FDA Proposes to Make GRAS Notifications Mandatory

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For decades, companies have been able to “self-affirm” that a substance is generally recognized as safe (GRAS) without notifying FDA, allowing certain substances to enter the food supply without direct agency review.  That framework could soon change.

In a proposed rule published August 11, 2026, FDA would require any person who introduces a substance into interstate commerce under the Federal Food, Drug, and Cosmetic Act’s (FFDCA’s) GRAS provision to notify FDA of the basis for that conclusion, with a handful of exceptions and a streamlined option for substances already in commerce.

Existing Regulatory Framework

Since 1958, the FFDCA has required premarket review and approval for food additives.  Section 201(s) defines “food additive” to include substances that are intended or expected to directly or indirectly become a component of or otherwise affect the characteristics of food.  Importantly, however, it excludes substances that are GRAS from this definition, thereby exempting them from premarket review.

Overy the years, FDA regulated GRAS substances through several mechanisms, including promulgating regulatory lists of GRAS substances and allowing interested parties to petition the agency to affirm a substance’s GRAS status.  In 1997, FDA pivoted to a voluntary “GRAS notification” system, under which a firm can notify FDA of its determination that a substance is GRAS under the conditions of its intended use.  Firms that submit a GRAS notice can immediately begin introducing the substance into interstate commerce without waiting for a response from FDA.

FDA typically responds to GRAS notices in one of three ways:

  1. Issuing a “no questions” letter, indicating that FDA does not question the basis for the GRAS conclusion;
  2. Indicating that the notice does not provide a sufficient basis for a GRAS conclusion; or
  3. Stating that FDA has ceased its evaluation of the notice at the submitter’s request.

But GRAS notices are optional.  Under the current framework, a firm can simply determine that a substance is GRAS introduce it into commerce without direct FDA oversight.  According to the proposed rule, in 2011, it was estimated that of the more than 10,000 additives used in food, 1,000 were substances for which firms had claimed independent conclusions of GRAS status.

Last year, Health and Human Services Secretary Robert F. Kennedy, Jr., directed FDA to explore revising its regulations to eliminate the self-affirmed GRAS pathway.  In the meantime, several lawmakers have introduced federal legislation to eliminate self-affirmed GRAS, and state legislators have proposed bills that would require manufacturers of self-affirmed GRAS to report information supporting the determination to their states.

What is FDA Proposing?

The proposed rule would amend 21 CFR parts 170 and 570 to make the current GRAS notification program mandatory.  Under proposed § 170.205(a), any person introducing a substance into interstate commerce under the FFDCA’s GRAS provision must notify FDA of the basis for their GRAS conclusion.

Notably, this requirement would extend to substances already in the food supply.  However, FDA is proposing a time-limited, streamlined reporting option for these substances.  Firms exercising this option would only be required to describe the substance’s conditions of intended use, including the foods in which the substance is used or is in contact with, its levels of use, and its purpose.  Submission of the statutory basis for the GRAS conclusion would be voluntary but recommended.

The proposed rule lists seven exceptions to the mandatory GRAS notification requirement:

  • No questions letter: a no questions letter covers the substance under the conditions of its intended use.
  • Substances listed or affirmed as GRAS under the conditions of its intended use under parts 182, 184, or 186.
  • Substances considered GRAS under the conditions of its intended use: this includes (1) certain food ingredients widely consumed before 1958 and (2) substances affirmed as GRAS under parts 184 and 186 if their conditions of use are not significantly different from those reported in the regulation.
  • Established FDA process: substances evaluated by FDA through Voluntary Premarket Consultations, Voluntary Premarket Meetings, and Animal Cell Culture Consultations, if documentation made publicly available by FDA does not recommend or otherwise identify the need for a GRAS notice.
  • TOR exemption: substances whose intended use is the subject of an exemption under the threshold of regulation process in § 170.39.
  • Effective premarket notification for an FCS: substances whose conditions of intended use are covered by a premarket notification for a food-contact substance, provided that the substance in interstate commerce originates from the manufacturer or supplier listed in the FCN.
  • Time-limited option to submit certain information to FDA: the streamlined reporting option for substances already in the food supply described above.

The proposed rule does not create a premarket approval framework.  Firms could continue marketing a substance before submitting a GRAS notification or while a notification is pending before FDA.  Noncompliance would not be subject to direct enforcement; instead, it would serve as a factor in the agency’s prioritization of a substance for post-market review.

FDA would continue to publicly post GRAS notices and related correspondence on its GRAS Notices Inventory.

Who Is Affected?
  • Ingredient makers and suppliers, facing notice obligations for both new and legacy substances;
  • Food-contact and packaging producers, since the rule reaches indirect additives and packaging migrants;
  • Flavor houses and other firms relying on expert-panel GRAS conclusions, which would need to bring legacy substances into the notification or streamlined-submission system;
  • The animal food sector, through a parallel part 570 program with its own AFIC and AAFCO exceptions; and
  • Foreign firms, which filed a large share of GRAS notices to date and would face a new English-translation requirement.
What to Watch Next

FDA proposes a 60-day effective date, an 18-month compliance date for the notification requirement, and a one-year window for streamlined legacy submissions.  The comment period on the proposed rule closes December 9, 2026.

