ILAR Journal Online, Volume 37(2) 1996: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1997
Laboratory Animal Care Policies and Regulations

Laboratory Animal Care Policies and Regulations

Canada
James Wong

James Wong, D.V.M., is director of assessments for the Canadian Council on Animal Care

OVERSIGHT

In Canada, all scientific use of vertebrates and cephalopods is subject to the requirements of the Canadian Council on Animal Care (CCAC), a national, peer-review organization founded in Ottawa in 1968. While Canadian federal legislation covers the prevention of cruelty to animals, research is exempt if it can be shown to be necessary. The provinces of Ontario, Saskatchewan, and Alberta have legislation dealing with laboratory animal use. Their provincial programs and the nationwide programs operated by the CCAC are mutually complementary.

The province of Ontario has the most comprehensive legislation, which regulates the use of animals in connection with research, teaching, testing, and production under the Animals for Research Act (1971). The Provinces of Alberta and Quebec are considering introducing legislation that will empower the use of CCAC guidelines in regulating the use of animals in research, teaching, and testing.

The CCAC comprises 20 member organizations, whose representatives include scientists, educators, and delegates from industry and the animal welfare movement.

The mandate of the CCAC states

The purpose of the Canadian Council on Animal Care is to act on behalf of the people of Canada to ensure, through programs of education, assessment and persuasion that the use of animals in Canada, where necessary for research, teaching and testing employs physical and psychological care according to acceptable scientific standards, and to promote an increased level of knowledge, awareness and sensitivity to the relevant ethical principles. (CCAC, 1995)
The CCAC does not act as an advocate for the use of animals in science nor does it act to oppose the responsible and ethical use of animals in Canadian science. Its mandate is to work with institutions, scientists, and animal care personnel to develop programs to optimize laboratory animal care and to make changes as required, based on sound expertise and input. CCAC guidelines are not all-encompassing or "etched in stone." Their application requires good judgement and common sense, based on training and experience. The CCAC programs encourage the development of consensus among those using the guidelines and those required to oversee their application.

FUNDING

From its inception in 1968 till the end of 1994, the costs of CCAC programs (which include assessment visits, publications, and development of guidelines), have been entirely funded by annual grants from the Medical Research Council (MRC) and the Natural Sciences and Engineering Research Council (NSERC), Canada's two main research granting agencies. In 1968, and for the first few years after it was established, the CCAC assessment program extended only to academic facilities. As the assessment program gained acceptance both in Canada and worldwide, other facilities began to participate in the program. The government and industry research sector now make up a significant proportion of the 201 facilities covered by the CCAC. Beginning in April of 1995, NSERC and MRC will no longer underwrite the costs associated with assessment of government and private industry sectors, due to their own budgetary constraints. The CCAC will therefore follow a user-pay system for facilities not covered by the MRC/NSERC umbrella.

ENFORCEMENT

The cornerstone of surveillance of the care and use of animals in Canadian science is maintained by CCAC's program of peer review. Essential to this program is the institutional animal care committee (ACC). The ACC, set up according to terms of reference laid down by the CCAC, is responsible for the standards of animal care and use within the institution and for evaluation of the ethical acceptability of the animal-based research conducted at the institution.

The effectiveness of each institutional ACC, and the appropriateness of animal care facilities, practices, and procedures, are subject to regular review as part of the CCAC assessment program. CCAC assessment panels are composed of scientists, veterinarians, and members of the animal welfare movement.

In-depth site visits are conducted at least every 3 years. Follow-up visits, most of which are unannounced, are often carried out by members of the CCAC secretariat. Assessments are based on CCAC's two-volume Guide to the Care and Use of Experimental Animals (CCAC, 1984, 1995) which includes the following regularly updated policy statements and guidelines on specific issues: (1) Ethics of Animal Investigation, (2) CCAC Guidelines on Acceptable Immunological Procedures, (3) Categories of Invasiveness in Animal Experiments, and (4) Social and Behavioral Requirements of Experimental Animals. The CCAC guide covers a wide range of topics from veterinary care to the social and behavioral requirements of experimental animals.

