This presentation addresses vivarium risk assessments for chemical and biological exposures in a research setting. Committee approval processes (IBC, IACUC, etc), controlling banding application, OEL development/validation, and IH monitoring results and control measures are just some of the topics presented.

1. Conducting Vivarium Risk
Assessments in the
Research Environment

2. Meet Your Moderator
James Ciccone
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3. During this Webinar
 All lines will be muted.
 Communicate via the questions tab in your webinar
panel.
 Unanswered questions will be responded to
personally after the webinar.
 Webinar recording and slides will be emailed to you
tomorrow.
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4. Meet Your Presenter
Tony Gemmellaro
EHS Manager/Senior Consultant
Triumvirate Environmental, Inc.
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5. Objectives
• Provide Basic Overview
 Review regulatory requirements
• Share Committee Involvement
(IBC, IACUC, etc)
 Risk assessments through protocols
 Vivarium management
 Worker and animal protection
• Review Current Practices
 Case studies, best practices, examples
of success
 Good, bad and ugly
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6. Good
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7. BAD
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8. UGLY
1. What are the hazards?
2. What are the worst things that
could happen?
3. What do I need to do to be
prepared?
4. What are the prudent practices,
protective facilities, and
protective equipment needed to
minimize the risk?
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9. Regulations
• Guide for the care and use of laboratory animals
 Use of hazardous materials and provision of a safe
working environment
• CDC/NIH
 Animal biosafety levels/ infectious agents
• OSHA fact sheet
• Office of Laboratory Animal Welfare (OLAW)
• Risks to Animals/Risks to Employees
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10. Program Management
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11. Who is Responsible for What
• It is not the same in every program
• Know who does what at your institution
• Are multiple roles held by the same individual?
• Everyone should know how their effort contributes to the program
• EHS?
Lines of Authority & Responsibilities
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12. Process
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13. • IACUC Review Process for Protocols and Amendments
• Authority of the Attending Veterinarian
• IACUC Policy on Studies with Severe Disease “Death as an Endpoint”
• IACUC Policy on Determination of Pain/Distress and Analgesia
• IACUC Policy on Euthanasia Criteria for Animals
• IACUC Policy on Laboratory Animal Euthanasia Guidelines
• EXPERIENCE & USE TRAINING RECORD
• Protocol registration/submission form
• Semiannual Program Review Checklist
• IACUC Identification and Monitoring of Sick and/or Injured Animals Policy
• Survival surgeries, blood collection, and more
• Whistleblower policy
SOP’s, Procedures & Controls
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14. Poll Question
What are the major
risks in your facility?
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15. Protocol Forms:
Hazard Identification/Risk Assessment
• Biologic agents (e.g., infectious agents, cell lines, select agents or toxins)
• Chemical agents (e.g., carcinogens and mutagens)
• Radiation (e.g., radionuclides, X-rays, lasers)
• Physical hazards (e.g., needles and syringes)
• Field studies or wildlife research should also be addressed
• Animal bites, kicks, allergies
• Exposure to allergens
• Chemical cleaning agents
• Slips, Trips, Falls: wet floors
• Cage washers and other equipment
• Ergonomics: lifting, ladder use,
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16. Protocol Forms:
Hazard Identification/Risk Assessment
• Occupational Health
• Health History/Questionnaire
 Allergy
 Ergonomics (lifting, bending, repetitive work)
 Work with TB, infectious agents, chemicals
• Treatment
 Vaccines
 Antidote (snake venom)
• Personal Protective Equipment
 Respirator qualification (required vs voluntary)
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17. Protocol Forms:
Hazard Identification/Risk Assessment
• Determine the severity or seriousness of the hazard
• The exposure intensity, duration, and frequency (prevalence of
the hazard)
• History of occupational illness and injury in the particular
workplace (e.g., immune status)
• Periodic inspections and reporting of potential hazardous
conditions or “near miss” incidents
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18. Biohazard Risk Assessment
1. What is the biohazard or procedure involving a potential biohazard?
2. What is the worst thing that can happen? (Consequences! to
personnel & community)
3. How common are adverse incidents? (LAI’s -- Rare, Moderate,
Frequent)
4. Are you prepared? (Emergency Planning, Treatment options, Medical
Surveillance)
5. What are the Control Measures? (elimination, substitution,
engineering, administrative, PPE, altered work practices, training)
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19. Hazards Associated with Material
• Blood plasma and/or urine from a cynomologus (Macaque)
monkeys
 Monkey B virus, Herpes B, Herpesvirus simiae
 Boston examples
• Tuberculosis
 Airborne exposure of concern
 Infectious in monkeys mainly arise from infected humans
• Ebola/Marburg/Filoviruses
 Very serious, but unlikely to be encountered in purpose-bred monkeys
Agents infectious to humans:
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20. Laboratory Animal Allergy (LAA)
Allergic reaction to animals is
among the most common
conditions that adversely affect
pharmaceutical research workers.
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21. Laboratory Animal Allergy (Cont’d)
Symptoms:
• Nasal symptoms (allergic rhinitis)
• Itchy eyes (allergic conjunctivitis)
• Rashes (contact urticaria, atopy)
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22. Mouse Allergen
The major mouse allergen is Mus m 1, or mouse
urinary protein.
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23. Rat Allergen
Rat n 1 is a known human allergen, protein appears to
be in the urine and saliva of the animal.
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24. Routes of Exposure
1. Inhalation of aeroallergens
2. Contaminated bedding
3. Direct skin and eye contact
Assessing Potential Risk
• What are “typical” exposures?
• What tasks have the highest risk?
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25. Assessing Potential Risk (Cont’d)
Activities most associated with allergen exposure
are:
 Handling animals and cages with bedding without ventilation
 Manual cage changing
 Dumping soiled bedding
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26. Monitoring Can Be Useful
No OSHA standard method for allergens – BUT…
• Allergens attach to particles and can be hazardous when
deposited anywhere in the respiratory tract
• Inhalable and respirable fraction includes particulate matter that
enter the head airways region, including the nose and mouth
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27. Poll Question
Are there any liability issues
within lab animal research
areas (such as animal bites
and scratches, exposures to
chemicals or biological
agents)?
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28. Ergonomics
What is wrong with
this picture?
Ventilated Cage?
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29. Chemical Containment Levels vs BSL
CCL 1
 Suitable for work involving the use of chemicals which can cause minimal potential harm to
laboratory personnel and the environment.
 No additional measure beyond approved Animal Biosafety level of work.
CCL 2
 Suitable for work involving the use of chemicals which can pose a moderate risk to laboratory
personnel and the environment from an animal exposed to a hazardous substance.
CCL 3
 Suitable for work involving the use of chemicals which can pose a serious risk to laboratory
personnel and the environment after an animal has been exposed to a hazardous substance.
CCL4
 Suitable for work involving the use of chemicals which can pose a life-threatening risk to the
laboratory personnel and environment before, during and/or after the animal is exposed to
hazardous substance.
Procedure for the Assignment of CCL
 A principal investigator applying for IACUC approval of a project involving chemicals in animals
will identify an initial CCL.

