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Vol. 78 Tuesday,No. 247 December 24, 2013

Part III

Department of Health and Human Services

Food and Drug Administration

21 CFR Parts 16 and 121Focused Mitigation Strategies To Protect Food Against IntentionalAdulteration; Proposed Rule

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78014 Federal Register / Vol. 78, No. 247/ Tuesday, December 24, 2013 / Proposed Rules

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 121

[Docket No. FDA2013N1425]

RIN 0910AG63

Focused Mitigation Strategies ToProtect Food Against IntentionalAdulteration

AGENCY: Food and Drug Administration,HHS.

ACTION: Proposed rule.

SUMMARY: The Food and DrugAdministration (FDA or we) isproposing to require domestic andforeign food facilities that are requiredto register under the Federal Food, Drug,and Cosmetic Act (the FD&C Act) to

address hazards that may beintentionally introduced by acts ofterrorism. These food facilities would berequired to identify and implementfocused mitigation strategies tosignificantly minimize or preventsignificant vulnerabilities identified atactionable process steps in a foodoperation. FDA is proposing theserequirements as part of ourimplementation of the FDA Food SafetyModernization Act (FSMA). Further, aspart of the proposal, FDA discusses anapproach to addressing economicallymotivated intentional adulteration. Weexpect the proposed rule, if finalized asproposed, would help to protect foodfrom intentional adulteration caused byacts of terrorism.

DATES: Submit either electronic orwritten comments on the proposed rule

by March 31, 2014. Submit commentson information collection issues underthe Paperwork Reduction Act of 1995 by

January 23, 2014, (see the PaperworkReduction Act of 1995 section of thisdocument).

ADDRESSES: You may submit comments,identified by Docket No. FDA2013N1425 and/or Regulatory Information

Number (RIN) 0910AG63, by any of thefollowing methods, except thatcomments on information collectionissues under the Paperwork ReductionAct of 1995 must be submitted to theOffice of Information and RegulatoryAffairs, Office of Management andBudget (OMB) (see the PaperworkReduction Act of 1995 section of thisdocument).

Electronic Submissions

Submit electronic comments in thefollowing way:

Federal eRulemaking Portal: http://www.regulations.gov.Follow theinstructions for submitting comments.

Written SubmissionsSubmit written submissions in the

following ways: Mail/Hand delivery/Courier (for

paper or CDROM submissions):Division of Dockets Management (HFA

305), Food and Drug Administration,5630 Fishers Lane, rm. 1061, Rockville,MD 20852.

Instructions: All submissions receivedmust include the Agency name andDocket No. FDA2013N1425 andRegulatory Information Number (RIN)0910AG63 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 INFORMATION

section of this document.Docket: For access to the docket toread background documents orcomments received, go to http://www.regulations.govand insert thedocket number, found in brackets in theheading 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:Regarding the provisions with respect tohuman food: Ryan Newkirk, Center forFood Safety and Applied Nutrition(HFS005), Food and DrugAdministration, 5100 Paint BranchPkwy., College Park, MD 20740, 2404022428. Regarding the provisionswith respect to food for animals: AlfredMontgomery, Center for VeterinaryMedicine (HFV200), Food and DrugAdministration, 7519 Standish Pl.,Rockville, MD 20855, 2404536836.SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Scope of Coverage of the Proposed RuleSummary of the Major Provisions of the

Proposed Rule

Costs and BenefitsI. IntroductionII. Background

A. Incidents of Intentional Adulteration ofFood

B. Interagency Approach to Food DefenseC. Resources for the Food SectorD. OutreachE. Industry StandardsF. International Food Defense Guidelines

III. Legal AuthorityA. Section 103 of FSMAB. Section 106 of FSMAC. Intrastate Activities

IV. Regulatory Approach

A. Framework of the RuleB. Activities That Occur on Produce FarmsC. Transportation CarriersD. Food for AnimalsE. Acts of Disgruntled Employees,

Consumers, or CompetitorsF. Economically Motivated AdulterationG. Low-Risk Activities at Farm Mixed-Type

FacilitiesH. Activities That Occur on Dairy Farms

I. Other Ways To Focus on Foods With aHigh Risk of Intentional AdulterationCaused by Terrorism

V. The ProposalA. DefinitionsB. ExemptionsC. Food Defense MeasuresD. Requirements Applying to Records That

Must Be Established and MaintainedE. Compliance

VI. Preliminary Regulatory Impact AnalysisVII. Analysis of Environmental ImpactVIII. FederalismIX. CommentsX. References

Executive Summary

This proposed regulation implementsthree provisions of the Federal Food,Drug, and Cosmetic (FD&C) Act, asamended by the FDA Food SafetyModernization Act (FSMA), that relateto the intentional adulteration of food.Section 418 of the FD&C Act (21 U.S.C.350g) addresses intentional adulterationin the context of facilities thatmanufacture, process, pack, or holdfood and are required to register undersection 415 of the FD&C Act (21 U.S.C.350d). Section 419 of the FD&C Act (21U.S.C. 350h) addresses intentionaladulteration in the context of fruits andvegetables that are raw agricultural

commodities. Section 420 of the FD&CAct (21 U.S.C. 350i) addressesintentional adulteration in the contextof high risk foods and exempts farmsexcept for farms that produce milk. FDAis implementing the intentionaladulteration provisions in sections 418,419, and 420 of the FD&C Act in thisrulemaking.

Scope of Coverage of the Proposed Rule

The subject of this proposed rule isprotection of food against intentionaladulteration caused by acts of terrorism.This proposed rule would apply to both

domestic and foreign facilities that arerequired to register under section 415 ofthe FD&C Act. However, as explained inthe remainder of this document andshown in Diagram 1 and Table 1, theproposed rule contains severalexemptions. (The diagrams and table

below are intended to illustrate theproposed scope and requirements of thisrule, and do not include all aspects ofthe proposed regulation.) Theseexemptions are:

The proposed rule would not applyto a qualified facility, except that the

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78015Federal Register / Vol. 78, No. 247/ Tuesday, December 24, 2013 / Proposed Rules

facility would be required to provide forofficial review, upon request,documentation that was relied upon todemonstrate that the facility qualifiesfor this exemption. As proposed, aqualified facility would be: (1) A verysmall business (i.e., a business that hasless than $10,000,000 in total annualsales of food, adjusted for inflation), or(2) a facility that meets tworequirements, i.e., (a) During the 3-yearperiod preceding the applicablecalendar year, the average annualmonetary value of the foodmanufactured, processed, packed orheld at such facility that is sold directly

to qualified end-users (as defined in thispart) during such period exceeded theaverage annual monetary value of thefood sold by such facility to all otherpurchasers; and (b) the average annualmonetary value of all food sold duringthe 3-year period preceding theapplicable calendar year was less than$500,000, adjusted for inflation.

This proposed rule would not applyto the holding of food, except theholding of food in liquid storage tanks.

This proposed rule would not applyto the packing, re-packing, labeling, orre-labeling of food where the containerthat directly contacts the food remainsintact.

This proposed rule would not applyto activities of a facility that are subjectto section 419 of the Federal Food, Drug,and Cosmetic Act (Standards forProduce Safety).

This proposed rule would not applywith respect to alcoholic beverages at afacility that meets certain conditions.

This proposed rule would not applyto the manufacturing, processing,packing, or holding of food for animalsother than man.

We seek comment on these exclusionsand whether additional exclusions arewarranted.BILLING CODE 416001P


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TABLE 1SCOPE OF INTENTIONAL ADULTERATION AND PROPOSED EXCLUSIONS AND EXEMPTIONS

Type of intentional adulterationCoverage within scope of proposed

21 CFR 121Brief rationale, and relevant corresponding

section of the rule *

I. Types of Intentional Adulteration Considered in this Proposed Rulemaking

1. Acts of disgruntled employees, consumers,or competitors intended to attack the reputa-tion of a company, and not to cause public

health harm, although public health harmmay occur.

Not within the scope of intentional adulterationcovered under proposed 21 CFR 121.

D Not considered high risk because not in-tended to cause widespread, significantpublic health harm.

D See section IV.E of this document.

2. Economically motivated adulteration (EMA)intended to obtain economic gain, and not tocause public health harm, although publichealth harm may occur.

Not within the scope of intentional adulterationcovered under proposed 21 CFR 121.

D Considering addressing as part of hazardanalysis in a preventive controls frameworkwhere EMA is reasonably likely to occur.

D See section IV.F of this document.3. Acts intended to cause massive public health

harm, including acts of terrorism.Covered within scope, and is the focus of pro-

posed 21 CFR 121.D Considered high risk because intent of

the act is to cause widespread, significantpublic health harm.

D See section IV.A of this document.

