UNIVERSITY OF PITTSBURGH DEPARTMENT OF ENVIRONMENTAL HEALTH & SAFETY
EH&S Agent Registration Workbooks
The Department of Environmental Health & Safety (EH&S) utilizes an electronic workbook to collect information from
investigators. There are several types of agent registration workbooks that are submitted to EH&S.
A. Animal Work Only:
B. Animal and rDNA Work:
C. rDNA Work Only:
D. Other Hazardous Materials:
T. Tissue Transfer:
M. Material Transfer Agreement:
Project associated with an IACUC protocol only
Project associated with an IACUC protocol and an IBC recombinant DNA (rDNA)
protocol
Project associated with an IBC rDNA protocol only
Any project using hazardous materials not described in an IACUC or IBC rDNA
protocol
Tissue transfer from an approved IACUC protocol to an authorized user
Registration with EH&S to obtain materials requiring an Material Transfer
Agreement
A. Animal Work Only
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For each IACUC protocol submitted, a new EH&S workbook must be submitted. All biological and chemical agents
(including routine surgical agents) described in IACUC protocols must be listed in the EH&S workbook.
When administrative information changes or new agents are added to an IACUC protocol, your EH&S workbook
must also be updated (e.g. PI change, title change, addition of new biological or chemical agent).
After initial approval by the IACUC, personnel changes do not merit an update to your EH&S workbook. However,
personnel additions/deletions must be submitted to the IACUC.
Type A workbooks expire as the associated IACUC protocol is terminated or expires.
B. Animal and rDNA Work
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All projects utilizing recombinant DNA must be registered with the IBC and EH&S. All biological and chemical
agents (including routine surgical agents) described in IACUC and IBC rDNA protocols must be listed in the EH&S
workbook.
If you are unsure if your project requires you to register with the IBC, please contact the rDNA office (phone: 412383-1768 or email: rdna@pitt.edu).
Examples of such projects:
o Protocol involving on-site breeding or cross-breeding of genetically modified animals
o Administration of viruses or viral vectors to animals
o Administration of transduced or transfected cells to animals
o For a full listing please visit http://www.rcco.pitt.edu/rdna/
Major changes to an IBC rDNA protocol require a new workbook to be submitted (e.g. lentivirus added to a protocol
previously only approved for adenovirus).
Minor changes to an IBC rDNA protocol do not require workbook changes (e.g. a new retrovirus differing only by
insert is added to a protocol previously approved for retrovirus).
Type B workbooks expire as the associated IACUC protocol expires or is terminated.
C. rDNA Work Only
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Each project involving recombinant DNA requires an IBC rDNA application and an EH&S workbook. All
biological agents IBC protocols must be listed in the EH&S workbook.
Examples of such projects:
o Cloning and vector construction in bacteria and yeast
o In vitro use of viruses or viral vectors
o In vitro use of transduced or transfected cells
o For a full listing please visit http://www.rcco.pitt.edu/rdna/
Type C workbooks expire as the associated IBC rDNA protocol is terminated or expires.
D. Other Hazardous Materials; No Animal or rDNA Work
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Any project not described in an IACUC or IBC rDNA protocol that is conducted at BSL-2 or higher and/or utilizes a
specified hazardous chemical agent should be registered with EH&S.
Examples of such projects:
o Study involving human cell lines or primary human tissues, cells, or blood
o Study involving hazardous chemicals (e.g. immunohistochemistry, western blots, etc.)
If you are unsure if your project should be registered with EH&S, please contact our Hazard Assessment
Coordinator at 412-648-0197.
Type D workbooks expire three years after submission.
T. Tissue Transfer
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An EH&S workbook must be submitted if tissue from one PI with an approved IACUC protocol is to be transferred
to another PI. The workbook provides information that allows EH&S to verify the recipient is equipped to handle
the material.
Type T workbooks must include the following information:
o Principle Investigator Information (PI receiving tissue)
o Project Information (description of the tissue transfer and approved IACUC protocol number from which
the tissue is obtained)
o Laboratory Information (where the tissue will be handled)
o Project Personnel Information (who will be handling the tissue in the recipient lab)
o Biological Agent Information (tissue procured and all applicable sections)
Type T workbooks expire three years after submission.
