Laws and Regulations

Scope Note

The Office of Laboratory Animal Welfare ensures the humane care and use of animals in PHS-supported research, testing, and training by providing guidance and interpretation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals, supporting educational programs, and monitoring compliance with the policy. Regulatory documents and references can be found in this section.

Cover of the Public Health Service Policy on Humane Care and Use of Laboratory Animals from the U.S. Department of Health and Human Services.

PHS Policy

The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) provides the regulatory framework for the use of live, vertebrate animals in any activity supported or conducted by the PHS agencies and U.S. Department of Health and Human Services components, or with entities which have an MOU with NIH to apply the PHS Policy.

First page of Public Law 99-158 (Health Research Extension Act of 1985) document.

Health Research Extension Act of 1985

The Health Research Extension Act of 1985 (HREA) provides the legislative mandate for the PHS Policy.

Federal Register page outlining U.S. Government Principles for the utilization and care of vertebrate animals in research, testing, and training

U.S. Government Principles

The U.S. Government Principles provide the ethical framework for currently accepted approaches in the care and housing of research animals.

First page of Public Law 114-255 (21st Century Cures Act) document.

21st Century Cures Act

The 21st Century Cures Act was signed into law on December 13, 2016. It’s purpose was to accelerate research to improve human health, and to that end, it contained the mandate that federal agencies reduce the administrative burden on investigators.

USDA Animal and Plant Health Inspection Service cover page titled “Animal Care” with silhouettes of various animals.

Animal Welfare Act (Administered by USDA)

The Animal Welfare Act (AWA), administered by the U.S. Department of Agriculture, regulates the treatment of animals in some research, teaching, testing, exhibition, transport activities. While the AWA and associated regulations have some requirements for research institutions that are similar to those in the PHS Policy, there are several key differences. Institutions should be aware that the AWA may apply to an activity even though the PHS Policy does not, and vice versa.

Person using a laptop with digital icons representing legal or regulatory concepts.

Regulatory References

Additional regulatory references such as the Guide, the AVMA Guidelines for the Euthanasia of Animals, the International Guiding Principles, and the text of agency memoranda of understanding with NIH can be found here.

Resources

Contact


This page last updated on: August 6, 2026
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