Canisius College Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals
October 19, 2000
Canisius College, hereinafter referred to as institution, hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
I. Applicability
This Assurance is applicable to all research, research training, experimentation, biological testing and related activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at this institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS-conducted or supported activity by this institution. "Institution" includes all branches and components of Canisius College.
II. Institutional Policy
A.This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
B.This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
C.This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. 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 Assurance as well as all other applicable laws and regulations pertaining to animal care and use.
D.This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).
III. Institutional Program for Animal Care and Use
A.The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:
- College President, Rev. Vincent M. Cooke, S.J.
- Vice President for Academic Affairs, Herbert J. Nelson, PhD
- IACUC Chair, Dr. Michael Noonan
- Veterinarian, Dr. Mary Brummer
- Biology Chair, Paula Dehn, PhD
- Laboratoy Manager, Lawrence Tassini
- Work study student employees
B.The qualifications, authority, and percent of time contributed by veterinarian who will participate in the program are:
Qualifications:
Dr. Brummer is licensed by New York State and has an animal practice in the nearby community.
Authority:
Dr. Brummer has the full authority of Institution Veterinarian as outlined in the Animal Welfare Act. Her responsibilities include, but are not limited to:
- administering all needed veterinary treatments.
- periodic inspection of all animals and animal facilities.
- membership and participation in all IACUC activities.
Percent of Time:
Dr. Brummer estimates that her service to Canisius College occupies 1% of her time.
Availability:
Dr. Brummer is ordinarily available to College personnel by telephone 24 hours per day, either in her office or her home.
C.This institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. Attached is a list of the names, degrees, position titles, specialties and institutional affiliations of the IACUC chairperson and members.
D.The IACUC will:
1.Review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semi-annual program evaluations are:
The Canisius College IACUC will meet at least semi-annually to review the College's program for humane care and use of animals (and to conduct an inspection tour of the college's animal facilities). The frequency of other meetings will be determined by the demands placed by the frequency of applications for review.
At these meetings, the IACUC will review and evaluate the College's program for humane care and use of animals. This review will follow the PHS Guide as its principal basis, but will also depend upon (1) the AAALAC Outline for Description of Institutional Animal Care and Use Program (although we are too small to make AAALAC Accreditation warranted in terms of cost, we periodically use their application forms to conduct our own internal evaluations), (2) the AVMA Panel on Euthanasia, and (3) the New York State Department of Health 19 point Lab Animal Facilities check list. At each meeting, the IACUC Chair will present an overview of the College's program using this Assurance as an outline, and he will invite discussion by the committee. At each meeting, the committee will also then focus particular scrutiny on a previously selected aspect of our college's animal-related activity (e.g., personnel training, disposition of surplus animals, HVAC/Humidity, etc.), reviewing it in depth and seeking ways to make improvements. If room for improvement is identified, specific steps will be outlined and responsibility for carrying them out will be assigned to particular individuals along with a targeted time frame. Progress on the desired steps will then be reviewed at the next IACUC meeting.
2. Inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the Guide as a basis for evaluation. The IACUC procedures for conducting semi-annual facility inspections are:
The IACUC will meet at least semi-annually to conduct inspection tours of the college's animal facility. Our IACUC as a whole will visit each room in the entire animal facility. During this inspection tour, each member will have the specific charge to satisfy themselves that the facility as a whole as well as each room and procedure specifically are in full compliance with the Guide. Each member will be encouraged to ask questions and to look for real or potential problems. The IACUC Chair will make note of any questions or concerns raised and will specifically ask the Committee to decide (by majority vote) whether the concern should be classified as a minor or major deficiency. The IACUC Chair will then specifically solicit minority points of view. All concerns raised, deficiencies identified (both minor and major), as well as minority views will be recorded in our IACUC minutes and in our report to our Institutional Official (Herbert Nelson). The Committee will also determine (by majority vote) the appropriate steps and timetable for correcting any deficiencies and the IACUC Chair will have the responsibility for including that information the committee's report to the Academic Vice President and also for communicating the need for corrective steps to other appropriate college personnel (e.g., animal care staff, maintenance department).
