By: Alison Burrows
Cutting-edge biotechnology companies have created a hamburger without having to slaughter a cow. That burger is made with lab-grown cell-cultured meat that tastes, feels, and looks like meat without the negative impacts of traditional meat production.[1]Advocates believe synthetic meat will not only significantly minimize environmental strain but will also reduce public health risk by minimizing exposure to bacteria and zoonotic diseases.[2]
But synthetic meat promises just as many challenges as it does benefits, many of which are derived from the complex and technical processes used to create it.
First, cells are collected from either a live biopsy of a living animal or an embryo.[3]The collected cells are then grown in nutrient broth made up of amino acids, salts, sugars, and growth signaling molecules.[4]As the cells grow, they require physical support from a scaffolding usually made from non-animal edible materials.[5]The scaffolding allows the cells to develop structure and eventually either biodegrades or becomes part of the final meat product.[6]At the end of the growth process, the cell-cultured product must be placed in a bioreactor.[7]
The final meat product looks like meat, smells like meat, tastes like meat, and is derived from meat. But the process is a far cry from even the most processed meat production processes. Can we call lab-grown meat, meat?
The answer to this question is important because FDA has authority to regulate all food productsexceptmeat, poultry, and eggs which are overseen by USDA.[8]If synthetic meat is meat, USDA will regulate it under the Federal Meat Inspection Act (FMIA) and the Food Safety Inspection Service (FSIS).[9]But if synthetic meat is notmeat, FDA will regulate it under the Food, Drug, and Cosmetic Act (FDC).[10]
The statutory definitions of “meat” provided in FMIA and FSIS do little to clarify the answer. FMIA does not even define “meat.”[11]However, it does define a “meat food product” as “human food… made wholly or in substantial part from meat” and “prepared meat” which broadly includes meat products that have been “slaughtered” or “otherwise manufactured or processed.”[12]
Cell-cultured meat could arguably fit within FMIA’s definition of “prepared meat,” but FSIS’s existing rule would not give them authority to inspect synthetic meat production labs.[13]FSIS’s rule applies only to establishments that produce “products of, or derived from, carcasses of livestock.”[14]Arguably, FDA regulations are better equipped to regulate laboratories as they more closely resemble food manufacturing facilities rather than livestock slaughterhouses regulated by FSIS.[15]
Whether lab-grown meat is “meat” will have significant implications for consumers and producers. As FDA and USDA carefully consider how to properly regulate such a unique and novel food product, it is clear that the “meat” debate is only just beginning.
[1]Alan Sachs and Sarah Kettenmann, A Burger by Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat, SciTech Lawyer(Jan. 11, 2019).
[2]Id.
[3]Id.
[4]Id.
[5]Id.
[6]Id.
[7]Id.
[8]Id.
[9]Id.
[10]Id.
[11]21 U.S.C. § 601.
[12]Id.
[13]Alan Sachs and Sarah Kettenmann, A Burger by Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat, SciTech Lawyer(Jan. 11, 2019).
[14]9 C.F.R. § 301.2
[15]Alan Sachs and Sarah Kettenmann, A Burger by Any Other Name: Regulatory Challenges and Opportunities for Cell-Cultured Meat, SciTech Lawyer(Jan. 11, 2019).