Disclosure and Fit Capability of the Filtering Facepiece Respirator

Introduction

Consider an employer or worker looking online for filtering facepiece respirators such as the commonly known “N95.” Cost may be a consideration, and each will find that a government-approved respirator can be quite affordable, much less than a dollar if purchased in sufficient quantities. Among the variety of models available, the workplace consumers may find general use information and in some cases links to more technical content and marketing. Regarding the important variable of fit, there likely will be no specific acknowledgment that the respirator model viewed may not fit the user. Instead, they may find that a particular model is listed with wording that suggests a universal fit without further qualification. Those knowledgeable about respirators will understand that such terms are not literal and that a fit test for each user is needed. Less knowledgeable consumers may be misled to a more literal understanding.

Whether the respirator actually fits the user is critical and problematic. It is critical in that a respirator that does not fit can lead to excessive face-to-seal leakage and exposure to harmful amounts of an airborne particulate. It is problematic in that the individual models of respirators differ in their fit profiles and capabilities and individual workers differ in their facial features. Matching the wearer with the model that fits is the reason why an Occupational Safety and Health Administration (OSHA) standard requires employers to provide a fit test to workers required to use a respirator. ¹ Training, work practice, and supervision cannot make up for a respirator that does not fit.

Regardless if the OSHA-accepted fit test ² is provided at a worksite, the employer and workers will likely not know that National Institute for Occupational Safety and Health (NIOSH)-approved filtering facepiece respirators are not certified for whether the product may fit any appreciable portion of the U.S. workforce. That disclosure to the consumer is not online, not provided with the product, and is not well known even among safety and health professionals. Most consumers may find it absurd that they could purchase a NIOSH-certified respirator that had not been subjected to a certification test for how well it may fit the intended users.

This commentary addresses the NIOSH certification of the filtering facepiece respirator as an effective occupational safety product and the disclosure of its fit capability. An effective filtering facepiece respirator starts with one that is well designed for facial fit. This commentary does not address the improper use, performance versus elastomeric designs, or the OSHA-accepted methods of fit testing used by employers to select individual models for their workers.

Missing NIOSH Certification

NIOSH made significant changes to the respirator certification requirements in 1995 that included the adoption of sorely needed improvements for air-purifying particulate respirators. ³ This change resulted in new types of cartridge filters and filtering facepieces, e.g., the “N95” or “P100.” However, one certification requirement was removed—fit capability testing of the newly created classes of filtering facepiece particulate respirators. Without the certification criteria, new respirator design is free of this regulatory specification, and fit capability could vary to the point that some respirators intended for the general worker population fit very few. The particulate filtering elastomeric facepiece respirator was also subject to the loss of fit capability certification. However, the loss was not as critical since the same facepiece was often part of an approval for a chemical cartridge respirator still subject to the extant qualitative fit capability testing protocol.

The reasons provided by NIOSH at the time the criteria was removed included the need to develop a better fit capability test because the isoamyl acetate protocol, then in use, was ill suited for testing of particulate respirators. ³ NIOSH committed to address the issue after completion of the needed research. During the interim, employers were expected to comply with the existing OSHA requirement for individual worker fit testing to select a model and size of filtering facepiece respirator that provided each user the required fit. There also was the assumption that employers, through fit testing of their workers, would identify and not purchase respirators with poor fit capability and thus remove them from the market.

Subsequent research by NIOSH and others have challenged these assumptions. A national survey of respirator use in the private sector by NIOSH estimated that 43 percent of the employers were not providing required fit tests, with the greatest noncompliance in small employer establishments.^4,5 More recent and regional studies found 58 percent of thirty-six and in a separate study 88 percent of forty-nine auto body shop employers, 91 percent of thirty-five small employers in seven industries with worker overexposure, and 100 percent of forty-two employers who fabricated granite countertops had not provided required fit tests.^6–9 The data indicate the likelihood of significant and ongoing noncompliance with required fit testing. This translates to more than a half million workers required to have a fit test but not provided one. ¹⁰ In other research, NIOSH found a number of poorly fitting certified filtering facepiece respirators in the marketplace. Comparative testing of certified half mask air-purifying respirators using a panel of test subjects with diverse facial features found fit capability to vary by respirator model and ranged from fitting less than 5 percent to those fitting more than 90 percent of the subjects.^11–16

NIOSH, in 2009, proposed a rule that added back the missing certification of fit capability. ¹⁵ The agency acknowledged in the preamble that the lack of fit capability criteria in certification could result in an employer wasting resources fit testing workers with a certified respirator that fits very few. Further, NIOSH recognized that a large number of workers who wear the respirator for protection were not provided the fit testing required by OSHA. NIOSH concluded that with certification of fit capability, there would be an increased likelihood that “these workers who lack fit testing will be protected, by obtaining respirators that are demonstrated to generally provide a good fit to intended users when worn properly.”