D.C. Circuit Upholds EPA’s CERCLA Designation of PFOA and PFOS

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The D.C. Circuit has upheld EPA’s designation of two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).  In Chamber of Commerce v. EPA, decided August 18, 2026, the court denied every petition challenging the designation, leaving the 2024 rule in place.

What the Court Decided

Industry petitioners, led by the U.S. Chamber of Commerce and joined by chemical, fuel, waste, recycling, construction, and paper trade associations, raised three lines of attack: (1) that EPA misread CERCLA’s “may present substantial danger” standard; (2) that its cost-benefit analysis violated the Administrative Procedure Act’s notice requirement and was arbitrary and capricious; and (3) that regulating amid scientific and economic uncertainty was itself unreasonable.  The panel rejected all three.

Starting with the standard for designation, 42 U.S.C. § 9602(a) directs EPA to designate as hazardous those substances that, when released into the environment, “may present substantial danger to the public health or welfare or the environment.”  Petitioners read that phrase to require a finding that harm will occur on release.  Interpreting the statute de novo and without deference to EPA under Loper Bright Enterprises v. Raimondo, the court disagreed.  “May” denotes possibility, not certainty, and the statute directs EPA to forecast the risk of harm at the time a substance is released, the court held.  The phrase “substantial danger” means that the risk of harm must be serious and real, not hypothesized, which the court said answers the worry that EPA’s reading would let the agency reach something as innocuous as table salt.  Requiring absolute certainty about every release, the court added, would paralyze a statute Congress designed to act on scientific probabilities.

The court rejected two related theories within the same challenge.  First, it declined to read an inflexible hierarchy into CERCLA under which “hazardous substances” must clear a higher bar than “pollutants or contaminants.”  The two are separate designation regimes, the court held, and a substance may begin as a pollutant or contaminant and later be designated a hazardous substance as the science develops.  Second, the court found no nondelegation or void-for-vagueness problem.  Tying EPA’s authority to scientific findings under a public-health standard supplies the “intelligible principle” the nondelegation doctrine requires, the decision states, and the prior regulation of PFOA and PFOS under CERCLA gave regulated parties fair notice that they could be listed.

On the notice challenge, the court held that EPA’s Regulatory Impact Analysis was a “logical outgrowth” of the earlier Economic Assessment, so the additional cost data introduced in the final rule required no fresh comment round.  Notably, the court did not decide whether CERCLA requires EPA to weigh costs in a designation at all.  EPA assumed it must, and the panel assumed the same without deciding, which leaves that question open for a future challenge.

As for regulating amid uncertainty, the court held that EPA acted reasonably in designating PFOA and PFOS despite acknowledged gaps in what it knows about where the chemicals are, what cleanup will cost, and the rule’s downstream effects.  The decisive point was that designation is only the first of many steps before liability attaches.  A long sequence of contingent regulatory actions, together with CERCLA’s statutory limits on liability, stands between listing a substance and any party actually bearing cleanup costs.  Accordingly, the court concluded that EPA’s choice to regulate now rather than wait for certainty was not arbitrary and capricious.

Why It Matters

The designation, effective July 8, 2024, was EPA’s first use of 42 U.S.C. § 9602(a) to list a substance directly, rather than by reference to another environmental statute.  Its practical consequences are now in force: releases of one pound or more of PFOA or PFOS in a 24-hour period trigger reporting obligations, federal property transfers carry notice duties, and most significantly, responsible parties face CERCLA’s strict, joint-and-several liability and cost-recovery regime.

The ruling reaches well beyond PFAS manufacturers.  Waste management, recycling, construction, and other “passive receivers” that handled PFOA- and PFOS-containing materials without making them may now sit within the liability chain.  As the court stressed in rejecting the uncertainty challenge, though, listing is not the same as liability: CERCLA’s defenses, including its act-of-God, third-party, de minimis, de micromis, and innocent-landowner provisions, continue to limit who ultimately pays.

What to Watch

The decision is recent, and the deadlines for a petition for rehearing en banc or a petition for certiorari have not yet run, so the litigation may not be over.

Several aspects of the ruling bear on future CERCLA designations.  Because the court reviewed EPA’s reading de novo and still upheld it, the agency’s designation authority now rests on the statute’s best reading rather than on judicial deference, a firmer footing in the wake of Loper Bright.  EPA committed to notice-and-comment rulemaking before updating this designation, and it has said it intends to develop a broader framework for § 9602(a) designations generally, though the scope and timing of any such rulemaking remain to be seen.  And because the court left open whether cost must be weighed in a designation at all, that question is likely to return as EPA considers additional substances.

For background on the agency’s decision to defend the rule, see our previous post on the litigation.

The case is Chamber of Commerce v. EPA, No. 24-1193 (D.C. Cir.), filed June 10, 2024.

