Kathi Cover

New Harvest’s Conference on Cellular Meat: Saturday Afternoon (4)

/ veganamericablog

MeatIn July, I (Martin) attended New Harvest’s 2018 conference on cellular meat at MIT’s Media Lab. I wrote an extensive report on this valuable, informative, and very well-organized colloquium—partly as a means of grappling with the science, but also as a way to think about what role cellular meat might play in imagining a vegan America. Over the next four blogs—divided into Friday morning, Friday  afternoon, Saturday morning, and Saturday afternoon—I report on what was said, and reactions to it, as well as my own observations. Note: New Harvest will no doubt be putting all the talks on YouTube, and so you can check out what was said (and whether I accurately reported it) at a later date.

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The final panel in the afternoon, which was also moderated by Isha Datar, concerned itself with the issue that was shadowing the entire conference: that of regulation.

The opening talk was given by Deepti Kulkani, formerly a lawyer at the FDA and now, like Kathi Cover, at Sidley Austin. Kulkani’s aim was to address the key regulatory questions facing cell ag and what could be answered now and how. She explained how both the FDA and USDA worked. The FDA, she said, was tasked with regulating food and ingredients and determining the safety of ingredients, including those in meat, poultry, and biotechnology. The USDA, on the other hand, was responsible for meat and poultry and their products. It regulated establishments that slaughtered or processed meat and poultry and determined the accuracy of labeling and the suitability of ingredients. In regards to new ingredients in meat and poultry, the FDA, said Kulkani, had authority over “food additives” and whether they were GRAS. (Indeed, two days after the conference ended, the FDA generally recognized as safe the “heme” GMO additive that Impossible Foods had added to its burger to give it its “bloody” taste and texture.)

Kulkani then described what might be regulated and how. She mentioned that the government would be concerned with the safety of substances used in manufacturing cellular meat before it came to market: such as animal cells, the growth medium, and the scaffold. Obviously, the agency would be interested in ensuring that the finished product was safe; and it would want a clear sense of the identity and history of safe use and common knowledge of safety, as well as the margin of exposure.

Kulkani then stated that regarding the manufacturing process, the government would want to know whether the process had changed the ingredient, whether there were controls set up to control for or prevent unique hazards, levels of purity, or toxicity—a process known as HACCP (Hazard Analysis and Critical Control Points). The government would also be concerned about the labeling of the product or elements of that product, and they’d wish to inspect the facility.

Kulkani noted that it was not yet self-evident that the FDA would be the ultimate agency making judgments on cell-ag’s processes and products. That the FDA had opened such hearings suggested that it certainly believed it had a role to play, but the USDA, she added, was beginning to throw its weight about by claiming that the FDA was overreaching its jurisdiction. This, she added, might simply be intra-agency chest-beating. As far as she was aware, the agencies had begun communicating with one another, which might indicate that the agencies might collaborate or divide the process under their various jurisdictions. Kulkani added that it was indicative that the FDA acknowledged in its preamble to the meeting of July 12 that although its primary concern was the safety of cell ag, how it might be labeled was also an area of interest.

As for what might happen next, Kulkani advised people to continue to make comments; that there would be a meeting before the FDA Science Board; and ultimately there would be a USDA/FSIS (Food Safety and Inspection Service) decision on the U.S. Cattlemen’s Association petition (or on naming of the product more generally). However this process continued, Kulkani concluded, it was likely that political interest would continue as would potentially federal legislation on cell ag.

Next up was Larisa Rudenko, who, like Kulkani, had formerly worked at the FDA. Rudenko’s role in the conversation was to layout the conceptual landscape from regulation to product delivery. Echoing the writer John Gardner, Rudenko noted that when it came to biotechnology, the story of innovation was either perceived as “a journey” or “a stranger comes to town”: in the former, the innovator is subject to whims of a peripatetic trek until he or she arrives at the destination; in the latter, the innovator is either perceived to be a threat to the status quo and ultimately ejected, or after initial resistance, through persistence or because she or he brings something new and valuable to the status quo, the innovator changes the nature of that place for the better, or is him- or herself incorporated into the status quo.

