Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Margaret R. Graham

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:

  1. Partnering with cities to design integrated waste management systems in large urban areas where infrastructure is lacking.  This work will include engaging local governments and stakeholders, and generate economically sustainable and replicable models that can be applied across multiple cities and regions.
  2. Funding The Incubator Network by Circulate Capital to develop and promote technologies, business models and entrepreneurs that prevent ocean plastic waste and improve waste management and recycling, with the intention of creating a pipeline of projects for investment, with an initial focus on Southeast Asia.
  3. Developing an open source, science-based global information project to support waste management projects globally with reliable data collection, metrics, standards, and methodologies to help governments, companies, and investors focus on and accelerate actions to stop plastic waste from entering the environment.
  4. Creating a capacity building collaboration with intergovernmental organizations such as the United Nations to conduct joint workshops and trainings for government officials and community-based leaders to help them identify and pursue the most effective and locally-relevant solutions in the highest priority areas.
  5. Supporting Renew Oceans to aid localized investment and engagement.  The program is designed to capture plastic waste before it reaches the ocean from the ten major rivers shown to carry the vast majority of land-based waste to the ocean.

The global internet broadcast that aired on January 16, 2019, is available at www.endplasticwaste.org/live.  More information is available on APEW’s website.


 

By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

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.

Background

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.

Commentary

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. 


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

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.


 

By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham

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):

  1. Amend the CDR rule to require immediate submission, “from January 1, 2019, to April [30], 2019,” of reports on asbestos for the 2016 reporting cycle. 
  2. Amend the naturally occurring chemical substance exemption at 40 C.F.R. § 711.6(a)(3) to make the exemption inapplicable to asbestos;
  3. Amend the articles exemption at 40 C.F.R. § 711.10(b) to require reporting pursuant to the CDR rule for all imported articles in which asbestos is present at detectable levels;
  4. Amend the CDR rule to exclude asbestos from the exemption at 40 C.F.R. § 711.10(c) to require the reporting of asbestos as a byproduct or impurity;
  5. Amend the reporting threshold for CDR at 40 C.F.R. § 711.8(b) to set a reporting threshold of ten pounds for asbestos; and
  6. Amend 40 C.F.R. § 711.8 to add processors of asbestos and asbestos-containing articles as persons required to report under the CDR rule.

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.

  1. 2016 Reporting Cycle:  EPA states that based on the extensive research and data gathering already conducted during the asbestos risk evaluation process, EPA believes that “the requested amendments to the CDR rule would not lead to the reporting of new information that would contribute to EPA’s ongoing asbestos risk evaluation or, if needed, subsequent risk management decision(s)” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require immediate past reporting of the manufacturing and use of asbestos under the CDR rule for the 2016 reporting cycle.”
  2. Naturally Occurring Substances Exemption:  EPA states that removing the exemption for reporting on naturally occurring substances for asbestos would not provide any additional data to EPA “given that the purpose of domestic manufacturing or importing of raw asbestos is to make asbestos diaphragms, for which EPA already has use and exposure information” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the naturally occurring chemical substances exemption for asbestos under the CDR rule.”
  3. Articles Exemption: EPA states that it believes that lifting the articles exemption for the reporting of asbestos under the CDR rule “would not provide any new use information that would inform the ongoing risk evaluation or any subsequent risk management decisions, if needed” and that Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the articles exemption for asbestos under the CDR rule.”
  4. Reporting as a Byproduct or Impurity:  EPA states that it does not believe that making the requested amendment to the CDR rule would result in “reporting of asbestos as an impurity or a byproduct, for uses that are known or reasonably ascertainable,” that Petitioners “have not provided evidence that there are such known uses that are ongoing but remain outside the scope of the asbestos risk evaluation,” and “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the byproducts and impurities exemptions for asbestos under the CDR rule.”
  5. Reporting Threshold of Ten Pounds:  EPA states that Petitioners “fail to show that lowering the reporting threshold would provide any new information to EPA” and, therefore, finds that the Petitioners “have failed to set sufficient facts to establish that it is necessary to issue the requested amendment to lower the CDR reporting threshold for asbestos.”
  6. Adding Processors to CDR:  EPA states that it does not believe that “requiring processors of asbestos under the CDR rule will provide useful information not already in its possession,” Petitioners “have failed to indicate what additional information EPA would collect by requiring asbestos processors to report under the CDR rule” and, therefore, EPA finds that the Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require processors of asbestos to report under the CDR rule.”
  7. Lifting CBI Claims:  EPA states that Petitioners’ request to lift CBI claims on asbestos information reported under the CDR rule is "not appropriate for a TSCA Section 21 petition, as a TSCA Section 21 only pertains to the “issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5(e) or (f),” therefore, a TSCA Section 21 petition “is not a vehicle to petition EPA to initiate an action under TSCA section 14.”  Further, EPA states that it believes that “disclosure of CBI would have no practical relevance to the risk evaluation or risk determination as the CBI claims are limited and EPA retains the ability to characterize the information without revealing the actual protected data.”

