August 11, 2020

Volume X, Number 224

August 11, 2020

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August 10, 2020

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U.S. Government Accountability Office Issues Recommendations to Clarify Joint Framework for Regulating Cell-Cultured Meat Products

The U.S. Government Accountability Office (GAO) is recommending that the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) strengthen existing efforts to prepare for oversight of “cell-cultured” meat. In a report published on April 7, 2020 and released to the public in early May, GAO analyzed the joint USDA-FDA regulatory framework for overseeing the production of cell-cultured meat and has recommended that the two agencies more fully incorporate leading practices for effective collaboration in their 2019 interagency agreement.

GAO released its recommendations as stakeholders are preparing to make cell-cultured meat commercially available but face uncertainties about the regulatory status of, and future requirements for, their products. However, because the technology to produce cell-cultured meat at a commercial scale is still in development, GAO acknowledged there are limitations on the agencies’ ability to make regulatory and other decisions at this time. For example, many producers have yet to disclose the ingredients in, or the composition of, their final products. Some producers have acknowledged that products will be largely plant-based, while others expect the majority to be comprised of animal cells. It is also not yet known whether the materials that are used to grow the cell-cultured meat, including structural scaffolding, will be edible parts of the final product. Without this type of information, regulators have struggled to establish enforceable labeling requirements. Stakeholders have also expressed concern about the ability of producers to ramp up production to a commercial scale and stressed that the impact to the environment, animal welfare, and human health must be clarified when these products are produced at scale.

GAO recommended that USDA and FDA engage in more robust collaboration, based on leading interagency collaborative practices, and formally memorialize their collaboration. Specifically, GAO suggested that the agencies, and the agency working groups established to oversee cell-cultured meat production, identify specific outcomes for harvesting the product, and monitor steps for achieving these outcomes. GAO has also recommended that the agencies formally articulate which agency will oversee the production of cell-cultured seafood (other than catfish, which is regulated by USDA).

Both FDA and USDA generally concurred with the GAO recommendations and suggested that they will incorporate many of the recommendations in a more detailed joint framework or standard operating procedure.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 139


About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

Sarah A. Kettenmann Environmental Attorney Beveridge & Diamond New York, NY

Sarah uses her knowledge of environmental law and the physical sciences to help clients solve complex problems in a conservation-minded manner.

She maintains a diverse environmental practice, which includes litigation matters involving toxic torts and products liability and class action litigation concerning environmental and regulatory claims. Her regulatory practice includes advising clients on compliance with, and enforcement of, land use restrictions and remediation, and due diligence for waste facility permits under federal and state statutes. She also counsels clients on procedural and substantive aspects of permitting and environmental impact review, and related strategic planning for project development. She further advises clients on Occupational Safety and Health Act (OSHA) and Toxic Substances Control Act (TSCA) compliance and enforcement. Sarah is a co-author of the Air Quality chapter in the Environmental Law and Regulation in New York treatise.

Before joining Beveridge & Diamond, Sarah clerked for the Hon. Chase T. Rogers, Chief Justice of the Connecticut Supreme Court, from June 2014 to July 2015. During her time at Pace Law School, Sarah served as a judicial extern for Judge Laura Taylor Swain in the United States District Court for the Southern District of New York (S.D.N.Y.). She interned in the Civil Division of the U.S. Attorney’s Office, S.D.N.Y., where she assisted with settlements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and under the Fair Housing Act to increase accessibility for people with disabilities. She also interned in the King’s County District Attorney’s Office and served as an environmental policy adviser and legal extern in the United Nations General Assembly, Permanent Mission of Saint Kitts & Nevis to the United Nations. She was as a research assistant in the Pace University Center for Environmental Legal Studies and acquisitions editor for Pace Environmental Law Review.

At Yale University, Sarah wrote her master's project on international legal frameworks for recovering electronic waste and also conducted field research on the impact of a proposed biofuels production plant in south Hawaii Island.

Prior to law school, Sarah participated in the first federally funded research expedition dedicated solely to examining the accumulation of plastic debris in the North Atlantic Ocean. Before that, she worked as a research associate for the Environmental Law Institute in Washington, D.C., where she assisted staff attorneys and senior attorneys on law and policy projects designed to strengthen environmental governance domestically and internationally.