The proposal contained the agency’s new quantitative fit capability protocol built on years of prior research. The protocol was statistically based and used a set number of test subjects representative of the facial diversity of the current U.S. working population. Subjects were to wear the submitted model of respirator and undergo a fit test protocol that included the OSHA quantitative fit test procedure with the condensation nuclei counter. Approved models would need to fit a minimum percentage of the test subjects set by the standard. The protocol had a number of other provisions that would prove helpful to the consumer.

The rule was groundbreaking, but generated controversy and criticism from respirator manufacturers and others over the pass/fail threshold and the testing protocol. ¹⁰ The rulemaking stalled and NIOSH in December 2015 requested the American Society of Safety Engineers to help develop an American National Standard Institute (ANSI) consensus standard for a respirator fit capability test for half-mask air-purifying particulate respirators. ¹⁷ NIOSH stated that they would consider the resultant standard for rulemaking. A subcommittee was formed in 2016 and drafting of the voluntary ANSI standard began in early 2017 (Sporrer JS, NIOSH, personal communication, August 8, 2017).

Given the lengthy processes of ANSI standards adoption and subsequent NIOSH rulemaking, a new certification rule is years away, if it does not get shelved. Adoption of a rule is not guaranteed due to possible opposition from stakeholders or from the newly elected administration. If not adopted, there is no assurance that respirator manufacturers would follow the voluntary consensus standard, given the added costs of testing and a possible negative result for a product. Without certification of fit capability, disclosure to the consumer of the filtering facepiece respirator’s fit limitations is ever more critical.

The Consumer, Respirator Fit, and Disclosure

The consumer in the workplace includes the purchaser, who may be an employer, the wearers of the safety product, and the safety and health professional—the latter an influential but, in comparison, much smaller group. Employers and particularly small employers account for a significant portion of the respirator market. The most comprehensive survey of respirator use in the private sector found that small employers with an employment of fewer than fifty made up 75 percent of worksites with required use of filtering facepiece respirators (disposable dust mask). ⁵ Based on the survey conducted in 2001, this alone amounted to more than 529,000 workers in more than 135,000 establishments.

The small employer is more likely to lack the technical knowledge or resources for the proper selection and use of the filtering facepiece respirator that appears so user friendly. This consumer, as well as others, may have expectations largely influenced by what they do not know about this product. This circumstance could be due to information not used, misunderstood, or not disclosed.

The NIOSH requirements for information to be provided to the consumer by the respirator manufacturer have essentially remained the same since 1972.^18,19 The information, referred to as a label, is required to include the respirator’s restrictions or limitations identified by NIOSH.^19–21 Disclosure of the fit capability of the respirator model is not required. Also, the disclosure of the requirement for fit testing is not always displayed on the outside of the package. Instead, it may be included with the more complete information on respirator use contained inside the package. The label rule, adopted before the advent of the Internet, requires the information to be placed on or in the respirator container, a “hard copy” disclosure. This rule may have been upended by the widespread use of the Internet for respirator marketing, sales, and information.

Disclosure of Fit and the Internet Marketing of the Filtering Facepiece Respirator

The information available on respirator fit for consumers purchasing filtering facepiece respirators on the Internet was surveyed by this author. The limited survey included web sites for five respirator manufacturers of NIOSH certified filtering facepiece respirators. These web sites did not retail directly to the consumer; however, they served as a source of information for both the consumer and the retailer. The five of about thirty-seven manufacturers included three of well-known brands and two that sold predominantly to retailers who sold the product under a private label. The web sites of twenty-two retailers or suppliers of filtering facepiece respirators to consumers were also reviewed. This group included thirteen safety equipment suppliers selected from different locations in the United States. Five would be considered national or multi-state in scope and eight were more regional. Additionally, web sites for six industrial supply companies (five judged as national in scope), two national chain stores, and one major e-commerce retailer were reviewed. Two to four specific models of NIOSH-certified filtering facepiece respirators were reviewed at each web site by progressing through the menus and selecting model web pages from the suppliers list of filtering facepiece respirators. A total of fifty-seven model web pages were selected that provided the information for a specific model and where the consumer could add the product to the “shopping cart.” The fifty-seven consisted of forty different models, thirteen of which were private label models. A total of eleven different respirator manufacturers were represented and forty-nine of the selected models were produced by the five surveyed manufacturers. Forty-five of the respirators were type N95s, six P100s, and the remaining were P95, N99, or N100. About a third cost less than $1.00 each, and for the entire group, the least expensive was $0.45 and the most expensive $13.23 each (shipping and handling costs were not included).

