Standardization News

As part of its 125th anniversary celebration, ASTM International invited case study submissions from committee members around the world, highlighting standards that have made a significant impact in society – and that have bettered the world around us. Numerous exceptional submissions were received, making the work of ASTM’s panel of judges even more difficult in narrowing down the list to eight winners.

Standardization News is publishing all eight winning entries in 2023. We continue the series with a standard for barrier face coverings from the committee on personal protective clothing and equipment (F23): The standard specification for barrier face coverings (F3502).

Identify the need for the development of this standard: What problem was this standard trying to solve? 

At the beginning of the COVID-19 pandemic, it became evident there would be shortages of personal protective equipment (PPE) to protect healthcare workers for a disease where the transmission mode was not clearly understood. As it became evident that the general population would need some form of a mask for diminishing the spread of COVID-19 as hospitals were overwhelmed, the U.S. Centers for Disease Control and Prevention (CDC) began to promote the use of face coverings as providing some measure of disease control and protection without taking away from the conventional PPE (namely, medical masks and respirators) greatly needed by healthcare professionals. The F23 committee recognized the need to create criteria for a previously undefined product and convened a special meeting of the committee to solicit priority actions for improving PPE standards in the wake of the worsening pandemic. Foremost among the identified needs was developing a product specification for face coverings, which eventually were referred to as “barrier face coverings.” The activity was undertaken by the relatively new subcommittee on respiratory protection (F23.65). Additional attention was brought forward for this topic by the National Institute for Occupational Safety and Health (NIOSH) within CDC, who learned from an industry trade group that alternative materials were available to support the use of face coverings that would not take away from badly needed respirators and surgical masks.

Identify the interest groups that participated in the development and/or revision to the standard?

With the announcement of the new work item committee, nearly 100 individuals representing government officials (CDC, U.S. FDA, NIST, and other national organizations including representatives from foreign governments); universities and research institutes; testing laboratories; health care provider organizations; end-user companies (e.g., Disney and Merck); PPE manufacturers; material suppliers; trade associations; product innovators; and general consumers joined the work group. Several participants had no prior PPE experience or interests. The influx of interested individuals rapidly doubled the membership of the respiratory subcommittee (F23.65) and further led to a large increase in overall F23 membership. The increased membership included participants from several countries outside the U.S. 

How is this standard commonly used by industry? 

The standard is primarily used by producers to make claims of barrier face covering products providing appropriate levels of particle filtration efficiency and pressure drop (as a measure of material breathability) as well as an assessment of their ability to fit the wearer’s face and limit leakage around the sides of the face covering. Manufacturers have been able to use this standard to position their product for consumers, healthcare workers, and others. The standard has been referenced by CDC; has become an FDA-recognized standard for medical devices; was used by the federal government in purchasing 25 million face coverings for disadvantaged populations (Source: WhiteHouse.gov); was specified by different organizations such as the Veterans Administration for its hospital system as well as other workplaces for employee use; and has been promoted by a range of face-covering manufacturers and material-suppliers for various products. The non-design restrictive nature of the standard has resulted in a multitude of product configurations in both disposable and reusable designs with a range of acceptable performance.

How has the standard impacted health and safety?

The standard filled an important gap in which a new product area had not defined design, performance, or labeling criteria. This type of product effectiveness has been the subject of multiple articles for determining the relative effectiveness of source control and protection features of face coverings. This has led to a better understanding for mitigating disease spread when the products are properly worn. (1)

How do consumers and the public benefit from this standard?

The standard was adopted at a time when it could provide a basis for qualifying a product where no prior specifications existed. It was developed at a time of considerable confusion around mask-wearing. As part of the specification, a simple classification scheme was instituted, which could easily be understood by the public for rating minimum and higher performance. CDC added its own criteria on top of F3502 criteria and created a list of reviewed face-covering products positioned against the standard, which could be accessed by the public for discerning products complying with the standard.

Just as importantly, a comprehensive introduction combined with an extensive significance and use section and other portions of the standard were used to educate the public about the differences between a respirator, surgical mask, and barrier face covering, which have different performance characteristics and performance levels. The specification provided a consensus approach for distinguishing between these products and highlighted the differences between inhalation protection (protecting the wearer) and source capture or control (protecting the public), which became important precepts for the global response to the pandemic.

