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1
CALIFORNIA STATE UNIVERSITY, FRESNO
BIOHAZARD USE AUTHORIZATION APPLICATION
Instructions:
Please use this form to register your work with biohazardous material and/or recombinant DNA.
You will need to reference the most current applicable guidelines.
• Download the NIH guidelines for work with recombinant DNA via the following link:
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
• Download the CDC publication “Biosafety in Microbiological and Biomedical Laboratories
(BMBL) via the following link: http://www.cdc.gov/biosafety/publications/bmbl5/
If you have any questions regarding the registration process, contact Environmental Health and Safety/
Risk Management at extension 8-7422.
SECTION A:
Date of Application: _________________
Type of application: New_____ Addendum _____
Principal Investigator/Instructor:
Phone # ______________________________ Email
Department/Mail Stop #:
Location of Instruction/Work/Storage Locations (Building, Room Numbers):
List of activities:
(use additional pages if necessary)
2
SECTION B:
Does your work involve the generation of recombinant DNA?
Yes __________ No __________ (Skip to Section C)
Please select all of the exempt categories below that apply to your recombinant DNA work.
___ rDNA molecules that are not in organisms or viruses
___ rDNA molecules that consist entirely of DNA segments from a single non-chromosomal or viral DNA
source
___ rDNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids
or viruses when propagated only in that host or when transferred to another host by well established
physiological means
___ rDNA molecules that consist entirely of DNA from a eukaryotic host, including its chloroplasts,
mitochondrial DNA, or plasmids when propagated only in that host or a closely related strain of the
same species
___ rDNA molecules that consist entirely of segments from different species that exchange DNA by
known physiological processes, though one or more may be a synthetic equivalent; see Appendices
A-I through A-VI of the NIH Guidelines for sublists of natural exchangers.
___ rDNA molecules that are not a significant risk to health or the environment as determined by the NIH
Director; see Appendix C of the NIH Guidelines for a detailed explanation of the following exemptions,
and please indicate which of the categories below apply to your work:
___ Recombinant DNA in tissue culture (Appendix C-I and C-IA)
___ Escherichia coli K-12 host-vector systems (Appendix C-II and C-II-A)
___ Saccharomyces host-vector systems (Appendix C-III and C-III-A)
___ Kluyveromyces Host-Vector Systems (Appendix C-IV and C-IV-A)
___ Bacillus subtilis or Bacillus lichenformis host-vector systems (Appendix C-V and C-V-A)
___ Extrachromosomal elements of gram positive organisms (Appendix C-VI and C-VI-A)
___ Purchase or transfer of transgenic rodents that require biosafety level1 (BSL 1) containment
(Appendix C-VII)
___ Generation of BL1 transgenic rodents via breeding (Appendix C-VIII)
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Experiments that require specific approval by both the NIH and the Institutional Biosafety Committee
(IBC) before initiation:
___ Transfer of a drug-resistance trait to microorganisms if such transfer might compromise use of the
drug therapeutically (see Section III-A-1-a for further information and examples).
Note: IBC, NIH Recombinant DNA Advisory Committee (RAC) review, and NIH Director review
andapproval are required before initiation.
___ Experiments Involving the Cloning of Toxin Molecules with LD
50
of Less than 100 nanograms per
Kilogram Body Weight (see Section III-B-1 for further information and examples).
Note: IBC approval and NIH review for containment determinations are required before initiation.
Experiments that require Institutional Biosafety Committee and Institutional Review Board approvals and
RAC review before research participant enrollment
___ Experiments involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from
recombinant DNA, into one or more human research participants (see Section III-C for further
information and examples).
Experiments that require approval by the IBC before initiation:
___ Experiments using human or animal pathogens (Risk Group 2-4 or restricted agents) as DNA source
or pathogenic host/vector systems (see Section III-D-1 for further information and examples).
___ Experiments in which human or animal pathogens (Risk Group 2-4 or restricted agents) are cloned in
nonpathogenic prokaryotic or lower eukaryotic host-vector systems (see Section III-D-2 for further
information and examples).
___ Experiments involving the use of infectious animal or plant viruses or defective viruses in the
presence of a helper virus in a tissue culture system (see Section III-D-3 for further information and
examples).
___ Experiments involving whole animals or plants (see Section III-D-4 and see Section III-D-5 for further
information and examples).
___ Experiments involving more than 10 liters of culture (see Section III-D-6 for further information and
examples).
___ Experiments involving influenza viruses (see Section III-D-7 for further information and examples).
Experiments that require IBC notice simultaneous with initiation of experiment:
___ Experiments involving the formation of recombinant DNA molecules containing no more than two-
thirds of the genome of any eukaryotic virus (see Section III-E-1 and Section III-F for further
information and examples).
