2014-02188 regla propuesta para transporte

8/12/2019 2014-02188 Regla Propuesta Para Transporte

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Vol. 79 Wednesday,

No. 24 February 5, 2014

Part II

Department of Health and Human Services

Food and Drug Administration

21 CFR Part 1Sanitary Transportation of Human and Animal Food; Proposed Rule

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7007Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Proposed Rules

controls necessary to preventcontamination and other safety hazards.

The proposed rule is intended toensure that persons engaged in thetransportation of food that is at thegreatest risk for contamination duringtransportation follow appropriatesanitary transportation practices. Forexample, the proposed rule would

require that shippers inspect a vehiclefor cleanliness prior to loading food thatis not completely enclosed by itscontainer, e.g., fresh produce in vented

boxes, onto the vehicle. The proposedrule would also require that personsengaged in transportation operations forfoods that require time/temperaturecontrol to ensure their safety (TCS food),e.g., meat, poultry, seafood, raw seedsprouts, or unpasteurized shell eggs, orto prevent microbial spoilage, e.g.,pasteurized juice, take actions to ensurethe maintenance of the transportationcold chain such as the pre-cooling of the

vehicle by the carrier with subsequentverification by the shipper before thefood is loaded onto the vehicle.

The proposed rule would require thatshippers specify to carriers in writingthe sanitary requirements for a vehicleor transportation equipment to beprovided for all food subject to thisproposal and the temperaturerequirements for foods subject totemperature control requirements. Theproposed rule would require thatshippers maintain records thatdemonstrate that they provide thisinformation to carriers.

Additionally, for food subject totemperature control requirements, theproposed rule would require thatcarriers demonstrate to shippers and,upon request, to receivers that they havemaintained appropriate temperaturecontrol for the food during thetransportation operation. The proposedrule would also require carriers toprovide information to shippers aboutprevious cargoes hauled in bulkvehicles offered for the transportation offood and the intervening cleaning ofthose vehicles. The proposed rulewould require that carriers develop andimplement written procedures subject torecordkeeping that describe how theywill provide these items of informationto shippers and receivers.

The proposed rule would establishrequirements for carriers to develop andimplement written procedures subject torecordkeeping that specify its practicesfor cleaning, sanitizing, and inspectingvehicles and transportation equipmentas required by this rule.

The proposed rule would establishrequirements for the training of carrierpersonnel engaged in transportation

operations, including a requirement forrecords that document the training.

Further, the proposed rule wouldestablish procedures by which FDA willwaive any of these requirements if FDAdetermines that the waiver will notresult in the transportation of foodunder conditions that would be unsafefor human or animal health and will not

be contrary to the public interest, andprocedures that FDA will follow whenrevoking such waivers.

The proposed rule would not covershippers, receivers, or carriers engagedin food transportation operations thathave less than $500,000 in total annualsales.

We have developed this proposed ruleimplementing the 2005 SFTA andFSMA to operate in conjunction withother rules we will be issuing underFSMA to ensure that the safety of foodduring transportation is effectivelyaddressed as part of FDAscomprehensive effort to strengthen thefood safety system. Under FSMA, FDAhas proposed rules on Current GoodManufacturing Practice and HazardAnalysis and Risk-Based PreventiveControls for Human Food (78 FR 3646,

January 16, 2013) and animal (78 FR64736, October 29, 2013) food facilities(the proposed preventive controls rulesfor human and animal food,respectively) and on Standards for theGrowing, Harvesting, Packing, andHolding of Produce for HumanConsumption (78 FR 3504, January 16,2013).

Costs and BenefitsThis proposed rule is estimated to

cover 83,609 firms. This numberincludes carriers engaged in foodtransportation and food facilitiesincluding the U.S. Department ofAgriculture (USDA) establishments thatship food subject to this proposed rule.Total first year cost is estimated to be$149.1 million (with an average of$1,784 per firm), and total annual costis estimated to be $30.08 million (withan average of $360 per firm).

We lack sufficient data to quantify thepotential benefits of the proposed rule.

The causal chain from inadequate foodtransportation to human and animalhealth and welfare can be specified butnot quantified. Because no completedata exist to precisely quantify thelikelihood of food becoming adulteratedduring its transport, we are unable toestimate the effectiveness of therequirements of the proposed rule toreduce potential adverse health effectsin humans or animals. Furthermore,while we expect small changes in

behavior (in the form of safer practices),we do not anticipate large scale changes

in practices as a result of therequirements of this proposed rule.Nevertheless, improving foodtransportation systems could reduce thenumber of recalls, reduce the risk ofadverse health effects related to suchcontaminated human and animal foodand feed, and reduce the losses ofcontaminated human and animal food

and feed ingredients and products.

Table of Contents

I. BackgroundII. Legal AuthorityIII. Description of the Proposed Rule

A. Scope (Proposed 1.900)B. Applicability (Proposed 1.902)C. Definitions (Proposed 1.904)D. Vehicles and Transportation Equipment

(Proposed 1.906)E. Transportation Operations (Proposed

1.908)F. Training (Proposed 1.910)G. Records (Proposed 1.912)H. Waivers (Proposed 1.9141.934)

IV. Preliminary Regulatory Impact AnalysisA. OverviewB. Regulatory Flexibility ActC. Unfunded Mandates Reform Act of 1995

V. Paperwork Reduction Act of 1995VI. Analysis of Environmental ImpactVII. FederalismVIII. Proposed Effective and Compliance

DatesIX. Request for CommentsX. References

I. Background

Due to illness outbreaks involvinghuman food and animal food that

became contaminated duringtransportation (Ref. 1) (Ref. 2) and

incidents and reports of insanitarytransportation practices (Ref. 3) (Ref. 4)(Ref. 5) (Ref. 6) (Ref. 7) (Ref. 8), therehave been concerns over the past fewdecades about the need to ensure thatfood is transported in the United Statesin a sanitary manner (Ref. 9). Pressaccounts in the late 1980s of truckscarrying food from the Midwest to boththe East and West Coasts and returningwith garbage for Midwest landfills led toconcern that food products could

become contaminated and unfit forhuman consumption if irresponsiblevehicle operators failed to prevent

contamination of food products invehicles that had been previously usedto haul waste or other non-foodmaterials. Congress responded to theseconcerns by passing the Sanitary FoodTransportation Act of 1990 (1990 SFTA)which directed the Department ofTransportation (DOT) to establishregulations to prevent food or foodadditives transported in certain types of

bulk vehicles from being contaminatedby nonfood products that weresimultaneously or previouslytransported in those vehicles. Following



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7008 Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Proposed Rules

the passage of the 1990 SFTA it becameclear that potential sources of foodcontamination during transport werenot just limited to nonfood products.Most notably, a 1994 outbreak ofsalmonellosis occurred in which icecream mix became contaminated duringtransport in tanker trucks that hadpreviously hauled raw liquid eggs. That

outbreak affected an estimated 224,000persons nationwide (Ref. 1).

In 2005 Congress withdrew the 1990SFTA and passed the 2005 SFTA, a

broader food transportation safety lawthan the 1990 SFTA in that its focus wasnot limited only to preventing foodcontamination from nonfood sourcesduring transportation. The 2005 SFTAdirected FDA to establish regulationsprescribing sanitary transportationpractices to be followed by shippers,carriers by motor vehicle or rail vehicle,receivers, and other persons engaged inthe transportation of food.

In April of 2010 FDA issued guidanceto provide the industry with broadlyapplicable recommendations forcontrols to prevent food safety problemsduring transport while it was in theprocess of implementing 2005 SFTA(Ref. 10).

As part of our implementation of the2005 SFTA, we also issued an advancenotice of proposed rulemaking in 2010(the 2010 ANPRM; 75 FR 22713) torequest data and information on thefood transportation industry and itspractices and on the contamination oftransported foods and any associatedoutbreaks.

In the 2010 ANPRM we discussed theconcerns about safe food transportationdating from the 1980s as well as currentpractices in the food transportationindustry and areas where food is at riskfor contamination. We discussed DOTsactions in response to the 1990 SFTA.We also noted findings released in 2007,of an Interstate Food TransportationProject carried out by a number ofMidwestern states (Refs. 3) (Ref. 4). Thepurpose of the project was to determinethe current state of food safety and fooddefense in the context of in-transit foodin interstate commerce. The project

identified several areas of concern infood transport relevant to thisrulemaking that increase the likelihoodof food contamination, such as improperrefrigeration, transport of raw meat andpoultry in a manner that could result incross-contamination of fresh fruits andvegetables transported in the samevehicle (cross-contamination is thetransfer of harmful bacteria to food fromother foods when food is improperlyhandled), improper packaging,infestation with insects, insanitarystorage (e.g., roof leaks and moldy walls,

animal blood and food on bed floors),low driver awareness of safe foodtemperatures, and inadequate foodsafety training of drivers. Most of thespecific instances where foodtransportation problems were foundinvolved smaller box trucks; there werelittle or no areas of concern identifiedwith larger (semi-tractor trailer) trucks

inspected during the projects survey.We also discussed the findings, issued

in a 2009 report, of a study conductedfor FDA by the Eastern Research Group(the ERG report) to characterize current

baseline practices in the sectorsinvolved in food transportation and toidentify current areas where food is atrisk for adulteration (Ref. 9).

