Great Lakes Fruit, Vegetable & Farm Market EXPO Michigan

Great Lakes Fruit, Vegetable & Farm MarketEXPO

Michigan Greenhouse Growers ExpoDecember 8-10, 2009

DeVos Place Convention Center, Grand Rapids, MI

GAP Audits - What Auditors Look For

Wednesday morning 9:00 amWhere: 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

“Third Party Audits: What Are They andWhy Are We Being Asked to Do Them?”

December 1, 2009Tom Kalchik, MSU Product Center

MICHIGAN FREEZE PACK (MFP)THIRD PARTY AUDITING TRAINING 1

BUSINESS INNOVATION IN FOOD,AGRICULTURE, NATURAL

RESOURCES, AND THE BIOECONOMY

Third Party Audits

What are they and why are webeing asked to do them?

www.productcenter.msu.edu

FoodborneFoodborne Illnesses in theIllnesses in theUSUS

• 76 million cases per year

• 325,000 hospitalizations per year

• > 5,000 preventable deaths per year

• Economic losses estimated to be10-83 billion dollars per year

Mead et al. 1999. Emerging Infectious Diseases 5:607


Food Recalls

• E. coli in spinach - 2006

• Salmonella Saintpaul - in tomatoes? No?Peppers - 2008

• Salmonella Typhimurium in peanuts –2009

• Salmonella in alfalfa sprouts – 2009

• Salmonella in pistachios - 2009

http://www.fda.gov/safety/recalls/default.htm


October 2009 Recalls• October 30, 2009 - Pointe Scientific Liquid Glucose Hexokinase

Reagent - Recall• October 30, 2009 - Alexia Foods issues nationwide allergy alert and

product recall on its Alexia Olive Oil, Sun-Dried Tomatoes & PestoOven Reds frozen potatoes due to undeclared pine nut allergen

• October 30, 2009 - Pointe Scientific, Inc Expands Nationwide Recall ofLiquid Glucose Hexokinase Reagent (G7517)

• October 30, 2009 - Allergy Alert on Possible Undeclared Soy Proteinin32-ounce Great Value Half & Half, 32-ounce Great Value 36% HeavyWhipping Cream, 32-ounce Kroger brand 36% Heavy WhippingCream, and 64-ounce Wholesome Farms Chocolate Ice Cream Mix

• October 28, 2009 - Pointe Scientific, Inc Issues Nationwide Recall ofLiquid Glucose Hexokinase Reagent (G7517)

• October 28, 2009 - Mrs. Rios Corn Products Issues Allergy Alert onUndeclared Whey in Flour Tortillas

• October 27, 2009 - Qualitest Pharmaceuticals Issues a VoluntaryNationwide Recall of All Accusure® Insulin Syringes

• October 27, 2009 - Pop’s Bakery Inc. Issues Allergy on UndeclaredWhey (Milk) in all Flour Tortillas


October 2009 Recalls• October 26, 2009 - Mars Snackfood US ISSUES ALLERGY ALERT

ON UNDECLARED PEANUTS In Dove Caramel Pecan Perfection IceCream

• October 26, 2009 - San Link Inc. Issues an Alert on UnevisceratedVacuum Pack Dried Lesh (Fish).

• October 23, 2009 - Cordis Initiates Nationwide Recall ofCROSSOVER™ Sheath Introducer

• October 22, 2009 - Unilever Issues Allergy Alert on Wheat in a LimitedNumber of Tubs of Breyers® Ice Cream

• October 22, 2009 - Undeclared Sulfites in "Agro Sun Dried Fruits andNuts Tropical Mix"

• October 21, 2009 - Nutkao Urgent Food Recall Due to UndeclaredPeanuts

• October 20, 2009 - American Regent Voluntarily Recalls All Lots ofKetorolac Tromethamine Injection

• October 19, 2009 - Domega International Co. Ltd Issues Allergy Alerton Undeclared Eggs in WHITE LOTUS SEED PASTE MOON CAKE (2YOLKS)

• October 19, 2009 - Plum Organics Voluntarily Recalls Select Batch ofApple & Carrot Portable Pouches Due to Potential Health Risk


October 2009 Recalls• October 16, 2009 - Hannaford Announces Removal of Frozen Taste of

Inspirations Vegetable Spring Rolls• October 15, 2009 - TGF PRODUCTION LLC Issues An Alert On

Uneviscerated Herring Salted• October 13, 2009 - Limited Voluntary Recall of Country Acres® Home

