On June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” The Committee’s only witness was Michal Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Freedhoff’s written testimony is available online.
In her opening statement, Freedhoff acknowledged that despite EPA’s best efforts, it has missed (and expects to continue to miss) statutory deadlines, its scientific peer reviewers and the courts have been critical of its work, and the public lacks confidence in EPA’s chemical safety efforts to date. According to Freedhoff, the Lautenberg Act directed EPA to “scale up.” Although EPA’s workload “skyrocketed virtually overnight and doubled again several years later,” in the first four years, EPA failed to request additional resources. President Biden’s fiscal year (FY) 2023 budget request seeks almost $64 million and 201 full-time equivalents (FTE) for the Toxic Substances Control Act (TSCA) program, based on an analysis of the resources necessary to implement the Lautenberg Act. Freedhoff stated that EPA is working as quickly as possible to prepare risk management rules for trichloroethylene (TCE), methylene chloride, and asbestos, all part of the first batch of existing chemicals evaluated under the Lautenberg Act. The deadlines for these final rules are in just a few months, but EPA will not meet any of them. Freedhoff testified that without additional resources, “we won’t get more than a handful of those rules on the books before 2025 or beyond.” According to Freedhoff, it is unclear whether EPA will be able to complete half of the risk evaluations for the second batch of high-priority chemicals before 2025.
The Committee then moved to the question and answer portion of the hearing. Senator Tom Carper (D-DE) asked about reports that the new chemical review process has stalled and how long it is taking EPA to complete these reviews. According to Freedhoff, it depends on the chemical as some are more complicated than others to review. Freedhoff stated that “for the entirety of the last six years, EPA has had typically 200-300 new chemical submittals that are waiting for Agency action and our backlog, so to speak, is the same as it has been for just about the last five years.” Receiving the resources in the FY 2023 budget request would help EPA meet the target of reviewing new chemicals in 90 days, but Freedhoff noted that the New Chemicals Program is more challenged under the Lautenberg Act because instead of reviewing about 20 percent of new chemicals, it must now review and issue affirmative determinations for 100 percent. The previous Administration not only failed to request more money for the New Chemicals Program, but it moved staff over to work on existing chemical risk evaluations instead, thereby reducing its budget by about 15 percent.
Carper asked whether chemical companies can do anything, when they submit their applications, that might help the process move more quickly. Freedhoff responded that companies often do not provide all the data upfront, but will instead provide data 30 or 60 days into the review. EPA will then restart the clock and redo the risk assessment, delaying the review for that chemical as well as for all the other chemicals waiting to be reviewed. Freedhoff stated that EPA looked at the types of data that companies have not provided with their initial submission and analyzed the reasons for delays in reviewing those submissions. As a result, EPA will be doing “some pretty aggressive educational outreach to industry so that they can know what would help us get the work done more quickly.”
Senator James R. Inhofe (R-OK) asked Freedhoff if she agreed that the delays in the new chemical review process are hampering innovation and contributing to supply chain constraints and inflationary pressures. Freedhoff agreed that delays in the review process are slowing the introduction of new chemicals into commerce, and stated that she does not fully understand how a chemical that is not yet in commerce could cause supply chain problems. Asked if there are things that could be done better or more efficiently, Freedhoff provided the biofuels initiative as an example in the new chemicals space. EPA noticed it had several dozen biofuels applications and instead of treating each application as an entirely new thing, giving the applications to different members of the team, EPA created a dedicated team and streamlined the review of those submittals so that it could get them out more quickly. According to Freedhoff, EPA is looking at different sectors where it has a number of applications for the same types of chemistries. Risk assessors are also writing down their process so that when the next risk assessor that sees a similar chemical, he or she does not have to start from scratch. The New Chemicals Program is also working with the Office of Research and Development (ORD) to modernize its scientific approach to reviewing these new chemicals.