Last but not least was Ronald Stotish, CEO at Aquabounty, and who had been a member of the team that had “produced” the AquAdvantage Salmon, the first FDA-approved genetically modified food animal. Stotish described the long and tortuous process from the creation of the fish in 1989 to the FDA approval in 2015, the first commercial sale of the fish in Canada in 2017, and the company’s current inability to bring the fish to market in the United States.

Whether it was wise (commercially or otherwise) to produce a GMO salmon was not the reason that Stotish was addressing the conference. His purpose was to provide a case study on the problems of bringing an innovative, scientifically engineered animal-based foodstuff to regulators and thence to market. Stotish could barely contain his contempt for, animus toward, and mystification about the environmental NGOs (such as Food & Water Watch) whom, he felt, had mischaracterized the data around the salmon, had disregarded the science, had engaged in scaremongering; and had failed to engage in good faith with industry—all (so he said) in order to generate donations to their organizations.

The lessons Stotish wished to communicate from his attenuated experience to attendees who might find themselves on a similar trajectory was to be an optimist, engage early and often with those who might oppose you, and to communicate what you’re doing and why. It was vital, he said, to conduct the best science you could but not to assume it would insulate you from attack. He urged the conference to resist assuming the regulatory process was free of politics (it most emphatically wasn’t), but instead to interact politically and to develop coalitions with like-minded organizations. He added that innovators should be prepared for delays, media attacks, and setbacks, but to believe in the product and to persevere.

In the conversation following the presentations, Isha Datar asked the panel what they felt would be the worst-case scenario for cellular meat. For Rudenko, the biggest danger was that a manufacturer moved too fast, broke things, and brought a product to market without any regulatory oversight and with a safety problem. She recommended that the audience read two books: Innovation and Its Enemies by Calestous Juma and Sheila Jassanoff’s The Ethics of Invention. These two books, she said, bracketed the two viewpoints on emerging technologies that she’d mentioned in her talk. Larisa admitted that the regulatory process could also prove fraught because it was difficult to provide expertise in something that hadn’t been around before.

Datar asked the panel how concerned the USDA and traditional animal agriculture industry should be about the role of the FDA. Kulkani replied that there was a long history of the FDA and USDA working together on issues, but that there was clearly a basis of concern in the USDA’s robust criticism of FDA “overreach,” especially on a political level.

Fielding a question from the audience, Datar then asked whether the cell-ag industry should hire lawyers and lobbyists. After the titters had died down, Rudenko recommended inviting regulators to industry meetings. “Regulators are people,” she announced: they would welcome learning more about the subject they were going to regulate. With respect to politics, Rudenko continued, fearlessly mixing her metaphors, it was important to take the temperature of the landscape. Kulkani urged the industry to use the processes the agencies were making available to make the best possible case to them.

The final talk was by Nadia Berenstein, a food historian and cultural critic, who through the lens of the history of (oleo)margarine, showed how perceptions around the product (and its comparison with the more “natural” butter) altered from its inception in the late nineteenth century as an untested product, technological breakthrough, and threat to the honest dairymaid churning her butter. Berenstein reminded the audience (as if it needed reminding) that it was necessary to supply people with the cultural and social context within which to eat the food.

The conference ended with one-minute pitches from various organizations that were present, including: New Age Meats; 3-D Heals (bioprinting and lab-grown solutions); the Good Food Institute’s Good Food Conference; Higher Steaks; a cultured meat podcast; cell.ag (a website on clean meat); New Culture (a company promoting clean dairy cultures in New Zealand; George Zeng (a producer of mushrooms, known as Loop foods); the New Omnivore (which would begin a discussion group in the Fall).

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What to make of a conference that had so many themes running through it—some of them contradictory? Many of the presenters (and not a few of the audience) were clearly driven by evidence-based convictions that traditional animal agriculture presented profound, even existential crises for food security, human wellness, environmental protection, climate-change mitigation, and animal welfare. Yet these same individuals were being urged by former regulators, fellow entrepreneurs, and their colleagues in cell ag to “play nice” with that same industry, the representatives of whom (as far as this correspondent can recall) refused to admit that their business needed to change at all, except in as much as cell ag might “improve” its products and thus, one assumes, allow for even more production of more efficient animals, more value-added processed meats, and better profit margins for beleaguered farmers.

