COMMENT - Houston Law Revie skyrocketing development of countries such as China and India, this population growth will place new burdens on the world s food supply, especially the

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991

COMMENT

IN VITRO MEAT: SPACE TRAVEL, CANNIBALISM, AND FEDERAL REGULATION∗

TABLE OF CONTENTS

I.� �INTRODUCTION ...................................................................... 992�

II.� �IN VITRO MEAT PRODUCTION SYSTEMS ................................ 997�A.� A History of In Vitro Meat............................................. 997�B.� Scaffold-Based In Vitro Production Methods ............... 999�

1.� Which Type of Cells Should Be Used in In Vitro Meat Production? ................................................... 999�

2.� Which Type of Scaffold? ....................................... 1002�C.� Self-Organizing In Vitro Meat Production ................. 1003�D.� Benefits of an In Vitro Meat Production System ........ 1004�

III.� �REGULATORY FRAMEWORK FOR GE CROPS AND ANIMALS ...................................................................... 1005�A.� Doctrine of Substantial Equivalence .......................... 1006�

1.� Labeling for Substantially Equivalent GE Foods ............................................................. 1007�

2.� Treatment of Clones ............................................. 1008�B.� Food, Drug, and Cosmetics Act (FDCA) ..................... 1008�

1.� FDCA and Generally Recognized as Safe Food ... 1009�2.� FDCA Applied to GE Crops ................................. 1009�

C.� New Animal Drug Application (NADA) Requirements ............................................................... 1010�

D.� Wholesome Meat Act (Federal Meat Inspection Act) ... 1011�E.� Legal Issues for GE Food ............................................ 1012�

∗ This Comment won the 2012 Shook, Hardy, Bacon Award for Best Paper in the Area of Health Law. I would like to thank my parents, Beth & Michael Schneider, for their encouragement and support. This Comment is dedicated to Sumner & Roz Bernstein and Abraham & Isabelle Schneider.


992 HOUSTON LAW REVIEW [50:3

IV.� �SUGGESTED REGULATORY FRAMEWORK FOR IN VITRO MEAT PRODUCTION ............................................................. 1013�A.� Applicability of Existing Law ..................................... 1014�B.� Regulating the Product of In Vitro Meat .................... 1015�C.� Regulating the Process of Creating In Vitro Meat ...... 1018�

1.� Wholesome Meat Act and In Vitro Meat .............. 1018�2.� Treating In Vitro Meat Production like the

Manufacture of Drugs?. ....................................... 1018�D.� Labeling of In Vitro Meat Products ............................ 1019�

1.� Vermont�s GE Seed Labels as a Guide. ................ 1020�2.� MPAA Style Labeling? ......................................... 1021�3.� Proposed Voluntary Labeling for GE Foods. ....... 1021�

E.� Criticisms of In Vitro Meat ......................................... 1022�1.� Naturalness of the Product .................................. 1022�2. � A Real Life Soylent Green? .................................. 1023�

V. �CONCLUSION ....................................................................... 1024�

I. INTRODUCTION

Over the course of the next few decades, the world population will surge from seven billion to nine billion people.1 Coupled with the skyrocketing development of countries such as China and India, this population growth will place new burdens on the world�s food supply, especially the production of meat.2 Currently, meat production consumes about 20% of the world�s energy, 70% of potable water, and 30% of arable land; and is responsible for between 15 and 24% of greenhouse gas emissions.3 At these rates, the world cannot sustain an increased burden on its natural resources due to heightened demand for meat.4

1. Michael Specter, Test-Tube Burgers, NEW YORKER, May 23, 2011, at 32, 35. 2. ADVISORY COMM. ON BIOTECHNOLOGY & 21ST CENTURY AGRIC., U.S. DEP�T

OF AGRIC., PREPARING FOR THE FUTURE 3 (2005) [hereinafter PREPARING FOR THE

FUTURE], available at http://www.usda.gov/documents/scenarios-4-5-05final.pdf; see also ADVISORY COMM. ON BIOTECHNOLOGY & 21ST CENTURY AGRIC., U.S. DEP�T OF

AGRIC., OPPORTUNITIES AND CHALLENGES IN AGRICULTURAL BIOTECHNOLOGY: THE

DECADE AHEAD 5 (2006) [hereinafter OPPORTUNITIES AND CHALLENGES IN

BIOTECHNOLOGY], available at http://www.usda.gov/documents/final_main_report-v6.pdf (declaring that some genetically engineered crops will likely come from developing countries). 3. Z.F. Bhat & Hina Bhat, Animal-Free Meat Biofabrication, 6 AM. J. FOOD TECH. 441, 441�42 (2011). 4. See PREPARING FOR THE FUTURE, supra note 2, at 3 (stating that as developing countries become more prosperous, their populations will consume ever-increasing


2013] IN VITRO MEAT 993

Genetic engineering and cloning are already being implemented to help ease some of the burdens on the world food supply.5 �In 2005, 52% of corn, 87% of soybeans, and 79% of cotton planted in the United States [were] genetically engineered . . . .�6 Genetically engineered (GE) plants enable farmers to produce more resilient crops, allowing the farmers to prevent economic damage to yearly harvests and waste.7 Creating fast-growing animals and inherently insect-resistant plants can alleviate strains on the environment and the global food supply.8 These techniques still face the same limitations of traditional farming, such as land and resource consumption.9

quantities of meat products); Jeffrey L. Fox, Test Tube Meat on the Menu?, 27 NATURE

BIOTECHNOLOGY 873, 873 (2009) (discussing the possible destruction of natural resources caused by an increase in meat consumption); see also Specter, supra note 1, at 34 (stating that by the year 2030, global meat consumption is expected to grow 70% from levels in the year 2000). 5. See CTR. FOR VETERINARY MED., U.S. DEP�T OF HEALTH & HUMAN SERVS., ANIMAL CLONING: A RISK ASSESSMENT 19 (2008) [hereinafter ANIMAL CLONING: A RISK

ASSESSMENT], available at http://www.fda.gov/downloads/AnimalVeterinary/Safety Health/AnimalCloning/UCM124756.pdf (expressing that cloned animals have been developed to create better livestock and lower food prices); OPPORTUNITIES AND

CHALLENGES IN BIOTECHNOLOGY, supra note 2, at 3 (denoting that in 2005, �transgenic crops� grew on 5.8% of global crop land). 6. OPPORTUNITIES AND CHALLENGES IN BIOTECHNOLOGY, supra note 2, at 3. 7. See, e.g., PLANT BIOTECHNOLOGY AND AGRICULTURE: PROSPECTS FOR THE 21ST

CENTURY 330�32, 339, 429�30, 436 (Arie Altman & Paul Michael Hasegawa eds., 2012) (discussing strategies for genetically modifying plants and increasing yield rates during harvest while reducing losses in storage); Peter J. Goss, Guiding the Hand that Feeds: Toward Socially Optimal Appropriability in Agricultural Biotechnology Innovation, 84 CALIF. L. REV. 1395, 1400�01 (1996) (predicting that if scientists could engineer frost resistance into crops normally susceptible to frost damage to resist cold weather, farmers could prevent $1.6 billion in annual losses). 8. See JORGE FERNANDEZ-CORNEJO & WILLIAM D. MCBRIDE, U.S. DEP�T OF AGRIC., AGRIC. ECON. REP. NO. 810, ADOPTION OF BIOENGINEERED CROPS 4 (2002), available at http://www.ers.usda.gov/publications/aer810/aer810.pdf (asserting that the herbicide-tolerant plants comprise the most common genetic modification); Ruxandra Draghia-Akli et al., Myogenic Expression of an Injectable Protease-Resistant Growth Hormone-Releasing Hormone Augments Long-Term Growth in Pigs, 17 NATURE BIOTECHNOLOGY 1179, 1182 (1999) (proclaiming that genetically modifying pigs increased their growth by up to 38% over a sixty-five-day period as well as increasing the ratio of amount of food consumed versus amount of weight gained); Andrew Pollack, In Lean Times, Biotech Grains Are Less Taboo, N.Y. TIMES, Apr. 21, 2008, at A1 (opining that genetically modified crops can be �resistan[t] to insects, herbicides or diseases�); Specter, supra note 1, at 34 (stating that the FDA is reviewing an application for a GE salmon which would �grow twice as fast as normal�); see also Jill U. Adams, Scoping Out a New Breed of Rules, L.A. TIMES, Jan. 26, 2009, at F1 (explaining that a strain of GE salmon grows faster because a naturally occurring gene turns on when normally it would be inactive). 9. See FOOD & WATER WATCH, GENETICALLY ENGINEERED FOOD: AN OVERVIEW 5, 7 (2012), available at http://documents.foodandwaterwatch.org/doc/ GeneticallyEngineeredFood.pdf; PREPARING FOR THE FUTURE, supra note 2, at 2 (predicting that a growing world population will force farmers to extract more productivity from their land or infringe on �non-agricultural lands, especially if



However, some genetic modifications produce faster growth, such as the AquAdvantage salmon, thereby reducing the cost of raising the animals and lessening their environmental impact.10

This Comment argues that growing demand for protein, especially from meat, will drive a search for alternatives to conventional meat production. A developing technology, in vitro11 meat, could help ease many of the environmental burdens of worldwide meat production.12 In vitro meat research seeks to develop a method to grow meat in a lab environment.13 Some researchers estimate that in vitro meat production systems could reduce use of land and water resources for raising meat by up to 80% and reduce greenhouse gas emissions from raising livestock by as much as 90%.14

Because in vitro meat facilities could be built vertically, taking up less ground space, producers could place production centers in or near cities.15 This would reduce the amount of land used to produce in vitro meat as compared to conventional cattle farming.16 Additionally, because the production facility would be close to city-dwelling consumers, in vitro meat could reduce the transportation costs of meat.17 Furthermore, as in vitro meat would not involve the slaughter of animals and possesses

agricultural productivity . . . does not keep pace with increases in global populations�). 10. See Bryan Walsh, Frankenfish: Is GM Salmon a Vital Part of Our Future?, TIME, July 12, 2011, at 28, 31�36. (asserting that GE animals, which grow faster, would reduce the environmental strains posed by increasing demand for salmon as fewer small fish would need to be harvested to maintain the farm populations). If farmers use farmed GE salmon, it could lessen the environmental impact that comes from importing large quantities of salmon to the United States by plane. Id. 11. In vitro means: �outside the living body and in an artificial environment.� MERRIAM-WEBSTER�S MEDICAL DICTIONARY 448 (2006). 12. See Patrick D. Hopkins & Austin Dacey, Vegetarian Meat: Could Technology Save Animals and Satisfy Meat Eaters?, 21 J. AGRIC. ENVTL. ETHICS 579, 585 (2008) (predicting that in vitro meat production could help eliminate environmental harm caused by raising livestock). 13. See infra Part II (describing in vitro meat as meat grown in a lab either from stem cells or from explanted muscle tissue). 14. Fox, supra note 4, at 873. 15. See I. Datar & M. Betti, Possibilities for an In Vitro Meat Production System, 11 INNOVATIVE FOOD SCI. & EMERGING TECH. 13, 19 (2010) (claiming that industrial scale in vitro meat production facilities would need to be three to five stories tall); Cliff Kuang, Farming in the Sky, POPULAR SCI., Sept. 2008, at 41 (proposing vertical farms within cities, capable of feeding up to 50,000 people, as a way to help solve issues related to the world food supply and resource consumption) 16. See Kuang, supra note 15, at 42. 17. Id. at 41.



