Guidelines and Regulations
- The National Institutes of Health (NIH) NIH Guideline for Research Involving Recombinant DNA Molecules (NIH Guidelines) mandates the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of Biological Research involving recombinant deoxyribonucleic acid (rDNA) and synthetic DNA molecules and specify practices for constructing and handling: (i) recombinant deoxyribonucleic acid (rDNA) molecules, and (ii) organisms and viruses containing rDNA molecules. Adherence to the NIH Guidelines is a requirement for all institutions receiving funding from the NIH.
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention is the guidance document for the practice for biosafety -- the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials.
- The NIH Office of Biotechnology Activities (OBA) promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. OBA accomplishes its mission through analysis, deliberation, and communication of scientific, medical, ethical, legal, and social issues.
- The Occupational Safety and Health Administration (OSHA) has established OSHA Bloodborne Pathogen Standard 1910.1030 for work with human blood and body fluids and tissue, primary cell lines and established cell lines that have not been proven to be free of bloodborne pathogens.
- Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. The U.S. lists of Select Agents and Toxins are maintained by the Departments of Health and Human Service and Agriculture, and are found in the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331). Possession of select agents (or toxins above identified thresholds) requires compliance with these Select Agent Regulations.
Compliance Quick Links