Program Description
Animal Care and Use Program
File number 000238
University of California Irvine
Office of Research
5171 California Avenue, Suite 150
Irvine, CA 92697-7600
For
AAALAC International
April 1, 2012
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Table of Contents
Section 1. Introduction ................................................................................................................. 1
Section 2. Description .................................................................................................................. 5
I. Animal Care and Use Program ............................................................................................... 5
A. Program Management ......................................................................................................... 5
1.
Program Management Responsibility ......................................................................... 5
a. The Institutional Official ............................................................................................. 5
b. The Attending Veterinarian ......................................................................................... 5
c. Collaborations ............................................................................................................. 6
2.
Personnel Management ............................................................................................... 7
a. Training and Education ............................................................................................... 7
i. Veterinary and Other Professional Staff .............................................................. 7
ii. Animal Care Personnel ........................................................................................ 8
iii. The Research Team.............................................................................................. 9
b. Occupational Health and Safety of Personnel ........................................................... 12
i. Hazard Identification and Risk Assessment ...................................................... 13
ii. Facilities, Equipment and Monitoring ............................................................... 15
iii. Personnel Training ............................................................................................. 19
iv. Personal Hygiene ............................................................................................... 20
v. Animal Experimentation Involving Hazards ..................................................... 21
vi. Personal Protection ............................................................................................ 26
vii. Medical Evaluation and Preventive Medicine for Personnel ............................. 28
c. Investigating and Reporting Animal Welfare Concerns ........................................... 30
B. Program Oversight ............................................................................................................ 31
1.
The Role of the IACUC/OB ...................................................................................... 31
a. IACUC/OB Composition and Function .................................................................... 31
b. Protocol Review ........................................................................................................ 32
c. Special Considerations for IACUC/OB Review ....................................................... 34
i. Experimental and Humane Endpoints ............................................................... 34
ii. Unexpected Outcomes that Affect Animal Well-being ..................................... 35
iii. Physical Restraint............................................................................................... 35
iv. Multiple Survival Surgical Procedures .............................................................. 36
v. Food and Fluid Regulation................................................................................. 37
vi. Use of Non-Pharmaceutical-Grade Drugs and Other Substances...................... 39
vii. Field Investigations ............................................................................................ 39
viii. Agricultural Animals ......................................................................................... 40
ix. Animal Reuse ..................................................................................................... 40
2.
Post-Approval Monitoring ........................................................................................ 40
II. Animal Environment, Housing and Management ................................................................ 42
A. Animal Environment ......................................................................................................... 42
1.
Temperature and Humidity ....................................................................................... 42
2.
Ventilation and Air Quality ....................................................................................... 43
3.
Life Support Systems for Aquatic Species ................................................................ 44
4.
Noise and Vibration................................................................................................... 44
B. Animal Housing (All terrestrial, flighted, and aquatic species)........................................ 44
1.
Primary Enclosures.................................................................................................... 44
2.
Environmental Enrichment, Social and Behavioral Management ............................ 45
a. Enrichment ................................................................................................................ 45
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b. Social Environment ................................................................................................... 46
c. Procedural Habituation and Training of Animals ..................................................... 47
d. Enrichment, Social and Behavioral Management Program Review ......................... 47
e. Sheltered or Outdoor Housing................................................................................... 47
f. Naturalistic Environments ......................................................................................... 48
C. Animal Facility Management ........................................................................................... 49
1.
Husbandry ................................................................................................................. 49
a. Food ........................................................................................................................... 49
b. Drinking Water .......................................................................................................... 51
c. Bedding and Nesting Materials ................................................................................. 52
d. Miscellaneous Animal Care and Use Equipment ...................................................... 53
e. Sanitation ................................................................................................................... 53
f. Waste Disposal .......................................................................................................... 55
g. Pest Control ............................................................................................................... 56
h. Emergency, Weekend and Holiday Care .................................................................. 57
2.
Population Management ............................................................................................ 58
a. Identification ............................................................................................................. 58
b. Record Keeping ......................................................................................................... 58
c. Breeding, Genetics and Nomenclature ...................................................................... 58
III.
Veterinary Care ................................................................................................................. 59
A. Animal Procurement and Transportation .......................................................................... 59
1.
Animal Procurement.................................................................................................. 59
2.
Transportation of Animals......................................................................................... 60
B. Preventive Medicine ......................................................................................................... 60
1.
Animal Biosecurity.................................................................................................... 61
2.
Quarantine and Stabilization ..................................................................................... 61
3.
Separation by Health Status and Species .................................................................. 63
4.
Surveillance, Diagnosis, Treatment and Control of Disease ..................................... 63
C. Clinical Care and Management ......................................................................................... 65
1.
Emergency Care ........................................................................................................ 65
2.
Clinical Record keeping ............................................................................................ 65
3.
Diagnostic Resources ................................................................................................ 66
4.
Drug Storage and Control.......................................................................................... 66
D. Surgery .............................................................................................................................. 67
1.
Pre-Surgical Planning ................................................................................................ 67
2.
Surgical Facilities ...................................................................................................... 68
3.
Surgical Procedures ................................................................................................... 70
4.
Aseptic Technique ..................................................................................................... 70
5.
Intraoperative Monitoring ......................................................................................... 71
6.
Postoperative Care ..................................................................................................... 71
E. Pain and Distress ............................................................................................................... 72
F. Anesthesia and Analgesia ................................................................................................. 73
G. Euthanasia ......................................................................................................................... 76
IV.
Physical Plant .................................................................................................................... 78
A. Location and Construction Guidelines.............................................................................. 78
B. Functional Areas and Operations ...................................................................................... 81
1.
Heating, Ventilation, and Air-Conditioning (HVAC) ............................................... 81
2.
Power and Lighting ................................................................................................... 82
3.
System Malfunctions ................................................................................................. 84
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Storage Areas ............................................................................................................ 84
Facilities for Sanitizing Materials ............................................................................. 85
C. Special Facilities ............................................................................................................... 87
1.
Specialized Types of Animal Housing ...................................................................... 88
2.
Surgery ...................................................................................................................... 88
3.
Other Specialized Animal Use Facilities................................................................... 89
4.
Other Animal Support Facilities................................................................................ 89
D. Security and Access Control ............................................................................................. 89
4.
5.
Appendices
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Organizational Chart(s)
Animal Usage Form A or B
Summary of Animal Housing and Support Sites
Line Drawings
Medical Evaluation Form
IACUC/OB Membership Roster
Blank IACUC/OB Protocol Form
IACUC/OB Minutes
IACUC/OB Periodic Report
Heating, Ventilation and Air Conditioning (HVAC) System Summary
Aquatic Systems Summary
Primary Enclosures and Animal Space Provisions
Cleaning and Disinfection of the Micro- and Macro-Environment
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Program Description
Link to Instructions for Completing and Submitting the Program Description for the Institutional
Animal Care and Use Program
Section 1. Introduction
A. State the name of the program unit and, if applicable, its parent organization. List all
organizations (schools, centers, etc.) included within the program unit.
The University of California, Irvine (UCI) has one animal care and use program
(the “Animal Program”) which is centrally administered by University Laboratory
Animal Resources (ULAR), the Institutional Animal Care and Use Committee
(IACUC) and the Office of Research Administration (ORA) within the Office of
Research (OR). The Animal Program covers research activities in the School of
Biological Sciences (SBS), the School of Medicine (SOM), School of
Engineering (SOE), School of Physical Sciences (SPS), Department of
Pharmaceutical Sciences and all campus research centers and institutes.
Animal Program research sites are located on the central campus (Irvine, CA) as
well as the UCI Medical Center (Orange, CA).
B. Give a brief overview of the institution, its purpose and how the animal care and use
program relates to the mission of the institution.
The University of California (UC) system is comprised of ten campuses
throughout California and is one of the world’s largest and most renowned
centers of higher education. The Irvine campus (UCI) opened in 1965 and has
since become an academic and research institution of national and international
stature, committed to the pursuit of quality research and transmission of
knowledge. At the undergraduate and graduate levels, UCI provides students
with access to faculty members who conduct research at the forefront of their
field. The Animal Program has the dual responsibility of supporting the teaching
and research missions of UCI, while ensuring the ethical care and use of all
vertebrate animals used in research, testing, teaching and related purposes.
University Laboratory Animal Resources (ULAR) functions primarily as the
service arm of the Animal Program with responsibilities for veterinary care,
animal husbandry, administrative support and animal facility
housekeeping/maintenance. The Office of Research (OR) is UCI's primary
institutional agent in administering federal, state, and private foundation
regulations and strives to maintain an ethical environment for research. Policy
guidance and regulatory oversight for the Animal Program are provided by
Research Protections, a subunit of the Office of Research, and the Institutional
Animal Care and Use Committee (IACUC).
C. Note that AAALAC International’s three primary standards are the Guide for the Care
and Use of Laboratory Animals (Guide), NRC, 2011; the Guide for the Care and Use of
Agricultural Animals in Research and Teaching (Ag Guide), FASS 2010, and the
European Convention for the Protection of Vertebrate Animals Used for Experimental
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and Other Scientific Purposes, Council of Europe (ETS 123). Other regulations and
guidelines used (U.S. Department of Agriculture (USDA), Public Health Service (PHS)
Policy, Good Laboratory Practice (GLP), Canadian Council on Animal Care (CCAC),
etc.) may also apply. Describe which of the three primary standards and other
regulations and guidelines are used as standards for the institutional animal care and use
program and how they are applied. For example, an academic institution in the United
States with an Office of Laboratory Animal Welfare (OLAW) Assurance may use the
standards of the Guide and PHS Policy for all animals, the Animal Welfare Act
regulations for covered species, and the Ag Guide for agricultural animals used in
agricultural research and teaching. In the European Union, the standards applied might
be the Guide, ETS 123, Directive 2010/63, and any country-specific regulations.
The Animal Program uses the Guide for the Care and Use of Laboratory
Animals (Guide), NRC 2011 as the primary evaluation standard for its Animal
Program, in addition to the Animal Welfare Act/Regulations and the Public
Health Service Policy. These standards are applied to all vertebrate animal
species, regardless of funding source.
D. Describe the organization and include an organizational chart or charts (as an
Appendix/Appendices) detailing the lines of authority from the Institutional Official to
the Attending Veterinarian, the Institutional Animal Care and Use Committee/Oversight
Body (IACUC/OB), and the personnel providing animal care. Please include the title,
name (Note: For individuals whose information is publically available, provide the titles
and names; for individuals whose information is not publically available, you may
provide titles only.), and degree (if applicable) of each individual at the level of
supervisor or above. Names of animal care staff below the title of supervisor need not
be included, but the titles and number of animal care personnel under each supervisor
should be included. If animal care responsibility is administratively decentralized, the
organizational chart or charts must include all animal care programs, indicating the
relationship between each administrative unit and personnel, the Attending Veterinarian,
and the Institutional Official.
The UC Board of Regents is appointed by the Governor of California and
oversees the entire University system with full powers of organization and
government. The Regents appoint the President of the University, as well as the
Chancellors and laboratory Directors. Authority in academic matters is delegated
by the Regents to the Academic Senate, which determines academic policy for
the university as a whole. UC President Mark Yudof is the executive head of the
ten-campus university system.
Each of the campuses has a chancellor as its chief administrative officer. UCI’s
Chancellor, Michael V. Drake, M.D., assumed his duties in 2005. Chancellor
Drake is responsible for the organization and operation of the campus, including
academic, student, and business affairs. The Chancellor's position has
delegated Institutional Official (IO) authority with oversight and administrative
duties of all aspects of the animal care and use program to the Vice Chancellor
for Research, John C. Hemminger, Ph.D., who has further delegated the role of
Institutional Official to Associate Vice Chancellor for Research James W. Hicks,
Ph.D. Dr. Hicks assumed his duties as IO in 2011 and is responsible for
compliance with applicable regulations set forth by all federal, state and local
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agencies that regulate the ethical care and use of animals. He is assisted in the
discharge of this responsibility by the IACUC, the Director of University
Laboratory Animal Resources and Attending Veterinarian, and the Office of
Research Administration.
Additionally, institutional oversight and administrative duties for the department
of Environmental Health and Safety (EH&S) have been delegated to the Vice
Chancellor for Administrative and Business Services, Wendell Brase. The
Department of Environmental Health and Safety (EH&S), under the direction of
Dick Sun, ensures that UCI complies with applicable health, safety and
environmental laws, regulations and requirements and that activities are
conducted in a manner that protects students, faculty, staff, visitors, and the
environment.
See also Appendix 1 – Organizational Charts
E. Identify the key institutional representatives (including, but not limited to, the
Institutional Official; IACUC/OB Chairperson; Attending Veterinarian; animal program
manager; individual(s) providing biosafety, chemical hazard, and radiation safety
oversight; etc.); and individuals anticipated to participate in the site visit.
James W. Hicks, Ph.D., Assoc Vice Chancellor for Research/Institutional Official
Vincent Caiozzo, Ph.D., IACUC Chair
Bruce Morgan, Assistant Vice Chancellor for Research
Karen Allen, Director of Research Protections, Office of Research Administration
Melanie Fabian, CPIA, IACUC Administrator, Office of Research Administration
Jeffrey Goodwin, D.V.M., Ph.D., DACLAM, Director (Attending Veterinarian),
ULAR
Claire Lindsell, B.V.Sc., Ph.D., DACLAM, Associate Director, ULAR
Roger Geertsema, D.V.M., DACPVM, DACLAM, Assistant Director, ULAR
Jefferson Chau, B.S., CMAR, Animal Facility Operations Manager, ULAR
Sheila Hedayati, M.P.H., Biosafety Officer, Environmental Health & Safety
Lorena Andrade, B.S., Vivarium Biosafety Specialist, Environmental Health &
Safety
F. Briefly describe the major types of research, testing, and teaching programs involving
animals and note the approximate number of principal investigators and protocols
involving the use of animals. As mentioned in the instructions, please complete one of
the animal use forms included with this outline or provide the information requested in a
similar format as an appendix.
The major areas of research and instruction that involve live animals at UCI
include neuroanatomy and physiology; ophthalmology; viral research; animal
models of brain diseases, spinal cord trauma and demyelination; minimallyinvasive robotic surgical training; virology; developmental and evolutionary
biology; molecular biology and biochemistry; and basic and applied stem cell
research. There are approximately 200 principal investigators currently involved
in the use of live vertebrate animals, with approximately 400 active animal
protocols. More than 95% of the vertebrate mammal research at UCI is
performed in rodents.
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G. Note the source(s) of research funding (grants, contracts, etc.) involving the use of
animals.
UCI receives extramural funding from both federal and non-federal agencies,
including state and local funds, private for-profit and non-profit entities.
H. List other units (divisions, institutes, areas, departments, colleges, etc.) of your
organization that house and use animals that are not included in this Description. If any
of these are contiguous, physically or operationally (e.g., same IACUC/OB, same animal
care staff), with the applicant unit, describe the association. Explain why such units are
not part of this program application.
None
I.
Contract Facilities: If the institution contracts for animal care facilities or services for
animals owned by the institution, the contractor and its AAALAC International
accreditation status must be identified. If a contractor's animal care and use program is
not accredited by AAALAC International, a brief description, following this Program
Description outline, of the relevant contractor's programs and facilities must be provided.
In addition, the species and approximate average number of animals housed in the
contract facilities and the approximate distance between the institution's animal facility
and the contract facility must be noted. Incorporation of the contractor program into the
site visit schedule will be discussed with institutional representatives. If the institution
does not contract for animal care facilities or services, so note.
UCI does not currently contract for animal care facilities or services.
J.
Note other relevant background that will assist reviewers of this report.
UCI holds Animal Welfare Assurance No. A3416-01 in accordance with PHS
Policy for the Humane Care and Use of Laboratory Animals. The current
Assurance became effective on February 15, 2012 and expires on February 28,
2016.
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Section 2. Description
I.
Animal Care and Use Program
A. Program Management
1.
Program Management Responsibility [Guide, pp. 13-15]
a.
The Institutional Official [Guide p. 13-14]
Describe how program needs are clearly and regularly communicated to the
Institutional Official by the Attending Veterinarian, IACUC/OB, and others
associated with the program.
There are direct and open lines of communication between the IACUC
and the Institutional Official (IO) and between the Veterinarian and the
IO. There are regularly scheduled meetings of the Office of Research
senior management group, including the Vice Chancellor for Research,
Associate Vice Chancellor for Research/Institutional Official, Associate
Vice Chancellor for Research Administration, Attending Veterinarian
and Assistant Vice Chancellor for Research Administration.
b. The Attending Veterinarian [Guide, p. 14]
i.
Describe the institutional arrangement for providing adequate veterinary
care. For each veterinarian associated with the program (including private
practitioners), provide the veterinarian's name(s), list responsibilities, and
how the veterinarian is involved in monitoring the care and use of
laboratory animals. If employed full-time by the institution, note the
percentage of time devoted to supporting the animal care and use program
of the institution. If employed part-time or as a consultant, note the
frequency and duration of visits.
Jeffrey Goodwin, D.V.M, Ph.D. serves on the IACUC, is the director
of University Laboratory Animal Resources (ULAR) and is
appointed by and reports to the Vice Chancellor for Research via
both the Associate Vice Chancellor for Research/Institutional
Official and the Associate Vice Chancellor for Research
Administration. He supervises housing and husbandry and ensures
that adequate veterinary care is provided to all animals used in
research, teaching and testing. He is authorized to enter any place
within the jurisdiction of UCI to conduct on-site inspections of
animal facilities and animals to ensure that husbandry, sanitation
practices and animal health and research techniques are in
compliance with relevant federal, state, local and institutional
requirements. The AV is authorized to halt any animal activity if the
safety or welfare of an animal is at risk or if the work being
performed on a project is not in accordance with the approved
protocol. Dr. Goodwin also assists in coordinating the Animal
Program, including the approval of animal facility renovations and
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new construction; he is a full time employee of UCI and contributes
100% of his time to the animal care and use program.
ii. List others (e.g., Principal Investigators, veterinarians serving as Principal
Investigators, veterinary faculty/staff, technical staff, farm managers) who
have a direct role in the provision of veterinary care and describe their
responsibilities. An organizational chart depicting the reporting
relationship between these individuals and the Attending Veterinarian
should be included as an appendix.
ULAR Associate Director Dr. Claire Lindsell and Assistant Director
Dr. Roger Geertsema assist the Attending Veterinarian in the
management of University Laboratory Animal Resources (ULAR).
Drs. Goodwin, Lindsell and Geertsema, in collaboration with the
Vivarium Operations Manager, establish the methods and
procedures for the housing, feeding, care and use of all research
animals housed at UCI facilities, including the design of new animal
facilities and the renovation of existing facilities.
ULAR is comprised of four functional areas: Operations and
Finance, Vivarium Operations, Veterinary Services and the
Transgenic Mouse Facility. Operations and Finance includes the
centralized acquisition of research animals; Vivarium Operations
provides oversight for the day-to-day husbandry and care of
animals in UCI vivarium facilities. Veterinary services are provided
by Drs. Goodwin, Lindsell and Geertsema with the assistance of
three Animal Health Technicians. The Transgenic Mouse Facility
(TMF) provides services for the production of genetically modified
mice.
c.
Collaborations [Guide, p. 15]
Describe processes for assigning animal care and use responsibility, animal
ownership and IACUC/OB oversight responsibilities at off-site locations (i.e.,
collaborations).
When proposed animal research performed by or under the direction of
UCI personnel will be conducted entirely offsite (i.e., not at UCI
facilities) at an OLAW-assured institution and the offsite location retains
ownership of the animals, UCI may accept registration of the offsite
entity’s IACUC approval in lieu of review and approval by the UCI
IACUC. Registration of an offsite IACUC approval requires submission
of the approved protocol and offsite entity’s approval letter to the UCI
IACUC for administrative review. UCI reserves the right to limit,
suspend or terminate the involvement of UCI personnel in studies
approved by offsite entities. Offsite protocol registrations reviewed
administratively are acknowledged at the next convened meeting of the
IACUC and appended to the minutes. Protocol registration dates
coincide with the offsite location’s approval period. All protocol
modifications and annual renewals approved by the offsite entity’s
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IACUC must be submitted to UCI’s IACUC in order to maintain the
registration in good standing.
In cases where a collaborator from another institution wishes to use
UCI facilities and will retain ownership of the animals, a UCI protocol
application must be reviewed and approved by the UCI IACUC which
covers the activities to be performed on UCI property (e.g., whole-body
irradiation, MRI scanning, etc.) A UCI faculty member eligible to serve
as a Principal Investigator must be identified as responsible for the
activities performed in UCI facilities.
2.
Personnel Management
a.
Training and Education
Describe how the IACUC/OB provides oversight and evaluates the
effectiveness of training programs. Describe how training is documented.
The IACUC routinely reassesses the training programs associated with
animal care and use as part of the semi-annual Program Evaluation
process. UCI’s program utilizes the Collaborative Institutional Training
Initiative (CITI) program for basic training in animal use, as well as
species- and procedure-specific training and training for new IACUC
members. A nightly data-feed transmits completion information from
CITI to the animal program database at UCI; the database has been
programed to reject all individuals from inclusion on animal protocols
until required training is completed.
Classroom training/orientation is required by ULAR as a condition for
animal-facility access. Records are maintained by ULAR and utilized in
the process of obtaining a photo identification/vivarium access card.
When questions regarding the training and/or expertise of research
personnel arise during protocol review, the IACUC requests that the
protocol be flagged for enhanced veterinary oversight and outreach in
order to ensure that personnel are adequately trained to perform the
approved procedures.
The IACUC has also developed a training record template for use in
laboratories to document training for all members of the laboratory staff
in the specific procedures used in the lab. IACUC Facility Inspection
teams have included the documentation of training as a topic for
discussion with researchers during semi-annual Facility Inspections.
The IACUC often requires retraining (e.g., repeating the CITI courses
and/or classroom training) as a condition of resolution for regulatory
non-compliance.
i.
Veterinary and Other Professional Staff [Guide, pp. 15-16]
Provide name and credentials of veterinary and other professional staff,
including the veterinary personnel listed above, and describe their
qualifications, training, and continuing education. Please do not provide
curriculum vitae of personnel.
Jeffrey Goodwin, ULAR Director
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•
B.S. degree in Distributed Sciences from Iowa State
University
•
D.V.M. degree from Iowa State University
•
Ph.D. degree in Anatomy from Iowa State University
•
Diplomate, ACLAM
•
Holds memberships in AALAS, AVMA, ASLAP
•
18 years experience as a laboratory animal veterinarian
Claire Lindsell, Associate Director
•
Bachelor of Veterinary Science from University of Sydney,
Australia
•
M.S. from University of Saskatchewan, Canada
•
Ph.D. in Molecular Endocrinology from University of
Saskatchewan, Canada
•
Diplomate, ACLAM
•
Holds memberships in AALAS, ASLAP
•
15 years experience as veterinarian, 9 years in biomedical
research
Roger Geertsema, Assistant Director
•
B.S. degree in Veterinary Science from University of
Minnesota
•
DVM degree from University of Minnesota
•
Diplomate, ACLAM and ACVPM,
•
Holds memberships in AALAS, AVMA, ASLAP
•
28 years experience as veterinarian, including 12 years in
private practice, 7 years in the military, and 9 years in biomedical
research
Andrea Ristig, Senior Animal Health Technician
•
Registered Laboratory Animal Technologist (RLATg) from
AALAS
•
AA degree in Liberal Studies
•
19 years laboratory animal experience
Amilee Kaye, Animal Health Technician
•
Laboratory Animal Technologist (LATg) from AALAS
•
AS degree in Animal Science, certificate as Veterinary
Technician
•
6 years laboratory animal experience
Sirinda Sriwanthana, Animal Health Technician
•
Laboratory Animal Technician (LAT) from AALAS
•
BS in animal science
•
7 years laboratory animal experience
ii. Animal Care Personnel [Guide, p. 16]
Indicate the number of animal care personnel. 31
Summarize their training, certification level and type, experience, and
continuing education opportunities provided.
Training Program
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ULAR utilizes a performance-based training program to develop
and enhance the core and advanced skills of Animal and Cage
Wash Technicians. This program was developed for new
employees but all current staff have completed this training as well.
Training for ULAR Animal Technicians is provided by an
experienced Supervisor, Lead Technician and Veterinary staff and
includes species-specific training modules (e.g. conventional
mouse and rat husbandry module), and task-specific modules (e.g.
cage wash operations module, animal health module).
Training progresses at a rate dictated by the knowledge,
understanding and abilities of the employee. This rate is assessed
by the Trainer or Supervisor.
Training modules may include:
•
Reading the applicable SOPs and asking questions
•
Observing the Trainer performing tasks
•
Performing tasks while being observed by the Trainer
•
Performing tasks alone with regular visits by the Trainer
•
Evaluation of competency by the Trainer
•
Documentation that the technician is qualified to perform the
tasks included in the training module.
