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Potentially Hazardous Biological Agents Rules (Colorado State University)

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Page 29
Potentially Hazardous Biological Agents Rules
Research using microorganisms (including bacteria, viruses, viroids, prions, rickettsia, fungi, parasites),
recombinant DNA technologies or human or animal fresh/frozen tissue, blood, or bodily fluids may involve
potentially hazardous biological agents.
When dealing with potentially hazardous biological agents,
it is the responsibility of the Student Researcher(s) and ALL
of the adults involved in a research project to conduct and
document a risk assessment (Form 6A on page 32) to define
the potential level of harm, injury or disease to PLANTS,
ANIMALS and HUMANS that may occur when working
with biological agents.
The risk assessment determines the biosafety level, which
in turn determines if the project can proceed, and if so, the
laboratory facilities, equipment, training and supervision
required.
All projects involving potentially hazardous biological
agents must be reviewed and approved BEFORE
experimentation begins by the appropriate review board:
IBC (for studies done at a research institution) or SRC (for
studies done in a school setting).
Experimentation involving the culturing of any
organism (even BSL-1) is PROHIBITED in a home
environment. Specimens may be collected at home or
other field sites as long as they are immediately
transported to a laboratory with the appropriate BSL
containment as determined by the school/local SRC.
Specimen collection sites must be de-identified on the
project board (use labels like Site A, B, etc.)
The initial risk assessment determination done by the
Student Researcher/Team Leader and Qualified
Scientist/Mentor must be confirmed by the appropriate
review board.
Student Researchers must be trained in standard microbiological practices.
Once the study has been approved, if the Student Researcher has any proposed changes to the methods
and/or procedures, they must repeat the review process before continuing with data collection/
experimentation.
ALL PHBAs must be properly disposed of, by the Designated Supervisor or Qualified Scientist/Mentor,
at the end of experimentation in accordance with their biosafety level. Acceptable disposal methods for
BSL-1 and BSL-2 organisms include:
o Autoclave at 121°C for 20 minutes;
o Use of a 10% bleach solution (1:10 dilution of domestic bleach);
o Incineration;
o Alkaline hydrolysis;
o Biosafety pick-up; or
o Other manufacturer recommendations.
Page 30
Potentially Hazardous Biological Agent Study Biosafety Levels (BSL)
BSL-1 - biological agents that pose low risk to personnel and the environment; highly unlikely to cause
disease in healthy laboratory workers, animals or plants
o BSL-1 research projects must be conducted in a BSL-1 or higher laboratory. This MAY be a
middle or high school science lab if it meets ALL of the standards for a BSL-1 lab (see the self-
certification form at http://www.csef.colostate.edu/Guidelines/Guidelines_BSL1.pdf).
o BSL-1 research projects must be reviewed by a Qualified Scientist/Mentor, but can be directly
supervised by a TRAINED Designated Supervisor at a verifiable BSL-1 laboratory.
o Examples of BSL-1 Organisms: Agrobacterium tumefaciens (soil bacteria), Micrococcus luteus,
Neurospora crassa (red bread mold), Bacillus subtilis (normal human gut bacteria).
o Examples of BSL-1 Studies (this is not an exhaustive list):
Studies involving naturally-occurring plant pathogens where they are not cultured or
introduced into the environment.
rDNA technology studies involving BSL-1 organisms and BSL-1 host vector systems (i.e.:
cloning of DNA in E. coli K-12, S. cerevisiae, and B. subtilis host vector systems).
Studies involving commercially available rDNA technology kits using BSL-1 organisms.
Studies of mold growth on food items where the project is NOT terminated at the first sign
of mold.
Studies involving unknown microorganisms collected from the environment as long as
ALL of the following conditions are followed:
Culturing is done in a plastic Petri dish and is SEALED.
The Petri dish remains SEALED throughout the experimentation.
The SEALED Petri dish is disposed of via autoclaving or disinfection by the
Designated Supervisor or Qualified Scientist/Mentor.
Studies involving genome editing with possible biological impact, including alteration of
germline cells.
Studies that insert antibiotic resistant markers for the clonal selection of bioengineered
organisms.
BSL-2 - biological agents that pose moderate risk to personnel and the environment; exposure in a lab
situation would result in limited risk of spreading and it would rarely cause infection that would lead to
serious disease; in the event that infection occurs, treatment and preventive measures are available
o BSL-2 research projects must be conducted in a BSL-2 or higher laboratory. This is usually a
regulated research institution, but a high school science lab MAY QUALIFY if it meets ALL of
the standards for a BSL-2 lab (see the self-certification form at
http://www.csef.colostate.edu/Guidelines/Guidelines_BSL2.pdf).
o BSL-2 research projects must be reviewed and directly supervised by a Qualified Scientist/Mentor
at a verifiable BSL-2 laboratory.
o Examples of BSL-2 Organisms: Mycobacterium (typically found in water and food sources),
Steptococcus pneumoniae (part of the normal upper respiratory tract flora), Salmonella
choleraesuis (typically found in raw food sources such as eggs and meat).
o Examples of BSL-2 Studies (this is not an exhaustive list):
Studies culturing known MRSA, VRE and KPC can only be done at a Regulated Research
Institution and must include written justification for their usage with documented IBC
review and approval.
