Assurance of Compliance with PHS Policy
On Humane Care and Use of Laboratory Animals

Assurance of Compliance with PHS Policy on Humane Care and Use of Laboratory Animals pdf format, Adobe Acrobat Required (for printing)

University of Wisconsin-Milwaukee

ANIMAL CARE PROGRAM

June 2003
Department of Environmental Health, Safety and Risk Management
University of Wisconsin - Milwaukee
P.O. Box 413
Milwaukee, Wisconsin 53201-0413
(414) 229-6016

The University of Wisconsin-Milwaukee (UWM), 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, and 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 sub-granting or sub-contracting of a PHS-conducted or supported activity by this institution. "Institution" includes the following branches and major components of the University of Wisconsin-Milwaukee, including The Great Lakes WATER Institute and the UWM Field Station. UWM has established and will maintain a program for activities involving animals in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals.

The following is excerpted from University of Wisconsin President Robert M. O’Neil’s letter dated December 18, 1981, to all University of Wisconsin – System Chancellors: “University of Wisconsin System Policy: All animals used for teaching, research, or other activities on all campuses shall be used and cared for according to the principles stated in the Guide for the Care and Use of Laboratory Animals … regardless of the species or source of funds used to conduct teaching, research or other activities.”

II. Institutional Policy

  1. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
  2. This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
  3. 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.
  4. 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

  1. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:

    The Animal Care Program (housed administratively in the Department of Environmental Health, Safety and Risk Management), the Animal Care and Use Committee and the campus veterinarian cooperate in ensuring compliance with animal regulations. [See the Animal Care Organizational Structure diagram in Attachment A]. The Chancellor of the University is charged with ensuring compliance with University of Wisconsin - System, state and federal laws and guidelines. The Chancellor is advised by the IACUC on how to accomplish this in accordance with current PHS standards. Dr. John Krezoski, Director of Environmental Health, Safety and Risk Management, is delegated primary responsibility for the institution’s Animal Care Program. As such he serves as the “Institutional Official”. Dr. Krezoski reports directly to the Vice Chancellor of Administrative Affairs who reports directly to the Chancellor. The Department of Environmental Health Safety and Risk Management employs a qualified veterinarian, who reports directly to the Director and whose duties and responsibilities are specified by the Director with input from the IACUC.

    Animal facilities housing birds and mammals make up the Animal Resource Center (ARC) component of the Animal Care Program. The campus veterinarian serves as the ARC Coordinator and manages the ARC facilities in accordance with applicable laws and regulations. A lab manager, who is responsible for daily management of the ARC, reports directly to the veterinarian. The veterinarian and lab manager are responsible for the management of the ARC facilities in accordance with standard operating procedures developed by an ARC Policy Committee, the veterinarian and the IACUC. Principal Investigators (PI’s) may make arrangements with the ARC Coordinator to manage their own bird or mammal facilities with appropriate scientific justification.

    Principal Investigators with aquatic animal species, who comprise the aquatic component of the Animal Care Program, are responsible for managing their own facilities. The campus veterinarian provides oversight to these PI’s and ensures that they obey all regulations, that they follow standard operating procedures, and that their workers are thoroughly trained in the humane care and use of animals.

  2. The qualifications, authority, and percent of time contributed by veterinarians who will participate in the program are as follows:

    Dr. Beryl R. Forman is a licensed veterinarian (DVM) and has 17 years of experience in lab animal medicine. She also has a teaching certification in broad-field science, biology and chemistry. Dr. Forman is a member of AALAS, LAMA and ASLAP and she attends local SWAALAS meetings as well as national AALAS and LAMA meetings. Dr. Forman is employed full time by the University to manage the Animal Care Program. Approximately 100% of her time involves coordinating the oversight of the maintenance and care of all vertebrate animals at the UWM Main Campus and satellite facilities. In addition, Dr. Forman serves as the Animal Resource Center (ARC) Coordinator, is responsible for providing education and training to all animal users, and manages all administrative aspects of the Animal Care Program. When Dr. Forman is unavailable, Dr. James Henderson, DVM, ACLAM, is available as a back-up. Dr. Henderson oversees animal care at two other research institutions in Milwaukee and has provided back-up for Dr. Forman for 17 years.

