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University of Nevada, Reno
Memorandum of Understanding and Agreement on
Use of Biological Agents and Recombinant DNA in Teaching Laboratories
PRIMARY INSTRUCTOR:
PRIMARY INSTRUCTOR’S TITLE:
DEPARTMENT:
TELEPHONE NUMBERS (office):
; (labs):
E-MAIL ADDRESS:
By signing below I certify that I agree to conduct the teaching laboratories covered by this
protocol in compliance with current guidelines regarding use and disposal of recombinant DNA
and biological agents and toxins as specified in the NIH Guidelines for Research Involving
Recombinant DNA Molecules, the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories, the UNR Biosafety Manual, and the UNR Bloodborne Pathogens Exposure Control
Plan (go to Safety Policies and Manuals for UNR safety plans).
As the primary instructor I accept responsibility for the health and safety of all employees
and unpaid students involved in the teaching laboratories covered by this MOUA and its scope
of work. Additionally, I certify that I have read the following statements and agree that all
employees and unpaid students working under this protocol will comply with these statements:
* Personnel have received or will receive appropriate safety training (including lab-specific and
experiment-specific training) prior to working in the laboratory.
* EH&S will be notified (327-5040, 24 hr/day) as soon as possible of laboratory associated
injuries or illnesses and spills or environmental releases of hazardous materials.
* Worker's Compensation will be notified of laboratory-associated injuries and illnesses (or
exposures) involving employees or unpaid students.
* Approval from the IBC will be requested for any modifications to biological agents or toxins,
facilities, or procedures by submitting an amendment to the approved MOUA.
Signature of Primary Instructor
Date
Signature of Department Chair
Date
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LABORATORY COURSE(S) COVERED BY MOUA:
List the prefix, number, and title of each course covered by this MOUA (e.g., MICR 276L,
Introduction to Microbiology Laboratory).
LABORATORY INSTRUCTOR(S):
List the name, job title, and academic department of the primary faculty instructor and all other
faculty instructors for each course covered by this MOUA. If teaching assistants will provide
instruction and supervision of individual laboratories without a faculty instructor present,
indicate this fact; however, individual names do not need to be listed.
1.
BIOLOGICAL AGENT(S) AND RECOMBINANT DNA TO BE USED:
Check all that apply:
Microbial agents (bacteria (including eubacteria), archaea, viruses, fungi, parasites)
Lentiviral Vectors (if lentiviral vectors will be used, MOUA Supplement 1 must be
submitted with this MOUA).
Recombinant DNA (check all that apply)
Specify the section(s) of the NIH Guidelines that correspond to the proposed recombinant DNA
research:
IBC and NIH Approval Required Before Initiation
Section III-A: Transfer of drug resistance to microorganisms
Section III-B: Cloning of genes coding for toxins with a LD50 less than 100 ng/kg
IBC, IRB, and NIH Approval Required Before Initiation
Section III-C: Transfer of recombinant DNA to humans (gene therapy)
IBC Approval Required Before Initiation
Section III-D-1: Use of Risk Group 2 or above agent as host-vector system
Section III-D-2: DNA from Risk Group 2 or above agent is cloned into a host-vector system
Section III-D-3: Use of infectious viruses (> 2/3 of viral genome) in tissue culture
Section III-D-4: Experiments involving whole animals (BL2-N or greater)
Section III-D-5: Experiments involving whole plants (BL2-P or greater)
Section III-D-6: Greater than 10 liters of culture
IBC Notification (MOUA submittal) Simultaneous With Initiation
Section III-E-1: Formation of recombinant DNA containing less than 2/3 of an eukaryotic
viral genome
Section III-E-2: Experiments involving whole plants (BL1 only)
Section III-E-3: Experiments involving transgenic rodents (BL1 only)
Exempt From NIH Guidelines
Section III-F: Specify applicable section of NIH Guidelines
Toxins or toxic products (produced by biological agents)
CDC or USDA Select Agent (Click here for list)
Humans, human blood, human body fluids, human tissues, or human cells/cell lines#
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Animals (non-human except insects), animal blood, body fluids, tissues, or cells
Plants, plant tissues, plant cell culture, or eukaryotic algae
#
Arthropods (e.g., insects, arachnids; insect or arachnid tissues; or insect or arachnid cell
cultures)
All employees or registered volunteers that have exposure to unfixed human tissue, or human cells or tissue culture requires
inclusion in the UNR Bloodborne Pathogens Program. This is not required of students (non-employees) participating in an academic
class. Contact Ben Owens (x5196) or Mike Kivistik (x4981) of EH&S for additional information.
