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An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2,...more

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

Microbes, Biotech Investigations, And Impacts: Midsummer Regulatory Updates From USDA-APHIS

After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more

UPOV Updates Explanatory Note On Essentially Derived Varieties (EDVS)

In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular...more

Update February 2024 On Commission Plans Liberalization Of New Genomic Techniques (NGTS) In The EU

On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into...more

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

U.S. Plant Variety Protection Office Lowers Burdens for Multinational Applications: Canadian and Japanese PBR Offices Now...

On Thursday, January 25, 2024, the U.S. Plant Variety Protection Office (U.S. PVPO) announced that the Plant Breeders’ Rights (PBR) Offices of Canada and Japan are now accepting Distinctness, Uniformity, and Stability (DUS)...more

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

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

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

IP Implications Of USDA Research Collaborations

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on...more

USDA PVP Office Waives Deposit Requirement For Asexually Reproduced Plants

The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical challenges and...more

USDA’S PVP System Embraces Transgenic And Gene Edited Plants

Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants....more

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

In Vineis Veritas: No Sour Grapes As Egyptian Court Orders Removal Of Illegal Vines

The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings....more

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

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