Director's DiaryBy Alan M. Goldberg, Ph.D. The summer of 1995 was remarkable for the range of activities in which the Center had a direct impact on national and international discussions. In June, I was invited to be one of five speakers at CSIS/ICLAS meetings in Spain to provide background information for ICLAS (International Committee on Laboratory Animal Sciences), to help them formulate policy about alternatives and the Three Rs. The other invited speakers were Drs. Michael Balls, Herman Koeter, Maria Gomez Lechon, and Horst Spielmann. The major recommendations of this workshop were: - ICLAS should take an active role in educating its members about developments in ethics, statistics, and Three Rs alternative methods and their validation.
- More fundamental research is essential to develop new non-animal methods. A reduction in animals use can be achieved if procedures involving animals are better designed and analyzed, and if stronger scientific justification is required before animal experiments are permitted.
- New animal tests should be required to satisfy similar standards of validations as non-whole animal methods to achieve regulatory acceptance.
- Although there are countries with minimal legislation on human and animal experimentation, changing the site of animal testing to those countries in order to avoid more stringent regulations in other nations is considered to be unethical. More stringent practices should be endorsed by all ICLAS member countries.
A second important event was an invitation by the Japanese Society of Toxicology to be one of two keynote speakers at their annual meeting. Frank Sharp, Professor of Neurology at University of California, San Francisco, and I both spoke on the issue of alternatives. This was an important opportunity to meet my counterparts in Japan and to share with them the state of activities in the United States. There were other trips and important activities, including a meeting held in Sheringham UK to examine the future of the Three Rs. This small workshop, hosted by ECVAM and co-organized by Dr. Michael Balls and me, will be the topic of a future newsletter. This meeting will clearly be a stimulus to more active pursuit of the Three Rs by the scientific community. At home, we have been busy pushing the frontiers of validation. Shortly after the CAAT symposium, we held a meeting of the CAAT Validation Committee to disucss recent international developments in validation activities and the role CAAT should play in continuing attempts to validate alternative methodologies. At the beginning of the meeting I summarized activities planned for 1995-1996 by COLIPA, ICCVAM, OECD, and IRAG (see Director's Diary, Summer 1995 newsletter). Stephen Gettings, Ph.D., Director for Toxicology, CTFA, discussed the November 1995 symposium planned by CTFA's European counterpart, COLIPA, to educate administrators and legislative staff in the European Union on global issues related to validation and progress toward development of alternative methods. Daniel Bagley, Ph.D., Senior Section Head, Toxicology, Colgate-Palmolive, reviewed the COLIPA validation program. William Stokes, D.V.M., Associate Director for Animal and Alternative Resources, Environmental Toxicology Program, National Institute of Environmental Health Sciences, informed the group about the NIEHS response to the NIH Revitalization Act of 1993, their implementation plan and the activities of ICCVAM. Janis Demetrulis, Ph.D., Advanced Tissue Sciences, presented the global ATS validation study for irritant dermatitis. Ari Epstein, Ph.D., assistant professor, Johns Hopkins University Bloomberg School of Public Health, provided an overview of his statistical approach to assess the degree of agreement between in vitro assays and various standards. Participants then discussed the nature of CAAT's role in the validation process. Suggestions included CAAT acting as a clearinghouse for information on validation, CAAT creating a validation database, CAAT working to educate scientists and the public on validation issues and the Three Rs, and CAAT continuing to act as an independent voice. The next meeting of the validation committee will be held in February 1996, after the November meeting of the OECD's working group on harmonization of validation criteria. It was a busy and productive summer for CAAT. | 
