Toolkit for Microbiological Risk Assessment for Primary Production of Fresh Fruit and Vegetables

GENERAL INFORMATION Toolkit for Microbiological Risk Assessment for Primary Production of Fresh Fruit and Vegetables ENGLISH VERSION VERSION 1.0_MAY2013 VALID FOR -STANDARD INTEGRATED FARM ASSURANCE V4 SCOPE: CROPS

Toolkit for Microbiological Risk Assessment for Primary Production of Fresh Fruit and Vegetables INTRODUCTION This toolkit for assessing microbiological risks for the primary production of fresh fruit and vegetables is the product of the work carried out by the Stakeholder Committee for Microbiological Risk Assessment. In the Integrated Farm Assurance Standard for Fruit and Vegetables V4, the Technical Committee included the requirement for risk assessments to be done by producers to identify possible sources of microbiological contamination of their entire operation. A general guideline (Annex AF.1 Guideline Risk Assessment General) was included to explain to producers in 5 steps what a risk assessment should cover. Additionally, Annex CB.1 Guideline Microbiological Hazards was developed and included. The scope of this guideline was to facilitate the identification of the hygiene hazards during the harvest of fresh fruit and vegetables and the comprehension of the measures to consider in mitigating those hazards. A clear guideline to help producers understand identified risks and to propose guidance for risk management was missing. The Stakeholder Committee for Microbiological Risk Assessment developed this guideline, which highlights the risk areas, the general assessed risk, why there is a potential risk and then guidance for risk management. Each identified risk is referenced to a relevant control point in the standard. Where the standard did not cover the risk per se, it is recommended to follow best practices to manage the risk and these can be seen as additional points that will be evaluated in the revision of the standard for possible inclusion in future versions. This is a guideline and is not exhaustive. Recommendations are made, but producers should evaluate their own operations based to see what is applicable. WHAT IS MICROBIAL CONTAMINATION? Foodborne illness is a major public health issue, and a cause for concern for consumers and the food industry. Illness can result from eating food contaminated with harmful microorganisms or chemicals such as pesticides or heavy metals. However, the question remains what are harmful microorganisms, and how can they get onto fruits and vegetables? As the name suggests, microorganisms are tiny living creatures that are too small to see with the naked eye or even a magnifying glass and hence they appear invisible to us. Most are harmless and some have beneficial uses but a few cause illness for Page: 2 of 38

humans and animals. The major groups that include organisms that can cause illness in humans are the bacteria, the viruses and some protozoa. In addition some fungi (often referred to as moulds) can produce poisons known as mycotoxins while growing on/in foods such as cereals, nuts, fruits, cocoa beans etc. For the fresh produce industry bacteria followed by viruses and protozoa are normally considered to represent the greatest risk of causing illness via fruits and vegetables. Bacteria are tiny single celled life forms that can grow very rapidly in the presence of water, food and warmth. Bacteria increase in numbers by simply dividing into two to produce two new individuals. Many bacteria can divide every 20 minutes, which means that 1 bacterial cell can become nearly 17 million cells within 8 hours under ideal conditions! Protozoa are similar to bacteria in many ways but divide more slowly. Viruses are unique in not requiring food, water, air or warmth to cause harm, they simply need to enter the body in order to cause illness. There are several major groups of bacteria that are responsible for most outbreaks of illness associated with fresh produce these include, Salmonella, Shigella, Listeria, and disease causing strains of E.coli. The most common types of protozoa associated with fresh produce are Crytosporidium, Cyclospora and Giardia. Outbreaks of illness caused by calcivirus, norovirus and hepatitis A virus have been linked to consumption of fruits and vegetables. Symptoms of illness can range from diarrhea and vomiting through to kidney failure and even death depending on the type and severity of infection. Many of the harmful microorganisms mentioned above are closely associated with man and animals and can also be found in human and animal feces. Some types of harmful microorganism can be found living in soil. To cause harm the microorganism must get onto or into the food product this is the process known as contamination. Contamination of fruits and vegetables can occur by many routes. Water contaminated with feces is likely to contain harmful microorganisms that could get onto produce if the water is used for irrigation or washing of produce, crates or harvest tools. Microorganisms can be transferred through contact with surfaces including the hands of workers. Flies, rodents and birds can also help to transfer harmful microorganisms to food products. Page: 3 of 38

TOOLKIT FOR GUIDANCE ON ASSESSING MICROBIOLOGICAL S Feb 2013 Id. AREA GENERAL ASSESSED 1.1 Farm Environment Is farm waste suitably managed? Farm waste includes for instance wastewater, field toilets, waste from processing, decaying produce in fields and stores. Contamination can transfer from farm waste to produce, water sources, growing areas, equipment and workers. GUIDANCE FOR A comprehensive, current, documented plan that covers wastage reduction, pollution and waste recycling is available. Air, soil, water, noise and light contamination should be considered along with all products and sources identified in the plan. AF5.2.1 (rec.) AF5.2.2 (M) 1.2 Are activities on adjacent land monitored and controlled? Contamination from animals and composting from adjacent land can be transferred by water, animals, wildlife, farm workers, equipment, wind and run-off from higher elevations. Visual assessment that there is no evidence of waste/litter in the immediate vicinity of the production or storage buildings. Incidental and insignificant litter and waste on the designated areas are acceptable as well as the waste from the current day s work. All other litter and waste has been cleared up, including fuel spills. A risk assessment is needed at the initial inspection to determine if the site is appropriate. The risk assessment must be reviewed annually and take into account risks that have changed or when new sites are used. Risk assessments must take into account site history and impact of AF1.2.1 (M) Page: 4 of 38

