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Vol. 78 Wednesday,No. 11 January 16, 2013

Part II

Department of Health and Human Services

Food and Drug Administration

21 CFR Parts 1, 16, 106, Et al.Standards for the Growing, Harvesting, Packing, and Holding of Producefor Human Consumption; Current Good Manufacturing Practice and HazardAnalysis and Risk-Based Preventive Controls for Human Food; DraftQualitative Risk Assessment of Risk of Activity/Food Combinations forActivities (Outside the Farm Definition) Conducted in a Facility Co-Locatedon a Farm; Availability; Proposed Rules

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3504 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 112

[Docket No. FDA2011N0921]

RIN 0910AG35

Standards for the Growing, Harvesting,Packing, and Holding of Produce forHuman Consumption

AGENCY: Food and Drug Administration,HHS.ACTION: Proposed rule.

SUMMARY: To minimize the risk ofserious adverse health consequences ordeath from consumption ofcontaminated produce, the Food andDrug Administration (FDA) is proposingto establish science-based minimumstandards for the safe growing,

harvesting, packing, and holding ofproduce, meaning fruits and vegetablesgrown for human consumption. FDA isproposing these standards as part of ourimplementation of the FDA Food SafetyModernization Act (FSMA). Thesestandards would not apply to producethat is rarely consumed raw, produce forpersonal or on-farm consumption, orproduce that is not a raw agriculturalcommodity. In addition, produce thatreceives commercial processing thatadequately reduces the presence ofmicroorganisms of public healthsignificance would be eligible for

exemption from the requirements of thisrule. The proposed rule would set forthprocedures, processes, and practicesthat minimize the risk of serious adversehealth consequences or death, includingthose reasonably necessary to preventthe introduction of known or reasonablyforeseeable biological hazards into oronto produce and to provide reasonableassurances that the produce is notadulterated on account of such hazards.We expect that the proposed rule, iffinalized as proposed, would reducefoodborne illness associated with theconsumption of contaminated produce.

DATES: Submit either electronic orwritten comments on the proposed rule

by May 16, 2013. Submit comments oninformation collection issues under thePaperwork Reduction Act of 1995 byFebruary 15, 2013 (see the PaperworkReduction Act of 1995 section of thisdocument).ADDRESSES: You may submit comments,identified by Docket No. FDA2011N0921 and/or Regulatory InformationNumber RIN 0910AG35, by any of thefollowing methods, except thatcomments on information collection

issues under the Paperwork ReductionAct of 1995 must be submitted to theOffice of Regulatory Affairs, Office ofManagement and Budget (OMB) (see thePaperwork Reduction Act of 1995section of this document).

Electronic Submissions

Submit electronic comments in the

following way: Federal eRulemaking Portal: http://

www.regulations.gov. Follow theinstructions for submitting comments.

Written Submissions

Submit written submissions in thefollowing ways:

Mail/Hand delivery/Courier (forpaper or CDROM submissions):Division of Dockets Management (HFA305), Food and Drug Administration,5630 Fishers Lane, rm. 1061, Rockville,MD 20852.

Instructions:All submissions received

must include the Agency name andDocket No. FDA2011N0921 andRegulatory Information Number RIN0910AG35 for this rulemaking. Allcomments received may be postedwithout change to http://www.regulations.gov, including anypersonal information provided. Foradditional information on submittingcomments, see the Comments headingof the SUPPLEMENTARY INFORMATIONsection of this document.

Docket:For access to the docket toread background documents orcomments received, go to http://www.regulations.govand insert thedocket number(s), found in brackets inthe heading of this document, into theSearch box and follow the promptsand/or go to the Division of DocketsManagement, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:Samir Assar, Center for Food Safety andApplied Nutrition (HFS317), Food andDrug Administration, 5100 Paint BranchPkwy., College Park, MD 20740, 2404021636.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive SummaryProposed RuleI. Introduction

A. Contamination With MicrobiologicalHazards

B. Contamination With Chemical, Physicalor Radiological Hazards

II. Efforts To Address Produce SafetyA. Inspections and InvestigationsB. Guidance Documents and Letters to

IndustryC. Produce Safety Action PlanD. Public HearingsE. Partnerships and Collaborations

F. Current Industry PracticesG. 2010 Federal Register Notice and

Preliminary Stakeholder CommentsH. White House Food Safety Working

GroupI. Other Related Issues

III. Legal AuthorityA. Section 105 of FSMA and Section 419

of the FD&C ActB. Other Provisions of the FD&C Act

C. The Public Health Service ActD. Legal Authority for Records

RequirementsE. Intrastate ActivitiesF. Relevance of Section 415 of the FD&C

Act to Farm Definition and RelatedDefinitions

IV. Regulatory ApproachA. Qualitative Assessment of RiskB. Focus on Biological HazardsC. Consideration of Differing Risk of

Different Commodities and PracticesD. Framework of the RuleE. RecordsF. Farm-specific Food Safety PlansG. Foreign FarmsH. Consistency With Codex Guidelines

I. Product Testing as a Strategy to ControlPathogensJ. Effective DatesK. Compliance Dates

V. The ProposalA. Subpart AGeneral ProvisionsB. Subpart BGeneral RequirementsC. Subpart CStandards Directed to

Personnel Qualifications and TrainingD. Subpart DStandards Directed to

Health and HygieneE. Subpart EStandards Directed to

Agricultural WaterF. Subpart FStandards Directed to

Biological Soil Amendments of AnimalOrigin and Human Waste

G. Reserved

H. ReservedI. Subpart IStandards Directed toDomesticated and Wild Animals

J. ReservedK. Subpart KStandards Directed to

Growing, Harvesting, Packing andHolding Activities

L. Subpart LStandards Directed toEquipment, Tools, Buildings, andSanitation

M. Subpart MStandards Directed toSprouts

N. Subpart NAnalytical MethodsO. Subpart ORequirements Applying to

Records That You Must Establish andKeep

P. Subpart PVariancesQ. Subpart QCompliance and

EnforcementR. Subpart RWithdrawal of Qualified

ExemptionVI. Preliminary Regulatory Impact AnalysisVII. Analysis Of Environmental ImpactVIII. FederalismIX. CommentsX. References

Executive Summary

The FDA Food Safety ModernizationAct (FSMA) (Pub. L. 111353) requiresFDA to publish a notice of proposedrulemaking to establish science-based

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3505Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules

minimum standards for the safeproduction and harvesting of thosetypes of fruits and vegetables that areraw agricultural commodities for whichwe have determined such standardsminimize the risk of serious adversehealth consequences or death. Further,new section 419 also requires FDA toadopt a final regulation based on known

safety risks, setting forth procedures,processes, and practices that wedetermine to minimize the risk ofserious adverse health consequences ordeath, including those that arereasonably necessary to prevent theintroduction of known or reasonablyforeseeable hazards into produce and toprovide reasonable assurances thatproduce is not adulterated under section402 of the FD&C Act.

This proposed rule focuses onmicrobiological hazards related toproduce growing, harvesting, packing,and holding. We conducted a Draft

Qualitative Assessment of Risk to PublicHealth from On-Farm Contamination ofProduce and considered the findings ofthis assessment in developing thisproposed rule. While we acknowledgethe potential for chemical, physical orradiological contamination of produce,for reasons discussed in this proposedrule, we are not proposing specificstandards for these hazards in thisrulemaking.

Scope of Coverage of the Proposed Rule

The proposed rule would apply toboth domestic and imported produce.However, as explained in the remainder

of this document, the proposed rulecontains several exemptions:

The proposed rule would not applyto certain specified producecommodities that are rarely consumedraw.

The proposed rule also would notapply to produce that is used forpersonal or on-farm consumption, orthat is not a raw agriculturalcommodity.

The proposed rule would providean exemption for produce that receivescommercial processing that adequatelyreduces the presence of microorganisms

(e.g. a kill step) as long as certaindocumentation is kept. The proposed rule would not cover

farms that have an average annual valueof food sold during the previous three-year period of $25,000 or less.

The proposed rule would provide aqualified exemption and modifiedrequirements for farms that meet tworequirements: (1) The farm must havefood sales averaging less than $500,000per year during the last three years; and(2) the farms sales to qualified end-users must exceed sales to others. A

qualified end-user is either (a) theconsumer of the food or (b) a restaurantor retail food establishment that islocated in the same State as the farm ornot more than 275 miles away. Instead,these farms would be required toinclude their name and complete

business address either on the label ofthe produce that would otherwise be

covered (if a label is required under theFD&C Act and its implementingregulations) or at the point-of-purchase.This exemption may be withdrawn inthe event of an active investigation of anoutbreak that is directly linked to thefarm, or if it is necessary to protect thepublic health and prevent or mitigate anoutbreak based on conduct orconditions on the farm that are materialto the safety of the produce. Asexplained in the Preamble, these entitiesare either exempt from all therequirements of the rule or are subjectto a narrower set of requirements.

