June 28, 2022

Volume XII, Number 179

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June 28, 2022

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June 27, 2022

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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.

© 2022 Beveridge & Diamond PC National Law Review, Volume X, Number 139
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About this Author

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

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...

202-789-6049
Sarah A. Kettenmann Environmental Attorney Beveridge & Diamond New York, NY
Associate

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...

212-702-5425
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