OSHA’s Hazard Communication Deadline Arrives for Employers on November 20

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Employers that use hazardous chemicals face a November 20, 2026 deadline to update, as necessary, their workplace labeling, written hazard communication programs, and employee training for the chemical substances they handle.  The obligation flows from OSHA’s 2024 revision of the Hazard Communication Standard, 29 C.F.R. § 1910.1200, and the compliance phase for substances is now underway.

Note that hazardous chemicals are components of many products used in commercial and industrial operations, such as cleaning and degreasing solvents, paints and coatings, adhesives, fuels and lubricants, and pool or water-treatment products.  Under the standard, a “substance,” defined at 29 C.F.R. § 1910.1200(c), is a chemical element or compound—including any stabilizing additives and process impurities, but not separable solvents—while a “mixture” is a combination or solution of two or more substances that do not react.  Many familiar commercial products are mixtures rather than single substances, which matters here because the standard’s compliance dates arrive earlier for substances than for mixtures.

What Happened

As discussed in a previous post, in May 2024, OSHA published a final rule revising the Hazard Communication Standard to align it primarily with Revision 7 of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  The rule also incorporated select elements of Revision 8.  In the final rule, OSHA set the following compliance dates:

  • For substances, chemical manufacturers, importers, and distributors were to comply by January 19, 2026, and employers by July 20, 2026.
  • For mixtures, manufacturers, importers, and distributors were to comply by July 19, 2027, and employers by January 19, 2028.

In January 2026, OSHA extended each of those compliance dates by four months.  The agency issued the extension as a final rule without notice and comment.  The Federal Register notice explained that the agency needed additional time to publish implementation guidance for the regulated community and its own personnel.  The extension left the standard’s transition provision intact, which allows covered entities to implement the 2012 standard, the 2024 standard, or a combination of the two, until the applicable date arrives.

Under the revised schedule, the deadline for manufacturers, importers, and distributors to bring labels and SDSs for substances into compliance has already passed—the deadline was May 19, 2026.  The corresponding employer deadline for substances is November 20, 2026.  For mixtures, the manufacturer deadline is November 19, 2027, and the employer deadline is May 19, 2028.

Why It Matters and Who Is Affected

Because the May 2026 date has passed, updated SDSs for substances should now be available.  Under the standard, chemical manufacturers and importers must provide an updated SDS with the first shipment after it is revised, and an employer that receives a shipment without one must obtain it from the manufacturer or importer as soon as possible, 29 C.F.R. § 1910.1200(g)(6).  Employers must, in turn, update their own workplace labels, written hazard communication programs, and training to reflect that information ahead of November 20.

The practical burden falls most heavily on downstream employers with large or varied chemical inventories and dispersed workforces, including manufacturers and firms in construction, oil and gas, warehousing, agriculture, and healthcare.  Hazard communication consistently ranks among OSHA’s most frequently cited standards, which raises the stakes for programs left unrevised.

What To Watch

OSHA tied the extension to implementation guidance it was still developing, and the content and timing of that guidance will shape how the revised classification and labeling requirements are applied.  Separately, the rule’s approach to hazard classification, including its treatment of reasonably anticipated uses, has drawn criticism from industry-side practitioners and rulemaking commenters.  Both bear on how the standard will operate in practice.

FTC Extends Its “Made in USA” Enforcement Push

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The Federal Trade Commission (FTC) announced on July 6, 2026, that it had sent seven warning letters to companies it says appear to have misrepresented products as “Made in the USA”—and, in one instance, as “Made in Texas”—that were imported in whole or in significant part.  The letters follow an April 2026 enforcement sweep that included three proposed settlements and a March 2026 executive order directing the Commission to prioritize U.S.-origin enforcement.  Companies that make domestic-origin claims should read the sequence as a signal of sustained regulatory attention.

What the Standard Requires

The FTC polices U.S.-origin claims under Section 5 of the FTC Act, 15 U.S.C. § 45, and, for labels, Section 45a.  The commission’s Made in USA Labeling Rule, 16 C.F.R. Part 323, effective August 13, 2021, codified the long-standing “all or virtually all” standard: an unqualified “Made in USA” claim requires that final assembly and all significant processing occur in the United States and that all or virtually all components be U.S.-sourced.

Many of the agency’s recent enforcement matters involve allegations that companies performed final assembly in the United States using imported components and treated that as sufficient for an unqualified claim.  The FTC’s position is that domestic final assembly does not, by itself, support an unqualified “Made in USA” representation.

The April Settlements

In April 2026, the commission announced three matters resolved through proposed stipulated orders.  The sellers of electronic dartboards, flag and patriotic products, and footwear stipulated to orders barring the challenged claims and providing consumer redress; the largest, involving the dartboard seller, provided $625,000, which the FTC described as the largest redress in a Made in USA Labeling Rule case to date.

By contrast, the July 2026 warning letters do not impose penalties or reflect a formal determination of an FTC Act violation.  Rather, they advise the recipients to “immediately come into compliance” with the FTC’s “Made in USA” requirements and request that each company contact the FTC to discuss its plan for doing so.

