Merchen says. “Many have a ‘cultural resistance’ tocentralized oversight.”In some cases, this aversion leads to a less-than-positiveattitude toward the value of AAALAC accreditation.Merchen believes that there are some legitimate issuescontributing to a lack of enthusiasm and limited supportfor accreditation at some institutions. At the sametime, he would like to see institutions do a better job ofincorporating agricultural components into their largeranimal care and use program, including making it a part oftheir accreditation.“I support the notion that the agricultural programshould be a mainstream element of the institutional animalprogram,” Merchen says. “The people that are engagedin the oversight of the agricultural program should behelping to provide leadership to the institutional animalcare program.” This, he feels, requires creating a strongrelationship between key institutional entities—the IACUC,the institutional veterinarian, the institutional offi cial, andthe agricultural animal program.CostFor most institutions, the fees required to apply for andmaintain accreditation are relatively modest. It’s the stafftime needed to prepare for the process that can make thereal cost of accreditation more signifi cant, particularly atvery large institutions.“The University of Illinois is a large program. We have12,000 to 14,000 animals in our facilities every day. Abouthalf are poultry, but we also have lots of beef and dairycattle and pigs. We have 10 livestock research and teachingunits, two out-of-state locations about 150- 200 miles fromcampus, 50 employees associated with these programsincluding academic staff and animal caretakers, and 150buildings where animals are housed,” Merchen explains.“So it took four AAALAC site visitors four days to gothrough our agricultural facilities and the laboratory animalfacilities. This means there are real costs associatedwith this process. We’re not concerned with thefees that go to AAALAC—those are relativelyinsignifi cant. What I mean by cost are the humanresources, and prep time,” Merchen says. “Wehad one person work full time for six months onpreparing for our accreditation.”It’s important to note that the commitment ofstaff time needed to prepare for accreditationvaries greatly from program to program. And oncea program is accredited, preparation time forsubsequent site visits is likely to be signifi cantly less.However preparation time is defi nitely a factor thatneeds to be planned for and incorporated into staffschedules.Misperceptions aboutaccreditation andagricultural programsAside from the very real challenges outlinedabove, there are also misperceptions that arekeeping agricultural programs from applying foraccreditation.“My farm facilities aren’t accreditable”One of the biggest misperceptions aboutaccreditation is the notion that the agriculturalresearch setting must meet the exact same standardsfor the “physical plant” as biomedical laboratories.While it’s true that all programs must meet theprinciples outlined in the fi rst three chapters ofthe Guide, AAALAC takes a basic, common senseapproach when it comes to conducting site visits offarm areas.“What we’re looking for is that the housing andcare for farmanimals meetthe standardsthat prevailtoday on a highquality,wellmanagedfarm,”says KathrynA. Bayne, M.S.,Ph.D., D.V.M.,AssociateDirector ofAAALACInternational.“We defi nitelyuse aperformanceWhat stops many from pursuing accreditation isthe belief that their agricultural facilities—barns,sheds, fence lines and the like—won’t meetAAALAC standards.approach.”John J.McGlone, aprofessor in theDepartment ofAnimal Scienceaaalac connection3
Winter/Spring 20044AAALAC Farm AnimalPosition StatementAAALAC International uses the current editionof the Guide for the Care and Use of LaboratoryAnimals (NRC 1996) as its primary standard forevaluating animal care facilities and programs.The full range of programmatic criteria outlined inSections I-III of the Guide are entirely applicableto farm animals and, in accredited facilities, theuse of farm animals in research should be subjectto the same general ethical considerations asthe use of other animals in research. However,uses of farm animals are often separated intobiomedical and agricultural, and different criteriafor evaluating standards of housing and care foranimals of the same species may be appropriate.Decisions on categorizing research uses of farmanimals and defi ning standards for their care anduse should be based on user goals, protocols,and concern for animal well-being and shouldbe made by the Institutional Animal Care andUse Committee. For animals in an agriculturalsetting, AAALAC International takes the positionthat, in accredited facilities, the housing andcare for farm animals should meet the standardsthat prevail on a high quality, well managed farm.The Guide for the Care and Use of AgriculturalAnimals in Agricultural Research and Teaching (FASS1999) is recognized by AAALAC International asa reference resource for individual farm animalspecies. Regardless of an investigator’s researchobjectives or funding source, institutions areexpected to provide oversight of all researchanimals and ensure that their pain and distress isminimized.at Texas Tech University and former member of AAALAC’sCouncil on Accreditation, concurs.“Really, if you are thinking about becoming AAALACaccredited and you are concerned about your facilities, asimple sealing of the fl oors, painting the walls, fi xing thefences, and $10 temperature recorders can solve mostof the problems in this category—despite what peopleimagine, most facilities are relatively easy to fi x,” McGlonesays.“Agricultural research programs don’tbenefit from AAALAC accreditation”Among agricultural professionals, the AAALAC process andthe potential value of accreditation are often not clearlycommunicated.“AAALAC is sometimes not well understood by peopleinvolved in agricultural animal programs,” Merchen says.