ELECTRONIC INFORMATION DOCUMENTS FROM AWIC ORDERING INFORMATION AND USER GUIDE Michael Kreger, Technical Information Specialist The Animal Welfare Information Center (AWIC) is compiling an electronic library of full-text animal welfare information which will be updated periodically. In response to the demand from our patrons for electronic animal welfare legislation and other related documents, we have compiled this collection of documents in WordPerfect 5.1 and ASCII (formatted for DOS systems). As other laws or policies become available and processed electronically, this project will be updated. We welcome any suggestions or contributions. Documents already in WordPerfect or ASCII format would be greatly appreciated. Requestors of electronic material must provide one formatted 3 1/2" high-density floppy disk for each volume. To request Volumes 1, 2, and 3, please send three (3) disks. Please specify the preferred format (WordPerfect or Ascii). For more information about contributing or receiving information for the electronic documents project contact AWIC, Fifth Floor, National Agricultural Library, 10301 Baltimore Blvd., Beltsville, MD 20705. Tel: 301/504-6212; Fax: 301/504-7125; Internet: AWIC@NALUSDA.GOV Please note that the filenames listed in this guide do not include extensions. If the format requested is WordPerfect, the file extension is WP. The ASCII extension is ASC. Other document additions, updates, and revisions will be included when available and announced in Animal Welfare Information Center Newsletter. Every effort has been made to minimize discrepencies between paper and electronic versions. The original paper documents are the official versions. Although each document has been proofread to assure accuracy, please let us know if you come across any mistakes. The Animal Welfare Information Center is not responsible for any changes made to the documents once they leave the center. Please note that the Animal Welfare Act and amendments are done in 2 columns because of reference notes found in the margins. Tim Allen, Jennifer Lyons-Carter, Ruth Criscio, Robin Hawkins, D'Anna Jensen, Jean Larson, and Cynthia Smith provided technical assistance for this project. ELECTRONIC DOCUMENTS I: ANIMAL WELFARE LEGISLATION AND POLICIES DOCUMENTS AS OF FEBRUARY 1995 THE ANIMAL WELFARE ACT, AMENDMENTS, AND REGULATIONS Animal Welfare Act as Amended (7 USC, 2131-2156) File Name: AWA The complete Animal Welfare Act including all amendments following the 1966 enactment. This version is current through 1993 and can be found in United States Code, Title 7, Sections 2131 to 2156. PL 89-544 Act of August 24, 1966 File Name: PL89544 Enacted August 24, 1966, Public Law 89-544 is what commonly is referred to as The Animal Welfare Act although that title is not mentioned within the law. It authorizes the Secretary of Agriculture to regulate transport, sale, and handling of dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits intended to be used in research or "for other purposes". It requires licensing and inspection of dog and cat dealers and humane handling at auction sales. The complete amended act can be found in United States Code, Title 7, Sections 2131-2156. PL 91-579 Animal Welfare Act of 1970 File Name: PL91579 Enacted December 24, 1970, Public Law 91-579 expands the list of animals covered by the act to include all warm-blooded animals determined by the Secretary of Agriculture as being used or intended for use in experimentation or exhibition except horses not used in research and farm animals used in production-related studies. Exhibitors are incorporated into the act and research facilities are defined. Retail pet stores, state and county fairs, rodeos, purebred dog and cat shows, and agricultural exhibitions are exempt from the act. The Secretary is directed to develop regulations regarding recordkeeping and humane care and treatment of animals in or during commerce, exhibition, experimentation, and transport. There is also mention of inspections, and appropriate anesthetics, analgesics, and tranquilizers. There are further regulations on dog and cat commerce. PL 94-279 Animal Welfare Act Amendments of 1976 File Name: PL94279 Enacted April 22, 1976, Public Law 94-279 is primarily refining previous regulations on animal transport and commerce. "Carrier" and "Intermediate Handler" are defined. Health certification prior to transport of sale is required and must be performed by a veterinarian. Licenses, method of payment, and penalties for violations are discussed. This amendment also introduces and defines "animal fighting ventures" to the act. Animals used in hunting waterfowl, foxes, etc. are exempt. It is illegal to exhibit or transport via interstate or foreign commerce animals used in fighting ventures such as dogs or roosters. PL 99-198 Food Security Act of 1985, Subtitle F - Animal Welfare File Name: PL99198 Also called "The Improved Laboratory Standards Act" and enacted December 23, 1985, this section clarifies what is meant by "humane care" by mentioning specifics such as sanitation, housing, and ventilation. It directs the Secretary of Agriculture to establish regulations to provide exercise for dogs and an adequate physical environment to promote the psychological well-being of nonhuman primates. It specifies that pain and distress must be minimized in experimental procedures and that alternatives to such procedures be considered by the principle investigator. It also defines practices that are considered to be painful. No animal can be used in more than one