LISTEN TO THIS ARTICLE Play Pause Skip backwardsGo ten seconds backward Skip forwardsGo ten seconds forward Progress 1.0x Mute Unmute Volume is at 50% 00:00 06:04 1.0x Audio is AI-generated. Report an issue | Give feedback The National Institutes of Health (NIH) this week announced a yearlong effort to update its policies governing biological safety in research. The Biosafety Modernization Initiative, designed to expand on and improve guidelines the agency has relied on for nearly half a century, will begin this fall with a series of regional listening sessions. A draft policy, set to be published in winter or spring, will then be open to public comment. “NIH is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions,” agency Director Jayanta “Jay” Bhattacharya writes in a statement. The initiative, he adds, seeks to “modernize and strengthen biosafety policies, practices, and oversight to keep pace with the evolving risks posed by today’s rapidly advancing science and technology.” Some researchers welcome the plan. “Updating biosafety oversight is long overdue,” says David Gillum, a biosecurity expert at the University of Nevada, Reno who emphasizes he is speaking in his personal capacity. The existing NIH policies “were groundbreaking when introduced nearly 50 years ago,” he argues, “but the science has far outpaced them.” Gene-drive technology that can reshape organisms, for example, has become far more sophisticated—but no less controversial. Some scientists are also beginning to worry about the dangers of “mirror life,” the so far hypothetical idea of using mirror-image molecular building blocks to create new life forms. SIGN UP FOR THE AWARD-WINNING SCIENCEADVISER NEWSLETTER The latest news, commentary, and research, free to your inbox daily Sign up But Gillum and others also wonder how the new initiative will work in practice—and how it will fit into the confusing mosaic of other federal biosafety rules, including several new policies that President Donald Trump’s administration has proposed or implemented. “The devil is in the details,” Gillum says. The focus on so-called gold-standard science “is aspirational but vague,” he adds, creating uncertainty about the scope of what NIH plans to do. “It feels more like a political positioning move than a fully formed policy.” Many of NIH’s current biosafety rules are rooted in the controversy that erupted in the 1970s after scientists invented technologies allowing them to move DNA among distantly related organisms. In 1976, following the influential Asilomar Conference on Recombinant DNA, where scientists debated how the new technologies should be regulated, NIH introduced its foundational Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. They established standards for laboratory containment and practices and required institutions receiving NIH funding to set up Institutional Biosafety Committees (IBCs) to assess risks and potential hazards of specific experiments. The guidelines have since undergone multiple revisions, with the most recent version published in 2024. Advertisement Despite these periodic updates, the NIH guidelines remain narrowly focused on recombinant DNA. The new initiative, Bhattacharya writes, aims to “revamp biosafety oversight to address potential risks beyond recombinant or synthetic nucleic acid technologies.” “We really want to think more holistically about the biosafety risks of today,” says Lyric Jorgenson, who serves as associate director for science policy at NIH. That may include developing new policies focused on reducing risks associated with work involving unmodified organisms, she explains, or organisms modified using passaging techniques in animals rather than recombinant or synthetic methods. At the same time, some types of research covered by the current rules might now be seen as posing little risk and might no longer require as much oversight. In these cases, some 4000 existing IBCs may be able to review requests that are currently reviewed by NIH. As part of this new effort, NIH also seeks to “empower” IBCs, which Jorgenson notes are often “on the front lines” when it comes to addressing biosafety risks. But Gillum questions whether IBCs will also get more money and resources to do their jobs—and where such funding might come from. Gillum is also curious how the agency will determine what research qualifies as “low risk.” The language of the initiative is so broad, he adds, that it could conceivably encompass all biosafety—potentially leading to a major expansion of NIH’s regulatory authority far beyond its traditional focus on recombinant DNA. Work with unmodified pathogens, for example, has historically been regulated by the Centers for Disease Control and Prevention, with other types of research falling under the domain of the U.S. Department of Agriculture or the Food and Drug Administration. It is unclear whether and how the new NIH policy will overlap with those implemented by other federal agencies with a role in biosafety oversight. “Getting the bounds of oversight right is critical,” the NIH Office of Science Policy writes in a statement to Science, “and this is why we plan to undertake a large engagement effort to address these questions.” Ideally, Jorgenson says NIH’s initiative should be part of an effort to develop an “interlocking framework” of policies that governs biosafety across the federal government. Efforts to develop that broader framework, however, are currently in limbo. In May, for example, Trump signed an executive order asking funding agencies to tighten rules on one kind of risky pathogen research, known as gain-of-function research. And he ordered the White House’s Office of Science and Technology Policy (OSTP) to release a plan for revising or replacing existing policies on dual-use research (which can have both military and civilian uses) and overseeing the synthesis and sale of nucleic acid sequences that might be used to build bioweapons. OSTP and agencies have already missed the deadline for releasing those policies, however, creating uncertainty for researchers and regulators alike.