388 • Alternatives to Animal Use in Research, Testing, and Education 
The panel did note that the system of care and treat- 
ment policies was too informal and based on the cur- 
rent personnel; it was unconvinced the system would 
remain in place if staff were transferred. The Aero- 
space Medical Division of the Air Force drafted a Sup- 
plement to Army Regulation 70-18 to implement some 
of the review panel's recommendations. The most sub- 
stantial change deals with the animal care and use com- 
mittee membership (21): 
The local commander will appoint at least one lay 
person from the local community who has no direct 
Department of Defense connections to serve as a mem- 
ber of the Committee. This lay member should not be 
a veterinarian or research scientist who works with 
animals; however, a background in sciences would be 
helpful. The Committee may have permanent or ad hoc 
membership. Its specific purpose is to review all pro- 
tocols, experimental designs, or lesson plans that in- 
volve the use of animals and assure compliance with 
[DOD policy]. 
The Air Force Supplement to Army Regulation 70-18 
also requires that each organization using animals sub- 
mit not just the Annual Report of Research Facility of 
USDA’s Animal and Plant Health Inspection Service 
(APHIS), but also an Annual Animal Use Report, listing 
all species used, the inventory at the beginning of the 
year, additions and losses to the facility, the ending in- 
ventory, the utilization of the animals, the different ex- 
perimental situations, and the projected use of animals 
for the next fiscal year (18). 
Department of Energy 
The Department of Energy has no intramural re- 
search facilities and so contracts for all its research. 
The division involved with animals is the Office of 
Health and Environmental Research (OHER); programs 
involving research with animals represented less than 
15 percent of OHER’s total research budget for fiscal 
year 1985 (5). Proposals for OHER-funded research are 
subjected to outside peer review for scientific merit. An 
OHER research committee from the Office’s four divi- 
sions has final approval before funding a research 
proposal. 
The OHER policy for animal use by its extramural 
contractors places the prime responsibility for the main- 
tenance of animal facilities and for animal care on the 
contractor. OHER contract research facilities are bound 
by law to comply with the Animal Welfare Act and its 
regulatory policies, and OHER personnel maintain close 
liaison to assure such compliance . In addition, the IRAC 
principles are part of the OHER policy statement, along 
with the requirement to maintain AAALAC accredita- 
tion (5). 
To enforce these policies, one OHER staff member 
has responsibility for monitoring animal research pro- 
grams for compliance. This staff member must main- 
tain contact with the research facilities to assure ac- 
creditation and to affirm, at least yearly, that it is being 
maintained. Site visits with at least one noncontract 
veterinarian who is an expert in laboratory -animal care 
may be conducted to evaluate the care and treatment 
of experimental animals (5,6). 
Department of Health and 
Human Services 
Food and Drug Administration 
The Food and Drug Administration has recently 
played a major role in attempting to address animal 
welfare issues. In 1983, the agency took two steps in 
this direction by sponsoring an acute studies workshop 
and by establishing an Agency Steering Committee on 
Animal Welfare Issues. 
The workshop helped clarify FDA’s position on its 
need for toxicity data, especially from the LD 50 test. 
The points emerging from the workshop were that: 
• FDA had no regulations mandating use of the LD S0 
test; 
• the requirement by Federal agencies for LD S0 data 
from regulated parties was much less than per- 
ceived by the public; 
• government and industry agreed that there are bet- 
ter determinants of acute toxicity than the LD S0 
test and that they supported developing valid alter- 
natives to the use of animals for testing chemicals; 
• U.S. Government agencies are cooperating with 
other countries through organizations like the 
Organization for Economic Cooperation and De- 
velopment; and 
• improvements in the way animals are used for tox - 
icity testing can and should be made administra- 
tively rather than through legislation (1,22). 
The steering committee, which in part grew out of 
the acute studies workshop, found several FDA refer- 
ences to the LD S0 that could be misinterpreted as re- 
quirements to perform the test, and one involving three 
antitumor antibiotics where the requirement still ex- 
isted (in contrast to the workshop findings). Its 1984 
report states that, in all these instances (except for the 
antitumor antibiotics), regulations and guidelines are 
being rewritten to resolve anv misunderstandings. 
They will then reflect the position of FDA that “the use 
of this test should be avoided except for those rare sit- 
uations where no alternative exists.’’ In the case of the 
antitumor antibiotics, FDA is considering eliminating 
the requirement (23). 
Addressing five specific considerations, all part of its 
investigation of agency testing guidelines and practices 