Summary of the Major Provisions of theRegulatory Action

The proposed rule would establishscience-based minimum standards forthe safe growing, harvesting, packing,and holding of produce on farms. Wepropose new standards in the followingmajor areas:

Worker Training and Heath andHygiene Establish qualification and training

requirements for all personnel whohandle (contact) covered produce orfood-contact surfaces and theirsupervisors (proposed 112.21, 112.22,

and 112.23); Require documentation of required

training (proposed 112.30); and Establish hygienic practices and

other measures needed to preventpersons, including visitors, fromcontaminating produce withmicroorganisms of public healthsignificance (proposed 112.31,112.32, and 112.33).

Agricultural Water Require that all agricultural water

must be of safe and sanitary quality forits intended use (proposed 112.41).Agricultural water is defined in part as

water that is intended to, or likely to,contact the harvestable portion ofcovered produce or food-contactsurfaces (proposed 112.3(c)); Establish requirements for

inspection, maintenance, and follow-upactions related to the use of agriculturalwater, water sources, and waterdistribution systems associated withgrowing, harvesting, packing, andholding of covered produce (proposed 112.42 and 112.46); Require treatment of agricultural

water if you know or have reason to

believe that the water is not safe and ofadequate sanitary quality for itsintended use, including requirementsfor treating such water and monitoringits treatment (proposed 112.43); Establish specific requirements for

the quality of agricultural water that isused for certain specified purposes,including provisions requiring periodic

analytical testing of such water (withexemptions provided for use of publicwater supplies under certain specifiedconditions or treated water), andrequiring certain actions to be takenwhen such water does not meet thequality standards (proposed 112.44and 112.45); and provide for alternativerequirements for certain provisionsunder certain conditions (proposed 112.12); and Require certain records, including

documentation of inspection findings,scientific data or information relied onto support the adequacy of water

treatment methods, treatmentmonitoring results, water testing results,and scientific data or information reliedon to support any permitted alternativesto requirements (proposed 112.50).

Biological Soil Amendments Establish requirements for

determining the status of a biologicalsoil amendment of animal origin astreated or untreated, and for theirhandling, conveying, and storing(proposed 112.51, 112.52) Prohibit the use of human waste for

growing covered produce except incompliance with EPA regulations forsuch uses or equivalent regulatory

requirements (proposed 112.53); Establish requirements for

treatment of biological soil amendmentsof animal origin with scientificallyvalid, controlled, physical and/orchemical processes or compostingprocesses that satisfy certain specificmicrobial standards (proposed 112.54and 112.55); and provide for alternativerequirements for certain provisionsunder certain conditions (proposed 112.12); Establish application requirements

and minimum application intervals foruntreated and treated biological soil

amendments of animal origin (proposed 112.56); and provide for alternativerequirements for certain provisionsunder certain conditions (proposed 112.12); and Require certain records, including

documentation of application andharvest dates relevant to applicationintervals; documentation from suppliersof treated biological soil amendments ofanimal origin, periodic test results, andscientific data or information relied onto support any permitted alternatives torequirements (proposed 112.60).



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Domesticated and Wild Animals

If animals are allowed to graze orare used as working animals in fieldswhere covered produce is grown andunder the circumstances there is areasonable probability that grazing orworking animals will contaminatecovered produce, require, at aminimum, an adequate waiting period

between grazing and harvesting forcovered produce in any growing areathat was grazed, and measures toprevent the introduction of known orreasonably foreseeable hazards into oronto covered produce (proposed 112.82); and

If under the circumstances there isa reasonable probability that animalintrusion will contaminate coveredproduce, require monitoring of thoseareas that are used for a covered activityfor evidence of animal intrusionimmediately prior to harvest and, asneeded, during the growing season(proposed 112.83).

Equipment, Tools, and Buildings

Establish requirements related toequipment and tools that contactcovered produce and instruments andcontrols (including equipment used intransport), buildings, domesticatedanimals in and around fully-enclosed

buildings, pest control, hand-washingand toilet facilities, sewage, trash,plumbing, and animal excreta (proposed 112.121134); and

Require certain records related tothe date and method of cleaning and

sanitizing equipment used in growingoperations for sprouts, and in covered

harvesting, packing, or holdingactivities (proposed 112.140).

Sprouts Establish measures that must be

taken related to seeds or beans forsprouting (proposed 112.141); Establish measures that must be

taken for the growing, harvesting,packing, and holding of sprouts

(proposed 112.142); Require that you test the growing

environment for Listeria spp. or L.monocytogenes and that you test eachproduction batch of spent irrigationwater or sprouts for E. coliO157:H7 andSalmonella species and take appropriatefollow-up actions (proposed 112.143,112.144, 112.145, 112.146); and Require certain records, including

documentation of your treatment ofseeds or beans for sprouting, a writtenenvironmental monitoring plan andsampling plan, test results, and certainmethods used (proposed 112.150).

As proposed, the effective date is 60

days after a final rule is published,however, we are providing for a longertimeline for farms to come intocompliance. Small businesses (i.e.,those subject to proposed part 112 and,on a rolling basis, the average annualmonetary value of food sold during theprevious three-year period is no morethan $500,000) would have three yearsafter the effective date to comply; forsome of the water requirements, theywould have five years. In addition, verysmall businesses (i.e., those subject toproposed part 112 and, on a rolling

basis, the average annual monetary

value of food sold during the previousthree-year period is no more than

$250,000) would have four years afterthe effective date to comply; for some ofthe water requirements, they wouldhave six years. All other farms wouldhave two years after the effective date tocomply; for some of the waterrequirements, they would have fouryears to comply.

Costs and BenefitsThe baseline estimate for preventing

all illnesses associated with microbialcontamination of produce covered bythis proposed regulation is $1.6 billion;however, we do not expect that we willeliminate all illnesses associated withcovered produce. Instead, we expectthat the proposed produce safetyregulation will prevent some portion ofthis illness burden from recurring. Weestimate the number of foodborneillness prevented by this regulation to

be 1.75 million, with an associatedbenefit of $1.04 billion, annually. As

described in the Preliminary RegulatoryImpact Analysis (PRIA), making aprecise estimate of the rules likelyeffectiveness is extremely difficult,

because FDA has only limited data thatwould establish a clear baselineestimate of how contamination occursand the likely impact of the proposedprovisions on that baseline, with respectto causing human illness. We estimatethe costs of the proposed rule to be$459.56 million annually for domesticfarms, $170.62 million annually forforeign farms covered by the rule (for agrand total of $630.18 million annually),

resulting in $406.22 million annually inestimated potential net benefits.

Summary of Costs andBenefits of the Proposed

Rule 1

Prevented foodborne Ill-nesses

(in millions)

Total benefits(in millions)

Total domesticcosts

(in millions)

Total foreigncosts

(in millions)

Total costs(domestic +

foreign)

Net benefits(in millions)

Total .................................... 1.75 ..................................... $1,036.40 $459.56 $170.62 $630.18 $406.22

Very small Small Large

Average Annual Cost per Farm ................................................................................................... $4,697 $12,972 $30,566

1As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited. Best estimates were made for both thecosts and the benefits of the rule, given the data available. We request comment on these estimations, and request, in particular, data related tothe amount of contamination attributable to each potential pathway of contamination, the relative effectiveness of each provision at reducing con-tamination, and data related to current industry food safety practices.

Proposed Rule

I. Introduction

Each year, about 48 millionAmericans (1 in 6) get sick, 128,000 arehospitalized, and 3,000 die fromfoodborne diseases, according toestimates from the Centers for DiseaseControl and Prevention. The FDA FoodSafety Modernization Act (FSMA) (Pub.L. 111353), signed into law byPresident Obama on January 4, 2011,

enables FDA to better protect publichealth by helping to ensure the safetyand security of the food supply. FSMAenables us to focus more on preventingfood safety problems rather thanprimarily reacting to problems after theyoccur. The law also provides us withnew enforcement authorities to help usachieve higher rates of compliance withprevention- and risk-based safetystandards and to better respond to andcontain problems when they do occur.

In addition, the law gives us importantnew tools to better ensure the safety ofimported foods and directs us to buildan integrated national food safetysystem in partnership with State andlocal authorities.

Section 105 of FSMA adds section419 to the Federal Food, Drug, andCosmetic Act (FD&C Act) (21 U.S.C.350h) requiring FDA to publish a noticeof proposed rulemaking to establishscience-based minimum standards for



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the safe production and harvesting ofthose types of fruits and vegetables thatare raw agricultural commodities forwhich we have determined suchstandards are necessary to minimize therisk of serious adverse healthconsequences or death. Further, newsection 419 also requires FDA to adopta final regulation based on known safety

risks, setting forth procedures,processes, and practices that wedetermine to minimize the risk ofserious adverse health consequences ordeath, including those that arereasonably necessary to prevent theintroduction of known or reasonablyforeseeable hazards into produce and toprovide reasonable assurances thatproduce is not adulterated under section402 of the FD&C Act. This proposed rulesets forth such standards, as well ascertain exemptions from the standards,consistent with section 419 of the FD&CAct.