potentially profound environmental benefits, in vitro meat has a strong basis of support in the scientific, animal rights, and environmental communities.18

At its most basic, in vitro meat production involves the growing of animal muscle tissue within a lab.19 Currently, this can be accomplished either by extracting a segment of existing muscle tissue from an animal, which can then survive and thrive in a growth medium, or by taking adult or embryonic stem cells and stimulating them to grow into muscle tissue.20 Both techniques have their benefits and their limitations.21 However, creating a method of producing meat that involves consuming fewer natural resources, emitting fewer greenhouse gasses, and requiring less surface land would be extremely beneficial.22

As in vitro meat has not yet reached the point where it can be implemented in large-scale production for human consumption,23 no regulatory framework currently exists to ensure the safety of future in vitro meat products. This Comment will examine approaches taken in regards to cloned and GE animals, as well as other areas of food and drug regulation, and will suggest a regulatory framework to ensure that in vitro meat production creates a safe product for consumers, while not stifling the technology in bureaucracy. Because the regulations for GE and cloned crops and animals were developed in the 1980s, they no longer accurately reflect the power of biotechnology.24 While some of the old system can still work to

18. See Hopkins & Dacey, supra note 12, at 584�85 (emphasizing that a number of scientists are pursuing in vitro meat in order to reduce animal suffering); PETA Offers $1 Million Reward to First to Make In Vitro Meat, PETA, http://www.peta.org/features/In-Vitro-Meat-Contest.aspx (last visited Jan. 26, 2013) (showing PETA�s support for meat that does not involve the slaughter of animals); see also John Schwartz, PETA�s Latest Tactic: $1 Million for Fake Meat, N.Y. TIMES, Apr. 21, 2008, at A16 (quoting a PETA representative as saying that �in vitro meat is a godsend�). 19. Hopkins & Dacey, supra note 12, at 582. 20. See Bhat & Bhat, supra note 3, at 443, 446�47; Hopkins & Dacey, supra note 12, at 582�83. 21. See infra Part II.B�C (describing the different in vitro meat production methods and potential problems in implementing them on a large scale). 22. See Hopkins & Dacey, supra note 12, at 585 (contending that in vitro meat could prove beneficial in lessening animal suffering, environmental damage from raising livestock, and allow for production of healthier meat); Kuang, supra note 15, at 41 (stating that transportation and manufacturing under current systems of agriculture accounts for �nearly 14 percent of the world�s greenhouse-gas emissions�). 23. See Hopkins & Dacey, supra note 12, at 584 (declaring that in vitro meat production is currently �commercially infeasible�). 24. See Rebecca Bratspies, Some Thoughts on the American Approach to Regulating Genetically Modified Organisms, 16 KAN. J.L. & PUB. POL�Y 393, 405�07 (2007) (explaining that the Coordinated Framework for Regulation of Biotechnology, developed during the Regan Administration by the Office of Science and Technology Policy, asserted



effectively regulate in vitro meat, a new regulatory scheme, under the auspices of the Food and Drug Administration (FDA), should be developed so that both production processes and end products are safe for consumers.

This Comment contends that in vitro meat production processes should be regulated in a fashion similar to a slaughterhouse to ensure sanitary and clean conditions. Furthermore, while generally the government currently requires no labeling for GE crops,25 this Comment argues that a uniform national labeling requirement should be imposed on in vitro meat products. Such a labeling system must inform consumers of the GE nature of the products while simultaneously not discouraging customers from purchasing and consuming in vitro meat.

Furthermore, depending on what substances scientists add to the animal muscle cells during the in vitro meat production process, this Comment asserts that the final in vitro meat product should be subject to regulation to ensure that it is safe for human consumption. Such regulation should include oversight of what growth formulas and additives can be introduced to the in vitro meat production system. However, any regulatory system must balance protecting the consumers through appropriate regulations with ensuring that regulations do not place significant economic burdens on producers, which would deter them from entering the market. This Comment maintains that coordinated regulation among federal agencies can help promote in vitro meat, a technology with massive potential to help alleviate environmental issues facing the world.

Part II of this Comment provides a brief history of in vitro meat, describes the two main techniques currently in development to create an in vitro meat production system, and discusses the benefits of in vitro meat. Part III explains a number of the regulatory approaches the FDA has taken in regards to GE and cloned crops and animals. Additionally, Part III delves into a few of the legal issues presented by GE and cloned food products. Finally, Part IV applies the rationale of current regulation for GE and cloned plants and animals to in vitro meat. Part IV proposes a regulatory approach that applies current law to in vitro meat and suggests additional regulations

that �biotechnology poses no unique risks� and that existing law should be used to regulate the products of biotechnology). 25. See infra note 110 and accompanying text (describing the lack of a national requirement for labeling GE crops and animals for food consumption).



that would help safeguard consumers while not stifling the development of in vitro meat.

II. IN VITRO MEAT PRODUCTION SYSTEMS

A. A History of In Vitro Meat

Alexis Carrel first demonstrated the concepts underlying an in vitro meat production system in the early 1900s.26 Carrel kept a portion of an embryonic chicken heart alive over a period of decades, during which time the muscle tissue grew considerably.27 This proved that muscle tissue could survive ex vivo,28 provided it received the necessary nutrients.29

Decades later, other scientists, inspired by Carrel�s experiment, began to develop in vitro meat.30 Willem van Eelen became entranced with the idea of growing meat ex vivo after his experiences with hunger and animal cruelty in a Japanese P.O.W. camp during World War II.31 In 1981, the discovery of embryonic stem cells in mice suggested a workable means of in vitro meat production to van Eelen.32 Van Eelen�s breakthrough came in 1999, when �he received U.S. and international patents

26. See Alexis Carrel, On the Permanent Life of Tissues Outside of the Organism, 15 J. EXPERIMENTAL MED. 516, 526 (1912) (describing how Carrel kept a chicken heart beating for three months, outside the organism). 27. See id. at 526 (explaining that, while Carrel had kept the heart alive for three months, in 1912 it was unknown how long the specimen could survive in vitro); M.A. Benjaminson, J.A. Gilchriest & M. Lorenz, In Vitro Edible Muscle Protein Production System (MPPS): Stage 1, Fish, 51 ACTA ASTRONAUTICA 879, 881 (2002) (describing how Carrel sustained tissue from a chicken heart in a nutrient solution in vitro, where it grew for decades until the experiment ended). Leonard Hayflick thought that embryonic stem cells in the growth medium caused the continuous growth because the embryonic stem cells could attach to the heart tissue, replicate, and differentiate into new heart cells, resulting in heart muscle growth. Id. at 881. 28. Ex vivo refers to �the use or positioning of a tissue or cell after removal from an organism while the tissue or cells remain viable.� STEDMAN�S MEDICAL DICTIONARY 636 (27th ed. 2000). 29. See Carrel, supra note 26, at 525 (explaining how the cells on the exterior of the specimen received abundant nutrients, resulting in ceaseless multiplication of those cells, while cells on the interior of the specimen disintegrated due to deficient nutrients). 30. See Marloes L.P. Langelaan et al., Meet the New Meat: Tissue Engineered Skeletal Muscle, 21 TRENDS FOOD SCI. & TECH. 59, 59 (2010) (declaring that the idea of growing muscle tissue ex vivo comes from Alexis Carrel�s 1912 experiments); Benjaminson, Gilchriest & Lorenz, supra note 27, at 881 (stating that Carrel�s experiments inspired Benjaminson�s later idea of using tissue explants for an in vitro meat production system). 31. Specter, supra note 1, at 32. 32. Id. at 33. Because stem cells can divide infinitely and can differentiate into other types of cells, van Eelen believed that such cells could be used to produce meat, although others at the time did not share his interest in using stem cells for such a purpose. Id.



for the Industrial Production of Meat Using Cell Culture Methods.�33 Shortly afterwards in 2004, the Dutch government awarded a grant of two million euros to a group of researchers at facilities spread throughout the country, helping the Netherlands become a focal point of research into in vitro meat.34

Concurrently, another group of scientists, led by Morris Benjaminson, began researching ways to produce in vitro meat for NASA.35 Benjaminson proposed an experiment similar to Carrel�s; he cultivated explants, or biopsied muscle tissue, in growth media.36 Through a grant from NASA�s Small Business Innovative Research (SBIR) Program, Benjaminson demonstrated that skeletal muscle could survive and grow in vitro.37

Benjaminson and van Eelen represent the two primary approaches to create an in vitro meat production system, which are self-organizing and scaffold-based, respectively.38 Scaffold-based in vitro meat production involves growing cells around a specific support structure.39 Self-organizing in vitro meat can, in

33. Id. 34. See id. (proclaiming that the grant �helped turn the Netherlands into the in-vitro-meat world�s version of Silicon Valley�). Van Eelen�s lobbying efforts played a large part in the award of this grant. Id. 35. See An In Vitro Edible Muscle Protein Production System, NASA SBIR & STTR

PROGRAM, http://sbir.nasa.gov/SBIR/abstracts/98/sbir/phase1/SBIR-98-1-09.05-6812.html (last visited Jan. 26, 2013) (describing Benjaminson�s 1998 grant proposal to develop an in vitro Edible Muscle Protein Production System (MPPS) for use on long-range space flights). Benjaminson thought in vitro meat could negate the necessity of taking large quantities of supplies in the shuttle�s limited space for multi-year voyages. Benjaminson, Gilchriest & Lorenz, supra note 27, at 879. Benjaminson also believed his methods could be applied to food supplies on space stations and colonies on other planets. Id. at 879�80. 36. Benjaminson, Gilchriest & Lorenz, supra note 27, at 882; see also MERRIAM-WEBSTER�S MEDICAL DESK DICTIONARY 79 (2006). 37. See Benjaminson, Gilchriest & Lorenz, supra note 27, at 885 (describing how the explants grew an average of 5.2% to 13.8%, depending on the growth medium used); Press Release, Michael Braukus, NASA, NASA Selects 345 Innovative Small Business Projects (Oct. 16, 1998), available at http://sbir.nasa.gov/SBIR/sbir98/98ph1/98newsrele.html (denoting that in 1998, NASA awarded SBIR research grants to 345 proposals, totaling almost $24 million); NASA Small Business Innovation Research (SBIR) Program: 98-1 Phase I Proposals Selected for Negotiation of SBIR Phase I Contracts, NASA SBIR &

STTR PROGRAM, http://sbir.nasa.gov/SBIR/sbir98/98ph1/98firm.html (last visited Jan. 26, 2013) (listing Benjaminson�s project as one of the 345 proposals to receive funding from NASA�s SBIR Program). 38. P.D. Edelman et al., Commentary: In Vitro-Cultured Meat Production, 11 TISSUE ENGINEERING 659, 659 (2005) (describing how van Eelen developed and patented scaffold-based techniques while Benjaminson experimented with self-organizing in vitro meat production). 39. See id. (describing how van Eelen and his colleagues were awarded a Dutch



theory, produce more structured meat products, such as steak.40 Additional production processes for in vitro meat may also exist in the future, for example, organ-printing techniques, biophotonics, and nanotechnologies.41

