GAP Audits - What Auditors Look For

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1 Great Lakes Fruit, Vegetable & Farm Market EXPO Michigan Greenhouse Growers Expo December 8-10, 2009 DeVos Place Convention Center, Grand Rapids, MI GAP Audits - What Auditors Look For Wednesday morning 9:00 am Where: Gallery Overlook (upper level) Room C-D CCA Credits: PD(2.0) 9:00 a.m. Overview of GAP Audits Tom Kalchik, MSU Product Center 9:15 a.m. USDA GAP Audits Colleen Bess, Michigan Dept. of Agriculture 10:00 a.m. NSF/Davis Fresh Audits Ed LaClair, NSF-Davis Fresh Technologies, Lake Placid, FL 10:45 a.m. Questions and Discussion

2 Third Party Audits: What Are They and Why Are We Being Asked to Do Them? December 1, 2009 Tom Kalchik, MSU Product Center Third Party Audits What are they and why are we being asked to do them? BUSINESS INNOVATION IN FOOD, AGRICULTURE, NATURAL RESOURCES, AND THE BIOECONOMY Foodborne Illnesses in the US 76 million cases per year 325,000 hospitalizations per year > 5,000 preventable deaths per year Economic losses estimated to be billion dollars per year Mead et al Emerging Infectious Diseases 5:607 Food Recalls E. coli in spinach Salmonella Saintpaul - in tomatoes? No? Peppers Salmonella Typhimurium in peanuts 2009 Salmonella in alfalfa sprouts 2009 Salmonella in pistachios October 2009 Recalls October 30, Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall October 30, Alexia Foods issues nationwide allergy alert and product recall on its Alexia Olive Oil, Sun-Dried Tomatoes & Pesto Oven Reds frozen potatoes due to undeclared pine nut allergen October 30, Pointe Scientific, Inc Expands Nationwide Recall of Liquid Glucose Hexokinase Reagent (G7517) October 30, Allergy Alert on Possible Undeclared Soy Protein in32-ounce Great Value Half & Half, 32-ounce Great Value 36% Heavy Whipping Cream, 32-ounce Kroger brand 36% Heavy Whipping Cream, and 64-ounce Wholesome Farms Chocolate Ice Cream Mix October 28, Pointe Scientific, Inc Issues Nationwide Recall of Liquid Glucose Hexokinase Reagent (G7517) October 28, Mrs. Rios Corn Products Issues Allergy Alert on Undeclared Whey in Flour Tortillas October 27, Qualitest Pharmaceuticals Issues a Voluntary Nationwide Recall of All Accusure Insulin Syringes October 27, Pop s Bakery Inc. Issues Allergy on Undeclared Whey (Milk) in all Flour Tortillas October 2009 Recalls October 26, Mars Snackfood US ISSUES ALLERGY ALERT ON UNDECLARED PEANUTS In Dove Caramel Pecan Perfection Ice Cream October 26, San Link Inc. Issues an Alert on Uneviscerated Vacuum Pack Dried Lesh (Fish). October 23, Cordis Initiates Nationwide Recall of CROSSOVER Sheath Introducer October 22, Unilever Issues Allergy Alert on Wheat in a Limited Number of Tubs of Breyers Ice Cream October 22, Undeclared Sulfites in "Agro Sun Dried Fruits and Nuts Tropical Mix" October 21, Nutkao Urgent Food Recall Due to Undeclared Peanuts October 20, American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection October 19, Domega International Co. Ltd Issues Allergy Alert on Undeclared Eggs in WHITE LOTUS SEED PASTE MOON CAKE (2 YOLKS) October 19, Plum Organics Voluntarily Recalls Select Batch of Apple & Carrot Portable Pouches Due to Potential Health Risk October 2009 Recalls October 16, Hannaford Announces Removal of Frozen Taste of Inspirations Vegetable Spring Rolls October 15, TGF PRODUCTION LLC Issues An Alert On Uneviscerated Herring Salted October 13, Limited Voluntary Recall of Country Acres Home Grown Turkey & Quail Starter October 12, Fisher/Rex Sandwiches Recalls Sandwiches Because of Possible Health Risk October 08, FDA Takes Enforcement Action against Ready-to- Eat Sandwich Manufacturer October 06, Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators October 02, Niles, Ill. Firm Issues Allergy Alert on Classic Candy October 01, Neuron 6F 070 Delivery Catheter [Penumbra] October 01, FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency October 01, Consumers Warned Not to Eat Certain Imported Dried Plums MICHIGAN FREEZE PACK (MFP) THIRD PARTY AUDITING TRAINING 1