6. Material Transfer Agreement (Type M Workbook)
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If you have not registered with EH&S for any other purpose, a workbook must be submitted if you wish to place an
order with American Type Culture Collection (ATCC) for materials at or above biosafety level two (BSL-2).
o All investigators submitting an Agent Registration Workbook in conjunction with a Verification of
Compliance with Material Transfer Agreement only need to complete the first two sections (Administrative
and Laboratory Information). A product list is not necessary for this registration type.
Visit http://www.ehs.pitt.edu/biological/mta.html for procedure details and to obtain a “Verification of Compliance
with Material Transfer Agreement” form.
Type M workbooks expire three years after submission.
EH&S WORKBOOK APPROVAL PROCESS
Follow the steps listed below to obtain EH&S approval. A checklist is provided for your convenience.
Action Items
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Visit http://www.ehs.pitt.edu/ to obtain an updated version of an
EH&S Agent Registration Workbook.
At the above mentioned website, you can also find instructional
guides for PC & MAC users, frequently asked questions, sample
phrases for the workbook, and web references (links to additional
health and safety information on Biosafety Levels, chemical/drug
hazards, risk mitigation strategies, etc.)
Once the workbook is filled to completion, submit electronically
to biosafe@ehs.pitt.edu(.)
EH&S will reply with a confirmation of receipt and an EH&S
workbook number. It is suggested that you keep a table with all
EH&S workbook numbers, titles, and associated IACUC and/or
IBC protocols.
After EH&S initiates its review, you will be notified of any issues
with your workbook, including out-of date training or medical
surveillance requirements.
EH&S will send you an approved risk assessment for type A, B,
C, & D workbooks (discussed below).
PI Checklist
Obtain updated version of WB
Complete all sections of workbook,
including tabs for individual agents
Submit workbook to EH&S
Record workbook number for
future reference
Revise workbook (if requested)
Complete training or medical surveillance
requirements if notified
Review Risk Assessment
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EH&S RISK ASSESSMENTS
A Risk Assessment is prepared from each EH&S workbook.
1. TYPE A & B Workbooks
Risk assessments generated for A and B workbooks will include complete descriptions of risk factors and safe
handling/use instructions for biological, chemical, and radiological materials listed in the IACUC protocol and
corresponding EH&S workbook.
An Implementation Review will be requested by EH&S if an investigator is new to the University or if an investigator is
working with a new or highly hazardous agent in animals. Implementation Reviews are meetings between the
investigator and the DLAR to establish hazard control procedures. EH&S is present at an Implementation Review when
requested.
2. TYPE C & D Workbooks
Risk assessments generated for C workbooks will include complete descriptions of risk factors and safe handling/use
instructions for biological, chemical, and radiological materials listed in the IBC rDNA protocol and corresponding
EH&S workbook.
Risk assessments generated for D workbooks will include standard risk phrasing handling instructions for all biological
and chemical agents that have been listed in the EH&S workbook.
EH&S TRAINING AND MEDICAL SURVEILLANCE REQUIREMENTS
One or more of the following requirements may be assigned to your laboratory personnel depending on the agents listed in
your protocol and corresponding EH&S workbook.
Training
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Bloodborne Pathogens (BBP)
o Training is required annually for work with the following materials:
 Human blood, tissue, body fluids, primary cells, cell lines
 Non-human primate blood, tissue, body fluids, primary cells, cell lines
 Agents requiring BSL-2 containment or higher
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Chemical Hygiene (CH)
o Training is required every three years for work with any laboratory chemical.
o CO2 does not require CH training. Most other chemicals do require CH training.
o “Use of Laboratory Animals in Research and Education (formerly RPF Module 3)” now counts towards the
CH training. EH&S encourages animal users to re-take this module every three years for the Chemical
Hygiene re-training, as the occupational health and safety section is specifically geared towards animal
users.
