Laws

Laws

Public Health Service Policy

While the Animal Welfare Act (AWA) technically applies to all research facilities, laboratories using live vertebrate animals in research funded by the Public Health Service must also adhere to the Public Health Service Policy on Humane Care and Use of Laboratory Animals—commonly known as PHS Policy. (1) The requirement to establish this policy was mandated by the Health Research Extension Act of 1985. (2)

While PHS Policy covers more species than the AWA, it is based on a “trust relationship” and is essentially self-policing. (3) It is not federal law, but facilities must state their compliance to qualify for PHS funding. (4) The most serious penalty for uncorrected infractions is only the suspension or loss of the federal grant or contract. (5)

Applicability

Research labs required to abide by PHS Policy include:

  • All facilities receiving Public Health Service grants, contracts, or cooperative agreements involving research on animals—the majority of which are granted by the National Institutes of Health (NIH)
  • Intramural and extramural laboratories run by the Public Health Service (including NIH itself, the Food and Drug Administration, and the Centers for Disease Control and Prevention) (6)

Requirements

The Office of Laboratory Animal Welfare (OLAW) oversees compliance. (7) To receive PHS funding involving animals, each facility must provide OLAW with a written Animal Welfare Assurance of Compliance with PHS Policy. (8) “…OLAW expects that institutions will adhere to the promises made and procedures described in their Assurances.” (9)

Facilities are expected to adhere to the Guide for the Care and Use of Laboratory Animals (commonly known as “the Guide”) produced by the Institute for Laboratory Animal Research (ILAR). (10)

The Guide is essentially recommendations and suggestions. It states: “The Guide charges users of research animals with the responsibility of achieving specified outcomes but leaves it up to them how to accomplish these goals.” (11)

There are no specific guidelines for nonhuman primates and little to no discussion of enrichment. For example, the brief section to no ”Behavioral Management for Laboratory Animals” begins with the comment: The plan must address the social needs of nonhuman primates. (12) This vague statement provides no guidance on how to adequately care for nonhuman primates’ social needs.

Facilities are subject to review by PHS staff and advisors “which may include a site visit” to check “accuracy of the institution’s compliance or expressed compliance.” (13) Information regarding the frequency of such visits is difficult to obtain” by OLAW. Further, facilities must provide a written Animal Welfare Assurance to OLAW. Inspection and review of a research facility’s Animal Welfare Assurance occur at least twice a year. (14) However, if OLAW finds a facility to be out of compliance, OLAW takes no action but instead allows the facility to take remedial action. The facility need only communicate to OLAW that compliance has been reached; no on-site inspection is required. (15)

Oversight committees: more self-policing

As with the AWA, facilities are expected to set up oversight Institutional Animal Care and Use Committees (IACUCs). (16) (For experiments involving animals covered under both the AWA and HREA, a single IACUC fulfills both requirements.)

PHS policy requires that the IACUC consist of at least five members, including: a veterinarian, a scientist with animal research experience, a member from a non-scientific area, and one not affiliated with the institution. (17) As with the AWA, members are chosen by the facility’s CEO (18)—a practice which puts the committee’s so-called independent oversight role into question.

At least twice a year, the IACUC reviews the institution’s program for humane care and use of animals and animal facilities using the Guide as its basis. (19) IACUC meeting notes, inspections, and notes about deficiencies are prepared for the “Institutional Official”—the individual who signs the facility’s status of OLAW assurance. (20) These IACUC documents must be made available for OLAW upon request (21) but are only a matter of public record if the facility is federally owned.

IACUC deficiencies

An article in Lab Animal in 2000 noted a number of problems with IACUCs, including

  • Lack one or more of the requisite members
  • Absence of a convened quorum (50 percent of the committee)
  • Failure to review and approve by an appropriately configured IACUC
  • Lack of approval to significant changes to previously approved activities
  • Failure to promptly report cases of non-compliance
  • Lack of appropriate measures to assure that discomfort, distress, and pain in animals is avoided or minimized—especially post-procedural care. (22)

For more information


Sources

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

(2) Health Research Extension Act of 1985 (Public Law 99-158, Section 495) Available at http://grants.nih.gov/grants/olaw/references/hrea1985.htm

(3) US Laws and Norms Related to Laboratory Animals, ILAR Journal V40(1) 1999 Bioethics of Laboratory Animals Research, section on PHS Policy

(4) Iowa State University, Office of Research Compliance. http://www.compliance.iastate.edu/ComplianceWeb/coacFederalLaw.aspx

(5) Health Research Extension Act. Section 495 (d) (3) http://grants.nih.gov/grants/olaw/references/phspol.htm#HealthResearchExtensionActof1985

(6) PHS Policy on Humane Care and Use of Laboratory Animals. Section II - Applicability. http://grants.nih.gov/grants/olaw/references/phspol.htm#Applicability

(7) PHS Policy on Humane Care and Use of Laboratory Animals - Section IV (a). http://grants.nih.gov/grants/olaw/references/phspol.htm#AnimalWelfareAssurance

(8) Ibid.

(9) Potkay, Stephen and Dehaven William R. OLAW and APHIS: Common Areas of Noncompliance. Lab Animal, 2000; 29(5):32-37. Available at http://grants.nih.gov/grants/olaw/LabAnimal.pdf

(10) Guide for the Care and Use of Laboratory Animals.

(11) The Guide, Section: Evaluation Criteria

(12) The Guide, ANIMAL ENVIRONMENT, HOUSING, AND MANAGEMENT 37.

(13) The Guide, Section: Federally Mandated Function of the IACUC

(14) PHS Policy, Section IV (C) http://grants.nih.gov/grants/olaw/references/phspol.htm#ConductofSpecialReviews/Site%20Visits

(15) Office of Laboratory Animal Welfare, Compliance Oversight Procedures. August 8, 2007.

(16) PHS Policy, Section IV (A) (3) http://grants.nih.gov/grants/olaw/references/phspol.htm#AnimalWelfareAssurance

(17) Ibid.

(18) Ibid.

(19) PHS Policy, Section IV (B)(1)(2) http://grants.nih.gov/grants/olaw/references/phspol.htm#FunctionsoftheInstitutionalAnimalCareandUseCommittee

(20) PHS Policy, Section IV (B)(3) http://grants.nih.gov/grants/olaw/references/phspol.htm#FunctionsoftheInstitutionalAnimalCareandUseCommittee

(21) Ibid.

(22) Potkay, Stephen and Dehaven William R. OLAW and APHIS: Common Areas of Noncompliance. Lab Animal, 2000; 29(5):32-37. Available at http://grants.nih.gov/grants/olaw/LabAnimal.pdf

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