Western Growers Members Guide to Implementing the Produce Safety Rule

Transcription

1 Western Growers Members Guide to Implementing the Produce Safety Rule January 25, Western Growers version1.0

2 Acknowledgements This report was made possible by the dedicated contributions of the following individuals: Susan Leaman, Vice President, idecisionsciences, LLC Sonia Salas, Director, Science and Technology, Western Growers

3 Table of Contents Background Purpose of the guide Disclaimer Introduction Subpart A General Provisions Subpart B General Requirements Subpart C Personnel Qualifications and Training Company food safety training Official FSMA Training Subpart D Health and Hygiene Worker hygiene program Visitor hygiene program Subpart E Agricultural Water Annual tasks Water system inspection Routine activities and maintenance The water distribution system Water sources Pooled water Microbial water quality surveys Initial microbial water quality survey Annual water quality survey Water quality test methods Water treatment Alternatives to agricultural water management Subpart F Biological Soil Amendments Untreated BSA Treated BSA Agricultural teas Composting Human waste Subpart I Domesticated and Wild Animals Subpart K Growing, Harvesting, Packing and Holding Activities Pre-harvest and harvest assessments Packing materials Subpart L Equipment, Tools, Buildings, and Sanitation Equipment and tools Transport vehicles and equipment Buildings Toilet Facilities and Hand-washing Stations Subpart O Records Glossary Western Growers 3 January 25, 2018

4 List of Appendices Appendix A Compliance Dates Appendix B Record Requirements Appendix C Self-Audit Guide List of Figures. Figure 1. Farm activities as defined by the Produce Safety Rule Figure 2. Who/What is exempt from the Produce Safety Rule? Figure 3. Required supply chain documentation for commercially-processed produce not covered by the PS Rule Figure 4. Decision-tree: Is my farm covered by the Produce Safety Rule? Figure 5. Situations when workers are required to wash their hands Figure 6. What is agricultural water? Figure 7. Microbial Quality Water Test Information Figure 8. Corrective action and/or mitigation measures when water does not meet Figure 9. the microbial criteria What are the requirements related to water directly applied during growing activities? Figure 10. What are the requirements related to water directly applied during and after harvest activities? List of Tables Table 1. Initial water quality survey for agricultural water used on crops during growing activities Table 2. Annual water quality survey for water used on crops during growing activities Table 3A and 3B: Process verification testing: The rules allow for the following two process verification testing schemes Western Growers 4 January 25, 2018

5 Background Before the Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, the United States (U.S.) food safety laws had not been significantly altered or reformed in over 70 years. In the 21 st century, we live in a globally connected world with a population whose internet-driven awareness and interest in food production is unprecedented. With the passing of FSMA, the U.S. legislature seeks to shift the regulatory focus of food safety from a reactive response when things go wrong to promoting a preventative approach to minimize food safety risks. In promulgating FSMA, the U.S. Food and Drug Administration (FDA) established the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption or, as it is commonly called, the Produce Safety Rule (PS Rule). The Produce Safety Rule is the first U.S. law to directly address produce production on a farm. It is one part of over a dozen rules established by the FDA to fulfill the requirements of FSMA. The Produce Safety Rule was developed from a combination of FDA s original proposal and supplemental documents and feedback from thousands of engaged members of the food industry and general public. For many years, many U.S. produce growers and handlers have been, voluntarily following standards they developed in collaboration with food safety experts in the industry-at-large, academia, and government agencies. The Produce Safety Rule, by and large, encompasses what many in the industry have already been doing. Purpose of the guide The purpose of this implementation guide is to assist your company in understanding and complying with the Produce Safety Rule requirements. The guide is developed directly from the final Produce Safety Rule and may be a useful tool when your company reviews its food safety program to ensure compliance. Definitions are located throughout the implementation guide but are also available in the glossary. Decision trees provide step-by-step processes to help your company decide on the best approach to Rule compliance. Graphics help to illustrate sometimes complex legislative terminology into easily understandable visuals. Resources and reference links are included for further information or clarifications. Key requirements from the FDA are highlighted to understand the principles behind specific provisions. Overall, use of this guide will benefit your company s understanding of and compliance with the Produce Safety Rule. Disclaimer All parts of this implementation guide are for information purposes only. It does not provide technical, medical or legal advice. The use of this guide, receipt of information contained on this guide, or the transmission of information from or to this guide does not constitute an attorney-client or any other relationship. The information in this guide is not intended to be a substitute for professional technical advice. Always seek the advice of a qualified expert with any questions you may have regarding your specific situation. Any legal information herein is not intended to be a substitute for professional legal advice. If you need legal advice for your specific situation, you should consult a licensed attorney in your area. The guidance documents, presentations, and other information on this document are general in nature. Western Growers does not warrant that following the guidance herein will ensure compliance with FDA rules or regulations. Rather, the tools herein may be useful in assisting members to develop their own preventive program that adheres to the new Food Safety Modernization Act (FSMA) rules. Western Growers and the authors accept no liability for any injury arising out of the use of material contained herein, and make no warranty, express or implied, with respect to the contents of information contained on this document. Western Growers 5 January 25, 2018