II. Facilities or Operations Excluded or Exempted from Proposed 21 CFR 121

Facility or Operation Exclusion or Exemption (and any associatedmodified requirements)

Brief rationale, and relevant correspondingsection of the rule *

Activities that fall within the definition of farm

(as defined in 21 CFR 1.227).

Excluded .......................................................... D Activities that occur on produce farms are

not considered high risk.D Activities that occur on dairy farms are ad-

dressed below.D Activities that occur on other farms are out-

side the scope of 103, 105, and 106 ofFSMA.

D See section IV.B of this document.Transportation carriers ....................................... Excluded .......................................................... D Transportation of bulk liquids is addressed

by coverage of shippers and receivers.D Other transportation activities are not con-

sidered high risk.D See section IV.C of this document.

Activities that occur on dairy farms .................... D Fluid milk storage and loading appear to pose a significant vulnerability.D We seek comment on practical and effective approach to address this vulnerability.D See section IV.H of this document.

Qualified facility, as defined in proposed 121.3 Exempt, except must provide for FDA review,upon request, documentation relied on todemonstrate that the facility qualifies for thisexemption.

D

Very small businesses are not consideredhigh risk.D See section V.B.1 of this document.

Holding of food, except the holding of food inliquid storage tanks.

Exempt ............................................................. D Not considered high risk because theseactivities do not fit within any of the FDA-identified key activity types.

D See section V.B.2 of this document.

Packing, re-packing, labeling, or re-labeling offood where the container that directly con-tacts the food remains intact.

Exempt ............................................................. D Not considered high risk because theseactivities do not fit within any of the FDA-identified key activity types.

D See section V.B.3 of this document.Activities of a facility that are subject to Stand-

ards for Produce Safety (proposed 21 CFR112).

Exempt ............................................................. D Activities that occur on produce farms arenot considered high risk.

D See section V.B.4 of this document.Alcoholic beverages at certain alcohol-related

facilities, and certain prepackaged food soldin limited quantities along with alcoholic bev-erages at the same facilities (see proposed 121.5(e)).

Exempt ............................................................. D Alcoholic beverages at these facilities are

outside the scope of 103, 105, and 106 ofFSMA.D See section V.B.5 of this document.

Manufacturing, processing, packing, or holdingof food for animals.

Exempt ............................................................. D Not considered high risk because unlikelyto impact human health.

D See section V.B.6 of this document.

* Please see the corresponding sections of the rule identified in the column for a complete discussion of our analysis, rationale, and tentativeconclusions related to the proposed exclusions or exemption.


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Summary of the Major Provisions of theProposed Rule

This proposed rule would establishvarious food defense measures that anowner, operator, or agent in charge of afacility would be required to implementto protect against the intentionaladulteration of food, as summarized inDiagram 2. Specifically:

Prepare and implement a writtenfood defense plan that includesactionable process steps, focusedmitigation strategies, and procedures formonitoring, corrective actions, andverification (proposed 121.126).

Identify any actionable processsteps, using one of two procedures. FDAhas analyzed vulnerability assessmentsconducted using the CARVER+Shockmethodology and identified four keyactivity types: Bulk liquid receiving andloading; Liquid storage and handling;Secondary ingredient handling; andMixing and similar activities. FDA has

determined that the presence of one ormore of these key activity types at aprocess step (e.g., manufacturing,processing, packing, or holding of food)indicates a significant vulnerabilityunder section 418 of the FD&C Act andthat the food is at high risk ofintentional adulteration caused by actsof terrorism under section 420 of theFD&C Act. Facilities may identifyactionable process steps using the FDA-identified key activity types as

described in proposed 121.130(a) orconduct their own facility-specificvulnerability assessments as provided inproposed 121.130(b).

Identify and implement focusedmitigation strategies at each actionableprocess step to provide assurances thatthe significant vulnerability at each stepwill be significantly minimized or

prevented and the food manufactured,processed, packed, or held by thefacility will not be adulterated(proposed 121.135).

Establish and implementprocedures, including the frequencywith which they are to be performed, formonitoring the focused mitigationstrategies (proposed 121.140).

Establish and implement correctiveaction procedures that must be taken iffocused mitigation strategies are notproperly implemented (proposed 121.145).

Verify that monitoring is being

conducted and appropriate decisionsabout corrective actions are being made;verify that the focused mitigationstrategies are consistently implementedand are effectively and significantlyminimizing or preventing the significantvulnerabilities; and conduct a reanalysisof the food defense plan (proposed 121.150).

Ensure that personnel andsupervisors assigned to actionableprocess steps receive appropriate

training in food defense awareness andtheir respective responsibilities inimplementing focused mitigationstrategies (proposed 121.160).

Establish and maintain certainrecords, including the written fooddefense plan; written identification ofactionable process steps and the

assessment leading to thatidentification; written focusedmitigation strategies; written proceduresfor monitoring, corrective actions, andverification; and documentation relatedto training of personnel (proposed 121.301 to 121.325).

As proposed, the effective date is 60days after a final rule is published.However, we are providing for a longertimeline for facilities to come intocompliance. Facilities, other than smalland very small businesses, would haveone year after the effective date tocomply with proposed part 121. Small

businesses (i.e., those employing fewerthan 500 persons) would have 2 yearsafter the effective date to comply withproposed part 121. Very small

businesses (i.e., businesses that haveless than $10,000,000 in total annualsales of food, adjusted for inflation)would be considered a qualified facilityand would have 3 years after theeffective date to comply with proposed 121.5(a).BILLING CODE 416001P


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In addition, we describe our currentthinking and seek comment on otherissues, including activities that occur ondairy farms and economically motivatedadulteration. Finally, elsewhere in thisissue of the Federal Register, FDA ispublishing for comment its evaluationthat identifies low-risk activities thatoccur at farm mixed-type facilities, with

a specific focus on the risk presented by

hazards that may be intentionallyintroduced by acts of terrorism.

Costs and Benefits

As described in the PreliminaryRegulatory Impact Analysis (PRIA), weestimate the annualized costs of theactions required by this proposed rule to

be about $370 million. The benefits of

these actions are a reduction in the

possibility of illness, death, andeconomic disruption resulting fromintentional adulteration of food. We areunable to quantify these benefits.However, we monetize the damage thatvarious intentional adulterationscenarios might cause, and present a

breakeven analysis showing the numberof prevented attacks at which the

benefits are larger than the costs.

ANNUALIZED COST AND BENEFIT OVERVIEW

All numbers are USD millions, annualized over 10 years 3% discount 7% discount

Costs:Learning about Rule ................................................................................................................................. $3 $3Mitigation Costs ........................................................................................................................................ 59 63Monitoring and Corrective Action ............................................................................................................. 100 100Employee Training .................................................................................................................................... 4 5Documentation .......................................................................................................................................... 6 6

Subtotal (Domestic cost) ................................................................................................................... 172 177Cost to Foreign Firms ............................................................................................................................... 185 190

Total ................................................................................................................................................... 357 367

Benefits: Lower Chance of Intentional Adulteration ........................................................................................ Unquantified.

I. Introduction

The FDA Food Safety ModernizationAct (FSMA) (Pub. L. 111353), signedinto law on January 4, 2011, enablesFDA to better protect public health byhelping to ensure the safety and securityof the food supply. FSMA enables us tofocus more on preventing food safetyproblems rather than primarily reactingto problems after they occur. The law

also provides us with new enforcementauthorities to help us achieve higherrates of compliance with prevention-and risk-based safety standards and to

better respond to and contain problemswhen they do occur. In addition, thelaw gives us important new tools to

better ensure the safety of importedfoods and directs us to build anintegrated national food safety system inpartnership with State, local, tribal, andterritorial authorities.

Section 103 of FSMA directs FDA toissue regulations establishingrequirements for facilities that

manufacture, process, pack or hold foodand requires facilities to considerhazards that may be intentionallyintroduced, including by acts ofterrorism. Section 106 of FSMA requiresFDA to issue regulations to protect foodfor which there is a high risk ofintentional contamination and forwhich such intentional contaminationcould cause serious adverse healthconsequences or death to humans oranimals. In addition, section 105 ofFSMA directs FDA to issue regulationssetting forth science-based minimum

standards for the safe production andharvesting of produce, and requires thatthe rulemaking consider hazards thatmay be intentionally introduced,including by acts of terrorism.

Efforts to protect against intentionaladulteration require a shift inperspective from that applied totraditional food safety. In proposedrules entitled Current GoodManufacturing Practice and Hazard

Analysis and Risk-Based PreventiveControls for Human Food (78 FR 3646,January 16, 2013) (Docket No. FDA2011N0920; hereafter referred to asthe PC proposed rule), Current GoodManufacturing Practice and HazardAnalysis and Risk-Based PreventiveControls for Food for Animals (78 FR64736, October 29, 2013) (Docket No.FDA2011N0922; hereafter referred toas the Animal Food PC proposedrule), and Standards for the Growing,Harvesting, Packing and Holding ofProduce for Human Consumption (78FR 3504, January 16, 2013) (Docket No.