Where the Risk Lies

The FTC’s recent Made in USA enforcement has reached companies across diverse industry sectors.  The products involved span industrial machinery, consumer electronics, footwear, vaping products, and flags.  Any marketer making an unqualified domestic-origin claim on a product with meaningful foreign content or offshore processing is a candidate for scrutiny.  Qualified claims—for example, “Assembled in USA” or “Made in USA with imported components”—remain available where accurate and clearly disclosed.

For companies that advertise environmental attributes alongside origin claims, the two obligations compound: each representation needs its own competent, reliable substantiation.  The FTC likewise expects environmental marketing claims to be truthful, non-misleading, and supported by competent and reliable evidence.

Federal Court Blocks California’s “Truth in Recycling” Law on First Amendment Grounds

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A federal court has preliminarily blocked California’s “Truth in Recycling” law, ruling that its restrictions on recyclability claims are likely unconstitutional under the First Amendment and finding that several of its key provisions are impermissibly vague under the Fourteenth Amendment.

In a July 14, 2026, order, the Southern District of California concluded that although the provisions likely to be unconstitutionally vague could be severed from the statute, the plaintiffs were likely to succeed on their broader First Amendment challenge.  As a result, the court enjoined enforcement of the law in its entirety pending further litigation.

What California’s “Truth in Recycling” Law Requires

California enacted SB 343, often referred to as the “Truth in Recycling” or “Truth in Labeling” law, in October 2021.  The law declares recyclability claims—including the chasing arrows symbol—deceptive or misleading unless certain criteria are met.  Chief among them is the “60/60 requirement,” which mandates that the labeled product or packaging be:

  1. Collected for recycling by jurisdictions serving at least 60% of Californians; and
  2. Processed by facilities serving at least 60% of recycling programs statewide, with the collected material sent to and reclaimed at a facility consistent with the Basel Convention (a 1989 treaty governing the transnational movement of hazardous waste).

The law also requires that:

  • The labeled product or packaging “routinely” become feedstock used to produce new products or packaging;
  • Plastic packaging not include any components, inks, adhesives, or labels that prevent recyclability, according to guidance published by a plastics trade association; and
  • Plastic products and non-plastic products and packaging be “designed to ensure recyclability” and not include any components, inks, adhesives, or labels that prevent recyclability.

These restrictions were set to take effect on October 4, 2026.  The plaintiffs—a coalition of roughly twenty trade associations spanning food, packaging, grocery, and retail industries—sued Attorney General Rob Bonta in March 2026, arguing the law is unconstitutional on its face.

Key Provisions Likely Unconstitutionally Vague

The plaintiffs argue that four of the law’s requirements are unconstitutionally vague under the Fourteenth Amendment.  For the purposes of a preliminary injunction, the court found that they are likely to succeed on each challenge:

  1. The “routinely becomes feedstock” provision, because the meaning of “routinely” is unclear.
  2. The Basel Convention requirement, because manufacturers were given no guidance on how compliance with the provision will be determined, which elements of the convention will be considered in reaching a determination, and which facilities are currently in compliance.
  3. The reference to industry guidance, because it is ambiguous whether materials categorized as “Detrimental to Recycling” or “Tolerated But Needs Improvement” are permissible, and because SB 343 does not address what happens when the guidance changes.
  4. The ensures or prevents recyclability provision, because the law provides no guidance on what those terms mean.

The court found all four requirements severable from the remaining text of the law, including the 60/60 requirement—meaning that the rest of the law could still theoretically be allowed to take effect even if the four vague provisions were enjoined.

First Amendment Analysis

The remainder of the law could not withstand scrutiny under the First Amendment, however.

As a threshold matter, the court first determined that the speech at issue is only “potentially” misleading, and not “inherently” misleading, and therefore within the scope of the First Amendment.  The court then applied the remaining prongs of Central Hudson Gas & Electric Corp. v. Public Service Commission, the framework applicable to many regulations of commercial speech.

While finding that California has substantial interests in (1) improving recycling rates and (2) reducing consumer confusion, the court concluded that neither interest was directly advanced by the law.  Addressing recycling rates first, the court held that California failed to adequately support its assertion that businesses would redesign products and packaging to make them recyclable under the law instead of simply removing their recyclability claims.  Gains in efficiency at recycling facilities from removing contaminants “may be substantially outweighed by the decreased rate at which recyclable materials reach those facilities,” the order states.

As to consumer confusion, the court held that the reduced number of recyclability claims would leave customers “with less information than they would receive in the absence of SB 343’s regulatory scheme.”  For example, a product only recyclable in one part of California could not be labeled with that information because the 60/60 requirement would not be satisfied, the court observed.

Finally, the court also held that the law is more extensive than necessary to serve its interests, observing that less extensive regulations, such as required disclosure of materials that may limit recycling, would also advance the state’s goal.

The case is California League of Food Producers v. Bonta, No. 3:26-cv-1675 (S.D. Cal.), filed March 17, 2026.

