Canadian Council on Animal Care

policy statement for:

senior administratorsresponsible for

animal care and use programs

© Canadian Council on Animal Care, 2008

ISBN 978-0-919087-48-4

Canadian Council on Animal Care1510–130 Albert StreetOttawa ON CANADA

K1P 5G4

http://www.ccac.ca

1. The main responsibilities of the senioradministrator responsible for an institution-al animal care and use program are summa-rized below, and are detailed in Appendix I(section D) and sections 3 through 10 of thisdocument. Institutions using animals forscientific purposes must have a CCACCertificate of GAP - Good Animal Practice®

to meet eligibility criteria for receiving andkeeping federal and other research funds(see Appendix I).

2. The senior administrator must ensure that:

a) there are mechanisms in place to ensurethat the proposed animal-based work hasmerit (see Appendices II and III);

b) one or more appropriately composed andstructured and well-functioning AnimalCare Committee(s) (ACC(s), see Section5 and Appendix IV) is (are) in place forthe institution, according to the mostrecent version of the CCAC policy state-ment on: terms of reference for animal carecommittees, and that this (these) commit-tee(s) is (are) provided with sufficient,qualified human resources (ACC coordi-nator(s), see Section 5.5) to functionappropriately and effectively and ensurecompliance with all relevant animal careand use standards;

c) there are sufficient and well structured(see Sections 4 and 7) veterinary andanimal care staff resources, knowledge-able with regard to the species used andtypes of animal use undertaken by themembers of the institution, and skilledwith regard to communicating with ani-mal users and the ACC. The veterinariansand animal care staff must have access tocontinuing education and training intheir field;

d) animal users (see Section 6 andAppendix V) are well informed with

regard to all aspects of the animal careand use program, and understand thatusing animals is a privilege that is grant-ed with the understanding that institu-tional, provincial and national standardswith respect to animal care and use,including CCAC policies and guidelines,are followed;

e) a sound structure is in place to supporta solid program and foster good commu-nication between the animal users, ACCand veterinary and animal care staff (seeSection 4), and to normally have themaddress differences of opinion withoutcalling upon the senior administrator.However, where serious differences ofopinion cannot be resolved, the senioradministrator must be prepared toaddress this (see Section 5.7).

f) where animals will be held within aninstitution, appropriate and sufficientanimal facilities are in place for thespecies to be held and the types of workto be undertaken (see Section 8).

g) institutional measures are in place to pro-tect all those who may be exposed to ani-mals from related hazards, to implementa complete occupational health andsafety program and a crisis manage-ment program (see Sections 9 and 10).

h) the institution prepares appropriatelyfor every CCAC assessment visit, andensures that it has each of the elementslisted above in place. The senior adminis-trator should also ensure that the mem-bers of the animal care and use program,including him/herself, are available toanswer the CCAC’s questions, and thatcomprehensive responses are provided ina timely manner to address CCAC rec-ommendations about institutional pro-gram deficiencies (see Appendix I, sec-tion D).

SUMMARYMAIN RESPONSIBILITIES OF THE SENIOR ADMINISTRATOR

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1. INTRODUCTION . . . . . . . . . . . . . . . . . . .1

2. THE CANADIAN COUNCIL ON ANIMAL CARE . . . . . . . . . . . . . . . . . . . .1

3. SENIOR ADMINISTRATORS OFINSTITUTIONAL PROGRAMS . . . . . . . . .1

3.1 Senior Administration Structures . . .23.1.1 Academic Sector . . . . . . . . . . . . .23.1.2 Private Sector . . . . . . . . . . . . . . .23.1.3 Government Sector . . . . . . . . . .3

4. ENSURING AN APPROPRIATESTRUCTURE FOR THE ANIMAL CARE AND USE PROGRAM . . . . . . . . .3

5. COMPLIANCE AND ANIMAL CARE COMMITTEES . . . . . . . . . . . . . . .3

5.1 Conflicts of Interest andConfidentiality . . . . . . . . . . . . . . . . . . .4

5.2 Composition, Authority andResponsibilities of the ACC . . . . . . . .4

5.3 ACC Reporting and Communication Lines . . . . . . . . . . . . .4

5.4 ACCs and the Senior Administration . . . . . . . . . . . . . . . . . . .4

5.5 ACC Coordinator . . . . . . . . . . . . . . . . .55.6 ACCs and Animal Users . . . . . . . . . . .55.7 Appeals of ACC Decisions . . . . . . . . .65.8 ACCs and Post-approval

Monitoring . . . . . . . . . . . . . . . . . . . . . .6

6. ANIMAL USERS . . . . . . . . . . . . . . . . . . .6

7. ANIMAL CARE AND USE OPERATIONSHEADED BY VETERINARIANS AND ANIMAL CARE STAFF . . . . . . . . . . . . . .7

7.1 Reporting, Management andCommunication Lines for theDirector/Manager and Staff of the Animal Facilities . . . . . . . . . . . . . .7

7.2 Qualifications and ContinuingEducation for Veterinarians and Staff . . . . . . . . . . . . . . . . . . . . . . . . .8

8. CONSTRUCTION/RENOVATION AND MAINTENANCE OF APPROPRIATE ANIMAL FACILITIES . . .8

9. OCCUPATIONAL HEALTH AND SAFETY . . . . . . . . . . . . . . . . . . . . .9

10. CRISIS MANAGEMENT . . . . . . . . . . . . .9

APPENDIX IWORK OF THE CANADIAN COUNCILON ANIMAL CARE (CCAC) . . . . . . . . .11

APPENDIX IISCIENTIFIC, PEDAGOGICAL AND REGULATORY MERIT . . . . . . . . .13

APPENDIX IIISAMPLE PEER REVIEW FORM . . . . . .15

APPENDIX IVINFORMATION ON ANIMAL CARE COMMITTEE OPERATIONS . . . . . . . . .16

APPENDIX VRESPONSIBILITIES OF ANIMAL USERS . . . . . . . . . . . . . . . . . .20

APPENDIX VICONTINUING EDUCATION (CE) FORCONSULTING AND NEWLY HIREDINSTITUTIONAL VETERINARIANSWORKING IN SCIENCE . . . . . . . . . . . .21

APPENDIX VIIANIMAL FACILITIES . . . . . . . . . . . . . . .24

APPENDIX VIIIOCCUPATIONAL HEALTH AND SAFETY . . . . . . . . . . . . . . . . . . . .26

APPENDIX IXCRISIS MANAGEMENT . . . . . . . . . . . .29

TABLE OF CONTENTS

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1. IntroductionThis first Canadian Council on Animal Care(CCAC) policy for senior administrators of ani-mal care and use programs has been written pri-marily as guidance for the senior administratorsresponsible for the animal-based programs ofCanadian scientific organizations and institu-tions. The Canadian public, federal GrantingAgencies, federal and provincial governments,national and international regulatory and scien-tific organizations expect that, where animalshave to be used for scientific purposes, they willbe cared for and used ethically and appropriate-ly, within well structured and administered pro-grams, with sufficient human, financial andphysical resources.

Senior administrators play a crucial role in meet-ing these expectations and ensuring that appro-priate standards of animal care and use, asdefined by the CCAC, are met. The CCAC worksconsultatively and collaboratively with organiza-tions and institutions to help them meet theseexpectations and standards. The CCAC bases itswork on the fact that appropriate, ethical animalcare and use is an essential and integral part ofgood quality, sound animal-based science. TheCCAC has produced and will continue to reviewand produce guidelines and policies that addressspecific components of animal care and use pro-grams. This policy is meant to provide an overallframework within which institutional programsshould operate, with references to guidance foreach component of the program.

The use of animals in science is the subject ofexternal questions and concerns by the publicand of internal ones, in particular by members ofthe institution who do not use animals. Thestructure that institutions put in place to ensureappropriate animal care and use, including theanimal care committee (ACC) and qualified vet-erinary and animal care staff, allow institutionsto demonstrate that they are taking seriouslytheir responsibility to meet national standards onanimal care and use.

This policy provides information on the CCACProgram, on all main components of an institu-tional animal care and use program, and on therole of the senior institutional administrator inensuring appropriate animal care and use inpartnership with institutional members and withthe CCAC. It is left to the discretion of each insti-tution to find an animal care and use programstructure that is appropriate and functions wellfor it, given its size, nature, history, objectivesand constituents. The CCAC does not imposespecific program structures. The elements out-lined in this policy are meant to guide each insti-tution as it defines and reviews its own program.Institutions are free to define the ways in whichthey will implement the elements outlined in thispolicy, but must be able to demonstrate to CCACassessment panels and the CCAC AssessmentCommittee that their program functions well, iswell structured and meets the principles outlinedin this policy.

2. The Canadian Councilon Animal Care

The Canadian Council on Animal Care (CCAC)is the national, peer review organization respon-sible for overseeing the care and use of animalsin science. The CCAC works with academic, gov-ernment and private institutions across Canadato ensure appropriate animal care and use inresearch, teaching, testing and production (ofanimals and biologics for scientific purposes).Further information on the CCAC is available inAppendix I.