major operative experiment with recovery (exceptions are listed). The establishment of the Institutional Animal Care and Use Committee (IACUC) is introduced with a description of its roles, composition, and responsibilities to the Animal and Plant Health Inspection Service (APHIS). Also included is the formation of an information service at the National Agricultural Library to assist those regulated by the act in prevention of unintended duplication of research, employee training, searching for ways to reduce or replace animal use, and to provide information on how to decrease pain and distress. The final section explains the penalties for release of trade secrets by regulators and the regulated community. PL 101-624 Food, Agriculture, Conservation, and Trade Act of 1990, Section 2503 - Protection of Pets File Name: PL101624 Public Law 101-624 was enacted November 28, 1990, and establishes a holding period for dogs and cats at shelters and other holding facilities before sale to dealers. It requires dealers to provide written certification regarding each animal's background to the recipient. Specific items included on the certificate are mechanisms of enforcement, injunctions, and penalties for violation. Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare. Available from: Regulatory Enforcement and Animal Care, APHIS, USDA, Federal Building, Room 268, Hyattsville, MD 20782. File Name: 9CFR93 The specific regulations developed by the U. S. Department of Agriculture to comply with the Animal Welfare Act and its amendments are included here. The section is divided into 4 sections: Definitions, Regulations, Standards, and Rules of Practice Governing Proceedings Under the Animal Welfare Act. The Definitions section describes exactly what is meant by terms used in the legislation. "Animal", for example, specifically excludes rats of the genus Rattus and mice of the genus Mus as well as birds used in research. The Regulations section includes subparts for licensing, registration, research facilities, attending veterinarians and adequate veterinary care, stolen animals, records, compliance with standards and holding periods, and miscellaneous topics such as confiscation and destruction of animals and access and inspection of records and property. The bulk of the subchapter is the third section which provides standards for specific species or groups of species. Included are sections for cats and dogs, guinea pigs and hamsters, rabbits, nonhuman primates, marine mammals, and the general category of "other warm-blooded animals". Standards include those for facilities and operations, health and husbandry systems, and transportation. The final section sets forth the Rules of Practice applicable to adjudicating administrative proceedings under Section 19 of the Animal Welfare Act. While the Code of Federal Regulations is updated each year, there will be no changes in the animal welfare subchapter from 1992 to 1993. PUBLIC HEALTH SERVICE LEGISLATION AND POLICIES PL 99-158 Health Research Extension Act of 1985, Section 495 File Name: PL99158 The Health Research Extension Act of 1985 was enacted on November 20, 1985. Section 495, "Animals in Research", requires the Secretary of the Public Health Service (PHS) to develop and implement regulations for the humane care and use of animals in research by institutions (including Federal facilities) that receive PHS funding. The complete law can be found in U.S. Code, Title 42. National Research Council. 1985. Guide for the Care and Use of Laboratory Animals. NIH Publication No. 86-23, 83 pp. Washington, D.C.: U.S. Department of Health and Human Services. Available from: Office for Protection from Research Risks, National Institutes of Health, Building 31 Room 5B59, 9000 Rockville Pike, Bethesda, MD 20892. File Name: GUIDE Public Health Service grantees and contractors are required to abide by the Animal Welfare Act and amendments and the recommendations found in the "Guide" and the "PHS Policy". The "Guide" includes minimum requirements for institutional policies, laboratory animal husbandry, veterinary care, physical plant, and special considerations such as farm animals. Unlike the Animal Welfare Act, the guide is used for all animal species. Public Health Service. 1986. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. Available from: Office for Protection from Research Risks, National Institutes of Health, Building 31 Room 5B59, 9000 Rockville Pike, Bethesda, MD 20892. File Name: POLICY The "Public Health Service (PHS) Policy" was established in accordance with the Health Research Extension Act of 1985 (PL 99-158). It must be used to supplement the Animal Welfare Act and amendments by PHS grantees and contractors. It includes policy on animal welfare assurance, composition and function of institutional animal care and use committees, information required to apply for PHS funding and review of research, recordkeeping and reporting requirements, and implementation by PHS. OTHER ANIMAL WELFARE LEGISLATION PL 102-346 Animal Enterprise Protection Act of 1992 File Name: PL102346 Public Law 102-346 was enacted August 26, 1992 and ammends Title 18, United States Code. Makes "physical disruption" of animal enterprises by property damage, theft, economic damage exceeding $10,000, serious bodily injury or death a criminal offense. The Attorney General and the Secretary of Agriculture must conduct a study on the extent and effects of terrorism on enterprises using animals for food and fiber production, agriculture, research, or testing and present