IACUC Learning Module - Laws & Regulations | Previous Next |
The original law was quite limited and many animals were excluded. However, the law has been amended several times and now includes virtually all warm-blooded vertebrates used for research, teaching or testing. (Research includes field studies as well as more traditional laboratory studies). Farm animals and horses used for biomedical research are included; farm animals used strictly for agricultural research are not at this time covered by this law.
The Act is administered by the U. S. Department of Agriculture-Animal Plant Health Inspection Service - Regulatory Enforcement and Animal Care (USDA-APHIS-AC). At least twice a year, unannounced inspections of research institutions are conducted by USDA-APHIS-AC veterinarians; they have the authority to inspect all housing areas, laboratories and offices where animals or records pertaining to animals are kept. The AC veterinarian will check for compliance with the thousands of rules and regulations written to implement the law (contained in the Code of Federal Regulations Title 9, Subchapter A, Parts 1-4).
Penalties under the Animal Welfare Act range from monetary fines ($2500 per day/violation-paid by the Institution) to an issuance of a "Cease and Desist Order". With abuse or life-threatening violations, USDA-APHIS-AC may request that project funds be suspended.
Violations of the PHS Policies may result in loss of
ALL PHS funding. Specific requirements are contained in a publication entitled, the Guide for the Care and Use of Laboratory Animals.
In addition to these important laws, there are several associations that have guidelines which impact on research and teaching institutions.
American Veterinary Medical Association Panel on Euthanasia
The recommendations of the AVMA Panel are the prime reference for methods of euthanasia of animals for both the Animal Welfare Act and the PHS policy.
All members of the University of Arizona community with potential exposure to animals or animal by-products are enfolded into the Animal Hazard Program. The program is administered by the Occupational Health Service (OHS) of the Campus Health Center under the direction of the Institutional Animal Care and Use Committee. All members are assessed for risk potential and assigned into a risk category. This is accomplished by a combination of on-site visits by a representative of the OHS and individual risk assessment at the Campus Health Center. Each risk category is monitored according to the potential for hazard exposure. Annually, all supervisory personnel are required to attend a training class. It is expected that costs are minimal to nonexistent to the individual or departments involved.
It is important to remember that participation in this program is mandatory with noncompliance potentially resulting in suspension of research grants and loss of the university's accreditation.
Questions about this program should be directed to Dr. Michael Rand, 626-6705. Appointments for the Occupational Health Clinic may be made at 626-6363.
PUBLIC HEALTH SERVICE
(PHS) POLICY: Each institution using animals in PHS sponsored projects must provide a written assurance of compliance (the assurance document is available for review at the Directors' office, College of Medicine Room 1128). ARIZONA GAME & FISH and AGENCIES such as FISH & WILDLIFE SERVICE:
A project using animals covered under State or Federal regulations may not proceed unless the investigator obtains valid permits for collection, purchasing, transporting and holding of these animals. The investigator is responsible for obtaining and maintaining valid permits.
If you have questions, please call the Protocol Coordinator at 621-9305.GOOD LABORATORY PRACTICES:
The Food and Drug Administration (FDA) requires the creation of Standard Operating Procedures for nonclinical safety assessment studies (such as drug toxicity and efficacy, new medical devices and food additives). When you are planning a research project where findings will be reported to the FDA, it is imperative that you notify University Animal Care and
Marilyn Marshall with the Quality Assurance office at 621-1469. There are complex and exacting procedures for record keeping and failure to follow the Standard Operating Procedures may render the study inadmissible for FDA review. CONTROLLED SUBSTANCE ACT:
Drugs which have the potential for addiction are classified under the law. The Department of Justice, Drug Enforcement Administration (DEA) enforces the law.
A principal investigator must obtain a DEA license to order and use scheduled drugs; all such drugs must be kept under double locked conditions and records of use must be kept for review by DEA officials. For information, write: U.S. Dept. of Justice, DEA, 3010 N. 2nd St, Suite 301, Phoenix, AZ 85012 or (602)664-5600.ARIZONA RESEARCH FACILITY PROTECTION ACT:
It is a class 6 felony for a person "to intentionally release an animal that is lawfully confined for scientific, research, commercial or educational purposes without the consent of the owner".
ARIZONA ANIMAL CRUELTY LAW:
The Animal Cruelty law does not exempt research animals from coverage. Therefore, persons committing cruel or abusive acts against research animals could be charged under this law and sentenced to jail.ARIZONA LAW:
Arizona permits unclaimed pound animals to be released for research. Most animal shelters and pounds in Arizona have chosen not to do so because of adverse public reaction.
Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
AAALAC is a voluntary organization and makes recommendations based on results of site visits. This is a peer review process in which standards are being continually upgraded to reflect current knowledge in laboratory animal science.
Unlike the Animal Welfare Act or the Public Health Service Policy, AAALAC reviews the quality of animal care for ALL animals (including invertebrates). The University of Arizona is fully accredited.UNIVERSITY OF ARIZONA'S ANIMAL HAZARD PROGRAM:
The Interagency Research Animal Committee (IRAC), composed of representatives of federal agencies that use or regulate the use of animals in research, asked the National Research Council (NRC) to conduct a study and produce a report that would provide for protecting the health and safety of workers who care for and use research animals. The need for such guidance was based both on the recognition of the broad array of occupational hazards when animals are used in research or educational activities and on the absence of authoritative guidance that institutions could use to develop appropriate occupational health and safety programs within their animal research facilities. The IRAC and NRC consider this study particularly important because grantees of the U.S. Public Health Service are required to address the need for an occupational health program.
This report, entitled Occupational Health and Safety in the Care and Use of Research Animals, has now been released for compliance by research institutions.
Previous PageNext Page
Back to Training Modules
Back to Table of Contents
