It is the policy of Sonoma State University (the University) to ensure the proper care, use, and humane treatment of animals used in research, testing, and instruction and to maintain an animal care and use program that is managed in accordance with applicable local, state, and federal laws and regulations. Also, this policy is intended to comply with the requirements of the Integrated California State University Administrative Manual (ICSUAM) §11000.
This policy applies to the procurement, housing, care and use of animals as defined below in sponsored or University-supported research, testing, or instruction; and to research, testing, or instruction using any University property or facility. It applies whether such research, testing, or instruction involves or is performed by University employees in the regular course of their employment or students in satisfaction of University requirements.
Two bodies of federal regulations exist: 1) The U.S. Department of Agriculture (USDA) regulations implementing the Animal Welfare Act as amended and as administered by the USDA Animal and Plant Health Inspection Service (APHIS); and 2) the Public Health Service (PHS) regulations implementing the requirements of the Health Research Extension Act of 1985. As a research facility, the University’s care and use of animals are governed by Animal Welfare Act regulations except where PHS-sponsored animal use activities, as defined below, are involved in which case the University must comply with the PHS Policy and the Guide for the Care and Use of Laboratory Animals.
A. Animal Welfare Act of 1966, as amended (AWA)
C. Guide for the Care and Use of Laboratory Animals (the Guide)
E. Public Health Service Policy (PHS Policy) - The Public Health Service Policy on Humane Care and Use of Laboratory Animals
A. Animal – Is defined as it is in the AWA as amended and its implementing regulations (9 CFR 1.1), except where PHS-sponsored or funded research is proposed or undertaken in which case animal is defined as those species covered by the PHS Policy, the Health Research Extension Act of 1985 and PHS implementing regulations.
B. Animal Facilities - Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, experiments, or surgical manipulation, including any animal study area where animals are maintained for more than 12 hours. A satellite facility is any containment outside of the University campus in Rohnert Park, California in which animals are housed for more than 24 hours.
C. Animal Use Activities - Any animal procurement, transport, confinement, housing, care, manipulation, experimentation, breeding, or use in research, research training, experimentation, instruction, biological testing or related purposes involving any University faculty, staff, or students or utilizing any University facility or property.
VI. Adoption of U.S. Government Principles
A. The University will adhere to the U.S. government principles for the utilization and care of vertebrate animals in testing, research, and training as set forth in the Health Research Extension Act of 1985. The Director for the Office of Research and Sponsored Programs and the University’s Institutional Animal Care and Use Committee (IACUC) shall ensure that these principles are followed for all animal use activities:
1. The transportation, care, and use of animals should be in accordance with the AWA and other applicable Federal laws, guidelines, and policies.
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on un-anesthetized animals paralyzed by chemical agents.
6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
9. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle 2, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.
VII. Institutional Animal Care and Use Committee (IACUC)
A. The University designates the Director for the Office of Research and Sponsored Programs as its Institutional Officer (IO). The IO is responsible for ensuring compliance with the AWA and where applicable PHS regulations and the proper functioning of the IACUC.
B. The President of the University shall appoint an IACUC qualified through the experience and expertise of its members to oversee and monitor the University’s animal care and use program, facilities, and procedures. The IACUC reports directly to the IO.
C. The IO has oversight responsibility for reporting to the USDA and other Federal agencies regarding University animal use activities as required by law and for providing related assurances, if any. The IO may delegate this responsibility as appropriate and necessary.
D. The IACUC shall have a minimum of five (5) members and must include:
1. A chair;
2. A Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine or who is approved by APHIS (where PHS-sponsored animal use activities are involved other qualifications may be required);
3. A practicing scientist experienced in research involving animals;
4. An individual whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, clergy);
5. An individual not affiliated with the University other than as a member of the IACUC who may be said to represent general community interests in the proper care and treatment of animals and is not a user of laboratory animals.
One individual may satisfy the requirements of more than one of the categories listed above.
E. IACUC meeting minutes (including committee meetings), attendance records, correspondence, reports, records, and research protocols shall be maintained by the chairman of the IACUC for three years or for three years following the conclusion of the related animal use activity, whichever applies.
VIII. IACUC Program Reviews and Facilities Inspections
A. The IACUC has primary responsibility for monitoring the University’s animal care and use program through its reviews and animal facilities inspections, as follows:
1. Every six months the IACUC shall review the University’s program for humane care and use of animals using the AWA regulations as a basis for evaluation and prepare a Program Review Report encompassing institutional policies and responsibilities including lines of authority and reporting channels, IACUC membership and functions, and IACUC record keeping and reporting procedures. It should also include a review of the adequacy and appropriateness of the veterinary medical care program, the University’s training program for personnel caring for or using animals in research, testing, or instruction, and the University’s occupational health and safety program as it applies to the care and use of animals.
