Comments & suggestions  should be directed to jroese@lssu.edu Visit my website REGULATIONS AND POLICIES Because the responsibility for compliance with regulations that affect the care and use of animals ultimately lies with investigators, it is important that they have a working knowledge of the basic regulatory requirements.  This page offers brief descriptions of the primary organizations or regulatory agencies responsible for setting and enforcing policies involving animal research. The Guide for the Care and Use of Laboratory Animals Since 1963, the Guide for the Care and Use of Laboratory Animals has served as the primary guide for animal care and use in the United States.  The purpose of the Guide is to assist institutions in developing and maintaining animal care and use programs that are scientifically, technically, and humanely appropriate. Revision of the Guide was a peer process by a committee appointed by the National Academy of Sciences.  It has been developed by the scientific community as a part of a self-governance strategy rather than as a regulatory or policy document of the government. The Guide is written for a diverse group of users, and its guidelines are intended to be applied to many species of animals in varied settings, types of institutions, and uses. The recommendations are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use.  The Guide makes general recommendations, the details of which must be addressed locally by animal care personnel and users, and  IACUC approvals. The Guide has been updated with regard to regulatory compliance, state-of-the-art techniques and equipment, and consideration of new scientific data.  The Guide encourages continued research into improved methods of animal care and use. Also, users, IACUCs, animal care givers, and producers must use professional judgment in making specific decisions regarding animal care and use.  The Guide has been partially reorganized to include an introduction and  chapters on the major components of an animal care and use program: institutional policies and responsibilities; animal environment, housing, and management; veterinary medical care; and physical plant. Animal Welfare Act The Animal Welfare Act of 1966 and its subsequent amendments regulate the transportation, purchase, care and treatment of animals used in research, for exhibitions, and sold as pets.  The Act defines 'animals' as any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, and wild animal species intended for use in research. To date, the Act does not cover farm animals, birds or laboratory rats and mice. The Animal Welfare Act is administered by the United States Department of Agriculture (USDA).  Research facilities are subject to unannounced inspections by USDA veterinarians, and are required to file an annual report listing the species and numbers of animals used in research, and certifying that anesthetic, analgesic, and tranquilizing drugs were used appropriately during research and testing. Failure of an investigator to comply with USDA regulations may result in civil or criminal prosecution and withholding of funding for, and suspension of, animal research activities. Any person observing a violation of the Animal Welfare Act should report this to a member of the IACUC.  Public Health Service Policy  (top of page) The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, requires each institution which receives PHS funds for research involving animals to file an approved Animal Welfare Assurance Statement with PHS.  This commits the institution to comply with the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, the Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and other applicable laws and regulations.  The assurance must describe in detail the institution's program for the care and use of animals (including all vertebrates) and its program for assuring compliance with the PHS Policy. 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.  The National Science Foundation (NSF) requires a similar assurance for each NSF funded project using vertebrates.  Animal care and use committees also are required to conduct semiannual assessments of the institution's program, using the Guide as a basis for evaluation.  Significant deficiencies in the institution's program must be identified, and the institution must adhere to an approved plan and schedule for correction of such deficiencies. The failure of an institution to comply with these policies may lead to various actions, including the termination of PHS  and NSF support for all projects at the institution which involve animals. Act 241, 1947 (Michigan Animal Care Law) Act 241, of 1947 established a program of registration and inspection of facilities that use and maintain laboratory animals.  The goal is to ensure humane care and use of animals. The law requires all Michigan scientific institutions that use animals to register with the state Department of Public Health and to be subject to inspection of their animal facilities by the Department.  