For each laboratory course covered by this MOUA, list all agents and the biosafety containment
level (BSL) assigned to each agent (including biological toxins). Include preserved stocks (even
if not currently in use), and organisms and toxins “inherited” from other laboratories or faculty
members. Indicate current use status (currently in use or only preserved stock).
--------------------------------------------------------------------------------------------------------------------If introducing foreign DNA or RNA into a gene expression system, indicate the source DNA or
RNA, and any expected toxic gene products. If not, indicate “NA.”
Source DNA or RNA:
Expected toxic gene products:
Location of use (for each course indicate the lab(s), and site(s) within lab if restricted):
Location of storage:
If biological agents are stored in a freezer that is located in either the Howard Medical Sciences (HMS) freezer room
(140) or the Fleischmann Agriculture (FA) freezer room (229), please indicate here the building and freezer number
(as indicated on the freezer room maps for HMS 140 and FA 229). Additionally, please print a copy of the relevant
freezer room map, label the appropriate freezer, and attach the map to the completed MOUA form.
Period/Frequency of use:
Quantity (give typical and maximal culture volumes, number of organisms, etc.):
List any permits required (e.g., CDC or USDA Import or Export, CDC or USDA Select Agent
Registration). For each permit indicate the agency or group issuing the permit; the agents,
materials, and work covered by the permit, and expiration date (if no permits are required
indicate “none”).
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For sections 2 through 10, provide a response for each separate laboratory course
covered by this MOUA. If the response for multiple courses is similar a single
response can be provided; however, indicate each course for which the response
applies.
2.
LABORATORY SUMMARY
Provide a short summary (no more than 2 – 3 sentences) of the work to be conducted that
describes the overall purpose and goals.
--------------------------------------------------------------------------------------------------------------------3.
LABORATORY PROCEDURES:
Provide an overview of the laboratory procedures associated with each biological agent, and the
biosafety practices to be used. Provide sufficient detail to allow the IBC to evaluate the risks
and proposed biosafety containment levels and procedures.
--------------------------------------------------------------------------------------------------------------------4.
BIOLOGICAL HAZARDS
For the biological agents and recombinant DNA to be used, describe the following. a) the
hazards of the materials with respect to humans, animals, plants, and the environment. If
agents are considered low risk (BSL1), briefly describe why this is the case (do not simply
indicate not applicable); b) The infectivity (or toxicity for toxins), and routes of transmission to
humans, the risk to humans from exposure, and symptoms that an infected person may display.
--------------------------------------------------------------------------------------------------------------------5.
a.
Personal Protective Equipment:
EXPOSURE CONTROL PROCEDURES:
b.
Engineered Containment Devices:
c.
Facility Controls:
Safety glasses
Disposable gloves
Face shield
Other (specify)
Biosafety cabinet (show location on lab
map; see Section 10)
Fume hood (specify use)
Other (specify)
Hand washing available*
Room
air
HEPA
filtered
exhausted to outside
Centrifuge safety
cups/rotors
Negative room pressure
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Lab coat
One-pass ventilation
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d.
Administrative Controls:
Door sign*
Lab-specific safety training for
employees and students*
Procedures for sharps collection and
disposal
EH&S laboratory safety training for
employees*
Written safety procedures for employees
and students*
* Required for all labs using any biological agents
Describe any additional controls used to protect personnel, animals, and plants from inadvertent
exposure to the agent(s), with consideration of unknown infectious agents (e.g., potential
unidentified agents in primary tissue or cells).
--------------------------------------------------------------------------------------------------------------------6.
SECURITY
a. Describe security procedures used to prevent unauthorized access to the agent(s) or
release of viable material to the environment (e.g., laboratory locked when not occupied,
storage freezers locked, security swipe cards, security cameras, etc.).
--------------------------------------------------------------------------------------------------------------------b. Describe procedures used to account for the agent(s) and to detect missing material (e.g.,
monthly inventory of biological materials).
--------------------------------------------------------------------------------------------------------------------7.
a.
