NEW FACE COVERING STANDARDS & Research Consortium CONSUMER ADVISORY
Efficacy, cost-effectiveness and value are important aspects of general-purpose face coverings — however being safe, healthy,
and ecofriendly is of equal concern to consumers. This is why the Research Consortium has been lobbying and working with standards organizations and consumer groups across the globe to require a consumer advisory product label...like ours below.
International standards intended to regulate general-purpose face coverings do not address the use of antimicrobial or antiviral materials, finishes, or mechanisms, many of which are subject to oversight by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) and may warrant additional testing and regulatory oversight as to their efficacy and safety. Further, there are several aspects that relate to the material composition and design of face coverings that are not addressed by many standards but warrant attention relative to the safety, health, and environmental impact of face coverings including, but not limited to potentially toxic finishes, inhalable substances from materials, and bioburden inhibitors. Knowing this, it is important that end users familiarize themselves with the specific special claims being made for products and ask for information to verify each.
The Stay Safer Reusable Protective Face Covering is neither a CDC/NIOSH certified respirator nor an FDA-approved surgical mask. It is technically a "medical device" per the FDA which classifies ALL face coverings that are intended to curb community spread as a medical device. Like other general purpose face coverings, it is authorized for use by the FDA under an Emergency Use Authorization (EUA) by the general public to help slow community spread during the pandemic. Without specific EPA or FDA approval, claims cannot be made about any antimicrobial agent’s protection or prevention against specific organisms infectious to humans or that of any fabric treated with the agent. As such, while this face covering does not cause damage nor bring additional risk to wearers when used as intended, it cannot be stated that it can prevent or protect the wearer from any form of risk to a person's health or safety, illness or disease. Accordingly, the research, studies and data provided in support of the science and technology behind our face covering — while truthful, accurate and complete — is presented for informational and educational purposes only. For more on this topic, see below.
Summary of Recent Key Developments
In November 2020, the CDC acknowledged for the first time that in addition to source control general-purpose face coverings can also serve to reduce the number of infected particles a wearer might inhale. This was a monumental move by the CDC as it carries broad employer regulatory compliance implications in addition to the suggestion that general-purpose face coverings can do something to afford the wearer some level of protection.
The American Association of Textile Chemists and Colorists (AATCC), a highly regarded international standards organization, created AATCC M14-2020 Guidance and Considerations for General Purpose Textile Face Coverings, a voluntary specification intended to be a manufacturer guide. Wanting a true standard, the CDC's National Institute for Occupational Safety and Health (NIOSH) engaged the American Society for Testing and Materials (ASTM International) to create a national standard to serve as a baseline for source control devices and to provide a level playing field for demonstration of product claims and avoid the general confusion related to community barrier face covering effectiveness. It is taking the form of ASTM WK73471: New Specification for Barrier Face Coverings and due to be issued in Q1 2021.
Mr. Richard Nicholas, the founder of the Research Consortium, is a member of the workgroup that wrote the AATCC M14-2020 specification. He is also a member of the ASTM F23.65 workgroup tasked by the CDC/NIOSH with developing a national face covering standard. This standard will ensure that general purpose face coverings meet minimum requirements for both source control and to reduce the amount of particulates inhaled by the wearer.
New standards will soon be released in Europe and the US that will impose design, leakage, filtration efficiency, breathability, safety and consumer labeling requirements on general-purpose face coverings. The traditional particle filtration efficiency (PFE) and bacterial filtration efficiency (BFE) testing results presently touted by manufacturers will largely become obsolete. Manufacturers will need to meet new NIOSH-based filtration and air flow testing and measurement standards that are far most broad, stringent and challenging. Laboratory testing protocols and requirements are more specific to eliminate the great variations that are allowed by other standards (e.g., particle filtration tests have specific face velocity, particle polarity and size range/blend/mix requirements, etc.) Ordinary face coverings will not likely meet the requirements of the new standards and many manufacturers may have to abandon or curtail their product claims and acknowledge the use of unsafe, unhealthy and non-ecofriendly characteristics (in their product labelling).
Import of CDC Scientific Brief
The CDC, in a monumental move, recently issued a Scientific Brief in that for the first time stated that wearing a face covering can help to reduce the wearers’ exposure by filtering infectious droplets. Community Use of Cloth Masks to Control the Spread of SARS-CoV-2 (found here) states that while it is well known that cloth masks block most large droplets effectively, they also block aerosols and can be excellent source control for exhaled viral particles (noting that some multi-layer masks can perform “on par with surgical masks as barriers for source control”.
