March 30, 2016

Toxics Use Reduction Institute Science Advisory Board Meeting Minutes

March 30, 2016

Massachusetts Department of Environmental Protection – 2nd Floor, 1 Winter Street, Boston

12:30 PM

Members present: David Williams (Chair), Larry Boise (Vice-Chair), Kenneth Weinberg, Christy Foran, Hilary Hackbart, Robin Dodson, Chris Rioux

Members not present: Amy Cannon

Program staff present: Mike Ellenbecker (TURI), Heather Tenney (TURI), Mary Butow (TURI), John Raschko (OTA)

Others present: Trish McCarthy (Coyne PC for ACC), Margaret Gorman (ACC), Tracy Guerrero (SEHSC), Kathy Plotzke (SEHSC), Michelle Andriot (SEHSC), Wendy Koch (SEHSC)

Welcome & Introductions

Program Updates

  • TURA Form S Trainings in May/June: 5/5 Fall River, 5/10 Fitchburg, 5/26 Chicopee, 6/2 Newburyport
  • CE Conference – Chicopee – April 14th
  • Champions of Toxics Use Reduction – June 8th  at the State House
  • Advisory Committee meeting – 5/11
  • Distributed TURI informational materials
    • Grants
    • Peer Mentoring Work Group
    • Conference Agenda for 4/14

Approve November Meeting Minutes

Motion to approve minutes

Vote: 6 in favor, 1 abstention ( DPH member needs to be added to the Administrative Council section)

Approve January Meeting Minutes

Motion to approve minutes

Vote: 5 in favor, 2 abstentions

D5 Discussion

Heather restated the context for the discussion: the SAB is reviewing current information on D5 in order to update the Alternatives Assessment for PERC. Focus areas and member workgroups were identified for three key endpoints: metabolites, effects on dopamine and PBT issues. If, after reviewing this information, any member would like to make a motion to list they may, otherwise information will be used to update the Alternatives Assessment.

Dopamine agonism.

There is still confusion about the effects on dopamine and prolactin.  There are non-specific effects on dopamine signaling through the membrane (cyclic AMP). There is potential for physiological disruption, but it is difficult to determine what that means.  The California OEHHA memo lists potential immune effects that could result from the disruption of dopamine. These could have detrimental consequences, yet there is uncertainty.

Still uncertainty regarding changes in membrane fluidity related to the dopamine signaling pathway (not agonism) could have impacts in mammals at high dose (160 ppm saturated air).

PBT

Program staff reviewed information collected on the persistence and bioaccumulation of D5, with a specific highlight of its persistence in sediment.  The figure in McGoldrick 2015 was highlighted and discussed, noting the levels of D4, D5 and D6 comparable to other known persistent chemicals.  Industry observers confirmed that D4 is less used in personal care products.

There is concern about accumulation of D5 in the lipid tissue of fish, and whether or not it will release over time and/or continue to build, given continuous exposure. Biota levels are generally highest in samples collected close to sources of emission.

It was noted that work has been done in both Canada and the European Union (EU). SEHSC noted that Canada said there was not a risk of danger to the environment from D5 biomagnification or bioaccumulation.  The sampling done by Canada did not specify location. There was discussion of discharge into the Great Lakes; again the exact location of the sampling is unknown.

The EU has designated D5 as vPvB, and recently adopted a restriction on the use of D4 and D5 in wash-off personal care products . SEHSC noted that the EU takes a hazard based approach.

A Board member noted that since it does not tend to biomagnify up the food chain, guidance on best practices for disposal could be provided since it is known to be highly persistent in the environment. There is consensus on the vPvB criteria established by the EU.

SEHSC noted that there has been a monitoring program through partnerships for the last 5 years (e.g. with Environment Canada and the Norwegian Water Institute).

Questions remained as to what was driving the persistence data, e.g. personal care product/individual use? What would the route of exposure be for humans? 

SEHSC noted that they are not seeing a continuous increase, rather there is steady state exposure in the water ways, and the substances are metabolized with many mechanisms for breakdown.  Temperature will affect the breakdown as well. They noted the substance prefers to partition to air vs. organic carbon. Also, they noted the substance is always working to leave fat (even though it is stored there) via the lungs, urine. There is an adaptive response of liver to metabolism.

Metabolites

Mary reviewed the one page handout on metabolites and the EHS data that was collected for them and also read Tsedash’s comments regarding the biotransformation of D5 (Pathway image from Dekant and Klaunig). Given the data, it was noted that it is highly likely the demethylation product is formic acid, which would further metabolize to CO2 and water. This allays the previous concern about methanol as a metabolite in the initial step of D5 metabolism. Since it is not clear if the removed methyl groups yield formic acid, methanol, or formaldehyde and currently there is no evidence of teratogenicity in rodent studies for D4/D5, this remains a data gap and should just be indicated as an uncertainty in the current evaluation.

Repro/Developmental effects

This was not an endpoint that was specifically assigned to a group for this meeting.  The Alternatives Assessment currently notes that “studies indicate concern”.  SEHSC noted limited concern with this endpoint in the Siddiqui study.  It was noted that the Green Screen summary for this endpoint did note effects: male pups in the F1 generation showed increased AGD at 160 ppm. The Green Screen also noted that AGD is typically decreased in studies of substances with reproductive concern. The Green Screen scored [reproductive/developmental effects] moderate based on lack of evidence. Low confidence in the study was listed as well.

SEHSC noted that there is an avian reproductive study as well.  It is currently unpublished but they can provide it.

Board Summary Notes:

Persistence: H2O (L); Soil (M); Sediment and Air (H). 

Bioaccumulation: Bioaccumulates, does not tend to biomagnify (>1 reported in some field studies)

Aquatic Toxicity: Does not exhibit aquatic toxicity up to its solubility limit.

Carcinogenicity: Positive animal study (1); F344 prone to uterine carcinoma

Reproductive/Developmental: ↑ AGD at 160 ppm F1 generation only in male rat (One 2nd generation study) Siddiqui 2007 provided by industry (#51 in their D5 Safety Overview)

Endocrine: Still concern/uncertainty regarding changes in membrane fluidity related to dopamine signal pathway (not agonism). Could have impacts in mammals at high dose (160 ppm saturated air)

**Also noted: use best practices for disposal, D5 is not a hazardous waste

D4 New Information

The D4 Safety overview from SEHSC was handed out and is on the LibGuide. Studies referenced in the safety overview are on the LibGuide as well.  Additional information from the literature search will be added to the Lib Guide for the next meeting. Endpoint assignments to the Board will be similar to D5 (PBT, metabolites, estrogenicity) .  Metabolites research so far has shown dimethylsilanediol has toxicity data from TSCA submissions. Our goal will be to complete the D4 discussion next time.

Upcoming SAB items

A call for information has gone out to various stakeholders on Dibutoxymethane, the main component of  Solvon K4 (an alternative dry cleaning solvent).  The Board will begin discussion of Dibutoxymethane in May with the intent to update the table in the perc alternatives assessment, similar to D5. A Green Screen for Dibutoxymethane was distributed.

Next Meeting

Wednesday, May 18th, 12:30pm, location TBA

Handouts (italicized = limited copies available)

OEHHA 2009: Bhatia, SD. Comments on Human Health and Environmental Hazards for “Green Earth®”, November 5, 2009, pages 3-6.

D5 Safety Overview (SEHSC)

Summary of information on D4/D5 PBT

Summary of information on D4/D5 Metabolites

D4 Safety Overview (SEHSC)

GreenScreenTM for D5

GreenScreenTM for Dibutoxymethane (Solvon K4)