Interim Animal Welfare Policy; Replaced by EM 93-001
Executive Memorandum 91-015
October 15, 1991
From: Robin S. Wilson, President
Subject: Interim Animal Welfare Policy; Replaced by EM 93-001
Upon recommendation of the Provost and Vice President for Academic Affairs, I approve the following document for immediate implementation.
California State University, Chico provides this policy to comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (hereinafter referred to as PHS Policy).
This policy is applicable to all research, research training, teaching, experimentation, biological testing, and related activities involving live, vertebrate animals conducted at this University or at another institution as a consequence of our subgranting or subcontracting externally conducted or supported activity. (For the present time, and until otherwise required by federal or state rules and regulations, horses and other farm animals, such as, but not limited to, livestock or poultry used or intended for use in traditional agricultural research classified as non-medical [animal nutrition, breeding, management, or production efficiency] are only required to be monitored and reported as described below.)
This policy will guide the University in the care and use of animals in research and education. In order to ensure continuing compliance with all federal or state rules and regulations governing the care and use of animals in research and education, this policy authorizes the university's Animal Care and Use Committee (ACUC) to amend or modify existing policies and procedures or to develop new policies and procedures in accordance with all new requirements promulgated by the federal or state government concerning animal welfare.
CSU, Chico will require semi-annual reports to the ACUC from any college or other campus unit where animals, defined as covered species by this policy or designated in the future by the ACUC, are being housed, used, or held for future research, teaching, testing, experimentation, or exhibition purposes or as a pet. The information to be included in these reports shall include the following:
- Number and species of animals
- The location and description of the facilities where the animals are housed
- Verification that these facilities are sanitary
- Verification that the animals are fed, watered, and provided with proper ventilation
- Verification that the animals are observed on a regular basis and that they are healthy
- Verification that the animals are provided adequate veterinary care
- Verification that animals' pain and distress are minimized and that alternatives to painful procedures are considered
- Notification to the ACUC at any time if any of these conditions change or if these animals are being housed, used, and cared for in any way which is not in compliance with prevailing governmental regulations.
Current units of California State University, Chico in which laboratory animals are used in teaching or research are:
- College of Agriculture and Human Environmental Sciences
- School of Agriculture, including the University Farm
- School of Human Environmental Sciences
- College of Behavioral and Social Sciences
- Department of Psychology
- College of Natural Sciences
- Department of Biological Sciences
California State University, Chico will comply with all applicable provisions of the Animal Welfare Act and other federal statutes and regulations relating to animals. As stated above, the ACUC is authorized to modify or amend existing policies and procedures or to develop new policies and procedures to ensure compliance with changing federal or state requirements.
- The University will use U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health (NIH)Guidelines, rules, and regulations as the minimum set of standards in defining and determining what is research and education involving animals, with the exception of farm animals as noted above; which research and educational activities are exempt from coverage; safeguards and restrictions to enforce for protection of animals in research and education; and which processes and procedures to use in regulating the care and use of animals in research.
- The following policies and procedures are in part direct extracts from 9 CFR, Parts 1, 2, and 3 Animal Welfare; Final Rules, August 31, 1989, United States Department of Agriculture, Animal and Plant Health Inspection Service; from The Guide for the Care and Use of Laboratory Animals, Public Health Service, NIH Publication No. 86-23, Revised, 1985; and from the Institutional Administrator's Manual for Laboratory Animal Care and Use, Public Health Service, NIH Publication No. 88-2959, revised, 1988, and any addenda or revisions.
CSU, Chico is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
The University acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this policy. As partial fulfillment of this responsibility this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this policy as well as all other applicable laws and regulations pertaining to animal care and use.
CSU, Chico has established and will maintain a program for activities involving animals in accordance with the National Institutes of Health Office for Protection from Research Risks (OPRR)Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised, September, 1986; and the Guide for the Care and Use of Laboratory Animals, NIH Publication No. 86-23, Revised, 1985, hereinafter Guide, until and unless the ACUC otherwise designates new guidelines, in accordance with changing federal or state requirements.
- Other references will include the NIH Guide for Grants and Contracts, (DHHS), Laboratory Animal Welfare, Special Edition, Vol. 14, No. 8, June 25, 1985 and NIH Guide Supplement for Grants and Contracts (DHHS), Laboratory Animal Welfare, Special Edition, Vol. 14, No. 8, June 25, 1985. The University will also maintain a program for activities involving animals in accordance with regulations governing the care and use of animals in research and education used by the National Science Foundation or other federal agencies, agencies of the State of California, or local government. These regulations constitute a body of widely recognized and published rules and may apply in special situations, as necessary and appropriate.
INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE
The lines of authority and responsibility for administering the program and ensuring compliance with this policy are as follows:
- The university Animal Care and Use Committee shall act as the inspection/enforcement arm of the animal care and use program while the administration, through the Institutional Official, shall be responsible for implementing the programs and facilities improvements recommended by the ACUC. The Dean of the Graduate School/Vice Provost for Research shall serve as the Institutional Official. See Appendix A for Organizational Chart.