Grown Turkey & Quail Starter• October 12, 2009 - Fisher/Rex Sandwiches Recalls Sandwiches

Because of Possible Health Risk• October 08, 2009 - FDA Takes Enforcement Action against Ready-to-

Eat Sandwich Manufacturer• October 06, 2009 - Unomedical Issues Worldwide Recall of Certain

Manual Pulmonary Resuscitators• October 02, 2009 - Niles, Ill. Firm Issues Allergy Alert on Classic

Candy• October 01, 2009 - Neuron 6F 070 Delivery Catheter [Penumbra]• October 01, 2009 - FDA Alert: New USP Standards for Heparin

Products Will Result in Decreased Potency• October 01, 2009 - Consumers Warned Not to Eat Certain Imported

Dried Plums





Potential sources of pathogenPotential sources of pathogencontamination of fresh producecontamination of fresh produce

meat, milk, eggs

harvesting,

handling,

processing

environments

HumansProduce

Feces Insects

soil

water

Feed

Animals

(cross contamination)

Modified from Beuchat, 1996


Food Safety StandardsFood 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, buyerorganizations, commodity groups, NGOs, etc.

– Often consider food hazards (perhaps not risk-based)as well as environmental issues and corporate socialresponsibility objectives.


US Food Regulatory SystemUS 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 PublicHow to Fill Voids in the PublicFood Safety Regulatory System?Food Safety Regulatory System?

• During the past several years, lack ofresources (and limited political will) haveimpaired the effectiveness of public sectorregulatory bodies to enforce food safetyrequirements

• Industry leadership – major buyers havetaken responsibility for driving requirementsdown to their suppliers


Private Food Safety StandardsPrivate Food Safety Standards

• Existence in some form for many years, butmajor push began in late 1990s.

• Driven by retailer demand for improved food riskmanagement in light of several high-profile foodscares 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 auditsseller (usually for a buyer)

• Not new

• Not government regulations

• They do work





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-farmpractices designed to minimize the risk of foodcontamination, maintain a clear record of how food wasproduced, handled and stored; and ensure peoplebuying produce that it is coming from a clean, well-managed environment. The application of the practiceson a farm may be verified by third party audits,depending on the policies of the customer. (Adaptedfrom Wholesale Success: A Farmer’s Guide to Selling,Postharvest Handling and Packing Produce, publishedby FamilyFarmed.org; and USDA Fresh AuditVerification Program)

• For more information about GAP, please visit thenational GAPsNET site at http://www.gaps.cornell.edu/.


GAPsGAPs Audits and ThirdAudits and Third--PartyPartyCertificationCertification

• No regulatory requirement in the U.S. forproduce growers and packers to undergothird-party certification or GAPs audits

• HOWEVER – This is increasingly becoming arequirement driven by the retail sector.

• Why?

– Enhanced food safety standards

– Shift liability upstream from retail sector


Examples of GAP Standards and otherExamples of GAP Standards and otherFood Safety Standards for PrimaryFood Safety Standards for Primary

ProductionProduction

• 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 byindustry concerns abut food borne illness

2. There are many potential sources ofpathogen contamination of fresh produce

3. While other segments of the supply chainhave been subject to inspections and auditsfor several years, primary production is justbecoming subject to this scrutiny

4. GAP is driven by private industry, notgovernment regulations

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Good Agricultural Practices &Good Agricultural Practices &Good Handling PracticesGood Handling Practices

Audit Verification ProgramAudit Verification Program

What is the USDA GAP & GHPAudit 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 anaudit program

• Voluntary, competitively priced user fee ($92.00 perhour)

• Verifies participant’s efforts to minimize microbialhazards in fresh fruits and vegetables

GAP & GHP Audit Program

• USDA’s Audit program isbased on establishedscientific principles andutilizes the Food DrugAdministration’s (FDA)guidance document

•• Published in October 1998Published in October 1998

• USDA works closely with:

– Other USDA Programs such as the AgriculturalResearch Service

– Academia; specifically the National GAPs Program

http://www.gaps.cornell.edu

– AFVISA

– Association of Food and Drug Officials (AFDO)

GAP & GHP Audit Program

Developing audit checklists for commodity specificguidance.http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5050869

– Leafy Greens

– Tomatoes– Mushrooms– Others?

