For decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.
Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive. Historically, FDA affirmed substances as GRAS on its own initiative or by petition. Today, that responsibility largely rests with industry.
Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged. But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.
Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups. FDA, Congress, and state legislators are all pursuing reform, as described below.
FDA Actions
FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS. The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter. It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.
The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025. FDA leadership reportedly projects publication late this spring or early summer of this year.
In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS. Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework. FDA released a draft framework for public comment last summer.
As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register. BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.
Legal uncertainty remains. In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA. “The remedy Plaintiffs seek lies with Congress,” the court said.
Federal Legislation
Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.
2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.
H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity. The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.
3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.
Two additional bills impose post-market review requirements without revising the broader GRAS framework. H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment. H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.
All of these bills are currently pending in committee. None have attracted a cosponsor from the opposing party.
State Legislation
Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space. Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.
Other states are targeting self-affirmed GRAS more directly. Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.
Pennsylvania and California would require the same information and data required as part of a federal GRAS notice. Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.
Additional provisions vary by state. New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools. California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection. California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.
Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026. That bill, as well as Pennsylvania’s, has sponsors from both parties.
Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework. Please contact us with any questions.
Keurig Hit with Class Action over “Recyclable” K-Cups
/in Green MarketingA California consumer has launched a putative class action against Keurig Dr. Pepper, alleging that the beverage giant’s single-serve coffee pods are deceptively labeled as “recyclable” because most recycling centers are unable to accept them.
According to the complaint, filed April 7, 2026, Keurig K-Cups are virtually non-recyclable due to their small size, multi-material design, residual coffee grounds and liquids, and limited economic value in recycling streams.
“Despite these facts, Keurig promotes its K-Cup pods as ‘recyclable’ because they are made from polypropylene #5 plastic,” the complaint alleges. “However, the company relies on a purely theoretical definition of recyclability that ignores the fundamental principles outlined in the FTC’s Green Guides and does not align with consumer understanding.”
The challenged representations are allegedly made on product packaging, Keurig’s website, online retail listings, and social media alongside the “chasing arrows” recyclability symbol.
The complaint further alleges that recycling centers serving at least 60 percent of US consumers do not accept K-Cups—the threshold for making unqualified recyclability claims under the Green Guides, which provide guidance for environmental marketing claims and are incorporated into California law. Qualifying language telling consumers to “check locally” or noting that the pods “are not recycled in many communities” is shown in fine print that is difficult to read, the complaint says.
“If Plaintiff had known that the Products were not recyclable, Plaintiff would not have purchased the Products,” the complaint states. “At a minimum, Plaintiff would not have paid as much as he did if he had known the Products could not be recycled.”
The lawsuit also notes that Keurig’s recyclability claims have previously been challenged. In 2023, Keurig settled similar allegations for $10 million but allegedly made only “minor modifications” to its marketing. The complaint also references a civil penalty imposed by the Securities and Exchange Commission because the company failed to disclose recyclability concerns raised by recycling facilities.
The plaintiff alleges violations of California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act, as well as for negligent misrepresentation and unjust enrichment.
The case is Dixon v. Keurig Dr Pepper, Inc., No. 26-cv-2172 (S.D. Cal.), filed 4/7/2026.
Update (April 15, 2026)
On April 10, 2026, an almost identical putative class action was filed against Keurig in New York. That case is Sulli v. Keurig Dr Pepper, Inc., No. 26-cv-6420 (W.D.N.Y.), filed 4/10/2026.
PFAS Reporting Rule Delayed Again Amid Ongoing Rulemaking
/in EPA, PFAS, TSCAEPA has delayed the start of the PFAS Reporting Rule reporting period for the third time as the agency finalizes amendments that would narrow the rule’s scope.
The reporting period will now begin January 31, 2027, or 60 days following the effective date of the final rule implementing the amendments, whichever is earlier. EPA says that it expects to release the final rule “well before” the January 31, 2027, fallback date.
The extension will be published in the Federal Register on April 13, 2026, the same day the reporting period had been scheduled to begin.
