05-20196 CMPAFs ProposedRule

8/12/2019 05-20196 CMPAFs ProposedRule

1/32

58570 Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005/ Proposed Rules

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2002N0273] (formerly DocketNo. 02N0273)

RIN 0910AF46

Substances Prohibited From Use inAnimal Food or Feed

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

SUMMARY : The Food and DrugAdministration (FDA) is proposing toamend the agencys regulations toprohibit the use of certain cattle originmaterials in the food or feed of allanimals. These materials include thefollowing: The brains and spinal cords

from cattle 30 months of age and older,the brains and spinal cords from cattleof any age not inspected and passed forhuman consumption, the entire carcassof cattle not inspected and passed forhuman consumption if the brains andspinal cords have not been removed,tallow that is derived from the materialsprohibited by this proposed rule thatcontains more than 0.15 percentinsoluble impurities, and mechanicallyseparated beef that is derived from thematerials prohibited by this proposedrule. These measures will furtherstrengthen existing safeguards designed

to help prevent the spread of bovinespongiform encephalopathy (BSE) inU.S. cattle.DATES : Submit written or electroniccomments by December 20, 2005.Submit written comments on theinformation collection provisions byNovember 7, 2005.ADDRESSES : You may submit comments,identified by [Docket No. 2002N0273or RIN 0910AF46], by any of thefollowing methods:Electronic Submissions

Submit electronic comments in thefollowing ways:

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

Agency Web site: http://www.fda.gov/dockets/ecomments .Follow the instructions for submittingcomments on the agency Web site.Written Submissions

Submit written submissions in thefollowing ways:

FAX: 3018276870. Mail/Hand delivery/Courier [For

paper, disk, or CDROM submissions]:Division of Dockets Management (HFA

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

To ensure more timely processing ofcomments, FDA is no longer acceptingcomments submitted to the agency by e-mail. FDA encourages you to continueto submit electronic comments by usingthe Federal eRulemaking Portal or theagency Web site, as described in theElectronic Submissions portion of thisparagraph.

Instructions : All submissions receivedmust include the agency name andDocket No(s). or Regulatory InformationNumber (RIN) for this rulemaking. Allcomments received may be postedwithout change to http://www.fda.gov/ohrms/dockets/default.htm , includingany personal information provided. Fordetailed instructions on submittingcomments and additional informationon the rulemaking process, see theComments heading of theSUPPLEMENTARY INFORMATION section ofthis document.

Docket : For access to the docket toread background documents orcomments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docketnumber(s), 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 : BurtPritchett, Center for Veterinary

Medicine (HFV222), Food and DrugAdministration, 7519 Standish Pl.,Rockville, MD 20855, 2404536860, e-mail: [email protected] .SUPPLEMENTARY INFORMATION :

Table of ContentsI. Background

A. Bovine SpongiformEncephalopathy

B. Current Animal Feed Safeguards inthe United States

C. Risk of BSE in North AmericaD. Additional Measures Considered to

Strengthen Animal Feed Safeguards

1. Comments on November 6, 2002Advance Notice of ProposedRulemaking (ANPRM)

2. Actions in Response to WashingtonState Case

3. Comments on July 14, 2004ANPRM

II. Proposed Measures to StrengthenAnimal Feed Safeguards

A. FDA Response to Comments to the2004 ANPRM

B. Additional Measures to FurtherStrengthen Feed Protection

C. Basis for Proposing to Apply

Additional Measures to All AnimalFood and Feed

D. Cattle Materials Proposed to beProhibited From Use in All AnimalFood and Feed

E. Disposal of Cattle MaterialsProhibited in Animal Feed

III. Description of Proposed Rule andLegal Authority

A. DefinitionsB. Proposed RequirementsC. Proposed Recordkeeping and

Access RequirementsD. Conforming Changes to 21 CFR

589.2000Animal ProteinsProhibited in Ruminant Feed

E. Legal AuthorityIV. Analysis of Economic Impacts

A. Summary of Proposed RegulatoryImpact Analysis

B. Need for RegulationC. BenefitsD. CostsE. Government CostsF. Sensitivity AnalysisG. Regulatory Flexibility Analysis

V. Paperwork Reduction ActVI. Environmental ImpactVII. FederalismVIII. CommentsIX. References

I. Background

A. Bovine Spongiform EncephalopathyBSE belongs to the family of diseases

known as transmissible spongiformencephalopathies (TSEs). In addition toBSE, TSEs also include scrapie in sheep

and goats, chronic wasting disease(CWD) in deer and elk, and Creutzfeldt- Jakob disease (CJD) in humans. Theagent that causes BSE and other TSEshas yet to be fully characterized. Themost widely accepted theory in thescientific community is that the agent isan abnormal form of a normal cellularprion protein. The abnormal form of theprion protein is less soluble and moreresistant to heat degradation than thenormal form. The abnormal prion doesnot evoke any demonstrated immuneresponse or inflammatory reaction inhost animals. BSE is diagnosed bypostmortem microscopic examination ofan animals brain tissue and bydetection of the abnormal form of theprion protein in an animals braintissue. There is currently no availabletest to detect the disease in a liveanimal.

Since November 1986, there have been more than 180,000 confirmed casesof BSE in cattle worldwide. Over 95percent of all BSE cases have occurredin the United Kingdom, where theepidemic peaked in 1992/1993, withapproximately 1,000 new cases reported

VerDate Aug2005 17:23 Oct 05, 2005 Jkt 208001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\06OCP3.SGM 06OCP3


2/32

58571Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005/ Proposed Rules

per week. In addition to the UnitedKingdom, the disease has beenconfirmed in native-born cattle in 22European countries and in somenonEuropean countries, including

Japan, Israel, Canada, and the UnitedStates.

Epidemiological studies havecharacterized the outbreak of BSE in theUnited Kingdom as a prolongedepidemic arising at various locations,with all occurrences due to a commonsource, and have suggested that feedcontaminated by a TSE agent was thecause of the disease outbreak (Ref. 1).The subsequent spread of BSE wasassociated with the feeding of meat-and-

bone-meal from rendered BSE-infectedcattle to non-infected cattle (Ref. 1). Itappears likely that the BSE agent wastransmitted among cattle at anincreasing rate by ruminant-to-ruminantfeeding until the United Kingdom banon such practices went into effect in

1988 (Ref. 2).Agricultural officials in the UnitedKingdom have taken a series of actionsto eliminate BSE. These actions includemaking BSE a reportable disease,

banning mammalian meat-and-bonemeal in feed for all food-producinganimals, prohibiting the inclusion ofanimals more than 30 months of age inthe animal and human food chains, anddestroying all animals showing signs ofBSE. As a result of these actions, mostnotably the feed bans, the rate of newlyreported cases of BSE in the UnitedKingdom has decreased sharply andcontinues on a downward trend.

In 1996, a newly recognized form ofthe human disease CJD, referred to asvariant CJD (vCJD), was reported in theUnited Kingdom. Scientific andepidemiological studies have linkedvCJD to exposure to the BSE agent, mostlikely through human consumption of

beef products contaminated with theagent. To date, approximately 150probable and confirmed cases of vCJDhave been reported in the UnitedKingdom, where there had likely been ahigh level of contamination of beefproducts. It is believed that in theUnited States, where measures to

prevent the introduction and spread ofBSE have been in place for some time,there is far less potential for humanexposure to the BSE agent. The Centersfor Disease Control and Prevention(CDC) leads a surveillance system forvCJD in the United States. To date, CDC,has not detected vCJD in any resident ofthe United States that had not lived inor traveled to the United Kingdom forextended periods of time. In 2002, aprobable case of vCJD was reported ina Florida resident who had lived in theUnited Kingdom during the BSE

epidemic. Epidemiological data indicatethat the patient likely was exposed tothe BSE agent before moving to theUnited States.B. Current Animal Feed Safeguards inthe United States

In the Federal Register of June 5, 1997(62 FR 30936) (the 1997 ruminant feed

final rule), FDA published a final ruleto provide that animal protein derivedfrom mammalian tissues is prohibitedfor use in ruminant feed. Although BSEhad not been identified in the UnitedStates at that time, the 1997 ruminantfeed final rule was put in place toprevent the establishment andamplification of BSE in the UnitedStates through animal feed and therebyminimize risk to humans and animals.The 1997 ruminant feed final rulecreated a new 589.2000 (21 CFR589.2000), Animal proteins prohibitedin ruminant feed, and established asystem of controls to ensure thatruminant feed did not contain animalprotein derived from mammaliantissues. The 1997 ruminant feed finalrule set out requirements for personswho manufacture, process, blend, ordistribute certain animal proteinproducts or ruminant feeds containingsuch products.

The 1997 ruminant feed final rule( 589.2000) prohibits the use ofmammalian-derived proteins inruminant feed, with the exception ofcertain proteins believed at that time notto pose a risk of BSE transmission.These exceptions to the definition ofprotein derived from mammaliantissues included: Blood and bloodproducts; gelatin; inspected meatproducts which have been cooked andoffered for human food and further heatprocessed for feed (such as plate wasteand used cellulosic food casings),referred to herein as plate waste milkproducts (milk and milk protein); andany product whose only mammalianprotein consists entirely of porcine orequine protein. The 1997 ruminant feedfinal rule does not prohibit ruminantanimals from being fed processedanimal proteins derived from

nonmammalian species (e.g., avian oraquatic animals). The 1997 ruminantfeed final rule permits the manufactureof non-ruminant feed containingprohibited mammalian protein andruminant feed on the same premises,provided that separate equipment isused in the production of ruminant feedor that documented adequate clean-outprocedures are used betweenproduction batches.

