U.S. Right to Know confirms a third maximum containment lab in China

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Representatives of the Chinese Academy of Medical Sciences are pictured with representatives of the University of Texas Medical Branch in September 2014. (Photo credit: UTMB)

A new maximum biocontainment lab in Kunming, China, was certified three years ago while remaining under-the-radar in the U.S. biodefense community, documents obtained through a Freedom of Information Act request show.

China’s plans to build an ABSL-4 under the Institute of Medical Biology and Chinese Academy of Medical Sciences in Kunming were previously known. But U.S. Right to Know can report for the first time that the lab has long been accredited by the China National Accreditation Service for Conformity Assessment, a pivotal step toward becoming operational. Animal biosafety level four, or ABSL-4, refers to the level of biosafety precautions needed to study the world’s most dangerous viruses and other pathogens in animals. 

The quiet start at the Kunming lab could suggest skittishness among Chinese authorities about publicizing it due to the controversy surrounding another BSL-4 lab – the Wuhan Institute of Virology. It also underscores that international standards for reporting and transparency have lagged behind the proliferation of labs working with pandemic potential pathogens. 

The “Kunming National Primate Research Center of High Level Biosafety” received accreditation in late 2018 or early 2019, according to a presentation given at a U.S.-China summit. 

The lab works with rhesus monkeys, according to the documents. 

Yunzhang Hu, a professor at the Institute of Medical Biology, told the summit that the lab’s aims include developing medical countermeasures and supporting emergency response to emerging infectious diseases. 

While U.S. institutions like the National Academies were aware of the Kunming lab, it was apparently not widely understood that the lab has been making strides toward research on high risk pathogens for years. 

A World Health Organization report in 2017 listed three BSL-4 or ABSL-4 labs in China: two in operation in Wuhan and Harbin and a third planned in Beijing. The Kunming lab is not mentioned. A map of BSL-4 labs assembled by top Western biodefense experts does not report the Kunming lab either. 

While the lab’s work appeared in scientific papers in 2020 and 2021, demonstrating it was operational, China may not have publicized it in part because of international concerns about the Wuhan Institute of Virology, a BSL-4 lab at the pandemic’s epicenter, according to Gregory Koblentz, director of the biodefense program at George Mason University’s Schar School of Policy and Government and co-creator of the map. Koblentz said he became aware of the lab shortly after his map was published in 2021 and that it would be added to its next iteration.

The maximum containment lab in Kunming is one of five to seven China has slated to construct by 2025, Nature reported. Accreditation from the CNAS is needed before the Ministry of Health can approve a BSL-4 lab, according to the scientific journal.

Efforts to support BSL-4 work in Kunming predate the lab’s accreditation.

U.S. researchers funded by the U.S. Army Medical Research Institute of Infectious Diseases traveled to Kunming in 2014 to review animal facilities and present information on BSL-4 technical requirements, according to a federal grant report. Training continued throughout the year. The Kunming lab’s researchers traveled to a U.S. maximum biocontainment lab at the University of Texas Medical Branch for further training. 

U.S.-China summit

The U.S.-China dialogue was co-hosted by the National Academy of Sciences and held in Harbin, China, in January 2019. The topics centered on the opportunities and risks of gene editing in infectious diseases research.

The Harbin summit was the fourth in a series on biosafety involving both American and Chinese institutions, and came just a year before reports of a novel coronavirus first emerged from Wuhan.

U.S. biodefense experts began planning in June for a firth summit slated for October or November 2019, according to other documents obtained by U.S. Right to Know. But Chinese partners suggested a summit under the Chinese Academy of Sciences in Wuhan rather than under the Chinese Academy of Medical Sciences in Kunming, the emails indicate. 

The January summit in Harbin included presentations from many experts who have since become central to the COVID-19 origins controversy. The summit included two sessions on “science and ethics in research with pathogens with pandemic potential” and “understanding and engineering viral pathogens with pandemic potential.” The sessions described technical challenges with engineering chimeric viruses as well as the safety and ethical questions the technology raises. 

Zhengli Shi, a top virologist at the Wuhan Institute of Virology, discussed the impact that spike binding domains play in determining whether MERS viruses can spillover from animal to human hosts.

Ralph Baric, one of the world’s leading coronavirus researchers at the University of North Carolina and a collaborator of the Wuhan Institute of Virology, gave a presentation on the lack of predictability when engineering viruses to be more pathogenic. 