The youthful scientists were likewise urged to make sure the safety of their products was backed up with solid data, to be transparent, to resist the siren song of systemic “disruption” in favor of incremental change, and not to be the company that ruined it for everyone else by bringing a product to market too soon. Yet nobody, as far as I can remember, asked why it was that current agribusiness was not held to account for its colossal waste of natural resources (not to say of the product itself), its poor safety levels regarding disease and meat recalls, its lack of transparency, and its manifest cruelty toward animals.

Beyond this, the presenters urged the scientists, entrepreneurs, and audience to attend closely to the construction of the narrative they wished to tell consumers and regulators about their industry and its products but to be leery of telling a story that contrasted too sharply with the prevailing story of America feeding the world—a narrative that remained unquestioned as the unimpeachable base narrative of American and global prosperity.

Ironically, the skewing of perspectives at this conference may have been a consequence (however unintentional) of not featuring plant-based companies and their ongoing inroads into the meat and dairy markets. Presenting cellular meat within the context of alternatives to conventional animal-based agriculture may have provided a focus for attendees. As it was, we were reminded that everyone in the space was in the business, in some way, of either growing animal flesh or supplementing it in some way. This may have made sense strategically—smoothing the pathway to regulation by not unnecessarily antagonizing the meat industry, its lobbyists, and vested interests in government. However, it may also have provided an opening for that same industry to coopt those seeking an early return on their investment to literally incorporate their technology within the bodies of animals destined for slaughter.

In fact, at the end of this conference, it wasn’t at all clear to me that the end of this process was a dramatic reduction in the number of farmed animals destined for slaughter, or, for that matter, a redefinition of the meaning of “meat.” Was this a diversion, a game-changer, or merely another option? Could this meeting be, in effect, a parallel to a motor carriage convention in 1895, where multiple start-ups and technologists were attempting to master a technology with huge potential and bring their various inventions to the market, all the time awaiting the scaling-up, economies of scale, and market penetration that Henry Ford would achieve with the Model T? And where should we place the emphasis: on the product itself or on the process? On the regulatory framework or the story? Did customers really care how their meat was prepared as long as it was cheap, readily available, and tasty? Would technology be a boon or a curse?

None of these questions were any clearer to me at the end of the conference than they were at the beginning. I await the Good Food Institute’s conference in September with interest.

New Harvest’s Conference on Cellular Agriculture: Friday Afternoon (2)

/ veganamericablog

MeatIn July, I (Martin) attended New Harvest’s 2018 conference on cellular meat at MIT’s Media Lab. I wrote an extensive report on this valuable, informative, and very well-organized colloquium—partly as a means of grappling with the science, but also as a way to think about what role cellular meat might play in imagining a vegan America. Over the next four blogs—divided into Friday morning, Friday  afternoon, Saturday morning, and Saturday afternoon—I report on what was said, and reactions to it, as well as my own observations. Note: New Harvest will no doubt be putting all the talks on YouTube, and so you can check out what was said (and whether I accurately reported it) at a later date.

* * *

In the afternoon panel, attendees heard from Jess Krieger, a New Harvest research fellow and PhD candidate in biological sciences at Kent State. According to her LinkedIn page, Krieger’s ethical and scientific goal is clear: to utilize “biomanufacturing processes to produce organs and tissues that replace the use of animals in research and the livestock industry.”

Krieger reflected on what she thought would be the trajectory of the science of cellular meat. Initially, she said, animal cells would be food additives in plant-based products; the next stage would see pure animal-cell products created; finally, full-animal products would be manufactured. In short, this development could be characterized as cell manufacturing leading to tissue biofabrication, and then to tissue manufacturing.

Krieger noted the many processes that were involved in cellular reproduction, from myogenesis (the development of skeletal muscle cells), vasculogenesis (the production of endothelial cells), and adipogenesis (which marbles the meat with fat). She also pointed out the various means by which meat cells can be developed, such as through extrusion or stereolithography (a form of 3-D printing), or a combination of the two. Krieger observed that tissue might require different kind of media formulation to differentiate and grow.

