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`t ~~' r ~ ~ ~~~ L F. VOLUME 15 ISSUE 2 ~ WINTER 2019 ~ SECTION 0 SCIENCE & TECHN Y LAW ~ AMERICAN p

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AND LARRY W. THORPE, ISSUE EDITORS

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REGULATORY CHALLENGES AND OPPORTUNITIES FOR CELL-CULTURED MEAT hamburger produced with zero to traditional meat—or meat that is pro- meat production through the adoption waste and without slaughtering cessedand derived from slaughtered ofcell-cultured meat. Greenhouse gas a single animal. A tuna sand- animals—in taste, texture, and appear- emissions, water usage, and land use wich prepared with no unpacts on ance. However,the process to develop would be reduced. Feed costs and crop marine ecosystems. cell-cultured meat is complex and far- footprints would be minimized. Cell- these are among the many environ- removed from either traditional animal cultured meat would be grown in a mentalbenefits touted by advocates of husbandry or commercial livestock sterile and sanitary laboratory and thus innovative cellular agriculture products production. public health risks from exposure to that may begin reaching neighborhood To create cell-cultured meat, cells are bacteria and zoonotic diseases could be grocery store shelves in the next few grown from either a live biopsy from a reduced. The lab environment would years. "Cell-cultured" meat—alterna- living animal, or from an embryo.3 The also lessen antibiotic resistance. Shelf tivelydescribed as `cell-based;' "clean;' collected cells are then grown in a ster- life could be increased based on the "synthetic;' or "lab-grown" meat—is ilelab environment. To grow the cells into sterile growing conditions. now under development by an expand- meat products, developers must differen- Advocates also stress that food secu- ingcadre of biotechnology companies tiatecells -for example,fat from muscle rityand social economic welfare would around the globe. These companies are -while allowing each cell to proliferate be distributed more evenly and once using cutting-edge laboratory science and mature. cell-cultured meat can be grown on to create a new and sustainable source The cells require a nutrient broth to a large scale, it would presumably be of meat that promises consumers the grow,a soup that includes amino acids, available to a greater population at a full taste, appearance, and texture of salts, sugars, and growth signaling mol- lower cost. animal products while reducing reli- ecules. The broth must be replaced and ance on, and in some cases replacing, supplemented as the cells grow This broth Challenges modern animal agriculture and indus- and growing media is currenfly extremely Technical Challenges trial production practices. ea~pensive, but companies are working to Cell-cultured meat is not yet avail- . As development of this technol- produce this growing environment eco- able to consumers, and faces numerous ogyrapidly advances, US. regulatory nomically on acommerciallyviable scale. challenges before large-scale produc- authorities have quickly recognized the As it matures,cell -cultured meat must tion, sale, and distribution may begin. need to develop a cooperative approach be physically supported by a scaffolding or The product is currently extremely to oversee the production of cell-cul- other structure. The scaffolding (usually expensive to develop and produce. turedmeat. After months of uncertainty made from anon-animal edible mate- Additional research is still needed and reported disagreement, the U.S. rial) allows already proliferated cells to to develop and further innovate the Department of Agriculture(USDA) an d develop structure and texture. Scaffolcling process, and more technology and the US. Food and Drug Administra- might become part ofthe product,or it resources are needed to develop the tion(FDA) issued a joint press release may be biodegradable and break down as product at scale. The product must also on November 16, 2018 announcing the meat grows. Following scaffolding, the be approved by regulators in a con- their intent to coordinate regulatory product must be housed in a bioreactor. sistent and uniform manner. Finally, efforts through joint oversight of the This growth process is technical, consumer acceptance and demand cell culture development process.' In expensive, and comple~r, but once the both must grow the absence of more details or a formal meat has been differentiated, matured and regulatory proposal, however, various proliferated, it is steps from the market. Regulatory Challenges consumer groups, technology propo- Currently manufacturers are designing Federal agriculture and food safety nents, and industry representatives and growing cell-cultured meat products agencies have not yet have not yet continue to separately advocate for their that mimic beefas well as poultry and addressed the status ofcell-cultured own favored legal approach. Among seafood meat by regulation, and such uncer- the key controversies: can a product Although the process relies on mod- taintymay stifle or slow the sale and be considered "meat" if it is grown in ernbiotechnology techniques,the process marketing of the products in the a laboratory instead of derived from a does not involve any genetic moclification United States. Given the unique prop- slaughtered animal? A federal court is and therefore does not constitute "genetic erties of cell-cultured meat, USDA and now considering that very question.Z engineering" under most existing regula- FDA announced their agreement on tory definitions.4 November 16, 2018, to participate in Background joint oversight over the production of Cell-cultured Meat: Harvesting a Goals cell-cultured food products, together Design Motivation for Cell-cultured Meat with "robust collaboration and infor- Cell-cultured meat is meat that is derived Technology advocates stress the posi- mation sharing:' Specifically, FDA from an animal product. It is very close tive impacts of replacing traditional will oversee the stages of growth from

