National Institutes of Health (NIH)
—Laboratory Primate Advocacy Group
When research institutions claim that their practices fall under current and applicable law, do not be comforted, because individuals living in these institutions are not. They suffer, day in and day out, under current and applicable law.
The major federal law covering chimpanzees and other select nonhuman species in U.S. laboratories is the Animal Welfare Act (AWA). Enacted in 1966, it has been amended six times in subsequent decades. (1)
Among other things, the law includes:
- Minimum animal husbandry and veterinary care requirements
- Required annual U.S. Department of Agriculture (USDA) inspections
- Penalties for facilities failing to correct non-compliant items
- Required oversight committees (Institutional Animal Care and Use Committee or IACUC).
However, provisions such as these and others in the law are riddled with problems. The AWA does not adequately protect chimpanzees and other animals used for research. Even the NIH admits that adherence is “… primarily through voluntary compliance.” (2)
While the AWA regulates basic husbandry, it allows free reign to what is actually done to animals in experiments. Experiments may proceed regardless of any resulting pain and suffering if deemed unavoidable by the researcher and approved by the IACUC—whose members are selected by the facility’s own CEO.
Coverage: when an animal is not an animal
The vast majority of animals used for research in the United States are not covered by the AWA. Certain species are not defined as "animals". AWA covers select species “used, or intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet.” (3)
These species range from dogs to dolphins, guinea pigs to monkeys. The law (4) excludes:
- Rats, mice, and birds, bred for use in research—by far the largest percentage of nonhuman animals used for research (over 90%)
- Farmed animals, including livestock and poultry, used for food, fiber, or other agricultural purposes
- Horses not used for research purposes
- All coldblooded animals
The USDA is in the process of developing a proposed rule for the creation of regulations to cover rats, mice, and birds other than those bred for research that will govern humane handling, care, treatment, and transportation, as mandated by the 2002 Farm Bill. Though the vast majority of mice and rats are exempt from the definition of "animal" under the law, the USDA estimates at least 5 million captive birds will become covered by this new regulation. (37) The comment period for the USDA-APHIS notice of proposed rulemaking (NPRM) ended August 2012. It may take 1-2 years to develop and publish a final rule. (38)
Research facilities covered
Under the law, “research facility” is defined as: “any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that  purchases or transports live animals in commerce, or  receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments.” (5)
Federal facilities (such as the Department of Defense or the Centers for Disease Control (CDC)) using animals must abide by the AWA, but are not required to register with or be inspected by the USDA. (6) They are required to have an IACUC, but this committee reports any problems to the head of its own agency. The agency head is directly responsible for all corrective actions and the granting of “all exceptions to inspection protocol.” (7)
Some of these agencies—intramural and extramural labs that are part of the Public Health Service such as the CDC and NIH itself—must abide by the Public Health Service (PHS) Policy. This policy has similar requirements to AWA and covers more species. It is almost entirely self-policing. (8)
The lab veterinarian: day-to-day discretionary power
“Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals.” (9)
Under the AWA, veterinarians employed by research facilities should:
- Be a voting member of the IACUC (or appoint another qualified veterinarian to do so) (10)
- Consult with the principal investigator to minimize pain and distress (11)
The research facility shall “assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.” (12)
The attending veterinarian has discretion over the quality of life for chimpanzees and other animals in labs. He or she can play a significant role in deciding whether a practice, material, or food substance will be allowed or withheld. His or her attitude toward nonhuman primates and what kind of food or environment “enrichment” should be provided sets the example for caregivers.
The attending veterinarian must wrestle with decisions which balance the needs of the animals and the demands of the researcher. Decisions such as whether a chimpanzee should be exempt from social contact or withheld food or water can place the veterinarian in a quandary over which needs take priority and may make it difficult for the veterinarian to promote the best interests of the chimpanzees.
At many facilities, the veterinarian is also responsible for filling orders from researchers to obtain animals.
According to Viktor Reinhardt, a veterinarian formerly employed at research facilities, the lack of adequate job security or some form of tenure makes attending veterinarians vulnerable to retribution “whenever their advice is in contradiction with the demands of a well-funded researcher.” (13)
Reinhardt notes that it is the investigator’s grant money that funds the experiment and ultimately the facility itself. Therefore, “fear of losing their job is a serious ethical challenge for many attending veterinarians.” (14)
Personnel training: no meaningful guidelines
The AWA requires that laboratories train personnel involved in the care of animals. Lab workers must be instructed on humane practices for animal maintenance and experimentation; methods to minimize or eliminate the use of animals or to limit pain or distress of animals who are used; how to access information on related topics from the National Agricultural Library; and how to report problems in animal care. (15)
While these AWA requirements sound useful, the language is too vague to require meaningful and consistent application in practice. The AWA leaves compliance with these requirements largely to the discretion of the lab.
