/>iThe Senate Environment and Public Works Committee held a hearing on January 24, 2024, on “Oversight of Toxic Substances Control Act (TSCA) Amendments Implementation.” Michal Freedhoff, Ph.D., Assistant Administrator (AA) of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) was the Committee’s sole witness. Committee Chair Tom Carper (D-DE) and Ranking Member Shelley Moore Capito (R-WV) provided opening statements. On the whole, no new ground was broken, and the takeaway is that everyone — EPA, the Hill, and industry — remains frustrated with TSCA’s implementation, but for very different reasons.
According to Carper, EPA is addressing the backlog of chemicals awaiting review while also reviewing new submissions, and since June 2023, EPA has more than doubled the average amount of new chemicals reviews completed each month. Capito noted that since 2021, the number of cases that have received a determination of “not likely to present risk” has dropped by 75 percent. Capito stated that submitters that have heeded EPA’s advice to come in earlier to find out what data EPA needs have not fared well and that no amount of data provided to EPA appears sufficient to overcome its worst-case assumptions of risk. Last week, before the hearing, Capito shared with Freedhoff a summary of ideas to improve management and accelerate the new chemicals review process.
In her testimony, Freedhoff highlighted changes that EPA has made, including meeting with stakeholders and obtaining their input before announcing the next five chemicals that it expects to evaluate. According to Freedhoff, in fiscal year (FY) 2023, EPA completed 70 percent more risk assessments compared to FY 2022. Since June 2023, EPA has more than doubled the average number of completed risk assessments as compared to the year before and cleared out about 50 percent of the older backlog of cases. Freedhoff stated that TSCA is underfunded, as concluded by EPA’s analysis, as well as that of EPA’s Office of Inspector General (OIG) and the U.S. Government Accountability Office (GAO). Full funding would mean 25 new hires to review new chemicals and 75 new people to finish risk evaluations and rules more quickly.
Below are highlights of the Committee’s questions and Freedhoff’s answers.
New Chemicals
Carper asked Freedhoff what EPA was able to do with increased funding in 2023 and what it could do with additional funding through both appropriations and user fees. Freedhoff responded that EPA focused on new hires and the New Chemicals Division (NCD), the area most under-resourced because of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to TSCA. According to Freedhoff, Lautenberg changed EPA’s past practice of reviewing 20 percent of new chemicals before they enter commerce to reviewing 100 percent. This produced five times the amount of work, and for six years, no additional funding with which to do it. EPA has tried to standardize its approach to chemistries when it knows that there will be a lot of applications. With more funding, EPA could more quickly modernize its standard operating procedures (SOP) and science policies, develop standard approaches for classes of chemistries, and write rules and do risk evaluations.
Capito referred to the document she shared with Freedhoff last week and asked Freedhoff for her initial reaction for any ideas that would help the most. Freedhoff stated that she would like to hire someone whose sole job would be to revamp the Sustainable Futures initiative and to build on the industry outreach that EPA has been doing. Freedhoff committed to being more transparent on why EPA sometimes uses its models instead of industry data. Capito asked about having a mid-review meeting between EPA’s engineering team members and submitters, allowing stakeholders to see where they are before they get into the engineering and other more technical phases of the assessments so that they can make adjustments mid-stage instead of at the end. According to Freedhoff, she took the idea back to her staff, but they believe that it could slow down, not just that application, but others as well. She suggested two ideas to address the issue: encouraging companies to come in for pre-submittal meetings and including engineers in those meetings and creating a second queue for submissions that are near the end of the process when something in the engineering changes and they need rework. Freedhoff stated that the job of this dedicated “tiger team” would be to get those applications over the finish line more quickly and that EPA thinks this might be a quicker solution to the problem.
Senator Pete Ricketts (R-NE) stated that he has heard that one problem holding up premanufacture notifications (PMN) is a change in EPA staff contacts during the review. Ricketts asked if EPA will commit to notifying a submitter within a week of a new project manager being assigned to a PMN. Freedhoff responded that this is an “incredibly reasonable idea” and that she thinks it would improve transparency for everybody.
