By David Gillum, Gregory D. Koblentz, Rebecca Moritz , Antony Schwartz, January 17, 2025
Editor’s note: This is part of a package of memos to the president.
A MEMORANDUM FOR THE PRESIDENT
SUBJECT: A UNIFIED APPROACH TO BIOLOGICAL RISK
Mr. President, as officials, scientific experts, and the public have grappled with the potential that high-risk laboratory research could cause a pandemic like COVID-19 or worse, the study and manipulation of high-consequence pathogens have come under a bright spotlight. At the same time, emerging and re-emerging infectious diseases from nature are ever threatening to disrupt the nation’s health and economy. While the Department of Health and Human Services has taken action in recent years, among other things by developing a new oversight framework for reviewing risky research, more should be done. You will the opportunity to save taxpayer dollars, improve government efficiency, and ensure that risky research with pathogens is subject to the highest level of technical scrutiny. You should establish a Unified National Biosafety and Biosecurity Agency to make certain that federal agencies act in unison to confront emerging biological risks. .
Such an agency would address critical gaps in the current oversight system and provide a centralized framework for protecting the nation from biological risks, including another pandemic. Current government biosafety and biosecurity oversight is fragmented, with responsibilities divided among multiple federal agencies: the Centers for Disease Control and Prevention (CDC); the National Institutes of Health (NIH); the US Department of Agriculture (USDA); and others. This decentralized approach has led to inconsistent requirements about which funding sources and pathogens and biological toxins are regulated. And regulations are often not rooted in evidence-based risk assessments. The fragmentation of oversight has also created unclear lines of authority and significant differences in interpretation of regulations and compliance enforcement among agencies. For example, overlap select agents—a category of high-consequence pathogens that are regulated by both the CDC and the USDA—are subject to incongruent regulatory interpretations by inspectors from diverse backgrounds dealing with human and animal health consequences.
A unified agency would provide clarity, consistency, and coordination. It would provide a “one-stop shop” for researchers and institutions in the government, academia, and the private sector subject to federal oversight. It would set national standards for biosafety and biosecurity practices, streamline oversight of high-risk research among the various agencies that engage in this work, and aid agencies responsible for biological threat response. A new unified agency could make sure the National Institute of Allergy and Infectious Disease (NIAID) and the Defense Advanced Research Projects Agency (DARPA) are on the same page in regard to biosafety and biosecurity oversight of pathogen research. The new agency would conduct, and sponsor applied research in biosafety and biosecurity, administer a comprehensive incident reporting and investigation system, provide education, training, and workforce development, lead efforts to share best practices, and conduct risk assessments of emerging technologies that could affect biosafety or biosecurity. It would also centralize training and certification programs to ensure all personnel and facilities handling dangerous pathogens are adequately credentialed and evaluated.
Beyond addressing weaknesses present in our system, a unified biosafety and biosecurity agency would save taxpayer dollars by consolidating activities at the federal level into one agency and removing redundancies. By creating such an agency, you would position the United States as a global leader in how to manage necessary high-risk biological experiments—ensuring our country is a leader in advancing a safe and secure bioeconomy—while better preparing the country for pandemics.
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