Regulatory Background
- The EPA is tasked with regulating pesticides in the United States under the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA). FIFRA controls the manufacture, sale, and use of a broad range or chemicals and biological pest controls, and its primary purpose is to protect human health and the environment.
- The EPA broadly defines “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” “ Pest” is also broadly defined, including insects, rodents, nematodes, fungus, weeds, or any other aquatic or terrestrial plant or animal life which the EPA Administrator deems to be a pest.
- Under FIFRA, every pesticide must undergo registration with the EPA before distribution or sale. The EPA may not register a pesticide unless it first determines and supports that the pesticide will perform its intended use without unreasonable adverse effects on the environment, and when used in accordance with widespread and common practices will not cause unreasonable adverse effects on the environment.
- Pesticides must be re-registered or newly registered if the claims for the unregistered pesticide differ significantly from the registered pesticide, if the composition of the unregistered pesticide is different, or if an already registered pesticide receives a new use.
- The EPA can choose to exempt pesticides from the regulations if the pesticide is adequately regulated by another federal agency or if it is “of a character which is unnecessary to be subject to [regulations]. . .”
- Currently, seeds coated with systemic insecticides are not regulated by EPA and are exempted from FIFRA registration and labeling requirements. The EPA had asserted that the seeds were “treated articles” under the Treated Article Exemption (40 C.F.R. § 152.25(a)). The EPA interprets a “treated article” as an product or substance that contains a pesticide used to protect the product or substance itself, rather than for protecting public health.
- On May 9, 2013, the EPA released guidance for inspecting alleged cases of pesticide-related bee incidents. The guidance document states that pesticide-treated seeds and any resulting dust-off from the seeds may be exempted under FIFRA as a treated article and therefore planting those seeds is not considered a “pesticide use.”
- On January 6, 2016, CFS filed suit against the EPA, challenging the agency’s position that coated seeds were exempt from FIFRA requirements per the 2013 guidance document. The EPA attempted to dismiss the case as it argued that the guidance document was not a “final” agency action, and the court therefore could not review the action. The court later agreed with the EPA and resolved the case in favor of the agency.
The Petition
- On April 26, 2017, CFS-represented organizations filed a petition requesting the EPA address the coated-seed exemption after 2016 suit failed.
- The petition requested that either (1) the EPA amend the Treated Article Exemption to clarify that it does not apply to coated seeds, or (2) publish a final, formal agency interpretation in the Federal register stating that the Treated Article Exemption does not apply to coated seeds.
- On December 26, 2018, the EPA published a notice in the Federal Register, opening the petition to public comment, receiving approximately 100 substantive comments over the course of the 90-day comment period.
- The EPA did not otherwise respond to the CFS petition.
The Lawsuit
- On December 16, 2021, CFS filed suit against the EPA in the Northern District of California, requesting the court compel the agency to respond to the 2017 petition. If an agency has not responded to matter presented to it “ within a reasonable time,” a court may compel the agency to act on the unreasonable delay.
- In its Complaint, CFS argued that because the coated seeds were not treated with pesticides to protect the seed itself, but the growing plant, the seeds could not be properly exempted as “treated articles” under the Treated Article Exemption.
- The Complaint also alleges that by not responding to the petition, the EPA had violated the Administrative Procedure Act. The Act requires that an agency cannot unlawfully withhold or delay a response to a petition. The Complaint argued that because the EPA had failed to respond to the petition, irreparable harm had been done to the environment and that CFS’s interests had continued to be harmed by the EPA’s lack of oversight.
- On April 21, 2022, the court granted the parties’ joint petition to put the case on hold until the parties could resolve the issues and determine how to appropriately settle the case. It took more than eight months between CFS filing the lawsuit and the consent decree, there was relatively little litigation between the parties.
- The parties filed a joint consent decree to resolve the dispute. A consent decree is a settlement between the parties in a lawsuit which resolves the issue without an admission of liability. The parties jointly propose the decree to the court, which can accept or deny the decree and will supervise the implementation of the decree.
- On August 31, 2022, the court accepted the consent decree. In the decree, the EPA agreed to respond to the 2017 petition by September 30, 2022.
Next Steps
- By September 30, 2022, the EPA will release a letter explaining whether or not the agency will stop exempting the pesticide-coated seeds from registration and labeling requirements under FIFRA.
- If the EPA agrees to begin to regulate pesticide-coated seeds, it will then likely proceed to a formal rulemaking process to amend its regulations to state that pesticide-coated seeds are not exempt from FIFRA. This will likely include a traditional notice of proposed rulemaking and note and comment period.
- Manufacturers of pesticide-coated seeds would then need to register all pesticide-coated seeds (and specific uses of those seeds) through the traditional EPA registration process. This process could take a significant amount of time, leading to uncertainty for manufacturers and farmers on the status and legality of pesticide-coated seeds.
- If the EPA does not release a letter by September 30, 2022, the litigation may continue.
To contact the author of this piece, please email Walker Livingston ( [email protected])
To contact the editor of this piece, please email Patricia Iscaro ( [email protected])
Key documents and dates
- Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
- Center for Food Safety (CFS) 2017 petition requesting the EPA address the coated-seed exemption
- Supplemental guidance for inspecting alleged cases of pesticide-related bee incidents
- Center for Food Safety Consent Decree August 31, 2022
- Center for Food Safety Joint Motion August 30 2022
- Center for Food Safety Complaint December 2021
