Rutgers LAS - Animal Research, Laws and Regulations

DOCUMENT/ORGANIZATION	STATUS	OVERSIGHT BY:
Animal Welfare Act	Federal Law	USDA
Principles for the Care and Use of Animals Used in Testing, Research and Education	Principles endorsed by 9 federal agencies	Federal agencies including Health and Human Services (including PHS and NIH)
PHS Policy on Humane Care and Use of Laboratory Animals	PHS policy – applies to all PHS funded grants and contracts. PHS’s implementation of the above Principles	Office of Laboratory Animal Welfare (OLAW, formerly OPRR), NIH, PHS, HHS
Health Research Extension Act of 1985	Federal law – gives statutory basis for pre-existing PHS Policy	NIH
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)	Non-profit, "voluntary" accrediting organization	AAALAC
Guide for the Care and Use of Laboratory Animals	Guidelines used by PHS Policy and AAALAC. Revised 1996	Written by an NRC committee, used by NIH and other organizations
2000 Report of the AVMA Panel on Euthanasia	The Guide defers to the AVMA report as the standard for acceptable methods of euthanasia	Used by AAALAC, NIH, IACUC’s, etc.
Institutional Animal Welfare Assurance of Compliance to PHS	Required by PHS Policy in order to receive PHS funds for animal research at Rutgers	OLAW for PHS. ACFC at Rutgers
Rutgers University Animal Welfare Policy	Internal policy	Animal Care and Facilities Committee (ACFC)

The new era of the animal rights movement has meant a wide range of activities, from demonstrations to illegal break-ins, resulting in increased media attention and attendant activity in federal and state legislatures. Due to tremendous constituent pressure and in an effort to strike a proper social balance between scientific needs and animal welfare, the U.S. Congress passed two pieces of legislation in 1985 which directly affect the use of animals in research.

The intent of this chapter is to provide an overview of the laws and regulations governing animal research including the two new laws passed in 1985-the Health Research Extension Act of 1985 (P.L. 99-198) and the Improved Standards for Laboratory Animals Act amending the Animal Welfare Act (P.L. 99-148). Every investigator and staff member who uses animals in research projects is governed by one or both of these laws. It is therefore essential that you have a sound understanding of both your rights and responsibilities in relation to the conduct of animal research.

Both the Public Health Service Policy and the amendments to the Animal Welfare Act stress increased self-regulation and greater public accountability. The ultimate responsibility for all animal research lies with the institution, but in both laws, the mandatory animal care committees are vested with oversight responsibility.

On September 1, 1985, the Executive Office of the President issued an Animal Welfare Policy Governing the Use of Animals in Research, Instruction and Demonstration.

The University Policy requires adherence to the Animal Welfare Act, the NIH Guide and the PHS Policy. Most importantly, the University Policy applies to all procedures using live vertebrate animals at the University regardless of funding source or species.

The Animal Welfare Act is the federal statutory authority for inspection of research facilities. It was originally passed in 1966 and subsequently amended in 1970, 1976 and 1985. The Act falls under the jurisdiction of the Secretary of Agriculture, with responsibility for administration delegated to the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS). APHIS is responsible for regulating not only research facilities but also animal dealers, exhibitors (including zoos, aquariums, circuses, etc.) and intermediate handlers of animals, including air and truck lines.

Whereas the PHS Policy affects only those institutions receiving Public Health Service funding, the Animal Welfare Act covers all research facilities in the U.S. that use laboratory animals in basic and biomedical research, education and product safety testing. Wild rats and mice are covered by the Act. Laboratory rats and mice, birds and some farm animals are not covered by the Animal Welfare Act regulations, and facilities using only those species do not have to be registered with the U.S. Department of Agriculture.

The Animal Welfare Act was historically concerned primarily with basic animal husbandry and veterinary care. The Guide, PHS and AAALAC are concerned not only about animal welfare, but the whole animal research environment, including personnel safety, and factors which although they might not adversely affect animal welfare, might interfere with the integrity of animal research projects. In this sense, regulations of the Animal Welfare Act are less rigorous than the guidelines set forth in the NIH Guide. As federal law, however, the Act allows little room for interpretation, whereas the recommendations of the Guide are meant to be used with professional judgement.

Existing statutory language prohibiting promulgation of rules or regulations with regard to "design, outlines, guidelines or performance of actual research" was revised to make exceptions for certain of the new standards.

As of August 15, 1990, all of the above regulations implementing the 1985 amendments were finalized. New regulations for Part 3, "Standards", were finalized at a later date. These new regulations include :

The principles below were prepared by the Interagency Research Animal Committee. This committee, which was established in 1983, serves as a focal point for federal agencies' discussions of issues involving all animal species needed for biomedical research and testing. The committee's principal concerns are the conservation, use, care, and welfare of research animals. Its responsibilities include information exchange, program coordination, and contributions to policy development.

The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research or training procedures involving the use of vertebrate animals, the principles shall be considered; and whenever these agencies actually perform or sponsor such procedures the responsible institutional official shall ensure that these principles are adhered to:

Institutions such as Rutgers which conduct U.S. Public Health Service (PHS) - supported animal research must comply with the Policy on Humane Care and Use of Laboratory Animals. The Policy, administered through the National Institutes of Health, Office of Protection from Research Risks, has evolved over the last twenty years. The Health Research Extension Act of 1985 Section 495 "Animals in Research," put a statutory foundation under the Policy.

As revised to meet new legal requirements effective in September 1986, following are the key elements of the Policy.

Written documentation of Rutgers's commitment to animal welfare is required in the form of detailed information on the animal care and use program. Institutions are required to designate clear lines of authority and responsibility for those involved. Each institution must identify an official who is ultimately responsible for the institution's animal program and a veterinarian qualified in laboratory animal medicine who will participate in implementation. The program description must also give details concerning veterinary care, animal husbandry and all animal facilities. A synopsis of mandatory training or instruction in the humane practice of animal care and use as well as the occupational health program for all personnel involved with animals must also be included in the assurance statement. Rutgers must ensure that the laboratory animal facilities meet the requirements outlined in the Guide for the Care and Use of Laboratory Animals. At Rutgers, the function of the Institutional Animal Care and Use Committee is delegated to two committees, the Animal Care and Facilities Committee and the Institutional Review Board for the Use and Care of Animals.

Rutgers has an Animal Welfare Assurance on file with OPRR. The effective date is April 27, 1987. The Assurance Number is A-3262-01.

The centerpiece of each research facility's animal research program is the mandatory Institutional Animal Care and Use Committee (IACUC). At Rutgers, the functions of the IACUC are delegated to two committees, the Animal Care and Facilities Committee and the Institutional Review Board for the Use and Care of Animals.

The research institution must keep on file the Animal Welfare Assurance, the minutes of IACUC meetings, records of IACUC review of research projects, and semi-annual IACUC reports and recommendations and records of determinations of accrediting bodies. Annual reporting requirements must include gain or loss of AAALAC accreditation, program or facility changes, IACUC membership changes, the dates of the semiannual IACUC reports and any minority views. If there are no changes, a statement indicating such must be submitted.

All PHS awarding units must have an Animal Welfare Assurance verification of IACUC review and approval on file.

The University is required to conduct a semi-annual self-assessment of its animal research program and facilities based on the Guide for the Care and Use of Laboratory Animals. Deficiencies in the program or facilities are reported to the responsible institutional official along with a timetable for correction of the deficiencies.

In addition to the Animal Welfare Act and the Public Health Service Policy, several other federal laws and regulations govern the acquisition and care of animals used in research and product safety testing.