Following the discovery of a BSEpositive cow in Washington State inDecember 2003, FDA provided guidance

on the use of materials from BSEpositive cattle. In Guidance for Industry,Use of Material from BSE PositiveCattle in Animal Feed, published inthe Federal Register in September 2004(69 FR 58448), FDA stated its view thatunder section 402(a)(5) of the FederalFood, Drug, and Cosmetic Act (the act)(21 U.S.C. 342(a)(5)), animal feed andfeed ingredients containing materialsderived from a BSE-positive animal areconsidered adulterated and should berecalled or otherwise removed from themarketplace.

C. Risk of BSE in North America

In April 1998, the United StatesDepartment of Agriculture (USDA)contracted with the Harvard Center forRisk Analysis (HCRA) at HarvardUniversity and the Center forComputational Epidemiology atTuskegee University to conduct acomprehensive investigation of the BSE

risk in the United States. The report,(Ref. 3) widely referred to as theHarvard Risk Assessment or the HarvardStudy, is referred to in this document asthe Harvard-Tuskegee Study. The studywas completed in 2001 and released byUSDA. Following a peer review of theHarvard-Tuskegee Study in 2002, theauthors released a revised riskassessment in 2003 (Ref. 4).

The Harvard-Tuskegee Studyreviewed available scientificinformation related to BSE and otherTSEs, assessed pathways by which BSEcould potentially occur in the United

States, and identified measures thatcould be taken to protect human andanimal health in the United States. Theassessment concluded that the UnitedStates is highly resistant to anyproliferation of BSE, and that measurestaken by the U.S. Government andindustry make the United States robustagainst the spread of BSE.

The Harvard-Tuskegee Studyconcluded that the most effectivemeasures for reducing potentialintroduction and spread of BSE are asfollows: (1) The ban placed by USDA sAnimal and Plant Health Inspection

Service on the importation of liveruminants and ruminant meat-and-bonemeal from the United Kingdom since1989 and all of Europe since 1997 and(2) the feed ban instituted in 1997 byFDA to prevent recycling of potentiallyinfectious cattle tissue. The Harvard-Tuskegee Study further indicated that, ifintroduction of BSE had occurred viaimportation of live animals from theUnited Kingdom before 1989, mitigationmeasures already in place would haveminimized exposure and begun toeliminate the disease from the cattle



3/32


population even assuming less thancomplete compliance with the feed ban.

The Harvard-Tuskegee Study alsoidentified pathways or practices that, ifaddressed, would further decrease thealready low risk of spread BSE if it wereintroduced into the United States. Theseinclude the following: (1) Failing tocomply with FDA s ruminant feedregulations that prohibit the use ofcertain proteins in feed for cattle andother ruminants; and (2) rendering ofanimals that die on the farm (consideredthe highest risk cattle), and thenincorporating (through illegal diversionor cross-contamination) the renderedproduct in ruminant feed. The Harvard-Tuskegee Study s independentevaluation of the potential additionalrisk mitigation measures predicts that aprohibition against rendering of animalsthat die on the farm would reducepotential new cases of BSE in cattlefollowing a hypothetical introduction of

10 infected animals by 80 percent (from4.3 to 0.77 cases) as compared to the base case scenario, (i.e., present state ofthe U.S. cattle population, along withgovernment regulations and prevailingagricultural practices, and anassumption of less than completecompliance with the feed ban) (Ref. 4).Further, the study evaluated the impactof a specified risk materials (SRMs) banthat would prohibit high risk materialssuch as the brain, spinal cord, vertebralcolumn and animals that die on thefarm, from inclusion in human andanimal food. The analysis predicts thatthis measure would reduce potentialnew BSE cases in cattle following ahypothetical introduction of teninfected animals by 90 percent (from 4.3to 0.53 cases).

In 2003, following the detection ofBSE in a native-born cow in Canada, theHCRA evaluated the implications of athen-hypothetical introduction of BSEinto the United States (Ref. 5), using thesame simulation model developed forthe initial Harvard-Tuskegee Study. Theresults of this assessment wereconsistent with the conclusions of theearlier study namely, that the UnitedStates presents a very low risk of

establishing or spreading BSE should it be introduced.On December 23, 2003, USDA

announced that a dairy cow inWashington State had tested positive forBSE. The results were confirmed onDecember 25, 2003, by the VeterinaryLaboratories Agency in Weybridge,England. Immediately after thediagnosis was confirmed, USDA, FDA,and other Federal and State agenciesinitiated an epidemiologicalinvestigation (Ref. 6), and beganworking together to trace any potentially

infected cattle, trace potentiallycontaminated rendered product,increase BSE surveillance, and takeadditional measures to address risks tohuman and animal health. Theepidemiological investigation and DNAtest results confirmed that the infectedcow was born and most likely becameinfected in Alberta, Canada, beforeCanada s 1997 implementation of a banon feeding mammalian protein toruminants.

On January 22 through 24, 2004, theSecretary of Agriculture convened aninternational panel of experts on BSE.The panel, referred to as theInternational Review Team (IRT), wasasked to: (1) Assess the epidemiologicalinvestigation conducted in response tothe BSE case in Washington State, (2)provide expert opinion about when theactive phase of the investigation should

be terminated, (3) consider the responseactions of the United States to date, and

(4) provide recommendations aboutactions that could be taken to provideadditional meaningful human or animalhealth benefits in light of the NorthAmerican experience. The IRT providedits report on February 4, 2004.

In May 2004, USDA contracted withHCRA to update the BSE riskassessment model to reflect its January2004 rulemaking to prohibit SRMs andcertain other cattle material in humanfood. HCRA was also asked to updatethe parameters in the model forcompliance with FDA s feed ban. HCRAwas also asked to model the impact thatthe IRT recommendation would have onthe BSE risk to humans and cattle.In December 2004, Canada announcedthat a third North American cow testedpositive for BSE. An ongoingepidemiologic investigation found thatthis animal, an 8-year-old,nonambulatory dairy cow, originated inAlberta, Canada and was born before theCanadian feed ban went into effect inAugust 1997. Shortly thereafter, in

January 2005, another cow in Albertawas found to be positive for BSE. Thiscase involved a beef cow born in March1998, 6 months after the Canadian feed

ban went into effect. Based on

preliminary information, Canada believes that the most likely source ofinfection in this animal was feedproduced before implementation ofCanada s feed ban (Ref. 7).

In June 2005, USDA announced thata 12-year-old beef cow, born and raisedin Texas, was confirmed BSE positive.The BSE-positive cow most likely

became infected before FDA simplementation of the 1997 ruminantfeed final rule. It was determined thatno part of the animal entered the humanfood or animal feed chains.

D. Additional Measures Considered toStrengthen Animal Feed Safeguards

1. Comments on November 6, 2002,Advance Notice of ProposedRulemaking (ANPRM)

In the Federal Register of October 5,2001 (66 FR 50929), FDA announced itsplan for an October 30, 2001 public

hearing in Kansas City, MO, to solicitcomments from the public on the 1997ruminant feed regulation. Recognizingthat new information had emerged sincepublication of the feed rule in 1997,FDA requested comments on whetherchanges to the rule or other additionalmeasures were necessary (Ref. 8).Information obtained from the publichearing and from the Harvard-TuskegeeStudy was used in the publication of anANPRM (2002 ANPRM) in the FederalRegister of November 6, 2002 (67 FR67572). This ANPRM sought commentfrom affected industries and the publicon possible ways to strengthen the 1997ruminant feed regulation. The ANPRMspecifically asked for comments on anumber of questions related to thefollowing five aspects of the BSE feedregulation: (1) Excluding brain andspinal cord from rendered animalproducts, (2) prohibiting the use ofpoultry litter in cattle feed, (3) assessingthe improper use of pet food as a feedfor ruminants, (4) preventing cross-contamination, and (5) eliminating theplate waste exemption.

The predominant view of those whosubmitted comments in response to theANPRM was that the BSE risk in theUnited States was low enough that nonew feed controls were needed. Mostsaid that the current feed ban providedmore than adequate protection againstBSE, that there was no scientificjustification for additional regulations,that compliance with the 1997 ruminantfeed final rule was extremely high, andthat over 19,900 USDA surveillancesamples in 2002 alone failed to detectBSE in U.S. cattle. They also cited theHarvard-Tuskegee Study conclusionthat existing control measures made therisk to U.S. cattle and to U.S. consumersfrom BSE very low.

In the 2002 ANPRM, FDA said thatthe Harvard-Tuskegee Study identifiedthe removal of high-risk bovine tissues,such as brain, spinal cord, intestine, andeyes, from human food and fromrendered material for all animal feed asa way to reduce the potential exposureof cattle and humans to the BSE agent.The 2002 ANPRM then asked forcomments on the following threequestions related to SRMs: (1) Shouldhigh risk materials be excluded fromrendered products?; (2) how feasiblewould it be for the rendering industry



4/32


to implement such an exclusion?; and(3) what will be the adverse and positiveeconomic, environmental, and healthimpacts from an exclusion?

