federal register vol. 54, no. 168 thursday, august 31 ... · 36112 federal register / vol. 54, no....

36112 Federal Register / Vol. 54, No. 168 / Thursday, August 31, 1989 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Animal and Plant Health InspectionService

9 CFR Part 1

[Docket No 69-1301

RIN 0579-AA18

Animal Welfare; Definition of Terms

AGENCY: Animal and Plant HealthInspection Service, USDA.ACTION: Final rule.

SUMMARY: We are amending part I ofthe Animal Welfare Act regulations inorder to update, clarify, and expand thelist of definitions of terms used in parts2 and 3 of the regulations. Thesechanges are necessary to assist thepublic in complying with the AnimalWelfare regulations and to facilitateenforcement. Many of these changes arerequired by the amendments to theAnimal Welfare Act (7 U.S.C. 2131, etseq.), enacted on December 23, 1985, andcomplement the final rule amending part2 of the regulations. They alsocomplement the standards set forth inpart 3 of the regulations.DATES: This final rule shall becomeeffective October 30, 1989; however, theportions of the rule which concern orrelate to information collection andrecordkeeping will become effectiveOctober 30, 1989, upon approval by theOffice of Management and Budget(OMB). The information collectionrequirements of this final rule have beensubmitted to OMB for review andapproval. The Department has requestedthat OMB conclude its review no laterthan October 30, 1989. If any portion isdisapproved, notice of disapproval willbe published in the Federal Registerprior to that date.FOR FURTHER INFORMATION CONTACT.Dr. Dale F. Schwindaman, REAC,APHIS, USDA, Room 206, 6505 BelcrestRoad, Hyattsville, MD 20782, (301) 436-6491.SUPPLEMENTARY INFORMATION:

BackgroundThis final rule amends 9 CFR part 1,

entitled "Definition of Terms" whichprovides the definitions for the termsused in the regulations in 9 CFR part 2,and the standards in 9 CFR part 3 for thehumane handling, care, treatment, andtransportation of regulated animals usedfor research or exhibition purposes, soldas pets, or transported in commerce. TheDefinitions, Regulations, and Standards(the regulations) are establishedpursuant to the authority in the AnimalWelfare Act, as amended (7 U.S.C. 2131,

et seq.) (the Act). This law requires theSecretary to promulgate regulations andstandards governing the humanehandling, housing, care, treatment, andtransportation of certain animals bydealers, research facilities, exhibitors,operators of auction sales, carriers, andintermediate handlers. The standardsand regulations must include minimumrequirements with respect to handling,housing, feeding, sanitation, veterinarycare, and other matters specified insection 13 of the Act (7 U.S.C. 2143). Thedefinitions contained in this final ruleprovide specific meanings for manyimportant terms used in the regulationsand standards.

Proposed RulesIn two documents published in the

Federal Register, on March 31, 1987 (52FR 10292-10298 and 52 FR 10298-10322,respectively), we proposed to reviseparts I and 2 of the Animal Welfareregulations to comply with the 1985amendments to the Act, and to expandclarify, and revise the currentregulations. At that time, we did notpublish a proposed rule to amend thestandards set forth in part 3 of theregulations.

We solicited comments concerning theproposals for a 60-day period endingJune 1, 1987. The comment period wastwice extended and ended on August 27,1987. A total of 7,857 comments weretimely received and considered. Many ofthe comments we received stated that itwas difficult to comment upon theproposals to amend parts 1 and 2 of theregulations independently of ourproposal to amend the standards in part3. We have maintained that upon theirpublication as final rules, parts I and 2of the regulations can be fullyimplemented with the existing standardsin part 3. In response to the comments,we decided to respond to the pointsraised by the commenters, and topublish revised proposals to amendparts 1 and 2 along with our proposedrule to amend part 3, to assist the publicin reviewing the proposed standards inpart 3 and to afford the public anopportunity to comment on theinterrelationship of the definitions andregulations in parts 1 and 2 with theproposed standards in part 3.Accordingly, on March 15, 1989, wepublished in the Federal Register threedocuments: Docket no. 88-013, aproposed rule to amend part 1-"Definition of Terms," (54 FR 10822-10835); docket no. 88-014, a proposedrule to amend part 2-"Regulations," (54FR 10835-10897); and docket no. 87-004,a proposed rule to amend subparts Athrough D of part 3-"Standards," (54 FR10897-10954).

The revised proposals published inMarch, 1989, were prepared with thebenefit of the public's comments andreflected our thinking at that time ofhow best to carry out our statutorymandate and animal welfare objectives.Throughout this rule-making process,however, we have continued ourconsideration of alternative means toimplement the complex regulatoryscheme required by the Animal WelfareAct, as amended, and addressed by thecommenters in response to our initialproposal. To fully address these issues,we continued our consultation inaccordance with the requirements of theAct (7 U.S.C. 2145), with the U.S.Department of Health and HumanServices (HHS] and members of theInteragency Research AnimalCommittee (IRAC), a commitfeecomprising representatives of Federalagencies concerned with animalwelfare. Together, we explored andevaluated different means ofaccomplishing our regulatory objectives.This final rule reflects our considerationof the comments we received inresponse to our initial proposal andthose addressing the interrelationship ofthe definitions in part 1 with theregulations proposed for part 2 and thestandards proposed for part 3. It alsoreflects our consultation with otherFederal agencies. We believe parts 1and 2 can now be readily implementedwhile we continue to review the public'scomments and consider alternativesconcerning the standards that should beincluded in part 3.Public Comments

The revised proposal published March15, 1989, solicited comments on thenarrow issue of the interrelationship ofthe definitions and regulations in parts 1and 2 of 9 CFR, chapter 1, subchapter A,with the standards we proposed in part3, for the reasons explained above.Comments were solicited for a 60-dayperiod, ending May 15, 1989. Commentsthat were postmarked or received bythat date were considered in preparingthis final rule. We solicited commentson the standards of part 3 for a 120-dayperiod, ending July 13, 1989. Commentsthat were not timely for consideration inpreparing final rules for parts I and 2will be considered if they address theproposed standards or the regulations ingeneral.

We received 5,582 comments thatwere timely for consideration inpreparing final rules for parts 1 and 2.Many comments concerned the AnimalWelfare regulations generally orconceptually. We considered thosecomments in preparing the final rules

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because they address, the Department'sregulatory approach as a; unit, andthereby implicate the interrelationshipof parts 1, 2,. and, 3. Ourresponse- tothose comments is set forth in thesupplementary informationaccompanying the final rule-to- amendpart2,, docket no.. 89A31, publishedelsewhere in this issue of the FederalRegister.

Onm the. basis of the comments wereceived and our-consultation with HHSandmembersof the IRAC,,wedetermined that certairr changes ti therevised proposal.are necessary and thatcertair terms should be adderLto: clarifyparts 2 and a of the regulations. Certain.changes are also necessary.' to- conformpart I with the-revisions~weare makingin the final rule to amend-part 2(see,docket no. 89-131, published elsewherein this issue of the Federal Register..Wediscuss below, in alphabetical order,,each of the terms thatis revised,replaced, or added- as a result of thecomments we received, and our.consultation with HHS and members- ofthe-IRAC. We also discuss those.comments we received addressing! theinterrelationship of terms contained- inpart 1. with the proposals: to amend parts2 and 3 for whichwe have determinedthat no revision of the final rule is,necessary., Comments addressing theinterrelationship. of the revised proposalto amend part 2-"Regulations" with theproposed standards in part a areaddressed in companion docket no..89-131, published elsewhere in this issue of-the Federal Register. Comments on the.regulatory impact analysis and theregulatory flexibility analysis prepared.by the Department inaccordance with.Executive Order 12291 and theRegulatory Flexibility Act (5 U.S.C. 601et seq.), respectively, are-also, addressedin that.document.

GeneralWe received,480 comments' (478'from

membersof the general' public-and' 2from members of the research- or"scientific community). expressing generalsupport for the revised proposals toamend parts 1 and 2-arid stating that thedefinitions in part 1 apply appropriatelyto part 3.

We are making two-changes in the.final rule for part 1- to reflect an internal :

agency reorganization, within theAnimal andPlant Health InspectionService (APHIS)-which createdthe.Regulatory Enforcement and Animar.Care- organization unit (REAC REAC ischarged with responsibility foradministering and enforcing the AnimaltWelfare Act. and regulations for APHISAccordingly, the term "DeputyAdmihistrator"'is revised tbmean "the,

Deputy Administrator for Regulatory-Enforcement and Animal-Care (REAC)or any other-official to whom authorityhas been delegated to act. in his stead."The term "Area Veterinarian in Charge"is replaced with "A PHIS REAC Sector'Supervisor"; however, the definitionremains unchanged in the regulations,This change in-designation reflects: theAgency's internal reorganization and isnonsubstantive.

Animal,, Exotic-Animal Wild*Animal.

Fifteen commenters, (9. members of, thegeneratpublic and 6-members of the'research- or scientific. community stated,that all animals should be. regulated,under the Act, including rats and mice,and 6 members of the research or,scientific community, commented thatrats and mice should not be:excludedfrom the regulations. In contrast 10members of the research or scientific:community stated that all rodentsshould, be-excluded from the.regulations.

