292 • Alternatives to Animal Use in Research, Testing, and Education 
used in research. These committees shall consist 
of at least three members, of which one must be 
a veterinarian and one an individual having no asso- 
ciation with the institution. The act thus specifies 
more modest requirements for the committees 
than does the PHS policy . The PHS policy requires 
a minimum of five committee members, and the 
veterinarian must have training or experience in 
laboratory -animal science or medicine. 
The animal care committees are responsible for: 
1) reviewing at least semiannually the care and 
treatment of animals in all animal study areas and 
facilities for compliance with NIH guidelines, 2) 
keeping appropriate records of such reviews, and 
3) certifying to NIH that such reviews have been 
conducted. In requiring a minimum of two inspec- 
tions per year, the law is more stringent than the 
PHS policy, which requires at least one per year. 
The act requires applicants for NIH funds to file 
assurances with NIH indicating both that the ap- 
plicant will meet the NIH guidelines for the care 
and treatment of animals and that the applicant’s 
institution has an animal care committee. Appli- 
cants must also assure NIH of the availability of 
instruction at their institutions in the humane prac- 
tices of animal care and in research methods that 
minimize the use of animals and limit animal dis- 
tress. All applications for NIH funds must include 
a statement of the reasons for using animals in 
the research. If NIH determines that a research 
entity is not meeting the guidelines, and if no ac- 
tion is taken after notification of the noncompli- 
ance, the act provides that the NTH Director shall 
suspend or revoke funding. 
Research on Alternatives 
The act directs NIH to establish a plan for re- 
search into methods of biomedical and behavioral 
experimentation that do not require the use of ani- 
mals, that reduce the number of animals used, or 
that produce less pain and distress than methods 
currendy in use. NIH is further directed to develop 
plans for evaluating the validity and reliability of 
such methods, proceeding with development of 
methods found to be valid and reliable, and train- 
ing scientists in the use of such methods. The law 
instructs NIH to disseminate information to investi- 
gators about alternative methods that are found 
to be valid and reliable, and to establish an internal 
coordinating committee (made up of the directors 
of each NIH institute) to assist in developing the 
NIH plan, which must be prepared by October 1, 
1986. With the creation in 1985 of the Biological 
Models and Materials Resources Section (see ch. 
12), NIH appears poised to respond to this legisla- 
tive mandate. 
Other Federal Laws and Regulations 
Beyond the Federal laws and regulations that 
either directly require or have been interpreted 
to require the use of certain animals in testing or 
research and guidelines adopted pursuant to gen- 
eral statutory authority, several other Federal laws 
and regulations establish duties for research fa- 
cilities concerning the acquisition and general care 
of animals used for experimentation. 
Good Laboratory Practices 
In the 1970s, concern at the Food and Drug 
Administration (FDA) about faulty toxicological 
data based on animals, generated both internally 
and externally (18), led to the promulgation of reg- 
ulations requiring all regulated parties conduct- 
ing nonclinical laboratory studies that test for 
safety or effectiveness to conduct, keep records 
about, and permit audits on all such tests in a speci- 
fied manner. In 1978, FDA adopted Good Labora- 
tory Practices (GLP) rules (43 FR 59986) and be- 
gan a laboratory audit and inspection program. 
In 1984, FDA published a notice proposing some 
changes in these regulations primarily to stream- 
line recordkeeping, data storage and retrieval, and 
reporting practice (49 FR 43530). Further action 
may occur in early 1986. 
Drawing on the FDA experience and mindful of 
its responsibility to collect and analyze substantial 
amounts of testing data for approval of new chem- 
icals and registration of pesticides, the Environ- 
mental Protection Agency (EPA) defined its own 
approach to GLPs (44FR 27362). In 1978, EPA exe- 
cuted a Memorandum of Understanding to permit 
FDA to inspect toxicity testing labs and audit pes- 
ticide data submitted in support of registration ap- 
plications (43 FR 14124). After much considera- 
tion— and the discovery by FDA of the submission 
of hundreds of fraudulent test results by one in- 