Comments in support of an SRM banincluded one comment from USDAciting conclusions from the Harvard-Tuskegee Study that this action wouldsignificantly reduce the amount ofinfectivity in the animal feed chain, andwould reduce risks resulting fromleaks in the feed ban. Othercomments stressed the infectivity ofthese tissues, and the recommendation

by the World Health Organization(WHO) that countries exclude thesetissues from the animal and human foodchain (Ref. 9).

Comments opposing an SRM ban saidthat the measure would be redundant

because the 1997 ruminant feed finalrule already prohibits this high-riskmaterial in ruminant feed. Therefore,the ban would only be beneficial if BSEwere present in the United States andthere were significant non-compliancewith the feed ban. The comments alsocited the conclusions of the Harvard-Tuskegee Study that the risks of BSE inthe United States are low. One commentsaid that restrictions on SRMs in animalfeed should be decoupled fromrestrictions for human food because ofthe substantial reduction in infectivityobtained during rendering. Anothercomment said that an SRM ban wouldgive only the perception of a riskreduction, not a real reduction, and thatit would send the message to our tradingpartners that our BSE risks are such thatmore controls are needed. Australiaasked that, if an SRM ban isimplemented, the ban not apply toAustralia because of its widelyrecognized status as a low-risk BSEcountry.

Numerous comments addressed thefeasibility and the adverse economicimpacts of an SRM ban. One commentpointed out that it is not feasible toremove central nervous system (CNS)tissue from decomposing carcasses.Comments from a trade association saidthat an SRM ban would require costlyrestructuring of facilities that would

force many small rendering plants out of business, depriving some parts of thecountry access to rendering as a meansof animal disposal. A June 2002 SparksReport estimated disposal costs of anSRM ban to be $54 million, based on theassumption that the ban would apply toall cattle because of the difficulty ofdetermining the age of cattle at slaughter(Ref. 10). According to an earlier 1996Sparks Report, the cost of disposal of 1.7

billion pounds of CNS tissue and deadstock would exceed $400 million.Another estimate for disposal was $50

million for the beef industry alone. Onecomment said that feed costs accountfor 70 percent of poultry productioncost, and that renderers would pass onthe costs of excluding brains and spinalcords to the poultry industry.

Several comments mentioned theenvironmental impact of an SRM ban.One comment stated that a total ban onSRMs in rendered animal productswould create a waste stream with noeconomic value. Another comment saidthat a ban on SRMs would encourageimproper disposal of dead stock becausethere are no federal regulations ondisposal of dead animals.2. Actions in Response to WashingtonState Case

In response to the BSE case identifiedin Washington State, USDA publishedan interim final rule in the FederalRegister of January 12, 2004 (69 FR1861), excluding high-risk tissues fromhuman food. The interim final ruleprohibited the use of SRMs and certainother cattle material in USDA-regulatedhuman food. USDA defined SRMs as

brain, skull, eyes, trigeminal ganglia,spinal cord, vertebral column(excluding the vertebra of the tail, thetransverse processes of the thoracic andlumbar vertebrae, and the wings of thesacrum), and dorsal root ganglia (DRG)of cattle 30 months of age and older, andthe tonsils and distal ileum of the smallintestine of cattle of all ages. To ensureeffective removal of the distal ileum,USDA requires that the entire smallintestine be removed and disposed of asinedible product. In its January 12,2004, interim final rule, USDA took theadditional step of making cattle that areunable to rise from a recumbentposition, referred to in this document asnonambulatory disabled cattle,ineligible to be slaughtered for humanconsumption.

On January 26, 2004, FDA announcedits intention to implement additionalmeasures to strengthen existing BSEsafeguards for FDA-regulated products.These measures included the issuanceof an interim final rule to implementadditional measures related to animal

feed. The interim final rule would haveimplemented four specific measuresrelated to animal feeds. These measuresincluded the elimination of theexemptions for blood and bloodproducts and plate waste from the1997 ruminant feed rule, a prohibitionon the use of poultry litter in ruminantfeed, and a requirement for dedicatedequipment and facilities to preventcross-contamination.

However, on February 4, 2004, IRTreleased its report on measures relatedto BSE in the United States. The report

recommendations included a somewhatdifferent set of measures for reducingthe risks associated with animal feedthan the measures FDA had announcedthat it intended to implement throughan interim final rule. Although FDA

believed its previously announcedmeasures would serve to reduce thealready small risk of BSE spreadthrough animal feed, the broadermeasures recommended by the IRT, ifimplemented, could make some of thepreviously announced measuresunnecessary. FDA believed thatadditional information was needed todetermine the best course of action inlight of the IRT recommendations anddecided to publish an ANPRM, whichrequested comments on therecommendations of the IRT, as well ason other measures under considerationto protect the animal feed supply.

Consistent with measuresimplemented by USDA to exclude high-

risk cattle tissues from human food (69FR 1861), FDA published an interimfinal rule on July 14, 2004 (69 FR42255), prohibiting a similar list of riskmaterials from FDA-regulated humanfood, including dietary supplements,and cosmetics.3. Comments on July 14, 2004, ANPRM

In the Federal Register of July 14,2004 (69 FR 42287), FDA published anANPRM (2004 ANPRM) jointly withUSDA in which FDA announced itstentative conclusion that it shouldpropose banning SRMs in all animalfeed. In this ANPRM, FDA asked forcomment on this measure and also onthe IRT s recommendations to requirededicated equipment or facilities forfeed manufacture and transport, and itsrecommendation to prohibit the use ofall mammalian and poultry protein inruminant feed. Finally, FDA also askedfor comment on the set of measures thatthe agency had announced in January2004. Comments submitted in responseto the 2004 ANPRM that relate to SRMsare summarized in sections I.D.3athrough I.D.3f by general topic area.

a. Need for SRM ban . As with thecomments received in response to the

2002 ANPRM, many commentsquestioned the need for an SRM ban atthe time of the 2004 ANPRM. Severalcomments argued that the comparisonmade by the IRT between the BSEsituations in Europe and the UnitedStates is inappropriate. One reasongiven for the invalid comparison wasthat there were an estimated 3 to 4million undiagnosed BSE cases in theUnited Kingdom, compared to twodiagnosed cases in North America incattle born before feed restrictions wereimplemented. Another comment said



5/32


that the United States did, in fact, learnfrom the European experience andimplemented controls early so thatpotential animal exposure to the BSEagent in the United States remainsexceedingly small compared to themassive exposure in the UnitedKingdom. One comment submitted bythe agriculture department of a statewith a large agriculture industry saidthat its findings from 600 inspections donot support the premise of the IRT srecommendation that an SRM ban isneeded to address problems of cross-contamination and on-farm misfeeding.The state indicated that, in theseinspections, it did not observe anyprohibited materials or feed containingprohibited materials on farms whereruminant feeds were being mixed.

Other comments said that thereduction in risk obtained through anSRM ban would be minimal, mostlyciting the effectiveness of the current

firewalls in reducing BSE infectivity inthe cattle population. One commentsaid that the Harvard-Tuskegee Studyconclusion that an SRM ban will reducepotential cattle exposure to BSEinfectivity by 88 percent sounds moreimpressive than it really is. Reducing avery small risk by 88 percent does notnecessarily provide significant riskreduction.

Finally, many comments questionedFDAs decision to ban SRMs fromanimal feed before the results of USDA senhanced BSE surveillance program areknown. USDA s one-time effort to test asmany high-risk cattle as possible wasstarted on June 1, 2004, and wasexpected to be completed by the end of2005. One comment pointed out that theIRTs recommendations for definingSRMs are predicated on the outcome ofthis aggressive surveillance program.

In support of FDA s tentativeconclusion that it should propose to banSRMs from all animal feed, manycomments cited the conclusion of theHarvard-Tuskegee Study that an SRM

ban will provide additional riskreduction, and also cited therecommendation of the IRT that SRMsshould be excluded from all animal

feed, including pet food. One commentsaid that an SRM ban would restoreconfidence in U.S. beef exports.

b. Definition of SRMs . SRMs aretypically defined as the tissues in whichBSE infectivity has been demonstratedin experimentally or naturally infectedanimals. SRMs are further defined bythe OIE Terrestrial Animal Health Code

based on the age of the animal and theBSE risk status of a country. In the 2004ANPRM, FDA asked how SRMs should

be defined for animal feed, specifically,if the SRM list should be the same list

as for human food. FDA also asked whatinformation is available to supporthaving two different lists.

Comments from one organizationincluded data from the Harvard-Tuskegee Report on the relativeinfectivity of specific tissues. These datawere based on pathogenesis studiescarried out in the United Kingdom andshowed the fraction of total infectivityof each tissue to be: Brain 64.1 percent;spinal cord 25.6 percent; dorsal rootganglia 3.8 percent; trigeminal ganglia2.6 percent; distal ileum 3.3 percent;tonsil


6/32


increasing environmental problems dueto improper disposal of animalcarcasses. Concerns were also expressedabout lack of infrastructure for non-feeddisposal of dead stock, and the seriouseconomic impact of diverting theseanimals to alternative disposal.

