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COVID: Biosafety Legislation Gets Political

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

In March 2021, three members of Congress sent a long letter to the director of the National Institutes of Health, the country’s premier funder of biomedical research. The lawmakers help lead a House subcommittee overseeing public health, and they wanted details about the agency’s support of coronavirus research in Wuhan, China, site of the first reported cases of Covid-19.

Their concerns about that research — and its possible role in the pandemic’s origin — were growing more mainstream. Days earlier, a group of 26 scientists and biosecurity experts had called for an investigation into a possible lab leak. In the coming weeks, a chorus of prominent scientists, including the head of the World Health Organization, would make similar appeals.

Conspicuously absent from the Congressional letter — and subsequent requests from the subcommittee — were the signatures of any Democrats. The omission seemed illustrative of a broader dynamic: The pandemic has brought unprecedented public attention to the safety practices of laboratories that work with dangerous pathogens. But it has also polarized a conversation about lab security that, until recently, was largely bipartisan — in the process leaving Congressional Democrats hesitant to engage publicly on biosafety and biosecurity issues, according to some analysts. (Biosafety deals with laboratory accidents and biosecurity with intentional breaches.)

“Understanding how this pandemic started is one of the most important public health questions of our time — and it is necessary to prevent future pandemics,” wrote Rep. Cathy McMorris Rodgers, who signed the House letter along with her colleagues Morgan Griffith and Brett Guthrie, in a statement to Undark earlier this year. “We continue to urge our Democrat colleagues to join us in our pursuit for the truth,” the statement said, adding that the committee “has a tradition over many years of bipartisan oversight into biolabs.”

At stake are questions about what lessons, exactly, the United States should learn from a pandemic that has now killed more than 1 million Americans. In the biosafety and biosecurity world, some observers hope that this moment will prompt substantial reforms to an oversight system they describe as patchy, poorly enforced, and ill-equipped to handle new kinds of research.

Amid partisan gridlock in Washington, however, another possibility looms: That, having lived through a devastating pandemic that some scientists believe could have emerged from a high-security laboratory, policymakers may actually expand such research in order to prepare for future pandemics — but without substantive changes to oversight.

Reforms are receiving “a lot more attention,” said Gregory Koblentz, a biodefense expert at George Mason University. But, he added, “the part that really concerns me right now is this kind of hyper-partisan polarization of this issue, which might make it harder to translate the level of concern that people are expressing into an effective policy response.”

Today, the U.S. has hundreds of laboratories equipped to deal with deadly pathogens, including 10 active facilities rated at the highest level of security, or BSL-4, which can handle some especially dangerous pathogens. These labs allow scientists to do crucial biomedical research, helping fight threats like Covid-19. In some cases, scientists enhance a pathogen’s ability to spread or infect people in order to study it — a practice often called gain-of-function research.

Experts sometimes compare work with the most dangerous pathogens to nuclear power: Both fields offer benefits (low-carbon electricity, insights into diseases.) And, in both areas, a single major safety incident could trigger a catastrophe.

An independent federal agency, the Nuclear Regulatory Commission, oversees nuclear activities in the U.S. Nothing similar exists for pathogens. Oversight is “really just composed of a patchwork, with no single entity in charge, which creates gaps in regulations, gaps in guidance, gaps in leadership, gaps in science that aren’t being addressed,” said Rocco Casagrande, a co-founder of Gryphon Scientific, a research and consulting firm that often works with government agencies.

The Federal Select Agent Program, run by the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, regulates research on certain pathogens, such as Ebola and anthrax. In the past, independent government auditors have described the program’s oversight as incomplete and beset with conflicts of interest. Other research, including work on dangerous influenza strains and some coronaviruses, isn’t subject to those regulations, governed instead by a set of guidelines, with minimal oversight from the NIH.

The part that really concerns me right now is this kind of hyper-partisan polarization of this issue,” said Gregory Koblentz, “which might make it harder to translate the level of concern that people are expressing into an effective policy response.”