WINTER 2019 TheSciTechLawyer 19 cell collection to differentiation, while both agencies to operate within their Through its implementing regula- USDA will handle the production and conventional roles: FDA generally tions, FSIS defines "meat" as the: labeling ofcell-cultured meats This regulates food products (including cell- unique approach marks the cell harvest cultured foods) to ensure that they are part of the muscle of any cat- stage as the point in time in which the properly labeled and safe, while USDA tle, sheep, swine, or goats which products will become subject to regu- holds exclusive jurisdiction over the is skeletal or which is found in lation as "meat;' and thereby allows regulation and inspection of meat and the tongue, diaphragm, heart, poultry. Yet the suggested division of or esophagus, with or without Alan J. Sachs(asachs@bdlaw com)is a agency authority leaves key questions the accompanying and overlying Principal at Beveridge e'r Diamond P.C. about the regulatory status of cell-cul- fat, and the portions of bone (in in Washington, D.C.> where his practice tured meat unanswered. bone-in product such as T-bone focuses on all aspects ofthe regulation In particular, are harvested cells or porterhouse steak), skin, sinew, ofconsumer and agriculturalpesticides, sufficiently covered by existing regula- nerve, and blood vessels which along with antimicrobial biocide, and tory definitions of"meat;' or will a new normally accompany the muscle biostimulantproducts, under the Federal rulemaking be required to expressly tissue and that are not separated Insecticide, Fungicide and Rodenticide address USDAs authority over the pro- from it in the process of dressing.9 Act(FIFRA), Federal Food Drub and duction and labeling ofcell-cultured Cosmetic Act, and other laws. Alan also meat products? USDAs Food Safety PSIS also clarifies that a meat or meat regularly counsels clients on the regulation Inspection Service(USDA -PSIS) reg- food product is "misbranded" if: ofgenetically engineered plants, animals, ulatesmost aspects of the safety and and insects by the U.S. EPA, US. FDA,and labeling of traditional(non -game) its labeling is false or misleading USDA.In addition, Alan advises clients on meats, poultry, and certain egg prod- in any particular; if it is offered for FDA's regulation offood food additives, and uctspursuant to its authority under sale under the name of another dietary supplements USDA's regulation of the Federal Meat Inspection Act food;[or] if it is an imitation plantpests and biological control agents; (FMIA). The FMIA does not define the of another food, unless its label and EPA's regulation ofethanol biodiese~ term "meat;' although it defines a "meat bears, in type of uniform size and and other alternativefuel products. Sarah food product" as "any article capable prominence, the word `imitation Kettenmann([email protected]) is for use as human food which is made and immediately thereafter, the an Associate at Beveridge er Diamond P.C. wholly or in substantial part from name of the food imitated.10 in New York City. Her regulatory practice meat or other portion of the carcass includes counseling clients on procedural of any cattle, sheep, swine, or goats:'6 The advent ofcell-cultured meat was and substantive aspects ofpermitting and At the same time, it defines "pre- obviously not considered when these environmental impact review, and related pared" meat as a product that has been provisions were originally crafted in strategic planningfor project development. "slaughtered, canned, salted, rendered, 1970, and the regulatory status of these She also assists pesticides companies in boned, cut up, or otherwise manufac- new products is consequently unclear. data compensation arbitrations under tured orprocessed:'' Afood product Arguably, cell-cultured meat fits FIFRA.In addition, Sarah advises clients on is "misbranded" under the FMIA if its within the statutory definition of"pre- OSHA and Toxic Substances Control Act "labeling is false or misleading in any pared meat" under the FMIA (which compliance and enforcement. particular:'$ broadly includes meat products that