Please look for the full analysis in our upcoming memorandum that will be posted on our Regulatory Developments page. 


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

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: 

  1. Alexandra Dapolito Dunn -- EPA Toxics Office:  The Senate approved the nomination of Alexandra Dunn to serve as the Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).  Ms. Dunn had been serving as the administrator for EPA Region 1.  She previously was executive director and general counsel for the Environmental Council of the States (ECOS).  Prior to joining ECOS, Ms. Dunn served as executive director and general counsel for the Association of Clean Water Administrators.  Ms. Dunn also has extensive experience in environmental education, having served as dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University.  In addition, she has taught at the Columbus School of Law, Catholic University of America, and, most recently, as an adjunct associate professor of law at the American University’s Washington College of Law.  Ms. Dunn received a B.A. in political science from James Madison University and a J.D. from the Columbus School of Law.  More information on Ms. Dunn’s confirmation hearing is available in our blog item Senate EPW Committee Holds Hearing on Nomination of Alexandra Dunn to Lead OCSPP.
  2. Mary Neumayr -- CEQ: The Senate also approved the nomination of Mary Neumayr to head the White House’s Council on Environmental Quality (CEQ).  Ms. Neumayr currently serves as chief of staff for the CEQ.  Prior to joining CEQ in March of 2017, she served in a variety of positions with the Committee on Energy and Commerce in the U.S. House of Representatives, including Deputy Chief Counsel, energy and environment in 2017; Senior Energy Counsel from 2011 to 2017; and Counsel from 2009 to 2010.  Ms. Neumayr also served as Deputy Counsel for environment and nuclear programs at the U.S. Department of Energy from 2006 to 2009, and Counsel to the Assistant Attorney General for the environment and natural resources division at the U.S. Department of Justice from 2003 to 2006.  Prior to her government service, Ms. Neumayr was in private legal practice from 1989 to 2003.  She received her B.A. from Thomas Aquinas College and her J.D. from the University of California, Hastings College of the Law.
  3. Kelvin Droegemeier -- OSTP:  Finally, the Senate also approved Kelvin Droegemeier to serve as the director of the White House Office of Science and Technology Policy (OSTP).  A meteorologist from the University of Oklahoma, Mr. Droegemeier previously served as Oklahoma Governor Mary Fallin’s secretary of science and technology.  He was also previously on the National Science Board for 12 years during the George W. Bush and Barack Obama administrations.

 

By Richard E. Engler, Ph.D. and Margaret R. Graham

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.


 

By Lynn L. Bergeson and Margaret R. Graham

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.


 

By Lynn L. Bergeson and Margaret R. Graham

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:

  1. EPA believes that the concerns about these provisions can be addressed through modifications to the language of the regulations;
  2. The unintended consequences of the Relevancy and Consistency Provisions that Petitioners allege are not serious; even if a manufacturer were to rely on those provisions to withhold information, EPA has independent authority to collect that information or require development of new information as needed to conduct its risk evaluations; and
  3. The disruptive effects to EPA could be considerable if these regulations were vacated while EPA completes its remand process; if the provisions are vacated, manufacturers could (intentionally or unintentionally) submit junk science or irrelevant material, requiring EPA to consume limited resources and take time out of the statutorily-mandated schedule to review the information.  Further, vacatur of the Relevancy Provision would be particularly disruptive because it would eliminate altogether the affirmative requirement for manufacturers to submit lists of information when requesting risk evaluations; and could delay EPA’s information gathering if it had to request or order such information from the outset.

More information on the appeals to the TSCA framework rule on risk evaluation is available on our blog.


 

By Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham

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.


 

By Lynn L. Bergeson and Margaret R. Graham

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.


 
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