B. Scaffold-Based In Vitro Production Methods

Meat consists primarily of skeletal muscle tissue.42 To grow meat in vitro successfully, a number of requirements must be met.43 First, a cell source that can replicate itself infinitely and also form into functioning skeletal muscle tissue must be found.44 Second, these cells must then be attached to a three-dimensional scaffold that encourages muscle development, while not interfering with the supply of nutrients and release of waste products.45 Third, a growth medium must be introduced to supply nutrients for the culture.46 Fourth, bioreactors are needed to mature and condition the muscle cells into �functional muscle fibers.�47

1. Which Type of Cells Should Be Used in In Vitro Meat Production? In vivo, muscle precursor cells called myoblasts fuse together into myotubes.48 The myotubes then mature into myofibers, or muscle tissue, which can no longer proliferate.49 After birth, myosatellite cells act in a similar fashion to myoblasts, replicating and differentiating into new muscle fibers to repair and grow muscle tissue.50 Various stimuli, including electrical and mechanical stimulation, can enhance the cell�s

patent for this in vitro meat production system). Scaffold-based techniques grow in vitro meat suitable for use only as processed or ground meat. Id. 40. Id. Benjaminson used this process in his experiments with goldfish tissue. Id. 41. Bhat & Bhat, supra note 3, at 445�46. 42. See Datar & Betti, supra note 15, at 14; Edelman et al., supra note 38, at 659. 43. Langelaan et al., supra note 30, at 60. 44. Id. 45. Id. The stem cells that give rise to skeletal muscle cells require a scaffold, or some other structure, which the cells can attach to so that they can proliferate and differentiate into skeletal muscle. Edelman et al., supra note 38, at 660. 46. Edelman et al., supra note 38, at 661. 47. Langelaan et al., supra note 30, at 60. Bioreactors are the vessels in which the cultures grow and work to �promote the growth of tissue cultures which accurately resemble native tissue architecture.� Datar & Betti, supra note 15, at 18. Bioreactors simply work to �synthesize useful substances . . . or breakdown harmful ones.� MERRIAM-WEBSTER�S MEDICAL DESK DICTIONARY 79 (2006). 48. Datar & Betti, supra note 15, at 15. 49. Id. 50. Id. Satellite cells �are the natural muscle stem cells responsible for regeneration,� and also have the benefit of being �already programmed to differentiate into skeletal muscle.� Langelaan et al., supra note 30, at 60�61.



proliferation and differentiation rates.51 To re-create the natural development of muscle tissue, in vitro meat cultures must utilize cells that can mimic in vivo muscle growth and maturation.52 Thus, in vitro meat production requires a type of cell that can go through many divisions and then can differentiate into skeletal muscle cells.53

Embryonic stem cells possess the benefits of virtually unlimited proliferation and the ability to differentiate into almost any other type of cell, including skeletal muscle cells.54 Because of this unlimited proliferation capacity, in vitro meat production utilizing embryonic stem cells theoretically could create an infinite supply of meat from a single line of cells.55 Using co-cultures of other cell types will allow an in vitro meat production system to create more realistic muscle tissues by replicating fat content and other factors that impact meat�s texture.56

51. Edelman et al., supra note 38, at 660. Scientists at Harvard recently announced that they developed �cyborg� tissue composed of rat heart cells combined with wires and transistors. Will Ferguson, Living, Beating Cyborg Tissue, NEWSCIENTIST, Sept. 1�7, 2012, at 12, 12. The researchers grew the heart cells on three-dimensional scaffolds, and have developed versions that replicate muscle and blood vessel cells. Id. Because of the electrical components intertwined with the cells, the researchers were able to stimulate the cells to re-create the natural beating of heart cells. Id. Although the Harvard scientists used the electrical components as only sensors, they anticipate that a similar scaffold could be used to communicate with the heart cells. Id. Because this technique allows for both the creation of blood vessels and potentially recreating the natural electrical stimulation of muscle cells, in vitro meat researchers could arguably utilize similar techniques to solve some of the problems they face. However, because the electrical components consist of nanowires and silicon sensors, id., researchers would need to determine whether such materials were edible and if not, whether an organic substitute could produce the same results. 52. See Langelaan et al., supra note 30, at 60 (contending that for satellite cells to be successfully utilized in in vitro meat production, their ability to replicate outside the animal must be improved so as to closely approximate satellite cell in vivo proliferation rates). 53. See Edelman et al., supra note 38, at 660 (emphasizing that skeletal muscle forms from the proliferation, differentiation, and fusion of cells). 54. See Datar & Betti, supra note 15, at 15 (discussing how embryonic stem cells possess an unlimited capacity to proliferate, although stimulation must be applied to differentiate the cells into skeletal muscle cells); see also Tim Magnus et al., Stem Cell Myths, 363 PHIL. TRANSACTIONS ROYAL SOC�Y B 9, 12�14 (2008) (describing key characteristics of embryonic stem cells including �pluripotency,� the ability to differentiate into more than one type of germ layer). 55. See Bhat & Bhat, supra note 3, at 452 (opining that, theoretically, a single specimen could produce an unlimited supply of meat). 56. See id. at 443, 445 (indicating that such co-cultures would allow for replicating the organization of natural meat tissue); Langelaan et al., supra note 30, at 61, 64 (asserting that to replicate in vivo muscles, adult stem cells will likely need to be co-cultured with other cells that form the underlying three-dimensional scaffold and that re-create fat and vasculature found in in vivo muscles).



Despite embryonic stem cells� abilities to proliferate infinitely and differentiate into skeletal muscle cells, they do have some drawbacks. First, embryonic stem cells must be stimulated to differentiate into the desired muscle cells. Second, a risk of mutation exists when the cells proliferate repeatedly over time.57 Third, there exists the possibility that embryonic stem cells might not differentiate into the desired muscle cells needed to form muscle tissue.58 Fourth, no suitable embryonic stem cell lines exist for many types of livestock.59 Fifth, it is more difficult to control embryonic stem cells� transformation into muscle tissue in vitro than in vivo.60 Finally, an ethical problem for embryonic stem cells arises due to their source, as opposed to any biological characteristic.61

Alternatively, in vitro meat production could use satellite cells to grow muscle tissue, as these cells work naturally to repair and grow new postnatal muscle.62 Compared to embryonic stem cells, satellite cells are better at differentiating into muscle and have already been isolated in livestock, including cattle, turkeys, and lambs.63 However, like embryonic stem cells, using satellite cells in an in vitro meat production system presents some challenges. First, satellite cells are rare within the body.64 Second, such cells have �limited regenerative potential� as most cells are constrained in their number of doublings, known as the Hayflick limit.65 Third, long-term proliferation of satellite cells

57. See Datar & Betti, supra note 15, at 15 (predicting that while an embryonic stem cell line could proliferate indefinitely, �the slow accumulation of genetic mutations over time may determine a maximum proliferation period for a useful long-term [embryonic stem cell] culture�). 58. See id. (stating that embryonic stem cells �must be specifically stimulated to differentiate into myoblasts,� otherwise repeated proliferation and differentiation could result in deviations in repeated creation of muscle tissue); Langelaan et al., supra note 30, at 60 (stating that embryonic stem cells would need to be �differentiat[ed] into [myogenic progenitor cells] while avoiding development of other lineages�). 59. See Datar & Betti, supra note 15, at 15 (stating that �no �proven� bovine, porcine, caprine nor ovine [embryonic stem] cell lines . . . have been established to the degree of a biological reagent like that of human, monkey or mouse [embryonic stem] cells�). 60. Langelaan et al., supra note 30, at 60. This could be due to the lack of �important in vivo niche components� in the in vitro system. Id. 61. See id. (discussing the ethical concerns about the use of embryonic stem cells for in vitro meat); see also John R. Meyer, Human Embryonic Stem Cells and Respect for Life, 26 J. MED. ETHICS 166, 167�68 (2000) (analyzing the conflict between viewing embryonic stem cells as human beings and the potential benefits of stem-cell-derived treatments). 62. See supra note 50 and accompanying text (describing how satellite cells act after birth to differentiate into new muscle cells). 63. Datar & Betti, supra note 15, at 15. 64. Id. 65. See id. at 15�16 (�An [in vitro meat production system] requires many cell divisions to mass culture muscle tissue, but most cells have a finite number of divisions in



can result in malignant transformations.66 Fourth, satellite cells �tend to differentiate spontaneously in vitro.�67

2. Which Type of Scaffold? Scientists have proposed two different approaches to scaffolding technique, both of which involve cultivating myoblasts68 in a growth medium.69 One comes from Vladimir Mironov�s proposal for an in vitro meat system for NASA.70 Mironov utilized collagen spheres, upon which the stem cells could grow, proliferate, and eventually differentiate into skeletal muscle cells.71 Mironov believes artificial muscles can be grown around �a branching network of edible porous polymer.�72 This method would allow the transportation of nutrients to the cells as well as provide a structure to which the cells could attach and grow.73

Van Eelen�s method utilized a collagen meshwork, through which the culture medium can percolate and be replaced as needed.74 An edible scaffold is ideal, as it would not need to be removed before processing.75 However, nonedible scaffolds can

culture before natural cell death; this number is termed the Hayflick Limit.�); see also Edelman et al., supra note 38, at 660 (stating that �[i]t is unclear how much cultured meat a single cell could yield� because cells in culture are constrained by the Hayflick limit). Researchers believe that some types of animal cells, even constrained by the Hayflick limit, could still produce enough meat to �satisfy the current annual global demand for meat.� Id. There are possible ways to get around the Hayflick limit. Such methods include the following: replacing the old cultures with new cells that have not reached their division limit, as would be necessary with myosatellite cells and other adult stem cells; using cell lines with unlimited divisions, such as embryonic stem cells; and making a cell line immortal, which would require genetic manipulation. Datar & Betti, supra note 15, at 15�16. 66. Datar & Betti, supra note 15, at 16. To prevent this risk from occurring, fresh satellite cells might need to be introduced into the in vitro meat production system. See id. (noting that re-harvesting of adult stem cells may be necessary to reduce the risk of spontaneous transformation). 67. Langelaan et al., supra note 30, at 61. This problem can potentially be solved by replicating the in vivo niche conditions in the in vitro culture. Id. 68. Myoblasts are muscle precursor cells. See MERRIAM-WEBSTER�S MEDICAL

DICTIONARY 582 (2006) (defining a myoblast as �an undifferentiated cell capable of giving rise to muscle cells�). 69. Bhat & Bhat, supra note 3, at 443. 70. Id. 71. Id. 72. Id. 73. Id. at 443�44. 74. Id. at 443. 75. See Datar & Betti, supra note 15, at 16 (�[a]n ideal scaffold would have a large surface area for growth and attachment, be flexible to allow for contraction, maximize medium diffusion and be easily dissociated from the meat culture. A scaffold that closely mimics the in vivo situation is best� and would be made of edible materials).



potentially be used, if easily separable from the muscle tissue.76 By either approach, thin sheets of muscle tissue grow on scaffolds, and then are layered to process the tissue into a ground-meat-like product.77

