Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

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Under the U.S. Coordinated Framework for the Regulation of Biotechnology, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) are the three primary agencies for regulation of plants, animals, and microorganisms derived from biotechnology. <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/modernizing-biotechnology-framework" target="_blank">As part of an effort to modernize the Coordinated Framework spurred by a 2019 Executive Order</a>, these agencies have released a <a href="https://zingtree.com/live/126497995/?tree_id=126497995000#1" target="_blank">web-based tool</a> to help researchers and developers navigate the regulatory landscape for genetically modified (GM) organisms. Through a series of interactive prompts, the tool provides guidance on the applicable regulatory requirements for a GM microorganism. The USDA, EPA, and FDA have distinct and overlapping roles in regulating biotechnology products based on their own statutory authorities, <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home" target="_blank">as detailed on the Unified Website for Biotechnology Regulation</a>. For example, the EPA regulates pesticides and certain genetically engineered microorganisms, the FDA regulates food and feed, and the USDA regulates plant pests. A newly developed GM microorganism or product may fall under more than one category and therefore be subject to regulation by multiple agencies. The interactive tool guides the user to determine if the microorganism is under the jurisdiction of one or more regulatory agencies based on the biological features of the microorganism, the genetic modification, and intended use(s) of the microorganism or products containing it. The tool outputs a summary of the regulatory requirements for the microorganism based on the selected answers to the prompts. The output includes an overview of permitting requirements, links to guidance and reference documents, and contact information for the agencies with jurisdiction over the microorganism. Below, we detail the prompts and portions of the output received when using the tool to review three hypothetical GM microbes, with a focus on the output text regarding permitting requirements. <ol><li>Microbial Fertilizer </li><li>Microbial Pesticide </li><li>Microbes that Produce Fermented Human Food </li></ol>These examples provide an overview of how the tool operates and guidance for the relevant regulation(s) governing three common types of GM microbes. The first prompt is to Choose your Product Type or Activity: <ol><li>Crop Agriculture ‒ GM microorganisms that associate with plants, and/or can be applied to crops or agricultural soil (including microorganisms intended to be used as pesticides). </li><li>Food or Feed ‒ GM microorganisms (viable or non-viable) used as human or animal food or as a component of such food, including food contact substances and food packaging. </li><li>Biomass or Chemical Conversion ‒ GM microorganisms developed for such purposes such as (but not limited to): biosensing, chemical production, microbial fuel cells, resource extraction, and waste remediation. </li><li>Other Biomanufacturing Application, or Research Purposes ‒ Developing or working with a microorganism for a non-food, non-drug, non-agricultural/pesticidal use, or are unsure where product belongs. </li></ol>For each hypothetical example, the prompts are listed in sequential order, with the selected option for each prompt in green text. The resulting permitting requirements are summarized below. Hypothetical Example #1 – Microbial Fertilizer<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blte99cd17ada74ba10&quot;,&quot;_version&quot;:1,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;div style=&#x27;position: relative;width: auto;padding: 0 0 66.8%;height: 0;top: 0;left: 0;bottom: 0;right: 0;margin: 0;border: 0 none&#x27; id=\&quot;experience-67e1a0732fdab\&quot; data-aspectRatio=\&quot;1.49700599\&quot; data-mobile-aspectRatio=\&quot;0.06512007\&quot;&gt;&lt;iframe allowfullscreen src=&#x27;https://view.ceros.com/mofo/challenge-solution-1-1?heightOverride=501&amp;mobileHeightOverride=12285&#x27; style=&#x27;position: