Companies with confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) should mark their calendars—prompt action may soon be required to maintain their claims. CBI claims asserted under amended TSCA will begin to expire in June 2026, and submitters must reassert their claims prior to expiration to prevent the public disclosure of commercially sensitive chemical information.
Update – January 7, 2026
On January 6, 2026, EPA published a Federal Register notice describing its intended process for implementing the statutory requirements governing CBI expirations and reassertions. This post has been updated to reflect new information provided by EPA in the notice.
The notice states that “EPA expects to provide further guidance [on CBI claim expirations], to solicit and answer questions, and potentially to host a webinar with information on notices of expiration and instructions for requesting extensions.”
When Will My CBI Claim Expire?
In 2016, Congress passed the Lautenberg Amendments to TSCA, which overhauled the statute’s CBI provisions. Under amended TSCA, most CBI claims—including claims for specific chemical identities—expire after ten years. As a result, many CBI claims asserted in 2016 will expire in 2026.
Under TSCA section 14(e)(1)(B), the ten-year protection period starts when a submitter asserts a claim, not when the submitter provides substantiation. Although substantiation is generally required at the time a claim is submitted, some submitters may have provided substantiation at a later date. This is especially true of claims that were submitted soon after the statute was amended. Submitters should therefore calculate expiration dates based on the date of assertion and note that claims might expire before the ten-year anniversary of their substantiation.
Expiration dates for some chemical identity CBI claims are available on the TSCA Inventory.
Update: EPA’s January 2026 notice clarifies that claims for specific chemical identities expire ten years from the date the first claim for that substance was asserted. If a chemical identity is claimed as confidential by multiple companies, this may result in a claim expiring less than ten years after it was asserted by a subsequent submitter.
For example, if Company A asserted a CBI claim for a chemical identity in 2016, and Company B asserted a CBI claim for the same chemical identity in 2019, CBI protection for the chemical identity would expire in 2026—even though only seven years have passed since Company B asserted its claim.
At present, it is unclear whether EPA would provide CDX notice of the impending expiration to both companies or only to the submitter that asserted the first claim. (Notice procedures are discussed below.)
What Do I Have to Do to Reassert and Re-Substantiate my CBI Claim?
Submitters may extend CBI claims for subsequent ten-year periods by submitting a request for extension to EPA. Section 14(e)(2). A request for extension must include substantiation and must be submitted to EPA at least 30 days before the claim is set to expire. Section 14(e)(2)(B)(i).
The substantiation requirements for a request for extension are the same as those that apply when asserting a claim initially. Under 40 CFR 703.7(g), submitters have the option to either submit new substantiation or rely on substantiation that was provided with the initial submission, certifying that the substantiation remains true and correct.
The CBI regulations require that claims be submitted through EPA’s Central Data Exchange (CDX). 40 CFR 703.5(f). In a response to comments document from the 2023 rulemaking that developed those regulations, the agency indicated that it anticipated developing a new CDX reporting form for submitters to reassert expiring claims. EPA’s CBI FAQ page, last updated in August 2025, continues to signal that an electronic reporting tool is planned.
In some cases, submitters may find that it is no longer necessary to maintain a CBI claim, or that the subject information is no longer eligible for CBI protections because it has become publicly available.
Update: In the January 2026 notice, EPA confirmed that it is currently developing a CDX reporting tool for requests for extension and expects to have the tool in place before the first claims expire. If implementation is delayed, EPA instructs submitters to postpone submitting requests for extension until the tool becomes available. The notice states that “EPA will not release any information subject to expiring claims until the notice and review requirements of section 14(e) are met.”
On a CBI expiration guidance webpage updated January 5, 2026, EPA added that it will not disclose information covered by a timely request for extension if the agency does not complete its review of the request before the expiration date. Under section 14(g)(1)(D), “the information will continue to be protected until the review is complete and any applicable appeal period under section 14(g) has elapsed,” the webpage states.
Will EPA Provide Advance Notice of My CBI Claim’s Expiration?
Section 14(e)(2)(A) provides that EPA “shall provide to the person that asserted the claim a notice of the impending expiration of the period” at least sixty days before a CBI claim expires. EPA will address this provision by publishing a list of TSCA submissions with expiring confidentiality claims on its website or other appropriate platform. 40 CFR 703.5(h)(3). Submissions must be added at least 60 days prior to expiration, along with instructions for reasserting and substantiating expiring claims.
In the response to comments document, EPA asserted that “Section 14(e) does not specify that EPA must provide individual notice of claim expiration.” Nonetheless, during the rulemaking the agency stated its intent to provide individual notice via CDX, which is authorized under 40 CFR 703.5(h)(2).