NOTE: Initial BBP/CH Training for staff and students must be a live session (visit
http://www.ehs.pitt.edu/workplace/training.html for a current training schedule). Subsequent training may be performed
online. Faculty and post-docs may complete all training online. The online trainings are offered at
http://cme.hs.pitt.edu/servlet/IteachControllerServlet?actiontotake=displaymainpage&site=rpf (.)
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Formaldehyde Use
o Training is required for individuals using formaldehyde above 0.1% concentration or if airborne
formaldehyde levels are verified by EH&S to be above 0.1ppm.
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Laser Safety
o Training is assigned by the EH&S laser safety officer.
Medical Surveillance
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Animal Exposure Surveillance Program (AESP)
o Enrollment is required for all personnel listed on an IACUC protocol.
o Visit http://www.ehs.pitt.edu/biological/animal.html for details regarding enrollment.
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Tuberculosis Protection Program
o TB screening is required on a semi-annual basis when any of the following apply:
 Entrance to areas where non-human primates (NHP) are housed
 Work with non-fixed, primary, non-human primate tissue or blood
 Entrance to labs where M. tuberculosis is used
o TB screening is required on an annual basis for University of Pittsburgh employees who only have
potential exposure to TB in a clinical setting.
o The required testing is either a PPD skin test or medical evaluation for PPD positive individuals.
o Tuberculosis Protection in Research Environments SOP available at http://www.ehs.pitt.edu/biological/.
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BSL-3 Employee Screening
o Medical evaluation via questionnaire is required for all persons working in BSL-3 assigned areas
(questionnaire available at http://www.ehs.pitt.edu/biological/, faxed to Pitt Employee Health 412-6471993)
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Serum Surveillance Program
o Surveillance is currently offered to all employees with potential exposure to lentivirus vectors or lentivirusinfected lab animals.
o Serum surveillance may be required based on the agent utilized.
o Serum Surveillance Program SOP available at http://www.ehs.pitt.edu/biological/.
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Respirator Fit Testing
o Required for personnel who wear a respirator when completing their work assignments (e.g. a laboratory
that works with Mycobacterium tuberculosis (TB) or TB-infected animals).
o Recommended if the PI mentions the use of respirators in the protocol but the use of respirators is not
mandated by the project.
o Respirator fit testing is required on an annual basis.
o Call EH&S to arrange an appointment for Respirator Fit Testing.
Vaccinations (required for work with specific agents)
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Vaccinia Vaccination
o Medical Evaluation is required for all individuals handling vaccinia virus or vaccinia exposed animals. An
exemption from the vaccine requirement is possible but is only approved on a case by case basis.
o Based on the vaccinia strain, vaccination may be recommended, required, or contra-indicated.
o Vaccina Virus Usage SOP available at http://www.ehs.pitt.edu/biological/.
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Botulinum Toxoid Vaccination
o Vaccination is offered to all individuals handling botulinum toxin.
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Influenza Vaccination
o Strongly recommended for personnel who work with influenza viruses or influenza-infected animals.
o If the vaccination is declined, personnel may by prohibited from work with certain agents.
o Reassortant Influenza Virus SOP available at http://www.ehs.pitt.edu/biological/.
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Measles Vaccination & Titer
o Proof of immunity is required for all personnel who directly contact or manipulate non-human primates, or
who utilize measles virus in research. Reevaluation is required 10 years following original enrollment.
o Vaccination is required for personnel with direct contact with non-human primates who have not been
previously vaccinated or lack sufficient measles immunity as demonstrated by titer.
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Rabies Vaccination & Titer
o Rabies vaccination is required for individuals who fall into the highest risk categories (see Rabies
Protection Program SOP available at http://www.ehs.pitt.edu/biological/).
o Individuals who fall into high risk categories (i.e. individuals handling rabies virus or exposed animals)
must have their immunity evaluated via titer every six months.
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Hepatitis B Vaccination
o Offered to all employees with potential exposure to bloodborne pathogens.
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Tetanus/Diphtheria Toxoid Vaccination
o Offered to personnel who handle animals.