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.