In addition to her research, Krieger and her team had developed a lab-scale bioreactor for cultured meat (the 2.0 version of which develops tissue more quickly, and will be available in December 2018). In the bioreactor a perfusion system pumps “blood” through tissue—delivering hormones, growth factors, trace elements, nutrients, and oxygen, and removing waste and other factors. In the question-and-answer session, Krieger was asked whether this process produced the meat quality of muscle. She replied that theoretically it could, but that it hadn’t been tested.

Krieger was followed by Glenn Gaudette, Professor of Biomedical Engineering at Worcester Polytechnic Institute. Gaudette is a tissue engineer, whose research was galvanized by the 100,000-person gap between those who needed organ replacements and the organs available. This was a moral as well as a technical challenge, and he thought about how to grow human muscle cells that might, for instance, take the place of the heart.

Gaudette knew that cells needed oxygen to grow, but that if they grew beyond the limit of 200 microns, they died—unless they had a vascular system that provided a regular and sustainable supply of the nutrients (much like Krieger’s bioreactor). Gaudette told the audience that he and his team had been eating lunch one day when a member had observed that the spinach leaves in their salad had veins that approximated the vascular structure of the human heart. Using detergents to kill cells that might contaminate or block the perfusion process, they then poured red dye and eventually blood into and through the vasculature of the now-transparent leaf to form a scaffold. They injected human muscle cells, which through the electrochemical reactions of calcium within the cells, created contractions that pumped the blood through the veins of the leaf.

For Gaudette and his team, the potential of such leaves to develop human heart cells was obvious. They’re now examining the structure of broccoli as a framework for the bronchi and bronchioles of the human lung, and bamboo for establishing bone growth. Both require much more research, but the theoretical possibilities are manifold.

Gaudette noted that using plant products for scaffolding to develop cells beyond the small-lab sample was not only more environmentally friendly than employing tissue-engineering scaffolds from animal or synthetic materials, but might well be cheaper. Plants were abundant, readily available, could be grown in different shapes and forms, and could be genetically engineered. Gaudette pointed to an article by George Toulomes called “Making Steak out of Spinach” for more information on his research and the elements of cellular biology that made it—and other tissue development—possible.

In the question-and-answer session, Gaudette was asked whether there were alternatives to spinach that might provide greater vascularity. He replied there were many types of spinach, let alone other forms of plants, such as lettuce (and its numerous forms) that might be employed.

Following Gaudette was a panel on a different form of transparency than see-through spinach: that of sharing research data within the scientific community and with people.

Andrew Stout was another PhD candidate and New Harvest Research Fellow working on “biomaterial functionalization, genetic engineering of skeletal muscle development, and computational approaches to understanding and directing cell metabolism,” at Tufts University. He discussed his work on manipulating cells to increase un- and polyunsaturated fatty acids and lessen saturated fatty acids within meat. He admitted there might be effects on flavor and texture (and cost) in this process, but that the possibility of adding value to cultured meat products by, for instance, reducing carnitine and lowering saturated fat might be worth it. Stout’s key point, however, was that in conducting his research, he’d made considerable use of open data and metabolic models drawn from research by government and meat-producers.

Next up was Kathi Cover, who worked as an intellectual property (IP) lawyer at Sidley Austin, with a focus on how one might go about formalizing one’s work on cellular agriculture. Cover described the four kinds of IP: patents, copyrights, trademarks, and trade secrets. Patents were for inventions that had to be new, couldn’t be obvious, and had to be useful. A patent typically lasted for twenty years. Copyrights were the original expressions of idea or authorship, and lasted the life of the author, plus another seventy years. Trademarks applied to words or symbols with a commercial value, and lasted a decade, with options to renew. And trade secrets were confidential information with a commercial value; by definition, they had to remain secret.

