ASC-BSO ANIMAL WELFARE ACT POLICY

This policy establishes the procedures required for Alaska Science Center - Biological Science Office (ASC-BSO) employees to comply with the Animal Welfare Act, as amended in 1985, and the US Department of the Interior’s Interagency Research Animal Committee’s Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, as published in the Federal Register, May 20, 1985, Vol. 80, No. 97. In addition, it establishes the procedures to be followed by the Institutional Animal Care and Use Committee. Nothing in this policy should be taken to supersede any requirement of the Controlled Substances regulations. It is not the intent of this policy to repeat every requirement of the Animal Welfare Act or the Interagency Research Animal Committee Principles.

DEFINITIONS:

Animal Welfare Act: It is the intent of this Act to mandate that animals used in research receive the best possible treatment and care, that alternatives to the use of animals be considered, that researchers using animals in their research are adequately trained for the procedures they wish to do, and that the quality of data obtained through animal usage is the highest possible. Initially passed as the Laboratory Animal Welfare Act (Public Law 8-544) in 1966, the Animal Welfare Act was extended by amendment several times, most recently in 1985. The most important modifications include requirements to adopt procedures to minimize pain and distress in experimental animals, establish an Institutional Animal Care and Use Committee at each research facility, consult with a veterinarian concerning veterinary care, use of pain-relieving drugs, and surgical procedures, requires training and continuing education for all facility personnel involved with animal care and use, and extends penalties for violations. The Animal Welfare Act covers mammals; rats, mice and birds are specifically omitted. The lead agency for administration of the Animal Welfare Act is the US Department of Agriculture.

Interagency Research Animal Committee (IRAC) Principles: See Appendix A. These principles commit all federal agencies to comply with the requirements of the Animal Welfare Act and extend the coverage of the Animal Welfare Act to all vertebrate animals. In this policy document, use of the term "Animal Welfare Act" implies the inclusion of the IRAC Principles.

Institutional Animal Care and Use Committee (ACUC): The ACUC, as mandated by the Animal Welfare Act, consists of at least three members, one of whom must be a doctor of veterinary medicine, and one of whom must be a representative of the interests of the general community (not affiliated with USGS, BRD, nor an immediate family member of an USGS, BRD employee).

Good Laboratories Practice (GLP) Act: The GLP Act represented Congress’ interest in ensuring the reliability of results coming from quality control laboratories. It has been extended for use by research laboratories. In relationship to the Animal Welfare Act, the GLP Act requires the development of standard operating protocols for efforts that are repeated. The GLP protocols should be documents that can be cited as references in research planning.

Attending Veterinarian: Known at ASC-BSO as the Wildlife Veterinarian, this is an individual possessing a doctor of veterinary medicine degree from an institution defined in the Animal Welfare Act who serves on the ACUC and who has primary responsibility for oversight of all animal experimentation, holding and utilization by ASC-BSO personnel. The veterinarian may or may not be an employee of ASC-BSO.

Experiments, procedures, manipulations: Any use of a vertebrate animal in a research project is covered by the Animal Welfare Act, regardless of the term used. In this document, research means any procedure using a vertebrate animal.

Facility Annual Report: As required by the Animal Welfare Act, a report is submitted by ASC-BSO to the US Department of Agriculture at the end of each fiscal year detailing the numbers and species of mammals used by ASC-BSO researchers and classifying the usage into several classes based on the level of pain and distress and the use of tranquilizers or anesthetics. The facility annual report must be signed by the Director of ASC-BSO.

Federal Awards: Federal awards are loans, grants, awards, contracts or cooperative agreements which result in research, testing or experimentation with animals.

