Science Advisory Board to Review Co-exposure Approach to TSCA Risk Evaluations

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This October, the Science Advisory Board (SAB) received an EPA briefing on a proposed “screening level analysis” that could account for cumulative chemical exposures in Toxic Substances Control Act (TSCA) risk evaluations.

Released in September 2023, EPA’s draft approach is designed to support the identification of potentially exposed or susceptible subpopulations (PESS) and co-exposures with other chemicals.  It relies heavily on AirToxScreen, a modelling tool already used by EPA to estimate chemical inhalation exposure and risk at the national level.

The draft approach “can be used to better inform chemical co-exposure, highlight geographic areas or population groups that may experience disproportionate impacts, and identify areas that may need more targeted or higher tier exposure and risk characterization.”  It is not intended to be “used as a sole basis for health or regulatory action,” however.

Limitations to the draft approach include its narrow focus on industrial releases to air and reliance on annual data, which makes it impossible to determine whether releases occurred concurrently.  In addition, the model does not calculate “a total additive exposure or total additive risk across the chemicals included in the analysis.”

Historically, TSCA risk evaluations have evaluated a single chemical and considered routes of exposure separately.  However, in a slideshow from the October 15–16 SAB meeting, EPA noted that there is “wide acknowledgement in [the] scientific and regulatory community [that] multiple facility and chemical exposures” meaningfully intersect.

The agency also emphasized the environmental justice concerns tied to cumulative exposures, which disproportionately affect marginalized communities.

The SAB is expected to provide formal comments on the approach in the coming months.

Industry Petitioners Challenge EPA’s Use of TSCA to Regulate Workplace Chemical Exposures

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Industry petitioners are arguing before the D.C. Circuit that EPA has overstepped its authority under the Toxic Substances Control Act (TSCA) by assuming powers to regulate worker chemical exposures—powers that they argue that rightfully belong to OSHA.

United Steel Workers v. EPA, No. 24-1151, consolidates multiple cases challenging EPA’s May 2024 revisions to the procedures for TSCA risk evaluations.  That rule reversed key Trump-era policies by requiring the agency to consider all possible uses of a chemical, issue a single risk determination, and not assume PPE usage.

The industry petitioners, which include the Texas Chemistry Council and the American Chemistry Council, are challenging these changes in full.  However, their October 10 brief also questions EPA’s ability to circumvent OSHA’s role in regulating workplace chemical exposures, arguing that “TSCA is not, and was not intended to be, a worker protection law.”

Their arguments center on TSCA section 9, which allows EPA to report a chemical’s unreasonable risks to another agency if EPA believes they could mitigate the risks.  “In context, TSCA requires EPA to refer regulation of TSCA chemicals that pose unreasonable risks to workers to OSHA if regulation under the OSH Act may prevent or reduce risks of chemical exposure in the workplace,” the industry petitioners’ brief states.  “Only if the referral agency fails to act may EPA proceed to regulate those risks to workers.”

The industry petitioners additionally argue that EPA should give greater consideration to existing OSHA regulations, including those requiring the use of PPE, when considering chemical exposures to workers.  However, a collection of labor petitioners in the case contend that EPA should be prohibited from considering PPE entirely during risk evaluations, asserting that the agency’s approach “confuses risk evaluation with risk management.”

EPA has declined to exercise its referral powers in recent rulemakings, arguing that “gaps exist between OSHA’s authority to set workplace standards under the OSH Act and EPA’s obligations under TSCA section 6 to eliminate unreasonable risk.”  For example, according to EPA, OSHA must consider the economic and technological feasibility of regulation in circumstances where EPA does not.

More on EPA’s 2024 revisions to the procedures for TSCA risk evaluations can be found in a previous blog post.

CEH Sues Chemical Company over CDR Import Reporting Omissions

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The Center for Environmental Health (CEH) has sued AOC, LLC, a resins and specialty materials company, alleging that it failed to report imports under EPA’s Chemical Data Reporting (CDR) rule.  The Toxic Substances Control Act citizen suit is the latest of several complaints filed by CEH against chemical importers for alleged CDR violations.