In response to the question in the2004 ANPRM about effective removal ofSRMs from dead stock andnonambulatory disabled cattle, severalcomments stated that such removalwould not be economically ortechnically feasible. Other commentsstated that SRM material could beeffectively removed because there is nosubstantial difference between theprocessing of dead and nonambulatoryanimals at rendering facilities and theprocessing of healthy cattle at slaughterplants. One other comment mentionedinstances where some USDA-inspecteddeboning facilities already removeSRMs from dead cattle at the request of

pet food manufacturers. This commentalso said that, based on their experience,SRMs can be removed from dead cattlein all but the hottest months of the yearwhen the rate of decompositionincreases. Another comment said thatremoving SRMs from dead stock mayincrease exposure of plant employees topathogens and zoonotic diseases.

One comment noted that theEuropean experience has shown thatcattle at highest risk for BSE are deadcattle, downer cattle, and ante-mortemcondemned cattle over 30 months ofage. This comment said that, while it ispossible to remove the meat from thesecarcasses for use in pet food, they arenot aware of any way of verifying theremoval of SRMs from dead andnonambulatory cattle (short of activegovernment oversight) that would allowthis material to be rendered for use infeeds for non-ruminant animals.Another comment suggested that as anoption for reducing the amount ofmaterial for disposal, dead stock under30 months of age be allowed to berendered for feed use. This commentalso said that USDA could test deadstock over 30 months of age, allowingmaterial from negative animals to be

used in feed.d. Small intestine . The 2004 ANPRMalso requested information to evaluatethe IRT recommendation that the entireintestine from cattle of all ages should

be excluded from the human and animalfood chains. With publication of itsinterim final rule on January 12, 2004,USDA required that the entire smallintestine be disposed of as inedible.Likewise, FDA prohibited the use of theentire small intestine in FDA-regulatedhuman food and cosmetics, even thoughthe agency only considers the distal

ileum portion of the small intestine to be a specified risk material (69 FR42259).

However, based on commentsreceived in response to the FDA interimfinal rule on human food and cosmetics,FDA concluded that processors have thetechnology to effectively remove thedistal ileum portion from the rest of thesmall intestine. Thus, FDA amended thehuman food and cosmetics interim finalrule to state that the small intestine isnot considered prohibited cattlematerial if the distal ileum is removed

by a procedure that removes at least 80inches of the uncoiled and trimmedsmall intestine as measured from thecaeco-colic junction and progressingproximally towards the jejunum or by aprocedure that the establishment candemonstrate is equally effective inensuring complete removal of the distalileum (70 FR 53063, September 7, 2005).This amendment is consistent with

USDA requirements (70 FR 53043,September 7, 2005).Many comments in response to the

2004 ANPRM stated that inclusion ofthe entire small intestine from cattle lessthan 30 months of age in the list ofprohibited material would double thevolume of SRMs from slaughterrequiring alternative disposal whileonly marginally decreasing infectivity.Several comments stated that only thedistal ileum should be included in thelist of SRMs and noted that it is easilyidentified for separation at slaughter.

One comment questioned the need todesignate the intestinal tract as SRM,pointing out that the distal ileumaccounts for only 5 percent ofinfectivity, which is reduced by twologs during rendering. Anothercomment said that it was unnecessary todesignate any portion of the intestinaltract of cattle less than 30 months of ageas SRM because these animals were

born 4 1/2 years after the feed ban wasimplemented, and are therefore low riskanimals. Several comments said that, ifpackers can demonstrate a satisfactorytechnique, they should be allowed toremove only the distal ileum rather thanthe entire small intestine.

One comment expressing concernabout the BSE risk associated with bovine intestines said that research inthe United Kingdom found positiveimmunostaining for the resistant form ofthe prion protein along the length of theintestine, which provides evidence thatthe entire intestine should beconsidered SRM.

e. Infrastructure for alternativedisposal . We received a number ofcomments addressing the issue ofdisposal infrastructure. One commentnoted that the IRT recognized that an

infrastructure was not in place todispose of SRM material and that theIRT had suggested that a stagedimplementation may be necessary toallow this infrastructure to develop. Onecomment said that before an SRM banis implemented a comprehensive planfor disposal of this material needs to bedeveloped. Another comment noted thatin Texas, SRMs are considered specialwaste, and that no landfill in the stateis capable of accommodating a largevolume of this material. Additionalcomments indicated that this concernwas also true for other states, includingNebraska and Utah.

Two organizations submittedslaughter and cattle mortality data toemphasize the amount of waste thatwould be generated by regulations thatwould exclude this material from beingrendered for use in animal feed. One ofthese organizations said that it is deeplyconcerned that FDA fails to recognizethat a suitable disposal infrastructuredoes not exist to deal with the very largequantities of SRMs that would begenerated on a daily basis. Its estimatefor the volume of waste generated fromslaughter and cattle mortalities was 2

billion pounds per year. The otherorganization submitted similarcomments saying that the U.S. system iscurrently unprepared to manage thewaste disposal challenges certain toarise if significant quantities of livestockmortalities and slaughter byproductsrequire disposal by means other thanrendering. The comments further stated

that the disposal and environmentalchallenges resulting from the ban would be faced immediately, but the solutionsto these challenges would arise onlyafter significant time and financialinvestment across the livestock sector.The comments also said that there is anabsence of direct regulatory control overalternative methods of disposing of theenormous quantities of this unpleasantmaterial.

Another comment suggested thatrenderers should be allowed to dedicatelines to SRM material and SRM-freematerial within a single facility.

Equipment for receiving, grinding,cooking, processing, and conveyingcould be dedicated lines, while thefacility itself, including the utilities,odor control, and wastewater treatmentsystems be shared. Further, anothercomment suggested FDA work with therendering industry to develop cleanoutprocedures that would allow a plant toprocess both SRMs and SRM-freematerial. These procedures would behelpful to allow for seasonal deerrendering, for cleaning up afteraccidental cross-contamination, and for



7/32


converting a facility back to SRM-freerendering.

One comment addressed the use ofrendered SRM material as an alternativefuel source for cement kilns, indicatingthat ruminant meat and bone meal andfat are being used as a fuel source inEurope and Japan. According to thecomment, these materials burnefficiently, and the heat from the kilnleaves virtually no organic residue.

f. Verification of SRM removal andSRM marking . One comment stated that,in the absence of a practical test forverification of SRM removal, thedocumentation required by HACCPplans should be sufficient to show thatSRMs at slaughter are excluded fromanimal feed channels. Thus, inspectionsof records could be used to verify SRMremoval. Also, the comment stated thatFDA can verify SRM removal by shiftingresources from inspections of thousandsof feed mills and farms to the much

smaller number of slaughter plants andrenderers.One comment stated that rendering

plants are capable of keeping rawmaterials from various sourcesseparated and capable of usingproduction, inventory, and shippingrecords to document the movement of

both SRM and SRM-free materials. Suchmanagement practices can be verified byinspection, much like those conductedat USDA-inspected cattle slaughterfacilities. The comment went on to saythat, if a rendering plant is dedicated torendering only SRMs, such a plant willhave to be inspected to determine howit disposes of SRMs.

Two comments suggested that raw orSRM-derived rendered materials can beeffectively marked using automaticdosage pumps to dispense markers likeglyceroltriheptanoate (GTH). GTH is aC7 synthetic fatty acid not found innature. A gas chromatography (GC)method for its detection is available.Charcoal was mentioned as anotherpotential marker for use in renderedproducts.

II. Proposed Measures to StrengthenAnimal Feed Safeguards

A. FDA Response to Comments to the2004 ANPRM

FDA agrees with the numerouscomments saying that it is important tokeep the BSE risk in the United Statesin proper perspective. FDAacknowledges that the risk is likely low,and acknowledges that it isinappropriate to compare the BSEsituation in the United States to thesituation in Europe. However, FDAdisagrees with comments concludingthat for these reasons no additional

measures are needed. Even thoughstrong control measures have been putin place and compliance with thecurrent BSE feed regulation is high byrenderers, protein blenders and feedmills, the Agency is concerned, asdiscussed further below, about suchissues as the presence of high riskmaterial in the non-ruminant feedsupply and cross-contamination ofruminant feed during the rendering orfeed manufacturing process. Forexample, without fully dedicatedequipment, it may not be possible toverify that there is zero carryover of feedor feed ingredients in equipment, evenwhere a firm s cleanout procedures have

been judged to be adequate. In addition,resource constraints limit FDA s abilityto assure full compliance by allsegments of the industry that are subjectto the current BSE feed regulation. Forexample, resources are not available tothe FDA and its state counterparts to

fully verify compliance on over 1million farms where cattle are being fed.FDA does not agree with comments

that the agency should wait until USDAcompletes its enhanced BSEsurveillance program before deciding ifadditional feed controls are needed. Asstated in the July 2004 ANPRM, FDAhad tentatively decided based on clearevidence that the BSE agent had beenintroduced into the North Americananimal feed supply, and based on therecommendation of the IRT, that SRMsshould be removed from all animal feed.Results from the enhanced surveillancethat was being conducted concurrentwith our rulemaking process indicatedthat BSE had been introduced into theUnited States, but was present at a verylow level. These results reinforcedFDAs decision that the measures beingproposed are appropriate.