EPA’s CDX notification system is imperfect. Submitters may miss CDX notifications if the contact information associated with CBI claims is outdated. Companies should therefore review their TSCA submissions to assess whether contact information is current. Companies may need to contact the CDX Helpdesk for assistance gaining access to submissions made by former employees. This process may take several weeks if a company needs to create a new CDX account and get that account connected to filings submitted by a former employee. If the original filing was submitted by an entity that was not part of the company at the time of the submission, additional steps may be required, such as filing a notice of transfer. 40 CFR 703.5(h)(1). That said, EPA’s response to comments document indicated that companies will not need access to the original CDX submission to reassert claims.
In general, TSCA requires EPA to provide actual notice before disclosing information claimed as CBI, such as information covered by a denied CBI claim or a denied request for extension. Section 14(g)(2). However, the statute makes an exception for expired CBI. Where no timely request for extension is submitted, TSCA does not require EPA to provide actual notice before disclosing expired CBI, provided EPA has given the 60-day notice described above. Section 14(g)(2)(C)(iii)(II). As a result, a company that does not receive a CDX notification and does not monitor EPA’s list of expiring claims may not learn that a CBI claim has expired until after the covered information has been publicly disclosed.
Update: EPA’s January 2026 notice reiterates that the agency anticipates providing notice of impending CBI claim expirations via CDX, “[a]lternatively, or in addition” to the website listing. The notice also reflects EPA’s view that publication of the website listing satisfies the 60-day notice requirement in section 14(e)(2)(A). Whether a court would agree that a website posting—as opposed to personal notice—is legally sufficient remains an open question.
The notice further affirms that a “notice of disclosure [is] not required where a CBI claim has expired and no person submitted a timely extension request following [a] timely notice of expiration.” EPA also observes that some companies may have submitted information claimed as CBI outside of CDX, such as paper filings predating electronic filing requirements or physical material provided to EPA pursuant to a TSCA subpoena or inspection.
Considering that:
- CDX contact information may be outdated;
- CBI claims may have been made outside of CDX; and
- It is unclear whether all companies with CBI claims for a specific chemical identity will be notified via CDX when the first claim expires;
It is highly advisable that companies regularly review EPA’s list of expiring claims, rather than relying solely on CDX notifications, to avoid inadvertent expiration of CBI protections.
Are Any CBI Claims Exempt from the Reassertion and Re-Substantiation Requirements?
Pursuant to section 14(e)(1)(A), no action is necessary to maintain CBI claims that are exempt from substantiation and review according to sections 14(c)(2) and 14(g). These include claims for specific information describing manufacturing processes, marketing and sales information, information identifying suppliers or customers, and specific production volumes, among others.
This post is for informational purposes only and does not constitute legal advice.
EuroChem Faces TSCA Lawsuit Over Alleged CDR Reporting Failures
/in CDR, Enforcement, TSCAOn December 15, 2025, the Center for Environmental Health (CEH) filed suit against EuroChem, alleging that the fertilizer giant failed to report billions of pounds of chemicals imported into the US between 2016 to 2019.
EPA’s Chemical Data Reporting (CDR) rule, promulgated under the Toxic Substances Control Act (TSCA), requires that manufacturers and importers report all chemicals manufactured or imported in volumes of 25,000 pounds or more per site per year. According to CEH, EuroChem failed to submit CDR reports by the 2021 reporting deadline for at least nine chemicals that allegedly exceeded this threshold during the 2016–19 reporting period.
The chemicals at issue include ammonium nitrate and ammonium sulfate, which CEH claims “cause respiratory irritation if inhaled and can lead to serious health problems with significant exposure,” according to a press release announcing the lawsuit. Another chemical, monoammonium phosphate, was allegedly imported in quantities of over 45 billion pounds in 2018 alone.
“Eurochem’s failure to report these imports undermines EPA’s efforts under TSCA to evaluate and address chemical risks,” the complaint reads. “It also prevents the public from tracking the movement of unsafe chemicals in commerce as well as monitoring their presence in communities”
The lawsuit is the latest in a series of actions brought by CEH, which systematically cross-references publicly available import data with CDR submissions to identify potential violations. According to the press release, CEH has settled with fourteen companies to date over their CDR omissions.
Chemium Settlement
In the press release, CEH also notes that it recently reached a settlement with Chemium International Corporation, a Texas-based chemical supplier, for similar alleged CDR violations. According to CEH, Chemium submitted CDR reports to EPA for eight chemicals imported between 2016 and 2019 and agreed to conduct an internal audit.
A post discussing another recent CEH CDR settlement, with Wego Chemical Group, can be found here.
Oregon Defends Packaging EPR Program, Argues Court Lacks Jurisdiction
/in EPR, State PolicyOregon Environmental Quality Commission (EQC) officials are asking a federal court to dismiss a challenge to the state’s extended producer responsibility (EPR) law and implementing regulations, arguing that the court lacks subject-matter jurisdiction.