3 Third Party Audits: What Are They and Why Are We Being Asked to Do Them? December 1, 2009 Tom Kalchik, MSU Product Center Potential sources of pathogen contamination of fresh produce Animals Feces Feed soil water Insects Produce (cross contamination) meat, milk, eggs harvesting, handling, processing environments Humans Food Safety Standards Public standards Government laws and regulations International Trade: Codex Alimentarius Commission Tend to focus primarily on risks due to food hazards Private Standards Driven by the food industry: retail buyers, buyer organizations, commodity groups, NGOs, etc. Often consider food hazards (perhaps not risk-based) as well as environmental issues and corporate social responsibility objectives. Modified from Beuchat, 1996 US Food Regulatory System Federal USDA, FDA Food processors, eggs, imports, most food products in interstate commerce States e.g. Michigan Dept. of Agriculture Foods in intrastate commerce, processors, contract inspections for FDA, milk, retail food operations Local Health Departments Restaurants, institutional food service operations Primary production is generally not regulated Fresh produce production and packing facilities How to Fill Voids in the Public Food Safety Regulatory System? During the past several years, lack of resources (and limited political will) have impaired the effectiveness of public sector regulatory bodies to enforce food safety requirements Industry leadership major buyers have taken responsibility for driving requirements down to their suppliers Private Food Safety Standards Existence in some form for many years, but major push began in late 1990s. Driven by retailer demand for improved food risk management in light of several high-profile food scares in Europe during the mid- to late-1990s. BSE (Mad Cow Disease) Dioxin crisis Etc. Audits First party = I audit myself Second party = Buyer audits seller Third party = independent entity audits seller (usually for a buyer) Not new Not government regulations They do work MICHIGAN FREEZE PACK (MFP) THIRD PARTY AUDITING TRAINING 2

4 Third Party Audits: What Are They and Why Are We Being Asked to Do Them? December 1, 2009 Tom Kalchik, MSU Product Center What does this mean for producers? GAP/GHP Good Agricultural Practices and Good Handling Practices GAP production agriculture GHP produce packing Overview of GAPs Guidance Manure Use Water in Production Field Sanitation Workers Animals Post-Harvest Water Usage Records What is GAP? Good Agricultural Practices (GAP) is a series of on-farm practices designed to minimize the risk of food contamination, maintain a clear record of how food was produced, handled and stored; and ensure people buying produce that it is coming from a clean, wellmanaged environment. The application of the practices on a farm may be verified by third party audits, depending on the policies of the customer. (Adapted from Wholesale Success: A Farmer s Guide to Selling, Postharvest Handling and Packing Produce, published by FamilyFarmed.org; and USDA Fresh Audit Verification Program) For more information about GAP, please visit the national GAPsNET site at GAPs Audits and Third-Party Certification No regulatory requirement in the U.S. for produce growers and packers to undergo third-party certification or GAPs audits HOWEVER This is increasingly becoming a requirement driven by the retail sector. Why? Enhanced food safety standards Shift liability upstream from retail sector Examples of GAP Standards and other Food Safety Standards for Primary Production FDA Guidance Document GlobalGAP SQF 1000 Etc. Auditing USDA AMS GAPs Audits Primus Labs Davis Fresh Etc. Key Take Aways 1. On-farm food safety (GAP) is driven by industry concerns abut food borne illness 2. There are many potential sources of pathogen contamination of fresh produce 3. While other segments of the supply chain have been subject to inspections and audits for several years, primary production is just becoming subject to this scrutiny 4. GAP is driven by private industry, not government regulations MICHIGAN FREEZE PACK (MFP) THIRD PARTY AUDITING TRAINING 3