___ Experiments involving whole plants (except those covered in the Section above; see Section III-E-2
and Section III-F for further information and examples).
___ Experiments involving transgenic rodents (see Section III-E-3 and Section III-F for further information
and examples).
SECTION C
Complete this section if your work involves the use of the following biohazardous materials:
bacteria, fungi, viruses, including oncogenic viruses, chlamydiae, parasites; human blood, blood products or
human tissues, primary human cell cultures, non-human primate blood or tissues; infected animals and animal
tissues; toxins (bacterial, plant fungi, etc.).
Does your work involve the use of above-mentioned biohazardous materials?
Yes __________ No __________ (Skip to Section D)
Is your work with biohazardous materials limited to Biosafety Level 1?
Yes No
(Only complete item 1 below) (Please complete items 1 – 7 below)
1. Name of biohazardous agent(s) (if known) or source of biohazardous source.
2. Brief description of human diseases caused by agent(s), if known.
3. Brief description of the research and use/manner in which agent(s) will be handled.
4. Proposed biosafety level and description of techniques.
5. List standard practices, equipment and facility requirements used to ensure containment (BSL 2 or
above) (see Appendix A for BSL2 checklist from BMBL, 4
th
edition; for all other BSL levels refer to
BMBL, 4
th
edition).
6. The method used for disinfection and disposal of the biological materials(s) and waste.
4
5
7. Please list largest volume, highest titer and frequency of use.
8. Does this project involve the use of experimental animals?
Yes No
SECTION D
Your signature below indicates that you acknowledge all requirements and restrictions of the most current
NIH/CDC guidelines for the biosafety level you have indicated above; that you accept responsibility for the safe
conduct of the experiments conducted at this biosafety level and that you have informed all associated personnel
of the conditions required for this work.
Signature of Investigator/ Instructor Date
SECTION E
I acknowledge that I have seen the Biohazard Use Authorization Application document and I agree to exercise
due diligence in ensuring compliance with the University’s Biosafety Policy.
Signature of Department Chair Date
SECTION F (Institutional Biosafety Committee only)
Comments:
Registration Accepted:
Yes No
Application Approved:
Yes No
Chairperson, Institutional Biosafety Committee Date
Please return completed form to the Office of Environmental Health and Safety/Risk Management,
Mail Stop PO-140, fax to extension 8-1153, or email to lisak@csufresno.edu.
Updated January 2013
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6
Appendix A
The following standard practices, safety equipment, and facility requirements apply to BSL-2:
Standard Microbiological Practices
□ The laboratory supervisor must enforce the institutional policies that control access to the laboratory.
□ Persons must wash their hands after working with potentially hazardous materials and before leaving the laboratory.
□ Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption must
not be permitted in laboratory areas.
□ Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.
□ Mouth pipetting is prohibited; mechanical pipetting devices must be used.
□ Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and broken glassware must be
developed and implemented. Whenever practical, laboratory supervisors should adopt improved engineering and
work practice controls that reduce risk of sharps injuries. Precautions, including those listed below, must always be
taken with sharp items. These include:
□ Careful management of needles and other sharps are of primary importance. Needles must not be bent, sheared,
broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.
□ Used disposable needles and syringes must be carefully placed in conveniently located puncture-resistant
containers used for sharps disposal.
□ Non-disposable sharps must be placed in a hard walled container for transport to a processing area for
decontamination, preferably by autoclaving.
□ Broken glassware must not be handled directly. Instead, it must be removed using a brush and dustpan, tongs, or
forceps. Plastic ware should be substituted for glassware whenever possible.
□ Perform all procedures to minimize the creation of splashes and/or aerosols.
□ Decontaminate work surfaces after completion of work and after any spill or splash of potentially infectious material
with appropriate disinfectant.
□ Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective
method.
□ Depending on where the decontamination will be performed, the following methods should be used prior to transport.
□ Materials to be decontaminated outside of the immediate laboratory must be placed in a durable, leak proof
container and secured for transport.
□ Materials to be removed from the facility for decontamination must be packed in accordance with applicable local,
state, and federal regulations.
□ A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious
agents are present. Posted information must include: the laboratory’s biosafety level, the supervisor’s name (or other
responsible personnel), telephone number, and required procedures for entering and exiting the laboratory. Agent
information should be posted in accordance with the institutional policy.
7
□ An effective integrated pest management program is required.
□ The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties,
the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive
annual updates or additional training when procedural or policy changes occur. Personal health status may impact an
individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all
laboratory personnel and particularly women of childbearing age should be provided with information regarding
immune competence and conditions that may predispose them to infection. Individuals having these conditions
should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.