C. Self-Organizing In Vitro Meat Production

Another potential method of creating in vitro meat utilizes explanted animal muscle tissue.78 Benjaminson sought to test if co-cultures of cells derived from similar �adult muscle tissue can adhere, attach and grow onto a muscle tissue explant �substrate.��79 Benjaminson utilized mature skeletal muscle explants from a goldfish because explants contain muscle fibers as well as �all the cell types generally associated with muscle in vivo.�80

Benjaminson tested a variety of growth media, such as fetal bovine serum, fish meal extract, and various mushroom extracts, to see how each enhanced the growth of the explant muscle tissue and to seek alternatives to fetal bovine serum.81 The surgically removed muscle tissue began healing after two weeks, with the ragged edges of the explant �exhibiting smooth and entire edges.�82

Out of forty-eight cultures grown, �81% showed tissue adherence to the culture vessel after 2 weeks in culture, 63%

76. Id.; see also Edelman et al., supra note 38, at 660�61 (asserting that some nonedible scaffolds can be separated simply through changing the temperature). 77. Edelman et al., supra note 38, at 660�61; see Datar & Betti, supra note 15, at 14 (declaring that scaffold-based in vitro meat can currently grow to a thickness of only 100�200 �m, and that under these constraints, the proposed in vitro meat production system would be useful in creating meat for use in only processed products). To achieve three-dimensional meat produced by the scaffold method, scientists propose layering multiple sheets of in vitro meat together. Id. However, to create meat that would be suitable for unprocessed uses, the scaffold would need to re-create an animal�s vascular network. Edelman et al., supra note 38, at 661. The current approach to produce a functional scaffold, which could allow for vascularization in vitro, �does not lend itself to mass production,� limiting its utility. Id. 78. Benjaminson, Gilchriest & Lorenz, supra note 27, at 880. 79. Id. at 881�82. Benjaminson utilized muscle tissue extracted from goldfish in co-cultures with �non-homologous disassociated brown bullhead fibroblasts (CCL 59) cells� and a �crude cell mixture (CCM) of dissociated cells� taken from goldfish skeletal muscle tissue. Id. at 882. 80. Id. at 880�81. Benjaminson selected goldfish cells because the animal�s muscle cells are primarily skeletal muscle, and the adult fish muscle contains myosatellite cells. Id. at 881. Even using explants, various forces that stimulate muscle in vivo are missing and thus need to be simulated to grow realistic meat in vitro. Id. at 880. 81. Id. at 882. Benjaminson wanted to find a more cost-effective alternative to fetal bovine serum to use as a growth medium. Id. 82. Id. at 883�84. The explants exhibited an unexpected �healing phenomenon,� evidenced by a smoothing of the edges of the explants. Id. at 884�86. The researchers did not fully understand the cause of this healing process. Id. at 886.



demonstrated the self-healing phenomenon, and 74% of the cultures showed cell proliferation . . . .�83 The control samples grew 4% in one week, whereas some of the experimental samples grew an average of 79% over the same period.84 The experiment showed that Maitake mushroom extract could serve as an alternative to fetal bovine serum as a growth medium.85

After the experiment, Benjaminson harvested and inspected the explants.86 The food panel observations of the cultured meat stated that the samples �were glistening, firm and odorless, and resembled fresh fish filets available in food stores.�87 As far as using the explants as food, they were easily removed from their cultures, cleaned, and cooked.88 The food panel reacted positively to the samples before cooking, and any �post-cooking objections were grounded in a dislike for fish or the method of cooking.�89 Despite this success, more developments need to be made in this area of in vitro meat production before effective large-scale production can be achieved.90

D. Benefits of an In Vitro Meat Production System

Besides using less land and natural resources,91 an in vitro meat production system could allow for creation of a healthier meat product. In vitro meat production could reduce the prevalence of food borne disease by use of controlled conditions.92

83. Id. at 884. Cell density was greatest near the original explant and became thinner as the distance from the explant increased. Id. 84. Id. at 885. Benjaminson attributes the growth of the experimental co-cultures to two factors. First, the crude cell mixtures tend to �form a centrally located aggregate� within the culture. Id. at 887. Second, the crude cell mixtures adhered to the explant itself. Id. 85. See id. at 885 (reporting that the two growth media presented the best results). Other growth media did not fare as well. Id. (reporting that fish meal extract and shiitake mushroom extract yielded average increases of 7.6% and 5.2%, respectively). 86. Id. 87. Id. �The panel agreed that the MPPS produce was acceptable as food given the absence of actually tasting it.� Id. 88. Id. at 887. 89. Id. 90. See Bhat & Bhat, supra note 3, at 443 (describing how explant tissues need blood flow to thrive; cells will die if they are more than 0.5 mm away from their source of nutrients for prolonged periods of time). 91. See supra note 14 and accompanying text (describing how in vitro meat would lead to less land and water use, and lower greenhouse gas emissions). 92. Datar & Betti, supra note 15, at 18�19. Because of the control scientists have in an in vitro meat production system, they can prevent contamination of their meat from diseases such as avian flu, swine flu, and other animal borne diseases. Id. As such



Such controlled conditions would minimize unpredictable complications as well as eliminate the hazards in a preslaughter environment.93

In vitro meat could also allow for the manipulation of various aspects of the meat itself, including taste, texture, and nutritional value.94 While meat currently contains fat that contributes to cardiovascular disease, in vitro meat production would allow for manipulation of the in vitro meat�s fat content.95 As in vitro meat production constructs the meat from various cultures of cells, introducing co-cultures of different types of cells could alter the nutrition of in vitro meat.96 This could allow for meat to contain higher levels of beneficial fatty acids, such as omega-3s.97 While altering the nutritional value of in vitro meat could help make a healthier product, scientists want to ensure that in vitro meat contains the same complement of nutrients as natural meat before they start altering the nutritional composition.98

III. REGULATORY FRAMEWORK FOR GE CROPS AND ANIMALS

Three agencies of the U.S. government oversee the regulation of GE and cloned specimens.99 The U.S. Department of Agriculture (USDA) regulates GE plants, the Environmental Protection Agency (EPA) oversees the regulation of pesticide-producing microbes and use of herbicides in areas planted with GE crops, and the Food and

diseases can spread more easily as globalization and international trade expand, this makes in vitro meat particularly beneficial. See id. (describing how animal-borne diseases can spread more easily as international trade expands). Furthermore, a recent study has cast some doubt about the health benefits of organic foods. Kenneth Chang, Stanford Scientists Cast Doubt on Advantages of Organic Meat and Produce, N.Y. TIMES, Sept. 4, 2012, at A20. 93. Datar & Betti, supra note 15, at 19. 94. Id. Arguably, this might allow for in vitro meat to compete with organic meat if it can be shown that in vitro meat provides additional health benefits that organic meat does not. See id. at 19 (stating that �[i]t is necessary that an in vitro grown meat product meets if not exceeds the nutritional value of traditional meat products to be competitive on the market�). 95. Id. 96. See id. (asserting that including or removing different types of cell co-cultures can result in the inclusion of nutritional fatty acids as opposed to those that lead to heart disease). 97. Id. 98. See id. (predicting that �one major obstacle likely to postpone the development of an IMPS is ensuring that the product has the full complement of nutrients available in meat harvested in vivo�). 99. Carl K. Winter & Lisa K. Gallegos, Safety of Genetically Engineered Food, in AGRIC. BIOTECHNOLOGY IN CAL. SERIES 1 (Regents of the Univ. of Cal., Div. of Agric. and Natural Res., Pub. 8180, 2006).



Drug Administration (FDA) regulates any product that will be consumed as food.100 Thus, something like GE corn, which has a built-in pesticide to make it more resilient, would fall under the purview of all three agencies.101

Through these agencies, the federal government regulates GE food through the use of a number of statutes and concepts. Among them are the doctrine of substantial equivalence, the Food, Drug, and Cosmetics Act (FDCA), and the Wholesome Meat Act (Meat Inspection Act). The current focus of government regulation is products of GE foods, not the processes used to create such products.102

In evaluating GE foods, the government conducts a risk assessment of the new plant or animal in determining whether or not to grant approval.103 In this process, the government looks to see what �environmental and agronomic benefits� the new plant or animal would provide.104

A. Doctrine of Substantial Equivalence

As the government regulates the products of biotechnology, it decides whether the products are substantially equivalent to their natural counterparts.105 The concept of substantial equivalence originated in regards to the

100. Id. at 1�2. 101. Id. at 1. 102. Bratspies, supra note 24, at 405�06; see Douglas A. Kysar, Preferences for Processes: The Process/Product Distinction and the Regulation of Consumer Choice, 118 HARV. L. REV. 525, 536�37 (2004) (contending that GE food manufacturers generally do not have to disclose their processes and increasingly find themselves protected legally from new government and consumer efforts to force disclosure of such information). 103. Sharlene R. Matten, Graham P. Head & Hector D. Quernada, How Governmental Regulation Can Help or Hinder the Integration of Bt Crops Within IPM Programs, in INTEGRATION OF INSECT-RESISTANT GENETICALLY MODIFIED CROPS WITHIN LPM 27, 28 (Jorg Romeis et al. eds., 2008); see also Genetically Engineered Animals: FDA�s Response to Public Comments, FDA, http://www.fda.gov/AnimalVeterinary/ DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113612.htm (last visited Jan. 26, 2012). 104. Matten, Head & Quernada, supra note 103, at 28. In the United States, the �risk assessments focus on non-target organisms� to determine whether or not the GE crops and animals will inflict �significant adverse impacts on these non-target groups.� Id. at 31. 105. Bratspies, supra note 24, at 406; James H. Maryanski, Eric L. Flamm & Linda S. Kahl, FDA�s Policy on Foods Derived From New Plant Varieties, 2 PROBE NEWSL., no. 3, Jan.�June 1993, at 1; Winter & Gallegos, supra note 99, at 1. �GE foods are considered to be �substantially equivalent� to conventional foods when levels of nutrients, allergens, or naturally occurring toxins are not substantially different and there are no new allergens or toxins detected.� Id.



