Projects Involving Potentially Hazardous Biological Agents
Some research projects may involve working with potentially hazardous biological agents. Examples are projects that use microorganisms (including bacteria, viruses, viroids, prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA) technologies, or human or animal fresh tissues, blood, or body fluids. To insure the safety of student researchers and their home and school environments, many fairs require pre-approval of projects involving potentially hazardous biological agents.
Projects Not Requiring Pre-approval
"The following types of tissue do not need to be treated as potentially hazardous biological agents" (Science Service, 2009):
- Studies involving baker's yeast and brewer's yeast, except when involved with rDNA studies
- Studies involving Lactobacillus, Bacillus thurgensis, nitrogen-fixing, oil-eating bacteria, slime mold, and algae-eating bacteria introduced into their natural environment. Not exempt if cultured in a Petri dish environment that could potentially be contaminated.
- Studies of mold growth on food items if the experiment is terminated at the first evidence of mold.
- Plant tissue
- Meat or meat by-products obtained from food stores, restaurants, or packing houses
- Teeth that have been sterilized to kill any blood borne pathogen that may be present. Chemical disinfection or autoclaving at 121 degrees Celsius for 20 minutes is a recommended procedure.
- Fossilized tissue or archeological specimens
- Prepared fixed tissue slides.
The following types of studies do not need SRC review, but you will need to complete the Risk Assessment Form:
- Studies involving most protists, archae and similar microorganisms
- Research using manure for composting or other non-culturing experiments and fuel production
- Commercially-available color change coliform water test kits which will remain sealed and will be properly disposed.
Projects Requiring Pre-Approval
If you are participating in a fair that follows the Intel International Science and Engineering Fair (ISEF) rules, your project involving potentially hazardous biological agents (microorganisms, recombinant DNA (rDNA) technologies, or human or animal fresh tissues, blood, or body fluids) must be reviewed by officials from your fair before you start. These officials are called a Scientific Review Committee (SRC). The SRC reviews a risk assessment that you prepare and assigns a biosafety level to the project. Projects are either deemed to not be a biological hazard at all, biosafety level 1 (BSL-1) or biosafety level 2 (BSL-2). Projects found to be more hazardous than BLS-2 are prohibited.
Often school science fairs and fairs for the primary grades or middle school rely on the teacher's judgment to insure safety, so their rules might be different. For complete information, consult the rules for your local fair, or the ISEF Rules and Guidelines.
Direct Supervision Is Required
For ISEF-affiliated fairs, all experiments involving hazardous biological agents must be carried out under the direct supervision of a competent scientist who understands the risks associated with the agents involved OR an adult designated and trained by that scientist. In ISEF jargon, these adult supervisors are called the Qualified Scientist or the Designated Supervisor. The Qualified Scientist must certify that the Designated Supervisor has been adequately trained and also understands the risks associated with working with the agents involved.
A Risk Assessment Is Required
The student and adults involved in the project are required to think ahead about the possible hazards that the project might involve. This analysis is called a risk assessment. The risk assessment will be reviewed by the SRC as part of the pre-approval process. The goal of your risk assessment is to determine the risk level of the project, which ISEF rules define as the potential level of harm, injury or disease to plants, animals and humans that may occur when working with biological agents. Projects will be assigned a biosafety level, that assignment will determine if and where a project can be conducted.
The following projects are not allowed due to excessive health and safety concerns:
- Projects determined to be biosafety level 3 or 4
- Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited.
Where Projects Can Be Carried Out:
To ensure the health and safety of the student and the environment there are strict regulations about where projects involving potentially hazardous biological agents can be performed. Specific rules and guidelines may vary from fair to fair. If your project involves It is best to check with your local fair and the ISEF rules and guidelines before experimenting.
Depending on the level of health and safety concerns, a project with biological agents may be conducted one of three places:
- At home
- In a biosafety level 1 (BSL-1) lab; most high school laboratories qualify as BSL-1 but confirm this with your school officials before starting experiments
- In a biosafety level 2 (BSL-2) lab; found at research institutions such as universities
Have your fair's SRC review your risk assessment forms and assign your project a biosafety level. The biosafety level will determine where the project can be carried out. In general these rules apply:
- Projects can be carried out at home if they:
- Only involve substances listed (under Projects Not Requiring Pre-Approval) that do not need to be treated as potentially hazardous biological agents.
- Potentially hazardous biological agents, including unknown bacteria, may be collected at home but must be immediately transported to a BSL-1 or BSL-2 laboratory. No culturing of potentially hazardous biological agents is allowed at home.
- Involve only self sampling of bodily fluids. For example, self sampling of blood for a glucose test
- Projects require a BSL-1 laboratory if they:
- Require handling or collection of BSL-1 microorganisms such as Escherichia coli strain K12, Agrobacterium tumifaciens, Micrococcus leuteus, Neurospora crassa, Bacillus subtilis.
- Involve culturing unknown bacteria. However, the Petri dishes must remain sealed. If the Petri dishes are to be opened, the project must be conducted in a BLS-2 lab.
- Include the collection and/or examination of fresh/frozen tissue and/or body fluids from non-infected sources. To qualify as BLS-1 these tissues and fluids must have little likelihood of being contaminated with microorganisms. Blood must be treated as BLS-2. (Self-sampled capillary blood is an exception and can be collected and examined at home.)
- Projects require a BLS-2 laboratory if they:
- Involve interacting with unknown bacteria.
- Involve the collection and/or examination of blood. Sampling of one's own capillary blood is an exception; it can be collected and examined at home.
- Include the collection and/or examination of fresh/frozen tissue and/or body fluids that may contain microorganisms.