The name, qualifications, and authority of the veterinarian who will participate in the program is
- Lewis H. Brogan, D.V.M. , Erickson Veterinary Hospital, 11181 The Midway, Chico, California 95928. Dr. Brogan will provide advice and veterinary care, as appropriate and as needed.
Animal Care and Use Committee Membership
- The University has established an Animal Care and Use Committee, which is qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. The ACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b.
- The committee shall be appointed and the chair name by the President of the University. The committee shall consist of at least five members including
- One representative from each department using animals for research or teaching, qualified by training and experience to judge the appropriateness of animal use in experimentation and teaching
- One Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine, who has direct or delegated responsibility for activities involving animals at the institution
- One institutional member whose primary concerns are in a non-scientific area
- One individual who is not affiliated with the University in any way other than as a member of the committee and is not a member of the immediate family of a person who is affiliated with the University
- A representative of the Institutional Official from the Office of Sponsored Projects
In accordance with PHS Policy IV.B. , the ACUC will
- Review at least once every six months the university's program for humane care and use of animals, using the Guide as a basis for evaluation.
- During the semi-annual Program Review, if appropriate, the committee will examine animal use records, interview animal care personnel, and interview investigators and educators that use animals.
- Inspect at least once every six months all of the University's animal housing and use areas including satellite facilities, using the Guide as a basis for evaluation.
- Prepare reports of ACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Official.
- An official semi-annual report of the committee's inspection and evaluation of the University's animal programs and facilities will be developed and approved by a quorum of the committee and submitted to the Institutional Official
- Review concerns involving the care and use of animals at the University.
- Any reports of concern over the care and use of animals at this institution which are received will be treated with confidentiality to protect the identity of the concerned individual(s). The ACUC chair will conduct the initial investigation and, if warranted, will convene the committee to determine the outcome.
- Make written recommendations to the Institutional Official regarding any aspect of the University's animal programs, facilities, or personnel training.
- Review, approve, and require modifications in (to secure approval of) or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C.
- The committee will require that an application for the use of animals in teaching or research be submitted and approved, as set forth in PHS Policy at IV.C. prior to the initiation of any such animal use.
- Review and approve and require modifications in (to secure approval of) or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C.
- The committee will require that changes to approved protocols must be submitted and approved prior to the initiation of any such changes.
- Notify investigators and the University in writing of its decision to approve or withhold approval of those activities related to the care and use of animals or of modifications required to secure ACUC approval as set forth in the PHS Policy at IV.C.4.
- Each applicant will receive written notification of the outcome of the committee's deliberations. Such notification is also sent to the appropriate department chair.
- Be authorized to suspend any activity involving laboratory animals as set forth in the PHS Policy at IV.C.6. Procedures for suspending an activity involving the use of animals are as follows:
- The Principal Investigator (PI)/educator is notified (in writing) of the committee's determination that significant departures from the approved protocol exist. Specific deviations are cited and the PI/educator is instructed to adhere to the approved protocol until such time as an application for revision of the approved protocol has been submitted and approved. A copy of this letter is sent to the Institutional Official and other appropriate administrators.
- A follow-up inspection is scheduled at which the committee determines whether appropriate action or satisfactory progress has been made by the PI/educator in correcting the cited deficiencies. The results of this inspection are submitted (in writing) to the PI/educator, the Institutional Official, and other appropriate administrators.
- If the results of the follow-up inspection are unsatisfactory, the report will recommend appropriate action ranging from extension of the schedule for correcting the deficiencies to suspension of the activity at once with notification made to the funding agency. This determination will be made by a quorum of the committee and will include consideration of the effect the deficiencies have on the welfare of the animals.
- The PI/educator and the Institutional Official are notified (in writing) of the committee's decision and the deadline by which appeals may be made before the action is instituted.
- An appeals hearing may be requested by the PI/educator prior to the deadline by contacting the committee chair in writing. Such a hearing will require a quorum of the committee to be in attendance with a majority vote of that quorum required to change the previous action. The PI/educator, the Institutional Official, and other appropriate administrators will be notified in writing of the committee's decision.
*If an ongoing animal use activity which has not been reviewed and approved by the committee is discovered, the project will be suspended immediately.
*All additional procedures required to implement this and future policy on animal care and use will be developed and promulgated under the authority of the ACUC with the approval of the Institutional Official and the President.
The University authorizes the chair of the ACUC to verify ACUC approval of those sections of applications and proposals related to the care and use of animals.
Personnel who work in laboratory animal facilities or have frequent contact with animals must follow a specific health program.
- For students and student workshops involved with the use and care of animals, each investigator/educator is responsible for issuing written guidelines which should include:
- Possible hazards associated with handling the animal species involved in the project or course;
- The procedures to be followed in the event of an animal-related injury and the importance of reporting such injuries immediately to the appropriate supervisor;
- The availability of student health care through the student health center on campus; and
- Information on the rabies pre-immunization requirement for any student handling any rabies suspect.
- For personnel (faculty and staff) having significant contact with laboratory animals, following is a description of the University's occupational health program:
- All individuals in contact with animals are made aware of possible dangers of disease transmission between animals and humans and the basic precautions which should be followed. This health education program emphasizes the importance of personal hygiene and tetanus immunization. In addition, individuals who have frequent contact with animals are encouraged to have an annual physical examination and appropriate immunizations (e.g. , tetanus toxoid booster, rabies immunization, etc. ) as needed.