their findings and recommendations to Congress. Code of Federal Regulations, Title 21, Chapter 1, Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies. Available from: Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. File Name: 21CFR92 Administered by the Food and Drug Administration, these regulations prescribe good laboratory practices for conducting nonclinical laboratory studies that support research or marketing permits for products regulated by the Food and Drug Administration including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Companion regulations for conducting studies relating to health effects, environmental effects, and chemical fate testing are found in Code of Federal Regulations, Title 40, Chapter 1, Part 792 - Good Laboratory Practice Standards and are administered by the Environmental Protection Agency. Federal Register, Volume 54, No. 75, Thursday, April 20, 1989 - Good Laboratory Practice: Minor Amendment. Available from: Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. File Name: FDACLIP The final rule discouraging toe clipping for laboratory animal identification is discussed as an amendment to the Food and Drug Administration's Good Laboratory Practice Standards. Code of Federal Regulations, Title 40, Chapter 1, Part 792 - Good Laboratory Practice Standards. Available from: Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 20460. File Name: 40CFR92 In accordance with section 4 of the Toxic Substances Control Act, the Environmental Protection Agency issued these regulations describing laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing. Companion regulations for product testing regulated by the Food and Drug Administration are found in Title 21, Chapter 1, Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies. ELECTRONIC DOCUMENTS II: ANIMAL WELFARE RECOMMENDATIONS AND RESOURCES VOLUME II DOCUMENTS AS OF NOVEMBER 1994 Allen, T. and Clingerman, K. (1992). Animal Care and Use Committees. United States Department of Agriculture, National Agricultural Library: Beltsville, MD, 38 pp. File Name: ACUC Contains 168 bibliographic citations relating to the institutional animal care and use committees (IACUC). Sections include animal care committees, institutional/industrial committees, ethics, investigator/public attitudes and concerns, membership and training, policy and procedure, protocol review, and regulation of animal care and use committees. American Association for Accreditation of Laboratory Animal Care AAALAC Position Statements. AAALAC, 11300 Rockville Pike, Suite 1211, Rockville, Maryland 20852, 7 pp. File Name: AAALACP Position statements used to evaluate animal care and use programs. Areas covered are laboratory animals, farm animals, adequate veterinary care, occupational health and safety programs, multiple major surgical procedures, survival surgery facilities, and AAALAC resources. American Association for Accreditation of Laboratory Animal Care AAALAC Rules of Accreditation. AAALAC, 11300 Rockville Pike, Suite 1211, Rockville, Maryland 20852, 17 pp. File Name: AAALACA Criteria for granting or denying accreditation of facilities. Defines accreditable units and status. Areas covered include standards, fees and procedures, site visits and visitors, hearings and appeals, certificates, and record confidentiality. Berry, D. (1993). Audio-visuals Relating to Animal Care, Use and Welfare. United States Department of Agriculture, National Agricultural Library: Beltsville, MD, 76 pp. File Name: AVLIST92 Updates AWIC Series #7 and includes descriptions, format, and call numbers of videotapes, slides, and films about animal care, use, and welfare contained in the National Agricultural Library collection. Borrowing information is provided. Berry, D. J.; Kreger, M. D.; and Lyons-Carter, J. L. (1992). Information Resources for Reptiles, Amphibians, Fish, and Cephalopods Used in Biomedical Research. United States Department of Agriculture, National Agricultural Library: Beltsville, MD, 80 pp. File Name: REPTILER Provides bibliographic citations for the care and use of reptiles, amphibians, fish, and cephalopods in biomedical research. Each group of animals is divided into general, biomedical models, and care and use sections. There is also a section on organizations that specialize in each group and their publications or funding resources. Office of Animal Care and Use (1991). National Institutes of Health Nonhuman Primate Management Plan. National Institutes of Health: Bethesda, MD, 54 pp. File Name: NIHPRIM The model used for nonhuman primate environmental enrichment programs at the National Institutes of Health. Includes designing, implementing, and evaluating programs as well as species-specific options. Pough, H. F. (1991). Recommendations for the care of amphibians and reptiles in academic institutions. ILAR News 33(4):S1-S21. National Academy Press: Washington, D. C. File Name: POUGH An introduction to the care of amphibians and reptiles used in academic research and teaching. Recommendations are suggested for housing, breeding, marking, and medical care. Health precautions for animal release and for caretakers are also considered. Includes a very extensive reference section. Swanson, J. C.; Kreger, M. D.; Berry, D. J.; Lyons-Carter, J. L.; Larson, J. A.; Gluckstein, F. P.; and Pritchard, J. (1992). Environmental Enrichment Information Resources for Nonhuman Primates: 1987-1992. United States Department of Agriculture, National Agricultural Library: Beltsville, MD, 106 pp. File Name: PRIMATER This resource guide was a