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On January 16, 2019, the Senate Environment and Public Works (EPW) Committee held a hearing on the nomination of Andrew Wheeler to serve as Administrator of the U.S. Environmental Protection Agency (EPA). Mr. Wheeler currently serves as the Acting Administrator, having taken the reins of EPA after former Administrator Scott Pruitt resigned in July 2018. An archived webcast of the hearing is available online. In introducing Mr. Wheeler, Senator John Barrasso (R-WY), Chair of the EPW Committee, stated: “under Acting Administrator Wheeler’s leadership, the agency has taken a number of significant actions to protect our nation’s environment, while also supporting economic growth. Acting Administrator Wheeler has led efforts to: issue common-sense regulatory proposals, like the Affordable Clean Energy Rule, and the revised definition of ‘Waters of the United States’; implement this Committee’s 2016 bipartisan reform of the Toxic Substances Control Act [(TSCA)] in an effective and efficient manner; reduce lead exposure, including through the Federal Lead Action Plan; provide greater regulatory certainty to states, to Tribes, localities, and to the regulated community; and improve enforcement and compliance assistance. Acting Administrator Wheeler is very well qualified to run the [EPA].” Republicans on the EPW Committee were supportive of his nomination and actions while serving as the EPA Acting Administrator. They noted with praise his deregulatory efforts, the repeal and replacement of the Obama-era Clean Power Plan, the proposed replacement of the Waters of the United States rule and the proposed repeal of the Corporate Average Fuel Economy (CAFE) standards.
Democrats on the EPW Committee, however, expressed their disapproval of Mr. Wheeler, as he faced sharp questions from them. EPW Ranking Member Tom Carper (D-DE) expressed his concern that Mr. Wheeler failed “to moderate some of Scott Pruitt’s most environmentally destructive policies,” adding that “upon examination, Mr. Wheeler’s environmental policies appear to be almost as extreme as his predecessor’s.” When questioned on his views on climate change by Senator Bernie Sanders (I-VT), Mr. Wheeler admitted that he believed it was a “huge issue” that should be addressed internationally, but he stopped short of agreeing with it being “one of the greatest crises facing our planet.” Despite the seeming Democratic opposition to his nomination, Mr. Wheeler is expected to be approved by the EPW Committee and, eventually, the Senate, and likely soon.
On January 16, 2019, a group of global companies from the plastics and consumer goods value chain announced the launch of the Alliance to End Plastic Waste (AEPW), which will advance solutions to eliminate plastic waste in the environment, especially in the ocean. AEPW membership, currently at 30 member companies, represents global companies located throughout North and South America, Europe, Asia, Southeast Asia, Africa, and the Middle East. APEW has committed over $1.0 billion with the goal of investing $1.5 billion over the next five years. The announcement of the launch states that APEW will “develop and bring to scale solutions that will minimize and manage plastic waste and promote solutions for used plastics by helping to enable a circular economy.” AEPW is a not-for-profit organization that includes companies that make, use, sell, process, collect, and recycle plastics including chemical and plastic manufacturers, consumer goods companies, retailers, converters, and waste management companies. The following companies are the founding members: BASF, Berry Global, Braskem, Chevron Phillips Chemical Company LLC, Clariant, Covestro, Dow, DSM, ExxonMobil, Formosa Plastics Corporation, U.S.A., Henkel, LyondellBasell, Mitsubishi Chemical Holdings, Mitsui Chemicals, NOVA Chemicals, OxyChem, PolyOne, Procter & Gamble, Reliance Industries, SABIC, Sasol, SUEZ, Shell, SCG Chemicals, Sumitomo Chemical, Total, Veolia, and Versalis (Eni).