  3. 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, which is appointed by the Chancellor, 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 (see Attachment B), is a list of the names, degrees, position titles, specialties and institutional affiliations of the IACUC chairperson and members.
  4. 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 will conduct program evaluations at IACUC meetings held semi-annually using the Office of Lab Animal Welfare (OLAW) sample checklist evaluation format. Dr. Forman will also revise and update the written animal care program every six months following the outline of the American Association for the Accreditation of Lab Animal Care (AAALAC) International. Dr. Forman will summarize any changes to the written program at least yearly at the IACUC meeting. The written program will then be finalized and any changes which the IACUC has approved will be implemented. The IACUC will also discuss other aspects of the program as agenda items and if there are any changes they will approve them and have them incorporated into the written animal care program.
    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 will divide into two teams and each team will tour one half of the facilities on campus prior to the semiannual meeting. Dr. Forman and at least one other committee member will tour the Great Lakes WATER Institute and the Field Station prior to the semiannual IACUC meeting, if animals are being housed there. The tour findings will be presented at the semiannual meeting and discussed by the Committee. A signature sheet is passed around for members to sign and to provide any minority comments. The approved tour report is then sent to all appropriate parties.
    3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to Dr. John Krezoski, Institutional Official. The semiannual program evaluation and tour report are developed as described above under items 1 and 2 above. The IACUC uses the OLAW sample format letter for reporting to the Institutional Official. The report summarizes the Committee’s findings at the semiannual meeting. A copy of the semiannual tour report and the semi-annual program evaluation checklist are attached. The Institutional Official also attends the IACUC meetings.
    4. Review concerns involving the care and use of animals at the institution. The IACUC’s procedures for reviewing concerns are summarized in Attachment C. As part of the training program for individuals using animals a section is devoted to dealing with problems and their resolutions. Individuals are informed that they are protected against reprisal for reporting any concerns they might have, as required under the Animal Welfare Act. Any concerns which are reportable to OLAW the U.S. Department of Agriculture (USDA) will be submitted by the Institutional Official.
    5. Make written recommendations to Dr. John Krezoski, Institutional Official, regarding any aspect of the institution's animal program, facilities, or personnel training. The IACUC makes recommendations to the Institutional Official through the Semiannual Animal Care Program Evaluation and Tour Report. As noted earlier, the Institutional Official also attends IACUC meetings. When necessary, the IACUC sends follow-up letters to the Institutional Official on critical issues. The campus veterinarian keeps the Institutional Official abreast of animal care program matters including training policies and facility problems on a daily basis. The Institutional Official attends IACUC meetings and is copied on all IACUC correspondence. The IO receives meeting agendas and minutes which detail all protocol actions taken,. The IO is also copied on the protocol review session minutes.
    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 presented in Attachment D.
    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 require that modifications to protocols must be documented in writing and submitted to the Animal Care Program. Minor protocol modifications will be reviewed by the IACUC Chair or his/her designee. Minor modifications include changes in title or funding agency with the animal protocol being the same; changes in personnel involved in animal procedures (except for PI’s). Major modifications will be treated the same as a new protocol submission. If no one on the Committee requests full review, the significant protocol modifications will be reviewed at the next monthly IACUC work session of designated reviewers or via an expedited fashion by a reviewer designated by the Chair. Major modifications include:
      • changes in the objectives of the study; proposals to switch from non-survival to survival surgery;
      • changes in the degree of invasiveness of a procedure or discomfort to an animal;
      • changes in species or in the approximate number of animals used; and
      • changes in anesthetic agents, the use or withholding of analgesics, and methods of euthanasia.

      Additional factors may involve changes in the duration, frequency or number of procedures performed on animals.

    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. All IACUC correspondence is coordinated by the Animal Care Program. This program office is under the direct supervision of the campus veterinarian, who also maintains all Animal Care Program records for the campus. Investigators are encouraged to attend IACUC meetings or working group sessions which review their protocol.

      The protocol is discussed with the investigator at the review session or full committee meeting. The protocol is then voted on by the full Committee to approve it, conditionally approve it, or disapprove it. The working group will vote on whether to approve it, require modifications, or request full committee review. The investigator will then be notified by the Animal Care Program in writing of the IACUC’s decisions. If necessary, the campus veterinarian will circulate any modifications made by the PI to the appropriate reviewers for final approval.

    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 1V.C. 1-4. at least once every three years. IACUC approval remains in effect for three years with continual reviews on at least an annual basis.

