CBRN Respirators8

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• NIOSH CBRN Respirator Certification Activities
  2001-2015

Terrence K. Cloonan Physical Scientist
NIOSH, NPPTL Pittsburgh, PA September 15, 2015
ISRP Americas Section Annual General
Meeting Morgantown, West Virginia
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Mapping of 8

• History
• Regulatory authority
• Standards publications
• Notifications
• Re-test phase
• Restoration phase
• National inventory
• 2015 and beyond

Previous photography is courtesy of U.S. Army
Edgewood Chemical Biological Center and NIOSH.
Above drawing was created by Terrence K. Cloonan,
NIOSH, and Mr. Marion Molchem, KI, LLC, with
technical input from John Kuhn, MSA, The Safety
Company.
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NIOSH CBRN History

• Tokyo, Japan, 1995
• NIOSH 1999 workshop
• NIOSH NPPTL 2001
• September 11, 2001
• NPPTL and ECBC 2001
• NIOSH and NFPA 2001-2007, 2012-2015
• NPPTL, NIST, and ECBC 2013-2015
• NIOSH and ECBC 2015/16 update to IAA

Images courtesy of Terrence K. Cloonan, NIOSH,
and NFPA.
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Regulatory Authority

• Occupational Safety and Health Act of 1970
• Mine Safety and Health Act of 1977
• OSHA 29 CFR 1910.132-138
• NIOSH invoked policy making authority for CBRN,
  per 42 CFR Part 84, 84.63 (c) (d) H-84.70,
  I-84.110, L-84.190
• Since CY 2007, informal rulemaking or consensus
  standards organizations

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Standards Developed

• CBRN SCBA
• CBRN SCBA upgrade (retrofit) kit
• CBRN APR
• CBRN APER
• CBRN SCER
• CBRN PAPR-Tight
• CBRN PAPR-Loose

Photograph courtesy of Terrence K. Cloonan,
NIOSH, Allegheny County Fire Academy, PA, and
MSA. Re-touch courtesy of Marion Molchem, KI, LLC.
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Publications

• NIOSH Pub No. 2011-183 Whats special about
  CBRN SCBA? http//www.cdc.gov/niosh/docs/2011-183/
  
• NIOSH Pub No. 2013-157 Whats special about
  CBRN APR? http//www.cdc.gov/niosh/docs/2013-157/
• NIOSH Pub No. 2013-156 Whats special about
  CBRN PAPR? http//www.cdc.gov/niosh/docs/2013-156/
  

Photograph courtesy of Terrence K. Cloonan,
NIOSH, NPPTL
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Notifications

• November 18, 2013
• Test concentrations were less than required
• All discrepancies were self-identified
• Impact period July, 2012 to October
  2013
• Root cause analysis conducted
• 5 approval holders notified on 11/21/2015

SMARTMAN mounted with SCBA for HD droplet
application. Drops 1-25 identified for test and
certification purposes. Photograph courtesy of
U.S. Army ECBC, APG, MD Terrence K. Cloonan,
NIOSH and MSA.
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Re-test Phase

• November 19, 2013 NIOSH met with ECBC to
  define a path forward
• ECBC corrective action plan developed, 12/2013
• ECBC corrective action reports created
• With NIOSH oversight, ECBC conducted vetted
  re-testing from January to April, 2014
• ECBC found to be conforming in June, 2014

Benchmark test configuration from October 2001.
Foundation test method. Photograph courtesy of
U.S. Army ECBC, APG, MD, Terrence K. Cloonan
NIOSH, Interspiro, http//www.interspiro.com/
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Restoration Phase

• NIOSH issues a respirator user notice on July 31,
  2014, lifting use restrictions http//www.cdc.gov/
  niosh/npptl/usernotices/notices/notice07312014.htm
  l
• NIOSH increases oversight of 5 ECBC unique areas
  
• Formal system to handle test method
  deviations
• Work instruction review
• Observe ISO 17025 debriefs
• NIOSH QA audits scheduled
• NIOSH randomly audits ECBC technicians conducting
  NIOSH CBRN live-agent testing (LAT)

Photograph of a pristine SMARTMAN headform
is courtesy of U.S. Army Edgewood
Chemical Biological Center, Protective Equipment
Team Branch (PETB) and Terrence K. Cloonan, U.S.
DHHS, CDC, NIOSH, NPPTL.
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Back to Normal? No.Back to the Future!