Background
Promulgated under section 8(a)(7) of the Toxic Substances Control Act (TSCA), the PFAS Reporting Rule requires all persons who manufactured or imported PFAS for commercial purposes between 2011 and 2022 to report chemical information to EPA. For most manufacturers and importers, the original reporting deadline was May 13, 2023. However, EPA delayed the start of the reporting period in 2024 and again in 2025, citing technical difficulties with the reporting tool.
In the 2025 postponement, EPA also signaled that it was considering reopening the rule’s reporting requirements. Subsequently, in November 2025, EPA released a proposed rule introducing various exemptions to the reporting requirements. These include exemptions for mixtures and products containing de minimis PFAS concentrations, imported articles, and certain byproducts and impurities.
More on the PFAS Reporting Rule can be found in our topic archive.
GRAS Reform Update: Where Do Things Stand?
/in FDA, FFDCA, State PolicyFor decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.
Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive. Historically, FDA affirmed substances as GRAS on its own initiative or by petition. Today, that responsibility largely rests with industry.
Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged. But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.
Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups. FDA, Congress, and state legislators are all pursuing reform, as described below.
FDA Actions
FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS. The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter. It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.
The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025. FDA leadership reportedly projects publication late this spring or early summer of this year.
In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS. Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework. FDA released a draft framework for public comment last summer.
As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register. BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.
Legal uncertainty remains. In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA. “The remedy Plaintiffs seek lies with Congress,” the court said.
Federal Legislation
Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.
2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.
H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity. The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.
3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.
Two additional bills impose post-market review requirements without revising the broader GRAS framework. H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment. H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.
All of these bills are currently pending in committee. None have attracted a cosponsor from the opposing party.
State Legislation
Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space. Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.
Other states are targeting self-affirmed GRAS more directly. Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.
Pennsylvania and California would require the same information and data required as part of a federal GRAS notice. Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.
Additional provisions vary by state. New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools. California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection. California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.
Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026. That bill, as well as Pennsylvania’s, has sponsors from both parties.
Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework. Please contact us with any questions.
New Mexico Adopts Nation’s Most Far-Reaching PFAS Labeling Rules
/in PFAS, Right-to-Know, State PolicyNew Mexico has approved “universal” PFAS labeling requirements beginning in 2027, according to the New Mexico Environment Department (NMED).
The Environmental Improvement Board approved the requirements on March 23, 2026. Although the final rule is not yet available, the final proposed rule requires the term “PFAS” inside an Erlenmeyer flask on all products containing intentionally added PFAS manufactured on or after January 1, 2027. “PFAS” is broadly defined by statute to include all substances with at least one fully fluorinated carbon atom.
Only used products, pesticides, veterinary products, and medical devices and drugs are exempt from the labeling requirements. Although the controlling statute includes additional exemptions from PFAS prohibitions and reporting requirements, the final proposed rule does not extend them to labeling. Manufacturers may, however, request a labeling waiver if the product falls within one of the statutory exemptions and no PFAS will ever come into direct contact with a consumer.
The New Mexico legislature recently instructed NMED to make recommendations on whether those statutory exemptions should be modified or removed, including an exemption for fluoropolymers.
In addition to the labeling requirements, the adopted regulations will implement the statutory prohibitions and reporting requirements, which also begin in 2027.
Changes Made During Rulemaking
The final proposed rule’s labeling requirements substantially differ from the original proposal. After commenters raised First Amendment concerns, NMED removed a requirement that manufacturers use labels with claims about the hazards of PFAS and link to a NMED webpage on PFAS.
In response to concerns about the practicability of labeling before January 1, 2027, NMED relaxed the deadline, allowing continued sale of unlabeled products manufactured prior to that date. And, after commenters argued that certain products labels are preempted by federal law, NMED added the exemptions for pesticides, veterinary products, and medical devices.
Nevertheless, New Mexico’s PFAS labeling requirements are now the most far-reaching in the country. Other states, like Connecticut, have adopted labeling requirements, but they only apply to a discrete selection of products.