The ERG report identified a number ofareas where food may be at risk forphysical, chemical, or biologicalcontamination during transport andstorage:

Improper refrigeration or

temperature control of food products(temperature abuse).

Improper management oftransportation units or storage facilitiesto preclude cross-contamination,including improper sanitation,

backhauling hazardous materials, notmaintaining tanker wash records,improper disposal of wastewater, andaluminum phosphide fumigationmethods in railcar transit;

Improper packing of transportationunits or storage facilities, includingincorrect use of packing materials andpoor pallet quality;

Improper loading practices,conditions, or equipment, includingimproper sanitation of loadingequipment, not using dedicated unitswhere appropriate, inappropriateloading patterns, and transportingmixed loads that increase the risk forcross-contamination;

Improper unloading practices,conditions, or equipment, includingimproper sanitation of equipment andleaving raw materials on loading docksafter hours;

Poor pest control in transportationunits or storage facilities;

Lack of driver/employee trainingand/or supervisor/manager/ownerknowledge of food safety and/orsecurity;

Poor transportation unit design andconstruction;

Inadequate preventive maintenancefor transportation units or storagefacilities, resulting in roof leaks, gaps indoors, and dripping condensation or iceaccumulations;

Poor employee hygiene; Inadequate policies for the safe and/

or secure transport or storage of foods;

Improper handling and tracking ofrejected loads and salvaged, reworked,and returned products or productsdestined for disposal; and

Improper holding practices for foodproducts awaiting shipment orinspection, including unattendedproduct, delayed holding of product,shipping of product while in

quarantine, and poor rotation andthroughput.

To obtain data that would be currentand relevant and to augment theinformation in the ERG report, werequested public comments containingdata and information on questionsassociated with several specific issues(see the 2010 ANPRM for the issues andquestions). We received about 45comments from a variety of submittersincluding human and animal foodprocessors and their trade organizations,food distributors and their tradeorganizations, food retailers and theirtrade organizations, transportationequipment manufacturers and suppliers,motor and rail carriers and their tradeorganizations, an organizationrepresenting independent truck owner-operators, a State government agency, aconsumer advocacy organization, andindividual consumers. Where commentsinformed specific provisions of thisproposed rule, we discuss thosecomments in the relevant part of sectionIII of this document.

A few comments addressed section416(c)(2)(A) and (c)(2)(B) of the 2005SFTA, which direct FDA to include inthe sanitary food transportation

regulations: (1) A list of nonfoodproducts that the Secretary of Healthand Human Services (the Secretary)determines may, if shipped in a bulkvehicle, render adulterated food that issubsequently transported in the samevehicle; and (2) a list of nonfoodproducts that the Secretary determinesmay, if shipped in a motor vehicle orrail vehicle (other than a tank vehicle or

bulk vehicle), render adulterated foodthat is simultaneously or subsequentlytransported in the same vehicle. Someof the comments addressing this subjectoffered that lists that prohibit the

transport of food and non-food itemstogether would be illogical because theywould create requirements forcommercial food transportation that donot reflect how consumers privatelytransport food, wherein they transportfood and non-food items together totheir homes. One comment asserted thatthe simultaneous transportation of foodand hazardous materials should beprohibited.

While certain combinations of non-food cargos and food cargos (either as aco-cargo or subsequent cargo) may



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present the potential for adulteration ofthe food cargo under certain conditionsof transportation, the likelihood of suchadulteration is very situation specific.This is because the ability of a non-foodproduct to adulterate a food product ineither case is dependent upon, amongother things: The construction of thevehicle; the nature and concentration of

the non-food product and anycontaminants therein contained; themanner and extent of cleaning andsanitizing operations between thecargos; the nature, subsequentprocessing, and intended use of the foodcargo; the manner in which the food andnon-food cargos are stored in the vehicle(for non-bulk vehicles); and the mannerin which food and non-food cargos arepackaged (for non-bulk vehicles). Forthis reason, we have tentativelyconcluded that we cannot identify anyspecific non-food product that may,under all circumstances, adulterate food

subsequently hauled in a bulk vehicle,such that we could propose a list ofsuch products in this proposed rule. Wehave also tentatively concluded that wecannot identify any specific non-foodproducts that may, under allcircumstances, adulterate foodsubsequently or simultaneously hauledin a non-bulk vehicle, such that wecould propose a list of such products inthis proposed rule. However, we havealso tentatively concluded that guidanceon how the specifics of thetransportation operation affect thepotential for non-food products to

adulterate food products would behelpful to the transportation industryand intend to develop such guidanceupon publication of this final rule. Werequest comment on these tentativeconclusions.

Further, we recognize that within thebulk and non-bulk segments of the foodtransportation industry, carriersroutinely transport non-food items invehicles that subsequently orsimultaneously (for non-bulk vehicles)haul food. Based upon the comments wereceived in response to the 2010ANPRM, we believe that in many

instances, shippers and carriers workingtogether, e.g., through informationsharing, establish procedures fortransportation operations thatadequately address any concerns thatmay exist about non-food prior and co-cargos. In other instances, transportationoperations are carried out in accordancewith various industry best practicesguidelines that address non-food priorand co-cargos. This proposed rule, andthe proposed preventive controls rulesfor human and animal food, willestablish new requirements that will,

respectively, provide for informationdisclosure between shippers andcarriers and consideration oftransportation practices within afacilitys hazard analysis, that wetentatively conclude will be sufficient toenable shippers covered by thisproposed rule and facilities covered bythe proposed preventive controls rules

to establish safe transportation practicesfor their bulk and non-bulk shipmentswhere non-food prior or co-cargos are aconsideration.

II. Legal Authority

We are issuing this proposed ruleunder the 2005 SFTA and as directed bysection 111(a) of FSMA.

The 2005 SFTA amended the FederalFood, Drug, and Cosmetic Act (FD&CAct), in part, by creating a new section416 of the FD&C Act (21 U.S.C. 350e).Section 416(b) of the FD&C Act directedus to issue regulations to requireshippers, carriers by motor vehicle orrail vehicle, receivers, and other personsengaged in the transportation of food touse prescribed sanitary transportationpractices to ensure that food is nottransported under conditions that mayrender the food adulterated. Section416(c) of the FD&C Act specifies that weshall prescribe those practices that wedetermine are appropriate relating to: (1)Sanitation; (2) packaging, isolation, andother protective measures; (3)limitations on the use of vehicles; (4)information to be disclosed to carriersand to manufacturers; and (5)recordkeeping. Section 416(c) of the

FD&C Act also states that the regulationsare to include a list of nonfood productsthat may, if shipped in a bulk vehicle,render adulterated food that issubsequently transported in the samevehicle and a list of nonfood productsthat may, if shipped in a motor vehicleor rail vehicle (other than a tank vehicleor bulk vehicle), render adulterated foodthat is simultaneously or subsequentlytransported in the same vehicle. Section111(a) of FSMA, directed us to issuethese sanitary transportationregulations.

In addition, the 2005 SFTA creatednew section 402(i) in the FD&C Act (21U.S.C. 342(i)) which provides that foodthat is transported or offered fortransport by a shipper, carrier by motorvehicle or rail vehicle, receiver, or anyother person engaged in thetransportation of food under conditionsthat are not in compliance with theregulations issued under section 416 isadulterated, and new section 301(hh) inthe FD&C Act (21 U.S.C. 331(hh)) toprohibit the failure by a shipper, carrier

by motor vehicle or rail vehicle,receiver, or any other person engaged in

the transportation of food to complywith the regulations issued undersection 416. The 2005 SFTA alsoamended section 703 of the FD&C Act(21 U.S.C. 373) by adding section703(b), which provides that a shipper,carrier by motor vehicle or rail vehicle,receiver, or other person subject tosection 416 shall, on request of an

officer or employee designated by FDA,permit the officer or employee, atreasonable times, to have access to andto copy all records that are required to

be kept under the regulations issuedunder section 416.

