Biotechnology

Coordinated Framework for the Regulation of Biotechnology

No developments since March 12, 2017

Regulatory Agencies Issue Joint Agreement to Regulate Laboratory-Grown Human Food

On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food and Safety and Inspection Service (USDA-FSIS) entered into a formal agreement to cooperatively regulate human food created from animal cell culture technology. Consistent with the agencies’ original announcement on November 16, 2018, the agreement establishes a roadmap for each agency to oversee various aspects of the growth and production process, from cell collection and development to labeling harvested products for grocery store shelves.

“Lab-grown” or “cell-cultured” human food is derived from animal cells drawn from either a live biopsy from a living animal, or from an embryo. Scientists grow the food in a sterile laboratory by differentiating cells and allowing them to mature in a nutrient broth. The food mimics products that are traditionally derived from butchered livestock, poultry, or fish. Advocates claim that its commercialization can help reduce emissions from raising livestock and eliminate ethical concerns associated with animal slaughter, among other benefits. Click here for more information about the regulatory challenges and opportunities associated with cell-cultured meat.

Under the formal agreement, FDA is charged with overseeing developers’ initial cell collection, proliferation, and differentiation activities; FDA will also evaluate facility conditions for compliance with FDA regulations. Regulatory oversight will shift to USDA-FSIS at the time of cell harvest, and USDA-FSIS will conduct inspections of facilities where cells cultured from livestock and poultry are harvested, processed, packaged, or labeled. USDA-FSIS will also determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection and ensure that products derived from livestock and poultry are labeled accurately. 

The agreement also lays the foundation for the agencies to develop a more detailed standard operating procedure to facilitate their coordination of shared regulatory oversight going forward. In addition, the agencies intend to develop joint principles for product labeling and claims to ensure that products are labeled consistently.

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A Burger By Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat

A hamburger produced with zero waste and without slaughtering a single animal. A tuna sandwich prepared with no impacts on marine ecosystems. These are among the many environmental benefits touted by advocates of innovative cellular agriculture products that may begin reaching neighborhood grocery store shelves in the next few years. “Cell-cultured” meat -- alternatively described as “cell-based,” “clean,” “synthetic,” or “lab-grown” meat – is now under development by an expanding cadre of biotechnology companies around the globe. These companies are using cutting-edge laboratory science to create a new and sustainable source of meat that promises consumers the full taste, appearance, and texture of animal products while reducing reliance on, and in some cases replacing, modern animal agriculture and industrial production practices.

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National Academies of Sciences, Engineering, and Medicine Issues Report on Future Biotechnology Products

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine released its report on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System”. Commissioned in connection with the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, the new report provides an overview of developing plant, animal, and microbial technologies and recommends that federal agencies expand their scientific capabilities and levels of expertise in order to prepare for significant biotechnology product innovations anticipated over the next decade.

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Federal Agencies Issue Final Update to Biotechnology Regulatory Framework

On January 4, 2017, the U.S. Environmental Protection Agency, U.S. Department of Agriculture, and U.S. Food and Drug Administration released their final version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.

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