He spoke about a “sweet spot” that optimizes the ability of a virus to infect humans and cause severe disease. 

“Creating a virus that is super-adapted to a particular host can actually result in an attenuation of virulence, if the virus interacts overly strongly with a cellular receptor,” the summary of his comments reads. “This shows the complexity of deliberate design as well as the potential sweet spot for pathogenicity.”

This unpredictability can undermine the value of models that attempt to predict viral evolution and the danger a virus could pose to humans, he said. 

Baric also said that a combination of altering a virus’ receptor binding domain and passaging through mice can sometimes be required to generate more dangerous viruses.

Baric also noted the ease of synthesizing coronaviruses, saying the cost had decreased from $42,000 to $6,000, and the relative ease of using CRISPR technology to create humanized mice. 

Stanford School of Medicine microbiologist David Relman ⁠— who has recently been critical of virologists who have prematurely declared the origins debate settled ​​⁠— gave a presentation on responsibly preventing lab accidents as BSL-4 labs proliferate. Relman also raised questions about the feasibility and safety of the Global Virome Project, an effort to collect and catalog millions of animal viruses involving EcoHealth Alliance and Shi. 

“In an era in which most viruses can be synthesized from a genetic sequence, the discovery of new viruses and elucidation of their properties may present both biosafety and biosecurity concerns,” Relman told the group.

Chinese experts expressed concerns about these issues too.

An expert with Tianjin University told the summit that balancing the positive uses and potential for misuse of pandemic potential pathogens made in the lab poses challenges.

The expert voiced concerns about “the potential for rapid changes in science and technology capabilities to outpace ethical and regulatory measures, and the need for appropriate governance,” the summary reads. 

China has invested at least $150 million to $240 million in approximately 50 synthetic biology research projects since 2018, according to the presentation. 

A summary of the summit’s presentations was obtained by U.S. Right to Know through a Freedom of Information Act litigation against the U.S. Department of Education, which had conducted an investigation of the University of Texas Medical Branch’s work with the Wuhan Institute of Virology.

Wuhan Iab can delete data in ‘explosive’ legal agreement with U.S. lab

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The interior of the Galveston National Laboratory is pictured. (Photo credit: UTMB)

April 20, 3:40 p.m.: This story has been updated with comment from UTMB. 

The Wuhan Institute of Virology has the right to ask a partnering lab in the U.S. to destroy all records of their work, according to a legal document obtained by U.S. Right to Know. 

A memorandum of understanding between the Wuhan lab and the Galveston National Laboratory at the University of Texas Medical Branch states that each lab can ask the other to return or “destroy” any so-called “secret files” — any communications, documents, data or equipment resulting from their collaboration — and ask that they wipe any copies. 

“The party is entitled to ask the other to destroy and/or return the secret files, materials and equipment without any backups,” it states. 

This right is retained even after the agreement’s five year term ends in October 2022. All documents are eligible for destruction under the agreement’s broad language.

“All cooperation … shall be treated as confidential information by the parties,” the agreement states.

The directors of the maximum biocontainment labs in Wuhan and Texas announced a formal cooperative agreement in Science in 2018. The labs are two of just a handful of facilities in the world that do similar cutting edge work on novel coronaviruses. The lab in Texas, with funding from the National Institutes of Health, was doing biosafety training with the lab in Wuhan, which operates under the Chinese Academy of Sciences. The labs also intended to do joint research projects and share resources, according to the agreement. 

The revelation that the Wuhan lab retained the right to call for the destruction of data on U.S. servers funded by U.S. taxpayers comes amid a debate about what sort of investigation is necessary to exculpate the city’s coronavirus research from suspicions it sparked the COVID-19 pandemic. It also raises questions about assurances from Wuhan Institute of Virology senior scientist Zhengli Shi that she would never delete sensitive data.

The clause also raises a number of legal red flags for the Texas lab, experts say.

“The clause is quite frankly explosive,” said Reuben Guttman, a partner at Guttman, Buschner & Brooks PLLC who specializes in ensuring the integrity of government programs. “Anytime I see a public entity, I would be very concerned about destroying records.”

Guttman said that even private entities are expected to have internal records retention and destruction policies, but that as a public institution the Texas lab faces an even higher standard under laws meant to safeguard federal and state taxpayer dollars. These laws include the federal False Claims Act and the Texas Public Information Act. The Galveston National Laboratory is part of the University of Texas System and receives federal funding. 

