The environmental organization Natural Resources Defense Council (NRDC) has filed a legal action with the D.C. Circuit Court of Appeals to compel the Environmental Protection Agency (EPA) to respond to a pesticide petition the group filed in 2020. In that petition, NRDC requested that EPA revisit pesticide tolerances for a class of pesticides known as neonicotinoids, or simply neonics. A pesticide may not be used on crops unless it has an established pesticide tolerance. While this legal action is in its early stages, should NRDC be successful in its goal of reducing or eliminating pesticide tolerances for neonics, it could result in a significant reduction of legal uses for those pesticides.
Neonics & the FFDCA
Neonicotinoids are a class of synthetic insecticides developed in the 1980s that are chemically similar to nicotine. Neonicotinoids work by targeting the central nervous system and are significantly more toxic to insects than mammals. Additionally, neonics are water soluble, which means that they break down more slowly in the environment and can be absorbed into plant tissue to provide protection from insects while the plant grows. For that reason, neonics are commonly used as a coating to treat crop seeds prior to planting. Plants grown from seeds treated with neonics absorb the pesticide, rendering the entire plant immune to various pests throughout its lifecycle. The use of neonicotinoid-treated seeds is particularly common for corn, soybeans, and other row crops.
Efforts to restrict or eliminate the use of neonicotinoids have increased in recent years with several states banning or limiting their use. Environmental groups have also sought unsuccessfully to have EPA more strictly regulate neonic-treated seeds. In general, those arguing that use of neonics should be restricted point to evidence which suggests that neonicotinoids pose a threat to pollinating insects such as bees and butterflies, and concerns regarding human health and child development.
In the United States, pesticides are primarily regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Under FIFRA, EPA approves pesticides and registers them for use. While most pesticide regulation is done pursuant to FIFRA, the Federal Food, Drug, and Cosmetic Act (“FFDCA”) governs one crucial aspect of pesticide registration. Specifically, section 346a of the FFDCA authorizes EPA to set limits known as “tolerances” on the amount of pesticides that can legally be in or on raw agricultural commodities or processed foods. Without an established tolerance, a pesticide may not be used on crops intended to enter the food system. 21 U.S.C. §§ 331(a), 346a(a)(1).
The FFDCA provides that EPA may “establish or leave in effect a tolerance for a pesticide chemical reside in or on a food if [EPA] determines that the tolerance is safe.” 21 U.S.C. § 346a(b)(2)(A)(i). The statute further elaborates that with respect to pesticide tolerances, “safe” means that EPA “has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.” 21 U.S.C. § 346a(b)(2)(A)(ii). In other words, a pesticide tolerance is safe if human health is not harmed by repeated exposure to the pesticide’s residue on food products. Additionally, the FFDCA requires EPA to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue,” 21 U.S.C. § 346a(b)(2)(C)(ii). When setting pesticide tolerances, the FFDCA instructs EPA to take care that the residue limit is not so high that repeated exposure will cause harm to infants and children.
EPA may decide to establish, modify, or revoke a pesticide tolerance at any time based either on the agency’s own initiative or in response to a petition filed by a third party. 21 U.S.C. § 346a(c)(1). While anyone may request that a pesticide tolerance be modified, if someone files a petition to revoke a tolerance, then they must include data supporting the request. 40 C.F.R. § 180.32(b). EPA must publish a copy of the petition in the Federal Register within 30 days of receiving it and provide at least 60 days of public comment before issuing a response. 40 C.F.R. §§ 180.7(f), 180.29(b).
Although it is up to EPA to make the final decision on whether or not to grant a petition to establish, revoke, or modify a pesticide tolerance, a 2021 decision from the Ninth Circuit Court of Appeals held that EPA should either revoke or modify an already established pesticide tolerance once the agency finds that the tolerance is unsafe. In League of United Latin Am. Citizens v. Regan, No. 19-71979 (9th Cir. 2021), the court held that once EPA becomes aware of “genuine questions” as to the safety of a pesticide tolerance, then the agency has a duty to determine whether the tolerance is still safe. If EPA then finds that the tolerance is unsafe, it may no longer remain in effect. To reach this conclusion, the court relied on language from the FFDCA which provides that EPA may “establish or leave in effect” a pesticide tolerance “only if [EPA] determines that the tolerance is safe.” 21 U.S.C. § 346a(b)(2)(A)(i). That case arose out of a petition to revoke tolerances for the pesticide chlorpyrifos, a commonly used insecticide, that the plaintiffs had submitted to EPA along with scientific data suggesting that current tolerances were not safe for infants and children. The Ninth Circuit reasoned that the evidence submitted by the plaintiffs raised the type of “genuine questions” that should have triggered an EPA review. As a result of the ruling, all the tolerances for chlorpyrifos were revoked. More information on that decision is available here.