Two additional proposed rules, withthe produce safety proposed rule, willbe the foundation of, and centralframework for, a new food safety systemin the United States. In anaccompanying notice in this issue of theFederal Register, FDA is publishing thepreventive controls proposed rule thatwould apply to human food and requiredomestic and foreign facilities that arerequired to register under the FD&C Actto have written plans that identifyhazards, specify the steps that will beput in place to minimize or preventthose hazards, monitor results, and actto correct problems that arise.

FDA also intends to publish theforeign supplier verification program(FSVP) proposed rule, which wouldhelp ensure the safety of foods importedinto the U.S. by making importersaccountable for verifying that the foodthey import is produced using processesand procedures that achieve the samelevel of public health protection forimported food as required of domesticgrowers and processors under FSMAsnew standards for produce safety andpreventive controls.

Eating fruits and vegetables is animportant part of a healthy diet (Ref. 1).

FDA is responsible for ensuring thesafety of all domestic and importedfruits and vegetables consumed in theUnited States. We place a high priorityon identifying and implementingmeasures that can reduce the incidenceof foodborne illness associated withproduce and maintain a high level ofconsumer confidence in this importantfood category. Produce is vulnerable tocontamination with microorganisms ofpublic health significance (e.g.,bacteriaand viruses that can cause disease), aswell as chemical, physical, and

radiological contaminants.Contamination of produce can occur on-farm during growing (either in an openenvironment or in a fully- or partially-enclosed building), harvesting, packing,or holding; or elsewhere along the farm-to-table continuum.

A. Contamination With Microbiological

HazardsAmerican consumers enjoy one of the

safest supplies of produce in the world.Over the last few decades, however,problems linked to produce, includingthe associated public healthimplications, have been reported in anumber of countries worldwide. Manyfactors affect the occurrence ofmicrobial contamination of freshproduce, including worker health andhygiene, the quality of agriculturalwater, the use of animal manure andother materials of animal origin asfertilizer, the presence of wild ordomestic animals in or near fields orpacking areas, growing and harvestingoperations, and equipment and buildingsanitation. As discussed in more detail

below, FDA has taken several steps tohelp reduce the likelihood of microbialcontamination; significant advanceshave been made. However, in spite ofthese efforts, produce-associatedfoodborne illnesses continue.

FDA has looked specifically atoutbreaks where the point ofcontamination is likely to havehappened early in the production chain,during growing, harvesting,manufacturing, processing, packing,

holding, or transportation (Ref. 2). Ofthe total reported outbreaks andoutbreak-related illnesses linked toFDA-regulated foods between 1996 and2010, in the FDA database, produceaccounted for 23.3% and 42.3%,respectively. Both domestic produceand imported produce were identifiedas vehicles in these outbreaks. From1996 to 2010, approximately 131produce-related reported outbreaksoccurred, resulting in 14,132 outbreak-related illnesses, 1,360 hospitalizationsand 27 deaths. These outbreaks wereassociated with approximately 20

different fresh produce commodities(Ref. 3). Commodities associated withoutbreaks during this time periodincluded sprouts; leafy greens such aslettuce and spinach; tomatoes; melonssuch as cantaloupe and honeydew;

berries such as raspberries, blueberries,blackberries, and strawberries; freshherbs such as basil and parsley; andgreen onions as well as fresh-cut fruitsand vegetables. FDA also has evidencethat contamination occurs on someproduce crops at least intermittently

based on sampling performed as part of

investigation, inspections, and FDADomestic and Import Field Assignmentsand data from United States Departmentof Agriculture (USDA)s AgriculturalMarketing Service (AMS)Microbiological Database program(MDP) (Ref. 4 Ref. 5). For instance, in2009, AMS tested eight types of producefor E. coli O157:H7, non-O157 E. coli

carrying shiga toxin and enterotoxingenes, and Salmonella. MDP identified51 samples with E. coli carrying shigatoxin genes; however only 24 of thesewere determined to be pathogenic. MDPidentified 32 samples with Salmonellaconfirmed by culture. The USDA AMSMDP was discontinued in 2012 andFDA is evaluating options for any futurecollection of similar microbiologicaldata.

The following commodities accountedfor 88.5% of the total produce-associated outbreaks:

34 outbreaks associated with

sprouts, 30 outbreaks associated with leafygreens such as lettuce and spinach

17 outbreaks associated withtomatoes

14 outbreaks associated withmelons such as cantaloupe andhoneydew

10 outbreaks associated withberries, such as raspberries, blueberries,blackberries and strawberries

6 outbreaks associated with freshherbs such as basil and parsley

3 outbreaks associated with greenonions.(Ref. 2)

In the FDA database, fresh-cut fruitsand vegetables accounted for 16.8% ofthe total produce-related outbreaks.Generally, the most likely point oforiginal contamination for the fresh-cut-related outbreaks, as determined byFDA and its federal and state partnersduring the outbreak investigations,appears to be during growing, harvest,packing or holding, while thecommodity is still in its raw agriculturalcommodity (RAC) form, rather thanduring manufacturing/processing of thefresh-cut product (Ref. 2). In a fewinstances, such as unwashed, fieldpacked tomatoes being removed from awarm ripening room and placed in coldwater to firm for slicing (which mayhave promoted infiltration of pathogens)(Ref. 6), it is possible that practices orconditions at the fresh-cut facilitycontributed to the contamination event.It is possible that the way product ishandled during processing, includingmixing large batches of fresh-cutproduct, may spread contaminationacross a larger volume of product,impacting the size and scope of anoutbreak associated with fresh-cut



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produce. However, there have also beena number of very large outbreaksassociated with RACs.

Pathogens associated with theproduce outbreaks include bacteria,viruses and parasites. Between 1996 and2010, the majority of fresh produce-related outbreaks and illnesses in theFDA database were associated with

bacterial agents (86.5%), followed byparasites (11.6%) and viruses (1.9%).These outbreaks involved a number ofpathogens, including E. coliO157:H7, E.coliO157, Salmonella species(Salmonella spp.), Listeriamonocytogenes (L. monocytogenes),Cyclospora, Shigella sonnei, andHepatitis A.

In an accompanying document titledDraft Qualitative Assessment of Risk toPublic Health from On-FarmContamination of Produce, FDA hasconducted a qualitative assessment ofrisk associated with growing,harvesting, packing, and holding ofproduce (hereafter referred to as theQualitative Assessment of Risk (QAR)).In particular, the QAR is intended toaddress various risk managementquestions related to biological hazardsof concern in fresh produce that canlead to serious adverse healthconsequences or death; potential routesof contamination; and the likelihood ofcontamination and likelihood of illnessattributable to consumption amongvarious types of produce commodities.The findings of this qualitativeassessment of risk informed ourregulatory approach and several

proposed provisions. We provide asummary of the findings in section IV;additionally, we refer to the QARthroughout this proposed rule,including the discussion of proposedprovisions in section V of thisdocument.

B. Contamination With Chemical,Physical or Radiological Hazards

Chemical contaminants of producecan originate from a variety of sources.Most common among these include soil(through previous chemical exposure),equipment (e.g., lubricants, fuels, and

refrigerants), pesticides, insecticidesand related agents, and cleaningcompounds (e.g., sanitizers) normallyused in the course of maintaining

buildings and equipment. FDA monitorschemical and pesticide residues infoods through its regulatory monitoringprograms with emphasis on rawagricultural commodities (RACs) andfoods consumed by infants andchildren. Illnesses attributable tochemical hazards are rare (Ref. 7). Infact, between 1997 and 2011, there have

been no Class I recalls of produce

associated with a chemical hazard forwhich there is a reasonable probabilityof causing serious health problems ordeath (Ref. 8). Current monitoring,regulations, and industry practice have

been sufficient to keep these hazardsunder control.

Similarly, the potential public healthconsequences of physical hazard

contamination (e.g. glass or metalfragments) in produce appear to berelatively (Ref. 7). Rarely do thephysical hazards associated withproduce suggest a risk of serious adversehealth consequences or death forindividuals that would consume theproduct. In fact, between 1997 and2011, there have been no Class I recallsof produce associated with a physicalhazard for which there is a reasonableprobability of causing serious healthproblems or death (Ref. 8).

The presence of radiological hazardsin foods is a rare event and consumer

exposure to harmful levels ofradionuclide hazards, outside ofcatastrophic events, is very low (Ref. 7.Ref. 9).