COVERAGE OF THE ANIMAL WELFARE ACT AND IRAC PRINCIPLES:

While the Animal Welfare Act specifically covers only mammals (and specifically excludes rats, mice and birds), the IRAC principles extended coverage to all vertebrate species. It will be the policy at ASC-BSO to require review and compliance of all efforts of ASC-BSO researchers involving animals. Federal agencies are responsible for procedures resulting from all federal awards. Therefore, when sponsoring other research organizations or cooperating in work with other agencies and organizations, ASC-BSO researchers have the responsibility of assuring full compliance with the requirements of the Animal Welfare Act. The permit systems of the Endangered Species Act, the Marine Mammal Protection Act, and the Migratory Bird Treaty Act are specifically excluded from coverage. Some wildlife management activities such as predator control, tagging and survey activities, and removal and relocation efforts are not included.

IMPLEMENTATION OF THE ANIMAL WELFARE ACT AND IRAC PRINCIPLES:

It is the policy of ASC-BSO that all research involving vertebrate animals, whether done directly by ASC-BSO researchers or done by others through federal awards administered by ASC-BSO researchers, shall be reviewed by the ASC-BSO’s ACUC. No such research shall be initiated until ACUC approval is obtained. In the case of research done under federal award at an institution that has its own institutional ACUC, review of procedures by the latter will suffice for day-to-day management of the project. However, all ASC-BSO work units, whether done by ASC-BSO researchers or under a federal award, must receive an initial review and approval by ASC-BSO’s ACUC.

RESPONSIBILITIES UNDER THE ANIMAL WELFARE ACT:

The Director of ASC-BSO bears the ultimate responsibility for compliance of all ASC-BSO personnel with the Animal Welfare Act. For that reason, the Director (or Acting Director) is the only individual who can sign the facility annual report. The Wildlife Veterinarian and members of the ACUC have the responsibility for reviewing research plans and protocols, inspecting animal facilities, assembling data for the facility annual report, assisting researchers in complying with the Animal Welfare Act, and reporting non-compliance. Researchers at ASC-BSO have the proximate responsibility of assuring compliance with the Animal Welfare Act in all of their research efforts, assuring compliance of all subordinates, assuring compliance of all contractors and cooperators, preparation and submission of adequate research plans and protocols, and reporting on animal usage for the facility annual report.

DUTIES OF THE ANIMAL CARE AND USE COMMITTEE:

Where applicable, the ACUC inspects all animal facilities operating under the authority of ASC-BSO twice yearly, filing an inspection certification that must be kept for the duration of the work plus three years. In addition, the ACUC reviews research proposals that involve the use of live animals to ensure consideration of the welfare of the animals involved and adherence to the Animal Welfare Act and the IRAC Principles. The ACUC advises the ASC-BSO Director on animal welfare issues and needs, and instances of non-compliance. All records of the meetings of the ACUC will be kept on file for the duration of the work plus three years.

The Animal Welfare Act requires the ACUC to conduct a continuing review of activities covered by the Animal Welfare Act at appropriate intervals, and at least annually. It is the intent of this review to provide current information to the researchers so that they can remain in compliance.

REPORTING:

The primary document required by the Animal Welfare Act is an annual experimental animal usage report covering the previous fiscal year (October 1 through September 30). The report deals solely with mammals, and requires the classification of each species of animals used into groups based on the level of pain or distress and the use of pain or stress-relieving drugs. The classes are as follows (the letter preceding each class is the letter used on the facility annual report form):

When in doubt as to which classification should be used, the Animal Welfare Act directs us to use the highest of two possible classes of pain or distress levels.

Exemptions from the requirements of the Animal Welfare Act and instances of non-compliance must be reported with the facility annual report. All reports and ancillary documents must be kept on file and available for inspection for a minimum of the duration of the work plus three years, but indefinite storage is highly suggested.

The Wildlife Veterinarian has the responsibility for polling all researchers for their usage and classification of mammals in the previous fiscal year. Researchers have the responsibility of keeping track of the numbers and species of all mammals used in their research. Classification for the purposes of reporting should be done in consultation with the Wildlife Veterinarian, who is to have the final say on all classifications.

