U.S. EPA withdraws glyphosate interim decision

Date:09-26-2022

The U.S EPA has announced withdrawal of all remaining portions of the interim registration review decision for glyphosate. Pesticide products containing glyphosate continue to remain on the market and be used according to the product label and are unaffected by this action.

Glyphosate is undergoing registration review, a periodic reevaluation of pesticide registrations to ensure that existing pesticide products continue to perform their intended function without unreasonable adverse effects on human health or the environment. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), each pesticide must be reviewed every 15 years.

On Feb. 3, 2020, EPA published the Glyphosate Interim Registration Review Decision (ID). The ID did not identify any human health risks of concern from exposure to glyphosate but did identify potential ecological risks. The ID included interim risk mitigation measures in the form of label changes, including labeling to manage spray drift and herbicide resistance. It concluded that the benefits of glyphosate outweigh the potential ecological risks when glyphosate is used in accordance with the labels.

On March 20, 2020, the glyphosate ID was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners challenged EPA’s analysis of human health and ecological risk, the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures and alleged that EPA violated the Endangered Species Act (ESA).

On May 18, 2021, EPA sought partial voluntary remand without vacatur of the ecological portion of the ID so the Agency could revisit aspects of its analysis in light of EPA’s November 2020 draft biological evaluation for glyphosate and recent court decisions for other herbicides, among other reasons.

On June 17, 2022, the U.S. Court of Appeals for the Ninth Circuit vacated the human health portion of the glyphosate ID and held that EPA’s registration review decision under FIFRA was an ‘action’ that triggered ESA obligations. The court also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the ID but imposed an Oct. 1, 2022, deadline for EPA to issue a new ecological portion. EPA sought relief from this deadline, which the court denied on Aug. 5, 2022.

EPA has determined that withdrawal of the glyphosate ID is appropriate in consideration of the Ninth Circuit’s June 17, 2022, decision. The Agency is unable to finalize a new ecological portion in a registration review decision for glyphosate by the court-imposed Oct. 1, 2022, deadline because of the time needed to address the issues for which EPA sought remand of the ecological portion and satisfy ESA requirements. EPA initiated formal ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) for glyphosate in November 2021, and consultation is ongoing. Moreover, before issuing any decision, EPA must first prepare a proposed decision, publish for a 60-day public comment period, and consider any comments received. EPA cannot complete these processes by the court-imposed deadline.

EPA’s underlying scientific findings regarding glyphosate, including its finding that glyphosate is not likely to be carcinogenic to humans, remain the same. In accordance with the court’s decision, the Agency intends to revisit and better explain its evaluation of the carcinogenic potential of glyphosate and to consider whether to do so for other aspects of its human health analysis. For the ecological portion, EPA intends to address the issues for which it sought remand, including: to consider whether additional or different risk mitigation may be necessary based on the outcome of ESA consultation for glyphosate, prepare an analysis of in-field effects of glyphosate on monarch butterfly habitat, consider whether there are other aspects of its analysis of ecological risks and costs to revisit, and consider what risk mitigation measures may be necessary to reduce potential risk following completion of analyses left outstanding in the ID. EPA also intends to complete ESA consultation with the Services, make a determination under the Endocrine Disruptor Screening Program, and respond to an administrative petition regarding glyphosate before issuing a final registration review decision.

A copy of the Withdrawal of the Glyphosate Interim Registration Review Decision is posted to the glyphosate registration review docket EPA-HQ-OPP-2009-0361 at www.regulations.gov. For more information about glyphosate, visit EPA’s website.