable production areas if they pose a threat to the safety and suitability of the food.

3.2.4 Equipment associated with growing and harvesting

As required, growers and harvesters should follow the technical specifications recommended by the equipment manufacturers for their proper usage and maintenance. Growers and harvesters should adopt the following sanitary practices:

3.3 HANDLING, STORAGE AND TRANSPORT


3.3.1 Prevention of cross-contamination
3.3.2 Storage and transport from the field to the packing facility

3.3.1 Prevention of cross-contamination

During the primary production and post-harvest activities, effective measures should be taken to prevent cross-contamination of fresh fruits and vegetables from agricultural inputs or personnel who come directly or indirectly into contact with fresh fruits and vegetables. To prevent the risk of cross-contaminating fresh fruits and vegetables, growers, harvesters and their employees should adhere to the recommendations presented elsewhere in section 3 of this code and the following:

3.3.2 Storage and transport from the field to the packing facility

Fresh fruits and vegetables should be stored and transported under conditions which will minimize the potential for microbial, chemical or physical contamination. The following practices should be adopted:

3.4 CLEANING, MAINTENANCE AND SANITATION


3.4.1 Cleaning programs
3.4.2 Cleaning procedures and methods
3.4.3 Pest control systems
3.4.4 Waste management

Premises and harvesting equipment should be kept in an appropriate state of repair and condition to facilitate cleaning and disinfection. Equipment should function as intended to prevent contamination of fresh fruits and vegetables. Cleaning materials and hazardous substances such as agricultural chemicals should be specifically identifiable and kept or stored separately in secure storage facilities. Cleaning materials and agricultural chemicals should be used according to manufacturer’s instructions for their intended purpose.

3.4.1 Cleaning programs

Cleaning and disinfection programs should be in place to ensure that any necessary cleaning and maintenance is carried out effectively and appropriately. Cleaning and disinfection systems should be monitored for effectiveness and should be regularly reviewed and adapted to reflect changing circumstances. Specific recommendations are as follows:

3.4.2 Cleaning procedures and methods

The appropriate cleaning methods and materials will depend on the type of equipment and the nature of the fruit or vegetable. The following procedure should be adopted:

3.4.3 Pest control systems

When primary production is carried out in indoor establishments (e.g. greenhouses), the recommendations of the General Principles of Food Hygiene, section 6.3 should be followed with respect to pest control.

3.4.4 Waste management

Suitable provision must be made for the storage and removal of waste. Waste must not be allowed to accumulate in fresh fruit and vegetable handling and storage areas or the adjoining environment. Storage areas for waste should be kept clean.

4. PACKING ESTABLISHMENT: DESIGN AND FACILITIES

Refer to the General principles of Food Hygiene.

5. CONTROL OF OPERATION


5.1 CONTROL OF FOOD HAZARDS
5.2 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS
5.3 INCOMING MATERIAL REQUIREMENTS
5.4 PACKING
5.5 WATER USED IN THE PACKING ESTABLISHMENT
5.6 MANAGEMENT AND SUPERVISION
5.7 DOCUMENTATION AND RECORDS
5.8 RECALL PROCEDURES AND TRACEBACK

5.1 CONTROL OF FOOD HAZARDS

Refer to the General principles of Food Hygiene.

5.2 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS


5.2.1 Time and temperature control
5.2.2 Specific process steps
5.2.3 Microbiological and other specifications
5.2.4 Microbial cross-contamination
5.2.5 Physical and chemical contamination

5.2.1 Time and temperature control

Refer to the General principles of Food Hygiene.

5.2.2 Specific process steps

5.2.2.1 Post-harvest water use

Water quality management will vary throughout all operations. Packers should follow GMPs to prevent or minimize the potential for the introduction or spread of pathogens in processing water. The quality of water used should be dependent on the stage of the operation. For example, clean water could be used for initial washing stages, whereas water used for final rinses should be of potable quality. [Refer to Proposed Draft Guidelines for the Hygienic Reuse of Processing Water in Food Plants.]