2. Every six months the IACUC shall physically inspect all of the University’s animal facilities again using the AWA regulations as a basis for evaluation and prepare an Animal Facilities Inspection Report noting any facility accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International or other such agency. Animal areas containing free-living wild animals in their natural habitat need not be included in such inspection. The University’s animal care and use program and the facilities inspections shall include attention to:
a. Aspects of the physical plant where animals are housed (such as location, components, construction, management, and operation);
b. The physical and social environment of the animals;
c. Animal husbandry which encompasses food, water, bedding, sanitation, waste disposal, and pest control;
d. Animal identification, genetic monitoring, and animal health records; and
e. Daily observation of the care for animals, including weekends and holidays.
B. For PHS-sponsored animal use activities, the IACUC reports prepared as directed in paragraph A.1 & 2 above shall set forth a description of the nature and extent of the University’s adherence to the Guide and to the PHS Policy, identify any departures from these authorities, and state the reasons for each departure. Reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one that, in the judgment of the IACUC and the IO, is or may be a threat to the health or safety of the animals. For any deficiency noted the report must contain a reasonable and specific plan and schedule to remedy it. Any failure to adhere to a remedial plan and schedule which results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC through the IO to APHIS and any Federal agency funding the subject animal use activity, if required by law.
C. The IACUC may determine the best means of conducting the evaluation of University animal care and use programs and facilities. It may use a subcommittee of at least two IACUC members to conduct such evaluations, and it may use consultants to assist in the evaluations; however, the IACUC may not exclude any IACUC member who wishes to participate in any aspect of the evaluations.
D. All reports prepared by the IACUC must be signed by a majority of members and include any minority view. IACUC Program Review Reports and Animal Facilities Inspection Reports shall be submitted to the IO.
E. The IACUC is responsible for making recommendations to the IO regarding any aspect of the University’s animal program, facilities, or personnel training.
F. The IACUC is also responsible for evaluating concerns or public complaints regarding University care and use of animals, including allegations of animal mistreatment, neglect or violation of law or this policy. The IACUC may develop guidelines or procedures for handling such concerns, allegations, or violations.
IX. IACUC Protocol Review
A. It is the responsibility of the principal investigator, project director, or faculty member (whichever applies) to obtain IACUC approval of a protocol for any animal use activities and determine that the proposed activities are in accordance with AWA regulations (or in the case of PHS-sponsored animal use activities in accordance with the PHS Policy and the Guide) prior to acquiring, transporting, handling, or manipulating the environment of any animal. In addition, research on endangered or protected species must meet all applicable federal and state laws and regulations for the use of those species, including the Marine Mammal Protection Act and the Endangered Species Act.
B. Protocols or descriptions of proposed activities involving animals must detail:
1. Identification of the species and the approximate number of animals to be used;
2. A rational for involving animals, and for the appropriateness of the species and numbers of animals to be used;
3. A complete description of the proposed use of the animals;
4. A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals;
5. A description of any euthanasia method to be used;
6. A description of the methods and sources used to determine that alternatives are not available to procedures that may cause more than momentary or slight pain or distress to the animals;
7. An assurance that the proposed activities do not unnecessarily duplicate previous experiments; and
8. Any other information the IACUC deems necessary.
C. It is the responsibility of the IACUC to oversee the specific use of animals by reviewing protocols either at a convened committee meeting or through the use of designated reviewers. Designated reviewers may only act instead of the full committee if each member of the committee has been advised of the protocol to be reviewed and given an opportunity to request a full committee review. Designated reviewers must be members of the IACUC. A simple majority or quorum of the IACUC must be present to conduct a full committee review of an animal care and use protocol. No member that has a personal or conflicting interest in the proposed animal use activity may participate in the IACUC review or approval of a protocol or contribute to the constitution of a quorum if the protocol is reviewed by the full committee.
D. In reviewing and approving research involving animal use activities, the IACUC shall determine that the research or animal use activity conforms to the U.S. Government Principles adopted in Part VI of this policy , AWA regulations, and meets the following requirements:
1. Procedures involving animals, including use of restraints, will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
2. The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources used to determine that alternatives were not available;
3. The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments; and
4. Procedures that may cause more than momentary or slight pain or distress to the animals will:
a. Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time;
b. Involve, in their planning, consultation with the attending veterinarian or his or her designee; and
c. Not include the use of paralytics without anesthesia.
5. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure;
6. The animals’ living conditions will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied;
7. Medical care for animals will be available and provided as necessary by a qualified veterinarian;
8. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
9. Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices and in compliance with AWA regulations (9 CFR 2.31(d)(ix)).
10. No animal will be used in more than one major operative procedure from which it is allowed to recover unless an exception is allowed under AWA regulations (9 CFR 2.31(d)(x)).
11. Methods of euthanasia used are in accordance with AWA regulations (9 CFR 1.1) unless a deviation is justified for scientific reasons, in writing, by the principal investigator.
