Americans may soon be able to choose between two clearly labeled levels of face mask protection while browsing store shelves.
The new national mask standard outlines minimum fit, design, performance and testing requirements for face masks and would require user instructions, package labeling and a permanent tag on the product.
ASTM International — an international standards organization — spent seven months conducting expedited testing and review and published its guidance on Tuesday. Experts and industry leaders say the new “Standard Specification for Barrier Face Coverings” has the potential to transform the quality of masks available for personal protection in the American marketplace.
“The new specification for barrier face coverings addresses a key gap and will support consumer confidence when purchasing a face covering that’s labeled as meeting the ASTM standard,” ASTM International told CNN in an email.
ASTM International has already created standards for a number of consumer products, including art supplies like crayons, playgrounds, sports equipment and baby cribs.
Until this point, there were no standards even though masks are highly recommended by US health officials to help prevent the spread of the coronavirus.
These standards are a joint effort between ASTM International, the National Personal Protective Technology Laboratory (NPPTL), academics, industry stakeholders, government agencies and independent participants.
To meet ASTM standards, manufacturers are required to test their facial coverings in accredited labs to certify performance, register their products and use the outlined ASTM labeling system on their products.
If a mask has ASTM labeling, it means that it meets testing and quality requirements outlined by ASTM. The standard has been created to evaluate only consumer masks. These new standards do not apply to medical masks and respirators used in healthcare settings.
The ASTM labeling requirements involve results of two testing criteria: breathability and filtration efficiency. Typically, when a mask has a higher filtration, it can make it harder to breathe.
ASTM tests for whether a mask can filter out particles measuring 0.3 microns. If a mask can handle these tiny particles, it can stop droplets most likely to carry viruses and bacteria.
According to the ASTM guidelines, a lower performance “level one” designation would require the product to filter at least 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. These criteria will apply to all face masks available to consumers, so anyone shopping for one can simply look at the label and immediately know how much protection it will provide.
Standards could become enforceable worker protection
How quickly consumers will see ASTM-labeled masks on store shelves may come down to how the standards are adopted by government agencies, such as the National Institute for Occupational Safety and Health (NIOSH) and Occupational Health and Safety Administration (OSHA).
Many are watching OSHA as the potential decision-maker. In a January 21 executive order on Protecting Worker Health and Safety, President Joe Biden asked OSHA to “consider whether any emergency temporary standards on COVID-19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021.”
OSHA is a regulatory agency that enforces workplace and worker protection, and OSHA adoption of the standard would mandate the use of ASTM-certified masks for most private sector employees in all 50 states. If OSHA were to adopt the ASTM standards in the workplace, it would be enforceable worker protection — not just a public health recommendation.
The standards are already getting the support of some notable experts and public health officials. In a memo to Biden’s top coronavirus advisers obtained by CNN on Wednesday, a dozen health and safety experts — including four members of Biden’s former advisory board — called on the CDC and OSHA to adopt the ASTM standard for the general public.
The memo asks OSHA to use the ASTM testing procedure to create a higher level of protection for workers in non-medical environments with less exposure that may not require an N95 mask.
The letter also urged the administration to “coordinate a national effort” to distribute NIOSH-certified respirators and ASTM-approved masks to workers in need and use the Defense Production Act to ramp up mask production.
“A step in the right direction”
Dave Rousse, president of the Association of the Nonwoven Fabrics Industry (INDA) that was instrumental in the standard development, believes buy-in from government agencies is critical.
“It would rapidly result in the entire supply chain to make masks to comply to that standard,” Rousse told CNN. “Two weeks at the most, I mean, those guys would turn around overnight, if they do what’s required.”
National Personal Protective Technology Laboratory Deputy Director Jonathan Szalajda, who led the work group for the face mask standard, told CNN that discussions on the next steps have begun within the CDC.
“By having a document in place now, it opens the opportunity for having those conversations to share in the understanding of how the face coverings work and that helps inform decisions that policymakers make,” he said.
Ultimately, many masks currently on the market may not make the cut. “There’s no question in my mind that some manufacturers will not be able to make a product, or their current product is not going to meet the standard,” said Rousse. “There is a fair amount of cloth masks out there of general textiles that have very low filtration efficiency.”
However, masks that don’t meet the ASTM standard will still be available for sale.
Because mask manufacturers are responsible for applying to use the standard, and it’s likely some will not pursue adoption because of the stringent testing requirements. But the ASTM seal of approval will help educate consumers.
As experts become increasingly concerned about the spread of more transmissible coronavirus variants, some believe the draft mask guidelines need to require a higher level of protection to protect the American public.
“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,” Dr. Donald Milton, a professor of environmental health at the University of Maryland who studies how viruses are transmitted 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 OK,” Linsey Marr, a professor of civil and environmental engineering at Virginia Tech told CNN. “But now 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%.”