FDAs authority for this proposed rulealso derives from sections 402(a)(1),(a)(3), (a)(4), and 701(a) of the FD&C Act(21 U.S.C. 371(a)). Section 402(a)(1) ofthe FD&C Act provides, in part, that afood is adulterated if it bears or containsany added poisonous or deleterioussubstance which may render it injuriousto health. Section 402(a)(3) of the FD&C

Act provides that a food is adulteratedif it consists in whole or in part of anyfilthy, putrid, or decomposed substance,or if it is otherwise unfit for food.Section 402(a)(4) of the FD&C Actprovides that a food is adulterated if ithas been prepared, packed, or heldunder insanitary conditions whereby itmay have become contaminated withfilth, or whereby it may have beenrendered injurious to health. Undersection 701(a) of the FD&C Act, FDA isauthorized to issue regulations for theefficient enforcement of the FD&C Act.The proposed rule includesrequirements that are necessary to

prevent food from being adulterated(either by becoming filthy, putrid,decomposed or otherwise unfit for food,or being rendered injurious to healthfrom any source) during transportationoperations. These requirements allowfor the efficient enforcement of theFD&C Act.

III. Description of the Proposed Rule

We are proposing to establish new 21CFR part 1, subpart O, entitledSanitary Transportation of Human andAnimal Food. The proposed rulewould specify sanitary transportation

practices to be used by shippers, carriersby motor vehicle and rail vehicle, andreceivers engaged in the transportationof food to ensure that food is nottransported under conditions that mayrender the food adulterated.

A. Scope (Proposed 1.900)

Proposed 1.900 addresses who issubject to the requirements of subpart O.Proposed 1.900(a) would provide thatexcept for non-covered businesses asdefined in proposed 1.904 (who wouldnot be subject to this rule as discussed



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in section III.C of this document), therequirements of subpart O would applyto shippers, receivers, and carriersengaged in transportation operations forfood whether or not the food is offeredfor or enters interstate commerce.Proposed 1.900(b) would provide thatthe requirements of subpart O do notapply to shippers, receivers, or carriers

when they are engaged in transportationoperations of: (1) Food that istransshipped through the United Statesto another country; or (2) food that isimported for future export and that isneither consumed or distributed in theUnited States.

1. Other Persons Engaged in theTransportation of Food

Section 416(b) of the FD&C Actexplicitly states that these regulationsshould address other persons engagedin the transportation of food. Weconsidered what other entities couldconstitute other persons engaged inthe transportation of food who are notshippers, receivers, or carriers andwhether proposing requirements forother persons engaged in thetransportation of food was necessary toensure that food is not transportedunder conditions that may render thefood adulterated. As part of thatconsideration we reviewed thecomments to the 2010 ANPRM for anyinformation that might suggest thatapplying the provisions of this proposedrule to such persons might substantiallyfurther the use of sanitary foodtransportation practices. After reviewing

these comments and other informationavailable to us about the transportationindustry, and considering thedefinitions we are proposing forshippers, carriers, and receivers, wehave tentatively concluded that thereare not other persons engaged in thetransportation of food whose function infood transportation would be expectedto affect the sanitary condition of food,and as such, should be subject to therequirements of this rule. Therefore weare not proposing to subject personsother than shippers, receivers, andcarriers to the requirements of this

proposed rule. We request comment onwhether any other persons should besubject to this proposed rule under theauthority provided by section 416(b) ofthe FD&C Act. The comments shouldidentify the specific function of theperson in food transportation, explainhow that person does not meet thedefinition of shipper, carrier, orreceiver, describe how that personsactions may affect the sanitary conditionof food, and describe the kinds ofregulatory provisions that should beapplied to that person.

2. Intrastate Activities

FDA tentatively concludes that theprovisions in the proposed rule should

be applicable to activities that areintrastate in character. The plainlanguage of section 416(a)(2) of theFD&C Act defines the termtransportation as any movement in

commerce by motor vehicle or railvehicle. Section 416(b) of the FD&C Actdirects FDA to create regulations torequire shippers, carriers by motorvehicle or rail vehicle, receivers, andother persons engaged in thetransportation of food to use sanitarytransportation practices prescribed bythe Secretary to ensure that food is nottransported under conditions that mayrender the food adulterated. Section 416does not include a limitation tointerstate commerce. FDA seekscomment on whether the provisionsshould be applicable to activities thatare intrastate in character.

3. Activities Outside the United States

This proposed rule sets forth sanitarytransportation practices for shippers,carriers, and receivers who transportfood that will be consumed ordistributed in the United States.However, some food may enter theUnited States and be transported withinthe United States but not be consumedor distributed into the U.S. market. Forexample, some food is transshippedfrom a foreign country through theUnited States to a different country (e.g.,food that is driven from Mexico through

the United States into Canada). Inaddition, food may be imported into theUnited States, transported to a facilityfor further processing, and exported toanother country without beingconsumed or distributed in U.S.commerce.

We have tentatively concluded thatsection 416 of the FD&C Act is notintended to apply to the transportationof food that is neither consumed nordistributed in the United States.Therefore, proposed 1.900(b) wouldprovide that the requirements of subpartO do not apply to shippers, receivers, or

carriers when they are engaged intransportation operations of: (1) Foodthat is transshipped through the UnitedStates to another country; or (2) foodthat is imported for future export andthat is neither consumed nor distributedin the United States.

However, the proposal would apply tothe transportation operations of foodthat will be directly transported into theUnited States by motor or rail vehicle.By contrast, the requirements of thisproposal would not apply to thetransportation operations of food that

may ultimately be intended for U.S.commerce, but will not be directlytransported into the United States bymotor or rail vehicle. For example, therequirements of this proposed rulewould apply to a shipper and carrierwho conduct a transportation operationabroad that includes direct shipment ofthe food into the United States by motor

vehicle or rail vehicle (e.g., food that isshipped from Mexico by truck and thatwill enter the United States on thattruck and be transported further withinthe United States). However, therequirements of this proposed rulewould not apply to a shipper and carrierwho conduct a transportation operationabroad for food that is ultimatelyintended for the United States, otherthan the direct shipment of the food tothe United States by motor or railvehicle (e.g., food that is shipped,carried, and received within China butthat will ultimately be transported to the

United States by air). As a furtherexample, the requirements of thisproposed rule would also apply to aperson outside of the United States,such as an exporter, who ships food tothe United States in an internationalfreight container by oceangoing vesselor in an air freight container, andarranges for the transfer of the intactcontainer in the United States onto amotor vehicle or rail vehicle fortransportation in U.S. commerce, if thatfood will be consumed or distributed inthe United States. We would considerthis person to be a shipper under thisproposed rule because he would be

initiating a shipment of food by motorvehicle or rail vehicle, even if doing sofrom abroad, that would be enteringU.S. commerce. If that shipper fails tocomply with the requirements of thisproposed rule and FDA determines thatfood shipped to the United States bythat shipper may as a result beadulterated, such shipments of foodwould be subject to refusal of admissionwhen offered for entry into the UnitedStates.

4. Other Requirements Applicable toFood Transportation

Proposed 1.900 would also providethat the requirements of subpart O applyin addition to any other requirements ofFDA that are applicable to foodtransportation. For example, FDA hasestablished regulations setting forthcurrent good manufacturing practices(CGMP) for medicated animal feeds inpart 225 (21 CFR part 225), whichinclude a provision in section 225.65Equipment and cleanout procedures,that addresses requirements for thecleaning of equipment used in thedistribution of medicated feeds to avoid



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unsafe contamination of feeds withdrugs. Similarly, FDA has establishedregulations addressing substancesprohibited from use in animal food orfeed in part 589 (21 CFR part 589),which include provisions in 589.2000 Animal proteinsprohibited in ruminant feed and589.2001 Cattle materials prohibited in

animal food or feed to prevent thetransmission of bovine spongiformencephalopathy addressing cleanoutrequirements and dedicated equipmentrequirements for equipment used in thedistribution of specified feedingredients to prevent thecontamination of ruminant feed andanimal food or feed respectively.

B. Applicability (Proposed 1.902)

Under section 402(i) of the FD&C Act(21 U.S.C. 342(i)), a food shall bedeemed to be adulterated if it istransported or offered for transport by ashipper, carrier by motor vehicle or railvehicle, receiver, or any other personengaged in the transportation of foodunder conditions that are not incompliance with regulations issuedunder section 416 of the 2005 SFTA.

Proposed 1.902(a) would providethat the criteria and definitions ofsubpart O apply in determining whetherfood is adulterated within the meaning

of section 402(i) of the FD&C Act in thatthe food has been transported or offeredfor transport by a shipper, carrier bymotor vehicle or rail vehicle, or receiverengaged in the transportation of foodunder conditions that are not incompliance with subpart O.

Under section 301(hh) of the FD&CAct, the following act, and the causing

thereof, is prohibited: the failure by ashipper, carrier by motor vehicle or railvehicle, receiver, or any other personengaged in the transportation of food tocomply with the sanitary transportationpractices prescribed by the Secretaryunder section 416. To clearlycommunicate that failure to complywith regulations established undersection 416 of the FD&C Act is aprohibited act, proposed 1.902(b)would provide that the failure by ashipper, carrier by motor vehicle or railvehicle, or receiver engaged in foodtransportation operations to comply

with the requirements of subpart O is aprohibited act under section 301(hh) ofthe FD&C Act.

