American Chestnut Project
At this time, Darling 58, 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 planted widely. A decision from the USDA-APHIS is expected first. The EPA’s decision will be slightly delayed and may involve a multi-phased approval process. Their initial phase will likely impose temporary restrictions that will limit public distribution of Darling 58 seedlings and other plant material, possibly based on geographic regions or existing permitted Darling 58 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 is conducting an intensive review of Darling 58 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.
The USDA has done their due diligence by spending more time on this review than is currently typical for transgenic agricultural crops. USDA-APHIS recently published drafts of two key documents for their review process. 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 58 trees. These documents state that “Darling 58 American chestnut is unlikely to pose a plant pest risk” (draft EIS, p. 3-3) and acknowledge that environmental impacts associated with planting Darling 58 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 58 blight tolerance is associated with a pathogen (the Cryphonectria parasitica fungus), these trees are evaluated under EPA pesticide rules. We are in the process of seeking an exemption from the pesticide registration process, since Darling 58 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 nuts from Darling 58 trees are safe for consumption by humans and animals. For this process, we have submitted nutritional analyses showing that Darling 58 nuts 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.