FDA2011N0921; hereafter referred toas the Produce Safety proposed rule),FDA tentatively decided not to includerequirements to address hazards thatmay be intentionally introduced,including by acts of terrorism (sections418(b)(2) and 419(a)(3)(C) of the FD&CAct (21 U.S.C. 350g(b)(2) and350h(a)(3)(C))) and to implementsections 103 and 105 of FSMA regardingsuch hazards in a separate rulemaking(this proposed rule). As noted in thoseproposed rules, FDA tentativelyconcluded that intentional adulteration,

which is not addressed by traditionalHazard Analysis and Critical ControlsPoint (HACCP) or other food safetysystems, likely will require differentkinds of controls. FDA is taking theaction described in this proposed rule toimplement the intentional adulterationprovisions in sections 103, 105, and 106of FSMA.

II. Background

Intentional adulteration of the foodsupply can result in catastrophic publichealth consequences, widespread publicfear, loss of public confidence in thesafety of food and the ability ofgovernment to ensure food safety, andsignificant adverse economic impacts,including disruption of trade (Ref. 1,Ref. 2, Ref. 3, Ref. 4). Acts of intentionaladulteration may take several forms,including acts of terrorism; acts ofdisgruntled employees, consumers, orcompetitors; and economicallymotivated adulteration. Acts ofterrorism are associated with an intentto cause massive public health harmand, to a lesser extent, economicdisruption (Ref. 5, Ref. 2, Ref. 3, Ref. 6).Acts of disgruntled employees,consumers, or competitors are generallyunderstood to be directed at attackingthe reputation of the company and notat public health harm. The primarypurpose of economically motivatedadulteration is to obtain economic gain,and not to impact public health (Ref. 7,Ref. 8, Ref. 9), although public healthharm may occur (Ref. 10, Ref. 11).


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Food defense and food securityare terms that are sometimes usedinterchangeably. We use the term fooddefense to refer to the effort to protectfood from acts of intentionaladulteration where there is an intent tocause public health harm and economicdisruption. Food security is defined

by the World Health Organization

(WHO) to mean when all people at alltimes have access to sufficient, safe,nutritious food to maintain a healthyand active life (Ref. 12). To avoidconfusion, we use the term fooddefense and not the term foodsecurity in the context of intentionaladulteration.

A. Incidents of Intentional Adulterationof Food

Several cases of intentionaladulteration with the intent to causepublic health harm and economicdisruption in the United States have

been documented. For example, in1984, in an attempt to prevent thegeneral public from voting in the localelections, members of a local religiouscommune in The Dalles, OR,intentionally contaminated food inrestaurants with Salmonella. A total of751 people became ill and 45 werehospitalized (Ref. 4). In anotherincident, in 1996, 12 laboratory workersat a large medical facility in Texas

became ill from consuminganonymously donated pastries that wereintentionally contaminated withShigella dysenteriae type 2, which waslater discovered to have originated from

the facilitys stock culture (Ref. 13). In2009, two related incidents resulted in49 individuals reporting rapid and acuteonset of gastrointestinal andneurological symptoms after eatingmeals at a restaurant in Lenexa, KS.Investigations concluded that theillnesses were caused by methomyl (aninsecticide) poisoning associated withthe consumption of salsa at therestaurant. Two former employees of therestaurant were found guilty ofintentionally contaminating the salsa(Ref. 14).

A widespread incident of

economically motivated adulterationoccurred in China in 2008. SomeChinese milk firms added melamine, anitrogen-rich industrial by-product, todiluted dairy products to increase theapparent protein content. Thisadulteration resulted in significantpublic health consequences, with morethan 290,000 ill infants and 6 deaths inChina. In addition, this incident causedsignificant economic disruption withinthe Chinese dairy industry, withestimates approaching $3 billion in lossto industry (Ref. 10, Ref. 11).

B. Interagency Approach to FoodDefense

1. Homeland Security PresidentialDirectives and Presidential PolicyDirectives for the Food and AgricultureSector

Intelligence gathered since the attackson the United States on September 11,

2001, indicates that terroristorganizations have discussedcontamination of the food supply as ameans to harm U.S. citizens and disruptthe global economy (Ref. 15). Inresponse, FDA, along with the Centersfor Disease Control and Prevention(CDC), the United States Department ofAgriculture (USDA), the Department ofHomeland Security (DHS), the FederalBureau of Investigation (FBI), theEnvironmental Protection Agency(EPA), the Department of Defense, theDepartment of Energy, the Departmentof Commerce, and the Department of theInterior, as well as with State, local,tribal, territorial, and private sectorpartners have coordinated efforts toprevent, prepare for, and respond tothreats against the food supply. Many ofthese efforts were accomplished inaccordance with applicable HomelandSecurity Presidential Directives (HSPD),specifically HSPD7, HSPD8, andHSPD9, and Presidential PolicyDirectives (PPD), specifically PPD8 andPPD21 (Ref. 16, Ref. 17, Ref. 18, Ref.19, Ref. 20). In accordance with thesedirectives, FDA, USDA, DHS, State andlocal governments and the food industrycollaborated to conduct vulnerability

assessments of a variety of products andprocesses within the food andagriculture sector.

2. The Evolution of VulnerabilityAssessments

Initially, FDA used Operational RiskManagement (ORM), which is avulnerability assessment methodologythat uses a six-step sequence ofidentifying hazards and reducing thepotential for negative public healthconsequences. The ORM processresulted in three main outcomes: (1) Acalculation of risk by combining

assessments of severity and probabilityof an attack on a specific food; (2)calculations for specific contaminantsand specific food processes or relatedactivities; and (3) a categorization ofspecific food/contaminant/food processor related activity into a high, medium,or low risk scheme.

At first, ORM-based assessments werefocused on reducing large public healthconsequences of attacks on the foodsupply. FDA realized that othersignificant considerations (i.e., largeeconomic disruptions, public alarm,

loss of confidence in the food supply,and interruption of the food stream)warranted incorporation into thevulnerability assessment calculus. Toincorporate these considerations, FDAand USDAs Food Safety and InspectionService (FSIS) adapted a militarytargeting tool known as CARVER toassess vulnerabilities of the food and

agriculture sector. CARVER is anacronym for the following six attributesused to evaluate the attractiveness of atarget for attack:

Criticalitymeasure of publichealth and economic impacts of anattack;

Accessibilityability to physicallyaccess and egress from target;

Recuperabilityability of a systemto recover from an attack;

Vulnerabilityease ofaccomplishing an attack;

Effectamount of direct loss froman attack as measured by loss inproduction; and

Recognizabilityease of identifyinga target.

A seventh attribute, Shock, wasadded to the original six attributes toassess the combined health, economic,and psychological impacts of an attackon the food industry. ORM andCARVER+Shock assessmentconclusions were consistent; however,the CARVER+Shock methodologyimproved vulnerability assessmentefforts because its process allowed forthe identification and estimation ofeconomic and psychological impactsthroughout the food system.

In 2005, the Strategic PartnershipProgram Agroterrorism (SPPA), apublic-private cooperative effort wasestablished by FDA, USDA, FBI, andDHS, in partnership with State andindustry partners. The intent of theSPPA Initiative was to collect thenecessary data to identify food andagriculture sector-specificvulnerabilities using theCARVER+Shock method, developmitigation strategies, identify researchgaps, and increase coordination betweengovernment and industry partners. TheSPPA initiative ran from 2005 to 2008,resulting in vulnerability assessments of36 food products and processes (Ref.21). The SPPA Initiative was asignificant step towards identifyingvulnerabilities, mitigation strategies,and research needs within the food andagriculture industries. This initiativealso provided Federal, State, and localgovernment agencies with an in-depthlook at the vulnerabilities that may beassociated with the food and agricultureindustry, and helped enhancecommunication among industry,government, and law enforcement


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stakeholders concerned with theprotection of the U.S. food supply.Since the conclusion of the SPPAInitiative, we have conducted additionalvulnerability assessments, whichcontinue to help inform our researchand policy.