CEH’s complaint, filed June 20, 2024, alleges that AOC imported hundreds of thousands of pounds of phthalic anhydride, neopentyl glycol, and dicyclopentadiene during the 2020 CDR reporting period.  However, despite the imports greatly exceeding CDR’s 25,000-pound threshold, the complaint claims that no evidence of the imports were found in EPA’s CDR database.

“CDR reporting is an essential tool for tracking the production and use of toxic substances,” the complaint states. “AOC’s failure to report large chemical imports under the CDR rule weakens the ability of EPA and local communities to evaluate and protect against serious threats to health.”

The complaint does not say how CEH identified the alleged imports.  However, the organization stated that it uncovered a previous violation through a “search of publicly available data” on chemical imports.

CEH filed similar complaints against three importers in June 2021.  A CEH notice also prompted the Chevron Phillips Company to disclose numerous violations concerning 24 chemicals in July 2021, according to a CEH press release.

Update

On October 30, 2024, CEH announced that it had filed additional suits against Entegris, Inc. and Lubrizol Corp. for alleged 2020 CDR reporting period violations.  According to the complaints, Entegris failed to report cobalt sulfate and phosphoric acid imports and Lubrizol failed to report 2-propylheptanol and di-(2-ethylhexyl)amine imports.

The press release also announced that CEH reached a settlement with AOC.  “[AOC’s] diligent response to CEH’s concerns is to be commended,” CEH attorney and former EPA official Bob Sussman said.

EPA Issues Test Order for PFAS 6:2 FTAc

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On October 9, 2024, EPA issued a test order under the Toxic Substances Control Act (TSCA) for the PFAS chemical 6:2 FTAc (CASRN 17527-29-6).  The order is the fifth issued under EPA’s National PFAS Testing Strategy, which was launched in 2021.

The order employs a tiered testing approach, as required by TSCA.  Studies on 6:2 FTAc’s physical and chemical properties and environmental fate and behavior will inform future testing on oral and inhalation health effects, reproductive and developmental toxicity, and bioaccumulation in fish.  The earliest test is due 255 days after the order took effect October 13, with most initial testing due within one year.

Depending on the results of hydrolysis testing, the companies subject to the order— Innovative Chemical Technologies, Chemours, Daikin America, Inc., Sumitomo Corp. of Americas, and Du Pont de Nemours and Co.—will also be required to conduct in vitro assays to assess skin absorption, genotoxicity, and/or mutagenicity.

According to an EPA press release, summaries of studies indicate 6:2 FTAc can “cause changes in blood cell counts, liver and kidney size, and animal behavior” in rodents.  However, EPA was unable to obtain the underlying data for these summaries and therefore determined that they did not meet the order’s data needs.

EPA also noted that 6:2 FTAc’s chemical structure “suggests that it may cause cancer.”  Like previous PFAS test orders, the agency plans to use the collected data to learn more about the potential human health effects of other structurally similar PFAS.

The order is the first issued since the D.C. Circuit’s July ruling in Vinyl Institute v. EPA, which vacated a test order due to insufficient justification in the public record.  The test order does not reference the case, which was discussed in a previous blog post.

6:2 FTAc is used to manufacture textiles, apparel, leather, and other basic organic chemicals.  Chemical Data Reporting indicates that 1–20 million pounds of 6:2 FTAc are manufactured annually.

eBay Not Liable for Environmental Violations on Its Platform, Court Rules

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A federal judge has dismissed a lawsuit brought by the Justice Department against eBay for allegedly selling products that violate environmental statutes, holding that eBay cannot be held liable under an internet speech law.

The September 30 order in United States of America v. eBay, Inc., No. 23-CV-7173, applies section 230 of the Communications Decency Act (CDA), which shields providers of interactive computer services from being “treated as the publisher” of information “provided by another information content provider.”