absolute;top: 0;left: 0;bottom: 0;right: 0;margin: 0;padding: 0;border: 0 none;height: 1px;width: 1px;min-height: 100%;min-width: 100%&#x27; frameborder=&#x27;0&#x27; class=&#x27;ceros-experience&#x27; title=&#x27;GM_Microbe-Carousel 01&#x27; scrolling=&#x27;no&#x27;&gt;&lt;/iframe&gt;&lt;/div&gt;&quot;,&quot;title&quot;:&quot;Ceros - USDA Interactive Tool Example 1&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-04-01T17:08:13.373Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div>Output:<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blt9b2426d0878bed73&quot;,&quot;_version&quot;:2,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;table&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;&lt;p&gt;&lt;u&gt;EPA/Office of Pollution Prevention and Toxics&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td&gt;&lt;p&gt;&lt;strong&gt;Permit requirement:&lt;/strong&gt; TSCA Experimental Release Application (TERA)&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;u&gt;USDA/APHIS/&lt;br&gt;Biotechnology Regulatory Services&lt;br&gt;&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;strong&gt;Permit requirement:&lt;/strong&gt; A permit is required for an environmental release of a GM microorganism that is a plant pest, contains DNA that encodes an infectious genome of a plant pest or a compound that can cause plant disease, or is used to control plant pests and could pose a plant pest risk (and if the unmodified version of the microorganism is regulated as a biological control agent by APHIS Plant Protection and Quarantine (PPQ)).&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt;&quot;,&quot;title&quot;:&quot;navigating-u-s-regulatory Table 1&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-05-06T20:40:41.873Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div>Hypothetical Example #2 – Microbial Pesticide<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blt21f7abed3a8f6d60&quot;,&quot;_version&quot;:1,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;div style=&#x27;position: relative;width: auto;padding: 0 0 66.8%;height: 0;top: 0;left: 0;bottom: 0;right: 0;margin: 0;border: 0 none&#x27; id=\&quot;experience-67e18398b4622\&quot; data-aspectRatio=\&quot;1.49700599\&quot; data-mobile-aspectRatio=\&quot;0.06512007\&quot;&gt;&lt;iframe allowfullscreen src=&#x27;https://view.ceros.com/mofo/challenge-solution-2?heightOverride=501&amp;mobileHeightOverride=12285&#x27; style=&#x27;position: absolute;top: 0;left: 0;bottom: 0;right: 0;margin: 0;padding: 0;border: 0 none;height: 1px;width: 1px;min-height: 100%;min-width: 100%&#x27; frameborder=&#x27;0&#x27; class=&#x27;ceros-experience&#x27; title=&#x27;GM_Microbe-Carousel 02&#x27; scrolling=&#x27;no&#x27;&gt;&lt;/iframe&gt;&lt;/div&gt;&quot;,&quot;title&quot;:&quot;Ceros - USDA Interactive Tool Example 2&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-04-01T17:23:14.691Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div>Output:<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blt85327a179952e7f6&quot;,&quot;_version&quot;:3,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;table&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;&lt;p&gt;&lt;u&gt;EPA/Office of Pesticide Programs&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td&gt;&lt;p&gt;&lt;strong&gt;Registration requirement:&lt;/strong&gt; Registration of a microbial pesticide with EPA/OPP under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) involves meeting certain reporting and data requirements.&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;u&gt;USDA/APHIS/Biotechnology Regulatory Services&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;strong&gt;Permit requirement:&lt;/strong&gt; A permit is not required from USDA/APHIS/BRS for the movement of a GM microorganism that is currently registered with the EPA as a microbial pesticide, so long as the microorganism is not a plant pest.