Potentially Hazardous Biological Agents (PHBA)


    • Microorganisms (bacteria, viruses, viroids, prions, rickettsia, fungi & parasites)
    • Recombinant DNA (rDNA) technologies
    • Human or vertebrate animal fresh 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 tissues, blood or body fluids are combined into this one section.


  • The following types of tissue are not considered to be hazardous, do not need Form 6A for PHBA or 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 should 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
    • 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 PHBA 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).  This is a change from last year.
    • Baker’s or brewer’s yeast (except when involved with rDNA studies)
    • 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.
    • Experiments involving lactobacillus, bacillus thurgensis, nitrogen-fixing, oil-eating bacteria and algae-eating bacteria introduced into their natural environment.  Studies are not exempt from SRC review if the bacteria are cultured in a petri dish environment since that could potentially be contaminated.



All 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 are below. For rules pertaining to specific types of PHBA projects, Risk Assessment & the Classification of Biological Agents Risk Groups see the links below.

 

  1. All projects involving PHBA will include a risk assessment, 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 teachers/adult sponsors must assign an initial biosafety level to the project when it is submitted to the SRC for prior approval. The biosafety level determines the precautions that must be taken in the experiment and also the laboratory facilities, training and supervision that are required.

 

  1. All projects involving any Potentially Hazardous Biological Agents must be reviewed and approved by the Fair 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.

 

  1. No experimentation with a PHBA, even those that are rated as Biosafety Level 1 (BSL-1), may be conducted at HOME.  Samples may be collected at home as long as they are immediately transported to a laboratory with the required biosafety level.  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.  This is a change from last year.

 

  1. 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.

 

  1. 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. 

 

  1. BSL-2 projects must be reviewed and approved by the Institutional Biosafety Committee (IBC) or an equivalent approval body at the institution or by the Fair SRC before the experiment begins.  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.

 

  1. Any research that is determined to be a BSL- 3 or BSL- 4 is not allowed.

 

  1. Experiments that are designed to produce bacteria with multiple antibiotic resistances are not allowed.  If working with organisms that are antibiotic resistant, students must use caution and maintain at least BSL-2 containment measures.

 

  1. Disposal of PHBA at the end of the experiment must be in accordance with their biosafety level.  The following methods are acceptable for disposal of cultured materials:

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

 

Links to Additional Rules & Information:

 

Recombinant DNA (rDNA)

 

Unknown Microorganisms (including environmentally collected bacteria)


Human or Vertebrate Animal Tissue (including blood & urine)

               This section was inadvertently left out.  For now, please refer to the ISEF rules on Tissue projects at http://www.sciserv.org/isef/rules/rules11.pdf, page 2, section C


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

The Mad Scientist Network

at Washington University School of Medicine

http://www.madsci.org

 8/28/07