Laws, Policies, and Standards Affecting the Care and Use of
Laboratory Animals in Research and Teaching

Individual faculty members who use animals in their research or teaching (including those whose research consists of field work involving animals) are, by law, accountable for conforming to the basic regulations and policies governing animal use on the UT Memphis campus. These regulations and policies cover:

• the acquisition, care and use of animals
• efforts to minimize animal pain and distress
• the training of personnel using animals
• consideration of alternatives to animal use
• methods whereby deficiencies in animal care and treatment are reported

As a matter of educational policy, faculty who do not themselves use animals should be aware of these regulations and policies since their students may use animals at a later time. Likewise, instruction of students in proper animal use is an essential component of graduate education in the biological and biomedical sciences.

Selected Laws and Regulations

As a registered research facility, the University of Tennessee, Memphis is regulated by the U.S. Department of Agriculture and complies with the Federal Animal Welfare Regulations. The Animal Welfare Act and the regulations which promulgate it contain specific requirements regarding the Institutional Animal Care and Use Committee, personnel qualifications, veterinary care, recordkeeping, as well as standards for animal health and husbandry. As part of their duties, the Institutional Animal Care and Use Committee reviews the university's program of humane care and use of laboratory animals and makes recommendations to the institutional official on matters involving compliance with regulations. The Committee is composed of a Chairman, a laboratory animal veterinarian, an unaffiliated member, a nonscientific member, and members who are scientists experienced with animal research.

One of the Congressional mandates of the 1985 amendment to the AWA is that investigators consider alternatives to painful procedures and assurance that pain and distress are minimized or avoided unless scientifically justified for research needs. As part of this amendment, Congress required the Secretary of Agriculture to establish the Animal Welfare Information Center at the National Agricultural Library to assist in searching for alternatives and other information that would help reduce or alleviate pain and distress in research animals.

Two additional requirements of the 1985 amendment pertain to providing nonhuman primates with an environment adequate to their psychological well being and providing dogs with the opportunity to exercise. The University of Tennessee, Memphis has implemented specific programs to ensure compliance with these requirements.

Each year the University is required to submit an annual report to the USDA, signed and certified by the institutional official (Chancellor or his designee) reporting the number and species of animals used by the University and whether pain relieving drugs were utilized as necessary or withheld because of research interference. This report also certifies that the University has complied with the regulations. Once submitted to the USDA, this report is accessible to the public through the Freedom of Information Act, as are reports generated from USDA compliance inspections.

Unannounced facility inspections are performed by the USDA to assess compliance with the regulations. As part of a compliance inspection, any area where animals are housed or used (i.e. investigator labs) are subject to inspection. Areas which are closely scrutinized during a compliance site visit by the USDA are survival surgical procedure areas, especially those which utilize larger animals such as dogs, cats, and pigs; nonhuman primate studies; and other studies which may involve pain or distress. From an animal care and regulatory standpoint, it is important that all survival surgical procedures utilize aseptic techniques and that major operative procedures in non rodents are conducted in dedicated surgical facilities such as those located in the DCM's Nash facility, Coleman facility, or the Department of Surgery's animal surgery facility. Equally important are the procedures, techniques, monitoring, etc. involved in post-anesthesia and post-surgical care. Areas of non-compliance are noted and correction deadlines are given. Repeated noncompliance or blatant violations that compromises the health or well-being of an animal are submitted for civil penalties or prosecution through the administrative law system.

The PHS Policy

National Institutes of Health require all institutions which receive Public Health Service support to comply with the PHS Policy on Humane Care and Use of Laboratory Animals and the NIH Guide for the Care and Use of Laboratory Animals.

As a PHS grantee institution, the University of Tennessee, Memphis maintains a letter of assurance on file with the Office of Protection from Research Risks at the NIH. This document, which is signed and certified by the Chancellor, assures the University's compliance with the Policy and guidelines. In a manner similar to the USDA animal welfare regulations under the AWA, the PHS policy implements the requirements of the 1985 Health Research Extension Act. As with the AWA, the PHS requires an IACUC and specific requirements regarding veterinary care, etc. For more information regarding the Federal Animal Welfare Act and the USDA regulations or the PHS Policy and the NIH Guide, please contact the Department of Comparative Medicine.

AAALAC International

This voluntary accreditation signifies that the University Program for the Care and Use of Laboratory Animals as having the highest recognition for its programs. The NIH Guide is the bible that we all use for assuring that standards are at the Gold Star level. This document was recently revised in July 1996 and all university activities using animals must be in compliance with new Guide by Jan 1, 1997

Other Regulatory Agencies and Policies

1. Public Health (USPHS) and Center for Disease Control (CDC)--Imported animals must be free from evidence of communicable diseases.
 
1. Dogs--Rabies, Echinococcus

 
2. Nonhuman Primates--Tuberculosis, Yellow Fever, Monkey Pox, Marburg-Ebola

 
3. Turtles--Salmonella

 
4. Psitticine Birds--Psittacosis
2. (USDA-APHIS)--Diseases of domestic livestock and poultry. Permit required to import ruminants, swine, poultry and other birds, other hoofstock. Permit required to import organisms or vectors, tissue cultures, cell lines, blood, serum, other animal products that could serve as a vector for animal pathogens i.e., fetal calf serum, polyclonal antibodies, animal tissue.
 
