Answer:
Rules for ALL Studies with Potentially Hazardous Biological Agents (PHBA)
1. Prior review and approval is required for the use of potentially hazardous microorganisms (including bacteria, viruses, viroids, prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA) technologies or human or animal fresh/frozen tissues, blood, or body fluids:
2. An affiliated fair SRC, an IBC or an 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, IBC or IACUC.
3. Experimentation involving the culturing of potentially hazardous biological agents, even BSL-1 organisms, is prohibited in a home environment. However, specimens may be collected at home as long as they are immediately transported to a laboratory with the BSL containment determined by the affiliated fair SRC.
4. Research determined to be at Biosafety Level 1 (BSL-1) must be conducted in a BSL-1 or higher laboratory. The research must be supervised by a trained Designated Supervisor or a Qualified Scientist. The student must be properly trained in standard microbiological practices.
5. Research determined to be a Biosafety Level 2 (BSL-2) must be conducted in a laboratory rated BSL-2 or above (commonly limited to a Regulated Research Institution). The research must be reviewed and approved by the Institutional Biosafety Committee (IBC) if the Regulated Research Institution requires the review. The research must be supervised by a Qualified Scientist. For a high school BSL-2 laboratory, the SRC must review and approve. The research must be supervised by a Qualified Scientist.
6. Students are prohibited from designing or participating in BSL- 3 or BSL-4 Research.
7. Laboratory studies designed to culture known clinically significant multidrug resistant organisms (MDROs) must have a written justification for usage and be conducted at a Regulated Research Institution laboratory with a minimum of BSL-2 containment and documented IBC review and approval. Representative examples include, but are not limited to the following known agents: MRSA (Methicillin- Resistant Staphylococcus aureus), VISA/VRSA (Vancomycin Intermediate or Resistant Staphylococcus aureus), VRE (Vancomycin-Resistant Enterococci), CRE (Carbapenem Resistant Enterobacteriacae), ESBLs (Extended Spectrum Beta-Lactamase producing gram negative organisms), and fungi (yeasts or molds) with known resistance to antifungal agents.
8. Insertion of antibiotic resistance markers for the clonal selection of bioengineered organisms is permitted, with the following exceptions:
Students are prohibited from the insertion of antibiotic-resistance traits or selection of organisms expressing traits that may affect the ability to provide effective treatment of infections acquired by humans, animals, or plants.
Students are prohibited from designing or selecting for multiple drug resistant organisms (MDROs) to investigate the pathology, development, or treatment of antibiotic-resistant infections.
9. Extreme caution must be exercised when selecting and sub-culturing antibiotic-resistant organisms. Studies using such organisms, including BSL-1 organisms that may have originally been exempt from prior SRC approval, require at least BSL-2 containment.
10. The culturing of human or animal waste, including sewage sludge, is considered a BSL-2 study.
11. Naturally-occurring plant pathogens may be studied (not cultured) at home, but may not be introduced into a home/garden environment.
12. All potentially hazardous biological agents must be properly disposed at the end of experimentation in accordance with their biosafety level. For BSL 1 or BSL 2 organisms: Autoclave at 121 degrees Celsius for 20 minutes, use of a 10% bleach solution (1:10 dilution of domestic bleach), incineration, alkaline hydrolysis, biosafety pick-up and other manufacturer recommendations are acceptable.
13. Any proposed changes in the Research Plan by the student after initial local or affiliated fair SRC approval must undergo subsequent SRC or IBC review and approval before such changes are made and before experimentation resumes.
14. The following forms are required:
Checklist for Adult Sponsor (1), Student Checklist (1A), Research Plan, and Approval Form (1B)
Regulated Research Institution Form (1C) – when applicable.
Qualified Scientist (2), when applicable
Risk Assessment (3), when applicable
PHBA Risk Assessment Form (6A), when applicable
Human and Vertebrate Animal Tissue Form (6B) – for all studies involving tissues and body fluids.
Explanation:
