Consumer masks could soon come with labels saying how well they work

10/20/2020 2:38:00 PM

Consumer masks could soon come with labels saying how well they work

for the group trying to hash out the rules, and its work would result in a voluntary standard that manufacturers can adhere to and advertise on their products.The goal, said Erick Couch, who used to work in the aerospace industry and is trying to coordinate manufacturers for the effort, is that the Centers for Disease Control and Prevention would then recommend to Americans that they use masks made to the ASTM standards — thereby creating instant market demand. Couch is not formally affiliated with ASTM but has been in close touch with people in the working group.

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“Companies won’t invest unless there’s demand that they can bet on,” Couch said. “What’s called for here is true leadership, and it can have immediate impact on reducing risk and helping the economy go roaring back because finally those of us who want to wear masks can have something that we can be confident will protect us.”

ADADThe new mask standards are being discussed by a group of about 50 scientists, industrial hygienists, government officials, special interest groups and manufacturers, some of whom stand to profit off the sale of the resulting masks. Employees from 3M, Honeywell, ExxonMobil’s chemical unit and DuPont have been involved in the discussions.

Standards for a mask for the general public fall into a regulatory gray area. The CDC’s National Institute for Occupational Safety and Health certifies respirators used in occupational settings, and the Food and Drug Administration regulates masks intended for medical purposes.

A CDC spokeswoman did not respond to questions, including whether the agency would consider encouraging the public to wear masks that adhere to the new standards.ADThe Food and Drug Administration has not been involved in the ASTM effort, but depending on how manufacturers market their masks and their claims of disease prevention, they may be required to submit testing data to the agency to verify their claims, an FDA official said.

ADThe process to nail down the standards has been marked by intense disagreements among working group members. The hours-long Zoom calls to decide what the standards will look like have resembled “cats and dogs fighting,” said Dave Rousse, the president of INDA, a trade association for the non-woven fabrics industry.

One of the major points of contention goes to the heart of how confident people should feel when they put on one of these masks and how manufacturers can market them. Someone wearing a surgical or fabric mask is mainly protecting others, as the CDC has asked Americans to do. People wearing a product qualifying as a respirator are going a step further and protecting themselves.

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ADSome members of the working group “think we should be able to assert that, even if these aren’t respirators, they offer a degree of respiratory protection,” Stull said.ADAt the moment, the group is contemplating two classifications within the new standards — one for face coverings that filter out between 20 and 50 percent of small particles and another for face coverings that are shown to filter out more than half. They would be tested using particles of the same size that are used to test N95 respirators, Stull said.

Others worry that advertising any level of respiratory protection for a non-respirator — even if the products are far more effective than a regular fabric mask — would offer Americans a false sense of safety.AD“We have warnings in the standard that will say, ‘This is not a respirator,’ ” Stull said. “That will be on the packaging. Some people say it needs to be printed on the product itself.”

ISEA, the International Safety Equipment Association, also makes standards for protective equipment. When construction workers choose a hard hat, for example, they can read the label and know that it will offer them a certain level of protection.AD“It’s exactly that level of clarity, transparency, understanding and predictive performance that can be provided for these barrier masks in the future,” ISEA President Charles Johnson said. “Is this thing protecting me? How much is it protecting me? How does it compare to this other product? Those are the questions the standards are designed to answer.”

But the ISEA, whose members include major N95 manufacturers 3M and Honeywell, has decided that creating standards that promise protection to both the wearer and people around the wearer would be impossible to do in a responsible and timely manner.Instead, the ISEA is attempting to develop its own standard, which would ensure only that the wearer was meeting CDC guidance by not contaminating the air around them — a process the industry calls “source control.” But with multiple standards comes the risk of confusing consumers.

So, too, could the multiple numbers and ratings that may appear on the packaging of the resulting masks. One major debate among ASTM members has been whether the new standards should advertise a face covering’s effectiveness in filtering out both large and small particles, effectively providing two numbers for consumers to judge. Small and large particles

are generatedwhen people talk, breathe, sneeze or cough.Advertising the effectiveness against just larger particles may give people false confidence in their face covering, while only providing the effectiveness against smaller particles may make the products less appealing.

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The ASTM working group has also argued over how much manufacturers can be trusted. Many say that an outside entity, such as an accredited laboratory, should be required to verify that masks meet the standards. But this could create bottlenecks and increase the cost of the final product.

The laboratories that would profit off such a requirement are also a part of the working group, along with the manufacturers who would benefit from a more lax arrangement.The group has landed on a “hybrid solution” for now, Stull said: Accredited laboratories will have to sign off on the masks’ filtration and airflow resistance, which is a measure of how hard it is to breathe through. All other criteria mentioned in the new standards — labeling, design, user instructions and so on — will be self-declared by the manufacturer.

Ensuring the masks fit people properly has also been a major debate in the ASTM discussions, participants said. For decades, scientists and manufacturers have been trying to make masks that form a tight seal to the face; N95s are designed to do so, which is why they can be so uncomfortable.

For now, the ASTM group has decided on an optional fit test, to be carried out by manufacturers rather than a laboratory, using a panel of people with “a range of different face sizes,” Stull said. But because the assessment will be done on test subjects rather than each individual wearer, it can provide only a general estimate of how well the masks fit, he said.

Compromising on fit is yet another example of how the experts and companies have had to balance competing priorities — making the most effective mask possible, while making it practical for millions of Americans to use every day.If these issues are resolved, by early 2021, masks on store shelves may be marketed with a promise of a certain level of protection for the wearer, akin to “N40s,” “N60s” or “N80s.”

Read more: The Washington Post »

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