6 Western Growers 6 January 25, 2018

7 INTRODUCTION The Produce Safety Rule specifically emphasizes safe practices for farms growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. It applies to both domestic and imported produce, with certain exemptions and limitations. What is a farm? Primary Production Farm (PPF): An operation under one management In one general (but not necessarily contiguous) physical location Devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities Secondary Activities Farm (SAF): An operation not located on a PPF Devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, the majority of which is owned by the PPF(s) A PPF must own or jointly own a majority interest in the SAF May also conduct those additional activities listed under the PPF definition in paragraphs b) and c) below The term farm includes operations that, in addition to the above activities also: a. Pack or hold raw agricultural commodities b. Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management c. Manufacture/process food, provided that: 1. All food used in such activities is consumed on that farm or another farm under the same management or 2. Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of: Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation) Western Growers 7 January 25, 2018

8 Figure 1. Farm activities as defined by the Produce Safety Rule Western Growers 8 January 25, 2018

9 Subpart A General Provisions What produce is subject to the Produce Safety Rule (referred to as covered )? Produce that is a raw agricultural commodity (RAC) is covered by this Rule both RACs that are grown domestically and those that are imported. RAC is defined as any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. The FDA refers to produce covered by the Rule as covered produce. Covered Fruits and vegetables include: almonds apples apricots apriums Artichokes globe-type Asian pears avocados babacos bananas Belgian endive blackberries blueberries boysenberries brazil nuts broad beans broccoli Brussels sprouts burdock cabbages Chinese cabbages (Bok Choy mustard, Napa) cantaloupes carambolas carrots cauliflower celeriac celery chayote fruit cherries (sweet) chestnuts chicory (roots and tops) clementine grapefruit lemons limes mandarin oranges tangerines tangors all citrus cowpea beans cress-garden cucumbers curly endive currants dandelion leaves fennel- Florence garlic genip gooseberries grapes green beans guavas basil chives cilantro oregano parsley all herbs honeydew huckleberries Jerusalem artichokes kale kiwifruit kohlrabi kumquats leek lettuce lychees macadamia nuts mangos Canary melons Crenshaw melons Persian melons all melons mulberries mushrooms mustard greens nectarines onions papayas parsnips passion fruit peaches pears peas peas-pigeon peppers pine nuts pineapples plantains plums plumcots quince radishes raspberries rhubarb rutabagas scallions shallots snow peas soursop spinach sprouts strawberries summer squash zucchini sweetsop Swiss chard taro tomatoes turmeric turnips (roots and tops) walnuts watercress watermelons yams Mixes of intact fruits and vegetables Exemptions yes, there are exceptions to the Rule Who / What is not required to follow the Produce Safety Rule? 1. The following farms are not covered by the Rule: Farms that do not grow, harvest, pack, or hold produce Farms or farm mixed-type facilities with produce sales that totaled less than an average Western Growers 9 January 25, 2018

10 annual monetary value of $25,000 (calculated on a rolling basis) during the previous 3-year period 2. Some produce items are not covered by the Rule. Produce that is not covered by this Rule includes: Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another under the same management Produce treated in such a way that it is no longer a raw agricultural commodity (RAC) i.e., activities transform produce from RAC into a processed/manufactured food that is no longer a RAC. (e.g., minimally processed, fresh-cut) Produce receiving commercial processing that adequately reduces the presence of microorganisms of public health significance (see Figure 3 for the required supply chain documentation; also the FDA has released draft guidance to industry about how to describe hazards in documents accompanying food) 1 Produce that is rarely consumed raw, specifically the produce on the following exhaustive list: asparagus beans, black beans, great Northern beans, kidney beans, lima beans, navy beans, pinto beets, garden (roots & tops) beets, sugar cashews cherries, sour chickpeas cocoa beans coffee beans collards corn, sweet cranberries dates dill (seeds & weed) eggplants figs ginger hazelnuts horseradish lentils okra peanuts pecans peppermint potatoes pumpkins squash, winter sweet potatoes water chestnuts 3. Operations that qualify for qualified exemptions status Eligibility for qualified exemptions status Farms that meet the following criteria are eligible for exemption status referred to as qualified exemptions by the FDA. A farm that on average over the previous three years has less than $500,000 in annual value of food sold AND The majority of the food is sold directly to qualified end users. (These are consumers in any location or a restaurant or retail food establishment in the same state / Indian reservation as your farm or within 275 miles of your farm.) Requirements for operations with a qualified exemptions status Farms that are eligible for the qualified exemption status are required to follow requirements, referred to as modified requirements, which are significantly less than those required of farms ineligible for exemption. 1 FDA issued an enforcement discretion related to written assurances; see FDA s fact sheet here: GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM pdf Western Growers 10 January 25, 2018

11 If your company is eligible for a qualified exemption, then you must abide by the following modified requirements: Subpart A General provisions Subpart O Records Subpart Q Compliance and Enforcement Subpart R Withdrawal of Qualified Exemption Customer notifications o OR o If a food packaging label is required, you must prominently and conspicuously on the food packaging label the name and the complete business address of the farm (street or PO box number, city, state, and zip code) where the produce was grown If a food packaging label is not required, you must prominently and conspicuously display: the name of the farm where the produce was grown the complete business address (street or PO box number, city, state, and zip code) of the farm where the produce was grown Where: at the point of purchase In what format: a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business (an electronic notice is permitted for Internet sales) Figure 2. Who/What is exempt from the Produce Safety Rule? Western Growers 11 January 25, 2018

