National Institutes of Health

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.

— Laboratory Primate Advocacy Group www.lpag.org

Animal Welfare Act Overview

The major federal law covering chimpanzees and other select nonhuman species in US laboratories is the Animal Welfare Act (AWA). Enacted in 1966, it was amended four times in subsequent decades. (1)

Among other things, the law includes:

• Minimum animal husbandry and veterinary care requirements
• Required annual USDA inspections
• Penalties for facilities failing to correct non-complaint 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 Animal Welfare Act. Certain species are not “defined” as animals. AWA covers select species “used, or is 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 excludes:

• Rats, mice, and birds (4) – by far the largest percentage of nonhumans used for research (an estimated 90%). For more information, read NEAVS’ brochures on birds and rats
• Farmed animals (except birds) used for food, fiber, or other agricultural purposes (5)
• All cold-blooded animals (6)

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 [1] purchases or transports live animals in commerce, or [2] 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.” (8)

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 APHIS. (9) 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.” (10)

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 PHS Policy. This policy has similar requirements to AWA and covers more species. It is almost entirely self-policing. (11)

“Oversight”: a system of self-policing

The AWA mandates that each research facility establish an Institutional Animal and Use Committee (IACUC). (12) The IACUC must consist of no less than three members and must include an attending veterinarian from the facility and one person not affiliated with the facility. (13) All members are selected by the facility’s CEO. (14)

The primary functions of this committee are to:

• Approve the use of animals in all research proposals
• Require changes to proposed studies if they are not in accordance with USDA regulations
• Approve any significant changes to ongoing protocols
• Ensure that procedures will “avoid or minimize pain and discomfort, distress, and pain to the animals”
• Verify that principle investigators [researchers] have considered alternatives to procedures that cause pain or distress
• Assure that the procedure does not “unnecessarily duplicate previous experiments”
• Review the facility’s “program for humane care and use of laboratory animals” and inspect all animals facilities for compliance with AWA regulations at least once every six months
• Send reports of their evaluations to the facility’s CEO, including records of significant deficiencies and specific plans and schedules for dates to correct these issues
• Investigate concerns involving the humane care of animals at the institution based on public complaints or non-compliance reports from lab employees (15)

The IACUC must provide an annual report including assurances that:

• The facility is using “professionally acceptable standards” in regard to animal care and pain management
• Each researcher has considered alternatives to painful procedures
• The facility is adhering to the AWA. (16)

It must also provide a summary of all exemptions to AWA regulations, including all experiments involving pain or distress for which animals did not receive pain relieving drugs. (17)

IACUC meeting minutes, records of attendance, activities and deliberations; proposed activities/changes and IACUC responses; and semiannual reports and recommendations are filed with the facility and are to be made available to USDA/APHIS inspectors on request (18) (under current APHIS/Animal Care policy this review may happen only every 2-3 years). (19)

The regulations state: “APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities’ premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes.” (20)

“Some IACUCs are not effectively monitoring research facilities.”

The IACUC system is the cornerstone of animal protection within laboratories, but in reality it is a system plagued with loopholes that leave animals without adequate protection. Repeated audits by the USDA’s Office of the Inspector General (OIG) have noted continuing issues with the IACUC system.

A September 2005 audit report by the OIG issued as one of its major findings: “Some IACUCs are not effectively monitoring research facilities.” (21) A 1995 OIG report raised similar issues. (22)

The OIG 2005 report noted that these failings included:

• Ineffective monitoring of animal care, protocols, and alternative research methods
• Lack of or poor follow-up on the correction of deficiencies
• Inaccurate annual reporting (23)

OIG’s conclusions noted the following problems – that IACUCs:

• Only conducted reviews on a semiannual basis
• Had high rates of member turnover
• Failed to properly train committee members (24)

The audit stated: “As a result, the facilities are not conducting research in compliance with the AWA or, in some cases, not providing humane conditions for research animals.” (25) The report noted that despite its previous reports highlighting IACUC issues, the number of research facilities cited for violations has steadily increased in recent years. (26)

A 2001 IACUC study funded by the National Science Foundation also casts serious doubt on the reliability of IACUCs to protect animals. (27)

APHIS Animal Care (AC) division has also noted its concerns about IACUCs’ effectiveness:

AC is concerned about the effectiveness of some IACUCs’ oversight of animal care and use, and the effectiveness of AC’s regulatory authority over these committees. This includes IACUC oversight of adequate pain and/or distress relief, and the use of alternatives to procedures that may cause more than momentary pain or distress. (28)

IACUC failures

An IACUC review is supposed to be an objective third-party check on the welfare of the animals involved in experiments. However, the potentially biased nature of these committees allows business and scientific interests to compete with concerns for the pain and suffering of the animals.