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have been either "slaughtered" or "oth- products, to which the FSIS responded On June 15, 2018, FDA announced erwise manufactured or processed"). with an Advance Notice of Proposed its own jurisdictional claim over Cell-cultured meat productions may Rulemaking in 2009.'Z FSIS could sim- cell-cultured meat, which received also come within FSIS's definition of ilarly address uncertainty over the immediate pushback from USDA.16 "meat;' if regulators determine that status ofcell-cultured meat production On July 12, 2018, FDA held a day- the lab-grown tissues are derived from through a new rulemaking process. long conference and webinar that an edible "part of the muscle" of an At the same time, FDA is also well addressed "Clean Meat;' and stressed animal. positioned to address the safety of cell- that it is very familiar with the cultured Less clear is whether FSIS can also culturedmeat pursuant to its broad meat concept and can draw from its inspect the laboratories that produce authority under tiie Federal Food, Drug expertise handling other cell-cultured cell-cultured meat. FSIS's existing & Cosmetic Act (FFDCA). The FFDCA technology to evaluate and regulate rules apply only to establishments authorizes FDA to regulate all foods cultured meat products. In late October "in which any products of, or derived except meat, poultry, and some egg 2018, USDA and FDA hosted a pub- from, carcasses of livestock are, wholly products. FDAs Center for Food Safety lic meeting addressing the use of cell or in part, prepared for transporta- and Applied Nutrition (CFSAN) han- culture technology to develop prod- tion or sale as articles of commerce, dles safety and sanitation requirements ucts derived from livestock. Moreover, which are intended for use as human for all food introduced into or offered in its joint November 2018 statement food:'" This provision cannot be read- for sale in interstate commerce, again with USDA, FDA claimed authority ily applied to cell-cultured meat, which with the exception of meat, poultry, over the cell development stages of cell- is designed to avoid the production of and some egg products. FDA also has cultured meat. Thus, it seems that FDA livestock carcasses altogether. Arguably, authority to regulate certain food ingre- has assumed a future role—albeit still the types of facilities that will produce dients (such as color additives) that may unclear from a regulatory standpoint— cell-cultured meat bear a much closer be used in the production of meat. for itself in regulating at least the early resemblance to food manufacturing The FFDCA requires pre-mar- development stages of the meat prod- sites and laboratories historically regu- ket approval of all food additives ucts that are derived from animal parts. lated by FDA, rather than the types of (essentially, any substance that may livestock slaughterhouses typically reg- reasonably be expected to become a Legal Challenges ulated by FSIS. component of any food).13 Produc- On February 2, 2018, the US. Cattle- In the face of uncertainty over the ers may submit a petition to FDA, with mensAssociation, which represents the status of new food technologies in data and information to show that the U.S. livestock industry, petitioned FSIS the past, USDA-FSIS has previously food additive is safe.14 Alternatively, to prohibit the use of the term "beef" attempted to use the rulemakixig pro- a food additive's safety maybe estab- and "meat" for products not derived cess to clarify its official policies. For lished through scientific procedures from animals that have been slaugh- example, public confusion arose from to be "Generally Regarded as Safe tered or butchered.17 The Association the term "natural" as applied to min- (GRAS)" thereby avoiding the petition argued that applying these terms to process.ls imallyprocessed meat and poultry and approval cell-cultured meat products would

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mislead the public and consumer, from "harvested production livestock clarifies each agency's independent who may not be aware that the prod- or poultry."19 The state law further lim- jurisdiction over various aspects of bio- uct that they purchased and consumed its the definition of"meat" to only the technologyproducts. It further outlines was derived from stem cells or animal "edible portion of livestock or poultry the roles of each agency with respect to tissues developed in a lab. The Asso- carcass or part thereof:"'20 biotechnology products that fall within ciation specifically requested that FSIS Cell-cultured meat industry pro- the scope of multiple agencies. "exclude man-made or artificially man- ponents promptly filed suit in federal A similarly coordinated cross- ufacturedproducts that are not derived court, challenging the law on First agency approach to the federal from animals born, raised, and har- Amendment grounds?' That case is regulation ofcell-cultured meat would vested in the traditional manner from now pending. While Missouri is the provide additional clarity and cer- the definition of both beef and meat." first U.S. state to modify the defini- tainry to the new regulatory landscape The changes, the Association urges, tion of"meat" in a way that is likely to for cell-cultured meat products and should be articulated in the FSIS Food exclude cell-cultured meat products, it clarify labeling rules to help reduce Standards and Labeling Policy Book. is unlikely to be the last amid continu- confusion for food producers and con- The petition, which remains pend- ing uncertainty among federal agencies sumers alike. It may also help pre-empt ing, was opposed by a group of leading on this topic. a scenario in which cell-cultured meat developers ofcell-cultured meat and becomes subject to a patchwork of other meat substitute producers.la In Potential Regulatory Framework individual and potentially conflicting their opposition, these companies As the first products of modern genetic state regulations. analogized cell-cultured meat to well- engineering became more widely avail- Encouragingly, USDA and FDA established plant-based food products able in the 1980s, federal agencies were have a long history of working together that supplement meat, poultry, and asked to take a cooperative approach and consulting with each other in dairy products (like tofu and soy milk). that relies on existing statutory author- efforts to regulate products, like color The group drew expressly from an ities to ensure the safety of products additives, that are subject to FDA earlier petition submitted to FDA in of biotechnology. The "Coordinated overview but maybe intended for March 2017 that had asked FDA to Framework for the Regulation of Bio- use in USDA-regulated meat prod- allow common labels for traditional technology" was first published by the ucts23 The agencies'joint November foods to be supplemented by distin- White House Office of Science and 16, 2018, statement announcing agree- guishing terms for alternative plant or Technology Policy in 1986 and most ment to collaborate on the regulation animal sources that replace the "main recently updated in 2017.22 ofcell-cultured food products is an characterizing ingredient;' such as Developed to clarify the roles of the encouraging starting point, but more "coconut milk" or "almond milk:' prunary agencies involved in the regula- detailed policies and formal regulations tion of biotechnology products(USDA, will likely be needed to further clarify State Policies FDA,and the U.S. Environmental Pro- and solidify the agencies' roles. Amid this controversy, and in the tection Agency), the Coordinated continued absence of more formal Framework specifically aims to address Conclusion direction at the federal level, states may novel types of products developed As technology advances and inter- attempt to establish their own poli- through technology and science, and to estgrows in cell-cultured meat,federal cies. For example, Missouri recently coordinate regulation of both existing U.S. agencies are being called upon to enacted a law to prohibit the labeling products and those that will be devel- address key questions about the prod- of products as "meat" if not derived oped in the future. The 2017 update uct's regulatory status under their