C. Definitions (Proposed 1.904)

Proposed 1.904 would defineadequate as that which is needed toaccomplish the intended purpose inkeeping with good public healthpractice. This proposed definition is

identical to the definition for this termin the existing CGMP regulations (see 21CFR 110.3(b)). We have retained thisdefinition in the proposed updates tothe CGMP provisions of the proposedpreventive controls rule for human foodand have also included the samedefinition in the CGMP provisions ofthe proposed preventive controls rulefor animal food. Given the broadapplicability of this term in describingessential principles and practices for thesanitary handling of food, we havetentatively concluded that using thisterm to express relevant requirements inthis proposed rule, e.g., transportationequipment must be designed to beadequately cleanable, will beunderstood by industry and will beeffective in ensuring that food is nottransported under conditions that mayrender it adulterated. Several provisionsof this proposed rule are comparable

(see Table 1) to provisions of our CGMPregulations and reflect establishedprinciples of sanitary operationsinvolving food, whether thoseoperations are carried out in a foodfacility or in a food transportationoperation. As a result, many firms arelikely to already be in compliance withthe proposed provisions of this rule.

TABLE 1PROVISIONS OF THIS PROPOSED RULE THAT ARE COMPARABLE TO PROVISIONS OF FDAS CGMPREGULATIONS

Provision As proposed in this rule Comparable to CGMP

1.904 ................ Defines adequate as that which is needed to accomplishthe intended purpose in keeping with good public healthpractice.

21 CFR 110.3(b)Adequate means that which is needed toaccomplish the intended purpose in keeping with goodpublic health practice.

1.906(b) ........... Requires that vehicles and transportation equipment bemaintained in such a sanitary condition as to prevent thefood that they transport from becoming filthy, putrid, de-composed, or otherwise unfit for food, or being renderedinjurious to health from any source during transportationoperations.

21 CFR 110.40(a)All plant equipment and utensils shallbe so designed and of such material and workmanship asto be adequately cleanable, and shall be properly main-tained.

1.906(c) ........... Requires that vehicles and transportation equipment that areused in transportation operations for food that can supportthe rapid growth of undesirable microorganisms in the ab-sence of temperature control during transportation be de-signed, maintained, and equipped, to maintain the foodunder temperature conditions that will prevent the rapidgrowth of undesirable microorganisms.

21 CFR 110.80(b)(6)Food that can support the rapidgrowth of undesirable microorganisms, particularly those ofpublic health significance, shall be held in a manner thatprevents the food from becoming adulterated within themeaning of the act.

1.906(d) ........... Requires that each freezer and mechanically refrigerated

cold storage compartment in vehicles or transportationequipment used in transportation operations for food thatcan support the rapid growth of undesirable microorga-nisms in the absence of temperature control during trans-portation be equipped with an indicating thermometer, tem-perature-measuring device, or temperature-recording de-vice so installed as to show the temperature accuratelywithin the compartment.

21 CFR 110.40(e)Each freezer and cold storage compart-

ment used to store and hold food capable of supportinggrowth of microorganisms shall be fitted with an indicatingthermometer, temperature-measuring device, or tempera-ture-recording device installed to show the temperature ac-curately within the compartment . . .



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TABLE 1PROVISIONS OF THIS PROPOSED RULE THAT ARE COMPARABLE TO PROVISIONS OF FDAS CGMPREGULATIONSContinued

Provision As proposed in this rule Comparable to CGMP

1.906(e) ........... Requires that vehicles and transportation equipment bestored in such a manner as to prevent the vehicles ortransportation equipment from harboring pests or becom-ing contaminated in any other manner that could result in

food for which they will be used becoming filthy, putrid, de-composed, or otherwise unfit for food, or being renderedinjurious to health from any source during transportationoperations.

21 CFR 110.35(e)Cleaned and sanitized portable equip-ment with food-contact surfaces and utensils should bestored in a location and manner that protects food-contactsurfaces from contamination.

1.908(a)(2) ....... Requires that responsibility for ensuring that transportationoperations are carried out in compliance with all require-ments of subpart O be assigned to competent supervisorypersonnel.

21 CFR 110.10(d)Responsibility for assuring complianceby all personnel with all requirements of this part shall beclearly assigned to competent supervisory personnel.

1.908(c)(1) ....... Requires that shippers and receivers provide vehicle opera-tors who are expected to handle food not completely en-closed by a container during loading and unloading oper-ations with access to a hand-washing facility that is con-venient and that provides running water.

21 CFR 110.10(b)All persons working in direct contactwith food, food-contact surfaces, and food-packaging ma-terials shall conform to hygienic practices while on duty tothe extent necessary to protect against contamination offood.

21 CFR 110.10(b)(3)Washing hands thoroughly (and sani-tizing if necessary to protect against contamination withundesirable microorganisms) in an adequate hand-washingfacili ty . . .

21 CFR 110.37(e)Hand-washing facilities shall be ade-quate and convenient and be furnished with running waterat a suitable temperature.

Proposed 1.904 would defineanimal food as food for animals otherthan man, and includes pet food, feed,and raw materials and ingredients. Thisdefinition is identical to the definitionof animal food in the proposedpreventive controls rule for animal food.

Proposed 1.904 would define abulk vehicle as a tank truck, hoppertruck, rail tank car, hopper car, cargo

tank, portable tank, freight container, orhopper bin, or any other vehicle inwhich food is shipped in bulk, with thefood coming into direct contact with thevehicle. This proposed definition istaken directly from section 416(a)(1) ofthe FD&C Act (21 U.S.C. 350e(a)(1)).This definition differentiates a subset ofmotor vehicles and rail vehicles subjectto this proposed rule, i.e., bulkvehicles, from other types of vehiclessubject to this proposed rule, i.e., non-

bulk vehicles such as trailers. Asdiscussed in section III.E, we haveproposed to establish several specificrequirements applicable totransportation operations involving bulkvehicles to ensure that food isadequately protected from adulterationduring such operations.

This proposed definition wouldinclude equipment used in foodtransportation because they are attachedto and carried on a motor or rail vehicle,e.g., a cargo tank. We tentativelyconclude that defining bulk vehicles aswe have proposed would ensure that theprovisions of this rule relating to bulkvehicles apply to all possible

transportation operations in which foodis hauled in bulk conveyances, rangingfrom tank trucks to cargo tanks.

Proposed 1.904 would define acarrier as a person who owns, leases,or is otherwise ultimately responsiblefor the use of a motor vehicle or railvehicle to transport food. Thisdefinition would further provide thatthe carrier is responsible for all

functions assigned to a carrier insubpart O even if they are performed byother persons, such as a driver that iseither employed or contracted by atrucking firm to operate the vehicle.Furthermore, a carrier may also be areceiver or a shipper if the person alsoperforms the functions of thoserespective persons as defined in subpartO.

The transportation of food may becarried out in different ways thatinvolve different entities. For example,a manufacturing facility that does nothave its own private truck fleet, drivers,

or contracted drivers may enter into acontract of carriage with a truckingcompany for the trucking company tophysically transport a food shipmentusing the trucking companys vehicle toanother facility designated in thecontract. In another instance, adistributor who has possession of thefood in a holding facility may operateleased vehicles to deliver food to hiscustomers. In both of these examples,the entity ultimately responsible for theuse of the vehicle that transports thefood, i.e., the trucking company in the

first case and the distributor in thesecond case, would be subject to therequirements applicable to the carrierunder this proposed rule. In the secondcase, the distributor may also be subjectto additional requirements applicable toshippers under this proposed rule dueto his operation of the holding facility.

This proposed definition wouldprovide that the carrier is responsible

for all functions assigned to that personin subpart O, even if they are performedby other persons such as a driver thatis employed or contracted by the carrier.Thus the carrier, being the entityultimately responsible for the use of thevehicle to physically transport food,would be responsible for ensuring thata driver, who operates the vehicle,functions in a manner that enables thecarrier to comply with all of hisresponsibilities under this proposedrule. For example, after a transportationoperation, the carrier may underproposed 1.908(d)(2), discussed insection III.E, provide a log oftemperature measurements to theshipper to demonstrate that it hasmaintained temperature conditionsduring the transportation operationconsistent with those specified by theshipper in accordance with proposed 1.908(b)(3). In practice, the driver ofthe vehicle would likely be the personwho compiles or retrieves this log fromthe temperature recording device;however it would be the responsibilityof the carrier to ensure that the driveractually compiles or retrieves the log as



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1FDA notes that, to prevent duplication of effort,its compliance policy is to inform FSIS when anapparent violation is encountered involving a meator poultry product that has left a USDA inspectedestablishment (Ref. 12).

part of his duties during thetransportation operation and makes itavailable to be provided to the shipper.

