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IBC Federal Regulations
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
NIH Reporting Obligations
- Any spills, accidents or other incidents that result in breach of containment, environmental release or exposures to laboratory or other research personnel or animals to viruses, cells or organisms containing recombinant or synthetic nucleic acid molecules shall be reported to Institutional Biosafety Committee (IBC), NIH OSP, and if applicable, the Animal Facility Director and other appropriate authorities.
- Additional reportable violations include: failure to obtain or maintain IBC approval, or when necessary, NIH OSP approval for research subject to Section III-A and III-B of the NIH Guidelines, or failure to request approval to use lower containment as described in NIH OSP Review of Requests to Lower the Minimum Required Biosafety Containment Level for Research Subject to the NIH Guidelines.
Investigator Responsibilities under NIH Guidelines
Principal Investigators (PIs) are responsible for full compliance with the NIH Guidelines during the conduct of research involving recombinant or synthetic nucleic acid molecules.
Investigator Responsibilities under the NIH Guidelines (pdf)
CDC: Biosafety in Microbiological and Biomedical Laboratories (BMBL)
"The recommended practices, safety equipment and facility safeguards described in the BMBL are advisory. The intent was and is to establish a voluntary code of practice, one that all members of a laboratory community will together embrace to safeguard themselves and their colleagues, and to protect the public health and environment."
BMBL 6th EditionQUICK LEARN: BIOSAFETY LEVELS
Federal Select Agent Program
The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Regulatory Science and Compliance and the Animal and Plant Health Inspection Service/Division of Agricultural Select Agents and Toxins. The Federal Select Agent Program oversees the possession, use and transfer of select agents and toxins, which pose a threat to public, animal or plant health.
CDC & USDA FEDERAL SELECT AGENT PROGRAM
The following biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. An attenuated strain of a select agent or an inactive form of a select toxin may be excluded from the requirements of the Select Agent Regulations.