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Federal Laws and Regulations

At the Federal level, the use of animals in research is governed by two agencies — the United States Department of Agriculture (USDA) — through the Animal Welfare Act –and the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health — through the U.S. Public Health Service Policy.

I. ANIMAL WELFARE ACT AND REGULATIONS

Animal Welfare Act and Amendments

The Animal Welfare Act (AWA) — which has become the principal Federal statute governing the sale, handling, transport and use of animals — was signed into law in on August 24, 1966 as the “Laboratory Animal Welfare Act” and authorized the Secretary of Agriculture to promulgate rules and regulations. Other laws, policies and guidelines

may include additional species coverage or specifications for animal care and use, but all refer to the AWA as the minimum acceptable standard.

The purposes of the original Act were to protect owners of dogs and cats from pet theft; prevent the sale or use of dogs and cats which had been stolen; and ensure that certain animals intended for use in research were provided with humane care and treatment. The original Act covered non-human primates, guinea pigs, hamsters, rabbits, dogs and cats. Humane treatment was required while they were with a dealer or research facility and while being transported by dealers, who were required to be licensed. Research facilities that used, or intended to use, dogs or cats and either purchased them in commerce or received any federal funds were required to be registered.

The Act has been amended a number of times – in 1970, 1976, 1985, 1990, 2002, 2007, 2008 and 2013– and can be found in the U.S. Code of Federal Regulations, Title 7, Sections 2131 to 2156.

In 1970 the original Act was amended (PL-91-579) and renamed the
Animal Welfare Act.” In the amended Act, the definition of “animal” was expanded to include all warm-blooded animals. The definition of “research facility” was expanded to include those institutions using covered live animals and not just dogs and cats. These facilities were required to file an annual report. The term “handling” was added to the basic categories for which standards were to be created and the phrase “adequate veterinary care” was broadened to include the appropriate use of anesthetics, analgesics and tranquilizers. The intent of the original Act to prohibit interference with research was clarified in the 1970 amendments.

In 1976, the Animal Welfare Act was further amended to enlarge and redefine the regulation of animals during transportation, among other things. The Act was broadened to include all forms of commercial transportation of animals and required all carriers and intermediate handlers who were not required to be licensed under the Act to register with the USDA. It also expanded the definition of a dealer and extended the record keeping requirements to carriers and intermediate handlers. In 1976, the Secretary of Agriculture also promulgated regulations that specifically excluded rats, mice, birds, horses and farm animals from the definition of an “animal.”

The Act was further amended with passage of the Food Security Act of 1985 (Public Law 99-198), which contained an amendment entitled the “Improved Standards for Laboratory Animals Act.” The 1985 amendments to the AWA are considered a turning point for laboratory animal welfare. Among other things, the amendments:

  • clarified what is meant by “humane” care (by mentioning specifics such as sanitation, housing, and ventilation);
  • specified that pain and distress must be minimized in experimental procedures;
  • specified that alternatives to such procedures be considered by the principal investigator;
  • established the Animal Welfare Information Center to provide researchers with a database of alternatives;
  • required the Chief Executive Officer of each research facility to establish an Institutional Animal Care and Use Committee (IACUC), and described the IACUC’s roles, composition, and responsibilities to the Animal and Plant Health Inspection Service (APHIS);
  • directed the Secretary of Agriculture to establish regulations to promote the psychological well-being of primates; and
  • directed the Secretary of Agriculture to establish regulations to provide for exercise for dogs.

Senator Robert Dole summarized the intended aim of the 1985 amendments in the following statement: “The… bill contains legislation dealing with the humane treatment of animals. The main thrust of the bill is to minimize pain and distress suffered by animals used for experiments and tests. In so doing, biomedical research will gain in accuracy and humanity. We owe much to laboratory animals and that debt can best be repaid by good treatment and keeping painful experiments to a minimum.”