In the initial training period, core training modules covering the
major job duties will be completed. As operational needs arise,
technicians are trained in additional duties.
AALAS Certification Program
There are currently 7 ALAT, 3 LAT, and 1 CMAR certified Animal
Technicians on the ULAR staff (this includes Senior Animal
Technicians and supervisory staff). The in-house AALAS
certification training program consist of 2 weekly 1 hour (paid)
training sessions for the ALAT and LAT training levels and is taught
by ULAR Managers, Supervisors and Veterinary Staff using the
AALAS Training Manual series. All staff are members in the local
Orange County branch of AALAS and are encouraged to participate
in AALAS-sponsored workshops and symposia as well as national
and District 8 AALAS meetings.
Other Educational Opportunities
ULAR schedules educational seminars for husbandry and
veterinary staff twice monthly. Seminars are quite varied and range
from investigator presentations on unique research models, review
of laboratory animal training materials, laboratory animal topics
such as microisolator technique, review of ULAR policies, and
vendor presentations on new equipment.
iii. The Research Team [Guide, pp. 16-17; 115-116; 122; 124]
1) Describe the general mechanisms, by which the institution or
IACUC/OB ensures that research personnel have the necessary
knowledge and expertise in the animal procedures proposed and the
species used.
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UCI IACUC policy requires that all individuals who have contact
with animals used in research, teaching or related activities be
adequately trained in the safe, humane and scientifically
acceptable care and use of the animals. This training
requirement applies to all investigators, instructors, technical
staff, trainees, students, husbandry and visiting personnel who
will have any contact with animals. Required training includes
the ethical care and use of animals and the regulations, policies
and procedures governing animal use in research as well as in
the actual procedures that may be performed on animals during
the course of the research. UCI uses the web-based training
resources of the Collaborative Institutional Training Initiative
(CITI) to provide basic training in the humane care and use of
animals in research and teaching as well as periodic refresher
courses for all research personnel (required of all personnel
involved with animal research every 3 years). This basic
training is required of all people before they can be approved to
work on an IACUC protocol before approval is granted. Handson training is also required to ensure proficiency in all protocolrelated animal procedures and may be obtained from other
researchers in the laboratory who are skilled at the procedure
in question or by campus veterinary staff. In addition to the
basic CITI training modules, researchers must also complete all
recommended additional species- or procedure-specific CITI
modules and complete an animal facility orientation before
gaining access to campus animal facilities.
All undergraduate Biological Science students (199 students)
must enroll in a mandatory training course that discusses
animal care and use, human subject protection and health and
safety issues. This course, Biological Sciences 194S, is a
prerequisite before 199 students may begin working in
laboratories.
ORA and ULAR staff are available to provide consultation and
assistance to research personnel in areas such as IACUC
policies and guidelines, protocol writing/pre-review services,
performance and documentation of searches for alternatives to
the use of animals, unnecessary duplication and avoidance or
minimization of painful or distressful procedures. ULAR staff
also provides hands-on training in animal handling and other
veterinary procedures to research personnel as needed.
a) Briefly describe the content of any required training.
The components of required training are:
1) CITI basic course “Working with Live Animals”
2) CITI species specific course(s)
3) CITI pain and distress course.
4) ULAR in-class seminar
5) ULAR animal facility orientation
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6) Hands on training conducted by ULAR or other
experienced lab personnel
b) Describe the timing of training requirements relative to the
commencement of work.
Completion of all required CITI training modules is required
of all personnel before being allowed to work with animals.
For specific facility access, personnel must also attend a
classroom and animal facility orientation. Hands-on
procedural training is normally conducted after new
personnel have been added to the protocol and granted
access to the facility.
c)
Describe continuing education opportunities offered.
All research personnel must complete CITI refresher
training once every three years; compliance is verified at
the time of de-novo protocol review. In addition, all existing
faculty and staff personnel were required, as part of the
transition to photo-identification keycard access to campus
vivaria in early 2012, to attend classroom training/facility
orientation in order to obtain the new keycards.
ULAR and/or the IACUC administrative office offer routine
access to workshops, seminars, presentations and
webinars offered by Jackson Laboratories, Charles River
Labs, OLAW, USDA, etc., on topics ranging from
procedural refinements to laboratory security.
2) Describe the process(es) to ensure surgical and related procedures are
performed by qualified and trained personnel. Who determines that
personnel are qualified and trained for surgical procedures? What
role does the Attending Veterinarian and IACUC/OB have in this
determination? [Guide, pp. 115-116]
The on-line training by CITI has a module in the basic course
on anesthesia and surgery and the on-line CITI training has
species-specific courses that contain information on anesthesia
and surgery for that species. All researchers performing
surgery are required to complete these courses as well as the
Pain and Distress module from CITI. The required classroom
seminar/vivarium orientation also discusses surgery and use of
analgesics. The CD produced by NIH Office of Laboratory
Animal Welfare is made available to researchers on the ULAR
website. ULAR veterinarians are available on an as needed
basis to train investigative staff in specific surgical procedures.
Investigators that propose surgical procedures in IACUC
protocols must document surgical expertise of the personnel
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performing the procedures prior to IACUC approval or confirm
that appropriate training takes place before the procedures are
performed; verification of required skills is a part of the IACUC
and ULAR’s veterinary outreach program. This hands-on
training may be conducted by ULAR veterinarians or other
experienced laboratory personnel. The IACUC may also require
that investigative staff attend ULAR sponsored training
sessions. To ensure personnel are competent, the IACUC
conducts a 6 month inspection of all labs, especially
concentrating on labs that perform surgery. ULAR veterinarians
perform routine rounds of animals in the facility, frequently
examining post surgical animals, and conduct an outreach
program that visits labs on an informal, but frequent basis.
During these visits surgical procedures are observed and
discussed as well as recent outcomes.
3) Describe the training and experience required to perform anesthesia.
[Guide, p. 122]
See #2 above
4) Describe how the proficiency of personnel conducting euthanasia is
ensured (especially physical methods of euthanasia). [Guide, p. 124]
The on-line training by CITI has a module in the basic course
and in the species-specific courses on euthanasia. All
researchers are required to complete these courses. The
required in-class seminar and animal facility orientation also
discusses euthanasia. ULAR personnel are available on an as
needed basis to provide additional training. Finally,
investigators must also describe the euthanasia method in their
IACUC protocol (including the means by which death is
confirmed in euthanized animals), as well as document the
expertise of the personnel performing the euthanasia prior to
IACUC approval. The IACUC requires scientific justification for
physical methods without prior use of anesthetic s for
euthanasia. Personnel performing this must be competent and
may require that they attend an ULAR sponsored training
sessions, if warranted.
b. Occupational Health and Safety of Personnel [Guide, pp. 17-23]
Describe the institutional entities that are involved in the planning, oversight,
and operation of the institutional occupational health and safety program.
The responsibility for compliance with applicable regulations concerning
hazardous biological, chemical and physical agents rests with UCI
Environmental Health & Safety (EH & S) under the direction of Dick
Sun, who reports to the Associate Vice Chancellor for Administrative
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and Business Services. EH&S, includes departments for biosafety,
radiation safety, fire safety, hazardous waste management, injury
prevention, industrial hygiene and occupational health. Each School
within the University has a dedicated EH & S Coordinator. EH&S also
employs a Vivarium/Biosafety Specialist, who is responsible for
coordinating all safety matters within the UCI animal facilities; the
Vivarium Biosafety Specialist reviews all protocols and modifications
submitted to the IACUC for review, and attends all IACUC convened
meetings as an ad hoc/non-voting member.
The Institutional Biosafety Committee (IBC) is the principal advisory
group to the Vice Chancellor of Research on the use of recombinant
DNA and biohazardous agents in research. The ULAR Associate
Director is a voting member of the IBC.
The Laboratory Animal Occupational Health Program (LAOHP) is the
joint responsibility of the IACUC and EH&S. Screening information is
collected via a web questionnaire located on the ORA-IACUC webpage.
Completion of the form is recorded in the IACUC database, but all
collected health screening information is forwarded directly to EH&S for
review by the Occupational Health Program Coordinator, a registered
nurse or Nurse Practitioner. The Occupational Health Program
Coordinator reviews all submitted health information and evaluates it
with the goal of preventing illnesses related to animal exposure,
determining medical clearance or referral and providing a preliminary
medical evaluation. In the event that an illness or injury related to work
with lab animals is reported via questionnaire, further assessment and
treatment is provided through referral to an Occupational Health Care
Provider. ULAR includes information about hazards of working with
animals in research in the classroom training required for all
researchers before facility access is granted.
The UCI Workers Compensation Office coordinates medical treatment
for workplace injuries. Personnel are directed to the appropriate
medical facility, which may be Gottschalk Medical Plaza on the Irvine
campus, the Occupational Health Clinic at UCI Medical Center in
Orange, Newport Urgent Care (for after hours care), UCI Medical
Center Emergency room or the closest Urgent Care Center or hospital
Emergency Department.
i.
Hazard Identification and Risk Assessment [Guide, pp. 18-19; See also
Chapters 2 and 3 in Occupational Health and Safety in the Care and Use of
Research Animals, NRC 1997]
1) Describe the process used to identify, evaluate and control
experimental and other potential hazards (such as ionizing and nonionizing radiation, chemical cleaning agents, animal bites, allergens,
zoonoses, and venomous species) inherent or intrinsic to the use of
animals by the institution. Describe how risks of these hazards are
assessed and how procedures are developed to manage the risks.
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Potential hazards are identified by a combination or methods
including:
1. Review of IACUC, IBC (Institutional Biosafety Committee),
and RUA (Radiation Use Authorization) applications;
2. Laboratory and vivarium visits by EH&S, IACUC and ULAR
personnel;
3. Oversight by each school’s EH&S Coordinator, whose
duties include identifying and mitigating hazards;
4. Evaluation and mitigation of hazards and risks involved with
animal use by the dedicated EH&S Vivarium Biosafety
Specialist, who attends monthly IACUC and IBC meetings
and coordinates communication between EH&S, IACUC,
IBC and ULAR to ensure identification and mitigation of
hazards.
IACUC protocol review includes review of safety issues, and
consultation between the researchers and EH&S to ensure that
safe procedures are followed. As a result of IACUC and IBC
protocol reviews, Animal Room Hazard Communication sheets
are generated for each hazardous agent used in animals.
These sheets are posted at the doors of rooms in which
hazardous agents are used in animals, so that all personnel
have access to the information before they enter the room.
Before being added to an animal use protocol, all researchers
are required to take the online Collaborative Institutional
Training Initiative (CITI) basic animal welfare course, which
discusses use of hazardous agents in animals, as well as
hazards inherent in working with animals (allergies, bites etc.).
Researchers are required to enroll in the Laboratory Animal
Occupational Health Program before being added to an animal
use protocol.
Before being approved for animal facility access, researchers
are required to attend a one-hour Researcher Training class
taught by ULAR veterinarians. This class includes discussion
of hazards inherent in animal use, as well as hazardous agents
used in research at UCI. Information includes how to identify
enclosures and rooms in which hazardous agents are used.
Before a researcher can begin work with hazardous agents,
EH&S communicates with the lab to ensure that all personnel
are trained in safe use of the hazardous agent. This may
include a Safety Considerations meeting with the researchers,
animal facility personnel, and EH&S Biosafety Vivarium
Specialist.
Training of animal facility and research personnel includes use
of personal protective equipment, proper safety practices,
disposal of animals and animal wastes, decontamination
processes, etc.
EH&S requires completion of applicable online courses
covering “Hazardous Waste”, “Laboratory Core Safety”,
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“Bloodborne Pathogens”, “Compressed Gas Safety” and
“Respiratory Protection”.
Animal husbandry staff are trained by ULAR managers,
veterinarians, and EH&S staff in general laboratory and animal
facility safety practices, including work with hazardous
materials when required.
MSDS information for chemical cleaning agents used in the
animal facilities is kept in each major animal facility.
2) Describe procedures for reporting and evaluating exposure to hazards,
work place injuries, etc.
UCI Emergency Procedures Flip-Charts are posted in all work
areas, describing procedures for various emergencies,
including Hazardous Materials Incidents. For emergencies,
personnel are instructed to call 911; on campus, these calls are
routed directly to the UCI Police Department Dispatch Center.
For non-emergencies, personnel are trained to report incidents
to their supervisors after first aid measures are performed. The
Supervisor ensures that the UCI Worker’s Compensation Office
is notified, and that EH&S is notified via their web portal
“Incident Report: Report an Injury, Incident or Safety Concern”.
Worker’s Compensation personnel provide EH&S staff with
reports of all injuries. EH&S staff then follow-up with personnel
for additional safety training, as needed.
Evaluating exposure to hazards and workplace injuries related
to animal research is the responsibility of UCI EH&S. Use of
hazardous agents and other workplace hazards in ULAR
facilities are monitored by the Biosafety Vivarium Specialist,
who works closely with ULAR managers. The Biosafety
Vivarium Specialist meets regularly with ULAR staff, and
conducts Safety Considerations meetings with researchers and
ULAR staff before hazardous materials are used in animals, so
that all personnel with potential exposure are informed about
the risks and trained to mitigate them.
ii. Facilities, Equipment and Monitoring [Guide, pp. 19-20]
1) Describe how hazardous agents are contained within the study
environment and in the animal housing area.
Engineering controls such as biological safety cabinets and
chemical fume hoods are used as required by EH&S when
working with hazardous agents. Rodents exposed to
hazardous agents are generally housed in microisolator cages
labeled with information about the specific hazard. If ventilated
racks are used, negative air flow is established within the cage
and the pressure in the room is negative with respect to the
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hallway. When animals are infected with biohazardous agents,
manipulations are performed either in a biological safety
cabinet or with additional PPE as described in the IBC protocol.
All animal carcasses are collected as pathological waste and
incinerated off-site by a third party vendor. In the ABSL3 facility,
all autoclavable materials and rodent carcasses are autoclaved
before removal using a pass-through certified autoclave.
Bedding and cages may be autoclaved before
disposal/washing if they contain infectious agents at Animal
Biosafety Level-2 or greater biosafety level, and if deemed
necessary by the IBC or Biosafety Officer. Bedding
contaminated with hazardous chemicals is bagged and
collected by EH&S for disposal.
2) Describe facilities that use hazardous agents. Note square feet/meters,
number of animal rooms, and support spaces. In addition, describe
design features, construction features, and special equipment,
especially as they relate to hazard containment. Note if, and how,
exhaust air is treated. If special facilities are not available and
animals exposed to hazardous agents are housed within conventional
animal rooms, so note.
UCI has some specialized facilities for animal studies using
hazardous agents:
1. Hewitt Hall includes a fully commissioned and certified
Animal Biosafety Level-3 rodent facility (ASF 1,937 including
animal housing and use space and support space). The facility
has two animal holding rooms and two animal procedure
rooms, each with biosafety cabinets. The facility is under
negative pressure with an anteroom. The air is single pass and
is exhausted to the outside after being HEPA filtered. The
facility is also equipped with a restroom and shower, so that the
facility may be used to manipulate infectious agents where
personnel may be required to shower in and out. The ABSL-3
facility has a certified pass-through autoclave for disinfection of
all medical and infectious waste generated within the facility.
2. McGaugh Hall includes a containment suite that is currently
used for ABSL2 rodent studies. Total ASF of this suite is 1,097
including animal housing and use space and support space.
This suite includes two animal housing rooms, one procedure
room, an anteroom, janitorial room and an autoclave room with
a pass-thorough autoclave. All autoclavable materials are
autoclaved out of this suite.
In some cases, animals exposed to hazardous agents are
housed within conventional animal rooms. In these cases,
enclosures containing hazardous agents are labeled with
special cage cards indicating the type of hazard and any
special handling required for animals, cages and wastes.
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3) Describe the oversight process and husbandry practices in place to
ensure personnel safety, including any personal protective equipment
provided when work assignment involves hazardous agents.
Control of exposure to occupational hazards associated with
animal research or handling is achieved through the application
of engineering controls, work practices and the use of personal
protective equipment (PPE). If engineering controls are not
considered sufficient to control the exposure potential, work
practices are modified to help minimize exposure potential.
PPE (including laboratory coats, disposable gowns, gloves,
shoe covers, respiratory protection and eye protection), may be
required and is provided at no cost to personnel who need to
work with hazardous agents. EH&S conducts periodic
inspections to ensure that the required laboratory practices and
procedures are followed. Investigators are responsible for
ensuring that laboratory personnel are trained in the safe use of
hazardous agents.
ULAR requires researchers to identify cages in which
hazardous agents are used in animals. If an entire housing or
procedure room is used for hazardous agent work, the room is
posted with applicable warning signs and safety instructions. If
only some cages contain hazardous agents, special cage cards
are used to identify the hazards and to provide instructions as
to how the animals and cages need to be handled safely.
Instructions on handling of specific hazardous agents are
developed by EH&S, ULAR and the research labs, and
communicated to all personnel with potential for exposure.
EH&S has developed Standard Operating Procedures
regarding safety procedures for the use of some commonly
used hazardous agents.
4) Describe any facilities that may also be used for human-based
research or patient areas, including the policies and procedures for
human patient protection, facility decontamination, animal transport
through common corridors or elevators, and other personnel
protection procedures.
On the Irvine campus, there are two human-size MRI systems
and one small animal MRI. Currently, animal and human
studies are not performed in the same scanner, although this
has been approved by the IACUC. The first human scanner
(4T) is solely used for instrumentation development and only
animal studies have been performed in the last couple of years.
The second scanner, (Philips 3T) has been solely used for
human clinical research up to now but recently, animal studies
were approved for this scanner, but only if the animal studies
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are performed at times when it is not used for humans (at night
or during weekends).
All of the MR systems are in separate trailers so there are no
common elevators or corridors.
Procedures are in place to thoroughly disinfect the coil and the
patient couch on which the rf-coil holder rests before and after
use by animals.
At the UCI Medical Center in Orange, the Epidemiology and
Infection Prevention (EIP) branch reviews applications for
animal use in human clinical settings. IACUC protocols
currently approved for animal research in human clinical areas
include irradiation (UCI MC irradiation rooms 125 (CT) and 148
(Trilogy) and MRI (UCIMC Building 22). Researchers must
submit an application to use animals in clinical areas, and must
demonstrate that they have IACUC approval for the work, and
that they have procedures planned to prevent crosscontamination of the facilities. UCIMC has a Policy for Animal
Research Procedures in Patient Care Areas. This policy
includes the following:
1. Instructions on transportation of animals within clinical areas,
including a requirement that animals are covered during
transportation.
2. Only non-invasive procedures may be performed on animals
in clinical areas.
3. Areas used for animal studies must be thoroughly
disinfected after use.
4. Animal studies in clinical areas can only be performed during
times when clinical use is not needed.
5. One to two hours should elapse between use of areas for
animal studies and subsequent clinical use, to allow complete
air changes to occur.
6. Any hazardous waste generated during the animal study
must be removed immediately after the animal procedure is
completed.
5) Describe any other circumstances in which animals or caging
equipment are transported in common use corridors or elevators (e.g.,
have the potential to come in contact with individuals not associated
with the animal care and use program), and measures taken to
mitigate risks associated with such use.
Animals may be transported between the animal facilities and
research laboratories for certain procedures. This may involve
transportation via common use corridors or elevators. ULAR
has a policy that all cages must be covered when being
transported outside the animal facilities. ULAR provides
disposable, plastic covers which researchers can use to loosely
cover cages during transportation.
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6) If motorized vehicles are used for animal transport, describe how the
driver is protected from exposure to hazards such as allergens or
zoonoses.
ULAR has three vehicles (a van and two trucks) which may be
used to transport animals between facilities on the Irvine
campus or between the Irvine and Orange campuses, The van
is used for transportation of small animals, such as rodents.
The cargo compartment of the van is open to the driver’s
compartment. Small animal cages are loosely covered with
disposable plastic bags or placed within sanitizable plastic
containers during transportation. The larger truck is used to
transport large numbers of small animals or any larger animals
such as pigs. The cargo compartment of the truck is
completely separated from the driver’s compartment. ULAR
personnel who transport animals wear scrubs and dedicated
shoes. They change scrubs daily, and are encouraged to
shower before changing into their street clothes at the end of
the work day.
Occasionally, small numbers of rodents are transported in
personally-owned vehicles (for instance between Irvine and
Orange campuses, or to and from other research institutions in
Southern California). ULAR has a Standard Operating
Procedure outlining procedures for this type of animal
transportation, which states that rodents should either be
secured into commercially-available transportation containers,
or if they are transported in their own cages, the cages must be
taped shut and placed within a large plastic bag or sanitizable
secondary container.
iii. Personnel Training [Guide, p. 20]
1) Describe educational program(s) to inform personnel about zoonoses,
personal hygiene, allergies, and other considerations regarding
occupational health and safety.
-
-
-
The online Collaborative Institutional Training Initiative
(CITI) basic animal welfare course and species specific
courses, required by all research personnel before they can
be added to a protocol, includes modules covering the use
of hazardous agents in animals, as well as hazards inherent
in working with animals (allergies, bites etc.).
The classroom vivarium orientation course required for
animal facility access includes specific information about
zoonoses, use of hazardous materials in the vivarium, and
use of personal protective equipment.
The Laboratory Animal Occupational Health Program
(LAOHP) website (where the online LAOHP form is located)
provides basic information about the hazards associated
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-
-
-
-
with animal use; additional information and training is
offered during personalized follow up provided by
Environmental Health & Safety and the Occupational Health
Training of animal facility and research personnel includes
use of personal protective equipment, proper safety
practices, disposal of animals and animal wastes,
decontamination processes, etc.
EH&S requires completion of applicable online or classroom
courses covering “Hazardous Waste”, “Laboratory Core
Safety”, “Bloodborne Pathogens”, “Compressed Gas Safety”
and “Respiratory Protection”.
Animal husbandry staff are trained by ULAR managers,
veterinarians, and EH&S staff in general laboratory and
animal facility safety practices, including work with
hazardous materials when required.
Before working in the ABSL3 facility, personnel are required
to attend a training course specific to this facility, including
hands-on practice in using the PPE required in this facility.
2) Describe special qualifications and training of staff involved with the
use of hazardous agents in animals.
Personnel working with certain hazards are required to take
applicable classes through EH&S (Radiation Safety, Viral
Vectors, Bloodborne Pathogens, Compressed Gas Safety,
Respiratory Protection Fit Testing.
Personnel working in the ABSL3 facility are required to take a
class on ABSL3 procedures.
iv. Personal Hygiene [Guide, p. 20; Ag Guide pp. 4-5]
1) List routine personal protective equipment and work clothing
provided for animal care personnel, technical staff, farm employees,
etc. Describe arrangements for laundering work clothing.
ULAR provides uniforms (scrub tops and pants) for animal
technicians and cage wash technicians to wear in the animal
facilities. Animal care and cage wash staff receive an annual
stipend to purchase one pair of dedicated work shoes per year.
Lockers are provided for storing street clothes. ULAR
personnel change into uniforms before working in the animal
facilities, and they are encouraged to shower before changing
back into their street clothes at the end of the work day.
Scrub suits for animal care staff are sent to a commercial
laundry each week. Washers and dryers are available in the
Med Sci A and McGaugh Hall animal facilities as a back-up if
there is a delay in the commercial laundry service. ULAR
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personnel are also required to wear the Personnel Protective
Equipment applicable to their work areas.
Research personnel are required to wear the Personnel
Protective Equipment applicable to the animal use area.
For most animal facilities, the minimum PPE required to enter is
a disposable long-sleeved gown and disposable shoe covers.
Certain work areas require additional PPE. Signs are
prominently posted to indicate the PPE requirements.
2) Describe provisions for washing hands, showering, and changing
clothes, including instances where work clothes may be worn outside
the animal facility.
Showers and change facilities are located in the major ULAR
animal facilities. Sinks are located in some animal holding
rooms, all procedure rooms, some corridors and all restrooms
for washing hands. Scrub suits may be worn into staff lounge
areas, but are not worn outside animal facilities except when
staff travels between facilities.
3) Describe policies regarding eating, drinking, and smoking in animal
facilities.
Smoking is not permitted within any University structure,
including animal facilities and laboratories. Eating and drinking
within animal facilities is only permitted in designated staff
lounge areas.
v.
Animal Experimentation Involving Hazards [Guide, pp. 20-22]
1) Describe briefly institutional policies governing experimentation with
hazardous biological, chemical, and physical agents, including the
oversight process for the use of hazardous agents. Note: Written
policies and standard operating procedures (SOPs) governing
experimentation with hazardous biological, chemical, and physical
agents should be available during the AAALAC site visit. If such
policies and procedures are not available, please explain.
