Ch. 13— Federal Regulation of Animal Use • 295 
AGENCY GUIDELINES AND ACTIVITIES 
Besides providing general assurances to USDA 
that intramural research activities involving warm- 
blooded animals meet the general requirements 
of the Animal Welfare Act, various Federal agen- 
cies have adopted general animal use guidelines 
or have taken steps to review relevant intramural 
and extramural policies. Most policies are confined 
to measures governing humane care and treatment 
of animals in testing and research— establishment 
of standards, review, and enforcement. Some pol- 
icies mention the actual conduct of experimen- 
tation. 
The Public Health Service Policy 
Pursuant to a delegation of authority from the 
Secretary of the Department of Health and Human 
Services (DHHS), NIH is responsible for implement- 
ing the Public Health Service Policy on Humane 
Care and Use of Laboratory Animals by Awardee 
Institutions (PHS Manual, chs. 1 through 43). Each 
institution that receives Federal support from PHS 
for research involving live vertebrate animals is 
subject to the policy, including agencies of the PHS 
itself (NIH; FDA; the Alcohol, Drug Abuse, and Men- 
tal Health Administration; the Centers for Disease 
Control; and the Health Resources and Services 
Administration). Provisions of the PHS policy, re- 
vised in 1985, are discussed in detail in chapter 
15 and the policy is reproduced in appendix C. 
Interagency Activities 
Governmentwide Standards 
Representatives from 14 Federal entities 3 in- 
volved in animal use sit on the Interagency Re- 
search Animal Committee (IRAC) formed in rec- 
ognition of the need for an interagency committee 
knowledgeable about the use, care, and welfare 
of research animals. 
3 USDA, Department of Defense, DHHS, Department of Energy, De- 
partment of State, Department of the Interior, EPA, the National Aero- 
nautics and Space Administration, the National Science Foundation, 
and the Veterans’ Administration. Components of the Public Health 
Service within DHHS that are represented on the committee include 
the Alcohol, Drug Abuse, and Mental Health Administration; the 
Centers for Disease Control; FDA; NIH; and the Office of Interna- 
tional Health. 
Staffed and sponsored by NIH, IRAC was estab- 
lished by the Assistant Secretary of Health in 1 983 
as an outgrowth of the Interagency Primate Steer- 
ing Committee that had been established within 
NIH in 1974 to assure both short- and long-term 
supplies of primates critical to biomedical research, 
testing, and vaccine development programs (48). 
Along with regular meetings to discuss current 
issues and needs, the Committee has undertaken 
two principal projects to date: serving in an advi- 
sory capacity to U.S. observers to the Council of 
Europe, which considered a draft convention on 
laboratory -animal use (see app . E), and writing the 
"Principles for the Utilization and Care of Ver- 
tebrate Animals Used in Testing, Research, and 
Training” (see box A). Developed and issued at the 
request of the Executive Office of Science and Tech- 
nology Policy, the principles are intended to serve 
as a model for Federal agencies developing spe- 
cific policies on the use of animals . The IRAC prin- 
ciples incorporate nine distinct injunctions on 
proper care and treatment of research animals, 
based primarily on similar principles promulgated 
by the Council for International Organizations of 
Medical Science (see app. E). 
These statements on establishment, review, and 
enforcement of standards of humane care and 
treatment are part of the NIH Guide for the Care 
and Use of Laboratory Animals and are explicitly 
endorsed in the PHS Policy on Humane Care and 
Use of Laboratory Animals by Awardee Institu- 
tions (47). 
Memorandum of Understanding 
In 1983, APHIS, NIH, and FDA executed a Memo- 
randum of Understanding and agreed to exchange 
information on animal welfare concerns and com- 
pliance with policies. Each has appointed liaison 
officers to serve on a standing committee to meet 
at least annually. Specifically, APHIS, NIH, and FDA 
have agreed to: 
• share information contained in the registry/ 
inventory /listing of establishments that fall un- 
der the purview of each; 
• send to one another, each quarter, a listing 
of establishments that have been inspected 