II. U.S. DEPARTMENT OF AGRICULTURE

The AWA is enforced by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA-APHIS-AC), which is headquartered in Maryland and is divided into an Eastern Region based in Raleigh, NC, and a Western Region based in Fort Collins, CO. Enforcement duties are the responsibility of the APHIS Deputy Administrator for Enforcement and Animal Care (REAC), which employs Veterinary Medical Officers to conduct inspections of licensed facilities.

USDA-APHIS-AC develops regulations that interpret the AWA – often referred to as the Animal Welfare Act Regulations (AWAR) or Animal Welfare Regulations (AWR) – beginning with “proposed rules.” Proposed rules are published in the Federal Register and are open for public comment. Comments can be presented at public hearings and sent via mail, e-mail, or facsimile. After comments are analyzed, AC develops final rules which are also published in the Federal Register. The final rules include a description of the public comments and the USDA’s response to them, followed by how the new rules will appear as regulations.

The AWR are the “manual” for complying with the AWA. Each year, they are published in the U.S. Code of Federal Regulations, Title 9, Chapter 1, Subchapter A – Animal Welfare, which is commonly known as 9CFR. The AWR are divided into four (4) sections:

  • Definition of Terms;

The Definitions section describes exactly what is meant by terms used in the legislation. This section is very important because the legal definitions include exemptions that may differ from how the word is commonly used.

For example, the term “Animal” includes specific species in some (but not all) situations. According to the AWA, an “animal” is defined as follows:

‘Animal’ means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit or any other warm-blooded animal, which is being used or is intended for use for research, teaching, testing, experimentation or exhibition purposes or as a pet.

The Farm Security and Rural Investment Act of 2002 amendments to the regulations that implement the AWA currently exempt birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research.

  • Regulations;

The Regulations section includes subparts for licensing; registration; research facilities; attending veterinarians and adequate veterinary care; stolen animals; records; compliance with standards and holding periods; and miscellaneous topics such as confiscation and destruction of animals and access and inspection of records and property. Most of the subchapter is the third section, which provides standards for specific species or groups of species. Included are sections for cats and dogs, guinea pigs and hamsters, rabbits, nonhuman primates, marine mammals, and the general category of “other warm-blooded animals.”

  • Standards; and

Standards include those for facilities and operations; health and husbandry systems; and transportation.

  • Rules of Practice Governing Proceedings under the Animal Welfare Act.

The final section sets forth the Rules of Practice applicable to adjudicating administrative proceedings under Section 19 of the AWA.

The USDA has a manual that includes policies issued by APHIS-AC. These policies clarify certain regulations that pertain to the AWA and determine many of the actions that IACUCs must take as they review protocols and inspect facilities. Among these are:

  • USDA’s policies on adequate veterinary care;
  • USDA’s guidelines for adequate literature search for alternatives to potentially painful procedures;
  • definitions of major and multiple survival surgery;
  • what procedures are considered painful or distressful; and
  • USDA’s requirement for an annual report of animal numbers for research facilities.

Institutions conducting research with AWA-regulated species must submit an annual report to the USDA. Annual reports must include, in addition to other information and assurances, the common names and numbers of animals used, listed by procedures involving:

  • Category B – breeding, conditioning, or holding only;
  • Category C – no pain or distress (routine procedures which produce only momentary pain, such as injections are included in this category);
  • Category D – pain or distress for which appropriate anesthetic, analgesic or tranquilizing drugs were used; and
  • Category E – pain or distress for which the use of appropriate drugs would adversely affect the procedures, results, or interpretation of the research.

The report must certify that anesthetic, analgesic, and tranquilizing drugs were used appropriately during research and testing and that the principal investigator has considered alternatives to painful procedures.

USDA-APHIS officers also conduct unannounced site inspections of research facilities at least once a year, review randomly-selected Animal Use applications, and randomly inspect research laboratories at all institutions that utilize animal species covered by the AWA.

Upon completion, the inspector issues a report summarizing any findings of non-compliance. The report states each aspect of the AWA which was violated, the finding(s) within the facility, and the required remedial action and timeline. Along with annual reports, inspection reports become publically available via FOIA requests to USDA APHIS.  Access to the list of licensed/registered facilities as well as reports by state can be found on the USDA APHIS website .