Assessment Panel Selection

The assessment visit is a key component of the CCAC program and assessment panel members assure that the program is applied fairly and consistently throughout Canada. Panel members are selected from institutions and animal welfare associations across the country. The spokesperson for each panel will have previously served on a number of assessment panels, but as a general rule, the Director and Associate Director of Assessments select panel members from a wide pool of volunteers. In this way, the program is subjected to a large cross section of researchers, administrators, and public representatives. Panel selection also involves inclusion of members who have a particular expertise in the assessed institution's area of research. Assessment panels can offer pertinent advice while at the same time assuring that the interpretation and application of CCAC's mandate comes under the scrutiny of a competent group of experts.

Visit Preparation

Prior to each assessment visit, the CCAC requests and receives pre-assessment documentation pertaining to the institution's (1) administration of animal care program; (2) animal care personnel; (3) space allocation and location of animal housing and use; (4) animal care procedures; (5) veterinary care; (6) statistics on annual animal use; (7) ongoing research and teaching protocols; and (8) occupational health and safety program.

Most assessments begin with a meeting with the ACC and senior administrative personnel. All areas that house or hold animals are visited, as are all areas in which procedures on animals are performed, such as surgical suites and laboratory testing areas.

An integral part of the assessment visit is the summary meeting, where institutional representatives and ACC members can introduce any topic for discussion. This meeting has also become a forum for an exchange of views on animal care and use during which the panel summarizes its findings and relays items of immediate concern to its ACC and institutional representatives. Panel members often use their experience with other institutions to suggest possible solutions to concerns raised at the summary meeting. Participants are encouraged to bring any animal care related concern to the attention of panel members during this meeting for discussion.

A subsequent in-depth report containing recommendations, prepared by the panel, is aimed at helping the institution to improve its animal care practices and facilities to a standard in keeping with the guidelines laid down by the CCAC. These reports are circulated to the members of the CCAC's Assessment Standing Committee (which reviews all assessment reports to ensure continuity) prior to being forwarded to the senior administrative official of the institution.

In response to the panel's report, the institution is required to submit to the CCAC within 6 months, a report describing how it proposes to implement the report's recommendations. Should this implementation report be considered unsatisfactory, the CCAC may instruct its secretariat to determine the reasons for noncompliance and to take such further actions as deemed necessary. For example, the CCAC notifies the MRC and NSERC of any institution that is in noncompliance with CCAC standards and has not responded satisfactorily within the time given to correct the situation. NSERC and MRC hold powerful enforcement options. On receipt of a statement of noncompliance and after reviewing the full evidence, the granting agencies reserve the right, either separately or together, to bring their concerns to the appropriate authorities in the research institution and, if they deem it necessary, to implement such financial or other sanctions as may be in the power of either research council. Such sanctions may include the freezing or withdrawal of research funds.

APPLICABILITY

When carrying out assessments of the various animal facilities, assessment panels focus on five main areas:

1. The functioning of the animal care committee. In particular, assessment panels look for appropriate membership, the quality of the ACC's documentation, the interaction with animal care personnel and investigators, and the ethical review process for scientific protocols. Animal care committees are also required to make sure that standard operating procedures are developed for routine techniques, and to put in place a crisis management program to cope with situations such as fire, electrical failure, and threats to facilities.
2. The animal holding facilities. An assessment is made of the state of the infrastructure and its maintenance, and also of the day-to-day operational management of the facilities.
3. The animal care and management practice. This includes examining the state, size, and appropriateness of the caging; the cleaning and feeding schedules; and the provision of environmental enrichment.
4. Veterinarypractices. In particular assessments are made of the use of anesthetics and analgesics; effectiveness of health monitoring programs; and interaction between the animal care staff, the veterinarian, and the investigator.
5. The provision of continuing education and training .for animal care staff and investigators.

The CCAC assessment program is aimed at the institutional level. Failure to comply with the requirements of the CCAC can result in the institution being placed in a state of "noncompliance" if severe deficiencies are found in any of the above categories. Potentially, an investigator who refuses to comply with CCAC guidelines could jeopardize the status of the institution.