As we stated in the supplementary;information, accompanying the revised,proposal, we do havethe authority to,regulate rats andmice; though we havenever included laboratory-bred rats andmice in; the regulations (54 FR 108231..Wild rats and mice are covered by theregulations. We received numerous-comments in response' to, the March 1987proposal suggesting that weinclude ratsand mice, and we are considering doing,so. Development of regulations andstandards applicable to rats and micewould be a lengthy endeavor, and we donot believe it is appropriate to delaypromulgation of these finar rules- whilewe proceed with our consideraton ofthis issue-

The statutory, definition of "animal"specifically includes guinea pigs and'hamsters, and- we do not have the -authorityto remove these-rodents fromthe regulations- (7U.SC. 2132(g)). In'.order to clarify- that rats. and mice arethe only- rodents not- covered' by theregulations, we are-revising thedefinition of "animal" in the final ruleby specifyingthat the term excludes ratsof the genus Rattus and mice of the-genus Mius'that have been bred' for usein research. Rodents- of other genera,such as kangaroo. rats, are included'within the definition;

We received 241 comments (67 from.members. of the general public, 172 frommembers- of-the researcir or scientificcommunity, and Z from dealers-requesting that. we clarifk- when, farmanimals are covered by the-regulatibns:One member of the'general public and 3members of the'research' or-scientificcommunity commented that-.the existing.standardsof'9 CFR part 3, subpart F,"Specifications for-the-Humane'

Handlihg, Care,. Treatment andTransportatibn of Warmblooded'Animals- OtherThan' Dogs, Cats;R abbits, Hamsters; Guinea, Pigs,,Nonhuman Primates; and.MarineMammals;' should be applied to farmanimals used or bred for'biomedical'research. rn accordance-with the Act,we have theauthority, to- regulate farmanimals when used forbiomedicalresearch and testingpurposes. We donot have the authority to regulate farmanimals under the.Animal Welfareregulations. when used' or intended foruse asfood'or-fiber, or when used orintended for use in agriculural research,.such as, improvinganimal nutrition,breeding, management, or productionefficiency, or for iinprovfng,the qualityof food. or fiber (7 U.S.C., 2132{g)),Weare considering exercising our authorityto enforce the regulations with respectto farm. animals. Ifwe determine. topursue this.matter further, we willpublish an: adVance notice ofiproposed'rulemaking i the. Fedrerat Registersolriting:public: comments on-whetherthe. Agency should exercise this.authority, and if 'so,, what.regulations.and standari should apply..-

Four membersof theresearch orscientific community requestedclarification as to whether the term"animal" includes-free-living wildanimals that are used in research. As-set.forth in- the revised:proposal, the term-"animar' includes, any, warmbloodedanimaL other than those specifically.excepted, that is'being. used, or-isintended for use for research teaching,testing, or experimentation (54 FR10823-10824-). Under-the finaruiLamending part 2 (docket, no 89;-131,publishedielsewherein this issue.of theFederal' Register), research involvinganimals- that are! studied in their'naturalhabitat without any invasivei procedureand withoutharming or materiallyaltering their behavior, is, exempt fromthe Committee review- and: inspection.requirements of 9 CFR. part 2; subpart C.

One exhibitor opposed'breakihg downnon-domestic animals into "wildanimals" and "exotic animals". Bothwild and exotic animals, as defined inthe revised.proposal, are covered by. theregulations. We are including definitionsof wild animals and, exotic animals ihthe final rule tu make,it clear thatcertain exotic anihals; now considered'by many people to be-domestic animals,are covered by the regulations. We arenot revising. these terms on the'basis of'this comment.

We received 236 comments (66 from.members' of the general public, 168 frommembers of the-research or scientificcommunity, and2 from dealers)

36114 Federal Register / Vol. 54, No. 168 / Thursday August 31, 1989 / Rules and Regulations

expressing agreement with the definitionof "exotic animal" as set forth in therevised proposal. We had revised thedefinition from that initially proposed toexclude those animals specificallyincluded in the definition of "animal", inresponse to the numerous comments wereceived. One member of the research orscientific community objected that therevised definition conflicts with the term"animal" when an exotic animal is usedfor exhibition purposes. The term"exotic animal", as well as "wildanimal", is included in the regulations tomake clear that all warmbloodedanimals (other than those specificallyexcluded) are covered by the regulationswhen used for research, teaching,testing, experimentation, exhibition, oras a pet. When the Act was first enactedin 1966, the term "animal" was definedas meaning "live dogs, cats, monkeys(nonhuman primate mammals), guineapigs, hamsters, and rabbits." In 1970,Congress amended the Act to includeother warm-blooded animals. Bydefining "exotic animal" as any animalnot identified in the definition of"animal" that is of foreign origin or notnative to the United States, theregulations make clear that exoticanimals are covered by the regulationsin addition to dogs, cats, nonhumanprimates, guinea pigs, hamsters, andrabbits. The definition of "exoticanimal" excludes the animalsspecifically identified in the Act becausemany species of these animals are nowcommonly found in the United States.Though originally of foreign origin, theyare not considered to be exotic.

Animal Care and Use Procedure

We received 237 comments (66 frommembers of the general public, 169 frommembers of the research or scientificcommunity, and 2 from dealers) statingthat there is no need for an animal careand use procedure, and therefore theterm should be deleted. We added theterm "animal care and use procedure"or "ACUP" in the revised proposal inlieu of "protocol" to avoid anymisunderstanding or implication thatAPHIS intends to become involved inthe evaluation of the design, outlines,guidelines, and scientific merit ofproposed research. The term "animalcare and use procedure" was selectedbecause it is descriptive of the areaswith which we are concerned under theregulations, namely, how the researchwill treat or affect an animal, thecondition of an animal, and thecircumstances under which an animal ismaintained.

As we describe in greater detail in thefinal rule to amend part 2 (docket no.89-131, published elsewhere in this issue

of the Federal Register), we have madecertain changes in the regulationsaffecting research facilities in order toharmonize our requirements with thoseof the Public Health Service Policy onHumane Care and Use of LaboratoryAnimals (PHS Policy), wherever it isconsistent with our statutory mandate todo so. As part of our harmonizationefforts, we are replacing the term"animal care and use procedure" withthe PHS Policy term, "activity." Theterm "activity" is defined to mean"those elements of research, testing, orteaching procedures that involve thatcare and use of animals." We considerthis to be a nonsubstantive change.

Attending Veterinarian

Under the revised proposal, the term'attending veterinarian" would mean "aperson who has graduated from aveterinary school accredited by theAmerican Veterinary MedicalAssociation's Council on Education, orhas a certificate issued by the AmericanVeterinary Medical Association'sEducation Commission for ForeignVeterinary Graduates, or has receivedequivalent formal education asdetermined by the Administrator; hasreceived training and/or experience inthe care and management of the speciesbeing attended; and who has direct ordelegated authority for activitiesinvolving animals at a facility subject tothe jurisdiction of the Secretary."

Two members of the research orscientific community objected to therequirement that the attendingveterinarian have formal education inveterinary medicine. Rather, they feltthat requiring equivalent formaleducation would be sufficient. Wedisagree with the commenters. Trainingin the sciences generally, or in medicalor biological areas, would not ensuresufficient knowledge in the health, well-being, and care of animals. Veterinarymedicine involves specializedknowledge and expertise that would nototherwise be acquired through non-veterinary training and education.Furthermore, we do not believe it wouldbe practical for the Administrator todetermine, on a case-by-case basis,whether someone is qualified to functionas a veterinarian. Therefore, we are notmaking any change to this requirementin the final rule. The Administrator willconsider equivalent formal education inveterinary medicine, as set forth in therevised proposal, so as not to excludethose graduates of foreign veterinaryprograms who do not have a certificatefrom the AVMA's EducationCommission for Foreign VeterinaryGraduates (see 54 FR 10824-10825).

We received 55 comments (5 frommembers of the general public, 14 frommembers of the research or scientificcommunity, 2 from exhibitors, and 34from dealers] stating that therequirement that the attendingveterinarian have experience in the careand management of the species beingattended would limit the pool ofqualified veterinarians, and thatexperience with similar species shouldbe sufficient. We disagree for thereasons set forth in the supplementaryinformation accompanying the revisedproposal (54 FR 10825). It is not ourobjective to severely limit the number ofveterinarians who would be qualified toserve as attending veterinarians, and wedo not believe that requiring somedegree of familiarity with the animalbeing attended will do so. We proposedthis requirement because differentspecies have different requirements andneeds that must be fulfilled in order topromote their health and well-being. Forthese reasons, we require that theattending veterinarian have training orexperience in the care and managementof the different species of animals beingattended.

Two hundred fifty-five commenters(70 members of the general public, 183members of the research or scientificcommunity, and 2 dealers) objected tothe requirement that attendingveterinarians be responsible for"activities involving animals", as setforth in the revised proposal, rather thanjust the health of the animals. Underthese regulations, the attendingveterinarian is responsible foroverseeing the care and use of animalsand for ensuring that adequateveterinary care is provided. Theseresponsibilities extend beyond thegeneral health of an animal. Theyinclude personnel training and guidancein animal care matters, such as properuse of pain-relieving drugs, adequatepre-procedural and post-proceduralcare, and animal behavior and well-being. We are making no changes to thedefinition of "attending veterinarian" onthe basis of these comments.