With respect to the definition ofSRMs, FDA agrees that prohibiting thefull list of SRMs would achieve greaterrisk reduction than prohibiting a partiallist, but also agrees with commentssaying that the infrastructure does notcurrently exist to handle the volume ofmaterial that would require non-feeddisposal if the full list of SRMs were

diverted from animal feed use.Therefore, FDA agrees that focusing on brain and spinal cord is an effectiveapproach for achieving additionalanimal and public health protectionwhile minimizing the economic,environmental, and public healthconcerns associated with disposal of thefull list of SRMs. FDA, however, seekscomments on whether a full SRM ban iswarranted.

Comments were mixed on thefeasibility of removing SRMs from deadstock. FDA therefore concluded that

some firms would elect to remove SRMsand render the remainder of the carcass,and that this could lessen difficultiesassociated with alternative disposal.FDA does not agree that allowing test-negative animals to be rendered foranimal feed use is appropriate. UnlikeEurope, rapid screening tests in theUnited States have been used only forsurveillance purposes. These tests havenot been used as food or feed safety tests

because currently available tests candetect BSE only in the late stages ofdisease. Finally, although FDA agreesthat vacuum rendering is less effectiveat inactivating TSEs than atmosphericrendering, the Agency disagrees thatvacuum rendering should be prohibited.Modeling results submitted with thecomment showed that such aprohibition would result in anadditional one percent reduction in risk.In light of other measures beingproposed and the fact that few plants

use vacuum rendering, FDA does not believe that prohibiting this renderingprocess would appreciably improveanimal or public health protection.B. Additional Measures to FurtherStrengthen Feed Protection

The United States and Canadian feedregulations implemented in 1997 werenecessary because of uncertainty aboutwhether BSE infectivity had already

been introduced into North America before new import restrictions on livecattle and meat and bone meal fromEurope were put in place. It is now clearfrom the five North American BSE casesthat the BSE agent was introduced intothe North American animal feed supplyat some point in time. While FDAcontinues to believe that compliancewith the feed regulation has providedstrong protection against the spread ofBSE, the agency believes that the recentcases are an indication that additionalanimal feed protections are needed toremove residual infectivity that may bepresent in the animal feed supply. FDAalso believes that of all the optionsconsidered since publication of the 2002ANPRM, excluding the highest risktissues from all animal feed is the best

approach to address the risks of BSE inthe United States. In the 2004 ANPRM,FDA announced its tentative conclusionthat it should propose a prohibition onthe use of SRMs in all animal feed.

The decision to propose banningSRMs from all animal feed led to thefollowing questions: (1) Which materialto exclude, (2) what alternative disposalmethods could be used, (3) what theeconomic and environmental impacts ofdiverting material to alternative disposalwould be, and (4) how an SRM bancould be enforced. As the IRT reported,



8/32


exclusion of large volumes of rawmaterial is a massive burden for allcountries affected by BSE. FDA receivedvaluable information pertaining to theseissues in comments submitted inresponse to the 2004 ANPRM.

In reaching a decision about whatspecific additional measures should beproposed at this time, FDA consideredthe magnitude of the BSE risk in theUnited States. While the recent NorthAmerican cases clearly show the BSEagent was introduced, the USDAenhanced BSE surveillance programindicates that the prevalence of thedisease in the United States is very low.As of July 2005, USDA has tested over418,000 high-risk cattle under itsenhanced BSE surveillance program(Ref. 11), and has found one positiveanimal in addition to the cow identifiedin Washington State in December 2003.Therefore, FDA believes that theadditional measures being proposed are

appropriate at this time. The agencyproposes to prohibit from use in allanimal feed the brains and spinal cordsfrom cattle 30 months of age and older,the brains and spinal cords from allcattle not inspected and passed forhuman consumption, and the entirecarcass of cattle not inspected andpassed for human consumption fromwhich brains and spinal cords were notremoved. The agency also proposes toprohibit from use in all animal feedmechanically separated beef and tallowthat are derived from materialsprohibited by the rule. However, therule proposes to exempt tallow from thisrequirement if it contains no more than0.15 percent insoluble impurities.C. Basis for Proposing to ApplyAdditional Measures to All AnimalFood and Feed

The current U.S. ruminant feedregulation prohibits the use of certainmammalian-origin proteins in ruminantfeed, but allows the use of thesematerials in feed for non-ruminantspecies. FDA believes that the presenceof high-risk materials in the non-ruminant feed supply presents apotential risk of BSE to cattle in the

United States. European experienceshowed that, in countries with highlevels of circulating BSE infectivity,controls on only ruminant feed were notsufficient to prevent furthertransmission of BSE. Until SRMs wereremoved from all animal feed, asignificant number of new casescontinued to be found in cattle born inthe United Kingdom afterimplementation of a ruminant-to-ruminant feed ban (Ref. 12). These newcases were attributed to either cross-contamination during feed manufacture

and transport, or to intentional orunintentional misfeeding on the farm.

The 1997 ruminant feed regulationrequires feed manufacturers anddistributors that handle both ruminantfeed and feed ingredients and materialsprohibited in ruminant feed to controlcross-contamination by either: (1)Maintaining separate equipment orfacilities or (2) using adequate clean-outprocedures or other means adequate toprevent carry-over of prohibitedmaterial into feed for ruminant animals.FDA has been concerned about theadequacy of such clean-out proceduresand sought public comment on thisissue in the 2002 ANPRM. Althoughmany firms using the clean-out optionhave written procedures in place,evaluating their adequacy is difficult

because of wide variation in equipmentand practices used by the feed industry,and because there is currently nodefinitive test method to detect

prohibited proteins.Further increasing FDA s concernsabout cross-contamination arepreliminary data from an unpublishedstudy showing that the minimuminfectious dose for BSE may be lowerthan previously thought. Interim resultsat approximately 5 years post exposureof an oral challenge experiment havedemonstrated transmission of BSE to 1out of 15 animals that received 0.01gram of brain tissue from a BSE-infectedanimal (Ref. 13). The lowest dosepreviously tested was 1.0 gram of braintissue which showed transmission ofBSE in 7 out of 10 animals in the trialgroup. This finding of a lower minimuminfectious dose for BSE would suggestthat the risk from cross-contamination isgreater than previously thought. Weseek comment on this interpretation oftheses interim results.

Instances of cattle being exposed toprohibited material throughnoncompliance with the 1997 feed banshave been identified in both Canada andthe United States. The investigation bythe Canadian Food Inspection Agency ofthe BSE case identified in May 2003found several instances where cattlemight have had access to non-ruminant

feed containing prohibited material. Inthe United States, FDA inspections haveidentified situations where cattle couldhave been exposed to materialprohibited in ruminant feed as a resultof ruminant feed being contaminatedwith non-ruminant feed, or non-ruminant feed not being properlylabeled.

In fiscal year 2004 and the first halfof fiscal year 2005, federal and stateinspections identified 41 instances (0.4percent of inspections) of cross-contamination or commingling

problems in firms that handle animalfeeds containing prohibited mammalianprotein (Ref. 14). During this sameperiod, inspections identified 165instances (1.7 percent of inspections) inwhich non-ruminant feeds containingprohibited material were not properlylabeled with the caution statement DoNot Feed to Cattle or Other Ruminants .Firms receiving mislabeled feed wouldnot be aware of the need to take stepsto prevent cross-contamination ofruminant feed with such products.Furthermore, inspections during thisperiod identified 604 instances (6.3percent of inspections) in which firmshandling animal feeds containingprohibited mammalian protein did notmeet the recordkeeping requirements.These instances involved a variety ofrecordkeeping deficiencies, includingnot maintaining sales records for feedsreceived or distributed, not establishingwritten protocols for avoiding

commingling, and not fullydocumenting clean-out measuresutilized. Such deficiencies are typicallycorrected by the involved firms withoutfurther action by the agency. However,the occurrence of these deficienciesnonetheless supports the need foradditional measures to address concernsabout the presence of high-risk materialsin the non-ruminant feed supply.Without sales records, it is difficult toverify the source of feed or feedingredients or to track distributed feedswhen conducting recalls in response toknown instances of productcontamination. Without appropriatedocumentation of procedures related tocommingling or cross-contamination, itis difficult to verify that workers areinformed of such procedures or that theprocedures are adequate.

FDA has issued warning and untitledletters to firms addressingnoncompliance with the currentruminant feed ban regulation and a feedmanufacturer has been permanentlyenjoined in connection withnoncompliance with the current feed

ban regulation.FDA is also concerned about

intentional and unintentional

misfeeding of non-ruminant feed toruminants on the farm. Financialincentives for intentional misfeedingcould occur any time inexpensivesources of prohibited protein are locallyavailable to the feeder. The use ofsalvaged pet food that containsruminant meat and bone meal is anexample. There may be other incentivesto intentionally feed non-ruminant feedto cattle. For example, the FloridaDepartment of Agriculture andConsumer Services issued a statementcautioning against the misuse of pet



9/32


1 A more recent report (Comer and Huntly, 2004, Journal of Risk Research , 7, (5) 523-543) attributes84.3 percent of infectivity to brain and spinal cordand 9.6 percent to distal ileum. We chose not to usethe data from this more recent report because itsauthor (personal communications) explained thatthe newer data suggesting that the level ofinfectivity in the distal ileum at 6 to 18 months ofage is higher than earlier estimates also suggest thatit is lower than earlier estimates at 32 months ofage.

food as feed for show cattle as a way toincrease the shine in the cattle coat (Ref.15). Unintentional feeding could occuron the farm from feeding ruminants andnon-ruminant in close proximity to eachother. If intentional or unintentionaluses occur, this proposed rule wouldprotect cattle by removing the highestrisk material from the non-ruminantfeed being used in cattle feed. Assuringthat misfeeding does not occur on thefarm is particularly difficult due to thelarge number of cattle feedingoperations in the United States, andFDAs extremely limited resources toinspect these operations, which numberover 1 million.