As part of its roll-out, APEW also announced an initial set of projects and collaborations that reflect a range of solutions to help end plastic waste:
On January 14, 2019, in the U.S. District Court for the District of Vermont, the Vermont Public Interest Group; Safer Chemicals, Health Families; and two individuals (plaintiffs) followed up on their earlier notice of intent to sue and filed a complaint against Andrew Wheeler and the U.S. Environmental Protection Agency (EPA) to compel EPA to perform its “mandatory duty” to “address the serious and imminent threat to human health presented by paint removal products containing methylene chloride.” Plaintiffs bring the action under Toxic Substances Control Act (TSCA) Section 20(a) which states that “any person may commence a civil action … against the Administrator to compel the Administrator to perform any act or duty under this Act which is not discretionary.” Plaintiffs allege that EPA has not performed its mandatory duty under TSCA Sections 6(a) and 7. TSCA Section 6(a) gives EPA the authority to regulate substances that present “an unreasonable risk of injury to health or the environment” and TSCA Section 7 gives EPA the authority to commence civil actions for seizure and/or relief of “imminent hazards.” Plaintiffs’ argument to direct EPA to ban methylene chloride is centered on the issue of risk to human health only, however, stating that it presents “an unreasonable risk to human health” as confirmed by EPA. Under TSCA Section 20(b)(2), plaintiffs are required to submit a notice of intent to sue 60 days prior to filing a complaint which they did on October 31, 2018.
On January 19, 2017, EPA issued a proposed rule under TSCA Section 6 to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal (82 Fed. Reg. 7464). EPA also proposed to prohibit the use of methylene chloride in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. EPA relied on a risk assessment of methylene chloride published in 2014, the scope of which EPA stated included “consumer and commercial paint and coating removal.” The proposed rule stated that in the risk assessment, EPA identified risks from inhalation exposure including “neurological effects such as cognitive impairment, sensory impairment, dizziness, incapacitation, and loss of consciousness (leading to risks of falls, concussion, and other injuries)” and, based on EPA’s analysis of worker and consumer populations' exposures to methylene chloride in paint and coating removal, EPA proposed “a determination that methylene chloride and NMP in paint and coating removal present an unreasonable risk to human health.” The comment period on the proposed rule was extended several times, ending in May 2017, and in September 2017 EPA held a workshop to help inform EPA’s understanding of methylene chloride use in furniture refinishing.
No further action was taken to issue the rule in final, however, until December 21, 2018, when EPA sent the final rule to the Office of Management and Budget (OMB) for review. On the same day, EPA also sent another rule to OMB for review titled “Methylene Chloride; Commercial Paint and Coating Removal Training, Certification and Limited Access Program,” which has not previously been included in EPA’s Regulatory Agenda; very little is known about this rule. Plaintiffs do not refer to it in the complaint but there is speculation, based on its title, that this second rule may allow for some commercial uses of methylene chloride.
We recall the lawsuit filed by the Natural Resources Defense Counsel (NRDC) in 2018 challenging EPA’s draft New Chemicals Decision-Making Framework document as a final rule. The current action further reflects the commitment of detractors of EPA to use the courts and every other means available to oppose the Administration’s TSCA implementation efforts. Whether and when this court will respond is unclear. What is clear is that the case will be closely watched, as the outcome will be an important signal to the TSCA stakeholder community regarding the utility of TSCA Section 20(a)(2) to force non-discretionary EPA actions that the Administration may be disinclined to take.
Following through on a commitment he made in November 2018, President Trump on January 9, 2019, formally nominated Andrew Wheeler to serve as the Administrator of the U.S. Environmental Protection Agency (EPA). Mr. Wheeler has served as EPA’s Acting Administrator since the resignation of Scott Pruitt in July 2018. Mr. Wheeler previously worked in the law firm of Faegre Baker Daniels and was chief counsel to the Senate’s Environment and Public Works (EPW) Committee. Before his time at the Senate EPW Committee, Mr. Wheeler served in a similar capacity for six years for the Subcommittee on Clean Air, Climate Change, Wetlands, and Nuclear Safety. Mr. Wheeler completed his law degree at Washington University in St. Louis, his MBA at George Mason University, and his undergraduate work at Case Western Reserve University in English and Biology. Mr. Wheeler’s confirmation hearing in front of the Senate EPW Committee is scheduled for 10:00 a.m. (EST) on January 16, 2019. It will be webcast on the EPW Committee website.
On December 21, 2018, the U.S. Environmental Protection Agency’s (EPA) Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) Nancy B. Beck, Ph.D., signed a Federal Register document denying a Toxic Substances Control Act (TSCA) Section 21 petition requesting that EPA amend the Chemical Data Reporting (CDR) rule to increase asbestos reporting, exclude asbestos from certain exemptions, and lift Confidential Business Information (CBI) claims on asbestos information reported under the CDR rule. Due to the government shutdown, the notice has not yet been published in the Federal Register, but EPA has posted a prepublication version. EPA’s carefully reasoned response to the request is set forth in the notice.