UCI is committed to providing a healthy and safe working
environment; University policy delegates responsibility to the
Department of Environmental Health and Safety (EH&S) to
ensure compliance with all applicable health, safety, and
environmental laws, regulations and requirements and to
confirm that all activities are conducted in a manner that
protects students, faculty, staff, visitors, the public, property and
the environment. UCI implements best practices and uses the
Integrated Safety and Environmental Management System
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(ISEM) to manage health, safety and environmental concerns
in all campus activities.
- The Institutional Biosafety Committee (IBC) is the principal
advisory group to the Vice Chancellor of Research and the
Associate Vice Chancellor for Research/Institutional Official
on the use of recombinant DNA and biohazardous agents
(including infectious agents, human and non-human primate
blood, bodily fluids, and tissues) in accordance with the NIH
Recombinant DNA Guidelines, Centers for Disease Control
and Prevention (CDC) Guidelines, and all Federal, State
and local laws. EH&S also includes departments for
biosafety, radiation safety, fire safety, hazardous waste
management, injury prevention, industrial hygiene and
occupational health.
- Procedures, guidelines, and other resources to support
radiation users on campus help ensure safety and make
certain that radiation exposures are reduced to levels that
are As Low As Reasonably Achievable (ALARA). Radiation
Use Authorization (RUA) must be obtained from the
Radiation Safety committee. Radiation Safety training is
required for personnel who may be exposed to radiation
sources.
- All UCI personnel who work with laboratory chemicals must
know and follow the standard operating procedures outlined
in the UCI Chemical Hygiene Plan. All laboratory operations
involving particularly hazardous chemicals must be planned
and executed in accordance with the standard operating
procedures described in this plan. In addition, each
laboratory worker is expected to practice safe personal
chemical hygiene habits aimed at reducing exposures to
potential hazards.
There is a dedicated EH & S Coordinator assigned to each
academic school to assist in coordination between laboratories
and required safety oversight; EH&S also employs a
Vivarium/Biosafety Specialist, who is responsible for
coordinating all safety matters within the UCI animal facilities
and reviews all IACUC protocols to identify potential hazards.
2) Describe aspects of the health and safety program specifically for
personnel potentially exposed to hazardous agents.
All animal use protocols submitted to the IACUC and all IBC
protocols involving animals are reviewed by the
Vivarium/Biosafety Specialist and referred to the appropriate
EH&S departments as needed to develop recommendations
and training for personnel.
If hazardous materials are used as a part of an animal use
protocol, Standard Operating Procedures and signs are
developed and posted. If procedures are complex or new, a
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Safety Considerations Meeting is scheduled in order to review
safe handling procedures for animals, equipment and waste
materials. EH&S personnel from the appropriate department
(e.g. biosafety, radiation safety, industrial hygiene), ULAR
personnel and research personnel attend the Safety
Considerations Meeting. Topics covered in the meeting may
include room entry requirements, review of the safety signage
and Standard Operating Procedure, personal protective
equipment, Material Safety Data Sheets and exposure control
plan, additional training requirements, waste management and
medical surveillance.
If personnel are immunocompromised due to treatment of
certain diseases, or as a result of chronic illness, special
considerations may need to be made. The employee or
student is encouraged to confidentially discuss the condition
with their personal medical provider or the EH&S Occupational
Health Program Coordinator.
3) Describe safety procedures for using volatile anesthetics and how
waste anesthetic gases are scavenged.
If volatile anesthetic agents are administered via a precision
vaporizer, waste anesthetic gases are scavenged using an
activated charcoal scavenging system, or directed to a building
exhaust vent via tubing, or performed within a chemical fume
hood or externally-ventilated biosafety cabinet. If volatile
anesthetic agents are used without a precision vaporizer,
procedures must be performed within in a chemical fume hood,
an externally-ventilated biosafety cabinet, or in a well-ventilated
area. The method used for scavenging waste anesthesia
gases must be described in the approved IACUC protocol and
is verified as part of the semi-annual facility inspection visits.
4) List, according to each of the categories noted below, hazardous or
potentially hazardous agents currently approved to be used in animals
that are or will be maintained for more than a few hours following
exposure. If the hazardous agent cannot be listed by name for
security/proprietary reasons, identify it by the general category of
agent and level of hazard. Note: This information may be provided as
an Appendix.
a) Biological agents, noting hazard level (CDC Biohazard Level,
Directive 93/88 EEC, CDC or USDA/DHHS Select Agent, etc.).
Hazards Contained at ABSL1:
1. Adeno-Associated Virus (helper-free)
2. Human cell lines
Hazards Contained at ABSL2:
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1. Adenovirus
2. Borrelia spp.
3. Chlamydia spp.
4. Herpes Simplex Virus
5. HIV
6. Lentiviral vectors
7. Human Cells
8. Modified Rabies Virus
9. Salmonella spp.
10. Toxoplasma gondii
11. Vaccinia virus
Hazards Contained at ABSL3:
1. Prions
2. West Nile Virus
3. Vaccinia Virus
b) Chemical agents, noting general category of hazard (toxicant,
toxin, irritant, carcinogen, etc.).
Toxicants:
1. Azoxymethane
2. Cyanide
3. Kainic acid
4. Streptozotocin
Carcinogens:
1. Adriamycin
2. Benzo-a-pyrene
3. Bromodeoxyuridine
4. N-ethyle-N-Nitrosurea
5. Cyclosporine
6. Cyclophosphamide
7. Dimethyl benzanthracene (DMBA)
8. Docetaxel
9. Mitomycin C
10. OH-BBN (N-butyl-butyl-nitrosamine)
11. Paraformaldehyde
12. Rapamycin
13. Tetradecanoyl-phorbol acetate (TPA)
14. Urethane
Antineoplastics:
1. Cisplatin
2. Colchicine
3. Cocetaxel
4. Doxorubicin
5. Pacitaxel
6. Streptozotocin
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7. Tacrolimus
8. Tamoxifen
9. Temozolomide
c)
Physical agents (radiation, UV light, magnetic fields, lasers,
noise, etc.).
1.
2.
3.
4.
5.
6.
Radiation
UV light
Magnetic fields (MRI)
Ultrasound
Lasers
UV light
5) Describe the program for housing and caring for animals exposed
experimentally to the hazardous agents noted above, with emphasis
on management and safety practices for containment of each class of
agent. Indicate how levels of personnel exposure are assessed.
Safety procedures are developed by EH&S, ULAR and the
research lab for each hazardous agent used in animals. For
biological agents, UCI follows the CDC guidelines as published
in the BMBL manual (Biosafety in Microbiological and
Biomedical Research, 5th ed.).
Typically, all animal work involving ABSL2 or ABSL3 agents is
performed within a biological safety cabinet, and rodents are
housed in microisolator cages. The minimum PPE required is a
disposable gown and disposable latex/nitrile gloves. Additional
PPE may be required for some biohazardous studies (including
face masks, hair covers, N-95 respirators, surgical face masks).
Rabbits infected with Herpes Simplex Virus (HSV) are housed
in conventional stainless steel cages. To handle the infected
rabbits and tissues, personnel must wear the basic vivarium
PPE (disposable gown, shoe covers and gloves, and also a
surgical face mask and eye protection (safety glasses or
goggles) to protect the mucous membranes.
For biohazardous agents, the IBC protocol includes
descriptions of how the contaminated wastes and carcasses
will be disposed of. For instance, the contaminated cage
containing the bedding may be autoclaved before the bedding
is disposed of as biohazardous waste.
For chemically hazardous agents, the Chemical Hygiene
Officer develops an SOP for safe handling of the agents,
including instructions for handling animals and their wastes that
may be contaminated. Levels of personnel exposure are
assessed for certain chemical hazards (e.g. isofluorane) when
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required by EH&S, by conducting an exposure assessment for
isoflurane for a full shift personal and area monitoring. The lab
results are calculated as an 8-hour Time Weighted Average
concentration that is compared to the OSHA Permissible
Exposure Limits.
For animals treated with radioisotopes, the Radiation Safety
Officer develops Standard Operating Procedures for safe
handling. Procedures are described for handling live animals,
their waste materials, carcasses, and soiled cages and other
equipment. Depending on the isotope used, procedures may
include allowing cages, wastes and carcasses to undergo
decay until levels of radioactivity are at a safe level for handling
without special precautions. Research staff and animal care
staff must undergo radiation safety training if they may be
exposed to radioisotopes in the course of their work. Radiation
dosimeter badges may be used to determine exposure levels,
according to the advice of the Radiation Safety Officer.
Hewitt Hall includes a fully commissioned and certified Animal
Biosafety Level-3 rodent facility. The facility has two animal
holding rooms and two animal procedure rooms, each with
biosafety cabinets. The facility is under negative pressure with
an anteroom. The air is single pass and is exhausted to the
outside after being HEPA filtered. The facility is also equipped
with a restroom and shower, so that the facility may be used to
manipulate infectious agents where personnel may be required
to shower in and out. The ABSL-3 lab has a certified passthrough autoclave for disinfection of all medical and infectious
waste generated within the facility.
For biohazardous agents, levels of personnel exposure are not
routinely assessed, and serum banking of pre-exposure serum
is not done. In certain cases, serum titers are measured to
determine whether pre-exposure immunization will be
recommended or required (e.g. rabies).
vi. Personal Protection [Guide, pp. 21-22]
1) Describe training, equipment and procedures employed to reduce
potential for physical injury, inherent to animal facilities (e.g., noisy
areas, large quantities of chemicals such as disinfectants, ergonomics)
or species used (e.g., nonhuman primates, agricultural animals).
All UCI employees are advised to view an online New
Employee Orientation, a 2-hour tutorial that includes an
introduction to safety information and training available to
personnel through EH&S. UCI has a program called Safety on
Site (SOS) to promote safety awareness in work areas. New
employees are required to log on to the University of California
Learning Center (UCLC) site and complete a risk assessment
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that will determine which training classes they need for their
type of work. It is the responsibility of the supervisor / PI to
ensure compliance. Animal care staff receives training at staff
meetings on ergonomic issues related to their work, including
back injuries, repetitive strain injuries and bloodborne pathogen
training. All personnel who work with animals must provide
evidence of experience and training to safely handle animals
and perform their duties, or such training is provided by ULAR.
Undergraduate students receive training in laboratory safety by
taking Biological Sciences 194S course, which is a requirement
for all students entering biological research. This course
includes a risk assessment and safety training. Graduate
students complete the Teaching Assistants and New Graduate
student Orientation (TANGO) course at EH&S. TANGO
includes a risk assessment and safety training.
Equipment to reduce physical injuries include gloves for
handling hot items (from autoclaves or cage washers for
instance); carts and pallet jacks for transporting heavy items;
aprons and face shields to prevent chemical injury; slipresistant boots in cage wash areas, and hearing protection
when required by EH&S.
2) Describe the procedures for the maintenance of protective equipment
and how its function is periodically validated.
Protective equipment is evaluated regularly by users. Any
defects are reported to supervisors, who arrange for protective
equipment to be repaired or replaced.
3) Describe situations where respiratory protective equipment is
available or required, such as cage washing facilities, feedmills, etc.
Describe how such equipment is selected and how respirator fit
testing and training in the proper use and maintenance of the
respirator is provided.
The Respiratory Protection Program is designed to provide for
the medical assessment and equipment fit testing as mandated
for all employees and students who require the use of a
respirator in the scope of their work at UCI. The purpose of the
Respiratory Protection Program is to prevent potential health
hazards, provide for early treatment of adverse health effects,
and to meet regulatory standards as set by the Occupational
Safety and Health Administration (OSHA) from exposure to
respiratory irritants in the occupational setting. The LAOHP risk
assessment is used to identify personnel who may need
respiratory protection. Personnel then complete an additional
Respiratory Hazard Identification. Based in this evaluation,
personnel may be enrolled in the Respirator Fit Test and
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Training through EH&S. The appropriate type of respirator is
determined and personnel are trained on its correct use.
Respirators are provided at no charge to the personnel who
require them for their work at UCI.
4) Describe program policies to ensure personnel safety when working
with rack/cage washers, other sanitation/sterilization equipment, and
other heavy equipment such as scrapers, tractors, and farm machinery.
Describe the training program that supports these policies.
Training for cage wash personnel is covered by a Standard
Operating Procedure. The Cage Wash Training SOP includes
directions for training personnel on safety procedures,
including:
(1) Correct methods to lift, push and pull heavy items
(2) Correct use of PPE
(3) Handling hot items from autoclaves
(4) Locations of emergency exits, eye wash stations, showers,
fire extinguishers, and first aid kits
(5) Emergency shut-off procedures for equipment such as
tunnel washers
(6) Emergency shut-off and exit procedures if trapped inside
rack washers
The UCI animal program does not have large farm machinery.
vii. Medical Evaluation and Preventive Medicine for Personnel [Guide, pp.
22-23]
1) Identify the individual(s) and/or office responsible for developing and
monitoring the medical evaluation and preventive medicine program.
Responsibility for medical evaluation and preventive medicine
for personnel (known as the Laboratory Animal Occupational
Health Program or LAOHP) is shared between Environmental
Health and Safety (EH&S) and the Office of Research. The
Occupational Health Program Coordinator or the Employee
Health Manager (both within EH&S) review the health risk
assessment questionnaires and evaluate the need for medical
evaluation by an occupational health physician at the UCI
Center for Occupational and Environmental Health (COEH), or
respirator fit testing and training within EH&S. Office of
Research maintains a database of personnel who are currently
enrolled in the LAOHP. At the time of protocol review, the
IACUC administrative staff (within Office of Research) check
that research personnel are enrolled in the LAOHP. For
personnel who are not listed on animal research protocols (e.g.
ULAR staff, Facilities Management staff etc.), supervisors
within those Departments are responsible for ensuring that their
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personnel enroll in the LAOHP if they have significant contact
with or exposure to animals.
2) Describe the categories of personnel (research staff, visiting scientists,
animal care staff, students, support staff, etc.) included in the
program.
UCI IACUC policy requires that all faculty, staff, visiting
researchers and students who work directly with vertebrate
animals or laboratory animal tissues (unfixed animal tissues or
body fluids) and Facilities Management personnel who work in
animal housing areas participate in the Laboratory Animal
Occupational Health Program (LAOHP) through submission of
a medical questionnaire. Completion of the questionnaire is
required once a year and at the time of a change in health
status. Reminders and links to additional information are sent to
all research personnel on an annual basis. For other
categories of personnel (ULAR and Facilities Management),
their supervisors are responsible for ensuring that they
complete the LAOHP medical questionnaires.
Persons with casual research-animal contact (e.g., IACUC
community members and staff that participate in semi-annual
Facility Inspections as well as researchers in open labs
adjacent to animal use areas, etc.) are also encouraged to
participate in the LAOHP by submission of the medical
questionnaire.
3) Describe general features of the medical evaluation and preventive
medicine programs, including pre-employment/pre-assignment health
evaluation, periodic medical evaluations, immunization programs, and
procedures for communicating health related issues.
Screening information is collected via a web questionnaire
located on the ORA-IACUC webpage (see Appendix 5.
Completion of the form is recorded in the IACUC database, but
all collected health screening information is forwarded directly
to EH&S for review by the Occupational Health Program
Coordinator. The Occupational Health Program Coordinator
reviews all submitted health information and evaluates it with
the goal of preventing illnesses related to animal exposure,
determining medical clearance or referral and providing a
preliminary medical evaluation. In the event that a health risk
related to work with laboratory animals is reported via
questionnaire, further assessment and treatment is provided
through referral to an Occupational Health Care Provider at the
UCI Center for Occupational and Environmental Health
(COEH). Tetanus immunizations are recommended for all
animal handling staff, in accordance with the guidelines of the
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Federal Centers for Disease Control. For projects involving the
use of certain ABSL2 agents (rabies, vaccinia), serum antibody
titers and immunization may be recommended for personnel
with the potential for exposure to these agents. Health risks of
working with animals are communicated in multiple ways.
Research personnel have to take online and classroom training
before being granted access to ULAR animal facilities. This
training includes discussion of health issues related to animal
studies. Animal care personnel receive classroom training on
health issues, coordinated by the UCI Biosafety Vivarium
Specialist. Posters within the animal facilities notify personnel
of certain health issues such as animal bites and sharps
injuries. For research projects involving hazardous agents,
EH&S arranges Safety Considerations meetings with personnel
potentially exposed to the hazards before the work can be
started. Animal Room Hazard Communication sheets are
posted at the doors or animal rooms in which hazardous agents
may be used.
4) Describe special precautions or procedures for personnel exposed to
potentially hazardous species (nonhuman primates, sheep, etc.) or
agents (infectious agents, human origin tissues, chemicals/toxins,
etc.).
No research involving non-human primates or sheep is
currently performed at UCI.
c.
Investigating and Reporting Animal Welfare Concerns [Guide, pp. 23-24]
Describe institutional methods for reporting and investigating animal welfare
concerns.
Any individual may report concerns to the IO, IACUC Chair, Attending
Veterinarian or any member of the IACUC. In addition, complaints or
concerns regarding the care and use of animals are directed to the
IACUC administrative staff or to other members of the Office of
Research where they are documented and kept confidential. There is
also a method in place for individuals to leave an anonymous telephone
message. Concerns may be reported either verbally or in writing.
Notices are located in all animal housing and use areas advising
individuals how and where to report animal concerns; such information
is also provided on ULAR and Office of Research websites and
reiterated in all animal-related training. University whistleblower policy
protects any individual against reprisals who, in good faith, reports an
animal concern.
Upon receipt of a concern or complaint, IACUC administrative staff may
perform an administrative audit with assistance of campus veterinary
staff as well as other members of the Office of Research Administration
to determine whether a possible occurrence of non-compliance
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warrants further attention. Substantiated occurrences of
noncompliance will be immediately reviewed by the IACUC Chair and
Attending Veterinarian, who determine whether immediate action is
required (e.g., temporarily halting animal use activity pending formal
review by the IACUC.) All reported concerns, regardless of the nature,
are brought to the attention of the full committee. However, unless
immediate IACUC action is warranted, the Committee is generally
informed at the next regularly scheduled meeting. Compliance issues
are a standing item on the monthly agenda.
B. Program Oversight
1.
The Role of the IACUC/OB [Guide, pp. 24-40]
a.
IACUC/OB Composition and Function [Guide, pp. 17; 24-25]
Please provide a Committee roster, indicating names, degrees, membership
role, and affiliation (e.g., Department/Division) as an appendix.
i.
Describe Committee membership appointment procedures.
Nominees for membership to the IACUC are submitted to the
Associate Vice Chancellor for Research/Institutional Official, who
reviews the qualifications of the nominees and makes the
appointments to the IACUC. The IACUC Chair is also appointed by
the Associate Vice Chancellor for Research. Membership needs of
the committee are regularly reviewed by IACUC administrative staff
and communicated to the IO to ensure that the committee remains
appropriately constituted.
ii. Describe frequency of Committee meetings.
Regular convened meetings with a quorum of members take place
monthly, on the second Thursday of the month. Two additional
meetings, on the fourth Thursday in January and July, are reserved
for the semi-annual Program Evaluation.
iii. Describe the orientation, training, and continuing education opportunities
for IACUC/OB members. [Guide, p. 17]
New members appointed to the IACUC are provided with copies or
web-based links to all relevant laws and regulations, institutional
policies and procedures, and The Guide for the Care and Use of
Laboratory Animals, and are asked to complete the “Essentials for
IACUC Members” module provided by the Collaborative
Institutional Training Initiative (CITI) prior to attendance at their first
IACUC meeting. New members are mentored by more seasoned
committee members and given an opportunity to observe the
workings of the committee, including protocol review, for at least
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two months before being assigned primary protocol review
responsibilities. Additional training for new and continuing
members is provided by Office of Research Administration staff
during regularly scheduled committee meetings and via a
“member’s only” website. Continuing education in the form of
articles, newsletters, etc., is routinely provided as an agenda item
at convened meetings for review and discussion. In addition, all
committee members are encouraged to take part in outside training
such as PRIM&R conferences and IACUC 101.
b. Protocol Review [Guide, pp. 25-26]
A blank copy of your institution’s protocol review form should be provided as
an appendix. Also include forms used for annual renewal, modifications,
amendments, etc., as applicable.
i.
Describe the process for reviewing and approving animal study protocols,
including research and teaching proposals. Include a description of how
animal study protocols that do not involve a formal grant proposal are
reviewed and approved (i.e., pilot studies or internally funded studies).
Include a description of how the IACUC/OB weighs the potential adverse
effects of the study against the potential benefits that may result from the
research. Describe how protocols that have the potential to cause pain or
distress to animals are reviewed, alternative methodologies reviewed,
veterinary input solicited, and studies controlled or overseen. Specify how
animals and experimental group sizes are justified.
Prior to beginning proposed activities involving the use of live
vertebrate animals, and upon the three-year anniversary of
approval of ongoing research projects, researchers must complete
a protocol application and submit it to the IACUC office. All new
and three-year renewal applications (with two exceptions noted
below) require full committee review at a convened meeting with a
quorum present. Once the submission deadline has passed, all
submitted materials are routed to campus veterinarians and EH&S
staff for pre-review. Administrative, veterinary and hazard-related
review comments are then compiled and posted with the protocols
and modifications submitted for full committee review on a
protected website and an announcement is made to all IACUC
members that materials are ready for review. A primary and
secondary reviewer is assigned for each protocol on the agenda.
IACUC reviewers submit their review comments back to the IACUC
administrative staff, who then compiles them with the veterinary
and other pre-review comments for forwarding to the Lead
Researcher. Lead Researchers then have approximately 5 days to
respond to the pre-review comments prior to final review at the
convened meeting. During the Committee meeting, the primary
and secondary reviewers are responsible for leading the discussion
with regard to the proposed research, summarizing the issues cited
in pre-review and assessing the researchers’ responses to those
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issues as well as making a recommendation for approval, require
modifications in (to secure approval), or withhold approval. If
modifications are required, the quorum of members present at the
full committee meeting determines if those modifications can be
reviewed by Designated Member Review (DMR) or must be
returned for review by the full committee at a convened meeting. All
members of the IACUC have agreed, as part of the Member
Standards document signed at the time they join the IACUC that
the quorum of members present at a convened meeting may
decide by unanimous vote to use DMR subsequent to full
committee review when modifications are required to secure
approval.
Exceptions to full committee review for new and three-year renewal
applications:
(A) Research involving animals that are studied in their natural
habitat without any invasive procedures and without harming or
materially altering their behavior (non-invasive field studies) may
qualify for Designated Review; and
(B) Research performed entirely offsite at an OLAW-assured
institution. UCI’s IACUC may accept registration of the offsite
institution’s IACUC approval in lieu of review and approval by the
UCI IACUC, following submission of the off-site entity’s approved
protocol and approval letter for review by the IACUC chair or
designee.
All animal study protocols are reviewed following the same
procedures and considerations, regardless of whether they are
supported by extramural funds. In cases where there is no
extramural funding, IACUC members may apply additional rigor to
the review to evaluate scientific elements of the protocol as they
relate to the welfare and use of the animals. The appropriateness
of the chosen species and the experimental group sizes must be
carefully justified; researchers are encouraged to provide statistical
support for the proposed experimental design wherever possible.
The IACUC routinely assesses the potential benefits of every study
in light of the potential harm to its animal subjects. In order to gain
approval, animal use protocols must clearly document
consideration of alternatives, refinement of procedures, and
appropriate use of mitigating factors such as anesthesia, postprocedural analgesics, and humane endpoints. Veterinary staff
members review all protocols and regularly consult with
researchers to ensure animal welfare; the IACUC may also require
enhanced veterinary oversight as a condition of approval for
protocols that have the potential to cause pain, distress or
discomfort in the animals.
ii. Describe process for reviewing and approving amendments,
modifications, and revised protocols. If applicable, include a description of
“major” vs. “minor” amendments.
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Review and approval of significant changes to approved protocols
require full committee review (FCR) at a convened meeting and are
handled in the same manner as new and de-novo renewal protocol
applications (see B.1.b.i above).
The IACUC has established criteria for the types of significant
protocol modifications suitable for Designated Member Review
(DMR). These include minor increases in the number of animals
allocated to the project (i.e., 10% or less of the originally approved
allocation); refinements in the anesthesia regimen; addition of an
AVMA approved euthanasia method; decrease in the invasiveness
of a procedure; modification to decrease pain or distress; addition
of a minimally-invasive procedure or any other changes deemed
appropriate by the full IACUC. Modification requests are reviewed
administratively; if they are determined to be suitable for DMR, the
modification request and all associated documents are forwarded to
all members of the IACUC electronically for review. Committee
members have five (5) business days to review the request, ask
questions and request additional information if needed; during this
review period, if any member calls for full committee review (FCR)
of the request, it is placed on the agenda for the next scheduled
IACUC meeting and the Principal Investigator is notified. If no one
calls for FCR during the review period, concurrence by silent assent
of all members is assumed and a subcommittee consisting of at
least one scientific member and one veterinarian is assigned to
review the modification request. The subcommittee may approve,
require modifications (to secure approval) or call for full committee
review of the modification request. If multiple designated reviewers
are used, their decisions must be unanimous; if not, the protocol
will be referred for FCR.
