A critique of Occupational Safety and Health Administration's halfmask respirator assigned protection factor

Halfmask air-purifying respirators are used by millions of workers to reduce inhaling air contaminants, both chemical (e.g., asbestos, styrene) and biological (e.g., SARS-CoV-2, Mycobacterium tuberculosis). In 2006, the federal Occupational Safety and Health Administration (OSHA) promulgated a standard that gave halfmask respirators an assigned protection factor (APF) of 10. This signified that OSHA assumes a fit-tested and trained wearer will experience a 10% maximum total inward leakage of contaminated air into the facepiece. To derive APF = 10, OSHA analyzed data from 16 workplace studies of the efficacy of halfmask respirators worn against particulate contaminants. In this commentary, I contend that, in considering the data, OSHA made several errors that overstated halfmask respirator efficacy. The errors were (i) failing to properly account for within-wearer and between-wearer variability in respirator efficacy; (ii) ignoring the effect of particle deposition in the respiratory tract; (iii) aggregating unbalanced data within and between studies, and effectively double-counting the data in some studies; and (iv) ignoring the effect that particle size exerts in penetrating respirator facepiece leak paths. The net result is that OSHA's APF = 10 can lead to excessive toxicant exposure for many workers.