Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>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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Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

Zak is an associate in the Litigation Department in Morrison Foerster’s New York office.Zak’s practice focuses on class actions, commercial litigation, white collar defense, government investigations, and antitrust litigation and counseling. He has represented clients before federal and state courts in complex commercial matters, as well as in arbitration tribunals.Zak received his J.D. from New York University School of Law in 2018, where he was inducted into the Order of the Barristers. During law school, Zak also served as the Marden executive editor for the NYU Law Moot Court Board. In 2013, Zak received his B.A. and M.A. in political science from Yale University, receiving honors in his major and the Ellsworth Prize for Best Senior Essay in the Social Sciences.

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Zak Newman

Mitchell A. Hokanson is an associate in the Litigation Department of Morrison Foerster’s San Diego office.Mitchell’s practice focuses on commercial litigation and consumer class actions. He has extensive experience with civil litigation, including managing day-to-day strategy, propounding and responding to discovery, taking and defending depositions, and engaging in motion practice. He also has experience providing regulatory advice to clients, including pro bono partners and multinational corporations. Mitchell maintains an active pro bono practice.After law school, Mitchell worked as a judicial clerk for Justice Susan M. Carney of the Alaska Supreme Court, where he drafted bench memoranda and opinions on a wide range of state and federal law topics. Prior to joining MoFo, Mitchell worked for another international law firm, where he was a member of the Complex Civil Litigation practice group, in Los Angeles, California.Mitchell received his J.D. from Columbia Law School, where he was honored as a James Kent Scholar and Harlan Fiske Stone Scholar. While in law school he was the senior executive editor of the Columbia Journal of Environmental Law and worked as a judicial intern for Judge Sandra S. Ikuta of the United States Court of Appeals for the Ninth Circuit and Judge George B. Daniels of the United States District Court, Southern District of New York. Prior to that, Mitchell earned his B.A. from Stanford University.

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

Michael Ward Ph.D.

William F. Tarantino

Krista S. deBoer

Liz Freeman Rosenzweig Ph.D.