GAP & GHP Program GAP & GHP Program

• Effective July 2007, GAP & GHP are arequirement for all fresh fruit andvegetable purchases by the USDA AMSCommodity Procurement Branch

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GAP & GHP Program

• Program covers entire production chain “farm tofork” and is broken down into 5 sections or“scopes”.

• Optional food defense scope.

General Questions

• Mandatory component of all audits

• Covers employee & visitor hygienicpractices

• 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 ScopesPart 3 - House Packing Facility

– Receiving

– Washing/Packing Line

– Worker Health and Personal Hygiene

– Packing House General Housekeeping

– Pest Control

• Part 4 - Storage and Transportation– Storage Areas, Containers and Pallets

– Pest Control

– Ice and Refrigeration

– Transportation/Loading

– Worker Health and Hygiene

Good Handling Practices Scopes

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Prerequisites• Must have implemented a food safety program

(Question P-1).

• Must have a designated person(s) to overseeimplementation of program (Question P-2).

On FarmFood SafetyManual

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 conditionsthat promote or cause the product to becomecontaminated

– Presence or evidence of rodents, excessive amountof insects or other pests in the produce duringpacking, processing, or storage

– Observation of employee practices thatjeopardize or may jeopardize the safety of theproduce

– Falsification of records

– Answering General Questions P1 or P2as“no”

Passing Score`

Automatic Unsatisfactory Cont’d

Website

Website has generalinformation, updates tothe program, & mostcurrent checklistlisted…

http://www.ams.usda.gov/gapghp

Websitehttp://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=

TemplateD&page=FreshFVGAPGHPStateIndex

Website shows farms &facilities that havesuccessfully passed anaudit. It is broken down bystate, month, andcommodity.

Websitehttp://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=

TemplateD&page=FreshFVGAPGHPStateIndex

Downloadable .pdf files for each commodity/state showingindividual farm/facilities and the scopes they were auditedto.

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Audits

• Audits are performed by Federal and/or Federal– State Cooperators from the inspection officesthroughout the country.

• Over 250 auditors available throughout thecountry.

• 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

Auditors

Requesting an AuditContact your local USDA or state

inspection office

Or

If your state does not offer GAP&GHPaudits call USDA Fresh Products

Branch in Washington DC

202-720-2482

Questions?

• Bob McCully – MDA

• (517)241-2978

• Colleen Bess – MDA

• (517) 373-0280

• Mike Moore - USDA

• (313) 928-1150Cb12/2009

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Great Lakes Fruit, Vegetable &Farm Market Expo

Ranch AuditGuidance and Expectations

December 9 , 2009

Ed LaClairSenior Auditor

NSF Davis Fresh2

Our Mission Has AlwaysFocused on Protection ofPublic Health and Safety

NSF International, an independent, not-for-profit, non-governmental organization, is

dedicated to being the leading globalprovider of public health and safety-based

risk management solutions while serving theinterests of all stakeholders.

Our core purpose is to protect and improve human health.

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Who is NSF Davis Fresh?

• Founded by fresh produce industry experts in1999

• Acquired by NSF International in 2006

• Highly technical auditors and program staff

• Trusted and respected source for Produce FoodSafety & Quality Solutions

• We partner with: Growers, Shippers,Processors, Distributors, Retailers to promote thesafest, most consistent and highest qualityproduce possible

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Local offices convenient toagricultural centers:

– USA - Watsonville, CA

– Santiago, Chile

– Lima, Peru

– Queretaro, Mexico

NSF Davis Fresh Global Presence

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Farm/Ranch Audit

• NSF-Davis Fresh audits focus on the implementationand documentation of Good Agricultural Practicesespecially as they relate to food safety.

• The audit evaluates the adequacy of documentation,compliance to documented policies, effectiveness ofprocedures to control risk factors and the ability toimplement corrective and preventative action plans.

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Manual Guidance

• The NSF-Davis Fresh manual is generic for all types ofgrowing operations.

• Some specific criteria may not be applicable. It is theresponsibility of the grower to justify that a specificcriteria is not applicable.

• Criteria may be added based on changing regulatoryrequirements, specific client needs or the ever-changingfood safety environment.