FDA�s regulation of new medical devices.106 In 1992, the FDA applied the concept of substantial equivalence to GE foods, in part �because both traditional and biotech foods have been altered from their original state by genetic manipulation.�107

In 1993, the Organisation for Economic Co-operation and Development (OECD) adopted the same terminology in its recommendation for how GE crops should be regulated by its member countries.108 In adopting the policy of substantial equivalence, the OECD believed �that the most practical approach to determining the safety of foods derived by modern biotechnology is to consider whether they represent a substantial equivalent to analogous traditional products.�109

1. Labeling for Substantially Equivalent GE Foods. No special federal labeling requirements exist for GE food products if they meet the standard of substantial equivalence.110 The FDA considers �substantially equivalent� GE plants as �generally recognized as safe (GRAS).�111 If the FDA considers a GE food as GRAS, the FDA exempts such a product from �premarket review.�112

GE food that differs in its nutritional composition or that contains different levels of naturally occurring toxins or allergens than the natural counterpart does not meet the doctrine of substantial equivalence.113 Such crops must be labeled to indicate how they differ from their natural counterparts.114 Some states, including Vermont and Maine, have imposed their own labeling statutes and regulations for GE crops and animals.115

106. See Marianna Schauzu, The Concept of Substantial Equivalence in Safety Assessment of Foods Derived from Genetically Modified Organisms, in 2 AGBIOTECHNET, Apr. 2000, at 1, available at http://www.bfr.bund.de/cm/349/schauzu.pdf; see also 21 U.S.C § 360c(i) (2006) (defining substantial equivalence in the context of medical devices). 107. Katharine Van Tassel, The Introduction of Biotech Foods to the Tort System: Creating a New Duty to Identify, 72 U. CIN. L. REV. 1645, 1652 (2004); see also Kysar, supra note 102, at 560. 108. Schauzu, supra note 106, at 1. 109. Id. 110. USDA ADVISORY COMM. ON BIOTECHNOLOGY & 21ST CENTURY AGRIC., U.S. DEP�T OF AGRIC., GLOBAL TRACEABILITY AND LABELING REQUIREMENTS FOR

AGRICULTURAL BIOTECHNOLOGY-DERIVED PRODUCTS: IMPACTS AND IMPLICATIONS FOR THE

UNITED STATES 7 (2005) [hereinafter GLOBAL TRACEABILITY AND LABELING

REQUIREMENTS], available at http://www.usda.gov/documents/tlpaperv37final.pdf; Winter & Gallegos, supra note 99, at 2. 111. Kysar, supra note 102, at 559. 112. Id. 113. Winter & Gallegos, supra note 99, at 2. 114. Id. 115. See ME. REV. STAT. tit. 7, § 530-A (Supp. 2011) (mandating the labeling of �any food, food product or food ingredient offered for sale in [Maine]� to indicate the use of genetic engineering, otherwise the statute considers such food misbranded in violation of



2. Treatment of Clones. Because both in vitro meat and cloning rely on replicating an animal�s cells,116 this Comment asserts that the FDA�s treatment of cloned animals can provide insight into how it should address in vitro meat. In 2008, the FDA announced that humans could safely consume cloned animals and products derived from them.117 In reaching this decision, the FDA considered factors, such as the use of clones predominantly for breeding and the nature of clones compared to GE animals.118 The FDA observed no abnormalities in the cloned animals compared to similar animals bred through other alternative reproductive techniques.119 The FDA also concluded that people could safely eat the offspring of cloned animals, and did not recommend additional regulations for such animals simply because they descended from clones.120

B. Food, Drug, and Cosmetics Act (FDCA)

The Food, Drug, and Cosmetics Act (FDCA), passed in 1938, gives the government the power to regulate food production in the United States.121 Under the FDCA, the government seeks to identify �adulterated� foods to prevent them from entering the

Maine law); 2-3 VT. CODE R. § 200 (2011) (requiring labeling to identify GE seeds as well as provide contact information and identification of the manufacturer or distributor of the GE seeds). 116. Supra notes 44, 80 and accompanying text; infra note 118. 117. Press Release, U.S. Food & Drug Admin., FDA Issues Documents on the Safety of Food from Animal Clones (Jan. 15, 2008), available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116836.htm. This decision applied to only cattle, swine, and goats. Id. The FDA lacked sufficient information to make a determination for clones of other types of livestock, such as sheep. Id. 118. Id. Clones are simply �a genetic copy of a donor animal, similar to an identical twin, but born at a different time.� Id. GE animals, on the other hand, have had their DNA manipulated in such a way as to suppress inherent negative traits or to introduce new positive traits. See Goss, supra note 7, at 1400�01 (describing how biotechnology can be used to introduce new genes or suppress existing genes to manipulate the traits of a plant). 119. CTR. FOR VETERINARY MED., U.S. DEP�T OF HEALTH & HUMAN SERVS., GUIDANCE

FOR INDUSTRY: USE OF ANIMAL CLONES AND CLONE PROGENY FOR HUMAN FOOD AND

ANIMAL FEED 2 (2008), available at http://www.fda.gov/downloads/AnimalVeterinary/ GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052469.pdf. 120. Id. at 3. 121. Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 301 (2006)); see Bratspies, supra note 24, at 407 (�The FDCA authorizes [the] FDA to protect the food supply from becoming �adulterated� . . . .�).



country�s food supply.122 In addition to adulterated foods, the FDCA allows the FDA to regulate food additives.123 The FDCA deems any food additive as unsafe in regards to 21 U.S.C. § 342, the adulterated foods section, unless an exemption is granted pursuant to the exception or the additive meets the standards of an existing regulation.124 Under the FDCA, the FDA can condemn foods deemed adulterated to prevent them from entering the food supply.125

1. FDCA and Generally Recognized as Safe Food. In connection with the FDCA, FDA regulations lay a framework for determining what foods and food additives the FDA considers as GRAS.126 Under these regulations, recognizing food or a food additive as GRAS must come from �experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.�127

When assessing a food or food additive for GRAS classification, the FDA requires the same quality and quantity of scientific analysis necessary for approval of a food additive under FDA regulations.128 For substances used in food before January 1, 1958, the FDA allows �experience based on common use in food� to determine the safety of the substance.129 The FDA determines the safety of a food or substance based on common knowledge in the scientific community.130

2. FDCA Applied to GE Crops. Some scholars feel that the two sections of the FDCA granting the FDA the power to regulate

122. See 21 U.S.C. § 341 (2006) (granting the Secretary of the FDA power to create regulations for food to �a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container�); 21 U.S.C. § 342(a)�(b) (2006) (including within adulterated food poisonous or unsanitary food which might make �it injurious to health� or food in which a �valuable constituent has been in whole or in part omitted or abstracted therefrom,� or �if any substance has been substituted wholly or in part therefor�); see also 21 U.S.C. § 334 (2006) (providing authority and procedures for condemnation and detention of adulterated food products). 123. 21 U.S.C. § 348 (2006). 124. 21 U.S.C. § 342(a)(2)(C) (2006); 21 U.S.C. § 348(a) (2006). 125. See 21 U.S.C. § 334 (2006) (describing the process for seizure and condemnation of adulterated foods); see also United States v. 484 Bags, More or Less, 423 F.2d 839, 840 (5th Cir. 1970) (proclaiming that courts have long held that 21 U.S.C § 342 allows the FDA to �condemn[ ] [adulterated food] as decomposed, filthy, or putrid even though it is not unfit for food�). 126. 21 C.F.R. § 170.30 (2012). 127. 21 C.F.R. § 170.30(a)�(b). 128. 21 C.F.R. § 170.30(b). 129. 21 C.F.R. § 170.30(a). 130. See id. (�General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.�).



adulterated foods and food additives, by extension, provide the FDA the power to regulate GE foods, whether they are substantially equivalent or not.131 Critics feel the FDA should utilize these powers more broadly with regards to GE crops because the manufacturers decide whether their products meet the standards of GRAS, and thus also whether the doctrine of substantial equivalence would apply.132 Despite public opposition to the FDA�s approach to GE foods, the FDA has remained steadfast in its approach to regulating GE foods, as described above in this Comment.133

C. New Animal Drug Application (NADA) Requirements

The New Animal Drug Application (NADA) requirements within the FDCA allow the FDA to regulate drugs given to animals, or added to their food.134 New Animal Drugs (NADs) consist of �any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed.�135 While the FDA does not think of GE animals as NADs, the agency does subject them to regulation under NADA requirements.136 The FDA views the genetic manipulations as falling within the definition of a drug under 21 U.S.C. § 321(g)(1)(C).137 Because scientists apply such manipulations to animals, the FDA considers such changes as the equivalent of a drug given to an animal.138 Thus, the FDCA

131. See, e.g., Kysar, supra note 102, at 559. 132. Id. 133. See id. at 561 (declaring that the majority of the comments the FDA received in regards to mandatory labeling of GE products supported such a regulation). 134. See 21 U.S.C. § 360b (2006) (deeming new animal drugs unsafe unless approved by the FDA); 21 C.F.R. § 510.3 (defining a new animal drug as �any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed�). 135. 21 C.F.R. § 510.3. 136. Genetic Engineering: General Q&A, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm (last visited Jan 15, 2012) [Hereinafter USDA Q&A]. 137. See 21 U.S.C. § 321(g)(1) (2006); CTR. FOR VETERINARY MED., U.S. DEP�T OF

HEALTH & HUMAN SERVS., GUIDANCE FOR INDUSTRY: REGULATION OF GENETICALLY

ENGINEERED ANIMALS CONTAINING HERITABLE RECOMBINANT DNA CONSTRUCTS 6�7 (2009) [hereinafter REGULATION OF GE ANIMALS], available at http://www.fda.gov/ downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm113903.pdf (stating that the rDNA added to GE animals falls within the definition of a drug under the FDCA). 138. USDA Q&A, supra note 136.



requires approval of GE animals, supplanting the doctrine of substantial equivalence.139

The FDCA also contains a section pertaining to adulterated drugs.140 Such adulterated drugs include those that �consist[ ] in whole or in part of any filthy, putrid, or decomposed substance.�141 Additionally, the FDA considers drugs not made in compliance with �current good manufacturing practice[s]� as adulterated and subject to condemnation.142

D. Wholesome Meat Act (Federal Meat Inspection Act)

The Wholesome Meat Act (WMA), which originated in 1907 as the Federal Meat Inspection Act, seeks to ensure a safe supply of meat for the United States.143 The WMA requires preslaughter inspections of animals and humane methods of slaughter.144 Additionally, the WMA grants the U.S. Department of Agriculture (USDA) the power to create regulations to ensure sanitary conditions at slaughterhouses and meatpacking plants.145

Pursuant to its powers under the WMA, the USDA promulgated regulations to ensure the safety of meat in the United States.146 The USDA regulations require sterile and sanitary conditions for any surface or tool that comes into contact with food, the use of safe cleaning products to ensure the upkeep

139. See Rebecca M. Bratspies, Glowing in the Dark: How America�s First Transgenic Animal Escaped Regulation, 6 MINN. J.L. SCI. & TECH. 457, 488�89 (2005) (stating that by announcing it will regulate GE animals, the FDA asserted that GE animals are �inherently different� from natural animals, and thus outside the purview of the doctrine of substantial equivalence). The FDA does not intend to apply NADA requirements to animals regulated by other agencies or those not intended for use as food, such as GE animals used in laboratory research. REGULATION OF GE ANIMALS, supra note 137, at 7. 140. 21 U.S.C. § 351(a)(5)�(6) (2006). 141. 21 U.S.C. § 351(a)(1) (2006). 142. Id.; 21 U.S.C. § 334(a)(1) (2006) (permitting seizure of adulterated foods); see 21 C.F.R. § 225.1 (2008) (stating that the standard of good manufacturing practices applies to the production of medicated animal feeds to ensure their safe production). 143. 21 U.S.C. § 602 (2006); Federal Meat Inspection Act, Pub. L. No. 4-242, 34 Stat. 1260 (1907) (codified as amended in 21 U.S.C. §§ 601�624 (2006)); see Dennis R. Johnson & Jolyda O. Swaim, The Food Safety and Inspection Service�s Lack of Statutory Authority to Suspend Inspection for Failure to Comply with HACCP Regulations, 1 J. FOOD L. &

POL�Y 337, 340�43 (2005) (detailing the evolution of the Act from its origin in 1907 as the Federal Meat Inspection Act, to its current title as the Wholesome Meat Act of 1967). Congress viewed a safe meat supply as essential to the health of the country, as well as to interstate trade. 21 U.S.C § 602 (2006). 144. 21 U.S.C. § 603 (2006). 145. 21 U.S.C. § 608 (2006). 146. See generally 9 C.F.R. § 416.4 (2012) (requiring sterilization of all surfaces and utensils that meat comes into contact with to ensure the products do not become adulterated).



