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Reform US Oversight Of Research On Dangerous Pathogens

Title: Biosafety Now: Reform US oversight of research on dangerous pathogens

Date:

Dear [Elected Representative],

I urge you to support measures to reform US oversight of research on dangerous pathogens. Reform is urgently needed to reduce the risk that research on dangerous pathogens could unintentionally trigger a lab-generated pandemic.

Existing US oversight of research on dangerous pathogens has four critical weaknesses.

  1. There are no US regulations with force of law for biosafety of research on pathogens other than select agents. Instead, federal biosafety oversight involves only unenforced guidelines.
  2. There are no US regulations with force of law for biorisk management of research on pathogens other than smallpox virus. Instead, federal biorisk management involves only an unused policy framework.
  3. Current US oversight of biosafety for pathogens other than select agents and biorisk management for pathogens other than smallpox virus applies only to federally funded research. Privately funded research is not covered.
  4. Current US oversight of biosafety and biorisk management is undermined by systemic conflicts of interest. Responsibility for oversight is assigned to federal agencies that perform research and fund research, and almost all actual oversight is delegated to, and left to the discretion of, researchers and their institutions.

To protect the public from the threat of lab-generated pandemics, four changes to US oversight should be implemented:

  1. Regulations with the force of law should be implemented for biosafety and biorisk management of all research on all pathogens.
  2. Regulations should apply to all research, independent of funding source.
  3. Responsibility for oversight should be assigned to an independent federal agency—a federal agency that does not perform research and does not fund research. The Nuclear Regulatory Commission provides a model.
  4. The US should encourage other nations to implement similar regulations and oversight mechanisms, and should advocate for assigning the oversight of biosafety and biorisk management for the highest-risk subset of research on pathogens to an international agency. The WHO Advisory Committee on Variola Virus Research, which currently oversees biosafety and biorisk management for research on smallpox virus, provides a model.

I look forward to hearing your opinion on this matter.

Sincerely,

[Your Name]