All Knowledge & Insights By Date

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...