United States 

Department of 

Agriculture Animal Care

www.aphis.usda.gov/animal_welfare April 2014

n APHIS

APHIS enforces the Animal Welfare Act (AWA), which was passed by Congress in 1966. The AWA is the 

foundation of humane animal care in research facilities. This law requires all facilities that use certain warmblooded 

animals (except rats, mice, and birds) in research to provide veterinary care, an appropriate diet, potable water, 

clean and structurally sound housing, protection from weather and temperature extremes, and safe handling during 

transportation. All non-Federal facilities must register with APHIS and are subject to unannounced inspections 

by APHIS Animal Care (AC) personnel. AC inspectors observe and assess animal health and thoroughly review 

all AWA-required records and documentation. Every research facility must be inspected at least once annually, but 

more inspections may be required. Serious or repeated instances of noncompliance may result in an enforcement 

action. In addition to regulatory responsibilities, AC offers and supports many training and educational programs 

on humane animal care.

n NIH

NIH is the largest source of funding for medical research in the world, and is made up of 27 Institutes and 

Centers, each with a specific research agenda, often focused on particular diseases or body systems. Before NIH 

and other Public Health Service (PHS) agencies award a grant or contract that involves the use of animals, the 

recipient institution and all performance sites using animals must have an Animal Welfare Assurance approved by 

NIH’s Office of Laboratory Animal Welfare (OLAW). Animals used in funded activities must receive humane 

care in accordance with the PHS Policy on Humane Care and Use of Laboratory Animals. Under the regulatory 

authority of the Health Research Extension Act, OLAW monitors funded institutions by evaluating self-reported 

noncompliance, annual reports, and potentially by conducting site visits. If noncompliance is identified, OLAW 

gives the institution a reasonable opportunity to take corrective action. If no action is taken, OLAW may restrict 

or withdraw the institution’s Assurance agreement which precludes the receipt of PHS funds for the conduct of 

animal activities. OLAW also supports educational programs and investigates allegations concerning research animal 

welfare to ensure the humane care and use of animals in PHS-supported research, testing, and training. 

n FDA

The FDA is responsible for ensuring good laboratory practice in FDA-regulated product development. When 

animal testing is done to support applications for such products, manufacturers and sponsors must follow FDA’s 

regulation, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Under authority of the Federal 

Food, Drugs, and Cosmetics Act, FDA’s Office of Regulatory Affairs conducts unannounced inspections of research 

facilities every 2 or 3 years depending on the number of GLP studies being performed. Findings of noncompliance 

with GLP standards may result in rejection of data and the denial of a product for market. There are five animal 

research facilities in FDA; all are accredited by the Association for the Assessment and Accreditation of Laboratory 

Animal Care International, all are OLAW assured, and those that conduct research with regulated species are 

registered with USDA. FDA investigators who use animals in research and testing are required to receive training 

on humane animal care and use.

Federal Oversight of Animal Use in Research Facilities

The three agencies involved with overseeing the welfare of animals used in research are the 

U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) and two 

U.S. Department of Health and Human Services agencies: the National Institutes of Health (NIH) 

and the Food and Drug Administration (FDA). While each agency has distinct authorities and 

areas of responsibility, they also collaborate to make sure laboratory animals receive the level of 

care required under Federal regulations. All three agencies also require research facilities to have 

an Institutional Animal Care and Use Committee (IACUC). This oversight body is empowered 

to conduct facility inspections, investigate complaints of inhumane animal care, and approve or 

suspend animal research activity.

[continued, reverse side]

Factsheet

Animal and Plant Health Inspection Service

APHIS 41-05-011
United States 

Department of 

Agriculture

www.aphis.usda.gov/animal_welfare

Animal Care Factsheet

n Working Together

APHIS, NIH, and FDA have a longstanding Memorandum of Understanding (MOU) setting forth a framework 

for reciprocal cooperation. This agreement is intended to maintain and enhance agency effectiveness while avoiding 

duplication of efforts to achieve required standards for the care and use of laboratory animals. The MOU also details 

an agreement to exchange information resulting from investigations, inspections, or site visits as well as information 

about actions taken in response to these findings. This enables the agencies to coordinate evaluations and reduce 

regulatory burden and redundancy. Matters of serious animal welfare concern are shared among the agencies. Some 

incidents or noncompliances are not mutually reported because the agencies operate under differing regulatory 

authorities and mechanisms of oversight. In addition, routine information from inspections, investigations, and 

record reviews is not generally shared. 

n More Information

For more specific information about the AWA and its regulations and standards, visit APHIS’ Animal Care Web 

site at www.aphis.usda.gov/animal_welfare. To learn more about NIH, FDA, and their respective regulations, visit 

www.nih.gov and www.fda.gov.

To view the MOU between these agencies, please go to http://grants.nih.gov/grants/olaw/references/finalmou.htm.

USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, 

sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720-2600 (voice and TDD). 

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326-W, Whitten Building, 1400 Independence Avenue, SW, 

Washington, DC 20250-9410 or call (202) 720-5964 (voice and TDD). USDA is an equal opportunity provider and employer.