3. Senior Administrators ofInstitutional Programs

While it is the organization/institution itself thatbears responsibility for its animal care and useprogram, a single, senior institutional officialmust be appointed to coordinate efforts andensure that all organizational/institutional

SENIOR ADMINISTRATORS RESPONSIBLE FOR ANIMALCARE AND USE PROGRAMS

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responsibilities are met. This official must be theperson to whom the institutional animal care com-mittee (ACC) reports and must be identified assuch in the terms of reference of the ACC. Thisperson must both ensure that appropriate animalcare and use operations are in place to meet theinstitution’s scientific goals of research, teaching,testing or production (of animals or biologics forscientific purposes) and that all animal care anduse is conducted appropriately, according to insti-tutional and CCAC policies and guidelines.

Funds for research, teaching, testing or produc-tion using animals are administered by institu-tions, including the funds used to acquire ani-mals. Therefore, animals acquired by/held ininstitutions are, except in specific pre-defined circumstances, the property and theresponsibility of the institution. There mustbe solid safeguards in place, through designatedinstitutional personnel and appropriate manage-ment tools, to ensure that no funds are releasedto acquire or use animals until the ACC hasapproved the use of animals described in the rel-evant protocol. In turn, before it can provide finalapproval to a protocol, the ACC counts on one ormore designated institutional official(s) to con-firm that each protocol has been found to haveeither scientific, pedagogical or regulatory merit(see Appendix II).

Senior administrators are the CCAC’s main con-tact with institutions, receive all formal CCACcommunications, and must send all formal insti-tutional responses to CCAC recommendations.Senior administrators delegate day-to-day basicresponsibilities for the operations of the animalcare and use program to the veterinarian(s), facil-ity managers or animal care technician(s) (in thecase of small programs) responsible for animalcare and use, and delegates day-to-day compli-ance responsibilities to the ACC. Senior admin-istrators must be in a position to oversee theentire animal care and use program, not only onepart of it, and to take action where concerns arenoted in the program, whether related to struc-ture, personnel, animal care committee function-ing, policies/procedures or facilities. They candelegate day-to-day administrative responsibili-ties to another senior administrator who is in anappropriate position to assume them. Where theperson who would normally serve as senioradministrator is an animal user, serious consider-ation should be given to appointing a superior as

senior administrator, in particular if the senioradministrator’s use of animals accounts for aconsiderable part of total animal use. As a mini-mum, questions related to animal use by a senioradministrator should be referred to a superior.

3.1 Senior Administration Structures

Where the senior administrator responsiblefor the animal care and use program does notcontrol the entire budget for the program, astructured process for ensuring that appro-priate budgets are allocated to the human andphysical resources necessary for animal careand use, working with the administratorsresponsible for those budgets, must bedefined and used, for example through theregular meetings of senior administrator,executive or management committees.

3.1.1 Academic Sector3.1.1.1 Universities

For universities, the senior administrator is nor-mally the Vice-President, Research, who workswith the President/Principal and fellow VPs andDeans. Day-to-day administration of the programmay be delegated to an Associate VP Research orother senior administrator in a similar position.

Where the position of VP Research does not exist,the senior administrator may be the President/Principal, or the VP Academic.

3.1.1.2 Hospitals

For hospital-based research centres, the senioradministrator is normally the Director of theresearch centre. If not, the Vice-President,Research or the Scientific Director may be thesenior administrator.

3.1.1.3 Colleges

For colleges, the senior administrator may be thePresident, the VP Academic or another seniorofficial occupying a similar position.

3.1.2 Private SectorFor private institutions, the senior administratoris normally either the CEO, the VP Research &Development or VP Discovery.

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3.1.3 Government Sector

For government research or testing centres, thesenior administrator is normally the Director ofthe centre or of the relevant national or provincialprogram. The director must work with the gov-ernment department or agency not only to ensuresufficient resources for the entire animal care anduse program, but also to ensure that issues thatmay be more appropriately dealt with at thenational or provincial level, such as peer review ofscientific merit and resources for the training ofstaff and animal users, are dealt with at that level.

4. Ensuring an AppropriateStructure for the AnimalCare and Use Program

Each animal care and use program must have asolid, balanced structure, to ensure that appro-priate animal care and use does not rest only onone or a few specific individuals. In fact, it mustbe the institution as a whole that is committed tothe ethical care and use of animals, with a struc-ture that is stronger than the sum of its parts andthat is strong enough to compensate for thepotential loss of a key individual.

In any animal care and use program, there aretwo main components that must be coveredappropriately:

• Compliance: which entails ensuring that allanimal care and use is appropriately conduct-ed, as overseen by the ACC working with theveterinarian(s) and animal care staff, accord-ing to all relevant guidelines, policies, proce-dures and regulations;

• Operations: which entail providing completeservices (in particular appropriate, well-equip-ped animal facilities and well qualified veteri-nary and animal care services) to animal users.

In smaller institutions, the veterinary and animalcare staff generally provide both services to animalusers and oversight of animal use for the ACC.However, some larger programs have begun todivide their personnel between those responsiblefor operations and those responsible for oversightof the program. In some cases, this has been found

to allow for greater clarity, effectiveness, efficiencyand accountability in the system.

Examples of animal care and use program struc-tures for the various categories of institutionswill be provided in the CCAC interpretation bul-letin on: human resources for animal care and use pro-grams. The CCAC does not mandate specificstructures for individual animal care and useprograms, nor division of compliance and opera-tions components. However, where problems inanimal care or use are noted and the structure ofthe program is contributing to these problems,the CCAC Assessment Program works with theinstitution to assist it in finding solutions.

Each institutional program includes:

a) a senior administrator, responsible for theentire program (see Section 3);

b) at least one animal care committee (ACC) (seeSection 5), which is the keystone of the pro-gram and the main compliance body for ani-mal care and use, representing all interestedparties;

c) animal users (see Section 6), whetherresearchers, scientists, teachers, students orstudy directors, whose primary goal is theadvancement of science or learning and whoalso actively participate in protecting animalhealth and welfare; and

d) veterinary and animal care personnel (Section7 and the CCAC interpretation bulletin on: humanresources for animal care and use programs), whomay be full- or part-time employees, or con-sultants, depending on the size and nature ofthe institution; these personnel must coveroperations and compliance requirements.

5. Compliance and AnimalCare Committees

The animal care committee (ACC) is at the heartof any animal care and use program. In oversee-ing the program, it must represent interestedparties from the entire animal care and use pro-gram and provide quality control services withrespect to animal care and use. It must functionaccording to Terms of Reference based on the

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most recent version of the CCAC policy statementon: terms of reference for animal care committees andon the institution’s own program. Where there ismore than one ACC in large institutions, anappropriate structure for ACCs must be definedto ensure that there is one institutional ACC withoverall responsibility for animal care and use.

The ACC is responsible for overseeing all animalcare and use undertaken by members of the insti-tution, and ensuring compliance with institu-tional and CCAC standards. In practice, the ACCworks side-by-side with the institutional veteri-narian(s) and animal care staff to oversee the eth-ical and appropriate care and use of animals.There may be a veterinarian and/or other per-sonnel specifically appointed to act as compli-ance officers, and this may help clarify the struc-ture of the program and help members of theprogram in knowing who to turn to for assis-tance with compliance, and for assistance withoperations. However, for many programs, espe-cially the smaller ones, the same veterinary andanimal care staff provide service to animal usersand work with the ACC to ensure that animalcare and use is appropriate in practice. Examplesof compliance staff and structures will be givenin the CCAC interpretation bulletin on: humanresources for animal care and use programs.

5.1 Conflicts of Interest and Confidentiality

The ACC(s) must be structured to avoid any real orperceived conflicts of interest, with each ACC hav-ing a broad perspective to ensure that it can under-take ethical review of animal use with as few bias-es as possible, and without potential intimidationof ACC members because of hierarchical or otherconsiderations (see also section 1 of Appendix IV).

5.2 Composition, Authority andResponsibilities of the ACC

These are defined in the CCAC policy statement on:terms of reference for animal care committees, and aresummarized in sections 2, 3 and 4 of Appendix IV.

5.3 ACC Reporting and Communication Lines

The institutional ACC must report directly to thesenior administrator responsible for animal care

and use. This must not be only a theoreticalreporting line; all ACC meeting minutes and sitevisit reports must be readily available to the sen-ior administrator (see also section 5.4).

The institutional ACC must also work very close-ly with the veterinarian(s) and animal care staffto ensure that all aspects of the animal care anduse program are appropriately covered.

With respect to communication lines, the ACCmust communicate frequently with the animalcare and use community as a whole with respectto general matters (explanations of the role of theACC and of practical animal care and use mat-ters including information for protocol submis-sion and ACC meeting schedules, policies, stan-dard operating procedures (SOPs), trainingopportunities, etc.), and with animal users, vet-erinary and animal care staff, hazardous sub-stances committees, occupational health andsafety groups and officials and others as often asneeded to ensure that the program is functioningappropriately.