The motion to dismiss, filed December 22, 2025, comes after the plaintiff, the National Association of Wholesaler-Distributors (NAW), asked the District Court for the District of Oregon to halt the program on November 24, 2025.
According to the defendants, the Eleventh Amendment bars NAW from bringing suit against EQC officials. While an exception to sovereign immunity exists for suits seeking prospective injunctive relief, the defendants contend that the named officials do not fall within the exception because they do not directly enforce the law.
“Absent allegations that EQC has an enforcement role or is continuously engaging in some activity that violates federal law, Plaintiff has not and cannot establish that the Ex parte Young exception should apply to the EQC Defendants,” the motion reads.
Enforcement authority, the defendants contend, rests with Oregon’s Department of Environmental Quality (DEQ), while EQC’s role is limited to promulgating administrative rules that “guide DEQ in its…administration” of the program. Although both EQC and DEQ were named in NAW’s original complaint, the association removed the agencies as defendants in an amended complaint filed October 27, 2025.
The defendants also argue that the Eleventh Amendment precludes NAW’s state-law claims from being heard in federal court.
Oregon’s packaging EPR program, which launched July 1, 2025, is the first such program to take effect nationwide. Many of its obligations are currently fulfilled by a single producer responsibility organization (PRO), Circular Action Alliance (CAA), though DEQ is authorized to approve additional PROs.
Last month, the Small Business Administration’s Office of Advocacy called for the federal government to preempt the program, citing concerns about interference with interstate commerce, the state’s delegation of authority to CAA, and the confidential methodologies used by CAA to calculate producer fees.
Merits Arguments
NAW raises similar concerns in its amended complaint, arguing that the program “produces unreasonable, arbitrary, and crushing burdens, including on wholesalers and distributors who are essential to moving products from manufacturers to Oregon consumers,” in part due to the delegation of “essential regulatory authority to a private, third-party organization.” CAA “has been granted wide discretion to apply a confidential methodology for setting fees, to establish other criteria and incentives for certain producers, and to penalize producers of certain materials,” NAW contends.
NAW alleges several constitutional violations. After contesting the court’s jurisdiction, the defendants’ motion to dismiss addresses each, arguing that all fail to state a plausible claim for relief.
First, the motion challenges NAW’s dormant Commerce Clause claim, asserting that the program does not discriminate against interstate commerce. “Increased compliance costs, even if borne largely by out-of-state businesses, do not amount to discrimination,” the defendants argue. Nor, they add, does the program “establish a substantial or an excessive burden on interstate commerce, regardless of whether it is compared to the putative local interests.”
The defendants also contend that the program does not have impermissible extraterritorial effects because it “does not force any producer to make any product or packaging design, sourcing, or distribution decisions.”
The motion next addresses NAW’s unconstitutional conditions claim, which alleged that producers are compelled to surrender “freedom of contract and due process protections” when joining CAA. In response, the defendants note that the law allows NAW’s members to form their own PRO, arguing that participation in CAA is a matter of choice.
NAW further argues that delegating fee-setting authority to CAA violates its members’ procedural due process rights. The defendants counter by pointing to statutory safeguards that provide “opportunity for public input and continuing DEQ oversight” of the fees program. These include DEQ approval of PRO program plans and fee methodologies, as well as annual reporting requirements.
Finally, the motion argues that Oregon has a rational basis for exempting small producers and does not unlawfully discriminate between mid-sized and large producers, rebutting NAW’s equal protection claim.
The case is National Association of Wholesaler-Distributors v. Feldon, 25-cv-1334 (D. Or.), filed July 30, 2025.
First TSCA CBI Claims Will Expire in 2026—Companies Should Prepare Now
/in CBI, EPA, TSCACompanies with confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) should mark their calendars—prompt action may soon be required to maintain their claims. CBI claims asserted under amended TSCA will begin to expire in June 2026, and submitters must reassert their claims prior to expiration to prevent the public disclosure of commercially sensitive chemical information.
Update – January 7, 2026
On January 6, 2026, EPA published a Federal Register notice describing its intended process for implementing the statutory requirements governing CBI expirations and reassertions. This post has been updated to reflect new information provided by EPA in the notice.
The notice states that “EPA expects to provide further guidance [on CBI claim expirations], to solicit and answer questions, and potentially to host a webinar with information on notices of expiration and instructions for requesting extensions.”
When Will My CBI Claim Expire?
In 2016, Congress passed the Lautenberg Amendments to TSCA, which overhauled the statute’s CBI provisions. Under amended TSCA, most CBI claims—including claims for specific chemical identities—expire after ten years. As a result, many CBI claims asserted in 2016 will expire in 2026.
Under TSCA section 14(e)(1)(B), the ten-year protection period starts when a submitter asserts a claim, not when the submitter provides substantiation. Although substantiation is generally required at the time a claim is submitted, some submitters may have provided substantiation at a later date. This is especially true of claims that were submitted soon after the statute was amended. Submitters should therefore calculate expiration dates based on the date of assertion and note that claims might expire before the ten-year anniversary of their substantiation.