New Mexico PFAS Labeling Mandate Faces First Amendment Challenge in Federal Court

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A collection of trade associations has sued in federal court to block New Mexico’s PFAS labeling requirement for consumer products, arguing that the regulation violates the First Amendment and the dormant Commerce Clause.

The plaintiffs—including the American Chemistry Council, Alliance for Automotive Innovation, American Coatings Association, National Association of Manufacturers, and several other industry groups—filed their complaint on July 1, 2026, along with a motion for a preliminary injunction based solely on their First Amendment claim.  As it stands, the labeling requirement applies to nearly all products manufactured for sale in New Mexico on or after January 1, 2027.  While several other states have adopted PFAS labeling rules, none apply so broadly.

The federal suit follows a state-court challenge to the labeling requirement, which also alleges First Amendment violations.  That case, filed by a paint manufacturer in May, separately argues that the regulation violates state law because it exceeds statutory authority and imposes an impracticable labeling deadline.

Regulatory Background

New Mexico’s PFAS Protection Act, enacted in 2025, phases in prohibitions on products containing intentionally added PFAS and requires manufacturers to report their use of PFAS to the state.  The law defines PFAS broadly but exempts certain products from its requirements, including fluoropolymers.

In April 2026, following a rulemaking hearing, the New Mexico Environmental Improvement Board (EIB) approved regulations proposed by the New Mexico Environmental Department (NMED) to implement the Act, including a labeling requirement.  The mandated label consists of the term “PFAS” inside an Erlenmeyer flask symbol.  Notably, the statutory exemptions to the prohibitions and reporting requirements do not extend to the labeling mandate.

The First Amendment Claims

The plaintiffs’ First Amendment arguments center on which level of scrutiny applies.  Compelled commercial speech is ordinarily subject to heightened scrutiny, which the plaintiffs argue the labeling requirement cannot survive.  A lesser standard applies only to disclosures that are purely factual and uncontroversial, relate to the terms under which a product or service is offered, and are not unduly burdensome—the test established in Zauderer v. Office of Disciplinary Counsel.  In the preliminary injunction motion, the plaintiffs contend the label fails on every count.

Not purely factual.  The plaintiffs argue the Erlenmeyer flask symbol doesn’t convey factual information so much as a warning.  Commercial manufacturing doesn’t actually use Erlenmeyer flasks, they note, and there is ongoing scientific debate over which substances even qualify as PFAS.  Like a skull-and-crossbones for poison or a flame symbol for flammability, the flask is designed to signal danger, the filing argues.  While NMED testified that the flask tells costumers that the product contains a chemical “they might want to know about,” that interpretation “does not pass the straight face test,” since the state “does not require the Erlenmeyer flask graphic for any other chemical on the neutral theory that consumers ‘might want to know about’ it.”

Not uncontroversial.  The filing next argues that this warning is controversial because the risks associated with PFAS as a class are “at best unsettled.”  For example, the plaintiffs point to fluoropolymers, which they say are understood to present little to no risk when used in products.  To the extent that uncertainty exists on this point, they argue it does not help New Mexico, because it only suggests that the question is controversial.  “If the government wants to present its position concerning an unsettled scientific topic to consumers, then it must do so itself,” the filing states.

Not related to the consumer transaction.  The plaintiffs argue that any upstream or downstream harms associated with PFAS—including releases from manufacturing or disposal—fall outside Zauderer‘s scope because they don’t relate to the terms of the transaction with the consumer.

Unduly burdensome.  Finally, the plaintiffs assert that compliance will be extraordinarily costly and disruptive, potentially running into the hundreds of millions of dollars, in part because manufacturers with global distribution chains may need to relabel their entire product lines.

The motion for a preliminary injunction ends by requesting that the court, at a minimum, enjoin enforcement of the labeling mandate as applied to products only containing fluoropolymers or PFAS to which consumers will not be exposed.

The Dormant Commerce Clause Claims

The complaint also raises two Commerce Clause claims not included in the preliminary injunction motion.

The first argues that the regulation improperly reaches conduct entirely outside New Mexico.  No products containing intentionally added PFAS are manufactured in the state, the complaint notes, yet the mandate applies even when a manufacturer never directly transacts in New Mexico—for instance, when it sells to a third-party wholesaler that independently distributes there.  The plaintiffs argue this amounts to direct regulation of interstate commerce.

The second claims that the regulation’s burdens on interstate commerce exceed its local benefits.  In part because no products are manufactured with intentionally added PFAS in New Mexico, the complaint argues, the costs of compliance will fall almost entirely on out-of-state commerce.  New Mexico had less burdensome alternatives—like carving out fluoropolymers or eliminating the flask symbol—that would have a lesser impact, evidencing that the requirement is excessive, the complaint concludes.

The case is American Chemistry Council v. Kenney, No. 1:26-cv-2130 (D.N.M.), filed July 1, 2026.  A hearing on the preliminary injunction motion has been set for August 27, 2026, at 8:30 AM MT.