While we acknowledge the potentialfor chemical, physical or radiologicalcontamination of produce, based on ouranalysis (Ref. 7), and for the reasonsdiscussed in section IV.B of thisdocument, we are not proposing specificstandards for these hazards in thisrulemaking.

II. Efforts to Address Produce Safety

FDA and others have taken a numberof actions to address produce safety inthe last two decades. This sectiondescribes several of these activities upto and including FSMA.

A. Inspections and Investigations

We have conducted a number ofinspections and investigations that haveprovided useful information about theroutes of contamination. Investigationsinvolved visiting multiple fieldlocations and packing operations.Observations during the investigationsrevealed several areas of farm practicesthat seem most likely to have beenpossible routes of contamination for

produce involved in the outbreaks. Ourinspections, investigations, andsurveillance sampling activities aredescribed in more detail inaccompanying documents.

B. Guidance Documents and Letters toIndustry

1. GAPs Guide

On October 2, 1997, President Clintonannounced the Initiative to Ensure theSafety of Imported and Domestic Fruitsand Vegetables (Produce and Imported

Food Safety Initiative or PIFSI). As partof this initiative, the President directedthe Secretary of the Department ofHealth and Human Services (HHS) andthe Secretary of the U.S. Department ofAgriculture (USDA), in cooperationwith the agricultural community, toissue guidance on good agriculturalpractices (GAPs) for fresh fruits and

vegetables. In October, 1998, we issuedfinal guidance to industry entitledGuide to Minimize Microbial FoodSafety Hazards for Fresh Fruits andVegetables (GAPs Guide) (Ref. 10).This guide contains voluntaryrecommendations for good agriculturalpractices (GAPs) that growers andpackers can undertake to addresscommon factors contributing tocontamination in their operations. TheGAPs Guide is a broad scope guidancethat takes into account the diversity ofconditions and practices associated withthe growing, harvesting, packing and

holding of fresh produce. We noted thatfirms should use the generalrecommendations in the GAPs Guide totailor practices to their individualoperations. As the GAPs Guide notes,current technologies cannot eliminateall potential food safety hazardsassociated with fresh produce that will

be eaten raw. Therefore, the focus of theGAPs Guide is on implementingmeasures to minimize the potential forintroduction of such hazards.

On September 2, 2008, we issued anotice in the Federal Register (73 FR51306) requesting comments and

scientific data and information to assistus in improving the GAPs Guide. Wespecifically asked for information about(1) current agricultural practices andconditions used to produce, harvest,pack, cool, and transport fresh produce;(2) risk factors for contamination offresh produce associated with thesepractices; and (3) possiblerecommendations or additionalmeasures that would enhance the safetyof fresh produce. We also requestedinformation about the estimated costsand benefits of current practices and/orthe cost and benefits of anyrecommendations. We receivedapproximately two dozen submissionsfrom organizations and individuals,including: Industry, government,universities, environmental groups,consumers, and consumer groups. Anumber of comments discussed thevalue of performing operationalassessments, developing food safetyplans and record keeping but suggestedthat any updated guidance acknowledgethat these activities should becommensurate with the complexity ofan operation and associated risks. Other



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comments requested additionalinformation on microbial testing toensure that when testing is done it ismeaningful and cost effective.

2. Letters to Lettuce, Tomato, andCilantro Industries

On February 5, 2004, we issued aletter to firms that grow, harvest, pack

or hold fresh lettuce and fresh tomatoes,expressing concern regarding outbreaksof foodborne illness associated with theconsumption of these products, andrecommending actions to enhance thesafety of these products (Ref. 11). OnNovember 4, 2005, we issued a secondletter to firms that grow, harvest, pack,hold or manufacture/process fresh andfresh-cut lettuce, reiterating concernsabout continuing outbreaks (Ref. 12). Inthe November 2005 letter, we stronglyencouraged applicable firms to reviewtheir current operations in light of theGAPs Guide, as well as other availableinformation regarding the reduction orelimination of pathogens on freshproduce. We encouraged firms toconsider modifying their operations toensure that they were taking theappropriate measures to provide a safeproduct to the consumer. Werecommended that firms from the farmlevel through the distribution levelundertake these steps.

In March, 2011, we issued a letter tofirms that grow, harvest, pack or holdfresh cilantro, expressing concern aboutpositive sample findings andrecommending actions to enhance thesafety of these products (Ref. 13).

Between 2004 and March, 2011, therehad been 28 confirmed Salmonellapositive sample results in fresh cilantroin, or entering into, commerce. Sampleswere of both U.S. and imported origin.As with earlier letters to the industry,we strongly encouraged applicable firmsto review their current operations inlight of the GAPs Guide, as well as otheravailable information regarding thereduction or elimination of pathogenson fresh produce. We encouraged firmsto consider modifying their operationsto ensure that they were taking theappropriate measures to provide a safe

product to the consumer. In addition,we encouraged these firms to assesshazards unique to the production ofcilantro and to develop commodity-specific preventive control strategies.We recommended that firms from thefarm level through the distribution levelundertake these steps.

3. Guidances and Letters RegardingSprouts

On October 27, 1999, we published anotice of availability (64 FR 57893) fortwo guidance documents to inform all

parties involved in the production ofsprouts (i.e., producers, conditioners,and distributors of seeds and beans usedfor sprouting, sprout producers) thatsprouts have been recognized as animportant cause of foodborne illnessand to provide recommendations forpreventive controls that we believedshould be taken immediately to reduce

the likelihood of sprouts serving as avehicle for foodborne illness (Ref.14).(Ref. 15) The first guidancedocument, Reducing Microbial FoodSafety Hazards for Sprouted Seeds (theSprout Guide), providesrecommendations based on therecommendations of the NationalAdvisory Committee on MicrobiologicalCriteria for Foods (NACMCF) (Ref. 16).We also released a second guidance,Sampling and Microbial Testing ofSpent Irrigation Water During SproutProduction (the Sprout Testing Guide),to assist sprouters in implementing one

of the principal recommendations in thebroader Sprout Guide, i.e., thatproducers test spent irrigation water fortwo pathogens (Salmonella spp. and EcoliO157:H7) before product enterscommerce. We refer to these guidancescollectively as the Sprout Guides.

On April 22, 2005, we announced inthe Federal Register (70 FR 20852) apublic meeting to elicit information oncurrent science related to foodborneillness associated with the consumptionof sprouts. The meeting noticecontained a series of questions to helpfocus comments, including questionsregarding: (1) Practices that may

contribute to contamination of seedsused for sprouting and interventionstrategies that could help prevent,reduce, or control contamination ofseeds used for sprouting; (2) Whetherthe preventive controls recommended inour Sprout Guides could be improvedand, if so, how this might be done; (3)What can or should be done to increasethe involvement of producers of seedsfor sprouting and seed distributors toensure the safety of sprouts; (4) How, ifat all, should the actions to improve thesafety of seeds for sprouting bestructured to take into account variation

within the seed and sprout industry,including variations in size ofestablishments, the types of seeds andsprouts produced and the practices usedin production; and (5) Existing foodsafety systems or standards (such asinternational standards) that we shouldconsider as part of our efforts tominimize foodborne illness associatedwith the consumption of sprouts.

In general, comments expressed aneed to include the seed industry, aswell as the sprout industry, in efforts toimprove the safety of sprouts. Several

comments stated that anyrecommendations should bescientifically sound, based onappropriate (and feasible) expectationsfor risk reduction, and be easy tounderstand and implement. Commentsexpressed concern about the effect onworker health of treating seed with20,000 ppm calcium hypochlorite.

Comments were generally supportive ofrecommendations in the Sprout Guidesto test spent irrigation water; severalcomments supported expanded testing,including seed testing by seedproducers and distributors. All but onecomment maintained that seeds werethe primary source of contamination insprout-associated outbreaks. Severalcomments discussed practices andconditions, such as animal grazing,which could contaminate seed in thefield. One comment suggested theindustry develop a GAPs guidancespecific to the production of seed for

use in sprouts. Several commentssupported applying Current GoodManufacturing Practices (CGMPs) (21CFR Part 110) to sprout facilities. Anumber of comments cited the diversityof sprout types currently beingproduced and noted this diversity ofproducts is likely to continue to grow.These comments maintained it wastherefore appropriate to provideflexibility for individual operations toselect mitigations appropriate for theproducts they produce. Comments tothe 2005 Sprout Public Meeting wereconsidered in this rulemaking and will

be further described when we discuss

proposed provisions specific to sproutsin section V.M. of this document.

On May 1, 2009, we issued a letter tosuppliers and distributors of seeds and

beans used for sprouting, and sprouters,to make firms aware of our seriousconcerns with continuing outbreaksassociated with the consumption of rawand lightly cooked sprouts and to urgefirms to review their operations in lightof our Sprout Guides and other availableinformation (Ref. 17), and to modifytheir operations accordingly to ensurethey are taking appropriate measures toprovide a safe product to consumers.