Expiration dates for some chemical identity CBI claims are available on the TSCA Inventory.
Update: EPA’s January 2026 notice clarifies that claims for specific chemical identities expire ten years from the date the first claim for that substance was asserted. If a chemical identity is claimed as confidential by multiple companies, this may result in a claim expiring less than ten years after it was asserted by a subsequent submitter.
For example, if Company A asserted a CBI claim for a chemical identity in 2016, and Company B asserted a CBI claim for the same chemical identity in 2019, CBI protection for the chemical identity would expire in 2026—even though only seven years have passed since Company B asserted its claim.
At present, it is unclear whether EPA would provide CDX notice of the impending expiration to both companies or only to the submitter that asserted the first claim. (Notice procedures are discussed below.)
What Do I Have to Do to Reassert and Re-Substantiate my CBI Claim?
Submitters may extend CBI claims for subsequent ten-year periods by submitting a request for extension to EPA. Section 14(e)(2). A request for extension must include substantiation and must be submitted to EPA at least 30 days before the claim is set to expire. Section 14(e)(2)(B)(i).
The substantiation requirements for a request for extension are the same as those that apply when asserting a claim initially. Under 40 CFR 703.7(g), submitters have the option to either submit new substantiation or rely on substantiation that was provided with the initial submission, certifying that the substantiation remains true and correct.
The CBI regulations require that claims be submitted through EPA’s Central Data Exchange (CDX). 40 CFR 703.5(f). In a response to comments document from the 2023 rulemaking that developed those regulations, the agency indicated that it anticipated developing a new CDX reporting form for submitters to reassert expiring claims. EPA’s CBI FAQ page, last updated in August 2025, continues to signal that an electronic reporting tool is planned.
In some cases, submitters may find that it is no longer necessary to maintain a CBI claim, or that the subject information is no longer eligible for CBI protections because it has become publicly available.
Update: In the January 2026 notice, EPA confirmed that it is currently developing a CDX reporting tool for requests for extension and expects to have the tool in place before the first claims expire. If implementation is delayed, EPA instructs submitters to postpone submitting requests for extension until the tool becomes available. The notice states that “EPA will not release any information subject to expiring claims until the notice and review requirements of section 14(e) are met.”
On a CBI expiration guidance webpage updated January 5, 2026, EPA added that it will not disclose information covered by a timely request for extension if the agency does not complete its review of the request before the expiration date. Under section 14(g)(1)(D), “the information will continue to be protected until the review is complete and any applicable appeal period under section 14(g) has elapsed,” the webpage states.
Will EPA Provide Advance Notice of My CBI Claim’s Expiration?
Section 14(e)(2)(A) provides that EPA “shall provide to the person that asserted the claim a notice of the impending expiration of the period” at least sixty days before a CBI claim expires. EPA will address this provision by publishing a list of TSCA submissions with expiring confidentiality claims on its website or other appropriate platform. 40 CFR 703.5(h)(3). Submissions must be added at least 60 days prior to expiration, along with instructions for reasserting and substantiating expiring claims.
In the response to comments document, EPA asserted that “Section 14(e) does not specify that EPA must provide individual notice of claim expiration.” Nonetheless, during the rulemaking the agency stated its intent to provide individual notice via CDX, which is authorized under 40 CFR 703.5(h)(2).
EPA’s CDX notification system is imperfect. Submitters may miss CDX notifications if the contact information associated with CBI claims is outdated. Companies should therefore review their TSCA submissions to assess whether contact information is current. Companies may need to contact the CDX Helpdesk for assistance gaining access to submissions made by former employees. This process may take several weeks if a company needs to create a new CDX account and get that account connected to filings submitted by a former employee. If the original filing was submitted by an entity that was not part of the company at the time of the submission, additional steps may be required, such as filing a notice of transfer. 40 CFR 703.5(h)(1). That said, EPA’s response to comments document indicated that companies will not need access to the original CDX submission to reassert claims.
In general, TSCA requires EPA to provide actual notice before disclosing information claimed as CBI, such as information covered by a denied CBI claim or a denied request for extension. Section 14(g)(2). However, the statute makes an exception for expired CBI. Where no timely request for extension is submitted, TSCA does not require EPA to provide actual notice before disclosing expired CBI, provided EPA has given the 60-day notice described above. Section 14(g)(2)(C)(iii)(II). As a result, a company that does not receive a CDX notification and does not monitor EPA’s list of expiring claims may not learn that a CBI claim has expired until after the covered information has been publicly disclosed.
Update: EPA’s January 2026 notice reiterates that the agency anticipates providing notice of impending CBI claim expirations via CDX, “[a]lternatively, or in addition” to the website listing. The notice also reflects EPA’s view that publication of the website listing satisfies the 60-day notice requirement in section 14(e)(2)(A). Whether a court would agree that a website posting—as opposed to personal notice—is legally sufficient remains an open question.