of sanitary conditions, and a set standard of cleanliness for those working with food products.147 Through these regulations, the USDA seeks to ensure meat products do not become adulterated because of unsanitary processing and handling.148 The USDA considers any adulterated products, including adulterated meat, unfit for human use and prevents such products from entering the market.149

E. Legal Issues for GE Food

While the government adopted the doctrine of substantial equivalence for GE foods, some feel that such a regulatory approach fails to recognize the scientific realities presented by GE food.150 Opponents of substantial equivalence feel a more appropriate approach would examine the safety and toxicology of GE food, much like the approach used for evaluating the safety of drugs and pesticides.151

The possibility of contamination poses another legal issue presented by GE crops and animals.152 As companies patent their GE crops, such contamination could lead to inadvertent patent infringement by ordinary farmers simply because their fields adjoined a field planted with GE crops.153 Critics also worry those

147. See id. (requiring sanitary tools and surfaces as well as approved cleaning products); 9 C.F.R. § 416.5 (2012) (addressing the cleanliness of those working with food products). 148. See 9 C.F.R. § 416.4(d) (�Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.�). 149. See 21 U.S.C. § 608 (2006) (�[W]here the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, [the Secretary of Agriculture] shall refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as �inspected and passed.��). 150. See Schauzu, supra note 106, at 1, 4 (contending some opponents to the doctrine of substantial equivalence characterize the method as �pseudo- or even anti-scientific� and inadequate to evaluate the safety of GE food). Opponents feel that scientists do not know enough about plant genetics and that �the relationship between genetics, chemical composition and toxicological risks are unknown,� making the doctrine of substantial equivalence unsuitable for evaluating new GE foods. Id. at 4. 151. Id. at 4. Opponents of substantial equivalence would also like to evaluate GE foods based on �acceptable daily intakes� of substances found within the food. Id. 152. By contamination in this situation, this Comment means not that a toxic substance has entered the GE crop or animal, but that the GE crop or animal reproduces and spreads, �contaminating� the natural stock. See, e.g., Monsanto Co. v. Geertson Seed Farms, 130 S. Ct. 2743, 2750�54 (2010) (describing a case where a GE crop, �Roundup Ready Alfalfa,� was deregulated, allowing it to be planted on 3,000 farms, potentially allowing the GE crop to spread to �organic and conventional alfalfa� fields). 153. See id.; Goss, supra note 7, at 1427�28 (arguing that patents on crop seeds



GE foods, such as �Roundup Ready� seeds and AquAdvantage salmon, could eliminate the natural stock of plants and animals.154 Such an occurrence would make the uniform GE stock vulnerable to �a single environmental factor [that] could wreak widespread crop damage.�155

In its environmental assessment of AquAdvantage salmon, the FDA decided they did not pose a significant risk to the environment, despite concerns that the AquAdvantage salmon would contaminate the natural stocks.156 The FDA reached this conclusion because of the preventative measures proposed to contain the AquAdvantage salmon. These measures included physically enclosing the AquAdvantage salmon and eggs, sterilizing the salmon, engineering the salmon so that only female offspring occur, and growing the salmon in locations whose geography serves to stifle the spread of the salmon.157

IV. SUGGESTED REGULATORY FRAMEWORK FOR IN VITRO MEAT PRODUCTION

Besides the technological hurdles still to overcome,158 opponents of in vitro meat present a number of challenges to adopting in vitro meat production.159 Some of these objections, such as the danger of an in vitro meat production system, can likely be assuaged by proper regulation.160 However, objections based on moral grounds are likely overcome through educating

would grant patent holders the right to �exclude others from making, using, or selling that variety without the patentee�s consent�). 154. See Monsanto, 130 S. Ct. at 2754 (emphasizing that the lower court found the plaintiffs had standing to sue based on �a �reasonable probability� that their organic and conventional alfalfa crops will be infected with the engineered gene�); see Mary Clare Jalonick, Super Salmon or �Frankenfish�? FDA to Decide, NBCNEWS.COM (Sept. 20, 2010), http://www.msnbc.msn.com/id/39265727/ns/health-food_safety/t/super-salmon-or-frankenfish-fda-decide/#.TxHTJG8V3_M (indicating that opponents of AquAdvantage salmon feared that it could spread and lead to the �decimation of the wild salmon population�). 155. Goss, supra note 7, at 1422. 156. CTR. FOR VETERINARY MED., U.S. DEP�T OF HEALTH & HUMAN SERVS., ENVIRONMENTAL ASSESSMENT FOR AQUADVANTAGE® SALMON, 73�74 (2010), http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224760.pdf. 157. Id. at 59, 62, 68. 158. See Datar & Betti, supra note 15, at 19 (explaining that there are currently no projects to develop a large scale in vitro meat production system). 159. See Hopkins & Dacey, supra note 12, at 585�95 (describing some of the various objections to in vitro meat, including the dangers associated with production and the �yuck factor� of lab-grown meat). 160. Id. at 585�86 (discussing concerns of dangers stemming from the novelty of in vitro meat). But see, e.g., 9 C.F.R. § 416.4 (2012) (describing the sanitary requirements for meat slaughter and processing).



people on the benefits of in vitro meat and correcting misconceptions that they have about in vitro meat�s characteristics.161 Whatever regulatory approach eventually applies to in vitro meat, the federal government should create a uniform national standard.162

A. Applicability of Existing Law

As both cloning and genetic engineering technologies bear similarities to certain in vitro meat production techniques, their regulation can illustrate the issues and possible solutions presented by in vitro meat production.163 Much like genetically altered foods, the FDA will likely bear responsibility for regulating in vitro meat because it is not a plant and is unlikely to involve the use of pesticides because it will be grown in a sterile lab environment.164

Based on definitions contained within the WMA and FDCA, the latter of which apply in the context of NADAs, it seems likely that such laws could be applied to the regulation of in vitro meat production.165 Because in vitro meat production seeks to create a meat product for human consumption, it appears that the FDCA and WMA would apply to oversee such production.166 As in vitro

161. See Hopkins & Dacey, supra note 12, at 589 (describing how moral objections to in vitro meat could be overcome by demonstrating how it would lead to less animal suffering); see also Jane Switzer, Would You Eat Test-Tube Meat?, NAT�L POST, July 16, 2011, at A10, available at http://news.nationalpost.com/2011/07/16/would-you-eat-test-tube-meat/ (discussing how common consumer misconceptions, such as in vitro foods being more unnatural than staple foods, can be remedied by proper marketing). 162. Courts have already ruled that the WMA overrides state regulations of meat based on the Supremacy Clause of the Constitution. See Armour & Co. v. Ball, 468 F.2d 76, 83�85 (6th Cir. 1972) (declaring that the Supremacy Clause of the Constitution meant that Michigan could not impose more stringent labeling, packaging, and other regulations than those imposed by the WMA). 163. See supra note 118 and accompanying text (explaining how GE products have had their DNA altered and how clones are genetic copies of the original organism); supra Parts II.B�C (discussing how in vitro meat can be grown using an organism�s stem cells, which replicate and differentiate into new skeletal muscle cells, and how scientists can alter the meat to adjust its nutritional properties). 164. See Winter & Gallegos, supra note 99, at 1�2 (comparing the regulatory scope of government agencies with respect to GE foods). 165. See 21 U.S.C. § 601(j) (2006) (defining �meat food product� under the WMA as �any product capable of use as human food which is made wholly or in part from any meat�); 21 U.S.C. § 321(f) (2006) (defining �food� under the FDCA as �(1) articles used for food or drink for man or other animals . . . and (3) articles used for components of any such article�); 21 U.S.C. § 321(g)(1)(C) (2006). 166. See Ben MacIntyre, Test-Tube Meat Science�s Next Leap, THE AUSTRALIAN, Jan. 20, 2007, at 21 (explaining that scientists are �racing to produce laboratory-grown or in



meat consists of skeletal muscle cells, WMA definitions of meat indicate that they would apply to in vitro meat.167 Similarly, because some scientists believe in vitro meat production will eventually lead to manipulating meat products to alter the nutritional composition,168 the NADA requirements will likely apply to in vitro meat production, much like it applies to GE animals with altered DNA.169

Additionally, because no natural version of in vitro meat exists, i.e., meat that grows divorced from a living creature, the doctrine of substantial equivalence should not apply to in vitro meat. It could be argued that in vitro meat with no additives meets the doctrine of substantial equivalence. However, this Comment takes the position that in vitro meat production will need to replicate vascularization and fat content, among other requirements, to re-create the taste and texture of natural meat. Recreating these natural characteristics of meat will require crafting artificial equivalents. This Comment argues that such artificiality takes in vitro meat outside the realm of substantial equivalence to natural meat. Because the doctrine of substantial equivalence should not apply to in vitro meat, the FDA needs to regulate in vitro meat products using its powers to ensure a safe product.

B. Regulating the Product of In Vitro Meat

In regulating the end product of an in vitro meat production system, the FDA should seek to alleviate fears related to the safety and authenticity, or naturalness, of the meat.170 Depending on the approach taken to grow the in vitro meat, the FDA should employ different regulatory solutions. While an in vitro meat production system based on explants uses existing animal muscle tissue, a system that grows muscles cells around a scaffold

vitro meat using cell-culture technology� for use as food); supra Part III.B�D (noting that the FDCA addresses safety of food and food additives while the WMA aims to maintain a safe and sanitary meat supply). 167. See 9 C.F.R. § 301.2 (2012) (defining �meat� as �[t]he part of the muscle of any cattle, sheep, swine, or goats which is skeletal�); Bhat & Bhat, supra note 3, at 443 (describing how scaffold-based in vitro meat seeks to grow skeletal muscle cells around artificial scaffolds). 168. See supra Part II.D (explaining how manipulating the composition of in vitro meat could eliminate harmful fats found in natural meat). 169. See REGULATION OF GE ANIMALS, supra note 137, at 6 (noting that manipulated animal DNA is subject to NADA requirements). 170. See Hopkins & Dacey, supra note 12, at 585�86 (contending that some worry about the safety of eating untested bioengineered foods and others worry that in vitro meat will not be �real� meat).



attempts to re-create animal muscles from scratch.171 In approaching explant systems, the FDA should view the

process much like foods that include NADs.172 Using explants involves taking existing muscles and applying growth solutions to stimulate muscle growth in a lab.173 To ensure a safe product, the FDA should treat the growth solutions, and any substance used to re-create blood flow in the explant, as a NAD. This approach would work because NADs include any �articles (other than food) intended to affect the structure or any function of the body of man or other animals.�174

While the growth formula provides nutrients to the explant, replicating the effect of food, the growth formula also affects the structure of the explant by increasing the production of muscle cells.175 This seems to fall within the definition of a NAD as something other than food that affects the structure of an animal. One possible problem with this approach is that the animal muscle explant may not qualify as an �animal� under NADA requirements. If the FDA feels that explants do not fit the framework of the FDCA�s NADA requirements, the proposed solution below for scaffold-based in vitro meat production system could work for both systems.