Id. AREA GENERAL ASSESSED 1.3 Is the storage and disposal of rejected produce suitably managed? 1.4 Are steps taken to minimize dust contamination of produce? Rejected produce can attract pests for instance insects, rodents and birds which pose a risk of contamination to produce, water sources, growing areas, equipment and workers. Produce that is decaying can contain pathogens that can transfer to other products. Higher ambient temperatures can increase the risks. Dust from manure and compost can contain pathogens. GUIDANCE FOR proposed enterprises on adjacent stock/crops/ environment (see AF Annex 1 Risk Assessment for basic information and AF Annex 2 for specific information on what must be covered).a management plan addresses the risks identified in AF 1.2.1 describes the strategies, which justify that the site in question is suitable for production. Rejected produce and waste materials are stored in clearly designated and segregated areas designed to avoid contamination of products. These areas are routinely cleaned and/or disinfected according to the cleaning schedule. Only daily accumulators of rejected produce and waste materials are acceptable. Best practice should be followed to manage risk. The disturbance of soil that can contaminate growing or harvested produce should be avoided in the field (e.g. vehicles disturbing dust, activities in neighboring fields, removal of fleecing, etc.). The use or storage of products that create dust should be avoided where AF1.2.2 (m) FV5.4.5 (m) Not in AF, CB or FV Page: 5 of 38

Id. AREA GENERAL ASSESSED 1.5 Are storage buildings maintained to reduce the risk of contamination? 1.6 Has the security of the site been considered to manage the risk of external sources of contamination? 1.7 Are controls in place to manage temperatures in cold storage areas? Pathogens can grow on unclean surfaces in buildings and equipment used at any stage of processing which can contaminate produce. Other uses of buildings and equipment during non-production times (e.g. use for livestock) can also pose a risk. Contamination can be caused by external sources for instance public access, visitors and vehicles. Poor temperature control in cold storage areas can allow growth of pathogens that do not normally grow if the correct temperature is maintained. GUIDANCE FOR cross contamination might occur. Consideration should be given to soil splash after wet conditions. To prevent contamination, produce handling and storage facilities and equipment (i.e. process lines and machinery, walls, floors, storage areas, pallets, etc.) must be cleaned and/or maintained according to the cleaning and maintenance schedule, which includes defined minimum frequency. Documented records of cleaning and maintenance must be kept. Best practice should be followed to manage risk. Consideration should be given to the security of the farmed area and potential contaminations from sources outside of the farm (e.g. public access points). When packed produce is stored on farm, temperature and humidity controls (where applicable) must be maintained and documented, in accordance with the hygiene risk assessment results and quality requirements. FV5.4.1 (m) Not in AF, CB or FV FV4.2.6 (M) FV5.5.1 (M) If packed produce is stored on farm, temperature and humidity Page: 6 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR controls (where applicable and also for controlled atmosphere storage) must be maintained and documented in accordance with the hygiene risk assessment results. FV5.5.2 (m) 1.8 Is the potential for flooding taken into consideration? Floodwaters can carry contamination on to fields and into storage areas from far distances. The risk is higher where floodwater could come into contact with edible portions of the crop. Equipment used for weighing and/or temperature control, must be routinely verified to see if equipment is calibrated according to the hygiene risk assessment. Hazardous contaminants can be deposited at the crop site by heavy flooding (e.g. toxic waste, fecal material, dead animals). Prevent cross-contamination by cleaning or sanitizing any equipment that may have been in contact with previously flooded soil. FDA considers any crop that has come into contact with floodwater to be an adulterated commodity that cannot be sold for human consumption. Areas that have been flooded in any time of the season must not be used to store produce or packing material. Annex CB1-3.2.1.4 Page: 7 of 38

