Respiratory Protection and the Role of NIOSH

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Presentation transcript:

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

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

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

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

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.

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

Where the testing happens ..

Silica Dust Chamber

Vibration table

Environmental Chamber

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

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

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

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

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

Required Product Markings

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

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

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

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

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

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

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

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

Where to get additional info www.cdc.gov/niosh/npptl

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.