Since 1978, the law has been applied to all vertebrate animals used in research and, for regulatory purposes, together with Act 368, utilizes the standards in the PHS Guide for the Care and Use of Laboratory Animals. Act 224, 1970 (Use of Dogs and Cats) Use of Dogs and Cats for Research essentially incorporates the standards of the Federal Animal Welfare Act into state regulations. The state law applies only to dogs and cats and inspection responsibility is assigned to the Michigan Department of Agriculture.  Several cities and counties in Michigan have adopted ordinances or policies permitting the release of unclaimed and unwanted dogs and cats to approved scientific institutions for use in research and education. Act 368, 1978 (Public Health Code) Section 2671 affirms that the public health and welfare depends upon the humane use of animals in research, education and testing.  Section 2672 specifies the composition of the Animal Research Advisory Board.  The Board's role is to regulate and establish standards controlling the humane use of animals.  In effect, Act 241 provides for the registration of animal facilities, Act 368 provides the regulatory standards. Institutional Animal Care and Use Committee (IACUC) (top of page) The IACUC is an important element of LSSU’s compliance with federal and state regulations and plays an essential role in advising the Institution on all matters related to its program for the care and use of animals.  IACUC members include faculty who are experienced users of animals, at least one non-user faculty member and a public member, not affiliated with the University. The IACUC conducts the reviews of research and instructional projects for the proper care and use of vertebrate animals that are required by PHS and University procedures.  IACUC approval is necessary before investigators and course instructors can procure animals or initiate any research, testing, or instructional project involving the use of vertebrate animals. The IACUC concerns itself with a number of aspects of a proposal: the proposed housing and husbandry procedures; the health status of the animals; the provisions for proper veterinary care; the measures taken to minimize the number of animals required to produce valid results and alleviate any potential animal pain or discomfort; and the adequacy of the training and experience of the personnel using and caring for the animals. The IACUC also performs program reviews and facilities inspections at least once every six months as required by law and files these reports with the Institutional Official. In order to serve broad educational objectives, all investigators who conduct vertebrate animal research will be directed to review this manual and its appendices.  They are expected to be familiar with this material and to sign a statement (incorporated in the AUVA) acknowledging responsibility for compliance with applicable rules and institutional policies. Animal Welfare Assurance Investigators who receive funding from federal sources (NIH, NSF, etc.)  may be required to submit an Animal Welfare Assurance document to the funding agency.  A template for such a document, consistent with LSSU policies, is available here. Principal Investigators / Coures Instructors Student and faculty investigators are entrusted with an essential role in assuring the humane use and care of animals. In activities they conduct or which are conducted under their direction, they have a direct and continuing responsibility to see that animals are adequately cared for and properly used. Investigators obtain approval of their projects from the IACUC by completing the IACUC’s form entitled Application for Use of Vertebrate Animals (AUVA).  Application forms can be downloaded here. Animal Welfare Information Center (top of page) The Animal Welfare Information Center (AWIC) was established at the National Agricultural Library (NAL) in 1986 as a result of the amended Animal Welfare Act (PL 99-189). In the act, Congress mandated that: "The Secretary [of the U.S. Department of Agriculture] shall establish an information service at the National Agricultural Library. Such service shall, in cooperation with the National Library of Medicine, provide information: •   Pertinent to employee training •   Which could prevent unintended duplication of animal experimentation •   On improved methods of animal experimentation, including methods which could reduce or replace animal use, and minimize pain and distress to animals As an information center within NAL, AWIC's role is to provide reference services, bibliographies and listings of relevant documents, establish the subject scope for acquisitions and indexing, conduct outreach activities and interact with user groups.  In turn, AWIC relies on NAL for the purchase and maintenance of the subject relevant part of the collection, lending services and other technical services that ensure user access.  Because of these cooperative efforts, the substantial resources of the Library enable the AWIC staff to supply information on a broad array of subjects, even though the main thrust of AWIC's subject responsibilities are determined by the Animal Welfare Act (AWA).  Materials commonly accessed for AWIC's clientele cover important technical, ethical, political and legal issues related to the welfare of animals.  