May 19, 2020
Toxics Use Reduction Institute Science Advisory Board Meeting Minutes
May 19, 2020
Virtual Zoom Meeting
Members Present: Robin Dodson (Vice Chair), Hilary Hackbart, Wendy Heiger-Bernays, Christy Foran, Christine Rioux, Heather Lynch, Denise Kmetzo, Rich Gurney
Members not present: Amy Cannon, Ken Weinberg, Dave Williams
Program staff present: Liz Harriman (TURI), Heather Tenney (TURI), Hayley Byra (TURI), Pam Eliason (TURI), Rachel Massey (TURI), Gregory Morose (TURI), John Raschko (OTA), Hardiesse Dicka-Bessonneau (MassDEP), Tiffany Skogstrom (OTA)
Others present: Katherine Robertson (MCTA), Steve Korzeniowski (Fluorocouncil/ACC), Carol Holahan (Foley Hoag ACC), Trisha McCarthy (Coyne PC for ACC), Erin Dickinson (ACC), Margaret Gorman (ACC), Harry Hechehouche (ACC), Kuper Jones (ACC), Erin DeSantis (ACC), Jay West (ACC), James Dunbar (MCTA via O’Neill and Associates)
Welcome & Introductions
Each name or phone number showing on Zoom was called out and all attendees introduced themselves and their association. Visitors were asked to then mute and use the chat function thereafter.
TURA Program Updates
- Due to the pandemic, TURA program staff are working remotely at this point. The TURI Spring Continuing Education Conference was held virtually, and you can view presentations on the TURI website.
- Due to the COVID-19 pandemic, companies have up to 90 days after the state of emergency is lifted to file a TURA report.
- Cleaning and disinfecting information is available on the TURI website.
- There were some recent changes to the TURA program staff. Rich Bizzozero, Director of OTA and Executive Director for the Administrative Council, has retired. Tiffany Skogstrom is now Acting Director/Executive Director. Andrea Lynch, Learning and Information Specialist at TURI has departed for another opportunity.
- TURI has several new publications: Assessment and Effective Alternatives for Coating Removal Products and a Fact Sheet on NaDCC Disinfection Tablets.
- New reportable substances under TRI for reportable year 2020 were mentioned. The National Defense Authorization Act 2020 PFAS TRI Listing. EPA has identified 172 PFAS chemicals that will be added to TRI/federal reporting for 2020 reporting year, as required in the NDAA 2020 legislation.
Approve January Minutes
A motion was made to approve the January minutes with the addition of page numbers. The motion was seconded and a roll call vote was taken. The minutes were unanimously approved.
PFAS: Final Category Discussions
Heather provided an overview of the SAB’s work on PFAS that began in the fall of 2016. Since then they have reviewed 12 individual PFAS and made recommendations to list 11 of them. The SAB looked at many other resources including the OECD 2018 report and database of 4700+ PFAS. During the last several meetings the SAB noted that it was no longer practical to consider individual PFAS given the diminishing amount of information available for further PFAS and the number of PFAS in existence. The Board previously noted that similar hazards would be expected in other PFAAs in the group. The Board also reviewed degradation and transformation of a range of PFAA precursors, building on the presentation in January of 2018 by the Fluorocouncil.
In addition to the listing recommendations of the 11 PFAS, a 12th substance (ADONA) was reviewed. The SAB found that the information was insufficient to arrive at an individual chemical listing decision on this substance. It became clear in this process that it would be more productive to shift to consideration of a broader class of PFAS, drawing on the lessons from the individual chemical reviews. The TURA Program sought scientific input regarding additional PFAS that are similar to or are precursors to the PFAS reviewed by the SAB.