“They see it as a ‘club’ or a regulatory body. This is whymany agricultural programs have limited enthusiasm foraccreditation.”This is something AAALAC is working to rectify. “We areplanning to put together an advisory body that will help usidentify areas of concern or misunderstanding so that wecan more effectively communicate with agricultural researchprofessionals,” says John G. Miller, D.V.M., AAALAC’sExecutive Director. “We truly believe these programs canbenefi t from accreditation, and we want to do a better jobof explaining why and how.”Merchen supports this idea. “AAALAC needs to clarifythe role that AAALAC plays for agricultural animalprofessionals.”So how do agriculturalprograms benefit fromaccreditation?Merchen feels that some of the arguments for agriculturalprograms to pursue accreditation are more compelling thanothers.“I do believe that accreditation is a symbol of quality,”Merchen says. “There is real value attached to the externalvalidation of the quality and compliance of our programswith the standards that are used in the AAALAC process.This validation enhances the credibility of agriculturalanimal programs as a primary component of the overallanimal care program within an institution.”“I also believe that the accountability that isdemonstrated by a commitment to accreditation isimportant,” Merchen adds.He explains that because all institutions have a “socialcontract” with the public, AAALAC also serves as one meansof establishing accountability—it shows a commitment tothe humane and ethical care and use of animals.“Going through the accreditation process reminds us ofthe concerns of the public, and increases the sensitivity of
staff to those concerns,” Merchen says.Along with demonstrating quality and accountability,Merchen also notes that accreditation gives agriculturalprograms a chance to “thoughtfully re-evaluate practices.”He says record keeping at his institution greatly improvedas a result of going through the AAALAC process,particularly with regard to medical records.“On the opportunities side, the ‘seal of quality andaccountability’ achieved through accreditation has realvalue,” Merchen says. “But self assessment is the singlebest reason for an agricultural program to be AAALACaccredited. Going through it helped us make improvementsto our processes. I also believe that going through AAALACaccreditation caused a noticeable upturn in the sense ofprofessionalism and pride among our caretaking staff.”What are the standards?AAALAC International uses two primary resources inevaluating agricultural animal care and use programs:the Guide for the Care and Use of Agricultural Animals inAgricultural Research and Teaching, , FASS 1999 (Ag Guide),and the principles of the fi rst three chapters of the ILARGuide that are applicable to agricultural animals. (For moredetail, see the sidebar on opposite page, “AAALAC FarmAnimal Position Statement.”)“AAALAC wants to see that the housing and care for farmanimals meet the standards of a high-quality farm,” Baynesays. “Other than that, we review agricultural programs thesame way we review other animal care and use programs—we look at the components of the program articulated inthe Guide.”These program components include: InstitutionalPolicies including the occupational health and safetyprogram (OHSP), the IACUC, veterinary care andadministrative organization; Animal Environment, Housingand Management including animal space provisions,support service, sanitation practices, caging/housingsystems, and aseptic surgery, husbandry practices,and identifi cation and record keeping, vermin control;Veterinary Care including preventive medicine, diseaseProgram deficiencies atland grant institutions65%20%7%8%Institutional PoliciesPhysical PlantAnimal ManagementVeterinary Carediagnosis, control, and treatment, surgical andpostsurgical care, anesthesia and analgesia, andeuthanasia; and issues related to the PhysicalPlant including HVAC, survival surgery support,facility maintenance, personnel safety concerns,general storage conditions, sanitation of facilities,illumination, emergency power, physical plantdesign, and security.What are the mostcommon deficiencies inagricultural programs?AAALAC International analyzed data fromJanuary 1993 through January 2002 collectedfrom institutional program reviews conductedby the Council on Accreditation. The goal wasto determine the defi ciencies most commonlyfound in the agricultural programs the Councilevaluated during that timeframe. AAALAC lookedat “mandatory defi ciencies,” items that must becorrected before accreditation is granted, as well as“suggestions for improvement.” Some interestingfacts were revealed:• More than half of the institutions evaluated—59percent—had no mandatory items for correction(i.e., they were granted “Full Accreditation” aftertheir site visit).• There was no signifi cant correlation between thenumber of mandatory items or suggestions forimprovement identifi ed, and whether the programwas “campus-wide” (a single accreditation forthe entire institution) or “university-limited”accredited (only one part of the institution isaccredited).The data showed that the challenges facing landgrant institutions are not much different than thosefaced by more traditional biomedical animal careand use programs. The top three defi ciencies facedby all institutions are the same as those facing landgrant institutions, namely:1. IACUC issues2. OHSP issues3. HVAC concernsAnd while there were a number of suggestionsfor improvement related to the physical plant ofagricultural facilities, they were all things thatwere relatively easy to repair—such as barnmaintenance, or repairing rusted chutes or weatherdamagedwood.Policy issuesAs happens in biomedical research programs, issuesrelated to institutional policies were the mostcommon defi ciencies found in programs at landgrant institutions. These issues included:aaalac connection5