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Evaluation Areas

• Specifically, the base audit evaluates 7 keysections:

– Ranch Documents

– Water Sources

– Employee Documents

– Chemicals

– Ranch Observations

– Employee Habits

– Harvest Operations

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Section Evaluation

• Evaluations will be based on 5 levels ofadherence:

– Acceptable (A)

– Needs Improvement (NI)

– Needs Correction (NC)

– Unacceptable (U)

– Critical (C)

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Ranch Documents

• Ranch History

In order to be considered clean the land can not havea 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 foragricultural crop production or use

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Documents

• Inspections and Logs

Grower has appropriate inspection reports andinspection logs that document that the growingoperation is following necessary practices.

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Risk Assessment

• Document.– Adjacent Land Use– Flooding– Animal Activity– Ranch Security– Water Distribution System Functionality– Buffers, Ditches, and Berms– Access Road Quality

» Any concerns that are found during theassessment must be controlled with afeasible mitigation plan that addresses allconcerns using best practices available. 12

Risk Assessment• Any concerns that are found

during the assessment must becontrolled with a feasiblemitigation plan that addressesall concerns using bestpractices available.

• An animal intrusion inspectionlog of appropriate frequency.

• An annual water distributionsystem evaluation.

• An open water sourceinspection log of appropriatefrequency.

• A storage area inspection logto include pest controlmeasures.

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Risk Assessment Observations

• Barb wire fence withsheep wool.

• Fence separatesgrazing land fromvegetable field.

• Sheep were enteringgrowing field underfence.

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Plant Source Material

Grower has evidence thatseed suppliers,nurseries, or other plantsource suppliers, forhigh risk food crops,use GAPs whileproducing or handlingsource material.

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Water Sources

• All water sources will betested at least annually or ata frequency as required bythe commodity specificguidelines for that particularcrop item. Such as thefrequencies required by theLeafy Greens MarketingAgreement.

• For water sources that usewells as the primary sourcethe well also needs to betested at least annually notjust the source for irrigation,such as reservoirs.

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Water Sources

• For high risk crops Generic E. coli levels must be 126MPN per 100 ml water sample maximum level forgeometric mean (rolling average of 5 most recentsamples)

• Lab results are to include the date of sample collection,the location of the sample collection, the result, the testmethod, and a signature from the lab.

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Employee Documents

• Company Policies

– Toilet and Hand Washing

– Illness and Injury

– Restricted Behavior

– Employee Training

– Supervisor Training

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Toilet and Hand WashingPolicies

• All toilet and hand washing facilities policies are presentand 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 handwashing stations.

– The policies will also have a maximum distance requirement anda maximum ratio of employees to restrooms. Typically this is 1toilet for every 20 employees and a maximum distance of ¼ mileor 5 minutes.

– The grower is required to have a policy mandating thatemployees 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 maybecome contaminated.

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Illness and Injury Policy

• All blood, or bodily fluid, contamination, employeeinjury, and employee illness policies are present andcomplete 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 toblood, or bodily fluids, will be thoroughly cleaned and disinfectedbefore being used.

– Injury policies need to specify that all employees with sores, cuts,boils, lesions, etc, on their hands must have the areas covered withfirst aid materials and use appropriate gloves, such as nitrile gloves,while working with products.

*Due to allergy concerns latex gloves should not beused while working directly with product.

– Illness policies need to specify that all employees who show signsof illness will not be permitted to perform job duties where theywill come in to contact with product.

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Restricted Behavior Policy

• All policies are present and complete and all policiesare titled appropriately.– Policies should clearly stipulate that the use of tobacco

products and food products is not allowed in anyproduction area and should explain the consequencesassociated with such actions.

– Policies should clearly stipulate that the use of jewelry andother loose items is not allowed in any production area andshould explain the consequences associated with suchactions.

– Policies should clearly stipulate that children and domesticanimals are not allowed in any production area and shouldexplain the consequences associated with such actions.

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Employee Training

• All employees must be trained in basic food safety andpersonal hygiene and must be able to demonstrate theirknowledge.

– This includes:

• Basic Food Handling

• Illness Recognition and Reporting

• Toilet Facility Usage

• Correct Hand Washing

• Blood Contamination

• Basics of Micro-Organisms.

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Supervisor Training

• Supervisors will receive the same training as allemployees but because of their responsibility they mustalso be trained in how to recognize the symptoms ofillness and be trained regarding how to manage illemployees.

• They must also be trained on how to manageemployees who have injuries to their hands that maycause contamination.

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Training Records

• All training should be documented and sign-in sheetsavailable for review.

– A current employee roster must be made available to theauditor. Rosters should be updated every 2 weeks.

– The sign in sheets must have the printed name of theemployee and their signature.

