Proposed Rule on Total Inward Leakage Requirements for Respirators Withdrawn

Published November 21, 2017

​In response to stakeholder input, the Department of Health and Human Services of the Centers for Disease Control and Prevention has withdrawn a notice of proposed rulemaking intended to establish total inward leakage requirements for half-mask, air-purifying particulate respirators approved by NIOSH. NIOSH will instead pursue improved inward leakage performance of this class of respirators through participation in national and international consensus standard development efforts.

Several stakeholders, including respirator manufacturers, individuals in the field of respiratory protection, and a manufacturer of laboratory test equipment, submitted comments in response to the NPRM, which was published in October 2009. According to NIOSH, commenters “presented evidence that the approval decision outcomes could vary significantly between human subject panels that would be constituted according to the proposed test protocol.” Stakeholders were also concerned that the proposed approval requirements might eliminate good-performing respirators from the market. The cost of conducting inward leakage testing using NIOSH’s proposed protocol was of further concern; stakeholders felt that the costs would likely outweigh the benefits.

The Federal Register notice clarifies that the withdrawal of the 2009 NPRM does not preclude the Department of Health and Human Services from initiating future rulemaking regarding total inward leakage requirements for half-mask, air-purifying particulate respirators.