Cover observed that each of these IP forms offered pros and cons to those working within the cultured meat space—especially on the question of whether it was wise or not to publish one’s work, patent it, or keep it secret. Publishing one’s research was free to do, and in theory it prevented a competitor from patenting your idea. The downside of publishing was that it only offered you limited rights (such as copyright) and removed your ability to leverage your research as an asset. Patenting your product had its benefits: a patent gave you exclusive rights, powerful leverage, and a valuable asset. However, patents were expensive and time-consuming to obtain, and were of limited duration. A trade secret, on the one hand, was a valuable asset with possible leverage; it was low-cost with a potentially infinite duration. On the other hand, trade secrets were easy to lose. All these factors, Cover observed, needed to be considered in thinking about how or whether to communicate one’s work or announce one’s product.

Yuki Hanyu from Japan was next, speaking on building a cultured meat community. Hanyu, who runs the Shojinmeat Project and Integriculture Inc., offered perhaps the most polemical and visionary definition of transparency. Hanyu argued that it was one thing to produce a safe product through regulation and legal transparency; it was quite another matter for consumers to feel safe, which was a psycho-cultural phenomenon. Hanyu was convinced it was necessary to develop a positive and accessible climate around cellular meat, emphasizing safety and trust-building; thus, he’d developed two strands for his interests: Integriculture for the commercialization of cellular meat, and Shojinmeat Project as an open source for information and imaginative constructs around cellular meat.

Hanyu’s purpose at Shojinmeat, he enthused, was to democratize cell ag: to encourage DIY bio-fab enthusiasts, students, researchers, artists, and writers to provide familiar contexts for people within which to imagine cellular meat—such as comic-cons and fantasy fiction featuring cellular meat. Hanyu claimed he saw no reason why, instead of using FBS or growth factors to develop cells, you couldn’t use the cells from the organs of the animal body that already performed that function. Thus, he and his team were growing the liver and other organs to produce a growth medium.

Hanyu offered his audience his vision for cellular meat. Brand ownership and regionalism could open up opportunities for local farmers and hobbyists to develop their own cellular meat recipes. He even raised the prospect that you could enjoy a burger and video-link to the individual cow from whose cells your meal had been cultivated, grazing peacefully as you ate her cells. He imagined industrial meat breweries with steaks developing inside would be accompanied in the marketplace by home-brew meat kits on the kitchen counter. Why stop at meat? he asked. You could do your own tissue-engineering, or grow your own kidney, or add your own components to meat to make it even tastier by, for instance, creating an algae–meat composite. At some point, one might ask, he said, whether the product even is meat?

For Hanyu, the appropriate trajectory for the widespread adoption of clean-meat technology was for academia to hint at the way forward, citizens to act and set the direction of where they wanted it to go, and businesses to scale and deliver. That, he felt, was democratized citizen agriculture.

The final panelist was Caleb Harper, the Principal Investigator and Director of the Open Agriculture Initiative at the MIT Media Lab. The mission of OpenAg, he said, was to record, decode, and recode—particularly through genome-editing technology such as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), gene drives, and daisy chains that would allow facets of an organism to be altered not only for that organism and all its offspring, but that would, likewise, change the ecosystem in which that organism operated.

In that regard, Harper noted, it was now possible to move biology into computation and so predict (or perhaps estimate) a yield and biochemical outcome within any given environment, allowing for a maximally efficient or desirable outcome for the organism within that biome. By way of an example, he suggested that it was now possible to calculate which plants within which part of a field would grow under which optimal conditions, rather than a single monoculture.

Such amalgamations of computational science with genetics obviously meant, Harper continued, that society needed to open up a conversation about what “science” and “natural” would mean in the Anthropocene. Through its plant and other programs at PFC_EDU, the OpenAg Initiative was growing, sensing, and producing enormous amounts of usable data (alongside its plants), and doing so for under $300. Data were gathered as part of the Open Phenome Project, “an open-source digital library with open data sets that cross link phenotypic response in plants (taste, nutrition, etc) to environmental variables, biologic variables, genetic variables and resources required in cultivation (inputs).” The MIT team was farming microbes and diving into the biochemical machinery, evolution, and ecology of plants to make growing programmable food for nutrition, flavor, and fragrance a reality.