Noncompliance with USDA standards for the humane handling, treatment, and transportation of animals may lead to substantial fines and/or suspension of animal research activities.

U.S. PUBLIC HEALTH SERVICE POLICY

The U.S. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, originally drafted by the National Institutes of Health in 1973 and extended to all PHS activities in 1979, today incorporates the changes in the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, (Public Law 99-158). This law applies to any research institution that receives funds from PHS, of which the National Institutes of Health (NIH), the major funding body for biomedical research, is a component.  Work that is funded by the NSF (National Science Foundation) must also comply with these regulations.

I. U.S. GOVERNMENT PRINCIPLES
The PHS Policy is based on the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, drafted by the Interagency Research Animal Committee, with representatives from all Federal agencies that fund biomedical research. Whenever U.S. government agencies develop requirements for testing, research, or training. procedures involving the use of vertebrate animals, the following nine (9) principles must be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official must ensure that these principles are adhered to.

  1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act 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 paralyzed by chemical agents.
  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 an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

II. PHS Policy and the Guide

The PHS policy, last revised in 2002, is broader than the Animal Welfare Act in that it covers all species of vertebrate animals, including rats, mice and birds, and it covers all research that is funded by the National Institutes of Health (NIH). The Office of Laboratory Animal Welfare (OLAW) at NIH is the agency that is responsible for enforcement of this policy.

In order to receive NIH support for activities involving animals, institutions covered by the PHS policy must submit a written document called an Animal Welfare Assurance of Compliance (or “assurance”) to NIH, which describes how the institution will comply with all the regulations covering animals used in research.

The Animal Welfare Assurance is approved for a period of up to 4 years. It provides details of the institution’s commitment to humane care and use of animals. It includes such things as the institutional policy regarding the care and use of animals; lines of authority within the institution; details concerning the Institutional Program for Animal Care and Use, including responsibilities of veterinarians and IACUC; a listing of approved Animal Facilities; a listing of members of the IACUC; and whether the institution has achieved accreditation through AAALAC (See below.). Each year, via an annual report, the institution provides an update to OLAW about any changes that have occurred in the institution’s animal care and use program.

OLAW approval of an institution’s Assurance Statement commits the institution, its officials, committees, investigators, and any of its other agents to full compliance with the provisions of the PHS Policy. In addition, approval commits the institution to comply with the US

Government Principles for the Utilization and Care of Vertebrate Animals, the Guide for the Care and Use of Laboratory Animals, and where applicable, the Animal Welfare Act.

The PHS Policy is based on a concept of enforced self-regulation. Once an institution has prepared an Animal Welfare Assurance and the Assurance has been approved by OLAW, the institution is in a position to regulate itself. If the institution fails to self-regulate, the approval of the Assurance may be restricted or withdrawn by OLAW and funding to the research may be jeopardized.

The PHS Policy is delineated in The Guide for the Care and Use of Laboratory Animals (known as the Guide), which was first developed in 1963 as a manual for research facilities receiving public funding for research using animals. It is written by experts in laboratory animal care and is published under the auspices of the Institute for Laboratory Animal Research of the National Academy of Sciences. The Guide is available in several languages.

The eighth and latest edition of the Guide, published in 2010, sets specific standards for the care and use of laboratory animals, including aquatic species for the first time. It addresses key concepts in laboratory animal care and use; the Animal Care and Use Program, including institutional responsibilities; husbandry and housing standards; veterinary care; and physical plant specifications.

The Guide states its purpose is “to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. It is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accordance with the highest scientific, humane, and ethical principles.”

The Guide demonstrates a shift toward performance standards, which emphasize outcomes, as opposed to engineering standards, which are prescriptive and may not allow sufficient flexibility or professional judgment to deal with unique circumstances. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that are consistent with high-quality, humane animal care and use. Extensive references found at the end of each chapter and in the appendices are key features of the Guide.