The US EPA has withdrawn its 2020 interim decision involving the herbicide, glyphosate. The development follows the regulator petitioning the US Court of Appeals for the Ninth Circuit for a partial rehearing of the latter's June ruling that ordered it to reconsider the interim decision.

However, the Agency's move poses no immediate threat to glyphosate uses, and pesticide products containing the active ingredient will continue to remain on the market. The active ingredient is undergoing its periodic registration review in the country, which is conducted every 15 years for all ais, and is mandated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

Legal debacle

The EPA's 2020 interim decision found "no risks of concern" from glyphosate when used in accordance with federal labels, extending the ai's registrations for use on more than 100 food crops, including maize, soybeans, cotton, canola, and sugar beets that have been genetically modified to tolerate the herbicide.

In March that year, environmentalist groups dragged the EPA to court, disputing its assessment that the ai did not pose risks to humans and the environment, and that the benefits of the herbicide outweighed its potential ecological risks when it was used according to label directions. The suit also alleged that the regulator violated the country's Endangered Species Act (ESA) when it published the interim decision.

Subsequently, in May, the Agency filed a plea seeking voluntary remand of the ecological portion of the interim decision without scrapping the section in its entirety. It stressed that the development would aid further analyses of glyphosate's ecological risk assessment and enable the EPA to consider the draft biological evaluation of the ai, which was published in November 2020.

In June this year, a three-judge panel largely agreed with the plaintiffs that the EPA's interim decision violated the FIFRA as well as the ESA, ruling that the regulator's registration review decision triggered obligations under the ESA. While the Court vacated the Agency's human health risk assessment on glyphosate's carcinogenic properties, it granted the plea for voluntary remand of the ecological risk assessment, stressing that the re-evaluation of the latter section must be completed by October 1st.

However, in August, the EPA cited its inability to comply with the directive, suggesting that the interim decision be vacated altogether in case the Court does not relax the deadline.

In its order revoking the interim decision, the Agency highlights that formal consultations are under way with the US National Marine Fisheries Service (NMFS) and the Fish and Wildlife Service for an ecological risk assessment of glyphosate. Furthermore, the regulator observes that it cannot adhere to the Court-issued deadline as it must open any proposed decision for a 60-day public consultation period before communicating any order.

Workplan

Although the EPA upholds its finding that glyphosate is unlikely to pose risks of cancer in humans, it seeks to "revisit and better explain" its evaluation of the ai's carcinogenic potential. As far as the ai's ecological risk assessment is concerned, the Agency intends to address the issues for which it initially sought remand from the Court, including: considering whether additional or different risk mitigation may be necessary based on the outcome of consultation under the US Endangered Species Act (ESA); preparing an analysis of in-field effects of glyphosate on monarch butterfly habitats; considering whether there are other aspects of its analysis of ecological risks; and assessing what risk mitigation measures may be necessary to reduce potential risks following completion of analyses left outstanding in the interim decision.

The Agency also intends to complete the ESA consultation with the NMFS and the Fish and Wildlife Service and make a determination under the country's endocrine disruptor screening programme. Furthermore, it is looking to respond to an administrative petition regarding glyphosate before issuing a final registration review decision.

Protracted controversy

Glyphosate has faced intense public scrutiny ever since the UN WHO's International Agency for Research on Cancer (IARC) found that the ai is a probable human carcinogen. While the findings were subsequently dismissed by regulatory bodies around the globe, Bayer's legacy business Monsanto was dragged into thousands of litigations in the US over allegations that its glyphosate-based Roundup herbicide was responsible for plaintiffs' cancer diagnoses.

US farmers annually use some 280 million lb (127 million kg) of glyphosate, while another 24 million lb are applied to non-agricultural sites, including 5 million lb sprayed by retail customers. Earlier, the EPA acknowledged that there were some ecological risks from legal uses of glyphosate and revised federal labels to include mitigation measures with an eye on helping farmers limit spray drift, protect pollinators, and reduce the potential for weeds to develop resistance to the herbicide.

Posted 06 October 2022 by Akashpratim Mukhopadhyay, Senior Journalist, Crop Science Market Reporting, S&P Global Commodity Insights

This article was published by S&P Global Commodity Insights and not by S&P Global Ratings, which is a separately managed division of S&P Global.