Briefly, subjects indexed include: anesthesia, analgesia, euthanasia, training and education of technicians and investigators, transportation and acquisition of animals, species husbandry, animal behavior, environmental factors affecting animals, laboratory animal management, Institutional Animal Care and Use Committees, regulations and legislation concerning the humane treatment of animals, philosophies of animal welfare/rights and alternatives to the use of animals in research, testing and education. One result of computer technology has been the advent of computer databases in general and the bibliographic database in particular.  These have become important repositories referencing the world's scientific literature.  Databases enable information providers to develop customized bibliographies for the patron's specific information needs. To access as well as disseminate the extensive information resources in the NAL collection, NAL staff generate an internationally available database called AGRIcultural On-Line Access (AGRICOLA).  Established in 1970, AGRICOLA contains over 3 million citations to books, articles and audiovisuals covering agriculture and related subjects.  There is no database specifically for animal welfare generated by AWIC.  Many published books, journals, videotapes, reports, etc. relevant to AWIC are included in the AGRICOLA database.  Approximately one-fifth of the AGRICOLA database is devoted to citations on animal production, laboratory animal science, veterinary medicine and animal welfare. Reference services are available to anyone who calls the Center.  However, most AWIC users are biomedical researchers, veterinarians, animal technicians and caretakers, USDA regulatory staff, facility managers, academics, organization personnel, curators in zoological parks, librarians and students.  These services may be a quick answer, a suggested general resource, reference to an article and/or a database search.  In the event that an extensive database search is suggested, the patron has the option of a free abbreviated search or to purchase the more comprehensive online DIALOG database search on a cost recovery basis.  Because many organizations and institutions have full-service libraries with the capability of multi-database searching, AWIC staff are a back-up resource, providing materials, other information resources and advice to librarians.  For those organizations or individuals with limited information resources, AWIC can provide more comprehensive services. Several types of publications are generated by the AWIC staff.  Most publications fall into the following five NAL publication series: Quick Bibliography (QBs) Special Reference Brief   (SRBs) AWIC Series Fact Sheets Animal Welfare Information Center Newsletter Efforts continue to address new and old welfare issues through either new publications or updates of old publications.  At the present time, all AWIC publications are supplied without charge.  It should be noted that AWIC-produced publications are not copyrighted and may be photocopied without permission.  For a current listing of publications available, please contact the AWIC. For your convenience there are various ways that you can contact the Center.  Staff members are available to take your calls between 8:00 a.m. and 4:30 p.m. •   Telephone - (301) 504-6212 •   FAX machine - (301) 504-6409 •   Email - awic@nalusda.gov •   http://www.nal.usda.gov/awic/ •   The AWIC mailing address is: Animal Welfare Information Center National Agricultural Library 10301 Baltimore Blvd. Beltsville, MD 20705-2351 Animal Use Protocols (top of page) Who Must Submit an Application? Any research or instructional use of animals by LSSU faculty, students or staff requires the submission of an Application to Use Vertebrate Animals (AUVA) to the IACUC.  The protocol must be fully approved before an animal user may acquire, house or use animals.  The application may be downloaded here. The Protocol Review Process Protocols undergo preliminary review by the IACUC Chair who ensures that the proposal is complete and that animal use procedures conform with LSSU guidelines and policies.  Following this preliminary review, the IACUC Chair will contact the applicant if clarifications or revisions are necessary.  The protocol is then distributed to all IACUC members for review. The Committee may approve, give conditional approval subject to minor changes, defer a vote until more information is provided, or deny the protocol. Information Required for the Protocol The application requires a nontechnical description of the research, a justification for the use of animals, a description of all procedures to be performed on animals and precautions to be taken to guarantee humane care and treatment.  Thorough preparation of protocols facilitates the review process and reduces the chance of delay in initiating projects.  Once approved, the protocol becomes a public document.  Accordingly, investigators should anticipate that copies of the protocol may be requested by members of the general public and should make every effort to prepare protocols that are appropriately nontechnical and clear. Timetable for Protocol Submission To allow sufficient time for protocol review and verification of approval, applicants should submit protocols to the IACUC at least 8 weeks before the use of animals is to begin. This lead time is required because protocols frequently require revision before they can be approved.