4a. Rules, policies, and guidelines

The current rules, policies, and professional guidelines for the responsible use of animals in research are the product of roughly 50 years of ongoing discussion between government, the public, animal care professionals, and researchers. The conclusions reached through thesediscussions are laid out in two key sources of informationfor researchers who use animals in their work: Federal regulations and professional guidelines.

     Federal regulations. Over the last 50 years, Congress has addressed the responsible use of animals in research on a number of occasions and drafted two important statutes:

• the 1966 Animal Welfare Act (revised 1970, 1976, 1985, and 1990) and
• the 1985 Health Research Extension Act, Sec. 495.

The former broadly assigns authority for the responsible transportation, care, and use of animals to the United States Department of Agriculture (USDA), as implemented by Title 9 of the Code of Federal Regulations. It covers animals used “in research facilities or for exhibition purposes or for use as pets.” The latter law delegates authority for the responsible use of animals in “biomedical and behavioral research” to the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH) and the Office of Laboratory Animal Welfare (OLAW), NIH.

Researchers who use animals in research, including observational research, or teaching, can come under the jurisdiction of the USDA animal welfare regulations and/or the PHS Policy on Humane Care and Use of Laboratory Animals (hereafter, PHS Policy), which carries out the provisions of the 1985 Health Research Extension Act. They therefore should be familiar with both.

Guidelines. In the late 1950’s, a group of animal-care professionals formed the “Animal Care Panel” (ACP) specifically for the purpose of establishing a professional standard for laboratory animal care and facilities. Their work led to the publication of a comprehensive and influential Guide for Laboratory Animal Facilities and Care (1963, revised 1965, 1968, 1972, 1978, 1985, and 1996). The current edition, now called the Guide for the Care and Use of Laboratory Animals, or Guide, as it is commonly referenced, was prepared by a committee appointed by the National Research Council of the National Academy of Sciences and provides guidance on:

• Institutional Policies and Responsibilities;
• Animal Environment, Housing, and Management;
• Veterinary Medical Care; and
• Physical Plant.

The Guide is widely accepted by both government and research institutions as the most authoritative source ofinformation on most animal care and use questions. The PHS Policy requires that PHS-funded institutions use the Guide as a basis for developing and implementing an institutional program for animal care and use.