doesn’t take place.In my personalexperience, we hadtwo individuals whohad worked withcattle for over 20years and suddenlydeveloped cattleallergies—soallergy assessmentis an importantconsideration.”It’s also importantto ensure thatappropriate policiesare in place toprotect employeesworking in anagricultural setting.Policies regardingentering confi nedspaces such as silosor manure areas,lone operator policies for people working with large animals,implementing lock out/tag out procedures, and appropriaterequirements for personal protective equipment (PPE)should be in place.Underwood notes other OHS issues found at land grantinstitutions…• Not wearing boots, safety glasses or work clothes in barnareas.• No awareness of zoonoses, such as ringworm, crypto,erysipelas, or fl ue.• No tetanus immunization for employees.• Storage issues for gas, diesel, formalin, and kerosene.• Poor or no biohazard signage.• Lack of heavy equipment training.• Not having fi rst aid kits readily accessible.• Not being aware of risks for physical injury and poorergonomics.While the OHSP is the same for both biomedical andagricultural programs, special consideration should be givento employees and personnel working in a farm environmentto make sure these issues are addressed.Managing agricultural animalsAAALAC’s data show that defi ciencies in animalmanagement at land grant institutions are rare.“Routine husbandry and management issues do notgenerally pose signifi cant challenges,” says Mench.The Guide says, “A good management program providesthe environment, housing and care that permit animals togrow, mature, reproduce and maintain good health; providesfor their well-being; and minimizes variations that can affectresearch results.”For the most part, institutions are succeeding inmeeting these standards. Mench does offer a fewtips pertinent to agricultural programs …Housing and enrichmentconsiderations• As in laboratory settings, be sure to provideopportunities for animals to express speciestypicalpostures, behaviors and activity.• Make sure there is social enrichment for socialspecies, perhaps through pair or group-housingor visual, olfactory and auditory contact.Check feed and water quality• Don’t hold feed for longer than therecommended storage times.• Check feed storage conditions to keep outvermin and other contaminants.• Review feeding conditions—for example, if pigsare fed on a fl oor, it can be a problem if the feedbecomes contaminated with urine and feces.• Check automatic water lines to minimize thechance of microbiological contamination.Sanitation issues• Make sure enclosure sanitation schedulesconform with the Guide or the Ag Guide asappropriate.• Check the effectiveness of sanitation proceduresthrough microbiological monitoring or otherappropriate methods.• Clean up and clear out cluttered and dirty rooms,particularly in support areas or areas whereaaalac connection7
Winter/Spring 20048procedures are performed. (This is the most commonsuggestion for improvement.)• Repair or replace rusted equipment.Other husbandry issuesVermin control—especially bird control—can be aproblem for farm locations, particularly in bulk feedstorage areas and open feed troughs. So an effectivevermin control program should be developed andmaintained.Also an issue for some agricultural programs isthe lack of a formal (or adequate) disaster plan.A plan should be in place and include appropriateemergency contacts, an “offi cial responder”—typicallya veterinarian or colony manger—and the plan’sprocedures should be posted in an accessible location.“Most importantly,” Mench says, “be sure the plan takesinto account both people and animals.”Finally, Mench says to be sure the IACUC is overseeinghusbandry practices related to agricultural animals thatmay cause pain or distress. These include castration,dehorning, molting of birds that requires an extendedperiod of feed withdrawal, and other practices routinelydone without anesthesia. “If the procedure is likelyto cause pain or distress, it must be reviewed andapproved by the IACUC,” Mench says.Veterinary care issuesWhen it comes to veterinary care in agriculturalresearch, most defi ciencies are in the design andimplementation of the overall veterinary care program.Problems in this area are often the result of insuffi cientoversight.“Poorly organized programs typically have problemswith implementation,” says AAALAC Council memberJoseph Thulin “Everyone involved in veterinary caremust be knowledgeable of institutional responsibilities.And we need to work hard to be cognizant of therelationships among the various standards and regulations,including the Guide, Ag Guide, Animal Welfare Regulationsand PHS Policy.”Thulin notes that AAALAC operates on the assumptionthat the fi rst three chapters of the Guide apply acrossthe board, including farm settings. He also notes thatagricultural programs sometimes fail to establish clear linesof authority for veterinary care.“You need to know who is responsible for ensuring there’san overall program of veterinary care—you need to knowwho the ‘attending veterinarian’ is,” Thulin says. “This is notnecessarily the person you call when an animal gets sick.”The attending veterinarian (AV) is responsible for allactivities involving animals at the institution and (ideally)reports to the IO. The attending veterinarian should beappropriately involved in overseeing care for agriculturalanimals.“An institution may have more than one AV,” Thulinadds. “So the lines of accountability and responsibilitiesMandatory items for improvementin veterinary carePreventive Medicine61%23%13%3%OrganizationSurgical CareEuthanasiaPain Management0% (Pain Management)among the veterinarians need to be clearly delineated andcoordinated. For example, one AV might be responsible forbiomedical research animals, another for agricultural, and soon. AAALAC will evaluate the organization of oversight.”Communication is another area where problems may arisebetween researchers and the AV. This is especially truein agricultural settings when an investigator may also bea veterinarian and is providing (or not providing) care tohis or her own animals. Or, when a dairy manager initiatesmedical treatment without input from the veterinarian.“The most frequently cited defi ciency involving veterinarycare in agricultural programs is inadequate notifi cation ofthe veterinary staff about ill animals,” Thulin notes. As inlaboratory settings, agricultural animals should be observeddaily, and proper health treatment and disease preventionshould be provided.