Commerce

Thirty-eight commenters (1 member ofthe general public, 2 members of theresearch or scientific community, 2exhibitors, and 33 dealers) objected toFederal regulation of intrastatecommerce. Twenty-two commenters (2exhibitors and 20 dealers) objected toconsidering gifts or donations of animalsas affecting commerce, and thereforerequiring that the recipient be licensedas an exhibitor. Under the definition of"exhibitor" in this final rule, any person

Federal Register / Vol. 54, No. 168 / Thursday, August 31, 1989 / Rules and Regulations,

exhibiting any animals which werepurchased in commerce-or the intendeddistribution ofwhich affects commerce,or will affect commerce, to-the public forcompensation is an. exhibitor and'mustbe licensed. The proposed definition of"commerce" .is taken, directly from thestatute. Congress has defined"commerce"' in the Act to mean "trade,traffic, transportation, or othercommerce: (1) Between, a place-in aState and' any place outside of suchState, or between. points. within thesame State but through, any, placeoutside thereof, or within any territory,.possession,. or the District of Coylumbia;(2) which affects trade,. traffic,transportatibn,.or other commercedescribed in paragraph- (1), * .... (7U.S.C..2132tc)). Animali receivedthroughT.donatiol. or as a gift must beacquired and transportedi.and therefore;such gifts or donations affect commerce:The definitionremains'as proposed..

Committee

Two hundred' thirty-six commenters'stated that a research facility shourdibe-able to identify, the COmmittee bywhatever name- it chooses, One memberof the'research or scientific communitynoted that thedefinition, of "Connnittee"is appropriately addtessed'in part-2 and-therefore need. not be defined in part 1.As we statedin' the supplementaryinformation, accompanyihg the revi'sedproposal, we are not concerned' with thename assigned to the' Committee by a.research facility. Rather we areconcerned that each research facility'establish an admiistrative body inaccordance' witlh thedefinition, of"Committee", as set forth in part, 1., thatis authorized' to carry out the duties, andreponsibilities assigned to it under theAct and the regulations, We'refer to this-body as, the lnstitutionar Animal Chre:and Use Commiltee to describe its-areasof concern and' for consistency with the'PHS Policy, which' simil'arlyrequi'esestablishment of an Institutibnal Animal:Care and Use Cbmmitthe. The PHSPolicy also.notesthat the term,Institutional Animal Care and' Use-Committee, is'ihtendud, as a.generic termfor a committee whose function is toensure appropriate, and humane aniial:care and use. We are not making anychanges.in the final, rule on the basis ofthe comments. We are makihg a change'to allow a Doctor of VeterinaryMedicine (DVM) to serve. on theCommittee instead of the attendingveterinarian, if theresearch facility hasmore than.one;DVM in accordance withthe final' rule to amend part. 2' ('seedocket no 89-131, published elsewherein this issue of the Federal. Register,

Euthanasia

We are revising the definition of"euthanasia" based upon the commentswe received.and. our ongoingdiscussions with members of the IRAC.In the revised proposaLthe term-"euthanasia" was defined. as. "thehumane. destruction of'an animal'.accomplished by a method which.produces. instantaneousunconsciousness and immediate deathwithout evid'ence of pain or distress, ora method' that utilizes anesthesiaproduced by an, agentwhich causespainlesadbss of'consciousness and'subsequent death.' Thirty-five.commenters, ('1 member of. the generaIpublic,.7, members. of' the: research orscientific community,. 2 exhibitors, and25 dealers] requested clarification. of theword "immediate" as it appears in theproposed definition. Twenty-nine'members. of the; research or scientificcommunity stated' that the definitionshould be consistent with. the-recommendations of the'AmericanVeterinary Medical. Association, Panelon Euthanasia..Two commenters (1member of, the general publiciandilmember of the research or scientific-community]' suggested, that the.term' bedefined as. "a. quiet painless' death"; and255 commenters, (70 members of thegeneral public, 183'members: of. theresearch, or-scientific-community; and 2'dealers): suggested- that the term be.defined! as. "thehumane destruction ofan animal, accomplished by a, method',which produces- unconsciousness' anddeath without evidence'of pai- or.distress or'a method', that, utilizes:anesthesia~produced by an agent whichcauses painless loss of consciousnessand subsequent death.' One comnnenterfrom the general public; and- 3- members-of the research or scientific communitysuggested using the word "killed" inplace of "destruction" in the definition.

Based upon these comments. and ourconsultationiwitk IRAC, members,. wehave determined that theproposeddefinition of "euthanasia" isunnecessarily restrictive. Methods ofeuthanizing, animali existwhich induce,rapidly occurring unconsciousnessfollowed'by subsequent'death vihoutevidence; ofipain or'diitress..The reportof the AVMA Panel or Euthanasia. listsnumerous methods which,.based upon'information the Panel deems reliable;.may be considered painless. We. aretherefore revising the' definitibn tb meanthe humane d'estruction' of an animal,accomplished by'a methodthat'produces rapid unconsciousness and,subsequent. death, without evidence of'pain, or distiress, ra method, tfiatutilizes- anesthesia, produced: by an agent

that'causes painless loss ofconsciousness and subsequent death.Methods of euthanasia that are-consistent with' this definition'may beused. We-believe that the definition asrevised in the final rule filly addressesthe commenters"concerns.

Housing Facility

The defihitiorrof "housingffacility" inthe revised proposal remained' asoriginally proposed and' has prompted'concern among'the commenters andmembers of the RAC The proposeddefinition would.include any land;premises, shed; barn, building,, trailer, or.other st'ucture or arealousingorintendbd to house. animals. Members ofthe IRAC'stated'cltat the proposeddefinitibn would be difficult to apply infield settings where. animals are studiedin their naturalhabit'at..The NationalScience Foundation, a Federal agencythat finds research conducted in fieldsettirgs;, expressed.concern that itwould, not he feasible, fbr researchfacilitiestoi comply with.many of thestandards proposed in part & for housingfacilities in suchenvironments. In.addition, 238 commenters.(66 membersof the general public, 170. members ofthe research or, scientificcommunity,and 2 dealers) requested clarification asto whether native habitats' of free-livinganimals woulbe. covered'by thedefinition., Four members of the research,or scientific community suggested thatthe definition be revised to exclude allfield study siteswhere animals are notrestrained for more: than, 12 hours beforebeing released.Five members.of, theresearch or scientific;communitysuggested that the definition excludeareas, where animals are held.for lessthan,24 hours. Wealso-received fourcomments from, the research- or scientificcommunity which stated that theproposeddefinition should be revised to,clearly include all animal study areas.Two)commenters, also from the. researchor scientific community; stated thatanimal study areas should only includesurvival surgery areas.

Upon, further consideration of these,suggestions, and for the reasons setforth in the'supplbmentary infbrmationaccompanying the final rule- to amendpart 2 {kIocket.-no: 89-1,31, publishedelsewhere'i iv this issue of the FederalRegister)'we' agree, that a distinctibnshould be-made between' research thatis conducted'under captiVe conditionsand that which is conductedl in the wild.A further distlhctiormust also be'madebetween, studies conducted: in the field'on the basis of whether or not itinvolves an, invasive procedure, orchange, in- the animal" behavior as part

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of the-study. The final rules differentiatebetween studies of animals in theirnatural habitat which involve aninvasive procedure, such as implanting atransponder, or which harm or alter thebehavior of the animals, and fieldstudies. Field studies are defined in thisfinal rule to mean "any study conductedon free-living wild animals in theirnatural habitat, which does not involvean invasive procedure, and which doesnot harm or materially alter thebehavior of the animals under study."Wildlife census studies and purelybehavioral studies would be within thedefinition. Under part 2, subpart C of thefinal rule, field studies are exempt fromCommittee review and inspection.

Under § 2.31(c)(2) of the final rule,Committee inspection of a researchfacility's animal facilities as an agent ofthe research facility, including animalstudy areas, may not include animalareas involving free-living wild animalsin their natural habitat. Such studies andareas must be maintained in compliancewith the Animal Welfare regulationsand standards, however.

We are also adding a definition of theterm "study area" in response to thecomments we received and to conformpart I with the revised regulations setforth in the final rule to amend part 2.The term is defined as "any building,room, area, enclosure, or othercontainment outside of a core facility orcentrally designated or managed area inwhich animals are housed for more than12 hours." A study area is a type ofhousing facility. "Satellite facilities"under the PHS Policy are study areas, asthat term is defined in this final rule. Italso includes buildings or temporarystructures set up at field sites whereanimals are maintained for more than 12hours. We are not limiting the term toareas where survival surgery isconducted, contrary to the suggestion oftwo commenters, since the need toensure animal welfare is not limited tosurgical procedures.Indoor Housing Facility

We received 236 comments (66 frommembers of the general public, 168 frommembers of the research or scientificcommunity, and 2 from dealers) statingthat the proposed requirement that anindoor housing facility be capable ofmaintaining humidity levels between 30to 70 percent should be removed. Threecommenters (1 member of the generalpublic and 2 members of the research orscientific community] stated that thehumidity control requirement should beclarified, and 1 member of the generalpublic and 3 members of the research orscientific community stated that thehumidity range provided in the

definition should be revised to bebetween 40-60 percent.