Apple’s Own Chemical Policies Sink Its Bid to Toss PFAS Watch Band Suit
/in Green Marketing, PFASA federal court has refused to toss a proposed class action accusing Apple of selling smartwatch bands laced with a PFAS known as PFHxA, finding that Apple’s own internal restrictions on PFHxA gave the plaintiffs enough to show the watchbands posed a plausible health risk.
The Northern District of California’s March 16, 2026, order found that the plaintiffs had adequately established standing and stated viable claims on nearly every count, citing both independent lab results and Apple’s internal supplier policies. According to the plaintiffs, Apple previously designated PFHxA as “reportable” at 25 parts per billion (ppb) and elevated the designation to “restricted” in 2023, prohibiting suppliers from exceeding that threshold.
Combined with the plaintiffs’ test results showing PFHxA concentrations exceeding 1,000 ppb, the court found sufficient basis for standing. Given that Apple and the European Union have designated 25 ppb PFHxA as “significant enough to raise concerns warranting some type of disclosure or prohibition,” the plaintiffs have plausibly alleged that the bands “have risky levels of PFHxA,” the court held.
Neither the lab results nor the internal Apple policies were included in the original complaint; both were added by amendment. The study underlying the original suit presented anonymized results and therefore “does not quite say” that the contested bands contain PFAS, the court noted, which was a central focus of Apple’s initial motion to dismiss.
Notably, the court did not address Apple’s arguments in its subsequent motion that the plaintiffs’ test results came from a single tested product and that the plaintiffs failed to allege that the specific products they purchased contained PFHxA—an omission that other courts have found fatal in similar suits.
Most Claims Clear the Pleading Bar
Apple’s supplier classifications proved central to the plaintiffs’ fraudulent concealment/omission claim, which the court found plausible given Apple’s internal recognition of PFHxA’s risks. The plaintiffs’ negligent misrepresentation, unjust enrichment, and California Unfair Competition Law claims also survived. On negligent misrepresentation, the court rejected Apple’s economic loss rule argument, reasoning that the alleged health risks placed the claims outside the rule’s reach.
The court similarly rejected Apple’s argument that the suit’s nationwide common law causes of action should be dismissed because the plaintiffs did not plead which state laws govern them. That analysis is inappropriate for the pleadings stage, and “Apple does not identify which other state law claims might apply or why they would apply over California law,” the opinion states.
Two claims did not survive. Despite making a variety of health and wellness representations about the watchbands, Apple secured dismissal of the suit’s fraudulent misrepresentations claim because the plaintiffs did not identify the specific claims they relied upon. The court also dismissed the plaintiffs’ implied warranty of merchantability claims, which were essentially conceded.
The case is Cavalier v. Apple, Inc., No. 25-cv-713 (N.D. Cal.), filed 1/21/2025.
California Bill Would Phase Out PFAS Pesticides, Require Label Disclosures
/in California, FIFRA, Pesticides, PFAS, Right-to-KnowCalifornia is considering legislation to phase out use, require labeling, and prohibit registrations of pesticides containing PFAS, defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.
AB 1603 states that PFAS exposure “poses a significant threat to the environment and public health” and that their intentional use in pesticides is increasing. The bill notes that EPA has approved 70 active ingredient PFAS pesticides, including 53 allowed for use in California by state regulators, and that a 2025 analysis found that approximately 2.5 million pounds of active ingredient PFAS pesticides are applied in California annually.
The bill would immediately prohibit the California Department of Pesticide Regulation (CDPR) from registering or re-registering pesticides with intentionally added PFAS as an active or inert ingredient, and would phase in the following additional requirements:
AB 1603 would also designate pesticides with intentionally added PFAS as a restricted material. By January 1, 2028, CDPR would be required to prescribe the times and conditions under which such materials may be used or possessed across the state, with authority to prohibit use or possession in certain areas. Use or possession would require a written permit from the county agricultural commissioner, and those permits and related public disclosures would be subject to the same label statement described above.
Any state labeling requirement must contend with the preemption provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which prohibit states from imposing labeling requirements “in addition to or different from those required under” the statute. EPA does not currently require any label disclosure for pesticides containing PFAS.
AB 1603 was introduced on January 16, 2026. The Assembly Committee on Environmental Safety and Toxic Materials will hold a hearing on the bill on April 14, 2026.
