Under 30 CFR 11 In 1992, NIOSH published a draft report on the effectiveness of respirator regulations under the then-current
30 CFR 11. Particulate respirators back then were mainly classified as either
DM, DFM, or HEPA.
Respirator risk modelling Assigned protection factors (APF) are predicated on the assumption that users are trained in the use of their respirators, and that
100% of users exceed the APF. This "simulated workplace protection factor" (SWPF) was said to be problematic: The ideal assumption of
all respirator users exceeding the APF is termed the
zero control failure rate by NIOSH. The term
control failure rate here refers to the number of respirator users, per 100 users, that fail to reach the APF. The risk of user error affecting the
failure rate, and the studies quantifying it, was, according to NIOSH, akin to the study of
contraception failure rates. This is despite there being a "reasonable expectation, of both purchasers and users, [that]
none of the users will receive less protection than the class APF (when the masks are properly selected, fit tested by the employer, and properly worn by the users)". NIOSH expands on the methods for measuring this error in Chapter 7 of the draft report. With regards to the effectiveness of fit testing in general, others have said: Neither exercise was included in the
OSHA fit test protocols. Put another way, it has been said: • Almost 80% of negative-pressure respirator wearers were not receiving fit testing. • Over 70% of 123,000 manufacturing plants did not perform exposure-level monitoring, when selecting respirators to use in the plants. • Noncompliance increased to almost 90% for the smallest plants. • 75% of manufacturing plants did not have a written program. • 56% of manufacturing plants did not have a professional respirator-program administrator (i.e., qualified individual supervising the program). • Almost 50% of wearers in manufacturing plants did not receive an annual examination by a physician. • Almost 50% of wearers in manufacturing plants did not receive respirator-use training. • 80% of wearers in manufacturing plants did not have access to more than one facial-size mask, even though nearly all reusable masks were available in at least three sizes.
Adherence to the regulatory minimum APFs may be based on the filtration performance from one or two manufacturers that barely pass the regulation. When the DM and DFM respirator filter standards at the time were found to have an unacceptably high filter leakage, NIOSH proposed lowering the APF for DM respirators from 10 to 2. On this scale, 1 is a completely ineffective respirator. Some respirator manufacturers, like
3M, complained that DM and DFM respirators with superior filtration, that would normally receive an APF well above 2, were being "held hostage" by poorly-performing respirators. While NIOSH acknowledged the predicament poorly-performing respirators were having on superior respirators in the same class, they concluded that the APFs, for respirator classes like DFM halfmask respirators, should be lowered to at least 6, despite APFs of 6 through 10 being allowed previously for DFM halfmasks.
ANSI suggested additional contaminant monitoring by employers to allow for the use of DM and DFM respirators, when the
mass median aerodynamic diameter of dusts in contaminated workplaces is such that DM and DFM respirators
could work. However, NIOSH pointed out that the poor adherence to OSHA regulations on exposure-level monitoring by employers, as well as lack of expertise in interpreting the collected data, would likely result in more workers being put at risk. In addition, NIOSH pointed out that the ANSI recommendations would effectively mandate the use of
expensive Part 11 HEPA filters under Part 11 regulations, due to lack of adherence to exposure-level monitoring rules.
Hierarchy of Controls point of view under 42 CFR 84 outbreak) The Hierarchy of Controls, noted as part of the
Prevention Through Design initiative started by
NIOSH with other standards bodies, is a set of guidelines emphasizing building in safety during design, as opposed to ad-hoc solutions like PPE, with multiple entities providing guidelines on how to implement safety during development outside of NIOSH-approved respirators. US Government entities currently and formerly involved in the regulation of respirators follow the Hierarchy of Controls, including
OSHA However, some HOC implementations, notably MSHA's, have been criticized for allowing mining operators to skirt
engineering control noncompliance by requiring miners to wear respirators instead if the
permissible exposure limit (PEL) is exceeded, without work stoppages, breaking the hierarchy of engineering controls. Another concern was fraud related to the inability to scrutinize engineering controls, unlike NIOSH-approved respirators, like the
N95, which can be fit tested by anyone, are subject to the scrutiny of NIOSH, and are
trademarked and protected under US federal law. NIOSH also noted, in a 2002 video about
TB respirator use, that "engineering controls, like negative pressure isolation rooms may not control the TB hazard completely. The use of respirators is necessary".
Respirator non-compliance With regards to people complying with requirements to wear respirators, various papers note high respirator non-compliance across industries, with a survey noting non-compliance was due in large part due to discomfort from temperature increases along the face, and a large amount of respondents also noting the social unacceptability of provided
N95 respirators during the survey. For reasons like mishandling, ill-fitting respirators and lack of training, the Hierarchy of Controls dictates respirators be evaluated last while other controls exist and are working. Alternative controls like
hazard elimination,
administrative controls, and engineering controls like
ventilation are less likely to fail due to user discomfort or error. A U.S. Department of Labor study showed that in almost 40 thousand American enterprises, the requirements for the correct use of respirators are not always met. Experts note that in practice it is difficult to achieve elimination of occupational morbidity with the help of respirators:
Beards Certain types of facial hair can reduce fit to a significant degree. For this reason, there are facial hair guidelines for respirator users.
Counterfeiting, modification, and revocation of regulated respirators Another disadvantage of respirators is that the onus is on the respirator user to determine if their respirator is counterfeit or has had its certification revoked.
Issues with fit testing If respirators
must be used, under 29 CFR 1910.134, OSHA requires respirator users to conduct a
respirator fit test, with a safety factor of 10 to offset lower fit during real world use. However, NIOSH notes the large amount of time required for fit testing has been a point of contention for employers. Other opinions concern the change in performance of respirators in use compared to when fit testing, and compared to engineering control alternatives:
Issues with respirator design Extended or off-label use of certain negative-pressure respirators, like a
filtering facepiece respirator paired with a
surgical mask, can result in higher levels of carbon dioxide from
dead space and breathing resistance (pressure drop) which can impact functioning and sometimes can exceed the PEL. This effect was significantly reduced with
powered air purifying respirators. In various surveys among healthcare workers,
headaches,
dermatitis and
acne have been reported. Complaints have been leveled at early
LANL NIOSH fit test panels (which included primarily military personnel) as being unrepresentative of the broader American populace. However, later fit test panels, based on a NIOSH facial survey conducted in 2003, were able to reach 95% representation of working US population surveyed. Despite these developments, 42 CFR 84, the US regulation NIOSH follows for respirator approval, allows for respirators that don't follow the NIOSH fit test panel provided that: more than one facepiece size is provided, and no chemical cartridges are made available.
Issues with lack of regulation Respirators designed to non-US standards may not be subject to as much or any scrutiny: • In China, under GB2626-2019, which includes standards like KN95, there is no procedure for
fit testing. Some jurisdictions allow for respirator filtration ratings lower than 95%, respirators which are
not rated to prevent respiratory infection, asbestos, or other dangerous occupational hazards. These respirators are sometimes known as
dust masks for their almost exclusive approval only against dust nuisances: • In Europe, regulation allows for
dust masks under
FFP1, where 20% inward leakage is allowed, with a minimum filtration efficiency of 80%. • South Korea allows 20% filter leakage under
KF80. In the US, NIOSH noted that under standards predating the
N95, 'Dust/Mist' rated respirators could not prevent the spread of
TB. == Regulation ==