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Compliance

Animal Welfare Act

I. PURPOSE

The Animal Welfare Act (AWA) aims to ensure that animals used in research, for exhibition, or as pets receive humane care and treatment; to assure the humane treatment of animals during transportation in commerce; and to protect pet owners from theft and prevent the sale of stolen animals. AWA regulates the transport, purchase, sale, housing, care, handling, and treatment of such animals.

II. HISTORY

Originally passed in 1966, AWA governs the treatment of certain warm-blooded animals that are transported in commerce or used for research, for exhibition, or as pets. AWA and its implementing regulations have been expanded and amended many times as research understanding and ethical guidelines have shifted. For example, in 2002, the definition of animals was amended to exclude birds, rats, and mice bred for use in research; in 2012, a contingency plan requirement was added, but the contingency planning regulations were indefinitely stayed in 2013. The Animal and Plant Health Inspection Service (APHIS), an organization within the U.S. Department of Agriculture (USDA), administers AWA. AWA gives the USDA latitude to regulate research using animals and authorizes the USDA to establish standards for research facilities, dealers, and exhibitors.

III. APPLICABILITY TO BYU–HAWAII

Under AWA, animals are generally defined as live or dead dogs, cats, monkeys, guinea pigs, hamsters, rabbits, or any other warm-blooded animals used for research or exhibition or as pets. A person or organization that transports, purchases, sells, houses, cares for, handles, or treats animals for research, experimental, or exhibition purposes must comply with AWA. A research facility—any institution that “uses or intends to use live animals in research, tests, or experiments” and either receives federal funds or purchases/transports live animals in commerce—must register with the USDA and comply with federal statutes and regulations governing the humane treatment and use of animals. Additionally, a research facility must maintain an Institutional Animal Care and Use Committee (IACUC) to oversee the use of animals in research. At present, BYU–Hawaii does not handle and otherwise engage in the treatment of animals for research purposes and thus is not subject to the AWA regulations. BYU–Hawaii likewise does not conduct occasional research on warm-blooded animals that are not research rats and mice and need not register with the USDA or maintain an IACUC. However, should the university determine to conduct research on animals protected under AWA regulations, BYU–Hawaii would be required to establish an IACUC and adhere to the applicable regulations. The following information is provided to inform the university should it determine to conduct such research.

IV. REQUIREMENTS

AWA and its amendments establish minimum treatment standards for certain animals used in research. AWA also imposes duties on dealers, exhibitors, handlers, carriers, sale operators, and research facilities.

A. Registration/Acknowledgement

Non-federal research facilities, including universities, must register with the USDA by completing and filing a form with the Animal Care (AC) Regional Director for the state in which the research facility operates. The university, not the school or department conducting the research, is the one who files for registration. This registration must be updated every three years. At the time of registration, a research facility must sign and file with the AC Regional Director a written acknowledgment indicating the facility has received a copy of the animal welfare regulations and standards and that it will comply.

If any changes are made to a research facility’s name, address, ownership, or operations, the AC Regional Director must be notified by certified mail within ten days of the change. If a research facility does not use, handle, or transport animals for a period of two years, it may send a written request to the Regional Director to be given inactive status, and the research facility must make an annual report of its status (active or inactive).

B. Licensure

AWA requires dealers and exhibitors of animals to be licensed with the USDA. However, a license is not required for retail pet stores; nor is a license required for a person or organization that exhibits animals “to advance agricultural arts and sciences.”

C. IACUC

A research facility’s CEO must appoint an IACUC to oversee animal care, treatment, and practices and to “represent society’s concerns” regarding animal welfare. The IACUC must have at least three members, including a chairperson, a veterinarian with direct responsibility for the facility’s animal activities, and a person unaffiliated with the facility and not an immediate family member of an affiliated person. If the committee has more than three members, no more than three may be from the same administrative unit.

Every six months, the IACUC must review the facility’s animal welfare program and inspect all facilities and study areas to assess practices involving pain and animal condition. Inspections may be waived if animals are studied in their natural environment and study areas prohibit easy access. Once the IACUC completes the review and inspection, it must file a certification report with the research facility’s institutional official (IO). The majority of IACUC members must sign the report and include reports of compliance and violations—specifically distinguishing between major and minor deficiencies. The report must include a plan for correcting noncompliance; if the plan is not followed, remaining major deficiencies must be reported within fifteen business days to APHIS and any federal agency that funds the facility. The report must be maintained for at least three years. The IACUC must also review and investigate any complaints or reports of noncompliance with AWA, recommend program improvements to the facility, and suspend or withhold approval for activities that do not meet federal standards.

The IACUC must review all new and continuing research projects involving animals to ensure the projects meet proper animal care standards. In reviewing proposed research, the IACUC must make sure all projects minimize distress and pain to animals, do not unnecessarily duplicate past experiments, involve the proper use of sedatives and euthanasia, involve consultation with the attending veterinarian, and provide proper medical care to animals before and after experimentation. The IACUC may invite consultants to assist in complex issues, but the consultant may not decide whether to approve or withhold any research activity. The IACUC must inform principal investigators of its decision to approve or deny research projects in writing, and the IACUC must perform a review of ongoing research projects at least once annually. The IACUC can suspend any activity that does not meet standards and must send an explanation of suspensions to APHIS and any federal funding agency.

D. Veterinarian

Each research facility must have an attending veterinarian to care for animals involved in research projects. The veterinarian must be employed under a formal agreement, hold authority to provide animal care, and be a voting member of the IACUC.42 Facilities must establish and maintain an adequate veterinary care program that includes disease control and prevention, daily animal observation, guidance to principal investigators, and pre- and post-procedural care.