3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to Herbert Nelson, PhD, the Vice-President For Academic Affairs. The IACUC process for developing reports and submitting them to the Institutional Official is:
The IACUC Chairperson will have the responsibility for preparing a summary report for the Academic Vice President following each IACUC meeting. This report is to include a summary of the Committee's review of the College's Program for Animal Welfare and a summary of our findings during our facility inspection. This report will contain specific mention of any minor or major deficiencies that were identified as well as specific steps and timetables for correcting such deficiencies. This summary report is to be reviewed and signed by all IACUC members before it is forwarded to the Academic Vice President.
4.Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are:
In the event that any concern regarding animal care or use is raised by any college personnel, the IACUC Chair will privately and confidentially interview that person and file a written report on the interview in the IACUC permanent record. The IACUC chair will immediately investigate the concern/complaint and, depending on its nature, either attempt to resolve the concern, call a meeting of the IACUC to review the concern or inform the appropriate administrator of the nature of the concern and its need for attention.
5.Make written recommendations to Dr. Nelson (the Vice-President For Academic Affairs) regarding any aspect of the institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are:
The IACUC Chairperson will have the responsibility for preparing a summary report for the Academic Vice President following each IACUC meeting. This report is to include full explanation of any recommendations that the Committee has developed regarding any aspect of the institution's animal program, facilities, or personnel training. This summary report is to be reviewed and signed by all IACUC members before it is forwarded to the Academic Vice President.
6.Review and approve, require modifications in (to secure approval), 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 IACUC procedures for protocol review are:
By College policy, no teaching or research use of non-human vertebrate animals can take place without prior review and approval by the College Institutional Animal Care and Use Committee. The Biology Department Laboratory Manager in conjunction with the College Purchasing Office have been directed to not allow the ordering of animal subjects for any given protocol until IACUC approval is obtained. The Biology Laboratory Manager sits as a member of the IACUC and thus has access to all records concerning the approval status of all protocols.
The IACUC Chair will disseminate relevant information and regulations to concerned individuals, will receive all applications for review, and will coordinate the review process on the part of the committee.
The IACUC in its entirety will convene in a meeting to review all applications. These meetings will be held at least three times per year (or more frequently if the number of new applications warrants this). The costs and benefits of each proposal will be reviewed with respect to animal welfare concerns, with respect to personnel safety and with respect to scientific merit. If any IACUC member expresses a reservation, the concern will be fully aired. Where possible, an attempt will be made at the meeting to generate modification of the proposal to be suggested to the applicant so that the project would be both allowable while simultaneously having the IACUC concerns addressed. This effort notwithstanding, the IACUC, by majority vote, is empowered to approve, or withhold approval from, any proposed animal-related activity.
The IACUC Chair will report the judgment of the committee both to the applicant and to the Institutional Official (Academic V. P.). The applicant will be informed by written memorandum from the IACUC Chair. The Institutional Official will be informed via a written meeting summary from the IACUC Chair.
7.Review and approve, require modifications in (to secure approval), 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 IACUC procedures for reviewing proposed significant changes in ongoing research projects are:
When a significant change is contemplated in any ongoing animal-related activity, the Canisius College IACUC will require that a new application/protocol be prepared by the user and the Committee will review it de novo. The determination whether a proposed change is to be deemed "significant" will be made by the IACUC Chair and he is to be conservative in this regard, requiring a new application whenever a given animal use is proposed to deviate from that which has been previously approved by any detail other than very slight margins. Any significant changes resulting in new applications will undergo IACUC review de novo at a meeting of the full IACUC as described in section III.D.6 above.
