Pesticide Litigation

AuthorClaudia O'Brien, Stacey VanBelleghem, Laura Glickman, and Stijn Van Osch
Pesticide Litigation
Claudia O’Brien, Stacey VanBelleghem, Laura Glickman, and Stijn Van Osch
The Environmental Protection Agency (EPA) comprehensively regulates pesti-
cides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which
requires registration of pesticides before they can be lawfully sold.1 FIFRA estab-
lishes a risk-benefit standard that EPA implements for approval of registrations.2
Pesticide residues in food are even more stringently regulated under the Federal
Food, Drug, and Cosmetic Act (FFDCA), which imposes a health-only safety stand-
ard for approval.3 Pesticide litigation often involves application and interpretation
of FIFRA and FFDCA, but it takes many other forms as well. Some of these forms
include EPA civil penalty actions for statutory violations; cases seeking to enforce
regulatory duties under other environmental statutes, including the Endangered
Species Act (ESA), the Clean Water Act (CWA), and the National Environmental Pol-
icy Act (NEPA); arbitrations seeking compensation for use of a registrant’s propri-
etary data to obtain “follow-on” registrations; litigation addressing new regulatory
questions relating to biotechnology; and tort cases implicating the preemption of
certain common law claims by pesticide law. This chapter discusses these as well
as other forms of pesticide litigation.
1. 7 U.S.C. § 136a(a) (2018).
2. 7 U.S.C. § 136(c)(5) (2018).
3. 21 U.S.C. §§ 301–399 (2018).
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328 Environmental Litigation
A. Registration and Labeling
Under FIFRA Section 3, all pesticides distributed or sold in the United States must
be registered with EPA.4 As a threshold matter, the term “pesticide” is defined in
the statute,5 and EPA generally regulates a substance as a pesticide if it is intended
for a pesticidal purpose.6 In determining such intent, EPA’s regulations identify fac-
tors, including the claims or conduct of the seller, characteristics of the product,
or the seller’s knowledge of the pesticidal use of the product.7
When applying for a registration, the prospective registrant must submit to
EPA a complete copy of the pesticide labeling, including a statement of all claims
to be made for the pesticide and directions for use; the complete formula of the
pesticide; and description of the tests, data, or public literature upon which the
claims are based.8 FIFRA expressly protects trade secrets or other confidential
commercial or financial information with certain limitations.9
In order to register a pesticide under FIFRA, EPA must make certain findings,
including that the product’s “composition is such as to warrant the proposed
claims for it,” the proposed label complies with FIFRA, and the chemical “when
used in accordance with widespread and commonly recognized practice . . . will
not generally cause unreasonable adverse effects on the environment.”10 The stat-
ute 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[].”11 Thus,
EPA’s registration evaluation takes into account both risks and benefits.
Upon evaluating these factors, EPA can approve a registration, deny a regis-
tration, or conditionally approve a registration.12 Conditional registrations under
FIFRA may be granted in circumstances where there are missing data and the
registration is conditioned upon submission of required data.13 EPA may also
impose conditions unrelated to data requirements when it conditionally registers
4. 7 U.S.C. § 136a(a).
5. 7 U.S.C. § 136(u) (“‘pesticide’ means (1) any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances
intended for use as a plant regulator, defoliant, or desiccant”).
6. 40 C.F.R. § 152.15 (2018) (explaining when “[a] substance is considered to be intended for a
pesticidal purpose”).
7. See id.
8. 7 U.S.C. § 136a(c)(1). See also 40 C.F.R. § 152.50 (describing application materials for new prod-
uct registration, including data requirements). Under 7 U.S.C. § 136d(a)(2), “[i]f at any time after the reg-
istration of a pesticide the registrant has additional factual information regarding unreasonable adverse
effects on the environment ... the registrant shall submit such information to the Administrator.”
9. 7 U.S.C. § 136h.
10. 7 U.S.C. § 136a(c)(5)(D).
11. 7 U.S.C. § 136(bb) (2018).
12. 7 U.S.C. § 136a(c)(5), (6), (7).
13. Id. § 136a(c)(7).
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