Id. AREA GENERAL ASSESSED 2.1 Water (irrigation, PPP, washing, cooling ice) Is the source of water on farm clearly identified? Water from different sources (e.g. bore hole, municipal, surface water, recycled, wells, rain) will have varying level of water quality and potential risk of containing pathogens. GUIDANCE FOR The risk from each source can vary over time. The risk assessment must consider potential microbial, chemical and physical pollution of all sources of irrigation/ fertigation water. At a minimum, the risk assessment shall cover identification of the water sources and others described in section 2.3. ( Is the method of water used in irrigation and fertigation identified? ) CB 6.3.2 (m) 2.2 Are water storage and distribution systems monitored and maintained? 2.3 Is the method of water used in irrigation and fertigation identified? Poor condition of water storage units (e.g. tanks, ponds, reservoirs, wells) and conduction systems can lead to contamination of water. Biofilms in water units can harbor and protect pathogens. Open water storage units can attract animals and insects, which can contaminate the water. Water that contacts the edible portion of the product has a higher risk of contamination with pathogens. There should be an appropriate cleaning regime for the water tank, piping and pumps. Untreated sewage is not used for irrigation/fertigation. Where treated sewage water or reclaimed water is used, water quality complies with the WHO published Guidelines for the Safe Use of Wastewater and Excreta in Agriculture and Aquaculture 1989. Annex CB1-3.2.1.2 CB 6.3.1 (M) CB 6.3.2 (m) CB 6.3.3 (m) CB 6.3.4 (m) Annex CB1-3.2.1.1 Page: 8 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR Also, when there is doubt if water is coming from a possibly polluted source (i.e. because of a village upstream, etc.) the farmer has to demonstrate through analysis that the water complies with the WHO guideline requirements or the local legislation for irrigation water. See Table 3 in Annex AF.1 for Risk Assessments. No N/A. The risk assessment must consider potential microbial, chemical and physical pollution of all sources of irrigation/fertigation water. At a minimum, the risk assessment shall cover: Irrigation method(s) Timing of irrigation (during crop growth stage) Contact of irrigation water with the crop Type of crop: Crops that can be eaten raw and which do not have a protective skin that is removed before eating Page: 9 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR Crops that can be eaten raw and either have no protective skin that is removed before eating or do have some risk or history of pathogen contamination Crops that can be eaten raw and either have a protective skin that is removed before eating, or grow clear of the ground or have no significant history of pathogen contamination. Crops that are always cooked See Annex CB.1 Microbiological Hazards The water analysis is carried out at a frequency according to the results of the risk assessment, which takes the characteristics of the crop into account. Samples are to be taken at exit point of the irrigation system or the nearest practical sampling point. According to the risk analysis (if there is a risk of microbial contaminants), laboratory analysis provides a documented record of the relevant microbial Page: 10 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR contaminants through a laboratory analysis. Depending on the source and distribution system, water can be contaminated from people and animals. There are some hazards because of water that carries pathogenic microorganisms and can survive to reach the consumer, especially in those products that according to their characteristics are of higher risks. 2.4 Is the quality of water used in the application of plant protection products considered? Plant protection products rarely kill human pathogens. Poor quality water used in the preparation of plant protection products can contaminate the edible portion of the product with pathogens. In case of irrigation, the water must comply with the local irrigation standards, but also it must be considered that if the water is used near harvest and gets into direct contact with the edible part of the produce, then the hazards are higher and measures must be taken to avoid water contamination from sewages, animals and birds. In case water is used in the application of plant protection products, this water should be from origins that are free of contamination from animal, birds and sewage. Annex CB1-3.2.1.1 FV 3.1.1 (M) Page: 11 of 38

Id. AREA GENERAL ASSESSED 2.5 Is the quality of water used in any other preharvest treatment such as sun damage mitigation, frost protection and misting considered? 2.6 Is the quality of water used during harvest considered? Poor quality water used in any pre-harvest treatment can contaminate the edible portion of the product with pathogens. Poor quality water used at the point of harvest can contaminate the product with pathogens. Recycled water poses a higher risk of cross contamination and pathogen growth than single use water. The weak points of the water treatment for recycled water are generally controls and supervision to maintain their effect. Often they are forgotten or loosely made, so special emphasis should be given GUIDANCE FOR A written risk assessment is conducted. It includes water source, type of plant protection product (herbicide, insecticide, etc.), application timing (growth stage of the crop), placement of application (edible part of the crop, other parts of the crop, ground between crops, etc.) and corrective action is taken if necessary. In case of water use for control of sun damage near harvest, then the water to be used should be from origins that are free of contamination from animal, birds and sewage. Water used to wash produce must be from safe sources, preferably potable water or water that has been treated to eliminate bacteria. Basically there are four aspects to consider for establish the best hygienic practices related with the water for washing produce: a) Always use fresh, potable water for the final wash. In case of water from wells, the extraction system must be designed, constructed and maintained as to protect Annex CB1-3.2.1.1 Annex CB1-3.2.1.2 Page: 12 of 38

Id. AREA GENERAL ASSESSED Is the quality of water used during the transportation of the product considered? to records and the frequency of monitoring and corrective actions. Cross contamination occurs when pathogens from an infected product transfer to clean product via the water. Poor quality water used in transportation of product (e.g. water transfer systems, dump tanks) can contaminate the product with pathogens. Prolonged use of the same water GUIDANCE FOR potential contamination from water. b) In case the water is recirculated it must be treated by using a sanitizer agent. c) There should be an appropriate cleaning regime for the water tank, piping and pumps. d) The frequency of the change of water. It should be determined in every specific case according to the type of produce, design of the washing equipment and information from the controls. Guidance or instructions should be sought from the supplier of any sanitizer. e) Refills of water must be made only by using potable or clean treated water. f) Never use irrigation water (unless of potable quality) for wash or to refresh produce. Best practice should be followed to manage this risk. It is recommended that wherever possible potable water is used for produce transportation, water quality should be monitored and water refreshed on a regular Not in AF, CB or FV Page: 13 of 38

Id. AREA GENERAL ASSESSED 2.7 Is the quality of water used during hydrocooling considered? 2.8 Is the quality of ice or water used in production of ice considered? can allow the growth of pathogens which can contaminate the product. Poor quality water used during cooling can contaminate the product with pathogens. Recirculated water poses a higher risk than single use water. Ice made from poor quality water may contain pathogens. Contamination of the ice can occur from poor storage. GUIDANCE FOR basis. Sanitizers may be used but should not be taken as a guarantee of food safety. If potable water is unavailable monitoring should be increased, water refreshed more frequently and sanitizers used. Best practice should be followed to manage this risk. Where possible, the water used during hydro-cooling should be of potable quality. A water quality monitoring program and use of suitable disinfectants should be used where a risk of product contamination exists. The same decision tree can be used to assess the hazards in case of water and ice used in cooling process, but there are some additional considerations related to the storage of the ice: Source of ice: Ice must always be obtained from drinking water (potable quality water). The grower must inform himself about the origin of the ice, by visiting the supplier and checking that it has been produced with controlled potable water. Not in AF, CB or FV Annex CB1-3.2.1.3 FV 4.1.12 (M) Page: 14 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR Storage of ice: Ice must always be separated from soil. Ice must be stored inside a covered tank or similar structure in order to avoid accidental contamination from animals or birds. Handling of ice All tools used to handle or triturate the ice must be clean and stored in cabinets. Never add non-potable water to wash or maintain ice. 2.9 Is the quality of water used during sorting and washing of the product considered? Poor quality water used during washing of the product can contaminate the product with pathogens. Re-circulated water poses a higher risk than single use water. Any ice or water used at point of harvest must be made with potable water and handled under sanitary conditions to prevent produce contamination. The water has been declared suitable by the competent authorities and/or within the last 12 months a water analysis has been carried out at the point of entry into the washing machinery. The levels of the parameters analyzed are within accepted WHO thresholds or are accepted as safe for the food industry by the competent authorities. FV 5.7.1 (M) FV 5.7.2 (M) Page: 15 of 38

