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EPA’s TSCA Pre-Prioritization Webinar
/in Chemicals of Concern, EPA, News & EventsOn September 30, 2024, a lead toxicologist in the Data Gathering Management and Policy Division within the Office of Pollution Prevent and Toxics presented an overview of prioritization and pre-prioritization efforts for existing chemicals under the Toxic Substances Control Act (TSCA). The Agency’s goal was to collaborate with attendees to evaluate the potential risks of existing industrial chemicals regulated under TSCA. Topics covered included a high-level overview of TSCA authorities, requirements, and timelines for evaluating existing chemicals. Additionally, EPA covered the Agency’s approach for identifying the chemicals that may undergo prioritization.
Under TSCA, EPA is required to evaluate the potential risks of chemical substances comprehensively, taking into account their cradle-to-grave life cycle. This process involves assessing the chemical’s potential exposure and risks from production through disposal and includes all identified uses. First, the webinar touched on the key aspects for the Risk Evaluation process.
EPA then noted that the prioritization process reflects the Agency’s evolving approach to addressing chemical risks efficiently and inclusively under TSCA. EPA identified 27 chemical substances that are being considered for prioritization under TSCA, focusing on their inclusion in the 2014 TSCA Work Plan, the interests of other agencies, and the availability of hazard and exposure data. The 2014 TSCA Work Plan identified approximately 90 chemicals as priorities for risk evaluation based on hazards, exposure risks, and their environmental or health impact. In addition, three chemical substances that were not listed in the 2014 Work plan are being considered for prioritization Two of these chemicals were identified through TSCA Section 21 petitions: Hydrogen fluoride (HF) and 6PPD. Bisphenol S (BPS) is also being considered for prioritization. The Agency explained that BPS could become a priority if bisphenol A (BPA) undergoes prioritization, as BPS is a key alternative to BPA in the market.
EPA reminded participants that the Agency uses Section 4 and Section 8 under TSCA to gather data on the chemicals for prioritization, risk evaluation, and risk management. TSCA Section 4 provides authority for mandatory testing of chemicals to fill data gaps through test orders, test rules, and consent agreements. TSCA Section 8 allows for reporting and recordkeeping of existing chemical-related data, including reports of significant adverse health or environmental reactions.
The Agency noted that it prioritizes chemicals with robust existing data to streamline risk evaluation and reduce delays caused by insufficient information. The inclusion of both 2014 TSCA Work Plan chemicals and newly highlighted substances reflects intent to address historical priorities while also adapting to emerging concerns raised by stakeholders or other agencies.
Work Plan Chemicals:
1-Hexadecanol
2-Ethylhexyl
tetrabromobenzoate (TBB)
4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)
Benzene
bis(2-Ethylhexyl) – 3,4,5,6-Tetrabromophthalate (TBPH)
Bisphenol A
Creosote
Di-n-octyl phthalate (DnOP)
Ethylbenzene
Naphthalene
N-Nitroso-diphenylamine
p,p’-Oxybis(benzenesulfonylhydrazide)
Styrene
Tribromomethane
Triglycidyl isocyanurate
m-Xylene
o-Xylene
p-Xylene
Antimony & Antimony Compounds
Arsenic & Arsenic Compounds
Cobalt & Cobalt Compounds
Lead & Lead Compounds
Long-chain chlorinated paraffins (C18-20)
Medium-chain chlorinated paraffins (C14-17)
Non-Work Plan Chemicals:
Bisphenol S
Hydrogen fluoride
N-(1,3-Dimethylbutyl)-N’-phenyl-pphenylenediamine (6PPD)
D.C. Circuit Rejects Environmentalist Arguments, Sides with Industry over TSCA CBI Rule
/in CBI, EPA, News & Events, TSCAEPA’s 2023 rule revising confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) is only unlawful insofar as it could lead to certain inadvertent waivers of confidentiality by downstream entities, the D.C. Circuit ruled on December 20, 2024.
The case, Environmental Defense Fund v. EPA, No. 23-01166, consolidated petitions from the Environmental Defense Fund (EDF) and the American Chemistry Council (ACC). EDF’s arguments in favor of narrower confidentiality protections were rejected by the court, whose ruling leaves EPA’s CBI rule largely intact.
