Court Approves Tight Deadlines for Overdue Risk Evaluations

/in , , ,

The D.C. District Court has entered two consent decrees concerning over twenty overdue Toxic Substances Control Act (TSCA) risk evaluations, holding the incoming administration’s EPA to aggressive deadlines for completing the chemical reviews.

The consent decrees, approved November 22, concern 20 risk evaluations initiated by EPA in December 2019 and two manufacturer-requested risk evaluations initiated in January 2020.  None were completed within TSCA’s 3.5-year deadline.

Under the consent decrees, linked here and here, EPA will be required to complete:

  • Draft risk evaluations for six of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for TCEP, formaldehyde, 1,1-dichloroethane, and DIDP by December 31, 2024;
  • A final risk evaluation for DINP by January 15, 2025;
  • A draft risk evaluation for one of the remaining substances by March 31, 2025;
  • Final risk evaluations for seven of the substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

The deadlines are largely unchanged from those in the proposed consent decrees, released in April and discussed in a previous blog post.  Since then, EPA has released a final risk evaluation for TCEP and drafts for 1,1-dichloroethane, DINP, and 1,3-butadiene.  However, as it stands, EPA will be required to complete three more final risk evaluations before the end of 2025—and a fourth before the presidential transition.

Meanwhile, EPA looks likely to designate another five chemicals as “high priority” this December, automatically triggering new risk evaluations.  More on those chemicals can be found here.

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

/in , ,

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

/in , , ,

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.

EPA Issues Test Order for PFAS 6:2 FTAc

/in , ,

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

/in , , , ,

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 Proposes Adding Over 100 PFAS to TRI List

/in , ,

Significantly more PFAS substances would be subject to Toxic Release Inventory (TRI) reporting under a proposed rule published by EPA on October 8, 2024.  The proposed rule would add 16 individual PFAS and 15 PFAS categories to the TRI list, which currently contains 196 PFAS.

The proposed additions would be made due to their potential human health effects, environmental effects, or both.  According to EPA, the 15 proposed category additions encompass over 100 individual PFAS.

The added PFAS would be subject to a reporting threshold of 100 pounds.  The manufacture, processing, and otherwise use of substances within a PFAS category would cumulatively count towards that category’s 100-pound threshold.

EPA is also proposing to add the proposed PFAS to the list of chemicals of special concern, which would make them ineligible for the de minimis exemption.  Under the de minimis exemption, facilities can disregard small concentrations of TRI chemicals in mixtures and trade name products when making threshold determinations.

EPA previously designated existing PFAS on the TRI list as chemicals of special concern in October 2023.  In that rulemaking, EPA argued that the move would “result in a more complete picture of the releases and waste management quantities for PFAS.”

The FY 2020 National Defense Authorization Act (NDAA) instructed EPA to add certain PFAS to the TRI list with a 100-pound reporting threshold.  “Congress’ use of this low reporting threshold demonstrates a concern for even relatively small quantities of these PFAS,” EPA said.

EPA was required to evaluate some of the proposed PFAS additions for possible inclusion by section 7321 of the NDAA.  However, the NDAA did not specify what the threshold should be for those additions.  In the proposed rule, EPA defended its proposed 100-pound threshold, saying that it would “maintain consistency for all chemicals added to TRI pursuant to the NDAA.”

The NDAA also instructs EPA to add PFAS automatically when certain conditions are met.  In the proposed rule, EPA clarified its interpretation of those conditions, which include when EPA “finalizes a toxicity value” for a PFAS.

Finally, EPA is proposing that it add related PFAS (like an acid and its associated salts) under the NDAA as a category going forward. The proposed rule would also consolidate certain existing individual PFAS on the list into categories.

Comments on the proposed rule are due November 7, 2024.

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

/in , ,

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.

Third Circuit FIFRA Preemption Ruling Creates Circuit Split

/in , ,

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts a Pennsylvania law that allegedly requires Monsanto to include a cancer warning on its “Roundup” weedkillers, the Third Circuit ruled on August 15, 2024.  The decision in Schaffner v. Monsanto Corp. creates a split with the Ninth and Eleventh Circuits, which have found that similar state-level duty to warn laws were not preempted because the state-law labelling requirements were equivalent to a requirement under FIFRA.

