Potentially Hazardous Biological Agents (PHBA)


    • Microorganisms (bacteria, viruses, viroids, prions, rickettsia, fungi & parasites)
    • Recombinant DNA (rDNA) technologies
    • Human or vertebrate animal fresh/frozen tissues, blood or body fluids

 

The Intel ISEF Scientific Review Committee has created this section of the rules to comply with current governmental regulations regarding research. The rules for projects involving microorganisms, rDNA technologies and human or animal fresh/frozen tissues, blood or body fluids are combined into this one section.



Exempt Projects

  • The following types of tissue are not considered to be hazardous, do not need Form 6A for PHBA or Form 6B for tissues, nor do they require prior SRC approval.  Safety issues still need to be discussed in the research plan and teachers can require that students be supervised by a Designated Supervisor:


    • Plant tissue
    • Established cell and tissue cultures (e.g. those obtained from the American Type Culture Collection).  The source and catalog number must be identified in the Research Plan when the project is submitted for competition.
    • Meat or meat by-products obtained from a grocery store, restaurant or packing house
    • ** NEW   Pasteurized milk and eggs
    • Hair (not still attached to the person or animal)
    • 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 recommended.)
    • Fossilized tissue or archeological specimens.
    • Prepared, fixed slides


  • The following studies are not considered hazardous, do not need Form 6A and do NOT require prior SRC approval. 

    • Baker’s or brewer’s yeast (except when involved with rDNA studies)
    • Experiments involving lactobacillus, Bacillus thurgensis, nitrogen-fixing, oil-eating bacteria , slime mold and algae-eating bacteria introduced into their natural environment.  (not exempt from SRC review if the organisms are cultured in a petri dish environment due to potential contamination)
    • ** NEW    Studies involving the growth of mold on food are exempt from review and may be conducted at home ONLY IF the experiment is stopped AS SOON AS any evidence of mold is found.  This rule change will help students who want to see which method of protection against mold works the best, but not those students who want to see how much mold, or what kind, can be grown.


  • The following studies are not considered hazardous, do not need Form 6A and do NOT require prior SRC approval.  They DO, however, require a Designated Supervisor, a risk assessment and the completion of the Risk Assessment Form (Form 3).
    • Projects using most protists, archae and microorganisms similar to these
    • Studies in which manure is used for composting or other experiments, such as fuel production, as long as the manure is not cultured
    • Commercially available color change coliform water test kits which will remain sealed and will be properly discarded



Prohibited Projects

  • The following types of projects are NOT ALLOWED by the MRSF or the Intel ISEF
    • Projects involving ANY PHBA, including BSL-1 organisms or environmental bacteria, which are cultured in a home environment.  Specimens may be collected in the home but then must be taken immediately to a lab with the proper biosafety level of containment for the experiment.

    • Experiments which are intended to genetically engineer (or create) bacteria with resistance to multiple antibiotics.  Students must be very cautious any time they work with a bacteria that has any type of resistance to antibiotics. 

    • Any project that would be considered a Biosafety Level 3 or 4, even if the lab is rated for that level of project.

 

All Remaining PHBA Projects:

Students are allowed to conduct research with potentially hazardous biological agents as long as the projects comply with the rules below. Teachers and/or Adult Sponsors need to be aware of the rules in order to ensure the safety of the students and to avoid disqualification of the project. 


General Rules for PHBA Projects 

For rules pertaining to specific types of PHBA projects see the links below.

  1.  All projects involving PHBA will include a risk assessment (Form 6A) which will define the potential level of harm, injury or disease to any humans, animals or plants that could come as a result of the experiment. Students and their teacher/adult sponsor must assign an initial biosafety level to the project when it is submitted to the SRC for prior approval.  The SRC will determine the final biosafety level.   The biosafety level determines the precautions that must be taken in the experiment and also the laboratory facilities, training and supervision that are required.

  2.  All projects involving any Potentially Hazardous Biological Agents must be reviewed and approved by the SRC, or an appropriate review board at a research institution, BEFORE experimentation begins. The SRC must confirm the initial biosafety level assigned as a result of the risk assessment.  No experiment may be started before the SRC approves the research plan.

  3. Plant pathogens which naturally occur in a home environment may be studied at home, but may not be cultured at home, nor can they be introduced into a home/garden environment.

  4. Projects that include the culturing of human or animal waste, including sewage sludge, must be considered a BSL-2 experiment.

