McIlvaine Coronavirus Market Ale

ASTM to Propose Two Efficiency Ratings for Public Masks and Voluntary Fit Testing

New ASTM Specification for Barrier Face Coverings WK73471

Total Inward Leakage Testing for Respirators

Small Mask Gaps Result in Big Efficiency Losses (Aug 20 CTS)

ASTM is likely to propose ratings for public masks. One would be for 25-50% and the other for over 50%. Fit testing data would be available on a voluntary basis. There has been considerable controversy among the participants and there will be balloting which could postpone implementation well into 2021.

If everyone had very efficient masks many lives would be saved. The fact that these are low efficiency ratings endorsed by ASTM rating is a communication that something is better than nothing.

However, there are efficient reusable masks available quickly for some percentage of the population. If 20% of the public were wearing 90% efficient masks it would be equivalent to everyone wearing 20% efficient masks.

CATER Mask Decisions is free to everyone and covers Comfort, Attractiveness, Tight fit, Efficiency, and Reusability.

It is proposed that suppliers provide evidence for publication in this service. Then a group of experts such as members of Waterloo Filtration Institute evaluate this evidence plus other data provided by suppliers and write an evaluation with a range of efficiencies based on the evidence presented.

Mask	Efficiency %	Unfiltered %	Defects	Net Efficiency%
CATER 99	98-99	-2-8	0-1	89-97
CATER 95	92-97	-2-8	0-1	83-95
CATER 93	90-95	-2-8	0-1	82-93
Cloth	50-60	-30-50	5-10	15-37-
Surgical	92-97	-25-40	0-1	40-72

Since much of the background evidence is already gathered in CATER Mask Decisions and is free to everyone this can be immediately used by decision makers. It is hoped that WFI would be able to quickly offer evaluation reports.

ASTM to Propose Two Efficiency Ratings for Public Masks and Voluntary Fit Testing

Ballots are being sent out this week to a working group within ASTM. The members will vote whether to approve to efficiency ratings. Millions of Americans adopted mask-wearing this year to stop the spread of the novel coronavirus, they confronted a wild West of options, including artisanal products sold on Etsy, cotton coverings sewn by their family members and mass-produced items marketed by favorite retailers.

The Washington Post provided a good summary of the activities a few weeks ago. Here are excerpts.

The personal protective equipment industry is trying to inject some clarity into the mask-purchasing experience by creating a uniform set of standards to show consumers how well the products would protect them and those around them.

But the industry players first have to overcome fierce disagreements among themselves, a rift that has delayed a process that is supposed to help businesses and schools reopen in 2021. Company executives and scientists have spent months on the painstaking effort, which has been rife with squabbling over how much protection they can and should promise, among other issues. And it’s unclear whether the federal government plans to bless any new standards, potentially scaring companies away from making any significant upgrades.

“This has been a nightmare,” said Jeffrey Stull, president of International Personnel Protection, who is organizing the group’s discussions on a volunteer basis. “We really see a whole spectrum. Some individuals say we need a standard, we need to get that standard out, let’s make it a bit more lenient. … And then we have some people who say, ‘No, this has to be absolutely right.”

Even President Trump has expressed an opinion about the effectiveness of masks in recent days. In one of several barbed attacks aimed at Anthony S. Fauci on Monday, Trump slammed his top infectious-disease specialist’s use of a Washington Nationals mask, saying “it is not up to the high standards that he should be exposing.” Fauci has advocated for months that Americans wear masks to protect others and frequently wears a mask in line with Centers for Disease Control and Prevention recommendations.

The process was born out of the chaotic scramble that millions of Americans faced this spring, as they sought access to face coverings during the coronavirus’s rapid spread. There was an immediate shortage of surgical masks and the more protective respirator masks most often used by construction workers, so many people had to adapt by turning to amateur solutions.

Without access to special laboratory equipment, it’s nearly impossible for most people to know which masks are the most effective at stopping the spread of infectious particles.

Though the details can be mind-numbingly technical, the stakes are high: If widely adopted, the standards could give Americans a sense of certainty and perhaps more confidence to return to offices, classrooms and public spaces next year. Masks that meet the standards could give additional protection to essential workers who have been largely unable to access N95 respirators, given the ongoing shortage.