5 Good Agricultural Practices & Good Handling Practices Audit Verification Program What is the USDA GAP & GHP Audit Program? Established at industry request Retailers began requiring suppliers to meet FDA s GAP & GHP, and Good Manufacturing Practices (GMP). Suppliers requested USDA to develop an audit program Voluntary, competitively priced user fee ($92.00 per hour) Verifies participant s efforts to minimize microbial hazards in fresh fruits and vegetables GAP & GHP Audit Program USDA s Audit program is based on established scientific principles and utilizes the Food Drug Administration s (FDA) guidance document Published in October 1998 GAP & GHP Audit Program USDA works closely with: Other USDA Programs such as the Agricultural Research Service Academia; specifically the National GAPs Program AFVISA Association of Food and Drug Officials (AFDO) GAP & GHP Program Developing audit checklists for commodity specific guidance. Name=STELPRDC GAP & GHP Program Effective July 2007, GAP & GHP are a requirement for all fresh fruit and vegetable purchases by the USDA AMS Commodity Procurement Branch Leafy Greens Tomatoes Mushrooms Others? 1

6 GAP & GHP Program Program covers entire production chain farm to fork and is broken down into 5 sections or scopes. Optional food defense scope. General Questions Mandatory component of all audits Covers employee & visitor hygienic practices Training of employees Sanitation of farm/facility Good Agricultural Practices Scopes Part 1 - Farm Review Water Sewage Manure Animal/Wildlife Land Use Good Agricultural Practices Scopes Part 2 - Field Harvest and Field Packing Worker Sanitation and Hygiene Field Harvesting and Transportation Good Handling Practices Scopes Part 3 - House Packing Facility Receiving Washing/Packing Line Worker Health and Personal Hygiene Packing House General Housekeeping Pest Control Good Handling Practices Scopes Part 4 - Storage and Transportation Storage Areas, Containers and Pallets Pest Control Ice and Refrigeration Transportation/Loading Worker Health and Hygiene 2

7 Prerequisites Must have implemented a food safety program (Question P-1). Must have a designated person(s) to oversee implementation of program (Question P-2). On Farm Food Safety Manual Passing Score Must achieve a minimum passing score of 80% in order to pass the audit. Five automatic unsatisfactory Immediate food safety risk is present when product is grown, processed, packed, or held under conditions that promote or cause the product to become contaminated Presence or evidence of rodents, excessive amount of insects or other pests in the produce during packing, processing, or storage ` Passing Score Automatic Unsatisfactory Cont d Observation of employee practices that jeopardize or may jeopardize the safety of the produce Falsification of records Answering General Questions P1 or P2 as no Website Website has general information, updates to the program, & most current checklist listed Website TemplateD&page=FreshFVGAPGHPStateIndex Website TemplateD&page=FreshFVGAPGHPStateIndex Website shows farms & facilities that have successfully passed an audit. It is broken down by state, month, and commodity. Downloadable.pdf files for each commodity/state showing individual farm/facilities and the scopes they were audited to. 3

8 Audits Audits are performed by Federal and/or Federal State Cooperators from the inspection offices throughout the country. Over 250 auditors available throughout the country. Auditors Selection Criteria Education, experience, skills and attributes Real-world agricultural marketing expertise Must be USDA licensed fruit and vegetable inspectors Training Established curriculum ensures integrity and nationwide uniformity Training based on leading-edge food safety related audit methods and procedures, including HACCP Better Process Control Facility Sanitation GAP/GHP/GMP Food Defense Requesting an Audit Contact your local USDA or state inspection office Or If your state does not offer GAP&GHP audits call USDA Fresh Products Branch in Washington DC Bob McCully MDA (517) Colleen Bess MDA (517) Mike Moore - USDA (313) Cb12/2009 Questions? 4