The notice further affirms that a “notice of disclosure [is] not required where a CBI claim has expired and no person submitted a timely extension request following [a] timely notice of expiration.” EPA also observes that some companies may have submitted information claimed as CBI outside of CDX, such as paper filings predating electronic filing requirements or physical material provided to EPA pursuant to a TSCA subpoena or inspection.
Considering that:
It is highly advisable that companies regularly review EPA’s list of expiring claims, rather than relying solely on CDX notifications, to avoid inadvertent expiration of CBI protections.
Are Any CBI Claims Exempt from the Reassertion and Re-Substantiation Requirements?
Pursuant to section 14(e)(1)(A), no action is necessary to maintain CBI claims that are exempt from substantiation and review according to sections 14(c)(2) and 14(g). These include claims for specific information describing manufacturing processes, marketing and sales information, information identifying suppliers or customers, and specific production volumes, among others.
This post is for informational purposes only and does not constitute legal advice.
EPA Formalizes “Compliance First” Enforcement Framework
/in Enforcement, EPAOn December 5, 2025, the acting assistant administrator for EPA’s Office of Enforcement and Compliance Assurance (OECA) issued a “compliance first” directive to the agency’s enforcement staff. A memo detailing this directive was issued to personnel both at headquarters and in regional EPA offices. The memo, obtained by POLITICO’s E&E News, signals a paradigm shift in the agency’s enforcement philosophy.
“The primary focus for the Agency in all inspection, investigation, EPA enforcement, state/tribal enforcement coordination, and compliance assistance activities must be on achieving and ensuring timely compliance,” the memo reads. OECA adds that compliance should be attained in “the most efficient, most economical, and swiftest means possible, while ensuring that our actions align with the clearest, most defensible interpretations of our statutory and regulatory mandates.”
OECA outlines six factors that will underpin the agency’s enforcement philosophy:
Key Changes to Enforcement Practice
Several provisions in the memo mark notable departures from previous practice.
First, EPA inspectors and enforcement staff must now immediately elevate concerns raised by regulated entities about how the agency has applied a statute or regulation in enforcement actions at their facilities. Decisions on how to proceed will be made at the national level, with regional counsel required to consult with the relevant Office of General Counsel (OGC) and OECA offices.
With respect to injunctive relief—court orders to compel or cease specific actions—the directive substantially narrows EPA’s authority. Approval from the OECA assistant administrator will now be required for injunctive relief that falls outside “clear regulatory or statutory requirements,” which will only “be appropriate in limited, case-specific circumstances.” The memo rescinds the agency’s earlier policy—issued in 2021—that allowed for more expansive injunctive relief. Under the 2021 policy, EPA could use tools such as advanced monitoring, third-party auditing and monitoring, electronic reporting, and enhanced public reporting. These tools are now generally discouraged.
In addition, the directive tightens settlement procedures. The memo explains that agency personnel must now obtain approval from the OECA assistant administrator prior to initiating negotiation on any proposed settlement that could include mitigation or a stipulated remedy until additional guidance is issued. Similarly, the memo prohibits the use of supplemental environmental projects (SEPs) in settlements until further guidance is developed.
Finally, in the memo EPA states that it plans to develop consolidated criteria across all media to categorize violations and assign appropriate enforcement responses to improve consistency across programs and regions. OECA says that existing enforcement response policies, “together with the best reading of each requirement,” will inform the basis of the consolidated criteria. The memo also notes that EPA “must act swiftly to limit actions from third parties who, through citizen suit litigation, unfairly impact policy through abusive litigation tactics.”
Implications for Industry
OECA’s compliance first framework—particularly its emphasis on achieving timely compliance through efficient and economical means—signals renewed support for industry self-policing.
The memo expressly directs enforcement staff to “promote voluntary compliance through self-reporting and voluntary audits.” That instruction, coupled with the memo’s focus on open communication, early issue elevation, and restrained use of injunctive relief, suggests an enforcement environment more receptive to self-identified violations that are promptly disclosed and corrected.
For companies that manufacture chemicals or use chemicals to produce consumer, commercial, or industrial products, self-auditing offers an opportunity to establish a clear compliance baseline and move potential violations off of balance sheets. EPA’s Audit Policy, discussed below, provides substantial protection to entities that systematically discover, disclose, and correct violations.
Given OECA’s new approach, companies facing compliance questions should strongly consider whether self-auditing and voluntary disclosure can help manage enforcement risk while demonstrating good-faith compliance efforts.
* * *
EPA’s long-standing Audit Policy, last revised in 2000, remains the primary mechanism for obtaining credit for self-auditing. Under the policy, regulated entities that systematically discover, disclose, and correct violations may be eligible for significant enforcement incentives, including:
More information on EPA’s Audit Policy can be found on EPA’s website.