Based upon our experience inadministering the Act and theregulations, we believe an indoorhousing facility must be capable ofcontrolling the environment, includingthe temperature and humidity level, inwhich an animal is maintained in orderto.promote its health and well-being.The humidity level provided in thedefinition is consistent with the NIHGuide for the Care and Use ofLaboratory Animals, and is appropriatefor most warm-blooded animals. Webelieve this to be a reasonablerequirement to impose upon personswho maintain animals in indoor housingfacilities and that it is necessary for thewelfare of the animals.

Institutional OfficialWe are adding a definition of the term

"institutional official." In our revisedproposal, we referred to the ChiefExecutive Officer of a research facilityor a responsible institutional officialwith authority to bind the facility. Weare replacing these terms with the singleterm "institutional official" in the finalrule to amend part 2, to simplify theregulations and to make them consistentwith the terminology used in the PHSPolicy. We consider this to be anonsubstantive change. Neither of the,terms used in the revised proposal weredefined in our proposals to amend part1. We are adding a definition tofacilitate understanding and compliancewith the regulations. Under the finalrule, "institutional official" means theindividual at a research facility who isauthorized to legally commit on behalfof the research facility that therequirements of 9 CFR parts 1, 2, and 3will be met.

IsolationTwo members of the research or

scientific community commented thatthe proposed definition of "isolation"would not be appropriate for open-seafloating pens for marine mammals. Useof such pens is generally not appropriatefor the temporary isolation of marinemammals under part 3, subpart E forpurposes of medical treatment ortraining. No change is made in theregulations on the basis of thiscomment.Major Operative Experiment

We received 269 comments (74 frommembers of the general public, 193 frommembers of the research or scientificcommunity, and 2 from dealers)objecting to the proposed definition ofthe term, "major operative experiment."The 1985 amendments to the Act

prohibit the use of an animal in morethan one major operative experimentfrom which it is allowed to recover,except under certain limitedcircumstances (7 U.S.C. 2143(a)(3) (D)and (E)). We are broadening thisprohibition in the final rule to amendpart 2 to apply to any major operativeprocedure, since an experiment couldencompass a vast number of procedures

In the supplementary informationaccompanying the revised proposal, westated that the potential for causingphysical disability would be sufficient toconsider an experiment to be within theproposed definition, and that we werenot concerned with the intended effectof the principal investigator inperforming the experiment. Upon furtherconsideration of the comments wereceived, we have determined thatdetermining whether a procedure is amajor operative procedure can best bedone retrospectively, rather thanprospectively, and that doing so willsatisfy the Act's prohibition againstusing the animal in a second majoroperative experiment. It is clear from aresearch proposal whether the researchwill involve surgical intervention thatpenetrates and exposes a body cavity.However, the permanent effects of aprocedure can best be determinedafterward. After a procedure isperformed, the principal investigatorand the Committee can determinewhether it has produced a permanentimpairment of the animal's physical orphysiological functions. If it has, theanimal cannot be used'again for survivalsurgical purposes or for proceduresgenerally considered to result inpermanent impairment of the animal'sfunctions. As four commenters stated, (1member of the general public and 3members of the research or scientificcommunity) non-surgical proceduressuch as impact tests and severe burnstudies are invasive and can result inpermanent impairment. We are revisingthe definition in the final rule to mean"any surgical intervention thatpenetrates and exposes a body cavity orany procedure which producespermanent impairment of physical orphysiological functions." The term"disability" is replaced in the definitionwith the term "impairment" to includeany reduction in the animal's range orability of functions.

Mobile or Traveling Housing Facility

Four commenters (1 member of thegeneral public and 3 members of theresearch or scientific community)endorsed inclusion of an explicitdefinition of "mobile or travelinghousing facility" in part 1. The

Federal Register / Vol. 54, No. 168 / Thursday, August 31, 1989 / Rules and Regulations 3611,

standards with which these facilitiesmust comply when used to house dogs,cats, and nonhuman primates arecontained in the proposal to amend part3. (See docket no. 87-004, published inthe Federal Register on March 15, 1989,54 FR 10897-10954). We are consideringcomments on the proposed standards.Outdoor Housing Facility

One dealer commented that the term"outdoor housing facility" should berevised to accommodate different typesof outdoor primate housing enclosuresand their temperature requirements.Specific housing facility requirementsfor nonhuman primates were proposedin docket no. 87-004, published in theFederal Register on March 15, 1989 forpublic comment (54 FR 10897-10954).Temperature requirements for indoor,outdoor, sheltered, and mobile housingfacilities are addressed in thatdocument. Some animals, such as dogsand cats can tolerate lowertemperatures than nonhuman primates,and different species of nonhumanprimates have different temperaturerequirements. Therefore, we do notbelieve it is appropriate to includespecific requirements in the definition.Accordingly, no change is made in thefinal rule on the basis of this comment.

Painful ProcedureWe received 240 comments (66 from

members of the general public, 172 frommembers of the research or scientificcommunity, and 2 from dealers) urgingus to adopt the PHS Policy definition ofa "painful procedure." As we stated inthe supplementary informationaccompanying the revised proposal, theproposed definition is similar to andconsistent with the PHS Policy, and wedo not believe that any modification isneeded.

Eleven commenters (2 members of thegeneral public and 9 members of theresearch or scientific community) statedthat the different species' perception ofpain should be taken into considerationand that the attending veterinarian isqualified to determine whether aprocedure should be considered painful.Under the Act, involvement by theattending veterinarian in planning apainful procedure is essential because ofhis or her expertise. To this extent, thecommenters' view is incorporated in theregulations. One of the principalconcerns of Congress underlying the1985 amendments to the Act is the needto minimize pain and distress. In orderto fulfill Congress's intent, we believe itis appropriate to define "painfulprocedum" in terms of human standardsof pain, as does the PHS Policy, toensure that all potentially painful

practices are accorded the protections ofthe Act, such as those set forth insections 13(a)(3)(C) and 13(b)(3)A). (7U.S.C. 2143 (a)(3)[C) and 2143(b)(3)(A)).Four commenters (1 member of thegeneral public and 3 members of theresearch or scientific community)endorsed using human standards of painin defining the term.

Twenty-two members of the researchor scientific community commented thatwhen pain is relieved throughanesthesia, a procedure should not beconsidered painful. The 1985amendments to the Act refer repeatedlyto the use of pain-relieving drugs andanesthetics in conducting painfulprocedures and practices (See, e.g., 7U.S.C. 2143(a)(3)(C)(ii) and2143(e)(3)(B)). Therefore, under the Act,a procedure in which pain is relieved isstill considered to be a painfulprocedure, and the provisions of the Actwhich address the conduct of painfulprocedures apply. We are not adoptingthe commenters' suggestion.

Pet Animal

We received 19 comments (2 frommembers of the general public, 3 frommembers of the research or scientificcommunity, 2 from exhibitors, and 13from dealers) stating that the definitionof "pet animal" should include wild andexotic animals when they are used orsold as pets. These are specificallyexcluded, as explained in thesupplementary informationaccompanying the revised proposal (54FR 10829). Congress has exempted retailpet stores from the definition of "dealer"unless they sell animals to a researchfacility (7 U.S.C. 2132(f)(2)(i)) andtherefore, they are not required to belicensed under the Act. We believe thatCongress intended to limit this exclusionfrom the licensing requirements of theAct, and that only animals commonlysold as pets can properly be consideredpet animals. In this manner, dealerswould not be able to avoid the licensingrequirements of the regulations -bycalling themselves retail pet stores.Excluding wild and exotic animals fromthe definition of pet animal is consistentwith the Act and the definition of "retailpet store" included in this final rule.Accordingly, retail pet stores that sellexotic animals must be licensed under 9CFR part 2, subpart A. We are notmaking any change in the definition ofpet animal on the basis of this comment.

Positive Physical Contact

One member of the general public and5 members of the research or scientificcommunity commented that "positivephysical contact" should be redefined tomean contact which is beneficial to the

animal in the opinion of the attendingveterinarian. We agree that attendingveterinarians will be involved inassessing positive physical contact, aspart of their responsibility for ensuringadequate veterinary care and providingfor the animals' health and well-being.We are not making any changes to thedefinition in the final rule, however, sothat all persons involved in the care anduse of animals have a properunderstanding of the term and theirresponsibilities under the regulations.

Primary Enclosure

Fourteen members of the research orscientific community stated that theterm "primary enclosure" should beredefined to exclude any temporaryenclosure used for less than 24 hours.We do not agree that it is appropriate todo so. Minimum requirements for thedesign, construction, and sanitation ofprimary enclosures and primaryenclosures used for transporting animal,are set-forth in part 3 of the regulations.We are proposing to revise theserequirements in accordance with the1985 amendments to the Act and ourexperience in enforcing the Act. (Seedocket no. 87-004 published March 15,1989, 54 FR 10897-10954). Based uponour experience, we believe that thesame requirements are appropriate forany primary enclosure in which ananimal is maintained, regardless ofwhether it is used on a short-term orlong-term basis. Accordingly, we notmaking any changes in the definition ofprimary enclosure.

