EPA Releases Updated Draft Guidance for Biostimulant Products

In an updated draft guidance document released for public review on November 24, 2020 and published in the Federal Register on November 30, the U.S. Environmental Protection Agency (EPA) has revised key aspects of its earlier effort to identify the types of plant biostimulant products that are subject to regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The updated guidance builds upon and responds to public comments EPA received on the Agency’s initial draft guidance, issued in March 2019. Consistent with its earlier approach, EPA again declined to propose its own definition of a “plant biostimulant,” which is not a defined term under FIFRA or any other federal statute. Still, the updated draft guidance does provide some additional clarity as to EPA’s position on the applicability of existing FIFRA requirements to this officially undefined – but continually evolving and growing – category of popular agricultural products.

For the full news alert, click here.

[Back to Top]

EPA Proposes to Allow Certain Uses of Biotechnology in Development of Plant-Incorporated Protectants

In a new rule proposed September 1, the U.S. Environmental Protection Agency (EPA) announced its intent to streamline the regulatory requirements for certain “plant-incorporated protectants” (PIPs)—regulated pesticidal substances produced by plants, as well as the genetic material necessary for the plant to produce those substances. Currently, only PIPs developed through conventional breeding are exempt from EPA’s pesticide registration requirements. All other PIPs, including those developed using biotechnology, must be registered by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and must obtain a tolerance or exemption from tolerance for pesticide food residues under the Federal Food, Drug, and Cosmetic Act (FFDCA) prior to their distribution or sale.

For the full news alert, click here.

[Back to Top]

Federal Agencies Launch New Unified Website for Biotechnology Regulation

On January 9, 2020, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) launched a new “Unified Website for Biotechnology Regulation” that provides a compilation of links to informational resources about biotechnology on each agency’s website as well as associated laws, regulations, and policies.

The website follows President Trump’s June 11, 2019 Executive Order, which directed his administration to modernize the regulatory framework for agricultural biotechnology products.  In addition to providing an overview of each agency’s responsibility under the U.S. Coordinated Framework for the Regulation of Biotechnology, the website also includes a list of Frequently Asked Questions and allows users to submit specific questions or comments to one or more agencies.

According to EPA, the goals of the website including providing enhanced customer service to innovators and developers, while offering the public an opportunity to “learn more about the safe use of biotechnology products.”

[Back to Top]

White House Issues Executive Order to Modernize Regulatory Framework for Agricultural Biotechnology

On June 11, 2019, President Trump issued an Executive Order (EO) calling on his administration to “modernize” the regulatory framework for agricultural biotechnology products. Citing the importance of biotechnology to U.S. food production and agricultural productivity, the EO calls on federal agencies to ensure the “transparency, predictability, and consistency” of applicable federal regulatory processes while basing regulatory decisions on scientific and technical evidence, and taking economic factors into account “as appropriate and consistent with applicable law.”

Specifically, the EO directs the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) to each identify relevant regulations and guidance that can be streamlined, along with any opportunities to exempt low-risk products from “undue regulation.” The EO also directs the three agencies to design a web-based “Unified Biotechnology” platform to allow technology developers to submit inquiries about particular products and receive a “single, coordinated response” with informal guidance on the applicable regulatory process.

In addition, the EO calls on EPA, USDA, and FDA to review their respective regulations and guidance applicable to “genome-edited specialty-crop-plant products designed to have significant health, agricultural, or environmental benefits, in particular those that are likely to benefit rural communities significantly,” with an eye toward updating and removing “undue barriers” that may impede commercialization. This effort is consistent with earlier steps taken by the administration, including USDA’s March 2018 clarification that it does not regulate plants produced through genome-editing and other innovative breeding techniques.

Finally, the EO directs USDA to take the lead on development of a consumer engagement action plan to build public confidence in the safe use of biotechnology in agriculture, and also requires the U.S. Department of State and U.S. Trade Representative to focus on international outreach and trade strategy to open and maintain markets for U.S. agricultural exports abroad.

[Back to Top]