Third Circuit Affirms Lanham Act Liability for False “Made in USA” Claims
/in Made in USAOn December 10, 2025, the Third Circuit affirmed a New Jersey district court’s finding that Albion Engineering Co. violated the Lanham Act by making false and misleading “Made in the USA” claims in connection with certain caulking guns, as well as the entry of a permanent injunction and an award of disgorgement.
Competitor Newborn Bros. Co., Inc. filed suit in 2012, alleging that Albion partially manufactured certain caulking guns overseas while making US-origin claims. Albion printed statements such as “USA Manufacturer and Designer” and “Made in USA” on some imported products and advertised that all of its products were “designed and manufactured in the USA” and “Made in America.” Newborn, however, also made potentially problematic US-origin representations in connection with its own imported caulking guns.
After 30 days of trial testimony spanning seven years, the district court held Albion liable for false advertising under the Lanham Act, entered a permanent injunction, and awarded Newborn more than $2 million in disgorgement, reducing the award under the unclean hands doctrine based on Newborn’s own conduct. Both parties appealed. The Third Circuit affirmed the district court’s rulings in all respects.
False Advertising and Permanent Injunction
Albion challenged several aspects of the false advertising holding, arguing that Newborn failed to present consumer survey evidence demonstrating deception and lacked evidence that any deception was material. The Third Circuit rejected these arguments, holding that testimony and expert evidence may establish deception and materiality without a consumer survey. The court also affirmed the finding that Newborn suffered injury in the form of diverted sales.
Albion additionally challenged the permanent injunction, which ordered Albion to send letters to recent distributors, request returns of mislabeled products, display notice of the litigation, and provide detailed country-of-origin information until it receives Customs and Border Patrol (CBP) guidance. Even if Albion’s current practices are compliant with the Lanham Act, the district court’s conclusion that old products and marketing materials was sufficient to warrant a permanent injunction, the panel held.
The Third Circuit likewise upheld the district court’s mandate regarding country-of-origin disclosures. Albion had previously sought CBP guidance on an adjacent issue and was informed that the country of origin would not be the United States, but it did not seek a subsequent clarifying ruling. “On this record, we cannot conclude that the District Court abused its discretion,” the panel stated.
Unclean Hands
Newborn, on the other hand, principally challenged the district court’s application of the unclean hands doctrine, which decreased the disgorgement award. The lower court focused on Newborn’s use of a “Newborn U.S.A.” trademark on caulking-gun advertisements without reference to its US warehouse facilities to justify its application. Newborn also used a logo incorporating its name within an outline of the United States and listed US-based offices and warehouses without disclosing that its caulking guns were manufactured overseas.
While these practices may not necessarily have caused consumer confusion or injury, they are sufficiently similar to Albion’s violations and “transgress[ed] equitable standards of conduct,” the court held. Accordingly, the panel found that the reduction of Newborn’s recovery fell within the district court’s discretion.
The court also rejected Newborn’s challenge to Albion’s expert witness, who testified that repeat purchasers of Albion products would be aware of their overseas origin. The panel held that this opinion fell within the expertise of the economist, who held a Ph.D.
The case is Newborn Bros. Co., Inc. v. Albion Engineering Co., Nos. 24-1548 & 24-3046 (3rd Cir.), filed Nov. 4, 2024.
EPA Moves to Dismiss Novel TSCA CBI Challenge as Untimely
/in CBI, EPA, TSCAA lawsuit seeking to prevent EPA from disclosing chemical identity information under the Toxic Substances Control Act (TSCA) was not timely filed, the agency told the District Court for the Middle District of Georgia on November 24, 2025.
Plaintiff Burgess Pigment Co. filed suit after receiving a 2025 notification from EPA stating that the agency would soon make a specific chemical identity publicly available. However, EPA argues that Burgess was actually required to file years earlier, when the agency first informed the company that the chemical identity was not entitled to confidential business information (CBI) protection.
At issue is TSCA section 14(g), which provides claimants 30 days to appeal a CBI denial after receiving notice from EPA. According to the agency, that notice was provided in 2020, when EPA issued an initial determination denying CBI claims Burgess had made in its 2016 Chemical Data Reporting (CDR) submission. The 2025 notification merely restated EPA’s earlier conclusion that the information was ineligible for CBI protection, the agency says.
“Allowing Burgess to challenge EPA’s determination five years later would not only undermine the statutory scheme contemplated by Congress, but it would also prove administratively unworkable,” EPA states in a memo accompanying its motion to dismiss. “Such a rule would permit companies to restart the ‘30-day clock’ simply by asking EPA to protect the confidentiality of information that EPA has already decided is not entitled to confidentiality.”