&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt;&quot;,&quot;title&quot;:&quot;navigating-u-s-regulatory Table 2&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-05-06T20:41:06.300Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div>Hypothetical Example #3 - Microbes that Produce Fermented Human Food<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blt148d8c8f5852d305&quot;,&quot;_version&quot;:1,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;div style=&#x27;position: relative;width: auto;padding: 0 0 66.8%;height: 0;top: 0;left: 0;bottom: 0;right: 0;margin: 0;border: 0 none&#x27; id=\&quot;experience-67e18388692f6\&quot; data-aspectRatio=\&quot;1.49700599\&quot; data-mobile-aspectRatio=\&quot;0.06512007\&quot;&gt;&lt;iframe allowfullscreen src=&#x27;https://view.ceros.com/mofo/challenge-solution-1?heightOverride=501&amp;mobileHeightOverride=12285&#x27; style=&#x27;position: absolute;top: 0;left: 0;bottom: 0;right: 0;margin: 0;padding: 0;border: 0 none;height: 1px;width: 1px;min-height: 100%;min-width: 100%&#x27; frameborder=&#x27;0&#x27; class=&#x27;ceros-experience&#x27; title=&#x27;GM_Microbe-Carousel 03&#x27; scrolling=&#x27;no&#x27;&gt;&lt;/iframe&gt;&lt;/div&gt;&quot;,&quot;title&quot;:&quot;Ceros - USDA Interactive Tool Example 3&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-04-01T17:23:49.008Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div>Output:<div data-reactroot=""><span class="rich-text-component-embed" data-component-info="{&quot;uid&quot;:&quot;blt8ec0c5bb33859b5a&quot;,&quot;_version&quot;:2,&quot;locale&quot;:&quot;en-us&quot;,&quot;table_source&quot;:&quot;&lt;table&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td&gt;&lt;p&gt;&lt;u&gt;FDA ‒ Center for Food Safety and Applied Nutrition&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td&gt;&lt;p&gt;&lt;strong&gt;Premarket responsibilities:&lt;/strong&gt; If you are developing a food product for human use that contains or is made from a GM microorganism, you should engage with FDA/CFSAN at &lt;a href=\&quot;mailto:premarkt@fda.hhs.gov\&quot; target=\&quot;_self\&quot;&gt;premarkt@fda.hhs.gov&lt;/a&gt; about any premarket responsibilities you have for food safety, no matter the type of genetic modification that you have made to the microorganism. &lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;u&gt;USDA ‒ Agricultural Marketing Service&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;strong&gt;Labeling requirement:&lt;/strong&gt; USDA/AMS Food Disclosure and Labeling Division requires labeling of bioengineered foods according to the &lt;a href=\&quot;https://www.ams.usda.gov/rules-regulations/be\&quot; target=\&quot;_blank\&quot;&gt;National Bioengineered Food Disclosure Standard&lt;/a&gt;.&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;u&gt;USDA/APHIS/Biotechnology Regulatory Services&lt;/u&gt;&lt;/p&gt;&lt;/td&gt;&lt;td style=\&quot;color: #000\&quot;&gt;&lt;p&gt;&lt;strong&gt;Permit requirement:&lt;/strong&gt; Permits are required for importation, interstate movement, and environmental release if subject to USDA/BSR jurisdiction, including for some modified versions of a wild-type strain.&lt;/p&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt;&quot;,&quot;title&quot;:&quot;navigating-u-s-regulatory Table 3&quot;,&quot;publish_details&quot;:{&quot;time&quot;:&quot;2025-05-06T20:41:28.366Z&quot;,&quot;user&quot;:&quot;blt02c6960575474003&quot;,&quot;environment&quot;:&quot;bltf4674cd9142c5020&quot;,&quot;locale&quot;:&quot;en-us&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields;publish_details&quot;,&quot;_key&quot;:&quot;publish_details&quot;},&quot;_fetched&quot;:true,&quot;_content_type_uid&quot;:&quot;table_content&quot;,&quot;_trace&quot;:&quot;array_node;blog_global_fields&quot;,&quot;_key&quot;:&quot;key&quot;}" data-component-type="table_content" data-component-inline="false"></div><hr class="divider">The Coordinated Framework for Biotechnology is notoriously challenging for the developers of GM organisms to navigate because of the divided and sometimes overlapping jurisdictions of the USDA, EPA, and FDA. This interactive tool for identifying the regulatory requirements applicable to different types of GM microbes provides a useful reference point for companies looking to make preliminary assessments of their regulatory obligations when developing a GM microbe for commercial or research purposes.