C. Resources for the Food Sector

FDA has issued guidance documentsand developed other resources to assistindustry in their efforts to protect thefood supply against intentionaladulteration. In 2003, FDA issued fiveguidance documents covering fooddefense preventive measures for varioussegments of the food and cosmeticindustry: (1) Guidance for Industry:Food Producers, Processors, andTransporters: Food Security PreventiveMeasures Guidance (Ref. 22); (2)Guidance for Industry: Importers andFilers: Food Security PreventiveMeasures Guidance (Ref. 23); (3)

Guidance for Industry: Dairy Farms,Bulk Milk Transporters, Bulk MilkTransfer Stations and Fluid MilkProcessors: Food Security PreventiveMeasures Guidance (Ref. 24); (4) RetailFood Stores and Food ServiceEstablishments: Food SecurityPreventive Measures Guidance (Ref. 25);and(5) Cosmetics Processors andTransporters of Cosmetics SecurityPreventive Measures Guidance (Ref. 26).These guidance documents provideFDAs recommendations for bestpractices in food defense, and describepreventive measures that establishmentscan take to minimize the risk ofintentional adulteration of food. Weupdated the guidance documents in2007 to include a self-assessment toolthat guides the user through anassessment of recommended preventivemeasures to identify those mostapplicable to the facility.

FDA also has made available otherresources to help industry identify andmitigate potential vulnerabilities forintentional adulteration. These include:

The ALERT program, The Employees FIRST training

tool, The CARVER+Shock Vulnerability

Assessment software tool, The Mitigations Strategies

Database, The Food Defense Plan Builder

software tool, The Food Related Emergency

Exercise Bundle, and The Food Defense 101 training

courses.We describe each briefly in this

section of the document.The ALERT program, originally

released in 2006, is an educationalprogram intended to raise the awareness

of State and local governments andindustry regarding food defense (Ref.27). ALERT identifies five key elementsthat industry can use in food defenseplanning:

AHow do you ASSURE that thesupplies and ingredients you use arefrom safe and secure sources?

LHow do you LOOK after the

security of the products and ingredientsin your facility?

EWhat do you know about yourEMPLOYEES and people coming in andout of your facility?

RCould you provide REPORTSabout the security of your productswhile under your control?

TWhat do you do and who doyou notify if you have a THREAT orissue at your facility, includingsuspicious behavior?

Similarly, the Employees FIRSTeducational tool, originally released in2008, is a food defense awarenesstraining program for front-line foodindustry workers about the risk ofintentional adulteration and the actionsthey can take to identify and reducethese risks (Ref. 28). This tool identifiesthe following five key elements:

FFollow company food defenseplan and procedures;

IInspect your work area andsurrounding areas;

RRecognize anything out of theordinary;

SSecure all ingredients, supplies,and finished product; and

TTell management if you noticeanything unusual or suspicious.

The CARVER+Shock VulnerabilityAssessment software tool, originallyreleased in 2007, helps users conductvulnerability assessments for theirestablishments to identify and prioritizethe critical nodes, (also known ascritical process steps) the potentialtargets vulnerable to intentionaladulteration attacks (Ref. 29). It guidesusers through a series of questions todetermine the vulnerability of each ofthe nodes within their facility. After thevulnerabilities are identified, thesoftware helps users to identifymitigation strategies for reducing the

risk of intentional adulteration. Usingthe software tool, the user can focusresources on protecting the mostsusceptible points in their system.

The Mitigation Strategies Database(MSD), originally released in 2011, is adatabase of mitigation strategies that can

be applied to different steps in a foodoperation to reduce the risk ofintentional adulteration (Ref. 30). Thedatabase is searchable by key words andprocessing steps common to agricultureand food operations (e.g., growing,harvesting, packing, manufacturing,

processing, and holding). See also thediscussion in section V.C.3 of thisdocument.

The Food Defense Plan Builder(FDPB) software tool, released in 2013,is a user-friendly computer softwareprogram designed to assist owners andoperators of food facilities in developingfood defense plans for their facilities

(Ref. 31). In addition to providing newfunctionality for food defense planningand implementation, the FDPB softwaretool harnesses our food defenseguidance documents, CARVER+ShockVulnerability Assessment software tool,and the MSD into a single application.

The Food Related Emergency ExerciseBundle (FREEB), which FDA releasedin 2011 and developed in collaborationwith CDC and FSIS and USDAs Animaland Plant Health Inspection Service(APHIS), is a compilation of scenarios

based on both intentional andunintentional food contaminationevents. The FREEB is designed to assistthe food industry, governmentregulatory agencies, and public healthorganizations in assessing existing foodemergency response plans, protocols,and procedures (Ref. 32). The FREEBtool is designed to allow an individualagency or industry entity to test its ownplans, protocols, and proceduresindependently. Additionally, the toolallows multiple jurisdictions andorganizations (e.g., medical community,private sector, law enforcement, andfirst responder communities) to jointlyconduct exercises. The tool is a set offive scenarios, each of which contains a

Facilitators Guide, a Lead Plannersguide, and a Situation Manual.

Finally, our food defense trainingcourses, entitled Food Defense 101and released in 2013, reflect FDAscurrent thinking on how to minimizethe likelihood and impact of incidentsof intentional adulteration (Ref. 27).Four courses integrated into one moduleinclude: (1) Food Defense Awareness forProfessionals, (2) Food DefenseAwareness for Frontline Employees, (3)FDA Regulations, and (4) ALERT forowners and operators of food facilities.The ALERT program is described

previously. The other programs aredescribed in section V.C.7 of thisdocument.

D. Outreach

We have conducted food defenseawareness outreach to international anddomestic stakeholders. Beginning in2008, under the auspices of the Asia-Pacific Economic Cooperation (APEC),we collaborated with the U.S.Department of State, USDAs ForeignAgricultural Service, and FSIS to launchthe Food Defense Pilot Program for the


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APEC member countries. The PilotProgram was developed with the intentto implement the food defenseprinciples endorsed by the APECCounter Terrorism Task Force. The goalof the program was to build and fosterglobal capacity to prevent and protectagainst deliberate tampering andintentional contamination of the food

supply through information sharing,outreach, and technical assistance onfood defense, thereby safeguarding foodtrade and public health across the APECmember countries. In addition, tosupport the international capacity

building goals of FSMA, we conductedseveral workshops in various countriesto discuss topics such as increasing fooddefense awareness, developing fooddefense plans, conducting vulnerabilityassessments, and implementingmitigation strategies.

In 2013, we increased our domesticoutreach activities with a series of

workshops in the United States. Usinga similar format and agenda as theinternational workshops, we conducted1-day food defense awarenessworkshops to provide industry, Stateand local governments, and academicpartners with information on fooddefense, and share tools and resources.During these workshops, we sharedinformation on how to use the newFDPB software tool to develop acomprehensive food defense plan.These workshops also served as a forumto discuss food defense concerns,understand industrys current practices,and share ideas for collaboration to

better protect the food supply againstintentional adulteration. We plan tocontinue to hold additional workshopsin 2014.

E. Industry Standards

Guidelines accompanying industrystandards in the United States haveaddressed intentional adulteration offood. For example, the Global FoodSafety Initiatives (GFSI) GuidanceDocument Sixth Edition (Ref. 33)addresses food defense. Someorganizations that own and manageindustry standards have worked or are

working to incorporate food defenserequirements into their standards tomeet this GFSI guideline. For example,the Safe Quality Foods (SQF) Code,edition 7.1, issued in 2013, is a processand product certification standard thatspecifies various food defense elements,including that the methods,responsibility, and criteria forpreventing food adulteration caused bya deliberate act of sabotage or terrorist-like incident shall be documented,implemented and maintained (Ref. 34).Another example of industry standards

that incorporate food defense elementsis the International Featured Standards(IFS) Food Version 6 Standard, whichspecifies that areas critical to security beidentified, food defense hazard analysisand assessment of associated risks beconducted annually or upon changesthat affect food integrity, and anappropriate alert system be defined and

periodically tested for effectiveness (Ref.35).

F. International Food DefenseGuidelines

In 2008, WHO issued its TerroristThreats to FoodGuidelines forEstablishing and StrengtheningPrevention and Response Systems toprovide policy guidance to its MemberStates for integrating consideration ofdeliberate acts of sabotage of food intoexisting prevention and responseprograms (Ref. 6). WHO uses the termfood terrorism and defines it as anact or threat of deliberate contaminationof food for human consumption with

biological, chemical and physical agentsor radionuclear materials for thepurpose of causing injury or death tocivilian populations and/or disruptingsocial, economic or political stability.Focusing on the two key strategies ofprevention and response, WHOrecommends that all segments of thefood industry consider the developmentof security and response plans for theirestablishments, proportional to thethreat and their resources. Theguidelines state that the key topreventing food terrorism is enhancing

existing food safety programs andimplementing reasonable securitymeasures on the basis of vulnerabilityassessments. The guidelines furtherstate that the most vulnerable foods,food ingredients, and food processesshould be identified, including: themost readily accessible food processes;foods that are most vulnerable toundetected tampering; foods that are themost widely disseminated or spread;and the least supervised foodproduction areas and processes.

Other national governments,including Australia, China, France,

Germany, and the United Kingdom, alsohave issued guidelines to assist theirfood industry stakeholders in protectingfood against intentional adulteration(Ref. 5, Ref. 36, Ref. 37, Ref. 38, Ref. 39).

