Center for Food Safety sues EPA over unanswered petition on inert ingredients in pesticides


Oct. 18, 2022

The Center for Food Safety (CFS) has filed a complaint against the Environmental Protection Agency (EPA) over the EPA’s lack of response to a petition focused on analyzing inert and adjuvant ingredients’ toxicity in pesticide formulations. The suit will set the stage for the EPA to respond to the petition unless the Agency decides to fight the CFS suit.

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 of 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 or intended for use as a plant regulator, defoliant, or desiccant, or any nitrogen stabilizer.” “ Pest” is also broadly defined, and includes 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, when used in accordance with widespread and common practices, will perform its intended use and 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.

EPA Regulation of Inert Ingredients

  • Inert ingredients are the inactive substances contained in pesticide products and can be referred to as “other ingredients” which are regulated under FIFRA. These substances can function as emulsifiers, solvents, carriers, aerosol propellants, fragrances, and dyes. Inert ingredients used in pesticide products applied to food have tolerances for residues or exemptions from tolerances.
  • A tolerance is an EPA-established maximum residue level of a specific pesticide chemical that is permitted in or on a specific human or animal food in the United States. An exemption from a tolerance means a residue of any amount may be left in or on the food due to its safety. Those used in pesticide products that are not used for food are considered “nonfood use” and are used on ornamental grasses and plants, rodent control, etc. InertFinder is a tool that allows users to search inert ingredients by chemical name and CAS RN for permitted ingredients for food, nonfood, and fragrance uses.
  • EPA’s inert ingredient list maintained by the EPA contains the inert ingredients that have been approved for use in pesticides and require no further approval prior to inclusion in a pesticide formulation for nonfood use. EPA also approves inert ingredients for use in minimal risk pesticide products which are exempt from regulation.

Center for Food Safety Actions

CFS Petition

  • On July 10, 2017, The Center for Food Safety (CFS) filed a petition with the EPA to persuade the agency to assess the whole formation of a pesticide or tank mixture, rather than just the active ingredients.
  • The petition noted that most EPA regulations only require toxicological data from a pesticide’s active ingredients, rather than requiring data from active, inert, and adjuvant ingredients in the pesticide. The petition alleges that without considering the effects of all ingredients, the EPA cannot determine whether a pesticide formulation will have unreasonably adverse effects on the environment.
  • The petition requested five distinct actions from the EPA: (1) revise pesticide registration regulations to take all pesticide ingredients into account; (2) revise pesticide registration regulations to take synergistic effects from pesticide ingredients into account; (3) revise pesticide registration regulations to require toxicological testing for inert ingredients and whole pesticide formulations; (4) revise pesticide registration regulations to require Endangered Species Act (ESA) consultation on whole pesticide formulation effects; and (5) comply with the previous four requests for mandated pesticide reviews.
  • The petition argued that the EPA violated FIFRA by not taking into account the inert ingredients because of the EPA’s statement that “[t]he safety of the [pesticide] formulation, including all its ingredients, is a critical factor in whether the pesticide ‘will perform its intended function without unreasonable adverse effects on the environment.’”

CFS Lawsuit

  • On October 12, 2022, CFS filed a lawsuit against the EPA in the U.S. District Court for the Northern District of California. The lawsuit alleges that the EPA’s failure to respond to the petition violates the Administrative Procedure Act (APA) and requests that the court force the EPA to respond to the petition by a date set by the court. The APA 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.
  • The petition alleges that inert ingredients in pesticides are “not ecotoxicologically benign” and points to a study noting certain inert ingredients are more toxic than a pesticide’s active ingredient. CFS specifically highlighted organosilicons and the ingredients’ effect on honeybee mortality rates.
  • The lawsuit also focuses on synergistic effects of pesticide ingredients, where the toxicity of individual active, inert, or adjuvant ingredients is magnified when used together. CFS cites more studies supporting its position, and notes that fungicides are especially susceptible to synergistic effects of pesticides. By failing to account for these synergistic possibilities, CFS alleges that although the EPA is aware of synergistic risk in pesticide ingredients, the Agency has not taken any formal actions to require whole testing and therefore is failing to comply with FIFRA regulations.

Implications of Suit

  • The suit was only recently filed and the EPA still has time to file an answer in the case (Federal Rules of Civil Procedure allow a defendant 21 days to answer a complaint after service). However, the EPA has recently been more receptive to litigation-based demands to change Agency policy. The EPA has recently requested voluntary remand on multiple pesticide cases (including one filed by CFS) over the past few months, indicating an Agency appetite for revisiting actions or inaction from the previous Administration.
  • The EPA may also agree to respond to the petition, and then deny each aspect of the petition, as the Agency recently did for another CFS petition focused on pesticide-treated seeds (EPA Dismisses CFS Claims in Response to Treated Seed Petition).
  • Therefore, it is likely that the EPA will file an answer or a motion requesting the court allow the EPA to respond to the petition. The EPA will request to not have a deadline imposed on the response to the petition, which CFS will oppose. The court will likely impose a deadline of 30 or 60 days on the EPA to respond to the petition, at which point the Agency will announce whether it plans to account for the toxicity of inert or adjuvant ingredients in pesticide formulations.

To contact the author of this analysis, please email Walker Livingston ( [email protected])
To contact the editor of this analysis, please email Patricia Iscaro ( [email protected])

Key Documents and Dates

Get an insider’s view on regulatory movements.

Sign up for AgencyIQ’s newsletters to receive exclusive regulatory updates and analysis impacting the life sciences or chemical industry.

Copy link
Powered by Social Snap