At the last SAB meeting in January, a group of PFAAs and Precursors as defined by OECD, were discussed. Some board members felt that ‘PFAAs and Precursors’ wasn’t comprehensive enough (i.e. there are additional PFAS that this group would not encompass) and some members felt that ‘PFAAs and Precursors’ was too broad (i.e. perhaps there are PFAS that are safer than others). To assist with the board’s deliberations, several information summaries were added to the LibGuide:
- PFAS – Selected Definitions
- Ultra-short Chain PFAS
- Thermal Degradation of Fluoropolymers
- Category Considerations
- OECD PFAS with EPA Info spreadsheet
In addition, at our January meeting, other groups known to be doing work on the grouping of PFAS were identified. An OECD working group and SETAC were specifically identified. TURI has continued to be in contact with members of these groups and no new publications are available at this time.
It was also noted that other regulatory programs have developed regulations regarding contaminated drinking water supplies and sites. Addition of a substance to the TURA reporting list is based on hazard (not risk levels) and requires reporting, developing a TUR plan to assess and reduce toxics use, and paying TURA fees; it does not restrict the use of the substances.
The information summaries were then reviewed:
PFAS - Selected Definitions: This background document summarizes PFAS definitions being used by OECD and EPA, and those set out in the seminal Buck, et al 2011 paper. The SAB has primarily used the OECD schematic and database, as it is the most comprehensive and internationally recognized work to date. OECD gathered as many chemicals and CAS numbers as possible, organizing them into eight structural categories and then further into numerous subcategories. While they have used a PFAS definition based on Buck, et al, of at least one fully fluorinated carbon, they focused their database efforts on substances with at least 3 fluorinated carbons and at least 2 for the ethers, as a lower bound. The Buck et al 2011, focused on how to define PFAS and provides a definition that anything with one fully fluorinated carbon (CF3) is in the PFAS category. EPA does not have a clear PFAS definition, however, the National Defense Authorization Act, which mandated that EPA add a set of long chain substances to TRI, establishes a definition for that subset, and also refers to previous Significant New Use Rules by EPA. The NDAA added GenX and long chain PFAS, their salts and precursors to TRI. A Fluorocouncil representative noted that the OECD definition is currently under review by an international working group, however a revised definition is not yet available.
Ultra-Short Chain PFAS: TURI reviewed the available information on ultra-short chain perfluorinated substances. Substances are considered ultra-short when they have a 1-3 carbon chain length. Many ultra-short PFAS remain unknown or unidentified as they may be manufacturing byproducts or have proprietary information or analytical detection challenges. The few available studies conclude that ultra-short-chain PFAAs are frequently found in the environment and are present at high concentrations in water connected to point sources such as sites where AFFFs are used, landfills, and hazardous waste management facilities. In general, less is known about the toxicity of ultra-short-chain PFAAs. Some studies have reported toxicity of trifluoroacetic acid (TFA) to aquatic organisms. Ultra-short chain PFAS are highly mobile in the environment because of high solubility in water and poor adsorption to organic matter. They are expected to be highly persistent, and continued emissions will result in environmental accumulation, leading to increased human external exposure. A Fluorocouncil representative indicated that these substances do not work in the end use products such as AFFF and no one is currently trying to use them in those applications.
Thermal degradation of fluoropolymers: Questions have come up at past meetings about thermal degradation in manufacturing/processing and in end of life incineration, particularly around fluoropolymers, which are often not susceptible to the degradation/transformation pathways previously examined by the board. A few key documents are referenced in the summary and were discussed. Elis, et al 2001, Thermolysis of Fluoropolymers as a Potential Source of Halogenated Organic Acids in the Environment described measured degradation products in the lab at various temperatures, and proposed decomposition pathways. It was noted that the Elis, et al project was not high temperature incineration (360 C and 500 C). They were not trying to incinerate to mineralization, but were looking to see what might occur during processing temperatures or high temperature uses of commercial products. Substances such as trifluoracetate, chlorodifluoroacetate, and HFP and carboxylic acids (minor product) were found to be breakdown products. In the handout summary, note that highlighted text was highlighted by the program staff and not by the author.
Excerpts from The Guide to Safe Handling of Fluoropolymer Resins summarize information about fluoropolymer breakdown by thermal decomposition during processing. The safe handling guide is helpful to companies to know about potential exposure and proper protection and ventilation. Fluoropolymers have high melting temperatures, which is a desirable performance property, but thus requires high extrusion and processing temperatures. The guide notes decomposition products at various temperatures, with initial decomposition beginning at or below melting/softening temperatures, and more significant decomposition just above typical processing temperatures.
