President Joe Biden’s administration has proposed updated rules governing risky research, excluding avian influenza and current forms of SARS-CoV-2, the virus that causes COVID-19.
The new “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” defines which research would require a formal risk-benefit assessment by U.S. officials before being conducted.
The research can involve creating, transferring, or altering a pathogen of pandemic potential (PPP).
The council also said that the highly pathogenic avian influenza strain H5N1, which recently jumped to cattle and infected at least one human this year, and the Ebola virus are not potential pandemic pathogens.
Critics said the exclusions were nonsensical.
SARS-CoV-2 “currently is causing a pandemic,” Richard Ebright, a chemistry and chemical biology professor at Rutgers University, wrote on the social media platform X.
H5N1, meanwhile, is “currently infecting cattle in multiple states and being monitored for pandemic potential,” he said.
Mr. Ebright, who holds a doctorate in microbiology and molecular genetics, said that the policy “is absurdly complex and has opaque, confusing, and self-contradictory definitions.” He said that “malfeasant researchers and research administrators will be able to violate the new policy at will and with impunity.”
Some other scientists said that the proposed framework was a welcome improvement from prior versions, citing how it expanded the list of pathogens covered under “Category 1” from 15 to 90. That list includes the swine fever virus.
“It also ensures that oversight for ”Category 2“ research -- ie research that creates a pathogen with pandemic potential with at least moderate virulence -- occurs not only at the pre-funding stage but also throughout the life cycle of the project,” Jaime Yassif, vice president of the Nuclear Threat Initiative, a nonprofit described as being focused on “reducing nuclear and biological threats imperiling humanity,” said on X.
If research falls into “Category 2,” the department funding it must carry out a review of the research. For the research to happen, the department must assess whether the potential benefits outweigh the potential risks to society, that there are no feasible alternatives with less risk, and that the scientists who want to conduct the research have the capability to carry out it responsibly.
Federal officials said they were promulgating the updated policy to strengthen oversight of risky research, under the White House’s 2022 National Biodefense Strategy and Implementation Plan and a 2023 congressional funding bill.
Dr. Monica Bertagnolli, the NIH’s director, said in a statement that the policy balances oversight while allowing scientists to work.
“This policy ushers in a new era of oversight that will support the nation’s ability to be prepared to counter biological threats, enhance pandemic preparedness, and achieve global health security,” she said.
The policy is currently set to take effect on May 6, 2025.
The policy guidance outlines scenarios in which SARS-CoV-2 and Ebola could become pathogens with enhanced pandemic potential (PEPP), a subcategory of PPP.
The original strain of SARS-CoV-2 “would be characterized as a PPP due to lack of population immunity and effective medical countermeasures,” according to the guidance.
Additionally, if a SARS-CoV-2 strain “were genetically modified to enhance transmissibility, virulence, and disrupt [the] effectiveness of pre-existing immunity in humans,” or if significant alterations were made to Ebola, such as enhancing its transmissibility, it could result in PEPPs, the council said.
Category 2 covers research that involves or could result in PPPs and, per federal agencies or research institutions, “is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.”
For the first time, the term “reasonably anticipated” is defined as “an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in question would expect this outcome to occur with a non-trivial likelihood.” The guidance says, “It does not require high confidence that the outcome will definitely occur and excludes experiments in which experts would anticipate the outcome to be technically possible, but highly unlikely.”