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31. Hierarchy of Controls
 Engineering
- Ventilation, substitution, eliminate the hazard
 Safe Work Practices
- Changing the way the work is done or by adding a tool to help. Remote entry.
 Administration
- Rotating workers more often to reduce exposure times, occupational health
program
 PPE
- Respirators, gloves, hearing protection, etc.
BEST
WORST
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32. Engineering Controls
• Enclosure
• Dilution ventilation
• Cage designs
• Use of containment equipment,
such as:
 Biosafety cabinets
 Cage changing stations and
bedding dump stations
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33. Engineering Controls
Filter Top Cage Ventilated Cage Rack
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34. Biosafety Cabinet
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36. Cage Charging
Station
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37. Administrative & Work
Practice Controls
 Reduce time with animal
 Reduce density of animals
 Good housekeeping practices
 Wet mopping in place of vacuuming or sweeping
 Procedures that minimize release of airborne materials
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38. Lab Animal Handler Questionnaire
• Job title / Description
• Hx of work with animals
• Tetanus status
• Allergies?
• Seasonal
• Latex
• Animals
• When working with animals do
you:
• Sneeze, cough
• Runny nose
• Itchy eyes
• Wheeze
• Hives
• Chest tightness / SOB
• Do symptoms go away when
you leave work?
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39. N-95 Respirator for
Allergen Protection
Face mask (N-95 Respirator) to reduce inhalation
and hand-to-face spread of allergens
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40. Examples of “Success”
• Injection of Staph aureus into devices in mice to study ways to
minimize contamination of orthopedic hardware. Originally
mandated BL2 housing of those mice, requiring more time and
waste handling costs by animal care staff.
 Staph aureus is not an excluded rodent pathogen in this colony
 All who handle mice already wear PPE equivalent to lab BL2 practices
 Staph aureus is injected into the animal rather than applied topically
 All who handle mice have been screened by our occupational health
provider (not at medical risk of infection)
• IBC appropriately approved this for BL1 containment
• Example of what makes sense, protection, and cost
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41. Examples of “Success”
• Some Research institutions have undergone changes in
IACUC protocol assessment
 Chemical and biological hazards: preference for rational and informed risk
management.
 Generic philosophies that every substance labeled as hazardous must be
maximally contained
 Expanded the scope of assessment to include the context in which each
substance is to be used in each protocol (case by case)
 Personal safety risk assessment goes beyond the MSDS to include
administration route, dose, a frequency, and documented evidence
of hazardous excreta
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42. Case Study: Exposure to
Laboratory Rats
• 21-year-old female worker at a pharmaceutical company
• Symptoms included hives on her forearms and hands
• The worker then began to suffer episodes of sneezing, nasal drainage,
watery eyes, and chest tightness
• She was transferred to another department, where her symptoms
ceased
• The worker had positive skin tests to animal dander and to rat hair.
• She also had elevated antibodies (IgE) to various rat proteins [DeGroot
and Messerschmidt 1984].
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43. Summary
• Clearly articulate policies and procedures
• Assures effective training programs
• Implement regulations
• Facilitate research and teaching
• Assure the public of quality care
• Determine appropriate strategies to
minimize or manage the risks
• Communication is the key
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44. References
• Websites
 Harvard
 Boston University
 UMASS
 Tufts
 University of Virginia
• Information from colleagues
 Case studies and current practices
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45. THANK YOU!
CONTACT US!
1-888-834-9697
www.triumvirate.com
Tony Gemmellaro: agemmellaro@triumvirate.com
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