Health Canada says a citizen complaint launched mask recall; other masks under investigation
CTVNewsMontreal.ca Digital Reporter
CTV News Montreal Videojournalist
MONTREAL -- An expert says much more needs to be known about a COVID-19 mask recalled last week before it’s clear whether it poses a danger to the thousands of Quebec workers who wore them.
Health Canada says these masks weren’t subject to strict regulation at first, but it’s now taking a much closer look—and it explained that a regular citizen raised the alarm.
A complaint “from a concerned citizen” first prompted the federal agency to look into the masks, the agency told CTV News.
It looked at research on rats and found troubling results.
“Health Canada has conducted a preliminary scientific assessment and has identified a potential for early lung toxicity in rats from inhaled graphene,” the substance coating the masks, said agency spokesman André Gagnon.
If the concerned citizen who originally made the complaint was experiencing strange symptoms from the mask, he or she wasn’t alone.
Some of the affected workers have since told CTV they noticed discomfort after wearing them repeatedly, including a feeling of “breathing in cat hair” or getting headaches.
The federal warning last week prompted Quebec to ban the problematic masks and try to trace which workers were given them—which so far includes groups of teachers, daycare workers, Montreal transit staff and some health-care workers.
There may be more bad news coming, as well, about a second type of mask.
The health warning last week referred to a single model of mask, referred to as #SNN200642, imported by one supplier, Metallifer.
But a second mask is also under review because it uses the same material, called nanoform graphene, as a coating, Gagnon said.
“Health Canada is currently reviewing data from two manufacturers of graphene-coated face masks to determine the safety and effectiveness of their devices, and will take appropriate action as necessary,” he said.
In a statement, Metallifer said that it has stopped selling another kind of mask as well, known by the serial number #SMDP20605.
It's not clear yet if the masks were used anywhere else in the country. The executive director of the Quebec-based company, François Dussault, told CTV that Metallifer didn't sell the masks in any other provinces and they don't know if the manufacturer had sold to any other companies in Canada.
The company said all the masks it imported followed all Health Canada guidelines at the time. "All our efforts" at the moment are going towards working with federal officials, Dussault said.
Health Canada told CTV that the masks didn’t need a licence, since the agency includes them in the lowest-risk category of medical devices.
“Face masks that make antiviral claims or use antiviral materials, including those coated with nanoform graphene, are classified as Class I medical devices (lowest risk)” under Canada’s medical device regulations, Gagnon said.
“Class I devices do not require individual authorization… prior to sale in Canada,” he said.
However, all medical devices are subject to a set of safety and effectiveness requirements “and companies are required to provide Health Canada with information promptly if requested.”
It was after requesting more information and failing to be reassured that Health Canada deemed the risk “unacceptable,” it said in the original warning.
On Tuesday, Health Canada told CTV that it’s now taking strict action against masks coated with graphene.
“The Department will not hesitate to take appropriate action to stop the import and sale of graphene masks,” Gagnon wrote.
MADE WITH A ‘NOVEL’ MATERIAL
Extremely tiny “nano” particles occur in nature but can also be man-made for many different scientific purposes. The field of nanoscience has been growing quickly for the last couple of decades, but many of the accompanying health risks are just starting to be understood.
In fact, that was the reasoning for eventually looking into them more closely, Gagnon said—“because graphene is a novel nanomaterial.”
The agency didn’t explain why that reasoning wasn’t enough to give them a closer look in the first place.
The masks in question are coated with a layer of graphene, a type of carbon, in its nano form. The tiny particles are so close together that they supposedly cannot let viruses pass through.
The problem identified last week is the particles themselves, and the risk of breathing them in.
It’s known that some of the very tiniest nanoparticles—by no means all of them—can damage the lungs and other organs if people inhale them over the long term, one expert told CTV.
“I can't say that all nanoparticles are bad, because we're inhaling 2,000 to 3,000 litres of air every day,” said Richard Nho, a research scientist at the University of Minnesota who studies health effects of nanoparticles.
“With that huge amount of air, there's inevitably a huge amount of particles or bacteria, but we don't die or we don’t have any problems right away,” he said.
DIFFERENT NANOPARTICLES, DIFFERENT RISKS
What nanoparticles are made of and their size both help determine if they’ll cause health problems. It also matters how long the person is exposed to them, and the density of how much they’re breathing in.
In general, we have “a defence system” in our lungs and this does a good job at clearing out nanoparticles, especially with short-term exposure, Nho said.
The most dangerous are the tiniest ones, known as “micrometre” sized, simply because they’re too tiny for people’s immune systems to clear out, Nho explained.
“Our body cannot remove this… because it’s so small,” he said.
“They're so small, they can accumulate in our lung alveoli. They can circulate, they can move to everywhere in your body, even [your] brain. That’s why we say they can be dangerous and they can be toxic.”
Breathing these in over months or years can lead to inflammation of various organs and long-term health problems like COPD lung disease, asthma, cancer, and disease of the heart or kidneys, among the problems Nho mentioned.
This can happen in nature, especially when people live in the aftermath of wildfires or volcanic eruptions, both of which naturally release these micrometre-sized nanoparticles into the air.
Air pollution in major cities, such as Los Angeles, can create the same effect.
For scale, a strand of hair is about 70 micrometres thick, Nho said. A nanoparticle considered micrometre-sized—the smallest category—is somewhere around 10 micrometres or less, with anything under 20 micrometres considered dangerous to breathe in.
TOO SOON TO SAY IF THE MASKS ARE DANGEROUS
It’s not clear how big the masks’ graphene particles are, and every company manufacturing nanomaterials does it differently, said Nho.
However, while he cautioned that he’s not an expert on graphene in particular, he said he believes it tends to fall just above the size threshold he mentioned, at about 25 micrometres, meaning the lungs may be able to clear it out.
It needs to be studied carefully, he said, especially as this material is also sometimes treated as antiviral and therefore as a health protection.
“Used properly, it can be a benefit for public health,” he said. “But the downside is that again, if there's no proper regulation on graphene or graphene oxide, there's some studies… that graphene oxide can potentially kill lung cells.”
When told of Quebec workers’ reported symptoms, he said he hopes more in-depth studies are done to determine what other factors could have played in, and whether the masks are definitely to blame for the symptoms.
“If there's correlation, it’s really alarming,” he said. “It's really a concern.”
Health Canada said it put out its warning as a precaution and that “no incidents involving serious harm have been reported to date.”
It also said that, in addition to the two reviews of the two mask manufacturers’ data, “further scientific assessment is underway.”
For those worrying, Nho said, it’s also important to note that some immune systems are better than others at clearing out nanoparticles. In general, young and middle-aged adults can do this efficiently.
Elderly people above about 65 are less efficient at this as their lung function deteriorates, so they’re “more vulnerable to lung injury” and need to be especially careful about what they breathe in, Nho said.
Small children can also suffer disproportionately.
Pregnant women and their babies in utero can also, in general, be at particular risk when breathing micro-sized nanoparticles—the kind that most people can’t clear out—because the particles can also circulate to the fetus, he said.
The masks also present an unusual case compared to many of the studies that have looked at air quality, Nho said.
“If the graphene oxide is highly concentrated, and if it's somehow not fixed [securely on the mask], the effect may be more detrimental,” he said.
“You just directly inhale, and then the amount of nanoparticle may be very high.”
He said he “didn’t expect” to hear that Health Canada hadn’t regulated the masks’ use at first.