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Respiratory Protection and the Role of NIOSH

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Presentation on theme: "Respiratory Protection and the Role of NIOSH"— Presentation transcript:

1 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

2 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

3 What is NIOSH? National Institute for Occupational Safety and Health Mission is to prevent workplace illness, injury, and death

4 Organizational Structure
HHS Department of Health and Human Services Centers for Disease Control and Prevention CDC NIOSH National Institute for Occupational Safety and Health Div/Labs NIOSH Divisions / Labs

5 Why is NIOSH involved with Respirators?
Federal mandate for NIOSH to test and certify all respirators used in the workplace

6 What does NIOSH approval or certification mean?

7 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.

8 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

9 Where the testing happens ..

10 Silica Dust Chamber

11 Vibration table

12 Environmental Chamber


14 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

15 Applying for Approval APPLICANT SUBMITS Standard Application Form
Drawings including assembly matrix Payment Respirators for testing No prototypes Pre test data

16 Performance NIOSH tests and approves only complete respirators not parts or sub-assemblies of respirators

17 NIOSH Approval Processing
Receiving/Records Room Initial Review Testing and Quality Assurance Final Review

18 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

19 Required Product Markings

20 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

21 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

22 Product Audits Product is purchased through commercial distribution Tested to performance specifications of approval Failures will result in a Certified Product Investigation Process

23 Certified Product Investigation Process
Failures of approved product to perform During customer use During product audit Based on manufacturer self report

24 Certification Standards Not Met … Now what?
User notice is issued By NIOSH or by manufacturer Approval is revoked - Cannot be advertised at NIOSH-approved

25 User Notices on Web Site

26 Why is it important to use NIOSH-certified Respirator?
It’s been tested and meets standards It is going to work as supposed to

27 Misleading Advertising
False claims of NIOSH certification Sale of products that have had approval revoked

28 Check it Out List of NIOSH-approved products on website Filtering facepiece respirators in table format Can call to verify

29 Where to get additional info

30 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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