Can you provide any data to support the safety, economic or other impacts of the standard? If yes, please summarize the data and provide citations.

Safety data were provided for barrier face covering effectiveness based on a metric within the standard for relative inhalation protection and source capture effective (1) that included findings for the length of time needed for reducing potential infection by wearing barrier face coverings at different leakage levels on both infected individuals and non-infected individuals. In addition, work undertaken directly by the CDC was able to distinguish characteristics of different face covering products for relative effectives for the purpose of source capture (2). F3502 has promoted proper fit (leakage resistance) among face covering products. The open criteria of the specification has also established a wide range of affordable products at similar costs related to respirators and surgical masks.

Are you aware of any regulatory adoption (domestic or international) or broad international use of the standard? If yes, please provide details.

This standard has been rapidly referenced by several government organizations. Within weeks of its adoption, it became a recognized FDA standard for medical devices, and months later it was included in the updated FDA’s enforcement policy for masks, which also addresses surgical masks and respirators.

The standard was cited on the CDC webpage for pandemic masks, where CDC used it as the basis to establish additional “workplace protection” and “workplace protection plus” face covering requirements for workers. CDC further instituted a listing of products complying with F3502 as part of its “PPEInfo” page on the CDC website. This page is continually updated and new products have been regularly added.

OSHA made reference to F3502 as part of its recommended requirements in interim regulations for COVID-19 and is planning to position the use of the specification as part of the broader PPE requirements against infectious disease protection for healthcare workers planned for public rulemaking in 2023. 

The World Health Organization also adopted the standard as the recommended basis for community face masks in early 2022. Through its outreach efforts, F3502 is being adopted as the national standard in other countries (e.g., Jordan).

Does this standard address any of the 17 United Nations Sustainable Development Goals?

SDG 3: Good Health and Well Being. The COVID-19 pandemic has and will continue to require a range of solutions for minimizing disease transmission where the use of masks and face coverings is a principal part of an agreed upon effective approach. The development of a standard for this product that has been adopted around the world helps to fulfill this goal.

SDG 12: Ensure sustainable consumption and production patterns. This is achieved by avoiding definitive product and material requirements and instead focusing on design and resources that can meet requirements that address reuse, reprocessing, and safe disposal. For example, in citing F3502, the WHO promotes the use of reusable barrier face coverings that meet the standard. The responsible committee is also investigating future revisions of the standard that will distinguish products that provide greater sustainability and less waste. Already, the standards requires the manufacturer to identify products that are reusable and asks them to describe procedures for the cleaning and reuse of such products.

Please provide any additional information here.

The most noteworthy aspect for the development of F3502 is how it demonstrated the nimbleness of the open and transparent ASTM process. Its promulgation in a 7-month period from the first work group meeting to an approved standard involving a 100-member work group with a diverse set of represented interests attained a level of success in meeting a global need not demonstrated by any other standards development organization. F23 followed ASTM regulations in not only providing a timely standard but one that properly incorporated the latest scientific findings for product design and performance as well as anticipating the correct disease transmission mode in how it set the requirements. Addressing face-covering leakage was one of the key features of the standard that appealed to the WHO and for which CDC was able to establish additional criteria building from F3502 for protective workers without access to respirators. 

Ultimately, the promulgation of the standard brought needed attention to not only masks in general related products, namely surgical masks and respirators. 

The standards development process had the further impact of greatly expanding the membership of F23 and overall interest in PPE. The future of F3502 and this particular standards development process is expected to have far-reaching consequences not only on barrier face coverings but the on the way producer, user, research, and regulatory organizations approach source control and inhalation practices. ■

References
1.    Brousseau, LM, Stull, JO. (2022), “Barrier Face Coverings for Workers. New Solutions,” DOI: 10.1177/ 10482911221116664.
2.    Brooks, John T., et al. “Maximizing fit for cloth and medical procedure masks to improve performance and reduce SARS-CoV-2 transmission and exposure,” Morbidity and Mortality Weekly Report 70.7 (2021): 254.