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Occupational Safety & Health Administration |
Standard Interpretations
05/30/2002 - Protection factors for respirators used in pharmaceutical industry: policy change. |
Standard Interpretations - Table of Contents |
Standard Number: | 1910.134; 1910.134(d)(3)(i)(A) |
May 30, 2002
This memorandum provides specific enforcement policy for respirator use in the Pharmaceutical Industry (SICs 2833 and 2834). Three points are especially important in this regard. First, the change only applies to the protection from particulates in the pharmaceutical industry. Second, the change only affects the nine respirators listed below. Third, the change is an interim change only, pending a final determination by OSHA of the proper protection factor to be assigned to these classes of respirators as part of the current respiratory protection standard rulemaking of 29 CFR 1910.134. Based upon the 1987 Respirator Decision Logic developed by the National Institute for Occupational Safety and Health (NIOSH), an Assigned Protection Factor (APF) of 25 for continuous-flow, loose fitting respirators (hood or helmet) has been enforced by OSHA. In January 1998, OSHA revised its respiratory protection standard, but reserved modifications to the APFs for future rulemaking. In 1996, during the respirator rulemaking process, the pharmaceutical industry members of Organization Resources Counselors, Inc. (ORC) approached OSHA about their need for a respirator with a higher protection factor to protect against biologically active compounds that pose a risk at orders of magnitude below aerosol levels typically found in OSHA PELs. ORC contracted with Lawrence Livermore National Laboratory (LLNL) to design, conduct, and interpret the results of a simulated workplace study. The study tested both Supplied Air Respirators (SARs) and Powered Air Purifying Respirators (PAPRs) against an airborne particulate. In that test most of the respirators achieved a minimum protection factor of 10,000 and maintained positive pressure inside the respirator throughout the testing. The simulated workplace study carried out by LLNL incorporated work procedures and body positions normally encountered by employees in the pharmaceutical industry. The study indicated that, if used properly and when equipped with the accessories mentioned below, these respirators are generally acceptable for exposures to particulates that are less than or equal to 1000 times their respective PELs. However, other studies have also indicated that in practice in the workplace, respirators may provide considerably less protection than indicated by a simulation study when they are used in ways that do not conform to the manufacturer's specifications (e.g., the air supply hose is too long, the hose diameter is incorrect and/or the manufacturer's specified pressure is not maintained) or in workplace situations where the requirements of 1910.134 are not being met. Based upon the simulated workplace evidence, OSHA recognizes that a protection factor greater than 25 is appropriate for these respirators when used and equipped as tested. The following respirators (with the accessories indicated) will be treated by OSHA as if they had an APF of 1000 for use in the pharmaceutical industry for protection against particulates: Powered-Air Purifying Respirators (PAPRs)
For these reasons, employers must ensure that these respirators are used only in accordance with the manufacturer's specifications, that the respirator is functioning properly, that the users are properly fitted and trained, and that the employer has implemented a continuing, effective respiratory protection program as specified by 29 CFR 1910.134. Documented deficiencies related to the respirator or the respiratory protection program should be cited. If you should have any further questions concerning this matter, please feel free to contact the [Office of Health Enforcement] at (202) 693-2190. |
Standard Interpretations - Table of Contents |
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