12 Figure 3. Required supply chain documentation for commercially processed produce not covered by the PS Rule Does your farm supply produce to customers where commercial processing adequately reduces microorganisms of public health significance (MPHS)? Yes? No? You are NOT covered by the following requirements. Enclose documentation stating that your produce is not processed to adequately reduce MPHS. Does your customer perform the commercial processing? No? Yes? Annually obtain written assurance from your customer they have established and are following procedures that adequately reduces MPHS. Annually obtain written assurance from your customer that: An entity in the distribution chain subsequent to the customer will perform commercial processing. They will disclose in documents accompanying the food that the food is not processed to adequately reduce MPHS Does their customer perform the commercial processing? Yes? No? Does their customer agree that it will follow procedures that adequately reduce MPHS? No? Do not sell to this entity. Yes? Obtain written assurance. Their customer must agree in writing that they will 1) disclose in documents accompanying the food that it is not processed to adequately reduce MPHS and 2) obtain written assurance from their customers that the produce will receive commercial processing to adequately reduce MPHS. Western Growers 12 January 25, 2018

13 Record Requirements If you are eligible for a qualified exemption, establish and keep records to support your determiniation that your operation satisfies the criteria. Maintain a written record reflecting an annual review and verification of farm s continued eligibility for the qualified exemption. Resources: FSMA Final Rule on Produce Safety: FDA s website for the Produce Safety Rule: FDA at a Glance. Key Requirements: Final Rule on Produce Safety: FDA s Draft Guidance for Industry: Describing a hazard that needs control in documents accompanying the food, as required by four rules implementing the FDA Food Safety Modernization Act. GuidanceDocumentsRegulatoryInformation/UCM pdf Western Growers 13 January 25, 2018

14 Figure 4. Decision-tree: Is my farm covered by the Produce Safety Rule? Does your farm grow, harvest, pack, or hold produce? Yes? No? You are NOT covered by this rule. Does your farm on average (in the previous 3 yrs) have < $25K in annual produce sales? No? Yes? You are NOT covered by this rule. Is your produce one of the commodities that FDA has identified as rarely consumed raw? No? Yes? You are NOT covered by this rule. Is your produce for personal/ on-farm consumption? No? Yes? You are NOT covered by this rule. Is your produce a Raw Agricultural Commodity* (RAC)? Yes? Is your produce intended for commercial processing with a kill step? No? Yes? Does your farm on average (in the previous 3 yrs.) have <$500K annual food sales and is a majority of the food (by value) sold directly to qualified endusers? No? No? Yes? You are COVERED by the Produce Safety Rule. Produce that is not a RAC is NOT covered by this rule. This produce is NOT covered by this rule EXCEPT you must establish and keep certain documentation. You are EXEMPT from this rule EXCEPT you must meet certain modified requirements. Any fruit or vegetable including mushrooms, sprouts, peanuts, tree nuts and herbs. *FDA definition of RAC: Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. The consumer of the food; or a restaurant or retail establishment that is located within 275 miles of or in the same state/indian reservation as the farm producing the food. Western Growers 14 January 25, 2018

15 Subpart B General Requirements Key Principle: Do all you can to prevent your crops from being contaminated. You must act appropriately to minimize the risk of serious harmful health consequences or death to consumers from the use of, or exposure to, your produce. Take measures reasonably necessary to prevent the introduction of known or foreseeable hazards in order to provide assurances that produce is unadulterated as defined by section 402 in the Federal Food, Drug, and Cosmetic Action. Alternatives to specific requirements of Subpart E Agricultural water can be established. You are not required to get FDA s approval, but you must establish and maintain documents o scientific data and information used to support such alternative. Points to note: this applies to individuals who are subject to the PS Rule. Subpart C Personnel Qualifications and Training Key Principle: Ensure all personnel understand their personal responsibility for compliance with food safety protocols and handling of produce. The company is responsible for training and educating all personnel. Company food safety training Every company covered by this Rule must assign/identify a person to be responsible for compliance to the Rule s requirements at your operations. What qualification do people who work in the production and handling of produce need to have? They must have a combination of education, training, and experience necessary to perform their assigned duties. They need to have knowledge of this Rule enough to ensure compliance with the requirements as appropriate to their duties. Who needs to be trained? Training is required for all (including part-time, temporary, seasonal, and contracted) personnel who handle produce or food-contact surfaces or are engaged in the supervision of those who do so. When do personnel need to be trained? When they are hired Periodically after hiring - at least once annually What topics must training cover (these are the minimum requirements)? Principles of food hygiene and food safety The importance of health and personal hygiene Western Growers 15 January 25, 2018