“You can’t just willy nilly say, ‘well, you know, the Chinese can tell us when to destroy a document.’ It doesn’t work like that,” he said. “There has to be a whole protocol.”

The clause could also risk obstructing Congressional investigations into the COVID-19 pandemic.

The Texas lab was “built by the National Institutes of Health to help combat global health threats,” said Christopher Smith, a spokesman for UTMB, in a statement. “As a government-funded entity, UTMB is required to comply with applicable public information law obligations, including the preservation of all documentation of its research and findings.”

“UTMB believes it is an operational — and moral — imperative that all scientists working in biocontainment anywhere in the world have first-hand knowledge of the proven best practices in biosafety and laboratory operations,” Smith continued. “All research at UTMB is subjected to a rigorous and transparent pre-experiment approval protocol, including involvement and oversight by scientific experts who helped design federal guidelines.”

Only the Texas attorney general can make a determination about what otherwise releasable public records should be exempted from disclosure, according to Kelley Shannon, executive director of the Freedom of Information Foundation of Texas. It’s also unlawful to destroy records requested under the Texas Public Information Act. 

Liza Vertinsky, an expert in global health law and intellectual property at Emory University, said that the all-encompassing definition of what is considered “secret” in the memorandum of understanding, or MOU, is problematic. 

“The way I read the MOU, although it is poorly drafted, ‘secret’ refers to the ‘cooperation and exchanges, documents, data, details and materials’ that are part of this MOU,”  she said. “It is as broad as the MOU, covering what the MOU is intended to cover.”

Edward Hammond, an independent biosafety proponent and a longtime advocate for more transparency at the Galveston lab, also flagged the broad language.

“In agreements like this that I’ve seen before, you have confidentiality provisions in relation to intellectual property…I can’t recall seeing an instance of these more general confidentiality provisions,” he said in an email. “Doesn’t this run against the purportedly pure academic interests of UTMB?”

In 2009, the Galveston lab unsuccessfully lobbied the Texas legislature for an exemption to the Texas Public Information Act to be written in order to prevent records being released to Hammond. 

WIV calls data deletion accusations appalling

The agreement could also undermine claims that the WIV would never delete records. A WIV virus database that went dark in 2019 remains a source of intrigue for reporters, scientists, and U.S. intelligence agencies interested in the pandemic’s origins. 

Wuhan Institute of Virology senior scientist Zhengli Shi told MIT Technology Review that allegations by Western biosecurity experts that her lab may have scrubbed records relevant to COVID-19 are “baseless and appalling.” 

“Even if we gave them all the records, they would still say we have hidden something or we have destroyed the evidence,” Shi told the outlet, which cast any such suspicions as rooted in anti-Chinese prejudice. 

The agreement also seems to address suspicions that the partnership could aid a bioweapons program either in the U.S. or in China, stating the labs will “exchange the virus resources strictly for the scientific research purposes.”

A number of clunky or unusual provisions in the agreement suggests it may have been drafted at least in part by Chinese partners and translated into English. 

For example, it states nothing in the agreement should be construed as establishing a relationship between “master and servant,” unusual language in modern American legal documents. 

Other documents obtained by U.S. Right to Know demonstrate that despite the formal collaboration, Galveston National Laboratory faced delays in obtaining a sample of SARS-CoV-2, the virus that causes COVID-19, from its partner lab at the pandemic’s epicenter. The Texas lab ended up obtaining its first sample from the U.S. Centers for Disease Control and Prevention. 

U.S. Right to Know obtained the WIV-UTMB memorandum of understanding through the Texas Public Information Act as part of an investigation into risky viral research funded through taxpayer dollars.

Written by Emily Kopp 

U.S. virologist let Wuhan scientists revise his Congressional briefing

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James Le Duc (left) gives a tour of Galveston National Laboratory. (Credit: UTMB)

An American virologist asked Wuhan Institute of Virology scientists to edit a briefing he prepared for Congressional staff, according to documents obtained by U.S. Right to Know. 

“I certainly do not want to compromise you or your research activities,” wrote leading biosafety expert and virologist James Le Duc to Shi Zhengli, a top virologist at the Wuhan Institute of Virology nicknamed the “Bat Woman,” in April 2020.