Like the Ninth and Eleventh circuits, the Third Circuit applied a “parallel requirements” test outlined by the Supreme Court in Bates v. Dow Agriscience LLC to determine whether the state law diverged from FIFRA requirements.  Those circuits determined that the state laws were not preempted because they were equivalent to FIFRA’s statutory definition of “misbranding.”

But the Third Circuit ruled that those circuits erred when conducting the test by failing to take into account EPA regulations limiting the modification of precautionary statements on labels.  According to the court, these regulations would require Monsanto to seek EPA approval before adding a warning.

“If EPA regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement,” the court said.  “The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.”

The highly technical decision had to contend with the Supreme Court’s holding in Bates, which it acknowledged “plausibly indicates that [FIFRA] does not on its own preempt all state-law duties to include a warning omitted from” its label.  The Third Circuit concluded that there was no discrepancy because the Supreme Court had not considered how regulations would affect preemption under FIFRA section 136v(b), which addresses preemption.

Writing for the panel, Chief Judge Michael A. Chagares rejected arguments that the Third Circuit should be bound to the Ninth Circuit’s decision.  “The complex subject of preemption under FIFRA has not been comprehensively analyzed in prior caselaw, and the Supreme Court has yet to address FIFRA preemption in the specific circumstances presented by this case,” the decision states.

He also noted that the Supreme Court’s recent overruling of Chevron deference did not undermine EPA’s authority to promulgate FIFRA regulations, including those requiring agency preapproval of product labels, because FIFRA explicitly grants EPA authority “to prescribe regulations to carry out the [statute’s] provisions.”

The Supreme Court denied Monsanto’s petition for certiorari in the Ninth Circuit’s case, Hardeman v. Monsanto Co., in 2022.  A blog post on the Eleventh Circuit’s case, Carson v. Monsanto Co., can be found here.

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

/in , ,

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.

EPA Issues Seldom-Used Emergency Order to Suspend Registrations of Pesticide DCPA

/in , , ,

For the first time in almost 40 years, EPA has issued an emergency order under section 6(c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act to suspend the registrations of all pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (DCPA).

The emergency measure is based on DCPA’s thyroid effects in fetuses, which EPA deemed so severe that continued use of DCPA during the time period required to cancel its registrations would pose an imminent hazard.  According to EPA, thyroid hormone perturbations linked to DCPA “can lead to downstream health problems such as low birth weight, impaired brain development, decreased IQ, impaired motor skills, and decreased bone deposition.”

Occupational exposures to DCPA can be over twice as high (as a factor of body weight) as the level at which the thyroid effects were observed in mouse fetuses, and the herbicide’s residues present risks of concern even 30 days after application to crops, EPA said.  DCPA is also registered for non-agricultural uses, including on golf courses and athletic fields.

American Vanguard Corporation (AMVAC), the sole registrant of DCPA, voluntarily canceled all but two of its DCPA products and their use on turf.  It also voluntarily ceased sale and distribution of the only remaining end-use product until EPA approved product labels that would address DCPA’s risks.  However, EPA “determined that there is no combination of practicable mitigations under which DCPA use can continue without presenting an imminent hazard.”

DCPA is currently undergoing registration review, which occurs every 15 years.  EPA assessed DCPA’s health risks in 2023 after AMVAC submitted a study on its thyroid effects and other information requested by the agency.

The agency intends to issue a notice of intent to cancel DCPA registrations within 90 days of the order, which was published on August 7, 2024.

Also known by its trade name Dacthal, DCPA is used on a variety of crops for weed control.  According to EPA, the emergency order will have a negligible impact on produce prices but may impact growers of crops including bok choy, collards, kale, green onions, and leeks.

Update:

On August 28, 2024, EPA announced that it is initiating a voluntary cancellation of DCPA after AMVAC notified the agency of its intent to cancel the remaining pesticide products.  According to EPA, AMVAC also intends to cancel its international registrations.