Chapter 6 and Chapter 8 section only from "Criteria for a Recommended Standard: Occupational Exposures to Diacetyl and 2, 3-pentanedione"
NIOSH Docket Number 245-A, CDC-2013-0021
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a final document, Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-Pentanedione, in October 2016. The links to the final document and the NIOSH responses to the peer and stakeholder and public review comments are provided below.
The entire criteria document had initially undergone external peer review and public comment from August 2011– May 2012. Information on this initial review can be found here. Subsequently, NIOSH conducted an additional peer and public review process for two revised chapters of the draft document from December 2013 – February 2014. Specifically, NIOSH sought external review and public comment on a revised Chapter 6 and a new section of Chapter 8. Descriptions of the new content for these chapters are provided below. This new content supports the conclusions in the draft criteria document so it was reviewed independently of the entire document.
For Chapter 6 – Quantitative Risk Assessment Based on Animal Data:
Overview of changes: After the previous peer review and public comment process was initiated, the National Toxicology Program released a new dataset on diacetyl and 2,3-pentanedione. Chapter 6, titled Quantitative Risk Assessment Based on Animal Data, was updated to accommodate this new dataset. The new dataset and associated quantitative risk assessment of these animal data support the previous conclusions of the human risk assessment in the original draft document.
For Chapter 8 – GHS section:
Overview of changes: After the previous peer review and public comment process was initiated, the Occupational Safety and Health Administration (OSHA) promulgated a revised Hazard Communication Standard aligned with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The new section of Chapter 8 includes classifications of these chemicals based on the OSHA GHS criteria. These classifications were added in response to comments received during the public and peer review comment period for the draft criteria document. It is of note that this is the first time that a NIOSH document has provided GHS classifications that were derived by NIOSH. Though other NIOSH documents have previously published GHS classifications (e.g. NIOSH Skin Notations), those GHS classifications were derived by and cited from another authoritative body.
NIOSH considers this Criteria Document to be a highly influential scientific assessment (HISA) containing significant guidance as defined by the Office of Management and Budget Peer Review Bulletin and Good Guidance Practices Bulletin. The overall goal of the peer review and public comment process is to enhance the quality and credibility of NIOSH recommendations by ensuring that the scientific and technical work underlying these recommendations receives appropriate review by independent scientific and technical experts as well as public review. A listing of the external peer reviewers as well as the charge to peer reviewers can be found on the peer review agenda website.
To view the notice and related material visit http://www.regulations.govexternal icon, enter CDC-2013-0021 in the search field, then click “Search”.
- Final Document: Occupational Exposure to Diacetyl and 2,3-Pentanedione, 2016-111pdf icon [PDF – 38.3 MB]
- Draft Chapter 6 documentpdf icon
- Draft Chapter 8 documentpdf icon