Principal Investigator

Four commenters from the research oiscientific community suggested that thedefinition of "principal investigator" berevised to include proposed activitiesintended for use in teaching. Researchconducted to instruct others is researchnonetheless, and proposals to useanimals in the course of teaching are th(responsibility of the principalinvestigator. The proposed definition isconsistent with the definition ofresearch facility, which, in accordancevith the Act, is defined to mean "anyschool * * * institution, organization, operson that uses or intends to use liveanimals in research, tests, orexperiments * * * " (final rule § 1.1)).There is no separate reference toteaching. We are making one -hange inthe definition to include any personassociated with the research facilitybecause it is common practice forpersons who are not employees to beinvolved in research activities at suchfacilities. For these reasons, we do not

36118 Federal Regisler / Vol. 54, No. 168 / Thursday, August 31, 1989 / Rules and Regulations

believe that any change in the definitionis necessary in the final rule.

Research Facility

Three commenters from the researchor scientific community suggestedrevising the definition of "researchfacility" to mean, in the case of acorporation, any administrative unitreasonably designated by thecorporation. We do not agree with thecommenters proposed change. Under theregistration requirements applicable toresearch facilities in the final rule, thecorporation must register as theresearch facility, or a subsidiary of acorporation must register as theresearch facility unless it is under thedirect control of the parent corporation.In developing the final rule to amendpart 2 of the regulations (see docket no.89-131, published elsewhere in this issueof the Federal Register, we determinedthat it is the responsibility of theresearch facility to ensure compliancewith the regulations. We did so toensure that animal welfare concerns areaddressed at the highest level ofcorporate or administrativeresponsibility. In this manner, we areassured of an entity's commitment topromoting animal welfare and that itwill take appropriate measures torequire compliance by all employees.We do not consider it appropriate oradvisable to reduce the level at whichthis responsibility rests.

Suggestions for Additional Definitions

A number of comnenters stated thatother terms used in the revised pr6posalto amend part 2 and the proposal toamend part 3 of the regulations,published in the Federal Register onMarch 15, 1989 (54 FR 10835-10897 and10897-10954, respectively) should bedefined for purposes of clarity. We donot believe it is necessary orappropriate to define these terms. Insome cases, we believe it is sufficient torely on ordinary usage and dictionarydefinitions. In others, we believe thatthe changes made to the regulations inthe final rule to amend part 2 willresolve the commenters' concerns. (Seedocket no. 89-131, published elsewherein this issue of the Federal Register. Forthe reasons -set forth below, we are notadding any terms to the final rule toamend part 1 on the basis of thesecomments.

One dealer commented that the words"verbal abuse" in § 2.4 of the revisedproposal, "Non-interference with APHISofficials" are not clearly defined. Webelieve that ordinary understanding ofthose words will suffice and that theyneed not be defined in the regulations.

One member of the general publicstated that "survival surgery" as theterm is used in part 2, should be defined.We believe that this term is commonlyunderstood to mean any surgery fromwhich the subject is reasonablyexpected to recover, and that no furtherdefinition is necessary.

One member of the research orscientific community suggested that weprovide a definition of the term "naturalenvironment" as used in § 2.35(b](1)(iiiof the revised proposal to clarifywhether outdoor environments alteredby man would be considered naturalenvironments. The final rule is revisedto provide an exception from therequirement for Committee inspectionfor studies of free-living wild animals intheir natural habitat (final rule§ 2.31(c)(2)). We are also exemptingfield studies from the Committee reviewand inspection requirements of 9 CFRpart 2, subpart C, and have defined thatterm to mean any study conducted onfree-living wild animals in their naturalhabitat which does not involve aninvasive procedure and which does notharm or materially alter the behavior ofthe animals. The term "natural habitat"necessarily excludes humanintervention, and we do not believefurther clarification is required.

We received 241 comments (67 frommembers of the general public, 172 frommembers of the research or scientificcommunity, and 2 from dealers)suggesting that we provide a definitionof the term "animal area" as used in therevised proposal to amend part 2Idocket no. 88-014, published in theFederal Register on March 15, 1989, 54FR 10835-10897). The revisions made inthe final rule obviate the need to definethe term. The term "animal area" is usedin the final regulations only with regardto free-living wild animals living in theirnatural habitat. We believe thatcommon understanding of the termwhen used in this context is sufficient,and that further clarification isunnecessary.

Eight commenters (1 member of thegeneral public, 4 members of theresearch or scientific community, and 3dealers) stated that we should include adefinition of the term "compatiblegroup". It is used in the proposed rule toamend part 3-"Standards" indescribing the social groupingrequirements proposed for dogs, cats,and nonhuman primates (docket no. 87-004, published in the Federal Register onMarch 15, 1989, 54 FR 10897-10954). Webelieve that this term is commonlyunderstood to refer to animals that co-exist peaceably and with a sense ofwell-being, without exhibiting

aggressive or hostile behavior towardsthe other animals. Certain speciesbehave hostilely towards others, orexhibit aggressive behavior whichwould be detrimental to the otheranimals. Within species, some animalsmay exhibit this type of behavior andwould be a source of harmful stress tofellow members of the same species.These animals would not be consideredcompatible. We believe that thecommon understanding of this term isappropriate when applied to theproposed standards and that furtherdefinition is not necessary. We are notmaking any changes in the regulationson the basis of these comments.

Seven commenters (2 members of thegeneral public, 4 members of theresearch or scientific community, and 1dealer) requested that we define "full-spectrum lighting". Under the proposedrule to amend part 3-"Standards", full-spectrum lighting is required if artificiallight is used to illuminate indoor,sheltered, and mobile housing facilitiesused to house nonhuman primates, andindoor and mobile housing facilitiesused to house dogs and cats (docket no.87-004, published in the Federal Registeron March 15, 1989, 54 FR 10897-10954).Under this proposed requirement, ifartificial lighting is used it must providea wide range of wavelengths, such asinfra-red and ultraviolet, so that itapproximates natural sunlight. We donot believe that further clarification Isnecessary while we consider thecomments received and developregulations addressing the lightingrequirements to be included in part 3.

We received 238 comments (68 frommembers of the general public, 168 frommembers of the research or scientificcommunity, and 2 from dealers) statingthat the terms "exercise" for dogs and"psychological well-being" of nonhumanprimates must be defined in the finalrules before research facilities candevelop procedures and systems whichsatisfy the regulations. Two members ofthe general public and 1 member of theresearch or scientific community statedthat "socialization" of dogs should bedefined in part 1, and 44 commenters (3members of the general public, 40members of the research or scientificcommunity, and 1 dealer) stated that..psychological well-being" of nonhumanprimates should be defined.Requirements for exercise for dogs andfor an environment that is adequate topromote the psychological well-being ofnonhuman primates are statutorilymandated by the 1985 amendments tothe Act. Congress directed the Secretaryof Agriculture to promulgate minimumrequirements that would fulfill these

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needs. We proposed minimumrequirements in docket no. 87-004,published in the Federal Register onMarch 15, 1989, 54 FR 10897-10954,based upon our own expertise and therecommendations of advisorycommittees that we formed to addressthe Congressional directives. We areconsidering the comments we receivedconcerning the proposal and arecontinuing to consult with HHS andmembers of the IRAC in formulatingmeans of fulfilling our objectives.Through these efforts, we are re-evaluating our proposal and arecontinuing to explore alternativeregulatory solutions that satisfy ourmandate from Congress. We do notbelieve that it is necessary to providedefinitions of these terms. Rather, bydeveloping appropriate standards, webelieve that upon promulgation of a finalrule to amend part 3, all regulatedentities will have adequate guidance incomplying with the Act, Accordingly, weare not making any changes in theregulations on the basis of thesecomments.

One dealer suggested that we define"quarantine period" as it is used in theproposal to amend part 3-"Standards",subpart D, as any isolation periodimposed by Federal, State, or local laws.The commenter further stated that theappropriate quarantine period fornewly-imported nonhuman primatesshould be 90-120 days, subject toextension at the direction of theattending veterinarian. Quarantinerequirements are imposed by Federal,State, and local law, as noted in theproposed regulations (proposed§ 3.80(c)(2)(v)(A)). Further definition ofthe term "quarantine period" istherefore unwarranted.

Another dealer suggested that wedefine "quarantine" as it relates to cagesize and exercise requirements fornonhuman primates that are caught inthe wild and those that are bred incaptivity. Cage size requirements foranimals maintained under quarantine bydealers are set forth in the proposedrules (proposed § 3.80(c)(2)(v)(A)), andthere is no requirement in the proposedregulations for release by dealers ofquarantined animals for exercise. We donot believe that defining the term"quarantine" is necessary.

Statutory Authority for This ProposedRule

This final rule is issued pursuant tothe Animal Welfare Act (Act), asamended, 7 U.S.C. 2131-2157. Congressrecently added significantly to theSecretary's responsibilities under theAct by amendments in the Food SecurityAct of 1985, Public Law No. 99-198,

approved December 23, 1985. Thedeclared policy of the Act is to ensurethat animals intended for use inresearch facilities, as pets, or forexhibition purposes are providedhumane care and treatment; to assurethe humane treatment of animals duringtransportation; and to prevent the saleof stolen animals.

The Act mandates that the Secretaryof Agriculture promulgate regulationsand standards to govern the humanehandling, care, treatment, andtransportation of animals by dealers,exhibitors, research facilities, carriers,and intermediate handlers. Toaccomplish this, the Secretary mustdefine certain key words used in theregulations and standards so thatpersons subject to the Act, regulations,and standards can comply with theirrequirements.