STANDARD PROTOCOLS:

Standard protocols are needed as a result of the interaction of the Animal Welfare Act and the GLP act. Protocols are written for each discrete use or handling of animals. Subjects of a protocol would include describing the capture of an animal species using net guns or chemicals, surgery for the implantation of transmitters, and lethal or non-lethal sampling of animals. Protocols are intended to be dynamic, multi-year documents. They describe in detail the methods used, the experience and training of the active participants, selection of the animals, safety precautions for the animals and the human participants, procedures for administration of drugs or for obtaining samples, and equipment required. Protocols can be referred to as references in other documents such as the Annual Work Plan.

Protocols dealing with animals are to be prepared and submitted to the ACUC for review. Submission can be as a separate document or as part of a proposal for review.

RESEARCH PLANS:

Any research involving vertebrate animals (e.g., capture, holding, manipulation, handling, sampling, killing, tracking, chasing, etc.) must be reviewed by, and receive approval of, the ACUC before the work begins. The plan must be submitted to the ACUC sufficiently in advance to permit an adequate review and to permit requests for changes and clarifications to be made. In some cases, the annual work plan proposal may suffice, if there is a limited scope of animal usage, or if all animal usage is covered by more detailed and approved standard protocols. In other cases, researchers may submit a series of research plans for approval as their work evolves and changes. It is clearly in the best interests of the researchers to ensure that their initial submissions contain sufficient information and detail to permit an adequate review by the ACUC. Some (but not all) reasons that call for additional submissions are changes in techniques, changes in drugs or medications, increases in the numbers of animals used or changes in the species used.

The extents of review of an experimental protocol depend on the nature of the animal procedures. Researchers must submit a research plan with sufficient detail to permit the members of the ACUC to evaluate the use of animals for the following:

EXEMPTIONS FROM RESPONSIBILITIES UNDER THE ANIMAL WELFARE ACT:

Exemptions from inspections of facilities at distant locations or without easy access can be granted by US Department of Agriculture.

Exemptions for protocols that cause pain and distress, withhold use of anesthetics, analgesics, or tranquilizers, or use animals in more than one operative experiment may be granted by the ACUC. The number of animals used will be reported in the highest category of pain and distress in the facility annual report.

Exemptions from compliance with certain Animal Welfare Act regulations may be granted by the ACUC when non-compliance is a necessary and unavoidable part of the research design. A written report must be on file with the ACUC; a copy may need to be submitted with the facility annual report.

Requests for exemptions must be submitted in writing by the researcher to the ACUC. A copy of this report will be submitted to the Department of Agriculture in the facility annual report.

Exemption cannot be made solely as a matter of convenience or because funds are not available.

CONDUCT OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE:

The Director of ASC-BSO shall appoint the members of the ACUC and decide which member shall be Chair. The chairperson of the ACUC will be an individual other than the Wildlife Veterinarian. The Chairman of the ACUC shall set the meeting schedule of the ACUC, copy and distribute research plans and protocols in advance of the meetings, conduct the meetings, assure that minutes are taken and stored, assure that accepted research plans and protocols are returned to researchers and are stored in the records of the ACUC.

A quorum (a majority of ACUC members) must be present to do business or to review plans or protocols. As a routine, work cannot begin until full approval of a plan or protocol is given by the ACUC. In an emergency, provisional approval may be given by the Wildlife Veterinarian pending an early meeting of the ACUC, with the understanding of all involved that provisional approval may be reversed following consideration of the ACUC, which will result in immediate cessation of work.

Any member of the ACUC that has direct supervisory or budgetary control of a project plan or protocol being reviewed should not participate in the consideration of the plan by the ACUC.

The ACUC will acknowledge receipt of protocols and research plans for review. The ACUC or its members may request clarification or alteration in any part of the plan at any time following its receipt. This will allow obvious problems to be corrected before a full meeting of the ACUC, which may speed the final approval of the plan or protocol.

The ACUC has the authority to dispose of research plans or protocols in three ways:

The ACUC will deliver its decision in writing to the researcher. There is no obligation of the ACUC to have the author present during routine consideration of plans and protocols. Generally, there is no need for the author to be present during consideration. The ACUC may invite the researcher to be present and participate when a plan or protocol is being considered. Likewise, an author is not obligated to be present, but when the author’s presence is requested by the ACUC, it is clearly in his or her best interest to attend to supply information that may speed approval of the plan.