5.2.2.2 Chemical treatments

5.2.2.3 Cooling of fresh fruits and vegetables

5.2.2.4 Cold storage

5.2.3 Microbiological and other specifications

Refer to the General principles of Food Hygiene.

5.2.4 Microbial cross-contamination

Refer to the General principles of Food Hygiene.

5.2.5 Physical and chemical contamination

Refer to the General principles of Food Hygiene.

5.3 INCOMING MATERIAL REQUIREMENTS

Refer to the General principles of Food Hygiene.

5.4 PACKING

Refer to the General principles of Food Hygiene.

5.5 WATER USED IN THE PACKING ESTABLISHMENT

Refer to the General principles of Food Hygiene.

5.6 MANAGEMENT AND SUPERVISION

Refer to the General principles of Food Hygiene.

5.7 DOCUMENTATION AND RECORDS

Where appropriate, records of processing, production and distribution should be kept long enough to facilitate a trace back and food borne illness investigation, if required. This period could be much longer than the shelf life of fresh fruits and vegetables. Documentation can enhance the credibility and effectiveness of the food safety control system.

5.8 RECALL PROCEDURES AND TRACEBACK

Refer to the General principles of Food Hygiene.

In addition, where appropriate:

6. PACKING ESTABLISHMENT: MAINTENANCE AND SANITATION

Refer to the General principles of Food Hygiene.

7. PACKING ESTABLISHMENT: PERSONNEL HYGIENE

Refer to the General principles of Food Hygiene.

8. TRANSPORTATION

Refer to the General principles of Food Hygiene and to the Code of Hygienic Practice for the Transport of Food in Bulk and Semi-Packed Food.

9. PRODUCT INFORMATION AND CONSUMER AWARENESS

Refer to the General principles of Food Hygiene.

10. TRAINING


10.1 AWARENESS AND RESPONSIBILITIES
10.2 TRAINING PROGRAMMES

Refer to the General principles of Food Hygiene except for section 10.1 and 10.2.

10.1 AWARENESS AND RESPONSIBILITIES

Personnel associated with growing and harvesting should be aware of GAPs, good hygienic practices and their role and responsibility in protecting fresh fruits and vegetables from contamination or deterioration. Agricultural workers should have the necessary knowledge and skills to enable them to carry out agricultural activities and to handle fresh fruits and vegetables and agricultural inputs hygienically.

Personnel associated with packing should be aware of GMPs, good hygienic practices and their role and responsibility in protecting fresh fruits and vegetables from contamination or deterioration. Packers should have the necessary knowledge and skills to enable them to perform packing operations and to handle fresh fruits and vegetables in a way that minimizes the potential for microbial, chemical, or physical contamination.

All personnel who handle cleaning chemicals or other potentially hazardous chemicals should be instructed in safe handling techniques.

10.2 TRAINING PROGRAMMES

Factors to take into account in assessing the level of training required in growing, harvesting and packing activities include:

Topics to be considered for training programmes include, but are not limited to, the following:

Annex I - Proposed Draft Annex for Sprout Production


INTRODUCTION
1. OBJECTIVES OF THE ANNEX
2. SCOPE, USE AND DEFINITION
3. PRIMARY PRODUCTION OF SEEDS
4. ESTABLISHMENT FOR SPROUT PRODUCTION
5. CONTROL OF OPERATION
6. ESTABLISHMENT: MAINTENANCE AND SANITATION
7. ESTABLISHMENT: PERSONAL HYGIENE
8. TRANSPORTATION
9. PRODUCT INFORMATION AND CONSUMER AWARENESS
10. TRAINING

INTRODUCTION

In recent years the popularity of sprouted seeds has increased dramatically and are favoured by many for their nutritional value. However, the recent increase in reports of food borne illness associated with raw sprouts has raised concerns from public health agencies and consumers about the safety of these products