9 Great Lakes Fruit, Vegetable & Farm Market Expo Ranch Audit Guidance and Expectations December 9, 2009 Our Mission Has Always Focused on Protection of Public Health and Safety NSF International, an independent, not-forprofit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving the interests of all stakeholders. 1 Ed LaClair Senior Auditor NSF Davis Fresh 2 Our core purpose is to protect and improve human health. 3 Who is NSF Davis Fresh? Founded by fresh produce industry experts in 1999 Acquired by NSF International in 2006 Highly technical auditors and program staff Trusted and respected source for Produce Food Safety & Quality Solutions We partner with: Growers, Shippers, Processors, Distributors, Retailers to promote the safest, most consistent and highest quality produce possible 4 NSF Davis Fresh Global Presence Local offices convenient to agricultural centers: USA - Watsonville, CA Santiago, Chile Lima, Peru Queretaro, Mexico Farm/Ranch Audit NSF-Davis Fresh audits focus on the implementation and documentation of Good Agricultural Practices especially as they relate to food safety. The audit evaluates the adequacy of documentation, compliance to documented policies, effectiveness of procedures to control risk factors and the ability to implement corrective and preventative action plans. Manual Guidance The NSF-Davis Fresh manual is generic for all types of growing operations. Some specific criteria may not be applicable. It is the responsibility of the grower to justify that a specific criteria is not applicable. Criteria may be added based on changing regulatory requirements, specific client needs or the ever-changing food safety environment

10 Evaluation Areas Specifically, the base audit evaluates 7 key sections: Ranch Documents Water Sources Employee Documents Chemicals Ranch Observations Employee Habits Harvest Operations Section Evaluation Evaluations will be based on 5 levels of adherence: Acceptable (A) Needs Improvement (NI) Needs Correction (NC) Unacceptable (U) Critical (C) 7 8 Ranch History Ranch Documents In order to be considered clean the land can not have a history of being used as, or be, a: Landfill Toxic Waste or Incinerator Waste Disposal Site Site for Animal Husbandry in the last 12 months Flood Zone within the last year Have any evidence that the land is unfit for agricultural crop production or use Inspections and Logs Documents Grower has appropriate inspection reports and inspection logs that document that the growing operation is following necessary practices Risk Assessment Any concerns that are found during the assessment must be Document. controlled with a feasible Adjacent Land Use mitigation plan that addresses all concerns using best Flooding practices available. Animal Activity An animal intrusion inspection Ranch Security log of appropriate frequency. An annual water distribution Water Distribution System Functionality system evaluation. Buffers, Ditches, and Berms An open water source Access Road Quality inspection log of appropriate frequency.» Any concerns that are found during the assessment must be controlled with a A storage area inspection log to include pest control feasible mitigation plan that addresses all measures. concerns using best practices available. 12 Risk Assessment 2

11 Risk Assessment Observations Plant Source Material 13 Barb wire fence with sheep wool. Fence separates grazing land from vegetable field. Sheep were entering growing field under fence. 14 Grower has evidence that seed suppliers, nurseries, or other plant source suppliers, for high risk food crops, use GAPs while producing or handling source material. 15 All water sources will be tested at least annually or at a frequency as required by the commodity specific guidelines for that particular crop item. Such as the frequencies required by the Leafy Greens Marketing Agreement. For water sources that use wells as the primary source the well also needs to be tested at least annually not just the source for irrigation, such as reservoirs. Water Sources 16 Water Sources For high risk crops Generic E. coli levels must be 126 MPN per 100 ml water sample maximum level for geometric mean (rolling average of 5 most recent samples) Lab results are to include the date of sample collection, the location of the sample collection, the result, the test method, and a signature from the lab. Employee Documents Company Policies Toilet and Hand Washing Illness and Injury Restricted Behavior Employee Training Supervisor Training Toilet and Hand Washing Policies All toilet and hand washing facilities policies are present and complete and all policies are clearly titled. The grower is required to have written policies that the organization will provide clean and stocked toilets and hand washing stations. The policies will also have a maximum distance requirement and a maximum ratio of employees to restrooms. Typically this is 1 toilet for every 20 employees and a maximum distance of ¼ mile or 5 minutes. The grower is required to have a policy mandating that employees wash their hands at the beginning of the work day, after using the toilet, after eating, after leaving the work area, after changing gloves, and any other time their hands may become contaminated

