EPA Withdraws Glyphosate Interim Registration Review Decision

Chemicals | By WALKER LIVINGSTON, ESQ

The EPA announced that it was withdrawing all sections of its interim registration review decisions for glyphosate after the Ninth Circuit vacated (or cancelled) the human health portions of the review in June. The move comes as Bayer, who manufactures glyphosate, gears up for additional litigation related to health issues allegedly caused by the herbicide.

Regulatory Background

Glyphosate (CAS RN 1071-83-6), commonly marketed as RoundUp, is an herbicide that has been in use in the United States since 1974. Glyphosate is used in a diverse number of agricultural practices to control weeds and is marketed in many different formulations to meet specific industry needs.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) governs the registration, distribution, sale, and use of pesticides and herbicides in the U.S. Under FIFRA section 3(g), each pesticide is re-reviewed every 15 years.
The EPA has evaluated glyphosate and determined that the herbicide is likely not carcinogenic in humans. The International Agency for Research on Cancer (IARC) determined that glyphosate was “probably carcinogenic to humans” but reviewed significantly fewer studies than the EPA.
In January 2020, the EPA published a notice of availability for the glyphosate interim registration review decision. The decision finalized several draft risk assessments on glyphosate that the EPA had previously published. The interim decision did not identify any human health risks of concern from exposure to glyphosate. There were multiple risk mitigation measures proposed by the EPA, including spray drift management language, herbicide resistance management language, a non-target organism advisory, and certain label consistency measures.
Monsanto, who marketed glyphosate under the RoundUp brand (and its parent company, Bayer), were the subject of a significant number of claims that glyphosate exposure caused non-Hodgkin’s lymphoma and other illnesses. These proceedings were combined into a multi-district litigation (MDL) in the United States District Court for the Northern District of California. In June 2020, Bayer agreed to pay more than $10 billion to resolve most of the glyphosate claims. However, in September 2022, Bayer rejected an additional global settlement that would resolve future claims against the company and appears ready to pursue additional litigation.
Bayer has committed to replacing glyphosate products in U.S. residential markets by 2023.
In 2022, the Ninth Circuit Court of Appeals issued an opinion vacating the human-health portion of the EPA’s 2020 interim registration review decision for glyphosate. The Ninth Circuit (a U.S. federal appeals court covering California, Alaska, Arizona, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington) remanded (or sent back) the decision to the EPA for further consideration.

Withdrawal of the Interim Decision

In a letter dated September 21, 2022, the EPA announced that it was withdrawing all remaining sections of the interim registration review decision.
The roots of this decision go back to the glyphosate Endangered Species Act (ESA) assessment required under section 7(a)(2) of the act. The ESA requires that federal agencies determine whether or not their planned actions are likely to jeopardize the existence of species listed as threatened or endangered under the ESA, or if the actions will destroy or adversely modify the habitats of those animals. The ESA assessment for glyphosate determined that glyphosate use may affect 1,795 listed species and 792 critical habitats and is likely to adversely affect 1,676 of those species and 759 of those habitats.
Lawsuits focusing on the EPA’s analysis of the human health and ecological risks for glyphosate, and arguing that the EPA violated the ESA when it issued its glyphosate interim decision before finishing its formal consultations with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service were filed back in March 2020 by the National Resources Defense Council and the Rural Coalition
Although the EPA defended how it analyzed human and ecological health risks as well as the ESA violation, the agency asked the Ninth Circuit to allow it to revise its analysis of ecological risks and costs. However, in its opinion, the Ninth Circuit vacated (or cancelled) the human health portion of the decision and held that the EPA had failed to make the necessary ESA effects determination before releasing the review decision. Although it allowed the EPA to review the ecological effects part of the glyphosate review, it gave the agency an October 1, 2022, deadline to issue a new ecological risks section.
On August 1, 2022, the EPA asked the Ninth Circuit to re-hear the case, though the request only focused on the deadline that the Ninth Circuit had set for the EPA to issue a new ecological risks section. The Ninth Circuit denied this request four days later.
Because the glyphosate review decision was an interim decision, the EPA can withdraw it without having to set a public comment period for the decision. The EPA stated that producing another interim or a final registration review would take significantly more time than the Ninth Circuit’s October 1, 2022, deadline.
The EPA noted that it had not yet solicited the label changes identified in the interim registration review from pesticide registrants. The agency stated that it expected to solicit label changes after it has completed the final registration review decision for glyphosate.
The EPA emphasized that although it had withdrawn the interim registration review, it does not mean that the EPA has withdrawn the underlying scientific findings and may use them in future reviews. This includes the EPA’s finding that glyphosate is not likely carcinogenic to humans.

Next Steps

The EPA has announced that it will consider whether additional or different risk mitigation measures may be necessary based on the outcome of the ESA consultation for glyphosate. The agency will prepare an analysis of in-field effects of glyphosate on monarch butterfly habitats and will also determine what risk mitigation measures may be necessary to reduce potential risks following completion of analyses left outstanding in the interim review decision.
Glyphosate is currently in an embattled state, with a large multi-district litigation ongoing in the Northern District of California. Changes to glyphosate’s registration, or if the EPA finds new health risks associated with glyphosate use could change the trajectory of the litigation or the registration of glyphosate in the U.S.
The EPA expects to release a final registration review decision for glyphosate in 2026.

To contact the author of this item, please email Walker Livingston.
To contact the editor of this item, please email Patricia Iscaro.

EPA Withdraws Glyphosate Interim Registration Review Decision

Regulatory Background

Withdrawal of the Interim Decision

Next Steps

Key Documents and Dates

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