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
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
The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation...more
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
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 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...more
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
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
The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more
The Office of Management and Budget (OMB) recently released the Fall 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more
Key Takeaways What Happened: USDA is seeking comment on its intent to transfer portions of the regulatory framework governing agricultural animals modified or produced by genetic engineering from USDA to FDA....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
FDA Finds Milk Allergens in Dark Chocolate Samples - The U.S. Food and Drug Administration (FDA) has announced the results of a study examining 52 dark chocolate products, determining that four of the products had...more
The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
LEGISLATION, REGULATIONS & STANDARDS - EU Announces “Farm to Fork Strategy” The European Commission has announced the adoption of strategies to support biodiversity and “transition to a sustainable EU food system that...more
On March 27, 2020, the President signed into law the “Coronavirus Aid, Relief, and Economic Security Act,” or the CARES Act. This is the third phase of federal legislation in response to the COVID-19 outbreak. The estimated...more
The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
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
FDA Holds Public Meeting on Cannabis - On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on...more
20 years or five months? On March 8, 2019, nearly 20 years after AquaBounty Technology discovered a novel approach to increase the growth of Atlantic salmon, the U.S. Food and Drug Administration (FDA) finally “deactivated”...more
The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on late June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection...more