Therefore, although overallcompliance with the 1997 ruminantfeed rule has been high for renderers,protein blenders, and feed mills,removal of the highest risk tissues fromanimal feed channels should serve toaddress noncompliance with the rule

that could result in cattle exposure toprohibited material through cross-contamination, mislabeling, orintentional or unintentional misfeeding.D. Cattle Materials Proposed to beProhibited From Use in All Animal Foodand Feed

1. Brain and Spinal Cord From Cattle 30months of Age and Older

The USDA interim final rulepublished on January 12, 2004, providesa full description of the scientificrationale for identifying the list oftissues and selection of the 30-month

age criterion used in its definition ofSRMs. FDA has adopted an identicaldefinition of SRMs in its interim finalrule regarding FDA-regulated humanfood and cosmetics. In the preamble ofits July 14, 2004 interim final ruleregarding human food, including dietarysupplements, and cosmetics, FDAincludes a detailed discussion of itsrationale for the SRM definition. Asdiscussed in the preamble to the USDAand FDA interim final rules, infectivityis not present in most tissues that harborBSE infectivity until more than 30months after the animal was exposed to

the agent. Although the epidemiologicaland experimental data indicate that BSEcan develop in animals less than 30months of age, the evidence available todate indicates that this was a very rareoccurrence, and was associated withhigh levels of circulating infectivity atthe peak of the BSE epidemic in theUnited Kingdom. The agency continuesto believe that the rationale for the 30-month age criterion describedpreviously for human food andcosmetics is appropriate and proposesthat it be applied to animal feed as well.

In response to a question posed in the2004 ANPRM as to which tissues should

be defined as SRMs for animal feed,FDA received suggestions ranging fromdefining all animal protein as SRMs tolimiting the SRM definition to the headonly. FDA considered prohibiting fromanimal feed the same materials definedas SRMs that are currently prohibitedfrom use in food for humans, butdecided that proposing to require theremoval of brain and spinal cord is themost appropriate approach at this time.

In reaching the decision to propose toexclude only the brain and spinal cordfrom animal feed, FDA consideredinformation regarding the tissuedistribution of BSE infectivity. Underfield conditions, BSE infectivity has

been found in the brain, spinal cord,and retina of the eye in animals withclinical disease (Ref. 16). The ScientificSteering Committee (SSC) of theEuropean Union (Ref. 17) has also

reported on the proportion of totalinfectivity in various tissues. 1 According to the report, in an animalwith clinical BSE, approximately 64percent of the infectivity is in the brain,26 percent is in the spinal cord, 4percent is in the dorsal root ganglia, 2.5percent is in the trigeminal ganglia, and3 percent is in the distal ileum. The eyesare estimated to contain less than 1percent of the infectivity. Althoughavailable data are limited on thedistribution of tissue infectivity, datafrom both naturally infected andexperimentally infected cattle supportthe finding that the brain and spinalcord are the tissues with the highestlevel of infectivity.

Because available data indicate thatthe brain and spinal cord contain about90 percent of BSE infectivity (Ref. 17),FDA believes that the most appropriatecourse of action is to concentrate effortson excluding these highest risk tissuesfrom animal feed. In deciding topropose to prohibit brain and spinalcord only, rather than the same list ofmaterials previously defined as SRMs,FDA also considered the following: (1)Surveillance data indicate the currentrisk of BSE to U.S. cattle is very low, (2)

the existing ruminant feed regulationprovides strong protection against BSE,and (3) the new measures considered inthis proposed rule represent a secondary

level of protection to address failures incompliance that may occur with theexisting ruminant feed rule. FDA

believes that the existing ruminant feedrule provides the primary line ofdefense by prohibiting the use inruminant feed of all material withpotential BSE infectivity. The measuresproposed by this rule will effectivelyreinforce existing ruminant feedprotection measures by removing thetissues with the highest infectivity fromall animal feed. As a result, thesemeasures greatly minimize BSE risks ifcross-contamination of ruminant feedwith non-ruminant feed, or diversion ofnon-ruminant feeds to ruminants, wereto occur.2. Cattle Not Inspected and Passed forHuman Consumption

As noted earlier in this document, theterm cattle not inspected and passedfor human consumption includes cattlenot inspected and passed for humanconsumption by the appropriateregulatory authority as well asnonambulatory disabled cattle.

European surveillance data indicatethat cattle found dead or culled onsite,where the carcass was submitted torendering (fallen stock), and cattle withhealth-related problems unfit for routineslaughter (emergency slaughter) have agreater incidence of BSE than healthyslaughter cattle. Surveillance data in theEuropean Union in 2002 showed thatthere were 27.95 positive animals per10,000 emergency slaughter bovineanimals tested and 6.15 positive animalsper 10,000 fallen stock bovine animalstested compared to 0.31 positiveanimals per 10,000 healthy slaughteranimals tested (Ref. 18). In Switzerland,the odds of finding a BSE case in fallenstock and emergency slaughter cattlewere found to be 49 and 58 timeshigher, respectively, compared to theodds of finding a BSE case throughpassive surveillance (Ref. 19). Thesefindings suggest that cattle notinspected and passed for humanconsumption are more likely to testpositive for BSE than healthy cattle thathave been inspected and passed for

human consumption.Because cattle not inspected andpassed for human consumption areincluded in the population of cattle athighest risk for BSE (Refs. 18 and 19),and processes are currently notestablished in the rendering industry forverifying the age of such cattle throughinspection, the agency is proposing todefine brains and spinal cords from allcattle not inspected and passed forhuman consumption, regardless of age,to be cattle materials prohibited inanimal feed. As noted previously, the



10/32


term cattle not inspected and passed forhuman consumption is defined in thisproposed rule to include nonambulatorydisabled cattle as defined by FDA in itsinterim final rule on human food andcosmetics and USDA in its interim finalrule on human food. If the brains andspinal cords are removed from theseanimals, FDA is proposing that theremaining material can still be used inanimal feed. FDA notes that for cattlenot inspected and passed that arediseased or that die other than byslaughter, the entire carcass of suchanimals is adulterated under section402(a)(5) of the act. FDA hastraditionally exercised enforcementdiscretion with regard to the use of suchanimals in animal feed. For example,see Compliance Policy Guide 675.400.FDA intends to continue exercisingsuch discretion for the use in animalfeed of the remaining material fromcattle that are diseased or that die other

than by slaughter when the brain andspinal cord are removed. Becausecomments to the ANPRM were mixedon the feasibility of removing SRMsfrom cattle mortalities, FDA requestsfurther comment on which tissuesshould be removed from this class ofanimals and the feasibility of removingthem.

In deciding to propose to allow theseremaining materials to be used inanimal feed, FDA considered thefollowing: (1) brain and spinal containabout 90 percent of BSE infectivity (Ref.17), (2) surveillance data indicate thecurrent risk of BSE to U.S. cattle is verylow, (3) the existing ruminant feed ruleprovides strong protection against BSE,and (4) the new measures considered inthis proposed rule represent a secondarylevel of protection to address failures incompliance that may occur with theexisting ruminant feed rule. FDA

believes that the existing ruminant feedrule provides the primary line ofdefense by prohibiting the use inruminant feed of all material withpotential BSE infectivity. If the brainsand spinal cords are not removed fromsuch animals, FDA proposes that allparts of cattle not inspected and passed

for human consumption be prohibited.3. Mechanically-Separated Beef (MS)

Mechanically-separated (MS) beef is afinely comminuted meat food productresulting from the mechanicalseparation and removal of most of the

bone from attached skeletal muscle ofcattle carcasses and parts of carcasses.This proposed definition of MS beef isconsistent with, but not identical to, thedefinition of the term used by USDA inits 2004 interim final rule (69 FR 1862)prohibiting its use in human food and

by FDA in its 2004 interim final rule (69FR 42255) prohibiting its use in humanfood, including dietary supplementsand cosmetics. Those definitionsprovide that MS beef means a meat foodproduct that meets the specification in9 CFR 319.5. This USDA regulationapplies to MS beef for human food use.Because there is MS beef producedsolely for animal feed use that wouldnot fall within the USDA specification,the definition of MS beef as proposed inthis rule is meant to refer to beef that isthe product of the mechanicalseparation process, regardless ofwhether it meets the USDAspecifications for MS species in 9 CFR319.5. The definition of MS beef is notmeant to include product produced byAdvanced Meat Recovery (AMR)systems used in the meat industry.

Although MS beef was not consideredin the 2002 ANPRM, 2004 ANPRM, orin the IRT report, FDA has included this

material in this animal feed proposedrule to ensure that any such materialthat is used in animal feed is notcontaminated with the other materialprohibited by this proposed rule. Acomment submitted in response to the2004 ANPRM said that FDA shouldallow mechanically separated beef to beused for pet food if SRMs are removedfrom material going into the mechanicaldeboning equipment that separates meatfrom bone, because some pet foodoperations are very similar to slaughterestablishments and are capable ofremoving SRMs.

