Quality Assurance Requirements for Respirators - 42 CFR Part 84, RIN 0920-AA04

December 2008
NIOSH Docket Number 109

FINAL ACTION: The proposed rulemaking was withdrawn by NIOSH on June 8, 2011.

Notice of proposed rulemaking; withdrawal; 76FR33188; 6/8/11pdf icon [PDF – 1,940 KB]

The National Institute for Occupational Safety and Health (NIOSH) proposed new quality assurance and control requirements for manufacturers of respirators approved by NIOSH or NIOSH and MSHA under 42 CFR Part 84 – Approval of Respiratory Protective Devices.

This docket collected the public comments related to the Notice of Proposed Rulemaking. Information submitted to the docket was considered in the context of developing a Final Rule to update the quality requirements for respirator manufacturers and ultimately the quality of respirators used by the American workforces.

NIOSH published a proposed rule on the Quality Assurance Requirements for Respirators on December 10, 2008 and requested comments on this proposed rule on or before February 9, 2009 (73 FR 75045). On March 4, 2009, NIOSH announced two public meetings and reopened the comment period for the proposed rule until April 10, 2009 (74 FR 9381). NIOSH held the two public meetings on March 23, 2009 and March 30, 2009. A commenter requested that the NIOSH extend the public comment period, noting that the costs associated with the proposed QA requirements related to inspections, audits, documentation, complaint management, and document control administration are significant. We reopened the comment period for this proposal until October 9, 2009 (74 FR 41309).

Information on the development of concepts that led to this Notice of Proposed Rulemaking can be found in NIOSH Docket number 001.

This proposed rulemaking was withdrawn by NIOSH on June 8, 2011. See withdrawal notice above.

Meeting Information

Notice of proposed rulemaking; reopening of comment period; 74FR23815; 5/21/09pdf icon [PDF – 818 KB]

Notice of proposed rulemaking; reopening of comment period and notice of public meetings; 74FR9381; 3/4/09pdf icon [PDF – 420 KB]

Materials Under Evaluation

Notice of proposed rulemaking; 73 FR 75045; 12/10/08pdf icon [PDF – 7.84 MB]

Technical analysis of proposed sampling plans, their statistical equivalence, and comparison with sampling plans covered by existing requirements of 42 CFR Part 84, Subpart E, §84.41. Supplement to Quality Assurance Requirements for Respirators; Notice of Proposed Rulemaking – Federal Register, Vol. 73, No. 238, Wednesday December 10, 2008.pdf icon [PDF – 15.9 MB] Written under NIOSH contract 254-2005-M-11458 by H&H Servicco Corporation, http://www.samplingplans.comexternal icon.

Full facepiece gas/vapor air-purifying respirator matrix; 4/10/09pdf icon [PDF – 785 KB]

Meeting Information – Adelphi, MD (3/23/09)

Transcript from NIOSH public meeting held at the University of Maryland University College Marriott, Adelphi, MD; 3/23/09pdf icon [PDF – 17,600 KB]

Attendees list for NIOSH public meeting in Adelphi, MD; 3/23/09pdf icon [PDF – 638 KB]

Oral comments presented at NIOSH public meeting in Adelphi, MD; 3/23/09pdf icon [PDF – 892 KB]

Meeting logistics for NIOSH public meeting in Adelphi, MD; 3/23/09pdf icon [PDF – 725 KB]

Presentation by Handeland (3M) at the NIOSH pubic meeting held in Adelphi, MD; 3/23/09pdf icon [PDF – 2,710 KB]

Meeting Information – Los Angeles, CA (3/30/09)

Transcript from NIOSH public meeting held at the Los Angeles Airport Marriott; 3/30/09pdf icon [PDF – 14,890 KB]

Attendees list for NIOSH public meeting in Los Angeles, CA; 3/30/09pdf icon [PDF – 431 KB]

Presentation by Lesiecki (Structural Composites Industries, LLC) at NIOSH public meeting in Los Angeles, CA; 3/30/09pdf icon [PDF – 1,990 KB]

Meeting logistics for NIOSH public meeting in Los Angeles, CA; 3/30/09pdf icon [PDF – 828 KB]

Submissions from the Public in Order of Receipt

Submission to the docket from Spelce (Navy and Marine Corps Public Health Center) – 2/3/09pdf icon [PDF – 828 KB]

Submission to the docket from Weber (3M Company) – 2/9/09pdf icon [PDF – 1.33 MB]

Submission to the docket from Sell (Draeger Safety, Inc.) – 2/16/09pdf icon [PDF – 224 KB]

Submission to eregulations.gov from Linda Stierle and Rebecca Patton (American Nurses Association) – 3/12/09pdf icon [PDF – 1,510 KB]

Request for extension to NIOSH docket from Birkner (Moldex-Metric, Inc.); 3/23/09pdf icon [PDF – 162 KB]

Request for extension to NIOSH docket from Bradley (ISEA); 3/24/09pdf icon [PDF – 437 KB]

Request for extension to NIOSH docket from Gutshall (Mine Safety Appliances Co.); 4/6/09pdf icon [PDF – 254 KB]

Submission to NIOSH docket from Lindsay Booher (AIHA) – 4/6/09pdf icon [PDF – 254 KB]

Submission to eregulations.gov from Werner (George Washington University School of Public Health and Health Services) – 4/8/09pdf icon [PDF – 2,740 KB]

Submission to NIOSH docket from Gutshall (Mine Safety Appliances Co.) – 4/8/09pdf icon [PDF – 1,050 KB]

Submission to NIOSH docket from Weber (3M) – 4/10/09pdf icon [PDF – 2,150 KB]

Submission to NIOSH docket from Kleinwort (Private person) – 6/25/09pdf icon [PDF – 274.13 KB]

Submission to NIOSH docket from Birkner (Moldex-Metric, Inc.) – 9/30/09pdf icon [PDF – 896.41 KB]

Submission to NIOSH docket from Kline (Kimberly-Clark) – 10/8/09pdf icon [PDF – 2.82 MB]

Submission to NIOSH docket from Shipp (ISEA) – 10/9/09pdf icon [PDF – 7.42 MB]

Submission to NIOSH docket from Weber (3M) – 10/9/09pdf icon [PDF – 2.84 MB]

Page last reviewed: July 6, 2010