Fees Rule
Carper asked Freedhoff to explain how EPA’s previous fees rule went wrong and how the proposed rule would correct it. Freedhoff testified that under Lautenberg, Congress expected EPA to write a fees rule to collect 25 percent of authorized TSCA costs from fees. The first fees rule, issued in 2016, did not collect any fees until FY 2019, and it exempted the costs of the first ten risk evaluations from being subject to fees. To calculate the 25 percent baseline, the previous administration used the costs of old TSCA, and the first fees rule collected only half of the authorized 25 percent of the costs under amended TSCA. Freedhoff stated that the Biden-Harris EPA has done things differently to calculate accurately 25 percent of its costs. The final fees rule is in the final stages of review with the Office of Management and Budget (OMB), and Freedhoff expects to issue the final rule “in the coming weeks.”
ECELs
Senator John Boozman (R-AR) asked if EPA is considering an existing chemical exposure level (ECEL) for formaldehyde that is lower than the levels of formaldehyde exhaled by humans and as much as 16 times below the exposure levels set in European jurisdictions. Freedhoff stated that EPA has not calculated a level like that and that it would be calculated at the risk management stage. According to Freedhoff, if EPA calculated a level like that in the draft risk evaluation that cannot be measured because it is lower than the background level, EPA would state that it will not base risk management on that level.
Ricketts noted that several chemicals have proposed risk management rules that included ECELs with no real opportunity for industry comment and these extremely low ECELs are often below the level of detection, resulting in a de facto ban. Ricketts asked Freedhoff to clarify if when EPA sets a final ECEL for industrial uses, that means that there is a level at which no unreasonable risk exists. According to Freedhoff, for some of the ECELs, the proposed levels address the unreasonable risk identified in the risk evaluation. Under Lautenberg, EPA cannot consider costs and other non-risk factors in the risk evaluation. As EPA moves through the process, following the risk evaluation, it is actively engaging with industry to make sure it understands what their occupational safety practices can achieve. Freedhoff stated that she thinks there will be changes between the proposed and final ECELs for some of the chemicals.
Capito asked Freedhoff how she distinguishes between where EPA is and where the Occupational Safety and Health Administration (OSHA) is. Freedhoff stated that Lautenberg requires EPA to consider the risks to potentially exposed and susceptible subpopulations (PESS) and that PESS is explicitly defined to include workers. According to Freedhoff, OSHA wrote most of its chemical-specific rules in the 1970s, and its website notes that the OSHA standards are outdated and inadequate for the protection of worker health. Freedhoff noted that another issue is that OSHA’s rules do not cover self-employed workers or public sector workers who are not covered by a state OSHA plan. EPA is working closely with both OSHA and the National Institute for Occupational Safety and Health (NIOSH) and trying to align its final rules with their practices for things like monitoring and detection. Freedhoff stated that EPA is also working closely with industry because in many cases, industry has gone way beyond the OSHA standards when it comes to protecting its workers, because sophisticated companies are aware that those standards are outdated. EPA is also working to align with the best industry practices as well and ensure that its final rules are implementable.
Asbestos
In response to a question from Senator Jeff Merkley (D-OR) regarding when the final asbestos part 1 rule will be out, Freedhoff stated that the rule is currently at OMB and that she thinks the 90-day review period ends in early March 2024. Since it is not within EPA’s control, it is hard to predict exactly when the rule will be out, but she is in active conversations with EPA’s agency partners and very eager to unveil it. Merkley noted that the rule will affect only one form of asbestos (chrysotile), but that there are seven other types. According to Freedhoff, EPA is in the middle of asbestos part 2, which includes the other forms of asbestos and legacy uses. EPA expects to release both a draft and final risk evaluation in 2024.
PFAS
Senator Cynthia Lummis (R-WY) noted the ongoing debate over the definition of per- and polyfluoroalkyl substances (PFAS) and that there is no consistent definition across government agencies. Lummis expressed concern that EPA is unnecessarily restricting PFAS chemistries needed for American manufacturing and referred to a 2023 Department of Defense (DoD) report on critical PFAS uses. Lummis asked Freedhoff if EPA intends to establish an expedited review process for PFAS that have less concerning hazard profiles or those used in limited volumes but critical to technological innovation. Freedhoff responded that EPA has already developed such a framework. According to the framework, if the PFAS is going to be used in a sophisticated industrial environment, such as the semiconductor industry has, and workers are protected and environmental releases are controlled, there will be a path through the new chemicals program for that PFAS. Lummis asked if Freedhoff has met with DoD to go through which PFAS chemistries are essential. Freedhoff stated that she is committed to working with DoD to make sure EPA’s work does not undermine military readiness or remove access to things they need.
