EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:
(a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part;
(b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111);
(c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application;
(d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable.
(e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment;
(f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter;
(g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and
(h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA.
[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 FR 75595, Dec. 12, 2008]
Notes of Decisions
Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).
· cites it 2× “The agency will register the pesticide if it determines that the pesticide is efficacious (with the caveat discussed below), § 136a(c)(5)(A); that it will not cause unreasonable adverse effects on humans and the environment, §§ 136a(c)(5)(C), (D); § 136(bb); and that its label…”
Nat'l Fam. Farm Coalition v. Usepa, 966 F.3d 893 (9th Cir. 2020).
· cites it 2× “40 C.F.R. § 152.112 (b), (c). EPA can unconditionally register the pesticide only if it will “not generally cause unreasonable adverse effects on the environment” “when used in accordance with widespread and commonly recognized practice.”
Pollinator Stewardship Council v. U.S. Env't Prot. Agency, 806 F.3d 520 (9th Cir. 2015).
· cites it 2× “40 C.F.R. § 152.112 (b)–(c). The regulations also require “field testing for pollinators” to be submitted as part of an application for registration if data from other sources indicates a risk to honey bees.”
Bourbia v. S.C. Johnson & Son, Inc., 375 F. Supp. 3d 454 (S.D. Ill. 2019).
· cites it 2× “112(d), and that its label complies with the requirements of FIFRA § 136a(c)(5)(B) and is not misbranded, 40 CFR § 152.112 (f). Once a manufacturer registers a pesticide with the EPA, the manufacturer generally may not modify the label without EPA approval.”
Etcheverry v. Tri-Ag Serv., Inc., 993 P.2d 366 (Cal. 2000).
· cites it 2× “" (See 40 C.F.R. § 152.112 (f).) A pesticide is misbranded if, inter alia, its label "does not contain a warning or caution statement which may be necessary and .”
David Schaffner, Jr. v. Monsanto Corp, 113 F.4th 364 (3rd Cir. 2024).
· cites it 2× “§ 136a(c)(5)(B), which requires the EPA to have “determined that the product is not misbranded as that term is defined in FIFRA,” 40 C.F.R. § 152.112 (f). Unlike the contractual obligation to honor an express warranty, the Preapproval Regulation does not permit a registrant to…”
Dj Coleman, Inc. v. Nufarm Americas, Inc., 693 F. Supp. 2d 1055 (D.N.D. 2010).
“§ 136a(c)(5); 40 C.F.R. § 152.112 (f) (2004)). 7 A pesticide is misbranded if, *1079 among other things, its label is false or misleading in any manner or its label does not contain adequate instructions for use.”
Davidson v. Velsicol Chem. Corp., 834 P.2d 931 (Nev. 1992).
“40 C.F.R. § 152.112 (f). The EPA has extensively regulated pesticide labeling, see generally 40 C.”
Lyall v. Leslie's Poolmart, 984 F. Supp. 587 (E.D. Mich. 1997).
“40 C.F.R. § 152.112 (f). Defendants maintain that because the labeling of the chlorine tablets met EPA requirements, plaintiffs’ claims for negligence and breach of express and implied warranty are preempted by the FIFRA.”
— 40 C.F.R. § 152.112(d) — 1 case
Bourbia v. S.C. Johnson & Son, Inc., 375 F. Supp. 3d 454 (S.D. Ill. 2019).
“112(d), and that its label complies with the requirements of FIFRA § 136a(c)(5)(B) and is not misbranded, 40 CFR § 152.112 (f). Once a manufacturer registers a pesticide with the EPA, the manufacturer generally may not modify the label without EPA approval.”
— 40 C.F.R. § 152.112(f) — 1 case
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