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

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 – 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; 5/27/10 [PDF – 435 KB]

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

74 FR 66935; Total inward leakage requirements for respirators; notice of proposed rulemaking (RIN 0920–AA33); extension of comment period; 12/17/09 [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.;11/18/09 [PDF – 1,702 KB]

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

74FR56141; Total inward leakage requirements for respirators; notice of proposed rulemaking; RIN 0920-AA33; 10/30/09 [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; 8/12/09 [PDF – 224 KB]

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

Meeting Information

Hyattsville, MD – July 29, 2010

On-site meeting registration; 7/29/10 [PDF – 1922 KB]

Registration for participation via live meeting; 7/29/10 [PDF – 497 KB]

Presentation by F Hearl (NIOSH); 7/29/10 [PDF – 5,625 KB]

Presentation by C Colton and P Eitzman (3M) entitled “Testimony on 42 CFR Part 84 Total Inward Leakage Requirements for Respirators”; 7/29/10 [PDF – 34,265 KB]

Presentation by J Weed (ISEA) entitled “Testimony – NIOSH TIL Public Hearing ISEA Respirator Fit Test Study”; 7/29/10 [PDF – 15,840 KB]

Transcript from meeting at the Marriott Inn and Conference Center UMUC, Hyattsville, MD; 7/29/10 [PDF – 16,568 KB]

Hyattsville, MD – December 3, 2009

On-site meeting registration; 12/3/09 [PDF – 969 KB]

Registration for participation via live meeting; 12/3/09 [PDF – 436 KB]

Meeting overview presentation by F Hearl (NIOSH); 12/3/09 [PDF – 317 KB]

Presentation by C Colton and P Eitzman (3M) entitled “Testimony on 42 CFR Part 84 – Total Inward Leakage Requirements for Respirators”; 12/3/09 [PDF – 543 KB]

Presentation by P Eitzman (3M) entitled “Testimony on 42 CFR Part 84 – Total Inward Leakage Requirements for Respirators”; 12/3/09 [PDF – 571 KB]

Presentation by J Weed (TSI) entitled “Instrumentation and measurement issues in the proposed NIOSH TIL rulemaking”; 12/3/09 [PDF – 81 KB]

Transcript from meeting at the Marriott Inn and Conference Center UMUC, Adelphi, MD; 12/3/09 [PDF – 14,806 KB]

Request from S Weinberg (WEIN Products) to present at meeting; 11/18/09 [PDF – 609 KB]

Notice from C Colton (3M) of intent to speak at public meeting; 11/19/09 [PDF – 969 KB]

Request from C Fargo (ISEA) to present at public meeting; 11/20/09 [PDF – 485 KB]

Notice from S Weinberg advising unable to attend meeting; 11/27/09 [PDF – 609 KB]

Request from C Colton (3M) for extension of the comment period; 11/28/09 [PDF – 1,268 KB]

2nd request from C Colton (3M) for extension of the comment period; 12/7/09 [PDF – 602 KB]

Submissions in order of Receipt

Submission to Docket from E deMedeiros (Honeywell Safety Products); 12/15/09 [PDF – 780 KB]

Submission to Docket from B Kojola (AFL-CIO); 12/17/09 [PDF – 1,460 KB]

Submission to Docket from D O’Dell (UMWA); 12/23/09 [PDF – 1,345 KB]

Letter to Secretary Sebelius (DHHS) from D Shipp (ISEA); request for evaluation of combined effect on availability and cost of respirators; 1/19/10 [PDF – 314 KB]

Submission to Docket from F Parker (Caliche, Ltd); 1/20/10 [PDF – 1,111 KB]

Request from R Weber (3M) for extension of the comment period; 3/1/10 [PDF – 65 KB]

Submission to Docket from K-M Ruck (Drager Safety AG & Co.); 3/26/10 [PDF – 194 KB]

Submission to Docket from L Welsh & L Rudolph (CDPH & Cal/OSHA); 3/26/10 [PDF – 479 KB]

Submission to Docket from P Stafford (Building and Construction Trades Department; 3/26/10 [PDF – 1,696 KB]

Submission to Docket from R Weber (3M) (2); 3/29/10 [PDF – 637 KB]

Submission to Docket from R Weber (3M) (1); 3/29/10 [PDF – 35,989 KB]

Submission to Docket from J Kline (Kimberly-Clark Professional); 3/29/10 [PDF – 4,236 KB]

Submission to Docket from D Woodhull (ORC Worldwide); 3/29/10 [PDF – 2,975 KB]

Submission to Docket from M Nicas (University of California); 3/29/10 [PDF – 2,542 KB]

Submission to Docket from D Shipp (ISEA); 3/29//10 [PDF – 81,363 KB]

Submission to Docket from D deAzevedo (TSI Incorporated); 3/29/10 [PDF – 8,468 KB]

Submission to Docket from L Green (Syntech, International); 7/29/10 [PDF – 1,547 KB]

Submission to Docket from L Green (Syntech, International); 8/4/10 [PDF – 465 KB]

Submission to Docket from Bruce V (Private person); 9/16/10 [PDF – 2,315 KB]

Submission to regulations.gov from W Alshammari (University of La Verne); 9/17/10 [PDF – 1,395 KB]

Submission to docket from B Kojola (AFL-CIO); 9/27/10 [PDF – 2,407 KB]

Submission to docket from C Colton (3M); 9/28/10 [PDF – 20,093 KB]

Submission to docket from J Kline (Kimberly-Clark Professional); 9/30/10 [PDF – 3,510 KB]

Submission to docket from D Shipp (ISEA); 9/30/10 [PDF – 3,191 KB]

Submission to regulations.gov from Ching-tsen Bien (LAO Consulting, Inc.); 9/30/10 [PDF – 7,691 KB]