40 C.F.R. § 156.64

Signal word

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(a) Requirement. Except as provided in paragraph (a)(4), each pesticide product must bear on the front panel a signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to which the product is assigned by any of the five routes of exposure in § 156.62. The signal word must also appear together with the heading for the human precautionary statement section of the labeling (see § 156.70).

(1) Toxicity Category I. Any pesticide product meeting the criteria of Toxicity Category I for any route of exposure must bear on the front panel the signal word “DANGER.” In addition, if the product is assigned to Toxicity Category I on the basis of its oral, inhalation or dermal toxicity (as distinct from skin and eye irritation), the word “Poison” must appear in red on a background of distinctly contrasting color, and the skull and crossbones symbol must appear in immediate proximity to the word “Poison.”

(2) Toxicity Category II. Any pesticide product meeting the criteria of Toxicity Category II as the highest category by any route of exposure must bear on the front panel the signal word “WARNING.”

(3) Toxicity Category III. Any pesticide product meeting the criteria of Toxicity Category III as the highest category by any route of exposure must bear on the front panel the signal word “CAUTION.”

(4) Toxicity Category IV. A pesticide product meeting the criteria of Toxicity Category IV by all routes of exposure is not required to bear a signal word. If a signal word is used, it must be “CAUTION.”

(b) Use of signal words. In no case may a product:

(1) Bear a signal word reflecting a higher Toxicity Category than indicated by the route of exposure of highest toxicity, unless the Agency determines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment;

(2) Bear a signal word reflecting a lesser Toxicity Category associated with a diluted product. Although precautionary statements for use dilutions may be included on label, the signal word must reflect the toxicity of the product as distributed or sold; or

(3) Bear different signal words on different parts of the label.

Notes of Decisions
Cited in 5 cases (2 in the last 5 years), 2005–2024 · leading case: Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).
Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005). · cites it 2× “For example, a failure-to-warn claim alleging that a given pesticide's label should have stated "DANGER" instead of the more subdued "CAUTION" would be pre-empted because it is inconsistent with 40 CFR § 156.64 (2004), which specifically assigns these warnings to particular…”
Edwin Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021). · cites it 2× “Generally, “Congress contemplates administrative action with the effect of law when it provides for a relatively formal administrative procedure tending to foster the fairness and deliberation that 7 Monsanto relies on Bates’s explanation that a failure-to-warn claim alleging…”
David Schaffner, Jr. v. Monsanto Corp, 113 F.4th 364 (3rd Cir. 2024). · cites it 3× “A state-law requirement to employ ‘DANGER’ on a pesticide label would thus be preempted were it “inconsistent with 40 CFR § 156.64 (2004), which specifically assigns [‘DANGER’ and ‘CAUTION’] to particular classes of pesticides based on their toxicity.”
Johnson v. Monsanto Co. (Cal. Ct. App. 2020). “) “For example, a failure-to-warn claim alleging that a given pesticide’s label should have stated ‘DANGER’ instead of the more subdued ‘CAUTION’ would be pre- empted because it is inconsistent with 40 C.F.R. § 156.64 (2004), which specifically assigns these warnings to…”
Johnson v. Monsanto Co. (Cal. Ct. App. 2020). “) “For example, a failure-to-warn claim alleging that a given pesticide’s label should have stated ‘DANGER’ instead of the more subdued ‘CAUTION’ would be pre- empted because it is inconsistent with 40 C.F.R. § 156.64 (2004), which specifically assigns these warnings to…”
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