Court Rejects EPA Bid to Dismiss TSCA Confidentiality Suit

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A federal judge in the Middle District of Georgia has denied EPA’s motion to dismiss a lawsuit brought by Burgess Pigment Company, which is seeking to stop the agency from publicly disclosing the identity of one of its chemical substances.  The dispute stems from Burgess’s failure to timely file a required notice under EPA’s “Active/Inactive Rule”—a mistake the company acknowledges, but which it argues does not justify the loss of confidential treatment it had maintained for two decades.

The July 31, 2026, order, which the court described as an easy call at this stage, may be a case of first impression on how confidential business information (CBI) claims are handled under the Toxic Substances Control Act (TSCA).  The question has implications beyond this single dispute, particularly as EPA works through the first wave of CBI expirations and renewals under the amended statute.

How We Got Here

The dispute traces back to 2016, when Congress passed the Lautenberg amendments to TSCA.  Among other changes, the amendments tightened the requirements for companies seeking to keep specific chemical identities confidential and directed EPA to determine which chemicals on the TSCA Inventory—EPA’s master list of chemicals in U.S. commerce—were active in commerce.

EPA implemented that requirement through its 2017 “Active/Inactive Rule,” which required manufacturers and processors to file a Notice of Activity Form A (NAA) for each active chemical.  Companies that wanted to keep a chemical identity confidential had to assert that claim in the NAA.  If no timely NAA was filed, EPA’s position is that it becomes statutorily obligated to disclose the substance’s identity.

Burgess missed the NAA for two chemical substances, which it admits was an error.  Burgess, a Georgia-based kaolin processor, has claimed confidential treatment for its chemical identities since at least 2000, and it argues that disclosure now would give competitors access to information they have not previously had, threatening its very existence.

EPA’s Basis for Denial

In April 2020, EPA informed Burgess that both chemical identities were no longer entitled to confidential treatment, triggering a 30-day window under TSCA for Burgess to seek judicial review.  EPA’s stated basis was not the missed NAA deadline—according to Burgess, EPA instead claimed that another company had waived protection for the substances’ identities.  Burgess disputed that characterization and pushed back through counsel.

In 2022, EPA reversed itself as to one chemical, agreeing to preserve its CBI status.  As to the second—the one now at issue in this case—EPA maintained that it was ineligible for CBI treatment but changed its rationale, instead relying on Burgess’s failure to file a timely NAA.

Burgess has continued to claim confidential treatment for that remaining substance in subsequent TSCA submissions.  Each time, EPA has responded by informing the company that it is not entitled to confidentiality, that EPA plans to disclose it, and that Burgess has 30 days to seek judicial review.  Yet despite years of these notices, EPA has never actually published the chemical’s identity on the public Inventory.

The Lawsuit

Following receipt of the latest denial letter in April 2025, Burgess filed suit in July 2025 under the Administrative Procedure Act (APA), alleging that EPA’s determination was arbitrary and capricious.  In its complaint, Burgess argued that the specific chemical identity is deserving of confidential treatment under TSCA, and that EPA’s approach “unreasonably elevate[s] form over function” by focusing solely on “an inadvertent mistake.”

EPA moved to dismiss in November 2025, arguing that the suit was untimely.  In EPA’s view, its latest letter simply reiterated the original 2020 determination, meaning the real target of Burgess’s challenge was a decision from years earlier—long outside TSCA’s 30-day review window.

The Court’s Ruling

The court was not persuaded, calling dismissal an easy call on the current record.  Much of the order walks through the case’s lengthy factual history, with the judge weaving in several notable observations along the way.  For example, the court appeared to emphasize that EPA has never actually disclosed the contested chemical identity despite years of warning that it would, and that EPA appears “mum on any assessment regarding the merits of Burgess’s potential assertion that the identity of its chemical substance is a trade secret” under the Freedom of Information Act.

The court’s most significant comment addressed Burgess’s argument that EPA itself recognizes the risk of irreparable harm when CBI is lost due to an inadvertent filing mistake.  If that’s true, the court stated, “it very well might be that the EPA’s refusal to withdraw its denial of the CBI claim . . . calls for judicial intervention via the APA.”

The court’s actual merits analysis is comparatively short.  Without appearing to take a definitive position on whether the 2020 or 2025 determination is really being challenged, the court pointed to statements on EPA’s website, cited by Burgess, that prior determinations are only one factor in a CBI review and that each claim is evaluated in the context of the submission in which it is received.  Because the sole reason EPA gave for its 2025 determination was that the chemical identity had already been denied, the court held that dismissal was not warranted on “such a limited record.”

“Until the Court can take a ‘hard look’ at the administrative record to determine whether the EPA has acted in an arbitrary or capricious manner, in an abuse of discretion, or otherwise not in accordance with law, the EPA’s efforts to dismiss Burgess’s APA fail at this early stage,” the order states.  In the order’s closing paragraph, the court cites Burgess’s allegation that nothing in TSCA authorizes EPA to disclose a confidential chemical identity because of a reporting entity’s mistake and notes that EPA’s “strict adherence to and unwillingness to budge on an overly technical rule may cement irreparable and irrevocable devastation to a small family-owned business.”

