FIFRA Stop-Sale Orders: Unsubstantiated “Device” or “Treated Article” Exemption Claims Do Not Defeat EPA’s “Reason to Believe”

Case: Berkey International, LLC v. U.S. Environmental Protection Agency (1st Cir. Sept. 18, 2026) — Appeal from the District of Puerto Rico (Vélez-Rivé, J.)

I. Introduction

This interlocutory appeal arose from the EPA’s issuance of a Stop Sale, Use, or Removal Order (“Stop Order”) under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) against Berkey International, LLC (“Berkey”), a manufacturer of water filtration products incorporating silver. The EPA concluded that Berkey’s “Black Berkey Filters” were unregistered and misbranded pesticidal products based on the presence of silver (a recognized pesticide) and marketing/label claims about removal of viruses, pathogenic bacteria, and other “pathogens.”

Berkey sought a preliminary injunction to halt enforcement, arguing the EPA lacked statutory “reason to believe” a FIFRA violation existed because (i) the filters were exempt “devices” and/or exempt “treated articles,” and (ii) the agency improperly relied on guidance without notice-and-comment rulemaking. Berkey also invoked due process, contending it was entitled to notice and a hearing before issuance of the Stop Order.

The central legal question was not whether Berkey’s products ultimately qualify for an exemption, but whether—on the administrative record and under deferential APA review—Berkey showed a likelihood of success in proving the EPA acted “contrary to law” or “arbitrary and capricious” when it found “reason to believe” FIFRA was being violated.

II. Summary of the Opinion

The First Circuit affirmed denial of preliminary injunctive relief. The court held Berkey failed to show a likelihood of success on its APA challenges because it did not substantiate—beyond a post hoc declaration from its president—that the silver in the filters was not intended for a pesticidal purpose and that the filters fell within the “device” or “treated article” exemptions. The administrative record contained ample basis for the EPA’s “reason to believe,” including inspection observations and multiple pesticidal claims on labels and websites.

The court also rejected Berkey’s notice-and-comment argument, finding the EPA could rely on existing regulations—particularly 40 C.F.R. § 152.15 (pesticidal intent shown by claims)—rather than treating PR Notice 2000-1 as a binding substantive rule. Berkey’s due process argument was deemed waived for failure to timely and adequately develop it below. Because likelihood of success is the “sine qua non” of a preliminary injunction, the court did not address irreparable harm, balance of equities, or public interest.

III. Analysis

A. Precedents Cited

1. Preliminary injunction framework and appellate review

  • Becky's Broncos, LLC v. Town of Nantucket (1st Cir. 2025): Provided the standard of review—abuse of discretion for denial of preliminary injunction; factual findings reviewed for clear error; legal questions de novo.
  • New York v. Trump (1st Cir. 2026) and Winter v. Nat. Res. Def. Council, Inc. (2008): Supplied the four-factor preliminary injunction test, emphasizing likelihood of success, irreparable harm, equities, and public interest.
  • Akebia Therapeutics, Inc. v. Azar (1st Cir. 2020): Reinforced that likelihood of success is the “sine qua non” of preliminary injunctive relief; failure on this factor ends the inquiry.

2. APA review and deference to EPA technical judgments

  • Campanale & Sons, Inc. v. Evans (1st Cir. 2002) and Dubois v. U.S. Dep't of Agric. (1st Cir. 1996): Confirmed that EPA action under FIFRA is reviewed under APA standards.
  • Housatonic River Initiative v. EPA (1st Cir. 2023) and Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. (1983): Anchored the “arbitrary and capricious” test—agency action stands unless it ignores important aspects, relies on improper factors, contradicts record evidence, or is implausible.
  • City of Taunton v. EPA (1st Cir. 2018): Heightened deference where EPA decisions are scientific/technical.
  • Marasco & Nesselbush, LLP v. Collins (1st Cir. 2021) (quoting Atieh v. Riordan (1st Cir. 2015)): The court will uphold agency determinations supported by “any rational view of the record.”