The filtering facepiece respirator web pages for the five selected manufacturers were surveyed for specific information on fit capability. This was defined for the survey as a description and percentage of intended users that may achieve a fit based on data obtained through an identified protocol. Although there is yet no voluntary or mandatory standard, respirator manufacturers that have developed their own fit capability protocols may have presented this specific information for consumer use. None was found. Rather, the manufacturers characterized respirator fit capability in general terms, such as “standard,” or a physical size (e.g., small, medium, large), or descriptive words, as “one fit,” “designed to fit most face sizes and shapes,” and “one size fits most.” These terms were used without further reference. The three manufacturers who primarily sold under their own brand offered support to the consumer on selection, fitting, training, along with the NIOSH restrictions and limitations and the purpose and methods of fit testing.

The fifty-seven specific model web pages sampled from the supplier web sites were also surveyed for information on fit capability. Disclosure was characterized as none, general, or specific as used for the manufacturers. Thirty of the model web pages provided general information by listing one or more sizes (twelve), e.g., small, medium, or large, or provided a descriptive word or phrase (eighteen), e.g., “size: universal,” “one size fits most,” and “standard.” Three provided what may be called specific fit capability, “one size fits all,” but offered no further information or links that supported the claim. Twenty-four offered no information on fit capability though two offered links to general information.

Fifty-five (96 percent) of the model web pages did not have a statement on the need for a fit test. Fifteen of these offered links that provided content with the information. Nine web pages without a statement on the need for a fit test also used words for fit capability that may imply a universal fit, e.g., “size: universal.” Two suppliers highlighted the fit test requirement on the web page that listed all of the available filtering facepiece models.

Nineteen of the twenty-two suppliers listed fit test kits for sale with the link on the same menu that listed respirators and related products. Only one of the model respirator web pages had a link to the purchase of a fit test kit.

An explicit warning that the particular model respirator may not fit the buyer or an intended user was not on any of the fifty-seven model webpages. Although an explicit warning may be warranted for a product used to prevent occupational illness or disease, it is also not required for the NIOSH container label. Five suppliers for one particular brand offered a link to the manufacturer’s product data sheet that stated the importance of determining if the respirator could be properly fitted which was followed by a notice on the requirement for a fit test.

Because of the small sample size, a caution is advised as the surveyed manufacturers’ and suppliers’ web pages may not represent the greater whole. Nevertheless, the survey indicates that a number of supplier model web pages lack specific information on fit capability and a warning that a fit test is needed. Further, some consumers may be at risk of understanding in error that models of filtering facepiece respirators literally have a universal fit and therefore further consideration on its fit is unnecessary. Unfortunately, many purchasers will have the first opportunity to learn that a fit test is required only after receiving the package and reading the required NIOSH label and the more complete instructions and warnings therein.

NIOSH Action

Poorly fitting certified filtering facepiece respirators need to be identified and removed from the market as soon as possible. This action may be achieved by NIOSH through the commitment of the necessary resources to timely adopt rules for the certification of fit capability. The disclosure by NIOSH of the fit capability of certified filtering facepiece respirators has been previously recommended. ²²

Further NIOSH action is needed during the interim of the rulemaking:

Update the contents and application of the NIOSH label. The consumer needs to know prior to purchase that any one model of filtering facepiece respirator may not fit the purchaser or an intended user, that an OSHA-required fit test is required to find the model and size for each user that provides the proper fit, and that one or more different models may be needed. This information needs to be placed with the product marketing in hard and electronic form.

Conclusion

The filtering facepiece respirator continues to be widely accepted as a means of protection from potentially harmful airborne particulates, including instances where good practice and regulation require the use of more reliable control methods. Employers that do provide filtering facepiece respirators through compliance with the OSHA-required fit test ² help ensure that their employees have a respirator that fits. However, the iterative nature of selecting and testing can be inefficient and costly with poorly fitting respirators on the market. Compliance with OSHA respirator rules is not a substitute for the consumer product protection offered by the NIOSH certification of fit capability. It may also be expected that compliance with OSHA fit testing will remain alarmingly low into the future. The large number of at-risk workers who were provided a model of filtering facepiece respirator without a fit test would have a greater chance of obtaining one that fits if only “good fitting” models were certified. A number of NIOSH and other published studies as well as credible fit test programs in the workplace have found certified models that may be considered as “poor fitting” and others as “good fitting.”^11–16 Confounding the issue of respirator selection is the inability of the consumer to know, prior to purchase, which may be the poor or good fitting model. NIOSH must take the necessary action to assure a protective threshold of fit capability and more fully disclose the limitations of a safety product which so many workers and their employers rely on.