Special Practices
□ All persons entering the laboratory must be advised of the potential hazards and meet specific entry/exit requirements.
□ Laboratory personnel must be provided medical surveillance, as appropriate, and offered available immunizations for
agents handled or potentially present in the laboratory.
□ Each institution should consider the need for collection and storage of serum samples from at-risk personnel.
□ A laboratory-specific biosafety manual must be prepared and adopted as policy. The biosafety manual must be
available and accessible.
□ The laboratory supervisor must ensure that laboratory personnel demonstrate proficiency in standard and special
microbiological practices before working with BSL-2 agents.
□ Potentially infectious materials must be placed in a durable, leak proof container during collection, handling,
processing, storage, or transport within a facility.
□ Laboratory equipment should be routinely decontaminated, as well as, after spills, splashes, or other potential
contamination.
□ Spills involving infectious materials must be contained, decontaminated, and cleaned up by staff properly trained
and equipped to work with infectious material.
□ Equipment must be decontaminated before repair, maintenance, or removal from the laboratory.
□ Incidents that may result in exposure to infectious materials must be immediately evaluated and treated according to
procedures described in the laboratory biosafety manual. All such incidents must be reported to the laboratory
supervisor. Medical evaluation, surveillance, and treatment should be provided and appropriate records maintained.
□ Animal and plants not associated with the work being performed must not be permitted in the laboratory.
□ All procedures involving the manipulation of infectious materials that may generate an aerosol should be conducted
within a
BSC or other physical containment devices.
Safety Equipment (Primary Barriers and Personal Protective Equipment)
□ Properly maintained BSCs, other appropriate personal protective equipment, or other physical containment devices
must be used whenever:
□ Procedures with a potential for creating infectious aerosols or splashes are conducted. These may include
pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening containers of infectious materials,
inoculating animals intranasally, and harvesting infected tissues from animals or eggs.
8
□ High concentrations or large volumes of infectious agents are used. Such materials may be centrifuged in the
open laboratory using sealed rotor heads or centrifuge safety cups.
□ Protective laboratory coats, gowns, smocks, or uniforms designated for laboratory use must be worn while working
with hazardous materials. Remove protective clothing before leaving for non-laboratory areas, e.g., cafeteria, library,
and administrative offices). Dispose of protective clothing appropriately, or deposit it for laundering by the institution.
It is recommended that laboratory clothing not be taken home.
□ Eye and face protection (goggles, mask, face shield or other splatter guard) is used for anticipated splashes or sprays
of infectious or other hazardous materials when the microorganisms must be handled outside the BSC or
containment device. Eye and face protection must be disposed of with other contaminated laboratory waste or
decontaminated before reuse. Persons who wear contact lenses in laboratories should also wear eye protection.
□ Gloves must be worn to protect hands from exposure to hazardous materials. Glove selection should be based on an
appropriate risk assessment. Alternatives to latex gloves should be available. Gloves must not be worn outside the
laboratory. In addition, BSL-2 laboratory workers should:
□ Change gloves when contaminated, glove integrity is compromised, or when otherwise necessary.
□ Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the
laboratory.
□ Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated laboratory waste. Hand
washing protocols must be rigorously followed.
□ Eye, face and respiratory protection should be used in rooms containing infected animals as determined by the
risk assessment.
Laboratory Facilities (Secondary Barriers)
□ Laboratory doors should be self-closing and have locks in accordance with the institutional policies.
□ Laboratories must have a sink for hand washing. The sink may be manually, hands-free, or automatically operated. It
should be located near the exit door.
□ The laboratory should be designed so that it can be easily cleaned and decontaminated. Carpets and rugs in
laboratories are not permitted.
□ Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces between benches, cabinets,
and equipment should be accessible for cleaning.
□ Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other
chemicals.
□ Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and
decontaminated with appropriate disinfectant.
□ Laboratory windows that open to the exterior are not recommended. However, if a laboratory does have windows that
open to the exterior, they must be fitted with screens.
□ BSCs must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations.
BSCs should be located away from doors, windows that can be opened, heavily traveled laboratory areas, and other
possible airflow disruptions.
□ Vacuum lines should be protected with liquid disinfectant traps.
9
□ An eyewash station must be readily available.
□ HEPA filtered exhaust air from a Class II BSC can be safely recirculation back into the laboratory environment if the
cabinet is tested and certified at least annually and operated according to manufacturer’s recommendations. BSCs
can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or directly exhausted
to the outside through a hard connection. Provisions to assure proper safety cabinet performance and air system
operation must be verified.
□ A method for decontaminating all laboratory wastes should be available in the facility (e.g., autoclave, chemical
disinfection, incineration, or other validated decontamination method).
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