Respirator Certification, March 2-3, 2010

Respirator Certification and
Post Certification Activities

J eff Peterson

ational Institute for Occupational Safety and Health
ational Personal Protective Technology Laboratory
PPT Stakeholder Meeting

March 3, 2010

CDC

Safety and Health

NPPTL

Respiratory Protection Regulations

OS HA Respiratory Protection Standard
(29 CFR 1919.134) requires use of NIOSH
approved respirators

NIOSH authority to approve respirators
found in 42 CFR 84

CDC

Safety and Health

NPPTL

Respirator Certification of Systems

NIOSH approves 'individual,
completely assembled
respirators'

-42CFR 84.30(a)

NIOSH will not issue
approval of 'any respirator
component or for any
respirator subassembly'

-42CFR 84.30(b)

Concept makes it easy to
track actual configurations J
and identify critical
performance characteristics

CDC

Safety and Health

NPPTL

Respirator Certification
Program Elements

Activities

Technical assistance

Post
Activities

- Certified Product
Investigations

- Firefighter Investigations

- Product Audits

- Manufacturing Site Audits

- Long Term Field Evaluation

CDC

Safety and Health

NPPTL

Respirator Certification Process

Hardware received

Electronic application
package received

Fees received

Initial administrative review

Initial engineering review

Lab testing

QA review

Final engineering review

Final documentation

CDC

Safety and Health

NPPTL

Final Engineering Review
Final Review

Final review of all documentation supporting
approval request

Review of NIOSH approval test data

Finalize approval labels

Recommendation made for approval /denial and
documentation generated

Update NIOSH internal databases (DEIMS)

Insures that Certified Equipment List (C EL) is
updated

These approval activities confirm certification.

CDC

Safety and Health

NPPTL

Post Certification Activities

Manufacturing Site Audits

-Two year schedule

- Evaluating approval holder against approved QA
plan submitted

Product Audits

-40-50 per year

- Equipment bought from open market

CDC

Safety and Health

NPPTL

Post Certification Activities

Certified Product Investigations

- Initiated by users/approval holder/NIOSH

- Can result in Stop Sale request/recall/retrofit or some other
corrective action

Fire Fighter Fatality and Injury Prevention Program

- Collaboration with NIOSH DSR

- Reported by Fire Department or State Agency

- Evaluation as to whether unit is in an approved condition

CDC

Safety and Health

NPPTL

Current NIOSH post certification activities
focused on filtering facepiece respirators

• 42 Code of Federal Regulations Part 84,
Section 84.34 (c) Revocation of certificates of
approval

• Typical Factors contributing to revocation

• Performance Failures

• Failure to Maintain a Quality System

• Misleading Advertising

• Misuse of approval labels

CDC

Safety and Health

NPPTL

Surgical mask being sold through WalMart Stores in
Canada as N95 mask - NIOSH notified Feb 2010

J iangsu Teyin Nonwoven Fabrics Co., Ltd (J TN)

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CDC

Safety and Health

NPPTL

Misleading Information

Misleading Representation: DuraMax Pro EN149 FPP1 Dust
Mask advertised as NIOSH approved N95 - May 5, 2009

NIOSH N95

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CDC

Safety and Health

NPPTL

Mainstays mask previously sold at Walmart

Packaging claimed
NIOSH N95

No certified products
available by "Mainstays"

NIOSH investigators
searched through photos
of numerous failed
applications

It appeared that J TN sold
products that had not
passed NIOSH testing
and tried to sell them
under a different name

CDC

Safety and Health

NPPTL

Recent NIOSH Revocations

J iangsu Teyin Nonwoven Fabrics Co., Ltd (J TN)

J une 22, 2009

14 approvals revoked for
failure to maintain an
acceptable quality control
plan

Can no longer be listed as
NIOSH approved

Can no longer be
manufactured, assembled,
sold or distributed

CDC

Safety and Health

NPPTL

Recent NIOSH Revocations

BeiBei Safety Company, Ltd. (BBE) - J uly 1, 2009

7 approvals revoked for
failure to maintain an
acceptable quality control
plan

Can no longer be listed as
NIOSH approved

Can no longer be
manufactured, assembled,
sold or distributed

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CDC

Safety and Health

NPPTL

NIOSH Approved Respirators altered to
create non-approved Aloha Masks

Disclaimer added to web site: "Our colored masks are made
from white stock masks that are N95 certified from the
manufacturer in unaltered form. We then apply the decorations
in Hawaii and the masks are not resubmitted to NIOSH orthe
manufacturer for recertification."

CDC

Safety and Health

NPPTL

Technical Assistance

Many calls, letters, emails, faxes

Variety of issues: selection, training,
enforcement, verify approval, APF,
interchanging parts, etc.

Inquiries from organizations, labor, other
government, contractors, general public

CDC

Safety and Health

NPPTL

Information Dissemination

• Letters to All Manufacturers

- Policy Changes

- Clarifications

• User Notices developed by NIOSH

- Inform users of product failures or recalls

• User Notices developed by Approval Holders

- Inform users of product failures or recalls

• Letters to all Interested Parties

- Inform all customers of new initiatives at NIOSH

• Certified Equipment List and Trusted Source Page

- Record of approved products

CDC

Safety and Health

NPPTL