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Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers

 

March 2011
NIOSH Docket Number 161A

NIOSH published a final document, Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, in April 2013. The final document and the NIOSH responses to the peer and public/stakeholder review comments are provided below.

Previously, a public meeting was held in Cincinnati, Ohio on February 3, 2011 to discuss the purpose and content of the draft document and to give the public an opportunity to ask questions and comment on the document. The document contains an evaluation of the toxicological data associated with exposure to carbon nanotubes and nanofibers and provides recommendations for minimizing adverse health effects to exposed workers including a recommendation for an occupational exposure limit. Information about the public meeting, the external review draft document, and the peer reviewer, and public/stakeholder comments received are also provided below.

Related Docket

Final Document and responses to reviewers comments

Notice of availability of guidance document; 78FR25454; 5/1/13 [PDF – 61 KB]

Final document “Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers”; DHHS (NIOSH) Publication No. 2013-145; 4/1/13

NIOSH response to Peer Review Comments; 1/22/13 [PDF – 1,163 KB]

NIOSH response to Public and Stakeholder Comments; 1/22/13 [PDF – 5,364 KB]

Information

Notice of public meeting; 75 FR 80819; 12/23/10 [PDF – 2455 KB]

Draft document – NIOSH Current Intelligence Bulletin: Occupational Exposure to Carbon Nanotubes and Nanofibers; 11/1/10 [PDF – 103,636 KB]

Meeting Information – Millennium Hotel Cincinnati, Grand Ballroom A, Cincinnati, OH 2/3/11

Meeting agenda; 2/3/11 [PDF – 659 KB]

List of attendees; 2/3/11 [PDF – 3698 KB]

Presentation by Charles Geraci (NIOSH) entitled, Overview of the draft NIOSH Current Intelligence Bulletin (CIB): Occupational Exposure to Carbon Nanotubes and Nanofibers; 2/3/11 [PDF – 27408 KB]

Presentation by Vincent Castranova (NIOSH) entitled, NIOSH CIB: Occupational Exposure to Carbon Nanotubes and Nanofibers; 2/3/11 [PDF – 10,926 KB]

Presentation by Eileen Kuempel (NIOSH) entitled, Risk Assessment of CNTs; 2/3/11 [PDF – 11,336 KB]

Presentation by Ralph Zumwalde (NIOSH) entitled, NIOSH CIB—Occupational Exposure to Carbon Nanotubes and Nanofibers; 2/3/11 [PDF – 11,336 KB]

Presentation by Douglas Trout (NIOSH) entitled, Summary of Medical Screening and Surveillance Recommendations for Workers Exposed to Carbon Nanotubes and Nanofibers; 2/3/11 [PDF – 23,147 KB]

Presentation by Jüergen Pauluhn (Bayer Schering Pharma AG) entitled, Common mechanism-based study design for Inhalation Toxicity Testing of Poorly Soluble (Nano-/Ultrafine-) Particles: Are new Testing Strategies and Interpretation Guidelines Needed?; 2/3/11 [PDF – 9665 KB]

Presentation by Jay Feitshans of written comments submitted to the docket from Ilise Feitshans (International Safety Resources Association (ISRA)), entitled Legal Basis and Justification: NIOSH Recommendations Preventing Risk from Carbon Nanotubes and Nanofibers; 2/18/11 [PDF – 11,407 KB]

Meeting transcript; 2/3/11 [PDF – 679 KB]

Comments from Peer Reviewers

Comments from Peer Reviewer 1; 3/4/11 [PDF – 4,264 KB]

Comments from Peer Reviewer 2; 3/11/11 [PDF – 319 KB]

Comments from Peer Reviewer 3; 3/21/11 [PDF – 1,642 KB]

Comments from Peer Reviewer 4; 3/17/11 [PDF – 2,252 KB]

Submissions in order of Receipt

Submission to the docket from Ron Challis (Canadian Auto Worker’s Union representative); 12/18/10 [PDF – 760 KB]

Submission to the docket from Christina Larson (University of Minnesota); 1/27/10 [PDF – 379 KB]

Reference submitted from Jüergen Pauluhn (Bayer Schering Pharma AG) – Poorly soluble particulates: searching for a unifying denominator of nanoparticles and fine particles for DNEL estimation; 11/11/10 [PDF – 1362 KB]

Submission to the docket from Debra Hahn (Private person); 2/4/11 [PDF – 407 KB]

Submission to the docket from Jüergen Pauluhn (Bayer Schering Pharma AG); 2/8/11 [PDF – 2875 KB]

Submission to the docket from James Melius (NYS Laborers Health and Safety Trust Fund); 2/15/11 [PDF – 1364 KB]

Submission to the docket from John Morawetz (International Chemical Workers Union Council); 2/15/11 [PDF – 1479 KB]

Submission to the docket from Jolanda Rijnkels (Health Council of the Netherlands); 2/16/11 [PDF – 2535 KB]

Submission to the docket from John Baker (ICU Environmental, Health and Safety); 2/17/11 [PDF – 434 KB]

Submission to the docket from Masahide Hayashi (Nanotechnology Business Ceation Initiative); 2/17/11 [PDF – 655 KB]

