SARS Labs Unsafe, Says WHO

Scientific advisors call for international regime to regulate pathogen biocontainment

June 3, 2004
By Robert Walgate

The World Health Organization (WHO) should take a stronger role in regulating the biocontainment of pathogens worldwide to help prevent outbreaks of lab origin like the recent severe acute respiratory syndrome (SARS) cases in Asia, according to microbiologist John MacKenzie, who advised WHO on SARS after last year's international outbreak.

In a recent update on the lab error that led to escapes of the virus from the Institute of Virology in Beijing, WHO said the SARS virus is being held in some laboratories around the world at an "inappropriate containment level."

"What SARS has shown us is that we do have problems, and that we don't have international standards," MacKenzie told The Scientist. "European countries, the US, and Australia have standards, but they don't in Asia nor in many other parts of the world."

In Singapore, for example, where a postdoctoral student caught SARS in a lab accident, the containment "was said to be a certain level but didn't meet most of the requirements," MacKenzie said.

Neither does WHO have a register of which labs worldwide hold the SARS virus, although "we hope countries keep a record of their own," said MacKenzie. "We certainly think all countries should, so we at least have a handle on who has the virus and under what conditions."

Ingegard Kallings, of the Swedish Institute for Infectious Disease Control and a member of the WHO Biosafety Advisory Group, told The Scientist she believed the problem was much wider than SARS. Global travel and fears of bioterrorism mean labs worldwide "are starting to handle a lot more dangerous, hazardous pathogens," said Kallings.

She had just returned from advising the Beijing Institute of Virology on decontamination after its own SARS accident. "It's very obvious that the facilities are not the biggest problem," in the lab accidents with SARS she said. "It's the procedures, call it the 'biosafety program,' in the institutions that is substandard, and that is more frightening."

Even a "sophisticated" lab like the Russian Institute of Virology recently suffered "a death from Ebola".

In the case of SARS, "deep down, the country I'd most worry about would be China," said MacKenzie. "We don't know where the virus is, who's been working with it, and under what conditions. And it's the largest country."

MacKenzie said international requirements should be established for the design, specifications, and certification of biosafety level (BSL) 3 and 4 labs and buildings, and for the rigorous training of people who will work in those labs.

"If we are serious about the consequences of outbreaks arising from labs—and I think we have to be after the SARS cases—then we have to be serious about how we monitor," said MacKenzie.

"I think WHO must have a role in this," like the International Atomic Energy Agency with radioactive sources, MacKenzie argued. "Because if any single country were given the role, like the US Centers for Disease Control, I think that would cause enormous consternation in some parts of the world."

However David Heymann, who oversaw the ending of the SARS outbreak last year and now heads WHO's polio eradication program, said "WHO can't police. All we can do is certify that labs… are following the right biosafety procedures."

"That's what we do with the [two] smallpox labs each year—certify they are biosecure. But we can't police the specimens that are in there. And we can't force the labs to improve their biosafety, just make recommendations."

But recent experience shows this isn't always enough, and Heymann is concerned about the implications for polio eradication. In an inventory of 160,000 facilities in 152 countries, 500 declared wildtype poliovirus or potential infectious materials, he reported in The Lancet.

One of the challenges, said Heymann, is to get these polio specimens consolidated and destroyed. WHO is using polio resources to strengthen its biosafety group, which organizes smallpox inspections, so they can extend their work into polio.

After polio, this could be extended to other organisms, Heymann agreed, but individual countries would have to implement any recommendations. "It has to be countries that make the legislation," he said. "But there must be models and standards and norms for them to follow."

Nicoletta Previsani, WHO's sole biosafety officer, told The Scientist the organization will soon publish a third edition of its laboratory biosafety manual. This will add new recommendations on testing a laboratory before it is commissioned and on annual retesting and certification.

Kallings believed that this manual should form the basis of a legally binding international standard, created for example through the International Organization for Standardization (ISO).

Mike Smith, ISO Director of Standards, told The Scientist that this would be possible. "We have a relationship with WHO, and quite a few committees working in the medical area, mostly for things like medical devices," he said. "We have a long-standing open-door policy to international organizations, and if they believe there's benefit in bringing one of their documents to ISO, we can put it through our mechanisms."

ISO standards can become national law. "There is a fairly strong practice amongst our members to adopt ISO standards as their national standards, and in many instances these are then cited in national regulations and become part of law in those countries," Smith said.

Links for this article
"China's latest SARS outbreak has been contained, but biosafety concerns remain: Update 7," World Health Organization disease outbreak news, May 18, 2004.
http://www.who.int/csr/don/2004_05_18a/en/ 
R. Walgate, "SARS escaped Beijing lab twice," The Scientist, April 26, 2004.
http://www.biomedcentral.com/news/20040426/05/ 
R. Walgate, "Singapore SARS case raises concerns," The Scientist, September 26, 2003.
http://www.biomedcentral.com/news/20030926/06/ 
D.L. Heymann et al., "Dangerous pathogens in the laboratory: from smallpox to today's SARS setbacks and tomorrow's polio-free world," Lancet, 363:1566-1567, May 15, 2004.
[PubMed Abstract] [Publisher Full Text]  
World Health Organization Laboratory biosafety manual, Second edition (revised), Interim guidelines
http://www.who.int/csr/resources/publications/biosafety/who_cds _csr_lyo_20034/en/ 
International Organization for Standardization
http://www.iso.ch/iso/en/aboutiso/introduction/index.html 

©2004, The Scientist Inc. in association with BioMed Central.

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