The Act itself defines some of theterms which appear in this rule. The Act'also authorizes the Secretary topromulgate such rules, includingadditional definitions, as he deemsnecessary to effectuate the purposes ofthe Act,

Executive Order 12291 and RegulatoryFlexibility Act

This final rule contains new andrevised definitions of terms thatcomplement regulatory changes for parts2 and 3 of the Animal Welfareregulations. The general intent is toupdate, clarify, and expand the list ofrelevant definitions as required by theamendments to the Act. The Departmenthas determined that no economicimpacts would result from this action.Therefore, this final rule is not a "majorrule" for the purposes of ExecutiveOrder 12291, under the criteria therein.In addition, the Administrator herebycertifies that this final rule will not havea significant economic impact on asubstantial number of small entities. It isanticipated that the economic impactswould result from final rules for part 2,"Animal Welfare Regulations," and part3, "Standards." The regulatory impactanalysis for part 2 of the regulations isincluded in the final rule for part 2,"Animal Welfare Regulations."

Executive Order 12372

This program/activity is listed in theCatalog of Federal Domestic Assistanceunder No 10.025 and is subject to theprovisions of Executive Order 12372,which requires intergovernmentalconsultation with State and localofficials. (See 7 CFR part 3015, subpartV).

Paperwork Reduction Act

The information collection andrecordkeeping provisions that areincluded in the final rules amending 9CFR parts 1 and 2 have been submittedfor apiproval to the Office ofManagement and Budget (OMB), inaccordance with the requirements of thePaperwork Reduction Act of 1980 (44U.S.C. chapter 35) under control number0579-0036, and upon approval, willbecome effective upon October 30, 1989.The Department has requested thatOMB conclude its review no later thanOctober 30, 1989.

The public reporting burden for thiscollection of information is estimated toaverage 0.96 hours per response,including the time for reviewinginstructions, searching existing datasources, gathering and maintaining thedata needed, and completing andreviewing the collection of information.The public recordkeeping burden isestimated to average 4.0 annual hoursper recordkeeper.

Send written comments regarding thisburden estimate or any other aspect ofthis collection of information, includingsuggestions for reducing this burden, tothe U.S. Department of Agriculture,Clearance Officer, OIRM, Room 404W,Washington, DC 20250; and to the Officeof Management and Budget, PaperworkReduction Project (OMB Control No.0579-0036), Washington, DC 20503.

List of Subjects in 9 CFR Part 1

Animal welfare, Animal housing,Dealers, Exhibitors, Research facilities,Humane animal handling.

We are amending 9 CFR part 1 asfollows:

PART I-DEFINITION OF TERMS

1. The authority citation for Part 1 isrevised to read as follows:

Authority: 7 U.S.C. 2131-2157; 7 CFR 2.17,2.51, and 371.2(g).

2. Section 1.1 is revised to read asfollows:

§ 1.1 Definitions.For the purposes of this subchapter,

unless the context otherwise requires,the following terms shall have themeanings assigned to them in thissection. The singular form shall alsosignify the plural and the masculineform shall also signify the feminine.Words undefined in the followingparagraphs shall have the meaningattributed to them in general usage asreflected by definitions in a standarddictionary.


Act means the Act of August 24, 1966(Pub. L. 89-544), (commonly known asthe Laboratory Animal Welfare Act), asamended by the Act of December 24,1970 (Pub. L. 91-579), (the AnimalWelfare Act of 1970), the Act of April 22,1976 (Pub. L. 94-279), (the AnimalWelfare Act of 1976), and the Act ofDecember 23, 1985 (Pub. L. 99-198), (theFood Security Act of 1985), and as itmay be subsequently amended.

Activity means, for purposes of part 2,subpart C of this subchapter, thoseelements of research, testing, or teachingprocedures that involve the care and useof animals.

Administrative unit means theorganizational or management unit atthe departmental level of a researchfacility.

Administrator means theAdministrator of the Animal and PlantHealth Inspection Service, U.S.Department of Agriculture, or any otherofficial of the Animal and Plant HealthInspection Service to whom authorityhas been delegated to act in his stead.

Ambient temperature means the airtemperature surrounding the animal.

Animal means any live or dead dog,cat, nonhuman primate, guinea pig,hamster, rabbit,,or any otherwarmblooded animal, which is beingused, or is intended for use for research,teaching, testing, experimentation, orexhibition purposes, or as a pet. Thisterm excludes: Birds, rats of the genusRattus and mice of the genus Mus bredfor use in research, and horses and otherfarm animals, such as, but not limited tolivestock or poultry, used or intended foruse as food or fiber, or livestock orpoultry used or intended for use forimproving animal nutrition, breeding,management, or production efficiency,or for improving the quality of food orfiber. With respect to a dog, the termmeans all dogs including those used forhunting, security, or breeding purposes.

Animal act means any performance ofanimals where such animals are trainedto perform some behavior or action orare part of a show, performance, orexhibition.

APHIS means the Animal and PlantHealth Inspection Service, United StatesDepartment of Agriculture.

APHIS official means any personemployed by the Department who isauthorized to perform a function underthe Act and the regulations in 9 CFRparts 1, 2, and 3.

APHIS, REAC Sector Supervisormeans a veterinarian or his designee,employed by APHIS, who is assigned by

* the Administrator to supervise andperform the official work of APHIS in agiven State or States. As used In part 2of this subchapter, the APHIS, REAC

Sector Supervisor shall be deemed to bethe person in charge of the official workof APHIS in the State in which thedealer, exhibitor, research facility,intermediate handler, carrier, oroperator of an auction sale has hisprincipal place of business.

Attending veterinarian means aperson who has graduated from aveterinary school accredited by theAmerican Veterinary MedicalAssociation's Council on Education, orhas a certificate issued by the AmericanVeterinary Medical Association'sEducation Commission for ForeignVeterinary Graduates, or has receivedequivalent formal education asdetermined by the Administrator; hasreceived training and/or experience inthe care and management of the speciesbeing attended; and who has direct ordelegated authority for activitiesinvolving animals at a facility subject tothe jurisdiction of the Secretary.

Business hours means a reasonablenumber of hours between 7 a.m. and 7p.m., Monday through Friday, except forlegal Federal holidays, each week of theyear, during which inspections byAPHIS may be made.

Business year means the 12-monthperiod during which business isconducted, and may be either on acalendar or fiscal-year basis.

Carrier means the operator of anyairline, railroad, motor carrier, shippingline, or other enterprise which isengaged in the business of transportingany animals for hire.

Cat means any live or dead cat (Feliscatus] or any cat-hybrid cross.

Class "A"licensee (breeder) means aperson subject to the licensingrequirements under part 2 and meetingthe definition of a "dealer" (§ 1.1), andwhose business involving animalsconsists only of animals that are bredand raised on the premises in a closedor stable colony and those animalsacquired for the sole purpose ofmaintaining or enhancing the breedingcolony.

Class "B" licensee means a personsubject to the licensing requirementsunder part 2 and meeting the definitionof a "dealer" (§ 1.1], and whose businessincludes the purchase and/or resale dfany animal. This term includes brokers,and operators of an auction sale, assuch individuals negotiate or arrange for.the purchase, sale, or transport ofanimals in commerce. Such individualsdo not usually take actual physicalpossession or control of the animals,and do not usually hold animals in anyfacilities. A class "B" licensee may alsoexhibit animals as a minor part of thebusiness.

Class "C" licensee (exhibitor) meansa person subject to the licensingrequirements under part 2 and meetingthe definition of an "exhibitor" (§ 1.1),and whose business involves theshowing or displaying of animals to thepublic. A class "C" licensee may buyand sell animals as a minor part of thebusiness in order to maintain or add tohis animal collection.

Commerce means trade, traffic,transportation, or other commerce:

(1) Between a place in a State and anyplace outside of such State, includingany foreign country, or between pointswithin the same State but through anyplace outside thereof, or within anyterritory, possession, or the District ofColumbia; or

(2) Which affects the commercedescribed in this part.

Committee means the InstitutionalAnimal Care and Use Committee(IACUC) established under section 13(b)of the Act. It shall consist of at leastthree (3) members, one of whom is theattending veterinarian of the researchfacility and one of whom is not affiliatedin any way with the facility other thanas a member of the committee, however,if the research facility has more thanone Doctor of Veterinary Medicine(DVM], another DVM with delegatedprogram responsibility may serve. Theresearch facility shall establish theCommittee for the purpose of evaluatingthe care, treatment, housing, and use ofanimals, and for certifying compliancewith the Act by the research facility.

Dealer means any person who, incommerce, for compensation or profit.delivers for transportation, ortransports, except as a carrier, buys, orsells, or negotiates the purchase or saleof: Any dog or other animal whetheralive or dead (including unborn animals,organs, limbs, blood, serum, or otherparts) for research, teaching, testing,experimentation, exhibition, or for useas a pet; or any dog for hunting, security,or breeding purposes. This term does notinclude: A retail pet store, as defined inthis section, unless such store sells anyanimals to a research facility, anexhibitor, or a dealer (wholesale); or anyperson who does not sell, or negotiatethe purchase or sale of any wild orexotic animal, dog, or cat and whoderives no more than $500 gross incomefrom the sale of animals other than wildor exotic animals, dogs, or cats, duringany calendar year.

