Respiratory Protection andRespiratory Protection and the Role of NIOSH the Role of NIOSH

Judi Coyne, MBA, MAHealth Communication Specialist

National Institute for Occupational Safety and HealthNational Personal Protective Technology Laboratory

Pennsylvania Governors Occupational Safety and Health Conference

October 3 – 4, 2011

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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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HHSHHS

CDCCDC

NIOSHNIOSH

Div/LabsDiv/Labs

Department of Health and Human Services

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

NIOSH Divisions / Labs

Organizational Structure

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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?

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.

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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

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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 NIOSH-approved

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User Notices on Web Site

Why is it important to use NIOSH-certified Respirator?

It’s been tested and meets standards

It is going to work as supposed to

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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.