According to EPA, after the initial determination, Burgess and EPA entered into a toll agreement to extend the 30-day deadline while the parties discussed the CBI denial. EPA ultimately affirmed its determination in January 2022, which, the agency says, triggered a new 30-day appeal period ending in February 2022.
The 2025 notification was issued in response to Burgess’s 2024 CDR submission, which again asserted that the chemical identity was CBI. EPA notes that it sent a similar notification in 2023 in response to Burgess’s 2020 CDR submission.
Nondiscretionary Duty
Even if the suit had been timely filed, EPA contends that there is no basis for Burgess’s claim.
The CBI denial resulted from Burgess’s failure to timely respond to the statutorily mandated 2017 Inventory Reset Rule, which required manufacturers to take affirmative steps to maintain existing CBI claims. Because Burgess did not do so, EPA says that TSCA required EPA to make the chemical identity public.
“EPA had no discretion to choose not to move the chemical to the nonconfidential portion of the list,” the memo reads. “EPA acted in accordance with its statutory directive, and it would have been inconsistent with TSCA for EPA to decline to move the chemical.”
Although Burgess later submitted materials intended to support confidentiality, EPA contends those efforts came too late. “[W]hen Burgess belatedly attempted to seek confidentiality in 2020 and beyond, there was no longer a confidentiality claim because EPA had already determined the information was not confidential,” the agency says.
Burgess has argued that EPA continues to treat the chemical identity as confidential despite the notification letters. EPA disputes that characterization, noting that although the chemical identity has not yet appeared on the nonconfidential TSCA Inventory, it is not being treated as CBI.
“If, for instance, EPA received a [Freedom of Information Act] request for the information in the years since the claim was denied, EPA would provide the chemical identity in response to that request,” the memo states.
APA Claims
EPA also argues that Burgess has no recourse outside of TSCA section 14. The agency contends that Burgess’s Administrative Procedure Act (APA) arguments fail because the APA limits judicial review to “final agency action for which there is no other adequate remedy in court.”
“Because Burgess had an adequate remedy under TSCA, it may not pursue its claim under the APA,” the memo states.
The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-00309 (M.D. Ga.), filed July 18, 2025. More information on the case is available in a previous post. Burgess’s response to the motion to dismiss is due December 30, 2025.
Federal Legislation Introduced to Create PFAS Cause of Action
/in PFAS, TSCAOn December 11, 2025, Senator Kirsten Gillibrand (D-NY) and Representative Madeleine Dean (D-PA-4) introduced the PFAS Accountability Act of 2025 (S.3460/H.R.6626). The legislation would establish a federal cause of action and allow courts to award medical monitoring for persons exposed to PFAS.
In a press release announcing the bill, Senator Gillibrand stated: “For years, companies have knowingly manufactured toxic, carcinogenic chemicals that have devastated families and communities. Those companies must be held accountable for their actions.”
Versions of the PFAS Accountability Act have been introduced in every Congress since 2018. The legislation has never passed either chamber, however.
Cause of Action
If enacted, the PFAS Accountability Act would add a new section to the Toxic Substances Control Act (TSCA) titled “Individuals Exposed to Perfluoroalkyl And Polyfluoroalkyl Substances.” The amendment would allow individuals who have been “significantly exposed to PFAS,” or have “reasonable grounds” to suspect significant exposure, to bring suit individually or as a class in any district court.
Claims could be brought against any person that:
The bill establishes rebuttable presumptions of “significant exposure.” An individual would be presumed to have been significantly exposed if:
If plaintiffs do not submit test results, defendants could rebut the presumption of significant exposure by offering test results conducted by an independent testing provider.
Medical Monitoring
The legislation would authorize courts to award medical monitoring for qualifying claimants if:
Where insufficient toxicological data exists to determine whether exposure resulted in an increased risk of disease, courts “may lower the standard for scientific proof” until such data exists. Courts would also have authority to order studies to assess whether an increased risk of disease occurred.
Definition of PFAS
Notably, the bill defines PFAS as “a perfluoroalkyl or polyfluoroalkyl substance with at least 1 fully fluorinated carbon atom,” which is significantly broader than the definition used by EPA in the TSCA section 8(a)(7) PFAS reporting rule and the 2024 significant new use rule (SNUR) for inactive PFAS.
More information on the PFAS Accountability Act of 2025 can be found here.
Connecticut Releases Approved PFAS Label Language
/in PFAS, Right-to-Know, State PolicyOn December 1, 2025, the commissioner of Connecticut’s Department of Energy & Environmental Protection (DEEP) issued an order approving the following phrases that satisfy the state’s PFAS labeling requirements. The approved language includes:
Manufacturers or producers can petition DEEP to approve other words or symbols. Petitions must be submitted via email to DEEP.PFASInProduct@ct.gov. Emails should include the proposed words or symbols, as well as the petitioner’s name, title, email address, and telephone number.