12 Illness and Injury Policy Restricted Behavior Policy 19 All blood, or bodily fluid, contamination, employee injury, and employee illness policies are present and complete and all policies are clearly titled. Blood policies need to specify that all products exposed to blood, or bodily fluids, will be destroyed, and that equipment exposed to blood, or bodily fluids, will be thoroughly cleaned and disinfected before being used. Injury policies need to specify that all employees with sores, cuts, boils, lesions, etc, on their hands must have the areas covered with first aid materials and use appropriate gloves, such as nitrile gloves, while working with products. *Due to allergy concerns latex gloves should not be used while working directly with product. Illness policies need to specify that all employees who show signs of illness will not be permitted to perform job duties where they will come in to contact with product. 20 All policies are present and complete and all policies are titled appropriately. Policies should clearly stipulate that the use of tobacco products and food products is not allowed in any production area and should explain the consequences associated with such actions. Policies should clearly stipulate that the use of jewelry and other loose items is not allowed in any production area and should explain the consequences associated with such actions. Policies should clearly stipulate that children and domestic animals are not allowed in any production area and should explain the consequences associated with such actions. Employee Training All employees must be trained in basic food safety and personal hygiene and must be able to demonstrate their knowledge. This includes: Basic Food Handling Illness Recognition and Reporting Toilet Facility Usage Correct Hand Washing Blood Contamination Supervisor Training Supervisors will receive the same training as all employees but because of their responsibility they must also be trained in how to recognize the symptoms of illness and be trained regarding how to manage ill employees. They must also be trained on how to manage employees who have injuries to their hands that may cause contamination. Basics of Micro-Organisms Training Records All training should be documented and sign-in sheets available for review. A current employee roster must be made available to the auditor. Rosters should be updated every 2 weeks. The sign in sheets must have the printed name of the employee and their signature. Third party and contractor labor companies should provide copies of training materials used for the same topics. Fertilizers All fertilizers should be approved for use on the current crop. For non-synthetic fertilizers the grower will supply the following information regarding crop being fertilized: Date of Application Amount Fertilizer Name and Application Method Growers will provide information regarding the sources of all fertilizers and they need to supply letters of guarantee that the fertilizers being applied are free of pathogens, toxins, or other contaminants that may cause illness or injury. When animal manure, or other types of manure, is used the grower will supply documentation that the manure has been properly composted, or treated to kill pathogens, and that the application intervals, before planting, meet all necessary requirements

