TSCA Insider

TSCA Insider

EPA Advances TSCA Policies For Existing Chemicals Despite Budget Crunch

June 29, 2022

EPA is taking fresh steps to set the stage for pending TSCA regulations for several existing chemicals that have already been evaluated as well as new risk evaluations of 20 more, even as toxics head Michal Freedhoff is warning that many of those projects could be put on hold if Congress does not boost the agency’s budget this fall.

This week, the agency finalized revised risk determinations for the flame retardant cluster HBCD and proposed a near-identical set of changes for its perchloroethylene (PCE) assessment. In both cases, the agency is aiming to convert Trump-era Toxic Substances Control Act (TSCA) evaluations that made separate findings of “unreasonable risk” for each of the chemicals’ dozens of conditions of use into a single determination for the “whole chemical,” which EPA says will better support more-effective risk-management rules.

And it is preparing to defend a recent round of chemical testing orders designed to bolster data on eight of the next 20 chemicals targeted for evaluation, after industry groups filed novel court challenges saying those mandates are either unjustified or targeting the wrong firms.

But despite those moves, on June 29 Freedhoff announced that unless the agency sees a major funding increase in fiscal year 2023 many of those evaluations and rulemakings will slow to a crawl. In a keynote speech to the Environmental Law Institute’s annual TSCA conference, she said that with its current resources, EPA can only focus on four of the nine outstanding risk management rules and five of the 20 pending evaluations.

Freedhoff Lays Out Limited Agenda For TSCA Rules Absent Budget Boost
EPA chemicals chief Michal Freedhoff says the agency is poised to propose four of the 10 pending TSCA risk management rules in the coming months, starting with the solvent methylene chloride, but rules for the remaining five substances the law requires the agency to regulate could take years longer if Congress does not boost funding for the cash-strapped program.

During her keynote address to the Environmental Law Institute’s June 29 online seminar marking the sixth anniversary of Congress’ reform of the Toxic Substances Control Act (TSCA), Freedhoff added new detail to prior warnings that without a major funding boost in fiscal year 2023, the toxics office will only have enough resources to craft risk-management rules for “a handful” of the 10 chemicals it evaluated during the Trump years, despite statutory deadlines.

"Methylene chloride will be the next proposed risk management rule we anticipate releasing,” she said, adding that the agency expects to follow that with rules for carbon tetrachloride, trichlorethylene (TCE) and perchloroethylene (PCE).

“Depending on how the FY23 budget process plays out, the remaining risk management rules may have a longer timeline,” she said.

Although House appropriators are advancing a bill that would more than double the toxics office’s budget, in line with EPA’s fiscal year 2023 funding request, its fate in the Senate is unclear as Republicans have been silent on whether they support that increase or any boost at all to TSCA.

House FY23 Bill Would Double TSCA Budget, But Also Urges Reforms
The House Appropriations Committee’s draft fiscal year 2023 EPA funding bill would grant the White House’s request to more than double funding for the TSCA office, setting the stage for negotiations with Senate Republicans who have remained quiet on the subject so far, while also pressing the agency to streamline key elements of the program.

In a committee report released on June 28 in advance of a June 29 full committee markup, the legislators specify that they are directing $162.727 million to the “Toxics Risk Review and Prevention” account that includes Toxic Substances Control Act (TSCA) implementation -- the exact amount in EPA’s budget request for the year, which asked Congress to more than double TSCA’s current $60 million funding to $124 million.

Officials, including chemicals chief Michal Freedhoff, have told lawmakers and stakeholders that the TSCA program needs a massive budget increase to provide the resources necessary for staff to meet aggressive deadlines Congress set when it overhauled the toxics law in 2016.

If enacted, the House bill would meet that request, as part of an overall $2 billion increase for EPA that would raise the agency’s budget to $11.5 billion for FY23.

Freedhoff’s warning, and a House committee vote on the FY23 bill, come just one day after EPA finalized the revised HBCD risk determinations -- a move it says is designed to set the stage for regulating the flame retardant, and the same morning that it floated similar changes for PCE.

In First, EPA Issues New HBCD Risk Finding Under ‘Whole Chemical’ Method
EPA has finalized its revised TSCA risk determination for the cluster of flame retardant chemicals known as HBCD that abandons a Trump-era model of separate findings for each use of the substances and instead makes a first-time single determination for the “whole chemical,” rejecting industry arguments that its new approach is unlawful.

“After review of these comments and consideration of the specific circumstances of HBCD, EPA concludes that the Agency's risk determination for HBCD is better characterized as a whole chemical risk determination rather than condition-of-use-specific risk determinations,” reads EPA’s Federal Register notice of the new findings, which is set for publication June 29.

Based on that decision, EPA continues, it is rewriting the Trump administration’s 2020 Toxic Substances Control Act (TSCA) evaluation of HBCD to scrap its determinations that six of the 12 uses the agency analyzed pose unreasonable risks to human health and the environment, and that the other six pose no such risks, replacing them with a broader finding that HBCD “as a whole chemical” poses unreasonable risks.

The new determinations mark the first final action in EPA’s ongoing effort to review and revise the Trump administration’s 10 TSCA evaluations of existing chemicals; it is also proposing to rework the evaluation of pigment violet 29 (PV29) to fit the whole-chemical model.

Meanwhile, industry is launching first-time litigation over EPA’s authority to order new toxicity testing of chemicals slated for TSCA evaluation, with the broadest such suit targeting one of the substances Freedhoff said will be sidelined if the toxics budget remains flat.

Industry Seeks To Set Animal Test Limits In Novel Suit On EPA TSCA Order
The Vinyl Institute (VI) plans to ask a federal appeals court to set a high bar for EPA to justify mandating live-animal tests of toxic chemicals as part of its novel challenge to a TSCA test order, setting up what would be the first court precedent on the legal effect of statutory provisions that direct the agency to minimize vertebrate testing.

On June 23, the group filed its statement of issues for VI v. EPA, likely the first legal challenge to an agency chemical testing order issued under the reformed Toxic Substances Control Act (TSCA). The statement outlines a host of potential arguments VI could raise in the case -- including that provisions in the 2016 law aiming to reduce the use of live-animal tests, which have never been tested in court, are in fact binding.

“EPA failed to adequately explain based on all available information and data . . . why the Avian Reproduction Test is required despite TSCA provisions seeking to reduce vertebrate testing,” reads one entry in the three-page statement to the U.S. Court of Appeals for the District of Columbia Circuit.

VI’s suit is one of at least two pending challenges to the block of TSCA orders EPA issued in March, requiring a host of chemical firms and industry consortia to conduct new toxicity tests on eight chemicals the agency is evaluating for unreasonable risks under the toxics law.


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