- On December 16, 2024, FDA released a new inventory of voluntary premarket meetings that the Agency has held with developers of foods from new genome-edited plant varieties. FDA
Biotechnology
USDA, FDA, EPA Release Joint Regulatory Plan for Biotechnology
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- In a press release issued on May 8, 2024, the U.S. Department of Agriculture (USDA) announced that has developed a joint regulatory plan with the U.S. Environmental Protection Agency (EPA)
FDA Issues Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing
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- On February 22, 2024, the U.S. Food and Drug Administration (FDA) issued a guidance for industry that addresses how firms should voluntarily engage with the Agency before marketing food produced
European Commission Adopts Proposal on Regulation of New Genomic Techniques
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- Today, the European Commission adopted its proposal for a regulation on plants obtained by certain new genomic techniques (targeted mutagenesis and cisgenesis) (‘NGTs’) and derived food and feed products. NGTs
FDA Cautions Industry on the Food Safety Risks of Transferring Genes for Proteins that are Food Allergens to New Plant Varieties Used for Food
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- FDA regulates human and animal food from plants, including plants produced through genetic engineering (GE), under the Federal, Food, Drug, and Cosmetic Act (FD&C Act). Foods derived from new plant
Office of Science and Technology Policy Requests Public Input on Biotechnology Regulation
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- The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology
FDA Completes Review of GE Canola Seeds After Response to Last Year’s Inadvertent Release
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- Plants produced through genetic engineering (GE) are subject to the same FDA safety standards as other plants. Given the possibility for food from some GE plants to have new allergens,
Release by FDA, USDA, and EPA of New Joint Website on Biotechnology Regulation
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- The U.S. 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, 2020.
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FDA Holds Ground in Challenge over GE Animal Regulatory Authority
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- As previously reported on this blog, on June 11, the President issued Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products, ensuring coordination across federal regulatory agencies
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FDA Promotes Programs for Safe Use of Biotechnology
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- Drs. Susan Mayne, head of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe (head of CFSAN’s Office of Food Additive Safety)
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