Johns Hopkins Bloomberg School of Public HealthCAAT

CAAT Newsletter: Vol. 14, No. 1, Fall 1996

Conference Highlights

By Rebecca Freeman

Scientists Center for Animal Welfare

Animal Welfare and Toxicity/Safety Studies: Current Issues and Trends
June 10-11, 1996

The Scientists' Center for Animal Welfare (SCAW) is an organization that fosters discussion and seeks solutions. SCAW provides a forum for voicing a variety of opinions and encourages the exchange of information about animal well-being, based on scientific data and observation. The Center promotes discussion and education about the issues surrounding animal use. SCAW held its national conference on on "Animal Welfare and Toxicity/Safety Studies: Current Issues and Trends for the Next Century" on June 10-11, 1996 in Baltimore. At the conference, experts in toxicology, safety assessment, the animal welfare regulatory environment, ethics and statistics among others, presented information about animal well-being and toxicology and safety studies.

The first day's presentations and panel discussions centered on international guidelines and/or regulations related to animal use in toxicity and safety studies. The second day of the conference focused on risk assessment, quality assurance and ethical considerations in toxicology and safety studies as well as future trends for consumer product and safety testing. Lilly-Marlene Russow, Ph.D., an Associate Professor of Philosophy at Purdue University, began the day with a presentation entitled "Where do Ethical Considerations Begin?" Dr. Russow pointed out that safety studies deal with risk to humans, not to animals. "We weigh risks versus gains, but we have to decide what counts as a risk and what counts as a gain," she said. As an ethical framework, Dr. Russow offered "the four C's." When weighing the risks and gains of animal use scientists should ensure that their values are consistent, clear, coherent and complete, she said.

Following a discussion of Dr. Russow's presentation, Michael F.W. Festing, Ph.D., CStat, MRC Toxicology Unit at the University of Leicester, presented an overview of the importance of variation and experimental design. Using statistician Dr. W. Edwards Demmings management philosophy as a starting point, which emphasizes process rather than results, Festing discussed the importance of an all-embracing concept of quality and an understanding of variation. Festing suggested that "more education in experimental design and laboratory animal genetics would probably soon pay for itself in terms of better experiments and the use of fewer resources, including animals."

Jerrold Tannebaum, M.A., J.D., Tufts Center for Animals and Public Policy, spoke about risk and potential gain assessment. Tannebaum pointed out that the field of risk analysis currently isn't prepared to deal with animals as subjects of risk, but if we include animals in the risk assessment, how should animal and human interests be balanced in toxicity and safety studies? Tannebaum sees this issue becoming increasingly important as the public appears less willing to accept animal testing for certain purposes.

Lewis B. Kinter, Ph.D., discussed issues surrounding safety pharmacology and harmonization. Dr. Kinter emphasized the need to review international animal welfare regulations and define internationally acceptable criteria to justify the use of painful procedures and animal suffering. Possibly the most disturbing point Kinter raised was that when research is conducted by contract outside the U.S., the research and testing is not bound by the Animal Welfare Act, but rather the laws of the country where the research takes place.

After an introduction about alternative methods, Alan M. Goldberg, Ph.D., director of the Center for Alternatives to Animal Testing, spoke about future trends in alternatives to animal use in toxicology and safety studies. Dr. Goldberg pointed out that in vitro studies are faster, cheaper, use less animals in the long run and have an added value. Bringing the participants up to date, Goldberg reviewed the current status of the European Cosmetic Legislation. As the legislation currently stands, no cosmetic can be sold in Europe if the finished product or ingredients have been tested on an animal after 1998. Opening the discussion to the audience, Goldberg asked how scientists can help other scientists implement the 3Rs. Although many points were raised, the general feeling of the discussion centered around the need for continued dialogue among scientists about the 3Rs and international harmonization.

The SCAW conference demonstrated the compassion and interest of the research community in ensuring the well-being of animals. The participants aimed to find a balance between animal and human interests, seeing humane treatment as compatible with scientific research and testing. SCAW's next conference, on genetic research, will be held in conjunction with the Academy of Surgical Research, Chicago, Illinois, September 5-6, 1996.

Ms. Freeman is a graduate student in public policy at the Johns Hopkins University.

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