We also shared a May 1, 2008, letterfrom the California Department ofPublic Health (CDPH) to the Californiasprout industry outlining several criticalareas of concern identified in recentinvestigations and CDPHrecommendations for controllinghazards associated with thoseobservations (Ref. 18).

4. Draft Commodity Specific Guidances

On August 3, 2009, we published anotice in the Federal Registerannouncing the availability for public



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comment of draft commodity specificguidances (CSGs) for melons (74 FR38437), tomatoes (74 FR 38438) andleafy greens (74 FR 38439). The draftCSGs are intended for growers, packers,processors, transporters, retailers, andothers throughout the supply chain. Thedraft CSGs, if finalized, would providea framework for identifying and

implementing appropriate measures tominimize the likelihood of microbialcontamination of tomatoes, leafy greens,and melons. The draft CSGs reflect bothcommodity specific information, suchas recommendations for tomatorepacking, and advances in collectivethinking in broader areas, such asassessing potential hazards in and nearthe field before beginning productionand immediately before harvest, andprotecting and maintaining waterquality at its source and duringdistribution and use. The draft CSGs aredesigned to complement our GAPs

Guide and Fresh-cut Guide. OnNovember 4, 2009, we published anotice in the Federal Register,extending to January 4, 2010, thecomment period on the draft CSGs. Wehave not yet issued these guidances infinal form.

In developing the draft CSGs, werelied heavily on existing industrycommodity specific guidelines, ourproduce safety initiatives and programs,lessons learned from outbreakinvestigations, and other public andprivate programs. We have sincereceived several dozen written

comments, from industry, States, andindividuals. Comments were generallysupportive of the scope and objectivesof the draft CSGs. Comments providedtheir views on both commodity specificissues (e.g., recommendations for fieldpacking tomatoes, water quality forrehydrating leafy greens after harvest)and cross-cutting issues (e.g.,management of wild animal intrusion,quality of water used in postharvestoperations). A number of commentsrequested that we recognize differentrisks may be associated with differentcommodities within the commodity

groups covered by the CSGs, noting, forexample, that cantaloupe (notwatermelon) have been identified as thevehicle in the majority of foodborneillness outbreaks associated withmelons. A number of commentsexpressed concern about potential biasof the CSG approach (i.e., separaterecommendations for differentcommodities) against small farmsgrowing a diversity of crops, especiallythe concern that the CSG approachcould require such farms to havemultiple food safety plans to cover each

of the commodities they grow.Additional comments will be discussedwhen we describe proposed provisionsrelevant to those comments.

5. Guidances Regarding Nuts

On March 11, 2009, we published anotice in the Federal Register (74 FR10598) announcing the availability for

public comment of draft guidance forindustry: Measures to Address the Riskfor Contamination by SalmonellaSpecies in Food Containing a Peanut-Derived Product as an Ingredient.Additionally, on June 29, 2009, wepublished a notice in the FederalRegister (74 FR 310308) announcing theavailability for public comment of draftguidance for industry: Measures toAddress the Risk for Contamination bySalmonella Species in Food Containinga Pistachio-Derived Product As AnIngredient. These draft guidancedocuments were intended formanufacturers who use a peanut-derived product or pistachio-derivedproduct as an ingredient in a foodproduct. These draft guidances providerecommendations for evaluating theeffectiveness of certain Salmonellacontrol measures. We have not yetissued these guidances in final form.

6. Fresh-cut Guide

On March 6, 2006, we published anotice in the Federal Register (71 FR11209) announcing the availability onour Web site of a draft Guidance forIndustry entitled Guide to MinimizeMicrobial Food Safety Hazards of Fresh-

cut Fruits and Vegetables (the Fresh-cut Guide). We received a number ofcomments from trade associations,consumer groups, and industry.Comments were generally supportive ofthe draft Guide. A few commentsincluded questions about our draftdefinition of fresh-cut produce andwhether the recommendations in thedraft guidance were mandatory orvoluntary, in light of the mandatoryrequirements in existing CGMPs.

On February 25, 2008, we publisheda notice (73 FR 10037) announcing ourfinalization and the availability of ourGuide to Minimize Microbial FoodSafety Hazards of Fresh-cut Fruits andVegetables (the Fresh-cut Guide). TheFresh-cut Guidance complements theCGMPs in 21 CFR, Part 110 andprovides recommendations for aframework for identifying andimplementing appropriate measures tominimize the likelihood of microbialcontamination during the processing offresh-cut produce. Examples ofrecommendations for fresh-cutprocessors in the Fresh-cut Guidanceinclude: (1) Know your suppliers and

have a mechanism to verify that yoursuppliers use good agriculturalpractices, good manufacturing practices,and other appropriate food safetypractices; and (2) ensure equipment isdesigned to prevent water collection.While fresh-cut produce is not coveredunder the scope of this proposed rule,we include a reference to our guidance

on fresh-cut produce as some of themeasures recommended in thatdocument are relevant to therequirements proposed for coveredproduce in this rule.

B. Produce Safety Action Plan

On June 15, 2004, we published aFederal Register notice (69 FR 33393)announcing a public meeting to elicitinformation from stakeholdersconcerning key elements of a draftproduce safety action plan entitledProduce Safety From Production toConsumption: An Action Plan toMinimize Foodborne Illness AssociatedWith Fresh Produce (the ProduceSafety Action Plan or PSAP). We postedthe draft PSAP on June 18, 2004 (Ref.19). The draft PSAP continued the 1997Produce and Imported Food SafetyInitiative, building on experience fromearlier efforts such as the developmentand implementation of the GAPs Guide,inspections of farms and producepacking facilities, surveillance samplingassignments, and investigations offoodborne illness outbreaks. The draftPSAP addressed all principal points

between the farm and table wherecontamination of produce could occur.

It covered fresh fruit and vegetables intheir native (RAC) form and raw,minimally processed products (i.e.,fresh-cut produce) that have receivedsome processing to alter their form buthave not been subject to a thermalprocess that would eliminate microbialhazards. The draft PSAP was notintended to cover processed productssuch as juice, or agricultural productsother than fruits and vegetables.

After considering comments receivedfrom various stakeholders, in October2004, we issued the final PSAP. Inrecognition that contamination of

produce can happen at any point in thesupply chain, the PSAP expands on theareas covered by the GAPs Guide (i.e.,farms and packing houses) to extend toall parts of the food supply chain fromfarm through retail or consumerpreparation and consumption. ThePSAP does not cover frozen fruits andvegetables, fruit and vegetable juices, ornuts. The PSAP has four mainobjectives: (1) Prevent contamination offresh produce with pathogens; (2)minimize the public health impactwhen contamination of fresh produce



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occurs; (3) improve communicationwith producers, packers, processors,transporters, distributors, preparers,consumers, and other governmententities about the safety of freshproduce; and (4) facilitate and supportresearch relevant to the contaminationof fresh produce. For each objective, thePSAP identifies steps or actions that

could contribute to the achievement ofthat objective. The PSAP hasmeasurable goals and outcomes, andseveral steps outlined in the PSAP arealready in progress or have beencompleted. For example, we issued theFresh-cut Guide and provided technicalassistance to industry efforts to developcommodity specific supply chainguidance as part of the PSAP objectiveregarding prevention of contamination.

C. Public Hearings

On February, 27, 2007, we publisheda notice (72 FR 8750) of two publichearings, and request for comment, onthe safety of fresh produce. In thatnotice, we stated that we believe thatthe measures outlined in the PSAP, theGAPs Guide, and other public andprivate sector actions, whenimplemented, can be effective inreducing the likelihood of microbialcontamination of fresh produce.However, the fact that outbreaks offoodborne illness associated with freshproduce continue to occur supports theneed for a close examination of: Theextent to which these measures have

been implemented; whether they havebeen effective when implemented

properly; and, what additional ordifferent interventions might beappropriate to reduce the likelihood offuture outbreaks.

We held the public hearings to shareinformation about recent outbreaks offoodborne illness associated withmicrobial contamination of freshproduce, and to invite comments, data,and other scientific information about:Current practices used to grow, harvest,pack, hold, manufacture/process, andtransport fresh produce; risk factors forcontamination of fresh produceassociated with these practices; and

measures FDA could take to enhancethe safety of fresh produce. The noticeof hearings included a list of issues andquestions to help focus comments andasked for scientific information anddata. We received approximately 48submissions from industry, government,universities, environmental groups,consumers, and consumer groups.Recurring comments included: Theimportance of activities to promote orenhance rapid, accurate traceback;strengthened coordination andcommunication between all sectors (i.e.,

researchers, regulators, and industry) onavailable science and currentunpublished data; and an integrated,multidisciplinary approach to identify

best practices not currently incorporatedby industry. A number of commentsexpressed concerns about the cost ofthird party audits and lack ofstandardization of such audits.

