Recent Actions on Ag Biotech by EPA’s Emerging Technologies Branch
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced an abrupt reversion to its pre-2020 approach to biotechnology regulation on December 19, in the wake of a December 2...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more
On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
USDA’s Agricultural Marketing Service (USDA-AMS) recently published a Request for Information soliciting stakeholder input on the electronic or digital link disclosure option for bioengineered (BE) foods under the National...more
Last week, the U.S. Department of Agriculture (USDA) issued grants of inspection to two companies, allowing them to begin producing and selling cell-cultivated chicken meat to consumers—a first in the U.S. This marks the end...more
The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is advancing ahead in growing the regulatory landscape for developers and sponsors of animals with investigational intentional genomic...more
On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food...more
On March 7, 2022, the US Food and Drug Administration (FDA), operating under its New Animal Drug Authority, took a new, important regulatory step forward in assessing genome editing in animals. Specifically, the Agency...more
On March 7, 2022, the U.S. Food and Drug Administration (“FDA”) announced its “low-risk determination” to clear the marketing of food products derived from beef cattle that have been genetically altered to be more tolerant of...more
USDA has filed its opposition to summary judgement in the case filed by the Center for Food Safety (CFS) regarding the agency’s implementation of the National Bioengineered Food Disclosure Standard (“BE rule”). As you may...more
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more
During the first quarter of 2021, various federal bills were introduced which impact the food industry. This article provides a primer on some of these bills and their potential impact on the food industry....more
Two contrasting regulatory decisions by authorities in the United States and Mexico highlight the continued progress toward, and challenges to, the development of science and evidence based regulatory policies applicable to...more
The United States Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA), two of the U.S. Federal agencies responsible for regulation of agricultural biotech recently announced two comment periods...more
Innovations in genetic engineering have provided us with advancements in medicine, agriculture, food, and other applications. More recently, genetic engineering has been used to create the technology to combat COVID-19. While...more
At the outset of the Biden Administration it is clear that there will be a sharp pivot in the Federal Government’s approach to many environmental regulatory policies. One area that will be interesting to keep track of...more
The United States’ regulation of genetically engineered (GE) animals recently advanced with two new developments from the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA). ...more
As the U.S. regulatory agencies responsible for oversight of agricultural biotechnology strive to evolve the regulatory framework applicable to such products, the U.S. Department of Agriculture (USDA) continues to lead the...more
AquaBounty Technologies’ path to the U.S. market for its genetically engineered (GE) salmon has been a long one. In 2015, the FDA approved AquaBounty’s application to create and farm its GE salmon (trade name, AquAdvantage)...more
In this webinar, Keith Matthews from Wiley's Environment & Product Regulation group discusses recent actions by the U.S. Environmental Protection Agency (EPA) Biopesticides and Pollution Prevention Division's (BPPD) Emerging...more
On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations...more
The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims...more
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has released Draft Instructions on Testing Methods (Draft Instructions) for use in compliance with the National Bioengineered Food Disclosure...more