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The Animal Care and Use Program

Institutions using animals for research, teaching, and/or testing must acknowledge and accept both legal and ethical responsibility for the animals under their care. In reality and practice, ensuring best practices that maximize laboratory animal welfare is a team effort that involves a number of institutional constituents — the Institutional Official, the Institutional Animal Care and Use Committee (IACUC) and its staff, the veterinarian, the animal caretakers and technicians, and the investigators and their research staff.

Every institution using animals, therefore, needs some framework for coordinating these constituents and the resources that accompany them. This framework is known as an Animal Care and Use Program (ACUP or Program). An ACUP is managed in accordance with PHS Policy, the Guide for the Care and Use of Laboratory Animals (Guide), the AWRs, and other applicable federal, state and local regulations and guidelines. An ACUP encompasses all physical, procedural, medical, and human resources required to ensure animals are cared for and used appropriately in both a scientific and a humane context.

Federal regulations and policies require specific outcomes for each of these components. These outcomes are achieved through the application of performance standards outlined in the Guide. According to the Guide, “Performance Standardmeans a standard of guideline that, while describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animals care and use program, the researcher, and the IACUC. The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals[1].”

Although no two Animal Care and Use Programs are identical, a comprehensive Program is expected to contain several components:

  1. Support of the Institution’s Mission:

The Animal Care and Use Program must effectively support and enhance the vision of the institution, arising from its mission and values, in the areas of animal research, teaching, testing, and/or outreach. Evaluation of the program must consider whether and how well it fulfills its reason for existence.

  1. An Institutional Official:

Institutions must appoint an Institutional Official, a senior administrator who legally commits the institution to meet all requirements embodied in the AWRs and PHS Policy by ensuring that the Animal Care and Use Program satisfies all performance criteria.

The role of the Institutional Official is discussed further below under IACUC Form, Function and Interaction.

  1. Program Integration, with procedures for self-monitoring:

For an Animal Care and Use Program to be effective, all program components must function well together within an institutional culture of compliance. Effective animal care and use programs have simple, clear and direct lines of responsibility and corresponding authority. The structure of an animal care and use program, as outlined by the National Institutes of Health’s Office of Laboratory Animal Welfare (NIH OLAW) in the diagram below[2], is designed with appropriate checks and balances as a means to evaluate the program on a continuing basis. Heavy lines represent the mandate from the Animal Welfare Act and Health Research Extension Act of 1985 (HREA) that the Secretaries of Agriculture and Health and Human Services develop guidelines for the use of animals in research and for IACUCs, and require established lines of authority from the Institutional Official to the IACUC, IACUC staff, and veterinarian. Dotted lines represent the need for cooperation and communication among components.week4-1

Evaluation of the Animal Care and Use Program takes place both internally – through the IACUC – and externally. PHS Policy requires an institutional Animal Welfare Assurance that provides details on the ACUP in order to award funds. The U.S. Department of Agriculture (USDA), which enforces the AWA, requires registration of facilities, and institutions registered with the USDA are visited and inspected by a Veterinary Medical Officer at least once annually. The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is a voluntary accreditation organization that evaluates institutional animal care and use programs every three years according to standards described in the Guide. External evaluation ensures institutional compliance with regulations and guidelines, and also can serve to guide improvement of animal care and use programs.

  1. A Physical Plant Program, with appropriately maintained facilities for housing and support:

According to the Guide[1], “a well-planned, well-designed, well-constructed, and properly maintained facility is an important element of good animal care and use, and it facilitates efficient, economical, and safe operation.”  As this statement implies, the Guide establishes performance standards in the areas of facility planning, design, construction, and maintenance. There are expectations that appropriate areas will be available for:

  • animal housing, care, and materials sanitation;
  • receipt, quarantine, and separation of animals;
  • separation of species or isolation of individual projects when necessary;
  • material receipt and storage;
  • other specialized spaces, facilities, and/or equipment that are required for the conduct of certain studies (e.g.: containment facilities, barrier housing for SPF animals, housing for aquatic species, space for cleaning/sterilization of equipment and supplies, storage for waste and carcasses, space for personnel including restroom and break areas, security access systems such as card-key systems, areas for maintenance and repair of dedicated/specialized equipment); and
  • performance of aseptic surgery.
  1. An Animal Environment, Housing and Management Program:

The Guide states3: “The design of animal facilities combined with appropriate housing and management are essential contributors to animal well-being, the quality of animal research and production, teaching or testing programs involving animals, and the health and safety of personnel.”

Provisions for animal housing must consider the shape, size, and construction of primary enclosures (cage, pen, etc.); temperature, humidity, ventilation, and illumination; and behavioral management, including needs for social housing and/or activity.

Appropriate management of animals and animal facilities must consider:

  • animal husbandry, including selection, storage, preparation, and provision of food, bedding, and water; sanitation of enclosures and physical plant; waste disposal; pest control; and emergency, weekend, and holiday animal care;
  • population management, including animal identification and records, and genetics and nomenclature; and
  • preparation of a disaster plan that takes into account both personnel and animals.

