7 - Federal Agencies Responsibilities



Two federal agencies have oversight responsibility of animal care and use programs. These agencies share a common concern for the care and welfare of laboratory animals used in research and testing. Each agency operates under its own authority and has specific responsibilities for fostering proper animal care and welfare. These follow below:

  • Animal and Plant Health Inspection Service, USDA

Primary responsibility for the Animal Welfare Act (AWA) is assigned to the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS). Implementing regulations of the AWA are established in the Code of Federal Regulations, Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3. The Department has regulatory responsibility to enforce the implementing regulations. The USDA regulations establish standards for the humane treatment of laboratory animals and a registration/licensing procedure for identifying institutions that breed, sell, transport, hold, and use such animals. Compliance with the USDA regulations is monitored by an active inspection program that provides for periodic inspections by veterinary medical officers or suitably trained paraprofessionals. Serious noncompliance is dealt with by procedures that range from civil penalties, to the issuance of "cease and desist" orders, to the confiscation of animals.

  • National Institutes of Health, HHS

The Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, National Institutes of Health (NIH), is responsible for the implementation and general administration of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy implements the Health Research Extension Act of 1985 (Public Law 99-158), and is based on the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Standards for institutional programs and facilities are described in the Guide for the Care and Use of Laboratory Animals. Institutions receiving PHS support must have an OLAW approved Animal Welfare Assurance that describes the institutional program and sets forth institutional compliance with PHS Policy. OLAW fosters compliance through the Assurance mechanism and a national education program, and monitors compliance by evaluating institutional reports of noncompliance. Institutions are required to correct confirmed noncompliance and institute appropriate measures to prevent repeated noncompliance. Potential sanctions for continued noncompliance appear in the NIH Grants Policy Statement, Part II, under authority derived from 45 CFR § 74.14 and 42 CFR § 52.9.

Source: Final MOU - http://grants.nih.gov/grants/olaw/references/finalmou.htm