– Third party and contractor labor companies should providecopies of training materials used for the same topics.

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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 thefertilizers being applied are free of pathogens, toxins, or othercontaminants that may cause illness or injury.

– When animal manure, or other types of manure, is used thegrower will supply documentation that the manure has beenproperly composted, or treated to kill pathogens, and thatthe application intervals, before planting, meet allnecessary requirements.

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Fertilizers

– Grower will provide documentation that they can perform a traceback 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 followinginformation regarding crop being fertilized:

• Date of application• Amount used• Fertilizer name and application method

– Growers will supply letters of guarantee that the fertilizers arefree of toxins or other contaminants.

– When not in use all fertilizers will be stored, and secure, toprevent any possible contamination.

– Grower will provide documentation that they can perform a traceback that shows fertilizer application history for all products.

– Growers will not use bio-solids. 26

Pesticide Application

– The grower should have a copy of the license issued totheir PCA and should be able to verify work performed bythe PCA. Such verification could include recommendationdocumentation with the PCA name and/or signature.

– If the grower acts as the PCA then the grower shouldprovide appropriate supporting documentation that they arethe only one who makes recommendations.

– Applications need to be made by trained and/or certifiedapplicators. Proper certification documents or trainingdocuments need to be available in order to show propertraining has been performed.

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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 allnecessary records should be on file with the grower.

– Spray equipment should be calibrated regularly and thecalibration 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 areauthorized, 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 thisinformation should be on file with the grower.

– A policy and program should be in place that clearly documentsthat pre-harvest intervals are being adhered to and followed.

– The grower should be able to clearly trace when a product washarvested against the last pesticide application.

– If products are being analyzed for pesticide residue the analysisneeds to be performed by an accredited laboratory.

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General Field Observations– Garbage and trash is lo kept in appropriate receptacles and is

not in the field. This includes wind blown garbage fromadjacent areas, employee refuse such as food wrappers, foodrefuse and food waste, soda cans, harvest company waste, andvisitor refuse.

– No biological waste, such as animal or human feces, is present.

– All ditch or canal materials, used to assist irrigation practices,are removed in an appropriate time frame.

– Equipment is maintained in a manner so that it appears cleanand is not leaking oil, excessively rusting or flaking paint,releasing grease in an mount that may cause contamination, orany other condition in which the equipment may cause apossible food safety risk.

– Equipment is operational and not in a state of disrepair in thefield. 30

General Field Observations– Fencing is whole, not broken, and has not fallen over. The fence is

also of a type that will prevent the intended risk for which it wasinstalled.

– Barriers, such as berms, ditches, or other structures, used toprevent runoff contamination should be whole, not broken, and ofsufficient depth, or height, in order to prevent the intended hazard.

– Chemicals, such as the type used for agricultural purposes likefertilizers and pesticides, should be stored appropriately and lockedor secured when not in use. Empty containers also need to bestored appropriately.

– All field signs such as ranch identification signs, pesticide re-entrysigns, or other notifications should be in appropriate locations thatare easy to see, are in appropriate languages, and are large enoughto see.

– Field roads should be maintained in good condition and should beeasy to navigate. Roads should not have large potholes, should notbe obstructed with items that will cause drivers to possibly need todrive in to the growing areas, and should be wide enough to allowfor reasonable amounts of traffic.

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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 orabandoned equipment, dead animals, green waste or yard waste, or otheritems that might present an animal harborage or food safety risk.

– High risk animal and human activity must not be permitted in the watersystem

– Chemicals should not be stored next to, mixed next to, or other wisemanipulated near the water system.

– If there is any potential that a water system could be subjected to highrisk animal or human activity, or that chemicals will be stored near thewater system, then adequate measures need to be taken in order toprevent the contamination of the water system. This includes the use ofbuffer zones and other barriers. 32

Animal Activity

– High risk animals are not present in the field this includes, butis not limited to, cows, horses, goats, sheep, pigs and wildpigs, deer, or other high risk animals.

– Large quantities of low risk animals are not in the field suchas migratory birds or rodent infestations.

– Animal activity is not observed such as feeding, tracks, orother signs.

– When animal activity is imminent then the grower must havethe necessary mitigation plans in place to prevent the harvestof contaminated products.

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Toilet and Hand WashingFacilities

– Toilet and hand washing facilities must be made available toemployees who are working in the field. A minimum of 1 toiletfor every 20 employees and all toilets should be within 5minutes, or a ¼ mile, from the work area.