However, the court agreed with ACC’s challenge to a provision in the rule that allowed downstream entities to waive CBI protections put in place by the upstream manufacturer when reporting information to EPA. Specifically, ACC argued that the rule’s requirement that downstream entities assert and substantiate confidentiality claims for chemical identities reported via an “accession number” is arbitrary and capricious. Under the CBI rule, if “any submitting entity fails to substantiate a confidentiality claim for a chemical identity…the chemical identity is no longer entitled to confidential treatment.”
Accession numbers are non-confidential identifiers assigned to chemicals whose identities are claimed as CBI. Downstream entities reporting information to EPA using an accession number may have no knowledge of the chemical’s actual identity, the court noted, and may not have any incentive to keep it secret. Nor would they necessarily have the information needed to adequately substantiate a claim, the opinion continues.
“This regulatory scheme cannot be squared with the commands of the statute, which require EPA to protect from disclosure chemical identities for which CBI claims have been properly assessed,” the court held, vacating the CBI rule “to the extent it allows for the unlawful disclosure of confidential information.”
Key Provisions are “Best Reading”
EDF challenged three provisions of the CBI rule. The court rejected these challenges, explaining that EPA’s positions were consistent with the “best reading” of the statute—the new legal framework adopted by the Supreme Court in Loper Bright v. Raimondo, the decision that struck down Chevron deference.
EDF argued that the rule’s use of “permissive” language and revised timeframe for when a CBI claim must first be substantiated were arbitrary and capricious. However, the court found that the CBI rule sufficiently justified why those changes were necessary. The permissive language at issue included a provision allowing EPA discretion in whether to disclose information that has lost CBI protection, unlike earlier regulations requiring its immediate and automatic release.
EDF also challenged the scope of the CBI rule’s definition of a “health and safety study,” which are statutorily ineligible for CBI protection. EDF contended that the definition should include the entirety of any written report submitted to EPA that presents findings of a health and safety study, including information like the identity of the company submitting the report and the name of the lab that conducted the study—information which is currently eligible for CBI protection. The court disagreed, holding that the statutory definition of health and safety study “suggest[s] that the term refers only to the evaluation of a chemical’s health and environmental effects, not the entire document containing that evaluation.”
More on the CBI rule can be found in a previous blog post. An earlier post on the case, written after EDF filed its statement of issues, can be found here.
Court Approves Tight Deadlines for Overdue Risk Evaluations
/in EPA, News & Events, Risk Evaluations, TSCAThe 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:
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.
CEH Sues Chemical Company over CDR Import Reporting Omissions
/in CDR, Enforcement, News & Events, TSCAThe 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.
California Sues ExxonMobil for Deceptive Marketing on Plastic Recycling
/in California, Green Marketing, News & Events, RecyclingExxonMobil deceived the people of California by falsely promoting single-use plastics as sustainable, a complaint filed by California’s attorney general on September 23, 2024, alleges.
The lawsuit, filed in the San Francisco County Superior Court, argues that ExxonMobil conducted a “decades-long campaign of deception” to convince the public that plastics recycling was a sustainable solution to plastic waste, despite knowing that plastics recycling “is technically and economically nonviable to handle the amount of plastic waste [the company] produces.” ExxonMobil is the largest producer of plastic polymers in the world.
“ExxonMobil’s deceptions undermined consumers’ ability to make informed choices to avoid the catastrophic harms we are experiencing,” the complaint states. The attorney general asserts that “single-use plastic chokes our waterways, poisons our oceans, harms already endangered and threatened wildlife, blights our landscapes, contaminates the recycling stream, increases waste management costs, pollutes our drinking water, and expands landfills.”
Special focus was given in the complaint to ExxonMobil’s claims about “advanced recycling,” a collection of non-mechanical recycling technologies designed to convert certain plastic wastes into “fuels, chemicals, waxes, and petrochemical feedstock.” According to the suit, ExxonMobil conceals several key limitations of its advanced recycling program, including that only 8% of processed waste becomes new plastic and that its “certified circular polymers” are made of “virtually no waste plastic.”
The lawsuit alleges violations of state nuisance, natural resources, water pollution, false advertisement, and unfair competition laws. The complaint seeks abatement funds, disgorgement, and civil penalties. California’s attorney general reportedly said they want “billions of dollars” for the abatement fund.