16 Recognition of symptoms for illnesses that could result in product or food-contact surface contamination The standards in this Rule that are applicable to the employee s job responsibilities What are the principles of food hygiene and food safety? Principle 1. Prevention of microbial contamination of fresh produce is favored over reliance on corrective actions once contamination has occurred. Principle 2. To minimize microbial food safety hazards in fresh produce, growers, packers, or shippers should use good agricultural and management practices in those areas over which they have control. Principle 3. Fresh produce can become microbiologically contaminated at any point along the farmto-table food chain. The major source of microbial contamination with fresh produce is associated with human or animal feces. Principle 4. Whenever water comes in contact with produce, its source and quality dictates the potential for contamination. Minimize the potential of microbial contamination from water used with fresh fruits and vegetables. Principle 5. Practices using animal manure or municipal biosolid wastes should be managed closely to minimize the potential for microbial contamination of fresh produce. Principle 6. Worker hygiene and sanitation practices during production, harvesting, sorting, packing, and transport play a critical role in minimizing the potential for microbial contamination of fresh produce. Principle 7. Follow all applicable local, state, and Federal laws and regulations, or corresponding or similar laws, regulations, or standards for operators outside the U.S., for agricultural practices. Principle 8. Accountability at all levels of the agricultural environment (farm, packing facility, distribution center, and transport operation) is important to a successful food safety program. There must be qualified personnel and effective monitoring to ensure that all elements of the program function correctly and to help track produce back through the distribution channels to the producer. Source: Are there additional topics to cover when training personnel for harvest? Persons who harvest produce must also receive training in: Recognizing produce that may be contaminated and must not be harvested Inspecting harvest containers and equipment to ensure they are functioning properly, clean, and maintained so they are not a source of contamination. Correcting problems with harvest containers or equipment, or reporting problems to a supervisor/responsible party How must training be conducted? Training must be easily understood by personnel being trained. Training must be repeated as necessary and appropriate in light of observations or information indicating personnel are not meeting the standards within this Rule. Western Growers 16 January 25, 2018

17 Resources: Ag/Safe and Western Growers upcoming PSA courses (January May 2018) California LGMA Tech Training California LGMA handwashing and glove usage training app Produce Safety Alliance: Worker Health, Hygiene and Training Arizona LGMA food safety training kit CFSAN training videos Official FSMA Training Who needs to take official FSMA training (i.e., a training course using standardized FDArecognized curriculum)? At least one supervisor or responsible party for your farm must successfully complete food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA. Currently, the Produce Safety Alliance (PSA) class meets this requirenment. Resources: For food safety training with standardized curriculum FDA s Strategy for FSMA Training website Produce Safety Alliance website The North Central Regional Center for Food Safety Training, Education, Extension, Outreach and Technical Assistance Located at Iowa State University, Ames, IA The Northeast Center for Food Safety, Training, Education, Extension, Outreach and Technical Assistance Located at University of Vermont, Burlington, VT The Southern Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Produce Safety Located at University of Florida, Grainseville, FL The Western Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Food Safety Located at Oregon State University, Corvallis, OR National Association of State Departments of Agriculture (NASDA) Western Growers 17 January 25, 2018

18 Record Requirements Establish and keep records of training that documents required training of personnel, including: the date of training topics covered the person(s) trained Subpart D Health and Hygiene Key Principle: Take measures to prevent contamination of produce and food-contact surfaces by ill or infected persons. Use hygienic practices especially when handling produce. What needs to be protected from contamination via worker contact? Both produce and produce contact surfaces What disqualifies a worker from working in areas around produce and produce contact surfaces? There are two types of health issues that disqualify a worker from working in areas where produce and produce contact surfaces may become contaminated: Workers with gastrointestinal, diarrheal or communicable/infectious illness Workers with open lesions What do workers need to do if they experience either of these conditions? Notify their supervisor or responsible party Worker hygiene program What practices should worker hygiene programs cover? Worker hygiene programs must include the following practices: Maintain adequate personal cleanliness Avoid contact with animals No eating, chewing gum or tobacco in food production areas Removing or covering jewelry that cannot be kept sanitary when handling produce Maintaining gloves in an intact and sanitary condition, and replacing when needed Wash hands (see Figure 5 below for the situations where workers are required to wash hands) Western Growers 18 January 25, 2018

19 Figure 5. Situations when workers are required to wash their hands Visitor hygiene program What practices should be in place for people who visit our fields and facilities? Visitors need to be aware of and comply with policies and procedures regarding hygiene. Toilet and hand-washing facilities need to be accessible to visitors. Resources: FDA s Good manufacturing Practices Personnel FDA s Retail Food Protection: Employee Health and Personal Hygiene Handbook IndustryandRegulatoryAssistanceandTrainingResources/ucm htm Western Growers 19 January 25, 2018

20 Subpart E Agricultural Water use. Key Principle: All agricultural water must be safe and of adequate sanitary quality for its intended What is agricultural water? The FDA defines agricultural water as water used in covered activities (activities subject to this rule) on covered produce (produce subject to this rule) where water is intended to, or is likely to, contact covered produce or food-contact surfaces, including water used in: Growing activities including water used for: o irrigation using direct water application methods o o preparing crop sprays growing sprouts Harvesting, packing, and holding activities including water used for: o washing or cooling harvested produce o preventing dehydration of covered produce Figure 6. What is agricultural water? Western Growers 20 January 25, 2018

