In 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.