Merkley asked when data submitted under the TSCA Section 8(a)(7) reporting rule for PFAS will be available to the public. Freedhoff noted that there are different deadlines for different reporters, but stated that she expects to start getting data in fall 2024 and that EPA will be working to make as much of it public as it can. According to Freedhoff, EPA will have to review submissions claimed as confidential business information (CBI), but otherwise the law was written to ensure that the public can see the data.
Commentary
B&C is encouraged by the significant attention the Senate is paying to TSCA implementation. Despite the fact that the law was enacted seven and a half years ago, EPA’s implementation is still in flux. Between litigation and two administration changes, there have been substantial changes in EPA’s approaches to Sections 4, 5, and 6 and, once EPA completes its rulemaking later this year, approaches will change again.
We remain of the view that EPA needs more resources to implement TSCA, but it is not yet clear to us how much more. Dr. Freedhoff repeated her contention that prior to Lautenberg, EPA only reviewed 20 percent of cases — a number that we cannot rationalize. It is true that EPA is now required to memorialize its determinations in either an order or a not likely determination document, but that is not a substantial amount more work than preparing the reports that it produced (prior to 2016) and still does produce. It is also true that EPA receives many fewer cases than in the past. Both Senator Carper and Dr. Freedhoff cited a significant jump in EPA’s new chemicals risk assessments, and we are heartened to hear this. Unfortunately, the bottleneck for determinations is now in risk management (writing and reviewing consent orders). Recent hires among risk management staff are expected to address delays at that point of the process.
Dr. Freedhoff again identified prenotice communication as an effective way to facilitate the new chemicals process. The reality is, however, overburdened new chemicals staff do not have the bandwidth to review cases in detail prior to submission, so prenotice meetings are effectively oral versions of EPA’s points to consider document and often an EPA “listening session.” It is not that these meetings lack value, especially to novice submitters, but, in our experience, the value is limited and not the panacea Dr. Freedhoff suggests they are. A mid-course meeting between the submitter and EPA’s technical reviewers strikes us as a better idea. By then, EPA experts would have taken a detailed review of the submission and would be able to provide granular feedback to address any misunderstandings or shortcomings in a submission. This method would avoid having to complete the health risk assessment (the last and most resource-intensive step) only to have to redo such an assessment if a submission is amended. It is true that such a meeting would delay cases, but since most cases are delayed well past that midpoint, a midpoint meeting could improve EPA’s throughput, as fewer cases would have to be reworked after completing a full review.
Dr. Freedhoff also stated that Sustainable Futures is a priority. We agree. Sustainable Futures training can be invaluable for all stakeholders. In our view, Sustainable Futures training would be much more valuable than prenotice meetings. Such training can help submitters prepare more robust submissions, it can help with training new EPA staff, and it can help the public better understand how EPA reviews new chemicals and what the various reports mean. EPA’s former policy of allowing simultaneous PMNs and test marketing exemptions (TME) to allow the product to go to market after the review is complete but before the 90-day review period has expired is no longer needed under Lautenberg, but the training is still valuable.
It is true that EPA spends more effort now on existing chemicals than prior to Lautenberg. It is unclear, however, whether EPA’s policies and procedures for existing chemicals reviews are sufficiently firm to give a clear picture of how much time is required for a “routine” review under TSCA Section 6.
We agree with Dr. Freedhoff that, under Lautenberg, EPA is required to consider workers in its risk assessments, but we disagree with the policy that EPA has implemented, under which EPA assumes personal protective equipment (PPE) is never used. We note that the policy is nominally that EPA does not assume that PPE is always used; in practice, however, experience has shown that means EPA assumes that PPE is never used. We agree that OSHA does not apply to self-employed individuals and municipal employees, but such employees are more like consumers than they are like industrial workers. We agree that it is appropriate to assume that consumers do not use PPE, but consumers also do not process or use chemicals in the same quantity, frequency, and duration as industrial or commercial employees in chemical-intensive business.
As we discuss in our 2024 Forecast, this year will be consequential for TSCA with the risk management rules for asbestos, trichlorethylene, methylene chloride, perchloroethylene, and carbon tetrachloride expected to be published in final, the promulgation of the updated new chemicals regulations and the existing chemicals framework, and the fees rule. All these steps are critical to EPA meeting its obligations under TSCA to protect health and the environment.