The potential for bias and other flaws in IACUC reviews include:

Committees are typically comprised of employees of the facility – often researchers themselves. Since all members are appointed by the facility’s CEO, they could be less likely to support a decision that may conflict with the status quo.

• Having researchers make decisions that would restrict the work of their peers could place additional pressure on them to acquiesce.
• While one “non-affiliated” member is to represent the concerns of the general public, this member is also chosen by the CEO. If this member opposes a protocol, he or she can be out-voted by the other members.
• The chairman has the authority to have only ONE qualified member review a protocol unless a full review has been requested. “That person shall review the activities and has the authority to approve, require modifications, or request a full committee review of the activities.”
• The bi-annual evaluations of the facility and animals must include any minority views, (29) but these reports are not publicly accessible unless the facility is federally owned. (30)
• If AWA violations at the facility are found, the report of the violation goes on file with the institution. Only if the problem is not corrected is the matter reported to APHIS. If the IACUC is part of a private institution or business, the public does not have access to these internal violation reports.

The major loophole: “exemptions” for science

While the AWA provides requirements for the care of animals in research, it allows IACUCs and researchers to make “exemptions” as they deem necessary for the needs of the experiment. This may involve such things as keeping an animal in prolonged isolation or withholding food or water for a specified period.

The most disturbing of these possible exemptions involves bypassing regulations to minimize an animal’s pain and distress.

The AWA allows for the withholding of tranquilizers, anesthesia, analgesia, or euthanasia “when scientifically necessary.” (31) Such exemptions are allowed when “specified by research protocol.” (32)

This language leaves critical judgments entirely in the hands of the principal investigators and their IACUC committees rather than defined by a stringent set of guidelines. If the IACUC agrees that pain medications will affect the outcome of the experiment or block the researcher’s ability to monitor the symptoms, these requirements may be waived.

Likewise, although there is a regulation stipulating that “no animal is used in more than one major operative experiment from which it is allowed to recover,” this, too, can be bypassed “in cases of…scientific necessity.” (33)

The reality is that many chimpanzees and other species have suffered tremendously in experiments. As a tragic example, read about Jerom.

Pain & distress: failure to acknowledge and report

The AWA requires that IACUCs report when animals are not provided with pain relief. However, the assessment of pain and stress is left to the interpretations of IACUC members and researchers.

The danger of a subjective interpretation of “pain and distress” is that animals are at the mercy of these individuals’ empathy or lack thereof. A study of laboratories located in two research institutions in the New York City area concluded that: “Although researchers always acknowledged the ability of animals to feel pain, this knowledge remained an abstraction for most. Scientists rarely saw any pain or suffering in their labs.” (34) The provision of painkillers following surgery did not even occur to many:

Analgesics [painkillers] are routinely given to human patients following surgery…. In the animal laboratories, however, analgesics were rarely used. No one (with the possible exception of some animal welfare advocates) considers this a violation of the regulations, but rather a (more or less) legitimate interpretation of the “appropriate use” and “as required” clauses. Whereas the regulations were invariably interpreted to require anesthesia for surgery, they were not construed to require analgesic drugs under any specific conditions. Analgesics were considered when they were considered at all to be a matter for individual judgment. (35)

There are numerous cases of the underreporting of pain and distress by laboratories. The USDA sought public comment on proposed changes to the pain and distress classification system in 2000, but the agency has taken no action to date. (36)

The lab veterinarian: day-to-day discretionary power

Under the AWA, veterinarians employed by research facilities should:

• “Provide adequate veterinary care to the facilities animals. Adequate Veterinary Care is usually determined as what is currently the accepted professional practice or treatment for that particular circumstance or condition” (37)
• Be a voting member of the IACUC (or appoint another qualified veterinarian to do so) and “have direct or delegated responsibility for the animals at the research facility” (38)
• Consult with the principal investigator to minimize pain and distress (39)

The research facility must: “provide the attending veterinarian with sufficient and appropriate authority to ensure that adequate veterinary care is provided at all times and that he or she is able to oversee the adequacy of all aspects of animal care and use for all animals.” (40)

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, or 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.” (41)

Reinhardt notes that it is the investigator’s grant money which funds the experiment and ultimately the facility itself. “The fear of losing their job is a serious ethical challenge for many attending veterinarians.” (42)

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. (43)

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 and Plant Inspection Service (APHIS), a USDA enforcement division.