III. Legal Authority

FDA is proposing this regulationunder the FD&C Act as amended byFSMA. Under sections 103 and 106 ofFSMA, FDA is proposing therequirements applicable to the owner,operator, or agent in charge of a facilityrequired to register under section 415 of

the FD&C Act. Under section 106 ofFSMA, FDA is proposing therequirements applicable to activities atsome facilities not covered by section103 of FSMA (i.e., activities subject toand in compliance with the juice andseafood HACCP regulations in parts 120and 123 (21 CFR parts 120 and 123) andthe manufacturing, processing, packing,

or holding of a dietary supplement incompliance with certain requirements).Under section 701(a) of the FD&C Act(21 U.S.C. 371(a)), FDA is authorized toissue regulations for the efficientenforcement of the FD&C Act.

A. Section 103 of FSMA

Section 103 of FSMA, HazardAnalysis and Risk-Based PreventiveControls, amends the FD&C Act tocreate a new section 418 that mandatesrulemaking. Section 418(n)(1)(A) of theFD&C Act requires that the Secretary ofHealth and Human Services issueregulations to establish science-basedminimum standards for conducting ahazard analysis, documenting hazards,implementing preventive controls, anddocumenting the implementation of thepreventive controls . . .. Section418(n)(1)(B) of the FD&C Act requiresthat the regulations define the termssmall business and very small

business, taking into consideration thestudy of the food processing sectorrequired by section 418(l)(5) of theFD&C Act. Further, section 103(e) ofFSMA creates a new section 301(uu) inthe FD&C Act (21 U.S.C. 331(uu)) toprohibit [t]he operation of a facility

that manufactures, processes, packs, orholds food for sale in the United Statesif the owner, operator, or agent in chargeof such facility is not in compliancewith section 418 [of the FD&C Act].

In addition to rulemakingrequirements, section 418 of the FD&CAct contains requirements applicable tothe owner, operator, or agent in chargeof a facility required to register undersection 415 of the FD&C Act. Section418(a) of the FD&C Act is a generalprovision that requires the owner,operator, or agent in charge of a facilityto evaluate the hazards that could affect

food manufactured, processed, packed,or held by the facility, identify andimplement preventive controls, monitorthe performance of those controls, andmaintain records of the monitoring. Inaddition to the general requirements insection 418(a) of the FD&C Act, sections418(b) to (i) of the FD&C Act containmore specific requirements applicableto facilities, including severalprovisions explicitly directed atintentional adulteration. For example,section 418(b)(2) of the FD&C Actspecifies that the owner, operator, or


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agent in charge of a facility shallidentify and evaluate hazards that may

be intentionally introduced, includingby acts of terrorism. Section 418(c)(2) ofthe FD&C Act specifies that the owner,operator, or agent in charge of a facilityshall identify and implement preventivecontrols to provide assurances that anyhazards that relate to intentional

adulteration will be significantlyminimized or prevented and addressed,consistent with section 420 of the FD&CAct. In sections IV and V of thisdocument, we discuss proposedrequirements (proposed subparts C andD of part 121) that would implementthese provisions of section 418 of theFD&C Act.

Sections 418(j) to (m) of the FD&C Actand sections 103(c)(1)(D) and (g) ofFSMA provide authority for certainexemptions and modifications to therequirements of section 418 of the FD&CAct. These include provisions related to

seafood and juice HACCP, and low-acidcanned food (section 418(j) of the FD&CAct); activities of facilities subject tosection 419 of the FD&C Act (Standardsfor Produce Safety) (section 418(k));qualified facilities (section 418(l));facilities that are solely engaged in theproduction of food for animals otherthan man, the storage of raw agriculturalcommodities (other than fruits andvegetables) intended for furtherdistribution or processing, or the storageof packaged foods that are not exposedto the environment (section 418(m));facilities engaged only in certain low-risk on-farm activities on certain foods

conducted by small or very smallbusinesses (section 103(c)(1)(D) ofFSMA), and dietary supplements(section 103(g) of FSMA). In sections IVand V of this document, we discuss therelated proposed provisions that wouldimplement these provisions of section418 of the FD&C Act and section 103 ofFSMA.

B. Section 106 of FSMA

Section 106 of FSMA, ProtectionAgainst Intentional Adulteration,amends the FD&C Act to create a newsection 420, which mandates

rulemaking. Section 420 of the FD&CAct requires FDA to issue regulations toprotect against the intentionaladulteration of food. Section 420(b)(1) ofthe FD&C Act requires that suchregulations are to specify how a personis to assess whether the person isrequired to implement mitigationstrategies or measures intended toprotect against the intentionaladulteration of food. Section 420(b)(2) ofthe FD&C Act requires that theregulations specify appropriatesciencebased mitigation strategies or

measures to prepare and protect thefood supply chain at specific vulnerablepoints, as appropriate. Section 420(c) ofthe FD&C Act provides that suchregulations are to apply only to food forwhich there is a high risk of intentionaladulteration and for which suchintentional adulteration could causeserious adverse health consequences or

death to humans or animals. Section420(c)(1) provides that such foods are toinclude those for which FDA hasidentified clear vulnerabilities. Section420(d) of the FD&C Act limitsapplicability on farms to farms thatproduce milk. Further, section 106(d) ofFSMA creates a new section 301(ww) inthe FD&C Act to prohibit [t]he failureto comply with section 420 [of the FD&CAct]. We are proposing all of theprovisions under section 420 of theFD&C Act.

C. Intrastate Activities

FDA tentatively concludes that theprovisions in the proposed rule shouldbe applicable to activities that areintrastate in character. Facilities arerequired to register under section 415 ofthe FD&C Act regardless of whether thefood from the facility enters interstatecommerce (1.225(b)). The plainlanguage of section 418 of the FD&C Actapplies to facilities that are required toregister under section 415 of the FD&CAct (section 418(o)(2)) and does notexclude a facility because food fromsuch a facility is not in interstatecommerce. Similarly, the plain languageof section 420 of the FD&C Act requiresFDA to issue regulations to protectagainst the intentional adulteration offood and does not include a limitationto interstate commerce. Further, theprohibited act provisions in sections301(uu) and (ww) of the FD&C Act (21U.S.C. 331(uu) and (ww)) do not requirean interstate commerce nexus. Notably,other subsections in section 301 of theFD&C Act, and section 304 of the FD&CAct (21 U.S.C. 334) demonstrate thatCongress has included a specificinterstate commerce nexus in theprovisions of the FD&C Act when thatis its intent. Accordingly, it is

reasonable to interpret sections 418,420, 301(uu) and (ww) of the FD&C Actas not limiting the application of theproposed rule only to those facilitieswith a direct connection to interstatecommerce. However, we seek commenton this interpretation and potentialalternatives.

IV. Regulatory Approach

A. Framework of the Rule

This proposed regulation implementsthree provisions of FSMA that relate to

the intentional adulteration of food.Section 103 of FSMA addressesintentional adulteration in the contextof facilities that manufacture, process,pack, or hold food and are required toregister under section 415 of the FD&CAct. Section 105 of FSMA addressesintentional adulteration in the contextof fruits and vegetables that are raw

agricultural commodities. Section 106 ofFSMA addresses intentionaladulteration in the context of high riskfoods and exempts farms except forfarms that produce milk.

1. Scope of Intentional AdulterationCovered by this Rule

As noted in section I of thisdocument, acts of intentionaladulteration may take several forms,including: (1) Acts of terrorism; (2) actsof disgruntled employees, consumers, orcompetitors; and (3) economicallymotivated adulteration. With regard tointentional adulteration from acts ofterrorism, we are proposing to requirecertain facilities covered by this rule toaddress significant vulnerabilities byimplementing focused mitigationstrategies at actionable process steps.While we refer to the protection of thefood supply from acts of terrorismthroughout this rule, we expect ourproposed approach and the proposedimplementation of focused mitigationstrategies would generally address actsintended to cause massive public healthharm and, to a lesser extent, economicdisruption, whether committed byterrorists, terrorist organizations,

individuals, or groups of individuals.For the reasons described in sectionIV.E of this document, we havetentatively concluded not to proposeadditional requirements for theprotection of food against intentionaladulteration caused by acts ofdisgruntled employees, consumers, orcompetitors. We describe our approachto address economically motivatedadulteration in section IV.F of thisdocument, and seek comment on ourcurrent thinking on this issue.

