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Regulatory Issues

Institutional animal care and use programs must comply with the regulations of several federal, state, and independent agencies.  Several of these agencies and their regulatory functions that apply to laboratory animal care and use programs are summarized in this section.

 

Federal Agencies, Laws, Regulations and Policies

 

Interagency Research Animal Committee (IRAC)

 

The IRAC was convened in 1983 to discuss the U.S. Governement's overall policy on the use of animals in research.  The reuslting "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training" , which summarizes the conservation, use, care, and welfare of reasearch animals, has been subsequently used by all major regulatory bodies in developing specific guidelines.

 

United States Department of Agricultrure (USDA)

 

The Animal Welfare Act was first enacted in 1966 and was amended in 1971, 1976, and 1985.  This act of Congress regulates the transportation, purhcase, care, and treatment of animals used in research, for exhibition, and sold as pets.  The Act specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, and wild animal species intended for use in research.  The Act exlcludes farm animals used for agricultrue reseach and laboratory-bred rats (Rattus spp.) and mice (Mus spp.).  Note, however, these species are covered by Public Health Service Policy.

Amendments of the Act address issues as exercise for dogs, psychological well-being of primates, the composition and duties of the Institutional Animal Care and Use Committee (IACUC), responsibilities of the attending veterinarian, and training for all personnel using animals in experimentation. They also require that the IACUC reviews all protocols using animals to verify that they meet criteria listed in the amendments, and conducts semiannual inspections of animal facilities and areas where animals are used.

The Animal Welfare Branch of the USDA administers the Animal Welfare Act by establishing animal care standards for most laboratory animal species known as the Animal Care Regulations. Compliance requirements include submission of an annual report totaling the number of animals receiving anesthetics, analgesics, and sedatives for potential pain and distress and the number of animals used under conditions of unalleviated pain and distress. Compliance with the Animal Welfare Act is monitored by periodic, unannounced inspections by the Animal and Plant Health Inspection Service (APHIS). Further clarification of the Animal Care Regulations can be found in the Animal Welfare Act Fact Sheet, and the Animal Care Policy Manual.

 
Deficiencies identified during annual, unannounced inspections by the APHIS can lead to severe institutional penalties, including fines and the suspension/revocation of an Institution’s registration with the USDA. Note that all inspection results are also available on the Internet for public viewing following Freedom of Information Act requirements.

 

United States Department of Health and Human Services:


Public Health Service, National Institutes of Health


The "Public Health Service Policy on the Humane Care and Use of Laboratory Animals" states that to receive NIH awards for projects involving animals, an institution must have an approved animal welfare "Assurance Statement" on file with the Office of Laboratory Animal Welfare (OLAW, formerly OPRR/Office for the Protection from Research Risks) within the Office of Extramural Research (OER). This statement commits the institution to following:

    -The Animal Welfare Act 
    -The Guide for the Care and Use of Laboratory Animals (a.k.a. "the Guide") 
    -IRAC's "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training"
    -Other applicable laws and standards

 

OlawThe Assurance Statement describes the mechanism used by the institution to determine compliance with laws and standards, and it identifies the membership and responsibilities of the institution's animal care committee. When accepted by NIH, an Assurance Statement is approved for a one to five year period. The "University of Louisville Assurance of Compliance with Public Health Service Policy on Human Care and Use of Laboratory Animals" can be obtained by visiting the IACUC web page dedicated to accreditation and compliance information located at the following link: http://louisville.edu/research/iacuc/compliance-accreditation-details-for-grants-and-contracts.html

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 animal care and use program, using the Guide as a basis for evaluation. Significant deficiencies in the institution's program must be identified and the institution must develop an approved plan and schedule for correction of such deficiencies.

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


Food and Drug Administration (FDA)


The FDA is involved with the regulation of animal care because it sets standards for the testing of foods, drugs, and other chemicals that will be used by or come into contact with humans. Federal regulations require animal testing for toxicity and carcinogenicity before these substances are approved for human use. The FDA establishes "Good Laboratory Practices (GLP)" regulations under which testing is done and it specifies that adequate diagnosis, treatment, and control of disease be provided for animals used for testing.