There are more than 8,000 facilities involved in research, exhibition, breeding, or dealing of animals that are required to be licensed by USDA, including over 1,000 laboratories. (44) (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). (45) 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,” (46) documenting “conditions and areas of noncompliance.” (47)

Despite these requirements, APHIS has struggled in carrying out its inspection duties. In recent years, APHIS has employed only about 100 inspectors to inspect thousands of facilities and conduct follow-up inspections on labs failing to comply. (48)

As a result, APHIS’s Animal Care (AC) arm implemented a new inspection policy in 1997:

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. (49)

In recent years, biomedical interests have successfully blocked or limited public access to APHIS inspection reports, which are meant to be public.

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.

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, the USDA can enter into a consent decree with the facility, whereby the parties attempt to find a solution without going to court. Alternatively, APHIS can take the matter before an Administrative Law Judge for resolution. (50)

The institution can be fined. APHIS typically funnels most of the money accrued from fines back into the facility for animal care. (51) The facility’s license can also be suspended or revoked. (52)

APHIS may also confiscate animals, unless the research subjects are deemed necessary for the research. (53) 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).

2005 Inspector General’s audit of APHIS highlights issues

Despite the 1997 change in APHIS Animal Care 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. (54)

The audit report noted that most AC employees were committed to protecting the welfare of animals through the enforcement of the AWA. (55) 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. (56)

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%). (57)

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.” (58)

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.” (59)

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. (60)

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. (61)

No public recourse

The AWA was not intended by Congress to be used by the American tax paying public who fund the research to bring lawsuits against laboratories.

In recent years, individual humans who can prove that they have been injured by witnessing the abuse of a nonhuman in a non-compliant, AWA-regulated facility have brought suit under a related law, the Administrative Procedure Act (APA). (62) 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 USDA/APHIS 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

• The full text of the law (http://www.nal.usda.gov/awic/legislat/awa.htm)
• AWA Interpretative Summaries (http://www.nal.usda.gov/awic/legislat/awabrief.htm)
• AWA Nonhuman Primate Regulations (Link to subpage of same name)
• Read about the Public Health Service Policy (required by the Health Research Extension Act (HREA) of 1985)
• Study Casts Doubts on IACUCs
• Efforts to improve reporting of pain and distress

Other related sites of interest:

• APHIS Publications page
• APHIS Animal Care FY 2004 AWA Inspection Report
• Policies - Painful Procedures, Animal Care Resource Guide (1997, Policy 11)

Last update: 1/19/06

Sources

(1) Animal Welfare Act and Regulations. Available at http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

(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.” Available at http://grants.nih.gov/grants/olaw/references/finalmou.htm

(3) Animal Welfare Act. 7 U.S.C. § 2132 (g)

(4) Ibid.

(5) Ibid.

(6) United States Department of Agriculture. Animal and Plant Health Inspection Service, Animal Care, “Answers for Frequently Searched Items” Available at http://www.aphis.usda.gov/ac/frequentquestions.html

(7) Animal Welfare Act. 7 U.S.C. § 2132 (f) (i)

(8) Animal Welfare Act. 7 U.S.C. § 2132 (e)

(9) Animal Welfare Act. 9 C.F.R. § 2.30 (a)(1)

(10) Animal Welfare Act. 9 C.F.R. § 2.37 (a)(b)

(11) National Institutes of Health. Office of Laboratory Animal Welfare. “Public Health Service Policy on Humane Care and Use of Laboratory Animals.” Available at http://grants.nih.gov/grants/olaw/references/phspol.htm

(12) Animal Welfare Act. 7 U.S.C. § 2143 (b)(1).

(13) Animal Welfare Act. 9 C.F.R. § 2.31 (b)

(14) Ibid.

(15) Animal Welfare Act. 9 C.F.R. § 2.31 (c - d)

(16) Animal Welfare Act. 9 C.F.R. § 2.36 (b)(1)(2)(3).