Decomposition products include PFIB and TFE, which both have significant hazards of their own, and fluoroalkenes, which OECD notes are PFAA precursors. Polymer fume fever is a widely recognized health effect that results from exposure to fluoropolymer decomposition products. Excerpts from two other papers were also noted in the summary, one a paper studying pyrolysis products of PTFE and PFEP at and above processing temperatures, and the other a study of thermolysis products of a commonly used Nafion (perfluorosulfonic acid) membrane.
A board member had a question about whether this information was intended for manufacturers or for the board. A representative from the TURA program stated, both. We have had questions from TUR planners, wondering about off gassing of chemicals in their facilities and the potential hazards of degradation products.
A Fluorocouncil representative suggested that this team look at the current Fluoropolymer handbook that was issued last year as well as the Henry et al Fluoropolymer Degradation paper which was not included in the current LibGuide. The representative emphasized the inertness of fluoropolymers if handled properly while agreeing that under some conditions they do break down.
Chemical Category Considerations: TURI reviewed this background information for general considerations for categories, with examples from TRI. Rationales for listing categories include similarities in chemical structure, precursors, cumulative effects, large groups in which not every chemical can be reviewed, CAS number limitations and mixtures. Categories can be defined by structure, structure with limitations, structure “NOL”, and delimited. A big picture goal for the TURA program is avoiding regrettable substitution. The program also wants to make it as easy as possible for companies to understand their reporting obligations.
OECD Document: The OECD spreadsheet consisted of 2 tabs, the first listed all the substances and indicated which would be included using a criteria of “PFAAs and Precursors” as defined by OECD. PFAAs are in red text, precursors are in orange text, and the substances that would be excluded (as neither a PFAA or precursor) are in black text. TURI matched this list of substances with other EPA lists so board members could get an idea of what substances might be in use and have an idea of whether substances in use would be captured under the current or revised definitions. The second sheet summarizes the OECD PFAA and precursor information by PFAS subcategory.
A board member supported using OECD as a reference point, noting that their database covers the most substances and is a great body of work that provides so much information and a well written methodology report.
The goals of the meeting were restated and discussion was opened up to the Board. How should a PFAS group be defined? Are there substances there is concern for that are not included in ‘PFAAs and PFAA precursors’ or alternatively are there PFAS that are on the ‘PFAA and PFAA precursor’ list that are not of concern?
A board member shared their chemistry perspective and insight on degradation pathways of chemicals that would not be included if the 89% of the OECD list was recommended (PFAAs and PFAA precursors). The board member specifically mentioned non-highlighted compounds on the list, structures (line items 3507-3526) straight chained C5,6,7,8,9 perfluorinated hydrocarbons. Referencing Joudan 2017 from slide 5 in the Degradation and Transformation slide deck, those substances could very well fall within those degradation pathways, via photolysis and oxidation, and asked if those should also be included.
Another member stated that they were hesitant about large categories and noted that there is evidence and reason to pause and consider that we might be missing some hazardous substances. There was discussion on metabolites and different pathways of degradation. Program staff noted that we examined different degradation pathways, and that was documented in the Degradation and Transformation slides. This was a broad set of examples of how various substances break down. Evidence was found that some PFAS do break down, and degrade to other substances that may not be included in the 89% of the OECD list. Fully fluorinated chemicals still pose concern regarding whether they would breakdown or not. Concerns were expressed around chemicals that may be considered essential.
Using the OECD list, ultra-short chains would not be included. The board was interested to learn about them and thought it was important to note that they exist, but perhaps from a TURA reporting perspective, they are not as important. Analytical challenges exist and knowledge about the actual hazards are really limited. The board would still like to see the forthcoming SETAC document. Concern was expressed about putting too much into a category - if we include too much it may not be ultimately helpful.
