Regulatory Developments

House Committee Holds Hearing on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act”

October 28, 2021

The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended the Toxic Substances Control Act (TSCA), “including key reforms to increase [the U.S. Environmental Protection Agency’s (EPA)] authority to mandate testing, require EPA to make affirmative decisions about the safety of new chemicals, and require the evaluation, and where merited, the regulation of existing chemicals.”

Dr. Michal Ilana Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), was the Subcommittee’s only witness. In her testimony, she emphasized several critical building blocks of a sustainable TSCA program:

  • Resources: EPA needs meaningful new funding to reflect its new responsibilities under the Lautenberg Act. Freedhoff estimates that EPA has less than 50 percent of the resources necessary to review and approve new chemicals in the way Congress intended;
     
  • Strong science and scientific integrity; and
     
  • Policies and processes that will lead to legally and scientifically defensible and protective chemical safety actions. The previous Administration issued ten final risk evaluations. While some EPA policy changes made under the Biden Administration will require revision to some of these risk evaluations, EPA’s intent is to do only what is necessary. These policy changes include reversing the assumption that all workers always use personal protective equipment (PPE) and reversing the decision to exclude exposures to chemicals from air, drinking water, and disposal.
     

Freedhoff stated that EPA’s goal is to move to rulemaking as soon as possible. She expects that the proposed rule for asbestos will be the very first of the first ten chemicals assessed under the Lautenberg Act that will be sent to the Office of Management and Budget (OMB) for interagency review later in 2021. According to Freedhoff, the scope for the next part of the asbestos risk evaluation that addresses uses and fiber types that the previous Administration excluded will be ready “roughly” by the end of 2021. EPA expects to complete that risk evaluation by the end of 2024.

Freedhoff described EPA’s work to improve implementation of the new chemicals program. Freedhoff noted that EPA has made policy changes intended to protect workers and ensure that the scope of new chemical reviews aligns with Congress’s expectations. EPA has also revised the process for reviewing and issuing final human health risk assessments and established a new internal advisory body to review and consider scientific policy issues related to new chemical submissions. Freedhoff stressed that she does not believe ensuring that new chemicals be used safely and reviewing new chemicals quickly are mutually exclusive. EPA can do both, and the Lautenberg Act states that EPA should. When questioned about the delay in review of premanufacture notices (PMN) within the allotted 90 days, Freedhoff stated that EPA is operating under the typical workload, as has been the case the past few years. According to Freedhoff, when EPA takes more than 90 days, it is typically because the companies have asked EPA to do so. Sometimes that is because the companies are providing new information late in the process and sometimes, especially in the past few years, it is because they disagree with EPA’s risk assessment and want to change EPA’s mind. Freedhoff reiterated her earlier point about needing resources, noting that EPA is operating with less than 50 percent of the resources that it thinks it needs to operate the New Chemicals Division in the way that Congress intended.

Freedhoff stated that in April 2021, she and the scientific integrity official found a way to initiate a review of a small number of human health assessments about which concerns were raised, and she shared the information with the Office of the Inspector General (OIG). She learned that sometimes very serious questions were raised about how hazardous a new chemical is found to be, even when there is agreement that hazard exists. She heard that changes to the scientific basis of the assessments is not always well explained or understandable. Freedhoff stated that there are legitimate questions about the process and science associated with reviewing new chemicals and that she takes these concerns seriously. She personally let the OIG know that OCSPP will cooperate fully with its investigation; launched a series of scientific integrity trainings; put into place new ways for scientists who believe that there is disagreement can elevate their concerns and obtain a review; and hired someone to come in and talk about ways to improve recordkeeping practices.

Freedhoff highlighted one of OCSPP’s contributions to the Biden Administration’s multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination, the national PFAS testing strategy. According to Freedhoff, most of the thousands of PFAS have no toxicity data, and if EPA continues to work on one PFAS at a time, EPA will not get through them. Freedhoff stated that the first TSCA test orders to manufacturers for about 20 different PFAS in 20 different categories will go out in a matter of months. EPA expects to extrapolate the information that it receives to more than 2,000 other PFAS in similar categories. EPA is currently determining what tests to require. The timeline for industry to conduct the testing and provide results to EPA depends on what tests are required.

After Freedhoff completed her opening statement, Committee and Subcommittee members had an opportunity to ask questions. During the question and answer period, Freedhoff agreed that the Lautenberg Act requires that EPA make health and safety studies public, such as those for Colour Index (C.I.) Pigment Violet 29 (PV29) that were initially declared confidential, and EPA is going to do that. EPA has updated the confidential status of almost 400 chemicals and will include those chemicals on the next update of the TSCA Inventory. EPA is also working to provide more information about new chemicals and make it more public as quickly as possible.

To address risks to communities that live near industrial facilities, EPA is creating a fenceline screening methodology to ensure that communities are not inadvertently left out of the risk evaluation process. According to Freedhoff, EPA will release the methodology for public comment and peer review in fall 2021. EPA also expects to release a new draft systematic review methodology for both public comment and peer review later in 2021.

When asked about the final rules for five persistent, bioaccumulative, and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), decabromodiphenyl ether (decaBDE), hexachlorobutadiene (HCBD), pentachlorothiophenol (PCTP), and phenol, isopropylated phosphate (3:1) (PIP (3:1)) -- that have caused concerns about the supply chain, Freedhoff noted that these final rules were issued under the Trump Administration. She stated that she believes that the former Administration made every effort to reach out to industry, but industry realized what the implications would be on their supply chains only after the final rules were issued. The Biden EPA immediately took action to extend the PIP (3:1) compliance date and is still working to address industry’s concerns and will continue to do so.

Under the previous Administration, EPA completed the risk evaluation of methylene chloride and banned it in all paint removers for consumer use. According to Freedhoff, EPA is now considering its commercial uses and working to ensure that the rule will not leave fenceline communities with additional exposures. EPA expects to send a proposed rule addressing these uses for interagency review sometime in 2022.

Commentary

There were not many surprises in the hearing. Freedhoff largely reiterated statements EPA has made in the past, rather than providing new information or additional clarity. Criticism from members followed fairly well-trodden lines of critique that have been raised since 2016, and Freedhoff responded predictably, asserting that EPA would follow the law and the science and urging repeatedly that EPA needs additional resources to fulfill its mission.

For critics on both sides, there was little assurance that OCSPP will take action timely on the many issues that have been delayed, including the Section 6 risk evaluations, new chemicals notices, and PBT regulations.


 
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