Industry players have had to wrestle over what that protection should look like: what size particles the masks should be tested against, whether and how to ensure masks fit properly, and what kind of third-party certification the standards should require.

These disputes are expected to come to a head in the coming weeks. By the end of this month, the working group hopes to send out a version of the standards to experts in protective clothing and equipment, most of whom have not been involved in crafting the language. They have a month to send in their ballots, which can include suggestions for changes.

This process is far faster than usual. The safety qualities of a variety of consumer products, including car seats and fireworks, are graded by either government agencies or industry groups as a way to set standards, inform consumers and keep companies honest. Those evaluations typically take more than a year to roll out. Rarely has there been the rapid growth of a product that has occurred in the mask market this year, and the diversity of products has been astounding, from “gaiters” worn around the neck to high-end masks made of silk or lace. Just in April, buyers purchased 12 million masks on Etsy.

“Whether it’s a standard or whether it’s something equivalent to the Consumer Reports rating (of) good, better or best, it is probably useful because otherwise people are lost,” said Philip Harber, a professor of public health at the University of Arizona who studies the use of respirators. He warned that given some Americans’ hostility toward masks, the standards have to be “very, very, very simple.”

The effort is being organized by ASTM International, formerly known as the American Society for Testing and Materials, which develops standards on a wide range of products, including amusement rides, cannabis devices and drones. ASTM is providing the platform 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.

“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.”

The 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.

The FDA 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.

The 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 nonwoven 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.

Some 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.

At 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.

“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.

“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 generated when 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.

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.”

“We are grappling with these issues, which, for a very simple product, have been considerably more complex than we ever imagined,” Stull said. “It’s hard to do all this, but ultimately we’re going to come out with a good standard.”

1.1.This specification establishes minimum design, performance, labeling, and care requirements for reusable, barrier masks for use by the general public and workers. 1.2.This specification is intended to apply to the general public and workers mask to serve as source control to reduce the number of expelled particles from the wearer into the air and have a degree of fit and particulate filtration capability to minimize the inhalation of particulate matter. 1.3.For the purposes of this specification, workers are those outside a healthcare setting and are not required by regulatory agencies such as the Occupational Safety and Health Administration to wear respiratory protection to prevent the inhalation of hazardous substances. 1.4.This specification provides requirements for barrier masks. 1.4.1.This specification includes design and general construction criteria. 1.4.2.This specification includes criteria for head suspensions. 1.4.3.This specification establishes bacterial and solid particulate filter efficiency criteria. 1.4.4.This specification includes criteria for inhalation and exhalation breathing resistances. 1.4.5.This specification includes sizing and fit testing criteria. 1.4.6.This specification establishes requirements for user instructions including donning and doffing, sizing, cleaning, and recommended period of use. 1.4.7.This specification may establish other requirements, for example splash resistance, rigidity, etc. 1.4.8.This specification establishes specific packaging and labeling requirements for barrier masks meeting the requirements of this specification. 1.5.Nothing in this specification is intended to contradict or replace criteria that are established in 42 CFR for air-purifying respirators or requirements for use of respirators in accordance with 29 CFR 1910.134. 1.6.Nothing in this specification is intended to infer that barrier masks are respiratory protection or can be used in a healthcare setting. 1.7.Nothing in this specification is intended to infer that barrier masks should be placed on young children under age 2 or anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance.