Minor modifications (e.g., addition or deletion of non-key personnel
such as graduate students, change in laboratory location) are
reviewed and processed administratively.
A list of modifications approved by subcommittee via DMR or
administratively review is provided to IACUC members for review
and appended to the minutes of the next convened IACUC
meeting.
c.
Special Considerations for IACUC/OB Review [Guide, pp. 5; 27-33]
i.
Experimental and Humane Endpoints [Guide, pp. 27-28]
Describe how criteria for determining alternatives to experimental
(humane) endpoints are developed, approved, and applied. Include a
description of monitoring systems in place for studies for which
information on alternative endpoints are not available.
The IACUC requires that every animal-use protocol include welldefined, humane endpoints for all experimental studies to ensure
the minimization of animal pain and distress. Criteria have been
established and are publicly available via the internet to assess
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species-specific signs of pain, distress and discomfort such as
weight loss, weakness, anorexia/cachexia, etc. In addition, specific
guidelines are provided for tumor studies to ensure that tumor
burden does not exceed acceptable levels. Wherever feasible,
investigators are asked to develop a scoring system to assess pain
and distress in the animals.
When questions regarding the appropriateness of established
endpoints are noted during protocol review, the IACUC requests
that the protocol be flagged for enhanced veterinary oversight and
outreach in order to ensure that humane experimental endpoints
are established and followed.
ii. Unexpected Outcomes that Affect Animal Well-being [Guide, pp. 2829]
Describe how unexpected outcomes of experimental procedures (e.g.,
unanticipated phenotypes in Genetically Modified Animals) are identified,
interpreted, and reported to the IACUC/OB.
IACUC guidelines have been developed to encourage open
communication between research personnel, ULAR veterinarians
and the IACUC. Researchers are encouraged to promptly report
adverse events, including unanticipated morbidity, injury or
pain/distress as well as unusually high frequency of expected
clinical signs associated with study procedures. Campus veterinary
staff works with researchers to troubleshoot experimental
procedures and develop alternative methods to address issues as
they arise. These issues are reported to and discussed with the
IACUC at the monthly convened meeting as part of the
Veterinarian’s Report, a standing agenda item.
iii. Physical Restraint [Guide, pp. 29-30]
Note: This section is to include only those protocols that require
prolonged restraint. Brief restraint for the purpose of performing routine
clinical or experimental procedures need not be described.
1) Briefly describe the policies for the use of physical restraint
procedures or devices.
IACUC policy requires that the use of prolonged restraint be
scientifically justified; that the period of restraint should be the
minimum required to accomplish the research objectives; that
animals should be adapted to the restraint device wherever
feasible prior to the actual experiment; and that animals under
restraint be monitored and observed for distress at appropriate
intervals (as described in detail in the approved protocol).
2) Describe animal restraint devices that are used or have been used
within the last three years. For each device, briefly describe the
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duration of confinement, acclimation procedures, monitoring
procedures, criteria for removing animals that do not adapt or
acclimate, and provision of veterinary care for animals with adverse
clinical consequences.
Most restraint currently used at UCI is minor in nature:
- Alligators, snakes and other reptiles are held in metabolic
chambers large enough for the animals to fit in a natural
posture for periods of up to four weeks. These species are
relatively sedentary in nature; it is believed that such
restraint is not particularly stressful for them
- Aquatic turtles are used in a forced-submersion experiment
where they are held underwater for an indeterminate time
(they are released 60 seconds after they begin to forcefully
try to return to the surface of the water.
- Rodents are held in various restraint devices (conical tubes
to elicit a stress response, brief restraint for various
procedures, etc).
A few currently approved studies include restraint procedures
that may involve more potential for distress:
- Goldfish are held in a custom-made Plexiglass holder for
electrophysiology recording and brain imaging. General
anesthesia is not used as it would disturb the pattern of
brain activity under study, but local anesthesia is given prior
to the surgical preparation for the imaging procedures. The
animals are kept moist and “ventilated” via a continuous
flow of water over the gills. Animals are held in this manner
for up to 6 hours and then euthanized.
- There is currently one approved protocol that uses the
hindlimb suspension model in rats as a simulation of zerogravity conditions. Animals are suspended by the tail from
the top of the cage so that only their front limbs bear weight
for up to 7 days; cage bottoms are specially designed
(sloped) to assist in maintaining animals’ posture as
horizontal as possible without enabling the hind limbs to
contact surfaces with weight-bearing force. Animals are not
acclimated prior to the procedure, but are carefully
monitored by both laboratory staff and animal-care
personnel. Animals that develop a necrotic tail or show
overt signs of pain or distress are euthanized immediately.
iv. Multiple Survival Surgical Procedures [Guide, p. 30]
Note: One survival surgical procedure followed by a non-survival
procedure is not included in this category.
1) Describe the institutional policy(ies) regarding multiple survival
surgery (major or minor) on a single animal.
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IACUC policy discourages the use of multiple major survival
surgery, but it may be permitted if there is a strong scientific
justification. The multiple surgeries should be interrelated
components of the same project.
2) Describe the procedure for approving multiple survival surgery
(major or minor) and the criteria used to determine the potential
impact on the animals’ well-being.
Protocols which included multiple surgeries are carefully
considered by the IACUC, with particular attention to the
timeframe of the multiple procedures, the post-operative care
provided to the animals and appropriate recordkeeping
throughout the duration of the study. The IACUC may request
progress reports from principal investigators and/or veterinary
staff to assess the health and well-being of the animals.
3) Summarize the protocols currently approved that involve multiple
major survival surgical procedures and the time allowed between
procedures on the same animal. Describe the method of institutional
monitoring.
Prot. #
1999-2064
Summary of Surgical Procedures
Burn injury followed by biopsies in rodent
1999-2128
2001-2259
2002-2365
2003-2498
2007-2705
2007-2754
2008-2846
Oocyte harvest (total 6) in frog
Sciatic nerve transection – 2 procedures (rodent)
Spinal cord injury followed by surgical injection (rodent)
Sciatic nerve injury followed by surgical treatment
Multiple limb amputation in axolotl
Multiple tracheal scrape injury in rabbits
Implantation of temperature logger followed by implantation of blood
flow probe and vascular catheter in alligator
Aortic occlusion, followed by implantation of flow probes in alligator
Tumor implantation followed by laser treatment in rat
Spinal cord injury followed by surgical injection in rodent
Brain injury followed by cranial injection in rodent
Tumor implantation followed by tumor resection in rat
Laminectomy followed by repair surgery in rat
Intracranial injection, headplate implant, eyelid closure in mouse
Microinjections into subarachnoid space in rat
Islet transplant into kidney or liver, followed by removal of implant in
rodent
2009-2876
2009-2895
2010-2940
2010-2945
2010-2959
2011-2976
2011-2994
2011-3005
2012-3028
Interval between surgeries
1, 2,7 and 14 days after
injury
At least one month
1 week
4 weeks – 1 year
3-6 months
48 hours to 2 weeks
2 days and 4 days
3 months
2-7 years
10 days
9 days
1-2 weeks
10 days
4 weeks
1-45 days
5-8 days
4 weeks
Depending on the severity/invasiveness of the procedure, the
IACUC may require enhanced veterinary oversight of animals
that undergo multiple survival surgical procedures. In all cases,
the justification for the multiple procedures is carefully
evaluated by the IACUC.
v.
Food and Fluid Regulation [Guide, pp. 30-31]
1) Describe experimental situations that require food and/or fluid
regulation. Note: This does not include pre-surgical fast. List title of
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the experiment(s), justification, species involved, and length and type
of food/fluid regulation.
Prot. #
1997-1608
Species
Rodent
1997-1965
Rat
1998-1301
1998-1306
Rodent
Rat
1998-1334
Finch
1998-2015
Rat
1999-1719
Rodent
1999-2086
Rat
2000-2165
Rat
2000-2220
2001-2259
2002-2365
2004-2514
2004-2554
2006-2620
Rodent
Rodent
Rodent
Rat
Fish
Mouse
2006-2630
Rat
2006-2636
Rat
2006-2649
2006-2666
Mouse
Mouse
2009-2866
Rat
2009-2867
Rat
2009-2879
Rat
2010-2919
Rat
2010-2945
Rodent
2011-2980
Rodent
2011-2994
Mouse
2011-3009
Rat
Reason and Duration of Restriction
Water restriction to train/motivate animals for behavior tests. 4 days, 10 ml
water/day
Food restriction to stimulate exploratory behavior during self-administration of test
agents. Maintain animals at 90% of normal body weight.
Overnight fasting to prevent contamination of urine sample collection.
Water restriction for motivation in reward training. Access to water limited to 10
min / day during training period
Withhold food overnight to motivate animals for behavior tests (4:00 p.m. – 9:00
a.m. daily)
Food restriction to increase motivation for behavior testing. Food reduced by 20%.
Weight loss not to exceed 15%
Food restriction to increase motivation for behavior testing. Maintain animals at
80% of normal (age matched) body weight
Food restriction to increase motivation for behavior testing. Maintain animals at
85% of normal (age matched) body weight.
Water restriction for Vogel testing (water removed at 5:00 p.m. night before
testing). Day of testing only.
Food restriction to increase motivation for behavior testing, 18-24 hours.
Food restriction to increase motivation for behavior testing (overnight).
Food restriction to increase motivation for behavior testing (overnight).
To determine effects of feeding on OEA biosysthesis in brain (up to 24 hours).
Adult zebrafish are fasted to enhance predator-prey experiments (6 days).
Food restriction to increase motivation for behavior testing. Maintain animals at
85% of normal (age matched) body weight.
Food restriction to increase motivation for behavior testing. Animals are fed after
testing and allowed to maintain normal weight.
Food restriction to increase motivation for behavior testing. Maintain animals at
85% of normal (age matched) body weight.
24 hour fast for increased glucogenesis.
Food restriction to increase motivation for behavior testing. Maintain animals at
85% of normal (age matched) body weight.
Animals are food-deprived prior to the sham-feeding procedure described in the
approved protocol (18-24 hours).
Food and water restriction to increase motivation for behavior testing. Maintain
animals at 85% of normal (age matched) body weight.
Food restriction to increase motivation for behavior testing. Maintain animals at
85% of normal (age matched) body weight.
Food restriction to increase motivation for behavior testing. Access to food
limited to daylight hours and one hour during dark cycle.
Water restriction to train/motivate animals for behavior tests. Access to water
limited to 15 minutes twice daily for 5 days.
Food is withheld for 24 hours prior to euthanasia/tissue harvest in study of MCH
system.
Water restriction to train/motivate animals for behavior tests. Access to water
limited to 2 hours/day
Food and water restriction prior to sucrose preference test (to assess depressive
behavior) – 20 hours.
2) Describe animal health monitoring procedures and frequency (e.g.,
body weight, blood urea nitrogen, urine/fecal output, food/fluid
consumed).
The primary variable measured to assess animal health during
food or fluid restriction in rodents is body weight. In general,
weight loss is limited to no more than 20% of age-matched
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controls. Researchers are required to include a detailed
description of their monitoring procedures, including the
frequency with which animals are weighed, in their approved
protocol. Husbandry and veterinary staff observe animals daily
for signs of distress such as ruffled coat, hunched posture,
obvious/significant weight loss, lack of urine/fecal output and
visual signs of dehydration.
3) Describe methods of ensuring adequate nutrition and hydration during
the regulated period.
Researchers are required to maintain a daily log sheet in the
animal room at all times when food or water is withheld. The
log must include a record of when food or water is provided,
notes about the health status of the animals (including weight)
and any adverse events associated with the restriction. The log
must be completed by laboratory staff on a daily basis,
including weekends and holidays. Husbandry and/or veterinary
staff check the logs daily; if the log is incomplete, staff will
provide the animals with food and water. A sample log is
available for researcher use on the IACUC website.
vi. Use of Non-Pharmaceutical-Grade Drugs and Other Substances
[Guide, p. 31]
Describe the rationale and consideration given by the IACUC/OB for use
of non-pharmaceutical grade drugs or other substances, if applicable.
IACUC policy requires the use of pharmaceutical grade drugs
whenever they are available, in all situations where the health and
well-being of the animal are at risk (e.g. anesthesia, analgesia,
emergency drugs and euthanasia agents) and for routine veterinary
care. Under certain circumstances, however, the IACUC may
approve the use of non-pharmaceutical grade chemical compounds
with adequate scientific justification or when an acceptable
veterinary or human pharmaceutical-grade product is unavailable.
In such cases, the method of preparation of the drug and the
storage conditions must be described in the animal-use protocol; in
particular, a detailed description of the methods used to ensure
sterility of the drug.
vii. Field Investigations [Guide, p. 32]
Describe special considerations used by the IACUC/OB when reviewing
field investigations of animals (non-domesticated vertebrate species), if
applicable.
Field studies are uncommon at UCI; when they are proposed, the
IACUC reviews the protocol in the same manner as any other
protocol. Such protocols are also carefully reviewed by
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Environmental Health and Safety to identify hazards associated
with the research or the location. IACUC and ULAR staff also works
with the research staff to ensure that all required permits (e.g.,
California Department of Fish and Game) are in place prior to
commencement of the study.
viii. Agricultural Animals [Guide, pp. 32-33]
Describe considerations given and guiding documents used by the
IACUC/OB when reviewing “biomedical” and “agricultural” research
projects involving agricultural species as study animals, if applicable.
UCI does not perform any agricultural research with animals.
ix. Animal Reuse [Guide, p. 5]
Describe institutional policies and/or oversight of animal reuse (i.e., on
multiple teaching or research protocols). Summarize the protocols
currently approved that involve the reuse of individual animals.
Individual animals are not reused under multiple teaching or
research protocols, with the possible exception of the ULAR
protocol “Education and Training in the Use of Laboratory Animals”
which will occasionally re-use the same animal to demonstrate
minimally-invasive techniques such as blood draw and suturing to
multiple groups. On occasion, the IACUC will approve a secondary
use of an animal either immediately before or after euthanasia on a
terminal procedure – for example, harvest of an organ from swine
used in terminal Urology teaching protocols. This type of request is
reviewed and approved by the IACUC on a case-by-case basis.
2.
Post-Approval Monitoring [Guide, pp. 33-34]
a.
Describe mechanisms for IACUC/OB review of ongoing studies and periodic
reviews (e.g., annual review, 3-year renewals if PHS funded, etc.).
All protocols are reviewed by a member or members of the IACUC at
least annually. Protocols are approved by the IACUC for a period of up
to 365 days. Prior to the expiration date of the project, investigators are
notified that a short application for annual continuation must be
reviewed and approved by the IACUC before the protocol expires.
Protocols are considered for annual continuing review twice; i.e., at the
end of the first and second protocol year, before they must be
resubmitted for full committee review. All IACUC members receive a
list of all expiring protocols one month prior to the expiration date. Any
member of the IACUC may obtain, upon request, full committee review
of a project scheduled for annual continuing review. If full committee
review is not requested and no significant changes are noted on the
annual continuation application, a subcommittee of one (e.g., the
IACUC Chair or designee) reviews the project and has the delegated
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authority to approve, require modifications or refer the submission for
full committee review. A list of protocols scheduled for annual review in
the upcoming month is included in each month’s meeting agenda and
appended to the IACUC meeting minutes. Any IACUC member can call
for Full Committee Review of any protocol scheduled for
annual/continuing review.
If an investigator wishes to continue animal use beyond the end of the
third year, a new protocol application must be submitted, reviewed and
approved as described above (Section 2.I.B.1.b.i) prior to expiration of
the original or preceding protocol (de-novo review). If the de-novo
protocol is not reviewed and approved prior to the preceding protocol
expiration date, all animal use must cease and may not resume until a
new protocol approval is in place. De novo review is required of all
protocols after three years, regardless of the source of funding.
b. Describe the process and frequency with which the Committee reviews the
animal care and use program and conducts facility and laboratory inspections.
Detail any criteria used for exempting or varying the frequency of reviewing
satellite holding facilities and animal use areas. If contract facilities or
contractor-provided personnel are used, describe procedures used by the
IACUC/OB to review such programs and facilities. Note: A copy of the last
report of these reviews should be included as an appendix.
The IACUC meets twice per year outside of regularly-convened
meetings to review the Institutional Program for Humane Care and Use
of Animals, using the Guide for the Care and Use of Laboratory
Animals, PHS Policy and Code of Federal Regulations as a basis for
the review. A checklist based on the Sample OLAW Program and
Facility Review Checklist is also used to facilitate the evaluation. The
evaluation typically includes a review of IACUC membership and
functions, records and reporting requirements, husbandry and
veterinary care, personnel qualifications and training, occupational
health and safety and disaster planning.
Facility inspections are performed in May and November of each year.
Subcommittees of the IACUC consisting of at least two voting members
visit all facilities where vertebrate animals are housed or used; i.e.
holding areas, animal care support areas, storage areas, procedure
areas and laboratories where animal manipulations are conducted.
(Note: Laboratories where animals are used in non-surgical/noninvasive procedures but not housed (as delineated in 9CFR and the
PHS Policy) may be visited once per year. The site-visit
subcommittees take full advantage of the opportunity to interface with
research personnel, review approved procedures, make
recommendations and hear investigator concerns.
If deficiencies are noted either during the Program Review or Facility
Inspections, they will be categorized as significant or minor and the
Committee will develop a reasonable and specific plan and schedule for
correction.
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c.
Describe institutional responses to deficiencies noted on regulatory inspection
reports (e.g., government, regulatory agencies). Note: Copies of all such
inspection reports for the past three years (if available) should be available for
review by the site visitors.
USDA-APHIS Inspection Report dated June 7, 2011 noted significant
cracking and chipping of floor surfaces in the cage-wash area of one
vivarium facility. A correction date of September 7, 2011 was assigned
for correction of the deficiency. The floor was completely replaced prior
to the correction date.
d. Describe other monitoring mechanisms or procedures used to facilitate
ongoing protocol assessment and regulatory compliance.
The IACUC’s monitoring and outreach program involves a variety of
oversight activities to assure animal welfare and compliance with
approved protocols, including:
- Centralized animal ordering and tracking of animal numbers
- Regular veterinary rounds to observe animals, particularly following
invasive procedures.
- Periodic veterinary review of medical records
- Regularly-scheduled facility inspections
- Periodic re-inspection of approved activities performed in follow-up to
routine facility inspections
- Enhanced veterinary oversight as requested by the IACUC at the time
of initial protocol review.
- For-cause protocol review by the IACUC in response to animal welfare
concerns or reports of possible non-compliance.
II. Animal Environment, Housing and Management
Note: Complete each section including where applicable, procedures performed in farm
settings, field studies and aquatic environments, etc.
A. Animal Environment
1.
Temperature and Humidity [Guide, pp. 43-45]
a.
Describe briefly the heating and air conditioning system performance. Provide
method and frequency for assessing, monitoring, and documenting animal
room or housing area temperature and humidity that is appropriate for each
species. Note current (measured within the last 12 months), detailed (by room)
performance data are to be provided as indicated on the enclosed Heating,
Ventilation, and Air Conditioning (HVAC) System Summary appendix. If
outdoor housing areas are used, so note.
Room high and low temperature and current humidity are observed and
recorded daily for each animal housing room. Observations are
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recorded on individual room maintenance sheets by the husbandry
staff. Current room ventilation data is provided in Appendix #10. This is
assessed once every three years by ULAR husbandry or facility HVAC
personnel using a balometer and assessing air pressure differential at
the room entry door. Within the past 3 years most of the animal facilities
had an HVAC air balancing update performed. In addition, many of the
animal facilities are continually monitored centrally by physical plant
personnel. If temperatures vary outside ranges defined in the Guide,
alarms are activated in central plant to alert staff 24 hours per day.
b. If temperature set points and/or environmental conditions are outside the
thermoneutral zone for the species, describe the process for ensuring
behavioral thermoregulation (e.g., nesting material, shelter, etc.) and/or
IACUC/OB approved exception.
Rats for one researcher are held at 6ºC for 8 weeks. This is part of an
approved IACUC protocol to induce cold stress. Rats are pair housed
and provided with “crinkled paper” for nesting. Rats’ health is monitored
daily, weight 3 times per week, and blood pressure once weekly.
2.
Ventilation and Air Quality [Guide, pp. 45-47]
a.
Briefly describe the performance aspects of the ventilation system. Provide
method and frequency for assessing, monitoring, and documenting the animal
room ventilation rates and pressure gradients (with adjacent areas). Note:
current (measured within the last 12 months) detailed (by room) information is
to be provided as indicated on the enclosed Heating, Ventilation, and Air
Conditioning (HVAC) System Summary appendix.
Ventilation in the animal rooms is 100% non-recirculated (with the
exception of 4 rooms noted in c below), course-filtered fresh air,
maintained within 2ºF of the temperature set point. Animal housing and
cage wash rooms are ventilated to maintain a minimum of 10 ACH with
procedure rooms at a minimum of 6 ACH. Differential air pressure is
balanced for each room as positive to exclude (i.e.: clean cage wash
and many transgenic mouse holding rooms) or as negative to retain
possible pathogen spread (i.e.: necropsy rooms, biohazard rooms,
soiled cage wash). Upon request, UCI Facilities Management adjusts
the animal room ventilation rates and/or pressure gradients.
b. Describe ventilation aspects of any special primary enclosures using forced
ventilation.
The majority (95% +) of mice and a small percent of rats are housed in
individually ventilated cages. The caging systems include HEPA-filtered
supply air to each cage and either HEPA-filtered exhaust air (which in
most rooms is vented into the building exhaust) or is directly vented into
the building exhaust without being HEPA filtered. Most of the cages are
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operated as positive pressure, with cages in ABSL2 areas operated as
negative.
c.
If any supply air used in a room or primary enclosure is recycled, describe the
percent and source of the air and how gaseous and particulate contaminants are
removed.
4 rooms in McGaugh Hall house reptiles that require a warmer
temperature. In order to maintain the warmer temperature, these rooms
utilize a recirculating system that maintains 10 ACH, but 65-75% of this
air is recirculated back into the room of origin.
3.
Life Support Systems for Aquatic Species [Guide, pp. 84-87]
Provide a general description of institutional requirements for enclosures using
water as the primary environmental medium for a species (e.g., aquatics). Describe
overall system design, housing densities, and water treatment, maintenance, and
quality assurance that are used to ensure species appropriateness. Please note that
facility-specific tank design and parameter monitoring frequencies should be
summarized in the Aquatic Systems Summary appendix.
Various aquatic housing systems are used at UCI, including simple static
tanks and re-circulating aquatic housing systems.
For ULAR-maintained aquatic species (currently limited to amphibians),
ULAR has Standard Operating Procedures for husbandry of the different
amphibian species. These SOPs include water quality parameters, water
treatment specifications, quality assurance procedures, stocking densities
etc. Laboratories that provide husbandry for their aquatic animals are also
required to have written SOPs describing the husbandry, water quality
parameters, quality assurance procedures, stocking densities etc.
UCI IACUC has a policy on the Care and Use of Ectothermic Vertebrates,
which includes some general guidance for housing aquatic vertebrates.
4.
Noise and Vibration [Guide, pp. 49-50]
Describe facility design features and other methods used to control, reduce, or
prevent excessive noise and vibration in the animal facility.
Service areas are located away from the animal rooms. Noisy species such
as cats and pigs are housed as far away as possible from rodents. If
repairs or construction is required within an animal facility, attempts are
made to relocate animals away from the noise and activity associated with
such work.
B. Animal Housing (All terrestrial, flighted, and aquatic species)
1.
Primary Enclosures
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Provide a description of primary enclosures used (e.g., cages (conventional,
individually-ventilated cage systems (IVCS), etc.), pens, stalls, pastures, aviaries,
tanks) in appendix.
a.
Describe considerations, performance criteria and guiding documents (e.g.
Guide, Ag Guide, ETS 123 and/or other applicable standards) used by the
IACUC/OB to verify adequacy of space provided for all research animals,
including traditional laboratory animal species, agricultural animals, aquatic
species, and wildlife when reviewing biomedical, field and agricultural
research studies.
