Ch. 13— Federal Regulation of Animal Use • 293 
dependent laboratory (22)— in 1983 EPA issued its 
own final GLP rules for its toxic substances con- 
trol (48 FR 53922) and pesticides (48 FR 53946) 
programs. 
The GLPs for FDA and EPA are similar. Both ad- 
dress all areas of laboratory operations, delineating 
requirements for the establishment of a Quality 
Assurance Unit to conduct periodic internal inspec- 
tions and keep records for audit and reporting pur- 
poses; Standard Operating Procedures (SOPs) for 
all aspects of each study and for all phases of lab- 
oratory maintenance; a formal mechanism for eval- 
uation and approval of study protocols and their 
amendments; and inclusion in reports of data in 
sufficient detail to support conclusions drawn from 
them. FDA performs four kinds of inspections in 
U.S. toxicology labs (8): 
• GLP compliance, including examination of 
an ongoing study as well as a completed study 
(once every 2 years); 
• data audit as needed, to verify that informa- 
tion submitted to the agency accurately re- 
flects the raw data; 
• directed, when prompted by questionable 
data, an informer’s tip, etc.; and 
• followup, to observe for correction of pre- 
viously discovered deficiencies. 
Inspections are conducted by investigators, who 
visit each facility and are given access to all parts 
of the premises where covered studies are per- 
formed and to all pertinent personnel and docu- 
mentation. The Final Report and a more detailed 
Establishment Inspection Report are prepared af- 
ter an audit is concluded; both can be obtained 
under FOIA. One (or more) of three sanctions can 
be imposed in cases of noncompliance: refusal to 
consider a study in support of an application; dis- 
qualification of the testing facility; or, in cases of 
alleged fraud, recommendation for criminal prose- 
cution. 
Provisions relating to care and housing of test 
animals are identical in both agencies’ GLP rules. 
Both regulations provide that, where animals are 
housed, "facilities shall exist for the collection and 
disposal of all animal waste and refuse or for safe 
sanitary storage of waste before removal from the 
testing facility. Disposal facilities shall be so pro- 
vided and operated as to minimize vermin infesta- 
tion, odors, disease hazards, and environmental 
contamination." Finally, each GLP has a full sec- 
tion on animal care, specifying SOPs for housing, 
feeding, handling, and care, with additional stand- 
ards on separation, disease control and treatment, 
identification, sanitation, feed and water inspec- 
tion, bedding, and pest control (21 CFR 1984 ed. 
58.43, 58.45, 58.49, 58.90; 40 CFR 1984 ed. 792.17, 
792.43, 792.45, 792.90). 
One chemical-industry representative summa- 
rized the benefits and problems of GLPs as follows: 
• Benefits: 
1) promotion of good science through good 
documentation; 
2) credibility— "clean bill of health”; and 
3) self-assurance through knowledge— reduc- 
ing chances of mistakes due to ignorance 
or use of shortcuts. 
• Problems: 
1) duplication— possibility of six distinct au- 
dits in the animal care operation— FDA, 
EPA, USDA/APHIS, American Association 
for the Accreditation of Laboratory Animal 
Care (if accredited), State, and internal Qual- 
ity Assurance Unit; 
2) adversarial climate— “guilty until proven in- 
nocent”; 
3) confidentiality and accessibility— inadvert- 
ent disclosure of confidential business in- 
formation or compromise of client con- 
fidentiality; 
4) time and cost— in larger facilities, single 
audits may occupy several hours per day 
for several weeks (7). 
Noting that the GLP compliance record has been 
good, the commentator suggests that some dupli- 
cation can be avoided by instituting a self -audit 
compliance program, using the Guide for the Care 
and Use of Laboratory Animals of the National In- 
stitutes of Health (47). 
If consideration is given to broadening USDA's 
enforcement of the Animal Welfare Act to reach 
more testing facilities that may not now be cov- 
ered— either by extending coverage to include ro- 
dents beyond only hamsters and guinea pigs or by 
increasing covered facilities’ compliance duties— 
the problems of cost and duplication assume more 
significance. One indication of the cost of increas- 