EPA: Single Fluorinated Compounds Aren’t PFAS
Late last year, EPA published a webpage pushing back on concerns about pesticides containing a single fluorinated carbon—the threshold for designation as PFAS under AB 1603.
“EPA-approved single fluorinated compounds are not forever chemicals, they are not PFAS, and do not pose any risks of concern when used as labeled,” the webpage states.
EPA emphasizes that, regardless of a pesticide’s contents, registration under FIFRA requires a determination that the product will not cause unreasonable adverse effects on human health or the environment. The agency conducts “robust, chemical-specific” hazard and exposure assessments, “ensuring that every scientific aspect of these compounds is thoroughly evaluated before any registration decision is made.” It conducts a similarly thorough evaluation when setting food tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires a “reasonable certainty of no harm,” EPA states.
EPA notes that pesticides containing a single fluorinated carbon can offer agronomic benefits and may replace more harmful alternatives, such as organochlorines. The agency also points to the European Union, United Kingdom, Canada, and other jurisdictions that have registered or are considering registering pesticides containing a fluorinated carbon.
Manufacturer Challenges Court-Ordered CBI Disclosure
/in CBI, EPA, New Chemicals, Transparency, TSCAA specialty materials manufacturer is suing EPA to prevent the release of its unredacted premanufacture notices (PMNs) under seal in separate litigation challenging the transparency of EPA’s new chemicals program under the Toxic Substances Control Act (TSCA).
A March 23, 2026, court deadline for EPA to produce the documents has now passed without EPA compliance, as the agency, environmental groups, and the manufacturer battle over the appropriate course of action.
The five environmental groups brought the original suit in 2020, alleging that EPA violates TSCA by withholding certain information from the public and allowing overly broad confidential business information (CBI) claims. In December 2025, over EPA’s objections, the D.C. District Court ordered the agency to produce unredacted PMNs under a protective order as part of the administrative record.
Arkema, Inc. submitted two of those 84 PMNs. After EPA notified the company of the impending disclosure, Arkema filed suit on March 13, 2026, to block it.
While TSCA allows EPA to disclose CBI as required by a court order, Arkema argues that the scope of the disclosure encompasses information beyond what is at issue in the case. EPA’s failure “to narrow appropriately the scope of CBI disclosures to only those necessary and related to the claims at issue is both arbitrary and capricious,” the complaint states.
Arkema further contends that “the terms of the protective order are insufficiently protective of proprietary information” and impose “substantially less stringent requirements than EPA itself requires to protect CBI” because they lack provisions for safe storage and handling, training, designated work areas, limits on the number of recipients, a central oversight contact, or recourse for inadvertent disclosures.
Arkema’s suit prompted EPA to move for a stay of the disclosure order on March 17. While “Arkema seeks relief only as to the information that it claims is CBI,” EPA argues that the lawsuit implicates all CBI-designated materials at issue in the case. In addition, the agency warns that allowing separate production of Arkema’s PMNs could inadvertently reveal which PMNs belong to Arkema and thereby compromise its CBI claim.
Environmentalists’ Response
In a March 19 response, the plaintiffs argue that Arkema’s suit and EPA’s motion are a delay tactic in the long-running litigation.
EPA should never have notified Arkema of the impending disclosure, the plaintiffs contend, because multiple statutory notification exceptions apply. Under the plaintiffs’ reading of TSCA, notification is a precondition to filing suit—meaning there is “no basis for” the new challenge.
This “should have been evident to EPA,” the plaintiffs allege. “Nevertheless, EPA voluntarily sent a letter to Arkema incorrectly stating they had a right to appeal….Now that a single manufacturer has submitted such an appeal, EPA turns around and asks this Court yet again to halt production of all 84” contested PMNs, not just Arkema’s.
If EPA believed that a manufacturer could challenge the disclosure and enjoin EPA from complying with the court’s order, it should have said so, the plaintiffs argue. “Instead, it remained silent, thereby inviting the current procedural mess.”
