4d. Federal and voluntary ovesight

OLAW, USDA, and a voluntary accreditation program (Association for Assessment and Accreditation of Laboratory Animal Care—AAALAC) are charged with or assume the task of assuring that research institutions live up to their responsibilities for the care and use of animals in research.

     OLAW. OLAW relies on an “assurance” mechanism to monitor institutional compliance with the PHS Policy. An “Assurance” is a signed agreement submitted by a research institution confirming that it will:

• comply with applicable rules and policies for animal care and use,
• provide a description of the institution’s program for animal care and use,
• maintain an appropriate IACUC, and
• appoint a responsible IO for compliance.

The Assurance is considered the cornerstone of a trust relationship between the institution and the PHS and grantsconsiderable authority to institutions for self-regulation.

An OLAW-approved Assurance and compliance with PHS policy are considered terms and conditions of receiving PHS funds. Compliance is monitored by OLAW through annual mandatory institutional reporting to OLAW and in the event of noncompliance, serious deviations from the Guide, or IACUC suspensions. OLAW conducts limited site visits and reviews, and if necessary conducts investigations of reported noncompliance. Institutions that fail to submit an Assurance or to live up to the terms of their Assurance can have their approval to use animals in research, teaching, and testing suspended.

     USDA. The animal welfare regulations also have mandatory reporting requirements, but USDA is an inspection-based system carried out by USDA Veterinary Medical Officers. Rather than allowing institutions to “assure” their own compliance, USDA visits sites, either announced or unannounced, to check whether institutions are in compliance. If violations are found, the institution is then subject to administrative fines and penalties.

     Accreditation programs. Animal use programs can be, and most large ones are, accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. AAALAC is “a private nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program.” It is governed by a Board of Trustees representing scientific, professional, and educational organizations. Its Council on Accreditation is composed of animal care and use professionals and researchers who conduct the program evaluations that determine which institutions are awarded accreditation.

AAALAC relies on widely accepted guidelines, such asthe Guide, and other peer-reviewed resources when evaluating an institution’s animal research program. During the accreditation process, AAALAC accreditors evaluate all aspects of an institution’s animal research program. If an institution meets AAALAC’s standards, it receives an accreditation for a specified period of time and can use this accreditation to demonstrate its commitment to high standards for the care and use of animals.