Federal Oversight

Much of the pathogen research conducted at UW–Madison is regulated by the federal government. Regulations prescribe requirements around safety training, security, facilities, documentation and reporting.

Safety Practices

The CDC maintains the Biosafety in Microbiological and Biomedical Laboratories manual, which describes best practices for biosafety and biosecurity measures.

Regulations

As an institution that receives research funds from the National Institutes of Health (NIH), UW-Madison is subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines specify safety practices and containment levels for research involving pathogens containing recombinant or synthetic DNA or RNA.

The Federal Select Agent Program, jointly administered by the Centers for Disease Control and Prevention (HHS) and the Animal and Plant Health Inspection Service (USDA), regulates laboratory work with certain pathogens or toxins deemed to have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.

Policy Information

The National Institutes of Health (NIH) Office of Science Policy sets and enforces certain policies that pertain to pathogen research, particularly around biosafety and biosecurity.

Education

The Administration for Strategic Preparedness and Response, an HHS entity, helps coordinate biorisk management education across federal agencies and labs working with federally regulated pathogens.