The microbial pathogens associated with sprouted seeds are for example Salmonella spp, pathogenic E. coli, Listeria monocytogenes, and Shigella spp. Outbreak investigations have indicated that microorganisms found on sprouts most likely originate from the seeds. Most seeds supplied to sprout producers are produced primarily for field planting where the good agricultural practices (GAP) necessary to prevent microbial contamination of seeds intended for sprouting are not followed, especially through the misuse of natural fertilizers or contaminated irrigation water. As a result, the seeds may be contaminated in the field or during harvesting, storage or transportation. Typically, the germination process in sprout production involves keeping seeds warm and moist for two to ten days. In these conditions, if low levels of microbial contaminants are present on seeds, they can quickly reach levels high enough to cause illness.

The scientific literature proposes seed disinfection treatments which can achieve different levels of pathogen reduction. There is currently no treatment available that can guarantee pathogen free seeds. Research is in progress to find efficient disinfection treatments which would provide sufficient pathogen reduction on seeds especially if pathogens are internalized.

1. OBJECTIVES OF THE ANNEX

This present annex recommends control measures to occur in two areas: during seed production and during sprout production. During seed production, conditioning and storage, the application of GAPs and good hygienic practices are aimed at preventing microbial pathogen contamination of seeds. During sprout production, the seed disinfection step is aimed at reducing potential contaminants and the good hygienic practices at preventing the introduction of microbial pathogens and minimizing their potential growth. The degree of control in these two areas has a significant impact on the safety of sprouts.

2. SCOPE, USE AND DEFINITION

2.1 SCOPE AND USE

This document follows the format of the Codex Recommended International Code of Practice -- General Principles of Food Hygiene? CAC/RCP 1-1969, Rev 3 (1997) and should be used in conjunction with the General Principles of Food Hygiene and Proposed Draft Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. This annex covers the hygienic practices that are specific for the primary production of seeds for sprouting and the production of sprouts for human consumption in order to produce a safe and wholesome product.

2.3 DEFINITIONS

Seed producer - any person responsible for the management of activities associated with the primary production of seeds including post-harvest practices.

Seed distributor - any person responsible for the distribution of seeds (handling, storage and transportation) to sprout producers. Seed distributors may deal with single or multiple seed producers and can be producers themselves.

Sprout producer - any person responsible for the management of the activities associated with the production of sprouted seeds.

Spent irrigation water - water that has been in contact with sprouts during the sprouting process.

3. PRIMARY PRODUCTION OF SEEDS

Refer to the Draft Code of Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

3.2 HYGIENIC PRODUCTION OF SEEDS

When seeds are destined for sprout production, animals should not be allowed to graze the fields where seeds are grown (e.g., employing sheep for spring clip back of alfalfa).

3.2.1.2 Manure and biosolids

It is particularly important to prevent microbial contamination during the production of seeds because of the potential for pathogens to grow during the sprouting process. Consequently, manure, biosolids and other natural fertilizers should only be used when they have undergone treatments which achieve a high level of pathogen reduction.

3.2.1.4 Agricultural chemicals

Seed producers should only use chemicals (e.g., pesticides, desiccants) which are acceptable for seeds intended for sprout production.

3.2.4 Equipment associated with growing and harvesting

Prior to harvest, harvesting equipment should be adjusted to minimize soil intake and seed damage and should be cleaned from any debris or earth. Diseased or damaged seeds, which could be susceptible to microbial contamination, should not be used for sprout production.

3.3 HANDLING, STORAGE AND TRANSPORT

Seeds produced for sprout production should be segregated from product to be used as animal feed (e.g., for silage production) and clearly labelled.

Recognising that seeds are vulnerable to microbial pathogens during thrashing and drying, adequate care is needed to maintain sanitation in drying yards, and exposure of seeds to mist, high humidity and fog should be avoided.

