Environmental Groups Urge EPA to Block Motiva Chemical Applications

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Environmental groups are urging EPA to deny 17 new chemical applications submitted by Motiva Enterprises for production at its refinery in Port Arthur, Texas, arguing that the new chemicals would endanger nearby residents who already experience disproportionately high exposures to pollution.

Joint comments on the premanufacture notices (PMNs) were submitted by Community In-Power and Development Association and Earthjustice on March 26.  The groups argue that at minimum, there is sufficient cause for EPA to conclude that the chemicals “may present” an unreasonable risk—triggering the agency’s duty under the Toxic Substances Control Act (TSCA) to prohibit or restrict them.

The comments claim that the publicly available versions of the PMNs provide evidence of carcinogenicity and other serious health harms, even though Motiva “unlawfully withheld and redacted critical information” from the submissions.  These hazards are compounded by high estimated production volumes, which the groups say exceed 450 million pounds annually across the 17 chemicals.

Much of the focus is on Port Arthur, “one of the nation’s most severely polluted communities.”  Decades of chemical exposures have led to elevated rates of cancer, heart disease, and respiratory illnesses, especially in the predominantly Black neighborhoods adjacent to the Motiva plant and other industrial facilities, according to the comments.  EPA should treat these neighborhoods as a “potentially exposed or susceptible subpopulation” under amended TSCA, the comments argue.

The groups also point to what they call “Motiva’s long history of malfunctions, accidents, and other chemical incidents” at the Port Arthur site, arguing that future incidents are “reasonably foreseen” and therefore fall within the “conditions of use” EPA must consider in evaluating the PMNs.

All 17 PMNs were submitted by Motiva in January 2025.  Most are generically described as “Hydrocarbon, processed.”

EPA Revises New Chemicals Review Process

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On December 18, 2024, EPA published a final rule revising the new chemicals review provisions under the Toxic Substances Control Act (TSCA).  The rule:

  • Requires an EPA determination on each notice before a submitter may begin manufacturing or processing the chemical, as mandated by amended TSCA;
  • Clarifies the level of detail expected for premanufacture notices (PMNs), significant new use notices (SNUNs), and exemption notices;
  • Modifies EPA’s review process for PMNs and SNUNs, including procedures for handling incomplete or inaccurate submissions;
  • Revises the regulations for low volume exemptions (LVEs) and low releases and low exposures exemptions (LoREXs) to require submitters to wait for EPA approval prior to manufacture; and
  • Prohibits PFAS and certain PBTs from qualifying for LVE and LoREX exemptions.

EPA’s clarification of existing PMN requirements includes greater detail on products that would contain the chemical, manufacturing processes, worker exposures, and releases.  To effectuate these changes, EPA is introducing new reporting fields to the PMN form.

One key change to the procedures for handling incomplete submissions is that EPA will now declare a submission incomplete and restart the review process if a submitter provides required information that was known or reasonably ascertainable at the time of the original submission.  Previously, EPA’s “longstanding practice” was to accept the amendments along with a request to suspend the review period.

Restrained Approach

The final rule largely follows EPA’s May 2023 proposal.  In response to comments, EPA agreed to proactively notify current LVE and LoREX holders about significant new use rules (SNURs) that apply to their chemicals, rather than only providing notice prospectively as originally proposed.  EPA also agreed to expressly codify that the agency has authority to strengthen protections in TSCA section 5 orders based on new information from any source.

Environmental organizations urged EPA to revoke previously granted LVEs for PFAS, but the agency declined to do so in the rule.  However, EPA left open the possibility of future revocations, stating that it “may take future action on a case-by-case basis.”  In general, EPA has not granted new LVEs for PFAS since 2021.

Industry groups, on the other hand, unsuccessfully pushed for more streamlined TSCA section 5 notices.  Among their rejected proposals was a request that EPA only require specific data elements on a case-by-case basis.

The rule takes effect January 17, 2025, shortly before the presidential transition.

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.

Fifth Circuit TSCA Ruling: Established Process Not a “New Use”

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A decades-old manufacturing process cannot constitute a significant new use under TSCA, the US Court of Appeals for the Fifth Circuit ruled on March 21, 2024, in the case Inhance Techs. v. EPA.

Inhance Technologies LLC (“Inhance”) has strengthened plastic containers using the same fluorination process since 1983.  Unbeknownst to Inhance and EPA until March 2022, the fluorination process resulted in the creation of multiple PFAS chemicals that were included in a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate substances, which took effect in September 2020.

When EPA detected PFAS in a container manufactured by Inhance, it issued the Texas-based company a notice of violation of the SNUR because Inhance had not filed significant new use notices (SNUNs) for the PFAS created during the fluorination process.  EPA instructed Inhance to stop or change the fluorination process so that it no longer created PFAS.  Inhance filed two SNUNs in December 2022 but continued fluorinating plastic containers using the same process.  Following review of the SNUNs, in December 2023, EPA issued two orders under TSCA sections 5(e) and 5(f) prohibiting Inhance from manufacturing or processing PFAS through their fluorination process.  In response, Inhance successfully petitioned the Fifth Circuit for expedited review and a stay pending appeal, stating that the company would be forced to shut down if the orders were put into effect.