21 Annual tasks The following agricultural water requirements are to be completed on an annual basis. Water system inspection Inspect your water system all the system components that are under your control. What am I looking for during the water system inspection? In light of your produce, practices, and conditions, identify conditions that are likely to introduce known or foreseeable hazards into or onto produce or food-contact surfaces. Consider and make note of the following: The origin of each agricultural water source (ground water or surface water) The extent of your control over each agricultural water source The degree of protection of each agricultural water source Use of adjacent land The likelihood that another user upstream of your operations may introduce hazards to the water before it reaches you When do I need to inspect the water system? At the beginning of a growing season, as appropriate, but at least once a year Routine activities and maintenance You must maintain all components of your water systems to the extent they are under your control to prevent them from being a contamination source for produce, food-contact surfaces, areas used for production activities, or water sources. What do I need to do for my water distribution system? Regular inspections Adequately storing all equipment used in the system Water distribution system: A water distribution system is a system to carry water from its primary source to its point of use, including pipes, sprinklers, irrigation canals, pumps, valves, storage tanks, reservoirs, meters, and fittings. What do I need to do for my water source(s)? Regular inspections to identify any conditions that may lead to contamination Correcting deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections) Keep it free of debris, trash, domestic animals, and other contamination sources Water sources: Water sources refers to the origin of the water (e.g. ground water, surface water). Western Growers 21 January 25, 2018

22 When am I NOT permitted to use untreated surface water? During and after harvest activities when water (and/or ice) is applied directly to produce When water (and/or ice) has contact with food-contact surfaces For washing hands during and after harvest activities For sprout irrigation If there is pooled water in the production area, what should I do? Implement measures to reduce potential contact between pooled water and produce (e.g., using protective barriers or staking to keep covered produce from touching the ground or using an alternative irrigation method). Pooled water: Pooled water is water that has accumulated on the ground; it is considered a potential source of contamination in the production area. How should water used during harvest, packing, and holding activities be managed? Establish and follow water-change schedules for re-circulated water Maintain adequate sanitary quality Minimize the potential for contamination of produce and food-contact surfaces Visually monitor water for build-up of organic material Maintain and monitor water temperature as appropriate to the commodity and operation to minimize the potential for microbial infiltration into susceptible produce When must I use only potable water (i.e., water that has no detectable generic E. coli)? During and after harvest activities when water (and/or ice) is applied directly to produce When water (and/or ice) has contact with food-contact surfaces For washing hands during and after harvest activities For sprout irrigation Microbial water quality surveys What are the water quality criteria for agricultural water used during growing activities? For water that is applied directly to produce during growing activities, there are two criteria for generic E. coli (both need to be met): A geometric mean of < 126 CFU/100 ml and A statistical threshold value < 410 CFU/100 ml Western Growers 22 January 25, 2018

23 What do these two values mean and how do I calculate them? The geometric mean is an average measure representing the central tendency of your water quality distribution. The statistical threshold value is a measure of variability of your water quality distribution, indicating E. coli levels when adverse conditions such as heavy rainfall washing waste into surface water. In simple terms, it can be described as the level at which 90% of the samples are below the threshold value (410 CPU/100 ml). Resources: Online calculator available at the University of Arizona s Fresh Produce Safety: Information from Farm to Fork Excel tool available at the Western Center for Food Safety: Do all types of agricultural water need to be tested? If any of the following is true, there is NO requirement for testing agricultural water used for growing activities, water used during or after harvest activities, or water used to make ice: Water treated using a method that effectively makes the water safe and of adequate sanitary quality for its intended use Water received from a Public Water System [defined in the Safe Drinking Water Act (SDWA)] that meets microbial requirements of either: o this Rule, or o Regulations of a state approved to administer the SDWA public water supply program Results or certificate of compliance needs to be on file. When do I need to test my agricultural water? To establish your agricultural water quality profile, you need to conduct an initial water quality survey of your water sources used in growing operations (see Appendix A for the dates by when this needs to be completed) After you establish your water quality profile, you must test your water at least annually to update your profile If there is reason to believe that microbial water quality no longer meets water quality criteria Who can collect and test the water samples for the microbial quality surveys? You A person or a third-party provider acting on your behalf A third-party entity (e.g., a group of growers in a particular area that share the same water source) - as long as the water source(s) sampled are representative of the water used in your operations and all other applicable requirements of the PS Rule are met Western Growers 23 January 25, 2018

24 How should water samples be collected and tested? Samples must be collected and tested aseptically Testing methods must meet the Rule s Analytical Methods requirements outlined in subpart N Initial microbial water quality survey In order to establish a microbial quality profile for your agricultural water, the FDA is requiring an initial water quality survey. For which types of water must I conduct the initial survey? For each untreated surface or ground water source(s) from which water is used in direct contact with the crop during growing activities and for untreated ground water source(s) used during and after harvest activities. How do I conduct an initial microbial water quality survey? The initial survey requirements differ slightly for untreated surface water or untreated ground water sources and are outlined in Table 1 below: Table 1. Initial water quality survey for agricultural water used on crops during growing activities Untreated surface water Untreated ground water Target organism: generic E. coli generic E. coli Sample volume 100 ml 100 ml Sample number: 20 water samples 4 water samples Sample collection frequency: Sampling time Sample location samples must be collected over 2-4 years As close as practical to, but prior to, harvest Water sample must be representative of your use samples must be collected over 1 year As close as practical to, but prior to, harvest Water sample must be representative of your use Annual water quality survey After the initial water quality survey, you must update your microbial water quality profile to confirm that the way(s) in which your agricultural water is used continues to be appropriate. For which types of water must I conduct the annual survey? For each untreated surface and ground water source(s) that is used in direct contact with the crop during Western Growers 24 January 25, 2018