The order states that DEEP will publish and maintain an updated list of all approved labeling language on its PFAS in Products website.
Labeling Requirements
Beginning July 1, 2026, no person may sell or distribute certain products in Connecticut that contain intentionally-added PFAS unless the products include the required labeling disclosures. A complete list of covered product categories can be found in a previous post.
Labeling is the responsibility of the manufacturer unless the wholesaler or retailer agrees to accept responsibility for their application. Labels must:
If a covered product is incorporated as a component of another product, the final product containing the component must be labeled.
Connecticut is not the only state that will soon impose PFAS labeling requirements. Effective January 1, 2027, New Mexico will require labeling on all products containing intentionally added PFAS that are sold or distributed in the state. More information on New Mexico’s requirements can be found here.
Final PFAS Reporting Requirements Set in Minnesota
/in PFAS, State PolicyOn December 8, 2025, the Minnesota Pollution Control Agency (MPCA) adopted a final rule governing manufacturer reporting on intentionally added PFAS in products, ahead of the July 1, 2026 deadline for initial submissions. The rule outlines what manufacturers must report, how reports must be submitted, and the conditions under which waivers or extensions may be granted.
Initial Reporting Requirements
A manufacturer or group of manufacturers of new products sold or distributed in the Minnesota that contain intentionally added PFAS must submit an initial report to MPCA by July 1, 2026. Each report must include:
A flat $800 fee must accompany each initial report. Manufacturers may request trade secret protection for chemical identities, identifying numbers, and certain supply-chain information. On its website, MPCA says that reported information that is not trade secret will be disclosed to the public.
All manufacturers must assume responsibility to report unless manufacturers in the same supply chain enter into an agreement to establish their respective reporting responsibilities. To meet due diligence requirements, manufacturers must “request detailed disclosure of information…from their supply chain until all required information is known.” Manufacturers must maintain documentation of all communication with other manufacturers regarding PFAS reporting compliance and reporting responsibility agreements and provide it to MPCA upon request.
MPCA may grant waiver requests for all or part of the required information upon request if substantially equivalent information is publicly available. Extension requests must be submitted at least 30 days before the deadline. Reports will be filed through MPCA’s PFAS Reporting and Information System for Manufacturers (PRISM), which MPCA plans to soft-launch to selected manufacturers this month and release in full in January 2026.
Changes from the Proposal
After two public comment periods and an administrative law judge’s review, the final rule incorporates several adjustments, including:
The final rule also makes several key changes to subsequent reporting requirements after the initial report, including:
The Minnesota Register notice for the rule, including MPCA’s explanation of changes, can be found here.
MPCA is in the process of developing a separate rule establishing a process for currently unavoidable use (CUU) determinations. More information on Minnesota’s PFAS in products program can be found on the agency’s website.
FDA Withdraws Asbestos Testing Proposal for Talc Cosmetics
/in Chemicals of Concern, Cosmetic Products, FDA, FFDCAOn November 28, 2025, in response to adverse comments, FDA published a notice announcing its withdrawal a December 2024 proposed rule that would have required manufacturers of talc-containing cosmetic products to test for asbestos.
The rulemaking is required by section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directs FDA to “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.” FDA’s notice makes clear that the agency plans to issue a new proposed rule in the future.
FDA cites “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” as good cause for the withdrawal.
The concern underlying the rulemaking stems from the geological relationship between asbestos and talc. According to FDA, asbestos is found in the same rock types that host talc deposits, which sometimes results in the presence of asbestos in talc cosmetics.
Although the testing requirements will not take effect, the Federal Food, Drug, and Cosmetic Act (FFDCA) continues to prohibit the sale of adulterated cosmetics, including those that contain “any poisonous or deleterious substance which may render [the product] injurious to users.” FDA has previously taken action in this area: testing in 2019 led to recalls of talc cosmetics potentially containing asbestos, while testing in 2023 did not detect asbestos in any of fifty sampled products.
December 2024 Proposal
The December 2024 proposed rule would have required manufacturers to test talc-containing cosmetic products—or the talc ingredient before use—and maintain records demonstrating compliance. Manufacturers would have needed to test a representative sample of each batch or lot using both:
Noncompliance would have rendered a cosmetic adulterated. A talc cosmetic product would also have been deemed adulterated if any asbestos was present—even if only a single fiber was detected.
Issues Raised by Commenters
In the withdrawal notice, FDA notes several provisions of the proposed rule that were contested by commenters, including:
In addition, commenters raised concerns about the proposed test methods, although FDA did not address these in the withdrawal notice. For example, the United States Pharmacopeia (USP) questioned whether TEM was superior to other test methods, arguing that it might yield more false positives. USP also asserted that a single-fiber threshold for positive samples diverges from generally accepted TEM fiber counting procedures and would pose challenges for reproducibility.
More information on talc and asbestos can be found on FDA’s website.