3.5 ANALYSES

Seed producers, distributors, and sprout producers should test lots of seeds for microbial pathogens using internationally accepted analytical methods. Sprouting seeds before testing increases the possibility of finding pathogens that may be present. If lots of seeds are found to be contaminated, seeds should not be sold or used for sprout production. Because of the limitations associated with sampling methods and analytical tests, failure to find contamination does not guarantee that the seeds are pathogen free. However, if contamination is found at this stage, it allows seeds to be diverted or destroyed before entering sprout production. Seed producers, distributers and sprout producers should refer to the Codex Principles for the Establishment and the Application of Microbiological Criteria for Foods, CAC/GL 21-1977, for guidance on establishing a sampling plan.

3.6 TRACEBACKS AND RECALLS

Seed producers for sprout production should ensure that traceback records and recall procedures are in place to effectively respond to health risk situations. Procedures should enable the complete and rapid recall of any implicated seed and provide detailed information to assist in the identification and investigation of any contaminated seeds and sprouts. The following should be adopted:

4. ESTABLISHMENT FOR SPROUT PRODUCTION

Refer to the General principles of Food Hygiene. In addition:

4.2.1 Design and layout

Where appropriate, the internal design and layout of sprout establishments should permit good food hygiene practices, including protection against cross-contamination between and during operations. Storage, seed rinsing and disinfection, germination and packaging areas should be physically separated from each other.

5. CONTROL OF OPERATION

Refer to the General principles of Food Hygiene. In addition:

5.2.2 Specific process steps in sprout production

5.2.2.1 Water use during sprout production

Water quality management will vary throughout all operations. Sprout producers should follow GMPs to minimize the potential for the introduction or spread of pathogens in processing water. The quality of water used should be dependent on the stage of the operation. Because of the potential for pathogen proliferation during the sprouting process, clean water could be used for initial washing stages, whereas water used later in the sprout production process (i.e., for the rinse following the seed disinfection and subsequent operations) should be of potable quality or at least clean water.

5.2.2.2 Initial rinse

The seeds should be rinsed thoroughly before the disinfection treatment to remove dirt and increase the efficiency of the disinfection treatment.

5.2.2.3 Seed disinfection

Due to the difficulty of obtaining seeds which can be guaranteed as pathogen free, it is recommended that seeds be treated prior to the sprouting process. Although there may be other options, liquid disinfection is the treatment that is generally used. During the disinfection treatment sprout producers should adhere to the following:

5.2.2.4 Rinse after seed treatment

As appropriate, seeds should be thoroughly rinsed after the disinfection treatment with potable water or at least clean water. Rinsing should be repeated sufficiently to eliminate disinfectant.

5.2.2.5 Pre-germination soak

Soaking is often necessary to improve germination. When soaking, the sprout producer should adhere to the following:

5.2.2.6 Germination

During germination, keep the environment and equipment clean to avoid potential contamination. All equipment should be cleaned and disinfected before each new batch.

5.2.2.7 Harvesting

All equipment should be cleaned and disinfected before each new batch. Harvesting should be done with cleaned and disinfected tools dedicated for this use.

5.2.2.8 Final rinse and cooling

A final water rinse will remove hulls, cool product, and may reduce microbial contamination on sprouts. The following should be adopted:

5.2.2.9 Storage of finished product

Where appropriate, sprouts should be kept under cold temperature (e.g. 5?C) that will minimize microbial growth for the intended shelf life of the product. Regular and effective monitoring of temperature of storage areas and transport vehicles should be carried out.

5.2.3 Microbiological and other specifications

It is recommended that seed and sprouts or spent irrigation water be tested for the presence of pathogens.

5.2.3.1 Testing of seed lots before entering production

It is recommended that each new lot of seeds received at the sprouting facility are tested before entering production (i.e. before seed disinfection steps).