13 Fertilizers Pesticide Application 25 Grower will provide documentation that they can perform a trace back that shows fertilizer application history for all products. Non-synthetic fertilizers will be stored properly, and secured, when not in use as to prevent possible contamination. For synthetic fertilizers the grower will supply the following information regarding crop being fertilized: Date of application Amount used Fertilizer name and application method Growers will supply letters of guarantee that the fertilizers are free of toxins or other contaminants. When not in use all fertilizers will be stored, and secure, to prevent any possible contamination. Grower will provide documentation that they can perform a trace back that shows fertilizer application history for all products. Growers will not use bio-solids. 26 The grower should have a copy of the license issued to their PCA and should be able to verify work performed by the PCA. Such verification could include recommendation documentation with the PCA name and/or signature. If the grower acts as the PCA then the grower should provide appropriate supporting documentation that they are the only one who makes recommendations. Applications need to be made by trained and/or certified applicators. Proper certification documents or training documents need to be available in order to show proper training has been performed. 27 Pesticide Application All application records should be available and records should include: Date of Application Re-Entry Intervals Type of Pesticide Used Crop Being Grown Quantity Used Purpose for the Application. If a third party performs the application then a copy of all necessary records should be on file with the grower. Spray equipment should be calibrated regularly and the calibration should be documented. SOPs should be on file showing the process for calibration A designated person should be available to review the equipment and to verify that it is working properly. If this is performed by a third party then copies of these records should be on file with the grower. 28 Pesticide Regulation The grower should have records verifying that pesticide use is authorized for the crops being grown. If pesticide application is performed by a third party applicator then copies of these records should be on file with the grower. The grower should have a mechanism or process for verifying that the pesticides being applied will be accepted, and are authorized, by the destination countries of the crop being grown. This is also the case for the country of origin. If a third party is used for applications then copies of this information should be on file with the grower. A policy and program should be in place that clearly documents that pre-harvest intervals are being adhered to and followed. The grower should be able to clearly trace when a product was harvested against the last pesticide application. If products are being analyzed for pesticide residue the analysis needs to be performed by an accredited laboratory. 29 General Field Observations General Field Observations Garbage and trash is lo kept in appropriate receptacles and is Fencing is whole, not broken, and has not fallen over. The fence is not in the field. This includes wind blown garbage from also of a type that will prevent the intended risk for which it was installed. adjacent areas, employee refuse such as food wrappers, food refuse and food waste, soda cans, harvest company waste, and Barriers, such as berms, ditches, or other structures, used to prevent runoff contamination should be whole, not broken, and of visitor refuse. sufficient depth, or height, in order to prevent the intended hazard. No biological waste, such as animal or human feces, is present. Chemicals, such as the type used for agricultural purposes like All ditch or canal materials, used to assist irrigation practices, fertilizers and pesticides, should be stored appropriately and locked are removed in an appropriate time frame. or secured when not in use. Empty containers also need to be stored appropriately. Equipment is maintained in a manner so that it appears clean and is not leaking oil, excessively rusting or flaking paint, All field signs such as ranch identification signs, pesticide re-entry signs, or other notifications should be in appropriate locations that releasing grease in an mount that may cause contamination, or are easy to see, are in appropriate languages, and are large enough any other condition in which the equipment may cause a to see. possible food safety risk. Field roads should be maintained in good condition and should be Equipment is operational and not in a state of disrepair in the easy to navigate. Roads should not have large potholes, should not field. 30 be obstructed with items that will cause drivers to possibly need to drive in to the growing areas, and should be wide enough to allow for reasonable amounts of traffic. 5

14 31 Water Distribution System The water distribution system is in good condition and there are no obvious contamination concerns. Wells and well casings should be intact and free of leaks. Canals should not have any significant structural issues such as damaged cement. All open water sources, including canals, ditches, and reservoirs should be free of debris. This includes garbage, irrigation accessories, broken or abandoned equipment, dead animals, green waste or yard waste, or other items that might present an animal harborage or food safety risk. High risk animal and human activity must not be permitted in the water system Chemicals should not be stored next to, mixed next to, or other wise manipulated near the water system. If there is any potential that a water system could be subjected to high risk animal or human activity, or that chemicals will be stored near the water system, then adequate measures need to be taken in order to prevent the contamination of the water system. This includes the use of buffer zones and other barriers. 32 Animal Activity High risk animals are not present in the field this includes, but is not limited to, cows, horses, goats, sheep, pigs and wild pigs, deer, or other high risk animals. Large quantities of low risk animals are not in the field such as migratory birds or rodent infestations. Animal activity is not observed such as feeding, tracks, or other signs. When animal activity is imminent then the grower must have the necessary mitigation plans in place to prevent the harvest of contaminated products. 33 Toilet and Hand Washing Facilities Toilet and hand washing facilities must be made available to employees who are working in the field. A minimum of 1 toilet for every 20 employees and all toilets should be within 5 minutes, or a ¼ mile, from the work area. All toilet facilities must be maintained so that they are clean and have all supporting equipment such as toilet paper. All toilet facilities must be monitored daily by a responsible individual and a checklist must be available for review. Toilets must have signs, in the appropriate language, that hand washing is mandatory after use. Toilets must be made of cleanable materials such as stainless steel or plastic and must use hands free technology when available. Toilets should not be serviced in the field, or near the field, to avoid any potential spills in the field. SSOPs should be available that outline the cleaning and maintenance procedures for the toilet facilities. 34 Employee Behavior Employees are following recognized GAPs and food safety protocols while working in production locations such as in the field, in post-harvest facilities, or in storage areas. Employees can not work while they are ill. Employees should always follow good hygiene practices and come to work clean and come to work in clean clothes. Employees must always wash their hands before they start working, after breaks, after bathroom use, and whenever their hands may have become contaminated. Employees should not use tobacco products, drink, eat food or candy, or chew gum while in production locations. Drinking water is acceptable in these areas. Employees should not be wearing jewelry, or other loose items, and should always wear appropriate personal protective equipment such as gloves and hairnets, when appropriate. Gloves, when used, should not be excessively dirty or torn or damaged. Harvest Operation Harvest Cleaning Logs 35 The harvest crew/company must have SSOPs that outline how all food contact and nonfood contact surfaces are cleaned. SSOPs must have information regarding: Equipment Name Frequency of Cleaning Chemicals Used and Dilutions Applicable Verification Procedures Forms Used to Verify Cleaning. All chemicals must be approved for use by the US EPA and/or FDA. All SSOPs must be in appropriate languages and must be legible. SSOPs must describe an appropriate cleaning procedure. 36 The harvesting company has cleaning and sanitizing records for food contact and non-food contact areas of all harvesting implements. Cleaning records are available on the day of the audit and must be current and legible. The harvesting company has signed documents that the product containers were cleaned prior to receipt. The cleaning process for the containers must be available. There is an inspection log for all incoming packaging materials to prevent adulterated or contaminated packaging from being used. Water used to rinse product or equipment must also be documented. All test strips must be used within their expiration dates and they must be appropriate for the concentrations being used. Other testing methods, (colorimetric, ORP, digital) must be appropriate 6