5.4 ACCs and the Senior Administration

In order to function appropriately, the institu-tional ACC depends on the strong support of thesenior administrator and his/her colleagues inthe administration. ACC members are volunteerswho give considerable amounts of time andeffort to providing ethical review and approvalof animal use proposals, and overseeing the ani-mal care and use program. However, since theyare not responsible for institutional programs orbudgets, they can only be fully effective by work-ing closely and constructively with those whoare.

The senior administrator, working with his/herdelegate(s) and colleagues as appropriate, mustsupport the role and responsibilities of the ACCas a whole by:

• ensuring that the ACC has a high profilewithin the institution, and that institutionalanimal care and use policies and proceduresare easily accessible to, well known by andfollowed by all interested parties, includingnewcomers to the institution. In order to dothis, there should be regular communications

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from the senior administrator to the entireanimal care and use community about theimportance of appropriate animal care anduse;

• ensuring that the ACC has a well-respectedchair;

• ensuring that the ACC has a coordinator orother employee(s) who can provide the sup-port necessary for the committee to functionappropriately;

• ensuring that all ACC members, and in par-ticular newcomers, have access to orientationmaterials about their role and training oppor-tunities to better understand their role andensure optimal functioning of the ACC;

• ensuring that any ACC concerns that cannotbe addressed by the committee alone,whether related to compliance, staffing orfacility issues, are appropriately addressed ina timely manner;

• meeting, as often as needed, with at least theChair of the ACC (of the main institutionalACC where there are several committees) andthe person(s) with overall responsibility foranimal care services to discuss concerns andways of addressing them, and to ensure thatthere are appropriate planning processes inplace for any changes to the program, as wellas for maintenance, renovation and replace-ment of animal facilities, as needed; and

• ensuring that individual members of the ACCare well supported, as detailed in sections 5and 6 of Appendix IV.

5.5 ACC Coordinator

Because ACCs are committees composed of vol-unteers, the institution must provide active sup-port by assigning staff preferably familiar withanimal care and use to assist in ensuring theappropriate functioning of the ACC. Each ACCmust have sufficient support from one ormore qualified personnel members. Oneemployee working part-time for the ACC may besufficient in the case of smaller institutions,whereas larger institutions will need to assignone or more employee(s) to this work (see also

section 7 of Appendix IV). As defined in theCCAC policy statement on: terms of reference for ani-mal care committees, “The ACC coordinator mustsupport the ACC by ensuring that animal useprotocols are well managed, that committee min-utes and reports are promptly produced and dis-tributed, that all exchanges between the ACCand animal users are well documented and filedin a timely manner, and that animal users andACC members are provided with necessaryinformation.”

5.6 ACCs and Animal Users

The link between ACCs and animal users isan essential one of trust, since animal userscount on professional, trustworthy service fromthe ACC in order to ensure that their animal-based work is appropriately reviewed and canthen normally be undertaken in a timely mannerand in good conditions. In turn, the ACC countson animal users to be trustworthy and profes-sional in carrying out their animal-based work,according to institutional and ACC instructions.

The organization/institution, senior administra-tor and ACC must therefore work together toensure that all animal users:

• are clearly informed of institutional ani-mal care and use policies and procedures,and of the importance of following thesepolicies and procedures;

• are clearly informed about how to completeinstitutional animal use protocol form(s),renewal and amendment forms, as well asabout how and when to submit their propos-als, and have access to assistance in thisregard (from the ACC coordinator or anothermember of the ACC or veterinary/animalcare staff);

• have received appropriate training in ani-mal care and use and an orientation withrespect to using the animal facilities (seethe most recent CCAC guidelines on: institu-tional animal user training); and

• are clearly informed about reporting on theiranimal use as directed by the ACC, and abouthow to report any changes or concerns with

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respect to their animal use, and any concernswith respect to animal health or welfare.

There should be representation from all ofthe major animal-using departments, sec-tors or units of the institution on the ACC.Institutional animal users on the ACC should beencouraged to assist their colleagues in present-ing animal use protocols to the committee and inunderstanding the institution’s animal care anduse program, policies and procedures. In turn,animal users in general should be encouraged toconsult with their representative on the ACCshould they have any questions or concernsabout any aspect of the program. Animal usersshould be discouraged from bringing their ani-mal care and use concerns directly to the senioradministration until they have made efforts towork with the ACC. In fact, it can be very usefulfor investigators to meet directly with the ACC toexplain and answer questions about their proto-cols; they must however leave during the deci-sion-making process.

5.7 Appeals of ACC Decisions

Senior administrators must encourage animalusers and the ACC to work constructivelytogether to arrive at the most appropriate meansof using and caring for animals for scientifical-ly/pedagogically valid ends.

The senior administrator must ensure that thereis an institutional appeal mechanism in place, toaddress the eventuality of an animal user dis-agreeing with an ACC decision despite extensivediscussions and attempts to find agreement. Asdefined in the CCAC policy statement on: terms ofreference for animal care committees, “this mecha-nism should include appropriate expertise andensure a separate, fair and impartial process. TheCCAC may be called upon for information pur-poses; however, appeals cannot be directed to theCCAC.”

5.8 ACCs and Post-approvalMonitoring

ACCs do much of their work when protocols arestill in the planning stages. However, they arealso responsible, along with the animal users,veterinarian(s) and animal care staff and senioradministrator, for ensuring that animal care

and use takes place in practice according toACC decisions and institutional and CCACstandards. While collegial working relation-ships must always be protected and promoted,there must also be safeguards in place to ensurethat difficulties experienced with any aspect ofanimal care or use can be effectively identifiedand addressed. These safeguards are known col-lectively as ‘post-approval monitoring’. Post-approval monitoring is defined in section 8 ofAppendix IV, and information is provided onways and means to apply it.

No matter what the exact structure of theanimal care and use program is, the ACCmust remain at the centre of the programand play an active part in ensuring that ani-mal use in practice takes place as approvedin principle. The veterinary and animal carestaff must not be left to address problematicsituations alone — the ACC or its delegate(s)must be part of the solution and must beassisted by the senior administration asneeded.

6. Animal UsersAnimal users encompass a great range of scien-tists, teachers, technicians and students. Theycan be highly experienced and expert animalhandlers or novices, and their work may bebased almost entirely on animal studies or mayonly involve animals in a minor way. This meansthat institutional programs must be flexibleenough to adapt to a variety of animal userneeds.

The work of the ACC and veterinary and animalcare staff with animal users is presented inSections 5.6 and 7. Animal users’ responsibilitieswith respect to animal care and use are summa-rized in Appendix V.

The role of senior administrators with respect toanimal users is twofold: they must ensure thatanimal users can successfully undertake theirresearch, teaching, testing or production work,while also ensuring that they are protecting ani-mal health and welfare and meeting institutionaland CCAC standards. When a new animal useris hired or a new type of animal use is to takeplace in an institution, the veterinarian(s) andanimal care staff must be informed and must

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report as to whether this new animal use can besuccessfully accommodated, and if not, what isneeded to do so.

7. Animal Care and UseOperations Headed byVeterinarians andAnimal Care Staff

In order for scientists and teachers to have ani-mals that are healthy subjects for research, teach-ing, testing or production, and for the institutionto meet its obligations to protect the health andwelfare of the animals, there must be competentveterinary and animal care service providerswhose numbers and expertise match thenature and scope of the institutional program(see CCAC interpretation bulletin on: humanresources for animal care and use programs).

Veterinarians must have well defined authority toexercise their professional judgment to treat oreuthanize animals as needed, as defined in theCanadian Association for Laboratory AnimalMedicine (CALAM) Standards of Veterinary Care.As stated in the CCAC policy statement on: terms ofreference for animal care committees: “The veterinar-ian must attempt to contact the animal user whoseanimal is in poor condition before beginning anytreatment that has not previously been agreedupon, and must also attempt to contact the ACCChair, but the veterinarian must have the authori-ty to proceed with any necessary emergencymeasures, whether or not the animal user andACC Chair are available. A written report shouldbe sent by the veterinarian to the animal user andto the ACC following any such event.”

Institutions that place animal care and use forresearch, testing or production purposes entirely,or almost entirely, in the hands of well trainedand experienced animal health professionals canobtain very high quality research, testing or pro-duction results, while protecting animal healthand welfare very effectively. While having ani-mal care and use undertaken exclusively by ani-mal health professionals is not possible for manyacademic and some other institutions, it is neces-sary to have well-structured and complete ani-mal care services, offered by professionals, in allcases.

While it is understood that researchers and studydirectors can be experts in animal use, and thatteamwork involving the sharing of best practicesby scientists and animal health professionals isessential for optimal results, as a general princi-ple, animal care cannot simply be left up toresearch/testing teams. Research/testing teamshave research/testing as their primary goal; ani-mal care needs to be the responsibility ofanimal health professionals whose primarygoal is animal health and welfare in theservice of high quality science. While someanimal care may be entrusted to well trained stu-dents or other members of research/testingteams with the approval of the ACC, these per-sons’ work must always be overseen by animalhealth professionals. There are fewer opportuni-ties for qualification as an animal health profes-sional for aquatic animals and some otherspecies, and therefore those working with aquat-ic animals are more likely to come from aresearch background. However, the same basicprinciple should apply: the person caring for theanimals should preferably not also be a memberof a research team, except in the case of verysmall institutions or specialized types of work,where research teams may provide care with theapproval of the ACC and oversight by veteri-nary/animal health staff/ACC.