Because the mechanical separationprocess may result in the contaminationof the MS beef product with spinal cord,FDA proposes to designate MS beef ascattle materials prohibited in animalfeed if it is derived from carcasses orparts of carcasses from which cattlematerials prohibited in animal feedwere not previously removed.4. Tallow

Tallow is an animal-derived hard fatthat has been heat processed; mosttallow is derived from cattle. Any riskof BSE transmission from tallow is aresult of protein that is present as an

impurity in the tallow. Taylor et al.(Refs. 20 and 21) found, in renderingstudies with abnormal prion protein,that the prion protein did notpreferentially migrate into the fatfraction, but remained with the proteinfraction. Therefore, there is no reason to

believe that tallow is likely to containunusually high amounts of prionprotein as a constituent of the insolubleimpurities fraction that remains intallow after rendering. Taylor et al.(Refs. 20 and 21) also reported that thevarious rendering processes used for

tallow production in the UnitedKingdom were sufficient to producetallow that did not result in infectionwhen injected into the brains of mice,even though the starting material washighly spiked with the scrapie agent.Wilesmith et al. (Ref. 22) noted that thegeographical variation in the incidenceof BSE in the United Kingdom was notconsistent with the use of tallow incattle feed and concluded that the mostlikely source of infection in cattle wasBSE-contaminated meat and bone meal.

The Office International desEpizooties (OIE), the world organizationfor animal health, categorizes tallowwith insoluble impurities of no morethan 0.15 percent as protein-free tallow.OIE guidelines recommend that tallowthat meets this standard can be safelytraded regardless of the BSE status ofthe exporting country (Ref. 23). FDA sTransmissible SpongiformEncephalopathy Advisory Committee

(TSEAC) considered the safety of tallowand tallow derivatives in 1998 (Ref. 24).Members of the committee indicatedthat tallow is a food with negligible orno risk of transmitting BSE to humansor animals.

For the purposes of this proposedrule, tallow is defined as the renderedfat of cattle obtained by pressing or byapplying any other extraction process totissues derived directly from discreteadipose tissue masses or to other carcassparts and tissues. The 1997 ruminantfeed final rule did not include tallow,fats, oils, and grease in the definition ofanimal proteins prohibited in ruminantfeed because they are not proteins andwere not considered to contain BSEinfectivity. The agency said thatinfectivity studies conducted on some ofthese products (e.g., tallow) haddemonstrated that they were at low riskof transmitting the TSE agent and; thus,it was unnecessary to restrict their usein ruminant feed (62 FR 30935). Whilethe agency is not aware of any newscientific information suggesting thatinfectivity is present in tallow itself, theagency is concerned about potential BSErisks that tallow poses as a result ofprotein that is present as an impurity.

These impurities may be of greaterconcern now because, as previouslynoted, new preliminary data suggestthat the minimum infectious dose forBSE may be substantially lower thanpreviously thought. We seek commenton this interpretation of the preliminaryresults.

The agency is proposing to prohibitthe use of tallow in animal food or feedthat is derived from cattle materialsprohibited in animal feed. However, theagency proposes to exempt from thisrequirement tallow that contains no



11/32


more than 0.15 percent insolubleimpurities. The proposal would requirethat impurities be measured by themethod entitled Insoluble Impurities (AOCS Official Method Ca 3a 46),American Oil Chemists Society, whichis incorporated by reference inaccordance with 5 U.S.C. 552(a) and 1CFR part 51, or another methodequivalent in accuracy, precision, andsensitivity to A.O.C.S. Official MethodCa 3a 46. In response to the 2004ANPRM, comments were submitted tothe agency requesting that the primarymethod for the impurity determinationfor tallow be one other than the methodin the Food Chemicals Codex.Comments stated that the domestictallow industry primarily uses a methodof AOCS to measure insolubleimpurities. In comparison to the FoodChemicals Codex method, commentsstated that the AOCS method is less

expensive, requires less solvent, and haslower solvent disposal costs. Inaddition, it does not require specializedequipment or supplies. FDA agrees withthese comments, and proposes that theprimary method for the impuritydetermination for tallow be the methodfrom AOCS rather than the method inthe Food Chemicals Codex.

This proposed requirement for tallowwould apply to all animal feed,including feed for ruminants. Since theexisting ruminant feed rule 589.2000(21 CFR 589.2000) does not includeprovisions relative to tallow, thisproposal represents a new requirementfor ruminant feed as well as for feed fornon-ruminants. To make clear that thisproposed requirement would apply toruminant feed, FDA is proposing toamend 589.2000 to include the tallowrequirements.

FDA is also proposing to exempttallow derivatives from therequirements of this rulemaking. Tallowderivatives are produced by subjectingtallow to chemical processes(hydrolysis, transesterification, andsaponification) that involve high

temperature and pressure. FDA sTSEAC considered tallow derivatives in1998 (Ref. 24), and determined that therigorous conditions of manufacture aresufficient to reduce the BSE risk intallow derivatives to insignificant levels.In addition, according to OIE guidelinestallow derivatives produced byhydrolysis, saponification, ortransesterification using hightemperature and pressure can be safelytraded regardless of the BSE risk statusof the country of origin (Ref. 23).

E. Disposal of Cattle MaterialsProhibited in Animal Feed

FDA agrees with comments from theaffected industry that a comprehensiveplan would be needed to safely disposeof approximately 2.5 billion pounds ofmaterial if FDA decided to prohibit alldead stock and the full list of SRMs, asdefined in the USDA interim final rule(69 FR 1862) and the FDA interim finalrule (69 FR 42255), from being renderedfor use in animal feed. The 2.5 bil lionpounds of cattle material includesapproximately 1.4 billion pounds ofmaterial from cattle slaughtered forhuman consumption and 1.1 billionpounds of material from cattle notinspected and passed for humanconsumption that are currently beingrendered for use in animal feed. FDA isconcerned about the feasibility ofestablishing a new infrastructure tosafely dispose of this large quantity ofmaterial, as well as the time it wouldtake to implement these processes.

Limiting the list of SRMs as proposed by this rule reduces the volume ofslaughter byproducts that would requirealternative disposal. First, this proposaldoes not require the diversion from usein animal feed the small intestine andtonsils from the 28 million head ofcattle under 30 months of age that areslaughtered annually. Second, only the

brain and spinal cord (weighing 1.3pounds per animal) rather than thehead, spinal column, and smallintestine, (weighing 88.5 pounds peranimal) are diverted from the estimated

7 million head of cattle over 30 monthsof age that are slaughtered annually inthe U.S. FDA believes that this morelimited amount of material fromslaughter operations can be disposed ofthrough landfill, incineration, oralkaline digestion.

Based on comments received, FDAacknowledges that there is someuncertainty regarding the amount ofmaterial that will require alternativedisposal as a result of the proposedrequirements pertaining to cattle notinspected and passed for humanconsumption (i.e., dead stock and

nonambulatory disabled cattle). FDA isincluding in this proposed rule theoption to remove brain and spinal cordfrom cattle not inspected and passed forhuman consumption so that most of thismaterial could continue to be renderedfor use in animal feed. As previouslynoted, FDA intends to continueexercising enforcement discretion forthe use in animal feed of the remainingmaterial from cattle that are diseased orthat die other than by slaughter whenthe brain and spinal cord are removed.As discussed in more detail in Section

IV, Analysis of Economic Impacts, FDAacknowledges that while the proposedrule will result in additional materialfrom these animals being disposed of bymeans other than rendering, FDA

believes such increases will be modest.FDA seeks comment and furtherinformation on the feasibility ofremoving brain and spinal cord fromcattle not inspected and passed forhuman consumption and on the impactof this proposed rule on the number ofthese cattle that would be disposed of

by rendering.In summary, FDA believes that the

measures proposed by this rule can bemore feasibly implemented than a fullSRM ban, and can add substantially tothe protection provided by the currentBSE feed regulation. With thisapproach, the resulting volume ofmaterial requiring special disposalwould be manageable in the short term.This approach is also consistent with

the advice of the IRT that a stagedapproach may be necessary inimplementation of an SRM ban. Further,FDA believes that other feed controlsthat FDA previously considered, such asdedicated facilities, are not needed ifthese high-risk tissues are excludedfrom animal feed channels. Therefore, atthis time FDA is not proposingrulemaking to address other feed controlrecommendations of the IRT or theadditional planned measuresannounced by FDA on January 26, 2004.III. Description of Proposed Rule andLegal Authority

FDA is proposing to establish a new 589.2001 (21 CFR 259.2001), Cattlematerials prohibited in animal food orfeed. While the existing 589.2000outlines requirements related toruminant feeds only, proposed 589.2001 outlines requirementsintended to apply to food or feed for allanimal species. The terms andrequirements of proposed 589.2001 aredescribed in section IV.A of thisdocument.A. Definitions

The proposed 589.2001(a) defines

the following terms for the purposes ofthis regulation:(1) Cattle materials prohibited in

animal feed includes : (i) the brains andspinal cords of cattle 30 months of ageand older; (ii) the brains and spinalcords of cattle of any age not inspectedand passed for human consumption;(iii) the entire carcass of cattle notinspected and passed for humanconsumption from which brains andspinal cords were not removed; (iv)mechanically separated beef that isderived from cattle materials prohibited



12/32


under (i), (ii), or (iii) above; and (v)tallow that is derived from cattlematerials prohibited under (i), (ii), or(iii) above. Tallow that is derived fromcattle materials prohibited under (i), (ii),or (iii) above that contains no more than0.15 percent insoluble impurities andtallow derivatives are not consideredcattle materials prohibited in animalfeeds.(2) Cattle not inspected and passed

for human consumption means cattle ofany age that were not inspected andpassed for human consumption by theappropriate regulatory authority. Thisterm includes nonambulatory disabledcattle. Non-ambulatory disabled cattleare cattle that cannot rise from arecumbent position or that cannot walk,including, but not limited to, those with

broken appendages, severed tendons orligaments, nerve paralysis, fracturedvertebral column, or metabolicconditions.