8.Notify investigators and the institution 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 IACUC approval as set forth in the PHS Policy at IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are:
The IACUC Chairperson will have the responsibility for disseminating the Committee's decision to approve or withhold approval of those activities related to the care and use of animals, or of any modifications that have been deemed necessary by the Committee to secure its approval. The IACUC Chair will report the committee's judgment both to the applicant and to the Institutional Official (Academic V. P.). The applicant will be informed by written memorandum from the IACUC Chair. The Institutional Official will be informed via a written meeting summary from the IACUC Chair.
In the event that any proposed animal-related activity is disapproved by the IACUC, the IACUC Chair will have the additional responsibility of notifying in writing all of the following institutional administrative officials: Academic Vice President (our "Institutional Official"), Departmental Chair, Consulting Veterinarian, Laboratory Manager, Purchasing Office. In such an event, the IACUC Chair is to seek follow-up confirmation that the disapproval has been specifically noted by each of the administrative officials listed here.
9. Conduct continuing review of each previously approved, ongoing activity covered by PHS policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS policy at IV.C.1-4. at least once every three years. The IACUC procedures for conducting continuing review are:
All previously approved, teaching-related animal protocols (which constitute the majority of animal uses here at Canisius College) are reviewed de novo annually. That is, each applicant/instructor will be obliged to re-apply to use animals each year and the IACUC will re-evaluate each teaching-related use on an annual basis.
All research-related animal protocols are approved for a limited time span as specified in the user's application. This time span will ordinarily be 12 months or less and it will never exceed 24 months. Any research-related animal use extending beyond 24 months in duration will necessitate the submission of a new application and the IACUC will review it de novo.
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The IACUC procedures for suspending an ongoing activity are:
The IACUC is also empowered to suspend, or withdraw approval from, any previously approved animal activity. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. In such an event, the IACUC Chairperson will have the responsibility for notifying investigators in writing of the Committee's decision to suspend approval of any given activity related to the care and use of animals. The IACUC Chair will have the additional responsibility of notifying in writing all of the following institutional administrative officials: Academic Vice President (our "Institutional Official"), Departmental Chair, Consulting Veterinarian, Laboratory Manager, Purchasing Office. In such an event, the IACUC Chair is to seek follow-up confirmation that the suspension has been specifically noted by each of the administrative officials listed here.
The College's Consulting Veterinarian sits as a full voting member of the IACUC. In addition to her role on that committee, the Consulting Veterinarian is separately authorized to suspend, or withdraw approval from, any animal activity that she deems unacceptable based on animal welfare considerations. The Consulting Veterinarian is charged to make her own unannounced inspections of our facilities, husbandry procedures and other animal-related activities. In the event that the Veterinarian exercises this separate authority to suspend or disallow any given activity, she will notify all of the following individuals in writing: the animal user (the "PI"), the IACUC Chair, the IACUC full membership, the Laboratory Manager, the Department Chair and the Academic Vice President (our "Institutional Official"). In such an event, the Consulting Veterinarian is to seek follow-up confirmation that the suspension has been specifically noted by each of the College personnel listed here.
E.The individual authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals is Michael Noonan, PhD, Chair IACUC, and Professor, Biology and Psychology.
F.The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is:
1. All employees of the college including work-study students, are covered by workman's compensation in the event of injury on the job. In the event of injury, this would provide for medical expenses and salary continuation.
2. All full-time employees and students are provided with the opportunity to choose among a number of private medical insurance plans and are strongly encouraged to carry a personal medical insurance policy.
3. A year-round OSHA-Committee exists on campus, which has oversight responsibilities for employee safety and working conditions. A brochure on safety and health concerns is provided to all college employees, including employees of the animal facility.
4. All animal facility employees attend a mandatory training session on occupational health and safety. This training session is conducted jointly by the IACUC Chair and the Consulting Veterinarian.
5. The college maintains an infirmary on campus staffed by a full-time nurse and a part-time physician. There is also a standing arrangement for ready-treatment at the Sister's Hospital Emergency Room which is four blocks from the campus.
6. Immunizations and health testing is available for all animal facility employees at the college infirmary and is free of charge.
