C.F.R. » Title 40 » CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY › SUBCHAPTER E—PESTICIDE PROGRAMS › PART 152—PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES › Subpart C—Registration Procedures

40 C.F.R. § 152.46

Notification and non-notification changes to registrations

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(a) Changes permitted by notification. (1) EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of modifications permitted by notification and any conditions and procedures for submitting notifications.

(2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any procedures issued thereunder and distribute or sell the modified product as soon as the Agency has received the notification. Based upon the notification, the Agency may require that the registrant submit an application for amended registration. If it does so, the Agency will notify the registrant and state its reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit an application the Agency may determine that the product is not in compliance with the requirements of the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of FIFRA section 12(a)(2)(M).

(b) Changes permitted without notification. EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished without notification to or approval by the Agency. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of amendments permitted without notification (also known as non-notification). A registrant may distribute or sell a product changed in a manner consistent with such procedures without notification to or approval by the Agency.

(c) Effect of non-compliance. Notwithstanding any other provision of this section, if the Agency determines that a product has been modified through notification or without notification in a manner inconsistent with paragraphs (a) or (b) of this section and any procedures issued thereunder, the Agency may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application for amended registration.

[61 FR 33041, June 26, 1996]
Notes of Decisions
Cited in 4 cases (3 in the last 5 years), 1997–2026 · leading case: David Schaffner, Jr. v. Monsanto Corp, 113 F.4th 364 (3d Cir. 2024).
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David Schaffner, Jr. v. Monsanto Corp, 113 F.4th 364 (3d Cir. 2024). · cites it 8× “46 (quoting 40 C.F.R. § 152.46 (a)(1)). Monsanto could have relied on this authorization, they suggest, to add the Cancer Warning to the Roundup label using modification by notification.”
Edwin Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021). “40 C.F.R. § 152.46 (a); EPA, HARDEMAN V. MONSANTO 27 Office of Pesticide Programs, Pesticide Registration Notice 98-10 (Oct.”
Lyall v. Leslie's Poolmart, 984 F. Supp. 587 (E.D. Mich. 1997). · cites it 2× “Defendants respond that EPA regulation 40 C.F.R. § 152.46 (b)(2), which was in effect at the time of Lyall’s injury, provides that changes in package size and net contents of a package do not require notification to the EPA.”
Monsanto v. Durnell, No. 24-1068, 2026 WL 1825691 (U.S. June 25, 2026). “40 CFR §152.46 (a)(1). But EPA’s regulations specifically require EPA approval for precautionary “statements pertaining to the hazards of the product,” which would include cancer warnings.”
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