Studies that select and subculture antibiotic-resistant organisms. Use EXTREME
CAUTION when doing this type of project.
Studies that culture human or animal waste (including sewage sludge).
Studies that insert antibiotic resistant markers for the clonal selection of bioengineered
organisms.
Page 31
rDNA technology studies using BSL-1 agents that may convert to BSL-2 agents during the
course of experimentation.
rDNA technology studies involving BSL-2 organisms and/or BSL-2 host vector systems.
Studies involving unknown organisms collected from the environment where the culturing
container (Petri dish) is opened for any purpose (except for disposal disinfection).
BSL-3 – biological agents that usually cause serious disease (human, animal or plant) or that can result in
serious economic consequences
BSL-4 – biological agents that usually produce very serious disease (human, animal or plant) that is often
untreatable
Prohibited PHBA Studies:
Research that cultures Carbapenem Resistant Enterbacteriacae (CRE).
Genetically engineered organisms with multiple drug resistance traits with the intended purpose of
investigating the pathology or treatment of antibiotic-resistant infections.
Insertion of antibiotic-resistant traits or selection of organisms expressing traits that may affect the ability
to provide effective treatment of infections acquired by humans, animals or plants.
BSL-3 AND BSL-4 research projects.
Propagation of recombinant containing DNA coding for human, plant or animal toxins (including viruses).
The introduction or disposal of non-native, genetically-altered and/or invasive species, pathogens, toxic
chemicals or foreign substances into the environment.
Studies Exempt from Prior SRC Review/Approval
The following types of studies are exempt from prior SRC review and approval, but MUST be included on the
Risk Assessment Form 3.
Studies involving baker’s yeast and brewer’s yeast, except in rDNA studies.
Studies involving Lactobacillus (starter cultures for controlled fermentation), Bacillus thurgensis
(typically found in insecticides), nitrogen-fixing/oil-eating bacteria, and algae-eating bacteria introduced
into their NATURAL ENVIRONMENT. None of these studies are exempt if they are cultured in a
Petri dish.
Studies involving water or soil where the Student Researcher(s) is not purposely culturing bacteria.
Studies of mold growth on food items, IF the experiment is TERMINATED at the first sign of mold.
Studies of mushrooms and slime molds.
Studies involving E. coli k-12 which are done at school and are not rDNA studies.
Studies involving protists or archaea.
Studies using manure for composting, fuel production or other non-culturing experiments.
Studies involving the use of commercially-available color change coliform water test kits. These kits must
remain sealed and be properly disposed.
Studies involving the decomposition of vertebrate organisms (such as in forensic projects).
Studies with microbial fuel cells.
Page 32
- Potentially Hazardous Biological Agents Form (6A)
This form is required for ALL projects involving microorganisms, rDNA, fresh/frozen tissue, blood, blood
products and body fluids. SRC/IACUC/IBC approval is required PRIOR to experimentation.
This form is to be completed by the Qualified Scientist/Mentor in collaboration with the Student Researcher/Team
Leader. All questions MUST be answered and additional pages may be attached.
Student’s Name(s):
Project Title:
1. Identify ALL of the potentially hazardous biological agents to be used in this experiment. Include where you obtained
them, how much you are using and the biosafety level of each one.
2. Where will you be conducting the experimentation? Include the level of biosafety containment available at each site.
3. How will you minimize any risk associated in working with these agents? (What personal protective equipment will
you be wearing, what type of hood is being used, will you be sealing the Petri dishes and not opening them, etc.?)
4. The final biosafety level I recommend for this project is: □ BSL-1 or □ BSL-2
5. How are you going to dispose of all cultured materials and other potentially hazardous biological agents?
6. What training will the Student Researcher(s) receive?
7. What experience/training does the Designated Supervisor (for BSL-1 studies only) have as it relates to the student’s
area of research?
Qualified Scientist/Mentor: (check only 1 certification statement below)
□ I certify that the experimentation was not conducted at a Regulated Research Institution, but was conducted at a (check one)
BSL-1 or BSL-2 laboratory. The study has been reviewed by the local or school SRC and the procedures have been approved
PRIOR to experimentation. OR
□ I certify that the experimentation was conducted at a Regulated Research Institution and was approved by the appropriate institutional
board PRIOR to experimentation. Institutional approval forms are attached. Date of IACUC/IBC Approval: OR
□ I certify that the experimentation was conducted at a Regulated Research Institution that does not require pre-approval for this type of
study. The local or school SRC has reviewed that the student received appropriate training and the project complies with the CSEF
Middle School rules.
Qualified Scientist’s Printed Name Qualified Scientist’s Signature Date of Acknowledgement (mm/dd/yy)
To be completed by the local or school Scientific Review Committee.
The SRC has seen this project’s research plan and supporting documentation and acknowledges the accuracy of the
information provided above.
SRC Chair’s Printed Name SRC Chair’s Signature Date of Approval (mm/dd/yy)
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Completed 22 October 2020

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