“Make any changes that you would like,” he wrote, attaching a copy of his prepared comments.  

Le Duc also shared his informal testimony with Yuan Zhiming, director of the Wuhan Institute of Virology’s highest security laboratory, the Wuhan National Biosafety Laboratory. Le Duc was the longtime director of the Galveston National Laboratory, another high security or “BSL-4” lab studying coronaviruses. The Wuhan National Biosafety Laboratory and the Galveston National Laboratory have a formal cooperative agreement. 

Scientists are continuing to investigate whether SARS-CoV-2, the virus that causes COVID-19, may have emerged from a lab accident or spilled over naturally from an animal. 

The House Foreign Affairs Committee had asked Le Duc for his input in the pandemic’s early months – and for good reason. The University of Texas Medical Branch’s BSL-4 lab has worked closely with labs in Wuhan for decades, including on issues of laboratory safety.

“Given the long history of collaborations between the GNL and the WIV, I have been approached repeatedly for details on our work,” Le Duc said to his colleagues at the WIV. “Attached is a draft summary that I will be providing to leadership of our University of Texas system and likely to Congressional committees that are being formed now.”

The exchange raises questions about whether Le Duc allowed the Wuhan Institute of Virology’s leading scientists to influence Congress’ understanding of an intensifying pandemic, irrespective of whether they were free to tell the truth.

Days earlier, Le Duc had forwarded Shi information about an article describing calls from Senate Republicans for an investigation of her lab. He asked to speak with her about it, but Shi declined. 

But Shi did send back a reply to Le Duc with reference materials – including several articles she co-authored underscoring the possibility of a spillover of bat coronaviruses into humans, including articles describing the creation of engineered viruses with new spike proteins. 

“I’ve added some detailed information for your reference,” she wrote. 

She did not initially send back a copy of Le Duc’s briefing document.

“I did not receive the document I sent for your review so if you made comments on that, please send,” he responded.

“Sorry, I forgot the reviewed document,” Shi wrote back, suggesting that she did indeed make comments or changes. 

The name of the file that Shi sent back to Le Duc was “WIV-drf2-zl.docx.” “WIV” may be shorthand for the Wuhan Institute of Virology, while “zl” may refer to Zhengli. 

“I’m afraid that this discussion will continue for some time regarding … exactly when scientists at WIV first became aware of the new coronavirus and had possession of specimens in the WIV and where was that work done (level of biocontainment),” Le Duc told Shi. 

Indeed, when exactly Chinese authorities became aware of SARS-CoV-2 was a key factor in an inconclusive 90-day review into COVID-19’s origins by the U.S. intelligence community compiled a year later.

“Next week will be busy,” Le Duc wrote on April 19, a Sunday.

Two days later, on April 21, a Tuesday, Le Duc told colleagues with the National Academy of Sciences that he had met via teleconference with five or six people with the House Foreign Affairs Committee’s Subcommittee on Oversight and Investigations. 

He passed along information he had shared with committee staff. One of the files attached was saved as “WIV-4-20-20.docx.”

Le Duc appears to ask Shi to review information he compiled in preparation for questions about when the Wuhan Institute of Virology first learned about the novel coronavirus.

Le Duc had also briefed the full committee’s Republican staff earlier that month, according to notes reviewed by a committee staffer.  

The exchange raises questions about how Shi’s influence may have shaped U.S. lawmakers’ understanding of the pandemic’s origins.  

It also indicates that at the height of a once-in-a-century public health crisis, the sort of coronavirus pandemic that Shi had been warning about for years, she was concerned about U.S. perceptions of her work.

Le Duc referred questions to UTMB Director of Media Relations Christopher A. Smith.

“Your organization’s characterization of Dr. Le Duc’s intent in contacting Dr. Shi is incorrect,” said Smith. “This email was very early in the outbreak and the information Dr. Le Duc wanted Dr. Shi to review was a description of her research on coronaviruses as he understood it. He asked her to review that description to ensure accuracy should he be asked.”

“Nothing ever came from this exchange, either in the form of a review/comments by Dr. Shi or any specific request for comments regarding her research,” he continued.

But the documents show that Le Duc told Shi that she could make any changes she would like to his briefing. 

Smith also said that Le Duc did not testify to Congress. After days of follow-up questions, Smith confirmed that Le Duc had briefed Congressional staff.

A request to see the documents exchanged between Shi and Le Duc was declined. 