Id. AREA GENERAL ASSESSED 2.10 Is the quality of water used in the application of post-harvest treatments considered? Products used in post-harvest treatments rarely kill human pathogens. Poor quality water used in the preparation of treatments can contaminate the product with pathogens GUIDANCE FOR Where water is re-circulated for final produce washing, it is filtered and disinfected, and ph, concentration and exposure levels to disinfectant are routinely monitored. Suitably documented records are maintained. Filtering must be done with an effective system for solids and suspensions that have a documented routine cleaning schedule according to usage rates and water volume. Where recording of automatic filter backwash events and changes in dosage rates by automated sanitizer injectors may be impossible, a written procedure/policy must explain the process. The water has been declared suitable by the competent authorities and/or within the last 12 months a water analysis has been carried out at the point of entry into the washing machinery. The levels of the parameters analyzed are within accepted WHO thresholds or are accepted as safe for the food industry by the competent authorities. FV 5.8.5 (M) Page: 16 of 38

Id. AREA GENERAL ASSESSED 2.11 Is the quality of water used in facility and equipment cleaning procedures considered? 3.1 Soil Amendments (organic fertilizers, soil, substrates, adjacent land, history) Is the crop and input history of the field known? Poor quality water used during cleaning procedures can contaminate the facilities, containers and equipment which can then transfer to the product. Pathogens from raw manure and grazing animals can survive up to 12 months and can contaminate produce. GUIDANCE FOR Best practice should be followed to manage this risk. Where possible, the water used to clean facilities and equipment should be of potable quality. Where appropriate, suitable disinfectants should be used and the water regularly replaced during cleaning to reduce the risk of cross contamination. A risk assessment is needed at the initial inspection to determine if the site is appropriate. The risk assessment must be reviewed annually and take into account risks that have changed or when new sites are used. Risk assessments must take into account site history and impact of proposed enterprises on adjacent stock/crops/ environment (see AF Annex 1 Risk Assessment for basic information and AF Annex 2 for specific information on what must be covered). Not in AF, CB or FV AF1.2.1 (M) AF1.2.2 (m) A management plan addresses the risks identified in AF.1.2.1 describes the strategies, which justify that the site in question is suitable for production. Page: 17 of 38

Id. AREA GENERAL ASSESSED 3.2 Does the storage and management of animal manure ensure that contamination risks are minimized? 3.3 Are manure teas and composts prepared following documented procedures? Contamination from manure can be transferred to produce, water sources, growing areas, equipment and workers. Composts may include material of animal or plant origin or mixtures of animal manures and plant material, which may contain pathogens if not properly treated. Contamination from poorly treated compost can be transferred to produce, water sources, growing areas, equipment and workers. GUIDANCE FOR The minimum requirement is to prevent physical cross contamination between fertilizers (organic and inorganic) and plant protection products by the use of a physical barrier (wall, sheeting, etc.). Organic fertilizers must be stored in a designated area. Appropriate measures have been taken to prevent contamination of surface water (e.g. concrete foundation and walls, specially built leak proof container, etc.) or must be stored at least 25 m from surface water bodies. Documentary evidence is available to demonstrate that at least the following potential risks have been considered: type of organic fertilizer, method of composting, weed/seed content, heavy metal content, timing of application, and placement of organic fertilizer (e.g. direct contact to edible part of crop, ground between crops, etc.). This also applies to substrates from biogas plants. See Annex CB.1 Microbiological Hazards. National guidelines should be followed. CB 5.4.1 (m) CB 5.5.4 (m) CB5.5.2. (m) Page: 18 of 38

Id. AREA GENERAL ASSESSED 3.4 Is sewage sludge used on the land? 3.5 Are organic or inorganic substrates used in production? Improperly treated sewage sludge is a likely source of human pathogens. Use of sewage sludge is not permitted under Organic substrates can have a risk of contamination. Reuse of substrates poses a potential risk of pathogen contamination. GUIDANCE FOR No human sewage sludge is used on the farm for the production of registered crops. No N/A. Documentary evidence is available to demonstrate that at least the following potential risks have been considered: type of organic fertilizer, method of composting, weed/seed content, heavy metal content, timing of application, and placement of organic fertilizer (e.g. direct contact to edible part of crop, ground between crops, etc.). This also applies to substrates from biogas plants. See Annex CB.1 Microbiological Hazards. CB5.5.1 (M) CB 5.5.2 (m) FV2.2 (M) When the substrates are sterilized on the farm, the name or reference of the field, orchard or greenhouse is recorded. If sterilized off farm, then the name and location of the company, which sterilizes the substrate, are recorded. The following are all correctly recorded: the dates of sterilization (day/month/year); the name and active ingredient; the machinery (e.g. 1000l-tank, etc.); Page: 19 of 38