7.1 Reporting, Management andCommunication Lines for theDirector/Manager and Staffof the Animal Facilities

For larger institutions, there should be one or sev-eral veterinary director(s) of animal care/animalresources/animal care services, with animal carestaff members typically reporting to this/thesedirector(s) through managers/supervisors. Theveterinary director(s) must work within a report-ing structure where final responsibility for animalwelfare related matters lies with the senior admin-istrator responsible for animal care and use.Veterinarians in Canadian scientific institutionsmust work according to the most recent CanadianAssociation of Laboratory Animal MedicineCALAM/ACMAL Standards of Veterinary Care,and all elements in these standards must be cov-ered by the veterinary services in place.

While individual managers may report to adepartment head or faculty administrator for

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budgetary and human resource purposes, themanager must also report and be accountable tothe veterinary head of services for animal healthand welfare related matters.

In smaller institutions where there is a facilitymanager and consulting veterinarian, they mustwork together and both must report to the sen-ior administrator responsible for animal careand use for all animal health and welfare relatedmatters.

The director(s) and facility manager(s) mustcommunicate effectively with all animal users toensure that the services offered are well under-stood and taken advantage of, and to ensure thatfacility users understand and respect institution-al animal care and use and facility managementpractices and procedures. In cases where direc-tor(s) and facility manager(s) have not beenappointed to act as compliance officers, theymust also communicate effectively with thoseresponsible for compliance, and in particularwith the ACC, to ensure that both groups areworking with the most up to date informationand are working collegially and effectively withanimal users to foster best practices in animalcare and use.

7.2 Qualifications and ContinuingEducation for Veterinariansand Staff

Veterinarians providing clinical services and/orcompliance oversight must normally belicensed to practice as veterinarians in one ormore Canadian provinces. They must also havethe experience/expertise necessary to appropri-ately evaluate the health and welfare of thespecies used, in the context of the work beingcarried out by the institution. All veterinariansmust have access to continuing educationopportunities relevant to their work, andopportunities to better understand the research,teaching, testing or production that is undertak-en in their institution. Appendix VI providesthe CCAC continuing education requirementsfor consulting and newly hired institutional vet-erinarians working for scientific animal careand use programs.

Laboratory animal care technical staff membersshould normally be animal health technicians/

veterinary technicians who have graduated fromcollege or university programs, especially thoseaccredited by the Canadian Veterinary MedicalAssociation, to ensure appropriate monitoring ofanimal health and welfare at the cage level on aday-to-day basis. Less formally trained personscan be employed for basic husbandry tasks(cleaning, cage changing) in animal facilities.Staff members should have experience/expertisein the area in which they will be working, or atleast basic training for the routine tasks. Themain source of certification and continuing edu-cation and training in laboratory animal sciencefor technical staff in Canada is the CanadianAssociation for Laboratory Animal Science(CALAS). There are also some provincial associ-ations that provide some continuing education,along with opportunities in the US through theAmerican Association for Laboratory AnimalScience (AALAS), among others. Where techni-cians are working with animals other than labo-ratory animals (farm animals, fish, wildlife),good use should be made of time spent in insti-tutions with appropriate expertise and coursesoffered through specialized institutions.

Those responsible for compliance should be pro-vided with continuing education opportunities,with an emphasis on compliance structures andprocedures (CCAC workshops, Public Responsi-bility in Medicine and Research (PRIM&R) meet-ings, etc.).

8. Construction/Renovationand Maintenance ofAppropriate AnimalFacilities

Animal facilities are expensive and complexto plan, design, build, manage and maintain.Existing and planned facilities must meet CCACguidelines, as described in Appendix VII.

9. Occupational Healthand Safety

All institutions must have occupational healthand safety (OHS) programs in place, according toprovincial, federal and municipal requirements.In the case of animal-based work, the institution

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must ensure that those caring for and using ani-mals, and those in the general vicinity of animal-based work, are not put at risk because of thiswork, as described in Appendix VIII.

10. Crisis ManagementAs defined in the CCAC policy statement on: termsof reference for animal care committees, the institu-tion and its ACC must have in place “a crisismanagement program for the animal facilitiesand for the animal care and use program, in con-junction with any general institutional crisismanagement plan(s).”

This program (see Appendix IX for more infor-mation) should detail plans in the event of:

• power outages (short and prolonged);

• work stoppages;

• conditions (such as severe weather orpandemics) that interfere with many staffmembers’ ability to come to work;

• fires;

• natural disasters;

• large chemical spills and other similarcrises;

and include a communications plan foraddressing public and media inquiries aboutanimal use.

With respect to work stoppages, “Animal Care isa Continuous and Daily Responsibility” (seeSection D4b), Chapter V, Volume 1 (2nd Edition) ofthe CCAC Guide to the Care and Use of ExperimentalAnimals). All institutions must have measures inplace to ensure the availability, through anystrikes or work stoppages, of daily animal careby qualified and experienced personnel.

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The CCAC has three main programs:

• the Guidelines Program, which publishes reg-ularly updated Canadian guidelines on ani-mal care and use in science, written andreviewed by peers (http://www.ccac.ca/en/CCAC_Main.htm);

• the Education, Training and CommunicationsProgram, which provides information andtraining materials (primarily through theCCAC website at www.ccac.ca); and

• the Assessment Program, through which theanimal care and use programs of participantsin the CCAC Program are evaluated by pan-els of peers, based on CCAC guidelines, poli-cies and associated documents (http://www.ccac.ca/en/CCAC_Programs/Assessment/intro.htm ).

When institutions become participants in theCCAC Program and successfully complete theassessment process (see Section D of this appen-dix), the institution receives a CCAC Certificateof GAP – Good Animal Practice®, http://www.ccac.ca/en/CCAC_Programs/Assessment/gap.htm. This Certificate is recognized by federal andother granting agencies, federal and provincialgovernments, and national and international reg-ulatory and scientific bodies, among others, as aconfirmation that the institution meets appropri-ate standards of animal care and use. Canadianstandards of animal care and use are recognizedto be among the highest in the world.

A. Work With the Academic Sector

For the academic sector, the CCAC works with thefederal Tri-Council Granting Agencies, as definedin the Memorandum of Understanding on the Rolesand Responsibilities in the Management of FederalGrants and Awards (and in particular in Schedules

3 and 8 of this MOU, which is signed by all insti-tutions receiving funds from the agencies) toensure that all institutions receiving their fundsmeet CCAC standards (http://www.nserc.ca/institution/mou_e.htm). Participation in theCCAC Program and the resulting CCACCertificate of GAP – Good Animal Practice® istherefore mandatory for any institutions receivingor hoping to receive federal funding for animal-based work. The CCAC Certificate also has thesame value for academic institutions as it does forall other institutions, in terms of confirming to thepublic, regulatory agencies, stakeholders, collabo-rators and others that the institution meetsCanadian standards of animal care and use.

B. Work With the Private Sector

For private institutions that use animals forresearch, testing or production, the CCACCertificate of GAP – Good Animal Practice® is aconfirmation, for regulatory agencies, govern-ment, clients, stakeholders, collaborators andothers, that the institution meets Canadian stan-dards of animal care and use. Through itsAssessment Program, the CCAC provides quali-ty assurance services to these institutions fortheir animal care and use programs.

C. Work With the Government Sector

For the government sector, federal governmentdepartments and agencies that have units inwhich animals are used for research or testingare all participants in the CCAC Program. Inaddition, the ‘Experimental Animals (A9015C)’clause governing “Research and Development”of the Standard Acquisition Clauses and Conditions(SACC) Manual of Public Works and GovernmentServices Canada (PWGSC) requires that “any

APPENDIX IWORK OF THE CANADIAN COUNCIL ON ANIMAL CARE

(CCAC)

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work performed under the (federal government)Contract involving the care and use of experi-mental animals must be carried out in compli-ance with the Canadian Council on Animal Care(CCAC) programs and only by an institutionholding a CCAC Certificate of GAP – GoodAnimal Practice®.” Several provincial depart-ment units using animals also choose to be partof the Program. As is the case for other institu-tions, holding the CCAC Certificate confirms tothe public, clients, collaborators and others thatthe institution meets Canadian standards of ani-mal care and use.

D. The AssessmentProcess

When an institution wishes to join the CCACProgram, it receives an orientation and/or initialvisit, during which a CCAC Assessment Directorexplains the CCAC Program and reviews theinstitution’s planned program according to CCACstandards. Following this preliminary work,which is adapted to the needs and goals of theinstitution, the institution receives a first, fullCCAC assessment visit followed by visits everythree years (see the CCAC policy statement on: theassessment program of the CCAC, http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/ASSESS.HTM and the CCAC policystatement on: assessment panels, http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/PANEL.HTM).

