Total inward leakage requirements for half-mask air-purifying particulate respirators

2008

NIOSH Docket Number 137

On October 30, 2009, the National Institute for Occupational Safety and Health (NIOSH) published a notice of proposed rulemaking to establish total inward leakage (TIL) requirements under 42 CFR Part 84 for half-mask air-purifying particulate respirators, including both elastomeric facepiece and filtering facepiece types (74 FR 56141). The proposed requirements would have specified TIL minimum performance requirements and testing standards to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) corona virus, and Mycobacterium tuberculosis).

On November 18, 2009, NIOSH announced a public meeting on the proposed rule to be held on December 3, 2009 (74 FR 59501). In response to requests for an extension to allow interested parties additional time for comments, the comment period was extended by 90 days to March 29, 2010.

On April 20, 2010, NIOSH announced that the comment period would be reopened and extended to to September 30, 2010 (75 FR 20546).

On May 27, 2010, NIOSH announced a second public meeting to be held on July 29, 2010 to allow participants to make presentations to NIOSH, share results of any new research on the topic of filtering facepiece or other half-mask respirator inward leakage measurements, and offer any additional comments on the anticipated economic impact of the proposed rule (75 FR 29699).

NIOSH suspended all activity on this rulemaking in 2012. The NIOSH National Personal Protective Technology Laboratory has been collaborating with ASTM since 2015 to prepare a consensus standard establishing a respirator fit capability test for half-mask air-purifying particulate respirators. The scope of this standard will be to define performance requirements that could be used as part of a conformity assessment program to ensure certified respirators/families of respirators are capable of fitting a specified percentage of their intended user population.

82 FR 54315: Total inward leakage requirements for respirators; notice of proposed rulemaking (RIN 0920-AA33); withdrawal pdf icon[PDF – 181 KB] – 11/17/17

75 FR 29699: Total inward leakage requirements for respirators; notice of proposed rulemaking (RIN 0920–AA33); second public meeting to be held on 7/29/10 at Marriot Inn and Conference Center, Hyattsville, MD; 5/27/10pdf icon [PDF – 435 KB]

75 FR 20546: Total Inward Leakage Requirements for Respirators; notice of proposed rulemaking (RIN 0920-AA33); reopening of comment period; 04/20/2010pdf icon [PDF – 59 KB]

74 FR 66935; Total inward leakage requirements for respirators; notice of proposed rulemaking (RIN 0920–AA33); extension of comment period; 12/17/09pdf icon [PDF – 824 KB]

74 FR 59501; Total inward leakage requirements for respirators; notice of proposed rulemaking (RIN 0920–AA33); notice of public meeting on December 3, 2009 in Adelphi, MD.;11/18/09pdf icon [PDF – 1,702 KB]

List serve notification of 12/3/09 TIL Rulemaking Public Meeting; 11/18/09pdf icon [PDF – 636 KB]

74FR56141; Total inward leakage requirements for respirators; notice of proposed rulemaking; RIN 0920-AA33; 10/30/09pdf icon [PDF – 10,443 KB]

NIOSH draft specific technical procedures to be applied for TIL testing – “Total Inward Leakage Test for Half-mask Air-purifying Particulate Respirators” Procedure No. RCT-APR-STP-0068, Revision-1; 8/12/09pdf icon [PDF – 224 KB]

NIOSH draft statistical basis for TIL testing – Determination of sample size and passing criteria for respirator fit test panels; 8/18/09pdf icon [PDF – 158.70 KB]