Inhance argued that EPA’s orders were unlawful for three reasons.  First, Inhance argued that its fluorination technology could not be understood as a “new” use under TSCA because it had been ongoing for over thirty years before EPA finalized the SNUR.  Second, Inhance argued that the PFAS created during the fluorination process constituted impurities, which are exempted from the scope of the SNUR.  Finally, Inhance argued that EPA’s interpretation of the SNUR as applying to all industries is a “reinterpretation” for which Inhance had not received fair notice.

In the end, the court did not address Inhance’s second and third points, finding the first argument sufficient to vacate EPA’s orders.  Though the statute does not define “new,” the court found Inhance’s interpretation, “not previously existing,” more compelling than EPA’s interpretation, “not previously known to the EPA,” for multiple reasons.  But ultimately, the court just did not think EPA’s interpretation was sensible, stating that it “lacks intuitive force.”  Inhance could not have been expected to submit its fluorination process as an ongoing use during the rulemaking process for the SNUR because it did not know that it created PFAS at that time, the court said.

Writing on behalf of the three-judge panel, Judge Cory T. Wilson concluded by stating that EPA is not powerless to regulate Inhance’s fluorination process.  TSCA section 6 allows for regulation of all chemical substances, unlike section 5, which only applies to new substances and significant new uses.  However, unlike section 5 rulemaking, section 6 requires EPA to conduct a cost-benefit analysis, which takes into account the substance’s benefits and economic considerations.  The court stressed that this requirement indicates that Congress wanted EPA to give more thoughtful consideration to the impact of its regulations on preexisting manufacturing processes.

Judge Wilson was joined by Chief Judge Priscilla Richman and Judge James E. Graves Jr., who concurred in the judgment only.

EPA Issues SNUR to Keep Inactive PFAS Out of Commerce

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Inactive PFAS chemicals can no longer reenter commerce without EPA approval under a final significant new use rule (SNUR) issued by EPA on January 11, 2024.

The 329 PFAS subject to the SNUR are currently designated as inactive on the Toxic Substances Control Act (TSCA) Inventory and are not subject to an existing SNUR.  (An inactive designation indicates that a substance has not been manufactured, imported, or processed since 2006, with a handful of exceptions addressed below.)  To identify these chemicals, EPA applied the same definition of PFAS the Agency used in its TSCA section 8(a)(7) PFAS reporting rule issued in October 2023, discussed in a previous Verdant Law blog post.

The SNUR requires companies to notify EPA via a significant new use notification at least 90 days before commencing the manufacture, import, or processing of any of these substances.  Upon receiving notification, EPA will assess whether the new use may present an unreasonable risk to human health or the environment and take appropriate action, if necessary, as required under TSCA section 5.

Import and processing of inactive PFAS-containing articles are exempt from the SNUR.  Covered PFAS also fall outside the scope of the SNUR when they are manufactured, imported, or processed:

  • As impurities;
  • As byproducts not for commercial use purposes;
  • In small quantities solely for R&D;
  • For test marketing purposes;
  • For use as a non-isolated intermediate; or
  • Solely for export from the United States.

To establish a significant new use, EPA must determine that the use is not ongoing.  Because the above uses do not result in an active designation on the TSCA Inventory, EPA could not conclude that there are no ongoing uses for these activities.

EPA Proposes SNURs for Flame Retardants

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EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

Audit Finds EPA’s New Chemicals Program Lacks Sufficient Guidance

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On August 2, 2023, EPA’s Office of Inspector General (“OIG”) released a report on its audit of EPA’s New Chemicals Program. The audit identified recordkeeping and quality assurance issues with the program as administered by EPA’s New Chemicals Division (“NCD”). The audit, which began in October 2021, was conducted in response to several internal complaints submitted to OIG.

The New Chemicals Program reviews whether new chemicals or significant new uses of existing chemicals pose an “unreasonable risk” to human health or the environment under the Toxic Substances Control Act (“TSCA”). According to the report, NCD did not have finalized, up-to-date guidance for recordkeeping or for many of the steps in the new chemicals review process, contrary to EPA protocol.  OIG stated that these issues resulted from insufficient staff resources, which prevented NCD from both conducting the chemical reviews within statutory time frames and finalizing guidance for the activities composing the review process. The report also found frequent technical issues with NCD’s TSCA Confidential Business Information systems.

Some of the complaints to OIG alleged that staff were pressured to focus on deadlines rather than chemicals’ potential risks during the new chemical review process. However, OIG found no evidence of this; for example, the report notes that NCD employees were not evaluated on the speed at which they reviewed chemicals.

OIG made the following four recommendations to EPA’s Office of Pollution Prevention and Toxics (“OCSPP”) based on its findings:

  1. Develop a plan to regularly review NCD’s guidance documents,
  2. Develop a plan to periodically assess the effectiveness of NCD’s recordkeeping system,
  3. Develop a plan to identify the root causes of the technical issues, and
  4. Conduct periodic reviews of NCD’s workload.