25 growing activities and for untreated ground water source(s) used during and after harvest activities. When do I need to update the microbial water quality profile for my agricultural water sources? Annually and If you have reason to believe that your microbial water quality profile no longer represents the quality of your agricultural water. How do I update the microbial water quality profile? Calculate revised GM and STV values using newest water samples collected from within the previous 4 years to make a rolling data set of: At least 20 samples for untreated surface water sources At least 4 samples for untreated ground water sources How do I update my microbial water quality survey each year? The annual survey requirements differ slightly for untreated surface water or untreated ground water sources and are outlined in Table 2 below: Table 2. Annual water quality survey for water used on crops during growing activities Untreated surface water Untreated ground water Target organism: generic E. coli generic E. coli Sample volume 100 ml 100 ml New sample number collected: 5 water samples per year 1 water sample per year Total to calculate GM & STV 20 most recent water samples 4 most recent water samples Sampling time Sample location As close as practical to, but prior to, harvest Where water sample is representative of your use As close as practical to, but prior to, harvest Where water sample is representative of your use Western Growers 25 January 25, 2018

26 Figure 7. Microbial Quality Water Test Information Does everyone need to test their water sources? No, water testing is not required when: Farms/ranches receive water from a public water system or supply. But they must still keep record of the water company s/utility s microbial test results or certificates of compliance Farms/ranches treat their water according to the Rule s water treatment standards There is scientific proof of water s adequate microbial quality (described below) Western Growers 26 January 25, 2018

27 What should I do if my agricultural water source does not meet the microbial criteria? Corrective action/mitigation measures depend on whether the water is being used for growing activities or during/after harvest. See Figure 8 for details. Figure 8. Corrective action and/or mitigation measures when water does not meet the microbial criteria Western Growers 27 January 25, 2018

28 Water quality test methods You must test the water using any of following methods: EPA method 1603 One of the scientifically valid methods that the FDA has deemed at least equivalent to EPA Method 1603 in accuracy, precision, and sensitivity in quantifying generic Escherichia coli in agricultural water. Equivalent testing methodology is available in the FDA s website A scientifically valid method for any other fecal indicator (if you use an alternative to agricultural water management as described below). Water treatment If your agricultural water does not meet the standards for microbiological quality for its intended use, you may opt to treat your water. If you treat your water, you must implement the following requirements: What water treatments can I use to treat my water? Any physical treatment, EPA-registered antimicrobial pesticide product, or other suitable method that: Effectively makes the water safe and of adequate sanitary quality for its intended use and Ensures the water meets the relevant microbial quality standards. Do I need to test my water if I treat it? No if you treat your water and follow requirements to ensure microbial quality criteria, you do not need to test your water quality. However, treated agricultural water must be delivered in a manner and monitored at a frequency to ensure that it is consistently safe and of adequate sanitary quality for its intended use. Alternatives to agricultural water management You may establish and use one or more of the following alternatives: An alternative microbial quality criterion (or criteria), using an appropriate indicator of fecal contamination An alternative microbial die-off rate and maximum time interval for water treatments An alternative minimum number of samples used in the initial water quality survey for untreated surface water source. An alternative minimum number of samples used in the annual water quality survey for untreated surface water source. If an alternative approach is used, what procedures are required? Alternatives may be established and used, only if, you have adequate scientific data or information to support a conclusion that the alternative would provide the same level of public health protection and that your produce will not be adulterated. The scientific data and information can be developed by you, available in scientific literature, or available to you by a third party. You must establish and maintain documentation of data and information. Western Growers 28 January 25, 2018

29 You are not required to notify or seek prior approval from FDA regarding your decision to establish or use an alternative under this Agricultural Water section. Record requirements Establish and keep the following records: Agricultural water system inspection results Results of all microbial quality analytical tests conducted on agricultural water. Scientific data or information used to support adequacy of water treatment method(s). Agricultural water treatment monitoring results Scientific data or information used to support microbial die-off removal rate to determine the time interval between harvest and end of storage, including other activities such as commercial washing used to achieve the calculated log reduction of generic E. coli. Remedial actions taken if water does not meet microbial requirements. Such documents should include specific time interval or log reduction applied, how the time interval or log reduction was determined and the dates of corresponding activities (such as last irrigation and harvest, harvest and end of storage, and/or commercial washing). Results (or certificates) of compliance from public water system (annual). Scientific data or information used to support any agricultural water management alternatives you establish and use. Any analytical methods, other than EPA Method 1603 used to test water samples. Western Growers 29 January 25, 2018