A board member posed the question of how you set up a system to deal with the release of chemicals in a way that the regulated community knows what to expect? We don’t have a method to measure every single analyte. Methods are available to measure groups. The member noted that they remain concerned about the polymers and whether we would capture them in the existing list.
A TURA program representative explained that it doesn’t take much to cause contamination with these chemicals and PFAS are tricky where they can be such a small contaminant and not listed on a safety data sheet. An example was discussed where small amounts of a PFAS chemical were present in a PTFE aqueous emulsion and the company had been emitting it for a while and likely did not realize the processing aids were present and being released. PFAS are not well regulated and often not listed at all. The goal is to help companies not make those costly mistakes. From a prevention stand point we want to be ahead of that.
A board member asked how many companies would possibly be affected by the listing. Millions of people in Massachusetts would be affected in comparison to the consequences to companies if they were to be listed. A TURA program representative explained that it is unclear at this time but we are estimating, based on very limited information, that 25-50 companies could be affected.
A member expressed that they were comfortable with the PFAAs and precursors on the OECD list which covers the majority, and were also comfortable excluding ultra short chains. Another member agreed that the PFAAs and precursors covered most everything, although a few of the excluded substances, e.g., ethers, need to be added back in.
The board discussed whether a definition of the category or a chemical/CAS list would be more helpful. Issues with a list include CBI (confidential business information) substances that are not included and new CAS numbers being developed, whereas a definition can be difficult for a non-chemist in terms of identifying chemicals.
Another member stated that they agree with going broader than just the OECD list. They like the structure and definition approach. Consistency is important and it makes sense to include a definition either way.
The Board discussed the desire to get it perfect versus getting the best recommendation possible made with the information available now. It is possible for delistings if necessary in the future. Many members advocated for a definition approach versus the list. OECD addresses limitations that exist due to confidential business information, lack of CAS numbers, and molecular structures behind the scenes.
A representative from the TURA program explained that when they were deciding on how to organize the C1-C4 halogenated hydrocarbons/halocarbons NOL category they defined it structurally and then also provided a list of substances as guidance. It was suggested that companies would most likely still be pointed to the OECD list if it was decided to just go with a definition.
A member stated a concern about using a definition and to be careful about generalizing it to anything with fluorine or a fluorocarbon, it might be necessary to bump the definition up to perfluorocarbons. The member noted that many pharma and drug related substances have fluorine. It was noted that we are looking at more than just perfluorinated, we are still concerned about polyfluorinated.
Many of the board members expressed their confidence in a definition rather than a list. Some clarity is needed including guidance for industry in addition to just a definition. A member stated that if we pick a list and use it, the list is going to change. How do we address that?
A newer member stated that they were confident in C5-C12, as there is much less literature on C4 and below. A TURA representative explained that the board evaluated and made decisions on C4 substances about a year and a half ago. C4 (PFBA and PFBS) has been covered by the board, but not below that. The possibility of making a more firm statement on C4 and above was proposed.
The discussion was extended until the next meeting, but an informal poll was conducted to determine who was in favor of a definition approach. All members were in favor of further discussing a definition approach moving forward.
For the sake of time, the future work agenda item was skipped.
It was suggested that the SAB have another meeting in the next month. It is necessary to assess how the meeting went virtually, and ways to improve moving forward as it does not look like there will be in-person public meetings any time soon. Consensus among the board was that a virtual meeting would be better than waiting. The board would like to schedule the meeting for the earlier side of June and Heather will follow up with members to pick a date. The chat will be added to the minutes.
All handout documents listed below were provided electronically to all attendees prior to the meeting.
- TURA Program Update
- SAB Remote Meeting Ground Rules
- Final PFAS Degradation/Transformation Examples
- Category Considerations Document
- Draft PFAS Policy Analysis January 2020
- Draft January SAB Minutes
- TURI Summary of Fluoropolymer Aqueous Emulsions
- OECD Spreadsheet with EPA Info
- TURI Summary of PFAS in Landfill Leachate
- TURI Summary of Ultra-Short Substances
- TURI Summary of Thermal Degradation of Fluoropolymers
- TURI Summary of Selected PFAS Definitions
- Patlewicz et al. 2019 A Chemical Category-Based Prioritization Approach for Selecting 75 Per- and Polyfluoroalkyl Substances (PFAS) for Tiered Toxicity and Toxicokinetic Testing, Environmental Health Perspectives, Volume 127, No. 1, https://doi.org/10.1289/EHP4555
Chat Box Conversation
TURA Representative: Thank you for joining. The SAB meeting begins at 1:00.