Alice Carli

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.This change comes in response to a <a href="https://lifesciences.mofo.com/topics/an-insecure-future-court-ruling-guts-usda-regs-on-genetically-engineered-plants" target="_blank">December 2, 2024, ruling</a> by the U.S. District Court for the Northern District of California that struck down the 2020 revisions to APHIS’s biotechnology regulations (“the 2020 Rule”), which had created exemptions for specific categories of GE plants that could otherwise have been developed through conventional breeding techniques. Although it was initially unclear whether the recent amendments to the 2020 Rule, which had added two additional exemptions and became effective on November 13, 2024, were included in the vacatur, APHIS recently acknowledged in a January 28, 2025, court filing that the December ruling also nullified the November 2024 amendments to the 2020 Rule.On January 28, 2025, the Court further ruled that plaintiffs’ remaining two challenges to the Rule (under the Endangered Species Act and the National Environmental Policy Act, respectively, neither of which had been addressed in the initial ruling) are moot in light of the vacatur of the 2020 Rule. With the remaining claims mooted, APHIS could now appeal the case to the 9th circuit to seek reinstatement of the 2020 Rule and its 2024 amendments. As of the publication of this post, APHIS has not publicly announced plans to appeal the ruling. Overview of the Reinstated APHIS Regulatory Process (7 CFR 340 (2019))In order to be regulated by the now-reinstated legacy framework, found in <a href="https://www.ecfr.gov/on/2019-12-31/title-7/subtitle-B/chapter-III/part-340/section-340.1" target="_blank">7 CFR §340.1 (2019)</a> (“the Reinstated Rule”), a GE organism must first be considered a “regulated article.” The Reinstated Rule defines a regulated article as a genetically engineered organism in which “the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in § 340.2 and meets the definition of plant pest,” or that APHIS otherwise believes to be a plant pest. As discussed in the section below, this definition may not apply to many GE plants being produced today.Under the Reinstated Rule, developers must determine whether their GE plant constitutes a regulated article and is thereby subject to the Reinstated Rule. Developers may request confirmation from APHIS that a GE organism is not subject to the Reinstated Rule via the “<a href="https://www.aphis.usda.gov/biotechnology/am-i-regulated" target="_blank">Am I Regulated</a>?” (AIR) process. This voluntary process allows developers to seek a determination of nonregulated status, meaning that the regulations under 7 CFR part 340 (2019) would not apply to the organism.If the organism is regulated, developers must apply to APHIS for a permit or use the notification procedure in order to import the organism, ship the organism interstate, or release the organism into the environment (including growth in an open field).The <a href="https://www.aphis.usda.gov/biotechnology/biotechnology-permits-notifications" target="_blank">notification procedure</a>, which has been reinstated as of February 7, 2025, allow developers to notify APHIS of their intent to move a regulated article that meets specific criteria, rather than undergoing a full permitting review.CRISPR Gene-Edited Plants May Fall Outside the Scope of APHIS RegulationAlthough the 2020 Rule was explicitly designed to exempt many plants produced using modern gene editing and to streamline the regulatory burdens for GE plants overall, in a surprising twist, the Reinstated Rule appears to be largely inapplicable to many edited plants being developed today, such as many plants developed using CRISPR. The Reinstated Rule was developed at a time in which genetic engineering effectively meant transgenic insertion, and often required use of plant pathogens, but modern methods such as CRISPR increasingly allow for precise, targeted modifications to DNA without the need for the stable integration of foreign DNA from plant pests. Although the 2020 Rule crafted an array of exemptions for plants that contained <a href="https://www.aphis.usda.gov/sites/default/files/confirmation-guide.pdf" target="_blank">specific types of edits</a>, the Reinstated Rule contained no such exemptions, and generally placed a high regulatory burden on developers of organisms that were subject to its provisions.Thus, while observers initially expected the vacatur of the 2020 Rule to yield a return to more stringent regulatory oversight, the rapid expansion and adoption of CRISPR and related techniques over the past five years has made the Reinstated Rule paradoxically more permissive than the 2020 Rule to some types of edits.As discussed above, regulation by APHIS under the reinstated framework centers on whether a GE organism is, or is altered with the use of, a plant pest, as defined by APHIS. A GE organism that is not a plant pest or reasonably likely to be a plant pest and has not been modified to contain foreign DNA is not subject to regulation by APHIS under 7 CFR Part 340.The definition of “regulated article” may leave a regulatory gap for GE plants modified using techniques that do not permanently introduce plant pest components into the plant’s DNA. This is illustrated by APHIS’ response to certain AIR inquiries from before the 2020 rule, which are <a href="https://www.aphis.usda.gov/biotechnology/regulated-article-inquiry" target="_blank">publicly available on APHIS’s website</a>.For example, APHIS’s 2020 response to a Corteva Agriscience inquiry regarding a line of GE corn concluded that the corn line was not a regulated article despite the use of plant pest components in components of the editing process, because the edited corn lines “are not themselves plant pests and no plant pest sequences were integrated into the plant genome of corn.” The corn lines were produced by biolistic introduction of CRISPR-Cas9 components and a repair template to introduce targeted base pair substitutions. Through subsequent reproduction and selection, the final edited corn lines contained the intended base pair substitutions but no unintentionally integrated DNA from the components of the editing process, leading APHIS to conclude that the genome-edited corn lines were not regulated under the Reinstated Rule.The foregoing example and other published 2020-era AIR letters suggest that many CRISPR‑edited plants, particularly those that do not permanently introduce foreign DNA, may fall outside the scope of APHIS regulation altogether. Thus, the vacatur of APHIS’s 2020 and 2024 rules, which exempted many CRISPR-edited GE plants, may not result in a categorical re‑regulation of all those products. However, developers who believe their GE plant may fall outside the scope of the Reinstated Rule will need to self-determine whether their GE plant meets the definition of a regulated article or submit an AIR inquiry to receive a determination from APHIS. If such plants are indeed nonregulated, they may be imported, shipped interstate, and released outside without a permit from APHIS, though other regulations may still apply.We are closely monitoring developments in this area and will continue to share updates.

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

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