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

On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt.  In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.”  In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA.  Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks.  Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth.  These issues/economic opportunities included:  investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the  Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos).  Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.”  In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources. 

Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater.  She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS.  She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.”  Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue.  Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him.  In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River.  Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue.  Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.

Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform:  specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days.  Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days).  EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward:  How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”

Several Senators indicated their intention to submit additional questions for the record.  Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website.  The full hearing is available on the EPW Committee’s website.  


By Lynn L. Bergeson

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available.  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018.  This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!


By Christopher R. Bryant and Lynn L. Bergeson

On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year.  A Cmty. Voice v. EPA, No. 16-72816.  The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.”  The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action.  The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued.  The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard.


While not entirely surprising given the Circuit, the decision relies on a seldom used remedy that rarely succeeds in judicial settings.  It reflects the court’s sharp rebuff of the Administration’s apparent decision to delay action on the lead standard.  Given the many challenges EPA’s Office of Pollution Prevention and Toxics will face in the New Year, complying with the court’s order will not be easy.  


By Lynn L. Bergeson and Margaret R. Graham

On November 29, 2017, the Senate Environment and Public Works Committee approved the nomination of Andrew R. Wheeler, Esquire for U.S. Environmental Protection Agency (EPA) Deputy Administrator.  Mr. Wheeler currently works as a Principal at Faegre Baker Daniels Consulting providing guidance on federal regulatory and legislative environmental and energy issues.  He began his environmental policy career at EPA in 1991 when he was Special Assistant to the Information Management Division Director in the Office of Pollution Prevention and Toxics (OPPT) during the George H.W. Bush and Bill Clinton administrations.  He also spent many years on Capitol Hill as Chief Counsel to U.S. Senator James Inhofe, and Staff Director and Chief Counsel for two Senate Committees:  the U.S. Senate Committee on Environment and Public Works (EPW) and the U.S. Senate Subcommittee on Clean Air, Climate Change, Wetlands, and Nuclear Safety.  Mr. Wheeler received his JD from Washington University in St. Louis School of Law, and his MBA from George Mason University.  


By Lynn L. Bergeson and Margaret R. Graham

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
  • New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.  EPA states that this document includes EPA’s general decision framework for new chemicals and a breakdown of how EPA intends to approach each of the five types of new-chemical determinations required.
  • Points to Consider When Preparing TSCA New Chemical Notifications (Draft).  This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice.  EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
  • Overview of Comments Received on the Draft "Points to Consider" Document.  This document summarizes 151 comments received on the draft Points to Consider document.  It organizes them by topic.  The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings.  These comments have not been posted in the docket for this meeting.
  • New Chemicals Decision Guidelines Manual – Detailed Outline.  EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5.  It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.

The December 6, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 20, 2018.

More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.


By Lynn L. Bergeson and Margaret R. Graham

On October 26, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on November 2, 2017, from 9:00 a.m. to 5:00 p.m. (EST) to obtain input from interested parties and the public on its development of a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing.  EPA is required under Section 4(h) of the Toxic Substances Control Act (TSCA), as amended, to develop this Strategic Plan by June 22, 2018.  EPA states that it “will consider input from the meeting and from written comments to develop a draft Strategic Plan that will be shared with the public for comment.”

EPA has posted materials for the meeting to inform the Strategic Plan and that can be used for discussion and comment on its website, including:

EPA is requesting input about the draft Strategic Plan to be shared during the meeting and in the form of written comments that may be submitted to Docket No. EPA-HQ-OPPT-2017-0559 on; comments must be received no later than 60 days following the meeting.  Registration for the meeting and further information is available on EPA’s Alternative Test Methods webpage.


By Lynn L. Bergeson and Margaret R. Graham

On October 25, 2017, the Senate Environment and Public Works (EPW) Committee confirmed the nominations of four U.S. Environmental Protection Agency (EPA) officials:  Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire, for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW).  Dourson and Wehrum, the more contentiously debated nominees, were confirmed along party lines with 11 votes (Committee Republicans) to 10 (Committee Democrats).  The nominees must now face a vote by the full Senate.

More information on the EPW Committee hearing held on October 4, 2017, and on the nominees is available on our blog under key word nomination.


By Lynn L. Bergeson and Margaret R. Graham

The U.S. Senate Committee on Environment and Public Works (EPW) has rescheduled its Committee Business Meeting to vote on nominees to the U.S. Environmental Protection Agency (EPA) for October 25, 2017, at 10:00 a.m. (EDT).  The EPA nominees are:  Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW). 