Comments also indicated a desire fortraining. Comments were divided onwhether we should continue to promoteadoption of voluntary GAPs guidance orpursue rulemaking to establishmandatory requirements. Commentssupporting mandatory requirementsdiffered on what these requirementsshould look like; suggestions rangedfrom mandatory GAPs to a HazardAnalysis and Critical Control Point(HACCP)-like approach, or acombination of the two. Comments werein general agreement that, whateverregulatory approach was chosen, it

should be consistent across the UnitedStates, based on sound science, andcover a broad range of commoditieswhile being flexible enough toaccommodate the needs of specificcommodities, regions, operations,practices, and different sizes ofoperations.

D. Partnerships and Collaborations

1. Public and Private Standards

Because the GAPs Guide is voluntary,FDA and food safety partners in thepublic and private sectors haveemphasized education and outreach to

industry to promote adoption of theguidance. Buyer requirements thatproducers and other suppliers provideself- or third party audit verification thatthey are following the GAPs Guide havefurther promoted adoption of theguidance. We have worked with thefresh produce industry since the releaseof the GAPs Guide to promote itsrecommendations and to advance thescientific knowledge applicable toenhancing the safety of fresh produce.For example, in conjunction with thePSAP, we have provided technicalassistance to industry in developing

several industry commodity specificguidelines that cover the entire supplychain, including commodity-specificguidelines for melons, leafy greens,tomatoes, and green onions; thesecommodities together accounted for 70percent of the foodborne outbreaksassociated with produce between 1998and 2009 (Ref. 3). These industryguidelines were in turn helpful to us indeveloping FDAs draft commodityspecific guidances for the samecommodities (see section II.B.4 of thisdocument). Additional industry

guidelines have been developed or arein progress for a broad range ofcommodities, including: strawberries,mushrooms, watermelon, potatoes,storage onions, and citrus.

We provided technical assistance tothe Association of Food and DrugOfficials (AFDO) to formulate a ModelCode of Practice for the Production of

Fresh Fruits and Vegetables (the ModelCode) (Ref. 20). This work grew out ofa request from the tomato industry inlate 2006 to address outbreaks offoodborne illness attributed to freshtomatoes. However, the AFDO Board

believed that it was also important toaddress GAPs in the production of a

broader range of fresh fruits andvegetables. Thus, AFDO convened aworking group to develop a Model Codefor produce safety during growing,harvesting, packing and holding thatcould be considered as a model forguidance and/or regulation by Federal

and State regulatory bodies, and forcollaboration among such parties andthe industry. The Model Code does notaddress the additional processing stepsthat may occur at a fresh-cut or otherprocessing facility, which is covered bythe CGMPs in 21 CFR part 110. TheModel Code focuses on minimizing thepotential for contamination of freshproduce with pathogens.

Through cooperative agreement withCornell University, FDA has, togetherwith USDA AMS, established a jointlyfunded Produce Safety Alliance (PSA),

based on the successful Seafood HACCPAlliance for Training and Education.

The PSA is a public-private partnershipthat will develop and disseminatescience- and risk-based training andeducation programs to provide producefarms with fundamental food safetyknowledge, starting in advance of thisproposed rule and continuing after thefinal rule is promulgated. The PSAincludes active participation from theproduce industry and academicinstitutions nationwide. The curriculumdevelopment process has alreadystarted, through establishment of topic-specific working committees chargedwith identifying challenges to

understanding and implementing GAPson farms. This first phase of work, inadvance of a final rule, is intended toassist farms, especially small farms, inestablishing appropriate food safetymeasures, consistent with the GAPsGuide and other existing guidances, sothat they will be better positioned whenwe issue a final rule establishingproduce safety standards under section419 of the FD&C Act. As this rulemakingprogresses, the PSA materials will bemodified, as needed, to be consistentwith the requirements in the rule.



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2. Foodborne Illness InvestigationsEnvironmental Assessment Model

An environmental assessment, inthe foodborne illness outbreak or foodcontamination setting, means aninvestigation that is triggered by anoutbreak of foodborne illness or foodcontamination incident with thepurpose of determining how theenvironment may have contributed tothe introduction or transmission ofpathogens or other hazards that causedillness or contamination. In addition toour more traditional investigationalteam approach, during this process wework collaboratively with a number ofexperts from CDC, State and localagencies, and industry.

In 2010, we conducted anenvironmental assessment in responseto a foodborne illness outbreakinvolving 33 cases of STEC O145infection in 5 States. While we have notmade a definitive determination

regarding how or at what point in thesupply chain E. coliO145contamination occurred, this assessmentwas important in a number of respects.As mentioned above, we workedcollaboratively with a number of expertsfrom CDC, State and local agencies, andindustry. Working with this team, weassessed potential sources ofE. coliO145 not just in the field of interest, butin the larger growing area surroundingthe field of interest, along with thepotential for E. coliO145 to betransported from a source in thesurrounding area to the field where

implicated lettuce was grown. Thishighly collaborative, systems-basedapproach allowed for the discovery ofimportant environmental risk factorsthat would not typically be explored byconventional investigation methods(Ref. 21). On December 29, 2010, weposted a report, entitled EnvironmentalAssessment: Non-O157 Shiga Toxin-Producing E. coli(STEC): Findings andPotential Preventive Control Strategies(Ref. 21), outlining the environmentalassessment approach used in thisinvestigation, our observations andtentative conclusions.

In 2011, we conducted anenvironmental assessment in responseto a foodborne illness outbreakinvolving a total of 139 persons infectedwith any of four outbreak-associatedstrains ofL. monocytogenes, including29 deaths, in 28 States (as of November1, 2011). On October 19, 2011, weposted a report, entitled EnvironmentalAssessment: Factors PotentiallyContributing to the Contamination ofFresh Whole Cantaloupe Implicated in aMulti-State Outbreak of Listeriosis,providing an overview of the assessment

process, potential contributing factors inthis outbreak, and recommendedmeasures firms should employ toprevent similar contamination (http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm). Asdiscussed further in sections III.F andV.A.2.b.i of this document, thisproposed rule would not apply to off-

farm packing facilities such as thepacking facility associated with thiscantaloupe outbreaksuch facilitieswould instead be subject to existing part110 and section 418 of the FD&C Act.However, we include the findings ofthis environmental assessment here

because the contributing factors arerelevant to both on-farm and off-farmproduce packing practices.

3. Produce Safety Initiative Assessments

In August 2006 we launched the LeafyGreens Safety Initiative (LGSI), a multi-year initiative which involvedassessments of practices and conditionsat select leafy greens farms and facilitiesin California (Ref. 22). In the summer of2007, we began a multi-year TomatoSafety Initiative (TSI) to assess practicesand conditions associated with growingand packing tomatoes on the EasternShore of Virginia, followed byassessments in three tomato growingareas in Florida (Ref. 23).

The initiatives were conducted as partof a strategy to reduce foodborne illness

by focusing food safety efforts onspecific products, practices, andgrowing areas that have been identifiedin past outbreak investigations. The

initiatives were a collaborative effortbetween FDA and the State health andagriculture departments in California,Virginia, and Florida, in cooperationwith several universities and membersof the produce industry. Both initiativescontained several importantcomponents, the most visible of whichwas a series of assignments to the fieldto assess conditions and practices atfarms and packing houses that couldlead to contamination and to observeactions taken by growers and packers inresponse to these conditions. Otherimportant components of the initiatives

included continuing communicationand outreach with the industry at allpoints along the supply chain,facilitating and promoting research toenhance leafy green and tomato safety,and strengthening collaboration

between Federal, State, and local publichealth officials in disease detection andresponse.

Assessments of tomato packingfacilities covered dump tank waterquality parameters, employee hygiene,and facility cleaning and sanitationpractices. Assessments of the farms

addressed irrigation water sources (suchas ponds and wells), source water andprocedures for mixing crop chemicals,the potential impacts of weather events,such as drought and flooding, andanimal proximity to growing fields.Assessments were scheduled tocoincide with tomato production andharvest seasons on the Eastern Shore of

Virginia and in three tomato producingregions in Florida.

Where the teams observed conditionsor practices at one or more locationsthat might be improved, they sharedthose observations directly with theindividual firm and also sharedobservations in general terms at a post-assessment meeting so that all interestedparties could apply the findings to theiroperations. For example, we identifiedissues related to proximity of portabletoilets to irrigating ponds and harvestingof drops at one or more locations. Theteams recommended that portable

toilets should be distanced from theirrigation pond and policies that forbidthe harvesting of drops should bestrictly enforced. We also sharedpreliminary observations through othervenues, including a tomato researchpriorities meeting in College Park(hosted by Joint Institute for Food Safetyand Applied Nutrition (JIFSAN) and theUniversity of Floridas Institute of Foodand Agricultural Sciences) (JIFSAN2010 (update)), a Leafy Greens ResearchNeeds workshop hosted by United Freshin Herndon, VA (United Fresh 2008),and as technical assistance to publicand private efforts to develop new or

enhanced guidances.

