The phs policy differs from the animal welfare act because it applies to which animals?

Animal Research

The use of animals in research is a key area of RCR because it is controversial. While animal research has improved the health of animals and humans, animal rights groups have been vocal in their opposition to experimentation on animals.

Key ethical questions concerning animal research include the following:

• Can the potential benefits to human health and welfare justify procedure that may result in discomfort to animals?
• Do animals have rights similar to or different from those of humans, which should influence how we understand the ethics of research with animals?
• Are all animals equal? (For example, is experimenting with insects morally equivalent to experimenting with non-human primates?)
• Do researchers have obligations towards animals under their care and control that they do not have towards wild animals of the same species because of the relationship created by having the animals in their care?

Most people who accept animal research believe that researchers have responsibilities towards animal subjects. The most basic responsibility is that experiments must have scientific merit. In addition, research projects must incorporate the three “R’s” of animal research.

What Rules Apply?

In 1966, Congress passed the Animal Welfare Act (AWA) establishing legal standards for laboratory animal care and use and appointing the US Department of Agriculture as the agency responsible for implementing and enforcing the law. Their legal oversight applies to select animals used in research. Public Health Service’s (PHS) Policy on the Humane Care and Use of Laboratory Animals (2000) also applies to PHS funded research. The Office of Laboratory Animal Welfare (OLAW) implements PHS policies.

Federal rules for animal research programs are summarized in the Institutional Animal Care and Use Committee Guidebook, issued most recently in 2002. The Guide is also followed by institutions engaged in animal research in the implementation of their animal care and use program. The program must include:

• Replacement-replacing animals with other experimental systems, such as tissue cultures or computer modeling, when possible and replacing “higher” animals with “lower” animals.
• Reduction-using the minimum number of animals for valid research results and not repeating one’s own or another’s experiments without compelling reasons.
• Refinement-designing research to minimize harms to animals including pain, suffering, disability, and death.
• An Institutional Animal Care and Use Committee (IACUC)
• Procedures for self monitoring
• An adequate veterinary care program
• An occupational health and safety program
• A personnel training program
• An environment, housing, and management program for animals
• Appropriately maintained facilities for housing and support

The Guide also specify the authority of the IACUC in the oversight of the animal care program for that institution. IACUCs must review all projects involving animal to ensure they meet humane and scientific standards. They can approve, disapprove, or require changes for approval of projects. They can suspend or terminate approval of research that is not being conducted in accordance with the IACUC's decisions, conditions, and requirements, or that has been associated with unexpected serious harm to animal subjects. IACUCs also conduct semiannual reviews of the institution’s program. There must be an organized training program for all that conduct animal research.

The Animal Welfare Act

The Animal Welfare Act is a federal law which was passed in 1966 to regulate animal research facilities, animal dealers and exhibitors, operators of animal auction sales, and carriers and intermediate handlers of animals in shipment. Species covered by the Animal Welfare Act are dogs, cats, rabbits, guinea pigs, hamsters, gerbils, nonhuman primates, marine mammals, captive wildlife, and domestic livestock species used in nonagricultural research and teaching. The Act and its amendments, as applied to research and teaching institutions, regulate the transportation, purchase, husbandry, and management of animals used or maintained in the institution.

The Animal Welfare Act requires that research institutions: 1) have an effective Institutional Animal Care and Use Committee, 2) have a veterinary care program in place, 3) have only qualified personnel using or caring for live animals, and 4) have a mechanism in place for reporting of concerns regarding animal care and use at the institution.

The Animal Welfare Act is administered through the United States Department of Agriculture (USDA) and is enforced through unannounced inspections by a USDA Veterinary Medical Officer. During inspections, the USDA veterinarian does have the right to observe laboratory personnel in the performance of their duties and to take photographs of noncompliance with the regulations. Inspection reports are available to the public through the Freedom of Information Act.

Violations of the Animal Welfare Act may result in fines, legal action or suspension of federal support for animal research.

The Public Health Service Policy on the Humane Care and Use of Laboratory Animals

The Public Health Service (PHS) Policy is based on the "US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching" which were developed by the Interagency Research Animal Committee. The requirements of the PHS policy are very similar to those listed above for the Animal Welfare Act.

The PHS policy is not federal law. However, institutions must be in compliance to qualify for funding from any PHS member agency. In addition, many funding agencies outside the PHS are adopting the PHS standards of animal care and use as described in the Guide for the Care and Use of Laboratory Animals (ILAR Guide), developed by the Institute for Laboratory Animal Resources. The PHS policy applies to all live vertebrate animals used in teaching, research and testing. The Guide describes the elements of acceptable institutional policies and veterinary care programs as well as specific physical requirements for the animal facility. The Guide for the Care and Use of Agricultural Animals in Research and Teaching also serves as a standard where agricultural animals are being used in agricultural research and teaching.

In order for an institution to be eligible for PHS funding it must have on file with the Office for Laboratory Animal Welfare (OLAW) an approved Animal Welfare Assurance Statement. This document describes the institution's animal care and use policies, the line of authority for animal care at the institution, veterinary care program, personnel and facilities. The PHS may approve the Assurance Statement for up to five years with a required annual report to OLAW in the intervening years. Although the PHS does not conduct regular inspections of each facility, any awardee institution may be inspected by a PHS team at any time. The PHS is required to investigate all complaints received on PHS funded projects.

Failure to comply with the PHS policy may result in suspension of a research contract or termination of PHS support for all projects involving animals at the institution.

Additional Resources

Veterinary Care Program, a brief description of ISU's veterinary care program

AVMA Guidelines on Euthanasia, 2020 Edition

What animals does the PHS Policy apply to?

What aspects are covered by the PHS Policy?

Which of the following animals are protected by the U.S. Animal Welfare Act?

Who must comply with PHS Policy?