The senior administrator needs to ensure that theinstitution prepares appropriately for everyCCAC assessment visit, and ensures that it hasall of the necessary elements for a complete ani-mal care and use program in place once regularCCAC visits begin. Institutions analyze allaspects of their own program before CCAC visitsby completing the CCAC Animal Care and Use

Program Review Form, and provide this as pre-assessment documentation to the CCAC. Thesenior administrator should also ensure that themembers of the animal care and use program,including him/herself, are available to answerthe CCAC’s questions during and between visits.

The institution is normally provided with a writ-ten report within 10 weeks of a regular CCACvisit. These reports generally include CCAC rec-ommendations, which are categorized as Major,Serious or Regular, as well as commendations (seeCCAC policy statement on: definitions of recommenda-tions made in CCAC reports, http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/DEFINI.HTM).

Major recommendations are rare, and signallarge and fundamental deficiencies in the animalcare and use program which must be thoroughlyaddressed with utmost urgency. The senioradministrator must answer any Major recom-mendations within the timeframe specified bythe CCAC.

Serious recommendations are more common,but still signal important deficiencies whichmust be thoroughly and promptly addressed.The senior administrator must answer anySerious recommendations within three monthsof receiving the CCAC report or letter.

Regular recommendations are the most com-mon type of CCAC recommendation, and signaldeficiencies that can normally be addressedthrough the processes already in place within theinstitution. The senior administrator mustanswer any Regular recommendations within sixmonths of receiving the CCAC report or letter.

Commendations are also common and are usedby the CCAC to emphasize the strengths in theinstitution’s program.

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A. Scientific Merit of Animal-based Research

It is the institution’s responsibility (or, in thecase of departments/agencies/organizationswith multiple sites, the organization’s responsi-bility) to have in place a mechanism to ensurethat proposed animal use for research is inde-pendently peer-reviewed for its scientific meritbefore it is given final approval by the animalcare committee (ACC) (see the CCAC policy state-ment on: the importance of independent peer review ofthe scientific merit of animal-based research projects,http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/PEER.HTM).The institutional office of research services, theoffice of the vice-president or associate vice-presi-dent of research or similar body should be respon-sible for this mechanism. The ACC coordinator orother administrator can help facilitate the process,and close links must be maintained between theACC and the office of research so that:

• the ACC receives confirmation that each ani-mal-based research protocol has been found tohave scientific merit before it is given finalapproval; and

• the office of research receives confirmation ofprotocol approval from the ACC before releas-ing funds for animal-based work for the corre-sponding project.

Where funding sources for research projects havecompetitive peer review processes with appro-priate independence and expertise (e.g. federalgranting agencies and others), the institution andACC can choose to accept these as providing evi-dence of scientific merit. Institutions can compilelists of such funding sources to which the institu-tion/ACC can refer when checking whether aresearch project has received appropriate peerreview.

For projects that are either internally funded orfor which the source of funding does not have in

place a peer review mechanism with appropriateindependence and expertise, it is recommendedthat the institution constitute a pool of reviewerswith expertise in the fields in which the membersof the institution work. The various departmentsand researchers may be called upon to assist inidentifying reviewers, including as many exter-nal scientists as possible, especially in the case ofsmaller institutions. Two independent reviewers(at least one of whom must be external to theACC) can then be selected for each project. Theyshould be asked to produce written reviews thatshould include the elements shown in theappended generic scientific merit review form(Appendix III). The reviews should be provided(without identifying the reviewers) to the authorof the protocol and any questions or concernsaddressed before the relevant information is for-warded to the ACC.

B. Pedagogical Merit of Animal-based Teaching

ACCs work closely with teachers to encouragethem to carefully justify any use of animals and touse alternatives as much as possible. While thisshould be encouraged, the institution and itsdepartments also have an important role to playby ensuring that, when curriculum reviews andother individual course reviews take place, thevalue of using animals for the various courses isthoroughly examined and documented. This doc-umented review can then be provided to the ACC.

C. Regulatory Merit of Animal-based Testing

With respect to the merit of proposed regulatorytests using animals, it is the responsibility of theinstitution to ensure that either the study direc-tor, a regulatory affairs official or other institu-tional representative has ascertained what datasets are acceptable to the regulatory authoritiesfor each compound or device to be tested (do the

APPENDIX IISCIENTIFIC, PEDAGOGICAL AND REGULATORY MERIT

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regulatory authorities require animal-basedtests and if so, what are the species, numbers ofanimals and types of procedures that arerequired?). In Canada, the onus is on the institu-tion submitting data to ask for a waiver if itwants to use an alternative test method (that isless invasive, uses a less sentient species or usesfewer animals), or if it opts to not produce a dataset it believes unnecessary. This discussionshould take place before the protocol is submit-ted to the ACC, and resulting informationshared with the ACC.

As stated in the CCAC policy statement on: terms ofreference for animal care committees, the testingmust be “planned according to the most currentregulatory requirements, using guidelinesacceptable to the regulatory agency(ies) and

which meet the requirements of the CCAC policystatement on: ethics of animal investigation.” Inaddition, the planned animal use must “notexceed the requirements of the regulatoryauthorities - if it does, justification for the addi-tional animal use must be provided”.

Because regulatory agencies do not always clear-ly require animal-based tests, and are themselveslooking for alternatives to live animal-based testsin several cases, institutions and their ACCs areencouraged to work with regulatory agenciestowards reducing animal distress in tests, and toprovide data whenever possible to the regulato-ry agencies to help work towards peer-reviewedvalidation of less invasive tests, as well as teststhat involve fewer animals or animals of lowerlevels of sentiency.

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PEER REVIEW FORM

The Canadian Council on Animal Care, which oversees animal use for research, teaching and testing,requires that all animal-based research projects receive scientific peer review from at least two inde-pendent experts prior to their approval by an Animal Care Committee.

The following set of questions will serve as a guideline for this review (please attach additional pagesif necessary).

Protocol #

1) Please comment on the objectives and potential contribution(s) of this study to scientific knowledge.

2) Please comment on the:

a) hypotheses of the study and appropriateness of the experimental design involving animals

b) animal-based methods

Signature Date

Name and title (please print)

APPENDIX IIISAMPLE PEER REVIEW FORM

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1. Conflicts of Interest andConfidentiality

In large institutions, ACCs representing only asmall proportion of animal users must be avoid-ed, to ensure that the ethical review process isbased on broad input and not simply on a smallnumber of close colleagues approving one anoth-er’s animal use protocols. In small institutions,consideration should be given to including addi-tional external members whose abilities comple-ment those of the internal members. There mustbe regular turnover of all ACC members exceptfor those who must be on the committee becauseof the nature of their work (veterinarian, facilitymanager, ACC coordinator). Other ACC mem-bers, including the chair, may not serve morethan eight consecutive years on the committee,except in the case of very small institutions(those with three animal users or less).

The senior administrator to whom the ACCreports must not be a member of the ACC,although it can be useful to have a representativeof the administration on the committee to facili-tate communication and address any concerns ina timely manner.

All ACC members must understand that all ofthe information from individual animal usersthat they are privy to must be kept entirely con-fidential, along with the ACC’s discussions anddecisions on animal use. Animal use proposals,in particular in a research setting, are intellectualproperty and must be treated as such. Severalinstitutions choose to have ACC members signconfidentiality agreements, and this can be use-ful to reassure animal users that their proposalswill not be used by ACC members for any pur-poses other than ethical review and decision-making. Agreements can be worked out, at thediscretion of the institution, to keep individualprotocols confidential, while allowing ACCmembers to be more open about the generalprocesses that the ACC uses.

2. Composition of theAnimal Care Committee

As defined in the CCAC policy statement on: termsof reference for animal care committees, the composi-tion of ACCs must include:

• scientists/teachers experienced in animal use;

• at least one veterinarian with experience/training with regard to the species being usedand the types of work;

• an institutional member who does not useanimals in his/her work;

• a minimum of one community representativewith no links to the institution or to animaluse in science (most institutions’ work-loads require more than one community representative);

• the director/manager of the animal facilities;where there are several directors or man-agers, their representation on the ACC shouldbe worked out in a manner consistent withthe program structure;

• technical staff representation;

• student representation in the case of academ-ic institutions; and

• the ACC coordinator, or person paid by theinstitution who assists the ACC in its work.

3. Authority of the ACCAs defined in the CCAC policy statement on: termsof reference for animal care committees, “the ACCmust have the authority, on behalf of the senioradministrator responsible for animal care anduse for the institution, to:

APPENDIX IVINFORMATION ON ANIMAL CARE COMMITTEE

OPERATIONS

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a) Stop any objectionable procedure if it consid-ers that unnecessary distress or pain is beingexperienced by an animal.

b) Stop immediately any use of animals whichdeviates from the approved use, any nonapproved procedure, or any procedure caus-ing unforeseen pain or distress to animals.

c) Have an animal killed humanely if pain ordistress caused to the animal is not part of theapproved protocol and cannot be alleviated.”