4. Research

FDA researchers have focused onrefining or developing methods todetect, isolate and subtype pathogens ofconcern in produce, to enhance ourability to analyze samples in support ofour compliance activities. As resourcespermit, FDA scientists also directlyinvestigate questions about factorscontributing to produce contamination.We also supported extramural researchand collaborations with other Federalagencies, academic institutions, and

industry-supported entities to leverageresearch efforts, expertise, and resources(such as experimental stations for fieldresearch). This includes successfulcollaborations with USDA on researchof mutual interest. To fill knowledgegaps, thus facilitating implementation ofany new policies, we have initiated newagreements with USDA to conductresearch in key areas such asagricultural water and soil amendments(Ref. 24). Specifically, FDA hasprovided approximately one milliondollars to sponsor research at USDA

http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htmhttp://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm


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ARS and to develop a produce safetyrule research network at the WesternCenter for Food Safety at University ofCalifornia Davis. We intend thesecollaborative efforts to result in thecollection of data that may help resolvequestions about the necessary time

between application of raw manure orcontaminated water and safe harvest of

produce in key agro-ecological growingconditions and for key crops. Our goalis for this research to result in suggestedprotocols that farms could follow incompliance with a final produce rule,and for this process to be duplicated forother crops and regions as furtherfunding is secured. This FDA sponsoredresearch was initiated to demonstratethe commitment of federal agencies toaddress the needs of farmers, to provideinitial data to finalize study protocolsfor further research, and to attractmatching funds from industry.

In partnership with academic

institutions across the country, FDA hasalso created four Centers of Excellence(CoE), each housed at a university andcharged with specific food-safety tasks(Ref. 25). In 2008, a 5-year cooperativeagreement was awarded to theUniversity of California, Davis (UCDavis) to establish the most recent ofthese CoEs, the Western Center for FoodSafety (WCFS). Through this agreement,FDA has been able to leverage theresources and expertise of UC Davis tostudy the impact of the uniquegeography and ecology of the growingregions of the Western United States.

5. Engagement With Other FederalAgencies

FDA regularly consults andcoordinates with other Federal agenciesin the area of produce safety. Examplesof these efforts can be found throughoutthis document and include collectingsamples, sharing data, providingtraining and technical assistance toindustry, and research. Our partnershipswith USDA and CDC have beenparticularly valuable to our efforts.

6. Engagement with Industry andAcademia

We regularly engage with experts inthe produce industry and in academia.These engagements serve to botheducate the industry about our thinking,activities, and expectations, and toeducate us about current industrypractices and academic efforts toenhance the safety of produce.

In addition to the collaborationsmentioned above, we initiated multipleproduce industry listening sessionsacross the country prior to the passageof FSMA. At these sessions, weprovided local industry and academia

an opportunity to ask questions andvoice concerns about the potential forlegislation impacting the produceindustry. We visited a total of 13 Stateswith significant produce production in2010. FDA and USDA technical experts,scientists and managers participated inthese meetings, and we were able to tourlarge and smaller scale farms, and talk

to people with practical experience inproduction and implementing foodsafety programs on farms.

We also were involved with theProduce Safety Project (PSP), a researchand advocacy organization based atGeorgetown University and funded bythe Pew Charitable Trust. The PSPprovided four issue briefs (Ref. 26.Ref.27.Ref. 28.Ref. 29) each focused onspecific aspects of produce production,the risks they may represent, preventionand mitigation strategies to addressthese risks, and further research needsin the area. Further, PSP held 6 regional

stakeholder discussion sessions to elicitcomment and reaction from the produceindustry, and to offer an avenue tospeak directly to the documentsauthors. A common message from theindustry during these discussions wasconcern about food safety and a desireto know how to reduce risks. Smallgrowers and packers in particularconveyed a need for information andtechnical support that would assistthem in implementing food safetypractices.

E. Current Industry Practices

In response to foodborne illnesses

associated with produce in the mid1990s, the produce industry developedproduce safety guidance, engaged inoutreach regarding produce safety bestpractices, developed complianceauditing programs, and funded producesafety research.

1. Industry Produce Safety BestPractices Guidance

In 1997, the International Fresh-cutProduce Association and the WesternGrowers Association publishedVoluntary Food Safety Guidelines forFresh Produce, which provided

generalized voluntary industryguidelines to minimize the potential forcontamination for fresh produce ingrowing, packing, shipping andprocessing operations. After FDA issuedour GAPs Guide, industry developedcommodity specific guidances forvarious produce industry segmentsincluding: Commodity Specific FoodSafety Guidelines for the Melon SupplyChain (2005), Commodity Specific FoodSafety Guidelines for the Lettuce andLeafy Greens Supply Chain (2006),Commodity Specific Food Safety

Guidelines for the Fresh Tomato SupplyChain (2006 1st Edition, 2008 2ndedition) and Commodity Specific FoodSafety Guidelines for the Production,Harvest, Post-Harvest, and Valued-Added Unit Operations of Green Onions(2010). In addition, other industrysegments including, but not limited tomushrooms, strawberries, watermelons,

citrus, avocados, almonds, and dry bulbonions developed commodity specificguidances. The fresh-cut produceindustry, via the International FreshProduce Association, published in 1992Food Safety Guidelines for the Fresh-cutProduce Industry and updated thispublication periodically, with the 4thedition being published most recently in2001.

2. Produce Industry Food SafetyCompliance Auditing

Shortly after the FDA GAPs Guidewas finalized, a number of retailproduce buyers informed suppliers thatas a condition of sale, their producesuppliers must follow, and be thirdparty audited for conformance with, theFDA GAPs guide (Ref. 30). In 1999USDA AMS began developing a GAPsand Good Handling Practices (GAP &GHP) Audit Verification Program, inresponse to requests from growers andthe Association of Fruit and VegetableInspection and StandardizationAgencies. The program, based on theGAPs Guide, was piloted in 2000 andfully available later that same year. InSeptember 2001 the United Fresh Fruitand Vegetable Association published

guidance entitled Food Safety AuditingGuidelines: Core Elements of GoodAgricultural Practices for Fresh Fruitsand Vegetables to provide the basis forGAPs audits in the produce industry. In2011 the United Fresh ProduceAssociation published a HarmonizedGAPs Standard for use by producers andthird party auditors in the fresh produceindustry.

In 2007 leafy greens growers inCalifornia, with the assistance of theUSDA AMS and CDFA, developed andimplemented the California LeafyGreens Marketing Agreement (CA

LGMA) (Ref. 31). The objective of theCA LGMA is to protect public health viacompliance with the food safetypractices accepted by the LGMA board,verified through mandatory governmentaudits of members and signatories to theagreement by CDFA auditors trainedand licensed by USDA AMS (Ref. 31).In 2007 leafy greens growers in Arizonaalso adopted a similar marketingagreement and audit structure for theirgrowers (Ref. 32). At the request ofindustry, the USDA AMS in 2009 heldseven hearings throughout the United



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States to solicit input from the leafygreens industries across the U.S.regarding their desire to develop aproposed national marketing agreementfor leafy greens (74 FR 45565). Adecision regarding the proposed USDAAMS national marketing agreement forleafy greens is currently pending.

In 2007, the Florida Legislature

passed a law that provided theDepartment of Agriculture andConsumer Services with the authority toaddress safety concerns related to freshtomatoes. Implementing regulationswhich became effective on July 1, 2008(Florida Tomato Inspection Regulation5G6, 2007) adopted and incorporated

by reference almost all of therecommendations in the CommoditySpecific Food Safety Guidelines for theFresh Tomato Supply Chain, 2ndEdition (July 2008).

GAPs implementation and GAPsaudits have now become commoncomponents of purchase specificationsfor produce in some market segments,and have been a significant force inincreasing awareness of GAPs andpromoting their implementation (Ref.33). However, growers and packers whosell product through direct marketingchannels, or to buyers who do notinclude GAPs as a condition of sale,may be less familiar with GAPs.

3. Produce Industry Produce SafetyEducation Outreach

In addition to participation in thePSA housed at Cornell University(discussed above in section II.D. of this

document), the produce industrypromoted adoption and implementationof the recommendations in the FDAGAPs Guide through education andoutreach efforts in cooperation with theland grant universities. The NationalGAPs Program at Cornell University,with collaborators at other land grantuniversities, developed a series ofpublications to train domestic growersand packers on the key principles ofproduce safety, including: Food SafetyBegins on the Farm: A Growers Guide(2000); Food Safety Begins on the Farm:A Grower Self Assessment of Food

Safety Risks (2003); and, Fruits,Vegetables, and Food Safety: Health andHygiene on the Farm (2004). Thesepublications and others developed byland grant universities throughout theUnited States have been used to trainthe produce industry on produce safety

best practices.