1. Cattle--Bovine Spongiform Encephalopathy, FMD, Rinderpest

 
2. Sheep--Scrapie, FMD, Rift Valley Fever

 
3. Swine--African Swine Fever, Hog Cholera, FMD

 
4. Fowl--Avian Influenza, Exotic Newcastle Disease
3. Endangered Species and Damaging (Pest) Species (USDI-USFWS)
 
1. Lacey Act--Harmful species i.e. Multimammae rat (Mastomys sp.), European rabbits (Oryctolagus sp.) that could be agricultural pest if released into wild.

 
2. U.S. Endangered Species Act and Convention on International Trade in Endangered Species (CITES) i.e. chimpanzee, gibbons, lemurs, other NHPs.

 
3. Marine Mammal Protection Act--covers all marine mammals (USDI-USFWS) and (NOAA-NMFS) i.e. dolphins, whales, sea lions.

Federal Agencies and Regulations-additional

The Centers for Disease Control and Prevention (CDC) regulate the importation of all nonhuman primates into the United States. Only organizations or individuals registered with the CDC may import nonhuman primates or receive them within a 31 day period of their arrival in the U.S. Importers are registered for a two-year period and importers must comply with CDC record-keeping and reporting requirements.

The Fish and Wildlife Service (Department of the Interior) is the federal agency charged with enforcing the Endangered Species Act and the Convention on International Trade in Endangered Species of Fauna and Flora (CITES). These regulations designate endangered or threatened species and, with limited exceptions, prohibit their use. Institutions which seek to use species covered by the Act for scientific research must obtain a permit from the Federal Wildlife Permit Office. If an institution needs to import or export an endangered or threatened species, appropriate documents must be obtained in advance as required by CITES.

The Animal and Plant Inspection Service (APHIS), an office of the United States Department of Agriculture (USDA), requires that individuals who intend to import animal materials into the United States must obtain an appropriate permit. To obtain information on the importation of biological materials of animal origin or derivation, contact the Import-Export Product Staff of APHIS' Veterinary Service Program at (301) 436-7885. Contact DCM 448 5656 for assistance.

The Drug Enforcement Act (Public Law 93-205) is enforced by the Drug Enforcement Administration (DEA) of the Department of Justice. This Act requires appropriate security and record management of substances considered to be potentially addictive or habituating for human and animal use.

The Food and Drug Administration (FDA) is involved in the regulation of animal care because it sets standards for the testing of foods, drugs and other chemicals which will be used by or come into contact with humans. Federal regulations require animal testing for toxicity or carcinogenicity before these substances are approved for human use. The FDA established Good Laboratory Practices (GLP) regulations under which this testing is done. The regulations require extensive documentation and quality assurance procedures for facets of animal care including quarantine and isolation, disease diagnosis, animal identification, routine animal husbandry, caging, sanitation, and training and qualifications of personnel working with animals.

State Agencies and Regulations State Laws--All states and the District of Columbia have anticruelty laws. Some states have additional regulations addressing animals in medical research. TN has a research vivarium vandalism statute. Several states and cities (Memphis) have laws regulating the release of pound animals for research purposes.

Contact DCM for specifics on interstate and intrastate information.

Field Research Guidelines

With the revision of the Public Health Service (PHS) Policy in 1986, the National Science Foundation announced that it would require investigators to comply with PHS Policy and that the Policy would apply to all vertebrate animals including field, as well as laboratory research. In addition, the recent enactment of the Amendment to the Animal Welfare Act emphasizes that all warm-blooded wild or exotic animals used for research, teaching, testing, and field studies when such studies involve an invasive procedure or alter the animals' behavior, are included under the regulations of the Animal Welfare Act.

Both federal law and the PHS Policy mandate the Institutional Animal Care and Use Committee (called the IACUC at UT Memphis) review the proposed use of wild or exotic animals for accepted humane policies involving field and/or laboratory research with vertebrate animals.

These guidelines for field research were formulated by the relevant professional societies including the mammologists, ornithologists, herpetologists, and ichthyologists. The guidelines, in general, deal with issues such as collection procedures, humane methods of euthanasia, identification practices, methods for collection of tissue and blood samples in the field, and transport and release of specimens. Guidelines can be obtained by contacting the DCM as to this area.

The IACUC's primary concern when reviewing the use of any animal in laboratory or field research or for educational use is the humaneness of the intended study. Members of the IACUC use the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training (shown above) when reviewing proposed animal studies since they apply to all vertebrate animals regardless of the location or conditions of the intended study.

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

The following principles were developed by the U.S. Government's Interagency Research Animal Committee. Both PHS Policy and Stanford University policy require that all research and teaching uses of animals conform to these Principles, which are reproduced below:
1. The transportation, care and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et seq) and other applicable Federal laws, guidelines and policies.

 
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge or the good of society.

 
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in-vitro biological systems should be considered.

 
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.

 
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals.

 
6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure, or, if appropriate, during the procedure.

 
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.

 
8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.

 
9. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as the institutional animal research committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

 
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