FASEBnews AUGUST 9, 2000 FEDERATION OF AMERICAN SOCIETIES FOR EXPERIMENTAL BIOLOGYOffice of Public Affairs9650 Rockville PikeBethesda, Md. 20814-3998www.faseb.org/opar

Contact: Paulette W. Campbell (301) 571-7795[email protected]

Participants at FASEB Workshop Urge USDA to Reconsider its Proposed Definition of Pain and Distress in Laboratory Animals

Bethesda, Md. -- Research scientists and experts on laboratory animal medicine are urging the U.S. Department of Agriculture (USDA) to replace its working definition of distress in laboratory animals with a definition similar to the one proposed by the National Research Council's Institute for Laboratory Animal Research (ILAR).

This was one of the conclusions of a workshop convened by the Federation of American Societies for Experimental Biology (FASEB) on August 6 and 7 at its Bethesda, Md., campus in anticipation of additional USDA rulemaking on issues related to pain and distress in laboratory animals under the Animal Welfare Act. Participants included representatives of scientific societies, individual researchers and laboratory animal veterinarians from industry, government and academia.

On July 10, the USDA's Animal and Plant Health Inspection Service (APHIS) published a Federal Register notice calling for comments on the definition and reporting of pain and distress under the Animal Welfare Act. The public has until September 8 to provide the agency with comments about the current system and possible alternatives that are under consideration, although agency officials said they would likely extend that deadline by 45 to 60 days.

APHIS plans to use these comments to decide whether to replace or modify the current classification and reporting system used by Institutional Animal Care and Use Committees (IACUCs) in reviewing research protocols. (The full text of the request is attached, and is available in PDF and HTML formats on the USDA website at http://www.aphis.usda.gov/ppd/rad/webrepor.html. It is listed as Docket #00-005-1 under the title "Animal Welfare; Definitions for and Reporting of Pain and Distress," dated 7/10/00.)

Although it was not included in the Federal Register notice, the USDA is planning to adopt, at least on an interim basis, the following as a working definition of distress: "Distress refers to a state in which an animal cannot escape from or adapt to the internal or external stressors or conditions it experiences, resulting in negative effects on its well-being."

The attendees at the FASEB workshop concluded that this definition of animal distress was too subjective to be workable. They voiced considerable support for the NRC's definition, contained in the 1992 ILAR report titled "Recognition and Alleviation of Pain and Distress in Laboratory Animals." That group defined distress as "an aversive state in which an animal is unable to adapt completed to stressors and the resulting stress and shows maladaptive behaviors."

Mary J. C. Hendrix, the president of FASEB, said it is important that the USDA develop regulations that continue to rely upon the professional judgment of laboratory animal veterinarians and scientists. Additionally, regulations should be simple in order to facilitate compliance.

"The participants at the FASEB workshop reviewed the regulatory policies governing the use of animals in research and the latest scientific information regarding the improved recognition and reduction of pain and distress in laboratory animals," Dr. Hendrix said. "Our discussions centered on how to develop an approach to pain and distress that will promote both animal welfare and research progress."

In recognition of the projected increase in the use of genetic models to study human diseases, the workshop attendees emphasized the importance of case-by-case reporting of pain and distress information based on the research protocol. In other words, transgenic animals should not automatically be classified as if they were involved in a painful procedure. Participants also agreed that recognition and reduction of pain and distress in laboratory animals could be further improved by additional training for research scientists and for the IACUCs that review every proposal for research involving animal subjects.

One of the goals of the workshop was to re-emphasize the scientific community's responsibility for good stewardship of laboratory animals at a time of expanding scientific opportunities. In 1994, FASEB adopted a Statement of Principles affirming "the essential contribution of animals in research and education aimed at improving the health of both humans and animals." According to that statement, "the use of animals in research and education is a privilege," which "imposes a major responsibility to provide for their proper care and humane treatment."

"As FASEB develops its official response to the USDA's proposal on pain and distress, the most important concern continues to be assuring the ethical treatment of animals without hampering research that will ultimately relieve suffering in humans and animals," said Dr. Hendrix. "The workshop participants all agreed that any changes proposed by the USDA should be examined carefully to determine whether they will actually improve the treatment of laboratory animals." In addition, she said, proposed changes must also be considered in light of the additional paperwork and administrative that would be generated if the USDA begins also to regulate rats, mice, and birds under the Animal Welfare Act.

FASEB is comprised of 21 societies with more than 60,000 members, making it the largest coalition of biomedical research associations in the United States. The mission of FASEB is to enhance the ability of biomedical and life scientists to improve, through their research, the health, well-being and productivity of all people. FASEB serves the interests of these scientists, particularly in those areas related to public policy. FASEB also facilitates coalition activities among Member Societies and disseminates information on biological research through scientific conferences and publications.

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