Department means the U.S.Department of Agriculture.

Deputy Administrator means theDeputy Administrator for RegulatoryEnforcement and Animal Care (REAC)or any other official of REAC to whom

Federal Register / Vol. 54, No. 168 / Thursday, August 31, 1989 / Rules and Regulations 36121

iuthority has been delegated to act inis stead.Dog means any live or dead dog

Canis familus] or any dog-hybrid:ross.

Dwarf hamster means any species of'iamster such as the Chinese andkrmenian species whose adult body4ize is substantially less than that,ittained by the Syrian or Golden speciesf hamsters.Endangered species means those

species defined in the EndangeredSpecies Act (16 U.S.C. 1531 et seq.) andas it may be subsequently amended.

Euthanasia means the humanedestruction of an animal accomplishedby a method that produces rapidunconsciousness and subsequent deathwithout evidence of pain or distress, ora method that utilizes anesthesiaproduced by an agent that causes.painless loss of consciousness andsubsequent death

Exhibitor means any person (public orprivate) exhibiting any animals, whichwere purchased in conerce or theintended distribution of which affectscommerce, or will affect commerce, tothe public for compensation, asdetermined by the Secretary. This termincludes carnivals, circuses, animal acts,zoos, and educational exhibits,exhibiting such animals whetheroperated for profit or not. This termexcludes retail pet stores, horse and dograces, organizations sponsoring and allpersons participating in State andcounty fairs, livestock shows, rodeos,field trials, coursing events, purebreddog and cat shows and any other fairsor exhibitions intended to advanceagricultural arts and sciences as may bedetermined by the Secretary.

Exotic animal means any animal notidentified in the definition of "animal"provided in this part that is native to aforeign country or of foreign origin orcharacter, is not native to the UnitedStates, or was introduced from abroad.This term specifically includes animalssuch as, but not limited to, lions, tigers,leopards, elephants, camels, antelope,anteaters, kangaroos, and water buffalo,and species of foreign domestic cattle,such as Ankole, Gayal, and Yak.

Form animal means any domesticspecies of cattle, sheep, swine, goats,llamas, or horses, which are normallyand have historically, been kept andraised on farms in the United States,and used or intended for use as food orfiber, or for improving animal nutrition,breeding, management, or productionefficiency, or for improving the qualityof food or fiber. This term also includesanimals such as rabbits, mink, andchinchilla. when they are used solely forpurposes of meat or fur, and animals

such as horses and llamas-when usedsolely as work and pack animals.

Federal agency means an Executiveagency as such term is defined insection 105 of title 5, United StatesCode, and with respect to any researchfacility means the agency from whichthe research facility receives a Federalaward for the conduct of research,experimentation, or testing involving theuse of animals.

Federal award means any mechanism(including a grant, award, loan, contract,or cooperative agreement) under whichFederal funds are used to support theconduct of research, experimentation, ortesting, involving the use of animals.The permit system established under theauthorities of the Endangered SpeciesAct, the Marine Mammal Protection Act,and the Migratory Bird Treaty Act, arenot considered to be Federal awardsunder the Animal Welfare Act.

Federal research facility means eachdepartment, agency, or instrumentalityof the United States which uses liveanimals for research or experimentation.

Field study means any studyconducted on free-living wild animals intheir natural habitat, which does notinvolve an invasive procedure, andwhich does not harm or materially alterthe behavior of the animals under study.

Handling means petting, feeding,watering, cleaning, manipulating,loading, crating, shifting, transferring,immobilizing, restraining, treating,training, working and moving, or anysimilar activity with respect to anyanimal..Housing facility means any land,

premises, shed, barn, building, trailer, orother structure or area housing orintended to house animals.

Hybrid cross means an animalresulting from the crossbreedingbetween two different species or typesof animals. Crosses between wildanimal species, such as lions and tigers,are considered to be wild animals.Crosses between wild animal speciesand domestic animals, such as dogs andwolves or buffalo and domestic cattle,are considered to be domestic animals.

Impervious surface means a surfacethat does not permit the absorption offluids. Such surfaces are those that canbe thoroughly and repeatedly cleanedand disinfected, will not retain odors,and from which fluids bead up and runoff or can be removed without theirbeing absorbed into the surfacematerial.

Indoor housing facility means anystructure or building with environmentalcontrols housing or intended to houseanimals and meeting the following threerequirements:

(1] It must be capable of controllingthe temperature within the building orstructure within the limits set forth forthat species of animal, of maintaininghumidity levels of 30 to 70 percent andof rapidly eliminating odors from withinthe building; and

(2) It must be an enclosure created bythe continuous connection of a roof,floor, and walls fa shed or barn set ontop of the ground does not have acontinuous connection between thewalls and the ground unless afoundation and floor are provided); and

13) It must have at least one door forentry and exit that can be opened andclosed (any windows or openings whichprovide natural light must be coveredwith a transparent material such asglass or hard plastic.

Intermediate handler means anyperson, including a department, agency,or instrumentality of the United Statesor of any State or local government(other than a dealer, research facility,exhibitor, any person excluded from thedefinition of a dealer, research facility,or exhibitor, an operator of an auctionsale, or a carrier), who is engaged in anybusiness in which he receives custody ofanimals in connection with theirtransportation in commerce.

Inspectormeans any person employedby the Department who is authorized toperform a function under the Act andthe regulations in 9 CFR parts 1, 2, and 3.

Institutional official means theindividual at a research facility who isauthorized to legally commit on behalfof the research facility that therequirements of 9 CFR parts 1, 2, and 3will be met.

Isolation in regard to marinemammals means the physical separationof animals to prevent contact and aseparate, noncommon, water circulationand filtration system for the isolatesanimals.

Licensed veterinarian means a personwho has graduated from an accreditedschool of veterinary medicine or hasreceived equivalent formal education asdetermined by the Administrator, andwho has a valid license to practiceveterinary medicine in some State.

Licensee means any person licensedaccording to the provisions of the Actand the regulations in part 2 of thissubchapter.

Major operative procedure means anysurgical intervention that penetrates andexposes a body cavity or any procedurewhich produces permanent impairmentof physical or physiological functions.

Minimum horizontal dimension(MHD) means the diameter of a circularpool of water, or in the case of a square,rectangle, oblong, or other shape pool,


the diameter of the largest circle thatcan be inserted within the confines ofsuch a pool of water.

Mobile or traveling housing facilitymeans a transporting vehicle such as atruck, trailer, or railway car, used tohouse animals while traveling forexhibition or public education purposes.

Nonconditioned animals meansanimals which have not been subjectedto special care and treatment forsufficient time to stabilize, and wherenecessary, to improve their health.

Nonhuman primate means anynonhuman member of the highest orderof mammals including prosimians,monkeys, and apes.

Operator of an auction sale meansany person who is engaged in operatingan auction at which animals arepurchased or sold in commerce.

Outdoor housing facility means anystructure, building, land, or premise,housing or intended to house animals,which does not meet the definition ofany other type of housing facilityprovided in the regulations, and inwhich temperatures cannot becontrolled within set limits.

Painfulprocedure as applied to anyanimal means any procedure that wouldreasonably be expected to cause morethan slight or momentary pain ordistress in a human being to which thatprocedure was applied, that is, pain inexcess of that caused by injections orother minor procedures.

Paralytic drug means a drug whichcauses partial or complete loss ofmuscle contraction and which has noanesthetic or analgesic properties, sothat the animal cannot move, but iscompletely aware of its surroundingsand can feel pain.

Person means any individual,partnership, firm, joint stock company,corporation, association, trust, estate, orother legal entity.

.Pet animal means any animal that hascommonly been kept as a pet in familyhouseholds in the United States, such asdogs, cats, guinea pigs, rabbits, andhamsters. This term excludes exoticanimals and wild animals.

Positive physical contact meanspetting, stroking, or other touching,which is beneficial to the well-being ofthe animal.

Primary conveyance means the mainmethod of transportation used to convey.an animal from origin to destination,such as a motor vehicle, plane, ship, ortrain.

Primary enclosure means anystructure or device used to restrict ananimal or animals to a limited amount ofspace, such as a room, pen, run, cage,compartment, pool, hutch, or tether. Inthe case of animals restrained by a

tether (e.g., dogs on chains), it includesthe shelter and the area within reach ofthe tether.

Principal investigator means anemployee of a research facility, or otherperson associated with a researchfacility, responsible for a proposal toconduct research and for the design andimplementation of research involvinganimals.

Quorum means a majority of theCommittee members.

Random source means dogs and catsobtained from animal pounds orshelters, auction sales, or from anyperson who did not breed and raisethem on his or her premises.

Registrant means any researchfacility, carrier, intermediate handler, orexhibitor not required to be licensedunder section 3 of the Act, registeredpursuant to the provisions of the Actand the regulations in part 2 of thissubchapter.

