'Cultured Meat': Lab-Grown Beef and Regulating the Future Meat Market.

• Author: Penn, Jennifer

TABLE OF CONTENTS INTRODUCTION I. What is Cultured Meat? II. Why Choose Cultured Meat? A. Environmental Concerns B. Humanitarian Concerns C. Human Health Issues III. How Should Cultured Meat be Regulated? A. FDA Regulation 1. Food Additive 2. Food B. USDA Regulation of Genetically-Modified Organisms C. FDA Regulation of New Animal Drugs D. FDA's Biotechnology Regulations E. USDA Day-to-Day Regulation of Meat F. New Regulation for Cultured Meat CONCLUSION INTRODUCTION

Consumers in the United States eat around fifty-two billion pounds of meat per year, averaging just over 270 pounds per person. (1) It has been documented that one pound of hamburger requires 26.8 pounds of feed, 232 square meters of farmland, and 4,144 British Thermal Units (BTUs) of energy. (2) Imagine if consumers were able to buy ground beef that had been produced in a laboratory and made far fewer demands on natural resources. Cultured meat is the process of taking a single cell of muscle tissue from a cow and replicating it in a controlled setting to create layers of muscle that can be ground together to produce ground beef. This laboratory process to create one pound of cultured meat requires no feed, 43.6 gallons of water, less than 1 square foot of farmland, and up to 45 percent less energy. (3) If cultured meat were substituted for ground meat, consumers could save 26.8 pounds of feed, which could be repurposed to feed the growing population or create ethanol. This would also free up Additionally, 167.6 gallons of water for use in other sectors, perhaps creating alternative solutions for crises like the recent one occurring in Flint, Michigan. Additionally, 3,455 square feet could be reforested or reclaimed for natural landscape and carbon sinks. Available land, or it could be dedicated to producing food for the world's expanding population. The use of fossil fuel energy could be cut almost in half. A laboratory running on renewable energy could entirely eliminate its dependence on fossil fuels.

While this scenario seems like science fiction for most, it is the fervent hope of those striving to make cultured meat a reality. Cultured meat is not the single answer to the challenges facing our climate, as there are many other causes and impacts that need to be addressed. That being said, traditional livestock practices have significantly contributed to climate change, which has, in turn, begun to impact traditional livestock practices. A drastic change needs to be made to keep the system from becoming a positive feedback loop. One in which climate change means more problems raising livestock, thus causing livestock farmers to produce more animals, which releases more Greenhouse Gases (GHGs) and increases climate change effects in severity.

A few decades ago, meat produced through cloning animals seemed improbable. Now meat harvested from the offspring of cloned animals is already on the shelves. Although cultured meat may face similarly intense challenges, it can overcome those barriers and solve many of the problems livestock farming faces today.

To determine the feasibility of exchanging meat, such as ground beef, for cultured meat, Part I defines and explains the product. Part II explores why consumers would be interested in cultured meat over traditional meat, such as the environmental and humanitarian concerns inherent in attempting to produce enough animal protein to feed the world's growing population. Part III examines the legal framework for inspection, certification, and sale of cultured meat. Cultured meat could be adopted into the Federal Drug Administration (FDA) meat product provisions, the FDA genetically modified organism provisions, or the United States Department of Agriculture (USDA) meat provisions. The Conclusion suggests an alternative--that cultured meat may need to its own provisions within the legal framework. If it is adequately regulated, cultured meat could soon provide an alternative to traditionally-produced meat.

1. WHAT IS CULTURED MEAT?

   Cultured meat is one of the newest additions to a field called cellular agriculture. (4) Cellular agriculture is the process of taking cells from animals, placing those cells into a controlled environment, and growing those cells. (5) The insulin used by most diabetics today is made using this process: (6) human insulin cells from humans are injected into yeast and grown in a lab. Scientists are able to grow insulin that is genetically identical to human insulin. (7) By switching from harvesting bovine insulin to creating human insulin in a laboratory, scientists made the process safer and the supply more consistent. (8) Scientists are also using this technology to grow living, transplantable tissue for medical use. (9)

   Growing a fully functional organ, such as skin, is a difficult and rigorous process. The tissue must survive transportation and transplantation to become a working part of the body.10 Cultured meat, by contrast, is much less demanding because it only needs to meet certain nutritional, textural, and taste parameters. It does not need to meet any functional parameters. (11)

   Although this process can be applied to any animal muscle, this paper specifically compares traditionally produced beef with bovine cultured meat. To create a cultured hamburger, stem cells are extracted from bovine muscle tissue. (12) Those cells are,then placed in a petri dish for the first cycle of growth, where they grow, divide, and replicate on their own. (13) The result is a myotube of muscle cells that is then placed around a cylinder of gelatin with other myotubes. (14) This donut-shaped ring of muscle cells attaches to the gelatin and then "exercises"; it expands, and contracts on its own, causing the muscle to grow and produce muscle tissue just as it would if it were part of a cow's shoulder muscle. (15) After time, these muscle cells grow into a layer of tissue the width of the petri dish and approximately one-half a millimeter in height. (16)

   This single layer of bovine muscle tissue is then combined with other layers (as many as twenty thousand) and ground into hamburger for easier cooking. (17) The resulting product is then mixed with a limited amount of egg powder and breadcrumbs to create a hamburger patty that looks and cooks like a traditional hamburger patty. (18) According to a study conducted of a test burger in August 2013, it also has the same texture, but with a taste between a traditional beef patty and a leading vegetarian substitute. (19) This textural similarity but slightly lighter taste could be due to the lack of fat and iron from blood flow found in traditional meat. (20) Since this study, labs have begun to produce the other components necessary to bring the taste closer to that of a traditional hamburger.

2. WHY CHOOSE CULTURED MEAT?

   [Livestock production] accounts for 40 percent of agricultural gross domestic product (GDP). It employs 1.3 billion people and creates livelihoods for one billion of the world's poor. Livestock products provide one-third of humanity's protein intake, and are a contributing cause of obesity and a potential remedy for undernourishment. (21)

   1. Environmental Concerns

      Climate change is the most serious problem facing the world today. GHG increases cause such effects as rising global temperatures, melting polar ice-caps and permafrost, rising sea levels, increasing extreme weather patterns, and natural disasters, ranging from toxic smog days to tsunamis that destroy entire islands. (22) This paper accepts the realities of climate change and delves solely into the contributions of livestock. Although people traditionally associate transportation and energy production with GHG emissions, livestock production contributes more than both the transportation and the energy production sectors, accounting for 18 percent of all GHG emissions. (23) Livestock production is responsible for some of the most potent and heat-trapping GHGs, including 37 percent of anthropogenic emissions of methane, 65 percent of anthropogenic nitrous oxide emissions, and 64 percent of anthropogenic ammonia emissions. (24) Even if all livestock farmers and processors switched to best available practices, however, GHG emissions would still be far too high to have an effect on climate change.

      GHG emissions are not the only problem. Livestock production is the largest anthropogenic (human-made) use of land. (25) When including land used to feed raise livestock, 30 percent of the earth's land is devoted to livestock production. (26) Land used for livestock production is highly susceptible to over-grazing, compaction, erosion, and run-off pollution. (27) Livestock production accounts for the vast majority of deforested land and for 70 percent of all agricultural land, and it is responsible for over 8 percent of global human water use. (28) It produces animal waste and antibiotic/hormone runoff from the farms in addition to the chemicals from the tanneries and those added to soils for feed crops. (29) It is also a...