January 10, 2018

   Toxics Use Reduction Institute Science Advisory Board Meeting Minutes

January 10, 2018

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

12:00 PM

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

Members not present: Amy Cannon, Denise Kmetzo, Ken Weinberg

Program staff present: Liz Harriman (TURI), Heather Tenney (TURI), John Raschko (OTA), Tsedash Zewdie (DEP), Mary Butow (TURI)

Others present: Patricia McCarthy (Coyne Legislative Services for ACC), Katherine Robertson (MCTA), Steve Rosario (ACC – New England), Jessica Bowman (ACC/FluoroCouncil), Steve Korzeniowski (ACC/FluoroCouncil), Ruthann Rudel (Silent Spring), Elisa Jazan (Tufts), Natalie Banacos (Boston University School of Public Health)

Welcome and Introductions

Program Updates

  • TURI is moving to Boott Mills in Lowell
  • Resource Conservation Planning Day 1 and 2 – Feb 5, 12 – will be at TURI’s new location.
  • February 27, 2018 - WEBINAR: Artificial Turf Alternatives
  • April 25, 2018 - Spring 2018 TURA Continuing Education Conference
  • OTA and TURI are conducting a nanomaterials survey of Massachusetts companies – Please encourage companies to participate. An OTA letter of invitation was distributed, and the link to the survey is: https://umasslowell.co1.qualtrics.com/jfe/form/SV_cO836sayokSXzNP.
  • The Mass.gov website has been updated.

December Minutes

 December minutes were approved, 6 in favor and one abstention.

PFAS Discussion

PFBA: The Board started with PFBA as this substance had not been discussed in the previous meeting.  A member noted that there was some neurotoxicity data but it was limited.

With regard to reproductive and developmental toxicity, Das 2008 showed some effects, mostly at the higher doses tested. It was noted that eye opening was delayed at all doses, and puberty was delayed at 175 and 350 mg/kg/day.  For genotoxicity, no effect was observed in one male rat study.

For endocrine/thyroid effects, decreased T4 levels and increased thyroid weight were noted. It was noted to check if neurodevelopment was evaluated. In a couple of studies it appeared that males were more sensitive.  It was also noted that there was a reduction in cholesterol (so there might be secondary lipid effects). 

There was discussion around PPAR alpha activity and its relevance to humans. The representative from the FluoroCouncil suggested it is a subject for further discussion. A Board member noted that PPAR alpha is a therapeutics direct target. An NIH study, Lu and Chang article addresses PPAR alpha relevance in humans -they will share that study. There was also discussion about PPAR gamma and its relevance to humans. It was noted that PPAR gamma is a master regulator of nuclear receptors and ligands and PPAR alpha is also an important regulator and affects steroid production. It was noted that Foreman 2009 shows effects in both wild-type mice and PPAR alpha humanized mice, but not PPAR alpha null mice.  

A question was asked if low dose studies are available and if there was further information on what constitutes a low dose in an animal study relative to humans. It was noted that the toxicokinetics are very different in animals versus humans. Biological half-lives are shorter in animals.

With regard to neurotoxicity and low doses, a Board member noted evidence of a biphasic dose response for PFBS and PFHxA. A Board member noted that a study shouldn’t automatically be eliminated if there is no evidence of linear dose response. If the study is consistent with effects seen, it shouldn’t be discounted if it is not seen at high doses, rather it should be evaluated to see if there is some reason to be concerned. All of the substances considered so far have shown non-linear dose responses (e.g. in some studies an effect is only seen at a low dose, and not at a higher dose, or the effect is seen at an intermediate dose). This is particularly important if changes are seen in hormone levels at low doses. The member noted it would be worth having a conversation about studies that do not demonstrate a typical linear dose response, and that kinetics and life stage should also be considered when evaluating these studies.

With regard to other organ toxicity – some effects were seen on red blood cells at lower doses (30 mg/kg/day) (Butenhoff 2009; Van Otterdijk 2007b).

In response to a question about corrosivity, a representative from the FluoroCouncil confirmed that these are all very strong acids and all chain lengths are very corrosive. This information will be added to EHS summaries under skin/eye/respiratory effects (if not already indicated).

Another note regarding toxicokinetics – the Perez study notes that PFBA behaves differently in animals than humans. Industry reiterated their concerns with the Perez study.  The study analyzed organs of cadavers to determine which PFAS concentrated in which tissues. Industry noted that they are not currently doing a cadaver study as it is not easy to get cadavers. However, the Department of Defense is initiating a very large biomonitoring study that will consider blood/serum and health effects, specifically considering how the substances are affecting these populations. A visitor noted it is important to look at clearance (as shown in Gannon).  A Board member noted that it may have to be inferred or measured as a function of biomonitoring studies.

Regarding presence in the environment and bioaccumulation, PFBA has been widely measured in ground and surface water, and was measured in home produced eggs at a fenceline community in China. Professor Chris Higgins with the Colorado School of Mines, is a researcher on PFAS contamination in the environment. The FluoroCouncil representative suggested reaching out to him.   