The seed sample selected for testing should be sprouted prior to analysis to increase the potential to detect pathogens if present. Analysis may be performed on the sprouted seeds or the water used to sprout the sample.

Seed samples for microbial analysis should not be subject to any disinfection treatment at the sprouting facility.

5.2.3.2 Testing irrigation water and/or sprouts

Current seed treatments cannot guarantee total elimination of pathogens. Further, if even a few pathogens survive treatment, they can grow to high numbers during sprouting. Therefore, producers should have in place a sampling/testing plan to regularly monitor for pathogens at one or more stages after the start of germination.

Analyses can be performed during the germination process (e.g., spent irrigation water or sprouts) and/or finished product may be analysed after harvest.

Testing spent irrigation water is a good indicator of microbial conditions of sprouts. It is homogeneous and is simpler to analyse. Further, sampling spent irrigation water (or sprouts) during germination allows earlier results compared to testing finished product.

Because of the sporadic nature of seed contamination, it is recommended that producers test every production lot.

5.2.4 Microbiological cross-contamination

Sprout producers should adhere to the following:

5.3 INCOMING MATERIAL REQUIREMENTS

5.3.1 Specifications for incoming seeds

Sprout producers should recommend that seed producers adopt good agricultural practices and provide evidence that the product was grown according to section 3 of this Annex and the Draft Code of Practice for the Primary Production and Packing of Fresh Fruits and Vegetables.

Seed and sprout producers should obtain assurance from seed producers or distributors that chemical residues of each incoming lot are within the limits established by the Codex Alimentarius Commission and, where appropriate, they should obtain certificates of analysis for microbial pathogens of concern.

5.3.2 Control of incoming seeds

Seed containers should be examined at their arrival to minimize the potential for introducing obvious contaminants in the establishment.

Seed containers should be examined for physical damage (e.g., holes from rodents) and signs of contamination (e.g., stains, rodent, insects, faeces, urine, foreign material, etc.). If found to be damaged, contaminated or potentially contaminated, its contents should not be used for sprout production.

If seed lots are analysed for the presence of microbial pathogens of concern, these should not be used until results of analysis are available.

5.3.3 Seed storage

Seeds should be handled and stored in a manner that will prevent damage and contamination.

Seeds should be stored off the floor, away from walls and in proper storage conditions to prevent mould and bacterial growth and facilitate pest control inspection.

Open containers should be stored in such a way that they are protected from pests and other sources of contamination.

5.7 DOCUMENTATION AND RECORDS

Refer to the Draft Code of Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

Written records that accurately reflect product information and operational controls should be available to demonstrate the adequacy of the production activities.

Upon receipt of seeds, records should be maintained of the seed supplier, the lot number and the country of origin to facilitate trace back and recall procedures.

Records should be legible, permanent and accurate. Records should include written procedures, controls, limits, monitoring results and subsequent follow-up documents. Records must include: seed sources and lot numbers, water analysis results, sanitation checks, pest control monitoring, sprout lot codes, analysis results, production volumes, storage temperature monitoring, product distribution and consumer complaints.

Records should be kept long enough to facilitate trace back and food borne illness investigation, if required. This period will likely be much longer than the shelf life of the product.

6. ESTABLISHMENT: MAINTENANCE AND SANITATION

Refer to the General principles of Food Hygiene

7. ESTABLISHMENT: PERSONAL HYGIENE

Refer to the General principles of Food Hygiene

8. TRANSPORTATION

Refer to the General principles of Food Hygiene

9. PRODUCT INFORMATION AND CONSUMER AWARENESS

Refer to the General principles of Food Hygiene

10. TRAINING

Refer to the General principles of Food Hygiene. In addition:

10.1 AWARENESS AND RESPONSIBILITIES

Refer to the Draft Code of Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

Annex II - Proposed Draft Annex for Ready-to-Eat Fresh Pre-cut Fruits and Vegetables


