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APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants

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USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy...

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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USDA Animal and Plant Health Inspection Service (APHIS) <a href="https://www.aphis.usda.gov/news/program-update/aphis-reinstates-notifications-products-biotechnology" target="_blank">announced</a> on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for regulated genetically engineered (GE) organisms.Read the full <a href="https://classdismissed.mofo.com/topics/aphis-reinstates-legacy-biotechnology-regulations-implications-for-crispr-edited-plants" target="_blank">blog post</a>.

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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.As co-chair of the Patent Group, Mike manages a team that includes 80+ Ph.D.s and 100+ attorneys and others with advanced scientific degrees in life sciences and related engineering disciplines. From small molecules and antibodies to gene editing, artificial intelligence, and machine learning, MoFo has deep experience protecting some of the most important innovations in the life sciences and food and agriculture sectors.Life SciencesFor his work across the life sciences sector, Mike was named San Francisco Biotechnology Lawyer of the Year by Best Lawyers in America in 2020 and is recommended for his patent strategy and prosecution practice in LMG Life Sciences. He also led the team that was named 2022 Patent Management and Strategy Firm of the Year at the 2022 LMG Life Sciences Americas Awards.Food + AgricultureRecognized as “one of the world’s foremost plant and agriculture IP lawyers,” Mike manages a wide range of intellectual property issues related to plants and plant products. He and his team advise clients on plant and plant utility patents; licensing agreements for plant IP; litigation in U.S. state and federal court and before the International Trade Commission; and regulatory approvals from the USDA, FDA, and EPA for gene edited and genetically engineered plants.Patent Strategy + ProsecutionMike is a Legal 500 US Hall of Fame lawyer for patent prosecution and is consistently named one of the leading IP lawyers by Managing Intellectual Property, Chambers USA and Chambers Global, and IAM Patent 1000.Mike works closely with many clients to develop and manage their patent portfolios. He helps clients identify, monitor, and assess the infringement risks of third-party patents. He also assists clients in preparing both offensive and defensive patent portfolios, with a particular emphasis on drafting patent applications that will be utilized in licensing and in litigation efforts.IP Due DiligenceFor venture capitalists seeking to invest in early- and mid-stage companies, underwriters involved in IPOs, and companies seeking to acquire or merge with other companies, Mike has managed extensive IP diligence. His work includes assessment of the strengths and weaknesses of patent portfolios, evaluation of freedom to operate issues, and strategic recommendations for maximizing the value of patent portfolios going forward.Mike also works closely with the IP Litigation Group on various litigation matters including patent interferences to determine the first-to-invent and patent re-examination work and actively participates in both mediation and arbitration proceedings on behalf of clients in the life sciences and food and agriculture areas.He is a frequent lecturer and speaker. Among numerous speaking engagements, Mike is the IP instructor at the UC Davis Licensing Academy and founded Morrison Foerster’s annual Harvard Biotechnology Club Fall Patent Law Course.Mike holds a Ph.D. in plant physiology (biochemistry) and an M.S. in agronomy from the University of California, Davis; a B.S. in biology from the University of California, Berkeley; and a J.D. from Golden Gate University School of Law. He was a post-doctoral fellow in plant molecular biology at the Harvard Medical School and the Department of Molecular Biology at Massachusetts General Hospital, where he worked on the Arabidopsis genome project.

Michael Ward

Partner

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. Bill started his career at the U.S. Environmental Protection Agency, Office of Regional Counsel in San Francisco, and he currently leads the firm’s environmental practice.Bill routinely advises clients in connection with their carbon reduction and climate-related goals and claims (including carbon neutral and net zero carbon commitments) and helps clients substantiate their claims and avoid greenwashing claims. He frequently advises clients in connection with the Federal Trade Commission’s Green Guides, state consumer protection statutes, and a broad range of sustainability and chemical disclosure laws. He defends clients in environmental and consumer class action litigation in courts throughout the country and is highly regarded for his ability to coordinate technical, legal, and communications teams to counsel clients through crises. He has tried cases in state and federal courts for a variety of complex and multidistrict litigation matters, including product liability claims and environmental and land use disputes.Bill represents the firm’s clients in nearly every aspect of environmental regulation and supports the firm’s global transactional practices in all areas of U.S. environmental law. He is also a member of the firm’s ESG + Sustainability Steering Committee.<h5>Environmental Litigation and Regulatory</h5>Bill has represented the firm’s clients before a broad range of environmental regulatory agencies in rulemaking proceedings, permit applications, and appeals and enforcement actions. Bill heads MoFo’s environmental due diligence teams and serves as the lead on transactional negotiations involving environmental liability risks, including significant experience in cross-border transactions.<h5>Consumer Class Action, False Advertising, and Product Liability</h5>Bill has broad experience in consumer class action and false advertising litigation, especially concerning claims of health or environmental benefits. He has also advised numerous well known life sciences, technology, and consumer product companies on consumer disclosures and warnings, including compliance with U.S. and European requirements governing product safety.<h5>More About Bill</h5>Before entering private practice, Bill clerked at the U.S. Environmental Protection Agency, Region IX Office of Regional Counsel, where he assisted in the prosecution and resolution of cases brought by the U.S. Department of Justice for violation of the Clean Air Act, Clean Water Act, and Resource Conservation and Recovery Act.Bill received his J.D. with honors from the Georgetown University Law Center and completed the Law and Public Health program sponsored by Georgetown University and the Johns Hopkins Bloomberg School of Public Health. Through this program, he earned a master’s in public health, as well as specialty certification in environmental health risk assessment from the Johns Hopkins Risk Sciences and Public Policy Institute. At Georgetown, he was an executive editor of the Georgetown International Environmental Law Journal and received the CALI Award for Excellence in International Environmental Law. In 2000, he studied law at the Universidad de Mendoza, in Mendoza, Argentina, as an international law fellow. He earned his bachelor’s degree from the University of California, Berkeley.

