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January 9, 2013

Toxics Use Reduction Institute Science Advisory Board Meeting Minutes
January 9, 2013
DEP Boston, 2nd Floor Hearing Room
1:00 PM

Members present: Dave Williams (Chair), Larry Boise (Vice-Chair), Ken Weinberg, Martha Mittelstaedt, Robin Dodson, Hilary Hackbart, Amy Cannon

Others present: Mary Butow (TURI), Liz Harriman (TURI), Heather Tenney (TURI), Carol Rowan-West (DEP), John Raschko (OTA), Dave Wawer (MCTA), Sean Moynihan (MCTA), Trish McCarthy (ACC), Margaret Gorman (ACC), Wendy Koch (SEHSC), Tracy Guerrero (SEHSC), Kathy Plotzke(SEHSC)

Members not present:  Igor Linkov

Welcome and Introductions

Program Updates

●    The Governor’s Report is in final draft.
●    DEP is making changes to the ERP program for drycleaners that use perc in order to promote TUR in that industry sector.
●    GreenEarth representatives visited TURI and provided information on their (licensed) product and updated equipment. 
●    OTA finished the Barriers Report on Asthmagens.  The report addesses formaldehyde, diisocyanates, and chlorine/chlorinated substances.
●    TURI is working with the Aerospace and Defense supply chain on hexavalent chromium which the program has designated as a HHS.  The program reported on the current research into corrosion resistant alternatives for hexavalent chromium.
●    Registration is still open for the EMS training event --- January 17, 2013.
●    John Raschko noted that OTA is working with the State procurement office on Environmentally Preferable Purchases – seeking alternatives to chlorine/bleach related cleaners.
●    The carcinogens report is under final review and will be distributed to the SAB shortly.

Approve November Meeting Minutes

Amend phrase on Page 3 to include full name of the Patty’s Toxicology reference.
Vote to approve minutes as amended:  Unanimous.

Volatile Methyl Siloxanes: New Materials from SEHSC

The Board’s VMS discussion began at the end of 2010.  VMSs are common alternatives for TURA Higher Hazard Substances TCE and PCE.  The Board has been in the process of reviewing alternatives for these substances in order to give good guidance to facilities switching away from them.  In March 2011 SEHSC gave a presentation on the VMSs. The SAB then reviewed the Canadian Board of Review document in late 2011.  The cyclic VMSs (D4 and D5 specifically) were tabled until additional information became available.  The linear VMS HMDS was recommended for listing due to its low flash point.

SEHSC gave the following summary of the information distributed on D5 (all SEHSC comments are in italics):
The Canadian D5 Board of Review was completed: Environment Canada said that D5 not a concern to environment now or in the future.  The following spring the Minister of Environment approved that action.

An Enforceable Consent Agreement (ECA) is being worked on with the US EPA.  They are close to an agreement regarding an environmental monitoring program for D4/D5.  The following public meetings were held regarding the ECA (public transcripts are available):

6/27/12 – Discussions regarding the number of public meetings/hearings for monitoring program.
12/6/12 – EPA did not have concerns for D5 (from an environmental perspective); they were focused on data for D4 moving forward.
12/27/12 – Discussions regarding the number of POTWs that would be monitored.  There was an extension granted in December until 2/27/13.

There is currently monitoring in Oregon – have not found D4 in effluents.

Regarding potential health effects from D5, SEHSC has been exploring a potential mode of action (MOA) to explain the increased uterine carcinomas seen in the Dow study.  In this MOA work SEHSC questioned the results of the 2-yr assay – can they be attributed to D5?  The Fisher 344 rats have different sub strains and the study used a strain that has a higher background incidence of uterine tumors.  NTP used a different F344 sub strain.  They are trying to ascertain if the effect is due to the test articles. A higher incidence was observed in the control group.

SEHSC has statistical and biologic experts to review data for both biological and statistical significance.  The statistical review is to be completed mid-2013 with a report to be out in the summer.

EPA has no health effect concerns with D4 or D5.  EPA looked at it from a risk assessment perspective and determined that there were adequate margins of safety.  Health Canada concluded the same thing.

Questions asked of SEHSC by Board members and liaisons (SEHSC answers in italics).

What office at EPA is working on this - are they health scientists?

They used to be the OPPTS.   Yes they are health scientists- the exposure group.

Why is EPA interested in environmental monitoring if they are not concerned about health effects?

They want better understanding of potential for exposure.  Volatility makes very difficult to even find D4 and which compartments is it getting into.

Why were other species not studied if the problem is with the Fisher rats?

SEHSC doesn’t know of any other studies being done.

Is D5 causing shift in hormonal patterns?

SEHSC is not finding anything D5 does to interfere with hormone action, etc. Studies on binding to the estrogen receptor or testosterone did not see any effects.  A slight effect on cyclicity was seen.  F344 rats have unique pattern of senescence very different than humans.  In the rats it is a dopamine controlled pathway.  Metabolism of D5 induced certain P450s; didn’t see any effects on estradiol – the metabolism effect is subtle for D5.  D5 did not show a dose-response in pre-cursor lesions.  Hyperplasia can lead to benign tumor and then ultimately malignant tumor.  In this case they saw tumors appearing out of nowhere.  Spontaneous tumors do not happen in humans – they are only seen in rats.  It is very difficult to affect modulation in a woman. 

Has there been any Occupational Exposure Monitoring?

There was a recent review of the IHG. It may not change much.  There is an article monitoring workers in China – SEHSC can provide us with that.

ENVIRON is going to do a Global Risk Assessment.  The draft for D5 will be available any day now – they are hoping to submit it mid-year for publication.  D4 will follow.

SEHSC will also provide us with Tony Plant’s review which shows rats/humans/primates modulation of the lutenizing hormone (LH) surge.  There is a distinct difference between animals/humans.
TURI will gather a list of what has been distributed and available for a bibliography so the Board can review what has been seen over the past two years.  SEHSC will extend the time on the current documents available in the DropBox.

Feel free to send questions to SEHSC as you review the information.

CERCLA Categories: Phthalate esters

Heather provided a brief synopsis of the work to date.  The Board has decided to start by reviewing data for the ortho group of phthalate esters.  Six are currently reportable under TURA. 

TURI will add branching/extra comments to structure TAB and scientific data sheet and organize by carbon chains.  TURI will add chemical names and abbreviations to structure sheet as well.

Monoester metabolites were identified as a large part of problem.  There was a question as to how non-symmetric ones breakdown?  What is the cumulative risk/hazard from metabolites?

For example, for DEHP the MOA is clear, but is not necessarily the same for other phthalate esters.   Also, the volatility is very different.

Compare Ortho C6/Six TURA listed/Eight EPA Action Plan chemicals.

TURI can bring in a researcher who is currently studying phthalate esters. The Fabjan or Howdeshell papers are a good place to look for an expert.  TURI will research possible guest speakers for the next meeting.

ACC notes that they have more information.

There is a cumulative risk – not just individual risk from each chemical. The Board is focusing on androgenic/reprotox effects.  The C4-C6 side chain and metabolites appear to have the most concern. Re-sorting the sheet by side chain length will help determine if the health effects correlate.

Next Meeting

March 6, 2013

Items Distributed/Circulated at Meeting

November Minutes

Revised D5 CSR on Carcinogenicity from SEHSC

PE Scientific and Regulatory Data Sheets