The coronavirus pandemic triggered a sudden intense need for masks that had Americans making masks at home out of T-shirts and bandanas. Hundreds of new and untested products flooded the marketplace with almost no oversight or regulation, making consumer masks the Wild West of personal protection equipment.
That is set to change.
ASTM International, an international technical standards organization, and the National Personal Protective Technology Laboratory, are working on standards to “establish minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.”
In other words, they hope to be able to help Americans tell which masks actually work.
The draft guidance includes both single use and reusable masks and outlines specific requirements for evaluating the performance of reusable masks.
They are set for review Wednesday by ASTM International and its Subcommittee on Respiratory Hazards, which includes representatives from academia, industry stakeholders, government agencies and independent participants. The review process is ongoing, and these guidelines are subject to further review and change.
The proposed standards are meant to create “a level playing field for demonstration of product claims and avoid the general confusion related to barrier face covering effectiveness,” according to a draft of the standards provided to CNN by ASTM International.
Some experts have called for mask guidance and regulation from the start of the pandemic, and the ASTM guidelines could be a crucial first step. CNN spoke with experts that did not see the confidential draft in its entirety.
Assessing size and fit
Dr. Donald Milton, a professor of environmental health at the University of Maryland who studies how viruses are transmitted, believes these standards will fill a major regulatory gap. “You’ve got all these knockoff masks coming in. They’re not very good, claiming to be N95 and they’re not. So having some benchmarks is a step in the right direction,” he told CNN.
“This is desperately needed because people have no guidance at all right now,” Linsey Marr, a professor of civil and environmental engineering at Virginia Tech with expertise in airborne transmission of viruses, air quality and nanotechnology, told CNN.
If the standards are adopted, each mask would come with a set of user instructions that describe proper sizing, fit and cleaning protocol. The standards strictly prohibit the use of vents, valves or any feature that allows people to blow out or breathe in unfiltered air.
The draft guidelines would also require manufacturers to test their facial coverings in accredited labs to certify performance, register their products and use the outlined labeling system to use the ASTM labeling designations.
Perhaps the most important change ASTM is proposing is a labeling system. Consumers in stores would be able to evaluate the quality of masks on store shelves from the labeling on the packaging. If a mask has ASTM labeling, it could ensure the customer that product has met the testing and quality requirements.
The drafted ASTM standard labeling requirements would indicate results of two testing criteria: breathability and filtration efficiency. Typically, when a mask has a higher filtration, it results in more resistance and can make it harder to breathe.
According to the ASTM draft guidelines, a lower performance, level one designation would require the product to filter 20% of particles — something that would make the mask easy to breathe through, but that would provide less protection. A level two certification would designate high performance filtration of at least 50% of particles but would provide less breathability.
“The use of the ‘levels’ defines a classification system intended to aid in understanding potential tradeoffs for higher levels of filtration efficiency with airflow (breathing) resistance,” Jonathan Szalajda, deputy director at the National Personal Protective Technology Laboratory, told CNN in a statement.
Trading comfort for protection
Milton believes information on breathability would be an important consideration for consumers with chronic lung or heart disease and other conditions that might require easier breathability in a mask.
“It gives people information to make decisions on what they want, and what level of protection they feel they need,” Milton told CNN.
ASTM’s main test — whether a mask can filter out particles measuring 0.3 microns. Why this size? It’s a hard one to stop, and if a mask can handle a particle that size, it can stop droplets most likely to carry viruses and bacteria.
Marr understands why 20% and 50% protection benchmarks might seem low to the public but believes the actual performance against the virus could surpass 50%.
“That criteria is for a certain size particle that is really the hardest size to filter out,” she told CNN. “It’s very likely that the virus is mostly in particles that are larger than that critical size, the test size.”
But while experts grow increasingly concerned at the growing spread of more transmissible coronavirus variants, some believe the draft mask guidelines need to require a higher level of protection to slow the spread and protect people.
“The first iteration may not be where are you want it to be, but it’s a step in the right direction to have some quality levels here,” Milton told CNN. “I would like to see a level three on the higher end.”
“If you would have asked me this in November last year, I would have said this is okay,” Marr told CNN. “But now with, with the more transmissible variants. I’m more concerned. I think it’s a higher level of certification…I would like to see another level of performance like 80%.”
Several European countries have already required people wear masks with a minimum filtration efficacy of 80-90% against 0.3-micron particles. Germany, Austria and France have mandated the public to wear high filtration masks on public transport, shopping or in public areas.
While she hopes for the addition of a higher level of protection added to these guidelines, Marr believes that if approved, the standards will have an impact because consumers want and need guidance.
“I think if these standards are out, there will be a demand for the highest level of protection that ASTM is willing to have a level for,” she told CNN. “The manufacturers, I think, will step up and provide that.”
Currently, only medical-grade masks and respirators must meet standards. These include the N95 masks, which are regulated by the US Food and Drug Administration, National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) for fit, filtration efficiency, flammability and other qualities.
There are exceptions to this proposed standard that reflect current CDC guidance, with warnings against mask use by children under 2 and those with breathing trouble or inability to remove masks. This guidance does not approve masks for any use in a healthcare setting and is not intended for previously evaluated surgical mask and respirators.
President Biden’s administration has emphasized the importance of mask wearing from his first day in office, when he challenged Americans to wear a mask for 100 days in order to reduce the spread of the coronavirus. Efforts to improve mask quality are also being taken in Congress. In a letter published Monday several Democratic lawmakers called on President Biden to increase the supply and availability of higher quality masks and encourage the education of the public about which masks are most effective.
“While many Americans understand that wearing a mask can help prevent transmission of the disease, many don’t realize that a high-quality mask can make it far less likely that the wearer will contract the disease, even if exposed to an infectious person,” Senators Bernie Sanders of Vermont and Brian Schatz of Hawaii, with California Representatives Adam Schiff and Ro Khanna wrote.
They urged President Biden to “consider invoking the Defense Production Act to increase the supply of higher quality masks, including N95 or other medical grade masks.”
The lawmakers also ask President Biden to direct the US Centers for Disease Control and Prevention and the FDA to “provide the public with clear, actionable, and specific information on how to discern which masks are most effective and where they can get them, as well as how to utilize existing options.”