In the question-and-answer session, the moderator Karien Bezuidenhout of the Shuttleworth Foundation, an NGO committed to an open-knowledge society, asked the panelists what they saw as the fundamental reason for transparency. Hanyu argued that openness was necessary for consumer acceptance; Cover said it was important that companies and scientists were transparent about the financial sources of their work and products; Walker warned attendees to be clear about the huge amount of risk in the space; indeed, he added, $20 million bankruptcies were common. Though risk was important, even necessary, he observed, taking it on wasn’t for the faint of heart.

Evidently, the reason for this panel was to figure out how open source and transparent (and therefore altruistic) one should be as a scientist or entrepreneur, given the potential demands of one’s investors and the possibilities of considerable wealth. It’s impossible to determine where on the spectrum the majority of attendees lay between absolute mercantilism and complete altruism, but it’s reasonable to assume that this space will reveal its sinners and saints in due course.

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 The next three presenters focused on using cellular technology to create products that would form part of the ecosystem of the cellular meat universe.

First up was Prakash Iyer of Gingko Bioworks, which describes its work as “biology by design.” Biology, Iyer noted, was the most powerful manufacturing tool on the planet: self-repairing, self-assembling, self-replicating—a proven form of nanotechnology on a global scale. At Gingko, teams worked on perfume and flavors, as well as the fermentation of design and built products, using yeast, enzymes, or bacteria over substrates of sugars, oils, and alcohols. The applications, Iyer suggested, lay in an analysis of products that might, for instance, provide “off-notes” (scents detected by the nose that couldn’t be determined by technology alone).

Next was Xun Wang, whose company (Triton Algae Innovations) was attempting to make animal proteins from algae—most particularly Chlamydomonas reinhardtii (“Chlamy”), a single-cell green alga that tasted like sweet parsley. Xun listed the many environmental and human–population growth reasons why it’s necessary to curtail animal-based agriculture (several presenters at the conference did the same), and argued that, as the mother of all plants and animals, microalgae offered many benefits to address the deficits caused by consuming earth’s resources feeding animals to feed to feed to humans. Chlamy, Xun reminded us, was distributed worldwide and was the ideal host for mammalian proteins, monoclonal antibodies, vaccines, and hormones.

As it stood, continued Xun, Chlamy production and utilization had not been economically scaled, but production costs for fermentation could range from between $7.75 per kilogram (of dried powder) to, under full-scale operations, $2.17. As a supplement, Xun said, Chlamy was not only safe to eat, but had a pleasant taste, was nutritious (it contained 847 percent of the recommended daily amount of Omega-3 fatty acids), and contained no pesticides or bacterial contaminations. Xun cautioned that not all algae were the same; Chlamy checked all the boxes in terms of its advanced genetic tools, its scalable production, its fermentation capability, and its standing as GRAS (generally recognized as safe).

Xun reported that Triton was attempting to replicate what Impossible Foods had done with its plant-based burger by developing “heme” legehemoglobin from Pichia (a yeast) and adding it to a plant-burger. Finally, Xun, said, Chlamy should be suitable as a “feedstock” for clean meat.

Third was Eben Bayer, of Ecovative, which uses mycelium (the vegetative part of fungus) to grow materials such as packaging and mycobricks, with the aim of using it as a scaffold on which to grow leather, bone, and meat. Mycelium, he observed, was earth compatible, could grow in nine days, and was durable and strong. Their leather-like material (textile.bio) and fabric design (partnering with Bolt Threads) was available for a limited market. In terms of cellular meat, Bayer observed, Ecovative had developed a mycelium scaffolding that was programmable, biocompatible, and edible; the strain of fungus the company used didn’t have a special flavor, so wouldn’t necessarily change the taste of the meat.

In reflecting on the panel on transparency and the technologists working with organismal components, algae, and mycelium it’s hard not to be impressed by the technical sophistication, state-of-the-art biochemical, computational, and genomic skills employed by these companies. It was hard to know exactly quite how market-ready any of these companies was, and what the ratio of pitch to scientific explanation to development overview to market scale was in each presentation. As it turned out, the following day provided a little perspective on what we’d heard.