Nor has EPA met its burden to receive its requested relief, since it has not alleged any hardship, the response continues. And despite the company’s CBI claims, the plaintiffs note that it may already be apparent which of the sanitized PMNs—already provided to the court—belong to Arkema: one contains an attached safety data sheet identifying the company by name, and another includes “a number of documents with Arkema’s letter head.”
The plaintiffs further argue that six years of media coverage make it implausible Arkema was unaware its PMNs might be disclosed, alleging the company “has slept on its rights.” Arkema “never claims that it did not know of this lawsuit or the potential implications for its PMNs, but instead has carefully worded its allegations” to say only that it was never informed of active discussions about the scope and terms of releasing its CBI.
EPA’s Reply
In a March 20 reply, EPA says it is agreeable to the environmental groups’ suggestion that the parties meet and confer about potential consolidation or modification of the protective order to address Arkema’s concerns. But EPA reiterates its request for a stay, arguing that the agency “is caught in an untenable situation” that demonstrates “clear hardship.”
“Requiring EPA to produce any of the unredacted PMNs would prematurely decide Arkema before the parties (EPA, Plaintiffs, and Arkema) have an opportunity to resolve the competing positions and defeat the purpose of coordination and possible consolidation or modifications to the protective order,” the reply states.
EPA contends its disclosure notifications to Arkema and other companies were required, arguing that none of the statutory exemptions apply. The agency also notes that, due to difficulties confirming receipt, a subset of companies are still within TSCA’s 30-day window—triggered by notification—to file suit to enjoin disclosure.
EPA further argues that whether it can selectively withhold only Arkema’s PMNs is a legal question that should be resolved in the new litigation. “Until the parties or the Court resolve that legal question, EPA proceeds cautiously,” the reply states, citing TSCA provisions imposing criminal penalties for wrongful CBI disclosures.
On March 25, the environmental groups notified the court that EPA failed to produce the unredacted PMNs by the March 23 deadline.
The case is Arkema Inc. v. EPA, No. 26-cv-886 (D.D.C.). The underlying case is Environmental Defense Fund v. Zeldin, No. 20-cv-762 (D.D.C.).
Ohio Introduces Phased PFAS Ban and Reporting Requirements
/in PFAS, State PolicyOn March 10, 2026, Ohio legislators introduced a bill that would phase-in prohibitions on the intentional addition of PFAS in products and require reporting to the Ohio Environmental Protection Agency (Ohio EPA).
HB 743 closely resembles Minnesota’s PFAS-in-products law, including its definition of PFAS as a class of chemicals containing at least one fully fluorinated carbon atom.
Reporting Requirements
The bill’s reporting requirements would take effect first, by January 1, 2027. Manufacturers would be required to provide a brief product description, the purpose of PFAS in the product, the amount of each PFAS by reporting range, contact information, and any other information requested by Ohio EPA.
Reporting would not apply to products exempted by statute: products preempted by federal law, used products, firefighting foam, pesticides, or medical devices and drugs. Products designated by Ohio EPA as having a currently unavoidable use would also be exempt.
Manufacturers would be required to update their reports within 30 days of a significant change and file reports for new products after January 1, 2027, within a time period specified by rulemaking. If Ohio EPA has reason to believe a product is noncompliant, the agency may require the manufacturer to provide testing results within 30 days.
Product Prohibitions
On January 1, 2028, HB 743’s first product prohibitions would take effect, banning the intentional use of PFAS in: carpets and rugs, cleaning products, cookware, cosmetics, dental floss, fabric treatments, juvenile products, feminine hygiene products, textile furnishings, ski wax, and upholstered furniture.
Beginning January 1, 2033, the prohibition would expand to all products not covered by a statutory exemption or designated as a currently unavoidable use by Ohio EPA. The agency may add prohibitions to additional products by rule before the 2033 general prohibition, though none could take effect earlier than 2028.
HB 743 grants Ohio EPA rulemaking authority to implement the legislation, including the ability to require reporting fees. Violations would be subject to civil penalties of up to $15,000 per day.