2. Identification of Key Activity Types

Terrorist attacks on the U.S. foodsupply have been exceedingly rare.However, vulnerability assessmentsperformed by FDA, USDA, DHS, andFBI, under the SPPA Initiative (Ref. 21),show that an attack could havedevastating public health and economicconsequences. Because such an attack isa low probability but potentiallyexceedingly high consequence event, wehave tentatively determined thatrequirements should focus on thosefacilities and process steps within thosefacilities that pose the greatest risk. To


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assess this risk, FDA and USDA, incollaboration with DHS, FBI, and Stateand local government and industrypartners, performed vulnerabilityassessments using the CARVER+Shockmethodology. This methodology isspecifically tailored to assess the risk ofa terrorist attack and is different from anassessment of risk posed by food safety

hazards (i.e., unintentionaladulteration).

As discussed in section V.C.2 of thisdocument, based on an analysis of thevulnerability assessments that FDA hasconducted using the CARVER+Shockmethodology, we have identified fourkey activity types: Bulk liquid receivingand loading; Liquid storage andhandling; Secondary ingredienthandling; and Mixing and similaractivities. FDA has tentativelydetermined that the presence of one ormore of these key activity types at aprocess step (e.g., manufacturing,processing, packing, or holding of food)indicates a significant vulnerabilityunder section 418 of the FD&C Act andthat the food is at high risk ofintentional adulteration caused by actsof terrorism under section 420 of theFD&C Act. We seek comment on theinclusion of these key activity types.

Designation of these key activity typeswould serve two purposes. First, itwould provide a facility with a meansto assess whether it is required toimplement focused mitigation strategiesor measures intended to protect againstintentional adulteration under section420(b)(1) of the FD&C Act. Second, itwould assist a facility subject to section418 of the FD&C Act with theperformance of a hazard analysis toidentify and evaluate hazards that may

be intentionally introduced by acts ofterrorism, in accordance with section418(b)(2).

Facilities would be able to determinewhether their operations involve one ormore of the key activity types or chooseto perform a vulnerability assessment.Our experience is that the mostchallenging part of developing a system

of controls for intentional adulterationrelated to terrorism is identifying thepoints in the food operation that aremost vulnerable to attack by performinga vulnerability assessment. By using theFDA-identified key activity types,facilities would be able to concentratetheir efforts on the identification ofappropriate focused mitigationstrategies and the development andimplementation of the HACCP-typesystem for ensuring that those strategiesare consistently and effectivelyimplemented.

3. Requirement for a HACCP-TypeSystem of Controls

We have tentatively concluded that apreventive controls approach like theone we proposed for the systematiccontrol of food safety hazards in the PCproposed rule is the most effectivemeans of ensuring that the focusedmitigation strategies are consistentlyapplied once the significantvulnerabilities are identified andappropriate focused mitigationstrategies are developed. The evolutionand advantages of this system, derivedfrom the HACCP methodology, isdiscussed in detail in section II.C of thePC proposed rule. The application ofHACCP-type controls for ensuring theimplementation of food defensemitigation strategies is consistent withthe approach taken in PubliclyAvailable Specification (PAS) 96,developed by the Centre for theProtection of National Infrastructure in

collaboration with the British StandardsInstitution, entitled The ThreatAssessment Critical Control Point(TACCP) Approach (Ref. 5). It is alsoconsistent with WHO recommendationson protection against intentionaladulteration (Ref. 6). We requestcomment on the appropriateness of aHACCP-type system to ensure thatmitigation strategies designed tosignificantly minimize or preventintentional adulteration related toterrorism and whether there areapproaches that would be more suitable.

Section 418 of the FD&C Act exempts

several kinds of activities (e.g., thoserelated to seafood, juice, dietarysupplements, low-acid canned food [forcertain microbiological hazards]). Theseactivities are subject to preventivecontrol-type regulations that addressfood safety, but not food defense,concerns. Section 420 of the FD&C Actinstructs FDA to issue regulations torequire that science-based mitigationstrategies or measures be applied tofoods that are at high risk of intentionaladulteration. The exemptions set out insection 418 of the FD&C Act are notapplicable to the provisions of section420 of the FD&C Act. We also havetentatively determined that someactivities that are not subject to section418 of the FD&C Act that involvemanufacturing, processing, packing, orholding of food are likely to involve oneof the key activity types (e.g., juicemanufacturing, breaded seafoodmanufacturing, and mixing activity in alow-acid canned food process). Basedon our tentative conclusion that theHACCP-type system in section 418 ofthe FD&C Act is generally appropriatefor application to intentional

adulteration related to terrorism, thissame system would be required forthese activities. Applying the sameregulatory framework under sections418 and 420 of the FD&C Act wouldfacilitate a concise and consistentapproach to protection againstintentional adulteration of food and theefficient enforcement of the

requirements. Further, this approachwould be consistent with the approachfor unintentional adulteration that manyof these facilities (those subject tosection 418 of the FD&C Act relative tothe control of food safety hazards)would already be required to take forunintentional hazards under the PCproposed rule.

We acknowledge that regulation ofentities in the food production system(in this case, facilities) to reduce the riskof intentional adulteration of foodcaused by acts of terrorism is,essentially, without precedent. Such an

endeavor is further complicated by thelow probability and potentially highimpact nature of such an attack whichmakes estimating potential publichealth benefits and establishing anappropriate threshold for requiringaction difficult. We are furtherchallenged by the paucity of data on theextent to which facilities have alreadyimplemented programs to mitigate thisrisk, and the effectiveness of variousstrategies to prevent intentionaladulteration of food caused by acts ofterrorism.

In developing this proposed rule wehave relied on our experience in both

implementing preventive controlschemes targeting unintentional foodsafety hazards as well as working withthe U.S. intelligence community on thethreat of a terrorist attack on the foodand agriculture sector, includingperforming vulnerability assessmentsand developing guidance for industry.While these activities have provided uswith a useful foundation on which todevelop this proposed rule, thechallenges described previously remain.We request comment on our proposedapproach, including on the followingissues:

From which entities wouldimplementation of measures to protectagainst intentional adulteration derivethe greatest benefit to public healthprotection? How could this proposedregulation be modified to better targetsuch entities?

Would it be feasible to requiremeasures to protect against intentionaladulteration only in the event of acredible threat? If so, would such anapproach be consistent with theintentional adulteration provisions ofFSMA? How would such requirements


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be communicated to industry in atimely and actionable manner?

What is an appropriate level ofpublic health protection with respect tointentional adulteration, considering theintentional adulteration provisions ofFSMA?

Are there other ways to furtherfocus the scope of the rule (see also

section IV.I of this document)?4. Compliance Dates

Section 103(i)(1) of FSMA, GeneralRule, provides that [t]he amendmentsmade by this section shall take effect 18months after the date of enactment(i.e., by July 4, 2012). Section 103(i)(2)of FSMA, Flexibility for SmallBusinesses, provides that[n]otwithstanding paragraph (1), theamendments made by this section shallapply to a small business and verysmall business beginning on the datethat are 6 months and 18 months,respectively, after the effective date ofFDAs final regulation. Section 106 ofFSMA does not contain similarlanguage. FDA is implementing theamendments made by sections 103 and106 of FSMA to the FD&C Act, as theyrelate to intentional adulteration,through this rulemaking.

We have tentatively concluded that itis appropriate to provide a sufficienttime period following publication of thefinal regulation for facilities to comeinto compliance with proposed part121. FDA recognizes that it can taketime to develop and implement a fooddefense plan that would require, among

other things, identification of actionableprocess steps, implementation offocused mitigation strategies, andmonitoring of focused mitigationstrategies.

FDA is proposing that the final rulewould be effective 60 days afterpublication in the Federal Register,with staggered compliance dates,consistent with the proposed effectivedates in the PC proposed rule andProduce Safety proposed rule. Similarly,we recognize that businesses of all sizesmay need more time to comply with thenew requirements established under

FSMA. As noted in section VII of the PCproposed rule, FDA believes that it isreasonable to allow for 1 year after thedate of publication of the final rule for

businesses other than small and verysmall businesses to come intocompliance with the new requirementsestablished under FSMA. FDA also

believes that it is reasonable to allow for2 years after the date of publication ofthe final rule for small businesses tocome into compliance with the newrequirements established under FSMA,and 3 years after the date of publication

of the final rule for very smallbusinesses to come into compliancewith the new requirements establishedunder FSMA.

Therefore, as proposed, facilities,other than small and very small

businesses, that are subject to part 121would have 1 year after the effectivedate to comply with proposed part 121.

Small businesses would have 2 yearsafter the effective date to comply withproposed part 121 (see section V.A ofthis document for a discussion of theproposed definition of a small

business). With respect to very smallbusinesses, we are proposing to exemptqualified facilities, which include verysmall businesses, from the requirementsof proposed part 121, except that suchfacilities must, upon request, providefor official review documentation thatwas relied upon to demonstrate that thefacility meets this exemption. Verysmall businesses then would have 3

years after the effective date to complywith proposed 121.5(a). FDA intendsto work closely with the food industry,extension and education organizations,and State partners to develop anynecessary additional tools and trainingprograms needed to facilitateimplementation of this rule.

