Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers
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.
Final Document and responses to reviewers comments
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]
Notice of public meeting; 75 FR 80819; 12/23/10 [PDF – 2455 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 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
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 James Votaw (WilmerHale); 2/18/11 [PDF – 5204 KB]
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
Phil Sayre, Ph.D.
Associate Director, OPPT/RAD
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:
- 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?
- Is the risk assessment and dosimetric modeling methods used in this document appropriate and relevant?
- Is the use of respirable mass as a dose metric appropriate for estimating worker risks from inhalation to CNT and CNF?
- Are the sampling and analytical methods adequate to measure worker exposure to carbon nanotubes and nanofibers?
- Are there additional relevant studies or methods that NIOSH should consider in developing the REL for CNT and CNF?