4. Main Responsibilities ofthe ACC

The main responsibilities of the ACC (seeSections 3, 4 and 5 of the most recent version ofthe CCAC policy statement on: terms of reference foranimal care committees for more details on this) are to:

• provide ethical review and approval of ani-mal use proposals (known as protocols) oncethey have been found to have scientific, ped-agogical or regulatory merit, and ensure thatthey are carried out in practice as they havebeen approved in principle;

• ensure that there are appropriate policies andstandard operating procedures (SOPs) inplace for the animal care and use program,that these are regularly reviewed and updat-ed with appropriate expertise and that theyare widely communicated to all members ofthe program;

• ensure, through regular site visits and workwith institutional officials, that the animalfacilities and areas used for animal care anduse by the institution are appropriate andmeet institutional and CCAC standards; and

• ensure, through work with institutional offi-cials, that there are sufficient numbers of wellqualified veterinary and animal care staffmembers receiving relevant continuing edu-cation and training, and that the animal usersin the institution have also been trained towork with animals appropriately.

5. ACC ChairThe Chair of the ACC is typically an animal userwith good experience in animal care and use, asthis facilitates his/her understanding of the ani-mal care and use program and his/her ability toeffectively meet the challenges involved in over-seeing it. However, in several cases non animalusers have successfully chaired their committee.Each institution must decide who can best chairits ACC at any given time. It is important thatthe chair not have any conflict of interest orappearance of conflict of interest in his/her role,and therefore should not be the author of a largeproportion of protocols within the institution,nor be directly involved in the management ofthe institutional animal facilities, nor be a clini-cal veterinarian for the institution, nor be an ani-mal health or veterinary personnel membercharged with ensuring compliance with CCACguidelines.

The role of the chair of the ACC should be welldefined, according to institutional and CCACpolicies, and once the chair is selected (either bythe senior administrator, by the ACC itself, orpreferably by both working together, often withothers) this person should be well supported bythe institution. Chairing an ACC requires consid-erable commitments of time and effort, and theACC itself provides an essential service to theinstitution in terms of quality control and riskmanagement for the animal care and use pro-gram. Therefore, the ACC chairmanship shouldbe a high profile position, which individualsshould have the time to undertake and for whichthey should be recognized by the institution.

6. Institutional ACC Members

The other members of the ACC from within theinstitution should be similarly well supportedand recognized.

6.1 External ACC Members

All ACCs must have community representativesas external committee members, and may haveother external members as well.

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Community RepresentativesThese members play a key role in providing aperspective that is external both to the institutionand to the use of animals in science, and provideconsiderable balance and credibility to a processthat would otherwise be strictly institutional.The role and responsibilities of the communityrepresentative are described in the CCAC –Canadian Federation of Humane Societies(CFHS) Manual for Community Representatives(http://www.ccac.ca/en/CCAC_Programs/Assessment/CCAC-CFHS_Manual_e.pdf ).

It is essential for institutions to make communityrepresentatives feel welcome, and to providethem with:

• an orientation session, including a site visit andan opportunity to meet with at least the keyplayers in the animal care and use program;

• all material relevant to the animal care anduse program of the institution;

• all material published by the CCAC; and

• opportunities to learn more about their role,ACC functioning and animal care and use inscience.

ACC meetings and activities must be held at timesthat are convenient for the community representa-tive, particularly since community representationis essential for ACC operations and decisions(they must be part of the committee quorum).While the institution does not employ the com-munity representative, the institution must reim-burse the community representative for expensesincurred for ACC work, including travel andparking expenses, any expenses related to receiv-ing and sending materials relevant to the ACC’swork, and expenses related to continuing educa-tion and training as an ACC member. Many insti-tutions also provide meals during ACC activitiesand try to provide opportunities for communitymembers to meet informally and socially withother members of the animal care and use com-munity, ACC and institutional members.

Other External ACC MembersInstitutions that have consulting veterinarianswho are responsible for providing services for all

or a large proportion of the animal care and useprogram will need to include them as ACC mem-bers (see also section 7).

Depending on the size and nature of the institu-tion, other external members may be useful aswell. Smaller institutions or institutions new tothe CCAC Program, in particular, may benefitfrom including external members familiar withanimal care and use in science.

As is the case for the community representatives,other external ACC members should be made tofeel welcome to the committee and valued by theinstitution, and should be provided with an ori-entation to the institution’s program and with allrelevant documentation.

7. ACC CoordinatorsACC coordinators have very varied back-grounds. They should be chosen to match theneeds of the institution according to their ownexperience and the size and nature of the institu-tion. In some cases, institutions have assignedanimal health technicians to be ACC coordina-tors: this can work well since they are wellversed in animal care and use and can thereforeassist animal users and the ACC very effectively,as well as play an active role in monitoring pro-tocols following their approval by the ACC. Insome cases, the ACC coordinator is an animalhealth technician who is also the training coordi-nator, and this can also work well in terms ofkeeping standard operating procedures up todate, along with managing protocols and poten-tially contributing to post-approval monitoring,as long as the program is not too large. An ani-mal health technician who already has extensiveresponsibilities in providing services within theanimal facilities should not also be asked to serveas ACC coordinator.

8. Post-approval Monitoring

As defined in the CCAC policy statement on: termsof reference for animal care committees:

Each institution must establish proceduresfor post-approval monitoring of animal

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use protocols, and must define the rolesand responsibilities of the members of theanimal care and use program in the moni-toring process. The institutional ACC isthe body responsible for determining andworking to correct breaches of compliancewith approved animal use protocols andSOPs. Breaches of compliance that cannotbe corrected by the ACC working with theconcerned animal users and veteri-nary/animal care staff must be referred tothe senior administration, which mustinform all members of the animal care anduse program about sanctions that will betaken by the administration in the event ofserious breaches of compliance.

As the ACC is generally not present whenanimal use protocols are being undertaken,the committee must work with the mem-bers of the veterinary and animal care staffto ensure compliance with its decisions andwith the conditions set out in approvedprotocols. The veterinary and animal carestaff must work in a collegial manner withanimal users and attempt to correct defi-ciencies collaboratively. Where there arepersistent breaches of compliance or threatsto the health and safety of personnel or ani-mals, these must be reported back to theChair of the ACC, and the Chair and ACCmust promptly address these issues,through communications with the animaluser(s), meetings and site visits, and even-tually communications with the senioradministrator, as necessary.

In order to undertake post-approval monitoringin practice, the ACC needs partners.

The most important partner is the animal user:s/he agrees to undertake his/her protocol inpractice as approved in principle by the ACCwhen s/he signs the final version of the protocol.The veterinarian(s) and animal care staff are alsoessential partners as they provide day-to-day

assistance and information with respect to ani-mal care and use, and provide training as well.

Post-approval monitoring procedures must notbe cumbersome or intrusive. In fact, the ACCs,veterinarians and animal care staff in mostCanadian institutions successfully identify andaddress most difficulties without ‘policing’, andthis collaborative approach must be retained inany post-approval monitoring program. Whileflexibility is important, the program should notbe left solely to good will. Each institutionshould develop and implement its own post-approval monitoring program based on the fol-lowing elements:

a) day-to-day collegial work of the veterinari-an(s) and animal care staff to help animalusers remain compliant with approved proto-cols and institutional and CCAC standards,focusing more specifically on ensuring that:

i) individual animal users are comfortablehandling animals and carrying out proce-dures successfully, and that they are ableto do so in appropriate conditions;

ii) endpoints are applied as approved by theACC to avoid unnecessary distress to theanimals.

b) availability of the ACC coordinator or otherACC members to assist animal users withtheir work, and to facilitate the process ofamending a protocol when it cannot be suc-cessfully continued in practice as originallyapproved for technical or logistical reasons;

c) site visits and discussion of protocols with ani-mal use teams by ACC members or other col-leagues, to address concerns through goodcommunication;

d) careful assistance and follow-up for new pro-cedures and for procedures more likely toresult in animal pain or distress.

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Scientists, teachers, technicians and students allhave the responsibility to:

• not use animals if a replacement alternative isavailable and appropriate;

• work with the animal care committee (ACC)and veterinary and animal care staff in a col-legial and respectful manner when animaluse is necessary;

• treat all animals with respect and dignity;

• respect institutional and CCAC standards.

Authors of animal use protocols have responsi-bility for all aspects of the protocol, including:

a) ensuring that the ACC receives all the infor-mation required to conduct an informedreview of the proposed animal use, and that itis approved before any animal use begins;

b) considering the Three Rs (replacement,reduction and refinement of animal use) and

documenting that the proposed animal use isnecessary, that the requested animal numbersare justified and that all appropriate refine-ments will be made (more information on theimplementation of the Three Rs is availablefrom the CCAC’s Three Rs microsite locatedat http://ccac.ca/en/ThreeRs);

c) ensuring that any amendments to the proto-col are submitted to and approved by theACC in a timely manner;

d) reporting back to the ACC on the work on atleast an annual basis;

e) ensuring that all those in their team who willhandle animals are appropriately trained andcompetent to undertake the procedures, andthat they understand what is in the approvedprotocol;

f) ensuring that the work is undertaken in prac-tice as approved in principle by the ACC, andmeets institutional and CCAC standards.