Suggestions for improvementin veterinary carePreventive Medicine11%32%9% 1%47%Surgical CareEuthanasiaPain ManagementOrganization“The Ag Guide requires a written and implemented programfor disease prevention,” Thulin says. “These programsshould include biosecurity, surveillance, diagnosis,treatment, end point resolution, and have stringentrequirements for health and production record keeping.”Thulin suggests looking at veterinary care as a holisticprogram that includes preventive medicine. Along withpreventive medicine, the Guide also requires veterinarycare to include surveillance, diagnosis, treatment, controlof disease, management of protocol-associated disease,disability, or other sequelae, anesthesia and analgesia,surgery and post surgical care, assessment of animalwell-being, and euthanasia. These requirements applyto agricultural animal care and use as well as biomedicalsettings.When a farm is the facilitySome people believe that their farm facilities are not“accreditable.” But, as stated earlier, AAALAC expectsthe agricultural program facilities to be on a par witha high-quality, well-managed farm and to follow therecommendations of the Ag Guide.Former AAALAC Council member John J. McGlonedeveloped this list of things not to worry about prior toapplying for accreditation …What is NOT a major concern for mostagricultural institutions• A farm setting.• Outdated facilities. McGlone notes that walls can bepainted, fl oors sealed, and facilities well managed toensure a safe and comfortable environment.• Natural ventilation. The 10-15 air changes per hourthat are suggested in the Guide are not met in thesefacilities—and this is not a problem in the eyes ofAAALAC. In fact, McGlone adds, it’s often healthier forsome agricultural animals to have naturally ventilatedfacilities.• Non-controlled photoperiod (as in open barns). Thisis also not a problem for farm animals that are notphotosensitive. If you’re dealing with species thatare photosensitive, such as chickens, the onlyconsequence is that they won’t lay eggs duringcertain times of the year. McGlone adds thatbecause this is not a welfare problem, it’s reallynot of concern to AAALAC.• Lack of temperature control. This is alsonot a problem as long as the animals canfi nd a microenvironment that’s comfortable.Temperatures in these areas must be monitoredand regularly recorded.The big facility issuesThough it’s not necessary to have brand newfacilities to earn accreditation, existing facilitiesmust be in sound condition. In particular, McGlonenotes, fl ooring should be refurbished, resealed,or replaced as needed to provide safe, sanitizablesurfaces.“When the concrete is cracked and the fl oor isnot sealed, animals can become injured and thefl oor can’t be properly sanitized,” McGlone says.He also suggests making simple improvements suchas checking for and fi xing unsealed animal roomsurfaces and repairing damaged fencing.“It’s important to understand that agriculturalfacilities can be accredited for what they are—modern, well-managed farms,” McGlone says.“If it’s a hybrid between a farm and a laboratory,the surgery facility might be a little less thanwhat’s typical in a biomedical facility. And that’sacceptable if the setting is appropriate for thesurgery—something less invasive than what’s donein biomedical research. After all, that’s why weselected agricultural animals for domestication—they are adaptable in a wide variety ofenvironments.”The road ahead“AAALAC offers some great opportunities foragricultural programs,” Merchen says. “But I alsobelieve that institutions and AAALAC face someserious challenges in developing enthusiasmand commitment toward the accreditation ofagricultural animal programs.”AAALAC encourages agricultural researchprograms to consider the benefi ts of accreditation,and understand that earning it may not be asdiffi cult as they think. At the same time, AAALACwill be working to better communicate thosebenefi ts to a much wider audience of agriculturalresearch professionals in the months and yearsahead.These efforts will be guided by several agriculturalexperts who currently serve AAALAC: ExecutiveCommittee Member John J. McGlone, Ph.D.,Professor, Department of Animal Science, Texasaaalac connection9
Winter/Spring 200410Tech University; Council Member Joy A. Mench,D.Phil., Professor and Director for the Center forAnimal Welfare in the Department of Animal Science,University of California, Davis; Council member-electCarmen Parkhurst, Ph.D., Professor, Department ofPoultry Science, North Carolina State University, andrepresentatives from AAALAC Member Organizationsincluding the American Dairy Science Association,American Society of Animal Science, Federation ofAnimal Science Societies, National Association of StateUniversities and Land Grant Colleges, and the PoultryScience Association. AAALAC will also be conveninga special task force on accreditation at agriculturalinstitutions.