F. 2010 Federal Register Notice andPreliminary Stakeholder Comments

On February 23, 2010, we publishedin the Federal Register (75 FR 8086;2010 FR notice) a notice opening a

docket to obtain information aboutcurrent practices and conditions for theproduction and packing of freshproduce. On May 20, 2010, we extendedthe original 90-day comment period forthe docket until July 23, 2010 (75 FR28263). We established this docket toprovide an opportunity for interestedparties to provide information and share

views that would inform thedevelopment of (1) safety standards forfresh produce at the farm and packinghouse and (2) strategies and cooperativeefforts to ensure compliance.

In particular, we welcomed input onthese general categories: (1) Role of thegood agricultural practicerecommendations in the GAPs Guide;(2) Standards for domestic and foreigngrowers and packers; (3) Identificationand prioritization of risk factors; (4)Environmental assessment of hazardsand possible pathways ofcontamination; (5) The impact of scale/

size of growing operations on the natureand degree of possible food safetyhazards; (6) Methods to tailor preventivecontrols to particular hazards andconditions affecting an operation; (7)Possible approaches to tailoringpreventive controls to the scale of anoperation so that the controls achieve anappropriate level of food safetyprotection and are feasible for a widerange of large and small operations; (8)Coordination of produce food safetypractices and sustainable and/or organicproduction methods; (9) Coordination ofproduce food safety practices andenvironmental and/or conservation

goals or practices; (10) Coordination ofproduce food safety practices andFederal, state, local and tribalgovernment statutes and regulations;(11) Microbial testing; (12) Postharvestoperations and the role of the CGMPs in21 CFR part 110; (13) Records and otherdocumentation that would be useful toindustry and regulators in ensuring thesafety of fresh produce; and (14)Strategies to enhance compliance.

We further advised that informationpreviously submitted to the docketsrequesting comments on the draftcommodity-specific guidances (CSGs),

or to the docket requesting commentsand scientific data and information toupdate the GAPs Guide, would beconsidered in this rulemaking and neednot be resubmitted. Commentssubmitted to these dockets, i.e., docketson the GAPs Guide update and draftCSGs, as well as comments at theSprouts Public Meeting and ProduceSafety Hearings, are discussed insections II.B. and II.D. of this document.

In response to the 2010 FR notice, wereceived about 880 comments fromconsumers, farmers and producers,

industry groups and trade associations,consumer groups, environmentalgroups, academia, retail establishments,packers and handlers, food markets andcoops, laboratories and public healthfacilities, and federal, state, local andforeign governments. The USDAAgricultural Marketing Service (AMS)submitted a record of their public

hearings related to their proposedvoluntary national marketing agreementfor leafy green vegetables (NLGMA) (74FR 45565, September 3, 2009 and 74 FR48423, September 23, 2009), andrequested that we consider the contentsof that record (which includedtestimony, exhibits, and writtenarguments or briefs based on evidencereceived at the public hearing) in ourdeliberations to develop safetystandards for fresh produce. A summaryof general comments received ispresented in this section while specificcomments relevant to the issues

addressed in this proposed rule arediscussed in sections V.C through V.R ofthis document.

1. Comments on Impact, Flexibility andTransparency

Overall, a majority of stakeholders,including farmers, producers,consumers and industry, expressedconcern about the scope and impact ofregulation on the livelihoods of thosewho produce food and on their abilityto produce food in an economically-feasible manner. Most commentssupported a food safety system,grounded in science, for the production

of produce in a fair and equitablemanner for both domestic and imports.Comments noted that regulationsdeveloped should be science-based andprovide for producers to manage risks ina manner appropriate to theiroperations. Several commentsmaintained that risk assessments,hazard assessments, operationalassessments and development of foodsafety plans are vital tools for farmers to

be able to demonstrate that the foodsafety practices they employ areeffective. Conversely, others questionedthe need for some industry segments,

such as small farms or growers of lowrisk commodities to establish foodsafety plans. A majority of commentsalso stated that research is needed onvarious issues relevant to producesafety, including water quality, soilamendments, animals (both wildlife anddomesticated), and worker health andhygiene. Comments urged the agency totailor regulations to reflect variablessuch as farm size, markets served,growing conditions, and risk. Inaddition, comments highlighted theimportance of transparency in the



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development and implementation offood safety standards, and expressedthat transparency provides regulators,

buyers, and the public with theconfidence they need to ensure that allreasonable and required practices have

been put in place and that any specificproducer or packer of produce is incompliance with required food safety

practices. FSMA directs us to establishscience-based minimum standards forproduce safety. These standards are toinclude procedures, processes, andpractices that we determine to bereasonably necessary to prevent theintroduction of known or reasonablyforeseeable biological, chemical, andphysical hazards into covered produceand to provide reasonable assurancesthat produce is not adulterated undersection 402 of the FD&C Act. Asdiscussed in section IV below, FDAintends to adopt a regulatory approachthat considers the risk posed by both the

commodity and relevant agronomicpractices, and provides the mostappropriate balance between publichealth protection and flexibility. Werecognize the need to incorporateappropriate flexibility withinregulations to reflect the diversity ofcommodities and associated processes,practices, and conditions coveredwithin the scope of this rule. Forexample, exemptions based onmonetary value of food sold by the farmand direct farm marketing, commercialprocessing of commodities, and othercriteria are reflected in proposed

subpart A. Under certain specifiedconditions, qualified exemptions andassociated modified requirements in acalendar year are also provided underproposed subpart A. In addition,proposed 112.12 would establish aframework for alternatives to certainrequirements of the rule. We realize thatnumerous differences exist amongpractices based on risk or agro-ecological conditions and thereforealternatives to certain requirementswould be permitted when adequate anddocumented scientific data orinformation support such alternatives.

Similarly, proposed subpart P setsprocedures for a State or foreign countryto request a variance from one or morerequirements of this part when certainconditions are met, as required bySection 419(c)(2) of the FD&C Act. Forexample, a State or foreign country mayconsider that the historical performanceof an industry within their jurisdiction(e.g., as indicated by theepidemiological record) and thecombination of measures taken by thatindustry merits requesting a variancefrom some or all provisions of this

proposed rule. In requesting a variance,among other things, the State or foreigncountry would submit information that,while the procedures, processes andpractices to be followed under thevariance would be different from thoseprescribed in this proposed rule, therequested variance is reasonably likelyto ensure that the produce is not

adulterated under section 402 of theFD&C Act and provide the same level ofpublic health protection as therequirements of the final regulations(see proposed 112.173). FDA wouldencourage consideration of these kindsof submissions.

Furthermore, in addition to solicitingcomments on the proposed regulationthrough this notice, we will be holdingpublic meetings in diverse geographicareas of the United States to providepersons in different regions anopportunity to comment, as requiredunder Section 419(a)(2) of the FD&C

Act.2. Comments on EnvironmentalConsiderations

Several comments pointed out thatthere are a number of state and federallaws and programs that relate toenvironmental stewardship, and notedthat environmental conservation andfood safety are not necessarily cross-competing goals. Comments favored auniform regulatory approach amongFederal, State, local and tribalgovernments statutes and regulations,and recommended that we consider thework of other Federal agencies,

including the Environmental ProtectionAgency, the Department of Agriculture,and the Department of the Interior indeveloping proposed requirements forproduce to ensure such requirements donot unnecessarily inhibit co-management of food safety andenvironmental concerns. In this regard,a few comments stated that while co-management of food safety andsustainability may be considered,ultimately, food safety has to be toppriority and it is unacceptable to sellunsafe food to customers.

Section 419(a)(3)(D) of the FD&C Actdirects that this proposed rule take intoconsideration, consistent with ensuringenforceable public health protection,conservation and environmentalpractice standards and policiesestablished by Federal natural resourceconservation, wildlife conservation, andenvironmental agencies. As discussedfurther in Sections III.A.8 and V.I, weconsulted with several Federal agenciesin order to take into considerationconservation and environmentalpractice standards and policiesestablished by those agencies. FDA also

plans to work closely with Federal,State, and local agencies inimplementing the final rule.

3. Comments on Guidance andEducation

A majority of comments alsoexpressed the need for guidance toassist stakeholders in implementing the

requirements established in finalregulations. Moreover, severalcomments stressed the importance ofeducational programs and incentives inany effective food safety system.

Section 419(e) of the FD&C Actrequires FDA to publish updated goodagricultural practices and guidance forthe safe production and harvesting ofspecific types of fresh produce, inconsultation with the Secretary ofAgriculture, representatives of Statedepartments of agriculture, farmerrepresentatives, and various types ofentities engaged in the production andharvesting or importing of fruits andvegetables that are raw agriculturalcommodities, including small

businesses. In addition, section 419(e) ofthe FD&C Act requires FDA to conductedu