News & Analysis as of

U.S. Department of Agriculture Food and Drug Administration (FDA) Genetically Engineered Animals

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

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

Perkins Coie

USDA APHIS Invites Stakeholder Comments on Regulation of Modified Microbes

Perkins Coie on

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

ArentFox Schiff

USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes

ArentFox Schiff on

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

Wilson Sonsini Goodrich & Rosati

Lab to Table Dining—Coming Soon to a Kitchen Near You

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

Wilson Sonsini Goodrich & Rosati

FDA Accelerates Approval of Animals with Investigational Intentional Genomic Alterations (IGAs)

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

MoFo Life Sciences

FDA Clears Crispr-Edited Cattle For Market Through Abbreviated Procedure: A First For Food-Use Animals

MoFo Life Sciences on

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

Morgan Lewis - Well Done

USDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration

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

Wiley Rein LLP

U.S. Federal Agencies Announce Comment Periods on Actions Related to Regulation of Ag Biotech

Wiley Rein LLP on

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

Wiley Rein LLP

Trump USDA and FDA Spar Over Regulation of Genetically Engineered Animals – Does This Sideshow Have Any Actual Implications for...

Wiley Rein LLP on

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

Hogan Lovells

U.S. policy on the regulation of genetically engineered animals evolves with steps by FDA and USDA

Hogan Lovells on

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

Wiley Rein LLP

USDA Announces ANPRM on a Transition of Regulatory Jurisdiction Over Certain Genetically Engineered Animals

Wiley Rein LLP on

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

Mintz - Consumer Product Safety Viewpoints

Regulatory Agencies Launch Unified Website for Biotechnology Regulation

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9,...more

Polsinelli

To BE or not to BE a GMO (UPDATED)

Polsinelli on

On June 11, 2019, President Trump signed an executive order directing the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and United States Department of Agriculture (USDA) to ease rules for...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l March 2019 #3

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Webinar on Genome Editing in Animals - The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about “genome editing in animals, an...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l March 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Lifts Import Alert on GE Salmon - The U.S. Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE)...more

Bergeson & Campbell, P.C.

FDA Commissioner Releases Statement On Biotechnology Innovations

On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on...more

King & Spalding

GMO Disclosures and Claims: A Possible End to the U.S. GMO Labeling Controversy?

King & Spalding on

On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified...more

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