•For questions or more information on applying foraccreditation, e-mail email@example.com or call+301.231.5353.Tips to ensure a smootherjourney to accrediting youragricultural research programDon’t assume that your farm facilities are not“accreditable” or that they must be brand newin order to meet AAALAC standards.Communicate the potential value ofaccreditation to everyone who will be involvedin the preparation—particularly faculty, butalso administrators, veterinarians, investigatorsand animal care staff—and make sure theyunderstand how the process works. (TheAAALAC offi ce has information that canhelp you with this. Handouts describingaccreditation are also available on the AAALACweb site, www.aaalac.org.)Make sure the OHSP adequately coversagricultural personnel.Create clear lines of authority, and make surethose who are responsible for the agriculturalanimal care program have the authority tomake necessary changes and improvements.This is particularly important if the agriculturalresearch component is part of a decentralizedanimal care and use program.Be sure the agricultural research component isrepresented on the IACUC. This helps developa strong institutional commitment to theagricultural animal care and use program, andensures it receives proper oversight.NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWSBRIEFS NEWS BRIEFS NEWS BRIEFSAAALAC electsnew officers andMember OrganizationsAt its annual meeting, the AAALAC Board ofTrustees elected the following offi cers:ChairFloyd J. Malveaux, M.D., Ph.D.Vice Provost for Health AffairsDean, College of MedicineHoward UniversityVice ChairHarry Rozmiarek, D.V.M., Ph.D.Professor and Chief,Laboratory Animal MedicineUniversity of PennsylvaniaTreasurerLoren D. Koller, D.V.M., Ph.D.Environmental Health and Toxicology ConsultantSecretarySonya K. Sobrian, Ph.D.College of Medicine/PharmacologyHoward UniversityMembers-at-LargeGregory A. Timberlake, M.D., F.A.C.S.Professor of Surgery, Physiology & BiophysicsUniversity of Mississippi School of MedicineJohn J. McGlone, Ph.D.Professor, Department of Animal ScienceTexas Tech UniversityThe following new member organizations were elected:The Association for Behavior Analysiswww.abainternational.orgEuropean Society of LaboratoryAnimal Veterinarianswww.eslav.orgSafety Pharmacology Societywww.safetypharmacology.orgBRIEFS NEWS BRIEFS NEWS BRIEFS
NEWSBRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFSAAALAC honors three leadersThe following awards were presented at the annual meeting of AAALAC’s Board of Trustees:Steven P. Pakes receives AAALAC’sBennett J. Cohen AwardAAALAC International presented its Bennett J. CohenAward to Steven P. Pakes, D.V.M., Ph.D.The Bennett J. Cohen Award recognizes outstandingindividuals who have provided exceptional service andsignifi cant contributions to AAALAC International, andhave demonstrated a strong and abiding commitmentto advancing science through the promotion of thehighest standards of laboratory animal care in research,testing, and education. Dr. Pakes has served as anAAALAC ad hoc Consultant, as a member and Chairof the Council on Accreditation, and as Treasurer onthe Executive Committee of the Board of Trustees. Hemost recently represented the International Council forLaboratory Animal Science (ICLAS) on AAALAC’s Board.Dr. Pakes is a professor of pathology at The Universityof Texas Southwestern Medical Center at Dallas,director of the animal resource program at the DallasVeterans Administration, and has served as a consultantin laboratory animal science to numerous academicinstitutions, pharmaceutical companies, researchinstitutions and federal laboratories.William I. Gay, D.V.M. receives AAALAC’sSpecial Recognition AwardWilliam I. Gay, D.V.M., was presented with the AAALACSpecial Recognition Award in acknowledgement of hisleadership in developing professional standards forlaboratory animal care. Dr. Gay was instrumentalin the formation of AAALAC’s predecessor,the American Association for Accreditation ofLaboratory Animal Care, and played a pivotal rolein prompting the development of standards thatbecame the fi rst Guide for the Care and Use ofLaboratory Animals. Dr. Gay spent much of his careerfurthering laboratory animal science and medicine,including serving in several positions at the NationalInstitutes of Health.Maureen K. Powers, Ph.D. receivesaward for Service to the ExecutiveCommitteeMaureen K. Powers, Ph.D. received an award forService to the Executive Committee. Dr. Powersserved several terms on the AAALAC ExecutiveCommittee as its vice chair, while representingthe Association for Research in Vision andOphthalmology on the Board of Trustees. Dr.Powers is internationally known for her researchon vision, and is currently a Research Psychologistat the University of California. She also serves asCEO of Gemstone Educational Management, anorganization that screens students for all types ofvision problems, and helps correct them throughdoctor-monitored, Internet-based vision training.aaalac connection11Article offers suggestionsfor post-approval monitoringof protocolsThe September 2003 issue of Contemporary Topics inLaboratory Animal Science (issue 42(5):62-67), featuresan article on, “Post-approval monitoring of animaluse protocols,” written by AAALAC Council membersBarbara Garibaldi, D.V.M., and Douglas Stone, D.V.M.,M.S. The article presents the authors’ expert opinionson ensuring proper follow-up and monitoring, and isavailable through the AALAS offi ce (www.aalas.org).Please note, however, that while the article is writtenby AAALAC Council members, it is not an AAALACdocument, and the suggestions offered are not AAALACrequirements.ACLAM releasesposition statement onanimal experimentationThe American College of Laboratory AnimalMedicine (ACLAM) has released a positionstatement on animal experimentation. Thisstatement is available at: www.aclam.org/PDF/pub_animal_experimentation.pdfNEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS NEWS BRIEFS
