Published: June 24, 2014
In a bid to prevent potentially deadly microbes like anthrax or SARS from getting loose in Canada, the federal government is proposing sweeping biosecurity regulations to govern pathogens found in about 8,500 laboratories across Canada.
Researchers working with particularly nasty micro-organisms and the toxins they produce will need licences and security clearance under the proposed regulations published in the Canada Gazette on June 21.
The government says the regulations are designed to improve safety and oversight and bring Canada in line with countries like the U.S. to “improve the deterrent for persons with malicious intent.”
Researchers support the move to shore up Canada’s biosecurity but say much will depend on how the regulations are applied.
“The devil is in the details,” says Bob Hancock, who works with disease-causing microbes at the University of British Columbia.
The new regulations have been in the works for years, and will replace interim rules in place since the government passed the Human Pathogens and Toxins Act four years ago.
Under the proposed regulations, labs will need to assign biosafety officers and apply for licences that will be good for one to five years depending on the kinds of pathogens they handle.
Most of Canada’s 8,500 labs — most of them located at medical facilities, universities and government operations — handle low- to moderate-risk organisms like E. coli, salmonella or Listeria and will qualify for five-year licences.
Tighter oversight will be aimed at higher-risk organisms like the ones that cause SARS and tuberculosis and even more deadly organisms like Ebola, Nipah and Marburg viruses that are restricted to high-security laboratories.
The biosafety officers will be responsible for ensuring regulations and licensing requirements are met, and that risky organisms being moved between labs get to their destinations.
The federal health minister is to be notified within 24 hours if a “security sensitive biological agent” is unexpectedly delayed.
The government says its new “safety and security regime” will also improve the ability to track where pathogens and toxins are stored and used in the event of an emergency.
The risk is small, but releases — either accidental or deliberate — have the “potential to cause catastrophic consequences,” says the preamble to the proposed regulations.
The government estimates it will cost labs across the country about $2.41 million to comply with the new rules, and $6.82 million for the federal government to administer the rules in the first year.
Hancock says close oversight of risky pathogens “is absolutely essential” for countries to maintain biosecurity. ”There is a level at which self-policing (by the academic and scientific community) isn’t sufficient and the government has to take responsibility,” he says.
The academic community generally supports the proposed regulations, he says, but there has been concern in some quarters over which organisms fall into higher-risk categories. “People feel strongly about whether their organisms fit or not,” says Hancock.
Gerry Wright at McMaster University in Hamilton works with so-called “superbugs” — bacteria that have grown resistant to antibiotics and are a growing international health threat.
At “first blush” Wright says the proposed regulations look good. “Of course you don’t want to have anyone who’s got ties to al-Qaida working on this stuff in your lab,” he says.
He expects the new rules to reduce the bureaucracy he has to deal with when bringing new strains of bacteria into his lab as he’s been told the university will take over the paperwork currently done by one of his staff.
But he says he needs to find out more about “this whole business” of security clearance checks and how the government will decide what qualifies as a high-risk organism.
At this stage he and his graduate students and staff do not have to undergo security clearance and criminal checks and he is hoping they will not have to in future. “So I’ve got my antennae up,” says Wright.
The high cost of microbes on the loose
— The SARS virus emerged naturally in Asia and spread rapidly with severe and costly consequences. It hit hard in Toronto, where the 2003 SARS outbreak resulted in 44 deaths, over 200 hospitalizations and over 23,000 people placed in quarantine. “Infections in laboratory settings due to improper safety procedures also contributed to the rate of illness,” says the federal government, which estimates the socio-economic impact of the SARS outbreak was at least $1.9 billion in 2012 dollars. “It is now known that laboratories hold the only remaining stocks of the SARS virus, which is still highly infectious,” it says.
— Soon after the 9/11 terrorist attacks, letters laced with anthrax began appearing in the U.S. mail in what the FBI describes as the worst biological attacks in U.S. history. Twenty-two people were exposed, five died and 42 buildings were contaminated in the attack, which had an estimated cost of over $1 billion. A scientist who worked at a U.S. government biodefence lab was the prime suspect, but he died before charges could be filed. Canada’s proposed federal rules would require individuals with access to a prescribed list of security-sensitive human pathogens and toxins, including anthrax, to hold “appropriate security clearance.”
– The field of synthetic biology has grown to the point where human pathogens and toxins, “such as a modified strain of highly virulent influenza,” can now be generated in non-laboratory settings. The proposed requirements would apply to all persons who possess or use these agents in Canada, in any type of facility, regardless of how they were generated.
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