For all animal studies the Guide is used to ensure all animals are
provided with adequate space.
b. Describe space exceptions to the guiding documents (Guide, Ag Guide, ETS
123, and/or applicable standards), indicating the references, considerations and
performance criteria used (e.g., by the IACUC/OB) to verify adequacy of
space provided for all animal species covered by the program. [Guide, pp. 5563]
Performance criteria are used in determining space requirement in
certain instances. For mice, we have determined that it is acceptable to
have more than one litter at a time in a cage as long there are no more
than 14 pups total and all pups are within 5 days of age. For rats with
litters, our cages are 144-147 in2. We typically leave the male in with the
nursing female so the male does not need to be single housed. Our rat
breeding is typically mutant or transgenic rats, and litter size typically is
in the 4-8 pups per liter range. In certain studies, rabbits may be held in
cages that are 15.25” in height. In these cages, the ears do not touch
the top of cage during normal postural movements of the rabbits.
2.
Environmental Enrichment, Social and Behavioral Management [Guide, pp.
52-55; 63: Ag Guide, Chapter 4]
a.
Enrichment
i.
Describe the structural elements of the environment of primary enclosures
that may enhance the well-being of animals housed (e.g. resting boards,
privacy areas, shelves/perches, swings, hammocks, etc.).
Most rodents are housed on contact bedding, which allows
expression of species-typical behaviors such as digging. Some
rodent cages are equipped with elevated resting areas or “lofts”
within the cage. Group-housed cats are provided with multilayered
shelves for climbing and resting. Most birds are housed in large
outdoor flight cages with multiple perches, swings and nest boxes.
Birds housed in smaller cages have perches. Xenopus frogs have
privacy areas (PVC tubes).
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ii. Describe nonstructural provisions to encourage animals to exhibit
species-typical activity patterns (e.g., exercise, gnawing, access to pens,
opportunity for exploration, control over environment, foraging, denning,
burrowing, nesting materials, toys/manipulanda, browsing, grazing,
rooting, climbing).
Mice have nesting material. Rats have paper towels for shredding,
and may have Nyla-bones or wooden tongue depressors for
gnawing. Rabbits have PVC pips, plastic chains or balls and hay.
Pigs have sanitizable toys such as Kong toys or plastic balls, as
well as brushes attached to the pen walls for rubbing and
scratching their skin. Group housed cats have large multilevel
shelves for climbing, as well as various toys and scratching
materials. Birds housed in outdoor flight cages have opportunities
for nesting and foraging.
b. Social Environment [Guide, p. 64]
i.
Describe institutional policy or strategy for social housing of social
species.
The policy for social housing of social animals is incorporated into
the following IACUC policy on environmental enrichment: “In
compliance with Federal Animal Welfare Regulations and guidance
and in consideration of the physical and social needs of research
animals the IACUC requires that appropriate environmental
enrichment be provided to standard animal housing unless there is
scientific justification, approved by the IACUC that precludes the
use of environmental enrichment materials or practices.” Most
animals are group-housed if compatible.
ii. If social animals are not socially housed, provide justification, as approved
by the IACUC/OB.
Although the default is to group-house most species when
compatible, social species may be single-housed for various
reasons, including:
1. Possible interference with instrumentation such as cranial
implants
2. Requirement to house individually in metabolic cages
3. During post-operative recovery
4. Due to lack of appropriate caging large enough for grouphousing (rabbits). We are working on implementing group
housing of female rabbits.
5. Adult male mice that are not littermates or that have been used
for breeding cannot be group-housed due to excess aggression.
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6. Adult male rabbits cannot be groups housed due to aggression;
similarly, male mice of known aggressive strains e.g. SJL or
Tg2576 cannot be group housed.
iii. Describe steps taken with isolated or individually housed animals to
compensate for the absence of other animals (e.g., interaction with
humans, environmental enrichment, etc.).
Single-housed rodents and rabbits are provided with nesting
material (rodents) and toys (rabbits). Most single-housed rats are
housed in open-topped wire-bar lidded cages, which allow them to
hear and smell other rats. Rabbits are housed in cages that allow
them to see, hear and smell other rabbits.
c.
Procedural Habituation and Training of Animals [Guide, pp. 64-65]
Describe how animals are habituated to routine husbandry or experimental
procedures, when possible, to assist animals to better cope with their
environment by reducing stress associated with novel procedures or people.
Animals arriving at UCI are required to undergo an acclimatization
period prior to being used for experimentation. This allows animals to
habituate to the new environment and the routine husbandry
procedures. For rodents, the acclimatization period is 48 hours. For
rabbits and larger animals, the acclimatization period is 72 hours.
Animals used in behavioral testing paradigms typically undergo a
training period to habituate them to the testing apparatus and
procedure. Positive reinforcement such as food treats and positive
human interactions are generally used to condition the animals to the
testing environment.
d. Enrichment, Social and Behavioral Management Program Review [Guide,
pp. 58, 69]
Describe how enrichment programs and exceptions to social housing of social
species are regularly reviewed to ensure that they are beneficial to animal wellbeing and consistent with the goals of animal use.
The IACUC’s environmental enrichment policy is reviewed periodically
by the committee and ULAR veterinarians. Housing exceptions,
including requests for single housing of social species or requests to
withhold standard enrichment items, are reviewed at the time of de
novo protocol review.
e.
Sheltered or Outdoor Housing [Guide, pp. 54-55]
i.
Describe the environment (e.g., barn, corral, pasture, field enclosure, flight
cage, pond, or island).
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Finches are housed in large outdoor flight cages constructed of
pipe and wire mesh. The flight cages have cement floors and
multiple perches. Nesting boxes and nesting material (grass and
feathers) is provided.
ii. Describe methods used to protect animals from weather extremes,
predators, and escape (e.g., windbreaks, shelters, shaded areas, areas with
forced ventilation, heat radiating structures, access to conditioned spaces,
etc.).
The flight cages are partially sheltered and thermostatically
controlled heaters are used to protect the animals from weather
extremes. Birds can shelter from wind, sun and rain. In really cold
weather, birds can be confined in the sheltered portion of the flights
if necessary. A double mesh ceiling protects finches from
occasional raptors.
iii. Describe protective or escape mechanisms for submissive animals, how
access to food and water is assured, provisions for enrichment, and efforts
to group compatible animals.
Food and water are provided ad libitum in the flight cages, in
multiple containers large enough to allow many birds to access
them at the same time. The flights are large (40 feet x10 feet x 7.5
feet) and the birds are small, so subordinate individuals can easily
avoid more dominant ones. Enrichment is provided by social
housing and opportunities for species-typical behaviors such as
nesting, breeding, allopreening, sunbathing, and foraging within the
flight cages.
f.
Naturalistic Environments [Guide, p. 55]
i.
Describe types of naturalistic environments (forests, islands) and how
animals are monitored for animal well-being.
UCI does not perform studies that require naturalistic environments
such as pastures or islands. However, the IACUC has approved a
protocol that allows rats to be placed in a “naturalistic” setting that
allows the animals to perform behaviors such as digging and
foraging for food. The protocol allows for housing rats in 6-ft.
diameter soil-filled troughs covered with wire mesh. The rats are
then allowed to burrow within the soil. The animals are checked
daily by laboratory personnel, water and food changed daily, and
the soil changed between cohorts. The apparatus is located in
existing animal facilities or within laboratory room, and proved
controlled lighting and ventilation per recommendations of the
Guide.
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ii. Describe how food, water, and shelter are provided.
Food is supplied in feed hoppers that are moved daily to force
animals to forage for food.
iii. Describe how animals are captured.
Animals are hand-captured at the completion of each experiment.
C. Animal Facility Management
1.
Husbandry
a.
Food [Guide, pp. 65-67]
i.
List type and source of food stuffs.
Mammals are fed research-grade commercial diets from either
Purina Lab-Diet through Newco Distributors or Harlan Teklad.
Some investigators purchase special diets that satisfy specific
research protocols after review and approval by ULAR and/or
IACUC, as appropriate. At the aviary, the principal food type is a
commercial seed mix designed for finches and budgies purchased
from Magnolia Bird Farm. Cuttlebone and oyster shell are added for
calcium and minerals. Fresh food such as hard boiled hen’s egg or
a mixture of cooked rice and raw peas are provided to the birds on
a regular schedule. Alligators and snakes are fed a variety of food,
including: chicken (purchased from local supermarkets, either cut
into appropriately-sized chunks, or ground in a commercial meat
grinder), commercial pellets, or whole rodents (previously
euthanized by CO2 inhalation) or occasionally, to assist newly
hatched or sick animals, crickets. Adult axolotls are fed pellets and
brine shrimp larvae. Frogs are provided frog pellets (Nasco or
Rangen, Inc) and/or live bloodworms. Zebra fish are fed either brine
shrimp or Silver Cup Zebrafish Food from Aquatica Tropicals.
ii. Describe storage facilities of vendors, noting temperature and vermin
control measures. If more than one source, describe each.
The majority of animal feed is purchased from either Purina Labdiet through Newco Distributors or Harlan Teklad. Newco is an ISO
9001:2000 certified company and a Purina Mills Certified Lab
Dealer. Laboratory diets are stored in an environmentally controlled
(temperature maintained at 72°F) and monitored room within in a
60,000 SF cement building. All materials are stored on pallets off
the floor and feed is rotated to assure freshness, usually within a
one-week period. Feed is manufactured exclusively in the Purina
Mills ISO 9001:2000 Richmond, Indiana facility. No antibiotics,
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synthetic estrogen, or other such chemicals enter the facility. Only
FDA and AAFCO approved feed additives for feed nutritional uses
are permitted in the facility. Both Purina Mills and Newco
Distributors, Inc. have certified pest control services for their
facilities. Rodent control is accomplished with liquid bait stations on
the outside of the facility. Non-toxic glue boards are used in the
interior of the facility as well as pheromone traps for flying insects.
Further insect control is conducted by the certified pest control
service utilizing Pyrethrin/Piperonyl-Butoxide when necessary. For
Harlan Teklad, feed is shipped from Madison, WI to a local
warehouse. Both the manufacturing plant and warehouse are ISO
9001 certified. In this warehouse, feed is stored off the ground at
least 18” from the wall. The warehouse is inspected and cleaned
daily. Temperature is controlled to never exceed 70°F or 55%
humidity. Vermin control is accomplished through exclusion
barriers, sanitation, observation, and glue boards and pheromone
traps.
iii. Describe bulk food storage facilities, if applicable, noting temperature and
vermin control measures. Note food storage areas within the specific
animal facilities are described below in Section IV.B.4.a. Physical Plant.
Feed is delivered weekly. The mill dates are checked upon arrival
and stored to ensure first-in first-out in feed rooms within the animal
facility or a central storage building. Temperature in all of the
storage facilities is maintained at 68°-72°F and floors are swept and
mopped weekly. Vermin control is accomplished through exclusion
barriers, immediate sanitation of any spilled product, daily
observation for any sign of infestation, and use of baited spring
traps. On the north campus, bird seed is stored unopened at room
temperature until 3 days prior to use, at which time it is placed into
a freezer for 3 days. The freezing procedure kills immature forms of
moths and beetles that are frequently found in these seed mixtures,
but does not compromise the nutritional value of the seed and the
seed still germinates after treatment. The seed is then transferred
to lined, plastic garbage cans and used immediately.
iv. Describe food storage in animal rooms.
Feed is placed into plastic bins with plastic liners and tight fitting
lids. A label with the type of feed, mill date and date placed in the
animal room is attached to the bin.
v.
Describe food preparation areas.
N/A
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vi. Describe how food is provided to various species (ad libitum, limited
amounts, types of feeders).
Food is provided daily ad lib to most rodents with the exception of
animals being fasted or limit fed as part of a research protocol.
Most rodent food is placed in wire bar food hoppers; feed is placed
on the cage bottom for gerbils and occasionally for mice and rats.
Cats are fed for a 4 hour period each day. Pigs and rabbits are fed
a measured amount of diet to prevent excessive weight gain. In the
aviary, food is provided on the floor of the flights, in pans or bowls
that are generally set in larger containers to contain seed husks,
etc. Cuttlebone holders are mounted on the wall of flights. In bird
cages, food is provided in bowls on the floor of the cage, and
cuttlebone is mounted on the side of the cage.
vii. Describe special food quality control procedures including procedures for
rotating stock, monitoring milling dates, nutritional quality, bio-load,
chemical contaminants, etc.
Food is purchased from established reputable sources.
Responsibility is placed on the manufacturer and vendors with
regard to nutritional quality, bio-load or possibility of chemical
contaminants. The mill date is checked upon receipt. Food with the
oldest milling date is used first. No food in excess of six months
from the milling date is used. As the seed is not milled and the seed
coat is intact, the shelf life of commercial bird seed is quite long
when stored appropriately. Bags are dated upon receipt and older
seed is used before recently acquired seed. It is generally used
within six months of purchase. Seed that has become wet or is
moldy is discarded.
b. Drinking Water [Guide, pp. 67-68]
i.
Describe the water source, treatment or purification process, and how it is
provided to the animals (e.g., bowls, bottles with sipper tubes, automatic
watering, troughs, ponds, streams, etc.).
Water is obtained from the city of Irvine. It is potable water by state
health standards. No additional treatment or purification is provided,
unless required by a protocol or specially conditioned animals.
Water bottles are used in all facilities. They are monitored daily,
replaced as required and sanitized at least once a week. Immunocompromised animals and barrier mice receive water that has been
autoclaved. Automatic watering devices are used for pigs and most
of the rabbits. The automatic water systems employ particulate
filters (Edstrom) in Med Sci A. At UCIMC Bdg. 55, the automatic
water system utilizes UV light purification. At the aviary, water is
provided in plastic containers or glass bowls (in small cages only);
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all aviary water containers are currently hand-washed daily in hot
water and the water is changed daily.
ii. Describe methods of quality control, including monitoring for
contaminants.
The water within University buildings is sampled at least once a
month by Facilities Management and tested for alkalinity, iron
content, and amount of total dissolved solids contained in the
water. The Irvine Ranch Water District publishes a summary of
water quality testing annually and this document is reviewed by
ULAR veterinarians. In addition, ULAR performs in-house analysis
of drinking water for coliforms and total bacterial counts quarterly.
iii. If automatic water delivery systems are used, describe how they are
maintained and sanitized.
The water delivered into the automatic watering system is
disinfected via ultraviolet light. The automatic watering systems are
flushed monthly. For rabbits on automatic water system, the lixits
are sanitized along with the animal racks in our mechanical rack
washers. For pigs on automatic watering systems, the lixits are
sprayed with a high pressure hose during pen cleaning.
c.
Bedding and Nesting Materials [Guide, pp. 68-69]
i.
Describe type(s) and how used for various species.
The primary material used for contact rodent bedding is ground
corncobs purchased from Harlan Teklad. Sani-Chips, a hardwood
product or Alpha-dri, a paper product, is used for some rodents. All
rodent cages receive a measured amount of bedding in the clean
cage and the bedding is changed only when the cage is sanitized.
Sani-Chips are used for cat litter boxes and hardwood shavings are
used as bedding in the pig runs, and these are changed daily.
Recycled newspaper is used for the reptiles and finches. Noncontact paper liners are used for rabbits and are changed three
times per week.
ii. Describe bulk bedding storage facilities, if applicable, including vermin
control measures. Note bedding storage areas within the specific animal
facilities are described below in Section IV.B.4.a.
Bedding is stored in the storage room of each facility or in a central
storage building. The room is cleaned weekly and vermin control is
accomplished through exclusion barriers, immediate sanitation of
any spilled product, daily observation for any sign of infestation,
and use of baited spring traps.
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iii. Describe quality control procedures, including monitoring for
contaminants.
Bedding is rotated to prevent long term storage of a given bag.
Complete technical specifications and the quality control measures
for contaminants of the bedding products used are available from
the manufacturer. No local monitoring for contaminants is
performed.
d. Miscellaneous Animal Care and Use Equipment
i.
Describe motorized vehicles and other equipment (e.g., trailers) used for
transporting animals, noting the type and how the cargo compartment is
environmentally controlled, if applicable.
ULAR maintains three climate controlled vehicles for transport of
animals between animal facilities and nearby research institutes.
ULAR will authorize individual researchers to transport small
numbers of rodents between the main campus and the medical
center or nearby research institutes. Prior to authorizing a
shipment, a ULAR veterinarian reviews concerns related to
transportation. Such animals must be contained within a
commercial (filtered) transport box or a sealed microisolator cage.
The transport box or cage must be in a ventilated vehicle
compartment (i.e. not a trunk).
ii. Describe other animal care related equipment used in the animal care
program (e.g., specialized equipment for exercise or enrichment, high
pressure sprayers, vacuum cleaners, tractors, trailers, spreaders, etc.).
Floor scrubbers and high pressure sprayers are available.
e.
Sanitation [Guide, pp. 69-73]
i.
Bedding/Substrate Change
1) Describe frequency of contact and non-contact bedding change for
each species and enclosure type (solid-bottom or suspended) or pen.
SPECIES
Birds (multiple spp.)
Cat
Gerbil
Guinea pig
Hamsters
Mice
CAGE TYPE
Flight and wire cages
Runs/room
Solid bottom
Solid bottom
Solid bottom
Solid bottom
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FREQUENCY
2-3x weekly
Litter box changed daily
1x weekly
2-3x weekly
1-2x weekly
1-2x weekly (static)
Every 7-14 days
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Pig
Rabbit
Rat
Snakes
Runs
Suspended
Solid bottom
Glass & plastic aquaria
(ventilated cages)
Daily
3x weekly
1-2x weekly
Weekly
2) Describe any IACUC/OB-approved exceptions to frequencies
recommended in the Guide or applicable regulations and the criteria
used to justify those exceptions.
Individually ventilated mouse cages are normally changed once
every two weeks. If the cage is found to be excessively dirty or
wet before this time, it will be spot changed. Wire bars are
changed out once every month and filter tops are changed
once every three months. We have performed intercage
ammonia, moisture, and bacteria testing to show that during
this time, the intercage micro-environment does not change
appreciatively during this time.
3) Note the location where soiled bedding is removed from the
cages/enclosures and where clean bedding is placed into the
cages/enclosures.
Soiled bedding is removed in the “dirty” side of the cage washer
area; soiled bedding is emptied out of cages and pans into
waste receptacles. Fresh bedding is added to clean cages on
the “clean” side of this area. At the aviary, cages are changed
in place on the shelf where the bird resides to minimize
disturbance to the birds.
ii. Cleaning and Disinfection of the Micro- and Macro-Environments
Describe the washing/sanitizing frequency, and methods used in the
Appendix, “Cleaning and Disinfection of the Micro- and MacroEnvironment.”
1) Describe any IACUC/OB-approved exceptions to the Guide (or
applicable regulations) recommended sanitization intervals.
Individually ventilated mouse cages are normally changed once
every two weeks. If the cage is found to be excessively dirty or
wet before this time, it will be spot changed. Wire bars are
changed out once every month and filter tops are changed
once every three months. We have performed intracage
ammonia, moisture, and bacteria testing. Results indicated that
during this time the intracage micro-environment does not
change appreciatively.
2) Assessing the Effectiveness of Sanitation and Mechanical Washer
Function
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a) Describe how the effectiveness of sanitization procedures is
monitored (e.g., water temperature monitoring, microbiological
monitoring, visual inspections, etc.).
Water temperature is monitored by indicator tags, heat
sensitive tape and chart recorders for each cage/rack
washer. The heat sensitive tape is used in each washer
daily and this record is maintained in the cage wash area.
Additionally, the automatic soap dispensers in the
cage/rack washer area are serviced and monitored
quarterly. New cage washers will not complete the wash
cycle if rinse temperature fails to meet 180oF. Due to
insufficient steam delivery to several older buildings,
several washers do not reliably attain 180oF during the
rinse cycle. To achieve adequate sanitation, these units
are supplied with chlorinated detergent (GNRF, Bonney
Center, and McGaugh Hall). Luminometer testing of clean
cage components are performed monthly from each cage
washer. Autoclaves are monitored by means of continuous
recording charts, which are archived in the animal facilities
manager’s office, and by the use of indicator tape placed
on material in each load. Further, microbiological spore
testing is performed monthly on all ULAR autoclaves.
Water is monitored quarterly by analyzing water samples
taken at the bottling source for microorganisms growth on
agar plates.
b) Describe preventive maintenance programs for mechanical
washers.
Tunnel and Rack Washer Maintenance: Daily checks and
cleaning of spray header jets and stainless steel filter
screens before start of operations. At the end of operation,
drain cycle is initiated to empty re-circulating tanks. Weekly
de-scaling cycle is activated to prevent excessive build up
of hard water scale deposits.
f.
Waste Disposal [Guide, p. 73-74]
Describe the handling, storage, method and frequency of disposal, and final
disposal location for each of the following:
i.
Soiled bedding and refuse
In the Gillespie and McGaugh facilities, cages are dumped into a
down-drafted Garbel-style disposal adjacent to the tunnel washer,
with the dirty bedding being disposed of in the sanitary sewer
system. In the Bio Sci III facility, the cages are dumped in a vacuum
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removal system, with the dirty bedding going into an enclosed
dumpster. In Med Sci A and UCIMC bldg 55, cages are dumped
into plastic lined garbage cans within a HEPA-filtered dump station.
In the Bonney Center the cages are dumped in the open. Bedding
is then transported to a dumpster located outside the building.
Dumpsters are emptied as needed and waste transported to a
sanitary landfill by an outside contractor.
ii. Animal carcasses
With the exception of pigs, all animal carcasses, including
biohazardous and chemically contaminated, are handled as
Pathological Waste. They are placed within plastic bags, sealed,
and placed in a designated freezer or cold-box located in each
animal facility. Carcasses are then removed by EH&S and disposed
of by a certified incineration company. Pig carcasses are shipped to
a rendering plant.
iii. Hazardous wastes - infectious, toxic, radioactive, sharps and glass
Dirty biohazardous rodent cages with bedding are autoclaved and
then the dirty bedding is bagged and stored in a cold box. Disposal
is handled by EH&S utilizing a local, certified biohazard waste
vendor. Chemically contaminated bedding is handled as
pathological waste and is incinerated. Contaminated carcasses,
cages with dirty bedding, and other supplies classified as ABSL-3
are bagged within the ABSL3 holding room or laboratory and then
decontaminated by a certified autoclave in Hewitt Hall. Radioactive
animal carcasses and bedding material are handled as radioactive
wastes under the direction of EH&S and collected by an EH&S
technician. They are then stored frozen at EH&S facilities until
radioactivity has decayed sufficiently for disposal as a nonradioactive waste, or until packed in an approved manner for
transport by an outside contractor to an NRC licensed disposal
facility.
g.
Pest Control [Guide, p. 74]
i.
Describe the program for controlling pests (insects, rodents, predators,
etc.) noting the control agent(s) used, where applied, and who oversees the
program and applies the agent(s). Include a description of natural
predators (e.g., barn cats) or guard animals (e.g., dogs, donkeys) used for
pest and predator control, if applicable.
Major emphasis for controlling vermin is focused on good sanitary
practices, eliminating breeding and refuge sites, and maintaining
facilities to prevent vermin entry. Facilities are monitored for wall,
ceiling or floor cracks. Any damaged area is immediately reported,
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and a work order is submitted to building management for repair.
Doors are equipped with self-sealing sweeps. University Facilities
Management maintains baited rodent stations on the exterior of
buildings and within landscape areas to control wild rodents. When
a feral rodent is identified within an animal facility, attempts are
made to capture the escaped animal. If these efforts are
unsuccessful, baited spring traps and/or glue traps may be
employed by ULAR personnel. We have identified rodent issues,
either feral or wild, in laboratory areas of several buildings. Where
identified, various types of live traps and/or baited spring traps have
been used, placed by research staff and/or facility personnel.
Occasional infestations of crickets have been noted in several
facilities. Control is through the use of sticky traps and chemically
treating exposed drains with “Fly Away”, which is a surfactant
without any pesticides.
ii. Note how animal users are informed of pesticide use and how animal users
may opt out of such use in specific areas.
No pesticides are used.
h. Emergency, Weekend and Holiday Care [Guide, pp. 74-75]
i.
Describe procedures for providing weekend and holiday care. Indicate
who (e.g., regular animal care staff, students, part-time staff, etc.) provides
and oversees care and what procedures are performed. Indicate
qualifications of weekend/holiday staff if not regular staff.
ULAR regular husbandry staff share responsibilities for weekend
care of the animals on a rotating weekend basis. All animals are
observed on a daily basis, checking animal health and cage
condition and ensuring the availability of food and water. On
weekends, rodent and rabbit cages are changed or cleaned as
needed. Cat rooms and pig runs are cleaned daily, including
weekends. For investigator maintained animals, the investigator’s
staff is responsible for providing daily care and feeding. The IACUC
requires that a daily log be maintained on all animal housing rooms,
including investigator maintained rooms to ensure all animals are
checked daily.
ii. Describe procedures for contacting responsible animal care and/or
veterinary personnel in case of an emergency.
ULAR veterinarians and ULAR supervisors provide after-hours
coverage on a rotating basis. Personnel can be reached at all
times by calling a phone tree number, which will direct the caller to
on-call staff. Signage with instructions for contacting personnel for
after hour emergency care is posted in all animal facilities.
