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June 27, 2013

Toxics Use Reduction Institute Science Advisory Board Meeting Minutes
June 27, 2013
DEP Boston, Commissioner’s Conference Room
1:00 PM

Members present: Dave Williams (Chair), Larry Boise (Vice-Chair), Ken Weinberg, Robin Dodson, Hilary Hackbart, Christine Rioux

Others present: Mary Butow (TURI), Liz Harriman (TURI), Heather Tenney (TURI), Carol Rowan-West (DEP), John Raschko (OTA), Sean Moynihan (MCTA), Robert Barter (ExxonMobil Biomedical Science), Tsedash Zewdie (DEP), Steve Rosario (ACC),
Margo Simon Golden (MA Breast Cancer Coalition)

Members not present: Martha Mittelstaedt, Amy Cannon, Igor Linkov

Welcome and Introductions

Program Updates
•    The Champions of Toxics Use Reduction Event was held at the statehouse on June 12, 2013.
•    The TURI Carcinogens Report has been published and was distributed to the Board.
•    The Administrative Council Designated Methylene Chloride as a Higher Hazard Substance at their June meeting.  A Regulation Package will be prepared over the summer and put out for public comment in the fall.
•    DEP noted that EPA has put out an RfC for Trichloroethylene based on cardiac fetal effects.

Approve May Meeting Minutes
A typo was indicated in the names section and will be corrected.
A motion was made to approve the minutes. 5 in favor, 0 opposed.

Consider nPB as potential higher hazard substance
Heather reviewed the history of nPB. The Board recommended listing nPB in 2009 and nPB was placed in the ‘uncategorized’ category at that time. The Board stated that they would like to stay informed about emerging information regarding nPB, including the NTP carcinogenesis report that was ongoing.  Since 2009, the NTP carcinogenesis report has been completed, along with other NTP reports supporting it. In addition, ACGIH has proposed lowering the TLV to 0.1ppm.  Also, the first two years of TURA data have been reported. In the first year of filing, three facilities reported around 45,000 pounds of nPB. About half of this was released to the environment, causing nPB to be on the top 20 list of substances released to the environment. Program staff noted that some dry cleaners are using it as a drop-in substitute for perchloroethylene.

The NTP report was completed in 2012, with the monograph being published May 14, 2013. The recommendation will go to the HHS Secretary as a candidate for inclusion into the next Report on Carcinogens – as ‘Reasonably Anticipated to be a Human Carcinogen’ 
Program staff noted that NTP will finalize the draft monograph by the end of the year.

Based on occupational considerations – a Board member thought nPB should definitely be considered as a higher hazard substance.

The Board would like to see a comparison with other currently designated Higher Hazard Substance solvents: Methylene Chloride, Trichloroethylene and Perchloroethylene.  Mary will bring a spreadsheet with the side-by-side comparison to the next meeting.

A Board member asked if OSHA filings were available for nPB.  One Board member had concerns over the assumptions made in the NIOSH poster (45 years continuous exposure).  It was noted that ACGIH did not use that data when proposing the new TLV.  Heather will confirm that Dr. Stelljes has received the ACGIH documents.  TURI will follow up with the author of the poster for more information about their work.

The Board will resume discussion in September.  TURI will get the studies listed in the EHS Summary and identify additional neurotoxicity studies (specifically OSHA/CDC).  TURI will also look for environmental exposure data (e.g. PBT).  The Board would like to see more information on long term low level effects.

CERCLA Categories: Phthalate esters
Program staff reviewed some of the questions the Board had from previous meetings.

Primary endpoints of concern are noted as Reproductive and Developmental
-OECD High Molecular Weight – Low Hazard for Repro Tox
    -NIC NAS – Hazard Profiles flag C4-C6
    -EU is focusing on C4-C6

Additionally, liver toxicity remains a concern.

Questions remain about metabolites.  The time of exposure is still a concern (i.e. how long does it take for the substance to break down in the body).

Mary will add Saravanabhavan, Boberg, and Clewell articles to the LibGuide.

A Board member asked what ‘no loss of reproductive function’ is defined as.  Dr. Barter described how the studies are performed.  Reproductive function is measured in terms of number of offspring. Dr. Barter noted two additional articles, Adamson (Finland) and Masatomi, which TURI will obtain.

Can the Board define a group of phthalates for which the reporting policy should be changed?  A Board member suggested C3-C7. A guest representing industry suggested C3-C6.

A Board member noted that all these substances are already listed - this would be a de-listing.  TURI will seek clarification about this from DEP.

Looking at substances outside of C3-C7 – should the Board form workgroups to consider low and high molecular weight substances?

Motion:  As a first step, SAB recommends to DEP a category for phthalate esters include ortho-substituted with side chains with longest straight chain (alkyl run) C3-C6 inclusive.

There was concern with establishing an upper limit of C6.  What about substances of concern that are C7, C8, C9, etc?  Will we be able to consider them promptly?

Motion withdrawn.  Discussion tabled until next meeting.

Next steps
Gather more information for C3-C6, C7-C9.
Gather more information on liver toxicity – what is the mechanism
Further define asymmetric chains
Add additional information about EU risk phrases
Check with DEP legal

Next Meeting
Wednesday, September 25, 12 PM

Handouts (limited copies available):
•    TURI – Ortho Phthalate Esters Scientific Data Sorted by Carbon Chain Length (Excel Sheet)
•    TURI - nPB EHS Summary Sheet (Updated 6/25/13)
•    SLR International Corp. – Comments On The Proposal To Increase The Hazard Ranking for 1-Bromopropane
•    ACGIH – Proposed TLV document
•    ACGIH – Criteria document for TLV
•    NTP – Abstract for technical report 564: ‘Toxicology and Carcinogenesis Studies of 1-Bromopropane (CAS #106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)’