Graphene mask report from QuebecThe story really outlines why graphene in any PPE now dead .
Even the US won't allow graphene in face masks
Any graphene maker will be impacted by this issue and the negtive fall out for a long time.
Here hoping ZEN can be all the approvals done by 2027
MONTREAL -- It’s the kind of anxiety-inducing news that most parents hope never to hear. After tens of thousands of Quebec teens were made to wear a new type of COVID-19 mask all winter, Health Canada suddenly declared the masks might be toxic.
The masks, easily identifiable because of their unusual grey-blue colour combination, were recalled in late March. They’re coated in a substance called graphene oxide that’s linked to lung disease and is now banned in Canada, at least temporarily.
But for months they were distributed in the millions—not just to adults but to minors, and across Canada, though the majority were used in Quebec, Health Canada says.
Now the question for many Quebec parents, not to mention teachers, daycare workers, transit workers and others who wore them, is how they were approved to be imported in the first place.
The answer is, they weren’t approved, at least not completely. CTV has learned that through a misstep on the supply chain, along with an emergency order to facilitate COVID-related supplies, the masks were subject to very little oversight.
While Health Canada had in principle authorized the use of graphene masks, it didn’t realize they had actually been imported into Canada until a citizen—a Montreal mother worried about her son’s school—emailed them.
No one else involved seems to have looked up the troubling studies on graphene, she said.
“For me it was a very easy question, like, ‘I've never heard of graphene, so what's graphene?’” said Alayne Moody, the mother who raised the alarm.
“I’m sort of surprised that that wasn’t something that came to mind when somebody ordered millions of them.”
USED BY TEENS, early TEENS ACROSS MONTREAL
The graphene masks were first described as not “pediatric” by the Quebec government during the recall, which is true—they’re not child-sized.
But in total, Quebec’s government spent $30 million to buy and distribute about 30 million of them, including, starting in January, almost 5 million to the province’s schools.
A provincial order decrees that students in high school, which in Quebec begins in Grade 7, must wear masks full-time at school. They may not bring masks from home.
For almost three months, students and teachers at several boards were required to wear the graphene masks, including in gym class.
So far, CTV has confirmed six school boards and service centres that were distributing them, all supplied by the board of education through Quebec’s central acquisitions centre:
- New Frontiers, on Montreal’s South Shore
- Riverside, also on the South Shore
- Lester B. Pearson, in the West Island
- Marguerite Bourgeoys, in Montreal
- Laval’s French-language schools
- Commission scolaire Trois Lacs, in Vaudreuil and Ile Perrot
The English Montreal School Board said it never used the masks.
Most parents who have contacted CTV have seen no symptoms in their kids. But one father from Ormstown said just the uncertainty is hard. He keeps monitoring his two children for health problems and says he’s not likely to stop anytime soon.
“I don’t think I'll ever feel completely reassured,” said Ian Godfree.
“If something comes down the road…in 10 years, am I going to go back and think that it’s because of the masks?”
Two parents told CTV that their kids did have some health problems this winter, including nosebleeds. But it’s far too soon to know if there’s a link, or whether the masks will create any long-term problems at all.
WORRYING STUDIES, FEW DETAILS
Graphene oxide, which coats the masks, is made up of a single layer of tiny carbon nanoparticles packed closely together, supposedly acting as a filter.
However, nanoparticles can pose serious risks to the lungs if inhaled, especially if the particles are small enough and breathed in over a long period, an expert told CTV News.
While nanotechnology is new, this can also happen in nature when, for example, people breathe in nanoparticles from wildfires, Dr. Richard Nho said.
Young children’s lungs, as well as seniors’, are especially vulnerable, he said, while young and middle-aged adults’ bodies can generally do a good job clearing out inhaled particles. It’s unclear how teenagers fit in.
A 2013 study on mice found early signs that inhaled nanoform graphene can lead to lung disease, including chronic pulmonary fibrosis, and warned there may be a long-term risk of cancer and “mutations” if the particles settle deep in the lung tissue.
Health Canada said its preliminary research shows that “inhaled graphene particles had some potential to cause early lung toxicity in animals.”
However, there isn’t nearly enough information to conclude these particular masks will be dangerous in the long term to kids who wore them.
Health Canada said in a statement Tuesday that “the health risk to people of any age is not clear.”
It’s studying the masks’ specifications, including how small the particles are and how easily they can be detached and breathed in. The details of the masks’ design may matter a great deal in determining the risk, it said.
“Health Canada is still performing a scientific assessment to look at, for example, better characterizing particle sizes, manufacturing process [and] potential for particle release,” said a statement from the agency. It’s also looking at how effective they are as a filter.
In the meantime, it asked people who do have new symptoms to see their doctors.
“Canadians who have used these masks and have health concerns, such as new or unexplained shortness of breath, discomfort or difficulty breathing, should consult their health care provider,” the agency said.
CITIZEN SLEUTHING LED TO DISCOVERY
After a supply-chain misstep, Health Canada told CTV it wasn’t aware for some time that the graphene masks had even been imported into Canada.
The earliest use of the masks that CTV is aware of was around August of 2020, when transit maintenance workers in Montreal began wearing them on the job.
But Health Canada only began looking into them in late January of 2021, when Moody, a mother of two, did some detective work and sent the agency an email.