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Brian P. Sylvester

Brian Sylvester

Associate

Alice Carli is an associate in MoFo’s Complex Litigation + Advisement Group in the Los Angeles office. 

Alice Carli

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Patent Agent

Dr. Edith Pierre-Jerome focuses her practice on patent drafting and prosecution in areas related to molecular and cellular biology, biochemistry, microbiology, and plant genetics.

Edith A. Pierre-Jerome Ph.D.

Edith Pierre-Jerome

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mofolifesciences-agtech

*UPDATE DECEMBER 19, 2024:* USDA-APHIS RESTORES LEGACY PERMITTING AND “AM I REGULATED” PROCESSES FOR GE ORGANISMSUSDA Animal and Plant Health Inspection Service (APHIS) <a href="https://www.aphis.usda.gov/news/program-update/aphis-restarts-permitting-am-i-regulated-processes-products-biotechnology" target="_blank">announced</a> on December 19, 2024, that it is restoring its legacy framework for permitting and deregulation of genetically engineered (GE) organisms that was in place before 2020. The move comes in response to the December 2, 2024, ruling by the U.S. District Court for the Northern District of California that struck down core APHIS regulations on GE organisms established by the agency in 2020. See our recent blog post (below) for a detailed discussion of the December 2 ruling and its potential implications.Under the now-current legacy framework, a GE organism is assessed with a greater focus on the processes used to create it, while the now-vacated 2020 regulations focused more on the potential plant pest risk of the final modified organism as a product. The now-effective legacy regulations also lack the categorical exemptions included in the vacated 2020 rule. However, APHIS maintains as of this writing that responses to <a href="https://www.aphis.usda.gov/biotechnology/am-i-regulated" target="_blank">requests for confirmation</a> of exemption that APHIS issued before Dec. 2, 2024, remain valid.While there are no longer categorical exemptions from APHIS regulation, APHIS is reestablishing the <a href="https://www.aphis.usda.gov/biotechnology/am-i-regulated" target="_blank">“Am I Regulated?”</a> process (also known as “AIR”), which allows developers to seek a determination of nonregulated status. This status will exempt the GE organism from regulation under <a href="https://www.ecfr.gov/on/2019-12-31/title-7/subtitle-B/chapter-III/part-340?toc=1" target="_blank">7 CFR part 340 (2019)</a>, including its permit requirements, as it had prior to the 2020 rule.The return to the legacy framework also reinstates the <a href="https://www.ecfr.gov/on/2019-12-31/title-7/subtitle-B/chapter-III/part-340/section-340.3" target="_blank">notification system</a>, a streamlined alternative to permitting for eligible regulated organisms considered to pose a lower plant pest risk.APHIS stated that it will resume issuing permits under the legacy framework within the coming days and will provide additional information in the coming weeks on resuming the notification process. MoFo is closely monitoring developments and is available to assist clients affected by these regulatory changes.<hr class="divider">ORIGINAL POST (DECEMBER 6, 2024):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, 2024, struck down the 2020 USDA Animal and Plant Health Inspection Service (APHIS) rule codified at 7 C.F.R. § 340 regarding GE plants. The court vacated APHIS’s 2020 rule, formerly known as the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) rule, which had been adopted to streamline USDA oversight of plants developed using genetic engineering.Summary judgment ruling on December 2, 2024On December 2, 2024, Judge James Donato issued a summary judgment ruling in <a href="https://www.bloomberglaw.com/document/X1M9DNOB0000N" target="_blank">National Family Farm Coalition et al. v. Tom Vilsack et al.</a>, vacating a 2020 update to APHIS’s biotechnology regulations (<a href="https://www.federalregister.gov/documents/2020/05/18/2020-10638/movement-of-certain-genetically-engineered-organisms" target="_blank">7 C.F.R. § 340</a>), which had exempted many GE plants from USDA regulation and streamlined the deregulation process for others. The three main exemptions under the now vacated 2020 rule are codified at 7 CFR § 340.1(b)(1)–(3) and relate to a genetic change caused by cellular repair of a targeted, single double-stranded break; a targeted single base pair substitution; and the introduction of certain types of known sequences from the plant’s gene pool, respectively.The November 2024 updates to the 