(a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.
(b) In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for amended registration;
(2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or
(3) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.
(c) A registrant may at any time submit identical minor labeling amendments affecting a number of products as a single application if no data are required for EPA to approve the amendment (for example, a change in the wording of a storage statement for designated residential use products). A consolidated application must clearly identify the labeling modification(s) to be made (which must be identical for all products included in the application), list the registration number of each product for which the modification is requested, and provide required supporting materials (for example, labeling) for each affected product.
[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 FR 64764, Dec. 14, 2001]
Notes of Decisions
David Schaffner, Jr. v. Monsanto Corp, 113 F.4th 364 (3rd Cir. 2024).
· cites it 7× “An EPA regulation promulgated pursuant to FIFRA (the “Preapproval Regulation”) prohibits modifying the health warnings included on a pesticide’s Preapproved Label, see 40 C.F.R. § 152.44 (a), and the exceptions to the Preapproval Regulation would not permit the addition of the…”
Reutzel v. Spartan Chem. Co., 903 F. Supp. 1272 (N.D. Iowa 1995).
“See 40 C.F.R. § 152.44 (a) (requiring “any modification in the composition, labeling or packaging of a registered product must be submitted with an application for amended registration.”
Migrant Clinicians Network v. Usepa, 88 F.4th 830 (9th Cir. 2023).
“§ 136a(c)(5)(C), (D); 40 C.F.R. § 152.44 . FIFRA defines “unreasonable adverse effects on the environment” to include “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.”
Monsanto v. Durnell (2026).
· cites it 10× “See §136a(f)(1); 40 CFR §§152.44 (a), 156.70(c). If a manufacturer does not use the EPA-approved label, it may be subject to civil and criminal penalties.”
In re: Fosamax (Alendronate Sodium) Prods. Liabi v., 118 F.4th 322 (3rd Cir. 2024).
“See 40 C.F.R. § 152.44 (a) (“If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.”
Ctr. for Food Saf. v. Michael Regan (9th Cir. 2022).
“EPA does not represent that it waived the application requirement, see 40 C.F.R. § 152.44 , so the question before us is whether the amended uses are “new uses.”
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