15 37 Harvest Tools All harvest tools must be made of cleanable materials such as stainless steel and plastic. Tools must be free of rust and damage. All tools must be clean when in use and must be routinely checked and cleaned by personnel when necessary. Tools must be in control of the grower or harvesting company and there must be records that prove harvest tools are being managed appropriately. All tools must be stored properly when not in use. Knife sheaths made of porous materials can not be used for storage. Tools should be stored in a sanitizer solution when not in use. Sanitizer solution containers should be adequate in size and should have enough solution to properly cover all tools when they are not being used. Tools, that could pose a contamination risk, for any reason, should not be used until they have been properly inspected or properly cleaned and have been approved for use by the harvesting supervisor. 38 Containers and Packaging All packaging must be free of contamination. This includes evidence of bird, rodent, or insect adulteration or infestation. All packaging must be clean and must be in good condition. Packaging, used for products not grown in soil, should not touch the ground. Packaging should only be used for product storage. Packaging should never be used to store garbage, tools, or employee articles. All cardboard should be used only once. If used more the once then a one time use liner must be used. Food Contact Surfaces and Equipment All food contact surfaces must be cleaned regularly and must appear clean. 2. Food contact surfaces must be free of rust or corrosion. 3. All seams must be smooth and must have complete access for cleaning. 4. All materials, used for food contact, must be made of cleanable materials such as stainless steel, UHMW, plastic, or other similar, non-porous material. 5. All areas near food contact zones must be designed to prevent contamination. This includes, but is not limited to, shatter resistant lights and light covers, drip pan design for motors or other bearings, and kick plates to prevent shoe drip in walk over areas. Transportation All vehicles need to be clean and functional. Transportation vehicles need to be dedicated and can not be used for the transportation of animals, or other items, that might cause a contamination issue. All trucks must have a pre-load checklist that verifies that the trucks are clean, that refrigeration units are clean and working properly, that no animals or animal products were transported, and that trucks are locked Post Harvest Water General Requirements Water used for the rinsing or cleaning of harvested products must be clean and free of generic E. coli. Testing methods used for generic E. coli should be for absence/presence or not have a detection limit greater then 2.2 MPN or CFU per 100 ml of sample. All wash water should include an US EPA or FDA approved sanitizer and all sanitizers must be maintained in their effective concentration ranges. Re-circulated water must be changed at least daily and logs should include sanitizer concentration, ph, and/or ORP records. Water is not otherwise contaminated. Growers, who are handlers, need an up to date growers list with contact and location information available for review. Grower needs to have a designated individual who is responsible for the food safety program and their 24 hour contact info is available. Grower must have a complete compliance plan for review