All Knowledge & Insights By Date

The U.S. Department of Agriculture (USDA) announced on December 20, 2024, that the United States prevailed in its dispute under the United States-Mexico-Canada Agreement (USMCA) challenging certain Mexican biotechnology measures concerning genetically engineered (GE) corn. Under a February 2023 presidential decree, Mexico banned immediately the use of GE corn in dough and tortillas and instructed government agencies to eliminate gradually the use of GE corn for other food uses and in animal...

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...

On April 10, 2024, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) published a request for information (RFI) about potential amendments to the electronic or digital link disclosure option as it pertains to the National Bioengineered Food Disclosure Standard (Standard). 89 Fed. Reg. 25187. Responses are due June 10, 2024. Background As amended in 2016, the Agricultural Marketing Act requires USDA to establish a national mandatory standard for disclosing any...

On March 28, 2024, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) requested information about potential additions to or subtractions from the List of Bioengineered Foods (List) as it pertains to the National Bioengineered Food Disclosure Standard (Standard). 89 Fed. Reg. 21484. Under 7 C.F.R. Section 66.1, a bioengineered food is a food that — subject to certain factors, conditions, and limitations — contains detectable genetic material that has...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 22, 2024, that it has prepared a draft environmental impact statement (EIS) and draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for maize developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid...

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the agencies have been...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 4, 2024, that it received a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that has been developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests. 89 Fed. Reg. 15542. APHIS is making the petition available for review and...

The U.S. Food and Drug Administration (FDA) has posted a February 2024 guidance entitled “Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.” According to FDA, one purpose of the guidance is to clarify how its 1992 policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 Fed. Reg. 22984) applies to foods derived from NPVs produced using genome editing. The NPV policy provides scientific and regulatory guidance on...

As reported in our November 16, 2023, blog item, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. Comments were due December 15,...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) “advis[ed] the public” on December 1, 2023, of its determination that DP23211 maize (corn) that has been developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides, as well as the gene that encodes for the phosphomannose isomerase...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. According to APHIS’s November 14, 2023, press release, the proposed exemptions...

On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 and a Response to Comments on the first draft of the Guide, published on March 23, 2023. APHIS’s Biotechnology Regulatory Services (BRS) received comments on a range of issues and grouped the comments...

The Congressional Research Service (CRS) published an updated report on August 4, 2023, on the U.S. Department of Agriculture’s (USDA) Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The revisions note that USDA’s Animal and Plant Health Inspection Service’s (APHIS) five-year Strategic Plan for fiscal years (FY) 2023-2027 states that “one of its objectives is to ensure the safe development of agricultural biotechnology products using a...

By Lynn L. Bergeson and Carla N. Hutton   On July 27, 2023, the Organization for Economic Cooperation and Development (OECD) published a new document in its Series on Harmonization of Regulatory Oversight in Biotechnology, Safety Assessment of Transgenic Organisms in the Environment, Volume 10: OECD Consensus Document on Environmental Considerations for the Release of Transgenic Plants. The document addresses environmental risk/safety assessment at a broader level than previous consensus...

By Lynn L. Bergeson and Carla N. Hutton   On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities: Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants: InnerPlant modified two soybean plants and one tomato plant to...

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms — such as viruses, bacteria, yeast, plants, or animals — to have new characteristics.” According to GAO, scientists are currently exploring the use...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using...

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not...