Because eBay did not “materially contribute to the illegal products’ ‘alleged unlawfulness,’” it is immune for content on its platform, the U.S. District Court for the Eastern District of New York held.

The government’s complaint alleged the sale of “hundreds of thousands” of products in violation of the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA), including automobile aftermarket defeat devices and unregistered pesticides.

The court also held that the challenges under the CAA and FIFRA would have failed regardless of CDA immunity because those laws require illegal products to be “sold” for a violation to occur.  “To ‘sell’ an item one must either possess the physical item or its title” and eBay possesses neither, the order states.

But the alleged TSCA violations—the distribution of products illegally containing methylene chloride—could have proceeded, the court noted, because TSCA only requires that a product be “introduc[ed] into commerce” for a violation to occur.

An earlier blog post on the case can be found here.

EPA’s Draft Risk Evaluation of DINP Finds Minimal Risks, but Determines That the Phthalate Presents an Unreasonable Risk

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On August 30, 2024, EPA released its draft risk evaluation for diisononyl phthalate (DINP).  The draft risk evaluation determined that most uses of DINP under the Toxic Substances Control Act (TSCA) “do not pose risk to the environment or the general population.”

The draft only identified three uses that “raise concerns” out of 47 evaluated conditions of use.  However, EPA preliminarily found that DINP presents an unreasonable risk of injury to human health due to the agency’s “single risk determination” approach to risk evaluations.

Two of these three uses were found to raise concerns for workers: industrial use of adhesives and sealants and industrial use of paints and coatings, specifically in scenarios in which unprotected workers used high-pressure sprayers.  According to the draft, these uses could create high concentrations of DINP in mist that an unprotected worker could inhale.

The other use—use of DINP in construction and building materials that cover large surface areas—was found to raise concerns for consumers.  This use could result in young children inhaling DINP-containing dust that settles “onto vinyl flooring, in-place wallpaper, and carpet backing and [is] resuspended into the indoor environment,” the draft says.

The draft risk evaluation identified developmental toxicity and liver damage as potential health effects of these types of exposures.  DINP also has the potential to cause “phthalate syndrome,” a collection of adverse effects on the developing male reproductive system, EPA said.

According to EPA, DINP is primarily used as a plasticizer to manufacture flexible polyvinyl chloride, better known as PVC.  Data from the Chemical Data Reporting rule indicates that hundreds of millions of pounds of DINP are manufactured annually.

EPA initiated the risk evaluation process after a 2019 request from ExxonMobil Chemical Company to review DINP and its chemical relative diisodecyl phthalate (DIDP).  EPA only found one concerning condition of use in DIDP’s draft risk evaluation, which was released this May.

DINP is a category of chemical substances which include 1,2-benzene-dicarboxylic acid, 1,2-diisononyl ester (CASRN 28553-12-0) and 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich (CASRN 68515-48-0).

Amended TSCA requires EPA to issue a risk management rule to address any unreasonable risks found by the final evaluation.  Comments on the draft risk evaluation are due on November 4, 2024.

Court Vacates EPA Test Order, Citing Incomplete Evidence in Public Record

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On August 28, 2024, the D.C. Circuit issued an order in Vinyl Institute v. EPA, a case challenging a Toxic Substances Control Act (TSCA) test order issued in March 2022.  The mandate signals that neither party intends to appeal the court’s July 5 ruling, which found EPA’s justification for the test order inadequate.

The test order, which required an avian reproduction study of 1,1,2-Trichloroethane, was vacated and remanded to EPA.  However, the panel noted several places in which additional EPA materials would have satisfied TSCA’s “substantial evidence” standard if they were included in the public record, suggesting that EPA would not necessarily be required to perform additional analyses to justify future test orders as long as the analyses were included in the record.

