American Chestnut Project
Regulatory Status

Current Status

At this time, Darling the transgenic American chestnuts with enhanced blight tolerance, are still undergoing federal regulatory review by the EPA, the USDA-APHIS, and the FDA. This is part of a process by which the safety of transgenic plants is verified before they are publicly distributed or widely planted. Timing is not predictable for any of the agencies, and the EPA specifically may involve a multi-phased approval process. Their initial phase will likely impose temporary restrictions that will limit public distribution of Darling seedlings and other plant material, possibly based on geographic regions or existing permitted Darling plantings.

We don't know exactly how long these reviews will take, especially since this is the first time a transgenic forest tree is being considered for restoration use! We are actively working with regulators to figure out the best way to make seedlings available, and we will update you with more details as our plans progress. 

USDA-APHIS Function and Process

USDA-APHIS reviews transgenic plants, including our blight-tolerant American chestnuts generally focused on the safety of the trees for people and for the environment. We submitted a "Petition for nonregulated Status" to the USDA-APHIS (read the Executive Summary or the full Petition in January 2020.

USDA-APHIS published drafts of two key documents for their review process in late 2022. These documents, a Plant Pest Risk Assessment (PPRA) and an Environmental Impact Statement (EIS), are draft versions of their final regulatory decisions on the Darling trees. These documents state that Darling American chestnuts with OxO are “unlikely to pose a plant pest risk and acknowledge that environmental impacts associated with planting Darling American chestnuts are likely to be either positive or similar to planting other types of chestnuts. 

EPA Function and Process

The EPA is reviewing our registration submission regarding environmental safety and interactions with the blight fungus. Because the gene that gives Darling trees blight tolerance is associated with a pathogen (the Cryphonectria parasitica fungus), these trees are evaluated under EPA pesticide rules. We are also seeking an exemption from the pesticide registration process, since OxO Darling does not kill the fungus and does not fit into the conventional definition of a pesticide. 

FDA Function and Process

We are also electing to go through an optional review by the FDA to confirm that chestnuts with OxO from Darling trees are safe for consumption by humans and animals. For this process, we have submitted nutritional analyses showing that chestnuts with OxO are no different nutritionally from nuts from other American chestnuts, and confirming the absence of wheat allergens or gluten.

Safety for people and the environment

A series of articles summarizing various safety tests relevant to the regulatory process were published by The American Chestnut Foundation (read about Nutrition, Wildlife, Plants & Fungi). You can read more about our environmental interaction research on our Environmental Interactions with Transgenic American Chestnuts page.