The ACUC has the obligation to bring to the attention of the Director of ASC-BSO any non-compliance with the Animal Welfare Act or IRAC Principles. If, after notification and an opportunity for correction, non-compliance continues, the Animal Welfare Act requires the ACUC to notify in writing the head of the Us Geological Survey, Biological Resources Center of the non-compliance. The Animal Welfare Act grants to the ACUC the authority to terminate any research immediately, as long as a majority of a quorum agrees.

APPENDIX A

RESOURCES FOR COMPLIANCE WITH ANIMAL WELFARE ACT REQUIREMENTS

Guide for the Care and Use of Laboratory Animals. NIH Publication No. 85-23, Revised 1985. Committee on Care and Use of Laboratory Animals of the Institute of Laboratory Animal Resources Commission on Life Sciences. National Research Council. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health.

Report of the American Ornithologist’s Union, Cooper Ornithological Society, Wilson Ornithological Society. Ad Hoc Committee on the Use of Wild Birds in Research. Supplement to The Auk, Vol. 105, No. 1. January, 1988.

Syllabus of the Basic Principles of Laboratory Animal Science. Canadian Council on Animal Care. October, 1985.

Guide to the Care and Use of Experimental Animals. Vol. 1. Canadian Council on Animal Care, 1980 (Reprinted 1984).

Guide to the Care and Use of Experimental Animals. Vol. 2. Canadian Council on Animal Care, 1980 (Reprinted 1984).

Field Research Guidelines. Impact on Animal Care and Use Committees. F. Barbara Orlans, ed. Scientists Center for Animal Welfare, Maryland. April, 1988.

1986 Report of the AVMA Panel on Euthanasia. J. Am. Vet. Med. Assoc. 188(3):252-269. February, 1986.

Acceptable Field Methods in Mammalogy: Preliminary Guidelines Approved by the American Society of Mammalogy. Ad Hoc Committee on Acceptable Field Methods in Mammology, American Society of Mammalogists. 1987.

Guidelines for Use of Live Amphibians and Reptiles in Field Research. American Society of Ichthyologists and Herpetologists (ASIH), The Herpetologist’s League (HL), and The Society for the Study of Amphibians and Reptiles (SSAR). 1987.

Guidelines for Use of Fishes in Field Research. American Society of Ichthyologists and Herpetologists (ASIH), The American Fisheries Society, and The American Institute of Fisheries Research Biologists (AIFRB). 1987.

APPENDIX B

LIST OF TOPICS TO BE ADDRESSED IN STUDY PLANS AND PROTOCOLS

ANIMAL WELFARE SECTION OF STUDY PROPOSALS:

1. Are justifications given for the use of any procedure that might cause pain or distress in experimental animals?
1. Has the researcher documented an assurance that the research does not duplicate research already done?
2. Have alternative procedures been considered and documented for any procedure likely to produce pain or distress in the experimental animals? Alternatives must be listed and the reasons they were found to be unacceptable must be given.
3. Have appropriate permits been obtained for capture and holding of animals?
4. Is there a rationale given for the species and numbers of animals to be used?
5. Is there identification of the individual(s) responsible for animal handling? Is their level of experience or training adequate?

METHODS SECTION(S) OF STUDY PROPOSALS:

Describe the following in detail or refer to approved established protocols:

1. Capture techniques, equipment and drugs.
1. Marking techniques, including chemicals used and devices attached to animals.
2. Methods of transportation.
3. Holding and handling procedures including restraint devices and cages.
4. Care and feeding of animals including food type and preparation, water, cage cleaning and waste removal.
5. Surgical procedures including anesthesia.
6. Euthanasia techniques and the disposal of live or dead animals at the termination of the study.
7. Description, preparation, storage, handling and transport of all chemicals including immobilization drugs and marking dyes.

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