(3) Mechanically separated beefmeans a meat food product that is finelycomminuted, resulting from themechanical separation and removal ofmost of the bone from attached skeletalmuscle of cattle carcasses and parts ofcarcasses.

(4) Renderer means any firm orindividual that processes slaughter

byproducts, animals unfit for humanconsumption, or meat scraps. The termincludes persons who collect suchmaterials and subject them to minimalprocessing, or distribute them to firmsother than renderers (as defined inparagraph (a)(1)) whose intended use forthe products may include animal feed,industrial use, or other uses. The termincludes renderers that also blendanimal protein products.

(5) Tallow means the rendered fat ofcattle obtained by pressing or byapplying any other extraction process totissues derived directly from discreteadipose tissue masses or to other carcassparts and tissues.

(6) Tallow derivative means anyproduct obtained through initialhydrolysis, saponification, or trans-esterification of tallow; chemicalconversion of material obtained by

hydrolysis, saponification, or trans-esterification may be applied to obtainthe desired product.B. Proposed Requirements

Proposed 589.2001(b)(1) providesthat no animal food or feed shall bemanufactured from, processed with, orotherwise contain cattle materialsprohibited in animal feed. Proposed 589.2001(b)(2) provides newrequirements for renderers that handlecattle material prohibited in animalfeed. Proposed 589.2001(b)(3) provides

new requirements for renderers thathandle any cattle material.1. Proposed Requirements for RenderersThat Manufacture, Process, Blend, orDistribute Cattle Materials Prohibited inAnimal Feed

The proposed 589.2001(b)(2)requires that renderers that handle cattle

materials prohibited in animal feed useseparate equipment or containers tohandle such material once it has beenseparated from other cattle materials.This requirement is intended to ensurethat equipment used to manufacture,process, blend, store, or transport cattlematerials prohibited in animal feed orproducts that contain or may containcattle materials prohibited in animalfeed do not serve as a source of cross-contamination for materials intended foranimal feed. In addition, proposed 589.2001(b)(2) requires renderers thatmanufacture, process, blend, ordistribute cattle materials prohibited inanimal feed or products that contain ormay contain cattle materials prohibitedin animal feed must: (1) Label theprohibited materials in a conspicuousmanner with the statement Do not feedto animals ; (2) mark the prohibitedmaterial with an agent that can bereadily detected on visual inspection;and (3) establish and maintain recordssufficient to track the prohibitedmaterials to ensure such material is notintroduced into animal feed, and makethe records available for inspection andcopying by FDA. These proposedrequirements are intended to ensure thatcattle materials prohibited in animalfeed do not enter the animal feed chainand thus have no opportunity forinclusion in animal food or feed. FDA

believes that such material must be bothlabeled and marked to ensure that itdoes not enter the feed channels sincewithout such measures this materialwould be indistinguishable from cattlematerials not prohibited by thisproposed rule. Marking the material willprovide a readily detectable method onvisual examination by which all personsin the animal feed chain can be madeaware that the a product is prohibited

material or contains prohibited material.Marking also will serve as a way tomake the status of the material knownif, for some reason, the label Do notfeed to animals is separated from theproduct.2. Proposed Requirements for Renderersthat Manufacture, Process, Blend, orDistribute Any Cattle Materials

Proposed 589.2001(b)(3) requiresthat renderers that handle any cattlematerials shall: (1) Establish andmaintain records sufficient to

demonstrate that material rendered foruse in animal feed was notmanufactured from, processed with, ordoes not otherwise contain, cattlematerials prohibited in animal feed, (2)make copies of records available forinspection and copying by FDA, and (3)

be in compliance with requirementsunder 589.2000 regarding animalproteins prohibited in ruminant feed.C. Proposed Recordkeeping and AccessRequirements

The proposed recordkeepingrequirements associated with this ruleare focused on renderers because FDA

believes this is the point at which cattlematerial prohibited in animal feed couldenter the animal feed channel.Renderers, as defined in this proposedrule, receive cattle materials fromslaughter facilities or receive entirecattle carcasses that were not inspectedand passed for human consumption andfurther process that material so that itmay be used in animal feed. FDA

believes this is the critical control pointin the feed and feed ingredientprocessing channel at which theexclusion of cattle material prohibitedin animal feed must be documented.Once material is removed from cattleand further processed, we may not beable to obtain the information necessaryto determine whether it is cattlematerial prohibited in animal feed.There is currently no way to reliably testfeed or feed ingredients for the presenceof the BSE agent or for the presence ofcattle materials prohibited in animalfeed.This proposed rule requires that noanimal feed or feed ingredient bemanufactured from, processed with, orotherwise contain cattle materialsprohibited in animal feed. However,FDA does not believe it is necessary forpersons, other than renderers, that areinvolved in the manufacture orprocessing of feed or feed ingredients tomaintain records documenting theexclusion of cattle materials prohibitedin animal feed. FDA believes, for thereasons cited previously, that it iscritical that such records be maintained

at the point of the renderer. However,FDA believes that requiring themaintenance of such records at allmanufacturing and processing pointsdownstream would be redundant andprovide little additional information ofvalue. FDA seeks comments on the needto require that records be maintained bypersons other than renderers.

Because at this time there is no wayto test reliably for the presence of theBSE agent or the presence of the cattlematerials prohibited in proposed 589.2001(b)(1), renderers must depend



13/32


on records to ensure that the materialsprohibited by this proposed rule areexcluded from material intended for usein animal feed and that such material isappropriately disposed. Similarly,without adequate records kept byrenderers and access to the records bythe agency, FDA may not know whetherrenderers have complied with therequirements. We are proposing in 589.2001(b)(2)(iv) that renderers thatmanufacture, process, blend, ordistribute cattle materials prohibited inanimal feed establish and maintainrecords sufficient to demonstrate thatsuch material was not introduced intoanimal feed. Furthermore, we areproposing in 589.2001(b)(3)(i) thatrenderers that manufacture, process,

blend, or distribute cattle materialsestablish and maintain recordssufficient to demonstrate that materialrendered for use in animal feed was notmanufactured from, processed with, or

does not otherwise contain, cattlematerials prohibited in animal feed.Proposed 589.2001(d) requires that

the records required by this proposedrule be maintained for a minimum of 1year. The 1-year record retention periodis consistent with the existingrequirements for ruminant feeds in 589.2000(h). We believe that for thepurposes of the recordkeepingrequirements, 1 year is appropriate inlight of the time that the products will

be in the animal feed production anddistribution systems. Extending therecord retention period would havelittle practical value in determining thesource of BSE in an animal. This is alsoconsidering the potentially long timeperiod from ingestion of the BSE agentin feed to manifestation of clinical signsand lesions and the lack of a reliableestimate for the latency period.

The proposed rule does not specifythe types of records that would need to

be maintained in order to comply withthe recordkeeping requirements. Theagency seeks comments on what type ofrecords would be appropriate andwhether further detail is needed in theregulation regarding specific recordrequirements such as the specific data

elements that must be included in suchrecords.D. Conforming Changes to 589.2000Animal Proteins Prohibited in RuminantFeed

The requirements related to tallow inthe proposed 589.2001 are intended toapply to all animal feed, including feedfor ruminants. Since the existingruminant feed rule ( 589.2000) does notinclude provisions relative to tallow,this proposal represents a newrequirement for ruminant feed as well as

for feed for non-ruminants. Therefore,due to concerns about proteinimpurities present in tallow, FDA isproposing to amend 589.2000 toinclude tallow in the definition ofprotein derived from mammaliantissues and to add language thatexcludes from the definition of proteinderived from mammalian tissues tallow containing no more than 0.15percent insoluble impurities and tallowderivatives as specified in proposed 589.2001.E. Legal Authority

FDA is issuing this proposedregulation on animal feed under thefood adulteration provisions in sections402(a)(2)(C), (a)(3), (a)(4), (a)(5), 409,and 701(a) of the Federal Food, Drug,and Cosmetic Act (the act) (21 U.S.C.342(a)(2)(C), (a)(3), (a)(4), (a)(5), 348,and 371(a)). The term food is definedto include articles used for food forman or other animals. See section 201of the act (21 U.S.C. 321(f)). We notethat the material that would beprohibited under this proposed rulefrom use in animal feed continues tomeet the definition of food. Therefore,this material would be adulterated ormisbranded under the act based onviolations of the proposed rule, as wellas any animal feed or feed ingredientsthat were manufactured from, processedwith, or otherwise contained, theprohibited material.

Under section 402(a)(3) of

05-20196 CMPAFs ProposedRule

Documents

Transcript of 05-20196 CMPAFs ProposedRule