Rationale: This specification describes a product that could be used as a source control for reducing the risk of the transmission of an infectious disease, and for reducing the risk of inhalation of particulate matter to protect the wearer. It is not intended for use in a health care setting. It is intended to be used in conjunction with public health recommendations regarding protective measures for the general public. The United States needs an actual standard specification not a guidance document or monograph such as what has been prepared by the AATCC (American Association of Textile Colorists and Chemists Monograph, AATCC MXXX 2020 Guidance and Considerations for General Purpose Textile Face Coverings: Adult (AATCC, 2020)). Europe has proposed a standard that is also a guide, though more comprehensive than AATCC because it addresses both child and adult sizing. Because personal protective equipment (PPE) plays an important role in keeping many workers within various industries safe while performing their professional duties, The National Personal Protective Technology Laboratory (NPPTL) was created to be the division of NIOSH charged with the mission of preventing disease, injury, and death for the millions of working men and women relying this equipment. To accomplish this mission, NPPTL conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard. The NPPTL is approaching Subcommittee F23.65 for the purpose of creating a specific barrier mask standard that adapts current standards and proposals to encourage the use of commercially manufactured barrier masks in the workplace, and commercially manufactured and homemade barrier masks by the general public, by having national standards that specify design and performance characteristics. The development of a comprehensive U.S. standard provides a level playing field for demonstration of product claims and avoid the general confusion related to barrier mask effectiveness with the contemplated need is for the COVID-19 pandemic and other infectious particulate exposure event applications. The mask described in this ASTM standard primarily forms a barrier to reduce the number of expelled particles from the wearer into the air and has an acceptable level of breathing resistance, but additionally has a degree of fit and particulate filtration capability to minimize the inhalation of particulate matter. The proposed standard sets two different levels of filtration efficiency based on a generalized (nonstandard) test method and sets requirements for breathing resistance in error ability based on existing European Norms, which are easily accessible. The standard would bring value to general population and industry by specifying minimum design, performance and testing requirements and allow comparison of products by end users where currently guidelines have been limited. It is NPPTLs opinion that federal rulemaking is not a viable option. Similarly, the development of this standard under other standard development organizations does not offer an expedient approach. ASTM International and its newly formed F23.65 Subcommittee on Respiratory [Hazards] is perceived to be an efficient, open and transparent, and balanced organization for the development of this standard. The NPPTL intends to encourage the participation of all interested parties in F23.65 in the development of this standard.

The title and scope are in draft form and are under development within this ASTM Committee.

ISEA is soliciting interested parties as consensus body participants in the proposed revision of ANSI/ISEA 125-2014, Conformity Assessment for Safety and Personal Protective Equipment.

The document establishes a standardized process by which suppliers – including manufacturers, importers, assemblers, subcontractors, and distributors – can provide evidence that products meet applicable performance standard. Three conformity assessment approaches are defined and differ in the type and rigor of testing and quality assurance, from self-testing to third-party certification.

Consensus bodies represent the views of a balanced cross-section of stakeholder interest categories to include:

· Producer – A manufacturer of the product covered by the standard or components thereof

· User – An organization that uses, specifies or purchases the product covered by the standard

· Government – An agency or department that has a regulatory or other interest in the product (government agencies that use the product fall under the User category)

· General Interest – An organization that has a special interest in this standard due to safety, technical or other requirements or an individual expert with knowledge in the area(s) covered by the standard, but who neither produces nor uses products covered by the standard.

Contact Cristine Fargo, ISEA’s vice president, operations, and technical services for additional information.

ANSI/ISEA 125 is designed to provide a standardized conformity assessment system that can be used by suppliers, specifiers, users and regulators. As a stand-alone document it can be applied as a uniform reference across a range of product categories. It is intended as a resource that can be referenced by end user purchasers of products, who may include compliance to this standard as a requirement of a purchase contract with a supplier; by regulatory authorities having jurisdiction over workplace safety and health; or by product standard development committees to define their conformity assessment requirements for a particular product performance standard. ANSI/ISEA 125 provides the option to select a method of conformity assessment that provides a suitable level of assurance of conformity for any product or application. It is not the intent of the standard to prescribe the appropriate method or level for any product category. This is a decision that is made by the supplier, the end use purchaser who references standards, by a regulatory body with authority over the use of PPE or by the product standards committee whose members are closest to the product category and the product’s application.

NIOSH proposed adding TIL certification in 2015 but ISEA successfully resisted enactment of an evaluation of fit be incorporated into the certification testing for respirators?

In October 2009, the National Institute for Occupational Safety and Health (NIOSH) proposed to add a test for Total Inward Leakage (TIL) to the certification process for half-mask air-purifying particulate respirators. NIOSH believes that adding this component to respirator testing will help ensure that more users will be able to get an adequate fit and increase the level of protection for users who are not individually fit tested. ISEA believes the proposed rule would not achieve the goal of improving worker protection, would be difficult for employers to implement, and might have the unintended consequence of less workplace fit testing.

NIOSH has the authority to test and approve respiratory protection devices used by workers, under 42 CFR part 84. OSHA requires that respirators used in the workplace be NIOSH approved, and further requires that workers be individually fit tested as part of the respirator selection process. Total inward leakage is defined as the combination of contaminated air that leaks through a respirator from various sources, including face seal, valves and gaskets, and penetration through the filter. Because a respirator’s performance is largely dependent on its fit to an individual user, there is no test for TIL in the NIOSH approval.