2020 rule are not explicitly included in the vacaturIn late 2023, <a href="https://www.mofo.com/resources/insights/231115-comment-morphing-us-biotechnology-regs" target="_blank">APHIS proposed five additional exemptions</a> to be incorporated into the 2020 rule. After a review of public comments, <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-announces-final-notice-additional-exemptions-movement-organisms" target="_blank">two new exemptions were finalized, effective November 13, 2024</a>, and APHIS immediately began to inform developers about their function and effects, including at a November 14, 2024, stakeholder meeting. However, following the December 2 ruling, the new exemptions, which APHIS termed “Additional Modification 1” (AM1) and “Additional Modification 2” (AM2), are now in jeopardy.The November 2024 exemptions are defined as follows:<ul><li>AM1: An indel or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without using a repair template, or without insertion of DNA if generated using a repair template.</li><li>AM2: A plant with up to twelve (12) modifications, made simultaneously or sequentially, if each modification individually qualifies for exemption and occurs in a different gene.</li></ul>The parties briefed the court regarding these new exemptions prior to the summary judgment ruling. However, the court did not rule on the 2024 updates, and addressed only the 2020 final rule in its December 2 opinion. The parties have been ordered to brief the court by January 13, 2025, as to the impact of the vacatur on the November 2024 exemptions.Thus, as of December 2, the 2020 rule and its exemptions have been vacated. The new exemptions under the 2024 revisions, however, appear to remain in place, at least for now, though it is unclear whether or how APHIS can process requests related to these new exemptions given the status of the 2020 rule.What happens to plants that were approved or exempted under the 2020 rule?APHIS confirmed in a December 4, 2024, <a href="https://www.aphis.usda.gov/news/program-update/aphis-acknowledges-new-court-ruling-vacating-updates-biotechnology-regulations" target="_blank">announcement</a> that “Regulatory Status Review responses, Confirmation Request responses, and active permits that USDA issued prior to December 2, 2024, remain valid.” However, it is uncertain how the ruling will impact both developers who did not engage in a voluntary confirmation of exemption or Regulatory Status Review (RSR) and were proceeding with development under a self-determined exempt status, and developers  with pending confirmation or RSR requests.The ruling does not affect applicable parallel regulatory oversight by the FDA, EPA, or other (e.g., non-APHIS) branches within the USDA.How did this happen?Judge Donato granted partial summary judgment in favor of the plaintiffs, a group of 29 farming and organic non-profit and public-interest groups, finding that APHIS’s adoption of the rule was arbitrary and capricious under the Administrative Procedure Act (APA). The plaintiffs argued in a lawsuit filed on July 6, 2021, that the 2020 rule failed to comply with federal statutes, including the Plant Protection Act (PPA).APHIS adopted the now-vacated rule after nearly 15 years of attempts to update its regulations under part 340 of the PPA for better efficiency in regulation and better reflection of the advances made in gene editing and crop breeding. The 2020 rule introduced regulatory exemptions for certain GE plant modifications, including targeted DNA breaks repaired without a template (part 340(b)(1)), targeted single base pair substitutions (part 340(b)(2)), and insertion of a gene from the plant’s gene pool (part 340(b)(3)). The effect of the rule was to remove certain categories of GE crops from oversight by USDA‑APHIS’s Biotechnology Regulatory Services, including some types of GE plants that could be created by conventional breeding techniques and those that the agency determined do not pose a plant pest risk. This change decreased the regulatory burden and facilitated entry for smaller developers.One issue in the December 2 ruling was how APHIS dealt with “noxious weeds” in the 2020 rule. The 2020 rule did not incorporate APHIS’s authority to regulate noxious weeds into its regulation of GE crops, despite previous proposed rules by APHIS that sought to evaluate GE plants for noxious-weed risk. Citing Transportation Division of the International Association of Sheet Metal, Air, Rail, & Transportation Workers v. Federal Railroad Administration (Transp. Workers), 988 F.3d 1170 (9th Cir. 2021), Judge Donato held that APHIS’s failure