More information on the nominees, including a recap of the confirmation hearing, is available on our blog under key word nomination


By Lynn L. Bergeson and Margaret R. Graham

On October 18, 2017, the Senate Environment and Public Works (EPW) Committee postponed a scheduled business meeting to vote on the nominations of four U.S. Environmental Protection Agency (EPA) officials:  Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP); William Wehrum, Esquire for AA of the Office of Air and Radiation (OAR), Matthew Leopold, Esquire, for General Counsel, and David Ross, Esquire for AA of the Office of Water (OW).  

The EPW Committee did not give a reason for the postponement nor announce a new date for the meeting, but it is being reported that EPW Committee members, including Senators Tammy Duckworth (D-IL), Joni Ernst (R-IA), and Chuck Grassley (R-IA), have reservations regarding Wehrum’s confirmation due to increasing friction with EPA on biofuels and the renewable fuel standard (RFS).  On October 16, 2017, 33 Senators on both sides of the aisle sent a letter to Administrator Pruitt regarding the proposed Renewable Volume Obligations (RVO) for advanced biofuel for 2018 and biomass-based diesel for 2019, stating the proposed volumes “could have a negative impact on jobs and economies” as they “would hold the biomass-based diesel volume for 2019 stagnant at 2.1 billion gallons and decrease the advanced biofuel volume for 2018 to 4.24 billion gallons.”

As mentioned in our blog item “Senate EPW Committee Hearing on Nominations of EPA Officials,” during the October 4, 2017, hearing, Dourson was questioned and criticized the most heavily, followed by Wehrum.

More information is available on our blog under key word nomination.


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

On October 4, 2017, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on the nomination of four U.S. Environmental Protection Agency (EPA) officials:

  • Michael Dourson, Ph.D., for Assistant Administrator (AA) of the Office of Chemical Safety and Pollution Prevention (OCSPP);
  • William L. Wehrum, Esquire, for AA of the Office of Air and Radiation (OAR);
  • Matthew Leopold, Esquire, for General Counsel; and
  • David Ross, Esquire, for AA of the Office of Water (OW).

More information on the backgrounds of these nominees is available in our blog item Senate EPW Committee to Hold Hearing on Nominations of EPA Officials.  Some of the highlights from the hearing portions on each of the nominees are below.  Dourson was questioned and criticized the most heavily, followed by Wehrum.

Michael Dourson, Ph.D., for AA of OCSPP

Dr. Dourson faced a barrage of criticism and questions from several EPW Committee members.  The first was from Senator Sheldon Whitehouse (D-RI), who stated that Dourson had relied on underrated exposure data when he was studying the dangers of smoking for Phillip Morris.  Senator Tammy Duckworth’s (D-IL) line of questioning was equally aggressive, referring to certain work Dourson conducted in Chicago as “pseudoscience” when he concluded there was no risk of adverse health effects.  Senator Cory Booker (D-NJ) claimed that the nomination of Dourson for a position that seeks to protect families from pesticides and toxic chemicals was “shocking,” as his track record has shown him to be a “corporate lackey” working only for the results that suit the corporations for which he conducted the assessments. 

Senator Kirsten Gillibrand (D-NY) was brought to tears recalling the fate of her constituents in Hoosick Falls, NY, regarding their experiences with perfluorooctanoic acid (PFOA) in the water supply.  Gillibrand asked Dourson whether he believed PFOA has been linked to kidney cancer and if he would uphold EPA’s standards for PFOA exposure.  Dourson replied that PFOA has been linked to some forms of cancer, science has progressed, and new standards are necessary.

Senator Jeff Merkley (D-OR) asked Dourson point blank whether chlorpyrifos has been linked to brain damage in children, as Dourson has worked on the safety aspects of this chemical for the chemical manufacturing community.  Dourson replied that he was aware of studies indicating some association and that the studies making these associations were part of a collaborative project that included government scientists.  Merkley noted Dourson’s involvement with several chemical trade groups and questioned whether he could be impartial.

Many of the Committee members asked why his recommendations on safe exposures to certain chemicals, including chlorpyrifos, trichloroethylene (TCE), and 1,4-dioxane, were many times higher than those of EPA’s standards.  Dourson’s response was that EPA in some instances does not use the most up to date science and data.  Dourson stated that he is committed to using the most credible and up to date science, as well as independent peer review, which is why many of his assessments differ from those at EPA.  He also noted that the use of good science should be the touchstone of everything that EPA does and is committed to working to ensure that the best science is considered and reviewed “even for the most vulnerable in our population,” through a transparent and a collaborative process. 