coordinated effort between the Animal Welfare Information Center at the National Agricultural Library, the National Library of Medicine, and the Primate Information Center at the University of Washington. It includes general and taxon specific bibliographic citations on regulations, facility design, programs, enrichment techniques and devices, animal training, well-being assessment, behavior, and breeding. There are sections containing monographs, pre-1987 bibliographies, as well as a list ofjournals that contain primate information. The Primate Information Sources section contains descriptions and contacts of 32 organizations that specialize in nonhuman primate environmental enrichment. ELECTRONIC DOCUMENTS III: ANIMAL WELFARE RECOMMENDATIONS, LEGISLATION, AND RESOURCES VOLUME III DOCUMENTS AS OF FEBRUARY 1995 National Research Council (1991). Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs. National Academy Press: Washington, D.C., 139 pp. File Name: EDUCNRC Produced by the Committee on Educational Programs in Laboratory Animal Science under the auspices of the Institute of Laboratory Animal Resources. Contains course modules, content outlines, resources, and information on how to develop, deliver, and evaluate an education program. Federal Register, Vol 58, No. 139, July 22, 1993, P. 39124. Final Rule: Random Source Dogs and Cats. File Name: CAT1 The final rules amending the regulations under the Animal Welfare Act requiring pounds and shelters to hold and care for dogs and cats for at least 5 days (including one weekend day) before providing them to a dealer. Dealers must provide valid certification to anyone acquiring random source dogs and cats from them. Public comments and rationale for the regulatory decisions are discussed. This information updates 9 Code of Federal Regulations, Subpart A, Parts 1 and 2. Federal Register, Vol. 58, No. 164, August 26, 1993, P. 45040. Final Rule: Correction, Random Source Dogs and Cats. File Name: CAT2 Revises several sentences in the original final rule. AVMA (American Veterinary Medical Association)(1993). 1993 Report of the AVMA Panel on Euthanasia. Journal of the American Veterinary Medical Association 202:229-249. File Name: AVMAEUTH Recommendations for humane euthanasia of vertebrates including acceptable methods, mechanisms of action, and special considerations. This document appears in the AWIC Electronic Library by permission of the American Veterinary Medical Association. It may be reproduced in its entirety, including the citation (J. Am. Vet. Med. Assoc. 1993;202:229-249), so long as it is used for educational purposes and distributed without charge. Neither the American Veterinary Medical Association nor the Animal Welfare Information Center is responsible for any alterations to the document after downloading from AWIC. Reprints of the 1993 Report of the AVMA Panel on Euthanasia are available for $.50 each, prepaid, from the AVMA, 1931 N. Meacham Rd., Suite 100, Schaumburg, IL 60173-4360, (708)925-8070, ext.250. ARENA (Applied Research Ethics National Association)(Updated version, 1994). Institutional Animal Care and Use Committee Guidebook. NIH Publication No. 92-3415 File Name: ARENA The Guidebook is produced through the Office of Protection from Research Risks, National Institutes of Health and authored by ARENA. It outlines and compares Institutional Animal Care and Use Committee (IACUC) reponsibilities under the Animal Welfare Act and the Public Health Service Policy. Topics covered include proposal review, program oversight, evaluation of animal welfare concerns, recordkeeping and reporting, special considerations, resources, and selected references. Dept. of Health and Human Services, United States Public Health Service, National Institutes of Health (October, 1993). Plan for the Use of Animals in Research. File Name: NIHUSE The Interagency Coordinating Committee for the Use of Animals in Research was charged with developing this plan as mandated by The National Institutes of Health (NIH) Revitalization Act of 1993, Public Law 103-43. It outlines research history, initiatives, meetings, training, and information dissemination sponsored by NIH that use animal and non-animal models for the study of human disease. Appendices include a list of committee members, Section 205 (Plan for use of animals in research) of Public Law 103-43, a summary of an NIH conference on modeling in biomedical research, and a list of model systems. Bennett, B. T.; Brown, M. J.; and Schofield, J. C. (Second edition, 1995). Essentials for Animal Research: A Primer for Research Personnel. United States Department of Agriculture, National Agricultural Library: Beltsville, MD. File Name: ESSENTIA Co-produced by the University of Illinois at Chicago, the ten-chapter volume provides an introduction to many animal care aspects of research. Chapters highlight regulations, anesthesia, analgesia, aseptic technique, alternative methodologies, euthanasia, perioperative care, and information resources. ELECTRONIC DOCUMENTS IV: ANIMAL WELFARE RECOMMENDATIONS, LEGISLATION, AND RESOURCES VOLUME IV DOCUMENTS AS OF MARCH 1995 Federal Register, Volume 59, No. 127, Tuesday, July 5, 1994: 34496-34547 - National Institutes of Health: Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). File Name: DNA The NIH Guidelines specify practices for constructing and handling recombinant deoxyribonucleic acid (DNA) molecules and organisms and viruses containing recombinant DNA molecules. Includes topics such as biosafety, gene transfer, and institutional responsibilities.