IBC Resources

Biosafety Manual

The purpose of this manual is to define the biological safety policies and procedures pertaining to research operations at Boston University and Boston Medical Center. These policies and procedures are designed to safeguard personnel and the environment from biologically hazardous materials and to comply with federal, state, and local regulatory requirements. All BU and BMC principal investigators and laboratory workers must adhere to the biological safety policies and procedures in the conduct of their research and the management of their laboratories.

Regulations

Boston Public Health Commission: Biological Laboratory Regulations

The Boston Public Health Commission Biological Laboratory Regulations govern labs using biological agents and recombinant DNA in the city of Boston.

Centers for Disease Control and Prevention

Provides more resources on biosafety guidelines, such as Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Dual Use Research of Concern and Pathogens with Pandemic Potential

Dual Use Research of Concern and Pathogens with Pandemic Potential are a focal point for the development of policies addressing life sciences research that yield information or technologies with the potential to be misused to threaten public health or national security.

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

The NIH guidelines provide the IBC with the standards that guide containment and safe reserach practices for recombinant DNA research. The Recombinant DNA Program promotes scientific advancement and safety in the conduct of basic and clinical recombinant DNA research.

Office of Biotechnology Activities (OBA)

The NIH Office of Biotechnology Activities (now under the Office of Science Policy or OSP) promotes science, safety, and ethics in the development of public policies in three areas: Biomedical Technology Assessment, Biosafety and Biosecurity.

Select Agents

Federal Select Agent Program

The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services/Agricultural Select Agent Program. The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins which have the potential to pose a severe threat to public, animal, or plant health, or to animal or plant products.

Agricultural Select Agent Program

APHIS issues permits for the import, transit, and release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms.

Final rule on Possession, Use, and Transfer of Select Agents and Toxins

Provides current select agent regulations and official interpretation of a specific provision regarding the select agent regulations.

IBC Minutes

Boston University IBC Meeting Minutes are available in redacted form here.

Risk Group

Risk Group Definitions

The investigator must make an initial risk assessment based on the Risk Group of an agent. Agents are classified into four Risk Groups according to their relative pathogenicity for healthy adult humans by the following criteria: More information can be found in the Appendix B of NIH Guidelines.

Risk Group 1

Agents that are not associated with disease in healthy adult humans

Risk Group 2

Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Risk Group 3

Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4

Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual and high community risk)

As a general rule, a biosafety level (BSL) should be used that matches the highest risk group classification of the agents involved.

Where to find the risk group of a specific pathogen?

US Department of Health and Human Services Risk Group Classification for Infectious Agent

Public Heath Agency of Canada Pathogen Safety Data Sheets and Risk Assessment

NIH OBA NIH Guidelines (Appendix B)