Purpose: To briefly describe the Public Health Service Policy on Humane Care and use of Laboratory Animals.

Scope: All University faculty, staff, researchers, and students who use or care for laboratory animals.

Policy: 

U.S. Department of Health and Human Services

a. National Institutes of Health (NIH)

NIH is a major funding source for biomedical research.  To receive NIH awards for projects involving animals, an institution must have an approved animal welfare assurance statement on file with NIH.  This statement commits the institution to following the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals (referred to as the "Guide" or the "NIH Guide"), the U.S. Government "Principles for Use of Animals", the U.S. Public Health Service's "Policy on Humane Care and Use of Laboratory Animals" and other applicable laws and regulations.  The 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.

i.    U.S. Public Health Service Policy

The Public Health Service requires all institutions which receive PHS funds for research, research training or biological testing involving animals to establish and maintain a program which ensures appropriate care and use of research animals.  Institutions with PHS funding for animal research must have an approved Assurance Statement on file with the Office of Laboratory Animal Welfare (OLAW) of the NIH.  The PHS requires institutions to use the NIH Guide as the basis for developing and implementing animal care and use programs.  To qualify for PHS funding of animal research, institutions must either be accredited by AAALAC or must comply with the PHS requirements for self-evaluation.  In the latter case all of the institution's animal facilities must be evaluated annually by the institutional animal care and use committee.  These evaluations are reported to the OPRR and any deviations from Guide recommendations must be noted and a plan and schedule for correcting the deficiencies must be provided and adhered to.  If an institution fails to comply with PHS policy, funds for animal research may be withdrawn.

ii. Guide for the Care and Use of Laboratory Animals

The Guide is prepared by the Institute of Laboratory Animal Resources (ILAR), National Research Council, under contract to NIH.  The Guide was first published in 1963 and has since been revised several times.  The most recent edition of the Guide was published in 2011.  The Guide's purpose is to "...assist institutions in caring for and using laboratory animals in ways judged to be professionally and humanely appropriate.  The [Guide's] recommendations are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proven to be consistent with high quality humane animal care and use."  The standards set forth in the Guide form the basis of accreditation of animal care and use programs by AAALAC and for determining whether programs meet Public Health Service policy requirements.

iii.  U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

This policy is located on Page 4 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

b. Centers for Disease Control (CDC)

The Centers for Disease Control in Atlanta 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.

c. Food and Drug Administration (FDA)

The 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 FDA established Good Laboratory Practices (GLP) regulations under which this testing is done and it specifies that adequate diagnosis, treatment, and control of disease be provided for animals used for testing.

Approvals:

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