A panel’s recommendations earlier this year to tighten U.S. rules for funding research on dangerous pathogens sparked concerns that some of the changes would hamper routine studies important to public health. Now, the White House is looking at ways to narrow the swath of federally funded research that would undergo the heightened reviews proposed in a final report released in March by the National Science Advisory Board for Biosecurity (NSABB).
A notice posted today in the Federal Register by the Office of Science and Technology Policy (OSTP) seeks comments by 16 October on a range of issues, including the following.
Dual-use research
Current U.S. policy on pathogen research requires special reviews by local institutional committees and funding agencies if the proposed studies are considered “dual-use research of concern” (DURC)—the results from them could, in theory, be used to cause harm. The existing policy covers just seven types of experiments, such as those that would make a pathogen resistant to drugs, involving only 15 pathogens or their toxins.
But NSABB recommended expanding the reviews beyond those 15 “select agents” to cover proposals to study any human, animal, or plant pathogen in the seven types of experiments. One scientist has called this “a potential for disaster” because it would require reviews of routine, relatively low-risk studies, such as certain experiments on cold viruses and viruses modified to fight cancer.
Today’s White House notice suggests that, instead, institutions could limit DURC reviews to the standard select agents and other pathogens so risky that they must be studied in facilities with the highest biocontainment conditions, known as biosafety level-3 and biosafety level-4 laboratories.
Gain of function
An existing Department of Health and Human Services (HHS) policy, known as the Potential Pandemic Pathogen Care and Oversight (P3CO) framework, requires a high-level government review of potential gain-of-function (GOF) research, where the concern is that scientists may modify already dangerous pathogens in ways that make them riskier. It currently limits such reviews to pathogens that are likely to be both highly transmissible and highly virulent, such as certain experiments with H5N1 avian influenza
NSABB recommended expanding the HHS policy to include pathogens that are only “moderately” transmissible and/or virulent. Supporters of that idea note, for example, that the SARS-CoV-2 virus is not covered by the policy because it kills less than 1% of people it infects. Such examples underscore the idea that even moderately virulent pathogens can cause a global pandemic, backers of expanding the policy say. Like the DURC proposals, however, the recommendation has drawn an outcry from microbiologists concerned about overreach.
To limit the P3CO policy, the White House notice suggests including only respiratory pathogens, which can be spread through the air or in saliva droplets. But that change would exclude research on deadly viruses such as Ebola, which is transmitted by contact with body fluids, and the less potent but fast-spreading strain of mpox that spread globally this year mainly through sexual contact. (A proposed GOF experiment on mpox has stirred controversy in the past year.)
Vaccine and surveillance research
The current P3CO policy exempts from review GOF studies involving pathogen surveillance, such as monitoring of flu viruses in wildlife, and vaccine development or production. For example, vaccine developers must create versions of viruses that grow well in cells to make vaccines. And to find out whether SARS-CoV-2 vaccines will work against new variants, company researchers have added the surface protein from those variants to the original SAR-CoV-2 virus.
NSABB recommends removing this exemption. Critics of that move worry it would impede the public health response to pandemics. The White House notice asks for feedback on whether some exemptions should remain, for example for vaccine production.
The definition of “reasonably anticipated”
The current DURC and P3CO definitions cover studies “reasonably anticipated” to result in some undesirable outcome, such as creation of a potential pandemic pathogen. Some policy experts and a federal watchdog have said the “reasonably anticipated” standard is too vague.
The OSTP notice suggests a lengthy definition for “reasonably anticipated” that specifies that “an individual with scientific expertise relevant to the research in question would expect this outcome.” Although the definition would “not require high confidence that the outcome will definitely occur,” it would exclude “technically possible, but highly unlikely” outcomes.
The White House also seeks input on adding “in silico” research to the policies, which would cover efforts using computers to design a new, dangerous pathogen. The final DURC and P3CO policies are due out in December.
The American Society for Microbiology, which has raised concerns about the NSABB recommendations, “welcomes the RFI [request for information] and the opportunity it offers for the community to weigh in on how the NSABB recommendations could be implemented and how current policies, grounded in science, should be updated to enable vital research on pathogens in the U.S. to continue while ensuring appropriate oversight and security guardrails,” says Mary Lee Watts, director of federal affairs for the society.
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