Latest Prop 65 Challenge Targets DEA After Series of Industry Wins
/in California, Prop. 65A cosmetics industry trade group is asking the Eastern District of California to enjoin a Proposition 65 warning for diethanolamine (DEA), arguing that the label disclosure violates the First Amendment.
The suit was filed March 2, 2026, by the Personal Care Products Council (PCPC). It follows a string of court victories challenging other Prop 65 warning requirements for chemicals including glyphosate, acrylamide, and titanium dioxide, the last of which was also brought by PCPC.
DEA was automatically added to the Prop 65 list after the International Agency for Research on Cancer (IARC) concluded that the substance is “possibly carcinogenic to humans.” However, PCPC argues that IARC was unable to find a single study establishing a link between DEA and cancer in humans, instead basing the determination on a study of “questionable relevance” in a highly susceptible strain of mice. Other regulatory bodies, like FDA and EPA, have not reached the same conclusion, and some have “expressed skepticism” about the mouse study, PCPC argues.
“Indeed, no California agency has made any scientific determination as to whether DEA causes cancer in humans. Nor has any federal agency done so,” the complaint states.
According to PCPC, laws regulating commercial speech are typically subject to intermediate scrutiny, with a more lenient standard for purely factual and noncontroversial disclosures. However, because the “cancer warning requirement as applied to DEA in cosmetic and personal products is false, misleading, and factually controversial, it cannot survive any level of constitutional scrutiny” and therefore violates the First Amendment, the complaint alleges.
PCPC argues that the warning requirement effectively forces companies to choose between “conveying the unsubstantiated message that DEA in cosmetic products increases cancer risk in humans” or facing “a significant and imminent risk of an enforcement action.” Although an exception exists for products that do not present significant risk, the complaint notes that companies must be able to prove that defense in court if challenged, a costly and uncertain process that leads many to “acquiesce and provide a warning” even if they believe it is inaccurate.
PCPC also claims that, since the warning requirement took effect in 2013, hundreds of companies manufacturing or selling personal care products have paid over $7 million in settlements with private enforcers.
The trade association seeks a declaration that the warning is unconstitutional as applied to personal care products and a permanent injunction barring enforcement by California or private parties.
The case is The Personal Care Products Council v. Bonta, No. 26-cv-682 (E.D. Cal.), filed 3/2/26.
DOJ Unveils First Unified Corporate Enforcement Policy
/in EnforcementOn March 10, 2026, the Department of Justice (DOJ) released its first-ever department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP). The CEP supersedes all existing enforcement policies at DOJ, including the Criminal Division’s policy that it closely resembles. The CEP applies to corporate criminal cases except those relating to antitrust.
“Incentivizing corporate self-disclosures — while still permitting prosecutions in appropriate circumstances — allows the Department to quickly pursue culpable individuals, secure justice for victims, and deter white-collar crime, all while not unduly burdening American businesses,” DOJ stated in a press release.
Part I: Declination Path
Under the CEP, DOJ will decline to prosecute a company for criminal conduct if all of the following criteria are met:
Even where aggravating circumstances exist, prosecutors retain discretion to recommend a declination. In all cases, the company must pay all disgorgement, forfeiture, restitution, and victim compensation. All declinations will be made public.
Part II: “Near Miss” Path
Companies that do not qualify for the Part I Declination Path—because their self-report falls short of a qualifying voluntary disclosure or because aggravating circumstances warrant a criminal resolution—may still be eligible for eased enforcement under Part II, provided they fully cooperated and timely remediated. Under Part II, DOJ shall:
Part III: All Other Cases
All remaining cases proceed under Part III, which grants prosecutors discretion to determine the appropriate resolution but caps any fine reduction at 50% under the Sentencing Guidelines.
How the CEP Differs from Existing Policy
The CEP’s three-part structure and criteria are largely identical to the DOJ Criminal Division’s enforcement policy, released in May 2025. However, there are a few differences:
The CEP also aligns with EPA’s new “Compliance First” enforcement policy, memorialized in December 2025, further signaling a broader regulatory shift toward industry self-policing and voluntary disclosure. While a disclosure made solely to a regulatory agency generally does not qualify under the CEP, “good faith disclosures…may qualify if appropriate under the circumstances.”