Appendix B 
Regulation of Animal Use Within 
Federal Departments and Agencies 
Six Federal departments and four Federal agencies 
conduct animal experimentation within Federal facil- 
ities, or "intramurally Of those, only the Departments 
of Commerce and Transportation, which use few ani- 
mals, have no specific guidelines. A seventh Federal 
department, the Department of Energy (DOE), conducts 
no intramural animal experimentation, but has a pol- 
icy on animal experimentation for its extramural con- 
tracted work. The other entities all have some type of 
policy for intramural use of animals. 
Effective December 1986, each Federal research fa- 
cility will be required to establish an animal care and 
use committee with composition and function as de- 
scribed in the 1985 amendments to the Animal Welfare 
Act (see ch. 13). Each Federal committee will report 
to the head of the Federal entity conducting the animal 
experimentation . 
Several generalizations can be drawn about the guide- 
lines of the Federal entities conducting intramural ani- 
mal experimentation. Most policies on proper animal 
care and treatment include: 
• adherence to the Animal Welfare Act and to the 
Guide for the Care and Use ofLabora tory Animals 
of the National Institutes of Health (NIH) (26) as well 
as the Public Health Service (PHS) Policy on Hu- 
mane Care and Use of Laboratory Animals by 
Awardee Institutions (see app. C); 
• an animal care and use committee with at least 
three members (the attending veterinarian and two 
scientists within the agency); 
• an attending veterinarian responsible for maintain- 
ing the proper animal care standards; 
• some prior review of protocols and animal species 
use, usually accomplished by an animal care and 
use committee; 
• no real mechanism for enforcement of the policy, 
with the primary responsibility for maintaining the 
proper standards and adhering to agency guide- 
lines lying with the individual investigator; 
• a minimal number of site inspections and no real 
oversight mechanism; and 
• a policy calling for using as few animals as possi- 
ble and encouraging the use of alternative meth- 
ods wherever feasible. 
Some agency policies are noteworthy for additional 
provisions intended to promote high standards of ani- 
mal care and use: 
• NIH requires all animal research committees to in- 
clude one member sensitive to bioethical issues and 
not employed in the same NIH bureau, institute, 
or division. This person must be a Federal Govern- 
ment employee and so may or may not be a lay- 
person. These committees have explicit responsi- 
bilities and a detailed administrative structure in 
which to carry out duties. 
• The Ames Research Center of the National Aero- 
nautics and Space Administration (NASA) has dem- 
onstrated the successful participation of lay com- 
mittee members in the consideration of animal 
welfare issues: 40 percent of the committee are 
laypeople, a format set up at NASA’s instigation. 
• Since 1971, the Veterans’ Administration (VA) has 
required that all facilities using animals seek and ob- 
tain accreditation by the American Association for 
Accreditation of Laboratory Animal Care (AAALAC). 
The VA has a contract with AAALAC covering all 
its research facilities, thus prohibiting failure of 
accreditation of any constituent facility solely for 
financial reasons. The Department of Energy also 
requires the facilities of its extramural contractors 
to be AAALAC -accredited. 
• The Department of Defense (DOD) has a policy and 
committee distinct from its general animal policy 
to ensure proper care and use of nonhuman primates. 
• The policies at the Food and Drug Administration 
(FDA) and the Department of the Interior give a 
great deal of flexibility to the research centers to 
allow specific policies tailored to the needs and de- 
mands of each animal facility. Although this may 
have many advantages, it may make the mainte- 
nance and monitoring of a standard of care through- 
out the agency difficult. 
Department of Agriculture 
Regulation of animal use in research within the U.S. 
Department of Agriculture (USDA) involves adherence 
to the Animal Welfare Act and to the NIH Guide (26). 
Much of the animal research performed by USDA in- 
volves farm animals, which are largely excluded from 
these policies. The system of compliance involves peri- 
odic checking of intramural research facilities. For ex- 
tramural research, no enforcement occurs; hence the 
system is largely voluntary and self-regulating (15). 
Department of Defense 
The general policy on animal use in all Department 
of Defense programs is contained in DOD Directive No. 
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