It is a major shortcoming that many facilities do not have an internal expert to provide guidance on the distinctly different behavioral and psychological needs of different species.
Inspection and enforcement: the impossible tasks
Inspection requirements, as well as AWA compliance generally, is administered and enforced by the Animal Care (AC) program of the Animal and Plant Health Inspection Service (APHIS), a USDA enforcement division.
There are more than 12,000 facilities involved in research, exhibition, breeding, or dealing of animals that are required to be licensed by the USDA, including over 1,000 laboratories. Currently, APHIS has 150 employees who are responsible for regulating and inspecting these facilities (16). To our knowledge, there are six main facilities that house and/or use chimpanzees for research. (Federal labs are not required to register with or be inspected by APHIS.)
Under law, the USDA is required to inspect each registered facility a minimum of once per year (more for those requiring follow-up for recent non-compliance). (17) The regulations require that the facility allow inspectors to enter, review, and make copies of records, and “inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, [and] the regulations,” (18) documenting “conditions and areas of noncompliance” (19).
Despite these requirements, APHIS has struggled in carrying out its inspection duties. As previously mentioned, APHIS employs only 150 inspectors to inspect thousands of facilities and conduct follow-up inspections on labs failing to comply (20). In the past, biomedical interest groups were also successful in limiting public access to APHIS inspection reports, which are meant to be public. (See “Uncovering the Truth” for more information.)
In 1997, APHIS’s AC program implemented a new inspection policy:
Facilities that meet all of the criteria qualify for low inspection frequency and are subject to inspections once every 2-3 years. Facilities that meet few or none of the criteria qualify for high inspection frequency and are subject to inspections at least every 6 months. Those in the middle qualify for medium inspection frequency and will be inspected once a year.
AC, of course, remains committed to inspecting research facilities once a year, as required under the law. AC must maintain confidentiality of the inspection frequency of all licensees and registrants to ensure the integrity of the system. (21)
In addition to the challenge of required inspections, APHIS’s stated policy to perform “unannounced” inspections appears to be unsuccessful. According to former laboratory caregivers, facilities are typically informed before the inspector arrives, either by the inspector, or by other nearby facilities.
In April 2010, APHIS announced that the AC program would start “taking a tougher stance on repeat offenders and moving more quickly and consistently in pursuing enforcement actions.” (22) In line with this, APHIS is now “making information about those enforcement actions available to the public” by providing online summaries of their enforcement cases. (23)
AWA enforcement procedure
A facility is in “non-compliance” with the AWA if inspected and found to have violations of AWA requirements. The inspector generally gives the facility a deadline by which the non-compliant items must be corrected.
If the matter is not resolved upon follow-up inspection, APHIS can issue an official warning letter stating that “more stringent enforcement action” will be taken if the violation is not corrected, or a stipulation offer, which allows “alleged violators to pay a penalty in lieu of formal administrative proceedings.” Alternatively, APHIS can take the matter before an Administrative Law Judge for resolution. (24)
While the institution can be fined, APHIS typically funnels most of the money accrued from fines back into the facility for animal care. (25) The facility’s license can also be suspended or revoked. (26)
APHIS may also confiscate animals, unless the research subjects are deemed necessary for the research. (27) However, in practice, APHIS rarely confiscates animals, and has never been known to confiscate chimpanzees from abusive situations (see information on the violations at the now-defunct Coulston facility and at other facilities with chimpanzees).
2005 Inspector General’s audit of APHIS highlights issues
Despite the 1997 change in APHIS Animal Care (AC) policy to conduct more frequent inspections on labs with a history of violations, problems with inspections and enforcements continue as identified in the USDA’s Office of Inspector General 2005 audit. (28)
The audit report noted that most AC employees were committed to protecting the welfare of animals through the enforcement of the AWA. (29) However among its key findings, the OIG found that the AC’s Eastern Region in particular was not aggressively enforcing actions against violations of the AWA. (30)
The failure of the AC’s Eastern Region included a significant decline in the number of referrals of suspected violators to its enforcement division (from 209 in 2002 to 82 in 2004) and decisions to decline to take action against a large percentage of violations (126 out of 475 facilities or 27%). (31)
The percentage of repeat violations was twice as high in the Eastern Region as in the Western Region. The report notes: “Eastern Region inspectors believe the lack of enforcement action undermines their credibility and authority to enforce the AWA.” (32)
The report also found that APHIS issues fines that are highly discounted (typically 75% to encourage violators to settle out of court) or lowered fines in other concessionary moves to such a degree that one enforcement official stated, “Violators consider the monetary stipulation as a normal cost of conducting business.” (33)
The report also found that some Veterinary Medical Officers (VMOs) wrongly relied on the “good faith” of the facilities to provide accurate records, rather than independently verifying the actual number of animals used in research or other records. (34)
Finally, the report concluded that some IACUCs were not monitoring animal care or reviewing protocols effectively:
During FYs 2002 through 2004, the number of research facilities cited for violations of the AWA has steadily increased from 463 to 600 facilities. Most VMOs believe there are still problems with the search for alternative research, veterinary care, review of painful procedures, and the researchers’ use of animals. (35)
No public recourse
Though Congress did not intend for the AWA to be used by the American tax-paying public, who fund the research, to bring lawsuits against laboratories, in recent years such suits have rightly occurred but were filed against the USDA and not the individual lab.