Research facility means any school(except an elementary or secondaryschool), institution, organization, orperson that uses or intends to use liveanimals in research, tests, orexperiments, and that (1) purchases ortransports live animals in commerce, or(2) receives funds under a grant, award,loan, or contract from a department,agency, or instrumentality of the UnitedStates for the purpose of carrying outresearch, tests, or experiments:Provided, That the Administrator mayexempt, by regulation, any such school,institution, organization, or person thatdoes not use or intend to use live dogsor cats, except those schools,institutions, organizations, or persons,which use substantial numbers (asdetermined by the Administrator) of liveanimals the principal function of whichschools, institutions, organizations, orpersons, is biomedical research ortesting, when in the judgment of the.Administrator, any such exemption doesnot vitiate the purpose of the Act.

Retailpet store means any outletwhere only the following animals aresold or offered for sale, at retail, for useas pets: Dogs, cats, rabbits, guinea pigs,hamsters, gerbils, rats, mice, gophers,chinchilla, domestic ferrets, domesticfarm animals, birds, and coldbloodedspecies. Such definition excludes-

(1) Establishments or persons whodeal in dogs used for hunting, security,or breeding purposes;

(2) Establishments or personsexhibiting, selling, or offering to exhibitor sell any wild or exotic or othernonpet species of warmblooded animals(except birds), such as skunks, raccoons,nonhuman primates, squirrels, ocelots,foxes, coyotes, etc.;

(3) Any establishment or personselling warmblooded animals (exceptbirds, and laboratory rats and mice) forresearch or exhibition purposes; and

(4) Any establishment wholesalingany animals (except birds, rats andmice).

(5) Any establishment exhibiting petanimals in a room that is separate fromor adjacent to the retail pet store, or inan outside area, or anywhere off theretail pet store premises.

Sanitize means to make physicallyclean and to remove and destroy, to themaximum degree that is practical,agents injurious to health.

Secretary means the Secretary ofAgriculture of the United States or hisrepresentative who shall be anemployee of the Department.

Sheltered housing facility means ahousing facility which provides theanimals with shelter; protection from theelements; and protection fromtemperature extremes at all times. Asheltered housing facility may consist ofruns or pens totally enclosed in a barnor building, or of connecting inside/outside runs or pens with the insidepens in a totally enclosed building.

Standards means the requirementswith respect to the humane housing,exhibition, handling, care, treatment,temperature, and transportation ofanimals by dealers, exhibitors researchfacilities, carriers, intermediatehandlers, and operators of auction salesas set forth in part 3 of this subchapter.

State means a State of the UnitedStates, the District of Columbia,Commonwealth of Puerto Rico, theVirgin Islands, Guam, American Samoa,or any other territory or possession ofthe United States.

Study area means any building room,area, enclosure, or other containmentoutside of a core facility or centrallydesignated or managed area in whichanimals are housed for more than 12hours.

Transporting device means an interimvehicle or device, other than man, usedto transport an animal between theprimary conveyance and the terminalfacility or in and around the terminalfacility of a carrier or intermediatehandler.

Transporting vehicle means any truckcar, trailer, airplane, ship, or railroad caiused for transporting animals.

Weaned means that an animal hasbecome accustomed to take solid foodand has so done, without nursing, for aperiod of at least 5 days.

Wild animal means any animal whichis now or historically has been found inthe wild, or in the wild state, within theboundaries of the United States, its

Federal Register I Vol. 54, No. 1C8 / Thursday, August 31, 1989 / Rules and Regulations 36123

territories, or possessions. This termincludes, but is not limited to, animalssuch as: Deer, skunk, opossum, raccoon,mink, armadillo, coyote, squirrel, fox,wolf.

Wildstate means living in its original,natural condition; not domesticated.

Zoo means any park, building, cage,enclosure, or other structure or premisein which a live animal or animals arekept for public exhibition or viewing,regardless of compensation.

Done in Washington, DC, this 25th day ofAugust, 1989.A. Strating,Acting AdAiinistmtor, Animal and PlantHealth Inspection Service.[FR Doc. 89-20425 Filed 8-30-89; 8:45 am]BLMNG CODE 341044-9

DEPARTMENT OF AGRICULTURE

9 CFR Parts 2 and 3

[Docket No. 89-1311

RIN 0579-AA11

Animal Weflare

AGENCY: Animal and Plant HealthInspection Service, USDA.ACTION: Final rule.

SUMMARY: We are amending the AnimalWelfare regulations contained in 9 CFRpart 2, to comply with and implementthe amendments to the Animal WelfareAct (7 U.S.C. 2131, et seq.) ("Act")contained in Pub. L. 99-198, "The FoodSecurity Act of 1985," enacted December23, 1985, and to reflect our experience inadministering the regulations. Inaddition to rewriting the regulations tofacilitate compliance by making themeasier to understand, we are adding anew subpart whichpertains exclusivelyto research facilities, and whichconsolidates all of the regulations inpart 2 applicable to research facilities.The revised regulations also providerequirements for registration andlicensing under the Act, adequateveterinary care, handling, holdingfacilities, identification of animals, andrecordkeeping. The revised regulationsare necessary to clarify theresponsibilities of regulated personsunder the Act, as amended, and topromote animal welfare.DATES: This final rule shall beconleeffective October 30, 1989; however, theportions of the rule which concern orrelate to information collection andrecordkeepirig will become effectiveOctober 30, 1989, upon approval by theOffice of Management and Budget(OMB). The information collectionrequirements of this final rule have been

submitted to OMB for review andapproval. The Department has requestedthat OMB conclude its review no laterthan October 30, 1989. If any portion isdisapproved, notice of disapproval willbe published in the Federal Registerprior to that date.FOR FURTHER 4NFORMATON CONTACT:Dr. Dale F. Schwindaman, REAC,APHIS, USDA, Room 206, 6505 BelcrestRoad, Hyattsville, MD 20782, (301) 436--6491.SUPPLEMENTARY INFORMATtON

BackgroundThis final rule revises the regulations

contained in 9CFR 2.1 through 2.130. Itis the result of an intensive effort thatbegan in 1985 when Congress amendedthe Animal Welfare Act (7 U.S.C. 2131,et seq.) (the Act) in Public Law 99-198,"The Food Security Act of 1985," anddirected the Secretary of Agriculture topromulgate regulations governing thehumane handling, care, treatment, andtransportation of animals by dealers,research facilities, and exhibitors,including requirements for exercise ofdogs and a physical environmentadequate to promote the psychologicalwell-being of nonhuman primates. Thefinal -rule reflects APHIS's many years ofexperience in enforcing the Act and theAnimal Welfare regulations. Weconsidered -many thousands of publiccomments in deciding upon the contentof the final rule. Our ongoingconsultation with the U.S. Department ofHealth and Human Services, as well asother Federal agencies concerned withanimal welfare, also contributedsignificantly to determining how best tofulfill our statutory mandate.

Due to the length and complexity ofthis document, it is broken down intogeneral headings and specificsubheadings where appropriate, toassist the reader. The supplementaryinformation begins with a brief historyof this rule-making. Next we describethe changes we have made in the finalrule, both in form and in content Thesechanges are based upon ourreconsideration of the proposedregulations in light of the comments wereceived and our consultation with otherFederal agencies. Part 2 has beenreorganized, in part, in this final rule, sothat alliequirements imposed uponresearch facilities are-contained in onesubpart of the regulations. We thendiscuss, in detail, how the requirementsimposed upon research facilities underthe final rule differ substantively fromthe two previous proposals, and howthey do not. We also describe otherchanges we are making to part 2 basedupon our .reconsideration -of those

provisions. Our response to thecomments we received in response tothe March 15, 1989 revised proposalfollows. Lastly, we address the concernsraised in the public comment letters andby Federal agencies regarding oureconomic assessments of the cost ofimplementing the proposed regulations.

Proposed Rules

The Animal Welfare regulations arecontained in Title 9 of the Code ofFederal Regulations, chapter 1,subchapter A-Animal Welfare, parts 1,2, and 3 (the regulations]. Part I providesdefinitions of the terms used in parts 2and 3. Part 2 sets forth theadministrative and institutionalresponsibilities of regulated personsunder the Act, and part 3 providesspecifications for the humane handling,care, treatment, and transportation ofanimals covered by the Act by regulatedentities.

In two documents published in theFederal Register, on March 31, 1987 (52FR 10292-10298 and 52 FR 10298-10322,respectively), we proposed to reviseparts I and 2 of the Animal Welfareregulations. In addition to the definitionsof terms, the proposed amendmentspertained to licensing of dealers andexhibitors, and registration ofintermediate handlers, researchfacilities, and carriers. The proposedregulations also set forth requirementsapplicable to all regulated entities forrecordkeeping and identification ofanimals, holding periods and facilities,inspections, adequate veterinary care,and requirements for InstitutionalAnimal Care and Use Committees asagents of the research facilities. Thesechanges were proposed under theauthority of the Animal Welfare Act, asamended by Congress in 1985. At thattime, we did not publish a proposed ruleto amend part 3-"Standards" of theregulations.

We solicited comments concerning theproposal for a 60-day period ending June1, 1987. The comment period was twiceextended and ended on August 27, 1987.A total of 7,857 comments were timelyreceived and considered. Many of thecomments we received stated that itwas difficult to comment -upon theproposals to amend parts I and 2 of theregulations independently of ourproposal to amend the standards in part3. We have maintained that upon theirpublication as final rules, parts I and 2of the regulations can be fullyimplemented with the existing standardsin part 3. In response to the comments,we decided to publish revised proposalsto amend parts 1 and 2 along with ourproposed rule to amend part 3, to assist

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