Id. AREA GENERAL ASSESSED 4.1 Animals Is there animal activity in the farm or in adjacent locations near the production site? Animal activity includes livestock production, animal grazing, domestic animals and wildlife. All animals have the potential to carry pathogens. Contamination from animals can be transferred directly or by water, farm workers, equipment, wind, run-off from higher elevations and vehicles. GUIDANCE FOR the method (e.g. drenching, fogging, etc.); the operator s name (i.e. the person who actually applied the chemicals and did the sterilization); and the pre-planting interval. At the initial inspection a risk assessment is available for all sites that are going to be certified. After that a risk assessment is needed when the risks have changed. This documented risk assessment must be carried out when production will be introduced onto new sites or when the risk has changed. The risk assessment must be reviewed annually and must take into account site history and impact of proposed enterprises on adjacent stock/crops/environment (see AF Annex 1 Risk Assessment for basic information and AF Annex 2 for specific information on what must be covered). AF 1.2.1 (M) AF 1.2.2 (m) A management plan that covers the risks identified in AF.1.2.1 describes the strategies to justify that the site in question is suitable for production. Page: 20 of 38

Id. AREA GENERAL ASSESSED 4.2. Are working animals on the farm managed and controlled? 4.3 Has consideration been given to potential risk of wildlife entering the production area? 4.4 Has consideration been given to potential risk of pests within the production and storage areas? Working animals such as horses, oxen, dogs or geese have the potential to carry human pathogens on them or in their waste. Wildlife includes large mammals such as deer, pigs, etc, small mammals such as rabbits, squirrels and rodents, reptiles such as snakes, lizards, etc, amphibians such as frogs and salamanders, birds according to the geographic area. All have the potential to transfer pathogens to produce. Pests include rodents, insects, snails and birds. All have the potential to transfer pathogens to produce. GUIDANCE FOR Best practice should be followed to manage this risk. There should be measures to control displacement of working animals. There should be measures to remove working animal waste in a way that prevents the possibility of contamination of the produce and any surfaces that could come into contact with the produce. Appropriate measures must be taken to reduce possible contamination onto the growing area. Subjects to be considered include: livestock near the field, high concentrations of wild life on the field, rodents, and domestic animals (own animals, dog walkers etc.). Where appropriate buffer areas, physical barriers, fences should be used. Measures are in place to prevent access by animals. Monitoring is scheduled and there are records of pest control inspections and follow up action plan(s). Not in AF, CB or FV AF 6.1.1 (m) AF 6.1.2 (rec.) FV 3.1.1 (M) FV 5.4.9 (m) FV 5.6.1 (m) FV 5.6.2 (m) FV 5.6.3 (m) 5.1 Personal Hygiene Are suitable hygiene practices for workers in place that protects Workers who come into contact with produce are a likely source of human pathogens. Workers can The written risk assessment for hygiene issues covers the production environment. AF 3.2.1 (m) Page: 21 of 38

Id. AREA GENERAL ASSESSED product from contamination? also transfer pathogens to produce, equipment, packaging and containers through poor hygienic practices. GUIDANCE FOR The risks are depending on the products produced and/or supplied. The risk assessment can be a generic one but it must be appropriate for conditions on the farm and must be reviewed and updated when changes in the organization (e.g. other activities) occur. No N/A. AF 3.2.2 (m) The hygiene instructions are visibly displayed: provided by way of clear signs (pictures) or in the predominant language(s) of the workforce. The instructions must at least include: the need for hand cleaning; the covering of skin cuts; limitation on smoking, eating and drinking to certain areas; notification of any relevant infections or conditions, this includes sign of illness (e.g. vomiting; jaundice, diarrhea) these workers shall be restricted from direct contact with the product or foodcontact surfaces. the use of suitable protective clothing. AF 3.2.3 (m) Page: 22 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR Both written and verbal training are given as an induction-training course for hygiene. Qualified people must provide training. All new workers must receive this training and confirm their participation. All instructions from AF.3.2.2 must be covered in this training. All workers, including the owners and managers, at any time of the year have reviewed and signed for the farm s hygiene instructions. Workers with tasks identified in the hygiene procedures must demonstrate competence during the inspection. No N/A. There is a documented and up to date (i.e. reviewed annually) risk assessment covering physical, chemical and microbiological contaminants and human transmissible diseases, customized to the products. It must also include FV.4.1.2 to FV.4.1.12. The risk analysis shall be tailored to the scale of the farm, the crop, and the technical level of the business. No N/A. And customized to the products and produce handling activities. AF 3.2.4 (M) FV 4.1.1 FV 5.1.1 (M) FV 4.1.2 (M) FV 5.1.2 (M) FV 5.2.4 (m) FV 5.2.5 (m) FV 5.3.2 (M) Page: 23 of 38

