Stanford School of Medicine
Comparative Medicine–

Laws, Policies, & Standards



Introduction

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 Stanford campus. These regulations and policies cover:

The privilege of using animals for research and teaching is accompanied by both ethical and legal responsibilities to use them in humane ways and in appropriate numbers. The use of animals in research and teaching is heavily regulated by federal, state, and local laws. These laws and regulations are the result, in part, of the pressures of animal activists groups and the failure of a few members of the scientific community to deal appropriately with animals. For their own protection, and for the protection of their institution, investigators who use animals must know, understand, and comply with applicable laws, and they are responsible for instructing their students and employees. The laws governing the use of animals, like those governing other regulated activities (e.g., the dispensing of controlled substances) are framed to ensure compliance via both civil and criminal laws; failure to comply can carry penalties that range from substantial fines to "cease and desist" orders which can suspend all research using animals at the offending institution and all funding for research. These regulations are typically applied against an entire institution, thus the innocent are punished as well as the guilty. These regulations are not subject to negotiation or individual interpretation by investigators. Both the professional reputation and the financial well-being of institutions which have failed to comply have suffered. For these reasons, the prudent investigator will be attentive to complying with these regulations and will encourage colleagues to do the same.

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.


Animal Welfare Act

The federal Animal Welfare Act (AWA) of 1966 and its amendments regulate the transportation, purchase, care, and treatment of animals used in research. The Act specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, and wild animal species intended for use in research. It should be noted that birds are currently excluded from the Act, as are rats (Genus Rattus) and mice (Genus Mus) that are specifically bred for research. Farm animals are now included if they are being used for purposes other than food or fiber production.

The 1985 amendments to the AWA address such issues as exercise for dogs; care of nonhuman primates to ensure their psychological well- being; the composition and duties of the Institutional Animal Care and Use Committee (IACUC); responsibilities of the attending veterinarian; and training of all personnel using laboratory animals in experimentation. The amendments also require the IACUC to review all protocols using animals to enusre that they meet criteria listed in the amendments, and to conduct semiannual inspections of all animal study areas and animal facilities.

The Animal Welfare Act is administered by the United States Department of Agriculture (USDA). Research facilities are subject to unannounced inspections by USDA veterinarians, and are required to file an annual report listing the species and numbers of animals used in research, and certify that anesthetic, analgesic, and tranquilizing drugs are used appropriately during research and testing.

Failure to comply with USDA standards may result in civil or criminal prosecution and suspension of animal research activities at the entire institution.


Public Health Service Policy (PHS Policy)

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, otherwise known as the PHS Policy, requires each institution which receives PHS funds for research involving animals to file an Animal Welfare Assurance Statement with National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW). This statement commits the institution to compliance with the Animal Welfare Act, the ILAR Guide for the Care and Use of Laboratory Animals (the Guide), the Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (quoted below), and other applicable laws and regulations. The statement must describe in detail the institution's program for the care and use of animals (including mice, rats, and birds) and its program for assuring compliance with the PHS Policy.

Stanford's Animal Welfare Assurance identification number is A3213-01. A list of institutions with Assurance Statements currently on file with OLAW/NIH is available online.

The PHS Policy requires institutional animal care and use committees to approve the care and use of animals as proposed in PHS grant applications before funds will be awarded. Animal care and use committees also are required to conduct semiannual assessments of the institution's program for care and use of animals, using the Guide as a basis for evaluation. Significant deficiencies in the institution's program must be identified, and the institution must adhere to an approved plan and schedule for correction of the deficiencies.

An institution's failure to comply with these policies may lead to various actions, including the termination of PHS support for all projects.

Copies of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, and/or the ILAR Guide for the Care and Use of Laboratory Animals are available online and through the office of the Administrative Panel on Laboratory Animal Care (A-PLAC) by calling (650) 723-4550.


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 inservice 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.

Other Regulatory Agencies and Policies

The use of specific animals (e.g., nonhuman primates, ferrets, Xenopus toads), certain procedures (e.g., drug or device testing, use of biohazardous agents or radioactive isotopes, carcinogens, etc.), may be subject to additional regulation at the federal, state, or institutional level.