3. FIFRA compliance obligations, labeling, and “intent”

  • Bates v. Dow Agrosciences LLC (2005): Cited for the “continuing obligation” to comply with FIFRA labeling requirements; also later used (via another case) to illustrate that EPA regulations can supply content to FIFRA misbranding standards.
  • Stearns Elec. Paste Co. v. EPA (7th Cir. 1972): Used to underscore that FIFRA’s design shifts compliance burdens to the regulated entity (here, Berkey) in a pre-authorization regime.
  • N. Jonas & Co. v. EPA (3d. Cir. 1981): Key for rejecting “subjective intent” as a means to avoid FIFRA; a seller cannot evade regulation by asserting a private intended use when objective representations suggest pesticidal purpose.

4. Labeling “requirements” and notice-and-comment argument

  • Monsanto Co. v. Durnell (2026) (quoting Bates v. Dow Agrosciences LLC): Supported the proposition that “requirements” can include EPA regulations that give content to FIFRA misbranding standards—undermining the claim that the agency needed PR Notice 2000-1 to act.

5. Waiver and undeveloped arguments

  • 133137, LLC v. Town of Harwich (1st Cir. 2025), Harriman v. Hancock Cnty. (1st Cir. 2010), Brox v. Woods Hole (1st Cir. 2026) (quoting Iverson v. City of Boston (1st Cir. 2006)), and United States v. Zannino (1st Cir. 1990): Applied to hold Berkey’s due process theory waived (not squarely and timely developed) and to treat other perfunctory assertions as forfeited.

B. Legal Reasoning

1. The “reason to believe” enforcement threshold under FIFRA

FIFRA authorizes a Stop Order if the EPA has “reason to believe on the basis of inspection or tests” that a pesticide/device is in violation or intended for distribution in violation. The First Circuit treated this as a comparatively low enforcement threshold, reviewed through the APA’s deferential lens: the question was whether the EPA had a rational, record-based basis to suspect a violation, not whether Berkey had definitively violated FIFRA.

2. Why Berkey failed to show likely success on its “device” exemption theory

Berkey argued its filters function mechanically (a “tortuous maze of micropores”) and therefore qualify as exempt “devices” under 40 C.F.R. § 152.500. The court accepted that mechanical filtration is typically device-like, but emphasized the regulatory divide the EPA relied upon: if the article “incorporates a substance” intended to mitigate pests, the entire product may be treated as a pesticide product subject to registration.

Critically, the court held Berkey did not carry its burden to show the incorporated silver lacked pesticidal intent. Its only proof was a litigation-generated declaration from its president asserting the silver merely protects the filter. Invoking N. Jonas & Co. v. EPA, the court rejected “subjective intent” as insufficient and found Berkey’s lack of substantiation fatal at the preliminary injunction stage.

Additional sting: Even if classified as a “device,” the court observed devices remain subject to FIFRA misbranding prohibitions, and the Stop Order alleged misbranding for failure to bear required establishment/registration information.

3. Why Berkey failed to show likely success on its “treated article” exemption theory

The “treated article” exemption (40 C.F.R. § 152.25(a)) requires (i) the pesticide’s purpose is to protect the article itself, and (ii) the pesticide is registered “for such use.” The court held Berkey failed on both prongs as a matter of proof:

  • Purpose prong: Berkey again offered only its president’s declaration to assert the silver protects the filter rather than providing pesticidal action beyond the article. The EPA stated it could not determine applicability “based on the information available at the time.” The court treated that uncertainty—combined with Berkey’s burden in a pre-authorization regime—as sufficient to sustain the EPA’s “reason to believe.”
  • Registration-for-such-use prong: Berkey asserted it incorporated “a registered antimicrobial pesticide containing silver” but provided no administrative-record citation establishing the registration covered the claimed use. The court highlighted that Berkey could have sought to supplement the record with proof but did not do so in a way that cured the gap.