For example, the court ruled that EPA’s “conclusory statements” in the public record on why vertebrate testing was necessary were inadequate, but also said that other documents showed that EPA considered new approach methodologies (as required by TSCA).  However, the court ruled that these documents—although covered by EPA’s brief—were not part of the administrative record that was available to the public, and that therefore “they are not part of the record subject to our review.”

According to the decision, not all studies referenced in the statement of need accompanying the test order were explained or even identified.  Nor did EPA publicly explain why those studies’ findings could not be used to fill the data gap, the court said.

“EPA should have explained why it could not extrapolate mammalian chronic exposure data to avian chronic exposure in its Statement of Need description of reasonably available information,” Judge Karen LeCraft Henderson wrote.  “Identifying close but ultimately inapplicable studies and explaining, in the record, why it could not extrapolate other potentially relevant findings could constitute substantial evidence.”

However, the court upheld EPA’s decision to issue a test order rather than pursuing a rule or consent agreement, agreeing with EPA that timeliness in acquiring the data was sufficient justification. EPA initiated the risk evaluation for 1,1,2-Trichloroethane in December 2019 but has yet to issue a report on its findings.

Judge Henderson also agreed that EPA was not required to demonstrate that exposure may exist at potentially toxic levels before issuing a test order.  That would “reverse[]…TSCA’s allocation of burdens,” the decision states.

Judge Henderson was joined in full by Judge Florence Pan and in part by Judge Justin Walker.  A previous blog post on the case, written after the December 2023 oral argument, can be found here.

Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

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EPA’s alleged failure to disclose certain information submitted to its New Chemicals Program is subject to judicial review under the Toxic Substances Control Act (TSCA) and the Administrative Procedure Act (APA), the D.C. District Court ruled on August 20, 2024.

In Environmental Defense Fund v. Regan,  No. 1:20-cv-00762-LLA, five environmental organizations allege that EPA engages in a pattern or practice of violating TSCA’s disclosure requirements for premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs).  The suit’s 10 counts include allegations that EPA failed to publish timely and complete notices of receipt of PMNs; failed to make health and safety studies, safety data sheets, and other information contained in PMN submissions available for examination; and failed to disclose information claimed as confidential business information when it facially did not qualify as confidential.

EPA moved for judgment on the pleadings, asserting that the plaintiffs are barred from seeking relief under TSCA for most of their claims.  While TSCA’s citizen suit provisions allow persons to compel the agency to perform nondiscretionary duties, EPA argued that the relevant statutory and regulatory provisions “do not impose a date-certain deadline” on EPA.  The agency also argued that judicial review under the APA would be inappropriate because the claims concern activities that are interlocutory in nature and too minor to meet the APA’s threshold for “agency action.”

The court denied EPA’s motion.  Even in instances where TSCA does not set an explicit deadline, the court said that it is sometimes apparent that activities must be taken in relation to other events.  Three of the plaintiffs’ 10 counts were found to fall in this category.  For example, TSCA directs EPA to provide immediate notice of TME applications for public input and requires EPA to make a determination on each application within 45 days.  Since “[n]otice must precede comment” and “comment must precede the EPA’s decision,” “[t]he only logical conclusion” is that notice is required prior to expiration of the 45-day period, the court held.

For the seven remaining allegations—which all concerned the availability of information submitted with a new chemical notification, and for which a deadline for agency disclosure to interested parties could not be ascertained from the statutory structure—the court was unconvinced by EPA’s argument that the APA could not offer relief.  The APA’s definition of agency action has been interpreted expansively by the courts, and the fact that the challenged activities are merely “interim steps” is not dispositive, the decision states.  Importantly, as part of this analysis, the court held that TSCA section 5(b) creates a “freestanding right to information” submitted as part of a new chemical notification.

Judge Loren L. AliKhan also granted the plaintiffs’ motion to compel the administrative record, rejecting EPA’s arguments that the claims should be understood as “failures to act” rather than actions—meaning that they would not have an administrative record.  However, she did not go so far as to agree with the plaintiffs on the merits.