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2.
Population Management [Guide, pp. 75-77]
a.
Identification
Describe animal identification methods for each species (e.g., microchips,
cage/tank cards, collars, leg bands, tattoo, ear tags, brands, etc.).
Cards are placed on cage fronts in metal and plastic card holders for all
animals. For purchased animals, information contained on the cage
cards includes the following: investigator’s name, protocol (IACUC)
number, laboratory contact name and phone number, vendor name,
Purchase Order number, species, strain, date of arrival, the animal’s
DOB or weight upon arrival, and sex. Some of this information will not
be present on the cage card for animals that were bred at UCI. For
rodents, typically there will be only one cage card per cage. If an
investigator wants the individual rodent ID’d, it is their responsibility to
perform this after review and approval of method of identification in the
IACUC protocol. Various means are utilized, including ear punches, ear
tags, toe or tail tattoos, microchips, and distal toe clipping. At the aviary,
each bird wears a uniquely numbered leg band; most birds also have
unique color band combinations. For caged birds, bird identification is
listed on cage cards, which are placed on the front of the bird cages.
The cage card also lists the purpose of housing the bird in a cage (e.g.,
the name of a particular experiment), and the birds’ sex (when known).
In addition to cage cards, rabbits, cats, and pigs have either a tattoo ID
number or an ear tag for identification.
b. Record Keeping
Describe procedure(s) for maintaining individual records on animals. Identify
the species for which individual records are maintained, individuals (titles, not
necessarily names) responsible for maintaining the records, and where they are
maintained and how veterinary and IACUC/OB access is assured.
All incoming shipments of animals are entered into an in-house
database. ULAR maintains individual records for cats and on other
individual animals when illness occurs or if individual medical therapy is
provided by Veterinary Services staff. Such records are maintained by
Veterinary Services, either as a hard copy or in an electronic database.
Investigators are responsible for maintaining individual procedure
records, including surgery, anesthesia, and post-operative monitoring.
These records are to be kept on file in their laboratories, but must be
available to ULAR and IACUC on request. Such records are periodically
reviewed by the IACUC during laboratory visits.
c.
Breeding, Genetics and Nomenclature
i.
Describe the program for advising investigators on the selection of
animals based on genetic characteristics.
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Investigators may request assistance from the campus veterinarian
on selection of particularly suitable genetic stocks or may be
required to do so by the IACUC. Relevant publications are
maintained in the ULAR offices and are available to investigators.
ii. Describe the program for advising investigators on using standardized
nomenclature to ensure proper reporting of the identification of the
research animals with regard to both the strain and substrain or the genetic
background of all animals used in a study.
Investigators that propose to create or maintain breeding programs
(i.e.: genetically modified rodents) must describe their record
keeping system, nomenclature and method of identifying animals in
the IACUC protocol. Investigators seeking guidance on proper
nomenclature for identifying genetically modified strains are
directed to information hosted on the Jackson Laboratory web site.
Investigators may also consult with ULAR veterinarians and
personnel in the Transgenic Mouse Facility.
iii. For newly generated genotypes, describe how new phenotypes that
negatively impact well-being will be monitored, managed and reported to
the IACUC/OB in a manner to ensure the animals’ health and well-being.
As part of the IACUC protocol, the researcher is asked to discuss
the phenotypic abnormalities that may be present in the animals.
This explanation must include possible clinical signs and
symptoms, monitoring parameters, management plan, frequency
and documentation of monitoring, and euthanasia criteria. These
parameters may vary depending on the genotype, severity of
phenotype, and nature of the research. The IACUC then considers
whether modifications to the proposed plan need to be
implemented in order to ensure the animals’ health and well-being
before approving the protocol.
III. Veterinary Care [Guide, pp. 105-132]
Note: Complete each section, including, where applicable, procedures performed in farm
settings, field studies, aquatic environments, etc.
A. Animal Procurement and Transportation [Guide, pp. 106-109; Ag Guide, pp. 8; 45;
51-57]
1.
Animal Procurement
Describe the method for evaluating the quality of animals supplied to the institution
(e.g., from commercial vendors, other institutions, etc.).
To ensure consistent quality of animals, acquisition (purchase or transfer) of
research animals is coordinated by the ULAR office. Most of the rodents
used at UCI are purchased from commercial vendors that breed animals
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specifically for use in research and teaching. These vendors perform
regular examinations of their production stock, including testing the animals
for the common infectious agents of each species. Test results are
reviewed by ULAR regularly and vendors that consistently meet ULAR's
standards are placed on an approved vendor list. Animals from these
approved vendors can be introduced directly into UCI animal facilities.
Rodents from unapproved sources, such as non-commercial vendors, other
universities, government agencies, and commercial vendors with
inadequate health assurance information are placed directly into one of two
quarantine rooms located in McGaugh Hall. Prior to accepting rodents into
quarantine, the health history from the sending institution is reviewed. If no
health concerns are identified, the animals are accepted. If there are health
concerns, the animals must be rederived either at the sending institution or
here at UCI. If the rederivation will be performed at UCI, the animals will be
brought into an isolation facility in Steinhaus Hall.
2.
Transportation of Animals
Describe how animals are transported between outside sources and the institution
and within the institution, including loading, unloading, level of biosecurity,
immune status and specific pathogen status (consider all species, including aquatic
and semi-aquatic species).
Mammals are transported to UCI directly by the vendor, a commercial
carrier selected by the vendor, or by USDA-licensed transporters. The
majority of amphibians, reptiles and avian species (i.e.: chicks) are sent by
express mail to the university. Some reptiles (alligators from Louisiana) are
transported by private vehicles driven by UCI research personnel after
obtaining special permission from ULAR and/or the IACUC. Upon delivery,
the shipment is inspected by ULAR personnel for any visible external
damage and brought into the facility. If the animals are contained within a
shipping box, the outside of the box is sprayed with facility approved
disinfectant in the receiving area before unpacking the animals in the animal
holding room.
ULAR maintains three climate-controlled vehicles for transport of animals
and supplies between animal facilities and nearby research institutes. All
cages, whether being transported by ULAR or research staff, must be
covered when taken out of the animal facility so other personnel cannot see
that an animal is being transported. Infrequently, ULAR will authorize
individual researchers to transport small numbers of rodents between the
main campus and the medical center or nearby research institutes. Prior to
authorizing a shipment, a ULAR veterinarian reviews concerns related to
transportation. Such animals must be contained within a commercial
(filtered) transport box or a sealed microisolator cage. The transport box or
cage must be in a ventilated vehicle compartment (i.e. not a trunk).
B. Preventive Medicine
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1.
Animal Biosecurity [Guide, pp. 109-110]
a.
Describe methods used to monitor for known or unknown infectious agents.
A rodent sentinel program is maintained by ULAR. Serological testing,
parasitology, and when indicated from gross necropsy, histological
examination of tissues are performed on sentinel rodents from each
room quarterly. Sentinel mice and rats are bred within the sentinel cage
or purchased by ULAR and are placed in all long-term, non-biohazard
rodent rooms. When cages are changed, soiled bedding from colony
animals is placed into the sentinel animal cages. Animals are
necropsied at UCI and sera submitted for testing at RADIL. Additional
testing includes examination of the pelt for ectoparasites, and gross
examination of cecal contents and perianal tape test to identify enteric
parasites.
b. Describe methods used to control, contain, or eliminate infectious agents.
Animals suspected of, or infected with unwanted infectious agents are
promptly removed via euthanasia or movement into the isolation facility
in Steinhaus Hall, or the housing room is placed under quarantine to
reduce exposure and possible disease spread to the general animal
facility population. Veterinary Services notifies affected research
personnel immediately and provides necessary training. Appropriate
isolation equipment (gowns, shoe covers, etc.) is provided immediately
outside the quarantined housing room. Depending on the infectious
agent, additional testing may be instituted to determine the extent of the
problem and a treatment or eradication plan developed and
implemented after discussion with the affected researcher(s).
2.
Quarantine and Stabilization [Guide, pp. 110-111]
a.
Describe the initial animal evaluation procedures for each species.
Animals are received at the designated receiving area at each animal
facility. Rodent shipping containers are sprayed with a disinfectant prior
to opening each box. As animals are transferred from shipping
containers into holding cages, technicians observe for abnormalities
and overt signs of disease. Any abnormalities are brought to the
attention of the veterinary staff and the decision to accept or reject the
animal is made at that time.
b. Describe quarantine procedures for each species that are purpose bred.
All rodents originating from unapproved sources must be quarantined
prior to release into the general population. Animals typically remain in
quarantine for 7-8 weeks. The rodents are placed on fenbendazole
medicated feed for endoparasites and treated topically with selamectin
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for ectoparasites while in quarantine. Sentinels that have been placed
with the shipment undergo testing (serology and parasitology) for a
number of rodent infectious agents. Alternatively, the animals may be
PCR tested immediately upon arrival via fecal pellets, oral and pelt
swabs. Animals testing positive for excluded agents are either
sacrificed or rederived prior to being released to animal facilities on
campus. Bringing rodents directly into a researcher’s laboratory is
allowed if the animals will be euthanized immediately upon arrival and
the researcher has both IACUC and ULAR approval.
The purchase of larger species such as cats, rabbits and swine is from
Class A vendors and to a lesser degree from other universities. To limit
the possibility of introduction and spread of infectious disease, the
number of approved vendors is limited and normally animals from only
one vendor are allowed in an animal facility at any one time. These
animals are not normally quarantined.
c.
Describe the quarantine facilities. In your description explain any special
measures used for quarantine/conditioning of each random source (not bred
and raised specifically for research) species used.
There are two rooms in McGaugh Hall that are used for quarantine of
mice. Each room is managed as all-in/all-out. When rats arrive that
need quarantine, a room is assigned for this.
Random source species used at UCI include several avian species
(finches, parakeets, chickens), fish (goldfish, zebra fish), amphibians
(axolotls, Xenopus spp., Rana spp., Bufo marinus) and reptiles (snakes,
turtles and alligators). Due to space limitations, separate quarantine for
each of these species is not possible. However, the number of vendors
providing these species is generally limited to one or two sources, and
whenever possible one group of animals is depopulated prior to
introduction of the next group. In addition, for birds, newly purchased
animals are separated for several weeks from resident birds to allow
clinical assessment for signs of disease. New zebra fish being brought
in are kept in isolation tanks, and after eggs are produced, the eggs are
disinfected and then allowed into the general tanks.
d. Describe the required/recommended stabilization period for each species.
Rodents and non-mammalian vertebrates: Rodents and nonmammalian vertebrates such as birds, amphibians and reptiles must
have a minimum acclimation period of 48 hours before undergoing any
survival procedures. For terminal procedures, an acclimation period is
not required. Other mammals: Non-rodent mammals must have a
minimum acclimation period of 72 hours before undergoing survival
procedures. In addition, before undergoing any research procedures,
animals must appear healthy with normal appetites and normal other
bodily functions. For terminal research procedures, an acclimation
period of 72 hours is recommended to ensure the validity of research
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results. For terminal training procedures, an acclimation period is not
required.
e.
Describe the program for the separation of animals by species, source, and
health status. If the animals in different status are not maintained separately,
describe circumstances in which mixing occurs and explain the rationale for
mixing.
Animals are separated by species by housing different species in
separate rooms or in separate cubicles within a room. In rodent rooms,
animals from different sources are likely to be in the same room. For
larger species, normally only one source for each species is used. The
IACUC has approved an exception to this in Irvine Hall where rats and
mice are maintained in a single animal holding room. (See 3.b. below)
3.
Separation by Health Status and Species [Guide, pp. 111-112]
a.
Describe isolation procedures and related facilities for animals.
Animals suspected of, or infected with unwanted infectious agents are
promptly removed via euthanasia or movement into the isolation facility
in Steinhaus Hall, or the housing room placed under quarantine to
reduce exposure and possible disease spread to the general animal
facility population. Veterinary Services notifies affected research
personnel immediately and provides necessary training. Appropriate
isolation equipment (gowns, shoe covers, etc.) is provided immediately
outside the quarantined housing room. Depending on the infectious
agent, additional testing may be instituted to determine the extent of the
problem and a treatment or eradication plan developed and
implemented after discussion with the affected researcher(s).
b. Describe situations where multiple species may be housed in the same room,
area, or enclosure.
Irvine Hall has one animal housing room with both rats and mice
maintained in the same animal holding room. The researchers in this
building routinely do studies requiring the close proximity of animals to
their labs. The mice in this room are maintained within positively
ventilated cages with the cage exhaust directly ventilated out of the
room, thus minimizing exposure to rat pheromones.
4.
Surveillance, Diagnosis, Treatment and Control of Disease [Guide, pp. 112-113]
a.
Describe 1) the procedure(s) for daily observation of animals for illness or
abnormal behavior, 2) the observer’s training for this responsibility, and 3)
method for reporting observations (written or verbal). Include a description of
the method for ensuring that reported cases are appropriately managed in a
timely manner.
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All animals are observed daily by ULAR husbandry staff or trained
research staff. ULAR employees are instructed on the basic
methodology for the care and maintenance of animals using on-the-job
training. Abnormal animal appearance and behavior is discussed at
least once per year at the general staff training sessions. The animal
room husbandry log contains a daily check box for observation of health
of animals. For investigator maintained animals, all research personnel
are trained by the Principal Investigator (PI) and ULAR to recognize
sick or injured animals and to report injuries to the PI and to vet
services. All animals, including investigator maintained, are checked
every day, including weekends and holidays. Animals found showing
signs of injury, illness or other abnormalities are reported to Veterinary
Services via a written Animal Health Report (AHR). This AHR is faxed
to Veterinary Services personnel. Urgent health problems are also
reported to Veterinary Services by phone.
b. Describe the methods of communication between the animal care
staff/veterinarians and the researcher(s).
Cages/animals with a health issue are flagged with a special Veterinary
Observation cage card. The Animal Health Report (AHR) with initial
observations and any updates is kept in the animal housing room. The
research staff is contacted via email, in-person, or phone any time
before treatment is initiated or if some action is required from the
research staff, such as the animal needs to euthanized. The research
staff is contacted by the animal husbandry technician whenever an
animal is found dead or a cage is identified that needs attention, such
as when a litter is present that needs to be weaned.
c.
Describe the procedure for providing veterinary medical care to ill animals and
note who is contacted and the method of communicating (written or verbal)
information to the veterinarian regarding sick animals.
Animals are examined by an AHT or veterinarian and notations are
made on the AHR. For routine cases, (fight wounds on a mouse for
example), treatment maybe initiated by the AHT without consultation
with a veterinarian. Normally the research staff will be contacted to
discuss options prior to executing therapy. For all non-routine or more
involved cases, a veterinarian will be directly involved in the diagnosis
and treatment.
d. Describe the preventive medicine and health management/ monitoring
programs (e.g., physical examination, TB testing, vaccination, hoof/nail
trimming, teeth cleaning/floating, vendor surveillance, use of sentinel animals,
etc.) for each species.
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All animals’ health is checked daily; any abnormalities are brought to
the attention of the veterinary staff. No TB testing or vaccination is
performed on any animals. Long-term rabbits have their nails trimmed
at least every 4 months.
C. Clinical Care and Management [Guide, pp. 113-115]
1.
Emergency Care [Guide, p. 114]
a.
Describe the procedures to ensure that emergency care is continuously
available for animals during and outside of regular work hours.
In the event of an animal health emergency during regular work hours,
the veterinarian on-duty is available by contacting the animal facilities
offices or ULAR office staff. ULAR veterinarians provide after-hours
coverage on a rotating basis. Personnel can be reached at all times by
calling a phone tree number, which will direct them to the person that is
on call. Appropriate signage for after hour emergency care is posted in
the animal facility as well as ULAR’s website and during research
animal training.
b. Describe the authority of the Attending Veterinarian or his/her designee
relative to the emergency treatment of animals in the program.
In the event of an animal emergency, the Attending Veterinarian (AV)
has ultimate authority. If possible, the AV, or his designee, will attempt
to contact the research staff before initiating any treatment or
implementing other measures. But in instances where time does not
permit this or the research staff can not be reached, or if there is
disagreement between the AV and the research staff, the AV will
implement the course of action that he/she sees fit. The AV is
authorized to enter any place within the jurisdiction of UCI to conduct
on-site inspections of animal facilities and animals to ensure that animal
husbandry, sanitation practices, and animal health and research
techniques are in compliance with relevant federal, state, local, and
institutional requirements. The AV is authorized to halt any animal
activity if the safety or welfare of an animal is at risk or if the work being
performed on a project is not in accordance with the approved protocol.
2.
Clinical Record Keeping [Guide, p. 115]
Describe the procedure for maintaining medical records and documenting treatment
of ill animals including: clinical laboratory findings, diagnoses, treatments, medical
progress records, etc. Identify individual(s) (titles, not necessarily names)
responsible for maintaining such records and identify where the records are
maintained and who has access to the records. Describe the role of the Attending
Veterinarian in record keeping.
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All clinical observations, diagnostics, updates, and treatments are
documented on the AHR, which are maintained in the housing room while
the case is open. Information is also entered into an electronic database
which assists in the management of open cases and makes the information
readily available to all AHTs and veterinarians. Once a case is resolved, the
paper copy of the AHR is destroyed after all pertinent information is entered
electronically.
3.
Diagnostic Resources. Describe available diagnostic methods used in the program
including:
a.
In-house diagnostic laboratory capabilities.
Procedure rooms are available to obtain samples for evaluation in each
of the major facilities. A procedure room in Med Sci A is equipped with
scales, microscopes, centrifuges, incubator, and biosafety hood for
performing or prepping samples for routine clinical laboratory testing,
parasitology and gross pathology.
b. Commercially provided diagnostic laboratory services.
UCI utilizes commercial laboratories for diagnostic services other than
parasitology and gross pathology. Bacteriological, hematological,
histopathological, serum chemistry and serological assays are
performed by commercial laboratories, with RADIL utilized most often.
c.
Necropsy facilities and histopathology capabilities.
The necropsy room at Med. Sci. A, room 113D is used for most
necropsies performed by ULAR personnel. Necropsy rooms are also
available in the Gillespie Neurosciences Research Facility, Bio Sci III,
and McGaugh Hall. All of these necropsies rooms are equipped with
down draft and/or biosafety cabinets. Gross necropsies are performed
as indicated by clinical presentation, or when requested by an
investigator.
d. Radiology and other imaging capabilities.
Dedicated radiology facilities and equipment for animal diagnostic
workups do not exist. If an animal is in need of diagnostic radiographs,
several options exist, including using one of several research
radiographs, utilizing the services of a local small animal veterinary
hospital, treat the animal as best as possible, or having the animal
humanely euthanized.
4.
Drug Storage and Control
a.
Describe the purchase and storage of controlled and non-controlled drugs.
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The IACUC encourages the use of pharmaceutical grade drugs when
feasible and requires justification for the use of non-pharmaceutical
drugs. For purchase of non-controlled drugs, a requisition is normally
made through the appropriate department’s financial office. For
controlled drugs, each lab must first have a Controlled Drug Usage
Authorization (CSUA), which is administered by EH&S. The purchases
of controlled drugs are handled by the student pharmacist at UCI.
Controlled substances must be stored separately from other drugs and
supplies in a locked cabinet.
b. Describe record keeping procedures for controlled substances.
Use of controlled drugs must be documented on a controlled substance
usage log to record the agent, date used, the amount used, the animal
or project identification, and the amount remaining. An inventory of
controlled substances and audit of records and storage is performed
annually by the EH&S Controlled Substances Coordinator.
D. Surgery [Guide, pp. 115-123]
1.
Pre-Surgical Planning [Guide, p. 124]
Describe the process(es) used to ensure adequate pre-surgical planning, including:
identifying personnel; locating equipment, supplies, veterinary involvement for
selecting analgesic and anesthetic agents and facilities; planning; and pre- and
postoperative care.
All personnel listed on animal use protocols must complete a training
program before ULAR will authorize them access to the animal facility.
When they register for this training, they identify whether they will be
performing surgery. If so, they need to complete the “Pain and Distress”
online module through the CITI program (Collaborative Institutional Training
Initiative), as well as the “Working with Live Animals in Research” module,
and the module(s) specific to the species with which they will be working.
Required researcher training also includes a UCI-specific classroom
session presented by a ULAR veterinarian, which includes information on
pain and distress. During the classroom session, the trainer discusses the
availability of further training on specific procedures, including surgery and
peri-operative care. The ULAR web site informs researchers that the
veterinarians are available for consultation and training on animal research
procedures including surgery. The ULAR and IACUC web sites provide
guidelines for surgery, including requirements for training, facilities, aseptic
surgery, surgical techniques, anesthetic monitoring, pre- and post-operative
care and surgical records.
The IACUC Application to Use Animals IACUC contains instructions that “a
ULAR veterinarian should be consulted in the planning of procedures
involving potential pain and/or distress”. The Application to Use Animals
contains sections on pre- and post-procedural monitoring and care.
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All IACUC protocols are pre-reviewed by a veterinarian before they are
submitted for IACUC review. If the descriptions of pre-surgical planning, or
peri-operative care are inadequate, the veterinarian sends comments to the
IACUC administrator, who then notifies the lead researcher, so that the
sections can be revised before the protocol is reviewed by the committee.
Recommendations may include specific changes to the surgical procedures
or peri-operative care, or may include a requirement to meet with a UCI
veterinarian to discuss the project in more detail before resubmitting a
revised protocol form.
2.
Surgical Facilities [Guide, p. 116]
a.
List building name(s) and room number(s) or other locations (coded, if
confidential) where surgical procedures are performed. Include areas where
surgical procedures are conducted in agricultural species. Indicate the type of
species, nature of procedure (major/minor/emergency; survival and nonsurvival, etc.). Indicate for each surgical area if the use is heavy (daily),
moderate (weekly), or light.
Building
Beckman
Laser
Beckman
Laser
Bio Sci III
Bonney
GNRF
Hewitt
Irvine Hall
McGaugh
Room(s)
Species
Nature
Usage
418
Maj, Survival
Mod
Min, Survival
Maj, Survival
Maj, Survival
Maj, Survival
Maj, Survival
Min, Survival
Maj, Survival
Mod
Mod
Mod
Heavy
Mod
Mod
Mod
McGaugh
McGaugh
2113
B324, B365, 1432
Maj, Survival
Maj, Survival
Mod
Mod
Med Sci A
113C
Rabbits
Hamsters,
mice
Mice
Rats
Mice, rats
Mice, rats
Rats
Rats
Mice,
Gerbils
Mice, rats
Rabbits,
cats,
swine
Med Sci B
Med Sci B
126
162
Swine
Mice, rats
Med Sci C
Med Sci C
Med Sci C
256
268
362
Med Sci D
Med Sci
Annex
404
Cats, rats
Frogs
Mice, rats
Cats,
guinea
pigs
1041
Mice
120, 306
106, 126, 312, 332
212, 216
131, 210, 211, 228
106, 112
192
B209, B305
68
Maj, Survival,
emergency
Maj,
nonsurvival
Maj, Survival
Maj,
nonsurvival
Maj, Survival
Maj, Survival
Light
Light
Light
Mod
Mod
Light
Maj, Survival
Mod
Maj, Survival
Mod
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Med Surge
II
Med Surge
II
336, 359
Mice, rats
318
Cats
Fish,
axolotls,
frogs
Nat Sci II
4300, 4313, 4410
UCIMC
20
UCIMC
UCIMC
82
38, 66, 76
Swine
Swine,
rabbits
Mice, rats
Maj, Survival
Maj,
nonsurvival
Mod
Maj, Survival
Maj,
nonsurvival
Mod
Maj, Survival
Maj, Survival
Heavy
Mod
Mod
Mod
b. List the major surgical support equipment available at each location where
survival or nonsurvival surgery is performed (e.g., gas anesthesia machines,
respirators, etc.).
Building
Beckman Laser
Beckman Laser
Bio Sci III
Bonney
GNRF
Hewitt
Irvine Hall
McGaugh
McGaugh
McGaugh
Med Sci A
Med Sci B
Med Sci B
Med Sci C
Med Sci C
Med Sci C
Med Sci D
Med Sci Annex
Med Surge II
Med Surge II
Nat Sci II
UCIMC
UCIMC
UCIMC
c.
Room(s)
418
306, 308
106, 126, 312, 332
212, 216
131, 210, 211, 228
106, 112
192
B209, B305
2113
B324, B365, 1432
113C
126
162
256
268
362
404
1041
336, 359
318
4300, 4313, 4410
20
82
38, 66, 76
Gas
Anesthesia
Available?
Yes
No
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
Yes
No
No
Yes
Yes
No
Yes
No
Yes
Yes
Yes
Ventilator &
Monitor
Available?