Winter/Spring 200412What is the“AAALAC Standard,”and how is it appliedinside and outside ofthe United States?by John. G. Miller, D.V.M.,Executive DirectorSometimes people mistakenlybelieve that AAALACInternational creates its ownset of standards for evaluatinganimal care and use programs.Instead, AAALAC appliesa combination of existing,science-based standardsand a peer-review process to create the “AAALACstandard” which programs must meet in order to earnaccreditation.The GuideAt this point in time, most people recognize thestandard most widely known in the global laboratoryanimal science community—the Institute forLaboratory Animal Research’s Guide for the Care andUse of Laboratory Animals (Guide). AAALAC is proudthat its parent organization, the Animal Care Panel,developed the fi rst edition of the Guide under a 1962contract from the National Institutes of Health (NIH).Serving as the principal standard used by both AAALACand the U.S. Public Health Service (PHS) in evaluatinganimal care and use, each of the seven editions of theGuide has benefi ted greatly from the input of scientists,with its guidance based on “published data, scientifi cprinciples, expert opinion and experience with methodsand practices that have proved to be consistent withhigh-quality, humane animal care and use.”This scientifi c support for its recommendations—from peer-reviewed data to experiential evidence—hasundoubtedly contributed to its widespread acceptanceby the laboratory animal and more general scientifi ccommunity. Its utility as an international standard isdemonstrated by the fact that the English version hasbeen translated into nine additional languages.While the Guide is the principal resource used byAAALAC to evaluate animal care and use programs allover the world, AAALAC has “harmonized” differentanimal care and use standards into the abovereferenced“AAALAC Standard.”AAALAC uses a variety of existing standards andguides when it assesses animal programs. And while theGuide is our principal standard and we apply its provisionsand principles world-wide, the Guide is intentionally writtenin general terms to allow fl exibility in its application. Takentogether with the Guide’s emphasis on performance as ameasure of successful application, situations naturally occurin which professional judgments regarding appropriateimplementation may differ.AAALAC’s Reference ResourcesTo assist AAALAC evaluators in these situations and tohelp prospective and current accredited units, we havedeveloped a list of publications and other documentswe call AAALAC’s “Reference Resources.” The full list isavailable at www.aaalac.org/resources.htm, and includesreferences from Europe and Canada, in addition to U.S.resources. These resources are more specifi c than theGuide in a wide variety of areas, and in many cases provideexamples of appropriate outcomes that are useful whenapplying the Guide’s performance standards.The Guide and AAALAC’s Reference Resources share avery important common characteristic—both are sciencebased. The process of adding references to our list requiresthat the Council on Accreditation vote to approve them.The key factor the Council considers before adopting anew reference is scientifi c documentation of its validityand value to an animal care and use program. Occasionally,this has led to Council’s disapproval of proposed resourcesthat, although originally science-based, have no currentsupporting data. Similarly, existing references that havebecome outdated or have been superseded by newerscience-based publications are removed from the list orreplaced.Applying these standardsin the United StatesBut evaluating an entire animal care and use programrequires more than just applying the provisions andprinciples of the Guide and Reference Resources. One mustalso look at the process by which AAALAC assesses andaccredits programs to understand how the wide varietyof local standards, guidance and policies are harmonizedthrough the accreditation process to result in a commonAAALAC Standard.In the U.S. and internationally, the legal and regulatoryrequirements applicable to the institution being evaluatedconstitute the baseline for accreditation. No program canreceive AAALAC accreditation if it is in violation of thelaw. Thus, in the U.S., all provisions of the Animal WelfareAct Regulations must be met for species covered bythe USDA. For units receiving PHS support, all elementsof their Assurance of Compliance with NIH’s Offi ce ofLaboratory Animal Welfare must also be met. Programelements are then evaluated based on the provisions ofthe Guide, and when necessary and appropriate, specifi cReference Resources are used to evaluate performance