B. Activities That Occur on ProduceFarms

Section 419 of the FD&C Act requiresFDA to issue regulations to establishscience-based minimum standards forthe safe production and harvesting offruits and vegetables. In developing

these regulations, the Act requires us toconsider, among others, those hazardsthat may be intentionally introduced,including by acts of terrorism (section419(a)(3)(C) and (c)(1)(A) of the FD&CAct). Note that neither section 418 of theFD&C Act nor section 420 of the FD&CAct apply to these activities. Section420 of the FD&C Act specificallyexempts farms, except those thatproduce milk, and section 418 of theFD&C Act exempts activities of facilitiessubject to section 419 of the FD&C Act.

In implementing section 419 of theFD&C Act, we considered the risks

posed by a terrorist attack on the kindsof activities that occur on producefarms. We considered those activitiesthat fall within the definition of farm(as defined in 21 CFR 1.227) (e.g.,planting, tilling, irrigating, treating withpesticides, harvesting, drying forpurposes of storing or transporting,hydro-cooling, packing, refrigerating,waxing, shelling, sifting, removingleaves, stems and husks, culling,shelling, and washing). We utilized datagathered from vulnerability assessmentsthat we conducted employing the

CARVER+Shock methodology, andevaluated whether activities that occuron produce farms pose significantvulnerabilities (Ref. 40).

Our evaluation found that activitiesthat are typically performed on producefarms are at relatively low risk forintentional adulteration of food fromacts of terrorism (Ref. 40). Based on this

evaluation, we have tentativelyconcluded that requirements forproduce farms are not necessary tominimize the risk of serious adversehealth consequences or death from thistype of adulteration. Further, we havetentatively concluded that requirementsrelating to this form of adulteration arenot reasonably necessary to prevent theintroduction of known or reasonablyforeseeable hazards and to providereasonable assurances that the produceis not adulterated under section 402 ofthe FD&C Act. For these reasons, we arenot proposing requirements for produce

farms to specifically address intentionaladulteration related to terrorism. Weseek comment on this tentativeconclusion and our analysis thatinformed this tentative decision.

We acknowledge that there may beactivities that occur on produce farmsfor which we are not proposingrequirements that are similar to off-farmactivities for which we are proposing torequire the implementation of focusedmitigation strategies. However, there areaspects of the specific on-farm activitiesthat minimize the risk for intentionaladulteration caused by acts of terrorism.For example, waxing is an on-farm

activity that is similar to coating andthat fits within one of the key activitytypes. However, there are keydifferences that make an on-farmwaxing operation less vulnerablecompared to a coating operation. Withwaxing, there is difficulty of mixing acontaminant into a clear, heated wax ina tank in close proximity to the busypacking line in an on-farm packinghouse. Conversely, a coating operationinvolves an opaque, ambient orrefrigerated, aqueous coating mix in atank and occurs in a relatively isolatedpart of the manufacturing plant. In

addition, the uncertainty about whetherthe produce leaving the farm is destinedfor direct consumption or for furtherprocessing, such as removal of the wax,which could inactivate or remove anycontaminant intentionally added, makesit a relatively less likely target forintentional adulteration.

C. Transportation Carriers

One of the key activity types that wehave tentatively determined indicates asignificant vulnerability to intentionaladulteration caused by acts of terrorism


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is Bulk liquid receiving and loading. Asproposed, receiving and loading of othertypes of foods (e.g., non-bulk liquids,solid foods, gaseous foods) are notidentified as key activity types becausewe determined that they do not presentthis same level of risk. By requiring thatshippers and receivers of bulk liquidsimplement focused mitigation strategies

at actionable process steps involvingthis key activity, as proposed in 121.135(a), we expect that shippersand receivers will institute focusedmitigation strategies that willsignificantly minimize or prevent thepotential for intention adulteration ofthese foods during transportation. Suchmitigation strategies may includesealing or locking outboundconveyances of bulk liquid, or requiringthat inbound conveyances be sealed orlocked as a condition of receipt of the

bulk liquid. Where such measures areimplemented by the shippers and

receivers of bulk liquids, we havetentatively concluded that the foodwould be sufficiently protected fromintentional adulteration caused by actsof terrorism, and that no further actions

by a carrier would be needed to ensurethe safety of the food. For this reason,we are not proposing to covertransportation carriers in this proposedrule. We request comment on ouranalysis of this issue, and our tentativeconclusion.

Note that FDA will issue a proposedrule in the near future related totransportation carriers and sanitarytransportation practices.

D. Food for Animals

As discussed in section V.B.6 of thisdocument, we are proposing to exemptthe manufacturing, processing, packing,and holding of animal food from thisproposed regulation with respect tointentional adulteration caused by actsof terrorism.

E. Acts of Disgruntled Employees,Consumers, or Competitors

While the goals and outcomes of actsof disgruntled employees, consumers orcompetitors can overlap with acts of

terrorism, generally, the distinction hasto do with differences in scale.Disgruntled employees are generallyunderstood to be interested primarily inattacking the reputation of the company,and otherwise have little interest inpublic health harm. On the other hand,terrorist organizations are generallyunderstood to be interested inmaximizing public health harm and, toa lesser extent, economic disruption(Ref. 5, Ref. 6).

Section 420(c) of the FD&C Actrequires that the regulation prepared

under that section apply to food forwhich there is a high risk of intentionalcontamination. In the spectrum of riskassociated with intentional adulterationof food, attacks perpetrated by terroristorganizations intent on causing massivecasualties and, to a lesser extent,economic disruption would be rankedas relatively high risk. On the other

hand, attacks by disgruntled employees,consumers, or competitors would beconsistently ranked as relatively lowrisk; although these events occurannually, their public health andeconomic impact would be generallyquite small. In general, the target foodand the point in its production are thoseof convenience (i.e., a point to whichthe employee, consumer, or competitorhas ready access). Should a disgruntledemployee, consumer, or competitorchoose to attack at an actionable processstep, where the adverse public healthand economic consequences could be

greater, the provisions of this proposedrule would be effective in minimizingthe opportunity for success. Actionstaken to mitigate the potential for aterrorist attack against the food supplyare likely to have collateral benefits inreducing the potential for an attack bya disgruntled employee, consumer, orcompetitor (as well as on other securityrelated issues, such as theft andvandalism). As a practical matter,hardening the food supply (i.e.,reducing the opportunity for attack) toattacks by disgruntled employees,consumers, or competitors could requiretaking steps at many more points in the

food system than would be required toharden the food supply to minimize thepotential for terrorist attack. We havetentatively concluded that the latter can

be accomplished by focusing on thosepoints in the food system where anattack would be expected to causemassive adverse public health impact,and, to a lesser extent, economicdisruption.

F. Economically Motivated Adulteration

Efforts to protect against intentionaladulteration require a shift inperspective from that applied to

traditional food safety. In the PC,Animal Food PC, and Produce Safetyproposed rules, we tentativelyconcluded that hazards associated withintentional adulteration, which are notaddressed in traditional HACCP or otherfood safety systems, likely will requiredifferent kinds of controls, and would

be best addressed in a separaterulemaking (this proposed rule).However, we also explained how insome circumstances economicallymotivated adulteration could be viewedas reasonably likely to occur. Further,

we requested comment on where toaddress those hazards that may beintentionally introduced for economicgain. After additional consideration, wepresent our current thinking in thissection of the document.

For facilities subject to section 418 ofthe FD&C Act, we have tentativelyconcluded that economically motivated

adulteration would be best addressedunder the regulatory regime describedin the PC and Animal Food PC proposedrules and thus best addressed in thoserulemakings. Before we decide tofinalize provisions on economicallymotivated adulteration in the PC andAnimal Food PC final rules, FDA plansto provide new language and an analysisof costs associated with theseprovisions, and seek comment. Underthis approach, the owner, operator, oragent in charge of a covered facilitywould be required to perform a hazardanalysis to identify those hazards

related to economically motivatedadulteration that are reasonably likely tooccur. Economically motivatedadulteration could be reasonably likelyto occur, for example, when obtainingcertain ingredients from a country inwhich economically motivatedadulteration has occurred in thoseingredients in the past. Because of pastincidents regarding the addition ofmelamine to certain food productsapparently to enhance perceived qualityand/or protein content, even if there isno known history regarding the specificsupplier or the specific food product, aprudent person would implement

preventive controls to address thepotential presence of this hazard in afood. The goal of the perpetrator ofeconomically motivated adulteration isfor the adulterant to be undetected inthe product, so that the perpetrator cancontinue to obtain the desired economic

benefits (Ref. 7, Ref. 9). Accordingly,unlike with acts of terrorism, suchoccurrences of economic adulterationare expected to be long term, and wouldnot be appropriately viewed as a rareoccurrence, but rather as reasonablylikely to occur.

