Under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), pesticide manufacturers work with the Environmental Protection Agency (“EPA”) to register pesticides for legal use. A pesticide may only be legally used in the United States if it is registered under FIFRA. Along with providing rules and regulations for pesticide registration, FIFRA contains mechanisms to cancel a pesticide registration, effectively making it no longer legal under FIFRA to use the pesticide.
According to the statute, there are two main ways in which a pesticide registration may be cancelled: EPA may choose to initiate cancellation proceedings; or the party that registered the pesticide under FIFRA – referred to as “the registrant” – may voluntarily ask EPA to cancel the registration. It is also possible that a court may vacate a pesticide registration, which EPA will typically treat as a cancellation. The following is an overview of each pathway to pesticide registration cancellation.
EPA Initiates Cancellation
In order to first register a pesticide product under FIFRA, the EPA is required to make a determination that use of the pesticide will not cause “unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(c)(5)(C). The term is defined to mean:
(1) 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, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of [the Food, Drug, and Cosmetic Act]. 7 U.SC. § 136(bb).
In turn, the Federal Food, Drug, and Cosmetic Act (“FFDCA”) requires EPA to establish tolerances for pesticide chemical residues in or an any food that may remain in effect only so long as the EPA determines that the tolerance is safe. 21 U.S.C. § 346a(c)(2)(a)(i). Taken all together, EPA may only register a pesticide for use under FIFRA if it determines that the pesticide will not result in unreasonable harm to humans or the environment, and if the tolerance established for the pesticide is “safe” according to the standards of the FFDCA. Under FIFRA, EPA may initiate cancellation proceedings for a pesticide registration if it finds that the pesticide is causing unreasonable adverse effects on the environment. 7 U.S.C. § 136d(b).
Once EPA has decided to initiate a cancellation proceeding, it must follow the steps laid out in section 136d(b) of FIFRA. First, EPA will be required to issue a Notice of Intent to Cancel (“NOIC”). The notice must consider the effect of cancellation on production, price of agricultural commodities, retail food prices, and the agricultural economy as a whole. Typically, EPA is required to issue the NOIC and an analysis on the impact of cancellation to the agricultural community to the United States Department of Agriculture (“USDA”) at least 60 days before issuing the NOIC to the pesticide registrant and the public. After receiving the NOIC, USDA has 30 days to comment. If it comments, then EPA must publish the comment along with EPA’s response to the comment in the Federal Register along with the NOIC. If USDA does not comment, then EPA may proceed with the cancellation process immediately. At the same time that EPA provides USDA with the NOIC, it must also submit the NOIC to the FIFRA Science Advisory Panel for comment on the effect of the NOIC on human health and the environment.
Once EPA has completed the above steps, it can submit the NOIC and the reasons for the action to the pesticide registrant, and publish all documents in the Federal Register for public availability. The pesticide cancellation will become final and legally effective either 30 days after the registrant receives the NOIC, or when the NOIC is published in the Federal Register, whichever occurs later. However, the date on which the cancellation becomes effective may be delayed if a hearing is requested by a person who would be adversely affected by the notice. If a hearing is held, any decision issued in regards to the pesticide is considered a final agency action. Additionally, EPA will be required to consider alternatives to cancellation, such as restricting the pesticide’s use, and any decision the agency reaches must be fully explained.
Registrant Initiates Cancellation
The second pathway to cancellation under FIFRA is known as “voluntary cancellation.” The process for voluntary cancellation is set out in FIFRA section 136d(f). Under that portion of FIFRA, a pesticide registrant may, at any time, request that its pesticide registration be cancelled. To initiate the cancellation process, the registrant may submit a letter to EPA requesting cancellation. After receiving the request, EPA will publish a notice in the Federal Register with a comment period of at least 30 days. At the end of the comment period, unless the registrant rescinds the cancellation request, the cancellation will become final and go into effect.
The third pathway to cancellation lies through the courts. In a handful of instances, plaintiffs have successfully petitioned courts to vacate a pesticide registration. However, a court decision vacating a pesticide registration is not the same thing as a pesticide cancellation order. Although the two actions will both result in a pesticide no longer being registered for use, FIFRA specifically states that EPA “may permit the continued sale and use of a pesticide whose registration is … cancelled.” 7. U.S.C. § 136d(a)(1). In other words, if a pesticide is cancelled under FIFRA, EPA has the power to allow limited use of the remainder of that pesticide that is still in the possession of pesticide users. However, if a court vacates a pesticide registration, FIFRA does not explicitly allow for EPA to permit the use of existing stocks. Depending on the timing of the court’s decision, this can harm pesticide users who have already purchased the pesticide and were relying on it for the coming growing season. In order to avoid that situation, EPA may choose to issue a cancellation order for a pesticide which has had its registration vacated by a court.
For example, in June 2020, the Ninth Circuit Court of Appeals vacated the registration for several dicamba-based pesticides. The order went into legal effect shortly after the decision was issued, causing the dicamba products to lose their registrations in the middle of that year’s growing season. Without a registration, the pesticides could not be legally applied. In that instance, EPA issued a cancellation order for the pesticide products so that it could allow the continued use of existing stocks during the remainder of the growing season. If EPA had not issued a cancel order, it is likely that the agency would not have had the statutory authority to allow the use of existing stocks of the dicamba pesticides whose registration the court had vacated. For more information on the court’s order and EPA’s response, click here.
The text of FIFRA makes it clear that there are only two primary ways in which a pesticide registration may be cancelled – either EPA or the registrant must initiate the cancellation proceeding. While third parties may attempt to convince a court to vacate a pesticide regulation, for the most part it is up to EPA to pursue cancellation for pesticides that are found to cause unreasonable adverse effects to human health or the environment.
To read the text of FIFRA, click here.
For more National Agricultural Law Center resources on pesticides, click here.