APPENDIX VRESPONSIBILITIES OF ANIMAL USERS

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The CCAC recommends that veterinarians work-ing with animals used in research, teaching, test-ing or production fulfill a requirement for contin-uing education (CE) in their field of practice. Inorder to identify appropriate levels of CE for vet-erinarians, and recognizing that veterinaryrequirements differ for the type of institutioninvolved, the CCAC has categorized animal careand use programs into three general types: small,medium and large (based mostly on the numberof days required for each CCAC assessment).The types of veterinarians that would typicallyprovide clinical services to these programs areidentified below:

A) Small program

a) Consulting (attending) veterinarian

B) Medium program

a) Multi-species consulting veterinarian

b) Newly hired institutional veterinarian(s)

c) Experienced institutional veterinarian(s)

C) Large program

a) Species-specific consulting veterinarians

b) Newly hired institutional veterinarians

c) Experienced institutional veterinarians

Consulting or attending veterinarians typicallypractice large, small or mixed animal medicine,in private practice. Large animal practitionerswork mostly with farm animals; small animalpractitioners work mostly with pets, includingbirds, reptiles and pocket pets (rodents for themost part); and mixed animal practitioners workwith all common species. They typically dedicate

a relatively small portion of their professionaltime to working with scientific institutions andtheir animal care committees (ACCs). However,some consulting veterinarians are experiencedexperimental animal medicine veterinarians whodivide their time between several different insti-tutions; they therefore do not need introductoryCE in their field, but need more advanced CE ontopics most relevant to them.

Institutional veterinarians spend most of theirtime working for and in one academic or non-academic institution. In Canada, the majority ofCCAC participants employ institutional veteri-narians to work with common species of labora-tory animals.

The CCAC has also identified a number of different types of CE available to Canadian veterinarians:

1. Subscriptions to relevant scientific journals

2. On-line resources and other distance learningmodalities

• Introduction to Lab Animal Medicine, Univer-sity of Guelph: http://www.open.uoguelph.ca/offerings/program.cfm?PID=59

• The Experimental Fish – Institutional AquaticAnimal User Training, Canadian Aquacul-ture Institute, http://www.upei.ca/cai/experimentalfish.htm

• COMP-MED (an electronic discussiongroup on comparative medicine and labo-ratory animals): http://www.aalas.org/online_resources/listserves.asp

3. Membership in professional associations(Canadian Association for Laboratory AnimalMedicine (CALAM, http://www.uwo.ca/

APPENDIX VICONTINUING EDUCATION (CE) FOR CONSULTING AND

NEWLY HIRED INSTITUTIONAL VETERINARIANS WORKING IN SCIENCE

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animal/website/CALAM/), Canadian Associ-ation for Laboratory Animal Science (CALAS,http://www.calas-acsal.org/), AmericanSociety of Laboratory Animal Practitioners(ASLAP, http://www.aslap.org/), AmericanAssociation for Laboratory Animal Science(AALAS, http://www.aalas.org/index.aspx ))

4. Conferences (CALAM, AALAS, CALAS andothers)

5. Workshops (CCAC national, regional andothers)

6. Practicum in other institutions (one-weekstay in an institution with a well-establishedanimal care and use program and expert personnel)

7. Short Courses

• Charles River: http://www.criver.com/about_charles_river/events/short_course/;

• Jackson Laboratory: http://www.jax.org/research/vet.html;

• Canadian Aquaculture Institute: http://www.upei.ca/cai/training.html;

• and others.

8. Certificate Course

• Certificate in Laboratory Animal Medicine,University of Guelph: http://www.open.uoguelph.ca/offerings/program.cfm?PID=59)

9. Diploma Course

• University of Guelph: http://www.ovc.uoguelph.ca/PathoBio/graduate.shtm#Diploma

After many discussions with various stakehold-ers, the CCAC recommends that veterinarianspursue the following CE as listed for the variouscategories of programs*:

Consulting veterinarian in a small program

• Introduction to Laboratory Animal Medicine:within first year

• Short Course: within second year

• Conference, workshop: at least one everythree years

• Membership in a relevant professional associ-ation: highly recommended

• At least one journal subscription

Multi-species consulting veterinarian in amedium program

• Same as above, plus

• Practicum: at least one every five years

Newly hired institutional veterinarian in amedium or large program

• Certificate course: once, within first year

• Workshop/conference: at least once, withinfirst three years

• Short course/practicum: once, within firstfour years

• Membership in relevant professional associa-tion: highly recommended

• Journal subscriptions

* Equivalencies to the stated requirements will beconsidered.

The CCAC minimum requirements for CE cur-rently apply only to consulting (attending) veteri-narians who spend most of their time in privatepractice and newly hired institutional veterinari-ans. However, experienced veterinarians whoconsult on or work/teach with less familiarspecies are expected to fulfill the minimumCCAC requirements for CE in the species they areless familiar with. For example, small animal vet-erinarians teaching rodent care in an animalhealth technician program would require mini-mum CE if they didn’t have much experiencewith rodents. Similarly, experienced laboratoryanimal veterinarians working in or consulting foran institution that is beginning to use fish wouldrequire minimum CE in fish care if they have lit-tle experience in aquatics. The same would applyfor other species, including non-human primates

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for which thorough and specialized training isneeded.

Consulting veterinarians whose consulting workmirrors the work of their regular practice (gener-ally large animal practitioners, or those workingwith cats and dogs, or with fish) currently meetthe minimum CCAC CE requirements throughtheir provincial licensing requirements. However,

they are encouraged to keep up to date withCCAC guidelines and policies, attend CCACworkshops and make good use of CCACresources such as the 12 web-based training mod-ules for animal users, so that they are entirelyfamiliar with the Canadian system of oversight ofanimal care and use. They should also benefitfrom veterinary CE in areas most relevant to theirwork.

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Animal facilities must meet CCAC guidelines, asfollows:

• Laboratory animal facilities need to beplanned for and maintained according to themost current version of the CCAC guidelineson: laboratory animal facilities – characteristics,design and development (http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Facilities/PDFs/Facilities_Gdlines_Eng.pdf )

• Farm animal facilities need to be planned forand maintained according to the most currentversion of the CCAC guidelines on: farm animals(http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GUIDES/ENGLISH/V1_93/CHAP/CHIV.HTM )

• Fish facilities need to be planned for andmaintained according to the most current ver-sion of the CCAC guidelines on: the care and useof fish in research, teaching and testing(http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Fish/Fish%20Guidelines%20English.pdf )

• Wildlife facilities need to be planned for andmaintained according to the most current ver-sion of the CCAC guidelines on: the care and useof wildlife (http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Wildlife/Wildlife.pdf ).

While funds for new animal facilities are oftentied to specific programs/projects, efforts toplan for appropriate facilities for the institu-tion as a whole are essential to the quality ofthe animal-based work undertaken in theinstitution, and to making the best possiblelong term investments for the institution andits members.

Institutional master plans should emphasize:

• taking stock of the strengths and weaknessesof existing animal facilities, examining all facil-

ities within the institution (and within the gen-eral area), and the current and potential futureroles of each facility within the network;

• making the best use of each existing facility, toavoid having underused or overcrowdedfacilities, and to plan for the sharing of certainspecialized and other facilities such as quar-antine, exclusive or inclusive barriers or sur-gery facilities;

• ensuring that maintenance/renovation plansare in place for existing facilities that are like-ly to continue to be used for animal-basedwork, to prevent deterioration and additionalcosts;

• planning for flexible and appropriate newfacilities for current and future animal careand use requirements;

• planning for facilities that will incorporatenot only animal housing areas, but also com-plete service and procedural areas, to avoidhaving to transport animals/equipmentbetween separate areas, as this is inefficientand creates concerns with respect to security,biosafety, biosecurity, animal stress, quality ofanimal-based work, laboratory animal aller-gies and oversight of animal care and use.

Institutions should avoid conducting masterplanning with only a few individuals — expen-sive mistakes can result from limited perspec-tives. The administration, animal users, the ACCand the veterinary and animal care staff shouldall be involved in planning for appropriate facil-ities for current and future needs. Institutionsalso benefit greatly from working with consult-ants who are well experienced in animal care anduse in science and in animal facility design.Project managers, architects and engineersshould also preferably have previous experiencewith animal facilities since this type of buildingis highly specialized and complex.

APPENDIX VIIANIMAL FACILITIES

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Section D of the CCAC guidelines on: laboratoryanimal facilities – characteristics, design and develop-ment provides guidance on the process for plan-ning, design and development of a laboratoryanimal facility, and includes general principlesthat can be used for developing facilities forother types of animals.

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There are general regulatory requirements thatgovern the use of animals and dangerous com-pounds at the federal and provincial levels andthat include:

• the federal Health of Animals Act (http://laws.justice.gc.ca/en/H-3.3/index.html), whichgoverns the control of animal diseases andtoxic substances;

• the Workplace Hazardous Materials Infor-mation System (WHMIS, http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/index_e.html/), which requires thateach employer provide safe working condi-tions and that employees be informed aboutall hazards that they will face;

• the federal Controlled Drugs and Substances Actand its related regulations (http://laws.justice.gc.ca/en/C-38.8/index.html), whichgoverns the use of narcotics and other con-trolled substances.

In addition to the precautions that need tobe taken to protect people from the usualhazards of workplaces, the use of animalsentails taking additional precautions. Theseprecautions are primarily the responsibility ofthe institution and its occupational health andsafety (OHS) office/officer/committee.

