App. B— Regulation of Animal Use Within Federal Departments and Agencies • 389 
to answer questions raised at the acute studies work- 
shop, the steering committee concluded that: 
• FDA practices and procedures are designed to ob- 
tain the maximum amount of data from the mini- 
mum number of animals; 
• despite general references to the use of LD S0 tests, 
FDA has no requirements for LD S0 data obtained 
by using the classical, statistically precise test, ex- 
cept for batch release toxicity tests of three anti- 
tumor antibiotics; 
• there are many alternative tests being studied and 
developed throughout FDA; 
• practices and procedures for assuring humane 
care and treatment of animals are agency-wide; 
and 
• FDA has a number of regular channels of commu- 
nication to industry, consumers, and the private 
sector in general and efforts to improve commu- 
nication channels will continue (23). 
The steering committee recommended workshops 
on acute toxicity studies throughout the agency, on the 
use of in vitro alternatives by various centers, and on 
agency and PHS practices and procedures for the care 
and handling of animals. The recommendations also 
called for the establishment of an agency -wide animal 
welfare committee (23). FDA is now setting up two in- 
house workshops to address the first two topics (1). 
Furthermore, it has established a Research Animal 
Council to see that the recommendations of the report 
are carried out, to consider animal research issues at 
FDA in a broad context, and to serve as an oversight 
committee for individual FDA centers. FDA’s Research 
Animal Council began meeting quarterly in 1984 and 
will report to the Commissioner; its membership in- 
cludes one representative from each of the centers 
within FDA (3). 
FDA’s policies on humane animal care and treatment 
require compliance with the Animal Welfare Act as well 
as with other standards for humane care and use of 
animals. The steering committee report found that all 
centers have acceptable procedures, but that they var- 
ied in specific details. The centers conduct different 
amounts of research and testing; some have more for- 
mal procedures than others and stronger veterinary 
staff capabilities. Accreditation by AAALAC is sought 
on a voluntary basis, and two of FDA's animal facilities, 
the National Center for Toxicological Research (NCTR) 
and the Center for Drugs and Biologies of the Office 
of Biologies Research and Review, are fully accredited 
(23). 
The policies and procedures in place at the National 
Center for Toxicological Research (Jefferson, AR) are 
a good example of FDA’s system for addressing animal 
welfare issues, since NCTR is the primary animal re- 
search facility within FDA (24): 
The policy of NCTR management is to use labora- 
tory animals under practical and reasonable conditions 
of humane treatment, in carefully planned experiments 
with in vitro methodologies balanced against minimally 
required test species numbers in in vivo bioassays, and 
via procedures set forth in national standards and 
guidelines. 
The Director of NCTR has primary responsibility for 
assuring compliance with the policy but delegates some 
aspects of that control. The duties of the Senior Scien- 
tists in NCTR’s Office of Research include technical over- 
view of animal use, strain selection, genetic quality con- 
trol, state-of-the-art reviews, and recommendations for 
adopting new concepts in animal care and control. The 
Director of the Division of Animal Husbandry is respon- 
sible for breeding-colony operations, animal produc- 
tion and laboratory -animal care in NCTR’s various hold- 
ing areas, and quarantine procedures (25). The animal 
care committee has adopted an “Animal Use Form for 
Experimental Protocols” and requires every investiga- 
tor using animals to provide the committee with detailed 
information for evaluation (23). Finally, the Director 
has set up ad hoc committees of in-house personnel 
to evaluate specific areas of animal care, such as change 
in feed for the facility (1,24). 
The FDA policy on extramural research requires ad- 
herence by awardee institutions to the PHS policy and 
procedures (23): 
This includes (1) having in place a program of animal 
care which meets federal and Department standards , 
(2) providing, through AAALAC accreditation or de- 
fined self-assessment procedures, assurance of institu- 
tional conformance, and (3) maintaining an animal 
research committee to provide oversight of the insti- 
tution’s animal program, facilities and associated 
activities . 
National Institutes of Health 
NIH has a specific animal care and use program for 
intramural research and for research within NIH- 
controlled space (25). The NIH policy requires individ- 
ual investigators to adhere to the NIH Guide. In addi- 
tion, each bureau, institute, or division (BID) is encour- 
aged to pursue accreditation of its animal facilities by 
either AAALAC or any other NIH -approved accrediting 
body (at present AAALAC is the sole body) and to re- 
port its accreditation status each year to the Deputy 
Director, who ensures compliance with the policy by 
each BID. 
The NIH policy delegates responsibility to five differ- 
ent authorities, including two types of committees. The 