outcomes in areas wherethe Guide is non-specifi cor there are institutionallyapproved deviations fromits recommendations.Critically important is thatall principles of the Guidemust be met. Finally, theexpert professional judgmentof the AAALAC Council onAccreditation is appliedthrough a peer review processbefore a fi nal accreditationstatus is granted.Applying thesestandardsinternationallyInternationally, the processis practically identical. Onceagain, no program canbecome AAALAC accredited if it is in violation of locallegal and regulatory requirements. AAALAC uses ad hocConsultants who are familiar with the local requirementsto ensure that those requirements are being appropriatelyfollowed and applied. Once AAALAC is satisfi ed that theselocal baseline requirements are met, the Guide becomesthe next standard to be applied. It is important to notethat when local requirements are more stringent than Guiderecommendations, the former must be met inorder to achieve accreditation.In some instances, the Guide includesprovisions not addressed in national orsupranational animal welfare legislation orregulations, e.g., in the area of occupationalhealth and safety. In such cases, two optionsare available. First, other local requirementsmay exist outside the animal welfare area, as isthe case with occupational health and safetyrequirements in the European Union (CouncilDirective on the Introduction of Measuresto Encourage Improvement in the Safety andHealth of Workers at Work (Directive 89/391/EEC). In the absence of alternative localstandards, the Guide standards are used as thebasis for evaluating program elements in theseareas.As AAALAC has grown internationally, it has conductedassessments in countries without national regulatorystandards or other requirements for animal care and use.In these instances—just as in the U.S.— the Guide andReference Resources serve as the basis for AAALAC’sevaluation.Peer review and professional judgmentFinally, the application of expert professional judgmentthrough the peer review process by the Council onAccreditation determines a program’s fi nal accreditationInternationally, the process [of earning AAALAC accreditation] is practically identical.The key tomaintainingconsistency anduniformity ofthe AAALACStandardacross diverseinternationalsettings andstandards is thatall principles ofthe Guide mustbe met.status. The key to maintaining consistency anduniformity of the AAALAC Standard across diverseinternational settings and standards is that allprinciples of the Guide must be met.But circumstances do occasionally arise forwhich there is no applicable published standard.In addition, professional judgments may differregarding the acceptability of practices orprocedures not specifi cally addressedin existing standards. In thesecircumstances AAALAC again looksto science for solutions. The Councillooks for published data in the area inquestion. When no relevant reports arelocated, scientifi c principles and expertopinion form the basis for resolution,with the fi nal decision often informedby Council members’ experience withproven methods or practices.Thus, the AAALAC Standard isnot a static document. In fact, it isnot a single document at all, butrather a compilation of many existingstandards, guidelines and policies thatencompass all aspects of an animalcare and use program. The majorityof these are science based—a fact that not onlygives credence to those, like the AAALAC Councilon Accreditation, who apply them within anaccreditation program, but also leads to the greaterlikelihood of acceptance and implementation by thescientists subject to their provisions.The AAALAC Standard is, therefore, anevolutionary product, developing as internationallyrecognized standards are interpreted through thecollective professional judgment of animal careand use experts, and applied through an in-depth,multi-layered scientifi c peer review process.•aaalac connection13
Winter/Spring 2004AAALAC at National AALASAAALACInternationalExecutiveDirector JohnMiller talkswith CCAC’sDirector ofGuidelinesDevelopmentDr. GillyGriffi n at theInternationalLuncheonhosted byAAALAC.AAALACCouncilCoordinatorSandyDexter (l)and ProgramAnalystDarleneBrown staffthe AAALACbooth.AAALACAssociateDirectorKathrynBayne (l),and KwangSup Kil andJung Sik Choof the KoreaFDA at theInternationalLuncheonhosted byAAALAC.(l to r) StevenPakesof ICLAS,John Millerof AAALAC,Cindy Pekowof AALAS,and GillesDemers ofICLAS at theInternationalLuncheon.14AAALACInternationalAssociateDirectorKathrynBayne talkswith CouncilmembersRobertWeichbrod (l)and JosephThulin.AAALACExecutiveCommitteeMemberHarry Rozmiarek(l)talks withTatsuji Nomura(center)and acolleagueat the InternationalLuncheonhosted byAAALAC.FormerAAALACCouncilPresidentJohn Harkness(center) leadsa workshop onthe role of thetechnician inthe AAALACaccreditationprocess.(l to r)AAALAC adhoc ConsultantPeteWillan, FredDouglasand LyndaWestall atthe InternationalLuncheon.