(17) Animal Welfare Act. 9 C.F.R. § 2.36 (b)(7)

(18) Animal Welfare Act. 9 C.F.R. § 2.35

(19) United States Department of Agriculture. Animal and Plant Health Inspection Service. APHIS Factsheet, Animal Care, February 22. Available at http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_awnewera.html

(20) Animal Welfare Act. 9 C.F.R. § 2.35 (f).

(21) 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. Available at http://www.usda.gov/oig/webdocs/33002-03-SF.pdf

(22) Ibid, pp 5, 28.

(23) Ibid (Finding 4, p. 19-22)

(24) Ibid (Finding 4, paragraph1)

(25) Ibid (Finding 4, paragraph 1)

(26) Ibid, Results in Brief, pp. ii-iii

(27) Plous, S., & Herzog, H. A., Jr. (2001). Reliability of protocol reviews for animal research. Science, 293, 608-609.

(28) United States Department of Agriculture. Animal and Plant Health Inspection Service. Strategic Direction for the Animal Care Program, January 2000. Executive Summary. Available at http://www.aphis.usda.gov/ac/strategicplan.html

(29) Animal Welfare Act. 9 C.F.R. § Sect. 2.35 (a)(3)

(30) United States Department of Justice. The Freedom of Information Act 5 U.S.C. § 552, As Amended By Public Law No. 104-231, 110 Stat. 3048. Available at http://www.usdoj.gov/oip/foia_updates/Vol_XVII_4/page2.htm

(31) Animal Welfare Act. Sect. 2.31 (d)(1) (iv)(A).

(32) Animal Welfare Act. 7 U.S.C. § 2143 (a)(3)(E).

(33) Animal Welfare Act. 7 U.S.C. § 2143 (a)(3)(E).

(34) Phillips, Mary T. Savages, Drunks and Lab Animals: The Research Perception of Pain. An ethnographic study of laboratories located in two research institutions in the New York City. Society and Animals, Vol. 1, Issue 1, 1993 Available at http://www.psyeta.org/sa/sa1.1/Notes

(35) Ibid

(36) The Humane Society of the United States. “Distress in Laboratory Animals Goes Unheeded.” Available at: Distress in Laboratory Animals Goes Unheeded

(37) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)).

(38) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)(3))

(39) Animal Welfare Act. 9 C.F.R. § Sect. (d)(1)(iv) through (xi) specifically.

(40) Animal Welfare Act. 9 C.F.R. § Sect. 2.33(a)(2)

(41) 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.

(42) Ibid.

(43) Animal Welfare Act. 7 U.S.C. § 2143 (d); see 9 C.F.R. § 2.32. (a).

(44) United States Department of Agriculture. APHIS Animal Care Annual Reports of Enforcement by Fiscal Year - 2004. Available at http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf

(45) Animal Welfare Act. 7 U.S.C. § 2131, Section 16. (a)

(46) Animal Welfare Act. 9 C.F.R. § 2.38(b)(1)(iv).

(47) Animal Welfare Act. 9 C.F.R. § 2.38(b)(1)(v).

(48) http://www.usda.gov/oig/webdocs/33002-03-SF.pdf

(49) United States Department of Agriculture. APHIS Factsheet, Animal Care, February 22. Available at http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_awnewera.html

(50) Animal Welfare Act. 7 U.S.C. § 2149

(51) United States Department of Agriculture. Innovative Enforcement: How USDA Has Used New Tools and Techniques to Improve Its Administration of the Animal Welfare Act. Available at http://www.aphis.usda.gov/ac/reports/ac1_00.pdf

(52) Animal Welfare Act. 7 U.S.C. § 2149

(53) Animal Welfare Act. 7 U.S.C. § 2146(a)(3).

(54) USDA-Office of Inspector General/Western Region - Audit Report - APHIS Animal Care Program Inspection and Enforcement Activities - Report No. 33002-3-SF, September 2005. Available at http://www.usda.gov/oig/webdocs/33002-03-SF.pdf)

(55) Ibid., Results in Brief, p. i

(56) Ibid.

(57) Ibid.

(58) Ibid., p. ii

(59) Ibid, p. ii

(60) Ibid, pp. ii

(61) Ibid, pp. ii-iii

(62) LSU Law Center’s Medical & Public Health Law Site, Federal Administrative Procedure Act. Available at http://www.nabr.org/AnimalLaw/CaseLaw/Subject.htm

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