The petition was filed on September 27, 2018, by the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental Working Group, Environmental Health Strategy Center, and Safer Chemicals, Healthy Families (Petitioners). According to EPA, Petitioners requested the following specific amendments to the existing CDR rule to collect information for the ongoing asbestos risk evaluation being conducted under TSCA Section 6(b) (required to be completed by December 22, 2019), and, if necessary, any subsequent risk management decisions under TSCA Section 6(a):
In addition to the above requests, Petitioners also requested that EPA use its authority under TSCA Sections 14(d)(3) and 14(d)(7) to lift CBI claims on asbestos information reported under the CDR rule. EPA responds in detail as to why it is denying each of these requests. A short summary is below.
Please look for the full analysis in our upcoming memorandum that will be posted on our Regulatory Developments page.
In the last hours of the 115th Congress, the Senate on January 2, 2019, approved the nominations of three individuals to serve in key environmental posts:
As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA). Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during the shutdown.
We are unaware of EPA publishing a formal notice that it is suspending the review period of new chemical notices, but EPA will not be making any determinations on such notices during the shutdown. Submitters should continue to submit any required information (e.g., Notices of Commencement) even though EPA will not process or review such submissions.
EPA actions on existing chemicals (including risk evaluations and publication of the updated TSCA Inventory with active/inactive status) will be delayed. As previously reported, the first preparatory meeting on the Colour Index (C.I.) Pigment Violet 29 risk evaluation (scheduled for January 8, 2019) will be cancelled if the shutdown continues through January 4, 2019, at 5:00 p.m., which appears probable.
On December 31, 2018, the U.S. Environmental Protection Agency (EPA), even though they had already shut down due to funding issues, announced that if the government shutdown continues through 5:00 p.m. (EST) January 4, 2019, the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals’ (SACC) January 8, 2019, Preparatory Virtual Meeting for the January 29 through February 1, 2019, meeting on Colour Index (C.I.) Pigment Violet 29 will be cancelled, and discussion of charge questions will be folded into the face-to-face meeting scheduled for January 29 through February 1, 2019. Further, if the shutdown continues through 5:00 p.m. (EST) January 11, 2019, the TSCA SACC’s January 29 through February 1, 2019, Peer Review of the draft risk evaluation for C.I. Pigment Violet 29 will be postponed. More information on the draft risk evaluation of C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.
Ninth Circuit Issues Order Partially Granting EPA’s Request for Remand of Certain Provisions of Risk Evaluation Final Rule
On December 18, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting in part respondent U.S. Environmental Protection Agency’s (EPA) motion for partial voluntary remand of certain provisions of its final rule on Procedures for Chemicals Risk Evaluation under the Toxic Substances Control Act (TSCA). Specifically, EPA’s motion for partial voluntary remand, filed August 6, 2018, sought remand with vacatur of 40 C.F.R. Section 702.31(d) (Penalty Provision) and remand without vacatur of 40 C.F.R. Sections 702.37(b)(4) (Relevancy Provision) and 702.37(b)(6) (Consistency Provision). The Ninth Circuit granted EPA’s motion to remand and to vacate the Penalty Provision, but referred EPA’s motion to remand without vacatur for the Relevancy and Consistency Provisions. The Penalty Provision states that “[s]ubmission to EPA of inaccurate, incomplete, or misleading information pursuant to a risk evaluation … is a prohibited act … subject to penalties.”
EPA stated in its motion that its “request to remand the Penalty, Relevancy, and Consistency provisions is reasonable, timely, and will serve the interests of judicial economy,” but it has not yet decided on a specific course of action. EPA sought remand to address the potential concerns that petitioners stated in their opening brief. EPA stated that vacatur was only appropriate for the Penalty Provision, however, as “nothing in the proposed rule or rulemaking record gave any indication that EPA was contemplating extending the Penalty Provision beyond manufacturers, and EPA did not purport to make that change in response to public comments, the Penalty Provision is not a logical outgrowth of the proposed rule.”
As for the Relevancy and Consistency Provisions, EPA stated that they should be remanded but not vacated for the following reasons:
More information on the appeals to the TSCA framework rule on risk evaluation is available on our blog.
On November 29, 2018, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The hearing was webcast and is available on the EPW Committee website.