30 Figure 9. What are the requirements related to water directly applied during growing activities? Is water applied to your produce using a direct water application method during growing activities? Yes? No? You do NOT have to test your water. Is your water from a public water system/supply that meets microbial drinking water standards? No? No? Do you treat your water? Yes? Yes? Do you use untreated surface water? You do NOT have to test your water. Retain certificate of compliance or water system test results. You do NOT have to test your water, but its sanitary quality and safety must be monitored. Do you use untreated ground water? No? Yes? Yes? Conduct an initial survey of > 20 samples collected in 2-4 years. Does the STV exceed 410 CFU generic E. coli/100 ml of water? Surface water Conduct an initial survey of > 4 samples collected in < 1 year. Does the STV exceed 410 CFU generic E. coli/100 ml of water? No? Yes? Does the geometric mean exceed 126 generic E. coli/100 ml of water? Treat your water or use the die-off rate to determine an application-to-harvest or harvest-to-end of storage interval and/or log reduction from other post-harvest activities. Yes? No? No? Yes? Water may be used on produce; conduct annual testing of > 5 samples/year (surface water) or > 1 sample/year (ground water) as used during the growing season and as close to harvest as possible. Ground water Western Growers 30 January 25, 2018

31 Figure 10. What are the requirements related to water directly applied during and after harvest activities? Is water applied to your produce using a direct water application method during or after harvesting activities? Yes? No? You do NOT have to test your water. Is your water from a public water system/supply that meets microbial drinking water standards? No? Do you treat your water? Yes? You do NOT have to test your water. Retain certificate of compliance or water system test results. No? Yes? You do NOT have to test your water, but its sanitary quality and safety must be monitored. Do you use untreated ground water? No? Yes? Do you use untreated surface water? Yes? Discontinue use. Use of untreated surface water during harvest and post-harvest activities is prohibited under the Produce Safety Rule. Establish your water quality profile by testing water > 4 times in < 1 year with >4 samples collected as close to harvest as possible. Is there detectable generic E. coli in the water? No? Yes? You may reduce testing to once annually using > 1 sample collected as close to harvest as possible. Is there detectable generic E. coli in the water? No? Yes? Treat your water or use the die-off rate to determine a harvest-toend of storage interval and/or log reduction from other post-harvest activities. Continue with current testing plan. Western Growers 31 January 25, 2018

32 Subpart F Biological Soil Amendments Key Principle: Biological soil amendments of animal origin must be processed, handled, conveyed, and stored in a manner that does not contaminate produce, food-contact surfaces, areas used for growing, harvesting, and post-harvest activities, water sources and distribution systems, and other soil amendments. What are biological soil amendments of animal origin (BSA)? According to the FDA, BSA consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts including animal mortalities, or table waste, alone or in combination. The definition of the term does not include any form of human waste. The regulations address treated and untreated BSAs. Untreated BSA What are untreated biological soil amendments of animal origin (BSA)? BSA is untreated when it: Has not been processed to completion to adequately reduce microorganisms of public health significance in accordance with the rule requirements Has become contaminated after treatment Has been recombined with an untreated BSA Is or contains a component that is untreated waste that may be contaminated Is an agricultural tea made with biological materials of animal origin that contains an agricultural tea additive Can untreated BSAs be used on produce fields? Yes, untreated BSAs can be used on produce fields, but the following application requirements must be met: If it is applied in a manner that does not contact produce during and after application, there is no minimum application-to-harvest interval. If it does not contact produce crops during application, and minimizes the potential for produce contact after application (e.g., applied to cantaloupe field when plants are young, but later, during the growing season, fruit may contact BSA on the ground) FDA is reserving requirements for a minimum application interval due to ongoing research. Treated BSA What are treated biological soil amendments of animal origin(bsa)? BSA that has been processed to completion to adequately reduce microorganisms of public health significance in accordance with the rule requirements. What treatment processes are permitted for treating BSAs? Western Growers 32 January 25, 2018

33 Scientifically valid controlled physical (e.g., thermal), chemical (e.g., high alkaline ph), or biological (e.g., composting) processes or a combination of these processes. What is the criteria for determining that a lot of BSA is adequately processed? Verification testing is required and two testing schemes are permitted as described in Table 3A and 3B below. Important to note: How BSA can be applied is restricted by which of the two process verification schemes are used. Table 3A and 3B: Process verification testing: The rule allows for the following two process verification testing schemes Table 3A Listeria monocytogenes Salmonella species Microbial std No detection E. coli O157:H7 Detection limit of testing method 1 CFU/5 g(ml) 3 MPN/4 g(ml) 0.3 MPN/g(mL) Application restrictions Application interval None can be applied in any manner 0 days there is no application-to-harvest interval Table 3B Salmonella species Fecal coliform Microbial std No detection <1,000 MPN/g of total solids (dry weight) Detection limit of testing method 3 MPN/4 g(ml) None given Application restrictions Application interval In a manner that minimizes the potential for contact with produce during and after application 0 days there is no application-to-harvest interval Agricultural teas What is an agricultural tea? The FDA defines an agricultural tea as a water extract of biological materials (such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table waste, or yard trimmings), excluding any form of human waste, produced to transfer microbial biomass, fine particulate organic matter, and soluble chemical components into an aqueous phase. Agricultural teas are held for longer than one hour before application. What are the requirements for agricultural teas to be considered treated? In order to be permitted to be used as treated BSAs, agricultural teas: Cannot be made with untreated surface water Must be made with water that contains no detectable generic E. coli Cannot contain additives (defined as a nutrient source such as molasses, yeast extract, or algal Western Growers 33 January 25, 2018

