Spring Issue 2006

Animals in Research Special Session Draws Large Crowd at Annual Meeting

The Animals in Research Committee sponsored a Special Session, “Using Animals for Toxicological Research and Testing: Best Practices for Assuring Compliance with Animal Welfare Regulations, Policies, and Guidelines,” during the 2006 SOT Annual Meeting. By all indicators, this March 6 session was a huge success. Co-chairs Jan Oberdoerster, Ph.D., and William S. Stokes, D.V.M., developed an interesting and valuable session with recognized leaders in this field from the United States and Europe giving excellent presentations. The size of the audience was 150-200 throughout the program, and the session was extended 30 minutes to accommodate questions from the audience.

The workshop was organized to discuss current compliance issues and best practices for adhering to animal care and use regulations, policies, and guidelines for laboratory animals used in toxicological research and testing, and to discuss opportunities for future progress. Best practices for regulatory testing include careful consideration and appropriate incorporation of in vitro methods, humane endpoints, tiered testing strategies, and weight-of-evidence evaluations at the completion of each stage of testing (i.e., to ascertain whether sufficient information is present for determination of hazard or if additional data are needed). Adoption of these best practices helps to ensure that animals are used in the most humane and judicious manner consistent with successful attainment of research and testing objectives and helps avoid deficiencies and disruptive mandatory corrective actions.

Jodie Kulpa-Eddy, D.V.M, reviewed and discussed the most common deficiencies cited by U.S. Department of Agriculture (USDA) Animal Care Inspectors in toxicological research and testing facilities. Real-life examples of non-compliance citations were given, and the current best practices used as inspection benchmarks by the USDA were highlighted. The most common citation in toxicology facilities is for investigators not adequately addressing the requirement for the consideration of alternatives to procedures that cause more than momentary or slight pain and distress. She also noted that toxicology facilities generally had a lower frequency of non-compliance than other types of facilities, with over half of these having no citations during the past year.

In an interesting presentation, Axel Wolff, D.V.M., reviewed current compliance issues with the U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals for institutions with NIH assurances. Compliance data analysis was presented and the type of non-compliance, the types of animals involved, and the corrective actions described. NIH expectations of compliance were presented, and expected best practices for assuring compliance also were discussed.

In his presentation, John Miller, D.V.M., reviewed the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) voluntary accreditation program for animal care and use programs and facilities and identified the most common suggestions for improvement. The AAALAC accreditation process and AAALAC expectations (e.g., use of analgesics, environmental enrichment), as well as suggestions for improving site visit outcomes, were included in the presentation. Current best practices for assuring adherence to AAALAC standards were highlighted.

Clement Gauthier, Ph.D., reviewed the Canadian Council on Animal Care (CCAC) animal care and use accreditation program and the current best practices used as benchmarks for site visits. He noted that the 3Rs concept of reduction, refinement, and replacement serves as an underlying basis for all CCAC guidelines and policies. Common deficiencies and best practices for animal care and use programs and facilities were presented.

Jon Richmond, M.D., reviewed regulatory compliance issues for toxicological research and testing facilities that must comply with European Union and United Kingdom animal welfare laws and regulations. The UK has the oldest animal protection laws in the world and current regulations and policies in the UK are also considered among the strictest in the world. Current best practices for animal care and use that are expected by the Home Office and lessons learned were reviewed.

Future programs are being developed by the Animals in Research Committee with the intent to provide these sessions at the Annual Meeting on a regular basis.