to explain the agency’s reversal of its position on additional risk assessments for noxious weeds was arbitrary and capricious.Judge Donato also took issue with the categorical exemptions, which treat the risk of conventionally bred plants as the baseline in determining the scope of regulatory oversight. His reasoning relied heavily on <a href="https://nap.nationalacademies.org/read/10258/chapter/1" target="_blank">a 2002 National Academy of Sciences publication</a> that concluded that risks associated with crop cultivars that could have been developed through conventional breeding “should not be assumed to be acceptable.” Despite APHIS’ position in the briefing that it had carefully assessed the risks of conventionally-bred plants over the past 30 years, Judge Donato categorized the 2020 rule as being in direct conflict with APHIS’s own experts.What’s next?The case may not be immediately appealable as the summary judgment order did not rule on all the plaintiffs’ claims. Plaintiffs also challenged the rule under the Endangered Species Act and the National Environmental Policy Act. The court asked the parties to jointly propose a status conference date to address the remaining claims. USDA could immediately appeal if the district court certifies the summary judgment ruling under Federal Rule of Civil Procedure 54(b), which allows a district court to certify for appeal an order granting summary judgment on an issue that is separate and distinct from other claims in the case. Even if such certification were to occur, expedited review by the Ninth Circuit would not be guaranteed.In the meantime, the vacatur of the 2020 rule reverts the core USDA biotechnology regulations to their pre-2020 framework. Under the pre-2020 system, APHIS regulated GE organisms based on the use of plant pests in the genetic engineering process, rather than the plant pest risks of the final edited products, to which the 2020 rule had shifted focus. Developers could petition APHIS under the old rule for a determination that a GE organism was unlikely to pose a plant pest risk, a process known as a petition for non-regulated status, or obtain an indication of non-regulated status under the legacy “Am I Regulated” (AIR) procedures.APHIS has <a href="https://www.aphis.usda.gov/news/program-update/aphis-acknowledges-new-court-ruling-vacating-updates-biotechnology-regulations" target="_blank">acknowledged</a> the court ruling and plans to provide more detailed guidance to stakeholders in the coming days, but as of this writing, the USDA has not announced any intent or capacity to enforce the old framework.Of note, in March 2018, then-Secretary of Agriculture Sonny Perdue <a href="https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation" target="_blank">stated</a> that the USDA had no plans to regulate plants that could be developed through conventional breeding techniques, provided they were not plant pests or created using plant pests. The incoming Trump administration may seek to retain this approach. However, the vacatur of the 2020 rule’s categorical exemptions undoes much of the groundwork to automatically exempt many such plants from USDA review, assuming the legacy regulations are back in place in the interim.If APHIS moves to propose a new rule to address the court’s ruling, the process would likely be subject to customary procedural requirements, including notice and comment procedures, before finalization.This is a developing story.We are closely monitoring developments in this case and USDA’s forthcoming guidance, and will continue to share updates. [On March 28, 2025, APHIS appealed the ruling to the U.S. Court of Appeals for the Ninth Circuit. However, the parties subsequently filed a joint stipulation to voluntarily dismiss the appeal, which was granted on April 15, 2025.] Alice Carli, a law clerk in our Los Angeles office, contributed significantly to the drafting of this post. Caressa Tsai, a law clerk in our San Francisco office, also contributed to the drafting of this post.

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Maxus Energy Corporation

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Los Angeles World Airport (LAWA)

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al

Fitbit Force Recall 

People of the State of California v. The Coca-Cola Company

Seagate Technology LLC

Clif Bar, Inc.

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Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.

William F. Tarantino

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Krista deBoer

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants