Liz Freeman Rosenzweig on Food and Drug Administration (FDA)

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

Earlier this year, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent...more

8/9/2024 / Agricultural Sector , APHIS , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Intellectual Property Protection , Life Sciences , Patent Cooperation Treaty , Plant Patents , Uruguay

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more

3/18/2024 / Biotechnology , CRISPR , Food and Drug Administration (FDA) , Food Safety , Food Supply , Life Sciences , Plant Based Products , USDA

New Regulations Rooted In Evidence: Looking Back On How EPA And USDA Updated Engineered Plant Regulations And Labeling In 2023

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more

1/30/2024 / APHIS , Biotechnology , Environmental Protection Agency (EPA) , FIFRA , Final Rules , Food and Drug Administration (FDA) , Life Sciences , Plant Based Products , USDA

Comment on Morphing U.S. Biotechnology Regulations

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more

11/21/2023 / Agricultural Sector , APHIS , Biotechnology , Comment Period , Environmental Protection Agency (EPA) , Federal Register , Food and Drug Administration (FDA) , Intellectual Property Protection , The Nagoya Protocol , USDA , USPTO

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

7/3/2023 / Agricultural Marketing Act , APHIS , Biotechnology , EU , Food and Drug Administration (FDA) , Genetically Engineered Seed , Life Sciences , Medical Foods , Pharmaceutical Industry , Plant Based Products , USDA

Purple Tomato Is First Genetically Engineered Plant To Be Deregulated Through USDA’S New Regulatory Status Review Process

On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered...more

9/12/2022 / Agricultural Sector , APHIS , DNA , Food and Drug Administration (FDA) , Genetically Engineered Seed , Plant Protection Act , USDA

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

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

3/23/2022 / Cattle , CRISPR , CVM , Food and Drug Administration (FDA) , Food Supply , Genetically Engineered Animals , Life Sciences , National Bioengineered Food Disclosure Standard (NBFDS) , USDA

Liz Freeman Rosenzweig

Morrison & Foerster LLP

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