      Annual renewal forms will automatically be sent to investigators prior to the first and second anniversary dates of the original approval date. The IACUC will be notified of the review at the time the renewal forms are sent out so they are given the opportunity to participate in the review. Otherwise the attending veterinarian and the Chair of the IACUC will review annual renewals. To renew a protocol on the third anniversary date of the original approval date the principal investigator will submit a current protocol form. The protocol will then go through the IACUC review process for all original protocols.

    10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The IACUC has the authority to suspend any activity involving animals if it determines that the activity is not being conducted in accordance with provisions of the Animal Welfare Act, the Guide, the institution’s assurance of compliance, or any criteria stated in Chapter 3 of the institutions “Guide to the Responsible Care and Use of Animals in Teaching and Research”.

      The IACUC may suspend an activity only after thorough review of the matter at a convened meeting (with a quorum) and with the approval of a majority vote. The IACUC shall review the reasons for any suspension with the Institutional Official (and, if necessary, with the Office of Legal Affairs), take appropriate action, and fully report that action OLAW, whether or not the project is extramurally funded.

  5. The individuals authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals are Dr. John Krezoski, Institutional Official, and Dr. Berri Forman, Campus Veterinarian.
  6. The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is described as follows:

    All individuals handling animals or animal tissues are provided with an Occupational Health Program brochure (See Attachment E for brochures and forms). Students in classes of instruction or individuals observing animals only will receive a training hand-out or it will be the class syllabus directing them to review the Occupational Health information on the Animal Care Program website (http://www.uwm.edu/Dept/EHSRM/ACP/).

    The Occupational Health Program brochure contains general information and discusses the overall program. Individuals who may come in contact with animals or animal tissues that can cause allergies will receive a Lab Animal Allergen brochure. There is a voluntary "Health Assessment Questionnaire" that all individuals may complete. This is the only portion of the occupational health program that is “voluntary.” The questionnaire is reviewed by the UWM Norris Health Center (students) or the Medical College of Wisconsin, Occupational Health Department (employees). Individuals will be advised to see their personal physician if necessary.

    The animal care program will not maintain or have access to any medical records. The University’s occupational health program recommends tetanus vaccinations for all animal users. During training animal users are provided information on tetanus and where to go for vaccination.

    Animal users are instructed, both in the Occupational Health Brochure and via signs posted throughout the animal facilities, that there is an official reporting system for all injuries which occur on the job. First Aid kits and disinfectant soaps are readily available to the animal users throughout the facilities. All animal users are required to go through the training and certification program to learn about working with hazardous materials, risk assessments, zoonoses, allergies, hazards, illness, personal protective equipment (PPE), etc. Students in classes of instruction and individuals observing animals only will be given training that will include information on where to locate the occupational health program brochures.

    The use of biohazardous substances must first be approved by the UWM Institutional Biosafety Committee prior to IACUC approval. The use of radionuclides must be approved by the UWM Radiation Safety Officer. An Animal Use of Radionuclides Form must be completed and submitted to the Radiation Safety Office prior to protocol approval. Training for working with radioactive materials is provided by the Radiation Safety Office. Appropriate personnel from the Department of Environmental Health, Safety and Risk Management will also review protocols, as necessary, to determine if other hazardous materials are involved. If so, the PI will complete the "Use of Hazardous Chemicals form" for follow-up review and approval.

    Personal protective equipment such as laboratory coats, scrub suits, boots, gloves and masks and allergy protection equipment is available for all animal care workers. Eye protection and face shields are provided for working with acids or other hazardous chemicals or biological agents that may splash. A respiratory protection program is available through the Industrial Hygiene Program if needed. Showers are available in the Lapham Hall and the Garland-Pearse facilities. Lockers are also provided in the Lapham Hall facility. Consumption of food and beverages is prohibited in all animal facilities. Smoking is prohibited in all University buildings.

    A training program is in place for animal users working in campus animal facilities that includes training on PPE, safety eyewash usage, injuries, bite wounds, disaster planning and other safety topics. All people using the animal facilities must complete this training.

  7. The total gross number of square feet in each animal facility (including satellite facilities), the species of animals housed therein, and the average daily inventory, by species, of animals in each facility is provided as a chart in Attachment F.
  8. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:

    The institution employs a full time veterinarian to manage the Animal Care Program. The veterinarian provides institution-wide training and education on the humane practice of animal care and use. The veterinarian trains potential animal users either individually or in small groups. A training manual provides individuals an overview of the Animal Care Program (A syllabus of the training is provided in Attachment G).