The definition of the term carrieracknowledges the potential distinction

between the carrier, who is the entityresponsible for the use of the vehicle,from the operator of the vehicle. TheFederal Motor Carrier Safety

Administration, part of DOT, makes asimilar distinction in its federal motorcarrier safety regulations (49 CFR part390) which define a driver as anyperson who operates a commercialmotor vehicle and specify that a drivercould be employed by a motor carrier(49 CFR 390.5). These regulations alsohold motor carriers responsible for,among other things, the oversight ofdrivers. We have acknowledged thepotential for a distinction between thecarrier and the driver for the purpose ofplacing the responsibilities assigned tothe carrier under this proposed rule

upon a single person. Further, we havetentatively concluded that placing theseresponsibilities on a single person willhelp to avoid any confusion regardingwho is responsible for the requirementsfor carriers set forth in this proposedrule.

Proposed 1.904 would define cross-contact to mean the unintentionalincorporation of a food allergen asdefined in section 201(qq) of the FD&CAct (21 U.S.C. 321(qq)) into food, exceptanimal food. We are proposing toestablish essentially the same definitionfor the term cross-contact that weincluded in the proposed preventive

controls rule for human food (seediscussion in 78 FR 3646 at 3693),except that we are adding the termexcept animal food to our proposeddefinition because, as discussed in thepreamble of the proposed preventivecontrols rule for animal food (78 FR64736 at 64771, October 29, 2013), weare not aware of evidence indicatingthat foodborne allergens pose asignificant health risk to animals, or tohumans through handling animal food.

Proposed 1.904 would define farmto mean a facility in one generalphysical location devoted to the

growing and harvesting of crops, theraising of animals (including seafood),or both. Further, we are proposing thatthe term farm includes facilities thatpack or hold food, regardless of whetherall food used in such activities is grown,raised, or consumed on that farm oranother farm under the same ownership.Our proposed definition of the termfarm differs from the definition of afarm in 1.227(b)(3) of this chapter,which is used to delineate whichentities are required to register undersection 415 of the FD&C Act. The reason

why we are proposing to define a farmdifferently for the purposes of thisproposed rule is discussed in ourproposed definition for transportationoperations later in this section.

Proposed 1.904 would define foodto mean food as defined in section201(f) of the FD&C Act, which includesraw materials and ingredients. This

definition is identical to the definitionof food in the proposed preventivecontrols rules for human and animalfood. To ensure that the readerunderstands the scope of food covered

by this proposed rule, this definitionprovision would also state consistentwith the definition of food in theFD&C Act, food includes animal foodand food subject to the Federal MeatInspection Act, the Poultry ProductsInspection Act, and the Egg ProductsInspection Act 1 administered by theFood Safety and Inspection Service(FSIS) of the USDA.

FSIS carries out in-commercesurveillance activities to verify thatentities whose business activitiesinvolve FSIS-regulated productsprepare, store, transport, sell, offer forsale or transportation, import, andexport such products in compliancewith FSIS statutory and regulatoryrequirements. FSIS has issued guidancefor the safe transportation anddistribution of meat, poultry and eggproducts (Ref. 11), however, they do nothave requirements that directly addresstransportation operations for thesefoods. This rulemaking willcomplement FSISs efforts to promote

the application of sanitary foodtransportation practices for FSIS-regulated meat, poultry, and eggproducts. We intend to work togetherwith FSIS to facilitate this sharedobjective while carrying out ourrespective regulatory programs.

Proposed 1.904 would define foodnot completely enclosed by a containerto mean any food that is placed into acontainer in such a manner that it ispartially open to the surroundingenvironment. This proposed definitionis used to designate a category of foodthat is subject to specific provisions of

this proposed rule intended to ensurethat such food is not potentiallyrendered adulterated duringtransportation because it is at increasedrisk of contamination due to beingexposed to the environment. Thisdefinition provision includes examplesof such containers such as an openwooden basket or crate, an open

cardboard box, a vented cardboard boxwith a top, or a vented plastic bag. Thedefinition also provides that this termdoes not include food transported in a

bulk vehicle as defined in this proposedrule.

This approach is consistent with howwe addressed unexposed refrigeratedpackaged foods in the proposed

preventive controls rules for human andanimal food. For instance in theproposed preventive controls rule forhuman food we stated that some of therequirements of that rule would notapply to facilities solely engaged in thestorage of packaged foods not exposedto the environment (78 FR 3646 at3713), and instead proposed to establishmodified requirements for such foodsthat are TCS foods (78 FR 3646 at 3773).In that proposed rule we stated that weconsidered unexposed packaged food,to mean packaged food not exposed tothe environment (78 FR 3646 at 3712).

In considering how unexposedpackaged food should be addressed inthe human preventive controls rule werecognized that in general, there arelimited routes of contamination forunexposed packaged food due to theprotective nature of the foods packaging(78 FR 3646 at 3713). The same wasstated in the proposed preventivecontrols rule for animal food (provideFR cite when published). In thisproposed rule, we recognize that theconverse is true, i.e., we are recognizingthat food not completely enclosed by acontainer is at greater risk of

contamination during transportation,and as such, we tentatively concludethat it is appropriate to propose certainrequirements that apply exclusively tosuch food.

Proposed 1.904 would definemicroorganisms to mean yeasts,molds, bacteria, viruses, protozoa, andmicroscopic parasites and includesspecies having public healthsignificance. Proposed 1.904 wouldalso specify that the term undesirablemicroorganisms includes thosemicroorganisms that are of public healthsignificance, that subject food to

decomposition, that indicate that food iscontaminated with filth, or thatotherwise may cause food to beadulterated. This proposed definition isidentical to the definition for this termin the proposed preventive controlsrules for human and animal food.Because they can adulterate food, weconsider the types of microorganismsidentified in this proposed definition to

be of importance to sanitarytransportation of foods as well as to thesafe and sanitary production of humanand animal food.



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Proposed 1.904 would define non-covered business as a shipper, receiver,or carrier engaged in transportationoperations that has less than $500,000in total annual sales.

Our proposed definition for a non-covered business is similar to one of theproposed definitions for a very small

business in the proposed preventive

controls rule for human food for whichwe requested comment (78 FR 3646 at3701). Under that proposed rule a verysmall business would be subject tomodified requirements that includeprovisions for an exemption from therequirements for hazard analysis andpreventive controls. We are proposing toexclude these businesses from coverageunder this rule to provide forcomparable treatment of these firms

between this proposed rule and theproposed preventive controls rules.Additionally, for firms that onlyfunction as carriers and thus would not

be subject to the proposed preventivecontrols rules, excluding carriers withless than $500,000 in total annual salesfrom coverage by this proposed rulewould treat carriers in a mannerconsistent with the treatment ofshippers and receivers subject to thisproposed rule. We estimate that notcovering carriers with less than$500,000 in total annual sales wouldstill result in an average of 97 percentof all food shipments by motor vehicleor rail being subject to this proposedrule. We note that a non-covered

business is and will continue to becovered under the adulteration

provisions and other applicableprovisions of the FD&C Act andapplicable implementing regulations,irrespective of whether that business isincluded within the scope of thisproposed rule. We are requestingcomment on whether the foods thatcomprise the $500,000 in total annualsales should be limited in some way,such as to those subject to this rule orto any of the FSMA rules whenfinalized.

Proposed 1.904 would define pestto mean any objectionable animals orinsects including birds, rodents, flies,

and larvae. This proposed definition isidentical to the definition for this termin the proposed preventive controls rulefor human food. That proposed rule alsoincludes a discussion, which is relevantto this proposal, of some circumstancesunder which animals would not beconsidered objectionable (78 FR 3646at 3721). We consider the types of pestsidentified in this proposed definition to

be of importance to sanitarytransportation of foods as well as to thesafe and sanitary production of humanand animal food.

Proposed 1.904 would definereceiver to mean any person whoreceives food after transportation,whether or not that person representsthe final point of receipt for the food.This definition also states that a receivermay also be a carrier or a shipper if theperson also performs the functions ofthose respective persons as defined in

this proposed rule. Proposed 1.904would also provide that a receiver doesnot include an individual consumer ora person who receives or holds food on

behalf of an individual consumer andwho is not also a party to the transactionand who is not in the business ofdistributing food, e.g., such as a hotelconcierge or the reception desk in anapartment building who is not holdingthe food for commercial purposes.

Within the transportation industry,shippers may direct goods to receiversin a single segment trip wherein theshipment proceeds directly to the

ultimate consignee, or in multi-segmenttrips that proceed through intermediatedestinations, such as a temporarystorage point. Therefore, this proposeddefinition will provide that all personswho receive food after transportation,not just the ultimate consignee, aresubject to the requirements applicable toreceivers in this proposed rule.