Meanwhile, if researchers work with a pathogen that does not appear on the select agent list, and they don’t receive government funding, they may not be subject to oversight at all. “Because I don’t have a pilot license, I am not allowed to fly a drone in certain places and beyond my line of sight,” said Casagrande. “But I can just get a really dangerous strain of flu, that’s not a select agent, and using my own money, do whatever the hell I want with it in my garage. That makes no sense.”

In a recent paper in the journal Health Security, Casagrande and five colleagues call for a single, independent federal agency to oversee all research on pathogens, similar to the Nuclear Regulatory Commission. Rebecca Moritz, the biosafety director at Colorado State University and the president-elect of ABSA International, the flagship biosafety professional organization in the U.S., said the idea has merit: “Just being someone who is regulated, it would be a lot easier — and there’d be a lot more consistency, probably — if there was one organization in charge of biosafety and biosecurity.”

Some experts have been airing concerns about the existing oversight process for years, as have lawmakers from both parties — but with limited results. “The pattern has been: incident involving handling of select agents, news stories, committee hearings, outrage, reaction, and short-term reform,” complained Griffith, a Virginia Republican, during a 2017 Congressional hearing about the Select Agent Program. “Wash, rinse, repeat.”

One of Griffith’s Democratic colleagues, Rep. Diana DeGette of Colorado, echoed those concerns during her opening remarks, citing previous safety lapses in federal labs. “At some point,” she warned, “something very bad is going to happen unless the CDC acts.”

The Covid-19 pandemic has brought renewed interest to biosafety and biosecurity. After the first reported cases of Covid-19 emerged just miles from the Wuhan Institute of Virology, a global hub of coronavirus research, some infectious disease experts suspected that the virus may have escaped from that facility. In public, though, some prominent researchers dismissed those allegations as a conspiracy theory. As Undark has reported, the issue swiftly grew partisan, with Republicans and right-wing media organizations boosting the lab leak theory.

By May 2021, though, more scientists were saying they thought the new coronavirus could have escaped from a lab. Rep. Anna Eshoo, the California Democrat who chairs the House committee that oversees public health, joined the calls for more scrutiny of the research in Wuhan. “In order to crush the virus and prevent future global pandemics, we must consider every hypothesis available,” she wrote in a statement that month, calling for an investigation by “non-partisan, independent, scientific experts.”

But, as The Christian Science Monitor reported in June of 2021, the Congressional Democratic majority was hesitant to launch an investigation, or to subpoena senior NIH officials and other scientists. (Eshoo’s office did not respond to requests for comment; nor did a spokesperson for the committee’s Democratic majority.)

Instead, Republicans have become the standard-bearers for the issue in Congress — often linking those concerns with opposition to Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, and the public face of the federal government’s Covid-19 response.

The Covid-19 pandemic has brought renewed interest to biosafety and biosecurity.

For years, Fauci has been a prominent defender of certain kinds of research that involves altering the properties of dangerous pathogens. “Important information and insights can come from generating a potentially dangerous virus in the laboratory,” he and two colleagues wrote in a Washington Post op-ed in 2011.

During a hearing last summer, Republican Sen. Rand Paul suggested Fauci was illegally lying to Congress about NIH-funded pathogen research, and accused him, with little evidence, of “trying to obscure responsibility for 4 million people dying around the world from a pandemic.”

For experts and advocates who have spent years calling for more scrutiny of laboratory practices, the resulting political landscape has been jarring: Some welcome the attention to biorisks and want further investigations, but have concerns about seeing their cause championed by Republicans who appear eager to score political points against Fauci and the Chinese government. “One political party has kind of gone off the rails,” said Laura Kahn, a physician and policy researcher who spent 18 years as a research scholar in the Program on Science and Global Security at Princeton University. “By having them be the main driver to try to get to the truth is actually quite distressing, because it really should be a bipartisan issue.”

Indeed, there are signs that the Covid-19 origins debate has polarized the broader discussion about the safety and oversight of pathogen research.

