Karen Ellis Carr

Partner and FDA Practice Leader

Karen counsels, advocates, and litigates on behalf of food and agriculture companies and industry groups, with a focus on agricultural technology, food, biotechnology, pesticides and other chemical substances, and environmental law. Karen leads ArentFox Schiff’s Agriculture & AgTech industry group.

Karen Ellis Carr Portrait

Karen has experience in litigation and regulatory counseling, strategy, and advocacy, with a primary focus on products regulated by the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA). Karen advises on pathways to commercialization for new products and technologies, advertising and labeling, testing and reporting, data use and compensation disputes, and litigation relating to product approvals. Karen has specific experience with the Plant Protection Act, the National Bioengineered Food Disclosure Standard, the National Organic Program, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the National Environmental Policy Act (NEPA), the Endangered Species Act (ESA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Administrative Procedure Act.

In addition to her work with individual companies, Karen represents industry associations and coalitions as outside general counsel, advising on regulatory strategy and policy and federal and state legislative issues, and in litigation matters as parties or amici. 

Karen has first- and second-chaired litigation matters in state and federal trial and appellate courts throughout the country and in arbitration and mediation, and has experience in all phases of litigation, from pre-litigation strategy and counseling to settlement negotiation and appeals. Karen also has extensive experience with enforcement and other regulatory matters at the state and federal levels, and assists with risk assessment and due diligence reviews of agricultural technology companies involved in mergers, acquisitions, and other corporate transactions. Karen is also a Fellow of the Farm Foundation Round Table.

Client Work

Karen’s representative litigation matters include:

  • Representing an industry coalition defending in litigation USDA’s authority to certify organic growers who use hydroponic and other container growing methods to produce agricultural products. Center for Food Safety v. Perdue – F.Supp.3d –- 2021 WL 1220949 (N.D. Cal., March 19, 2021)
  • Representing a biotechnology developer in a federal court challenge to FDA’s first approval of a genetically engineered animal for food use. Institute for Fisheries Resources v. Hahn, 424 F.Supp.3d 740 (N.D. Cal. 2019); 499 F.Supp.3d 657 2020 (N.D. Cal. Nov. 5, 2020)
  • Representing crop protection developers and industry trade associations in challenges to EPA’s approval of agricultural herbicides (various federal District and Circuit courts, some ongoing)
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Representative regulatory matters include:

  • Assisting companies in obtaining approvals for new, genetically engineered varieties of plants, animals, and microbes from USDA, FDA, and EPA
  • Serving as outside counsel to biotechnology, seed, crop protection, and controlled environment agriculture industry associations
  • Representing an industry coalition successfully seeking passage of a uniform federal disclosure standard for bioengineered foods and in associated rulemaking proceedings
  • Providing pre-litigation strategy and counseling for agricultural products companies on matters relating to biotechnology

Firm Activities and Pro Bono

Karen serves in numerous firm leadership positions and maintains an active pro bono practice. She currently serves on the Board of Directors for Legal Counsel for the Elderly, a DC-based legal services provider.

Karen is a member of the firm’s Strategic Advisory Committee, Financial Management Committee, and Pro Bono Committee and is active in the firm’s Women’s Initiative.

Previous Work

Before joining ArentFox Schiff, Karen served as a law clerk for the Honorable James P. Jones, then Chief Judge of the US District Court for the Western District of Virginia. While in law school, Karen served as a judicial extern for Judge Ann Aiken, US District Court for the District of Oregon, as a law clerk for the Special Litigation Unit of the Oregon Department of Justice, and as an executive editor of Oregon Law Review. She also served as a fellow for the Wayne Morse Center for Law and Politics.

Publications, Presentations & Recognitions

Presentations

Karen routinely speaks on biotechnology, crop protection and chemical regulation, and food labeling, and environmental law. Her speaking engagements include:

  • Moderator, Regulatory Panel, Farm Foundation Round Table; January 16, 2025 (Raleigh, NC)
  • “Food and Agriculture in a Post-Chevron World,” ArentFox Schiff & Invariant Webinar; October 1, 2024 (virtual)
  • “What’s New with Genetically Engineered Microbes for Use in Agriculture: A Regulatory Update,” American Agricultural Law Association Webinar; August 29, 2024 (virtual)
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Publications

Karen writes often on biotechnology, crop protection, and food labeling topics. Her recent publications include:

  • “Rise in VCM Business May Trigger CFTC Oversight on Sales of Carbon Offset Credits,” ArentFox Schiff Client Alert; May 30, 2023
  • “FCC Announces March 28 Meeting of Precision Agriculture Connectivity Task Force,” ArentFox Schiff Client Alert; March 16, 2023
  • “Proposed Legislation Would Authorize CFIUS to Scrutinize Farmland Purchases by Foreign Buyers,” ArentFox Schiff Client Alert; February 13, 2023
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Recognitions

Karen was recognized as one of the nation’s leading Food & Beverages: Regulatory & Litigation lawyers by Chambers USA in 2023 and 2024. She was recognized by The Best Lawyers in America 2025 in FDA Law. In addition, Karen has been recognized by Super Lawyers as a “Rising Star” in the Complex Litigation category. 

Insights

Awards

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