Nothing ever came of the email exchange between Le Duc and Shi, a spokesman for the University of Texas Medical Branch said. Pressed further, he confirmed Le Duc had indeed briefed Congressional staff.

Shi’s behind-the-scenes influence

In spring 2020, U.S. foreign policy officials privately circulated concerns that Shi’s international influence in the field of virology could cloud an impartial investigation into the possibility of a lab accident at the Wuhan Institute of Virology.

In a State Department memo obtained by U.S. Right to Know, government officials expressed concerns that international virologists would back up Shi before a complete inquiry into the lab in Wuhan was conducted.

“Suspicion lingers that Shi holds an important and powerful position in the field in China and has extensive cooperation with many [international] virologists who might be doing her a favor,” it reads.

In a media interview in April 2020, Le Duc said that Shi was being unfairly scrutinized. 

“I just hate to see a world-class coronavirologist, who’s dedicated her life working with this, being scrutinized as the possible source,” he said.

Shi shaped the discourse about the possibility of an escape from her lab in other ways, too.

She also edited a Feb. 2020 commentary that declared there was “no credible evidence” behind claims that SARS-CoV-2 may have been genetically engineered, according to documents obtained by U.S. Right to Know last year. 

The commentary’s authors shared a copy with Shi before its publication in Emerging Microbes & Infections, the emails show. 

Her involvement was not disclosed. 

U.S. Right to Know obtained the records for this article through a Texas Public Information Act request to the University of Texas Medical Branch and from a Freedom of Information Act lawsuit against the State Department.

Written by Emily Kopp 

‘What would Jim do?’: U.S. virologist close to Wuhan lab quietly called for investigation

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Galveston National Laboratory is pictured on the right. (Courtesy of: Wikimedia Commons)

James Le Duc, a biosafety expert and virologist who collaborated closely with the Wuhan Institute of Virology, outlines how he might investigate whether that lab or any other in Wuhan could be implicated in the COVID-19 pandemic in an email obtained by U.S. Right to Know.  

In a June 2021 email titled “What would Jim do?,” Le Duc proposes a set of questions and a survey of coronavirus research at the Wuhan Institute of Virology and other nearby labs.

Le Duc suggests a “detailed examination of the work underway” at each lab, including: 

  1. specimens from bats collected from the field
  2. attempts to adapt [coronaviruses] to growth in cell cultures
  3. gain of function research 
  4. the use of humanized mouse lines expressing human lung ACE-2 receptors

“If nothing significant [was] found, it would help reassure the world that it is unlikely that SARS-CoV2 originated from a laboratory,” Le Duc wrote in the email, which was sent to staff at the National Academy of Sciences.

U.S. Right to Know obtained the emails through a Texas Public Information Act request.

In a separate email published by U.S. Right to Know last year, Le Duc expressed concerns that a lab accident would have been more likely to happen at less secure BSL-2 or BSL-3 labs than the high security BSL-4 lab that has been the focus of international attention and concern. 

Still, the investigation proposed by Le Duc as necessary to absolve Wuhan’s labs has yet to be conducted. 

Le Duc provided training to Chinese researchers who worked at the Wuhan Institute of Virology ⁠— including in biosafety, lab operations and biocontainment ⁠— through a formal cooperative agreement. Since 1986, he has traveled to Wuhan to assist the lab and to meet with Yuan Zhiming, a director at the Wuhan Institute of Virology.

Le Duc was the longtime director of the Galveston National Laboratory at the University of Texas Medical Branch until his February 2021 retirement. The Galveston lab and the Wuhan Institute of Virology are two of three labs in the world that perform similar risky research on novel coronaviruses, according to Richard Ebright, board of governors professor of chemistry and chemical biology at Rutgers University. 

While the email has not previously been reported, Le Duc’s questions were also shared at a public meeting of the World Microbe Forum in June 2021.

Le Duc did not respond to a request for comment. 

In other media interviews, Le Duc has expressed warm feelings about Shi Zhengli, the director of the Center of Emerging Infectious Diseases at the Wuhan Institute of Virology, and their scientific collaborations. Still, Le Duc has said he supports an impartial investigation into all possibilities related to the pandemic’s origins.

More questions

In the 2021 email, Le Duc suggests this investigation should include an evaluation of the levels of biocontainment used in Wuhan’s labs and an examination of the biosafety infrastructure in place. 