TURA Representative: Please feel free to pose questions or comments here in the chat function
Visitor: These categories and groupings and classifications are under current discussions by the OECD/PFC workgroup.
TURA Representative: Thank you for sharing
Visitor: Are all of the SAB Members able to see comments and will there be a pause in between presentations for SAB to address or ask questions of comments provided by guests?
Visitor: can you please identify the title of the document?
TURA Representative: PFAS Definitions
TURA Representative: Now moving on to Ultra-Short PFAS Info doc
Visitor: The short chains do not work in current end-use categories and no one is trying to do that.
TURA Representative: Now moving on to Thermal degradation of fluoropolymers summary
Visitor: Is there an opportunity for guests to provide oral comment as follow up? For example, Visitor may need to address the recent oral comment through microphone and not chat.
Visitor: This team should look at the current Fluoropolymer handbook as well as the Henry et al Fluoropolymer Degradation paper which was not included in your lib guide.
TURA Representative: We will stop to ask for discussion.
Visitor: The issue with this publication (Mabury et al) is the relevance to normal use temperatures by fluoropolymers
Visitor: I would like to make some comments
TURA Representative: We will invite you to comment shortly
SAB Member: Disclaimer for the Henry et al. paper. BJ Henry, JP Carlin, and JA Hammerschmidt are employees of W.L. Gore, a global manufacturer of products made with fluoropolymers. W.L. Gore & Associates, Inc., the Chemours Company, and the MTM Research Centre School of Science and Technology, Örebro University, Örebro, Sweden donated data and employee time to support this work
SAB Member: Henry paper is on 3/27/19 LibGuide
TURA Representative: Now looking at OECD PFAS with EPA Info spreadsheet
Visitor: A large number of the OECD list compounds are no longer being made by US and other Stewardship companies
TURA Representative: now looking at Chemical Categories Overview document
Visitor: Our SETAC FTM Manuscript will have a substantive section on grouping as I noted previously.
TURA Representative: Thanks, re OECD list - yes OECD gathered chemicals and CAS numbers from many entities, and many are no longer, or were never, in commercial production. Helpful to look at Heather's first page where EPA TSCA is noted
Visitor: The EPA TSCA list only has 600 compounds on it.
Visitor: Discussing 600's which are PF alkanes and alkenes, some of which could degrade to PFAAs depending on structures
Visitor: The analytical methods and technology do not exist for many of the normal targeted compounds people study.
Visitor: Our SETAC document will address the current analytical challenges with PFAS.
Visitor: Most lists are 30 or so targeted analytes and are matrix dependent
Visitor: How do you plan to measure the 85% of the OECD list when methods do not exist? How will customers do this? There seem to be practical considerations that should be considered.
Visitor: The FDA will regulate the pharma materials and all their breakdown products
Visitor: in light of the importance of this issue to ACC, its members and other stakeholders, as well as the significant ramifications of the vote, and the likelihood additional relevant information will soon be available, would the Board please consider delaying this vote until social distancing and other pandemic-related restrictions are lifted? A vote of this importance should involve robust scientific debate that is not and cannot adequately occur via a Zoom meeting.
Visitor: The definition is in a state of flux by Cousins, Wang et al in OECD
Visitor: Also, will the Board please make sure that the "chat" comments are copied and included as a part of the formal record of this meeting?
TURA Representative: Yes, the chat will be captured
Visitor: Most FP's are regarded as inert and not water soluble and do not biodegrade
Visitor: I am going to have to jump off for other meeting. I echo previous comments. I would like further clarification on how one could "delist" a chemistry once it is listed if its listing is based on the possibility of toxicity.