Statement of Ethical Principles for the Care and Use of Animals in Biotechnology Research

Preamble

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

Research involving animals has been critical to understanding the fundamental processes of human biology that are so integral to modern medicine. Biotechnology companies have depended on this research to develop more than 160 drugs and vaccines approved by the U.S. Food and Drug Administration, helping 325 million people worldwide and preventing incalculable human suffering. There are now a number of research techniques involving animals, which hold great promise for aiding humanity. However, many serious diseases such as AIDS, Alzheimer's Disease, Parkinson's Disease, hepatitis, cancer, cardiovascular diseases, and diabetes, are still poorly understood and treated. Therefore, new and more effective therapies and diagnostics are desperately needed to improve the lives of patients.

BIO members are compelled by ethical and legal concerns to evaluate the safety and efficacy of potential medicines and food products before they are given to humans and animals; the use of animals in research is a requirement for many such products. The appropriate and responsible use of animals is therefore an indispensable part of biomedical and agricultural research. BIO members are committed to act ethically and to apply high standards of care when using animals in scientific procedures.

BIO members are committed to reducing the number of animals used for research when it is possible to develop, validate and use alternative methodologies consistent with regulatory requirements for testing, while maintaining the scientific integrity of the research. BIO affirms and upholds the science-based regulation and oversight of animal research by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Fish and Wildlife Service (FWS) and other local agencies. Furthermore, BIO members abide by the regulatory requirements of all other countries in which they conduct animal research. In addition to complying with mandatory government regulations, many BIO members welcome external unbiased agencies, such as the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International), to evaluate their facilities, provide feedback on programs, and accredit their work.

Scientists are developing transgenic animals to provide solutions for disease treatment. Recombinant DNA technologies are providing excellent animal models for studying genetic diseases, the process of aging, and cancer. These technologies will lead to the discovery of drugs and other forms of therapy, such as gene and cell therapy.

Animal research has also been critical to the development of 110 biotechnology-derived veterinary biologics and vaccines approved by the USDA to improve the health of livestock, poultry and companion animals. Genomics, transgenics, and cloning technologies provide new approaches for advancing the quality and efficiency of the production of meat, milk, and eggs and reducing the environmental impact of agriculture. These technologies are also being used to help preserve endangered species.

The ability to conduct humane and responsible animal-based research must be preserved to help conquer disease, alleviate suffering, and improve quality of life. BIO believes that such use is a privilege, imposing a responsibility to provide proper care and humane treatment in accordance with the following principles:

Principles

1. Humane Treatment of Animals BIO members are committed to improving the quality of human and animal life with biotechnology, while taking responsibility for respecting the animals that support their research and for treating those animals humanely.
2. Judicious Use of Animals BIO is committed to the judicious use of animals in biotechnology research for experimental purposes. Alternative methodologies that reduce the number of animals used for research, replace animal experiments with non-animal methods when possible, and refine the use of animals in research (such as using cell and tissue cultures and computer modeling in early screening of the toxic potential of a substance) should be used whenever possible. Biotechnology offers great promise for further reducing use of animals in research.
3. High Standards of Care High standards of care should be maintained for animals used in biotechnology research as published by the Institute for Laboratory Animal Research, Commission on Life Sciences, National Research Council (The Guide for the Care and Use of Laboratory Animals, 7th ed.,1996) and the Federation of Animal Science Societies (The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, 1999). Animals must be properly housed, fed and kept in surroundings appropriate to their species. BIO is committed to the minimization of discomfort, distress, and pain consistent with sound scientific practices. Investigators and personnel shall be appropriately qualified for and experienced in conducting procedures on animals and in the husbandry and handling of the species being studied.
4. Regulatory Oversight Animal biotechnology research (including products from transgenic animals) is subject to science-based regulatory oversight by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Fish and Wildlife Service (FWS) and other local agencies. BIO will actively work with these agencies to ensure high standards of care and use for all animals involved in biotechnology research.
5. Increased Public Awareness BIO encourages increased public awareness and understanding by raising awareness of how biotechnology research involving animals is being applied in human health, animal health, agricultural, industrial and environmental areas.
6. Open Discussion of Ethical Considerations BIO seeks to actively and thoroughly study the ethical considerations involved in the use of animals in biotechnology, and to openly discuss these issues with ethicists, consumers, medical professionals, farmers, legislators, scientists, opinion leaders, and other interested groups.

References

NRC, 1996. The Guide for the Care and Use of Laboratory Animals, Institute for Laboratory Animal Research, National Research Council, National Academy of Sciences, http://dels.nas.edu/ilar/careanduse.asp?id=careanduse

FASS. 1999. The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, Federation of Animal Science Societies, http://www.fass.org/publications.asp