Legislative/Regulatory Affairs Committee Draft Minutes
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MI BOD 3/23/2018 Linked Docs - Leg/Reg Committee Call Minutes Legislative/Regulatory Affairs Committee Draft Minutes Thursday 1 March 2018 Steffen Erler, SABIC (Chairman) Mari Veldekens, Southern Chemical (Vice Chair) Meg Mahoney, Methanex Christen Downie, Methanex Daphne Ferguson, Enerkem Joe Rosso, SCC Chris Chatterton, MI Dom LaVigne, MI Larry Navin, MI Kai Zhao, MI I. REVIEW DRAFT MINUTES OF THE 27 SEPTEMBER 2017 CONFERENCE CALL The Committee reviewed the draft minutes of the 27 September call, which were approved as sent. II. CANADA ACTIVITIES i. Health Canada Methanol Assessment Discussion The Canadian Government is conducting a two-part risk assessment review of methanol though Environment Canada, and Health Canada. The Environment Canada portion of the review has already been concluded and methanol was found to be a substance which causes a “lower relative risk to the environment,” which was the best possible outcome and is the lowest risk category that methanol could have been assigned to. In September 2016, MI prepared and submitted comments to Environment Canada introducing MI to Canadian regulators as the voice of the global methanol industry and a potential partner to them going forward. The second component of the review is a risk assessment for human health which is being conducted by Health Canada. MI first met with Health Canada in November 2016, and has since been working to coordinate their access to the REACH Methanol Dossier to aid in their assessment. Most recently, as Steffen Erler detailed, on February 13, 2018, Greg Dolan of MI, Steffen Erler of SABIC, and Jody Magill of Methanex, along with Scott Thurlow of the Chemistry Industry Association of Canada, and Shannon Coombs of the Canadian Consumer Specialty Products Association (CCSPA) met with Health Canada’s Risk evaluation team in Ottawa, Canada to share information related to Health Canada’s assessment and learn about the timeline under which Health Canada is operating for release of the 1 1 MI BOD 3/23/2018 Linked Docs - Leg/Reg Committee Call Minutes assessment. Through this meeting MI learned that Health Canada’s Draft Methanol Risk Assessment will most likely be published in the third or fourth quarter of 2018 (the methanol assessment is being grouped with 29 other alcohols which will be published together as a group). Also learned through the meeting is that there is some, though a relatively low risk, of methanol being designated as CEPA Toxic, a definition based on risk assessment, not hazard. Health Canada’s use of a REACH DNEL of 8mg/kg bw/d rather than the US IRIS reference dose of 2 mg/kg bw/d is more likely to result in a positive outcome for methanol. Also, meeting participants were learned that Health Canada has no overall or specific concerns regarding product misuse in Canada. Additionally, Steffen noted that MI has contacted an outside consultant to provide PBPK modeling scenarios that can be shared with Health Canada to lessen the likelihood of methanol receiving a CEPA Toxic designation. The committee has $10,000 budgeted for potential consultant resources related to the Health Canada assessment which should be sufficient to cover the needed work. Action Items: (1) MI to continue to engage with Health Canada. (2) MI to contract consultant to provide PBPK modeling data to share with Health Canada. III. POLISH METHANOL CONSUMER PRODUCT RESTRICTION The European Chemical Agency’s (ECHA) Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) reviewed the Polish proposal to limit the amount of methanol in windshield wash fluid and denatured alcohol sold in the EU to no more than 3% by volume. Following its initial review, the RAC proposed setting the restriction limit to no more than 0.6% by volume of methanol in both windshield wash fluid and denatured alcohol, and used limited citations in finding that the use of bitterants was not a suitable alternative risk management option. The SEAC supported the lower restriction on windshield wash fluid, but excluded any restriction for denatured alcohol. The Methanol REACH Consortium believes that the restriction is too low and does not adequately reflect the current science. The consortium had a socio- economic analysis prepared by TNO Triskelion which was submitted as part of the public consultation. Methanol Institute also submitted comments to the SEAC public consultation. Unfortunately, the SEAC adopted an opinion to restrict methanol in windshield wash to 0.6%, though with four member-state representatives dissenting; the United Kingdom, Belgium, Portugal and Slovenia. The RAC and SEAC opinions have been forwarded to the European Commission which formalizes the addition of substance restrictions to Annex XV of the EU’s REACH law, via a process of review by the EU Council REACH Committee, and then a European Parliament committee. Once final text of a