Shelley Moore Capito (R-WV), Ranking Member of the Committee, asked Freedhoff why companies fail to provide all the data necessary to review their new chemicals and whether EPA tells the companies in a timely manner what data it needs. Freedhoff responded that EPA has realized that it is part of the problem. EPA will be releasing its analysis that lists and documents the types of information that will help the New Chemicals Program if it is received at the time of the submission. EPA will be reaching out to companies to make sure that they understand what EPA’s data needs are.
Capito asked about the two definitions of per- and polyfluoroalkyl substances (PFAS) that EPA is using and whether a clear and consistent definition would be useful. Freedhoff responded that OCSPP prepared a definition in 2006 for purposes of the TSCA New Chemicals Program and proposed using that definition in rulemaking. The Organization for Economic Cooperation and Development (OECD) later proposed a much broader definition. EPA is reviewing public comments and considering what a more robust definition might look like and whether additional PFAS should be added to its rulemaking. Capito noted that EPA Assistant Administrator for Water Radhika Fox testified before the Committee that EPA would not be developing a uniform definition. According to Freedhoff, when OECD created its definition, it stated that individual regulators might do different things. A definition that would work for EPA’s Office of Water would probably focus on PFAS that would be expected to be in water, whereas a definition that worked for TSCA might be one for PFAS that are expected to be manufactured and processed. Freedhoff thinks that there will be some differences, but that it is important to think about what is meant when EPA states that something is or is not a PFAS.
Senator Alex Padilla (D-CA) asked how the use of supercomputing and computational toxicology could assist EPA in assessing new chemicals. He suggested that animal testing could be reduced by using super computers to run models to predict better the adverse health effects caused by chemicals and identify safer alternatives before they are used in manufacturing. Padilla stated that he is working on legislation that would create a consortium called Super Safe that would include federal agencies (EPA, the U.S. Department of Health and Human Services, and the Department of Energy), state agencies, and academic and other research institutions with similar capabilities to use super computing and machine learning to establish rapid approaches for the large scale identification of toxic substances and the development of safer alternatives. Padilla asked if such a consortium could assist EPA in assessing new chemicals. Freedhoff stated that she is excited by any new scientific tool that can speed up EPA’s reviews and help it meet its obligation under the Lautenberg Act to reduce the use of animal testing.
Senator Ed Markey (D-MA) asked Freedhoff if additional budgetary support would help EPA work with states or local educational agencies to understand better and work on the risks that toxic polychlorinated biphenyls (PCB) pose to children. According to Freedhoff, there is a modest amount of money in the FY 2023 budget request that is designed to augment those efforts in the states. Markey noted that asbestos is included in the Lautenberg Act and asked Freedhoff what progress EPA is making and what additional resources are needed. Freedhoff stated that EPA’s first proposed risk management rule is for asbestos and would ban the ongoing uses of chrysotile asbestos. EPA is taking comments now and intends to issue a final rule sometime in 2023. When preparing the risk evaluation for asbestos, the previous Administration excluded other fiber types of asbestos, as well as legacy uses. A court found that EPA improperly excluded those uses and types, and EPA is now preparing a second part of the risk evaluation that will be done by December 2024.
Senator Mark Kelly (D-AZ) asked about the recently released updated drinking water health advisories for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) and OCSPP’s National PFAS Testing Strategy. Freedhoff explained that the National PFAS Testing Strategy is focused on testing categories that are PFAS to fill in the data gaps. According to Freedhoff, the results of the first PFAS test order will help EPA understand more about the health effects for 500 other similar PFAS. Regarding the updated drinking water health advisories for PFOA and PFOS, which are in parts per quadrillion, beyond the level of detection, Freedhoff compared them to the rules for lead. It is generally accepted that there is no safe level of lead, and the goal for the level of lead in drinking water is zero. The drinking water rules are what factor in detection levels, methods of detection, how to treat it, and how to remove it, and that would be the difference between a drinking water health advisory for PFAS and a drinking water rule.
Senator Dan Sullivan (R-AK) asked about a recent petition, filed under TSCA Section 21, seeking to “phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” Freedhoff stated that EPA just received the petition and that she has not reviewed it yet. EPA has an obligation to review and respond to the petition, and it will do so.