INTRODUCTION
1. OBJECTIVE
2. SCOPE, USE AND DEFINITIONS
3. PRIMARY PRODUCTION
4. ESTABLISHMENT: DESIGN AND FACILITIES
5. CONTROL OF OPERATIONS
6. ESTABLISHMENT: MAINTENANCE AND SANITATION
7. ESTABLISHMENT: PERSONNEL HYGIENE
8. TRANSPORTATION
9. PRODUCT INFORMATION AND CONSUMER AWARENESS
10. TRAINING

INTRODUCTION

Scientific research over the last decades has shown that a diet rich in fruits and vegetables is protective, among others, against many cancers and lowers the occurrence of coronary heart disease. This recognition of the importance of routine consumption of fresh fruits and vegetables, together with an on-going consumer interest in ready-to-eat fresh foods have contributed to a substantial increase in consumption of fresh pre-cut fruits and vegetables over the past two decades. However, the recent increase in reports of food borne illness associated with ready-to-eat fresh fruits and vegetables has raised concerns from public health agencies and consumers about the safety of these products.

1. OBJECTIVE

The recommendations for the primary production of fresh fruits and vegetables are covered under the Draft Code of Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. This present draft Annex deals with good manufacturing practices (GMP) for all stages involved in the production of ready-to-eat fresh pre-cut fruits and vegetables, from receipt of raw materials to distribution of finished products. It provides a general framework of recommendations that can be adopted uniformly by the sector rather than offering detailed recommendations concerning activities or products. The fresh produce industry is very complex. A wide variety of fruits and vegetables are processed and packaged under variable climatic and environmental conditions. For this reason, this Annex is flexible by necessity and can be adapted to various systems used to control and prevent contamination in various food groups.

The primary objective of this Annex is to identify GMPs that will help control microbiological, physical, and chemical hazards associated with the processing of fresh pre-cut fruits and vegetables. Particular attention is given to minimizing microbiological hazards. This Annex provides elements that should be taken into account in the production, processing and distribution of these foods.

2. SCOPE, USE AND DEFINITIONS

2.1 SCOPE

This Annex specifically applies to ready to eat fresh fruit and vegetables that have been peeled, cut or otherwise physically altered from their original form but remain in the fresh state and particularly those that are intended to be consumed raw. This Annex applies irrespective of where the operations take place (e.g. in the field, at the farm, at the retailer, at the wholesaler, at the processing establishment, etc.)

For some establishments that process fresh pre-cut fruit and vegetables, this Annex will cover all operations from receipt of raw material to the distribution of the final product. For other establishments, (e.g. those that use ready to eat pre-cut fresh fruit and vegetables in combination with other products, such as sauces, meat, cheese, etc.) only the specific sections that relate to the processing of the fresh pre-cut fruit and vegetable components will apply.

This Annex does not directly apply to fresh fruit and vegetables that have been trimmed leaving the food intact. Nor does it apply to other fresh fruit and vegetables that are pre-cut but are destined for further processing that would be expected to eliminate any pathogen that may be present (e.g. cooking, juice processing, fermentation) nor to fresh fruit or vegetable juices. However, some of the basic principles of the Annex could still be applicable to such products.

Packaging includes single serving containers (e.g., sealed pouches or plastic trays), larger consumer or institutional size packages and bulk containers. This Annex concentrates on microbial hazards and addresses physical and chemical hazards only in so far as these relate to GMPs.

2.2 USE

This document follows the format of the Codex Recommended International Code of Practice -- General Principles of Food Hygiene CAC/RCP 1-1969, Rev 3 (1997) and should be used in conjunction with the General Principles of Food Hygiene and Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. This Annex contains only the recommendations complementing the General Principles necessary to take into account the requirements of plant-based foodstuffs that it specifically deals with.

2.3 DEFINITIONS

Processor - the person responsible for the management of the activities associated with the production of ready-to-eat fresh pre-cut fruits and vegetables.

