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The Bayer Corporation has made it clear that the creation of a biological research facility on its waterfront property in Berkeley, California, will not have any significant impact on birds, air quality, greenhouse gas emissions, traffic, or noise levels. But while the company’s application to the Berkeley City Council to extend the 30-year development plan for its 46-acre campus is filled with meticulous details, down to the vibration levels of the various pieces of construction equipment that may build it and the degree to which sunlight will reflect off the new buildings, the company has provided area residents with far less clarity on the research that will go on inside its newly expanded complex and how it might affect them.
“What are they going to do there? What kind of microorganisms are they going to be working with?” asked Marcy Darnovsky. “They say they’re going to follow all the rules. Well, is there any oversight?” Darnovsky, a resident of the area and executive director of the Center for Genetics and Society, which advocates for the responsible use of biotechnology, is asking questions that have become more pointed and urgent with the growing body of evidence that the coronavirus responsible for the pandemic may have escaped from a biolab in China.
Whatever the origins of Covid-19, it is now clear that a lab error could have caused the pandemic, which has already claimed more than 3.7 million deaths around the world.
“The debate about the origins of Covid-19 should be a wake-up call for biolab safety in the U.S.,” said Jeremy Gruber, an attorney who was president of the Council for Responsible Genetics for a decade and is currently on the board of the Alliance for Humane Biotechnology. The Centers for Disease Control has strict guidelines as to how labs should safely conduct research on dangerous biological agents. But according to Gruber, the government doesn’t have the resources to make sure that the biolabs across the U.S. are following those rules. “We have very poor oversight and enforcement,” said Gruber. “So much of biolab safety in this country is left to the labs themselves.”
Bayer, which has had a research lab in Berkeley since at least 1978, has already acknowledged that biological agents will be used at its new facility — as they are now — and its proposal requests that restrictions on certain kinds of DNA research be lifted. In an email to The Intercept, Bayer spokesperson Cathy Keck wrote that the company’s research on treatments for cancer, hemophilia, Parkinson’s disease, and other serious conditions are regulated by 10 federal and state agencies to ensure safety and legal compliance. Keck also stated that Bayer’s Berkeley site has a biosafety committee that ensures its operations comply with all standards for the safety of its employees and the community.
“The denial that they don’t intend to do gain-of-function research is not very persuasive because you don’t always know ahead of time what’s going to turn out to be gain-of-function research.”
According to a slide Bayer showed at a community presentation, labs at the expanded facility will not be allowed to manipulate viral particles to make them more pathogenic, one particular kind of “gain-of-function” research that’s come under scrutiny in light of the lab-leak hypothesis. In her email, Keck wrote, “At Bayer in Berkeley, there is no gain of function research, and we do not have plans to do so.” But the company has so far refused to commit in writing to ruling out all the research on viruses and bacteria that could be considered gain of function — a category that is difficult to define, according to Stuart Newman, a professor of cell biology who has directed the developmental biology laboratory at New York Medical College for 42 years.
“The assertion that they don’t intend to do gain-of-function research is not very persuasive because you don’t always know ahead of time what’s going to turn out to be gain-of-function research,” said Newman. “If they’re doing any virus research to develop drugs against viral pathogens or bacterial research against bacterial pathogens, then they’re doing manipulation, which could potentially be gain-of-function research.” Newman emphasized that the research can present unexpected dangers. “You can make a change that you think is innocuous, and because biology is so complex, it turns out to be deadly.”
Others emphasize that because of the pace of change in the field, it is impossible to predict what sort of research will be conducted at the facility during the 30 years covered by the proposal. “Bayer cannot guarantee at all what the focus of their work will be in one year, two years, five years,” said Gruber. “Technology in the area of pathogenic research and viruses is developing extremely rapidly, and we just don’t have the oversight tools and the enforcement to ensure communities are safe and protected at this point.”
A History of Leaks
Even before the coronavirus pandemic demonstrated the degree of suffering and devastation that could potentially emerge from a single release from a single biolab, communities around the country were expressing concerns about the facilities where scientists work with dangerous biological agents.
In 2013, Boston residents were worried about the proposed siting of a biolab at Boston University that would be working with some of the most lethal pathogens in the world. The Conservation Law Center sued the National Institutes of Health and the university on behalf of the residents over the location of the lab, in part on the grounds that it didn’t have an adequate plan to protect them from infections from agents that might escape. In Manhattan, Kansas, residents also objected to a biosafety lab that would be working on the Nipah and Ebola viruses, which are lethal to people, as well as diseases that affect animals and pose a grave threat to local agriculture. Both efforts to stop the labs failed.
Concern about the labs in Boston and Kansas ran particularly high because both are biosafety level 4 labs, the most restrictive of the CDC’s four-point rating system based on the dangers of the agents allowed there. BSL-4 labs deal with the most lethal pathogens in the world, including the Marburg virus and the viruses that cause Ebola and Bolivian hemorrhagic fever — diseases for which there is no cure. Workers who deal with these agents there are required to take extreme precautions, including wearing positive pressure suits that have their own air supplies. One step down, BSL-3 labs also work with infectious agents that can cause serious harm to lab workers and the surrounding community, including tuberculosis and coronaviruses.
“It’s actually these lower-level labs that you have to be most worried about.”
Bayer has promised that its expanded facility will not include any BSL-3 or BSL-4 labs. But it’s clear that even BSL-2 labs, which work with less dangerous pathogens such as HIV, salmonella, and plasmodium falciparum, a protozoa that causes malaria, can pose a danger. “It’s actually these lower-level labs that you have to be most worried about,” said Gruber. “Because the government has such limited personnel in terms of oversight and enforcement, they tend to focus on the higher-level biolabs. It’s usually up to self-monitoring for these lower-level biosafety labs. And there have been plenty of errors and mistakes at lower-level labs as well as at some of these very higher-level labs that are supposedly even better monitoring.”
