Ch. 13— Federal Regulation of Animal Use • 297 
minated by any agency on 90-day advance writ- 
ten notice to the other two agencies (37). 
Specific Agency Activities 
Six departments and four agencies within the 
Federal Government do intramural research in- 
volving animals. At least 1.6 million animals were 
used by these branches for such research during 
fiscalyear 1983 (see ch. 3). In addition, extramural 
research is conducted by many of these depart- 
ments. Two departments, Commerce and Trans- 
portation, conduct almost all research extramurally 
and so have no specific policy regulating animal 
use other than the PHS policy (17,23). Fora detailed 
discussion of the regulation of animal use within 
Federal departments and agencies, see appendix B. 
CRITICISMS OF THE PRESENT SYSTEM OF FEDERAL REGULATION 
The operation of the Animal Welfare Act, as ap- 
plied to research, has been criticized since its pas- 
sage. In addition to obvious shortcomings— lack 
of coverage for actual research practices and in- 
adequate resources for enforcement— critics have 
questioned the presumption that researchers know 
best how to care for experimental animals (20,49) 
and the choice of APHIS as the primary enforce- 
ment agency (16,24). Complex recordkeeping re- 
quirements imposed on APHIS inspectors and 
other field enforcement staff have been decried; 
the process of noting, investigating, and evaluat- 
ing violations for prosecution, and the attendant 
rights of suspected violators that can result in de- 
lay in disposition of cases, are viewed by some as 
too cumbersome and bureaucratic (20). Some ques- 
tion the expertise and the will of APHIS, pointing 
out its traditional reluctance to accept broader 
responsibilities under the act. Indeed, USD A re- 
mains opposed to its further extension (34,37). A 
1982 review of the APHIS reporting system by the 
Humane Society of the United States concluded 
that the present system, as it is administered (24): 
. . . fails to achieve its primary statutory objec- 
tive: it does not provide APHIS with information 
sufficient to demonstrate that researchers have 
used pain-relieving drugs “appropriately” and in 
accordance with “professionally acceptable stand- 
ards.” The chief reasons for this failing are: 1) reg- 
ulations and guidelines do not define "pain” or 
"distress,” 2) regulations and guidelines do not 
adequately define “routine procedures,” and 3) 
regulations and guidelines do not require mean- 
ingful explanations for the withholding of pain- 
relieving drugs in procedures acknowledged to 
cause pain. 
The Reporting System, as presently adminis- 
tered, for the same reasons also fails to achieve 
a secondary— but nonetheless important— objec- 
tive : it does not generate reliable and meaningful 
information to the public about the use of ani- 
mals in research. 
Humane groups have used the Freedom of Infor- 
mation Act with increasing frequency to obtain 
copies of inspection and annual reports in attempts 
to demonstrate their claims that the system does 
not work. Members of the research community 
opposed to the act's extension defend existing prac- 
tices as adequate (16,34,37). 
Could the Secretary of Agriculture require greater 
proof that "professionally acceptable” standards 
of care are being followed, require more detailed 
explanations of the use and withholding of anes- 
thetics and pain relievers, and more effectively au- 
dit annual reports? The law permits such greater 
discretion. Several competing factors, however, 
are worth noting. First, consistent with Congress' 
enumerated powers to spend and to regulate inter- 
state commerce, the objectives for the regulation 
of research are more limited than is often admit- 
ted by the critics. The remarks of congressional 
sponsors of the first bills, in the record of debates 
on the 1966 conference report, recognize that only 
a fraction of research animals would be covered 
(30) and that the new act was "nothing more than 
a very small first step toward the elimination of 
cruelty, mistreatment, and abuse of laboratory ani- 
mals.” The absolute power that remained with the 
experimenter to determine the nature of experi- 
mentation prompted the remark that “animals that 
are under research or experimentation for sev- 