7. The following personal protective equipment is supplied free of charge for all animal workers: vinyl gloves, dust respiration masks, safety glasses, vinyl aprons. These items are to be used in all animal care work and in all applicable research procedures. Additionally, cloth laboratory coats, disposable laboratory coats, shoe protectors, and sleeve protectors are freely available and their use is expected whenever applicable.
G.The total gross number of square feet in our animal facility is approximately 2000. (There are no satellite facilities.) The average daily inventory, by species, of animals in our facility is:
Laboratory mice (Mus musculus) 25
Fish (miscellaneous species) 30
Additionally, small numbers of other species are brought into our facility for periods of time ranging from one to four weeks as per specific teaching-related protocols that undergo prior review by our IACUC.
H.The training or instruction of scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:
The College conducts a mandatory training session once each year for all personnel associated with animal work (scientists, instructors, lab assistants, caretakers, and facility manager). These animal-related sessions are conducted in conjunction with the semi-annual Biology Department Laboratory Safety training sessions, and they are jointly conducted by the IACUC Chair and the College's Consulting Veterinarian. These sessions specifically include, among other topics, instruction and discussion on research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress. Written records of these sessions is maintained by the IACUC Chair including documentation of the particular topics covered and the specific individuals in attendance.
Additional instruction to our work-study animal caretakers on animal husbandry techniques, standards, and practices, is provided on-the-job by Dr. Michael Noonan (IACUC Chair and Professor of Biology and Psychology) and by Lawrence Tassini (Biology Department Laboratory Manager), and the caretakers are supervised by those two individuals on a day to day basis. Dr. Burgwardt (our Consulting Veterinarian) supplements this training in person during her scheduled and unannounced visits to the campus.
Beyond this, according to College policy, Canisius faculty members involved in, or supervising, the care, handling, or treatment, of animals will be expected to satisfy the IACUC of satisfactory knowledge and/or training regarding the procedures to be employed. This occurs as part of the protocol-review process by the provision of relevant biographical information in the application.
Additionally, faculty members are expected to provide in-person training, or personally verify the ability of, any one else involved in animal activities before he or she is allowed to conduct such tasks in the absence of direct supervision. A written record must be kept specifying each training session, including the name of all persons involved and the nature and extent of their training, this record being kept available for inspection by the college IACUC.
IV. Institutional Status
As specified in the PHS Policy at IV.A.2, as Category 2, all of this institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accord with IV.B.1 and 2. of the PHS Policy, and reports prepared in accord with IV.B.3. of the PHS policy.
All IACUC semi-annual reports will include 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. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, the report will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluation will be submitted to the Institutional Official (Herbert J. Nelson, PhD, the Vice-president For Academic Affairs). Semiannual reports of IACUC evaluations will be maintained by this institution and made available to Office of Laboratory Animal Welfare (OLAW) upon request. The most recent semi-annual report of the IACUC is attached.
V. Recordkeeping Requirements
A.This institution will maintain for at least three years:
1.A copy of this Assurance and any modifications thereto, as approved by PHS.
2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.
3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to Herbert Nelson, PhD, the Vice-president for Academic Affairs.
5. Records of accrediting body determinations.
B.This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.
C.All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.
VI. Reporting Requirements
A.At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to OLAW:
1.Any change in the status of the institution (e.g., if the institution becomes accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution's program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will provide OLAW with written notification that that there are no changes.
2. Notification of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to Herbert Nelson, PhD, the Vice-President for Academic Affairs.
B.The IACUC, through the Institutional Official, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:
1.Any serious or continuing noncompliance with the PHS Policy.
2.Any serious deviations from the provisions of the Guide.
3.Any suspension of an activity by the IACUC.
C. Reports filed under VI.A.2. and VI.B. above shall include any minority views filed by members of the IACUC.
VII. Institutional Endorsement and PHS Approval
A. Authorized Institutional Official
Herbert J. Nelson, PhD
Vice-President For Academic Affairs
Canisius College
Buffalo, New York 14208