Respiratory Protection and the Role of NIOSH Judi

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 NPPTL Year Month Day Initials BRANCH

What is NIOSH? National Institute for Occupational Safety and Health Mission is to prevent workplace illness, injury, and death NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

Why is NIOSH involved with Respirators? Federal mandate for NIOSH to test and certify all respirators used in the workplace NPPTL Year Month Day Initials BRANCH

What does NIOSH approval or certification mean? NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

Where the testing happens. . NPPTL Year Month Day Initials BRANCH

Silica Dust Chamber NPPTL Year Month Day Initials BRANCH

Vibration table NPPTL Year Month Day Initials BRANCH

Environmental Chamber NPPTL Year Month Day Initials BRANCH

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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 NIOSHapproved NPPTL Year Month Day Initials BRANCH

Applying for Approval APPLICANT SUBMITS - Standard Application Form - Drawings including assembly matrix - Payment - Respirators for testing · No prototypes - Pre test data NPPTL Year Month Day Initials BRANCH

Performance NIOSH tests and approves only complete respirators not parts or sub-assemblies of respirators NPPTL Year Month Day Initials BRANCH

NIOSH Approval Processing Receiving/Records Room Initial Review Testing and Quality Assurance Final Review NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

Required Product Markings NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

Product Audits Product is purchased through commercial distribution Tested to performance specifications of approval Failures will result in a Certified Product Investigation Process NPPTL Year Month Day Initials BRANCH

Certified Product Investigation Process Failures of approved product to perform - During customer use - During product audit - Based on manufacturer self report NPPTL Year Month Day Initials BRANCH

Certification Standards Not Met … Now what? User notice is issued By NIOSH or by manufacturer Approval is revoked - Cannot be advertised at NIOSHapproved NPPTL Year Month Day Initials BRANCH

User Notices on Web Site NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

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 NPPTL Year Month Day Initials BRANCH

Where to get additional info www. cdc. gov/niosh/npptl NPPTL Year Month Day Initials BRANCH

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. NPPTL Year Month Day Initials BRANCH