• In parallel, next generation test methods and
  equipment are being assessed, procured,
  integrated, vetted, and validated for the future
• Lab relocation in November
• Lab renovation in December
• Fume hoods and walk-ins
• A U.S. Army defined form, the DD Form 1222, is
  the lynchpin for requesting tests
• Simultaneously, alternative labs are being
  considered

Photograph of a research and development SMARTMAN
headform configuration in a non-contaminated
exposure chamber is courtesy of U.S. Army ECBC,
APG, MD, and Terrence K. Cloonan, NIOSH, NPPTL
Pittsburgh. PA
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National Inventory of Respirators - CBRN

• NIOSH Certified Equipment List (CEL) Approval
  holders continue to add to the United States
  national inventory of NIOSH-approved CBRN
  respirators
• Since January 7, 2014
  over 45 requests for test issued to ECBC
• accounting for 141 individual
  respirator systems
• As of September 11, 2015
• 33 candidate CBRN SCBA, 1 PAPR, 5 APR, and
  1 APER are in LAT queue
• Out of all the NIOSH approvals,
  204 are active CBRN records in the NIOSH CEL 167
  SCBA, 15 APR, 7 APER, 15 PAPR
  http//www2a.cdc.gov/drds/cel/cel_form_code.asp

Photographs courtesy of Scott Safety, MSA, ILC
Dover. U.S. Army ECBC, and NIOSH NPPTL.
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2015 and Beyond

• NFPA 1981 2013 edition SCBAs are commercially
  available for purchase
• NIOSH acknowledges the contributions of ECBC,
  NFPA, SEI, the DHS/FEMA Assistance to
  Firefighter Grant Program and the affected
  approval holders
• NIOSH is working with ECBC to enhance the IAA for
  2016
• 5 areas of additional oversight
• CASARM grade or equivalent agent
• NIOSH specification for LAT CWA-TBD
• Alternative laboratory initiatives continue in
  the U.S. and abroad

Going on-air photograph courtesy of Terrence
K. Cloonan, NIOSH, and Director
Al Wickline, Allegheny County
Fire Academy, PA
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Questions?
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Quality Partnerships Enhance Worker Safety
Health
Visit Us at http//www.cdc.gov/niosh/npptl
Disclaimer The findings and conclusions 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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Re-Stated Abstract

• Since 2001, NIOSH has developed chemical,
  biological, radiological, and nuclear (CBRN)
  respirator standards to evaluate devices meant to
  provide such protection. Through its research,
  standards development, certification programs,
  post-market evaluations and collaborative
  relationships with the Armys Edgewood Chemical
  Biological Center (ECBC) Edgewood, as well as
  the National Fire Protection Association (NFPA),
  and other partners, NIOSH continues to identify
  opportunities to improve existing standards and
  enhance operational laboratory efficiencies. In
  2013, while conducting respirator evaluations
  under an interagency agreement, Edgewood
  self-identified technical errors with toxic
  agent challenge concentrations. NIOSH was
  notified and a plan was formulated to increase
  oversight, conduct re-tests, recommence
  certification support, and begin work on next
  generation capabilities. Simultaneously, NIOSH is
  determining the feasibility of using alternative
  laboratories and their capacity to perform NIOSH
  special CBRN GB and HD tests. The Army plan is
  expected to result in repeatable performances
  that verify Edgewoods laboratory capacity and
  sustainability. In 2015, NIOSH seeks a renewed
  Edgewood capacity to generate sustainable
  challenge agent concentrations over time, while
  improving current methods and designing new
  methods needed to move toxic agent wet chemistry
  protocols into the year 2020 and beyond. NIOSH
  expects to work collaboratively with interested
  parties to create conformity assessment
  infrastructure improvements in data sensitive
  areas such as test methods and reports that rely
  on the use of SiMulant Agent Resistant Test
  MANikin (SMARTMAN) headforms and equivalent torso
  or full body articulated technologies.
  All of this is done in parallel with NIOSH
  sustaining cooperation with appropriate standards
  development organizations such as the NFPA and
  interested private and public stakeholders. TKC,
  9/11/2015.