NRDC’s Legal Challenge
The lawsuit filed by NRDC focuses on EPA’s delay in responding to a petition the group submitted in 2020 asking the agency to make changes to the current tolerances for neonicotinoid pesticides. In its petition, NRDC claimed that evidence suggests that current tolerance levels lead to an unsafe rate of exposure to neonicotinoids, particularly for children. NRDC argues that the delay is unreasonable and asks that the court order EPA to make a response.
NRDC submitted its petition to EPA on May 4, 2020. In that petition, the group asked EPA to revoke all pesticide tolerances for five specific neonicotinoid pesticides – acetamiprid, clothianidin, dinotefuran, imidacloprid, and thiamethoxam – until the agency could fully assess their overall toxicity. As part of that request, NRDC cited recent studies purporting to show that exposure to neurotoxic chemicals such as those found in neonicotinoids can cause greater neurodevelopmental harm than previously realized, particularly in children. NRDC claimed that EPA had failed to fully evaluate the cumulative effects of exposure to neonics that are likely to occur based on current tolerances. Although NRDC requested a response to its petition “as soon as practicable,” EPA’s current schedule indicates that it is not planning to respond to the petition until after 2026.
In its complaint filed with the D.C. Circuit Court of Appeals, NRDC argues that EPA has both a legal duty to respond to the 2020 petition, and that the agency’s “unreasonable delay” weighs in favor of the court compelling EPA to respond. According to NRDC, EPA’s duty to respond stems from the FFDCA itself which provides that EPA “shall” issue a final response to a petition to modify pesticide tolerances either by establishing, modifying, or revoking the tolerance or denying the petition. 21 U.S.C. § 346a(d)(4). NRDC also argues that EPA’s duty to respond is established under the Administrative Procedure Act (“APA”), which requires federal agencies to issue final decisions within a “reasonable time[.]” 5 U.S.C. § 555. While the APA does not specify what constitutes a “reasonable time,” courts generally measure that period by months rather than years.
NRDC goes on to argue that EPA’s delay in responding to the 2020 petition should prompt the court to compel the agency to respond. First, NRDC argues that EPA’s five-year delay violates the general understanding that a reasonable time for response is measured by months rather than years, and that the text of the FFDCA requires EPA to make a response. Next, NRDC claims that the human health concerns raised in the 2020 petition make EPA’s failure to respond even more unreasonable. Once again, NRDC cites the FFDCA which provides that EPA may establish a pesticide tolerance only if it is “safe” for aggregate exposure, in particular for infants and children. NRDC argues that because the 2020 petition presented evidence suggesting that current pesticide tolerances for neonics are not safe for adults or children, that five years has been “too great” a wait. Finally, NRDC claims that EPA has presented no reason to justify the delay, and that for those reasons, the court should order EPA to make a final response to the 2020 petition.
The Road Ahead
NRDC’s request to the D.C. Circuit Court of Appeals is likely the beginning of what could be a long legal battle. However this particular legal action is resolved – whether the court orders EPA to respond, sides with the agency, or approves a settlement agreement between the parties – whatever final action EPA does take on the 2020 petition is likely to result in further litigation. Should EPA ultimately deny the 2020 petition, NRDC is likely to challenge the denial. In such a challenge, it is likely that NRDC would cite the Ninth Circuit’s ruling in League of United Latin Am. Citizens v. Regan that EPA’s duty to modify or revoke established pesticide tolerances is triggered once the agency receives evidence showing that the current tolerance is no longer safe. While courts are not bound by rulings from different circuits, they can be persuaded by such rulings. In that way, League of United Latin Am. Citizens v. Regan could ultimately play a role in the matter at hand.
A pesticide may only be used on a food crop so long as it has a tolerance in place for that particular crop. Any modification to the pesticide tolerances for neonicotinoids is likely to result in limiting their overall use. While it is still early days, the outcome of this litigation could impact the future use of neonicotinoids across the country.
To view NRDC’s complaint, click here.
To view NRDC’s 2020 petition, click here.
To view the relevant text of the FFDCA, click here.
For more information on pesticide regulation from the National Agricultural Law Center, click here.