UPDATE: Late on June 11, 2020, the plaintiffs filed a motion with the court seeking to have EPA’s cancellation order overturned. As of June 12, 2020, the defendants have not filed a response. Be sure to check the Ag & Food Law Update as we will provide more information on this motion and its potential outcomes once the defendants have filed a response.
On June 8, 2020, the Environmental Protection Agency (“EPA”) issued a formal guidance document in response to a ruling from the United States Court of Appeals for the Ninth Circuit that vacated the federal registration of three dicamba-based pesticides. The Ninth Circuit’s ruling, issued on June 3, 2020, vacated the registrations of “XtendiMax With VaporGrip Technology” (“XtendiMax”), “DuPont FeXapan Herbicide” (“FeXapan”), “Engenia Herbicide” (“Engenia”). In response to the court’s decision, EPA has released the Final Cancellation Order for Three Dicamba Products (“the Order”) announcing that the agency will consider all three pesticides to be cancelled under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), and providing guidance for what to do with existing stock of the pesticides.
The Ninth Circuit’s decision in Nat’l Family Farm Coal. v. U.S. Envtl. Prot. Agency, No. 19-70115 (9th Cir. 2020) vacated the federal registrations for XtendiMax, FeXapan, and Engenia after concluding that EPA had failed to make necessary findings under FIFRA to safely register the pesticides. More information on the decision can be found here. Following the court’s decision, the question remained as to what would happen to existing stock of the three pesticides. EPA has answered that question by deciding to treat the court’s order the same as a cancellation order under FIFRA.
The Order is effective as of June 3, 2020 and defines existing stock as “those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the [Order].”
The text of FIFRA provides EPA with the authority to either cancel or suspend pesticide registrations. FIFRA and its regulations also permit EPA to decide whether, and under what conditions, a pesticide that has had its registration cancelled or suspended may be sold, distributed, or used. The regulations determine what factors EPA will consider when making decisions about what to do with existing stock depending on whether the pesticide regulation has been cancelled or suspended. The Order issued by EPA states that the agency will view the registrations vacated by the Ninth Circuit as cancelled and has determined what to do with existing stocks of XtendiMax, FeXapan, and Engenia according to the regulations for cancelled pesticides.
In the Order, EPA states that it has chosen to treat the pesticide registrations as cancelled because the agency has consistently interpreted FIFRA to allow EPA to issue a cancellation order anytime a pesticide that has been sold with the guarantee of a valid registration has that registration terminated by any mechanism. EPA notes that a cancellation order allows the agency to appropriately regulate distribution and use of existing stocks of a pesticide with a cancelled registration. According to EPA, without a cancellation order the text of FIFRA would prevent the sale of XtendiMax, FeXapan, and Engenia, as well as any further movement of those pesticides, including shipping them back to their manufacturers for disposal. Finally, EPA states that because nothing in the text of FIFRA requires unregistered pesticides to be used according to their label, without a cancellation order, users of XtendiMax, FeXapan, and Engenia would not be required to follow the labeling of those pesticides.
How EPA Decides What Happens Next
When determining what to do with existing stock of a pesticide that has had its registration cancelled, EPA follows FIFRA regulations adopted in 1991. Those regulations require EPA to take into account six factors when making an existing stock decision: (1) quantities of existing stock at different levels of trade; (2) risks of using existing stock; (3) benefits of using existing stock; (4) amount of money already spent by users on existing stock; (5) costs and risks of disposal; and (6) the practicality of restricting disposition, sale, and use of existing stock. After evaluating those factors, EPA will make its decision on what to do with existing stock of a pesticide with a cancelled registration.
In evaluating what to do with existing stock of XtendiMax, FeXapan, and Engenia, EPA reviewed each of the necessary factors before making its decision. With regard to the first factor, EPA determined that there was a large amount of all three of the dicamba-based pesticides present in various levels of trade, including end users and retailers. EPA stated that it could not determine the exact quantities of existing stocks currently in the market. In examining the second factor, EPA concluded that there would be a risk to the environment if users applied XtendiMax, FeXapan, and Engenia without following the labels. When reviewing the third factor, EPA noted that all three pesticides had been approved for a variety of uses beyond the over-the-top use considered by the Ninth Circuit. According to EPA, it would be more beneficial to permit the three pesticides to be used for those other uses than to dispose of them. Additionally, EPA stated that it would be beneficial to allow over-the-top use of all three pesticides given that growing season is already underway. With regard to the fourth factor, EPA stated that farmers and commercial applicators had already spent a significant amount of money in reliance on their ability to apply XtendiMax, FeXapan, and Engenia. When considering the fifth factor, EPA concluded that disposal would result in a large amount of spillage from already opened pesticide containers. Finally, in reviewing the sixth factor, EPA stated that it would be difficult to track and regulate all existing stock of XtendiMax, FeXapan, and Engenia. Therefore, restricting the use of the three pesticides would be highly impracticable.
What the Order Allows
After reviewing all six factors, EPA concluded that it would authorize limited distribution and use of the existing stock of all three pesticides. Importantly, EPA uses the definition of “distribution” that is found in FIFRA which defines the term as “to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver.” It is a broad definition that includes shipping existing stock back to its manufacturer.
The Order has authorized the following:
- Distribution or sale by the registrant. Distribution or sale by the registrant of all existing stocks of the products listed below is prohibited effective as of the time of the order on June 3, except for distribution for the purposes of proper disposal.
- Distribution or sale by persons other than the registrant. Distribution or sale of existing stocks of the products listed below that are already in the possession of persons other than the registrant is permitted only for the purposes of proper disposal or to facilitate return to the registrant or a registered establishment under contract with the registrant, unless otherwise allowed below.
- Distribution or sale by commercial applicators. For the purpose of facilitating use no later than July 31, 2020, distribution or sale of existing stocks of products listed below that are in the possession of commercial applicators is permitted.
- Use. Use of existing stocks of products listed below inconsistent in any respect with the previously-approved labeling accompanying the product is prohibited. All use is prohibited after July 31, 2020.
Although the Order answers certain questions about the use of existing stock of XtendiMax, FeXapan, and Engenia following the decision from the Ninth Circuit, it raises issues of its own. For instance, there is some confusion around where the line is drawn between a commercial applicator and a distributor. The Order is also unclear of what to do with existing stock that was ordered and paid for by end users prior to the Ninth Circuit’s decision but has yet to be shipped to those users.
To read the EPA’s Order, click here.
To read the regulations for cancelled pesticide registrations, click here.
To read the text of FIFRA, click here.
To read the court’s opinion in Nat’l Family Farm Coal. v. U.S. Envtl. Prot. Agency, click here.
For more National Agricultural Law Center Resources on pesticides, click here.