“I noticed while walking in my neighbourhood, right before my son went back to school after the Christmas holiday, that a boy was wearing a mask that had a grey lining on it,” said the mother, Alayne Moody.
She had been researching various kinds of masks, but for an unrelated reason. As part of an environmental group, she had been putting together a petition to the province to allow schoolchildren to wear reusable cloth masks instead of disposable ones.
“I'd never seen a mask like that in any of my research,” she said of the grey-lined mask.
Sure enough, she quickly learned it was the same mask her son, Leo, was asked to wear at school. Moody, a researcher at McGill University, didn’t want her neighbourhood or her son’s school to be identified, saying the school did nothing wrong.
Curious, she asked her son to take a picture of the mask at school. He sent her a photo of the box with the serial number.
The label clearly referred to “biomass graphene,” so she googled the substance and the Chinese company that produced the masks, called the Shangquan Group.
"There was nothing hidden there,” she said. “They were really sort of advertising that and promoting this mask around the idea that it had this nanoform graphene material in it.”
She became worried about whether it was safe. “My son was wearing that mask every day, including gym class,” she said.
“You know, five days a week, six to seven hours a day, including while running around and exercising. So, a lot."
Moody gave Health Canada kudos for snapping to attention—she had also written to some other authorities but got no response, she said, though she didn’t want to name them.
She exchanged a few emails with the agency, heard some brief updates, and then heard on March 26 about the nation-wide recall.
There are two models of masks that have been named by serial number, but overall, “graphene masks manufactured by Shandong Shengquan New Materials Co. Ltd. and imported by four Canadian establishments are being recalled at Health Canada’s direction,” Health Canada said this week.
WHAT WENT WRONG?
It’s unclear how much the pandemic emergency created a loophole that allowed the masks in. What is clear is that at least one basic step wasn’t followed during a critical period.
Under an interim order to allow COVID supplies, Health Canada had authorized three distributors to import graphene masks from Shandong Shengquan New Materials Co., the agency told CTV.
In normal, pre-pandemic times, however, it’s not clear that the masks would have gotten more scrutiny. Masks are still considered Class 1 medical devices, meaning they carry generally low risk and are not subject to “pre-market review.” This includes graphene masks.
In the Class 1 category, the manufacturers are responsible for making sure their products are safe and effective.
However, under the COVID-19 interim order for distributors, Health Canada also built in a special accountability measure—it required suppliers to notify it of incoming shipments at least five business days in advance.
With a flurry of products arriving in huge quantities, that rule was meant “to keep us informed,” said Health Canada spokesperson Geoffroy Legault-Thivierge.
With it, “we're aware of what's coming,” he said, and can “be informed, and catch and take action if needed.”
In this case, Health Canada never got any notification that graphene mask shipments were on the way, he said.
“Prior to importation, [authorization] holders are required to notify Health Canada of any incoming shipments,” said a statement emailed by the agency.
“Health Canada was not notified of any shipments by the importers authorized through this exceptional importation pathway.”
After getting Moody’s email, Health Canada began its research and revoked suppliers’ authorizations to import the masks in February, it said—at least a month before it sent out a national warning about the ones already in circulation. It didn’t explain the delay.
A ‘WILD WEST’ OF COVID MASKS
Health Canada named two distributors who imported the masks: Quebec-based Metallifer, and a numbered company that doesn’t show up in records of Quebec government acquisitions.
Metallifer told CTV that the masks it supplied met “all applicable standards” and referred other questions to Health Canada. When asked about the alleged failure to send notification of its shipments, it repeated that it is fully cooperating with Health Canada and referred questions to the agency.
For another Montreal distributor, however, the Shangquan masks raised some red flags.
"Some testing looked a little fishy to me,” said Peter Forlini of the company Universal Safety. “We did our due diligence, and we passed on it, of course."
CTV found that in some of its materials, Shengquan Group wrote that its graphene masks had “passed the United States FDA certification.”
That’s not exactly true, though—the FDA told CTV that there’s no such thing as an FDA certification. In fact, they had to send letters to several mask manufacturers telling them to stop making such claims, said FDA spokesperson Audra Harrison.
The FDA hasn’t authorized any graphene-coated masks and “is unaware of any face masks with graphene being legally marketed or distributed in the U.S. at this time,” she wrote.
In the U.S., any devices that include drugs, biologics [biological materials] or additives such as graphene…require FDA’s specific review and marketing authorization,” she said.
That also applies to any devices that have “antimicrobial or antiviral purposes.”
Forlini, the other Montreal supplier, said that in the first months of the pandemic, people were desperate for supplies, and it led to a chaotic, panicked time with a huge number of seemingly random people “from every walk of life” both selling and buying masks.
This was the period when Quebec signed its $30 million contract for the graphene masks.
"Some people imported masks, just hoping that these people from overseas were giving them what they were buying, and some people were just selling whatever they could to make a quick buck,” he said.
"It was really the Wild West.”
A man from Shengquan, the manufacturer, told CTV in a statement after publication time that the company is cooperating fully with Health Canada and will provide all necessary information about the masks.
The spokesperson, who gave his name only as Mike, said the company is "disappointed" by the recall and stands by its masks' safety.
For Moody, who blew the whistle on the masks, the brand-new material “slipped in under the radar—that's my read of the situation,” she said.
“It kind of took advantage of the COVID crisis to slip this new technology in under the radar, make a bunch of money.”