Ch. 15— Institutional and Self-Regulation of Animal Use • 337 
i protocol as before , visits were made to a stratified 
sample of institutions without AAALAC accredita- 
tion during the months of July and August 1984. 
The site-visit teams consisted of a representative 
of the NIH Office of Extramural Research and 
Training; a scientist or administrator from OPRR, 
and two non-Federal consultants (a veterinarian 
experienced in laboratory -animal medicine and a 
biomedical scientist currently conducting research 
requiring laboratory animals) (44). 
The conclusions following these additional visits 
are almost identical to the earlier ones. The teams 
noted that the small institutions were capable of 
both meeting the responsibilities of the 1979 PHS 
policy and assuming additional responsibilities in 
response to changes made in the 1985 PHS policy. 
The site visitors did find; however; that these in- 
stitutions needed to improve the advisory and over- 
sight roles of their institutional animal care and 
use committees (IACUCs) and upgrade their veteri- 
nary oversight (44). 
Public Health Service Policy 
In mid-1985; the Department of Health and Hu- 
man Services (DHHS) released its new PHS Policy 
on Humane Care and Use of Laboratory Animals 
by Awardee Institutions (44) to replace the 1979 
PHS Extramural Animal Welfare Policy (41). (For 
the full text of the new policy; see app. C.) This 
new policy is a result of the proposed PHS policy 
(43); the conclusions from the 15 site visits to ani- 
mal care facilities by NIH ; and 340 written and oral 
comments on the proposed policy. It took effect 
December 31, 1985, for all potential grantees of 
PHS wishing to use animals in experimentation. 
This policy has many of the same features as 
the 1979 version. It applies to all PHS-supported 
activities involving animals in the United States. 
Animal is defined as “any live, vertebrate animal 
used or intended for use in research, research 
training, experimentation or biological testing or 
for related purposes.” The Public Health Service 
includes the Alcohol, Drug Abuse, and Mental 
Health Administration; the Centers for Disease 
Control; the Food and Drug Administration; the 
Health Resources and Services Administration; and 
the National Institutes of Health. The policy relies 
on the NIH Guide for the Care and Use of Labora- 
tory Animals for the standards for animal care and 
treatment. Finally, the PHS policy is based on a 
set of overall principles governing animal experi- 
mentation. The 1979 policy was based on 12 prin- 
ciples on the use of animals. The new policy im- 
plements and supplements the "Principles for the 
Utilization and Care of Vertebrate Animals Used 
in Testing, Research, and Training” (50 FR 20864) 
prepared by the U.S. Interagency Research Ani- 
mal Committee (see ch. 13, box A). The principles 
contained in these two documents are very similar. 
Two major requirements form the core of the 
PHS policy— the institutional animal welfare assur- 
ance to NIH and an institutional animal care and 
use committee. Each institution wishing to obtain 
PHS funding for a research project involving ani- 
mals must have on file with NIH's Office for Pro- 
tection from Research Risks a written assurance 
setting forth compliance with this policy. The as- 
surance must describe in detail the institution’s 
program for the care and use of animals in PHS- 
supported activities including; 
• a list of every branch and major component 
of the institution; 
• the lines of authority and responsibility for 
administering the program (each institution 
must identify an official who is ultimately re- 
sponsible for the institution's animal program); 
• the qualifications , authority , and responsibility 
of the veterinarian who will participate in the 
program; 
• the membership list of the IACUC; 
• the procedures that the IACUC will follow to 
implement this policy; 
• the health-care practices for personnel who 
work with laboratory animals or their facil- 
ities; and 
• the gross square footage of each animal facil- 
ity (including satellite facilities), the species 
housed therein, and the average daily inven- 
tory, by species, of animals in each facility. 
In addition, each assurance must categorize the 
evaluation of its program and facilities as either 
accredited by AAALAC or as evaluated by the in- 
stitution itself. The second category requires that 
the IACUC assess its own program every year and 
maintain records on the nature and extent of the 
institution’s adherence to the NIH Guide and the 
PHS policy. This report must also contain justifi- 
