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Requirements for Potentially Hazardous Biological Agent Projects

SAMPLE COMPLETED FORM 6A's

See a sample Form 6A for a project where the SRC has determined the risk level of the study is BSL-1.

See a sample Form 6A for a project where the SRC has determined the risk level of the study is BSL-2.

See a sample Form 6A for a project where the research was done at a regulated research institution.

SAMPLE COMPLETED FORM 6B's

See a sample Form 6B for a project that that is using human and/or vertebrate animal tissue. Form 1C Form 1C

Tips for Forms & Projects:

Projects incorporating microorganisms (including bacteria, viruses, viroids, prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA) technologies or human/animal fresh tissues, blood or bodily fluids may involve working with potentially hazardous biological agents. All of these types of projects must complete a Potentially Hazardous Biological Agents Form 6A.

When dealing with potentially hazardous biological agents, it is the responsibility of the student and all of the adults involved in a research project to conduct a risk assessment. Risk assessment defines the potential level of harm, injury or disease to plants, animals or humans that may occur when working with biological agents.

Experimentation with potentially hazardous biological agents is prohibited in a home environment. This means absolutely NO CULTURING may be done at home, but COLLECTION may be done there.

Research with unknown microorganisms can be treated as a Biosafety Level-1 (BSL-1) study under the following conditions:

  • Organism is cultured in a plastic Petri dish and sealed.
  • Experiment involves only procedures in which the Petri dish remains sealed throughout the experiment.
  • The sealed Petri dish is disposed of via autoclaving or disinfection by the Designated Supervisor.

If a culture is opened for identification, sub-culturing or isolation, it must be treated as a Biosafety Level-2 (BSL-2) study and involve BSL-2 laboratory procedures and equipment.

Not all schools are equipped with the proper safety equipment and procedures to do even BSL-1 studies. To see what is required to for each safety level, view the Intel ISEF Rules and Guidelines for BSL-1 self-certification and BSL-2 self-certification for details. A high school laboratory is not typically considered a BSL-2 lab. The CSEF or Intel ISEF SRC may request a completed self-certification checksheet in order to verify the biosafety level of the laboratory.

The following types of studies are exempt from prior SRC review, are not considered Potentially Hazardous Biological Agent studies and do not require additional forms:

  • Studies involving baker's yeast and brewer's yeast, except when used with rDNA studies.
  • Studies involving Lactobacillus, Bacillus thurgensis, nitrogen-fixing, oil-eating bacteria and algae-eating bacteria introduced into their natural environment. (Not exempt if cultured in a petri dish environment.)
  • Studies of mold growth on food items IF the experiment is terminated at the first evidence of mold.

The following types of studies are exempt from prior SRC review, are not considered Potentially Hazardous Biological Agent studies, but do require a Risk Assessment Form 3:

  • Studies involving protists, archae and similar microorganisms.
  • Research using manure for composting, fuel production or other non-culturing experiments.
  • Commercially-available color change coliform water test kits which will remain sealed and will be properly disposed.
  • Studies involving decomposition of vertebrate organisms (such as forensic projects).

There are additional rules that apply to projects that involve tissues and body fluids, including blood and blood products. These types of projects must ALSO complete a Human and Vertebrate Animal Tissue Form 6B.

  • Established human and/or non-human primate cell lines and tissue culture collections must be treated according to the source's BSL information and catalog numbers included in the research plan.
  • If tissue is obtained from an animal that was sacrificed for a purpose other than the student's project, it can be considered a tissue study and Form 5B does not need to be completed. Documentation of the Institutional Animal Care and Use Committee (IACUC) approval for the original animal study from which the tissue was obtain is required however.
  • If the animal was euthanized solely for the student's project, the study must be considered a Vertebrate Animal project and is subject to the vertebrate animal rules for studies conducted at a regulated research institution and a Form 5B must also be completed.
  • All studies involving human or wild animal blood or blood products must be considered a BSL-2 study and involve BSL-2 laboratory procedures and equipment under the supervision of a Qualified Scientist.
  • All studies involving domestic animals may be considered a BSL-1 study.
  • Human breast milk of unknown origin, unless certified free of HIV and Hepatitis C and domestic unpasteurized animal milk must be considered BSL-2 agents.
  • Studies of human body fluids, where the sample can be identified with a specific person, must ALSO be considered a Human Subjects project and have IRB review and informed consent. Students may use their own body fluid without review and consent.
  • Studies involving embryonic human stem cells must be conducted at a regulated research institute and reviewed and approved by the Embryonic Stem Cell Research Oversight Committee.

The following types of tissue do not need to be treated as potentially hazardous biological agents:

  • Plant tissue;
  • Plant and non-primate established cell lines and tissue culture collection where the source and/or catalog number of the cultures have been identified in the research plan;
  • Fresh or frozen meat, meat by-products, pasteurized milk or eggs obtained from food stores, restaurants, or packing houses;
  • Hair;
  • Teeth that have been sterilized to kill any blood borne pathogen that may be present;
  • Fossilized tissue or archeological specimens; and
  • Prepared fixed tissue.

Any study involving agents belong to the BSL-3 or BSL-4 groups ARE NOT ALLOWED AT ALL!!! BSL-3 contains agents that usually cause serious disease or that can result in serious economic consequences (i.e.: West Nile virus, equine encephalitis virus, Riskettsia riskettsii, SARS coronavirus, etc.). BSL-4 contains agents that usually produce disease that is often untreatable (i.e.: hemorrhagic fevers, Ebola virus, etc.).

SRC approval is needed BEFORE laboratory/data collection begins.

Read more about ISEF rules regarding Potentially Hazardous Biological Agents projects.

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Last modified 11/6/14