In October 2021, when Kansas Sen. Roger Marshall, a Republican, sponsored a bill that would place a moratorium on research that imparts enhanced properties to influenza and coronaviruses, he enlisted 10 co-sponsors — none of them Democrats. Another bill in the Senate, calling for the nonpartisan Government Accountability Office to audit NIH’s funding of such research, also has all-Republican co-sponsors. (Some scientists have expressed concern that broad restrictions on gain-of-function experiments will shut down important biomedical research.)

“It’s a very strange political environment,” said Richard Ebright, a microbiologist at Rutgers University. Shortly after the September 11 attacks, Ebright opposed the expansion of pathogen and bioweapons research. In the years since, Ebright has emerged as one of the most prominent scientific critics of U.S. government biosafety and biosecurity policy. In that role, he told Undark, he sometimes sparred with Fauci, as well as with Republicans in the George W. Bush administration.

Recently, Ebright said, he has heard strong interest in biosafety reform from Congressional Republicans. According to Ebright and other experts, officials in the White House also are engaged on these issues. But, Ebright added, there is “strong opposition” among House and Senate Democratic leadership.

Policymakers have taken some steps to address biosafety and biosecurity. Last September, the Biden administration proposed a sweeping package of pandemic preparedness measures that would include some funding for biosafety research. In February, White House and NIH officials instructed the National Science Advisory Board for Biosecurity, a federal committee, to evaluate that agency’s policies for reviewing certain kinds of pathogen research.

The PREVENT Pandemics Act, a bill introduced in March by Sen. Patty Murray, a Washington Democrat, and Richard Burr, a North Carolina Republican, includes several provisions for improving biosafety, including more research on safety practices and new reporting requirements for accidents. The bill also tasks the White House Office of Science and Technology Policy with establishing a new strategy to oversee federal BSL-3 and BSL-4 laboratories.

For people pushing for more comprehensive reform, the bill is welcome — but does not go far enough. “I wish there was more,” said Nikki Teran, the senior biosecurity fellow at the Institute for Progress, a non-partisan science policy think tank that receives funding from tech industry philanthropists. “I appreciate that they’re thinking about it,” Teran added. “And I suppose that some step in that direction is better than none.”

Biosafety legislation has also popped up in Kansas, where a major new high-security federal research facility will soon open near the campus of Kansas State University. The bill calls for the facility to maintain a public list of all laboratory accidents or near-misses — a requirement that Kansas State officials say is burdensome, unnecessary, and likely to “create a sense of danger that does not exist.”

It’s a very strange political environment,” said Richard Ebright.

“It felt important, considering what happened in Wuhan,” State Sen. Richard Hilderbrand, the bill’s sponsor, told The Topeka Capital-Journal earlier this year. The bill narrowly passed the state senate in February, exclusively with Republican votes.

Behind the scenes in Washington, some policy analysts say, there’s interest in new biosafety legislation among lawmakers in both parties. But building political capital can be difficult. “These issues are not really of concern to the average voter,” said Koblentz. “People don’t get elected because they improve biosafety. It’s just too narrow and technical of an issue — unless you can tie it to some higher partisan issue, which is what Republicans have done.”

In recent remarks to the Bipartisan Commission on Biodefense, a nonprofit group, Koblentz warned that the stakes of inaction are only getting higher: New developments in genome editing, synthetic biology, and other fields could pose fresh risks. More private companies are doing work in this area, often with virtually no public scrutiny. And the pandemic, he predicted, would lead to a surge in pathogen research — fueling a growth of BSL-3 and BSL-4 laboratories in countries that have limited biosafety oversight. It’s time, he wrote, for reforms at home — and for a “new global architecture for biorisk management.”

In the U.S., Ebright, the Rutgers professor, said the November 2022 elections could point toward more legislative action on biosafety — at least if Republicans win control of the House or Senate. “If there is a change in control in either or both houses,” he said, “for the first time in four or five decades, the matter will be on the table.”

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