Elements of lab safety Le Duc drills down on include whether any of the labs were studying coronaviruses that can replicate in culture, which may have made them better adapted to infect human cells. He also asks whether biological safety cabinets were certified and used; whether the lab has a history of disgruntled employees; and whether there is controlled access to pathogens.

He suggests an examination of whether the air handling systems were properly maintained, citing the 1979 release of anthrax from a Soviet lab

In an earlier email exchange in April 2020, former president of the American Society of Tropical Medicine and Hygiene Phillip Russell voiced concerns to Le Duc about obfuscation by scientists akin to the longtime coverup of that lab accident. 

“This reminds me of the efforts by Matt Messelson [Meselson] and many colleagues to coverup up the Sverdeslosk [Sverdlovsk] anthrax outbreak,” he wrote. “They succeeded for many years aided and abetted by many in academia until Ken Alibek defected and the truth came out.”

Le Duc also suggests an evaluation of waste decontamination procedures, citing a 2001 foot-and-mouth disease outbreak in the United Kingdom that resulted from wastewater runoff from a lab. 

‘Unfortunately, I never received a response’

Le Duc, who provided training in biosafety to some Wuhan Institute of Virology staff, suggested asking whether personnel were properly trained in key instruments like autoclaves, a sterilization tool. He also asks whether there is a history of needle sticks or accidental exposures at Wuhan labs. 

He asks: Were any employees sick in the months prior to the start of the pandemic? Were family members or close contacts sick?

Le Duc suggests that investigators could test whether serum banks contain antibodies to SARS-CoV-2, the virus that causes COVID-19.

Further, he asks, is there an occupational health program or special clinic that serves staff from each institute where coronavirus research was underway? If so, did they see an uptick in cases consistent with COVID-19?

Le Duc posed a similar set of questions to his former collaborator Zhiming, according to an email uncovered by U.S. Right to Know in December.

“Unfortunately, I never received a response,” he wrote.

Written by Emily Kopp 

Wuhan’s lower biosafety level labs posed greater risk for coronavirus lab leak, experts said

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Biosafety experts, including one with longstanding ties to the Wuhan Institute of Virology (WIV), privately harbored questions about risks taken with coronavirus research at biosafety level 3 (BSL-3) labs, including those in Wuhan, according to emails obtained by U.S. Right to Know. The researchers felt that BSL-3 labs were more vulnerable to accidents, even more so than BSL-4 labs, a level used for the most potentially dangerous of pathogens.

While the WIV’s BSL-4 has been at the center of attention about biosafety practices related to the origin of Covid-19, the emails raise more questions about whether SARS-CoV-2 could have emerged from a lower biosafety level lab in Wuhan.

The emails cast doubt upon the biosafety protocols in place when the U.S. National Institutes of Health (NIH) funded EcoHealth Alliance (EHA), a U.S-based nonprofit research organization, to carry out research with the WIV and the University of North Carolina (UNC) that infected mice expressing human receptors with engineered novel bat coronaviruses. Much of that work on bat coronaviruses appears to have taken place in BSL-3 labs in Wuhan, according to grant documents submitted to the NIH; and in some cases, even lower containment BSL-2 labs in Wuhan, according to a Journal of Virology article, and other sources.

James Le Duc, a leading biosafety expert, and former director of the Galveston National Laboratory at the University of Texas Medical Branch (UTMB), and David Franz, a bioweapons expert and former commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), exchanged concerns about U.S. and Chinese BSL-2 and BSL-3 labs.

Le Duc has had significant contact with scientists in Wuhan over the years. He trained WIV scientists at the Galveston National Laboratory, and records show he made multiple trips to Wuhan since 1986 to train virologists there.

On May 15, 2021, after Franz shared a letter in Science in support of investigating the origins of Covid-19, including a possible lab origin, Le Duc wrote: “I’m afraid that it may be way too late to find much out but it should be attempted, including the bsl2 and bsl3 labs where I suspect the risk for accidental release is greater.”

On Jun 2, 2021, Le Duc wrote to Franz: “The focus on BSL4 is justified but the bigger problem is likely at BSL3 where many more exist and standards are varied.”

Franz wrote back to Le Duc, “I also mentioned the issue you raise about a focus on 4s, both because they tend to be taken more seriously by governments (possibly making them safer and more secure) than 2s or 3s and also that the 2s and 3s are generally more vulnerable than 4s.”