4. Pesticidal “claims” as evidence of intended pesticidal purpose

The Stop Order relied not only on silver’s presence but also on label and website statements about removal of “viruses,” “pathogenic bacteria,” and “100% of the pathogens.” The court connected these statements to 40 C.F.R. § 152.15(a)(1), which treats a substance as intended for pesticidal purpose when sellers “claim, state, or imply (by labeling or otherwise)” pesticidal use. This provided an independent regulatory footing for the EPA’s inference of pesticidal intent.

5. Notice-and-comment challenge rejected: regulation, not guidance, did the work

Berkey argued the EPA effectively treated PR Notice 2000-1 as a binding rule (contending pesticidal claims strip the treated-article exemption) without notice and comment under 5 U.S.C. § 553. The court rejected the premise: even if PR Notice 2000-1 were nonbinding, 40 C.F.R. § 152.15 already supplies enforceable authority tying pesticidal claims to pesticidal intent. The court therefore found no likelihood of success on an APA procedural claim.

6. Due process claim waived

The court declined to reach Berkey’s Fifth Amendment due process argument because it was not timely and adequately developed in the preliminary injunction proceedings. Citing waiver precedents, the court treated the sporadic references (including raising the issue mainly in a reply brief) as insufficient to preserve the claim.

C. Impact

  • Heightened practical burden on regulated parties seeking emergency relief: The decision signals that, at least at the preliminary injunction stage, a company contesting a FIFRA Stop Order must come forward with objective, verifiable support (e.g., registrations, product composition evidence, determinations, consistent labeling history) rather than relying on post hoc declarations.
  • Marketing claims can be dispositive evidence of “intent”: Claims about pathogens, viruses, or bacteria removal may supply EPA with a straightforward path under 40 C.F.R. § 152.15 to conclude pesticidal intent—especially when a recognized pesticidal substance (like silver) is present.
  • Exemptions are not “safe harbors” without documentation: The court implicitly encourages the use of EPA’s formal classification/determination processes (the opinion notes that manufacturers may request determinations), because absence of such prior determinations can leave businesses vulnerable when enforcement begins.
  • Agency enforcement threshold remains low and review remains deferential: By focusing on “reason to believe” and “any rational view of the record,” the opinion strengthens EPA’s hand in early-stage enforcement disputes where the record contains inspection findings and outward-facing claims.

IV. Complex Concepts Simplified

  • FIFRA “pesticide” vs. “device”: A “device” typically uses physical means (e.g., trapping) to mitigate pests and is not registered under FIFRA § 3. But if the product incorporates a pesticidal substance intended to control pests, the entire product can be treated as a pesticide product subject to registration.
  • “Treated article” exemption: An item containing a pesticide can be exempt if the pesticide’s role is only to protect the item itself (not to act as a pesticide in the environment) and the pesticide is registered for that protective use.
  • “Intended for a pesticidal purpose” (40 C.F.R. § 152.15): Intent is inferred objectively. If a seller’s labeling or advertising claims pesticidal effects (e.g., killing/removing pathogens), the law may treat the substance as intended for pesticidal use.
  • “Misbranding”: Even apart from registration, FIFRA prohibits distributing pesticides/devices with deficient labeling information (including required numbers/identification), exposing products to enforcement.
  • APA “arbitrary and capricious” review: Courts generally do not redo the agency’s factfinding; they ask whether the agency’s decision is rational and grounded in the record.
  • Waiver on appeal: Constitutional or statutory arguments must be clearly and timely presented in the trial court. Raising a point late (e.g., primarily in a reply) risks forfeiture.

V. Conclusion

Berkey International, LLC v. U.S. Environmental Protection Agency reinforces a practical rule for FIFRA enforcement litigation: when the EPA issues a Stop Order based on inspection evidence and pesticidal claims—particularly where a known pesticidal substance is incorporated—the regulated party must substantiate any “device” or “treated article” exemption with objective support to show the agency lacked “reason to believe” a violation occurred. Post hoc assertions of benign intent, without corroboration, will not likely support emergency injunctive relief under the APA’s deferential standard. The opinion also underscores that existing EPA regulations (not merely guidance) can supply the operative legal basis for treating marketing claims as evidence of pesticidal intent.