Proposed 1.904 would define shelf-stable food to mean a food that can bestored under ambient temperature andhumidity conditions and, if the packageintegrity is maintained, will not spoil or

become unsafe throughout its storagelife. We based this proposed definition

on several inherently similar definitionsof this term in the literature (Ref. 13)(Ref. 14) (Ref. 15) (Ref. 16). Thisdefinition provision would also providesome examples of shelf stable food,including canned juice, cannedvegetables, canned meat, bottled water,and dry food items.

Proposed 1.904 would defineshipper to mean a person whoinitiates a shipment of food by motorvehicle or rail vehicle. This definitionfurther provides that the shipper isresponsible for all functions assigned toa shipper in subpart O even if they are

performed by other persons such as aperson who only holds food andphysically transfers it onto a vehiclearranged for by the shipper. Forexample, a produce distributor (theshipper) may initiate a shipment of food

by arranging for a carrier to pick up ashipment of fresh produce at a holdingfacility for transport by truck to aproduce distribution facility hundredsof miles away. Employees of the holdingfacility who are not employed by thedistributor may load the produce ontothe truck. Under this proposed rule, the

distributor would be responsible, e.g.,through contractual arrangements, forensuring that the employees of theholding facility visually inspect thevehicle for cleanliness and determinethat it appears to be in appropriatesanitary condition for the transport ofthe food, as required by proposed 1.908(b)(2), discussed in section III.E,

and that all other requirements of thisproposed rule are met. We believe thatperiodically reviewing and updatingcontractual relationships is a commonand regular industry practice.

This definition also states that ashipper may also be a carrier or areceiver if the shipper also performs thefunctions of those respective persons asdefined in subpart O, e.g., a supermarketchain may arrange for the shipment offresh produce to be received at itsdistribution center.

We have defined the term shipperin this manner to place theresponsibilities assigned to shippers,discussed in section III.E, upon a singleperson, the initiator of a transportationoperation, as we expect this person to beknowledgeable about all factorsconcerning the food, e.g., its packagingand holding temperature requirements,relevant to its sanitary transport. Wehave tentatively concluded that definingshipper in this manner will ensure thatfood is not transported under conditionsthat may render it adulterated and alsothat placing these responsibilities on asingle person will help to avoid anyconfusion regarding who is responsiblefor the requirements of a shipper set

forth in this proposed rule.Proposed 1.904 would define small

business to mean a business, subjectto proposed 1.900(a) (discussed insection III.A) employing fewer than 500persons except that for carriers by motorvehicle that are not also shippers and/or receivers, this term would mean a

business, subject to proposed 1.900(a)having less than $25,500,000 in annualreceipts, consistent with the size basedstandard that has been established bythe U.S. Small Business Administrationfor truck transportation firms. Theproposed limit of 500 employees would

include all employees of the businessrather than be limited to the employeesat a particular facility. For all personssubject to this rule except carriers bymotor vehicle, we are proposing toestablish the same definition for a small

business as the size based standard(expressed in terms of numbers ofemployees) that has been established bythe U.S. Small Business Administrationunder 13 CFR part 121 for most foodmanufacturers. For carriers by motorvehicle, we are proposing to establishessentially the same definition for a



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small business as the size basedstandard (expressed in terms of millionsof dollars) that has been established bythe U.S. Small Business Administrationunder 13 CFR part 121 for trucktransportation firms. The definition of asmall business affects what thecompliance date is for such entities.

Proposed 1.904 would define

Time/Temperature Control for SafetyFood (TCS Food) as a food thatrequires time/temperature control forsafety to limit pathogenicmicroorganism growth or toxinformation. This proposed definition isidentical to that for the termPotentially Hazardous Food (Time/Temperature Control for Safety Food)in the 2009 Edition of FDAs Food Code(Ref. 17) and this term, having the samemeaning, is also used within theproposed preventive controls rules forhuman and animal food (78 FR 3646 at3712 and 78 FR 64736 at 64768).

Proposed 1.904 would definetransportation as any movement offood in commerce by motor vehicle orrail vehicle. This proposed definition isidentical to the definition of this term insection 416(a)(2) of the FD&C Act exceptthat we added the words of food forclarity.

Proposed 1.904 would definetransportation equipment to meanequipment used in transportationoperations, other than vehicles, e.g.,

bulk and non-bulk containers, bins,totes, pallets, pumps, fittings, hoses,gaskets, and loading and unloadingsystems and also state that

transportation equipment would alsoinclude a railcar not attached to alocomotive or a trailer not attached to atractor. We tentatively conclude thatthis definition, which encompasses allof the basic types of equipment that may

be used in food transportation, isnecessary to help ensure the safetransportation of food. The examples oftransportation equipment in thisdefinition are not all inclusive, but are

broadly representative of the types ofequipment used in food transportationas identified in the ERG report and incomments to the 2010 ANPRM.

Proposed 1.904 would definetransportation operations to mean allactivities associated with foodtransportation that may affect thesanitary condition of food including thecleaning, inspection, maintenance,loading and unloading of, and operationof vehicles and transportationequipment. This proposed definitionwould further provide thattransportation operations do not includeany activities associated with thetransportation solely of shelf stable foodthat is completely enclosed by a

container, compressed food gases, orlive food animals.

As noted previously in this section,section 416(a)(2) of the FD&C Actdefines transportation to mean anymovement in commerce by motorvehicle or rail vehicle. In establishingthis definition of transportationoperations, we intend to more

precisely define the scope of certainrequirements of this proposed rule bydistinguishing between activities thatoccur in association with foodtransportation that may render the foodadulterated and other activities that donot pose this potential. Therequirements of this proposed rulewould only apply to those activities thatmay render the food adulterated ifcarried out in an insanitary manner. Anexample of such an activity would bethe transfer of juice from a bulk tanktruck into a receivers stationary storagetanks. An example of an activity that

would not be considered to be atransportation operation under thisproposed rule would be the filling of avehicles fuel tank while it istransporting food.

In addition, the proposed definition oftransportation operations wouldexclude activities associated with thetransportation of shelf stable food that iscompletely enclosed by a container,compressed food gases, and live foodanimals. We have tentatively concludedthat shelf stable foods completelyenclosed by a container are at little riskof adulteration during transportation.They do not require temperature control

and as such, are not at risk of microbialspoilage or the growth ofmicroorganisms of public healthsignificance, and they are not directlyexposed to the transportationenvironment due to their being fullyenclosed by their container, e.g., a metalcan, a glass or plastic bottle, or a sealed

bag or box. Therefore, we havetentatively concluded that requirementsfor sanitary transportation practices donot need to apply to such foods.

Comments to the 2010 ANPRM (Ref.18) (Ref. 19) stated that compressed foodgases such as carbon dioxide used for

carbonating beverages, are transportedin cylinders or bulk containers or inbulk vehicles such as trailers or railcarsthat are dedicated to the transport of asingle product. These comments alsostated that compressed food gases donot support microbial growth and aretransported under pressure incontainers and vehicles that protectagainst chemical and physicalcontamination because they have noman-holes and only provide for exit andentry through valving. As such, we havetentatively concluded that compressed

food gases are at little risk foradulteration during transport due to themanner in which they are transportedand are proposing to exclude such foodsfrom the scope of these requirements.

We are not aware of food safetyconcerns related to the transportation oflive food animals intended for slaughterthat could be addressed through the

sanitary transportation practices setforth in this proposed rule. Nocomments to the 2010 ANPRM raisedany such concerns. Furthermore,slaughter operations at facilities subjectto FSIS jurisdiction are subject torequirements intended to minimize therisk of adulteration posed by thepresence of contaminants on theexternal surfaces of live food animals.Therefore, we have tentativelyconcluded that sanitary transportationpractices are not necessary to preventlive food animals from becomingadulterated during transportation, and

are proposing to exclude such foodsfrom the scope of these requirements.We are specifically requesting

comment on our tentative conclusionthat shelf stable food that is completelyenclosed by a container, compressedfood gases, and live food animals should

be excluded from the scope of thisproposed rule.

Further, the proposed definition oftransportation operations wouldexclude transportation activities forRACs that are performed by a farm. Weuse the term raw agriculturalcommodities as it is defined in section201(r) of the FD&C Act. We discuss the

meaning of the term in the proposedrule for preventive controls for humanfood (78 FR 3646 at 3678). Previously inthis section, we proposed that, for thepurposes of this proposed rule, the termfarm means a facility in one generalphysical location devoted to thegrowing and harvesting of crops, theraising of animals (including seafood),or both and that the term includesfacilities that pack or hold food,regardless of whether all food used insuch activities is grown, raised, orconsumed on that farm or another farmunder the same ownership. For

purposes of this proposed regulation, afarm could be a facility that alsoperforms activities other than thegrowing and harvesting of crops and theraising of animals; however, onlytransportation activities for rawagricultural commodities would beexcluded from the proposed definitionof transportation operations.