New ad hoc Consultants appointedThe following new AAALAC ad hoc Consultants have been appointed by the Council on Accreditation …Bruce J. Bernacky, D.V.M.Assistant Professor of Comparative MedicineDepartment of Veterinary SciencesUniversity of Texas Anderson Cancer CenterJung Sik Cho, Ph.D.Director of Laboratory Animal ResourcesKorea Food and Drug AdministrationStephen K. Fisk, D.V.M., M.S.ConsultantNaomi M. Gades, D.V.M., M.S.Assistant ProfessorDepartment of Health Sciences ResearchMayo ClinicLynn E. Gerow, Ph.D.Associate DirectorOffi ce for the Protection of Research SubjectsUniversity of California - Los AngelesMolly GreeneSpecial Assistant to the Vice PresidentThe University of Texas Health Science Centerat San AntonioLorraine R. Hill, D.V.M., Ph.D.Institutional VeterinarianBaylor College of MedicineMarilyn A. Keaney, D.V.M., Ph.D.University Veterinarian and DirectorAnimal Care and Veterinary ServicesUniversity of OttawaBruce W. Kennedy, M.S., RLATGAnimal Facility ManagerTransgenic Animal FacilityCalifornia Institute of TechnologyYong S. Lee, M.S.CommissionerKorea Food and Drug AdministrationTeresa A. Liberati, D.V.M., Ph.D.Laboratory Animal VeterinarianSanofi -Synthelabo ResearchEddy Rommel, D.V.M.Rommel Consulting PartnersWilliam C. Satterfield, D.V.M.Associate VeterinarianDepartment of Veterinary SciencesUniversity of Texas MD Anderson Cancer CenterKathleen L. Smiler, D.V.M.Senior Director, BioresourcesWyeth Drug SafetyGregory Stickrod, M.S., LATGSenior Manager, Animal ResourcesProtein Design Labs, Inc.Peggy T. Tinkey, D.V.M.Associate Professor of Comparitive Medicine/Chief, Sec of Veterinary Medicine & SurgeryDepartment of Veterinary Medicine & SurgeryUniversity of Texas MD Anderson Cancer CenterMary Ann Vasbinder, D.V.M.Veterinary ManagerGlaxoSmithKlineRebecca A. Wiltshire, D.V.M.Special Assistant for Veterinary Medicineto the Navy Surgeon GeneralJeffrey D. Wyatt, D.V.M., M.P.H.Director of Animal Health and ConservationSeneca Park Zooaaalac connection15Institutions in the Philippines, Canadaand Switzerland earn accreditation in 2003Congratulations to the following international institutions that earned accreditation in 2003 …INA Research, Philippines, Inc. – Testing Facility Laguna Technopark IndustrialEstate, Binan, Laguna, PhilippinesINA Research, Philippines, Inc. – Primate Quality Control Center, Santo Tomas,Bantangas, PhilippinesLAB Pre-Clinical Research International Inc., Laval, Quebec, CanadaRoche Pharma Basel, Basel, Switzerland
Winter 200416connectionConnecting science and responsible animal care.Connection is published by theAssociation for Assessment andAccreditation of Laboratory AnimalCare International (AAALAC), a privatenonprofi t organization that promotes thehumane treatment of animals in sciencethrough voluntary accreditation andassessment programs. More than 650institutions in 19 countries have earnedAAALAC accreditation, demonstratingtheir commitment to responsible animalcare and use, and good science.Comments and submissions forConnection are welcome and should bedirected to the editor.Articles and information in Connectioncan be duplicated with attribution.Staff:John G. Miller, D.V.M.Executive Directorjmiller@aaalac.orgKathryn A. Bayne, M.S., Ph.D., D.V.M.Associate Directorkbayne@aaalac.orgLori Wieder, Editor/Designerlwieder@aaalac.org© 2004 AAALAC InternationalOrder the Guide inSpanish or FrenchYou can purchase multiple copies of theGuide for the Care and Use of LaboratoryAnimals (Guide) in Spanish and Frenchthrough AAALAC. Multiple copies are $4or €4 each (including shipping). Ordermore than 10 copies and receive a 15percent discount on your entire order.The Guide is also available in a numberof other languages including Chinese,Japanese, Korean, Portuguese, Russian,Taiwanese and Thai. Contact AAALACabout availability.To order copies of the Guide inother languages, contact AAALACat firstname.lastname@example.org or tel:+301.231.5353 (U.S. offi ce) or +32.2.761.66.78(European offi ce). To purchase additional copies of theGuide in English, visit the National Academy Press web siteat www.nap.edu.Order the AAALACCONFERENCE PRESENTATIONS AND MATERIALSConference onCD-ROM!The 2003 AAALACConference on QualityLaboratory Animal Careis available on CD ROM,complete with all PowerPoint ®aaalacpresentations, audio fi les andsupporting graphics. The costis $100. Visit www.aaalac.orgto download an order form, or call +301.231.5353or e-mail email@example.comASSOCIATION FOR ASSESSMENT AND ACCREDITATIONOF LABORATORY ANIMAL CARE INTERNATIONAL11300 Rockville Pike, Suite 1211Rockville, Maryland 20852-3035301.231.5353 tel301.231.8282 faxIn Europe:Avenue de Tervuren 4021150 Brussels, Belgium+32.2.761.6678 tel+32.2.761.6679 firstname.lastname@example.orgPresorted STDU.S. PostagePAIDPermit No. 3344Southern, MD