22 TheSciTechlawyer WINTER 2019 e}usting statutory authorities. A har- 4. See, e.g., USDA 7 C.F.R. § 66.1 (pro- politico.com/story/2018/06/ 15/ monized and cooperative federal posed), defining "bioengineered food" to lab-grown-meat-feds-turf-battle-629774. approach, taken by all potentially rele- mean "a food that contains genetic material 17. http://www.uscattlemen.org/ vant agencies, can help avoid conflicting that has been modified through in vitro Templates/pdfs_USCA/2018-PDFs/2- regulatory requirements and provide recombinant deoxyribonucleic acid(DNA) 9-18USCA-AM S-Petition-re-definition-of- much-needed certainty to develop- techniques and for which the modification beef-and-meat.pdf. ~ ers, manufacturers, and consumers could not otherwise be obtained through 18. https://www.gfi.org/images/ alike. While recent signals of coop- conventional breeding or found in nature:' uploads/2018/04/GFIetal-Comment- eration between FDA and USDA are 5. See endnote 1 (U.S. Dep't Agric., State- FSIS-2018-0016.pdf. 4 encouraging, both industry and con- mentfrom USDA Secretary Perdue and FDA 19. Mo. S.B. 627. sumerswill benefit from more detailed Commissioner Gottlieb on the Regulation of 20. 17 Mo. 265.300. legal guidance and policy direction as Cell-Cultured Food Productsfrom Cell Lines 21. Turtle Island Foods, et. al. v Richard- cell-cultured meat products enter the ofLivestock and Poultry, Release No. 0248.18, son, Case No. 2:18-cv-04173-FJG (W.D. Mo. marketplace in the very near future. ~ Nov. 16, 2018, available at https://www Aug. 27, 2018). usda.gov/media/press-releases/2018/11/16/ 22. Biotechnology Working Grp., Fxec. Endnotes statement-usda-secretary-perdue-and-fda- Office ofthe President, Modernizing the Regula- 1. U.S. Dept Agric., Statementfrom commissioner-gottlieb). tory Systemfor Biotechnology Products: Final USDA Secretary Perdue and FDA Com- 6.21 U.S.C. 601. Version ofthe 2017 Update to the Coordinated missioner Gottlieb on the Regulation of 7.Id. Frameworkfor the Regulation ofBiotechnology Cell-Cultured Food Productsfrom Cell Lines 8.21 U.S.C. 601(n)(1). (Jan. 4,2017), available at https://www.epagov/ ofLivestock and Poultry, Release No. 0248.18, 9.9 CFR 301.2. sites/produchion/files/2017-0l/documents/2017_ Nov 16, 2018, available at https://www. 10. Id. coordinated_framework update.pdf: usda.gov/media/press-releases/2018/11/16/ 11. Id. 23.2015 MOU 225-00-2000 Amendment 1, statement-usda-secretary-perdue-and-fda- 12. 74 Fed. Reg. 46,951, 46,954 (Sept. 14, Memorandum of Understanding between the commissioner-gottlieb. 2009). United States Departrnent of Agriculture Food 2. Turtle Island Foods et. al. v Richard- 13.21 U.S.C. 348. and Safety Inspection Service and the United son, Case No. 2:18-cv-04173-FJG (W.D. Mo. 14.21 CFR 170.3(1). States Department of Health and Human Ser- Aug. 27, 2018). 15.21 CFR 170.30. vices Food and Drug Administration, https:// 3. Liz Specht,Is the Future ofMeat 16. https://www.fda.gov/NewsEvents/ wwwfda.gov/AboutFDA/PartnershipsCollabo- Animal-Free?, ~2 FOOD TECH. MAGAZINE. Newsroom/PressAnnouncements/ rations/MemorandaofUnderstandingMOUs/ 16, 19 (2018). ucm610869.htm; https://www. DomestiMOUs/ucm441552.htm.

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