We note previously in this sectionthat the definition of the term farm inthis proposed rule differs from thedefinition of a farm in 1.227(b)(3) ofthis chapter. The definition of a farm in



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1.227(b)(3) applies only to facilitiesthat pack or hold food if the food usedin such activities was grown, raised, orconsumed on that farm or a farm underthe same ownership. The definition in 1.227(b)(3) was developed for thepurposes of implementing theregistration requirements of section 415of the FD&C Act. However, as discussed

further in the paragraphs that follow, wehave tentatively concluded that that thesanitary transportation practices thatwould be required by this proposed ruleare not necessary to prevent RACs from

becoming adulterated duringtransportation by farms regardless ofwhether the farms are conductingtransportation operations for RACs thatwere grown, raised, or consumed on thesame farm or on another farm underdifferent ownership, and therefore haveconcluded that a different definition ofthe term farm for the purposes of thisproposed rule is necessary.

We are not aware of food safetyconcerns related to the transportation ofRACs by farms that could be addressedthrough the sanitary transportationpractices set forth in this proposed rule.No comments to the 2010 ANPRMraised any such concerns. Specifically,we are not aware of instances in whichinsanitary conditions or practices (e.g.,improper temperature control, improperequipment construction, inadequateequipment cleaning) with regard totransportation operations conducted byfarms involving the transportation ofRACs have contributed to foodborne

illness. We note that this is the caseregardless of whether the farms areconducting transportation operations forRACs that were grown, raised, orconsumed on the same farm or onanother farm under different ownership.We recognize the diversity of farms andtheir transportation operations,including the size of the operation, thenature of the crop(s) being transported(e.g., large trailer loads of dry grain orlivestock, small loads of fresh produceor shell eggs), the nature of existingtransportation equipment (e.g., largetractor-trailers, small farm trucks and

wagons), and the destination of theshipment (e.g., a local cooling facility,farmers market or restaurant, a moredistant market), and the challenge thatthis diversity presents in developing aset of mandatory requirements thatwould be broadly suitable for thissector. Therefore, we have tentativelyconcluded that the sanitarytransportation practices that would berequired by this proposed rule are notnecessary to prevent RACs from

becoming adulterated duringtransportation by farms, and are

proposing to exclude such foods fromthe scope of these requirements.

The proposed exclusion is intended toapply to the activities of farms,regardless of whether the farm is servingin the role of shipper, carrier, orreceiver. We acknowledge thattransportation from farm to market isoften performed by independent carriers

as arranged by shippers or receivers thatare not farms. Similarly, farms mayarrange for transportation (i.e., serve asa shipper) by a common carrier.Transportation by independent carriers,as compared to farms, is likely to beover long distances and to involve theuse of much larger vehicles andtransportation equipment that isgenerally more consistent withequipment used outside the farm sector.Furthermore, long distancetransportation operations may involveseveral stops for dropping and pickingup additional loads. Communication

and coordination between carriers,shippers and receivers is a criticalelement in properly carrying out suchtransport. To advance best practices forthe transport of produce, the industryhas developed guidance that addressesamong other things, recommendedpractices for independent carriers (Ref.20). Building on industry experience wehave tentatively concluded that therequirements of this proposedregulation should apply to such carrierswith regard to the transportation ofRACs from farms.

We are specifically requestingcomment on our tentative conclusion

that the sanitary transportation practicesthat would be required by this proposedrule are not necessary to prevent RACsfrom becoming adulterated duringtransportation by farms. Further, we arerequesting comment on whether thedefinition of transportationoperations should include TCS rawagricultural commodities (e.g., sprouts,raw molluscan shellfish) because thetemperature control requirements ofthese commodities warrant coverageunder this proposed rule, and if so,what requirements would beappropriate.

Proposed 1.904 would definevehicle to mean a land conveyancethat is motorized, e.g., a motor vehicle,or that moves on rails, e.g., a railcar,which is used in transportationoperations. We are proposing a broaddefinition of vehicle in order toencompass all of the types of motorizedand rail conveyances that may be usedin food transportation to ensure that allsuch conveyances are subject to theprovisions of this proposed rule.Although a trailer is not motorized, wewould consider a trailer to be a vehicle

when attached to a tractor and used forfood transportation because the trailerfunctions as part of the conveyance.Similarly, railcars would be consideredto be vehicles when attached to alocomotive. The examples of vehicles inthis definition are not all inclusive, butare broadly representative of the typesof land conveyances used in food

transportation as identified in thecomments to the 2010 ANPRM.

D. Vehicles and TransportationEquipment (Proposed 1.906)

Proposed 1.906(a) would requirethat the design of vehicles andtransportation equipment used intransportation operations, the materialsused in their manufacture, and theirworkmanship be suitable and that they

be adequately cleanable for theirintended use to prevent the food thatthey transport from becoming filthy,putrid, decomposed or otherwise unfitfor food, or being rendered injurious tohealth from any source duringtransportation operations.

Comments we received in response tothe 2010 ANPRM stated that vehiclesand transportation equipment aregenerally made to meet industry andthird party standards for sanitaryfabrication, design, and construction.For example, a comment stated thatstandards for coatings may require thatthey maintain corrosion resistance, and

be free of surface delamination, pitting,flaking, chipping, blistering, anddistortion under conditions of intendeduse. However, vehicles and

transportation equipment that arepoorly designed can be a source ofcontamination of food during transport.For example, food contact surfacecoatings on vehicles or transportationequipment that are not corrosionresistant or are flaking or chipping, forexample, could contaminate foodtransported in bulk, due to chemicalcontamination or by causing the food to

become unfit, and would render thevehicles or equipment as not suitable fortheir intended use.

Similarly, vehicles and transportationequipment that are not adequatelycleanable can be a source ofcontamination of food during transport.For example, wood containers used tohold raw meat or poultry duringtransportation typically cannot be

brought to a sanitary condition to holdready to consume produce duringtransportation due to the potential forthe wood to retain contaminants such asharmful microorganisms in its porousstructure (Ref. 21). Thus, woodcontainers used to hold ready toconsume produce after their use to holdraw meat or poultry could be a source



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of contamination of the produce andFDA would not consider suchcontainers to be adequately cleanablefor the transportation of producefollowing the transportation of raw meator poultry.

We have tentatively concluded thatproposed 1.906(a) is consistent with

best practices that have been established

within the food transportation industryrelative to vehicle and equipmentdesign based upon the precedingdiscussion and the comments to the2010 ANPRM.

Proposed 1.906(b) would requirethat vehicles and transportationequipment be maintained in such asanitary condition as to prevent the foodthat they transport from becomingfilthy, putrid, decomposed, or otherwiseunfit for food, or being renderedinjurious to health from any sourceduring transportation operations.Vehicles and transportation equipmentthat are not maintained in a sanitarycondition can become a source ofcontamination of food or of allergens

being incorporated into food throughcross-contact during transport (Ref. 1).For example, FDA would not considerequipment used in bulk food transferoperations, such as pumps and hoses, to

be maintained in an appropriatesanitary condition if the equipment wasnot cleaned after its use in handlingmilk, because this failure could lead tothe incorporation of milk (a major foodallergen) through cross-contact into foodthat was subsequently handled on theequipment. We note that proposed

1.906(b) would be consistent withmeasures routinely practiced within thejuice industry to avoid the incorporationof allergens into juice by cross contact(Ref. 22).

Similarly, FDA would not considerpallets to be maintained in anappropriate sanitary condition if theyare in such poor repair, e.g., jaggedwood edges, that they could damagefood packaging causing a loss ofcontainer integrity and increasing thepotential that the food is directlycontaminated. We note that proposed 1.906(b) would also be consistent with

pallet control measures practiced withinthe food transportation industry asdescribed in a comment to the 2010ANPRM which stated that pallets usedwithin food distribution centers arecleaned and rotated or disposed of on aregular basis.

Furthermore, proposed 1.906(b) isconsistent with FDAs CGMPregulations in part 110 (21 CFR part110) (see 110.40(a) and Table 1) andthe CGMP provisions of the proposedpreventive controls rules for human andanimal food that require that equipment

and utensils in food plants be properlymaintained. As such, proposed 1.906(b) would similarly applysanitary maintenance requirements tofood transportation vehicles andequipment as such requirements have

been and will continue to be applied toequipment and utensils that are used toproduce food in facilities.

Proposed 1.906(c) would requirethat vehicles and transportationequipment used in transportationoperations for food that can support therapid growth of undesirablemicroorganisms in the absence oftemperature control duringtransportation (any food that requirestime/temperature control either toensure its safety or to prevent microbialspoilage, e.g., meat, poultry, seafood,raw seed sprouts, unpasteurized shelleggs, or pasteurized juice) be sodesigned, maintained, and equipped to

be able to maintain the food under

temperature conditions that will preventit from supporting such microbialgrowth. As discussed previously, FDA isproposing in 1.904 that the termundesirable microorganisms includesthose microorganisms that are of publichealth significance, that subject food todecomposition, that indicate that food iscontaminated with filth, or thatotherwise may cause food to beadulterated.