For a number of years, NIOSH has been studying whether such a test could be feasibly added to the certification requirements. The agency believes that a certification fit test will eliminate respirator models that are inherently poor-fitting and increase the likelihood that approved respirators will fit a larger number of users. In benchmark testing, NIOSH found wide variability among half-mask respirators. Using the results of this testing, it drafted a proposed rule that was published on October 30, 2009. A public meeting was held in December 2009, and comment period, initially ending December 29, was extended to March 29, 2010. In a January 2010 petition to the Secretary of Health and Human Services, ISEA asked for a one-year extension of the comment period. NIOSH reopened the docket, scheduling an additional public meeting in July 2010 and accepting comments until September 30, 2010.

The NIOSH Proposal in 2015: NIOSH proposed procedures for testing to limit approval to respirators that will have a high probability of fitting a large majority of users in a group. The group would be identified by the manufacturer based on facial shapes and sizes. Using the information supplied by the manufacturer, NIOSH would conduct testing on subjects chosen match the target group, e.g. sex, general facial characteristics and facial measurements. For respirators aimed at the general population, 35 subjects would be tested. For respirators aimed at specific subpopulations, 15 subjects would be tested. The respirator passes if 80% of test subjects achieve a fit factor of 100. Fit factor is the ratio of test agent concentration outside the respirator to the concentration inside the respirator. A fit factor of 100 is equivalent to a total inward leakage of 1.0%.

ISEA Response: ISEA commented on the TIL concept following a NIOSH public meeting in 2007. It expressed the belief that the proposed TIL certification would not enhance the efficacy of respirators or increase worker protection, while increasing the regulatory burden for employers. It found the proposed fit test panels and methods introduced a high degree of variability that had not been identified, quantified or controlled to assure reproducible results. ISEA recommended that NIOSH should not move forward with the project.

ISEA repeated its position at the public meeting held on December 3, 2009, noting issues unresolved from its August 2007 comments. In its testimony, ISEA suggested that the proposed changes to certification could actually result in less workplace fit testing and make respirator selection more complex for employers. To further underscore its belief that the proposed tests were inadequate, ISEA’s Respiratory Protection Group commissioned an independent analysis by Environmental Health & Safety, Inc. For this study, the researchers analyzed available data from the NIOSH benchmark tests and conducted a full series of TIL tests on two models of half-mask respirators. The results of the analysis were included as part of ISEA’s comments to the docket submitted March 29 and were further explained at the July 2010 public meeting.

The researchers found that the proposed NIOSH criteria are overly stringent and would likely exclude almost all filtering facepiece respirators and half of elastomeric facepiece respirators from the market. ISEA suggested modifying the pass-fail criteria and fit factor as a more reasonable approach. ISEA made other recommendations to change the test protocols, based on the findings of the researchers.

ISEA also addressed the larger question of whether having a fit test as part of certification will increase the likelihood that non-fit-tested users will be protected. Given the way the testing would be conducted, and lack of data on the effects of training and experience on the level of fit, there is not convincing evidence that adding a TIL test would lead to better chances that non-fit-tested users would get a better fit or be adequately protected. ISEA questions whether NIOSH should address the issue of adequate fit at all, as the use of respirators is under OSHA’s purview and should be addressed by that agency’s standards and enforcement activities. The association recommends that NIOSH use its research capabilities to improve fit testing at the user level, work with OSHA, MSHA and employers to educate employers and workers about the need for fit testing and promote enforcement of respiratory protection standards and regulations.

On September 30, 2010, ISEA submitted additional comments to the docket challenging the NIOSH assumption that the proposed rule is not economically significant. ISEA presented data from the Respiratory Protection Group estimating that the TIL proposal’s economic impact could exceed $1 billion.

A study by the University of Chicago and Argonne National Labs showed that cloth masks lose much of their efficiency due to leaks. Gaps (as caused by an improper fit of the mask) can result in over a 60% decrease in the filtration efficiency, a 1% gap reduced the filtering efficiency by half or more, emphasizing the importance of a properly fitted mask.”