This acknowledgement of the expanded utility of face coverings to include wearer protection, is consistent with initiatives, and worldwide, to develop a community face covering standard that addresses both in- and outbound filtration as a means by which to spurn the creation of better face coverings and to provide users with the confidence they need to feel safe about wearing in public.
Current Regulatory Compliance Requirements
Presently, although no formal national standard exists for general-purpose, community use barrier face coverings in general, various government agencies are responsible for regulating certain aspects of such coverings. By example, both the EPA and FDA are charged with regulating antimicrobial agents based on their intended application. * In general, antimicrobial agents used on inanimate objects are regulated by the EPA as antimicrobial pesticides under FIFRA; and antimicrobials used in or on living animals or humans are regulated by the FDA under FFDCA.
The EPA has established strict rules regarding marketing claims made about the capabilities of anti-microbials. Among them are prohibitions against making claims beyond that of the “treated article” itself. Without specific EPA approval, claims cannot be made about an antimicrobial’s protection against or prevention from specific organisms infectious to humans or that of the treated fabric. Any claim must be limited to the face covering itself; be specific and not unqualified; refrain from referencing health-related microbes and from denoting personal (e.g., “for skin, wound, or respiratory”) protection. These prohibitions cover product packaging, advertising and communications. Graphic representations of the covering’s antimicrobial protections cannot include or imply protection of public health significance or take prominence above other normal product claims.
New Community Face Covering Standards
New standards are being developed that will transform voluntary specifications into requirements for community face coverings throughout the Europe and the US. An American Society for Testing and Materials (ASTM) International workgroup, overseen by the CDC/NIOSH, has been hard at work developing a "standard" for barrier face coverings to be published in early 2021. This standard will require meeting minimum performance levels on tests similar to those used to evaluate respirator devices and measure leakage, particle filtration and breathability. Community mask specifications are in the process of being converted into a standard by the European Committee for Standardization (CEN) as well. Ordinary (lower quality) fabric face coverings will not likely meet these requirements. It is also likely that certain manufacturer performance and safety claims will to be limited or prohibited. *
The Foundation of Our Authority
The Research Consortium took an early interest in face coverings at the outset of the pandemic as it was in keeping with our work: to evaluate new medical technologies/health innovations for health plan sponsors. Our study, COVID-19, ITS TRANSMISSION AND FACE MASK EFFICACY, has been downloaded thousands of times. The Research Consortium's founder, Richard Nicholas, has done extensive research on face mask guidelines. He is a member of the American Association of Textile Chemists & Colorists committee that created M14-2020 Guidance and Considerations for General Purpose Textile Face Coverings and the American Society for Testing and Materials International committee that is developing (with the CDC/NIOSH) a soon-to-be-released national "standard" for barrier face coverings. Mr. Nicholas has studied most all of the community face covering specifications issued by the leading international standards entities and has made recommendations that are under consideration by some of these entities:
AATCC M14-2020 Guidance and Considerations for General Purpose Textile Face Coverings (US)
ASTM WK73471: New Specification for Barrier Face Coverings (US)
CWA17553 Community Face Coverings: Guide to Minimum Requirements, Methods of Testing and Use (EU)
BSI Flex 5555 Community Face Coverings - Specification: Version 1 (UK)
AFNOR Specification S76-001: Masques Barrières (France)
NEN-Spec 1-2:2020-11-09 Certification Scheme Community Face Masks (The Netherlands)
NM ST 21.5.200/2020 Réglementation Relative aux Masques de Protection (Islamic Countries)
TU 13.92.29-005-00302178-2020: Hygienic Face Masks (Russian Federation)
Health Commission Policy Update: Community Use of Face Masks (African Union)
He also reviewed the standards of dozens of countries that have modified one of the specifications above or developed their own guidelines from scratch.
Note: Though claims are often made by manufacturers about an antimicrobial’s perceived ability to kill the COVID-19 virus,
no entity can justly make such a claim as, to date, there has been no approval, or any form of government - sanctioned testing performed to prove the effectiveness of any antimicrobial agent against COVID - 19. Despite this, many face covering makers disregard these prohibitions or adopt the default position that the intended purpose of their antimicrobial is for odor control.