Regulatory Resources and Guidance
The IBC would like investigators and research staff to be aware of the following resources:
- National Institutes of Health (NIH):
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Centers for Disease Control (CDC)
- Biosafety in Microbiological and Biomedical Laboratories
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Select Agent Regulations:
- Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73 HHS Final Rule)
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HHS Regulations:
- Interstate Shipment of Etiologic Agents (42 CFR Part 72)
- Etiologic Agent Import Permit Program (42 CFR Part 71)
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Department of Labor Occupational Safety & Health Administration (OSHA)
- Occupational exposure to bloodborne pathogens (29CFR Part 1910.1930)
- Bloodborne Pathogen and Needle Stick Prevention Program (OSHA 29 CFR 1910.1030)
- Letter of Interpretation on Established Human Cell Lines
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U.S. Department of Agriculture (USDA-APHIS)
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Biotechnology Regulation Services (BRS)
- Permits - for introduction of GE organisms
- Notifications – to submit a notification
- Report an accidental release of genetically modified organism
- Plant Pest Program Information
- Agricultural Select Agent Program
- Biotechnology Title IV Plant Protection Act Introduction of Organisms altered or produced through Genetic Engineering which are Plant Pests or which there is reason to believe are Plant Pests (7 CFR, Section 340)
- Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins (7 CFR 331, 9 CFR 121 USDA Final Rule)
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Biotechnology Regulation Services (BRS)
- ATCC guidance for use of human cell lines (search by keyword - biohazard)
- IATA Guidance on Infectious Substances
- American Biological Safety Association (ABSA) Risk Group Classification
- Lab Disinfectant Reference Table
State Regulations
- New York State Department of Health: Title 10 Part 61
- New York State Public Health Law: Article 32 - (3200-3203) Live Pathogenic Microorganisms and viruses
- New York State Public Health Law: Article 32A - (3220-3223) Recombinant DNA experiments