Senator Sheldon Whitehouse (D-RI) noted that the Lautenberg Act gave EPA the authority to levy fees on industry so that 25 percent of the program would be covered by industry contributions. He asked what percentage is currently covered by user fees. According to Freedhoff, it is far less than 25 percent. The first TSCA fees rule did not take effect until FY 2019, and it excluded all the costs of the first ten risk evaluations. The fees collected under that rule covered about 12 or 13 percent of EPA’s costs, not the 25 percent that Congress expected and that every stakeholder supported. In the 2022 appropriations bill, Congress directed EPA to write a fees rule that would reflect the actual cost of implementing TSCA, and EPA is planning to do so. Freedhoff stated that EPA expects to send a supplemental rule to the Office of Management and Budget (OMB) in summer or fall 2022. Freedhoff hopes for the final rule to be issued before FY 2024.
In a second round of questioning, Capito asked Freedhoff why EPA is assuming that workers are not wearing their personal protective equipment (PPE) and is that not the Occupational Safety and Health Administration’s (OSHA) job rather than EPA’s. Freedhoff stated that the Lautenberg Act instructs EPA to look at potentially exposed and susceptible subpopulations and that includes workers. According to Freedhoff, the OSHA rules do not apply to everybody (self-employed workers, public sector workers that work in a state that does not have an OSHA-approved plan). OSHA’s web page for its chemical-specific standards states that the standards are outdated and inadequate for protecting worker health. Finally, OSHA’s annual list of the ten most frequent safety violations includes respirator, eye, and skin protection safety standards among the most frequent. Freedhoff acknowledged that a lot of companies, including the larger manufacturers, go beyond the OSHA requirements. Freedhoff thinks that it is incumbent on EPA to make sure and communicate that when it writes its risk evaluation, people are not unduly afraid of the absence of a safety measure that is actually in place at the facility where they work. EPA is striving toward consistency with OSHA rules when OSHA rules are enough, consistency with best industry practices when best industry practices are enough, and to level the playing field and make sure that everyone is protected.
Carper asked Freedhoff about EPA’s evaluation of the whole chemical versus the conditions of use. Freedhoff responded that the Lautenberg Act directs EPA to study the chemical substance over its conditions of use. The risk evaluations look at the risk attached to each condition of use, and EPA analyzes that risk and will continue to do so. According to Freedhoff, where industry is not in full agreement with EPA’s approach is that when EPA states that an entire chemical substance poses an unreasonable risk, industry thinks that is unfair because they think there are some conditions of use that have less or no risk, and they want everyone to know which those are. Freedhoff stated that EPA agrees, and it will continue to tell people which of the conditions of use are more risky than others and which are most likely to be regulated. Freedhoff noted that it is on EPA to communicate properly and EPA plans on doing a better job in this regard. EPA also would welcome industry’s feedback when they think EPA has missed the mark on the communications front.
Members asked questions on familiar topics (new chemicals, delays, budget constraints), but little new information was revealed. While we appreciate these hearings take considerable time to organize, and are helpful in educating Congress and the public on Lautenberg implementation challenges, they are often a bit frustrating in their lack of substance. The venue is not conducive to in-depth discussions that TSCA’s complexity demands. For example, while we agree that OCSPP does not have the budget it wants or needs, achieving that elusive goal has eluded other Administrations, and lack of resources is one of many challenges hampering the TSCA implementation process. We continue to be of the view that TSCA stakeholders need to engage more with EPA before EPA issues proposals, before test orders are prepared in final, and before new chemical notifications are submitted. Our collective hope is OCSPP is receptive to engagement, solicitous of comment and collaborative opportunities to get to yes, and is provided the resources to achieve these goals.
In this regard, we urge readers to register for next week’s conference, “TSCA Reform -- Six Years Later.” This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. EPA has generously offered five of its senior leaders to join with industry and non-governmental organization presenters to discuss Lautenberg’s implementation. Registration will close on June 27, 2022.