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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
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need for respirators to prevent the spread of COVID19 is discussed in the Need for Specific Provisions for Respirators, further below.
Well-fitting facemasks, not face coverings, are the baseline requirement in healthcare settings because of their fluid resistant qualities discussed in detail below. However, the role of facemasks and face coverings are otherwise similar in source control and personal protection for the wearer.
OSHAs position on the importance of face coverings and facemasks is supported by a substantial body of evidence. Consistent and correct use of face coverings and facemasks is widely recognized and scientifically supported as an important evidence-based strategy for COVID19 control. Accordingly, with specific exceptions relevant to outdoor areas and vaccinated persons, the CDC recommends everyone two years of age and older wear a face covering in public settings and when around people outside of their household CDC, April 19, 2021. And, on January 21, 2021, President Biden issued Executive Order 13998, which recognizes the use of face coverings or facemasks as a necessary, science-based public health measure to prevent the spread of COVID19, and therefore directed regulatory action to require that they be worn in compliance with CDC
guidance while traveling on public transportation e.g., buses, trains, subway and while at airports Executive Order 13998, 86 FR 7205, 7205 Jan. 21, 2021; CDC, February 2, 2021. Similarly, the World Health Organization WHO has recognized face coverings as a key measure in suppressing COVID19 transmission, and thus, saving lives. The WHO
observes that face coverings and facemasks serve two purposes, to both protect healthy people from acquiring COVID19 and to prevent sick people from further spreading it WHO, December 1, 2020.
I. Need for Facemasks Facemasks are simple bi-directional barriers that tend to keep droplets, and to a lesser extent airborne particulates, on the side of the filter from which they originate. The term facemask, as used in this ETS, is defined as a surgical, medical procedure, dental, or isolation mask that is FDA-cleared, FDAauthorized, or offered or distributed as described in an FDA enforcement policy. These are most commonly referred to as surgical masks or medical procedure masks. As previously mentioned, facemasks reduce the risk of droplet transmission through their dual function as both
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source control and personal protection OSHA, January 28, 2021; Siegel et al., 2007. In healthcare settings, facemasks have long been recognized as an important method of source control for preventing the spread of infectious agents transmitted via respiratory droplets e.g., in the operating room to prevent provider saliva and respiratory secretions from contaminating the surgical field and infecting patients.
However, facemasks do not filter out very small airborne particles and do not provide complete protection even from larger particles because the mask seal is not tight FDA, December 7, 2020.
Facemasks are designed and regulated through various FDA processes to protect the person wearing them. Not all devices that resemble facemasks are FDA-cleared or authorized. To receive FDA clearance, manufacturers are required to submit an FDA premarket notification also known as a 510k notification for new products. Data in the 510k submission must show that the facemask is substantially equivalent to a facemask already on the market in terms of safety and effectiveness.
Facemasks are tested for fluid resistance, filtration efficiency particulate filtration efficiency and bacterial filtration efficiency, differential pressure, flammability and biocompatibility FDA, July 14, 2004.23
Research developed during the current SARSCoV2 pandemic provides evidence of the protection afforded by facemasks. First, a universal surgical masking requirement for all healthcare workers and patients was implemented in Spring 2020 in the Mass General Brigham healthcare system, which is the largest in Massachusetts Wang et al., July 14, 2020. Based on daily infection rates among healthcare workers, the authors found that universal masking was associated with a significantly lower 23 Medical devices are subject to premarket review through risk-based classification under the Federal Food, Drug, and Cosmetic Act. Premarket approval PMA applies to the highest-risk, Class III
devices, and 510k notification applies to most Class II and some Class I devices. Under the 510k notification pathway, FDA determines whether the device is substantially equivalent to a lawfully marketed predicate device. Medical device manufacturers are required to submit a 510k notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. For more information, see https www.fda.gov/medicaldevices/device-advice-comprehensive-regulatoryassistance/how-study-and-market-your-device and https www.fda.gov/medical-devices/deviceapprovals-denials-and-clearances/510k-clearances.

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rate of SARSCoV2 positivity.
Although the authors noted that other interventions, such as restricting visitors, were also put in place, they concluded that their results supported universal masking as part of a multipronged infection reduction strategy in healthcare settings.
Second, a systematic review and meta-analysis evaluated research on healthcare workers exposed to SARS
CoV2, as well as the SARS and Middle East respiratory syndrome MERS
viruses Chu et al., June 27, 2020. Six studies compared the odds of infection in those who wore surgical or similar facemasks compared to those who did not wear any facemask; four of the six studies were on healthcare workers and all six were from the 2003 SARS
epidemic. Participants who wore surgical or similar facemasks had only a third of the infection risk of those who did not wear any facemask.
Third, a review of respiratory protection for healthcare workers during pandemics noted that surgical mask material has been shown to protect against more than 95% of viral aerosols under laboratory conditions GarciaGodoy et al., May 5, 2020. The authors also reviewed research showing that surgical masks reduced aerosolized influenza exposure by an average of sixfold, depending on mask design.24
Finally, in one epidemiological study, a specialized team of contact tracers at Duke University Health System in North Carolina categorized recorded COVID
19 cases among their healthcare workers Seidelman et al., June 25, 2020. Of the cases that were categorized as healthcare-acquired meaning acquired as a result of either an unmasked exposure for greater than 10 minutes at less than 6 feet to another healthcare worker who was symptomatic and tested positive for the virus, or an exposure to a COVID19-positive patient while not wearing all CDCrecommended PPE or while there was a breach in PPE, 70% were linked to an unmasked exposure to another healthcare worker.
Although cloth face coverings have gained widespread use outside of healthcare settings during this pandemic, OSHA has determined that cloth face coverings do not offer sufficient protection for covered healthcare workers for multiple reasons.
First, cloth face coverings, as defined by the CDC, encompass such a wide variety of coverings that there is no assurance 24 For a discussion of the efficacy of respirators over facemasks for protection against aerosolized particles, please see the respirator discussion in the Need for Specific Provisions section, below.

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