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Clinical Laboratories and Pathology Groups

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Of 27 BSL-4 labs assessed, Global Biolabs ranked only seven as having ‘good’ biosafety management

In a new report, a research firm assessed the conditions at the handful of laboratories across the world that handle the most dangerous pathogens. In the wake of the SARS-CoV-2 global pandemic, there is heightened awareness of the risks of a lab accident that might release such pathogens into the environment, putting humans at risk.

Medical laboratory scientists working in clinical laboratories worldwide understand the critical nature of biosafety laboratory (BSL) criteria. Nearly all clinical laboratories that test for infectious disease agents are biosafety level-1 and -2 (BSL-1, BSL-2).

Other high-containment laboratories (HCL) that handle deadly, highly transmissible pathogens are typically government-run or university-affiliated. HCL labs have BSL-3 and BSL-4 levels and require rigorous adherence to protocols that ensure worker safety and prevent escape of dangerous pathogens.

Thus, the new report from Global Biolabs, which is critical of biorisk management protocols at existing and planned BSL-4 laboratories—especially given the increasing construction of new HCL labs worldwide—will be of interest to medical technologists, pathologists, and clinical scientists working with highly infectious diseases.

The biosafety experts who make up the Global Biolabs research team conduct risk-assessments and “provide key policy recommendations for strengthening biorisk management in BSL-4 labs,” according to the organization’s website.

Many countries did not fare well in Global Biolabs’ analysis of their policies. “The report urges the World Health Organization to strengthen guidance and individual countries to agree to audits by outside experts to ensure that their labs meet international standards,” Science reported in “Growing Number of High-Security Pathogen Labs Around World Raises Concerns.”

“The more labs and people working with dangerous pathogens, the risks go up,” biosecurity expert Filippa Lentzos, PhD (above), Associate Professor, Science and International Security, King’s College London, told Science magazine. Lentzos was part of the team that created the Global Biolabs mapping project two years ago. Clinical laboratory managers may want to review the findings in the Global Biolabs report. (Photo copyright: King’s College London.)

Only Seven Out of 27 Countries Get ‘Good’ Overall Score

“The boom in BSL-4 lab construction appears, so far, not to have been accompanied by strengthened biorisk management oversight,” according to the Global Biolabs 2023 report from the Global Biolabs Initiative. “Additionally, most planned BSL-4 labs will be in countries with relatively low scores for governance and stability,” the report’s authors wrote.

The report included a ranking of countries by total biorisk management score, the Daily Mail noted, adding:

  • Of 27 countries analyzed, seven ranked as good (above 70%) for biorisk policies,
  • 15 scored medium (above 30%),
  • five scored below.

Those with the best biorisk management scores (maximum 48):

  • Canada scored 46 (96%),
  • US scored 42 (88%),
  • Australia and the United Kingdom each scored 40 (83%).

Notably, China “scored zero on modifying pathogen rules.” According to the Daily Mail, “China’s overall management score (33) was in the middle of the pack, 69%.”

More Labs, More Danger

The Global Biolabs Initiative was launched in 2021 by Filippa Lentzos, PhD,

Associate Professor in Science and International Security, King’s College London, and Gregory Koblentz, PhD, Associate Professor and Director Biodefense Graduate Program, George Mason University, Fairfax, Virginia. The organization tracks maximum containment labs worldwide, noting trends that raise biosafety and biosecurity concerns.

According to the Daily Mail, Lentzos noted “that a particular worrying aspect of the BSL-4 boom was those countries looking to open their first lab were the bottom scorers in terms of good biorisk management.

“Many of the countries building new labs, some for the first time, score poorly on biorisk management. However, there is still time to strengthen national laws and regulations on biosafety, biosecurity, and dual-use research [biological research that could cause harm] to bring them up to international standards,” the Global Biolabs researchers wrote in their report.

Global Mapping of BSL-4 Labs

There are 51 BSL-4 labs operating worldwide, and 18 are planned or under construction, according to Global BioLab’s report. Here’s where they are located:

  • Europe: 24
  • North America: 12
  • Asia: 9
  • Oceania: 4
  • Africa: 2
  • South America: 0

Also, BSL-3+ labs total 55:

  • Europe: 21
  • North America: 18
  • Asia: 10
  • South America: 3
  • Africa: 2
  • Oceania: 1

The report also noted:

  • Of the 18 BSL-4 labs under construction, 11 are planned to open in Asia.
  • About half of BSL-4 labs are “less than the size of a tennis court.”

“Eighty percent (of BSL-4 labs) are located in urban areas, which heightens concerns about accidents at these facilities,” Koblentz told the Daily Mail.

According to Science, the number of BSL-4 labs has doubled since 2013. Growth in BLS-4 labs began around the time of the 2001 anthrax attacks and picked up speed in 2003 following the SARS outbreak, University World News reported.

Biosecurity and Biosafety Analyzed

Global Biolabs’ analysis included countries’ biosecurity and biosafety scores. Just 12 out of 27 countries with BSL-4 labs scored high on biosecurity, nine scored medium, and six scored low.

A high score for biosecurity—which US and France received—reflects laws for biosecurity, a national list of dangerous pathogens, and whistleblower protection.

Out of 27 countries, 21 with BSL-4 labs scored high on biosafety. However, two countries scored medium, and four scored low. The two countries that earned the highest scores for biosafety—Canada and Australia—have physical/engineering controls, occupational health, and transportation safety, among other areas reviewed.

Opportunities for Improvement

Global Biolabs made the following recommendations in their report:

  • Nations with BSL-4 and BSL-3 labs need to have in place biorisk management systems including comprehensive laws, regulations, and institutions that require safety and security risk assessments of proposed research.
  • Strengthening of biorisk management is called for by the World Health Organization and Biological Weapons Convention.
  • Labs, of all biosafety levels, are advised to aim toward safety, security, and responsible research. 

The effort by Global BioLabs to create a public record of how each BSL-4 and BSL-3 laboratory adheres to strict standards of safety and operations demonstrates that some degree of risk exists in the operation of these labs. Whether government and world health authorities make it a priority to address known deficiencies in those labs is a question yet to be answered.  

—Donna Marie Pocius

Related Information:

Global Biolabs Report 2023

Dangerous Labs Ranked, and China Scores Zero When It Comes to Safety in Handling “Risky” Experiments on World’s Most Dangerous Pathogens

Growing Number of High-Security Pathogen Labs Around World Raises Concerns

Lab Leak Most Likely Origin of COVID-19 Pandemic, Energy Department Now Says

China Rejects US Assertion that COVID-19 Originated from Lab Leak

It’s Boom Time for Biosafety Labs: Who is Keeping Tabs?

CDC: Biological Risk Assessment, General Considerations for Laboratories