3. PRIMARY PRODUCTION

Refer to Proposed Draft Code of Hygienic Practice for Primary Production and Packing of Fresh Fruits and Vegetables.

4. ESTABLISHMENT: DESIGN AND FACILITIES

Refer to the General Principles of Food Hygiene. In addition:

4.4 FACILITIES

4.4.2 Drainage and Waste Disposal

The processing of products covered by this Annex generates a large quantity of waste that can serve as food and shelter for pests. It is therefore very important to plan an effective waste disposal system. This system should always be maintained in good condition.

5. CONTROL OF OPERATIONS

Refer to the Proposed Draft Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

5.1 CONTROL OF FOOD HAZARDS

For the products covered by this Annex it should be recognised that while processing may reduce the level of contamination initially present on the raw materials, it will not be able to guarantee elimination of such contamination. Consequently, the processor should ensure that steps are taken by their suppliers (growers, harvesters, packers and distributors) to minimise contamination of the raw materials during primary production. It is recommended that processors ensure that their suppliers have adopted the principles outlined in the Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables.

There are certain pathogens, Listeria monocytogenes and Clostridium botulinum, which present specific concern in relation to ready to eat fresh pre-cut vegetables packaged in a modified atmosphere. Processors should ensure that they have addressed all relevant safety issues relating to the use of such packaging.

5.2 KEY ASPECTS OF CONTROL SYSTEMS

5.2.2 Specific Process Steps

5.2.2.1 Receipt and inspection of raw materials

Inspect incoming produce delivery food transportation unit for cleanliness and raw materials for evidence of contamination. There should be trimming to remove any damaged, rotten or mouldy material.

Physical hazards (such as the presence of animal and plant debris, metal, and other foreign material) should be removed through manual sorting or the use of detectors, such as metal detectors.

5.2.2.2 Washing and disinfection

Refer to section 5.2.2.1 of the Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

5.2.2.3 Pre-cooling Fresh Fruits and Vegetables

Refer to section 5.2.2.3 of the Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables.

5.2.2.4 Cutting, slicing, shredding, and similar pre-cut processes

Procedures should be in place to minimize contamination with physical (e.g. metal) and microbial contaminants during cutting, slicing, shredding or similar pre-cut processes.

5.2.2.5 Washing after cutting, slicing, shredding, and similar pre-cut processes

Washing cut produce with potable water may reduce microbial contamination. In addition, it removes some of the cellular fluids that were released during the cutting process thereby reducing the level of available nutrients for microbial growth. The following should be considered:

5.2.2.6 Cold Storage

Refer to section 5.2.2.4 of the Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

5.7 DOCUMENTATION AND RECORDS

Where appropriate, records should be maintained to adequately reflect product information, such as product formulations or specifications and operational controls. Maintaining adequate documentation and records of processing operations is important in the event of a traceback with fresh pre-cut fruits and vegetables. Records should be kept long enough to facilitate trace back and foodborne illness investigations, if required. This period will likely be much longer that the shelf life of the product. Some examples of records to keep are the following:

5.8 RECALL PROCEDURES AND TRACEBACK

Refer to the General Principles of Food Hygiene.

6. ESTABLISHMENT: MAINTENANCE AND SANITATION

Refer to the General Principles of Food Hygiene.

7. ESTABLISHMENT: PERSONNEL HYGIENE

Refer to the General Principles of Food Hygiene.

8. TRANSPORTATION

Refer to the General Principles of Food Hygiene.

9. PRODUCT INFORMATION AND CONSUMER AWARENESS

Refer to the General Principles of Food Hygiene.

10. TRAINING

Refer to the General Principles of Food Hygiene and the Proposed Code of Hygienic Practice for the Primary Production and Packing of Fresh Fruits and Vegetables. In addition:

10.2 TRAINING PROGRAMS

To evaluate the level of training required of persons responsible for the production of fresh pre-cut fruits and vegetables, the additional following factors should be taken into account:


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