October 20, 2010

Science Advisory Board Meeting Minutes

October 20, 2010

Mass DEP: 2nd Floor

12:30PM

Members Present: Dave Williams, Larry Boise, Martha Mittelstaedt, Veronica Vieira, Hilary Hackbart, Robin Dodson, Igor Linkov

Others Present: Mary Butow (TURI), Heather Tenney (TURI), Dr. Richard Clapp (BU), Carol Rowan West (DEP), Rick Reibstein (OTA), John Raschko (OTA), Liz Harriman (TURI), Patricia McCarthy (ACC), Steve Rosario (ACC), Dave Wawer (MCTA), Ray Monkly (Hexion), Mark Greunwald (Hexion), Dr. Bob Golden (Toxicologist representing the Formaldehyde Industry), Shawn Moynihan (MCTA), Dr. Sandy Baird(DEP)

Lunch presentation

Dr. Dick Clapp presented about his work for the President’s Cancer Panel

Welcome and Introductions

June Minutes

Approved as written

Program Updates

● On November 3rd there will be a TURA continuing education conference in Norwood. Sessions which the SAB may be interested in include TSCA Reform and EPA Chemical Action Plan sessions.

● We are looking for two new Board members. Please let Heather know if you have any recommendations.

● There is a new wet cleaning demonstration site; trainings are coming up.

● The program is working on an implementation plan for TCE.

Finalizing the Recommendation for Formaldehyde

Heather provided history of the designations of formaldehyde: The SAB recognized formaldehyde as More Hazardous during the original categorization process in 1999. When the 2006 amendments were passed, the SAB recommended that formaldehyde be one of the first 10 Higher Hazard Substances. Since 2006 the program has been putting forth chemicals from that list of 10 that the SAB recommended to the Administrative Council for vote as official Higher Hazard Chemicals. Formaldehyde is the 5th chemical to be presented to the Administrative Council.

After the SAB’s 2006 recommendation, IARC changed the formaldehyde classification from 2A to IARC 1 in 2006. In 2009, IARC reaffirmed formaldehyde’s IARC 1 status for nasopharyngeal cancer as well as making it an IARC 1 for leukemia.

TURI developed its Policy Analysis for formaldehyde in early 2010 and it was then presented to the Advisory Committee and the Administrative Council. The Advisory Committee raised questions regarding paraformaldehyde and whether it should be included with formaldehyde. These questions were referred back to the SAB.

The industry representatives in attendance were given 10 minutes to present their information on formaldehyde. Dr. Golden performed this presentation and distributed slides. Key points were as follows (the following points represent the views of the presenter only):

● Formaldehyde is naturally occurring

● Formaldehyde binds to DNA

● Use of labeled form (13) to distinguish source

● No detectable exogenous formaldehyde

● Does not get into the body

● Human breath exceeds EPA’s 10-4 cancer risk

● Clear thresholds for sensory irritation and nasal cancer

The National Academy of Science (NAS) is reviewing the EPA/IRIS documentation.

He is suggesting that Massachusetts wait for NAS deliberation to be completed. He feels there was a reliance (by EPA) on outdated data. There is some controversy around formaldehyde causing or exacerbating asthma. The 2007 NAS report concluded formaldehyde is not an asthma trigger. He feels the IARC (2006) studies were not designed to evaluate formaldehyde- there was potential confounding from multiple chemical exposures. He noted that the World Health Organization (WHO) published papers that are at odds with IARC/NTP/EPA. He also showed a TCEQ graph of indoor air formaldehyde levels showing a large contribution from natural sources.

Steve Rosario noted that he has attended Advisory committee meetings. He passed out some materials for the Board to review.

Dr. Baird from MASS DEP Office of Research and Standards is currently serving on an NAS committee to review EPA’s Formaldehyde document. She gave a brief summary of the goals and timeline of the NAS review. The NAS was tasked with conducting an independent scientific review of the EPA draft. Deliberations are sealed until the release of the report. They are reviewing EPA’s report and providing review and comment. There will be a pre-release at the end of February 2011 and a final report to be published in March 2011. An anonymous group reviews their draft. They meet in December 2010. The EPA draft is located on the IRIS website and is over 1000 pages. Dr.Baird was invited to come and speak to the SAB again after they have completed the report.

A question was raised on paraformaldehyde. It has its own unique CAS number. Should it be treated the same? The risk from paraformaldehyde is the off-gassing of formaldehyde.

The industry representatives were asked if there was any plan to challenge IARC’s Group 1 recommendation. It does not appear that there is, however industry representatives commented that the 2009 addition based on Leukemia risk may not have been debated long enough and that new compelling data ought to be reviewed. The IARC vote was close (11-9), specifically with regard to leukemia.

Regarding Nasopharyngeal Cancer, the industry representatives do not agree with IARC’s Group 1 designations for that as well. There was a 10 plant cohort of 25 thousand workers. Six of the cases occurred in one plant. Four of the cases concerned workers who had worked there less than 1 year; apparently they had previously worked in metal working industries and had been exposed to acid mists. Also, there was an Epi study done in the UK with 14 thousand workers. No NPC was found.

The Administrative Council is asking the SAB to affirm Formaldehyde (HHS) recommendation and decide on the recommendation for paraformaldehyde.

Motion Recommendation for Formaldehyde originally made by SAB be tabled until report from NAS is released.

Further discussion:

A member expressed interest in seeing the reports prior to finalizing a decision. It was noted that formaldehyde is already being reported (tracked) in MA. The question was asked if formaldehyde is widely used in MA. It was noted that about 10 companies use it at the current thresholds. A member questioned the procedure: generally IARC is considered the gold standard.

The possibility that NAS disagrees with IARC was discussed. It was noted that the report may not be cut and dry. It was suggested that the Board formalize contingency if there is a delay. It was noted that the Board has a protocol of following IARC recommendations.

Motion to Table: 5 in favor; 2 opposed

Motion: If no data presented in the NAS report conflicts w/ IARC Nasopharyngeal Cancer assessment, the Board recommends retaining their recommendation of Formaldehyde as a HHS.

Vote: 7 in Favor

It was noted that the SAB will review the nasopharyngeal information themselves so if there are some disagreements regarding nasopharyngeal cancer they can act quickly once the NAS review is complete.

Motion: Paraformaldehyde remain uncategorized recognizing that as formaldehyde is generated it will be accounted for.

Vote: 5 in Favor, 2 Opposed

Decision Making Document

Liz reviewed the updates to the Decision Making Document that she and Anne Marie worked on over the summer. The objective is to have a background document for decision making in the Program.

One member commented that the text referring to the Precautionary Principle is misleading and too much in this context. More information on the Delphi method would be more appropriate. It was clarified that the Precautionary Principal is there because the Administrative Council kept asking if SAB was being “precautionary”. Fundamentally TURA looks at hazard vs. risk. However, sometimes additional information (such as use information) is considered for context. Other suggestions were made regarding clear references to Appendices and a correction to the title of Appendix C. It was noted that this is a living document and can be updated as necessary.

Motion: approve Appendices B & C of Decision Making Document

Vote: 5 in Favor

Adjourn

Next Meeting Dates: Tuesday, 12/7/10; Tuesday 1/11/11