Yes
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
Yes
No
No
No
No
Yes
Yes
No
Describe any specialized considerations for designation of surgical areas (e.g.,
rodents, aquatics, farm animals, etc.).
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N/A
3.
Surgical Procedures [Guide, pp. 117-118]
a.
Describe the criteria used to differentiate major from minor survival surgery,
including classification for certain procedures (e.g., laparoscopic technique,
etc.).
Major survival surgery: A surgical procedure that penetrates and
exposes a body cavity or produces substantial impairment of physical
or physiologic functions. Examples include: laparotomy, thoracotomy,
craniotomy, orthopedic procedures, and limb amputation.
Minor survival surgery: A surgical procedure that does not expose a
body cavity and causes little or no physical impairment. Examples
include wound suturing, peripheral vessel cannulation, and placement
of subcutaneous implants.
b. How is non-survival surgery defined?
Survival surgery: A surgical procedure from which an animal is
expected to recover from anesthesia.
Non-survival (Terminal) surgery: A surgical procedure from which an
animal is euthanatized before recovery from anesthesia.
4.
Aseptic Technique [Guide, pp. 118-119]
a.
Describe procedures, equipment, and protective clothing used for aseptic
surgery. Include patient and surgeon preparation.
Survival surgery must be performed using aseptic techniques. The
IACUC has developed a Surgery Policy and Guidelines and ULAR has
posted aseptic surgery guidelines, including performing the surgery in a
dedicated space, removal of hair, cleaning and disinfecting the surgical
site, usage of sterile gloves and instruments, and adherence to
appropriate technique during surgery. The investigator is responsible
for supervising the surgical procedure and providing adequate support
staff, instruments, supplies and drugs. Major survival surgical
procedures in large animal species are conducted in dedicated surgical
suites intended for that purpose, maintained and operated under
aseptic conditions. Surgery on rodents does not require a dedicated
surgical suite. ULAR Veterinary Services provides training in aseptic
surgical technique upon request and as needed.
b. Describe methods used to sterilize instruments and protective clothing.
Indicate how effectiveness of sterilization is monitored and, if applicable, any
approved alternate methods for instrument re-sterilization between serial
surgeries. If used, include a description of approved liquid sterilants and
instrument exposure time(s) required for each.
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Methods used to sterilize instruments and other equipment include
autoclaving, gas sterilization, or use of a hot-bead device for sterilizing
instruments in between multiple rodent surgeries. Autoclaves are
available in or near each large animal surgical suite (Med. Sci. A,
Beckman Laser, and UCIMC Bldg. 55) as well as multiple other
locations. Temperature sensitive tape or indicators are included in
autoclave loads, and the autoclaves are tested monthly to assure
adequate temperature attainment using commercially-available
biological indicators (bacterial spore vials) included with the operational
load.
Protective clothing, such as sterile surgical gloves, face masks, shoe
covers and hair covers are discarded after each use. Cloth surgical
gowns are laundered and autoclaved before use. Disposable surgical
gowns are either purchased sterile, or autoclaved and then discarded
after use. Some instruments, such as disposable scalpels, are
purchased sterile and disposed of after each use.
c.
Describe surgical support functions provided by the program to investigators.
ULAR Veterinary Services maintains a large animal anesthesia
machine with ventilator and monitor and several portable rodent
isoflurane anesthesia systems for use by investigators on an as-needed
basis. These systems may be used in dedicated surgical suites, animal
facility procedure rooms and within investigator labs, if approved as a
performance site in an IACUC protocol. ULAR Veterinary Services
provides surgical support duties as needed and requested. This
includes training and oversight of surgeries, but may also include other
surgical, anesthetic, or post-op monitoring duties.
5.
Intraoperative Monitoring [Guide, p. 119]
Describe monitoring and recording requirements for each species, including the
type of record(s) maintained. Also note monitoring of anesthesia during nonsurvival procedures.
For rodents, monitoring must include a post-anesthetic pre-surgical
assessment to ensure the animal is adequately anesthetized prior to
commencement of the surgical procedure. Monitoring during surgery must
occur continuously, observing for any signs of movement or increases in
respiration or changes in respiratory pattern. Records may be maintained in
a laboratory type notebook, and should include date of procedure, animal
ID, surgical procedure performed, dosages of anesthetic agents(s)
administered. For large animals, additional monitoring may include heart
rate, SpO2, end tidal CO2, and blood pressure. Observations must be
recorded on an anesthetic record at least every 15 min.
6.
Postoperative Care [Guide, pp. 119-120]
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Describe the postoperative care program, including who is responsible for
overseeing and providing the care, types of records maintained (e.g., perioperative),
where the records are maintained, etc.
The investigators are primarily responsible for postsurgical care, which must
be described in the approved IACUC protocol. Animals must be
continuously observed until they have recovered from anesthesia, e.g. can
independently maintain themselves in a sternal position. Postsurgical care
includes: observing the animal to ensure uneventful recovery from
anesthesia and surgery; monitoring vital signs; providing supplemental
heating; administering supportive fluids, analgesics, and other drugs as
required or approved in the study proposed; and providing adequate care
for surgical incisions. Investigators are responsible for maintaining
postoperative records. Veterinary Services personnel are available to assist
with postsurgical recovery and supportive care, as well for training in
postprocedural care. Veterinary Services personnel also provide oversight
of postoperative care, reviewing records and providing feedback to
investigators and the IACUC if problems arise.
E. Pain and Distress [Guide, pp. 120-121]
1.
Describe how and by whom pain and distress are assessed and categorized.
When submitting an IACUC protocol, the investigator describes the
procedures to be performed and defines the criteria to be used to assign the
animals to one of the pain categories listed on the annual report to the
USDA (APHIS form 7023). An outline of the USDA pain categories is
included with the protocol application form. Veterinarians are available to
consult with the investigator and can evaluate procedures for pain or
distress. The IACUC reviews all procedures, including those with the
potential for animal pain or distress, the USDA pain category to which the
animals have been assigned and requires protocol adjustments as needed.
If the IACUC has particular concerns that a procedure may be high risk for
producing post procedural pain or distress, the IACUC will request that a
ULAR veterinarian observe such animals when a study begins, initiate
appropriate refinements and then report back to the IACUC as part of the
IACUC Monitoring and Outreach Program. Animals in the animal facility are
assessed for signs of pain or distress by the investigative staff as described
in the IACUC protocol, daily by the animal husbandry staff, and when
animals are reported for illness or injury by Veterinary Services.
2.
Describe how the IACUC/OB ensures that unnecessary pain and distress are
avoided (e.g., pilot studies, monitoring by veterinary staff, animal use protocols,
humane endpoints, other refinements, etc.).
The IACUC requires the appropriate use of anesthetics and analgesics
when procedures performed on animals are reasonably considered to
produce pain or distress. Such procedures must be identified in the IACUC
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protocol and include criteria used to assess pain and distress in the
animals. ULAR veterinarians pre-review all IACUC protocols and have the
opportunity to discuss with the investigator issues around animal pain
and/or distress prior to committee review and approval. Veterinary and
IACUC review of protocols includes the assessment of the investigator’s
criteria for administration of anesthetics and analgesics, the management
plan to assess and treat pain and distress, including unexpected events, the
establishment of humane endpoints, the criteria for removal of an animal
from the study and euthanasia. IACUC policies and guidelines designed to
minimize pain and distress are available to investigators on the ORA
website; policies and guidelines have been developed to cover the use of
analgesia, humane endpoints, survival surgery, ascites production, use of
Freund’s Adjuvant and many other relevant topics. Deviations from IACUC
policies and guidelines must be scientifically justified in a protocol before
approval by the IACUC. For protocols involving pain and distress, the
IACUC may request that a ULAR veterinarian observe animals on a study
and report back to the committee as part of the IACUC Monitoring and
Outreach Program. Finally, the animal husbandry staff notifies Veterinary
Services when an animal is found to be in apparent pain or distress. If the
monitoring and management plan described in the protocol has not been
followed by the investigator, after any necessary action by a ULAR
veterinarian to alleviate pain or distress, these cases are reported
immediately to the IACUC Chair and administrator for committee review and
possible action.
F. Anesthesia and Analgesia [Guide, pp. 121-123]
1.
List the agents used for each species. Dosages, routes of administration and drug
combination should be included in guidelines and available at the time of the site
visit. Describe also any non-pharmacologic means used to diminish pain and
distress.
SPECIES
ANALGESICS USED
ANESTHETIC AGENTS USED
Alligators
Flunixin meglumine
Isoflurane, Pentobarbital
Axolotls
None
Tricaine (MS-222)
Birds
N/A
N/A
Cats
Butorphanol
buprenorphine
Flunixin meglumine
Pentobarbital, ketamine, valium,
isoflurane, alpha-chloralose,
and acepromazine
Fish
None
Tricaine (MS-222)
Frogs
Xylazine
Benzocaine, Tricaine (MS-222)
Snakes
Flunixin
Isoflurane, Pentobarbital
Pigs
Buprenorphine, flunixin,
meloxicam
Ketamine/xylazine,
telazol/xylazine, pentobarbital,
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isoflurane
Rabbits
Buprenorphine,
butorphenol, EMLA cream
Pentobarbital, ketamine,
ketamine/xylazine,
ketamine/promazine, telazol,
isoflurane, lidocaine
Rodents
Buprenorphine,
butorphanol, meperidine,
morphine, ketoprofen,
carprofen, acetaminophen,
flunixin, meloxicam
Ketamine, pentobarbital,
xylazine/ketamine, isoflurane,
avertin, urethane
Non-pharmaceutical methods used to diminish pain and distress depends
on the procedure that was performed. Some things that may be done
include placing food on the bottom of cage post surgery or using food
supplements such as commercial breakfast cereals or nutra-gel packs.
Some animals may also receive extra enrichment items such as shredded
paper, plastic houses or tunnels or blocks of wood for gnawing.
2.
Describe how the veterinarian provides guidance and advice to researchers
concerning choice and use of anesthetics, analgesics or other pain moderating
methods.
ULAR veterinarians maintain guidelines for our investigators on anesthetic
and analgesic drug choices for our most common species on the ULAR
website at http://www.research.uci.edu/ular/index_vet.htm. A ULAR
veterinarian pre-reviews each research protocol prior to IACUC review
(paying close attention to painful procedures and pain-relieving medication
use and requiring modifications as necessary). ULAR Veterinarians are
available for consultation regarding painful procedures and on drug
selection and proper usage during the protocol submission process and on
an as needed basis at any time. Consultation with a ULAR veterinarian is
advertised and encouraged via the IACUC protocol application instructions,
and our website at
http://apps.research.uci.edu/ular/uci/vet_consultation.cfm. Advertising
veterinary consultation services as well as discussing general information
on the use of anesthetics and analgesics is provided during the required
researcher training classes conducted by Veterinary Services.
3.
Describe the monitoring of the effectiveness of anesthetics and analgesics,
including who does the monitoring.
The IACUC protocol requires the investigator to describe their plan for postop monitoring of animals; this includes frequency, who is to perform, what to
observe for, and to list analgesics and anesthetics to be used on the
protocol, noting the dosage, route of administration, frequency and purpose,
and indications when the use is required (i.e.: clinical signs). Using this
information during the semiannual inspections, the IACUC targets
investigators using anesthetics and analgesics, and examines stored drugs
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for expiration date and drug logs for evidence of use. Veterinary staff often
interacts with the investigative staff and conducts routine lab visits during
rounds or in response to an animal illness or injury report; this allows for
additional monitoring of the use of anesthetics and analgesics. As
mentioned above, veterinary monitoring of painful procedures may be
required as part of the IACUC Monitoring and Outreach program which
leads to a more formal review of anesthetic and analgesic use. Large
animals recovering from survival surgery are frequently monitored in the
recovery room by research staff or Veterinary Services before they are
returned to the animal facility. Some animals require the use of the
centralized recovery room and/or anesthesia or post-operative care support
by Veterinary Services, therefore veterinary staff is sometimes directly
involved in the anesthesia and post-operative care process.
4.
Describe how the veterinarian(s) and the IACUC/OB evaluate the proposed use of
neuromuscular blocking agent to ensure the well-being of the animal.
In the IACUC protocol the researcher must identify the paralytic agent(s)
and provide a scientific justification for their use. They need to indicate
which procedure(s) described in the Experimental Design require the use of
paralytic agents and why. A detailed description of how the paralytic agent
will be administered must be provided, including the point in the
surgical/experimental procedure at which it is first administered and
approximately how long animals will be under its influence. They must
describe the anesthesia regimen that will be used while the animals are
under the influence of the paralytic agent, indicate how the depth of
anesthesia will be assessed prior to administration of the paralytic agent
and how animals will be monitored for adequate depth of anesthesia while
the paralytic agent is in effect. A description must be provided of how
mechanical ventilation will be performed while the paralytic agent is in
effect, including a description of the equipment used and details of the tidal
volume and respiration rate. A surgical plane of anesthesia must be
established and verified prior to administration of the paralytic agent; this
anesthesia level must be maintained during the entire time that the agent is
in effect. Endotracheal intubation and provision for mechanical ventilation
must be initiated prior to the administration of the paralytic agent. The use
of paralytic/neuromuscular blocking agents should be confined solely to the
phase of the procedure for which they are indicated. During the period of
paralysis, multiple physiologic indicators of pain and distress (e.g., heart
rate, blood pressure) must be monitored at least every 15 minutes as
appropriate to the species and recorded in the surgical record. An increase
of >20% in any monitored parameter should be considered indicative of a
pain/stress response and additional doses of anesthetic must be
administered. The use of automated monitoring devices, however, cannot
substitute for direct monitoring of the animal by a human observer. A
member of the laboratory staff must be present at all times while paralytic
agents are in use. The use of end-tidal carbon dioxide monitoring is
strongly recommended to ensure adequate ventilation. Core temperature
and fluid balance must be maintained within normal levels during the period
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of paralysis. In the event that animals will be under the influence of the
paralytic for long periods of time (e.g., more than 4-6 hours), a urinary
catheter must be placed or the urinary bladder must be manually voided.
5.
Describe policies and practices for maintaining and ensuring function of equipment
used for anesthesia.
IACUC policy requires that all equipment associated with the delivery of
inhalant anesthetics be evaluated regularly to assure its proper function and
integrity. Anesthetic vaporizers must periodically have the calibrations
verified by a professional as recommended by the manufacturer; when
manufacturer recommendations are unknown or not available, equipment
should be inspected at least once every 3 years and calibrated as
necessary. Before each use, the vaporizer and other components should be
inspected by the user to ensure that all components are correctly set up.
Vaporizers must be tested at least once every three years by an authorized
anesthetic machine service provider to verify accuracy of calibration. If the
verified anesthetic delivery is > 10% out of calibration, the unit should be
serviced by an authorized service provider. Vaporizers should have a
certificate of the calibration date affixed directly to the machine/vaporizer
after each service. In addition, written manufacturer's recommendations for
service of vaporizer systems should be kept in the laboratory and all
research staff should be familiar with them.
G. Euthanasia [Guide, pp. 123-124]
1.
Describe approved methods of euthanasia, including humane slaughter. Include
consideration of species, age, condition (e.g., gestational period, or neonatal) and
location(s) for the conduct of the procedure.
All euthanasia methods must be described in the IACUC protocol and
conform to recommendations of the AVMA Guidelines on Euthanasia and
the IACUC Policy for Euthanasia of Research Animals at
http://www.research.uci.edu/ora/acup/euthanasia.htm. Rodents are
primarily euthanatized by CO2 delivered from compressed-gas canisters,
followed by a secondary method, such as cervical dislocation, to ensure
death. Parenteral (ip) pentobarbital and cervical dislocation or decapitation
with prior use of an anesthetic are also commonly used for rodents. Use of
cervical dislocation or decapitation without prior anesthesia requires a
scientific justification in the approved protocol. Cardiac perfusion is also
commonly used. This is also performed in a deeply anesthetized or recently
expired animal and the procedure must be describe in the IACUC protocol.
Cats, pigs, rabbits, birds, and larger rodents are generally euthanatized
using pentobarbital-based products (e.g.: Euthasol®) after initiation of
anesthesia. Aquatic animals are overdosed with MS-222.
2.
Describe policies and practices for maintaining and ensuring function of equipment
used for euthanasia.
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The most common piece of equipment used is CO2 delivered from H size
compressed-gas canisters. The canister has a regulator and flow valve
attached with a tube that goes to either a chamber or can be directly
attached to a ventilated mouse cage. This is regularly inspected and
maintained by ULAR personnel. Guillotines are also common used, and
these are inspected regularly by the users and also by the IACUC during
the 6-month facility inspections. The guillotines are mostly used after an
animal is anesthetized, or even commonly after death; only rarely are they
used on an unanesthetized mouse or rat.
3.
Describe the methods used to confirm death of an animal.
The IACUC requires a secondary physical method of euthanasia for all
rodents after the animal is profoundly anesthetized, prior to carcass
disposal. Acceptable secondary physical methods for adult and neonatal
rodents include:
•Decapitation
•Cardiac perfusion
•Removal of vital organs (e.g. heart, lungs, brain)
•Opening of the chest cavity to induce pneumothorax
•Cutting the major blood vessels to induce exsanguination (e.g. aorta, vena
cava)
•Cervical dislocation may only be used in adult rodents, as it can be difficult
to perform in neonates and thus is not appropriate for use in animals prior to
weaning. These procedures may not be performed in conscious animals
without specific IACUC approval.
For confirmation of death in non-rodent mammalian species the following
procedures are followed:
1.Heart beat: must be assessed for five minutes or more. The best
assessment is through direct palpation of either the pulse in the carotid or
femoral artery or direct cardiac palpation. If there is any question, the thorax
should be opened, the heart exposed and viewed directly or palpated to
confirm lack of activity. Arterial pulse of smaller species may be difficult to
palpate, so direct inspection of cardiac mechanical activity is necessary.
Lack of electrical activity of the heart as determined by ECG (provided that
the leads are correctly connected) may also be utilized to confirm death.
2.Pupillary response to light: Shine a bright light into the eyes of the animal.
A constriction (narrowing) of the pupil indicates a neurological response.
Upon death, the pupils will become dilated and unresponsive to light. Some
drugs and experimental agents (e.g., anticholinergics such as atropine) can
prevent pupillary reactivity or otherwise affect this neurological response.
3. Respiratory pattern: Profoundly anesthetized animals may exhibit shallow
and irregular breathing patterns that may be confused for lack of
spontaneous breathing. Thus, lack of spontaneous breathing should not be
used as sole criteria for confirming euthanasia.
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For confirmation of death in ectothermic vertebrates a secondary method
should always be performed, such as pithing, removal of the heart or
decapitation.
IV. Physical Plant [Guide, pp. 133-151]
Repeat this section for each animal housing area, including agricultural settings, temporary
holding areas for field studies, aquatic environments, and each IACUC/OB approved
satellite housing facility. Include as an appendix the floor plans of each (if applicable) on
8.5" x 11" or A4 paper.
A. Location and Construction Guidelines
1.
Note the location (building, floor, wing, etc.) of the animal facility(ies). Describe
the management structure and program oversight for each of the areas listed in this
section.
Biological Science 3: The vivarium is located in the basement of the building. The
vivarium is managed by ULAR.
McGaugh Hall: The vivarium is located in the basement of the building. The
vivarium is managed by ULAR.
Bonny Center: The vivarium is located on the first floor in rooms 300A-G. The
vivarium is managed by ULAR.
Gillespie Neuroscience Research Facility: The vivarium is located in the
basement of the building. The vivarium is managed by ULAR.
Hewitt Hall- BSL-3: The vivarium is located on the third floor of Hewitt Hall.
The vivarium is managed by Gary Landucci.
Hewitt Hall: The vivarium is located in the basement. The vivarium is managed
by ULAR.
Irvine Hall: The vivarium is located on the first floor in room 198. The vivarium
is managed by ULAR.
Medical Science A: The vivarium is on the first floor. The vivarium is managed
by ULAR.
Medical Science A Annex: The entire one storey building is the vivarium and it is
managed by ULAR.
Med Surge II: The vivarium is located in the basement and first floor. The
vivarium is managed by ULAR.
Natural Science 2 Aquatics Facility: The aquatics facility is located on the third
floor. The facility is managed by the Principal Investigators and their staff.
North Campus Aviary (including Mate Choice Laboratories): This facility is
located on the north campus, approximately 1.4 miles from the School of
Biological Sciences animal housing facilities. The vivarium is managed by the
Principal Investigators and their staff.
North Campus Air Pollution Health Effects Laboratory (APHEL): APHEL is
located on the north campus in building 239, rooms 106,107, 107a, 107b, 107c,
107d, 107e, 108a, and 108b. The vivarium is managed by the Principal
Investigators and their staff.
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Steinhaus Hall: The vivarium is located in the basement. The vivarium is
managed by ULAR.
UCIMC Building 55: UCIMC Building 55 is located approximately 12 miles from
the main campus at the UCI Medical Center, Orange. The vivarium is located in the
basement. The vivarium is managed by ULAR.
2.
Describe the physical relationship of the animal facilities to the research
laboratories where animals may be used.
Research laboratories are located on separate floors, in different rooms, or in
another building in relation to the vivaria.
3.
Describe the general arrangement of the animal facilities (e.g., conventional,
clean/dirty corridor, etc.). For animals that are maintained in a laboratory in order
to satisfy the scientific aims of a protocol, describe the housing and care provided
and the maximum period of stay required.
The vivaria are operated as conventional facilities with the exception of:
Biological Science 3: 2 suites (4 animal housing rooms) dedicated to the
Transgenic Mouse program, which is operated as a Barrier.
Hewitt Hall: Entire vivarium is operated as a Barrier.
McGaugh Hall: B520 suite (3 housing room) is operataed as a Barrier.
Hewitt Hall BSL-3: The vivarium is operated as a Containment/Barrier.
In order for researchers to keep animals outside of central vivarium facilities (e.g.,
in the laboratory) for more than 12 hours, two appendices must be submitted with
the protocol for review and approval by the IACUC: Appendix I, which serves as a
Standard Operating Procedure for researcher-provided husbandry and care of
animals; and Appendix J, the request for exception to standard ULAR-provided
vivarium housing. The request for housing exception must include a scientificallybased justification for housing animals outside of ULAR vivarium space. The
Principal Investigator and his/her staff are responsible for the husbandry, care and
maintenance of the animals at all times while they are outside of the vivarium.
4.
Describe finishes throughout the animal facility(ies) for floors, walls, ceilings,
doors, alleyways, and gates. Note any areas that are not easily sanitized and
describe how these areas are maintained.
Biological Science 3:
Floors: Resinous floor finish (Neogard-Tan) with integral cove base.
Walls: High Impact Wallboard with epoxy coating
Ceilings: Gyp Board ceiling with epoxy finish
Doors: Hollow Metal doors with epoxy paint.
McGaugh Hall:
Floors: Resinous flooring (Dur-A-Flex) with integral wall coved base (renovated
part); Dexotex TM (other areas)
Walls:
Gyp Board with epoxy paint (renovated part); Epoxy finish (other areas)
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Ceilings: Gyp Board in the corridor with epoxy paint; fully gasketed 2’x4’ extruded
aluminum ceiling grid and fiberglass tile (renovated part); Epoxy finish (other
areas)
Doors: Painted steel doors and polished steel hardware (renovated part); Epoxy
finish (other areas)
Bonney Center:
Floors: Epoxy finish (replaced in 2009)
Walls: Epoxy finish
Ceilings: Gyp Board ceiling with epoxy finish
Doors: Hollow Metal doors with epoxy finish
Gillespie Neuroscience Research Facility:
Floors: Epoxy Aggregate finish
Walls: Glaze-coat fiberglass
Ceilings: Glaze-coat fiberglass
Doors: Hollow Metal doors with epoxy finish
Hewitt Hall- BSL-3:
Floors: Sheet vinyl (industrial grade)
Walls: Fiberglass reinforced panels over wallboard
Ceilings: Fiberglass reinforced panels
Doors: Hollow Metal doors with epoxy finish
Hewitt Hall:
Floors: Resinous flooring (Stoneblend GSI) with integral coved base
Walls: Gyp Board with epoxy paint
Ceilings: Gyp Board in the corridor with epoxy paint; Fully, gasketed 2’x4’
fiberglass ceiling grid and tile
Doors: Stainless steel doors and hardware
Irvine Hall:
Floors: Dexotex TM covered concrete
Walls: Gypsum Board with Epoxy finish
Ceilings: Gypsum Board with Epoxy finish
Doors: Varnished Wood
Medical Science A:
Floors: Dexotrex TM troweled-on epoxy. Newly replaced floor (2011-2012) are
methyl methacrylate (MMA). The cage wash area has UCRETE floor.