The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-309 (M.D. Ga.), complaint filed July 18, 2025.  EPA has agreed to maintain the confidentiality of the chemical identity for the duration of the litigation.

Microplastics Regulation: EPA Declines to Act, California Moves Forward

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EPA and California took opposite approaches to microplastics regulation within weeks of each other.  On July 1, 2026, EPA proposed to omit microplastics from the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6).  Two weeks earlier on June 18, California’s Department of Toxic Substances Control (DTSC) finalized a regulation adding microplastics to the state’s Safer Consumer Products (SCP) Candidate Chemicals List.

What EPA Proposed

In the proposed UCMR 6, EPA proposed not to include microplastics despite a petition from the governors of seven states—New Jersey, Delaware, Illinois, Maryland, Michigan, Wisconsin, and Connecticut.  That petition matters because the Safe Drinking Water Act section 1445(a)(2)(B)(ii) directs that the administrator “shall include” a contaminant recommended by seven or more governors, unless listing it would prevent listing other contaminants of higher public health concern.

EPA’s basis for declining is analytical feasibility.  The agency states there is no validated EPA or consensus drinking water method with the necessary accuracy and precision to measure microplastics for UCMR 6, and that developing one before the statutory deadline of December 27, 2026, is not feasible.  EPA points out that the governors’ petition itself acknowledges the absence of such a method.  Because monitoring is the entire purpose of the UCMR, EPA argues, requiring systems to test for something no approved method can quantify would yield no usable data while displacing contaminants that can be measured.  Instead, EPA has placed microplastics on the draft Contaminant Candidate List 6 as a first step, and says it will keep evaluating existing consensus practices toward a future method.

It is worth watching whether EPA’s feasibility rationale squarely fits the statutory exception, which is written in terms of “higher public health concern” rather than measurability.  This is a proposed rule open for comment through August 31, 2026, so the final reasoning—and outcome—could change.

What California Did

DTSC’s action runs the other way.  The Office of Administrative Law approved the regulation on June 18, 2026, with an effective date of October 1, 2026; it amends Title 22 to add microplastics—defined as plastics under 5 millimeters in their longest dimension, whether intentionally manufactured or generated by the fragmentation of larger plastics—to the Candidate Chemicals List.  As discussed in a previous post, listing does not itself regulate anything; it is a predicate that lets DTSC evaluate products that contain or generate microplastics and potentially designate them priority products through a later rulemaking.  Listing requires only a hazard trait and consideration of adverse impacts, exposures, and information availability, not a validated quantification method.  As part of its research on microplastics, DTSC published a background document in November 2025 identifying products that could be designated as priority products.

According to DTSC’s Final Statement of Reasons, the agency declined to explicitly define “plastics” in the regulation “because ‘plastics’ has an ordinary English meaning.”  Manufacturers should be aware that DTSC considers biobased and biodegradable polymeric substances within its jurisdiction; DTSC states that

All microplastics, including biodegradable ones, exhibit at least one hazard trait under the Safer Consumer Products Regulations, namely the particle size and fiber dimension hazard trait. Therefore, it is appropriate for DTSC to designate the entire class of microplastics as a Candidate Chemical.

In response to comments that microplastics are more than one chemical and therefore cannot be added to the Candidate Chemicals List through a single rulemaking for a categorical definition, the agency asserted that “there is nothing in the statutes or regulatory history that even implies categorical identities are unauthorized,” noting that list already contains categorical listings, such as PFAS.

The statement of reasons adds that any subsequent priority products proposal for microplastics “will involve an evaluation of potential exposures and significant or widespread adverse impacts associated with those specific products, as well as a formal rulemaking process with opportunity for public input.”  A challenge to the rule is expected.

Coalition Argues TSCA Bars EPA From Weighing Data-Center Benefits in a New-Chemical Review

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A coalition of seventeen environmental organizations, led by Earthjustice, has asked EPA to deny a premanufacture notice (PMN) under the Toxic Substances Control Act (TSCA) for a fluorinated immersion-cooling fluid intended to cool data-center equipment.  The comments press three lines of attack: that the substance poses an unreasonable risk EPA must act on, that the substance’s asserted benefits for data centers are legally irrelevant to that judgment, and that the applicant redacted health and safety information it was required to disclose.

The comments, filed July 15, 2026, respond to EPA’s notice of receipt of the PMN.  The substance is 3-Hexene, 1,1,1,2,2,5,5,6,6,6-decafluoro-, (3E) (CASRN 1256353-26-0), also known as Opteon 2P50.  The PMN applicant’s identity was claimed as confidential business information (CBI).

The Risk the Comments Describe

The coalition’s core argument is that the fluid presents an unreasonable risk that TSCA section 5 obligates EPA to prevent.  It characterizes the substance as a PFAS and urges EPA to find unreasonable risk on that basis alone, citing concerns including persistence, mobility, bioaccumulation potential, and toxicity.  The substance’s status as a PFAS is contested: when chemical supplier Chemours launched the fluid in 2023, it stated that it does not consider the compound a PFAS, describing it as a hydrofluoroolefin (HFO) that degrades quickly in the atmosphere.  The coalition, on the other hand, characterizes HFOs as PFAS and argues that HFOs break down in the atmosphere into shorter-chain PFAS—principally perfluoropropanoic acid (PFPrA) and trifluoroacetic acid (TFA)—that are persistent, highly mobile in water, and difficult to remediate.  They also cite a recent European Chemicals Agency risk assessment committee’s June 2026 opinion—adopted by consensus, now before the European Commission—proposing that TFA be classified as toxic to reproduction.