Unlike an explant system, a scaffold-based in vitro meat production system grows the muscle cells from scratch.176 This system does not involve applying a growth formula to existing animal muscle; therefore the NADA requirements should not apply, because an in vitro meat scaffold system does not involve an initial, fully formed portion of animal muscle.177 The entire scaffold-based construction could legally be considered a composition of various food additives.178 The scaffolds and growth

171. See supra Part II.B�C (describing the methods for growing in vitro meat scaffold and explant approaches). 172. See 21 U.S.C. § 360b (2006) (deeming new animal drugs unsafe unless approved by the FDA). 173. See, e.g., Benjaminson, Gilchriest & Lorenz, supra note 27, at 882�85 (detailing the process as applied to the abdominal muscle of goldfish). 174. 21 U.S.C. § 321(g)(1) (2006); 21 C.F.R. § 510.3 (2007). 175. See Benjaminson, Gilchriest & Lorenz, supra note 27, at 882�83 (describing the goldfish explant experiment). 176. Langlaan et al., supra note 30, at 60�61. 177. Compare id. (describing the process of tissue engineering, which involves embedding a cell source (e.g. stem cells) in a matrix that allows for muscle growth), with 21 U.S.C. § 321(g)(1) (2006) (describing a drug as a substance other than food that affects the structure of an animal). 178. See 21 U.S.C. § 321(s) (2006) (��[F]ood additive� means any substance the



factors used are �food additives� because their intended use is to �becom[e] a component or otherwise affect[ ] the characteristics of . . . food.�179 Thus, the existing FDA regulations used to determine the safety of food additives should be used to evaluate the components of an in vitro meat production system.180 Provided the FDA finds the growth factors and nutrients safe for human consumption, it should also test the final product to ensure that it meets food safety standards. Such a process would allow the FDA to ensure the safety of not only all of the components, but also the final in vitro meat products, using existing law and regulations.181

When technology advances to the stage at which scientists can manipulate the nutrition and other characteristics of in vitro meat,182 the FDA should continue to regulate such changes under the FDCA.183 Any adjustments to the taste, nutrition, or texture should be viewed as becoming a component of the in vitro meat and affecting the characteristics of the food. The production of in vitro meat may initially appear similar to the manipulation of GE animals, and thus fall under the purview of NADA requirements.184 However, the GE animal does not constitute the final product for human consumption, whereas in vitro meat can go straight from the production facility to a kitchen.185 The fact that producers intend for in vitro meat to go to consumers directly as food suggests that the food additive provisions of the FDCA should apply to regulation of in vitro meat.

intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . .�). 179. See id.; Edelman et al., supra note 38, at 660�61 (explaining how growth factors and scaffolds become part of the in vitro meat final product). 180. See 21 C.F.R. § 170.20 (2012) (stating that in determining the safety of food additives, the FDA Commissioner should consider the �biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use� and that the Commissioner �will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council�) 181. See 21 U.S.C. § 342(a) (2006) (defining as adulterated, and therefore unsafe for consumption, any food that contains an additive not approved under the proper regulations). 182. See Datar & Betti, supra note 15, at 19 (stating that in vitro meat research has not reached the point where scientists can manipulate the taste, texture, or nutrition of in vitro meat). 183. See 21 U.S.C. § 321(s) (2006) (defining food additives under the FDCA); 21 C.F.R. § 170.6 (2012) (requiring the FDA to reevaluate the safety of food additives and their continued use �in light of current scientific information�). 184. REGULATION OF GE ANIMALS, supra note 137, at 6. 185. See Benjaminson, Gilchriest & Lorenz, supra note 27, at 887 (describing how scientists harvested in vitro explants and cooked them).



C. Regulating the Process of Creating In Vitro Meat

While the FDA does not regulate the process of creating GE crops,186 it should oversee the process of producing in vitro meat to ensure a safe and sanitary product. As no natural equivalent of in vitro meat exists, the USDA and FDA should utilize components of the WMA as well as regulations issued under the FDCA that pertain to the manufacturing of drugs.187

1. Wholesome Meat Act and In Vitro Meat. Under the WMA, the USDA has issued a number of regulations aimed at ensuring the safety of meat production and processing.188 Much as the WMA requires sanitary environments in slaughterhouses and meatpacking plants,189 a similar requirement should be imposed on in vitro meat production facilities. Proper regulation of the tools and equipment used for in vitro meat production should be implemented to help prevent the product from becoming adulterated, and thus unsafe for consumption.190 The USDA should also require that in vitro meat production facilities develop and implement a standard operating procedure (SOP) for sanitation to facilitate employee maintenance of sanitary environments.191 Such a SOP would help ensure employees �prevent direct contamination or adulteration of product(s).�192

2. Treating In Vitro Meat Production like the Manufacture of Drugs? While the USDA can use regulations promulgated under the WMA to regulate the production of in vitro meat, more appropriate requirements might come from FDA regulation of drug manufacturers. Such regulations seek to ensure that each drug �meets the requirements of the act as to safety . . . and

186. 7 C.F.R. § 340.0 (2012); see also Kysar, supra note 102, at 537. 187. See 21 U.S.C. § 360b (a)(1)(A) (2006) (requiring approval of applications for use of a new animal drug); 21 U.S.C. § 348 (2006) (regulating the use of food additives). 188. See, e.g., 9 C.F.R. § 416.4 (describing the sanitary requirements for facilities and equipment used in meat processing and packaging). 189. Id. 190. See, e.g., 9 C.F.R. § 416.3(a) (�Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adulteration of product during processing, handling, or storage. Equipment and utensils must be maintained in sanitary condition so as not to adulterate product.�). 191. See 9 C.F.R. § 416.11 (requiring facilities subject to WMA to develop and implement a SOP to ensure a sanitary environment). 192. 9 C.F.R. § 416.12.



meets the quality and purity characteristics that it purports.�193 FDA regulations of drug manufacturers seek to guarantee compliance with �minimum current good manufacturing practice[s].�194 As these regulations apply �to drugs that are also human cells, tissues, and cellular and tissue-based products,�195 applying the same regulations to products made from animal cells and tissues does not seem like a stretch.

The regulations for drug manufacturing seek to ensure safe and sanitary facilities196 and equipment.197 The regulations also require that a �quality control unit� participate in the manufacturing.198 The quality control unit monitors and makes certain that the facilities and the final product both meet applicable quality and purity standards.199 The quality control unit can reject any product if it does not meet the relevant safety and quality standards.200 In addition to the quality control unit, the FDA requires that anyone engaged in manufacturing drugs possesses the appropriate training and education so that they can follow the current good manufacturing practices.201

Applying these requirements in combination with the WMA regulations would help guarantee safe and reliable in vitro meat products. Both the WMA and the FDCA regulations mandate sanitary equipment and facilities.202 Necessitating in vitro meat producers to implement both the sanitary SOP from the WMA and the quality control unit and personnel training requirements from the drug manufacturing regulations would make certain that in vitro meat production meets all safety standards. Having additional safety procedures would also help reduce the risk of contamination or adulteration of in vitro meat.

D. Labeling of In Vitro Meat Products

Concern from consumers over knowing exactly what they are eating will pose a major challenge to federal regulators.203

193. 21 C.F.R. § 210.1. 194. Id. 195. 21 C.F.R. § 211.1. 196. 21 C.F.R. §§ 211.42, 44, 46, 48, 50, 52, 56, 58. 197. 21 C.F.R. §§ 211.63, 65, 67, 68, 72. 198. 21 C.F.R. § 211.22. 199. See id. (�The quality control unit shall be responsible for approving or rejecting drug products manufactured . . . .�). 200. Id. 201. 21 C.F.R. § 211.25. 202. 21 C.F.R. §§ 210.1, 211.63�72; 9 C.F.R. § 416.4. 203. See Dacey & Hopkins, supra note 12, at 587�88 (describing the �yuck factor�



Currently no federal labeling requirement exists for GE foods.204 The FDA should develop some type of labeling system to identify in vitro meat products and which, if any, nutritional or other manipulations occurred in the production process.

The FDA should avoid a label similar to those recently approved for use on cigarette and other tobacco products. The FDA intends such labels to dissuade people from smoking cigarettes, especially by inclusion of new graphic and disturbing images of the effects of smoking.205 This Comment argues that labels should inform customers in choosing their meat products, not scare them away from in vitro meat.

1. Vermont�s GE Seed Labels as a Guide. A label, such as that used by Vermont for GE seeds, presents a good starting

as it might apply to people eating in vitro meat). Supporters of labeling genetically modified foods in California are working on a ballot initiative for the November 2012 elections. Amy Harmon & Andrew Pollack, Battle Brewing over Labeling of Genetically Modified Food, N.Y. TIMES, May 25, 2012, at A1. Further, supporters of labeling believe that the differences between genetic engineering and selective breeding necessitate informing customers that certain products contain materials they might not want to consume. Id. Opponents believe that such laws really seek to drive genetically modified foods out of the market because organic foods cannot compete with them otherwise. Id. Currently, about nine in ten Americans would want some type of labeling for genetically modified foods. Id. 204. GLOBAL TRACEABILITY AND LABELING REQUIREMENTS, supra note 110, at 7. 205. See 15 U.S.C. § 1333 (Supp. IV 2011) (requiring multiple warnings from the surgeon general about the health risks from smoking); Catherine Pearson, New Cigarette Warnings Released, HUFFINGTON POST (Aug. 20, 2011, 6:12 AM), http://www. huffingtonpost.com/2011/06/20/cigarette-warnings-labels-photos-fda_n_880885.html (stating that the FDA intends the new labels �to have a significant public health impact by decreasing the number of smokers�). On February 29th, 2012, a federal district court judge blocked the implementation of the new graphic warning labels on cigarette packages, citing free speech concerns. R.J. Reynolds Tobacco Co. v. FDA, 845 F. Supp. 2d 266, 275�77 (D.D.C. 2012); Bill Mears, Federal Judge Blocks Anti-Smoking Images Required on Tobacco Products, CNN.COM (Feb. 29, 2012), http://articles.cnn.com/2012-02-29/us/us_tobacco-warnings_1_tracheotomy-hole-tobacco-control-act-smoking-epidemic?_s=PM:US. Since then, two federal circuit courts have issued conflicting holdings on the constitutionality of the new cigarette labeling requirements. Compare Disc. Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 569 (6th Cir. 2012) (holding that because the graphic images provide �factual information regarding the health risks of using tobacco� and also lessens �consumer confusion,� the new labeling requirements are constitutional), with R.J. Reynolds Tobacco Co. v. FDA, Nos. 11-5332, 12-5063, 2012 WL 3532003, at *12 (D.C. Cir. Aug. 24, 2012) (holding that the FDA failed to present the �substantial evidence� required to show that the labeling requirements would directly advance its goal of reducing smoking, thus violating the tobacco companies� First Amendment rights). These conflicting rulings mean that the Supreme Court will likely need to take up the issue to resolve the circuit split. See Bill Mears, Federal Judges Strikes Down FDA Tobacco Warning Label Law, CNN.COM (Aug. 25, 2012, 11:38 AM), http://www.cnn.com/2012/08/24/justice/tobacco-warning-label-law/index.html?iref=allsearch.



point. While Vermont requires the label to give some identification as to what manipulation has occurred, some of the suggested labels might be too technical for the average consumer.206 One of the proposed labels, though, could be adapted for in vitro meat. Vermont�s example of �biotech seed�207 could be modified to �biotech meat� or �in vitro meat.� Such a label could work as a baseline to inform consumers that this product was created using in vitro meat production biotechnology.