– All toilet facilities must be maintained so that they are clean andhave all supporting equipment such as toilet paper.

– All toilet facilities must be monitored daily by a responsibleindividual and a checklist must be available for review. Toiletsmust have signs, in the appropriate language, that hand washingis mandatory after use.

– Toilets must be made of cleanable materials such as stainlesssteel or plastic and must use hands free technology whenavailable.

– Toilets should not be serviced in the field, or near the field, toavoid any potential spills in the field.

– SSOPs should be available that outline the cleaning andmaintenance procedures for the toilet facilities.

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Employee Behavior– Employees are following recognized GAPs and food safety

protocols while working in production locations such as inthe 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 whenevertheir hands may have become contaminated.

– Employees should not use tobacco products, drink, eat foodor candy, or chew gum while in production locations.Drinking water is acceptable in these areas.

– Employees should not be wearing jewelry, or other looseitems, and should always wear appropriate personalprotective equipment such as gloves and hairnets, whenappropriate.

– Gloves, when used, should not be excessively dirty or tornor damaged.

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Harvest Operation

– The harvest crew/company must have SSOPs that outlinehow all food contact and nonfood contact surfaces arecleaned.

– 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 EPAand/or FDA.

– All SSOPs must be in appropriate languages and must belegible.

– SSOPs must describe an appropriate cleaning procedure.

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Harvest Cleaning Logs

– The harvesting company has cleaning and sanitizing records forfood contact and non-food contact areas of all harvestingimplements.

– Cleaning records are available on the day of the audit and must becurrent and legible.

– The harvesting company has signed documents that the productcontainers were cleaned prior to receipt.

– The cleaning process for the containers must be available.

– There is an inspection log for all incoming packaging materials toprevent adulterated or contaminated packaging from being used.

– Water used to rinse product or equipment must also bedocumented.

– All test strips must be used within their expiration dates and theymust be appropriate for the concentrations being used. Othertesting methods, (colorimetric, ORP, digital) must be appropriate

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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 managedappropriately.

– All tools must be stored properly when not in use. Knife sheathsmade 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 notbeing used.

– Tools, that could pose a contamination risk, for any reason, shouldnot be used until they have been properly inspected or properlycleaned and have been approved for use by the harvestingsupervisor.

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Containers and Packaging

– All packaging must be free of contamination. This includesevidence of bird, rodent, or insect adulteration orinfestation.

– All packaging must be clean and must be in goodcondition.

– Packaging, used for products not grown in soil, should nottouch the ground.

– Packaging should only be used for product storage.Packaging should never be used to store garbage, tools, oremployee articles.

– All cardboard should be used only once. If used more theonce then a one time use liner must be used.

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Food Contact Surfaces andEquipment

– All food contact surfaces must be cleaned regularly and mustappear clean.

– 2. Food contact surfaces must be free of rust or corrosion.

– 3. All seams must be smooth and must have complete accessfor cleaning.

– 4. All materials, used for food contact, must be made ofcleanable materials such as stainless steel, UHMW, plastic, orother similar, non-porous material.

– 5. All areas near food contact zones must be designed toprevent contamination. This includes, but is not limited to, shatterresistant lights and light covers, drip pan design for motors orother bearings, and kick plates to prevent shoe drip in walk overareas.

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Transportation

– All vehicles need to be clean and functional.

– Transportation vehicles need to be dedicated and can not beused for the transportation of animals, or other items, thatmight cause a contamination issue.

– All trucks must have a pre-load checklist that verifies that thetrucks are clean, that refrigeration units are clean and workingproperly, that no animals or animal products were transported,and that trucks are locked.

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Post Harvest Water

– Water used for the rinsing or cleaning of harvestedproducts must be clean and free of generic E. coli.

– Testing methods used for generic E. coli should be forabsence/presence or not have a detection limit greater then2.2 MPN or CFU per 100 ml of sample.

– All wash water should include an US EPA or FDAapproved sanitizer and all sanitizers must be maintained intheir effective concentration ranges.

– Re-circulated water must be changed at least daily and logsshould include sanitizer concentration, pH, and/or ORPrecords.

– Water is not otherwise contaminated.

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General Requirements

– Growers, who are handlers, need an up to date growers listwith contact and location information available for review.

– Grower needs to have a designated individual who isresponsible for the food safety program and their 24 hourcontact info is available.

– Grower must have a complete compliance plan for review.