Adequate management requires appropriate and sufficient physical, procedural, and human resources. The Guide establishes performance standards in each of these areas. The institution must establish a plan to monitor and maintain the physical, procedural, and human contributions to adequate animal environment, housing, and management, to ensure that it meets all performance standards for all animals.

  1. A Personnel Qualifications and Training Program:

Both the AWRs and PHS Policy require institutions to ensure that people caring for or using animals are qualified to do so. Because personnel represent both an essential resource and a source of complexity within an Animal Care and Use Program, proper training is critical in maintaining an effective program.

With regard to personnel, the Guide[2] makes the following statements:

  • personnel caring for animals should be appropriately trained, including animal care and use legislation, IACUC function, ethics of animal use and the concepts of the Three Rs, methods for reporting concerns about animal use, occupational health and safety issues pertaining to animal use, animal handling, aseptic surgical technique, anesthesia and analgesia, and euthanasia;
  • an institution should provide for formal and/or on-the-job training to facilitate effective implementation of the program;
  • personnel using or caring for animals should also participate regularly in continuing education activities relevant to their responsibilities; and
  • researchers conducting surgical procedures must have appropriate training to ensure that good surgical technique is practiced.

The categories of personnel that must receive appropriate training include:

  • physical plant and security staff;
  • animal care staff;
  • management and supervisory personnel;
  • veterinarians and veterinary staff;
  • research personnel, including investigators, instructors, technicians, trainees, and students; and
  • IACUC members and Institutional Officials.

PHS Policy explicitly requires that training includes research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress.

Because of the importance of personnel training and the diversity of training needs, the institution must establish a plan to provide appropriate training and continuing education that is both comprehensive and flexible. Each individual must understand the components of the Animal Care and Use Program, his/her role within the Program, and how that role interacts with the roles of others.

  1. An Occupational Health and Safety Program (OHSP; required under PHS Policy, but not under the AWA):

According to the Guide[3], “an occupational health and safety program must be part of the overall animal care and use program…. An effective program relies on strong administrative support and interactions among several institutional functions or activities, including the research program (as represented by the investigator), the animal care and use program (as represented by the veterinarian and the IACUC), the environmental health and safety program, occupational-health services, and administration (e.g., human resources, finance, and facility maintenance personnel).”

As the above statement implies, the Occupational Health and Safety component of the Animal Care and Use Program requires that several groups work together closely and effectively.

The Guide establishes performance criteria for Occupational Health and Safety in several areas.

  • hazard identification and risk assessment;
  • facilities, equipment and monitoring;
  • personnel training;
  • personal hygiene;
  • animal experimentation involving hazards
  • personal protection;
  • medical evaluation and preventive medicine for personnel; and
  • personnel security.

The Guide identifies the need for formal safety programs to address these performance standards, both for routine animal care and for animal experimentation involving hazards.

Occupational Health and Safety in the Care and Use of Research Animals, published in 1997 by the National Research Council, includes helpful guidelines and references for establishing and maintaining an effective and comprehensive program.

  1. An adequate program of Veterinary Medical Care:

Adequate veterinary medical care is a component of the Animal Care and Use Program that affects all other components. According to the Guide[4], “a veterinary care program that offers a high quality of care and ethical standards must be provided, regardless of the number of animals or species maintained.”

Arrangements for veterinary care will depend on the institution and the size of the Animal Care and Use Program. Consultant or part-time veterinary services may be appropriate for small Programs with limited numbers of animals. Under all circumstances, there must be a direct channel of open communication between the Institutional Official and the veterinarian.

The Guide establishes standards for adequate veterinary care in the following areas:

  • animal procurement and transportation;
  • appropriate facilities, personnel, equipment, and services;
  • preventive medicine, including animal biosecurity, quarantine and stabilization, separation by health status and species, as well as surveillance, diagnosis, treatment, and control of disease;
  • clinical care and management, including treatment of diseases and injuries, and the availability of emergency, weekend and holiday care;
  • access to all animals and periodic assessment of animal well-being;
  • surgery, including establishment of appropriate surgical and post-surgical care and monitoring, aseptic technique, and appropriate use of anesthesia and analgesia;
  • relief of pain and distress including choice of analgesics, anesthetics, and tranquilizers;
  • drug storage and control;
  • proper selection and conduct of euthanasia; and
  • participation in protocol development and review.

Laboratory animal veterinarians participate in all aspects of ACUP development, implementation, and evaluation. Institutions must develop methods to monitor veterinary care and ensure that it remains adequate and appropriate, and must establish procedures to identify, communicate, and correct all deficiencies.

 

  1. A properly constituted and functioning Institutional Animal Care and Use Committee (IACUC):

The Guide6 states that it is the responsibility of the IACUC to “oversee and routinely evaluate the [animal care and use] Program.”  More than any other component, the Institutional Animal Care and Use Committee (IACUC) is directly responsible for ensuring the adequacy of all aspects of the Animal Care and Use Program. The Guide describes required committee membership, meeting frequency, and maintenance of records. It also establishes performance criteria for several committee functions.

An extensive discussion of the Institutional Animal Care and Use Committee is provided below under IACUC Form, Function and Interaction.

The Guide is clear that, in each of these areas, the institution must establish procedures to monitor and maintain these activities and their effectiveness, and to identify, communicate, and correct all deficiencies.