- For on-the-job animal-related injuries, employees of the University should seek appropriate medical attention and file Worker's Compensation (not personal insurance) with the medical agency rendering treatment. The employee and supervisor are to file accident reports with the appropriate university offices.
- As part of the University's program for animal care and use, the Graduate School will provide the following training or instruction to scientists, educators, animal technicians, students, and other personnel involved in animal care, treatment, or use:
- Audiovisual training tapes, such as those produced by the National Association for Biomedical Research or the American Veterinary Medical Association, or other appropriate video tapes will be purchased by the University and made available for use by appropriate audiences.
- Demonstrations and instruction by the Attending Veterinarian, faculty, or technical staff provided to students prior to actual animal use in courses.
- The University or the University Foundation may provide funds, if necessary, to support the required continuing education of faculty and staff in the areas of laboratory animal use and care.
As specified in the PHS Policy at IV.A.2, under Category 2, all of the University's programs and facilities (including the University Farm) with activities involving laboratory animals will be evaluated by the ACUC at least once every six months. The report of the ACUC evaluation will be submitted to the Institutional Official.
The report will contain a description of the nature and extent of this institution's adherence to the Guide. Any departures from the Guide will be identified specifically and reasons for each departure will be stated. Where program or facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency.
The report will distinguish significant deficiencies from minor deficiencies. Semi-annual reports of the ACUC evaluation submitted to the Institutional Official also will contain a reasonable and specific plan and schedule for correcting each deficiency and will distinguish significant deficiencies from minor deficiencies.
Semi-annual reports of ACUC evaluations will be maintained by the University and made available to the Office for Protection from Research Risks (OPRR) upon request.
CSU, Chico will maintain for at least three years
- A copy of this policy and modifications thereto
- Minutes of ACUC meetings, including records of attendance, activities of the committee, and committee deliberations
- Records of applications, proposals, and proposed significant changes in the care and use of animals and whether ACUC approval was given or withheld
- Records of semi-annual ACUC reports and recommendations as forwarded to the Institutional Official
- Records of accrediting body determinations.
The University will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the ACUC for the duration of the activity and for an additional three years after completion of the activity.
All records shall be accessible for inspection and copying by authorized USDA, OPRR, or other PHS representatives or other required agencies, at reasonable times and in a reasonable manner.
The Office of Sponsored Projects will be the central administrative recordkeeping office responsible for housing ACUC records according to federal regulations.
The ACUC, through the Institutional Official, will promptly provide any applicable funding agencies with a full explanation of the circumstances and actions taken with respect to
- Any serious or continuing noncompliance with the PHS Policy;
- Any serious deviations from the provisions of the Guide
- Any suspension of an activity by the ACUC.
Reports filed under the above sections shall include any minority views filed by members of the ACUC.
Completion of required reports will be made by the deadlines issued by cognizant federal or state agencies. These reports will include at the least the U.S. Department of Agriculture VS Form 18-23, Annual Report of Research Facility for submission to the Chancellor's Office of The California State University by October 15 of each year. This report will be first distributed to appropriate college deans for review. The ACUC will then complete the report with the assistance of department chairs, principal investigators, research assistants, and technicians.
This report will include the following required information:
- Species of covered animals in use during the last year or anticipated in the upcoming year
- The number of each covered species, including both the number of species and the number of individual animals
- A detailed description of the proposed/ongoing research or education activity for which these species will be/are being used
- Changes in the number and condition of each species, including the number and species of animals which are euthanized each year
- Where and under what conditions each species is housed on campus
- Who is responsible for the supervision and care of each species
- The number of species used in research and education, experiments, or tests where appropriate anesthetic, analgesic, or tranquilizer drugs were administered to avoid pain or distress. 8. The number of species used in research and education, experiments, or tests involving pain or distress without administration of appropriate anesthetic, analgesic, or tranquilizing drugs and an explanation as to why drugs are not being used in such cases
- Individuals, by name, title, and department, who use animals on a routine or intermittent basis for research or other experimental purposes
- What formal training programs are in place for all personnel who handle animals in research, including instructionally related research
- Policy that individual principal investigators are trained appropriately in the care and use of animals in research and education
- Verification that all federal guidelines and regulations governing the use of live animals in research, as outlined in the Code of Federal Regulations (CFR), Title 9 (Animal and Animal Products), Subchapter A -- Animal Welfare, Parts 1, 2, and 3, including the most recent Final Rules, (Federal Register, August 31, 1989, 9 CFR, Parts 1, 2, and 3, pp. 36112 to 36163, are being strictly adhered to by all campus units. Also reference can be made to the Guide for the Care and Use of Laboratory Animals, U.S. Government Printing Office, NIH Publication No. 86-23, Revised 1985)
- Procedures for reporting problems with laboratory animals. In the event emergency care is required, a Doctor of Veterinary Medicine (D.V.M. ) will be on call. Appendix A Animal Welfare - Organization Original chart on file with document in President's Office.