Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione
NIOSH Docket Number 245
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 final document and the NIOSH responses to the peer and stakeholder and public review comments are provided below.
Previously, NIOSH held a public meeting on August 26, 2011 in Washington, DC to discuss and obtain comments on the draft document, "Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-Pentanedione" which was released in August 2011. Public comments on the draft document were received for submission to this docket from August 2011 until the closing of the comment period in May 2012. This docket also contains the draft document, presentations from the public meeting, the public meeting transcript, and the public comments/submissions received.
From December 2013 through February 2014, external review and public comment on two revised portions of the document, including a revised Chapter 6 and a new section of Chapter 8 were conducted. The new content supported the conclusions in the draft criteria document so it was reviewed independently of the entire document. To view the notice and related material and the public comment/submissions visit http://www.regulations.gov, enter CDC-2013-0021 in the search field, then click "Search". Information from the December 2013-February 2014 review can also be viewed here.
NIOSH considers this Criteria Document to be a highly influential scientific assessment (HISA) containing significant guidance as defined by the OMB Peer Review Bulletin and Good Guidance Practices Bulletin. The overall goal of the peer review and public comment process was 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.
- Final Document: Occupational Exposure to Diacetyl and 2,3-Pentanedione, 2016-111 [PDF - 38.3 MB]
- Federal Register Notice 11/3/16 [PDF - 174 KB]
Material Under Consideration
NIOSH Response to Peer Review Comments [PDF - 849 KB]
NIOSH Response to Public and Stakeholder Comments [PDF - 1,523 KB]
Notice of Public Meeting; 76 FR 44338; 7/25/11 [PDF - 57 KB]
Notice of extension of comment period; 10/18/11 [PDF - 1,377 KB]
Notice of expanded charge for peer review; 77 FR 21777; 4/11/12 [PDF - 1,548 KB]
NIOSH draft document, Criteria for a recommended standard: Occupational exposure to diacetyl and 2,3-pentanedione. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; external review draft; 8/12/11 [PDF - 4,668 KB]
The public review draft of "Criteria for a recommended standard: occupational exposure to diacetyl and 2,3-pentanedione" is amended for clarity and accuracy as specified below:
Page 202, lines 15, 18, and 25 – change "female" to "male."
Page 202, line 28, to page 203, line 2 – Strike the sentence beginning "One suitable nasal endpoint…" and replace with the following: "A suitable nasal endpoint, suppurative exudate of the lumen, was identified in male mice exposed to either diacetyl or 2,3-pentanedione. A second suitable endpoint, bronchial inflammation, was identified in male mice exposed to diacetyl and female mice exposed to 2,3-pentanedione."
Page 208, line 20 – change "female" to "male."
Post meeting information
Transcript from public meeting; 8/26/11 [PDF - 509 KB]
Meeting held at OMNI Shoreham, Washington, DC on August 26, 2011
Agenda for meeting; 8/26/11 [PDF - 1,452 KB]
Sign in sheet from public meeting; 8/26/11 [PDF - 2,020 KB]
Presentation by David Egilman (Private person); 8/26/11 [PDF - 389 KB]
Presentation by Dana Hollins (ChemRisk, LLC); 8/26/11 [PDF - 144 KB]
Submissions in Order of Receipt
Submission to the docket from Egilman (Brown University) – 8/28/11 [PDF - 14,524 KB]
- A proposal for a safe exposure level for diacetyl - article
- Emissions from cooking microwave popcorn - article
- ILLOVO – Safety data sheet
- IPCS – International Chemical Safety Card
- Exposure simulation to diacetyl from popcorn – Deemed Confidential
- Report – Study on the acute inhalation toxicity LC50 of diacetyl FCC as a vapor in rats 4-hour exposure – Deemed Confidential
- Consumer safety estimate for inhalation of synthetic butter flavoring component of microwave-ready popcorn – Deemed Confidential
Submission to the docket from private person – 10/11/11 [PDF - 1,140 KB]
Submission to the docket from Hollins (ChemRisk, LLC) – 11/17/11 [PDF - 12,142 KB]
Submission to the docket from Gold (Cal/OSHA) – 11/17/11 [PDF - 5,422 KB]
Submission to the docket from Whitmyre (toXcel) – 11/17/11 [PDF - 12,417 KB]
Submission to the docket from Smigal (USDA/FSIS/OM/OCHRO) – 11/18/11 [PDF - 1,870 KB]
Submission to the docket from Schroeder (private person) – 11/18/11 [PDF - 2,222 KB]
Submission to the docket from private person – 11/18/11 [PDF - 603 KB]
- Page last reviewed: August 12, 2011
- Page last updated: October 31, 2016
- Content source:
- National Institute for Occupational Safety and Health Education and Information Division