NIOSH Conformity Assessment Meeting

Subject: Meeting with Respirator Manufacturers, October 29, 2019, 9:00 AM – 4:00 PM EST
NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

NIOSH CA 2019-1020
August 2019

The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory is holding a meeting on Tuesday, October 29, 2019 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 meeting Agenda.

Topics to be discussed may include: 2019 NIOSH Conformity Assessment notices posted and under development, state of the NIOSH NPPTL laboratories, U.S. ARMY Combat Capabilities Development Command Chemical Biological Center update, respirator-related regulatory and consensus standard development activities, post market (audit) reports, and an update on respirator stockpiling research.

Registration is required for participation. Because this meeting is being held at a Federal facility, pre-registration is required on or before October 22, 2019 and 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 2, 2019 to allow sufficient time for mandatory facility security clearance procedures to be completed. Once your registration form 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 facility 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 at lmy5@cdc.gov, or by phone at (412) 386-5295.

NPPTL personnel will be available for one-on-one meetings from 9:00 AM to 11:00 AM and 1:00 PM to 3:30 PM on Monday, October 28, 2019. The meetings can be scheduled in half hour segments. If you would like to schedule time to discuss quality assurance, project review, or approval issues, please contact Tom Pouchot via email at clq0@cdc.gov or by phone at (412) 386-4036. If you would like to schedule time to discuss testing operations, post-approval monitoring activities, or to setup a lab tour, please contact Jeff Palcic via email at dwk6@cdc.gov or by phone at (412) 386-5247. International visitors requesting a meeting must be sure to include both dates (October 28 and 29) on the visitor request form.

The agenda will include a break for lunch. Attendees wishing to have lunch (pizza, salad, water or soft drink) can pay $10.00 upon arrival and check in. NPPTL staff will order and pick up the food prior to the break.

To register for the meeting, please complete the registration form at the following link: https://www.cdc.gov/niosh/npptl/resources/certpgmspt/meetings/10292019/registration.html

Meeting Agenda

 

Meeting Agenda
 Time  Topic  Presenter(s)
 8:30-9:00 Registration/Check in/Pay for Lunch
 9:00-9:15  Welcome and Opening Remarks  Maryann D’Alessandro
9:15-10:15 Approval Program Updates since the 2018 meeting

Introduce NIOSH NPPTL Staff
Metrics Achieved and Issues Encountered
NIOSH CA 2019-1011 (NIOSH Panel and Isoamyl Acetate Fit Testing)
NIOSH CA 2019-1013 (Labeling Requirements)
NIOSH CA 2019-1017 (ISO 11119-2)
NIOSH CA 2019-1019 (NIOSH Quality Control Plan Requirements)
Standard Test Procedure Updates

Jeff Peterson, John Powers,
Colleen Miller
10:15-10:30 Break
10:30-10:50 CCDC CBC Status Update Mark Ciampaglio
10:50-11:20 2019 Topics

Standard Application Procedures Workgroup

Input from meeting attendees

Respirator Accessories

Rescinding approvals, informing NIOSH about changes

Company name
Manufacturing locations
Primary contact

 

ISEA and NIOSH members

 

NIOSH TBD

Bob Stein

11:20-11:45 Discussion and Questions All
11:45-12:45 Lunch
12:45-1:30 Manufacturer Roundtable/Panel Topics

Experience with turn-around times
Assigning reviewers to companies
Proposed regulatory approaches for RFC
Perceived limitation of the DEIMS
ISO TC 94/SC15 Update

 

Kati Wenzel
Dan Glucksman or Lynn Feiner
Dan Glucksman
ISEA or Panel Member
Geoff Betsinger

1:30-1:50 Cylinder Manufacturer Perspective ISEA Member
1:50-2:10 Break
2:10-2:30 42 CFR 84 Regulatory Updates

Fee Tables
Powered Air Purifying Respirators

PAPR Research Federal Register Notice

 

Jeff Peterson
Jeff Palcic

Jon Szalajda

2:30-3:00 Respiratory Consensus Standards Development

Combination Unit Respirators
Respirator Fit Capability
NFPA Committee Updates

 

Jon Szalajda
Chris Coffey
Bob Stein, Heidi Sewchok

3:00-3:20 Respirator Stockpiling Research Lee Greenawald
3:20-3:50 Wrap–up/Questions All

Agenda pdf icon[PDF – 125 KB]

Supplemental Information

Hotel Accommodations: There are several hotels located in close proximity to the NIOSH facility:

Comfort Inn – 4.0 miles from NIOSH. No local shuttle service.
1340 Lebanon Church Road, Pittsburgh PA 15236
(412) 653-6600

Hampton Inn Pittsburgh/West Mifflin – 4.3 miles from NIOSH. Shuttle service does not extend to NIOSH.
1550 Lebanon Church Road, Pittsburgh PA 15236
(412) 650-1000

Spring Hill Suites by Marriott West Mifflin – 4.5 miles from NIOSH. Shuttle service does not extend to NIOSH.
1000 Regis Avenue, Pittsburgh PA 15236
(412) 653-9800

Crowne Plaza Suites Pittsburgh South – 6.6 miles from NIOSH. Shuttle service does not extend to NIOSH.
164 Fort Couch Road, Pittsburgh PA 15241
(412) 833-5300

Holiday Inn Express – 7.0 miles from NIOSH. Shuttle service does not extend to NIOSH.
3122 Lebanon Church Road, West Mifflin PA 15122
(412) 469-1900

None of these hotels offers shuttle service to/from the airport.

If you do not want to rent a car, other visitors have used a few limo services with success:

Super Shuttle (800) 258-3826
J&W Airport Transportation (412) 720-7721
Carey Pittsburgh / Allegheny Limousine (800) 660-8671

Uber and Lyft are other options.

Page last reviewed: August 21, 2019