University of Wisconsin-Madison

The Rules We Live By

Animal Welfare Act (AWA)

• originally passed in 1966, with further amendments in 1970, 1976, 1985, and 1990
• regulatory authority delegated to the Secretary of the U. S. Department of Agriculture (USDA), implemented by USDA's Animal and Plant Health Inspection Service (APHIS), and enforced by the Regulatory Enforcement and Animal Care Division (REAC)
• species covered-- all warm-blooded vertebrate animals used for research except: farm animals used in food and fiber research
• sets standards for animal transportation, husbandry practices, record-keeping, animal acquisition, animal identification, environmental enrichment, exercise requirements
• requires research institutions to submit to unannounced inspections by USDA Veterinary Medical Officers (VMOs) and file annual reports listing the species and numbers of animals used in research
• mandates the formation of an Institutional Animal Care and Use Committee (IACUC) for each research institution, which reviews and approves all proposed uses of animals in research
• requires the IACUC to review and investigate complaints and reports of noncompliance involving the care and use of animals at the research facility ("whistle-blower")
• copies of the AWA, and its associated regulations and policies promulgated by USDA are available online at www.aphis.usda.gov/ac/awa.html, or hard copies are available in the RARC office
• rules to cover the recent inclusion of mice, rats and birds under the AWA are under development

Health Research Extension Act

• passed in 1985, written to protect vertebrate animals used in research funded by the Public Health Service (PHS) and now used by most federal granting agencies and many private funding agencies
• full text available at: http://grants.nih.gov/grants/olaw/references/hrea1985.htm
• regulatory authority is delegated to the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW)--formerly known as the Office for the Prevention of Research Risk (OPRR)
• oversight is provided by the IACUC, which in turn is responsible to the Institutional Official. The Institutional Official has the authority to sign the institution's assurance, making a commitment on behalf of the institution that the requirements of PHS Policy will be met. The Institutional Official provides assurances on file with OLAW that the institution is in compliance with PHS policy (chain of command for animal use responsibility is available in Appendix)
• species covered---all vertebrate animals (including rats, mice, and birds)
• PHS policy for animal care and use is described in the Guide for the Care and Use of Laboratory Animals (usually referred to as the Guide); the entire text is available on the RARC website (www.rarc.wisc.edu). The entire text of the PHS Policy can be found at: http://grants.nih.gov/grants/olaw/references/phspol.htm

Wildlife Research

• a multitude of state and federal regulations apply to the use of wildlife in research, both in the laboratory and in the field
  • USDA
  • Wisconsin State Department of Agriculture
  • Wisconsin Department of Natural Resources (DNR)
  • US Department of the Interior
• researcher is responsible for the acquisition and updates of the appropriate permits for the use of wildlife in research. Sometimes these take a long time to get, so plan ahead

Others…

• Occupational Health and Safety Administration (OSHA)
  • Material Safety Data Sheets (MSDS) postings
  • ether (and other volatile anesthetics) must be used under a fume hood
• Good Laboratory Practices (GLP)--if doing research to license chemicals or drugs under the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA).
  • sometimes necessary if work is supported by industry
  • stringent and complex, with LOTS of record-keeping involved
  • not very common at UW-Madison, since these types of studies are not usually considered "basic science"