Submission to the docket from Junko Nakanishi (Research Institute of Science and Technology (AIST)) w/2 attachments; 2/18/11 [PDF – 2298 KB]

Attachment #1 – Risk Assessment of Manufactured Nanomaterials – Carbon Nanotubes (CNTs) – Interim report issued on October 16, 2009: Executive Summary; 10/16/09 [PDF – 30,883 KB]

Attachment #2 – Risk Assessment of Manufactured Nanomaterials – Titanium Dioxide (Ti02) – Interim report issued on October 16, 2009: Executive Summary; 10/16/09 [PDF – 38,438 KB]

Submission to the docket from Barbara Materna (California Department of Public Health): 2/18/11 [PDF – 1994 KB]

Submission to the docket from Pete Stafford (Building and Construction Trades Department); 2/18/11 [PDF – 19,216 KB]

Submission to the docket from Paul Wambach (Department of Energy); 2/18/11 [PDF – 3661 KB]

Submission to the docket from Robert Landsiedel (BASF Product Safety); 2/18/11 [PDF – 2566 KB]

Submission to the docket from Mariko Ono-Ogasawra (Japan National Institute of Occupational Safety and Health); 2/18/11 [PDF – 616 KB]

Submission to the docket from David Warheit (DuPont Haskell Global Centers); 2/18/11 [PDF – 6294 KB]

Submission to the docket from Bill Kojola (American Federation of Labor and Congress of Industrial Organizations); 2/18/11 [PDF – 3642 KB]

Submission to the docket from Sebastien Gallet (European Chemical Industry Council); 2/18/11 [PDF – 1858 KB]

Submission to the docket from Lisa Goldberg (Aerospace Industries Association); 2/18/11 [PDF – 3016 KB]

Submission to the docket from Gary Casuccio (RJ Lee Group); 2/18/11 [PDF – 990 KB]

Submission to the docket from James Votaw (WilmerHale); 2/18/11 [PDF – 5204 KB]

Submission to the docket from Jay West (American Chemistry Council); 2/18/11 [PDF – 3486 KB]

Submission to the docket from Barbara Cummings (Bayer MaterialScience); 2/18/11 [PDF – 5555 KB]

Submission to the docket from Bruce Lippy (The Lippy Group, LLC); 2/18/11 [PDF – 838 KB]

Submission to the docket from Michael Kosnett (Colorado School of Public Health); 2/18/11 [PDF – 2000 KB]

Submission to the docket from Patrick O’Connor (American College of Occupational and Environmental Medicine (ACOEM)); 2/18/11 [PDF – 1478 KB]

Submission to the docket from Scott Hollenbeck (Oak Ridge National Lab); 2/22/11 [PDF -1293 KB]

Peer review

Cross-Clearance Agencies: None

Anticipated Date of Dissemination: December, 2010

Subject of Report: Review of relevant scientific literature on occupational exposure to carbon nanotubes and nanofibers along with recommendations for preventing worker exposure.

Purpose of Report: To evaluate the health data associated with exposure to carbon nanotube and nanofibers and provide risk management recommendations to prevent worker exposure and to reduce the risk for adverse lung effects (e.g., fibrosis).

Type of Dissemination: Copy of 2010 draft given to Peer reviewers

Timing of Review: Spring 2011

Primary Disciplines or Expertise Needed for Review: Toxicology, risk assessment, risk management, and industrial hygiene Type of Review: Individual

Number of Reviewers: 4

Reviewers Selected by: NIOSH

Public Nominations Requested for Reviewers: No

Opportunities for the Public to Comment: Yes

Peer Reviewers Provided with Public Comments before Their Review: Yes

Peer Reviewers:

Phil Sayre, Ph.D.
Associate Director, OPPT/RAD
U.S. EPA
Area of Expertise, Discipline, or Relevant Experience: Risk management

Ron White, MST (master of science in taxation)
Associate Scientist, Deputy Director, Risk Sciences and public Policy Institute
Johns Hopkins Bloomberg School of Public Health
Area of Expertise, Discipline, or Relevant Experience: SRA nano risk assessment chair

Andrew Maynard, Ph.D.
Charles and Rita Gelman Professor of Risk Science, Director
University of Michigan Risk Science Center
Area of Expertise, Discipline, or Relevant Experience: Aerosol physics, nanoparticle sampling instrumentation

Robert Aitken, Ph.D.
Director of Strategic Consulting, Nanotechnology Programme Director, and Director of SAFENANO
Institute of Occupational Medicine, Edinburgh, UK
Area of Expertise, Discipline, or Relevant Experience: Risk Management

Charge to Peer Reviewers:

  1. Is the hazard identification and discussion of health effects for CNT and CNF a full and reasonable reflection of the animal studies and other scientific evidence in the scientific literature?
  2. Is the risk assessment and dosimetric modeling methods used in this document appropriate and relevant?
  3. Is the use of respirable mass as a dose metric appropriate for estimating worker risks from inhalation to CNT and CNF?
  4. Are the sampling and analytical methods adequate to measure worker exposure to carbon nanotubes and nanofibers?
  5. Are there additional relevant studies or methods that NIOSH should consider in developing the REL for CNT and CNF?