restriction is agreed upon, the restriction would be published in the Official Journal of the EU. MI has engaged repeatedly with the Commission, including directly sending individual member state REACH Committee members communications outlining our objections to the restriction. In November, 2017, MI learned that the REACH Committee had adopted the restriction at their 25 October meeting. The restriction passed very narrowly by a vote of 68% through the qualified majority voting system. A threshold of 65% is necessary for passage. Following this vote MI put out a press release again detailing our objections to the restriction, and reached out to European Commission members. Steffen noted that we are now waiting to see if the EU will indeed adopt the restriction. Larry added that the ECHA website still lists the restriction as a pending matter, and that the final regulation will need to be signed by EU Commissioners and published in the Official Journal of the EU in order to take effect. Should that happen, a one-year transition period will commence before the regulation takes full effect. 2 2 MI BOD 3/23/2018 Linked Docs - Leg/Reg Committee Call Minutes Steffen noted that MI should prepare a press release again detailing our objections to the restriction should it come into force. Action Items: 1) MI staff to continue to monitor EU sources and publications to determine if the restriction is implemented. 2) MI staff to prepare a press release to respond to implementation of the restriction. IV. AP/ME ACTIVITIES i. Korea MI had filed a submission with the Korean Agency for Technology & Standards (KATS) on April 28, 2017 expressing concerns about proposed revisions to a Korea windshield wiper fluid (WWF) standard. The proposed, revised standard would mandate nearly 100% ethanol content, while mitigating methanol in WWF to 0.6%. This standard was proposed in light of inaccurate TV/media reporting and anecdotal Korean consumer concerns about health risks from inhalation of methanol-based WWF. KATS did not accede to MI staff’s request for a meeting, and indicated that MI should follow-up with the Ministry of Environment (MoE), to whom KATS would send the standard for implementation. KATS sent the standard to MoE’s Chemical Products & Biocides Division in July. Dom LaVigne requested a meeting with MoE to discuss re-revisions to the standard. Korean authorities have so far been non-responsive. Steffen asked if we know what the timeline is for any potential Korean revised standard to be released. Dom noted that initially it was supposed to be released in October/November 2017, but currently, no revised standard has been released. ii. Government & Regulatory Affairs Matrix Dom provided an overview of MI’s efforts to complete a Government & Regulatory Affairs Matrix for the AP/ME regions. The matrix will allow MI to first map the amount of methanol in trade in various jurisdictions and the legislation and regulations currently in effect in those jurisdictions. With that information MI will be able to more proactively reach out and build effective relationships with decision making entities in the region. This will allow MI to more quickly receive notification of new regulatory or legislative challenges facing methanol, more effectively respond to such challenges, and best decide how to focus our resources. The matrix is expected to be completed in April. Action Item: Complete and share Government & Regulatory Affairs Matrix with MI members. V. US EPA IRIS ASSESSMENT OF METHANOL/FORMALDEHYDE There is no current update on the IRIS Methanol (Cancer) Assessment which is not listed on the EPA’s current work plan. Steffen provided an update of the current toxicology literature surrounding the IRIS program, noting that information that has come to light through the MTBE assessment has found no causal link between cancer and formaldehyde. Larry noted that the IRIS program remains a target of Republicans in the U.S. House and Senate, and that the program would receive no funding under the budget request submitted to Congress by the Trump Administration. On February 8-9, 2018 at a meeting called by the EPA to review reforms to the IRIS 3 3 MI BOD 3/23/2018 Linked Docs - Leg/Reg Committee Call Minutes program, the program’s director Kristina Thayer, and Tina Bahadori, director of the National Center for Environmental Assessment, which oversees the program, stated that the program has been hit hard by the staff attrition that is widespread at the EPA, and that IRIS staff is down to roughly 30 people. Furthermore, efficiency directives by EPA Administrator Scott Pruitt have limited the use of consultants. The most recent pronouncements by the EPA have stated that the Formaldehyde Assessment will hopefully be ready for National Academy of Sciences (NAS) review by the end of 2018. Larry noted that given the constant delays and unmet deadlines that have plagued the assessment thus far, that date may also be pushed back.