Rules for Potentially Hazardous Biological Agents

1. The use of microorganisms (including bacteria, viruses, viroids, prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA) technologies or human or animal fresh tissues, blood, or body fluids is allowable under the conditions and rules that follow. All of these areas of research may involve potentially hazardous biological agents and require special precautions.
   
   
2. An appropriate review and approval committee (SRC, IBC, RAC, IACUC) must approve all research before experimentation begins. The initial risk assessment determined by the student researcher and adults supervising the project must be confirmed by the SRC.
   
   
3. Experimentation with potentially hazardous biological agents, even BSL-1 organisms, is prohibited in a home environment. However, specimens are allowed to be collected at home as long as they are immediately transported to a laboratory with the appropriate level of biosafety containment.
   
   
4. A risk assessment must be conducted by the student and adult supervisors prior to experimentation and a final biosafety level should be determined or confirmed by the SRC.
   
   
5. Research determined to be at Biosafety Level 1(BSL-1) may be conducted in a BSL-1 or higher laboratory. The research must be supervised by a qualified scientist or a trained designated supervisor. The student must be properly trained in standard microbiological practices.
   
   
6. Research determined to be a Biosafety Level 2 (BSL-2) MUST be conducted in a laboratory rated BSL-2 or above (commonly found in a regulated research institution) and must be reviewed and approved by the Institutional Biosafety Committee (IBC) or equivalent approval body at the research institution. The research must be supervised by a Qualified Scientist. The student researcher must receive extensive training, demonstrate competency and be directly supervised while conducting microbiological procedures.
   
   
7. Research determined to be biosafety levels 3 or 4 is prohibited for precollege students.
   
   
8. Studies intended to produce or genetically engineer bacteria with multiple antibiotic resistance are prohibited. Extreme caution should be exercised when selecting out antibiotic resistant organisms and studies using such organisms require at least BSL-2 containment.
   
   
9. All potentially hazardous biological agents must be properly disposed of at the end of experimentation in accordance with their biosafety level. Following are acceptable procedures for disposal of cultured materials: Autoclaving at 121 degrees Celsius for 20 minutes, use of 10% sodium hypochlorite, incineration and alkaline hydrolysis.
   
   
10. Studies involving baker's yeast and brewer's yeast are exempt from these rules except when involved with rDNA studies.
    
    
11. Any proposed changes in the Research Plan (1A) and Attachment by the student after initial SRC approval must have subsequent SRC or IBC review and approval before such changes are made and before experimentation resumes.
    
    
12. The following forms are required:
    1. Checklist for Adult Sponsor
    2. Research Plan (1A) and Attachment
    3. Approval Form (1B)
    4. Regulated Research Institution Form (1C) - if applicable
    5. Qualified Scientist Form (2) - if applicable
    6. Designated Supervisor Form (3) - if applicable
    7. Hazardous Risk Assessment Form (6A)
    8. Human and Vertebrate Animal Tissue Form (6B) - for all studies involving body fluids and tissues