William F. Tarantino

Krista deBoer’s practice involves the full range of environmental, climate, and green claims issues.As a partner in MoFo’s Complex Litigation + Advisement practice group, Krista represents clients in environmental and toxic tort litigation, Proposition 65 litigation, and consumer class actions involving hazardous material exposures and claims of health and environmental benefits. She is recommended by The Legal 500 for toxic tort defense (2022-2024). Krista has broad experience in Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and California Hazardous Substance Account Act (HSAA) litigation, multi-party allocation and cost recovery proceedings, natural resource damages claims, and contaminated site cleanup, often involving parallel agency enforcement, where she is skilled at developing integrated strategies to maximize outcomes in both actions.Krista also assists clients with regulatory approvals, compliance, and risk mitigation under federal and state environmental laws, including Department of Energy and California Energy Commission regulations, California Air Resources Board regulations, Federal Trade Commission Green Guides, hazardous waste management regulation, and climate disclosure laws. She has defended and negotiated favorable settlements for clients in enforcement actions brought by the Environmental Protection Agency, California Air Resources Board, California Energy Commission, and California Regional Water Quality Control Boards. In addition, Krista leads environmental due diligence for clients in a range of corporate and real estate transactions involving environmental liability risks and advises on matters involving development of carbon-capture projects and transacting in carbon offsets.Krista has represented and advised aerospace and defense, internet marketplace, food and beverage, importer logistics, healthcare, manufacturing, residential development, energy, transportation, and retail companies.Beyond advocating for clients, Krista also has experience as a mediator and has taught negotiation, advanced negotiation, and difficult conversations seminars to organizations in the United States and abroad, including with the Harvard Negotiation Institute and as an adjunct professor at Georgetown Law School. Krista has a passion for working with clients to design dispute systems and develop persuasive negotiation and communication strategies aimed at achieving optimal outcomes, both within organizations and across the table.Prior to joining Morrison Foerster, Krista practiced at a boutique environmental law firm serving clients in California, Washington, and Oregon, and at an international law firm, where she was a member of the firm’s general litigation and mass tort and environmental practice groups.Krista received her J.D. from Harvard Law School cum laude. At Harvard Law School she was awarded the Dean’s Scholar Prize for her work in the Environmental Law & Policy Clinic and was the president and founding member of the HLS Food Law Society. Krista earned her master’s in education from Antioch University and had a previous career as a public high school teacher. She earned her bachelor’s with honors, magna cum laude, from the University of Washington.

Krista deBoer

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; algae; environmental incentives such as carbon credits; crop science; gene editing; genetics; GM/GE plants; molecular biology; plant breeders’ rights/plant variety protection; plant breeding; plant IP; and soil technologies.Prior to joining the firm as an associate, Dr. Freeman Rosenzweig was a summer associate, a law clerk, and a scientific analyst intern at Morrison & Foerster, where she drafted office action responses for foreign and domestic patent applications, amended claims, drafted domestic utility and plant patent applications, and analyzed freedom to operate agreements.Liz earned her J.D. from the University of California, Berkeley, School of Law. At Berkeley Law, Liz was an associate editor of the Berkeley Technology Law Journal, in which she published “<a href="https://btlj.org/2022/01/volume-35-issue-4/" target="_blank">A Framework for Patent Exhaustion of Self-Replicating Technologies</a>”. She was also vice president of Faculty Relations for the Patent Law Society; she also earned a Law & Technology Certificate from the Berkeley Center for Law & Technology. Prior to law school, she received her Ph.D. in plant cell and molecular biology from Stanford University, where her doctoral research focused on high-efficiency carbon fixation in green algae. Her doctoral work was published in and featured on the cover of Cell. At Stanford, she designed and conducted experiments in algal cell biology using genetic engineering, recombinant protein design, fluorescent biosensors, quantitative confocal microscopy, and computational image analysis. Liz obtained her A.B. in biology magna cum laude from Washington University in St. Louis, with a focus in biochemistry and a minor in Modern Hebrew.

Liz Freeman Rosenzweig

Associate

Alice Carli is an associate in MoFo’s Complex Litigation + Advisement Group in the Los Angeles office. Alice's practice focuses on environmental law and regulatory matters across the food, agriculture, sustainability, and energy sectors. She supports clients in regulatory enforcement, compliance, and due diligence matters.Alice earned her J.D. from the University of California, Los Angeles School of Law, earning induction into the Order of the Coif. While at UCLA, she won first place in the Skye Donald Moot Court Competition and received multiple Masin Family Academic Excellence Awards in topics such as Energy Law, Land Use and Regulation, and Administrative Law. Alice also served as the chief managing editor of the Journal of Environmental Law and Policy and supported policy development for the Climate Overshoot Commission through UCLA’s International Climate Change Law and Policy Clinic. Additionally, she externed for the Honorable Ronald Lew at the U.S. District Court for the Central District of California, preparing legal memoranda and orders.Alice has diverse experience across a variety of environmental and sustainability issues. She has authored a forthcoming publication on plant biotechnology regulation and conducted extensive research on the economic and regulatory dynamics of renewable energy development in the United States.Prior to law school, Alice owned a small business providing food and nutrition education for students K–12. Alice holds a B.A. cum laude in public health from the University of Washington. She will clerk with Judge Stanley Blumenfeld in the Central District Court of California beginning in August 2025.