Under PHSPolicy, the primary responsibility for meeting applicable federal and state rules rests with the research facility or PHS awardee institution. The IO is the individual held responsible on behalf of the research facility for ensuring compliance. Failure to comply with PHSPolicy could result in OLAW’s withdrawal of approval of the institution’s Animal Welfare Assur-ance, thereby making the institution ineligible to receive funds for activities involving animals.
Under applicable statutory provisions (7 U.S.C. Section 2149), the USDA has the authority to order a facility to cease and desist, and to impose a fine for noncompliance with the AWRs and AWA. The AWA provides for penalties of up to $2,500 per count and one year in prison, or both for violations of the AWRs.
Freedom of Information
The Freedom of Information Act (FOIA), 5.U.S.C.552, provides individuals with a right to access to records in the possession of the federal govern-ment. The government may withhold information pursuant to the nine exemptions and three exclusions contained in the Act.
The Electronic FOIA Amendments of 1996 (Public Law 104-231) amended the law in a number of ways that primarily address information systems, use of telecommunications, and electronic reading rooms. Most federal agencies provide guidelines for submitting FOIA requests through their agency Web sites.
Information about federally conducted or supported research projects, PHS Assurance documents, USDA annual reports filed by research facilities, and inspection reports of USDA, Environmental Protection Agency (EPA) and FDA, are generally available to the public under FOIA.
Many states have public records laws and/or open meetings acts, known as “sunshine” laws, which may permit public access to information re-viewed and generated by the IACUC, and public attendance at IACUC meetings. However, even in some “sunshine” law states, the IACUC, because it serves in an advisory capacity to the IO, may hold closed sessions. IACUC members need to be aware of specific state laws regarding these issues and should always seek legal counsel if necessary to ensure compliance with applicable laws.
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B. Oversight of the
Animal Care and
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B.1. Program and Facility Review
The PHSPolicy and Animal Welfare Regulations (AWRs) stipulate that the IACUC must review the program for humane care and use of animals at least once every six months, using the Guide as the basis for evaluation for the PHS Policy and title 9, chapter I, subchapter A-Animal Welfare for the U.S. Department of Agriculture (USDA). Federal requirements also state that the IACUC must inspect all institutional animal facilities at least once every six months.
Benefits of the Reviews
Reviews provide an ongoing mechanism for ensuring that the insti-tution maintains compliance with applicable animal care and use policies, guidelines and laws.
Reviews serve as an opportunity for constructive interaction and education for the animal care personnel, research staff and IACUC members.
Reviews can help an institution prepare for subsequent visits by outside evaluators, such as USDA inspectors, Office of Laboratory Animal Welfare (OLAW) staff and Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) site visitors.
A summary of recurring IACUC issues related to semiannual program review and facility inspection identified by AAALAC during site visits is provided in Appendix C.
OLAW has developed a sample format for the program review and facility inspection that may be modified to meet the institution’s needs (see the OLAW Web site). The Table of Contents of the Guide or an institution’s AAALAC Program Description can also serve as an outline for the semi-annual evaluation.
Conducting Program Evaluations Key aspects of an animal care and use program that should be emphasized in the semiannual evaluation include:
IACUC membership, functions and procedures, including protocol review (e.g., using page 10 of the Guide as a template, and PHSPolicy IV.B. and C.);
facility inspection process;
provisions for reviewing and investigating concerns regarding animal care and use;
Specific procedures to accomplish program evaluation may include pre-sentations by appropriate individuals (e.g., the veterinarian, an occupational health and safety representative, etc.) and review of written institutional policies such as standard operating procedures, guidelines on use of anes-thetics and analgesics, and euthanasia procedures. Verifying conformance with the USDA Animal Care Policies (1999 et seq.) during the semiannual program review will help ensure that current practices are consistent with USDA regulatory interpretations.
All animal housing facilities must be inspected in the semiannual review, including:
satellite facilities (containment areas outside the central/core animal facility where animals are housed for more than 24 hours (PHS Policy),
areas in which surgical manipulations are performed (PHS Policy),
animal study areas (locations where USDA-covered species are held for more than 12 hours) (AWRs), and
holding facilities (AWRs).
Laboratories in which routine procedures, such as immunization, dosing, and weighing, are conducted may be evaluated by other means such as random inspections. However, the institution, through its IACUC, is still responsible for all animal-related activities regardless of where animals are maintained or the duration of the housing. The IACUC must have reason-able access to these areas for the purpose of verifying that activities involving animals are being conducted in accordance with the proposal approved by the IACUC.