Department of the Interior Fish and Wildlife Service


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

 

State Agencies and Regulation:


Fortunately, state laws in Kentucky are limited to providing research facility protection and the use of unclaimed pound animals (municipalities have jurisdiction). The Commonwealth also has an Animal Cruelty law that exempts research activities

 

Independent National Regulatory Bodies and Professional Groups


Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) 


Until recently, this organization was known as the American Association for the Accreditation of Laboratory Animal Care. In 1997, the name was changed to reflect the international nature of the association (retaining the acronym).

AAALAC is currently the only non-profit organization whose mission is to assess the animal care and use program of research institutions on a voluntary basis. After an initial assessment and accreditation, accredited institutions AAALACare required to submit an annual report outlining any changes in the animal care and use program. Every three years, AAALAC performs a site visit of accredited institutions, using a program description as their written guide to the program. Like OLAW, AAALAC requires the use of the Guide for the Care and Use of Laboratory Animals as the primary instruction manual for programs, policies, and facilities.

Although voluntary, there appears to be a preference for AAALAC accreditation with many funding agencies. Regardless, the University has long recognized the importance of holding its Animal Care and Use Program to the highest of standards, and as such, is one of only two institutions that has maintained continued accreditation by AAALAC since its inception in 1965.

 

Institute of Laboratory Animal Resources (ILAR) 


ILAR serves as a resource for the development of standards in laboratory animal care under the auspices of the National Academy of Sciences. ILAR acts as the principal advisor to the U.S. government on matters related to Guidelaboratory animal science and policy. The list of ILAR publications is impressive, and includes the Guide for the Care and Use of Laboratory Animals, and most recently, Occupational Health and Safety in the Care and Use of Research Animals (both of which are available in the Research Resources Facilities Library). ILAR also publishes a quarterly newsletter, ILAR News, which includes reviews of policies and standards for laboratory animals and their use.

 

 

 

American Association for Laboratory Animal Science (AALAS)


The first meeting of individuals working with laboratory animals occurred on November 28, 1950, in Chicago, Illinois. The organization was initially called the Animal Care Panel; the mission of the Panel was to strive to enhance the stature and training of technical staff, veterinarians, and research investigators, and therefore improve the health and well being of laboratory animals. In 1967, the name of the organization was changed to AALAS.

Membership in AALAS is only limited to personnel actively engaged in laboratory animal science. As the major laboratory animal science organization, AALAS has many important roles. Among the most active include:

 

-Publication of the periodicals Comparative Medicine (formerly Laboratory Animal Science) and Contemporary  Topics in Laboratory Animal Science.
-Sponsorship of a training and certification program for laboratory animal technicians, which leads to the nationally recognized status of Assistant Laboratory Animal Technician (ALAT), Laboratory Animal Technician (LAT), and Laboratory Animal Technologist (LATg).
-Hosting an annual meeting to disseminate information and encourage discussion over all aspects of laboratory animal medicine, husbandry, welfare, and biomethodology.

 

AALAS is divided into several districts. Each district is made up of several branches. The local branch for the Kentucky area is aptly named the Kentucky Branch of AALAS. Kentucky Branch AALAS hosts approximately 8 meetings annually, for discussions and lectures on current topics in laboratory animal science and care.

 

American College of Laboratory Animal Medicine (ACLAM)


In 1957, laboratory animal medicine became one of the first specialties of Veterinary Medicine that was recognized ACLAM(by the state of Illinois) and was organized as the American Board of Laboratory Animal Medicine. Soon, this specialty became recognized by the American Veterinary Medical Association (AVMA), and in 1961 the name was changed to ACLAM. ACLAM hosts many meetings during the annual AALAS and AVMA meetings, as well as the annual ACLAM Forum. 

ACLAM was established to encourage education, training, and research in laboratory animal medicine; to establish standards of training and experience for qualification of specialists, and to certify specialists by examination. There are now approximately 600 Diplomats of ACLAM within the U.S.

 

American Society of Laboratory Animal Practitioners (ASLAP)


ASLAPASLAP was founded in 1967 to promote dissemination of knowledge about laboratory animal medicine, foster research, and serve as spokesman for veterinarians in laboratory animal medicine. Membership in ASLAP is limited to veterinarians actively engaged in the practice of laboratory animal medicine. ASLAP hosts discussions and lectures at both the national AALAS and AVMA annual meetings, and publishes a quarterly newsletter.

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