We have tentatively concluded that

this hazard-analysis type approach isbetter suited to address economicallymotivated adulteration than thevulnerability assessment-type approachwe are proposing to address intentionaladulteration related to terrorism. In thelatter approach, which we are notproposing, significant vulnerabilitieswould be identified based either on thepresence of key activity types (whichreflect FDA-conducted vulnerabilityassessments) or facility-specificvulnerability assessments. Under avulnerability assessment-type approach,


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the assessment would need to considerthe degree to which a food is a likelytarget for economically motivatedadulteration based on the attributes ofthe food (such as the nature of the food,its production system, and its supplychain) and the capabilities of aperpetrator (such as availability andaccess to adulterants that can be readily

disguised and undetected by currentlyaccepted testing methods). Factors toconsider could include previousoccurrences of economically motivatedadulteration; a highly complex supplychain; sudden changes in commodityprices; known inadequacies inidentification and assay testing methodsfor potential adulterants; a highlycomplex and variable food ingredient;the widespread availability of apotential adulterant; the lack oforganoleptic properties of a potentialadulterant; the high cost or scarcity ofan ingredient; and variation in the value

of a food based on variations in levelsof a high value attribute of that food.The nature of economically motivatedadulteration makes it difficult toidentify all relevant factors to beconsidered in a vulnerability assessmentto predict when novel events ofeconomic adulteration are expected tooccur. Moreover, predictive tools suchas CARVER+Shock are not currentlyconfigured to assess the risk ofeconomically motivated adulteration,nor have extensive vulnerabilityassessments for economically motivatedadulteration in food products been

conducted by FDA or others. Therefore,we believe the most appropriateframework to assess the risk ofeconomically motivated adulteration isto consider whether it is reasonablylikely to occur (such as whether it hasoccurred under similar circumstanceswith some regularity in the past) as partof a hazard analysis.

Under this approach, facilities subjectto section 418 of the FD&C Act would

be expected to implement controlsagainst economically motivatedadulteration under circumstances wherethere has been a pattern of such

adulteration in the past, even though thepast occurrences may not be associatedwith the specific supplier or the specificfood product but the pattern suggests apotential for intentional adulteration.Further, a system of monitoring,corrective action, verification, andrecordkeeping that is similar to those inthe PC and Animal Food PC proposedrules would be appropriate foreconomically motivated adulteration. Inaddition, the elements of a preventivecontrol system, including hazardanalysis, preventive controls,

monitoring, corrective actions,verification, and recordkeeping would

be documented in a food safety planthat would include control ofeconomically motivated adulteration.We believe that addressing both of thesepotential sources for contaminationwithin the same framework is likely tostreamline requirements and reduce

costs to industry.We seek comment on our tentative

conclusions presented above.Specifically, we are interested ininformation on the specific factors thatare most relevant for determiningwhether economically motivatedadulteration is reasonably likely tooccur, particularly in instances wherethe specific product or supplier has not

been previously associated with suchadulteration. In addition, we seekcomment on whether and how theserelevant factors may be used to developappropriate predictive tools or establish

a standard for when preventive controlsare necessary.Section 418 of the FD&C Act contains

certain exemptions related tocompliance with FDAs seafood andjuice HACCP regulations and withregard to manufacturing, processing,packing or holding dietary supplementsthat are in compliance with therequirements of sections 402(g)(2) and761 of the FD&C Act. Section 420 of theFD&C Act does not contain theseexemptions and requires FDA to issueregulations to protect against theintentional adulteration of food. Seafoodand juice are currently subject to

HACCP-type regulations in 123 and120, respectively, and our currentthinking is that under section 420economically motivated adulterationcould be addressed through the existingframeworks for these foods. Under thisoption, FDA would amend the seafoodand juice HACCP regulations to specifythat economically motivatedadulteration is a hazard that must beconsidered in a hazard analysis of thesefoods, and addressed in a HACCP plan.For example, for seafood, we couldpropose to add economicallymotivated adulteration that could result

in serious adverse health consequencesor death to the list of hazards to beconsidered in a hazard analysis inaccordance with 123.6(c)(1). Similarly,for juice we could propose to addeconomically motivated adulterationthat could result in serious adversehealth consequences or death to thelist of hazards to be considered in ahazard analysis in accordance with 120.7(c). Also under this option, FDAwould consider proposing to amendpart 111 (21 CFR part 111), the DietarySupplements current good

manufacturing practice (CGMP) rule, toinclude economically motivatedadulteration that could result in seriousadverse health consequences or death.Current 111.70(b) and (c) requireestablishing component specificationsand in-process specifications to ensurethe identity, purity, strength, andcomposition of the dietary supplement,

and we could amend these provisions tocover economically motivatedadulteration that could result in seriousadverse health consequences or death.

We have also tentatively concludednot to require produce farms subject tosection 419 of the FD&C Act and farmsthat produce milk (also referred to inthis document as dairy farms) subjectto section 420 of the FD&C Act to takemeasures to address economicallymotivated adulteration. With regard toproduce farms subject to section 419 ofthe FD&C Act, we have tentativelyconcluded that there are not procedures,

processes, or practices that arereasonably necessary to be implemented

by these entities to prevent theintroduction of known or reasonablyforeseeable biological, chemical, orphysical hazards that can cause seriousadverse health consequences or death asa result of economically motivatedadulteration. With regard to farms thatproduce milk subject to section 420 ofthe FD&C Act, we have tentativelyconcluded that there are not appropriatescience-based strategies or measuresintended to protect againsteconomically motivated adulteration

that can be applied at the farm. Thesetentative conclusions are based on ourassessment that preventive controls foreconomically motivated adulteration aresuitable to address such adulterationwhen it is perpetrated by the entityssupplier, but not when it is perpetrated

by the entity itself, as would be the casefor economically motivated adulterationat a produce farm or a farm thatproduces milk. Actions such as auditingof suppliers or reliance upon supplier-supplied test results or productioncontrol records are generally consideredunsuitable to address economicallymotivated adulteration where thesupplier, if intentionally adulteratingthe food, would already be violating thelaw and would be able to subvert thesecontrols. For both types of farms, we arenot aware of inputs into the growing,harvesting, packing, or holding ofproduce or milk (i.e., within our farmdefinition) that could be subject toeconomically motivated adulterationthat could cause serious adverse healthconsequences or death under sections419 and 420 of the FD&C Act. We seekcomment on this tentative conclusion.


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G. Low-Risk Activities at Farm Mixed-Type Facilities

Section 103(c)(1)(C) of FSMA directsthe Secretary of Health and HumanServices to conduct a science-based riskanalysis as part of the section 103(c)rulemaking. The science-based riskanalysis is to cover (i) specific types of

on-farm packing or holding of food thatis not grown, raised, or consumed onsuch farm or another farm under thesame ownership, as such packing andholding relates to specific foods; and (ii)specific on-farm manufacturing andprocessing activities as such activitiesrelate to specific foods that are notconsumed on that farm or on anotherfarm under common ownership. Insection VIII.G of the PC proposed rule,we describe a draft Qualitative RiskAssessment (the draft RA) we performedto satisfy this requirement. Section103(c)(1)(D)(i) of FSMA requires FDA touse the results of this analysis toestablish exemptions and inspectionfrequencies, or modify requirements, forfacilities engaged only in specific typesof on-farm activities that FDAdetermines to be low risk.

Elsewhere in this issue of the FederalRegister, FDA is publishing a noticeannouncing the availability for publiccomment Appendix 4 to the draft RA(the draft RA Appendix). The purpose ofthe draft RA Appendix is to provide ascience-based risk analysis of thosefoods whose production processeswould be considered low risk withrespect to the risk of intentionaladulteration caused by acts of terrorism.FDA conducted this evaluation tosatisfy the requirement in Section103(c)(1)(C) of FSMA to conduct ascience-based risk analysis with respectto the risk of intentional adulterationcaused by acts of terrorism. Weevaluated the production processes forthe types of finished foods we expectare produced at farm mixed-typefacilities to determine whether or notthey are low-risk with respect to hazardsthat may be intentionally introduced byacts of terrorism. For the purposes ofthis analysis, we evaluated whether a

production process involved any of thefour FDA-identified key activity types,and identified a production process thatdid not involve any of the four keyactivity types as a low risk productionprocess. Based on this evaluation, weconcluded that the production processesfor the following finished foods arelow-risk:

Eggs (In-Shell)

Fruits & Vegetables Other ThanPods, Seeds for Direct Consumption,and Hesperidia (Fresh, Intact)

Game Meats (Whole or Cut, NotGround or Shredded, WithoutSecondary Ingredients)

Pe

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