The comments also argue that the limited information available on the substance raises additional concerns about its risks.  Available toxicity data, they say, come largely from rat studies that understate PFAS risk to humans, and a workplace exposure limit derived by a group the comments describe as industry-linked relied on assumptions it did not disclose.  They add that the fluid is acutely toxic to aquatic life and not readily biodegradable, and that a hyperscale data center could hold tens of thousands of liters of dielectric fluid, with routine evaporative losses and disposal creating recurring releases near workers, fenceline communities, and waters around data centers and disposal sites.

How EPA Must Conduct the Review

A second line of argument concerns EPA’s review process.  TSCA section 5 directs EPA to decide whether a new chemical presents an unreasonable risk “without consideration of costs or other nonrisk factors.” EPA announced in September 2025 that it would prioritize review of new chemicals intended for data-center projects, inviting manufacturers to seek that treatment under Executive Order 14318.  The applicant filed a request for priority review premised on an urgent national need for AI infrastructure, which the coalition contends is irrelevant to the risk determination.  Priority review, they argue, affects when EPA takes up a submission, not the standard it must apply.

Two related arguments target how EPA models exposure.  The comments say EPA cannot assume workers will wear protective equipment, because under the occupational hierarchy of controls such equipment is a last line of defense and, in any event, accounting for its use would violate TSCA by conflating risk evaluation with risk management.  They also argue that EPA must weigh aggregate exposures from many facilities and other reasonably foreseen uses in its analysis.  As an example, the comments claim that the substance is marketed for other cooling applications, including use in electric-vehicle batteries.

The Confidentiality Dispute

The comments separately challenge the applicant’s CBI redactions.  They contend that TSCA generally bars confidentiality claims over health and safety information, yet the filing withheld entire toxicity-profile slides, the toxicological section of the safety data sheet, the applicant’s occupational exposure assessment, and its list of prior substantial risk notices under TSCA Section 8(e).  Other redactions concern information available on Chemours’ website, the coalition argues.

These arguments coincide with litigation brought by Earthjustice-represented environmental groups, which contends that EPA systemically fails to disclose information in PMNs claimed as CBI when the covered information does not facially qualify as confidential.

The comment period for the notice of receipt of the PMN closed July 15, 2026.

Bipartisan Bill Would Give Safer Choice Program Its First Statutory Authorization

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For a voluntary program with roughly 2,000 certified products and unusually broad industry support, Safer Choice has always rested on thin statutory footing.  EPA has run it for more than a decade under general Toxic Substances Control Act (TSCA) authority, without any statute naming the program or directing the agency to operate it.  A bill introduced in the Senate on June 2, 2026, would change that.

What the Bill Does

Senators Chris Coons (D-DE) and Jon Husted (R-OH) introduced S. 4664, the Safer Choice Program Authorization Act of 2026, which would direct the EPA administrator to carry out a voluntary Safer Choice Program encompassing both the Safer Choice and Design for the Environment (DfE) Standards. The bill has been read twice and referred to the Committee on Environment and Public Works.

The legislation would codify much of what EPA already does administratively.  It directs the Administrator to certify products against those Standards, criteria the agency updated in 2024; to maintain the Safer Chemical Ingredients List; and to authorize use of the Safer Choice and DfE labels, which the bill treats as agency marks that may not be used in a false or unauthorized manner.  It would formalize the role of qualified third-party profilers—the outside reviewers who evaluate ingredients and formulations—subject to independence and conflict-of-interest requirements, while reserving final certification decisions to the administrator.  The bill would also authorize the administrator to add product categories—a direction EPA explored through a 2023 request for comment.  It directs coordination with the Food and Drug Administration and the Consumer Product Safety Commission and authorizes $6 million per year for fiscal years 2028 through 2034.

Why It Matters

Because Congress never authorized Safer Choice, the program has been exposed to elimination through budget and reorganization decisions rather than legislation.  Project 2025’s Mandate for Leadership recommended transitioning the Safer Choice program to the private sector, and in 2025 EPA reportedly moved the program into a larger chemicals division as part of a broader reorganization.  The administration’s recent budget requests have proposed steep reductions across EPA.  Statutory authorization would make the program meaningfully harder to unwind administratively.

Who Is Affected

The interested parties here are mostly proponents.  Cleaning-product manufacturers account for most Safer Choice certifications, and they, along with ingredient suppliers, retailers, and institutional and government purchasers who use the label as a procurement benchmark, have an interest in the program’s continuity.  Trade associations representing these sectors have supported authorization.  In addition, third-party profilers would gain a defined statutory role under the legislation.