E. Training

Research facilities must ensure all personnel involved in animal care, treatment, and use are properly trained and qualified. The research facility must provide training in at least the following areas:

• humane methods of animal maintenance and experimentation
• research or testing methods that limit the use of animals or minimize animal distress
• proper use of anesthetics, analgesics, and tranquilizers
• methods to report any deficiencies in animal care and treatment
• use of services available to provide information on appropriate animal care and use, alternatives to animal research, ways to prevent duplication of animal research, and AWA’s requirements

F. Identification of Dogs and Cats

Research facilities must identify live dogs and cats pursuant to USDA standards. Facilities must affix official identification tags to live dogs or cats that they acquire, transport, sell, or dispose of. Tags can be purchased from official commercial suppliers and must have a number identifying the research facility and another number identifying the animal for use in the facility’s records. When a dog or cat dies, the research facility must retain the tag for at least one year and must not reuse the animal’s identification number for at least five years.

G. Stolen Animals

Research facilities must not buy, sell, or use stolen animals. To protect the rights of owners of lost or stolen pets, facilities that obtain dogs and cats from sources other than dealers, exhibitors, and exempt persons must have the animals for five days before using them. Research facilities must also allow law enforcement officers to enter the premises and inspect animals and records for missing animals if the police officer gives the research facility a written description of the missing animal and abides by all security measures when inspecting the animals.

H. Animal Care Standards

Animals may not be used for more than one major operative experiment, except with permission from the USDA and when scientifically necessary. In any practice that would cause pain, the facility must require the following:

  • a doctor of veterinary medicine is consulted in planning these procedures
  • tranquilizers, analgesics, and anesthetics are used
  • pre- and post-surgical care by lab workers is performed in accordance with established veterinary medical and nursing procedures
  • paralytics without anesthesia and withholding tranquilizers, anesthesia, analgesia, or euthanasia when scientifically necessary, is only continued for the necessary period of time

Exceptions to these standards may be granted only when specified by research protocol and if the exception is detailed and explained in the annual USDA inspection report and filed with the IACUC. A research facility will be held liable for its employees’ acts or omissions regarding animal welfare if they are acting within the scope of their employment.

I. Recordkeeping

Research facilities must keep records of the following:

  • minutes of IACUC meetings
  • proposed activities and proposed significant changes in activities involving animals and whether IACUC approval was given
  • IACUC semiannual reports and recommendations
  • information regarding the purchase, sale, transportation, identification, and previous ownership of live dogs and cats (including offspring) in the possession or control of the research facility

A copy of the records for live cats and dogs must accompany each shipment of any live cat or dog sold or otherwise disposed of by the research facility. Records and reports must be kept for at least three years and must be available during business hours for examination and copying by APHIS officials.

J. Annual Report

Research facilities must annually report their compliance with AWA and show that they are following “professionally acceptable standards” governing animal care. The report is made by each department of a research facility that “uses or intends to use live animals in research” and must be submitted to the applicable AC regional director on or before December 1 of each year. “The report shall be signed and certified by the CEO or institutional official, and shall cover the previous federal fiscal year.” The report must include information about procedures likely to cause pain or distress in animals and must assure that the principal investigator considered alternatives to those procedures. A facility must provide an explanation and IACUC approval if it deviates from animal welfare standards. The annual report must state the location of all facilities where animals are housed or used and the common names and numbers of animals used in research or being held for future research.

K. Notifications

Within ten days of any change to its name, address, management, control and ownership, or research sites, a research facility must notify the relevant AC regional director by certified mail. If a research facility or its programs fail to comply with regulations or correct a significant deficiency—as reported in IACUC’s inspection certification report—IACUC must report the failure in writing through its IO to APHIS and any federal agency funding the research activity within fifteen business days.

L. PHS-Supported Research

Entities performing animal research that is supported or conducted by a Public Health Service (PHS) agency must abide by the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) in addition to AWA. The PHS Policy, which is administered by the Office of Laboratory Animal Welfare (OLAW), requires institutions to maintain the same level of care for animals that is set forth in AWA and extends protections to additional vertebrate animals. OLAW requires animal researchers to use the Guide for the Care and Use of Laboratory Animals in implementing and abiding the PHS policy. Before research facilities can perform PHS-funded animal research, they must provide written assurance to OLAW, signed by the IO, stating that the facility meets the PHS policy requirements and has a functioning IACUC. The assurance must be updated every four years and accompanied by the “most recent semiannual report of the IACUC evaluation[.]” The IACUC must report to OLAW annually regarding the institution’s compliance.

V. PENALTIES

USDA officials may inspect research facilities to check compliance with federal requirements. Any person who assaults, resists, opposes, impedes, intimidates, or interferes with officials conducting these inspections can face up to a $5,000 fine and a three-year prison sentence. If a research facility is in violation of the animal welfare regulations, the USDA can, after issuing a notice, assess a civil penalty of up to $10,000 for each offense and order that the facility cease and desist from its noncompliant behavior. A research facility that disobeys a cease-and-desist order can also be subject to a $1,500 penalty per offense. Many infractions are settled with a warning letter, although they may lead to a compliance or enforcement action.

VI. COMPLIANCE CALENDAR

Every six months, the IACUC must review the facility’s animal welfare program, inspect all animal facilities, and file an inspection certification report with the institutional official. On or before December 1 of each year, each department at a research facility that uses or intends to use live animals (as defined by AWA) must submit an annual report to the AC Regional Director that covers the previous federal fiscal year. Once a research facility has registered with the USDA, its registration must be renewed every three years by filing a new registration form with the AC Regional Director.