Id. AREA GENERAL ASSESSED 5.2 Are suitable hygiene practices for visitor, contractors, etc. in place that protects product from contamination? Visitors, non-contractors and other individuals occasionally are at the operation can also be a source of human pathogens. All can transfer pathogens to GUIDANCE FOR Based on the risk analysis there is a documented hygiene procedure for the harvesting process and the produce handling activities. Smoking, eating, chewing and drinking are confined to designated areas and are never allowed in the produce handling or storage areas. (Drinking water is the exception). Signs with the main hygiene instructions must be visibly displayed in the packing facility. Signs must be visible with clear instructions that hands must be washed before handling products. Workers shall wash their hands prior to start of work, after each visit to a toilet, after using a handkerchief/tissue, after handling contaminated material, after smoking, eating or drinking, after breaks and prior to returning to work and at any other time when their hands may have become a source of contamination. There is evidence that the relevant procedures on personal health, safety and hygiene are officially communicated to visitors and subcontractors AF 4.2 (m) Page: 24 of 38

Id. AREA GENERAL ASSESSED produce, equipment, packaging and containers through poor hygienic practices. GUIDANCE FOR (e. g. relevant instructions are in a visible place where all visitors or subcontractors can read them). 5.3 Are toilets and sanitary stations managed to reduce risk of contamination? Toilets and sanitary stations are likely sources of human pathogens if not appropriately maintained. Contamination can come from leaks, spillages, during cleaning and transfer to workers using the facilities. Hand washing facilities, potable drinking water, a place to store food and to eat must be provided to the workers. The on farm living quarters for the workers are habitable, have a sound roof, windows and doors, and have the basic services of running water, toilets, and drains. In case of no drains, septic pits can be accepted if compliant with local regulations. Field cleaning and disinfection units shall be designed, constructed, and located in a manner that minimizes the potential risk for product contamination and are directly accessible for servicing. Fixed or mobile toilets (including pit latrines) are constructed of materials that are easy to clean and they are in good state of hygiene. Toilets are expected to be in a reasonable proximity (500m or 7 minutes) to place of work Failure point = no or insufficient toilet in reasonable AF 3.6.3. (m) AF 3.6.4 (m) FV 4.1.9 (m) FV 5.3.1 (M) Page: 25 of 38

Id. AREA GENERAL ASSESSED 5.4 Are there hand-washing procedures in place and implemented for all workers, visitors and others on the farm? Human pathogens can be transferred from unclean hands to produce, equipment, packaging and containers. GUIDANCE FOR proximity to place of work. Not applicable is only possible when harvest workers don t come in contact with marketable produce during harvesting (e.g. mechanical harvesting). Toilets in a good state of hygiene must not open directly onto the produce handling area, unless the door is self-closing. Hand washing facilities, containing non-perfumed soap, water to clean and disinfect hands, and hand dry facilities must be accessible and near to the toilets (as near as possible without the potential for crosscontamination). Workers shall wash their hands prior to start of work, after each visit to a toilet, after using a handkerchief/tissue, after handling contaminated material, after smoking, eating or drinking, after breaks and prior to returning to work and at any other time when their hands may have become a source of contamination. Wash stations shall be maintained in a clean and sanitary condition to allow workers to clean and disinfect their hands. Personnel shall wash their hands or make FV 4.1.8 (M) Page: 26 of 38

Id. AREA GENERAL ASSESSED 5.5 Is the quality of the water used in hand washing considered? 5.6 Are procedures in place to avoid workers, visitors and others who are ill from contacting product and food contact surfaces? Poor quality water used for hand washing can be a source of pathogens that can be transferred to the produce. Use of soap or hand sanitizers does not eliminate the risk of pathogens from poor quality water. Individuals can be infected with human pathogens. Ill people are likely to transfer pathogens to produce, equipment, packaging and containers. GUIDANCE FOR use of an alcohol-based hand sanitizer prior to start of work, after each visit to a toilet, after using a handkerchief/tissue, after handling contaminated material, after smoking, eating or drinking, after breaks and prior to returning to work and at any other time when their hands may have become a source of contamination. No N/A. Best practice should be followed to manage this risk. It is recommended that all water used in hand washing is free flowing and single use to avoid risk of cross contamination between workers. Where possible, water should be of potable quality. Notification of any relevant infections or conditions, this includes sign of illness (e.g. vomiting; jaundice, diarrhea) these workers shall be restricted from direct contact with the product or food-contact surfaces. It is recommended that the same procedures should apply to visitors and others who could come into contact with the produce. FV 5.3.1 (M) AF 3.2.2 (m) Page: 27 of 38