It has been reported that ExxonMobil responded by claiming that California officials have known for decades that their state recycling program is ineffective, arguing that the officials “failed to act, and now…seek to blame others.” The company has been quoted as asserting that “[i]nstead of suing us, they could have worked with use to fix the problem and keep plastic out of landfills.”
Irene Hantman and Philip Moffat Present on Green Marketing at PSX 2024
/in Green Marketing, News & EventsVerdant Law is pleased to announce that Irene Hantman and Philip Moffat presented on green marketing and product stewardship at the PSX 2024 conference in Denver. Their October 16 presentation covered greenwashing, US regulation of green marketing, and enforcement and litigation.
Green marketing is on the rise, partly because consumers are willing to pay more for “green” products. However, many green marketing claims are overstated. In the presentation, Ms. Hantman and Mr. Moffat described the various ways in which green marketing claims can be misleading and the potential consequences of deceptive marketing.
Special focus was given to the Green Guides, guidance published by the Federal Trade Commission (FTC) that helps advertisers avoid making unfair or deceptive claims. While the Green Guides are non-binding, they provide insight into what advertising claims the FTC may determine to be illegal. The presentation noted that the FTC is considering whether the Green Guides should be codified as rules and whether the commission should revisit its guidance for terms like “recyclable” and “degradable.”
The presentation also covered notable enforcement actions and litigation pertaining to green marking, including California’s recent suit against ExxonMobil for deceptive public messaging about plastic recycling. Ms. Hantman and Mr. Moffat concluded by emphasizing the importance of developing green marketing claims that are clear, specific, and substantiated with evidence.
PSX is an annual conference hosted by the Product Stewardship Society. According to its website, PSX is “the most comprehensive leadership forum for strategies that guide product stewardship professionals in an ever-changing global economy.” Ms. Hantman serves on the PSX Conference Program Committee.
If you have any questions about the presentation, please contact Ms. Hantman or Mr. Moffat.
EPA Issues Test Order for PFAS 6:2 FTAc
/in EPA, PFAS, TSCAOn 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.
EPA Proposes Adding Over 100 PFAS to TRI List
/in EPA, PFAS, TRISignificantly 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 EPA, Risk Evaluations, TSCAOn 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.
Maine Releases Draft Language Clarifying Proposals for Currently Unavoidable PFAS
/in News & Events, PFASThis August, the Maine Department of Environmental Protection (DEP) released draft language to implement April 2024 amendments to Maine’s PFAS in products legislation. The draft language was described by DEP as an “initial, informal outreach process” with the goal of initiating rulemaking this fall.
Under Maine’s PFAS in Products law, DEP has broad authority to determine whether PFAS uses are “currently unavoidable.” Currently unavoidable uses (CUUs) will be granted a five-year exemption to the amended statute’s incremental sales prohibitions for products containing intentionally added PFAS.
Tight timelines
Under the draft language, CUU proposals would only be accepted 18–36 months prior to the applicable sales prohibition or 12–24 months prior to the expiration of an existing CUU determination. However, sales prohibitions for cleaning products, cookware, cosmetics, and other products containing intentionally added PFAS take effect in less than 18 months (January 1, 2026). In an October 1 email, DEP stated that they “recognize the tight timeline with the new statutory prohibitions starting in 2026 and are making efforts to streamline the process as much as possible.”
DEP solicited currently unavoidable use proposals for the 2026 prohibitions earlier this year, before the April amendments forced the department to redraft its rulemaking. In the email, DEP clarified that they are “still considering” whether they will be able to utilize some of the previously submitted information and that “manufacturers may need to resubmit information” to meet the requirements of the eventual final rule.
Proposal requirements
According to the draft language, proposals for CUU determinations could be submitted by manufacturers individually or collectively. A separate proposal would be required for each combination of product category and industrial sector. As part of the proposal, manufacturers would be required to include:
The draft language “strongly recommends that all proposals for currently unavoidable use determinations do not contain claims of confidentiality” because “the Department may determine that there is insufficient publicly available information to justify a rulemaking.”
Other provisions of the draft rulemaking, including the notification requirements for manufacturers of products covered by a currently unavoidable use determination, largely mirror the requirements of the amended statute. More information on the April 2024 amendments can be found in a previous blog post.