CAAT Newsletter: Vol. 14, No. 3, Summer 1997

SGOMSEC - Alternative Testing Methodologies

By Bernard D. Goldstein, M.D.

The 13^th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals (SGOMSEC) was held in Ispra, Italy January 26-31, 1997 on the subject of "Alternative Testing Methodologies." The host of the meeting was the European Centre for the Validation of Alternative Methodology (ECVAM), under the direction of Dr. Michael Balls. The co-chairs were Dr. Ermino Marafante of ECVAM and Dr. William Stokes of the U.S. National Institute of Environmental Health Sciences. The meeting was supported by the U.S. National Institute of Environmental Health, the European Center for the Validation of Alternative Methodology, the European Economic Community, the Scientific Committee on Problems of the Environment, the U.S. Environmental Protection Agency and the U.S. Food and Drug Administration.

SGOMSEC is an interesting organization. Designed primarily by the late Dr. Norton Nelson, founder of the Institute of Environmental Medicine at New York University, it reports to the Scientific Committee on Problems of the Environment, which is headquartered in Paris, and is part of the International Council of Scientific Unions (ICSU), and to the International Program on Chemical Safety (established within WHO with the cooperation of UNEP and ILO). The focus of SGOMSEC is solely on methodology, including methods appropriate for use in less developed countries. Attendees are about 20 invited experts in the specific workshop field, and members of SGOMSEC who are approximately a dozen senior scientists from throughout the world. The goal of SGOMSEC is to provide authoritative reviews of methodological approaches and issues. Meetings on specific subjects are held every year or two.

To those of us who are SGOMSEC members, each workshop has been a remarkable learning experience. We sit with experts in the field during an intense week-long effort focused not on formal presentations but rather on discussions of significant aspects of the methodology in the field and the translation of this discussion into a succinct workshop document. Our job as generalists is to listen carefully, ask questions, and keep the participants to the goal of distilling their collective wisdom about methods into the working document.

The SGOMSEC Meeting on Alternative Testing Methodologies was notable for an interesting perceptual gap that developed between many of the SGOMSEC members, including myself and the invited experts. We in SGOMSEC were impressed at how rapidly the field was moving and at how many new and highly promising assays were under development or ready to be validated. We viewed the work of researchers in this field to be highly successful on two grounds: in their search for new and valid approaches, researchers on alternative methods had clearly advanced the field of biological science and could take much pride in the quality and quantity of their scientific activities; secondly, there is no question that through their efforts there had been a substantial reduction, refinement and replacement of animals in tests aimed at protecting public health and the environment. Our impression, however, is that the scientists in this field thought they were less successful than we did.

Of course, there are frustrations for those working in this area. There is no question that resource limitations affect the rate of successful development and validation of alternative methodologies. Exciting new advances in biology in general, and molecular techniques in particular, provide much promise for the future; but these advances are occurring so rapidly there are not enough resources or people to take full advantage. As emphasized by the participants at the SGOMSEC workshop, understanding biological mechanisms is the driving force in developing valid alternative methodologies. Scientists in the field should take much pride in contributing to this driving force and in moving the vector of this force toward the directions of reduction, refinement, and replacement of animal tests. The gap between scientific expectations and effective development of new alternative methodologies certainly is not a reflection on the skill of scientists involved.

The report of the SGOMSEC meeting is in final preparation. It is expected to appear in an issue of Environmental Health Perspectives in less than one year. The workshop report is organized under four headings: Conceptual Issues, Acute Toxicity, Systemic/Organ Toxicity and Ecosystems. Along with the workshop report, the review papers prepared by the invited attendees on a wide range of subjects pertinent to the workshop will also be included after suitable peer review. The final document should provide a series of useful overviews of alternative methodologies as well as distillation of the wisdom and judgment of the attendees.

Dr. Goldstein is director, Environmental and Occupational Health Sciences Institute (EOHSI), at UMDNJ - Robert Wood Johnson Medical School, Piscataway, N.J.