DECONTAMINATION AND DISPOSAL:
Chemical Disinfectants for Decontamination of Surfaces and Equipment:
Ethanol (70%)
Phenolic*
Bleach (10%
household bleach)
Quaternary
ammonium*
Iodophore*
Other* (specify)
* mix and use according to manufacturer’s instructions
If any BSL-2 or BSL-3 pathogens (human, animal, or plant) are used or present, specify
chemical disinfectants and concentrations used for decontamination of surfaces and equipment.
---------------------------------------------------------------------------------------------------------------------
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b.
Biohazardous Waste Decontamination:
Autoclave# (indicate location)
Bleach*
Sanitary Sewer (small quantities of blood/body fluids)
# A minimum autoclave time of 60 minutes is required by regulation for decontamination of biohazardous waste.
* The only chemical disinfectant allowed by regulation for treatment of biohazardous waste (liquid microbial
cultures and stocks) is sodium hypochlorite at a minimum final concentration of 5,000 ppm and a minimum 30
minutes residence time. A concentration of 5,000 ppm can be achieved by a 1/10 final dilution of consumer
bleach (5-6% sodium hypochlorite). Sodium hypochlorite solutions used to treat spore-forming pathogenic
organisms must be pH adjusted to 7 prior to treatment (must be freshly prepared).
If biological toxins are used, describe deactivation and disposal procedures (for chemical
treatment include residence time). If no toxins are used, indicate “none.”
--------------------------------------------------------------------------------------------------------------------8.
EMERGENCY PROCEDURES:
Standard response and reporting procedures for incidents involving personnel exposure to
biological agents, or spills or releases of biological agents, are described in chapters 10 and 11
of the UNR Biosafety Manual.
a. Location of nearest eyewash:
b. Indicate response procedures for personnel exposure incidents involving biological agents
covered by this MOUA.
--------------------------------------------------------------------------------------------------------------------The standard response procedures described in the UNR Biosafety Manual have been
reviewed, are judged to be adequate, and will be implemented as needed.
Additional or alternative response procedures are needed and are described below.
c. Indicate response procedures for spills or releases of biological agents covered by this MOUA.
--------------------------------------------------------------------------------------------------------------------The standard response procedures described in the UNR Biosafety Manual have been
reviewed, are judged to be adequate, and will be implemented as needed.
Additional or alternative response procedures are needed and are described below.
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9.
MONITORING PROCEDURES:
a. List vaccinations* and medical surveillance required for the work covered by this MOUA,
including animal handlers#.
--------------------------------------------------------------------------------------------------------------------Vaccinations:
hepatitis B
tetanus
other (specify)
Describe applicable medical surveillance and personnel sampling procedures or indicate “not
applicable” as appropriate.
* Employees and registered volunteers exposed to human fluids, cells, or unfixed tissue (or other sources of HIV or
#
HBV) must take UNR's bloodborne pathogens training annually and be offered the Hepatitis B vaccination, which
they may decline.
Employees and registered volunteers included in the animal handlers program must be offered the tetanus
vaccination, which they may decline.
b. Describe applicable laboratory and environmental monitoring or indicate “not applicable” as
appropriate.
--------------------------------------------------------------------------------------------------------------------10.
FACILITY OPERATIONAL PROCEDURES:
Describe any special facility access control measures, controlled areas, and other special
facility/laboratory procedures not normally associated with standard laboratories.
--------------------------------------------------------------------------------------------------------------------11.
LAB MAP:
Attach a floor plan of each laboratory that shows the following: 1) where the agent(s) will be
cultured, incubated, and stored; 2) location of biological safety cabinets and other safety
equipment; and 3) any special room ventilation features not included in standard laboratories
(including items marked in Section 4, Facility Controls).
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12.
INSTITUTIONAL BIOSAFETY COMMITTEE APPROVAL
The procedures and facilities described in this document have been reviewed by the University
of Nevada, Reno (UNR) Institutional Biosafety Committee (IBC). The IBC considers the
procedures and facilities listed to be appropriate for the described project, and consistent with
NIH and UNR guidelines. The IBC, in conjunction with the Environmental Health and Safety
Department, will monitor the procedures, facilities, and training of personnel.
Signature of IBC Chair
Protocol Activation Date
Protocol Termination Date
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