Federal Agencies and Regulations

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. The Stanford Biosafety Officer in the Department of Environmental Health and Safety can also be contacted at (650) 725-1473 for information on importing these materials.

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 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

The California Department of Fish and Game administers state law which regulates the importation, quarantine and housing of nonindigenous wildlife species and the collection and use of California native species (California Administrative Code, Title 14, Sections 671-671.4). Institutions seeking to import restricted or prohibited species for research must obtain the appropriate permits through the Animal Welfare section of this department. These regulations are intended to protect native California wildlife and the public from diseases which may be carried by imported wildlife.

The California Department of Health Services is charged with investigating reportable infectious human diseases which have a possible zoonotic source. This agency is also responsible for the regulation of importation of non-native birds and mammals into California. The Department publishes a list of species which can only be imported by permit and sets quarantine requirements for non-native and non- domesticated species. In particular, carnivores which are neither native nor domesticated must be quarantined for a period of 90 days, and nonhuman primates must be quarantined for a period long enough to include two tuberculin tests spaced 30 days apart.


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 (AWA) 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 AWA.

Both federal law and PHS Policy mandate the Institutional Animal Care and Use Committee (called the Administrative Panel on Laboratory Animal Care, or A-PLAC, at Stanford University) 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. Copies of the guidelines can be obtained by contacting the A-PLAC at (650) 723-4550. Copies of guidelines for field studies can also be found at the following links:

The A-PLAC'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 A-PLAC 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.


Accreditation of Stanford Facilites

In June, 1988, Stanford University was granted full accreditation by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). AAALAC is a non-profit organization directed by thirty-one research, educational, and health organizations. Accredited facilities must submit annual reports and have their program and facilities evaluated for compliance with the requirements and recommendations of the ILAR Guide for the Care and Use of Laboratory Animals at least every three years.


Stanford Policy of the Use of Vertebrate Animals in Teaching Activities

STANFORD UNIVERSITY
Approved by the Senate of the
Academic Council on April 6, 1989

It is the policy of Stanford University that the use of either live or deceased vertebrate animals for solely instructional purposes is permitted when 1) the cognizant instructor(s) judges that the educational goals of the program or course will be best achieved by such usage and when 2) the Administrative Panel on Laboratory Animal Care determines such usage is humane, proper, and appropriate, consistent with government principles and regulations for the utilization and care of vertebrate animals used in teaching and research. Only the minimum number of animals essential to instructional objectives should be used. Instructors should be encouraged to use alternatives to animals whenever feasible.

Information to Students. Academic departments and programs should alert prospective students if any courses which are required for a major or degree involve the use of animals. This requirement may be met by a statement to the effect that some required courses for certain degrees may involve use of animals or animal tissue, and that interested students should seek further information about such requirements from the department. Normally this statement should appear in Courses and Degrees.

Instructors must inform their students during the first week of class if animals or animal tissue will or may be used as part of that course. Students who have concerns about the use of animals may then choose whether or not to take the class. Students should feel free to discuss their concerns with the instructor, but should be aware that instructors and departments are not obligated to alter course requirements which are consistent with University policies.

Procedures for Use of Animals. Any faculty member who intends to use vertebrate animals for teaching purposes must submit an Animal Use Protocol signed by the department chairperson to the Administrative Panel on Laboratory Animal Care. Reuse of previously approved preserved material requires no approval. Courses taught each year with no significant changes in animal usage must submit a Renewal Animal Use Protocol every year.

The protocol must include information about the source from which animals are procured. In addition, the protocol must explain why animals are needed to achieve the goals of the course, and justify the species and the number of animals to be used. If the Administrative Panel on Laboratory Animal Care questions the species of animals chosen, the procurement process, the number of animals to be used or other related matters, such questions need to be resolved before the animals may be ordered.

Live vertebrate animals must be cared for according to the Veterinary Service Center policies and procedures governing the use of laboratory animals. Disposal of animal tissue must be in compliance with relevant health and safety regulations.


Other Stanford Policies and Guidelines Regarding the Care and Use of Animals in Research and Teaching

Copies of other applicable Stanford policies and guidelines can be found on the A-PLAC website or obtained by calling A-PLAC at (650) 723-4550.

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