Id. AREA GENERAL ASSESSED 5.7 Are procedures in place to reduce the risk of contamination from clothing and other outer garments? Clothing, smocks, aprons, sleeves and gloves can become contaminated and transfer pathogens to produce, equipment, packaging and containers. GUIDANCE FOR Reusable harvesting containers, harvesting tools (i.e., scissors, knifes, pruning shears, etc.) and harvesting equipment (machinery) are cleaned and maintained, and a cleaning and disinfection schedule is in place to prevent produce contamination? Records are available. FV 4.1.6 (M) FV 4.1.7 (M) Farm vehicles used for transport of harvested produce that are also used for any purpose other than transport of harvested produce, are clean and maintenance take place according to a schedule so as to prevent produce contamination (i.e. soil, dirt, organic fertilizer, spills, etc.). FV 4.1.10 (M) Produce containers are only used to contain harvested product (i.e. no agricultural chemicals, lubricants, oil, cleaning chemicals, plant or other debris, lunch bags, tools, etc.). If multi-purpose trailers, carts, etc. are used as produce containers, they must be cleaned prior to use. FV 5.2.3 (rec.) FV 5.3.3 (rec.) All workers wear outer garments (e.g. smocks, aprons, sleeves, gloves) that are clean and Page: 28 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR appropriate for the task(s) according to the risk analysis. This will be tailored to the crop and the technical level of business. 5.8 Have all workers received training or instruction in hygiene practices? Workers who are unaware of the hygiene procedures are more likely to be sources of contamination. The changing facilities should be used to change clothing and protective outer garments as required. If there are hygiene requirements exceeding AF 3.2.2, then there must be evidence that the workers received specific training regarding the hygiene procedures for the harvesting process. Workers must be trained using written (in appropriate languages) and/or pictorial instructions to prevent physical (e.g. snails, stones, insects, knives, fruit residues, watches, mobile phones, etc.), microbiological and chemical contamination of the product during harvesting. FV 4.1.4 (M) FV 4.1.5 (M) FV 5.2.1 (M) There is visual evidence that the workers are complying with the training instructions and procedures. FV 5.2.2 (m) There must be evidence that the workers received training Page: 29 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR regarding the topics of the risk assessment for produce handling. 5.9 Is the implementation of the hygiene practices monitored? Even a single failure in hygiene practice implementation can lead to contamination of produce, equipment, packaging and containers. There is evidence that the workers are complying with the hygiene instructions. The farm manager or other nominated person is responsible for implementation of the hygiene procedures. No N/A. FV 4.1.3 (M) FV 5.1.3 (M) 6.1 Equipment & Containers Are cleaning and disinfection procedures in place for food contact equipment and containers? Food contact equipment, tools, utensils, tables, grading lines, transfer belts, harvesting machinery, transportation and containers used at any stages of production, harvesting, handling and storage can become contaminated with pathogens from prior use. Pathogens can grow on unclean food contact surfaces used at any stage of processing which can contaminate produce. Reusable harvesting containers, harvesting tools (e.g. scissors, knives, pruning shears, etc.) and harvesting equipment (e.g. machinery) are cleaned and maintained. A cleaning and disinfection schedule is in place to prevent produce contamination. Records are available. Produce containers are only used to contain harvested product (i.e. no agricultural chemicals, lubricants, oil, cleaning chemicals, plant or other debris, lunch bags, tools, etc.). If multi-purpose trailers, carts, etc. are used as produce containers, they must be cleaned prior to use. FV 4.1.6. (M) FV 4.1.10 (M) Annex CB1 4.1 Harvest containers and tools must be maintained clean and in good Page: 30 of 38

Id. AREA GENERAL ASSESSED 6.2 Are equipment and containers managed in a manner to reduce risk of contamination? Improper use, handling, storage, stacking, transportation, etc. of food contact equipment, tools, utensils and containers can lead to contamination of produce. GUIDANCE FOR condition so they cannot contaminate nor damage the produce. Workers with tasks identified in the hygiene procedures must demonstrate competence during the inspection and there is visual evidence that the hygiene procedures are implemented. No N/A. AF 3.2.4. (M) FV 4.1.4 (M) If there are hygiene requirements exceeding AF3.2.2, then there must be evidence that the workers received specific training regarding the hygiene procedures for the harvesting process. Workers must be trained using written (in appropriate languages) and/or pictorial instructions to prevent physical (e.g. snails, stones, insects, knives, fruit residues, watches, mobile phones, etc.) microbiological, and chemical contamination of the product during harvesting. There is visual evidence that the workers are complying with the training instructions and procedures. The farm manager or other nominated person is responsible FV 4.1.5 (M) FV 5.1.3 (M) Page: 31 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR for implementation of the hygiene procedure as a direct result of the produce handling hygiene risk assessment. Annex CB1 4.1 Harvest containers and tools must be maintained clean and in good condition so they cannot contaminate nor damage the produce. Workers should be trained to use only those containers and tools that are clean and in good condition. Remove all dirt as practicable from trailers and boxes between harvest uses. 6.3 Are equipment and containers appropriate for their use? Equipment, tools, utensils and containers can potentially be a source of contamination if previous use has not been for produce, where they have not been designed for use in produce or are in poor condition. Any container or tool suspected to have been in contact with animals manure or animal/human feces, blood or having bird droppings, must be washed and disinfected before re use. Produce containers are only used to contain harvested product (i.e. no agricultural chemicals, lubricants, oil, cleaning chemicals, plant or other debris, lunch bags, tools, etc.). If multi-purpose trailers, carts, etc. are used as produce containers, they must be FV 4.1.10 (M) Page: 32 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR cleaned prior to use. Annex CB 4.1. Harvesting containers should not be used for carrying any material or substance other than harvested fruit and vegetables. Agricultural workers should be trained in this aspect. Any container or tool suspected to have been in contact with animals manure or animal/human feces, blood or having bird droppings, must be washed and disinfected before re use. Annex CB1 4.2. 6.4 Are containers used for waste, by-products, inedible or dangerous substances clearly identified and part of the monitoring? Containers used for waste, byproducts, inedible or dangerous substances can carry pathogens, which can be transferred if the containers are then used for produce. Harvest machinery and equipment should be properly calibrated and handled to prevent physical damage to produce Every day the machinery should be revised to assure that no produce is left inside the equipment. Produce containers are only used to contain harvested product (i.e. no agricultural chemicals, lubricants, oil, cleaning chemicals, plant or other debris, lunch bags, tools, etc.). If multi-purpose trailers, carts, etc. are used as produce containers, they must be cleaned prior to use. FV 4.1.10 (M) Annex CB1 4.1 Page: 33 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR 6.5 Are equipment, containers, packaging and packing materials staged and stored in a manner that reduces the risk of contamination? Equipment, containers, packaging and packing materials that are staged or stored outside, unprotected, exposed to pests or in contact with the ground can become a source of contamination. Harvest containers and tools - Containers for waste, by-products and inedible or dangerous substances, should be specifically identified. They should not be used for maintain fresh fruit or vegetables or packaging material that is used for fresh fruit and vegetables. Reusable harvesting containers, harvesting tools (e.g. scissors, knives, pruning shears, etc.) and harvesting equipment (e.g. machinery) are cleaned and maintained. A cleaning and disinfection schedule is in place to prevent produce contamination. Records are available. FV 4.1.6 (M) FV 4.2.4 (M) Packing material must be stored to protect it against contamination. FV. 5.4.8 (m) 7.1 Temporary Storage Areas Are temporary storage areas maintained in clean and hygienic Contamination can occur when produce is stored in an unclean environment, such as poorly To prevent product contamination until used, packing materials (including re-useable crates) are stored in a clean and hygienic area. All produce packed and handled directly in the field, orchard or greenhouse must be removed FV 4.2.1 (M) Page: 34 of 38

