This quarterly newsletter provides updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our present focus is on substances which are the subject of regulatory activity or scrutiny by various government agencies and potential litigants. This includes emerging contaminants, such as perfluorinated chemicals (PFCs), hexavalent chromium, trichloroethylene (TCE), 1,2,3-Trichloropropane (TCP), and 1,4-dioxane, as well as substances identified by EPA under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, or regulation. We hope you find this publication informative, and we welcome your feedback on chemicals of interest to your organization.
TABLE OF CONTENTS
» Impact of the Government Shutdown
In re Aqueous Film-Forming Foams Products Liability Litigation Challenge to EPA's Failure to Issue Final TSCA Regulation for Methylene Chloride Challenge to TSCA Risk Evaluation & Risk Prioritization Rules » Federal Developments
Alexandra Dunn Confirmed as Assistant Administrator for EPA's Office of Chemical Safety & Pollution Prevention Andrew Wheeler Nominated to Serve as EPA Administrator EPA Releases Draft Risk Evaluation for Pigment Violet 29 National PFAS Management Plan » TSCA Regulatory Actions
EPA Releases First List of Unique Identifiers EPA Publishes Draft Toxicity Assessments for GenX and PFBS Office of Management and Budget Reviewing Methylene Chloride Rules PFAS Groundwater Cleanup Recommendations Likely to Reflect EPA Health Advisory » Legislative Developments
America's Drinking Water Infrastructure Act Becomes Law Legislation Introduced to Designate PFAS Chemicals as Hazardous Substances Under CERCLA » State Regulatory & Legislative Action
Alaska California Michigan New Hampshire New York Impact of the Government Shutdown
On January 25, 2019, President Trump signed a three week continuing resolution to fund the federal government through February 15. The Environmental Protection Agency (EPA), which had not been funded since December 28, 2018, had been operating with less than one percent of its staff. During the shutdown, EPA was permitted to undertake only activities such as conducting response actions at Superfund sites where failure to take action would "pose an imminent threat to human life," and supporting state and local agencies in responding to environmental emergencies.1 Many other activities were put on hold.
Numerous EPA actions are likely to be delayed as a result of the lapse in appropriations. For example, EPA did not process applications for the manufacture of new chemicals, or exemptions from pre-manufacture notice (PMN) reporting during the shutdown. EPA is required to review PMN applications for new chemicals within 90 days of receipt,2 for test-marketing exemptions within 45 days,3 and for low volume, and low release and low exposure exemptions within 30 days of receipt.4 If EPA fails to complete its review within the relevant time period, it is required to refund fees paid by the submitters.5
Neither TSCA nor its implementing regulations provide instruction about the impact of a government shutdown on TSCA Section 5 deadlines. However, EPA actions following previous government shutdowns shed light on how EPA is likely to proceed this time. Following the 1995-1996 and 2013 government shutdowns, EPA published Federal Register notices extending the review period for PMNs and PMN exemption applications.6 In extending the review period, EPA relied on its authority under Section 5(c) of TSCA, which gives EPA the power to unilaterally extend the review period for PMNs by up to 90 days.7 TSCA regulations qualify this authority, stating that EPA may extend the notice period "at any time during the notice review period,"8 therefore raising questions about whether EPA may extend the review period if it has already expired during the government shutdown (though it does not appear that EPA has faced pushback on this basis in the past).
EPA is likely to again extend the review period for PMNs and exemptions. If this occurs: (1) PMNs and exemptions submitted during the shutdown would likely be deemed to have been received by EPA on the day that the Agency reopens; and (2) the review periods for PMNs and exemptions received by EPA prior to the beginning of the government shutdown would likely be extended by the length of the shutdown (35 days).9
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In re Aqueous Film-Forming Foams Products Liability Litigation
On December 7, 2018, the United States Judicial Panel on Multidistrict Litigation (the Panel) centralized 75 lawsuits from across the country involving claims of PFC contamination from aqueous film-forming foams (AFFF).10 The cases have been transferred to Judge Richard M. Gergel in the District of South Carolina. In September 2018, Tyco Fire Products and Chemguard filed a motion to centralize these actions in the Southern District of New York. This motion was followed shortly thereafter by a motion from 3M Company which sought to include in the multidistrict litigation (MDL) nine actions involving PFCs outside of the context of AFFF in which 3M was also named as a defendant. The Panel granted in part the motion from Tyco Fire Products and Chemguard, centralizing the AFFF cases outlined in the parties' motion in the District of South Carolina, but declining to include the non-AFFF cases in the MDL as 3M Company had requested. With respect to the AFFF cases, the Panel held that these actions had common factual questions, including allegations of the "toxicity of PFOA and PFOS and their effects on human health; the chemical properties of these substances and their propensity to migrate in groundwater supplies; the knowledge of the AFFF manufacturers regarding the dangers of PFOA and PFOS; [and] their warnings, if any, regarding proper use and storage of AFFFs." On the other hand, the non-AFFF cases were held to be "quite different" from the AFFF cases, and the Panel held that including these cases in the MDL could cause it to become "unwieldy."
Challenge to EPA's Failure to Issue Final TSCA Regulation for Methylene Chloride
Several environmental non-governmental organizations and individual plaintiffs have filed a lawsuit against EPA in the District of Vermont challenging EPA's failure to finalize its TSCA Section 6(a) rule regulating the use of methylene chloride-containing paint and coating removers.11 The plaintiffs are bringing the lawsuit under Section 20(a)(2) of TSCA, the statute's citizen suit provision.12 The plaintiffs argue that, under Section 6(a) of TSCA, EPA is required to issue a rule restricting the use of any substance that EPA determines presents an unreasonable risk of injury, and that EPA has violated Section 6(a) by failing to publish its final rule for methylene chloride. Plaintiffs seek a declaration from the court that, by failing to issue the final rule, EPA has not performed its "non-discretionary duty" under TSCA Section 6(a). The plaintiffs also seek an order requiring EPA to finalize the Section 6(a) rule to "ban" the use of methylene chloride-containing paint and coating removers and to file a civil action under Section 7 of TSCA (which allows EPA to file a civil action requesting relief to address "imminently hazardous chemical substance[s]").13 As discussed in further detail below, EPA sent its final Section 6(a) rule for methylene chloride-containing paint and coating removers to the White House Office of Management and Budget (OMB) for review in December 2018.
Challenge to TSCA Risk Evaluation & Risk Prioritization Rules
The Ninth Circuit partially granted EPA's request to remand three provisions of its Risk Evaluation Rule on December 18, 2018.14 In August, EPA moved to remand provisions of its Risk Evaluation Rule relating to how the Agency collects and analyzes information in the context of risk evaluations (40 C.F.R. §§ 702.37(b)(4), (b)(6)) and a provision imposing penalties upon persons who submit "inaccurate, incomplete, or misleading information pursuant to a risk evaluation" (40 C.F.R. § 702.31(d)).15 Plaintiff Safer Chemicals Healthy Families opposed EPA's request to remand the provisions of the rule relating to the collection and analysis of information relating to risk evaluations, but did not oppose EPA's request to remand the provision relating to criminal penalties.16 The Ninth Circuit granted EPA's request to remand the...