    The training manual includes a chapter on research or testing methods that minimize the quantity of animals needed to obtain valid results and that limit animal pain or distress. Individuals are "certified" for animal use once they have passed a multiple-choice exam based on the training manual. Students using animals in classes of instruction are given an abbreviated training handout as part of their class syllabus and will not be expected to complete the certification exam. Instructors for courses using animals will be given a more comprehensive training handout that they can share with the students. Individuals who only observe animals as part of a study will receive the abbreviated training hand-out and will not be expected to complete the training exam.

    A “facilities” training program is also available that encompasses safety procedures, equipment operation and animal handling. This training is provided by either the campus veterinarian or the lab manager. All individuals using animals are required to have this training prior to using animals.

    The campus veterinarian is available to provide surgery training to individuals or groups. All people who perform surgeries are expected to review the rodent surgery training module available on CD-ROM. The campus veterinarian has conducted many surgery training sessions with various labs that perform survival surgeries.

    Animal caretakers are further trained by the lab manager and the campus veterinarian on campus and animal facility policies and standard operating procedures using an employee training manual that is dedicated to ARC staff. All animal caretakers also receive project-specific training by the PI’s, who discuss the details of their projects so that the animal caretakers can understand the importance of the animals that they are responsible for.

    As part of the ARC continuing education program, animal users are sent pertinent information about alternatives to animal use and any other relevant material that the campus veterinarian may receive via the Internet, through recent professional publications, or from professional meetings. The campus veterinarian also provides animal workers with educational materials that cover the particular species they are working with and provides the IACUC with continuing education sessions at the conclusion of all meetings.

    The Animal Care Program maintains individual training records. In addition, student and post-doctoral investigators receive further training on proper research and testing methods from their major advisors or PI’s.

    The campus veterinarian is available upon request for any additional training that is desired and is available to assist with the performance of any surgical procedures. A dedicated reference library is also available, which provides pertinent materials (including audio-visual aids) on many aspects of animal care and use. The campus veterinarian continually updates this library by purchasing books and maintaining appropriate journal subscriptions. An Animal Care Program website is also available, which is kept up-to-date with many links related to lab animal welfare and education. The institution promotes the continuous improvement of the Animal Care Program by providing continuing educational opportunities for the campus veterinarian and the lab manager. The campus veterinarian usually attends at least one major national professional or educational meeting as well as local meetings in the field of laboratory animal science each year. The campus veterinarian and lab manager also take advantage of various staff development programs offered at the institution that are applicable to the operation of the Animal Care Program.

IV. Institutional Status

As specified in the PHS Policy IV.A.2, UWM is a Category 2 institution. Therefore, all of its programs and facilities, including satellite facilities, which conduct activities involving animals, have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accordance with PHS Policy IV.B.1. and 2. Moreover, appropriate reports will be prepared in accordance with PHS Policy IV.B.3.

IACUC semiannual 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 specifically identified and reasons for each departure will be stated. Reports will also distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluations will be submitted to the Institutional Official; maintained by this institution; and made available to OLAW upon request. The most recent semiannual report of the IACUC is included as Attachment I.

V. Record-Keeping Requirements

  1. 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 the Institutional Official.
    5. Records of accrediting body determinations.
  2. 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.
  3. 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

  1. 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 if 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 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 the Institutional Official.
  2. 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.
  3. Reports filed under VI.A. and VI.B. above shall include any minority views filed by members of the IACUC.

VII. Institutional Endorsement and PHS Approval

  1. Authorized Institutional Official
    Name: John R. Krezoski, Ph.D.
    Title: Director, University Safety and Assurances
    Address: University of Wisconsin - Milwaukee
    P.O. Box 413, Engelmann Hall, Room 270
    Milwaukee, WI 53201 - 0413
    Phone: 414-229-5265
    Fax: 414-229-6729
    Date: __________
    Signature: ___________________________________
  2. PHS Approving Official
    Name:__________________________________________________
    Title:_________________________________________________
    Address: 6705 Rockledge Drive-RKL1, Suite 360, MSC 7982
    Bethesda, MD 20892 - 7982
    Phone: 301-496-7163
    Fax: 301-402-7065
    Date:____________
    Signature: ___________________________________
  3. Effective Date of Assurance ______________________________________
  4. Expiration Date of Assurance ______________________________________

Updated February 9, 2007 by SAK