In a rare sharing of bipartisan support for a Trump Administration nominee, Senator Sheldon Whitehouse (D-RI) introduced Ms. Dunn, stating “Ms. Dunn has a deep passion for working with communities, for environmental justice, and for leveraging the expertise of nongovernmental organizations.” Senator Tom Carper (D-DE) stated he was encouraged by her plans for the office. Ms. Dunn assured lawmakers that, if confirmed, she will “commit to implementing the law, following the law, and bringing all the provisions of the law to full effect.” Dunn also emphasized her intention, if confirmed, to leverage the experience and expertise of EPA career staff, including establishing “open door” hours dedicated to connecting with career staff. Dunn’s written testimony is available on the EPW Committee website. Senators may submit additional questions for the record (QFR) through November 29, 2018, for Ms. Dunn’s response by December 3, 2018. It is being reported that Ms. Dunn could be confirmed as early as next week assuming there are no objections.
Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year. Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans. More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.
On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST). The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST). The official announcement is scheduled to be published in the Federal Register on November 30, 2018. Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.
The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA. EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23). The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).
During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting. Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions.
More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.
On November 26, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that Lek Kadeli joined OCSPP’s Immediate Office as Acting Deputy Assistant Administrator (AA) (Management). EPA states that Lek has extensive experience managing and supporting a wide range of environmental and human health related programs. Lek has worked at EPA previously; for eight years he was the Principal Deputy AA in EPA’s Office of Research of Development (ORD), serving several periods during that time as ORD’s Acting AA. Lek has also served as Director for ORD’s Office of Resource Management and Administration; Chief of ORD’s Resources Planning and Execution Staff; Office of International Activities Senior Budget Officer; and, as a budget analyst in the Office of Administration and Resource Management’s Office of Comptroller.
Most recently, Lek worked at the World Bank Group in Washington, D.C. as the co-program manager of the Pollution Management and Environmental Health Program, Environment and National Resources Global Practice. Lek holds a B.A. in Political Science from George Mason University, and a M.A. in National Security Studies from Georgetown University.
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation. EPA intends to publish a separate Federal Register notice containing the peer review meeting details. Comments on the draft risk evaluation are due January 14, 2019. EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions. More information is available in the full memorandum.
The U.S. Senate Committee on Environment and Public Works (EPW) will hold a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) on Thursday, November 29, 2018, at 10:30 a.m. (EST) in room 406 of the Dirksen Senate Office Building. The hearing will be webcast and will be available on the EPW Committee website.
Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year. Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans. While at ECOS, Ms. Dunn helped state governments improve water infrastructure, reduce air pollution, clean up contaminated sites, manage chemical safety, and enhance economic development. Before joining ECOS, Ms. Dunn was Executive Director and General Counsel for the Association of Clean Water Administrators. Ms. Dunn was also a former chair of the American Bar Association’s (ABA) Section of Environment, Energy, and Resources (SEER). More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.
In September 2018, the U.S. Environmental Protection Agency (EPA) issued a consent agreement with Chevron USA, Inc. (Chevron) related to an alleged violation of the Toxic Substances Control Act (TSCA).
EPA’s issuance of a consent agreement for the alleged TSCA violation is not especially newsworthy. Neither is the agreed upon penalty for the violation, which could be considered minor based on the penalty provisions allowed under TSCA. What is newsworthy here is that the alleged violation, technically three as the violation occurred on three separate days, was related to the research and development (R&D) exemption. Specifically, EPA alleged that Chevron did not appropriately label chemicals that it had distributed to other companies for R&D purposes. In our experience, the R&D exemption under TSCA is seldom the subject of enforcement scrutiny. This may be changing.
The R&D exemption is a critical aspect of TSCA and it offers many companies significant flexibility to research new chemical innovations. The exemption is self-implementing and thus does not require pre-approval by or submissions to EPA. Nonetheless, there are specific restrictions and recordkeeping requirements associated with reliance on that exemption. The consent agreement at issue here confirms that EPA will hold companies accountable to these requirements. The enforcement action is an important reminder to all entities relying upon the R&D exemption to ensure that they comply strictly with each element of the exemption requirements as identified under TSCA Section 5(h)(3).
Companies relying on the R&D exemption for new chemical development may wish to review internal files and processes to ensure compliance, as EPA has shown its intent to pursue violations and associated penalties for non-compliance instances.