The use of vehicles and transportationequipment not designed, maintained, orotherwise equipped to maintain foodunder appropriate temperatureconditions can, if used to transport TCS

foods result in increased levels ofmicroorganisms capable of causinghuman illness, and cause such foods to

be adulterated. For instance,temperature control is used to minimizethe growth of pathogens in TCS foodssuch as Salmonella enteritidis (SE) inunpasteurized shell eggs and Listeriamonocytogenes, Salmonella spp., andother pathogens in other TCS foods (Ref.17) (Ref. 23) (Ref. 24) (Ref. 25) (Ref. 26).Given this, we tentatively conclude thatcertain temperature controls arenecessary to prevent TCS food from

becoming adulterated during

transportation.In addition, the use of vehicles andtransportation equipment not designed,maintained, or otherwise equipped tomaintain food under appropriatetemperature conditions can, if used totransport foods subject to microbialspoilage, result in food spoilage andcause such foods to be adulterated. Forexample, some foods that arepasteurized to ensure their safety are notprocessed to be shelf-stable. Thesepasteurized foods would still requirerefrigeration during transportation to

prevent the spoilage of the food due tothe growth of non-pathogenic spoilagemicroorganisms. For instance,pasteurized citrus juice (this term asused in this proposal excludes shelf-stable juice) requires refrigerationduring distribution to control thegrowth of non-pathogenic spoilagemicroorganisms that are not killed by

the pasteurization process, e.g., yeastsand lactobacilli (Ref. 27) (Ref. 28). Giventhis, we tentatively conclude thatcertain temperature controls arenecessary to prevent food subject tomicrobial spoilage from becomingadulterated during transportation.

We continue to receive reports orotherwise learn of foods, such as meatand some seafood products, that requiretime/temperature control to ensure theirsafety, as well as foods subject tomicrobial spoilage if temperatureabused, being transported inunrefrigerated vehicles not otherwise

equipped, e.g., with insulated coolersand ice packs, to maintain the foodunder appropriate temperatureconditions (Ref. 5) (Ref. 6) (Ref. 7) (Ref.8). We would consider unrefrigeratedvehicles or equipment used to transportfoods requiring temperature control toprevent the growth or undesirablemicroorganisms to comply withproposed 1.906(c) only if theyincorporate design features such asthermal insulation for maintaining foodin a chilled state or are otherwiseequipped to maintain the food underappropriate temperature conditions,e.g., with insulated coolers and ice

packs.The intent of proposed 1.906(c) is

consistent with our CGMP regulationsin part 110 (see 110.80(b)(6) and Table1) and the proposed preventive controlsrules for human and animal food thatrequire that food subject to theserespective regulations that can supportthe rapid growth of undesirablemicroorganisms be held at temperaturesthat will prevent the food from

becoming adulterated during prescribedoperations. Proposed 1.906(c) wouldapply appropriate holding temperaturerequirements to food transportation

vehicles and equipment as suchrequirements have been and willcontinue to be applied to facilities inwhich food is produced.

Proposed 1.906(d) would requirethat each freezer and mechanicallyrefrigerated cold storage compartment invehicles or transportation equipmentused in transportation operations forfood that can support the rapid growthof undesirable microorganisms in theabsence of temperature control duringtransportation be equipped with anindicating thermometer, temperature-



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measuring device, or temperature-recording device so installed as to showthe temperature accurately within thecompartment. This proposedrequirement would provide a means bywhich the shipper, receiver or carrier,through checking the compartmenttemperature during the operation, canensure as required by proposed

1.908(a)(3)(iii) (discussed in sectionIII.E), that the temperature conditionsduring the transportation operation aresuch that the operation meets therequirements of proposed 1.908(a)(3)and are adequate to ensure that the foodis not rendered adulterated duringtransportation. Furthermore, thisproposed requirement would provide ameans by which a shipper could verify

before loading food that each freezerand mechanically refrigerated coldstorage compartment or containeroffered by a carrier has been pre-cooledin accordance with information

submitted by the shipper, as required byproposed 1.908(b)(4) (discussed insection III.E). This proposedrequirement would also provide ameans by which officials carrying outtransportation safety inspections can,along with other inspectionalobservations, assess whether thetransportation operation is being carriedout in accord with proposed 1.908(a)(3) (discussed in section III.E).

The intent of proposed 1.906(d) isconsistent with FDAs CGMPregulations in part 110 (see 110.40(e)and Table 1) and the proposedpreventive controls rules for human and

animal food that require that eachfreezer and cold storage compartmentused to store and hold food capable ofsupporting growth of microorganisms befitted with an indicating thermometer,temperature-measuring device, ortemperature-recording device installedto show the temperature accuratelywithin the compartment. As such,proposed 1.906(d) would establishrequirements for food temperaturedisplaying devices for foodtransportation vehicles and equipmentas such requirements have been andwill continue to be applied to facilities

in which food is produced.Proposed 1.906(e) would requirethat vehicles and transportationequipment be stored in such a manneras to prevent the vehicles ortransportation equipment fromharboring pests or becomingcontaminated in any other manner thatcould result in food for which they will

be used becoming filthy, putrid,decomposed, or otherwise unfit forfood, or being rendered injurious tohealth from any source duringtransportation operations. Vehicles and

transportation equipment that harborpests or are otherwise contaminatedwhile they are stored can contaminatefood during transport if the vehicles andequipment cannot be adequatelycleaned before being used for thetransport of food. For example, FDAwould not consider trucks, railcars, orcontainers stored in such a manner that

they could develop persistent rodentpopulations in food holding areas tomeet the requirements of proposed 1.906(e).

The requirements of proposed 1.906(e) clearly represent a sanitarytransportation practice and we havetentatively concluded that theserequirements are necessary to ensurethat food is not transported underconditions that may render itadulterated. Furthermore, the intent ofthis provision is consistent with ourCGMP regulations in part 110 (see 110.35(e) and Table 1) that

recommend that cleaned and sanitizedportable equipment with food-contactsurfaces and utensils be stored in alocation and manner that protects food-contact surfaces from contamination.

E. Transportation Operations (Proposed 1.908)

1. General Requirements

Proposed 1.908(a) would set forthgeneral provisions and requirementsapplicable to transportation operations.

Proposed 1.908(a)(1) would providethat the requirements of proposed 1.908 apply to all shippers, carriers,

and receivers engaged in transportationoperations unless specifically statedotherwise. We have included thisprovision to make it clear that unless arequirement of proposed 1.908specifically only applies to shippers,receivers or carriers, the requirementapplies to all of these persons.

Proposed 1.908(a)(2) would requirethat responsibility for ensuring thattransportation operations are carried outin compliance with all requirements ofsubpart O be assigned to competentsupervisory personnel. Proposed 1.908(a)(2) is intended to ensure that

shippers, receivers, and carriers engagedin food transportation operations willidentify the requirements they mustmeet under this proposed rule andestablish accountability at theindividual level for ensuring thattransportation operations are carried outin compliance with those requirementsand in a way that prevents food from

becoming adulterated duringtransportation. This provision mirrors alongstanding provision in the currentCGMP regulation regarding themanufacturing, processing, packing, or

holding of human food (see 110.10(d)and Table 1) and essentially equivalentprovisions in the proposed preventivecontrols for both human and animalfood, which require that competentsupervisory personnel be assignedresponsibility for assuring (orensuring, in the case of the twoproposed rules) compliance with the

requirements of the regulations.Proposed 1.908(a)(3) would require

that all transportation operations beconducted under such conditions andcontrols as are necessary to prevent thefood that they are transporting from

becoming filthy, putrid, decomposed, orotherwise unfit for food, or beingrendered injurious to health from anysource during transportation operations.

This proposed provision sets forthcircumstances under which we envisionthat food could be rendered adulteratedas a result of contamination orinsanitary conditions that could occurduring a transportation operation. Forexample, if animal feed becamecontaminated by glass fragments duringtransport in an inadequately cleaned

bulk vehicle, FDA would consider thatthe transportation operation was notconducted under conditions andcontrols necessary to prevent the foodfrom being rendered injurious to animalhealth. Similarly, if a product such asshell eggs, which requires refrigerationduring transportation to ensure itssafety, was left unattended for severalhours on a loading dock on a warm day,FDA would consider that the receivingstage of the transportation operation was

not conducted under conditions andcontrols necessary to prevent the foodfrom being rendered injurious to humanhealth. Further, if pasteurized citrusjuice became spoiled during transportdue to inadequate refrigeration of theproduct, FDA would consider that thetransportation operation was notconducted under conditions andcontrols necessary to prevent the foodfrom becoming unfit for food.

Proposed 1.908(a)(3)(i), (a)(3)(ii),and (a)(3)(iii) would identify specificactions that persons engaged intransportatio

2014-02188 regla propuesta para transporte

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