Archives

January 3, 2024

APHIS Reopens Comment Period on Proposed Additional Exemptions for Plants Modified or Produced Through Genetic Engineering

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,...
December 4, 2023

APHIS Announces Determination of Nonregulated Status for Insect-Resistant and Herbicide-Tolerant Maize

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...
November 30, 2023

USDA Updates List of Bioengineered Foods

The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on November 29, 2023, updating the National Bioengineered Food Disclosure Standard’s (the Standard) List of Bioengineered (BE) Foods (the List) by adding “sugarcane (Bt insect-resistant varieties)” and amending “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).” 88 Fed. Reg. 83305. AMS states that in updating the List, “this final rule...
November 16, 2023

APHIS Proposes Five Additional Exemptions for Plants Modified or Produced Through Genetic Engineering

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...
November 14, 2023

USDA, EPA, and FDA Post Report on Stakeholder Comments on Coordinated Framework for the Regulation of Biotechnology and Plain-Language Regulatory Information

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s...
November 6, 2023

EPA Extends the Comment Period on the Proposed Framework to Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides

On September 26, 2023, the U.S. Environmental Protection Agency (EPA) requested comment on a proposed framework to strengthen the assessment of antimicrobial-resistance risks associated with pesticide use. EPA, the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA), under the oversight of the White House Executive Office of the President, have published a concept note. EPA states that the concept note is the first step in creating the framework...
October 5, 2023

CRS Overview of Cell-Cultivated Meat Includes Policy Considerations for Congress

On September 19, 2023, the Congressional Research Service (CRS) published a report providing an overview of cell-cultivated meat. The report provides an overview of the science of cell-cultivated meat, the industry, the regulatory framework for cell-cultivated meat products, congressional interests, and potential policy considerations. CRS states that cell-cultivated meat is developed in a lab, grown from a sample of animal cells that does not require the slaughter of animals. Developing...
August 23, 2023

CRS Updates Report on USDA’s SECURE Rule to Regulate Agricultural Biotechnology

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...
July 31, 2023

APHIS 2022 Impact Report Includes Summary of Biotechnology Activities

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...
July 26, 2023

Bipartisan Legislation Would Strengthen USDA’s BioPreferred Program

By Lynn L. Bergeson and Carla N. Hutton   On July 24, 2023, Senators Amy Klobuchar (D-MN), Joni Ernst (R-IA), Debbie Stabenow (D-MI), and Pete Ricketts (R-NE) introduced the Biomanufacturing and Jobs Act to strengthen the U.S. Department of Agriculture’s (USDA) BioPreferred program. According to Klobuchar’s July 24, 2023, press release, the bill would: Strengthen markets for farmers while also supporting well-paying manufacturing jobs; Allow the Secretary of Agriculture to set...