As technology advances to allow manipulation of the various components and qualities of in vitro meat, the Vermont type of labeling would need to develop so that it reflects any manipulations or alterations to the in vitro meat. It could be as simple as adding adjustments to the federally required nutritional information for packaged food products.208 Alternatively, the label could include information, such as �omega-3 fatty acid enhanced,�209 along with something like �biotech meat.�

2. MPAA Style Labeling? Another possibility would be to adopt a voluntary scaled system that identifies to what degree a particular in vitro meat product has been biologically engineered. This would work in a fashion similar to the Motion Picture Association of America ratings for films.210 The FDA could develop a scale to reflect how much biotech engineering was applied to a product. However, such a method could prove more confusing than simply including additional information on the label to indicate what manipulations occurred.

3. Proposed Voluntary Labeling for GE Foods. In 2001, the FDA issued guidance for voluntary labeling of GE foods that could also apply to in vitro meat products.211 The FDA guidelines suggest including on a label that the product was manufactured using biotechnology, as well as indicating why biotechnology was

206. See 2-3 VT. CODE R. § 200 (2011) (proposing as one possible label �contain genes that confer tolerance to glyphosate�). 207. Id. 208. See 21 C.F.R. § 101.9 (2012). 209. See Datar & Betti, supra note 15, at 19 (predicting that in vitro meat could include beneficial omega-3 fatty acids not found in natural meat). 210. See What Each Rating Means, MOTION PICTURE ASS�N. AM., http://www.mpaa.org/ratings/what-each-rating-means (last visited Jan. 26, 2012). 211. CTR. FOR FOOD SAFETY & APPLIED NUTRITION, FOOD & DRUG ADMIN., U.S. DEP�T

OF HEALTH & HUMAN SERVS., GUIDANCE FOR INDUSTRY: VOLUNTARY LABELING

INDICATING WHETHER FOODS HAVE OR HAVE NOT BEEN DEVELOPED USING

BIOENGINEERING 7�9 (2001) [hereinafter VOLUNTARY LABELING].



used.212 Among the recommendations, the FDA proposed including what the genetic engineering added to the product as well as the source of the material used in genetic engineering.213 In vitro meat labels could also reflect whether the products possess an altered taste or texture.214 This Comment argues that, even though companies producing in vitro meat might not be inclined to adopt voluntary labeling, the FDA�s guidance on the subject still provides helpful insight into the type of labeling that should be adopted. No matter which labeling system the FDA implements, it should select one that clearly identifies the product as in vitro and specifies any manipulation performed by manufacturers.

E. Criticisms of In Vitro Meat

In addition to a general concern over the safety of a new product like in vitro meat,215 potential consumers might have other qualms about this novel food. Critics have expressed concern that using technology to solve social problems avoids making tough choices and is actually �moral cowardice� and delays moral change.216 Additionally, some people feel that allowing food animals to live is better than them having no life at all.217 This Comment argues that regulation cannot directly address such moral opposition to in vitro meat. Instead, scientists and in vitro meat advocates need to engage in a dialogue with opponents to inform them of the benefits of in vitro meat and assuage their fears of this new technology. Part IV.E.1�2 of this Comment will address additional trepidations associated with in vitro meat that federal regulation could address.

1. Naturalness of the Product. Potential consumers worry about the unnatural character of in vitro meat.218 However, as

212. Id. at 7�8. Focus groups conducted by the FDA also found that consumers preferred the term �biotechnology� over �genetic modification� and �genetic engineering,� suggesting that the former term creates less of a stigma. Id. at 8. 213. See id. at 8 (suggesting as one example of a label, �This product contains high oleic acid soybean oil from soybeans developed using biotechnology to decrease the amount of saturated fat�). 214. See id. at 8�9 (suggesting that a label could include information that a tomato was engineered to alter its texture). 215. Hopkins & Dacey, supra note 12, at 585�86. 216. Id. at 588�90. 217. Id. at 590. 218. Id. at 586�87.



Hopkins and Dacey state, �Just because something is natural, does not mean it is good for you.�219 When conducting risk analyses in regards to in vitro meat, the government could juxtapose the concerns over �naturalness� against environmental and animal welfare concerns.220 While it might prove impossible to eliminate the criticism of in vitro meat as �unnatural,� by focusing on how in vitro production allows for the consumption of meat without the harmful effects to animals or the environment, people might be persuaded to overcome this objection and accept in vitro meat as simply the most recent innovation.

2. A Real Life Soylent Green?221 While somewhat far-fetched, some worry the development of in vitro meat could lead to growing human muscle cells for food.222 Opponents worry in vitro meat technology could result in �victimless cannibalism.�223 Currently, no federal law prohibits human cloning in the United States.224 A number of states have passed their own legislation outlawing human cloning.225 As a medical application for growing human muscles in vitro likely exists, enacting a federal ban on growing such tissue would go too far.226 Instead of an outright ban, the FDA could prohibit the use of human cells for in vitro

219. Id. at 587. 220. See, e.g., ANIMAL CLONING: A RISK ASSESSMENT, supra note 5, at 42 (explaining the various factors considered in assessing the safety of cloned animals and their products). 221. Soylent Green is a science fiction movie in which growing populations have strained food supplies, leading companies, like the Soylent Corporation, to develop food rations. SOYLENT GREEN (Metro-Goldwyn-Mayer 1973). 222. Hopkins & Dacey, supra note 12, at 586. 223. Id. This concern reflects the end of Soylent Green, when the main character discovers that Soylent Corporation makes Soylent Green from people. SOYLENT GREEN, supra note 221. The movie culminates in Charlton Heston�s character distraughtly proclaiming, �It�s people. Soylent Green is made out of people.� Id. 224. As recently as 2009, the House of Representatives proposed a bill to ban human cloning. H.R. 110, 111th Cong. (2009). This bill, however, has remained stuck in the House Subcommittee on Crime, Terrorism, and Homeland Security since February 9, 2009. Bill Summary & Status 111th Congress (2009�2010): H.R. 110, http://thomas.loc.gov/cgi-bin/bdquery/D?d111:110:./list/bss/d111HR.lst:: (last visited Jan. 26, 2013). 225. See, e.g., MONT. CODE ANN. § 50-11-102 (Supp. 2011) (making it a crime to clone a human in Montana); R.I. GEN. LAWS §§ 23-16.4-1, 23-16.4-2 (2008) (banning human cloning in Rhode Island); S.D. CODIFIED LAWS § 34-14-27 (2011) (making human cloning a felony in South Dakota); VA. CODE ANN. § 32.1-162.22 (2011) (banning human cloning in Virginia). 226. See, e.g., VA. CODE ANN. § 32.1-162.22 (2011) (carving out an exception for biomedical research in Virginia�s ban on human cloning); H.R. 4808, 111th Cong. (2010) (proposing a ban on federal funding of human cloning while allowing use of human stem cells for biomedical research); Datar & Betti, supra note 15, at 20 (stating that almost all current research related to in vitro meat production �is intended for biomedical application�).



meat production.227 By banning human cells for use in food and allowing the FDA to properly oversee in vitro meat production systems, Congress could assuage fears of a Soylent Green situation becoming a reality.

V. CONCLUSION

In vitro meat presents many possibilities and challenges. While opponents will attack in vitro meat�s unnatural qualities or see it as a quick technological fix to larger moral problems, the government should encourage development of larger scale in vitro meat production systems. Currently, livestock occupy 26% of all surface land.228 Of the remaining land that could sustain livestock, 45% is covered by forests.229 As experts estimate meat consumption will almost double from 2000 levels of 229 billion kg/year to 465 billion kg/year in 2050, it is important to develop methods of producing meat which will not require leveling forests to create grazing land.230

In addition to helping preserve the forests, in vitro meat could help reduce greenhouse gas emissions and water used in raising livestock.231 While in vitro meat can help alleviate environmental concerns, it should not be viewed as a replacement for conventional livestock. While livestock do consume natural resources and contribute to greenhouse gas emissions,232 they also help the biodiversity of the planet.233

Economically, it seems feasible that in vitro meat could act as a cost-efficient alternative to natural meat.234 Current estimates state that it would cost between � 3,300�� 3,500 per ton to produce in vitro meat.235 In comparison, it costs around � 3,500, not including

227. This takes a similar approach to Virginia�s ban on human cloning, which allows the use of human stem cells for research. See VA. CODE ANN. § 32.1-162.22 (2011). 228. Stig Omholt, In Vitro Meat Production Could Provide a Sustainable Way to Produce Meat, in FACTORY FARMING 122, 122 (Debra A. Miller ed., 2010). 229. Id. 230. Id. Each year, around 130,000 square kilometers of forest is lost, mostly because it is converted to use as agricultural land. Id. at 123. 231. Fox, supra note 4, at 873. 232. Id. 233. See Specter, supra note 1, at 38 (stating that cows help the diversity of grasses and contribute to the biological activity within soil). 234. THE IN VITRO MEAT CONSORTIUM, PRELIMINARY ECONOMICS STUDY: PROJECT

29071, at 3�4, 6 (2008), available at http://www.new-harvest.org/img/files/ culturedmeatecon.pdf (recognizing that despite far less expensive, traditional methods of producing meat, current estimates of costs for in vitro meat production warrant continued investment despite technical challenges). 235. Id. This figure excludes up-front research and development and assumes that



subsidies, to produce one ton of beef and around � 1,800 per ton of chicken.236 Currently, experts predict the first hamburger consisting of in vitro meat will cost £200,000 to produce.237

Through proper regulation, the FDA and USDA can encourage the development of in vitro meat production to work in conjunction with existing livestock rearing. By setting fair, but definite rules for producers while simultaneously easing public concerns about the products of in vitro meat, the FDA and USDA can help create an environment in which in vitro meat production can thrive. This can be accomplished by establishing stringent regulations, based off of those in existence under the WMA and FDCA, for assuring the safety and quality of the final in vitro meat product.

The USDA must also work to ensure the safety of in vitro meat production processes. It can either approach in vitro meat production as the equivalent of a slaughterhouse or meatpacking facility, or instead view in vitro meat production as the equivalent of a drug manufacturing process. This Comment proposes a combination of the two sets of regulations. This would allow for the USDA to confirm that the facilities and equipment meet standards for sanitation, that employees follow a SOP for ensuring such sanitary standards, that quality control teams constantly monitor the safety of the product, and that those who work to produce in vitro meat meet specific training standards.

Finally, the FDA should establish a system of labeling to inform consumers. Such a system should draw inspiration from both the Vermont standards for labeling GE seeds and the FDA�s guidance for voluntary labeling of GE foods. Any such labeling system should classify the product as in vitro meat. Additionally, labels should include any information relevant to manipulation of in vitro meat undertaken to adjust its nutrition, taste, texture, or any of its other attributes. With proper regulation, in vitro meat can help assuage environmental and ethical concerns.

Zachary Schneider

the technology for in vitro meat production would be made freely available. Id. at 3�4. 236. Id. at 7. 237. Chi Chi Izundu, Could Vegetarians Eat a �Test Tube� Burger?, BBC NEWS (Feb. 23, 2012, 5:53 ET), http://www.bbc.co.uk/news/magazine-17113214.