A visitor noted that PFBA is a byproduct of PFBS manufacture. A member inquired about the trajectory of manufacture for PFBS. The FluoroCouncil noted that the company 3M, moved toward PFBS in 2002, but they weren’t positive what markets they were in or if 3M still manufactured PFBS.  They confirmed that PFBS is currently manufactured in U.S. and elsewhere.

A Board member questioned where the foods in the Lorenzo Spanish study were grown (measured PFAS in baby food, dry cereal and formula). PFBA’s presence was noted in biota, breast milk, infant formula, dry cereal, and baby food pots.  It was noted that there are many biomonitoring studies coming out of China.

A Board member noted the Minnesota Department of Health drinking water guideline for PFBA (MN DPH 2011a) is based on liver weight changes, decreased T4, decreased red blood cell hematocrit and hemoglobin.  As drinking water contaminants, shorter chain PFAS are known to be particularly difficult to remove.

It was noted that long range transport of FTOH leads to breakdown to PFBA. 6,2-FTOH was noted as a volatile precursor of PFBA (Wang 2014). PFBA was noted to be persistent, measured in the environment (surface and ground water) yet there is not a lot of bioaccumulation in fish. PFBA has been shown to phytoaccumulate, e.g., in a study of lettuce and strawberry crops PFBA and PFPeA accumulated in edible portions more than other PFAS (Blaine 2014).

PFBA – Board summary of concerns:

  • Persistence
  • Very mobile – potential for long range transport
  • Thyroid effects
  • Liver effects
  • Endocrine effects
  • Hematological
  • Developmental effects
  • Corrosivity
  • Bioaccumulation - phytoaccumulation (plant uptake)
  • Widespread presence in serum and breast milk (can come from continuous exposure from our built environment/products, water, environment and other sources or from bioaccumulation)
  • Long half-life in humans, with some uncertainty re: toxicokinetics

A discussion followed with visitors posing questions and commenting on the process, and board members and program staff clarifying the process and objectives.  Points covered included:

  • TURA includes protection of the environment and wildlife as well as human health
  • TURA focus on inherent hazard vs. risk assessment
  • SAB focus on scientific considerations around environmental and health effects, while policy issues (such as use, existence of safer alternatives, etc.) are covered by TURI and the Advisory Committee.
  • Current concerns by states and the public about PFAS in drinking water, difficulty in removing them, and movement by authoritative bodies to regulate these chemicals
  • When considering a substance for listing, the SAB is looking for health and environmental concerns. This is not a weight of evidence approach, however a thorough literature review is conducted and both positive and negative studies are considered.
  • TURA doesn’t set standards or restrict chemical use in any way, it just requires reporting and planning.
  • Concerns about interpretation of animal studies given the longer half-lives in humans
  • Would extreme persistence be considered an “other” effect under the SAB decision process?

There was significant input from observers in the meeting and the Board discussed their process and timing for feedback from observers. Visitor input should not occur after a motion has been made, in order to allow adequate time and focus for Board discussion.  Outside visitors wanting to comment when a motion is not on the floor, must raise their hand and can be recognized by the chair.

The Board discussed how to proceed now that they had reviewed PFBA, PFBS, PFHxS and PFHxA.  There was discussion about voting on PFBA or a category. It was noted that a step wise process was also possible, e.g. voting now on PFBA and amending the recommendation later to add salts or other precursors.  Another approach mentioned was to consider classes, for example by carbon chain length. A visitor noted that if a distinction is made between “short chain” and “long chain”, PFHxS is considered long chain.

The Board chose to make a list of concerns for each of the 4 substances and then ask others to comment for the next meeting. It was made clear that this is not a comprehensive weight-of-evidence process, but rather a review of the evidence to identify concerns.

Motion: Move that Board completes table on whiteboard for 4 chemicals, notes endpoints where Board has concerns, that document will be available for public/stakeholders. Then at the next meeting put forward motions to list or not list. Motion was seconded, vote in favor was unanimous. A list of concerns for PFBA was generated by the Board, and was then made into a table where similar lists of concerns for PFBS, PFHxS and PFHxA were recorded.

TURI requested that the Board provide any additions or edits to the January 10th draft EHS summaries; members of the public are also welcome to comment.  Parties are also invited to comment on the list of concerns generated by the Board at this meeting.  All comments should provide specific scientific information; if studies not already on the bibliography are referenced, the study should be provided.

A Board member noted that it will be difficult to go through the comments quickly at the next meeting, if many are submitted and all comments are discussed, or if they are seeing material for the first time. TURI will provide the information for comment well before the next meeting. The deadline for comments will be two weeks before the meeting and comments will be distributed to the Board at that time. A screenshot of the SAB Lib Guide will be available for all stakeholders. TURI noted that while the Board has elected to put their list of concerns out for feedback from stakeholders, this is not a standard process for the SAB.

A FluoroCouncil representative re-iterated that PFHxS is considered a “long-chain” chemical, while PFBA, PFBS, and PFHxA are considered “short-chain” chemicals.

Next Meeting

March 7, 2018

Handouts

Draft PFBA EHS Summary

Draft PFHxA EHS Summary

Draft PFBS EHS Summary

Note: Information was posted on 4/12/18.