Transcript Overview of the National institute for Occupational Safety

Respiratory Protection and
the Role of NIOSH
Judi Coyne, MBA, MA
Health Communication Specialist
National Institute for Occupational Safety and Health
National Personal Protective Technology Laboratory
Pennsylvania Governors Occupational
Safety and Health Conference
October 3 – 4, 2011
Objectives
At the end of this presentation, attendees should know
- What NIOSH is and the role in respirator certification
- What NIOSH approval / certification means
- How respirators become approved /certified
- What happens when certification standards are not
met or maintained
- Why it’s important to use NIOSH-certified respirators
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What is NIOSH?
National Institute for Occupational
Safety and Health
Mission is to prevent workplace
illness, injury, and death
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Organizational Structure
HHS
Department of Health
and Human Services
CDC
Centers for
Disease Control
and Prevention
NIOSH
National Institute
for Occupational
Safety and Health
Div/Labs
NIOSH Divisions /
Labs
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Why is NIOSH involved with
Respirators?
Federal mandate for NIOSH to test
and certify all respirators used in
the workplace
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What does NIOSH
approval or
certification mean?
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What does it mean?
The respirator has been stringently
tested prior to earning the NIOSH
certification.
Post-certification, the product continues
to perform at the high level of standards
to which it was originally tested.
What kinds of tests?
Testing requirement are specified in
42 CFR Part 84
Examples: breathing resistance –
inhalation and exhalation, gas flow,
leakage, service time, climactic,
filter efficiency
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Where the testing happens ..
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Silica Dust Chamber
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Vibration table
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Environmental Chamber
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What is NIOSH Approval?
- formal document issued by NIOSH for a
specific respirator
- issued when a respirator meets the
minimum requirements of chapter Title
42, of the Code of Federal Regulations,
Part 84 (42 CFR 84)
- approval holder may label and
advertise the approved respirator as
NIOSH-approved
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Applying for Approval
APPLICANT SUBMITS
 Standard Application Form
 Drawings including assembly
matrix
 Payment
 Respirators for testing
 No prototypes
 Pre test data
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Performance
NIOSH tests and approves only
complete respirators not parts or
sub-assemblies of respirators
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NIOSH Approval Processing
Receiving/Records Room
Initial Review
Testing and Quality
Assurance
Final Review
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NIOSH Certificate of Approval
Allows the listed applicant to produce the
listed approved respirator
Requires production under the quality control
provisions specified in the approval
Requires the respirator label as specified in
the approval
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Required Product Markings
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NIOSH Certificate of Approval
DOES NOT ALLOW
 Changes without notifying NIOSH for a
modification of approval
Including
 changes to the label
 changes to user instructions
 changes to QA plans
 changes to materials or design
 Changing / moving manufacturing site
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NIOSH Site Audits
 NIOSH audits the manufacturing site
 At least every two years
 Full compliance with parts and drawings
 Full compliance with all quality plans
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Product Audits
Product is purchased through
commercial distribution
Tested to performance specifications
of approval
Failures will result in a Certified
Product Investigation Process
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Certified Product Investigation Process
Failures of approved product to perform
 During customer use
 During product audit
 Based on manufacturer self report
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Certification Standards Not Met …
Now what?
User notice is issued
By NIOSH or by manufacturer
Approval is revoked
- Cannot be advertised at NIOSHapproved
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User Notices on Web Site
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Why is it important to use
NIOSH-certified Respirator?
It’s been tested and meets standards
It is going to work as supposed to
Misleading Advertising
False claims of NIOSH certification
Sale of products that have had
approval revoked
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Check it Out
List of NIOSH-approved products on
website
Filtering facepiece respirators in
table format
http://knowits.niosh.gov
Can call to verify 412 386 4000
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Where to get additional info
www.cdc.gov/niosh/npptl
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Thank You
Disclaimer:
The findings and conclusion in this presentation have not been
formally disseminated by the National Institute for Occupational
Safety and Health and should not be construed to represent any
agency determination or policy.
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