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NIOSH Conformity Assessment Meeting

Subject: Meeting with Respirator Manufacturers, October 17, 2018
9:00 AM – 4:00 PM EST NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

NIOSH CA 2018-1007
September 2018

The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL)  is holding a meeting on Wednesday, October 17, 2018 at the NIOSH Pittsburgh Facility. All manufacturers, manufacturer application preparers, and other interested parties are welcome to attend. Remote participation, via Adobe Connect, will be available for this meeting. The meeting is scheduled from 9:00 AM until 4:00 PM EST.

View the Agenda.

Topics of discussion include:

  • the August 7, 2018 Manufacturers Meeting tabletop exercise update;
  • implementation of the NIOSH Bivariate Panel and updating the standard test procedure (STP) for isoamyl acetate facepiece fit evaluations (August 30, 2018 webinar was postponed);
  • other STPs undergoing revision and discussion of ways for stakeholders to inform NPPTL about recommended revisions;
  • information about the new respirator approval program communication strategy, including the August 2018 Conformity Assessment Interpretation notice regarding facial hair and the Respiratory Protective Device Information notice about the Department of Transportation special permit 16320.

Other potential topics include:

  • an update from Edgewood Chemical and Biological Center about actions to resolve recent issues with live agent test systems;
  • validation studies and proposed round robin testing with Dugway Proving Grounds;
  • the NIOSH and U.S. Food and Drug Administration’s unified process for approval of N95 filtering facepiece respirators for use in healthcare settings;
  • the use of ISO 9001:2015 quality assurance manuals;
  • discussion of the use of ISO 11119-2; an update about respiratory standard development activities; and topics relevant to respirator manufacturers including the meaning of obsolete and rescinded approvals;
  • the use of multiple standard application procedures or a combined procedure; and all-inclusive respirator labeling.

Registration is required for participation. Because this meeting is being held at a federal facility, pre-registration is required on or before October 11, 2018. A government-issued photo ID will be required to obtain entrance to the facility.

Non‐U.S. citizens need to register on or before September 20, 2018 to allow sufficient time for mandatory facility security clearance procedures to be completed. Once your registration form is completed, indicating you are not a U.S. citizen, is received you will receive an email from the Center for Disease Control and Prevention (CDC) International Visitor Requests. This email will include a link to a secure site requesting additional information. CDC approval must be established before entry to the CDC NIOSH site will be permitted. All foreign nationals must present the same documents submitted with the visitor registration form (current passport, entry visa, or permanent residency card) at the security gate on the day of your visit. If you have any questions regarding this process, please email Mike Dojcak. Mike may also be reached by telephone at 412-386-5295.

Members of the Conformity Verification and Standards Development Branch staff will be available for one-on-one meetings from 9:00 AM to 11:00 AM and 1:00 AM to 3:30 PM on Tuesday, October 16, 2018. The meetings can be scheduled in half hour segments. If you would like to schedule time to discuss quality assurance, project review, approval issues, or lab operations and post-approval monitoring activities, please contact Tom Pouchot. Tom may also be reached by telephone at 412- 386-4036. International visitors requesting a meeting must be sure to include both dates (October 16 and 17) on the visitor request form.

The agenda will include a break for lunch. Attendees wanting to order lunch (pizza, salad, water or soft drink) must indicate this upon registration and pay $5.00 upon arrival and check in. Please bring the exact amount as no change can be given. Federal employees, and federal contractors wanting to order lunch can pay $5.00 to CVSDB Administrative Personnel before October 12, 2018. NPPTL staff will order and pick up the food prior to the break.

Meeting Agenda

Meeting Agenda
 Time  Topic  Presenter(s)
 8:15 – 9:00  Registration
 9:00 – 9:15  Welcome and Opening Remarks  Maryann D’Alessandro
9:15 – 9:35 Respirator Approval Program Updates & Metrics Jeffrey Peterson
9:35 – 9:45 Overview of August 7, 2018 Workshop Jeffrey Peterson
9:45 – 10:00 ECBC Status Update Mark Ciampaglio/Jeff Peterson
10:00 – 10:15 Break
10:15 – 10:35 The Meaning of the NIOSH Approval Robert Stein
10:35 – 10:50 NPPTL CVSDB Communications Strategy Colleen Miller
10:50 – 11:05 DOT SP 16320 Guidance Colleen Miller
11:05 – 11:20 Facial Hair Guidance Tom Pouchot
11:20 – 11:45 FDA Process and User Guidance Heidi Sewchok, Kerri Wizner, Colleen Miller
11:45 – 12:45 Lunch
12:45 – 1:00 STP Update Process Pat Wiltanger
1:00 – 1:20 NIOSH Panel Implementation Colleen Miller
1:20 – 1:40 Quality System Requirements Pat Wiltanger
1:40 – 2:00 Labeling Requirements Robert Stein
2:00 – 2:20 42 CFR 84 Regulatory Updates:
Powered Air Purifying Respirators
Fee Tables
Closed Circuit Escape Respirators
Jeff Palcic
Jeff Peterson
Robert Stein
2:20 – 3:00 Consensus Standards:
Combination Unit Respirators
Respirator Fit Capability
ISO TC94/SC15 TAG Administration
Jon Szalajda
Chris Coffey
Colleen Miller
3:00 – 3:15 Post Market Reporting Discussion John Powers, Kim Gavel
3:15 – 4:00 Questions and Discussion Panel

Supplemental Information

Hotel Accommodations: Accommodations for out of town attendees may be made at the following nearby hotels.

Hampton Inn – 4.6 miles from NIOSH. Shuttle service does not extend to NIOSH.
1550 Lebanon Church Road, Pittsburgh PA 15236
(412) 650-1000

Spring Hill Suites – 4.4 miles from NIOSH. Shuttle service does not extend to NIOSH.
1000 Regis Avenue, Pittsburgh PA 15236
(412) 653-9800

Holiday Inn Express – 5.8 miles from NIOSH. Shuttle service does not extend to NIOSH
3122 Lebanon Church Road, West Mifflin PA 15122
(412) 469-1900

Comfort Inn – 4.4 miles from NIOSH. No local shuttle service.
1340 Lebanon Church Road, Pittsburgh PA 15236
(412) 653-6600
None of these hotels offer shuttle service to/from the airport.

Attendees that do not wish to rent a vehicle may use the option of these limo services.

J&W – (412) 720-7721
Carey Limo – (412) 731-8671
Uber is another resource for your travel needs.