In order to develop and implement complete andappropriate precautionary measures, thoseresponsible for OHS should work with the insti-tutional veterinarian(s) and the ACC to ensurethat they understand and have identified and arecovering all risks adequately. In addition to hav-ing these measures in place, usually in the formof standard operating procedures (SOPs), regularvisits should be conducted to areas where ani-mals are cared for and used to ensure that OHSmeasures are being well implemented in practiceand that all risks are being appropriately cov-ered. These visits should preferably be undertak-en jointly by those responsible for OHS and byACC delegates. It is also very useful for there to

be cross-appointments between the ACC andOHS committee so that both committees areaware of any concerns that need to be addressedand can work together to address them.

The most recent CCAC guidance on occupation-al health and safety should be consulted (http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GUIDES/ENGLISH/V1_93/CHAP/CHVIII.HTM ).

In order to fully implement OHS measures,all those involved in animal care or use mustbe thoroughly trained to fully understandhow to protect themselves from animal-related risks. Institutions are encouraged tomake this training and the implementation ofOHS measures a high priority, particularly giventhe considerable liabilities that may be involved.

Before specialized training is given, basic train-ing related to appropriate, general handling ofthe species that will be used is essential, so thatthose who will handle animals understand howthey are likely to react and take appropriatemeasures to protect themselves and the animals.

A. Hazards Related toAnimal-based Work

A.1 Zoonoses (Infections ThatCan be Secondarily Transmitted From Animals to Humans)

Those who handle wild animals or non-humanprimates are at the greatest risk of contractingdangerous infections from the animals, but allanimal use carries some degree of risk. The insti-tutional veterinarian(s) can provide informationwith regard to the zoonoses that can be contract-ed from the species used by the institution, andto the measures needed (personal protectiveequipment, vaccinations, etc.) to protect animalhandlers. Those responsible for OHS and for the

APPENDIX VIIIOCCUPATIONAL HEALTH AND SAFETY

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animal facilities can then use this information todevelop and implement complete and appropri-ate measures to protect all those who may beexposed to zoonoses.

A.2 Biological Hazards

In addition to the hazards associated with thepathogens that animals may ‘naturally’ carry,there are also the hazards related to thepathogens (bacteria, viruses, parasites, fungi,prions) used for specific studies in some institu-tions. Where such agents are used, the mostrecent federal guidance should be followed(http://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index.html and http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/index_e.html/). Those responsible for OHS and the ani-mal facilities should use this and any other rele-vant guidance to appropriately inform, train andprotect all those potentially exposed to thesepathogens.

A.3 Allergies

Allergies to animals, and in particular to labora-tory animals, are common. Those who areexposed to laboratory animal allergens, even ifthey do not handle the animals directly, run aconsiderable risk of developing allergies.Therefore, those responsible for OHS and theanimal facilities must develop protective meas-ures not only for those who will directly handleanimals but also for those who may be exposedto their allergens. These measures include:

• appropriate environmental control and air han-dling systems to limit exposure to allergens;

• personal protective equipment includingmasks and gloves, as well as clothing wornonly in animal rooms;

• appropriate equipment such as filtered bed-ding disposal units and vented hoods; and

• use of filtered transfer cages and containmentof animal allergens in the areas where animalswill be used, where transportation of animalsoutside of the animal facility is necessary.

Special measures must also be taken in agricul-tural facilities, to protect those working there

from allergic reactions to animals, feed, beddingand dust.

A.4 Physical Injuries

Those who conduct animal-based work may beexposed to several physical hazards including:

• bites/scratches inflicted by animals;

• other types of injuries directly related to ani-mal handling, including those related to cap-turing/holding/lifting animals, or being cor-nered, kicked, stepped on or crushed by larg-er animals;

• electrical dangers, particularly in wet areas;

• repetitive stress related injuries;

• injuries related to lifting large weights;

• injuries related to working with potentiallydangerous equipment/substances, in laborato-ry and agricultural facilities and field settings;

• burns related to sterilizing/washing equip-ment or other sources of heat;

• potentially explosive or toxic accumulations ofgases, in laboratory and agricultural facilities;

• injuries related to steps and other differencesin floor levels, e.g. the pits around cage wash-ers; and

• injuries related to pipes and other conduits athead-level, or to other objects (hoses, etc.)obstructing passageways.

Once again, all of the potential risks present ineach facility must be identified, and thoseresponsible for OHS must work with thoseresponsible for the facilities to ensure that every-one is well-informed, well-trained and appropri-ately protected from the risks.

A.5 Chemical Injuries

There are several potentially hazardous materi-als involved in almost all animal-based work,including:

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• veterinary drugs: anesthetics, anestheticantagonists, analgesics, euthanasia agents,tranquillizers, sedatives, neuromuscularblocking agents, etc.;

• cleaning agents, detergents and disinfectants;and

• a large variety of chemical compounds usedfor research, teaching or testing purposes.

Narcotics and other controlled drugs and sub-stances must be handled, stored and usedaccording to the Controlled Drugs andSubstances Act and its related regulations( h t t p : // l a w s . j u s t i c e . g c . c a / e n / C - 3 8 . 8 /index.html). It is essential to keep these sub-stances secure since some are sought by thoseconsidering suicide and many are highly soughtas street drugs. Either a veterinarian or a scientistmust have a license to purchase and use thesesubstances, and is responsible and liable for theiruse. Veterinarians must ensure, working withtheir ACC, that veterinary drugs are appropriate-ly used to minimize pain and distress and protectanimal health and welfare.

The Workplace Hazardous Materials InformationSystem (WHMIS) is applied by the federal gov-ernment in its laboratories, and elsewhereWHMIS is applied under provincial legislationthrough ministries of labour. All those who will be

handling any potentially dangerous compoundsmust receive WHMIS training, and all potentiallyhazardous substances must have Material SafetyData Sheets that are readily available to thoseusing them. Those responsible for OHS and forthe animal facilities must ensure that those usingchemicals are well-informed of their propertiesand are protecting themselves appropriately.

A.6 Radiation

Where radioactive materials are to be used,radioisotope licenses from the federal CanadianNuclear Safety Commission must be held. ARadiation Safety Officer must be designatedwithin the institution to be responsible forradioactive material use. S/he is an ex officiomember of the institutional OHS committee andshould also work closely with the ACC and thoseresponsible for the animal facilities, in particularwhere radioisotopes are administered to ani-mals. In these cases, strict measures must be inplace to limit and contain radioactive contamina-tion and to protect those working with animals,animal wastes and carcasses from radiation.

Personal dosimeters must be used by all thoseworking in proximity to radiation, including x-rays. The use of x-rays is governed by provincialOHS acts, and institutional measures must be inplace to appropriately protect those likely to beexposed to x-rays.

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In order to implement a crisis management pro-gram, the senior administration, ACC and vet-erinary and animal care staff must work togeth-er to ensure that all categories of potential crisesare well covered in practical, comprehensiveplans that are readily available to all who mayneed them. Information on crisis managementcan be found at http://www.ccac.ca/en/CCAC_Programs/Assessment/crisis.htm.

A. Elements of a CrisisManagement Program

A.1 Crisis Management Team orTask Force

This team should include:

• a senior administrator (e.g., VP Research orAcademic);

• deans/heads of faculties/departments/unitsin which animals are used;

• director/supervisor of animal care services;

• chair of the animal care committee(s);

• communications/public relations officer;

• head of security; and

• other representatives as needed, including,for example, the chair of the OccupationalHealth and Safety Committee and possibly alawyer.

A communications plan should be established bythe team to ensure that:

a) telephone numbers are available so that themembers of the crisis management team canbe reached easily during regular workinghours as outside of normal working hours;

b) emergency telephone numbers are availablefor:

• medical assistance

• police

• fire

• assistance with hazardous materials spills;and

c) information can be efficiently processed andcommunicated at any time to:

• members of the institution

• the media (through a single spokesperson,preferably the person responsible for pub-lic relations for the institution)

• the public (through the same spokesper-son or delegate).

The local police must be informed of any seriousincidents. The CCAC should also be informed ofany serious incidents, in order to coordinate theresponse of the institution and of the CCAC toany queries related to the incident.

A.2 Emergency Power

All animal facilities must have access to emer-gency power in case of power outages.Generators must be regularly tested to ensurethat they will work well when needed. In case ofprolonged power outages, a standard operatingprocedure should be in place to determine thefate of the animals, either though evacuation toanother facility or euthanasia.

A.3 Links with Police and FireDepartments

Before the crisis management program is final-ized, local police and fire department officialsshould be invited to tour the animal facilities and

APPENDIX IXCRISIS MANAGEMENT

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provide recommendations on ways to improvesecurity/safety in the facilities.

Plans should be made with respect to if, whenand how animals will be evacuated in the eventof a fire, natural disaster or large chemical spill.

A.4 Public Relations

The crisis management plan should include ageneral policy statement on the care and use ofanimals by the institution. This statement can beused for general inquiries on experimental ani-mal care and use, or can be incorporated into apress release following an incident.