Ranking Member Senator Tom Carper (D-DE), Senators Kamala D. Harris (D-CA), Ed Markey (D-MA), Merkley, and Booker all asked Dourson to recuse himself from working on any chemical issues on which he had been contracted to work in the past on industry’s behalf, claiming that to do less would be unethical and pose a danger to the health and welfare of the American public.  Dourson replied that he would do what was requested of him by the EPA ethics officials, and that he will bring “new science and thinking” into the Agency. 

Senator Marion Rounds (R-SD) requested that Dourson keep Congress apprised on implementation of the Toxic Substances Control Act (TSCA), which Dourson confirmed he would do.

William Wehrum, for AA of OAR

In his opening statement, Wehrum signaled his intent to follow the “clear agenda” set by President Trump and EPA Administrator Scott Pruitt.  He also pledged to adhere to three key objectives set forth by Administrator Pruitt.  First, he noted that EPA’s role is to administer laws faithfully and to avoid the temptation to bootstrap its own powers and tools through rulemaking.  Second, he stated that EPA must “acknowledge, respect, and promote the critical role of the states in implementing Federal environmental laws and in protecting human health and the environment.”  Third, he emphasized the important role that the public plays in the regulatory process.

Ranking Member Senator Carper provided a particularly harsh critique of Wehrum’s fitness for office.  Although stating that he believed Wehrum to be a good person, he opined that he did not think him an appropriate choice for the OAR post, stating that “he defers too frequently to industry, suppresses scientific information, and declines to respond to Congressional inquiry.”  During a second round of questioning, Carper asked Wehrum to defend actions that, in Carper’s view, demonstrate that he is not faithfully committed to implementing the Clean Air Act (CAA). 

Democratic Senators’ questions to Wehrum belied their doubts about his adequacy to serve as the AA, while Republican committee members’ questions unsurprisingly were less severe.  When asked about potential conflicts, Wehrum noted that he would be required to comply with comprehensive ethics rules, if confirmed.  Senator James Inhofe (R-OK) cited a court decision on EPA’s Mercury and Air Toxics Standards (MATS) establishing emission limits for coal-fired power plants, and that the decision compels EPA to consider the costs of compliance in setting such standards.  To this Wehrum replied that EPA “absolutely” must follow the law and implement two goals:  to protect human health and the environment and to promote economic growth. 

Senator Merkley asked whether Wehrum believed that human activity is the major factor in climate change.  Wehrum responded that he believed it was a factor, but that human activity was not clearly the major factor. 

David Ross Esquire, for AA of OW, and Matthew Leopold, Esquire, for General Counsel

In stark contrast to the cross-examination endured by Dourson and Wehrum, Committee Members directed only a few, soft ball questions to David Ross and Matthew Leopold, the nominees for AA of OW and EPA General Counsel, respectively.  Ross currently serves as an Assistant Attorney General and Director of the Environmental Protection Unit for the Wisconsin Department of Justice. His water quality law and policy career also includes positions with the Wyoming Attorney General’s Office and the Wyoming Water and Natural Resources Division, as well as positions held in private environmental law practice.  Given Ross’ extensive experience in state government, it came as no surprise that his testimony emphasized the importance of cooperative federalism and the need for EPA to reach “outside the beltway” and improve its collaboration with state regulators.  Ross acknowledged that there are divergent views on how to best manage U.S. water resources, and that he is committed to identifying approaches that will protect public health and the environment without hindering economic growth.  Ross is likely to be confirmed without much resistance, although it is unclear at this time when his nomination will be scheduled for a Senate floor vote. 

Leopold is currently Of Counsel at Carlton Fields Jorden Burt, P.A., in their government law and consulting practice group.  He previously served as General Counsel for the Florida Department of Environmental Protection from 2013 to 2015.  Leopold’s testimony included expressions of his respect for environmental protection and the rule of law, the pride he has taken in helping to restore the Everglades ecosystem, and his work on reparations related to the Deepwater Horizon oil spill in the Gulf of Mexico.

Some press outlets are reporting that Dourson’s nomination may be at risk.  Given the simple majority vote needed to progress to a full Senate vote, this is by no means clear.  What is clear is that the hearing yesterday was as emotional as we have viewed in a long time, and a vivid depiction of how environmental issues, particularly issues involving chemicals and exposure to them, remain divisive, emotional, and political.

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