Walls: Epoxy paint
Ceilings: Main corridor: fiberglass panels with gel coat, Rooms 115, 119, 121,
122A-122H, 112, 114, 116, 118, A124A and A124S, : solid epoxy finished ceilings
with recessed lights
Doors: Hollow Metal doors with epoxy finish
Medical Science A Annex:
Floors: Epoxy
Walls: Fiberglass reinforced panels over wallboard
Ceilings: Fiberglass reinforced panels
Doors: Hollow Metal doors with epoxy finish
Med Surge II:
Floors: Epoxy coated cement
Walls: Gypsum Board with epoxy finish
Ceilings: Gypsum Board with Epoxy finish
Doors: Hollow Metal doors with epoxy finish
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Natural Science 2 Aquatics Facility:
Floors: Broadcast epoxy coating.
Walls: Moisture resistant, impact resistant wall board with epoxy finish
Ceilings: Moisture resistant ceiling tiles
Doors: Hollow Metal doors with epoxy finish
North Campus Aviary (including Mate Choice Laboratories):
Floors: Epoxy finish
Walls: Epoxy finish
Ceilings: Epoxy finish
Doors: Epoxy finish
North Campus Air Pollution Health Effects Laboratory (APHEL):
Floors: Dexotex TM finish
Walls: Epoxy finish
Ceilings: Epoxy finish
Doors: Solid Wood
Steinhaus Hall:
Floors: Epoxy finish and sheet vinyl
Walls: Epoxy finish
Ceilings: Epoxy finish
Doors: Epoxy finish
UCIMC Building 55:
Floors: Broadcast epoxy
Walls: Epoxy with imbedded fiberglass reinforcement
Ceilings: Fiberglass panels with gel coat
Doors: Hollow Metal doors with epoxy finish
5.
If exterior windows are present within the animal housing or procedure areas,
describe IACUC/OB consideration regarding temperature and photoperiod control,
as well as potential security risks.
With the exception of the Medical Science A vivarium, no exterior windows are
present within the animal housing or procedure areas. In Medical Science A, the
exterior windows are blacked out with black paint for photoperiod control and
security. Room temperature is controlled via our HVAC system.
B. Functional Areas and Operations
1.
Heating, Ventilation, and Air-Conditioning (HVAC) [Guide, pp. 139-140, 143]
a.
Describe the mechanical systems used to provide temperature, humidity and air
pressure control. Include details such as the use of variable air volume (VAV)
systems, and additional key features of HVAC systems affecting performance.
Air pressures are controlled by Phoenix Control systems with the exception of
Medical Science A Annex, which has a Siemens Control system.
Temperatures are controlled by Siemens or Johnsons systems. Humidity is not
controlled.
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b. Describe construction features that minimize the potential for adverse
consequences to animal well-being, such as re-heat coils that fail closed or that
are equipped with high-temperature cut-off systems.
The majority of the facilities are being monitored through the Building
Management Systems, so when they are out of range, an alarm is generated at
the Central Plant. The campus standard for all valves is fail closed. That is not
to say there are older installations that are otherwise.
c.
Describe how critical air pressures, ventilation, and temperature are monitored
and maintained in the event of a system or component failure.
Significant changes (e.g. <64oF or >77oF) in holding room air temperature
trigger alarms in the FM control room, which are manned 24-hours per day.
In the event of an alarm, FM will dispatch mechanics to troubleshoot the
problem. FM will notify ULAR if the problem cannot be resolved in 3 hours
or less. Also, temperature and humidity gauges are placed in each animal
housing room and checked daily by the animal care staff. In the event of a
significant change, UCI Facilities are notified and appropriate actions will be
taken. At North Campus APHEL, the HVAC is not on automatic backup –
the HVAC for the mouse rooms can be attached to an emergency generator and
portable A/C units are brought into the rat rooms for emergency use. If the airconditioner fails at the North Campus Aviary Mate Choice lab, Facilities
Management will provide a temporary air-conditioning unit.
d. Describe procedures for monitoring animal facility mechanical systems and
notifying appropriate personnel in the event of a significant failure that occurs
outside regular work hours.
Significant changes (e.g. <64oF or >77oF) in holding room air temperature
trigger alarms in the Facilities Management control room, which is manned 24hours per day. In the event of an alarm, FM will dispatch mechanics to
troubleshoot the problem. FM will notify ULAR if the problem cannot be
resolved in 3 hours or less and the appropriate action is initiated to respond to
the emergency.
2.
Power and Lighting [Guide, p. 141]
a.
Note if emergency power is provided for the animal facility and if so, what
electrical services and equipment are maintained in the event the primary
power source fails.
With the exceptions of North Campus facilities, the vivarium corridor lights
and emergency exit signs are maintained by emergency power.
Biological Science 3: All animal holding rooms have emergency power
outlets. IVC animal racks’ air supply and/or exhaust blowers are plugged into
the emergency power outlets.
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McGaugh Hall: About 80% of IVC air supply and/or exhaust blowers are
plugged into emergency power outlets. The remaining 20% consist of static
housed animals and housing rooms without emergency power.
Bonney Center: The animal housing rooms do not have emergency power.
Gillespie Neuroscience Research Facility: Most animal housing rooms do
not have emergency power with the exception of the follow rooms:
B101 (housing room): The biological safety cabinet is plugged into e-power
B241 (housing room): Has one outlet on e-power; however no equipment is
plugged into it.
Hewitt Hall- BSL-3: All animal support systems are on emergency power
(includes HVAC system).
Hewitt Hall: IVC animal racks and surgical room equipment is plugged into
the emergency power outlets.
Irvine Hall: The housing room does not have emergency power.
Medical Science A: The housing rooms do not have emergency power.
Medical Science A Annex: The housing rooms do not have emergency power.
Med Surge II: Emergency power outlets are available in holding rooms and
procedure room. In B341, an animal change station is plugged into an
emergency power outlet. Other emergency power outlets are used for a
dedicated piece of equipment.
Natural Science 2 Aquatics Facility: Aquatic animal housing systems in Nat
Sci II are on emergency power.
North Campus Aviary (including Mate Choice Laboratories): The facility
is not on emergency power.
North Campus Air Pollution Health Effects Laboratory (APHEL):
In the event of a power failure, Facilities Management will provide a backup
generator.
Steinhaus Hall: The animal housing rooms do not have emergency power.
UCIMC Building 55: Room 048 (swine housing) has emergency power
outlets; however, no equipment is plugged into it. Other animal housing rooms
do not have emergency power. The vivarium surgery rooms have emergency
power outlets and surgical lights, monitoring devices, tools…etc are plugged
into the e-power outlets.
b. Give history of power failures for the animal facility. Note frequency and
duration. If emergency power was not available during a power failure,
describe steps taken to ensure the comfort and well-being of the animals and
the temperature extremes reached in the animal rooms during the failure.
We experienced four outages in the last 3 years. However, it took less a
minute for the backup generator to kick into operation. In Nov. 2009 the
chilled water supply for Gillespie and Hewitt Hall was interrupted for a 4
hour period. This chilled water supplied cool water to power the air
conditioning. During this period animal room temperatures reached 80ºF.
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Temperatures in the animal rooms returned to normal as soon as the line was
repaired and no animal deaths or health issues resulted.
c. Describe lighting system(s) for the animal housing facility(ies). For each species
or holding room type, list light intensity, photoperiod (Light:Dark), construction
features (e.g., water resistance), and control (e.g., automatic versus manual,
phasing). For systems automatically controlling photoperiod, describe override
mechanisms.
Species
Light
Intensity
All
300-480
lux (1 m
off floor)
Photoperiod
(L:D)
12:12 – Majority of
rooms
14:10 – Some mouse
breeding rooms
Water-resistant
light fixtures
(yes/no)
Yes
Automatic
control
(yes/no)
Yes
Windows
(yes/no)
No
Lights cycles can be overridden via an override switch at each animal housing
room.
3.
System Malfunctions. If not previously reported, describe animal losses or health
problems resulting from power, HVAC, or other life support system (e.g.,
individually ventilated cages) failures, and mechanisms for reporting such
incidences. AAALAC International Rules of Accreditation (Section 2.f)
We have had no animal losses or animal health problems resulting from system
failures.
4.
Storage Areas [Guide, pp. 141-142]
a.
Describe storage areas for feed and bedding, including temperature and vermin
control.
Feed is delivered weekly. The mill dates are checked upon arrival and stored to
ensure first-in first-out in feed rooms within the animal facility or a central
storage building. Temperature in all of the storage facilities is maintained at
68°-72°F and floors are swept and mopped weekly. Vermin control is
accomplished through exclusion barriers, immediate sanitation of any spilled
product, daily observation for any sign of infestation, and use of baited spring
traps. On the north campus, bird seed is stored unopened at room temperature
until 3 days prior to use, at which time it is placed into a freezer for 3 days.
The freezing procedure kills immature forms of moths and beetles that are
frequently found in these seed mixtures, but does not compromise the
nutritional value of the seed and the seed still germinates after treatment. The
seed is then transferred to lined, plastic garbage cans and used immediately.
These garbage cans are labeled and have tight-fitting lids. Most food
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supplements are kept refrigerated, but grit and cuttlebone are maintained at
room temperature in plastic garbage cans.
b. Describe storage areas for cages, equipment, supplies, etc.
Cages and supplies are stored in designated rooms within the vivaria.
c.
Describe storage areas for flammable or hazardous agents and materials (e.g.,
disinfectants, pesticides, fuel).
Flammable or hazardous agents are stored in cabinets or secondary containers
appropriate for the specified hazards.
5.
Facilities for Sanitizing Materials [Guide, pp. 153]
Describe for each cage sanitation area its location, the traffic flow pattern (soiled to
clean, or in and out) within the facility, and kinds of equipment (tunnel washer,
bottle washer, rack washer, etc. and other related equipment such as bedding
dispensing units).
Biological Science 3
1) Location: The sanitizing facility is located in B640/dirty side, B620/clean side
and B610/sterile cage room.
2) General Features: The traffic flow pattern is from the dirty to the clean side of
the cage wash area. Soiled bedding is removed from the cages on the dirty side and
the cages are loaded into the cage washer. After sanitization, the clean cages are
removed on the clean side for storage or use. Clean items are autoclaved and
wrapped barrier operations.
3) Equipment: Within these areas are one pass-through tunnel washer with
garbel/vacuum unit and bedding dispenser, a double door Lynx rack washer, a
small autoclave and a large, pass-through sterilizer to support barrier operations
locally as well as in Hewitt Hall and the Annex facilities.
McGaugh Hall:
1) Location: The sanitizing facility is located in B502/dirty side, B500/clean side
and B500A/sterile cage room. A pass-through sterilizer is also located within the
B451 suite to process biohazard items out of B451 suite.
2) General Features: The traffic flow pattern is from the dirty to the clean side of
the cage wash area. Soiled bedding is removed from the cages on the dirty side and
the cages are loaded into the cage washer. After sanitization, the clean cages are
removed on the clean side for storage or use. Clean items are autoclaved and
wrapped for barrier operations.
3) Equipment: The facility has one pass-through tunnel washer (including garbel
and bedding dispenser) and rack washer. On the dirty side is a front-loaded
sterilizer to process dirty items prior to washing. The clean side cage washer has a
pass-through sterilizer which is used to support barrier housing supply needs. A
pass-through sterilizer is also located within B451 suite to process biohazard items
out of the suite.
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Bonney Center:
1) Location: The Bonney Center has a double door Better Built rack washer in a
“dirty” and “clean” space (room 306) at the end of the vivarium (there is no
physical separation between the two sides).
2) General Features: Soiled cages are entered through the “dirty” side, bedding
removed, cages washed, unloaded from the “clean side,” then rolled down the
corridor to the clean cage area. The floor and walls are sealed concrete and the
ceiling is sheet rock construction with epoxy finish.
3) Equipment: Double-door Better Built rack washer. The washer was installed
without steam service; it uses 100 ppm sodium hypochlorite to sanitize caging
equipment
Gillespie Neuroscience Research Facility:
1) Location The dirty side of the cage wash is located in room B243; the clean
side is located in room B209.
2) General Features: The traffic flow pattern is from the dirty to the clean side of
the cage wash area. Soiled bedding is removed from the cages on the dirty side and
the cages are loaded into the cage washer. After sanitization, the clean cages are
removed on the clean side for storage or use.
3) Equipment: A Basil 4600 pass-through cage and rack washer and a Lynx tunnel
washer is installed. It has recovery tanks for optional reuse of acid and alkaline
detergent solutions as well as cool-down of waste discharge.
Hewitt Hall- BSL-3:
The BSL-3 suite includes a pass-through autoclave for sterilization of material
exiting the suite. Once waste has passed through the autoclave it is treated as nonhazardous soiled material and processed as routine waste in the Gillespie vivarium.
The Gillespie vivarium cage wash includes a double door, pass-through rack
washer and tunnel washer.
Hewitt Hall:
Soiled materials are transported to Biological Science 3 cage wash area for
sanitization and cleaned materials are transport back to Hewitt for use.
Irvine Hall:
Soiled materials are transported to Gillespie Neuroscience Facility vivarium cage
wash area for sanitization and cleaned material are transport back to Irvine Hall for
use.
Medical Science A:
1) Location: The Med. Sci. A cage cleaning facility is in Room 108 (dirty side)
and Room 102 (clean side).
2) General Features: The traffic flow pattern is always from the dirty room to the
clean room. Soiled cages enter the dirty side, bedding dumped, cages washed,
unloaded and dried in the clean side. The bedding is then added and the cages are
rolled down the corridor on carts to the animal housing area.
3) Equipment: Med. Sci. A has a double door, IWT rack washer, a pass-through
Scientek bottle washer, a double door Eagle 3000 pre-vacuum sterilizer, size 24" x
36" x 5', located in room 102 (clean side cage wash area) and an acid dip tank used
to remove urine scale from rabbit pans.
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Medical Science A Annex:
Soiled materials are transported to Gillespie Neuroscience Facility/Biological
Science 3 vivarium cage wash area for sanitization and cleaned material are
transport back to Med Sci A Annex for use.
Med Surge II:
Soiled materials are transported to Medical Science A Facility vivarium cage wash
area for sanitization and cleaned material are transport back to Med Surge II for
use.
Natural Science 2 Aquatics Facility:
Tanks are washed within housing rooms (in large tub sinks) or in the shared support
area. Washing is performed manually be laboratory personnel.
North Campus Aviary (including Mate Choice Laboratories):
1) Location: Room 101 in the Wild Life Vivarium, room 3 in the Mate Choice
Laboratory.
2) General Features: The cages are brought to the sanitizing areas where they are
hand cleaned and taken back to the animal rooms.
3) Equipment: A dishwasher is located in room 101, but most of the equipment is
washed by hand.
North Campus Air Pollution Health Effects Laboratory (APHEL): 1)
Location: Cage sanitation facility is located behind Bldg. 238. Cages are rolled
from rooms 108a and/or room 107 to the cage washer.
2) General Features: The APHEL facility is too small to have separate traffic
lanes for clean and soiled. The animal care personnel are required to change gloves
and lab coats depending on the function that they are performing.
3) Equipment: North campus has its own cage and rack washer to sanitize the
rodent cages. The cage washer is located outside, enclosed by three walls and a
roof. The rack washer and steam generator are located next to the cage washer but
are fully enclosed.
Steinhaus Hall:
Most animal cages used in Steinhaus Hall are disposable; some soiled materials are
transported to McGaugh Hall vivarium cage wash area for sanitization and cleaned
material are transport back to Steinhaus Hall for use.
UCIMC Building 55:
1) Location: The clean side of the cage wash is room 084A and dirty side is room
084B.
2) General Features: The traffic flow pattern is from the dirty to the clean side of
the cage wash area. Soiled bedding is removed from the cages on the dirty side and
the cages are loaded into the cage washer. After sanitization, the clean cages are
removed on the clean side for storage or use. Clean items are autoclaved and
wrapped barrier operations.
3) Equipment: Cages are sanitized using a rack washer. A ventilated bedding
dump station is available in the soiled cage wash. A pass through autoclave is also
available. The clean cage wash includes an automatic bedding dispenser.
C. Special Facilities [Guide, pp. 144-146, 150]
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1.
Specialized Types of Animal Housing
Note specialized types of available animal housing spaces such as barrier, hazard
containment (infectious, radioactive, chemical), "animal cubicles" (also known as
"Illinois Cubicles”, "Horsfal Cubicles," and "animal modules"), or facilities
designed specifically for housing certain species such as aquatic or agricultural
animals (e.g., barns, feedlots). [Guide, pp. 160-161]
Barriers:
Hewitt Hall was designed to operate as a rodent barrier facility.
Biological Sciences 3 has 2 suites of rooms and McGaugh Hall has one suite of
rooms operated as a barrier facility.
Hazard containment:
McGaugh Hall has an ABSL2 containment suite (B451), consisting of two holding
rooms, one procedure room and a cage processing room with a pass-through
autoclave.
Hewitt Hall has an ABSL3 facility on the 3rd floor that was designed and
commissioned for use with ABSL3 agents, including Select Agents. It consists of
two holding rooms,
Cubicles:
Med Sci A has two rooms with cubicles. One of these rooms (124S) is used for
small ABSL2 studies. The other room (124A) is used to house small numbers of
animals that need to be housed separately from other animals for experimental
reasons or because they are a different species. These cubicles are only used for
rodent studies.
Gillespie has one room with cubicles (223). This room is used to house small
numbers of animals that need to be housed separately from other animals for
experimental reasons or because they are a different species. These cubicles are
only used for rodent studies.
Nat Sci 2 Aquatic Housing:
Nat Sci 2 has a dedicated aquatic vivarium. Species currently housed here include
zebrafish, Xenopus (laevis and tropicalis), axolotls, tilapia, and goldfish.
North Campus Aviary:
North Campus Aviary has outdoor flight cages specifically designed to house small
birds, such as finches and budgerigars.
2.
Surgery [Guide, pp. 144-145]
a.
Describe facilities for aseptic surgery, surgical support, animal preparation,
surgeon’s scrub, operating room, and postoperative recovery.
Rodent and minor and non-survival large animal surgeries are performed in a
number of locations (see list in Section III.D.2.a.) These locations vary from
dedicated procedure rooms within the animal facility to bench space within a
research laboratory. Major large animal survival surgery is performed in one of
three dedicated surgical facilities. These are located in Beckman Laser
Institute, Medical Science A, and UCI Medical Center building 55. Each of
these locations has a surgical room that is separate from the animal prep room
and surgeon’s scrub room.
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b. Describe construction features of the operating room(s), including interior
surfaces, ventilation, lighting, and fixed equipment used to support surgical
procedures and enhance contamination control.
Construction features of rodent and minor or non-survival large animal
surgical facilities vary by location. In some locations the facility may consist of
a dedicated bench space within a research lab. In others the facility consists of
a dedicated procedure room within the animal facility that includes features
such as positive air flow, impervious floors, walls and ceilings, stainless steel
or surgical tables, fixed surgical lights, emergency powered electrical outlets,
piped-in oxygen supply and built-in gas scavenging system. The 3 dedicated
large animal survival surgical facilities have epoxy coated floors and walls
with moisture resistant fiberglass ceiling panels or epoxy coated plaster. The
main surgical room is positively ventilated with coarse filtered air. The
surgical room is equipped with fixed surgical lights, piped in oxygen or Htanks secured to the wall and built-in gas scavenging system. The surgical
support area in each facility contains a built-in autoclave.
3.
Other Specialized Animal Use Facilities [Guide, pp. 146-150]
Describe other facilities such as imaging, irradiation, and core behavioral
laboratories or rooms. Include a description of decontamination and methods for
preventing cross-contamination in multi-species facilities.
Specialized imaging (MRI, PET, Fluorescent, two-photon microscopy, optical
coherence tomography (OCT)) facilities are located in Irvine Hall, Med Sci C,
Med Sci Annex, Beckman Laser Institute, and McGaugh Hall. A cesium
based irradiator is located in Med Sci B. These facilities are located in dedicated
rooms within the animal facility or in research lab areas. Facilities and equipment
are cleaned and decontaminated after each use, with special emphasis placed on
disinfecting any animal contact areas. Most of the animal work performed is with
SPF status rodents. Several human clinical facilities located at UCIMC are
occasionally used for animal studies (see Section I.A.2.b.ii.4) for a description,
including procedures followed for prevention of cross-contamination.)
4.
Other Animal Support Facilities
Describe other facilities providing animal care and use support, such as food
preparation areas, feedmills, abattoirs, etc.
N/A
D. Security and Access Control [Guide, p. 151]
Describe such features as control of entry, perimeter fences, gates, entryways, cameras,
guards.
A photo card-key is required to gain entrance to the most vivarium areas, with the
exception of Nat Sci 2 Aquatic Facility, North Campus APHEL and North
Campus Aviary and Mate Choice Labs. The photo card keys must be worn
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visibly at all times while in the vivaria. The card-key security system is used to
enter the building after hours and on holidays and weekends. The system is alarmed
directly to the UCI Police Department. All laboratory and vivarium facilities are
patrolled on the exterior by UCI police.
Video security cameras are positioned at all entrances and exits for the following
vivaria: Biological Science 3, McGaugh Hall, Med Sci A, Med Sci A Annex,
GNRF, Hewitt Hall, Steinhaus Hall, Bonney Center.
The video feeds are record on DVRs and can be played back in the event of a
security breach.
Hewitt ABSL 3 Facility is secured with electronic locks that use both biometric
and card key access control. Video security cameras are positioned inside and
outside the facility. Images are stored on a DVR in the facility manager’s office,
and the images are accessible by UCI Police Department,
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November 21. 2012
James W. hicks. Ph.D.
:\sSociate Vice Chancellor tar Research
Office of Research
University of California-Irvine
5171 California Avenue. Suite 150
Irvine, CA 92697-7600
Dear Dr. Hicks:
The Council on Accreditation of the Association for Assessment and Accreditation of Laboratory Animal
Care (AAALAC International) has reviewed the report of the recent site visit to the University of
California, Irvine. California. The Council commends you and the staff for providing and maintaining a
high quality program of laboratory animal care and use. Especially noteworthy were the strong
administrative support for the animal care and use program; the clean and well maintained animal facilities;
the knowledgeable and enthusiastic facility managers; the overall good health of the animals; the well
written Program Description: the effective oversight by environmental health and safety personnel.
demonstrated by the improvement in the review of protocols involving hazardous agents, interactions with
the principal investigators, and the provision of training for those working with hazards; the excellent
documentation of postoperative monitoring on spinal cord injury protocols, including all supportive care
and medications administered: and the well managed surgical center, evidenced by the detailed monitoring
records. the well organized facility, and the extremely knowledgeable manager. The Council is pleased to
inform you that the program conforms with AAALAC International standards as set forth by the Guide for
the (‘are and Uve of tahoraiorv Animals. NRC 2011. Therefore. FULL ACCREDITATION shall
continue.
Council acknowledges receipt of the correspondence dated September 13. September 6. August 16. and
July 9, 2012 detailing actions taken relative to concerns expressed h’ the site visitors during the exit
briefing. Specifically, the items addressed satisfactorily included: ensuring the oversight of protocols 19982023 and 1998-201 9 so that appropriate anesthesia and analgesia are provided: reassessing the ease of
egress and dc-energizing mechanism of the rack washer in the Bonnev Center: classifying deficiencies
noted in the semiannual inspections as significant or minor, developing a plan for their correction, and
modifying the semiannual inspection template; providing justification for the single housing of social
species of animals: revising Protocol 2001 -2303 to include information regarding experimental side effects;
ensuring that documentation of husbandry practices provided by an investigator conforms with Institutional
Animal Care and Use Committee policy: verifying that servicing of anesthesia vaporizers is performed in
accordance with the manufacturers recommendations: re-evaluating the anesthetic waste scavenging device
in BioScience 3. Room B2 1 5 to ensure the protection of personnel: assessing the effectiveness of sanitation
procedures of hand—washed primary enclosures; and erifying the relative air pressure differential of the
surgery room in the Gillespie Neuroscience Research Facility.
‘
James \V. Hicks. Ph.D.
November 21. 2012
Page 2
Council has no further recommendations to oiler tbr improvement of the animal care and use program at
this time. We look forward to tbilo ing your program activities and wish on continued success.
Ar\A[:\C International requires an Annual Report detailing changes made during the year in accredited
units. In the interim, AAALAC International expects to he apprised in a timely manner of significant
programmatic changes or concerns should they occur. Please note that, at your request, AAALAC
International . ill provide your institution with a separate letter simply verifying that our animal care and
use program is accredited. Should you also wish to distribute an electronic copy of this letter to program
staff a Portable Document Format (pdf) version will he sent upon request.
Sincerely,
William W. King. D.V.M.. Ph.D.
President, Council on Accreditation
WWK:cmw
000238
cc:
Jeffrey L. Goodwin, D.V.M.. Ph.D.. Director. University of Laboratory Animal Resources