According to EPA, since the case was filed in 2020, the agency has made “substantial and ongoing improvements to its practices for preparing and publishing public notices and public files as part of its ongoing commitment to improving the administration and transparency” of its New Chemicals Program.

In addition to the Environmental Defense Fund, the plaintiffs include the Center for Environmental Health, the Environmental Health Strategy Center, the Natural Resources Defense Council, and the Sierra Club.

EPA Proposes Risk Management Rule for 1-Bromopropane

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On August 8, 2024, EPA published a proposed rule to restrict use of the solvent 1-bromopropane (1-BP) (CASRN 106-94-5).  The proposed rule is the result of the agency’s revised 2022 determination that 1-BP presents an unreasonable risk of injury to human health due to effects including neurotoxicity, developmental toxicity, and carcinogenicity.

According to EPA, 1-BP is used in a wide variety of applications, including “vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation.”  Data from the Chemical Data Reporting rule shows that annual production of the substance, also known as n-propyl bromide, increased from 15.4 to 25.8 million pounds between 2012 and 2015.  This increase was because 1-BP is “an alternative to ozone-depleting substances and chlorinated solvents,” according to a 2020 EPA risk evaluation.

Under the proposed rule, all consumer uses of 1-BP would be banned except for use in insulation.  EPA is also proposing to prohibit four industrial and commercial uses, including use in adhesives and sealants, dry cleaning solvents, and automotive care products.  EPA estimates that these banned uses represent about 3% of the current annual production of 1-BP.

Other industrial and commercial uses would be subject to a workplace chemical protection program (WCPP), which would implement an inhalation exposure concentration limit for 1-BP of 0.05 ppm as an eight-hour time weighted average.  Use of chemically resistant gloves would also be required for uses including manufacturing, processing, and disposal.

Notably, in an effort to protect fenceline communities, EPA is proposing to prohibit owners or operators from increasing releases of 1-BP to outdoor air to comply with WCPP requirements.

EPA is proposing staggered compliance dates for the prohibited uses, which would become effective in six months for manufacturers, nine months for processors, and in 12 months for distribution to retailers.  Non-federal entities subject to the WCPP would be required to conduct baseline airborne exposure testing within six months and ensure that the inhalation exposure limit is met within nine months.

1-BP was added to the Toxics Release Inventory list of reportable chemicals in 2015 and became the first addition to the list of hazardous air pollutants in 2022.  More on 1-BP’s addition to the list can be found in a previous blog post.

Comments on the proposed rule are due September 23, 2024.

EPA Proposes to Designate Five Substances as High Priority

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On July 25, 2024, EPA published a notice proposing to designate a new batch of existing chemicals as high priority substances under section 6 of the Toxic Substances Control Act (TSCA).  TSCA section 6 requires EPA to continually designate existing chemicals as “high-priority” based on factors including hazard and exposure potential.  Once a high priority designation is made, EPA is required to conduct a risk evaluation and regulate the chemical if it is found to present an unreasonable risk.

If the notice is finalized as proposed, EPA would immediately initiate risk evaluations for the following five substances:

  • Vinyl Chloride (CASRN 75-01-4)
  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

According to an EPA press release, vinyl chloride is a known human carcinogen linked to liver, brain, and lung cancer in exposed workers.  In the release, EPA stated that vinyl chloride’s health hazards helped motivate the passage of TSCA in 1976.

The press release noted that the other four substances are probable human carcinogens and that some pose other types of hazards, such as respiratory and reproductive harms.  All five substances are used to make plastic; vinyl chloride is mostly used to make polyvinyl chloride, better known as PVC.

EPA announced that it was beginning the process of prioritizing these chemicals in December 2023.  In that announcement, EPA also stated that that it “expects to initiate prioritization on five chemicals every year, which will create a sustainable and effective pace for risk evaluations.”

Comments on the notice are due October 23, 2024.