ADMINISTRATIVE METHODS AND THEIR COSTS

Institutional ACCs were introduced in 1968 to administer the CCAC program at the local level, and are now embodied in American legislation and have been introduced in other countries. The ACC must function under terms of reference that describe its membership (at least one person must represent the community's interests and concerns), its authority (the ACC must be able to terminate any procedure if it considers that unnecessary pain is being experienced by the animal), its responsibilities, and its meetings (such as for protocol review and site visits).

At the local level the program cost is defrayed by the institution. In some instances, institutions charge a per diem for housing animals. This money, drawn from the investigators' budgets, covers animal care costs, including space, veterinary care, and other animal care items.

STRENGTHS AND WEAKNESSES

The CCAC program has helped to improve animal care in Canada since its inception 25 years ago. The program unites researchers with animal welfare societies in the common goal of promoting the concept of the 3Rs of Russell and Butch (1959). As the concepts of replacement, refinement, and reduction of the scientific use of animals are difficult to encourage through legislation, the CCAC program succeeds where the legislative approach fails. ACCs are mandated in their terms of reference to question all aspects of animal use, including whether animals should be used, whether protocols can be refined to minimize suffering, whether the number of animals used can be reduced, and whether there are any viable alternatives to the use of animals.

One of the most powerful attributes of the CCAC program, which is not evident in legislative strategies, is the in-depth review of all research protocols as part of the assessment process. Assessment panels not only examine every protocol, but they also evaluate the institutional process that led to protocol approval. Lack of, or the ineffective operation of such a process leads to a critical recommendation in the assessment report.

Another important aspect of the CCAC program is the promotion of the social and behavioral welfare requirements of animals in institutions. Through its newsletter, conferences, workshops, and discussions during assessment visits, the CCAC promotes the improvement of animal care through environmental enrichment. This field is constantly changing, and the CCAC disseminates information among institutions as researchers, technicians, and veterinarians all find new ways to improve the daily lives of animals. These types of improvements in animal care would be very difficult to achieve through legislation.

Through its program of peer review, the CCAC is able to identify the successes or failures of an institution's animal care program. Whether weaknesses are due to the administration's failure to allocate adequate funding, a lack of veterinary care, or the improper functioning of an animal care committee, the CCAC assessment panel is able to target a deficient area in its report.

Although assessment panels are generally considered to be one of the programs strongest assets, they can also be considered to be one of the program's weaknesses. Panel members are volunteers, and as such must be drawn from a large pool of potential candidates. The size of the pool allows for inconsistencies between reports. To overcome this, the CCAC Assessment Standing Committee reviews all reports so that oversights can be corrected, inconsistencies eliminated, and recommendations strengthened. To ensure continuity, one of two CCAC staff laboratory animal veterinarians participates in each assessment.

Another drawback to using volunteers on the assessment panel is that members must fit their CCAC duties into otherwise busy schedules, which can delay the production of final reports. To avoid delay in implementation of important animal care issues, a summary of the most serious recommendations is sent to the institution prior to completion of the assessment report.

THE FUTURE

Through continual contact with the animal welfare community and member institutions, the CCAC system will continue to evolve. Initially, emphasis was placed on animal research facilities and infrastructure deficiencies. As new facilities are built and older ones improved, the emphasis has shifted to ensuring that the ACC is strong and functional. Future directions will include further emphasis on enrichment strategies, alternatives, and education.

REFERENCES

Canadian Council on Animal Care (CCAC). 1984. Guide to the Care and Use of Experimental Animals, Volume 1. Ottawa, Ontario, Canada: CCAC. (Available from CCAC, 315-350 Albert, Ottawa, ON KIR IBI, Canada. Tel: 613-238-4031; Fax: 613-238-2837; E-mail: ccac@carleton.ca)

Canadian Council on Animal Care. 1995. Guide to the Care and Use of Experimental Animals, Volume 2. Ottawa, Ontario, Canada: CCAC. (Available from CCAC, 315-350 Albert, Ottawa, ON K I R I B I, Canada. Tel: 613 238 4031; Fax: 613-238-2837: E-mail: ccac@carleton.ca)

Russell, W. M. S., and R. L. Burch. 1959. The Principles of Humane Experimental Technique (Special Edition). Herts, England: Universities Federation for Animal Welfare.