OCSPP’s response, which was included in the report, agreed with each of OIG’s recommendations and proposed corrective actions in line with the recommendations.

This audit was not the first to find issues with EPA’s implementation of TSCA provisions. A 2019 GAO report identified similar issues, such as insufficient guidance and resources, with the new chemicals review process. In 2020, OIG found that EPA had missed deadlines on existing chemical risk evaluations and that EPA’s ability to meet future deadlines was at risk. EPA has since proposed a fee adjustment designed to increase TSCA fee collections. Most recently, in February 2023, GAO determined that EPA had missed most TSCA deadlines for reviewing new and existing chemicals.  In general, EPA agreed in part or in full when recommendations were made in these reports and corrective actions have been completed or are pending.

EPA Releases Framework for Addressing New PFAS and New Uses Under TSCA

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EPA has released the Framework for Addressing New PFAS and New Uses of PFAS. This document details the Agency’s planned strategy for evaluating Premanufacture Notices  (“PMNs”) for new PFAS compounds and Significant New Use Notices (“SNUNs”) for “new uses” of existing PFAS to ensure they do not pose harm to human health and the environment.

The Agency states that new PFAS substances present challenges for regulators, as there is frequently limited information available to assess their potential risks accurately. Many PFAS compounds are known to persist in the environment, bioaccumulate, and be toxic (known as “PBT”); the framework aims to qualitatively evaluate PFAS based on how likely they truly are to become PBTs in the body and environment.

The framework distinguishes between PFAS uses that may result in environmental releases and potential exposures and those that don’t. For example, PFAS applications that are deemed to have negligible exposure and minimal environmental release, such as in the closed systems used in the manufacture of electronics. EPA generally anticipates allowing the compounds to enter commerce after exposure data is provided.

The framework calls for more comprehensive testing, including toxicokinetic data, for PBT PFAS compounds that are expected to have a low but greater than negligible potential for environmental release and exposure. If initial testing raises concerns about exposure levels and risks, EPA will mandate further testing and risk mitigation before permitting manufacturing. This comprehensive testing would encompass physical-chemical properties, toxicity, and fate analysis. For example, uses of PFAS in spray-applied stain guards inherently involve releases into the environment. If required testing finds potential hazards, EPA has the authority under TSCA section 5 to demand additional testing and risk mitigation strategies or prohibit manufacturing entirely.

If EPA determines a new chemical substance poses an unreasonable risk, lacks sufficient risk information, or involves substantial production with potential exposure, it must issue a section 5(e) order for human health and environmental protection, which may include testing requirements. If PFAS data suggests it’s a PBT chemical and EPA anticipates exposures, the substance or significant new use could be deemed to present an unreasonable risk, therefore requiring either a section 5(f) order or an immediately effective proposed rule under TSCA section 6(a). The section 5(f) order applies to the submitter, while the 6(a) rule covers all users. For a SNUN, the 6(a) rule typically targets the specified new use. The chart below further details the possible EPA determinations and related actions following their review.

Determination Related Action
In the absence of sufficient information to permit a reasoned evaluation of risk from the substance or significant new use, the substance or significant new use may present an unreasonable risk. EPA must issue an order under TSCA section 5(e).
There is insufficient information to permit a reasoned evaluation of risk from the substance or new use. EPA must issue an order under TSCA section 5(e).
The substance or significant new use presents an unreasonable risk. EPA must take action under TSCA section 5(f).
The substance is or will be produced in substantial quantities, and there may be significant or substantial human and/or environmental exposure (exposure-based). EPA must issue an order under TSCA section 5(e).
The substance or significant new use is not likely to present an unreasonable risk. EPA notifies the submitter of its decision and publishes its findings in the Federal Register.

 

TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR

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In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.

The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”).  The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.

Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.

According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”)  Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements.  The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.

Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.

In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.

In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.

EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:

  • Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
  • Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
  • Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
  • Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.

Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.

Case Update

In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”

On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.

EPA Updates New Chemical Review Program Webpage to Increase Transparency

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In December 2022, EPA announced updates to its New Chemicals Review Program website to include additional information and metrics on the Agency’s review of new chemicals and significant new uses.  In the announcement, the Agency stressed its commitment to increasing efficiency, effectiveness, and transparency through the chemical review process. To progress in this goal, the website will now include:

  • A more detailed breakdown of new chemical submissions, including a month-by-month count of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions.
  • Greater details and explanations on each step of the review process. This includes “the extent to which the submitter has provided additional information during the review period – subsequent to the original submission – and the level of effort needed to potentially rework some or all of the risk assessment as a result” and applicability of new approaches developed by the Agency to standardize reviews for certain new chemicals.
  • A status tracker for new chemical exemptions (e.g., Low Volume Exemptions (LVEs) and Test Market Exemptions (TMEs)).

According to EPA, the new website will be updated monthly.