E. In the case of PHS-sponsored animal use activities, the IACUC shall determine that the research project or animal use activity conforms to the U.S. Government Principles adopted in paragraph VI, above, the PHS Policy, and the Guide.
F. Whether acting after full committee review or review by a designated reviewer, the IACUC may approve a protocol, require modifications to it, or withhold approval entirely. The IACUC shall notify the investigator(s) and the IO in writing of its decision to approve, require modifications or withhold approval of any protocol. If the IACUC decides to withhold approval of an activity involving animals it shall include in its written notification a statement of the reasons for its decision and provide an opportunity for the investigator(s) to respond in person or in writing.
G. Where there are significant changes planned to animal use activities previously approved by the IACUC further IACUC review is required. The IACUC has authority to determine if any change to a protocol or to any animal use activity constitutes a significant change. In any case, all protocols must be reviewed by the IACUC at least once every three (3) years.
H. The IACUC may conduct continuing review of previously approved activities involving animals as it deems necessary but not less than annually, and it may require modifications or corrective action at any time.
I. The IACUC is authorized to suspend a previously approved activity involving animals by a majority vote of the quorum present if it determines that the activity is not being conducted in accordance with the protocol approved by it after review of the matter at a convened meeting. The IO shall be responsible for reporting IACUC suspension of animal use activities to APHIS, federal funding agents, and in the case of PHS-sponsored activities to the U.S. Office of Laboratory Animal Welfare (OLAW).
J. Applications, proposals, and protocols approved by the IACUC may be subject to further review or modification at the request or direction of the President of the University, the Provost, or the IO; however, University officials may not approve an activity involving the care and use of animals that has not been previously approved by the IACUC.
X. Veterinary Care
A. The University shall have an attending veterinarian, or another veterinarian who has delegated responsibilities for animal use activities, who shall provide adequate veterinary care to its animals in compliance with AWA regulations (9 CFR 2.33). For PHS-sponsored animal use activities, adequate veterinary care must be provided by a veterinarian who is certified by the American College of Laboratory Animal Medicine (ACLAM) or has training or experience in laboratory animal science and medicine.
B. The attending veterinarian has the authority to review any and all aspects of the University’s animal use and care program, to make determinations concerning animal well-being, and to remove an animal from any environment, experiment, or use which is adversely affecting its well-being beyond the level reviewed and approved by the IACUC.
C. The IO is responsible for developing and maintaining a veterinary care program that is appropriate to the nature and extent of the University’s animal use activities.
D. Adequate veterinary care is an integral component of humane animal care and use in research, testing, and instruction. Adequate veterinary care includes:
1. The availability of appropriate facilities, personnel, equipment, and services to comply with AWA regulations;
2. The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries; and the availability of emergency, weekend, and holiday care;
3. Daily observation, including weekends and holidays, of all animals to assess their health and well-being which may be conducted by someone other than the attending veterinarian provided there is a mechanism of direct and frequent communication so that timely and accurate information on problems of animal health, behavior, and well-being may be conveyed to the attending veterinarian;
4. Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and
5. Adequate care and monitoring of an animal's well-being before, during, and after experimentation or testing in accordance with current established veterinary medical and nursing procedures. Animal well-being includes both physical and psychological aspects of an animal's condition evaluated in terms of environmental comfort, freedom from pain and distress, and appropriate social interactions, both with conspecifics and with man.
E. As set forth in Part VIII, A.1 of this policy the veterinary care program should be reviewed and reported upon by the IACUC as part of its semiannual review of the University’s animal care and use program.
XI. Personnel Qualifications and Training
All personnel involved in animal care and use shall be appropriately qualified to perform their duties. The IO is responsible for the development and implementation of an appropriate training program for personnel involved in animal care and use that meets the requirements of AWA regulations (9 CFR 2.32). For PHS-sponsored animal use activities, training must include instruction on research or testing methods that minimizes the number of animals required to obtain valid results and minimize animal distress.
XII. Occupational Health and Safety
A. An occupational health and safety program is part of the overall animal care and use program. The IO in consultation with the University’s Environmental Health and Safety Department is responsible for the development and implementation of an appropriate occupational health and safety program for all personnel who have contact with animals.
B. The University’s occupational health and safety program shall include:
1. Pre-placement medical evaluation;
2. Identification of hazards to personnel and safeguards appropriate to the risks;
3. Appropriate testing and vaccinations;
4. Training of personnel regarding their duties, hazards, and safeguards;
5. Policies and facilities that promote cleanliness; and
6. Provisions for treating and documenting (zoonosis surveillance) job-related injuries and illnesses.
XIII. Other Provisions
A. The disposal of dead animals, carcasses, or tissues shall be carried out in accordance with University Environmental Health and Safety regulations.
B. This policy is effective immediately.