[OSHA wrote this letter to Jeanne Pfeiffer, RN, MPH, CIC, APIC president, responding to objections to the application of the General Industry Respiratory Protection Standard (1910.134) to health care.]

Dear Ms. Pfeiffer:

This is in response to your letter of Jan. 21, 2004, in which you comment on the recent actions by OSHA regarding the proposed rule for tuberculosis. More specifically, you express four major concerns regarding the application of the Respiratory Protection Standard (29 CFR 1910.134) to protect against TB.

First, you state that the general industry Respiratory Protection Standard is not applicable to occupational exposures to patients. It is important to note that the general industry Respiratory Protection Standard always has applied to hospitals and other health care institutions. The standard was developed to protect workers in all industries against airborne hazards, including biological hazards (63 Fed Reg 1,180). Since particulates containing TB bacilli (droplet nuclei) behave no differently from other types of particulates, their removal by respirator filter media would not be different.

Second, you state that TB was controlled prior to the use of certified respirators and/or performing initial or annual fit-testing. While progress has been made in reducing the rate of TB in the general population, employees still are required to care for individuals identified as having suspected or confirmed infectious TB. In such circumstances, these employees must be protected against occupational TB exposure. This includes appropriate respiratory protection. In its 1990 document, �Guidelines for preventing the transmission of tuberculosis in health care settings, with special focus on HIV-related issues,� [Centers for Disease Control and Prevention (CDC). MMWR 1990; 39(RR-17)], the CDC questioned the ability of surgical masks to protect workers against inhalation of droplet nuclei. CDC stated that a better alternative was use of �disposable personal respirators.� This recommendation was further refined in the CDC�s 1994 guidelines, which stated that OSHA required the use of NIOSH-certified personal respiratory protection that met specific performance criteria set by CDC, including the ability to be fit-tested to assure 10% or less face-seal leakage.

Fit-testing is the only way to determine that a respirator fits properly and provides the expected protection. OSHA has previously established the necessity of annual fit-testing in the Respiratory Protection rulemaking, and the agency�s conclusions have been upheld by the courts. OSHA�s reasoning for requiring annual fit-testing is explained in detail in the revocation notice (68 Fed Reg 75,776-75,780). In addition, annual fit-testing already is required for other contaminants (e.g., ethylene oxide and formaldehyde) when their presence in health care facilities requires employees to use respirators. Therefore, the obligation to annually fit-test is not unique to tuberculosis and may be incorporated in to a health care facility�s existing respiratory protection program.

Third, you indicate that current methods of fit-testing N95 respirators are not reproducible, reliable, or reflective of in-use situations. In support of this, you cite the article, �Comparison of five methods for fit-testing N95 filtering face-piece respirators,� [Coffey, et al. Applied Occupational and Environmental Hygiene 2002; 17(10):723-730]. In the article you reference, the authors concluded that the �. . . error rates [observed in their study] should be considered when selecting a fit-testing method for fitting N95 filtering face pieces [p. 723].� Thus, it does appear to be the position of these researchers that fit-testing of N95 filtering face pieces is necessary in that current fit-test methods provide useful information about respirator performance. The authors also concluded that further research is needed (p. 729). These conclusions from the researchers� 2002 study should be considered in conjunction with the authors� conclusions from their 1999 article that �. . . fit-testing of N95 respirators is necessary to ensure that the user receives the expected level of protection.� (Coffey, et al. Simulated workplace performance of N95 respirators. Am Ind Hyg Assoc J 1990; 60:618-624.) Also, in a 2002 presentation to the American Industrial Hygiene Conference and Exposition (Fitting characteristics of 18 filtering-face-piece respirators�), Coffey, et al. reported their findings from their studies of fit-tests and concluded that subject sample size, the fit-test panel, and the exercise regime, among other factors, limited the studies. In their summary, they concluded that N95 respirators vary in terms of performance, that fit-testing enhances performance, and that using well-designed respirators and performing fit-testing provide the most protection.

Finally, you express concern that the action to apply the Respiratory Protection Standard (29 CFR 1910.134) to TB was undertaken without the opportunity for public review and comment. Both the 1997 TB proposal and the Respiratory Protection proposal published a few years earlier contained provisions for initial and annual fit-testing. OSHA informed participants in the rulemakings for Respiratory Protection and Tuberculosis that it intended to consider all issues related to respirator use for TB in the TB rulemaking and incorporated all relevant submissions to the Respirator Protection Standard rulemaking into the TB record. In addition, in the TB proposal, OSHA asked for comment on whether a TB standard should contain separate respirator provisions or, alternatively, whether the general industry respirator standard should apply to TB-related use. The public comments on this issue are discussed extensively in the revocation notice (68 Fed Reg 75,776-75,778). The revocation of the interim TB respiratory protection standard in December 2003 was supported by the TB rulemaking record, including many suggestions that OSHA include TB-related respirator use within the scope of the general industry Respiratory Protection Standard and not have separate respirator provisions applicable only to potential TB exposures. With the application of the Respiratory Protection Standard to TB, workers occupationally exposed to tuberculosis are provided with the same protections as workers exposed to other air contaminants.

I hope that you find this information useful.

Sincerely,

John L. Henshaw