Biosafety level (BSL) designations were established in the mid-1970s. Biosafety labs are designated BSL-1 to BSL-4, with 4 as the most stringent in practices and containment of potential pathogens. In the U.S., the Centers for Disease Control and Prevention (CDC) and the NIH establish BSL designations. Pathogen Level [P] lab 1 to 4 designations are used interchangeably with BSL.

BSL-2 labs include ‘biosafety cabinets’ with HEPA filtration, where experiments are performed, providing lab researchers protection from infectious agents, according to the biosafety manuals of the CDC and Boston University. Personal protective equipment (PPE), including lab coats, gloves, and eye protection as well as decontaminating procedures, are standard. BSL-3 labs have additional biosafety measures, particularly to protect against agents with respiratory transmission routes; these include full gowns or Tyvek suits, face shields, and additional “risk-based” protections such as ventilation devices, which may differ depending on the agent being used. BSL-3 labs require negative pressure and a specialized anteroom, so that agents will be contained within the lab even in the case of an accidental spill or contamination; and have more extensive HEPA filtration systems.

BSL-4 facilities have been a focus of biosafety discussions because the most deadly and dangerous pathogens, such as Ebola and Marburg viruses, are studied there. BSL-4s have more custom-designed containment and stricter requirements, including “mandatory use of positive-pressure (“space”) suits” and “dedicated nonrecirculating ventilation systems.

In EHA-led work conducted in Wuhan, scientists infected humanized mice with engineered novel bat coronaviruses in a BSL-3 facility, according to grant documents EHA submitted to the NIH.  Some collection and engineering of bat coronaviruses were done in a BSL-2, with less stringent protocols and containment, according to multiple sources including a paper in the Journal of Virology .

“I think we need to remember that a lot of the work, especially on coronaviruses, has been done (presumably) at BSL3…”, wrote Le Duc.

In the NIH-funded EHA grant proposal, there was ambiguity as to where the humanized mouse infections would be performed. While many biosafety details were specified in the proposal for Ralph Baric’s UNC BSL-3 animal facility – such as “rodent-sized Seal-Safe systems (~192 cages) for maintaining animals in a Hepa-filtered Air in/out environment, exhausted into the BSL3 Hepa-filtered exhaust system” – few details were provided about biosafety measures for the animal work in Wuhan. EHA President Peter Daszak wrote to NIH staff in the summer of 2017, that “UNC has no oversight of the chimeric work, all of which will be conducted at the Wuhan Institute of Virology,” according to emails obtained by the White Coat Waste Project, a nonprofit watchdog group.

Confusingly, the infections of humanized mice with chimeric coronaviruses were said to be performed not only in Ralph Baric’s UNC animal BSL-3 lab, but at two locations in Wuhan – Wuhan University and the WIV. The animal BSL-3 labs at Wuhan University, were more sparsely described than those at the WIV, with general statements such as, experimental work using humanized mice will be conducted at the Center for Animal Experiment Biosafety 3 lab of Wuhan University at the School of Medicine in Wuhan, China…Animals will be housed in a BSL-3 facility and will be under the care of a full-time veterinarian.” More detailed descriptions of the animal protocols, however, were said to be available through the WIV or Wuhan University Institutional Animal Care and Use Committees (IACUC) .

Franz wrote to Le Duc: “I haven’t worried about the BSL-4 lab, but certainly the one downtown [in Wuhan].”

Earlier this year, the Global Times reported that, “Bai Chunli, president of the Chinese Academy of Sciences, said in April 2020 that China had two P4 labs in operation and 81 P3 labs in operation or approved for construction.”

Franz wrote, “There are also so many 2s and 3s that it is almost impossible to deal with them; it’s what happened with the legally binding protocol proposal to the BWC [Biological Weapons Convention] in the mid-90s.”

Le Duc wrote to Franz: “…the greatest risk is from the lower levels of biocontainment, but we don’t want to suggest that everything be moved to BSL4 either.”

U.S. Right to Know obtained the records reported on in this article through a Texas Public Information Act request to the University of Texas Medical Branch. We believe these records underscore the importance of transparency to minimize biosafety risks, prevent lab leaks and contain potential pandemic pathogens. They also highlight the need for scrutiny of current biosafety precautions.

Written by Sainath Suryanarayanan