Indeed, two deaths in the U.S. were traced to infections with biological agents from BSL-2s in recent years. In 2009, a University of Chicago researcher who worked with the plague in a BSL-2 lab died of the disease. And in 2012, a researcher at a Veterans Administration hospital in San Francisco died after becoming infected with N. meningitidis, a bacteria that is classified as a BSL-2 pathogen. It’s also become clear that the Wuhan Institute of Virology was conducting coronavirus research in BSL-2 facilities.
There were 219 reported releases of biological select agents or toxins from biolabs in the U.S. in 2019, according to the most recent annual report of the Federal Select Agent Program, a joint effort of the CDC, NIH, and U.S. Department of Agriculture to manage the use and transport of some of the most dangerous biological agents and toxins, including ricin, Ebola, and anthrax. Of those releases, 195 led to occupational exposures and 177 led to the administration of health services, including prophylaxis. The Federal Select Agent Program did not respond to questions about how many of the select agents and toxins it oversees were released in 2020 and how many times the agents that were released came from BSL-2, BSL-3, or BSL-4 labs.
“There’s a lot of pressure on these lower-level biolabs … to do the type of work that starts to push the boundaries between designated safe BSL-2 and BSL-3 labs.”
Even after the year-and-a-half in which the dangers of the new coronavirus were on tragic display, there’s an active campaign to allow BSL-2 labs to handle it. The effort to ease the restrictions, which companies say hinder their efforts to create treatments for Covid-19, is just one example of the forces pushing BSL-2 labs to work with more dangerous biological agents.
“There’s a lot of pressure on these lower-level biolabs, which are easier to set up and easier to get accredited with the federal government, to do the type of work that starts to push the boundaries between designated safe BSL-2 and BSL-3 labs,” said Gruber. “They’re handling higher-virulent pathogens. And, without transparency, there is no oversight of the growth of that type of work and type of pathogens they are operating with.”
Despite the dangers they pose, the number of these labs has increased greatly since February 2002, when the National Institute of Allergy and Infectious Diseases, a division of the NIH, launched an expansion of research on dangerous pathogens for biodefense purposes in the wake of 9/11. While there were just two BSL-4 labs in the U.S. before 1990, there are now 11 planned, under construction, or in operation (and 48 throughout the rest of the world), according to researchers at George Mason University and King’s College London. The number of BSL-3 labs is less clear, though several estimates put the number at more than 200. NIAID recently funded the construction of four new facilities that will include BSL-4 and BSL-3 labs, including two more at Boston University, and 13 regional biocontainment labs.
Oversight appears to have lagged behind the development of these facilities, according to the Government Accountability Office, which raised concerns about the labs that handle hazardous pathogens back in 2009, when it noted that despite the surge in the number of biolabs, no one was “determining the aggregate risks associated with this expansion.” The GAO returned to the issue in 2017, when it found that the Federal Select Agent Program’s oversight of the biolabs “may not target the highest-risk activities, in part because it has not formally assessed which activities pose the highest risk.”
In 2014, the Obama administration launched a review of federal oversight over select biological agents following a series of high-profile controversies that year. In one incident, decades-old vials of live smallpox were discovered in an unguarded refrigerator in the basement of the NIH Bethesda, Maryland, campus. In another, the CDC accidentally shipped containers of anthrax to another CDC lab that was not equipped to handle live bacteria. Over 80 CDC workers were potentially exposed.
The 2014 review exposed the resistance some of the scientific community had to the efforts to rein in their work. Arizona State University researchers, in a letter to regulators, noted that the personnel requirements have been “onerous and ineffective.” The FBI background check requirement added weeks of time before new personnel can start, according to one researcher from the University of Florida. Several agricultural researchers said that some pathogens impacting plants posed such low risks that they deserved to be taken off the list of select agents. And others noted that certain federal rules made little sense, such as a requirement to keep an inventory of pathogen vials.
The American Society for Microbiology also wrote a letter to regulators, citing “burdensome” record-keeping requirements and problems with the vial inventory rule. The ASM noted that the University of Texas Medical Branch’s Galveston National Laboratory could “no longer can get strains of hemorrhagic fever viruses into the United States because the laboratories overseas that, in fact, are holding those organisms may not meet U.S. standards.”
In the end, after the Obama administration review, little changed. Many critics had called for a single independent agency that enforces safety standards for dangerous pathogens, more funding for safety upgrades, and more public transparency, but these changes were never implemented.
In the absence of strong government oversight of the labs, the task may fall to local governments that don’t have the scientific expertise to judge or monitor the safety of activities there.
“It seemed clear to me that Bayer organized its side and turned out speakers on its behalf.”
In Berkeley, some locals are finding that public discussions about the proposed expansion of the research center have been dominated by people who will benefit financially from it. At one recent meeting about the environmental impact of the expansion, several well-informed representatives of the biotech industry made the case for approving the proposal.
“It seemed clear to me that Bayer organized its side and turned out speakers on its behalf,” said Anna Lappé, a Berkeley resident who attended the meeting. “It was framed very much as, you know, we’re just producing life-saving medicines for children,” said Lappé. “Your heart just breaks, right?”
But Lappé, who works as a researcher, funder, and advocate on agricultural issues, is also aware of a side of the company that was not on display. Bayer, which bought Monsanto in 2018, makes Roundup, Dicamba, and fipronil, and has paid billions of dollars in settlements in lawsuits over lasting harms caused by the products. “Looking at the history of this company and the history of its practices gives me a healthy dose of concern,” said Lappé. “It raises for me big questions about how does a community protect itself before something happens? That’s the question we should be asking.”