Ottawa proposes new biosecurity regulations
Potentially deadly microbes on government radar
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 Saturday.
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,” said Bob Hancock, who works with disease-causing microbes at the University of British Columbia.
The new regulations, in the works for years, would replace interim rules in place since the government passed the Human Pathogens and Toxins Act four years ago.
Under the proposed regulations, labs would need to assign biosafety officers and apply for licences good for one to five years depending on the pathogen.
Most of Canada’s 8,500 labs — at medical facilities, universities and government operations — handle low- to moderate-risk organisms such as 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 highsecurity laboratories.
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 regula- tions.
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 said.
There has been concern in some academic quarters over which organisms fall into higher-risk categories. “People feel strongly about whether their organisms fit or not,” Hancock said.
The question of security clearances and criminal checks is also a concern.