Individuals who can prove that they have been injured by witnessing the abuse of a nonhuman animal in a non-compliant, AWA-regulated facility have brought suit under a related law, the Federal Administrative Procedure Act . (36) But under the APA, only the USDA can be sued for failure to enforce the AWA—it is not possible to directly sue a facility for violations of the AWA.
Such a scenario places the enforcement agency in the position of bearing the brunt of blame for a laboratory’s failure to comply with the AWA. While the USDA does have a share of this responsibility, the culpable party—the violating lab—is thus allowed to sidestep the direct responsibility for its failures. In the case of repeated violators, this serves to protect the offenders.
For more information
- AWA Interpretive Summaries
- Public Health Service Policy (required by the Health Research Extension Act (HREA) of 1985)
- APHIS AWA Inspection Reports
- APHIS Publications
(1) Legislative History of the Animal Welfare Act
(2) National Institutes of Health. “Memorandum of Understanding Among the Animal and Plant Health Inspection Service U.S. Department of Agriculture and The Food and Drug Administration U.S. Department of Health and Human Services and the National Institutes Of Health U.S. Department of Health and Human Services Concerning Laboratory Animal Welfare.”
(3) Animal Welfare Act. 7 U.S.C. § 2132 (g)
(4) U.S. Department of Agriculture. APHIS, Animal Welfare Act Brochure, June 2008.
(5) Animal Welfare Act. 7 U.S.C. § 2132 (e)
(6) Animal Welfare Act. 9 C.F.R. § 2.30 (a)(1)
(7) Animal Welfare Act. 9 C.F.R. § 2.37 (a)(b)
(8) National Institutes of Health. Office of Laboratory Animal Welfare. “Public Health Service Policy on Humane Care and Use of Laboratory Animals.”
(9) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)).
(10) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)(3))
(11) Animal Welfare Act. 9 C.F.R. § Sect. (d)(1)(iv) through (xi) specifically.
(12) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)(2)
(13) Reinhardt, Viktor. The Attending Veterinarian’s Contract of Employment: Curse or Blessing for Animals in Research Institutions? Journal of Applied Animal Welfare Science 2002, Vol. 5, No. 1, Pages 73-74, Animal Welfare Institute, Washington, D.C.
(15) Animal Welfare Act. 7 U.S.C. § 2143 (d); see 9 C.F.R. § 2.32. (a).
(16) United States Department of Agriculture. APHIS, Animal Care National Meeting, April 19-22, 2010.
(17) Animal Welfare Act. 7 U.S.C. § 2146 (a).
(18) Animal Welfare Act. 9 C.F.R. § 2.38(b)(1)(iv).
(19) Animal Welfare Act. 9 C.F.R. § 2.38(b)(1)(v).
(20) United States Department of Agriculture. APHIS, Animal Care National Meeting, April 19-22, 2010.
(21) United States Department of Agriculture. APHIS Factsheet, Animal Care, February 2002.
(22) United States Department of Agriculture. APHIS, Animal Care National Meeting, April 19-22, 2010.
(23) United States Department of Agriculture. APHIS Press Release, “APHIS to Issue Animal Welfare Enforcement Information,” April 29, 2010.
(24) United States Department of Agriculture. APHIS, AWA Enforcement Information.
(25) United States Department of Agriculture. APHIS Factsheet, The Animal Welfare Act: Research Facilities, August 2003.
(26) Animal Welfare Act. 7 U.S.C. § 2149.
(27) Animal Welfare Act. 7 U.S.C. § 2146(a)(3).
(28) United States Department of Agriculture-Office of Inspector General/Western Region - Audit Report - APHIS Animal Care Program Inspection and Enforcement Activities - Report No. 33002-3-SF, September 2005.
(29) Ibid., Results in Brief, p. i
(32) Ibid., p. ii
(33) Ibid, p. ii
(34) Ibid, pp. ii
(35) Ibid, pp. ii-iii
(36) LSU Law Center’s Medical & Public Health Law Site, Federal Administrative Procedure Act.
(37) United States Department of Agriculture. APHIS Factsheet, Animal Care, August 2012.
(38) Federal Register. Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions: Animal Welfare; Regulations and Standards for Birds. 2012.