FDA’s Regulation of Plant and Animal Biotechnology Products

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data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">FDA’s Regulation of Plant and Animal Biotechnology Products</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fsafety%2Ffdas-regulation-plant-and-animal-biotechnology-products" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=FDA%E2%80%99s%20Regulation%20of%20Plant%20and%20Animal%20Biotechnology%20Products&url=https://www.fda.gov%2Fsafety%2Ffdas-regulation-plant-and-animal-biotechnology-products" target="_blank" class="lcds-share__btn 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aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <div class="inset-column"> <div type="info"> <div class="alert alert-info"> <h3>What's New</h3> <p style="margin-top:20px; margin-bottom:10px">On February 22, 2024, the FDA <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0a27d58e-7972-4129-ac57-f93459798213" href="/food/hfp-constituent-updates/fda-releases-guidance-voluntary-premarket-engagement-foods-derived-plants-produced-using-genome" title="FDA Releases Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing">issued a guidance for industry</a> that describes how firms can voluntarily engage with the FDA before marketing food from <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="70d1a16d-4fbb-4a7c-961f-97d505203767" href="/food/agricultural-biotechnology/genome-editing-agricultural-biotechnology" title="Genome Editing in Agricultural Biotechnology">genome-edited plants</a>. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, this guidance describes two processes through which they may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place. </p> </div> </div> <div class="aside"> <div alt="Feed Your Mind Education and Outreach Initiative" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-type="media" data-entity-uuid="e012d343-3435-401c-bad8-cb8baee0b62e" data-langcode="en" title="Feed Your Mind Education and Outreach Initiative" class="embedded-entity"> <img loading="lazy" src="/files/Feed%20Your%20Mind%20Education%20Campaign%202_0.png" alt="Feed Your Mind Education and Outreach Initiative" title="Feed Your Mind Education and Outreach Initiative" class="img-responsive"> </div> <p><em>Better understand <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="feb831b0-c300-47e6-8a65-0d612664eea4" href="/food/consumers/agricultural-biotechnology" title="Agricultural Biotechnology">genetically engineered foods</a> (commonly called GMOs)</em></p> </div> <p>The FDA regulates plant and animal biotechnology products in coordination with the <a href="https://www.usda.gov/topics/biotechnology">U.S. Department of Agriculture (USDA)</a> and <a href="https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra">U.S. Environmental Protection Agency (EPA)</a>, consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology. Each of these regulatory agencies has developed regulations and guidance documents to implement its authority under existing laws to help ensure the safety and, where applicable, the effectiveness of biotechnology products.</p> <p>As the landscape of biotechnology products evolves along with advances in molecular techniques, the FDA is committed to protecting public and animal health and to working with stakeholders to increase the transparency, coordination, and predictability of the regulatory system to enhance public confidence in the regulatory system while also avoiding unnecessary barriers to innovation.</p> <h2>Plant and Animal Biotechnology Programs and Activities at the FDA</h2> <ul> <li><a href="https://usbiotechnologyregulation.mrp.usda.gov/eo14081-8a-stakeholder-engagement.pdf">Report on Stakeholder Comments on the Coordinated Framework for the Regulation of Biotechnology</a><br> On November 13, 2023, and in response to President Biden’s Executive Order 14081, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA) posted two documents on the Unified Website for Biotechnology Regulation. The agencies issued a report on stakeholder comments on the Coordinated Framework for the Regulation of Biotechnology. The agencies also posted <a href="https://usbiotechnologyregulation.mrp.usda.gov/eo14081-8b-plain-language.pdf">plain-language information</a> on agency roles, responsibilities, and processes for the regulation of products of biotechnology. Each agency provided updates on the availability of the reports to their respective stakeholders.</li> <li><a href="https://www.federalregister.gov/public-inspection/2022-27599/request-for-information-identifying-ambiguities-gaps-inefficiencies-and-uncertainties-in-the">Request for Information Related to the Coordinated Framework for the Regulation of Biotechnology</a><br> On December 19, 2022, the White House Office of Science and Technology Policy (OSTP) — in coordination with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products.</li> <li><a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/">Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (Executive Order Number 14081)</a><br> The Executive Order signed September 12, 2022, launched a <a href="https://www.hhs.gov/about/news/2022/09/14/fact-sheet-hhs-takes-action-executive-order-launching-national-biotechnology-biomanufacturing-initiative.html">National Biotechnology and Biomanufacturing Initiative (NBBI)</a>. This initiative will help drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market opportunities for biobased products, train a diverse and skilled workforce, streamline regulatory processes for products of biotechnology, advance biosafety and biosecurity to reduce risk, protect the U.S. biotechnology ecosystem, and build a thriving and secure global bioeconomy with partners and allies.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8ebe0345-4ff6-41b5-999c-39f67a009f33" href="/food/agricultural-biotechnology/agricultural-biotechnology-education-and-outreach-initiative" title="Agricultural Biotechnology Education and Outreach Initiative">Feed Your Mind--Agricultural Biotechnology Education and Outreach Initiative</a><br> The FDA continues to work with EPA and USDA to modernize the regulatory system for plant and animal biotechnology products.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="da02e090-72c9-4a0a-9e50-0c43560c7cc2" href="/food/food-ingredients-packaging/food-new-plant-varieties" title="Food from New Plant Varieties">Food from New Plant Varieties</a><br> Information about the FDA’s role in overseeing the safety of human and animal foods derived from genetically engineered plants.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e2c16447-4508-4dba-9d48-e9b6d0857e55" href="/animal-veterinary/development-approval-process/biotechnology-products-cvm-animals-and-animal-food" title="Biotechnology Products at CVM: Animals and Animal Food">Biotechnology Products at the Center for Veterinary Medicine: Animals and Animal Food</a><br> Information about animal-related biotechnology products.</li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d127539b-d451-4a96-a70c-e6c89671eca8" href="/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/intentional-genomic-alterations-igas-animals" title="Intentional Genomic Alterations (IGAs) in Animals">Intentional Genomic Alterations in Animals</a><br> Guidance documents, approvals, and other information related to animals with intentional genomic alterations.</li> </ul> <h2>Resources for You</h2> <ul> <li><a href="/biotechnology">Human & Animal Food Biotechnology Guidance Documents & Regulatory Information</a></li> <li><a href="/animal-veterinary/guidance-industry/biotechnology-guidances">Center for Veterinary Medicine Biotechnology Guidances</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0115fc47-21b0-4f21-b603-49134454fdac" href="/media/102658/download?attachment" title="2017 Update to the Coordinated Framework for the Regulation of Biotechnology">Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology</a></li> <li><a href="https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf">Coordinated Framework for the Regulation of Biotechnology (1986)</a></li> <li><a href="https://www.nationalacademies.org/our-work/future-biotechnology-products-and-opportunities-to-enhance-capabilities-of-the-biotechnology-regulatory-system">Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System | National Academies (2017)</a></li> <li><a href="https://nap.nationalacademies.org/catalog/23395/genetically-engineered-crops-experiences-and-prospects">Genetically Engineered Crops: Experiences and Prospects |National Academies (2016)</a></li> </ul> </div> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region 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FDA’s Regulation of Plant and Animal Biotechnology Products | FDA