Id. AREA GENERAL ASSESSED conditions? maintained overhead structures, excessive weeds, contact with soil, litter, dirty covers, unclean water etc. GUIDANCE FOR from the field overnight, in accordance with the harvest hygiene risk assessment results. Food safety requirements have to be complied with if produce is stored on a short time basis at the farm. FV 4.2.3. (M) If packed produce is stored on farm, storage areas must be cleaned. FV 5.4.1. (m) To prevent contamination, produce handling and storage facilities and equipment (i.e. process lines and machinery, walls, floors, storage areas, pallets, etc.) must be cleaned and/or maintained according to the cleaning and maintenance schedule that includes defined minimum frequency. Documented records of cleaning and maintenance must be kept. FV 5.4.5. (m) Rejected produce and waste materials are stored in clearly designated and segregated areas designed to avoid contamination of products. These areas are routinely cleaned and/or disinfected according to the Annex CB1 4.4 Page: 35 of 38

Id. AREA GENERAL ASSESSED GUIDANCE FOR cleaning schedule. Only daily accumulations of rejected produce and waste materials are acceptable. 7.2 Do temporary storage areas protect the produce against sources of contamination? Contamination can occur from pest and animal activity if storage areas do not offer adequate protection. Harvested produce must be maintained always in clean area. All field packed produce must be protected from contamination. When packed produce is stored on farm, temperature and humidity controls (where applicable) must be maintained and documented, in accordance with the hygiene risk assessment results and quality requirements. FV 4.2.2. (M) FV 4.2.6. (M) FV 5.6.2. (m) There visual evidence that the pest monitoring and correcting process are effective. Harvested produce must be protected from heat, animals or any source of possible contamination. Annex CB1 4.4 Annex CB1 4.4 8.1 Transportation Is the previous use of the vehicle known and a potential source of contamination? Prior use of vehicles for transport of animals, raw animal products, waste, humans, non-food materials and other sources of contamination may transfer pathogens to produce. A pest control must be in place. Vehicles used for transport of fresh and packed fruit and vegetables should not be used for the transport of hygienically hazardous substances. Annex CB1 4.3. Page: 36 of 38

Id. AREA GENERAL ASSESSED 8.2 Are vehicles used from transport of produce clean, free of odors and visible sources of contamination? 8.3 Has consideration been given to risks from other materials transported with the produce? Unclean surfaces of transport vehicles may be sources of contamination. Contamination can occur from other materials such as animals, raw animal products, waste, humans, non-food materials and other sources when transported together with produce. GUIDANCE FOR Any vehicle should be adequately cleaned, and where necessary disinfected, to avoid crosscontamination. A dirty vehicle or one having remnants of produce should never be used. Farm vehicles used for transport of harvested produce that are also used for any purpose(s) other than transport of harvested produce, are cleaned and maintained according to a schedule so as to prevent produce contamination (e.g. soil, dirt, organic fertilizer, spills, etc.). A hygiene risk analysis has been performed for the harvest and pre-farm gate transport process, is documented and up to date (i.e. reviewed annually), covering physical, chemical and microbiological contaminants and human transmissible diseases, customized to the products. It must also include FV.4.1.2 to FV.4.1.12. The risk assessment shall be tailored to the scale of the farm, the crop, and the technical level of the business. No N/A. Annex CB1 4.3. FV4.1.7 (M) FV 4.1.1. (M) Page: 37 of 38

would like to acknowledge the members of the Stakeholder Committee for Microbiological Risk Assessment who worked on this guideline for their contribution. Members: Andrew Graffham Ian Harrison Javier Garcia Ruiz Richard Stanley Paul Bol Gyula Pal Miguel Vela Ricardo Adonis Lindi Benic Jean Francois Proust Frédéric Rosseneu Thorsten Strissel Mansour Samadpour Barbara Sanderson Bizhan Pourkomailian Jeremy Cooper Richard Barrett Cynthia Andersson Gerard Meijerink David Gombas Raf de Blaiser Ann de Craene Natural Resources Institute IP Ltd / ASDA Bureau Veritas Campden BRI Dutch Produce Association Eisberg Group FEPEX FDF/Asoex Hortgro South Africa ForumPhyto Freshfel Europe Gemüsering IEH Jonathan Sprouts Inc. McDonald s Natural Resources Institute Nature s Way Food Nyttogyrönt AB Syngenta United Fresh VBT/Lava VBT Page: 38 of 38