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NIOSH - National Institute for Occupational Safety and Health

NIOSH Docket Number 109:

Quality Assurance Requirements for Respirators

 

The National Institute for Occupational Safety and Health (NIOSH) has 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 collects the public comments related to the Notice of Proposed Rulemaking.  Information submitted to the docket will be 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.  Information on the development of concepts that led to this Notice of Proposed Rulemaking can be found in NIOSH Docket number 001.

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Meeting Information

Notice of proposed rulemaking; reopening of comment period and notice of public meetings; 74FR9381; 3/4/09 (1 page, 420KB)

Materials Under Evaluation

Notice of proposed rulemaking; 73 FR 75057; 12/10/08 (12 pages, 11.4MB)

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. (33 pages, 15.9MB)

Written under NIOSH contract 254-2005-M-11458 by H&H Servicco Corporation, http://www.samplingplans.com.

Full facepiece gas/vapor air-purifying respirator matrix; 4/10/09 (2 pages, 785KB)

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

Transcript from NIOSH public meeting held at the University of Maryland University College Marriott, Adelphi, MD; 3/23/09 (54 pages, 17,600KB)
Attendees list for NIOSH public meeting in Adelphi, MD; 3/23/09 (1 page, 638KB)
Oral comments presented at NIOSH public meeting in Adelphi, MD; 3/23/09 (4 pages, 892KB)
Meeting logistics for NIOSH public meeting in Adelphi, MD; 3/23/09 (6 pages, 725KB)

Presentation by Handeland (3M) at the NIOSH pubic meeting held in Adelphi, MD; 3/23/09 (19 pages, 2,710KB)

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

Transcript from NIOSH public meeting held at the Los Angeles Airport Marriott; 3/30/09 (46 pages, 14,890KB)
Attendees list for NIOSH public meeting in Los Angeles, CA; 3/30/09 (1 page, 431KB)
Presentation by Lesiecki (Structural Composites Industries, LLC) at NIOSH public meeting in Los Angeles, CA; 3/30/09 (11 pages, 1,990KB)

Meeting logistics for NIOSH public meeting in Los Angeles, CA; 3/30/09 (2 pages, 828KB)

Submissions from the Public in Order of Receipt

Submission to the docket from Spelce (Navy and Marine Corps Public Health Center) – 2/3/09 (2 pages, 828KB)

Submission to the docket from Colton (3M Company) – 2/9/09 (3 pages, 1.33MB)

Submission to the docket from Sell (Draeger Safety, Inc.) – 2/16/09 (4 pages, 224KB)

Submission to eregulations.gov from Linda Stierle and Rebecca Patton (American Nurses Association) – 3/12/09 (4 pages, 1,510KB)
Submission to NIOSH docket from Bradley (ISEA) requesting extension – 3/24/09 (1 page, 437KB)
Submission to NIOSH docket from Gutshall (Mine Safety Appliance Co.) requesting extension – 4/6/09 (2 pages, 254KB)
Submission to eregulations.gov from Werner (George Washington University School of Public Health and Health Services) – 4/8/09 (6 pages, 2,740KB)
Submission to NIOSH docket from Gutshall (Mine Safety Appliance Co.) – 4/8/09 (5 pages, 1,050KB)

Submission to NIOSH docket from Weber (3M) – 4/10/09 (11 pages, 2,150KB)

 

The NIOSH Docket