34 powder added to agricultural tea to increase microbial biomass) Must be made with BSA that is treated using a scientifically valid controlled physical, chemical, biological, or combination process and meet testing requirements per Table 3A or 3B. Can agricultural teas be used in water distribution systems (e.g., irrigation systems)? Yes, as long as all other requirements of the rule are met. Composting Composting is a biological process. Examples of scientifically valid controlled biological process that must meet the microbial standards in Table 3B (Salmonella spp. and fecal coliform) include: Static composting: maintains aerobic (oxygenated) conditions at a minimum of 131 F (55 C) for 3 consecutive days and is followed by adequate curing Turned composting: maintains aerobic conditions at a minimum of 131 F (55 C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing. Human waste Can human waste be used on crops? No, with one exception: You may use sewage sludge on crops that has been processed according to the requirements of 40 CFR part 503, subpart D, or equivalent regulatory requirements. Record requirements For soil amendment of animal origin received from a third party, annual documentation (such as a Certificate of Conformance) is required to confirm the following: Scientifically valid process was used to treat the BSA. BSA treatment process was monitored. BSA was handled, conveyed, and stored to minimize the risk of cross-contamination by an untreated or in process BSA. If you produce your own biological soil amendment from animal origin documentation of established and performed process controls are required, include: time, temperature, and turnings. Resources: The Federal Biosolids Rule: Western Growers 34 January 25, 2018

35 Subpart I Domesticated and Wild Animals Key Principle: When growing and handling produce outdoors or in partially-enclosed buildings, measures must be taken to protect produce from contamination due to the presence and/or intrusion of animals. What types of animal activity are addressed? Grazing animals Working animals Animal intrusion What product handling activities are covered under these requirements? Outdoor activities Handling activities conducted in partially-enclosed buildings Any activity when there is a probable chance that animals will contaminate produce Do NOT apply to: Fully-enclosed buildings or when fish are used in aquaculture operations What measures need to be taken when wildlife and domestic animals (including grazing and working animals) will or may be in contact with produce production areas? During the growing season look for evidence of potential produce contamination based on your produce, practices, conditions, observations, and experience. If significant evidence of potential contamination is found, evaluate whether the produce can be harvested. Evidence includes: o Observation of animals in area o o Animal excreta Crop destruction Identify and do not harvest produce visibly contaminated with animal excreta or other known or potential hazard(s). If potential contamination is identified prior to harvest, mark the area so it can be identified during harvest and not harvested. For example, place flags outlining the affected area. Although a waiting period between grazing and harvesting is not a requirement, the FDA encourages farmers to voluntarily consider establishing such waiting periods as appropriate for the commodity and operation. Western Growers 35 January 25, 2018

36 How do these requirements apply when the animals identified as a contamination risk are threatened or endangered species? 2 The same requirenments apply, but the regulation does not authorize farms to take measures to exclude threatened or endangered species from outdoor growing areas, or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas. Record requirements There are no record requirements. Subpart K Growing, Harvesting, Packing and Holding Activities Key Principle: Conduct a pre-harvest and harvest visual assessment of the production area. Maintain sanitary processing procedures from harvesting through final packing and ensure all packing material is sanitary. What requirements apply when I grow and handle produce that is covered by the Rule and produce that is excluded from the Rule (except when both produce are placed in the same container for distribution)? Keep them separate. Adequately clean and sanitize any food-contact surfaces that come in contact with the excluded produce before using them for covered produce. Pre-harvest and harvest assessments What must I do before harvesting? Conduct a visual assessment of the production area to be harvested for animal excreta (defined as solid or liquid animal waste) or any other known or reasonably foreseeable hazard. Identify potential hazard(s) and do not harvest. What are the requirements for harvesting? Handle produce in a manner that protects it from contamination such as avoiding contact of cut surfaces of harvested produce with soil. Do not harvest dropped produce (produce that drops to the ground before harvest). This does not apply to crops that are grown underground (such as carrots), on the ground (such as cantaloupe) or intentionally dropped during harvest (such as almonds). 2 Defined by the Endangered Species act: 16 U.S.C Western Growers 36 January 25, 2018

37 Dropped Produce Packing materials What are the requirements related to packing produce? Food-packing material must: Prevent the formation of Clostridium botulim toxin (if it is identified as a hazard for your produce crops) Be adequate for its intended use Be cleanable or designed for single use Not support bacterial growth or transfer Can food packing materials be reused? If reusing food-packing material, you must take adequate steps to ensure that the food-contact surfaces are clean or use a clean liner. Record requirements There are no record requirements. Subpart L Equipment, Tools, Buildings, and Sanitation Key Principle: Implement standards to prevent equipment, tools, and building from contaminating produce or food-contact surfaces. Equipment and tools are to be maintained and properly clean. Buildings needs to be sanitary and operational with properly functioning toilet facilities and hand washing stations. Equipment and tools Which equipment and tools are subject to these requirements? All those that are intended to, or likely to contact produce. Examples include: Knives, implements, mechanical harvester equipment, waxing machinery, cooling equipment, Western Growers 37 January 25, 2018