  5. Experiments that are determined to be Biosafety Level 1 (BSL-1) may be conducted at a BSL-1 or higher laboratory.  The student must be supervised by a Qualified Scientist or a TRAINED Designated Supervisor and must be trained in standard microbiological practices.  Some schools may qualify as a BSL-1 lab if they have the proper equipment.  Check with the Coordinator for more details.
     
  6. Experiments that are determined to be a Biosafety Level 2 (BSL-2) MUST be conducted in a laboratory that is rated as a BSL-2 or higher.  Most regulated research institutions should be rated at this level, but the student should check to make sure.  See either the ISEF Guidelines for Biosafety Level 2 Laboratory Facilities & Operations or Classification of Biological Agents Risk Groups/Levels of Biological Containment to help determine if a lab meets BSL-2 requirements. 

    BSL-2 projects must be supervised by a Qualified Scientist.  The student must receive extensive training, demonstrate competency and be directly supervised while conducting microbiological procedures.
  7. Projects involving MRSA (Methicillin resistant Staphylococcus aureus) and VRE (Vancomycin-resistant enterococci) must be conducted in a Registered Research Institution under the direct supervision of a Qualified Scientist.

  8.  BSL-2 projects which are conducted in a regulated research institution (VCU, etc.) must be reviewed and approved by the Institutional Biosafety Committee (IBC) or an equivalent approval body at the institution before the experiment begins.  If the institution does not review this type of project then a letter to that effect from a representative of the institution must be included with a Research Proposal which is submitted to the Fair SRC before the start of the experiment.

  9. Disposal of PHBA at the end of the experiment must be in accordance with their biosafety level.  Students must include the method of disposal in their Research Proposal which is submitted to the SRC before the start of the experiment.  The following methods are acceptable for disposal of cultured materials:

    • Autoclaving at 121 degrees Celsius for 20 minutes
    • Use of 10% sodium hypochlorite (chlorine bleach)
    • Incineration
    • Alkaline hydrolysis
    • Biosafety pickup


The Research Proposal that is submitted to the SRC must include the following:

  • Checklist for Adult Sponsor (Form 1),
  • Student Checklist (Form 1A)
  • Research Plan that includes all of the elements in Section #3 of the Research Plan Instructions.
  • Approval Form (Form 1B)
  • Qualified Scientist (Form 2), when required
  • PHBA Risk Assessment Form (Form 6A) (no need to send Form 3 in addition to Form 6A)
  • Human & Vertebrate animal Tissue Form (Form 6B), for studies involving tissues and body fluids
  • Any other applicable forms (Form 7)

Form 1C for research done in a regulated research institution is not sent at this time.  This form is filled out and signed AFTER the research is completed.


Links to Additional Rules & Information:

 

Recombinant DNA (rDNA)

 

Unknown Microorganisms (including environmentally collected bacteria)


Human or Vertebrate Animal Tissue (including blood & urine)

              

Classification of Biological Agents Risk Groups/Levels of Biological Containment

 

Risk Assessment

 


Sources of Information:

American Biological Safety Association: 
ABSA Risk Group Classification – list of organisms
http://www.absa.org/resriskgroup.html

American Type Culture Collection

800-638-6597

http://www.atcc.org

Bergey’s Manual of Systematic Bacteriology
Follow the links to “Resources” for a collection of international web sites of microorganisms and cell cultures.
http://www.bergeys.org

Canada - Agency for Public Health

List of non-pathogenic organisms
http://www.phac-aspc.gc.ca/ols-bsl/pathogen/organism_e.html

CDC-NIH Biosafety in Microbiological & Biomedical Laboratories
Office of Health & Safety
Centers for Disease Control & Prevention
1600 Clifton Rd., N.E. Mailstop F05
Atlanta, GA 30333
http://www.cdc.gov/od/ohs/biosfty/biosfty.htm

Microorganisms for Education Web site

List of organisms deemed "safe" for classroom use.
http://www.science-projects.com/safemicrobes.htm

NIH Guidelines for Research Involving Recombinant DNA Molecules
Published by National Institutes of Health
http://www4.od.nih.gov/oba

OSHA
Occupational Heath & Safety Administration
The link “Laws, Regulations & Interpretations” provides a comprehensive and easy to use reference for current OSHA standards.
http://www.osha.gov/

World Health Organization

Laboratory Safety Manual - 3rd Edition

http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf
Updated 10/22/2010