By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2022, the Senate Committee on Environment and Public Works will hold a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).
By Lynn L. Bergeson and Carla N. Hutton
On June 14, 2021, the Senate confirmed by voice vote Michal Freedhoff to be the Assistant Administrator for Chemical Safety and Pollution Prevention of the U.S. Environmental Protection Agency (EPA). As reported in our January 22, 2021, blog item, Freedhoff was onboarded in January 2021 as Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention. On April 14, 2021, President Joseph Biden nominated Freedhoff for Assistant Administrator for Chemical Safety and Pollution Prevention. According to Biden’s announcement, Freedhoff has more than 20 years of government experience, most recently as the Minority Director of Oversight for the Senate Environment and Public Works Committee. She began her Congressional service in 1996 in then-Representative Ed Markey’s (D-MA) office as a Congressional Science and Engineering fellow after receiving a Ph.D. in physical chemistry at the University of Rochester. Freedhoff also served on the staffs of the House Science Committee, the House Select Committee on Energy Independence and Global Warming, the House Energy and Commerce Committee, and the House Natural Resources Committee. The announcement states that Freedhoff’s legislative work includes the 2016 re-authorization of the Toxic Substances Control Act (TSCA), 2019 legislation to address per- and polyfluoroalkyl substances (PFAS) contamination, the fuel economy provisions in the 2007 Energy Independence and Security Act, and a law requiring the creation of an online database of potential consumer product safety defects.
By Lynn L. Bergeson and Carla N. Hutton
On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler requesting information on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The letter notes that the Lautenberg Act was intended to enact reforms addressing “longstanding structural problems” with the Toxic Substances Control Act (TSCA). According to the letter, EPA’s implementation of the Lautenberg Act “has deviated dramatically from Congress’ intent and the new law’s requirements.” The Senators’ letter requests EPA’s responses to a number of questions regarding the following areas of concern:
- Section 4: EPA’s failure to use its enhanced information authorities under TSCA. Under the Lautenberg Act, EPA can now acquire information where needed to review new chemicals or to prioritize or review the risks of a chemical already on the market. The law also makes clear that EPA can require the development of real-world exposure information. According to the Senators, in the nearly three years since enactment of the Lautenberg Act, “EPA has not once used these new authorities, and seems to be avoiding using them at all costs -- even where there are critical information gaps.”
- Section 5, Part 1: EPA’s failure to protect workers when reviewing new chemicals under TSCA. The Lautenberg Act strengthened EPA’s authority to regulate chemicals that may present risks to workers “by explicitly naming workers as a ‘potentially exposed or susceptible subpopulation’ and requiring that EPA consider and address potential risks to workers when assessing new or existing chemicals.” According to the Senators, EPA is failing to use TSCA’s health standard, which is more stringent than the Occupational Safety and Health Administration’s (OSHA) workplace standards, to determine whether any of the new chemicals “may present an unreasonable risk” to workers. Where EPA finds a new chemical does or may present serious risks to workers, it is allowing that chemical onto the market without imposing any conditions to protect the workers. EPA’s “only justification for this is that it simply ‘expects’ that workers will protect themselves from harmful workplace exposures by wearing personal protective equipment (PPE) that the company is not required to provide or train workers to use properly.” This deference to OSHA regulations “allow[s] workers to be exposed to chemical risks that are a thousand or more times higher than are acceptable under TSCA.
- Section 5, Part 2: EPA’s failure to adequately identify and review “reasonably foreseen” conditions of use when reviewing new chemicals under TSCA. When reviewing a new chemical, the Lautenberg Act directs EPA to examine the chemical under its “conditions of use” -- “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” According to the Senators, “EPA has attempted to skirt this requirement for an integrated assessment of both intended and reasonably foreseen conditions of use in several ways that are contrary” to TSCA’s requirements:
- For most new chemicals that EPA has reviewed in recent months, it simply asserts there are no such reasonably foreseen uses;
- For those new chemicals where EPA identifies a reasonably foreseen use, it merely states, without providing any analysis, that it expects that use to present no greater risk than the intended use. By doing this, EPA not only fails to demonstrate that the reasonably foreseen use is not likely to present an unreasonable risk, it also fails to consider that the combination of use could present such a risk; and
- For the remaining new chemicals where EPA does identify a reasonably foreseen use and identifies some potential concern with that use, EPA has separately promulgated a significant new use rule (SNUR) that requires a company to notify EPA prior to engaging in that reasonably foreseen use. In these SNURs, EPA has not made clear that it would assess the potential exposure and risks from that use in combination with the already approved intended uses as part of its review of any such notice, however.
The Senators note that none of these recent policy changes to EPA’s examination of new chemicals’ conditions of use has been made public or subject to a public comment opportunity.
- Section 6: EPA’s failure to assess even known conditions of use and pathways of exposure in conducting risk evaluations of existing chemicals under TSCA. The Lautenberg Act requires EPA to evaluate potential risks arising from activities across the entire lifecycle of a chemical, considering all “known” and “reasonably foreseen” circumstances, not just those “intended” by a company making or using a chemical. The letter states that EPA “has sought in numerous ways to limit the scope of its risk evaluations and risk determinations.” In its final Risk Evaluation Rule, EPA “asserted sweeping authority to pick and choose what activities and what exposures it includes in its risk evaluation of a chemical.” According to EPA, it can ignore any exposure to a chemical that also falls under the authority of another agency, such as OSHA, regardless of whether that agency has actually taken any action to mitigate the risks of the chemical. EPA also stated that it will exclude “legacy” activities associated with a chemical. EPA has begun to conduct risk evaluations that exclude most or all pathways of exposure to a chemical that falls under the jurisdiction of another statute administered by EPA.
- Section 14: EPA’s failure to provide timely public access to non-confidential information and access by eligible parties to confidential business information under TSCA. The Lautenberg Act amended Section 14, enhancing requirements for companies’ assertion and substantiation, and EPA’s review of confidential business information (CBI) claims; for providing public access to chemical information; and for providing expanded access to CBI. Although these provisions were immediately effective, nearly three years after enactment, “there is little evidence that EPA is effectively implementing these provisions or requiring compliance with them.”
The letter is well written if not quite one-sided. Complicated issues require thoughtful analysis, and this letter demands a clear and compelling response from industry advocates that may well respectfully disagree with the Senators’ position on many of the points made in the letter. We suspect this letter may well be a point of discussion at Monday’s TSCA at Three conference.
By Lynn L. Bergeson and Christopher R. Bryant
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.
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, 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:
- 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.
- 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.
- 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 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 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 March 28, 2017, Senators Chris Coons (D-DE), Shelley Moore Capito (R-WV), Steve Daines (R-MT), and Gary Peters (D-MI) announced that they will serve as co-chairs of the newly formed Senate Chemistry Caucus. Senators John Boozman (R-AR), Joe Donnelly (D-IN), John Neely Kennedy (R-LA) and Joe Manchin (D-WV) have also agreed to join the Caucus. Senator Coons’ press release states that the Senate Chemistry Caucus will provide “a bipartisan forum for Senators to work together on issues dealing with the science of chemistry, the nation’s chemical business sector and their importance to our economy and the central role they play in the creation of innovative products vital to everyday life,” and that the group will work with their colleagues in the Senate to “underscore the importance of employing sound science to create effective public policy and to promote initiatives that encourage the development of chemical manufacturing and a new generation of chemists in the U.S. through world-class education and research programs.”
By Lynn L. Bergeson and Margaret R. Graham
On March 8, 2017, Senator James Lankford (R-OK) introduced S. 578, the “Better Evaluation of Science and Technology Act” or “BEST Act,” a bill that would amend title 5 of the United States Code, commonly referred to as the Administrative Procedure Act (APA), to “provide requirements for agency decision making based on science.” Although the BEST Act does not refer to the recently amended Toxic Substances Control Act (TSCA), it is apparent that it plans to implement the same science standards stipulated in amended TSCA, for all federal agencies that use “scientific information” (which the bill does not define) in their rulemakings, including the U.S. Environmental Protection Agency (EPA). Section 2 of the BEST Act uses language quoted verbatim from TSCA Section 26, subsections (h) Scientific Standards, (i) Weight of Scientific Evidence, and (j) Availability of Information.
S. 578 was one in a package of regulatory improvement bills that Lankford introduced on March 8, 2017, which his press release stated were “aimed at improving the federal rulemaking process so the final regulations work better for the American people.” Lankford is a vocal critic of some agencies’ practices regarding scientific integrity, stating that “agencies occasionally use hidden science to support their regulatory decisions instead of transparent conclusions, data, and methods,” and that, instead, “Agencies should use the best available science that has been peer-reviewed by an independent third-party, make sure conclusions are verifiable and reproducible, and assure the data is transparent and publically available.”