Sustainable Protein: Where Law Specialties Converge
Expertise in business law, IP law, animal law, and environmental law are all needed in this innovative space. Lewis & Clark Law School leads the way with an annual conference that brings experts together.
By Koren Wetmore
The word protein connotes animal-sourced foods such as meat, fish or cheese. Those sources come at a cost, though, in terms of environmental impacts, animal suffering, and food security. That is why all eyes are on the alternative protein industry as a potential solution.
Our global community is projected to swell to 9.8 billion people by 2050. How will we feed that crowd when today’s animal farming system provides only 18 percent of the calories eaten worldwide—and does so while using more than three-quarters of the available land, adding to greenhouse gas emissions, and driving deforestation?
The alternative protein industry draws from sources as diverse as plants, algae, and lab-grown meat (cell-based), and shifts the focus away from industrial animal agriculture. Alt-protein garnered $3.1 billion in investments in 2020 and another $5 billion last year, bolstering a food biotech space where multiple areas of legal expertise converge.
Drawing from sources as diverse as plants, algae, and lab-grown meat (cell-based), alt-protein shifts the focus away from industrial animal agriculture.
“This emerging industry requires people with the brains and experience—in business, environmental, animal, and food law—to help guide its development in a way that’s sustainable for the earth, people, and animals,” said professor of law and the Brooks McCormick Jr. Scholar of Animal Law and Policy Pamela Frasch, founder of the Center for Animal Law Studies (CALS). “Lewis & Clark has deep expertise in all of these areas, which uniquely positions our graduates to become important contributors to this rapidly growing field.”
Aware of the alt-protein market’s potential and investments by big players such as Tyson and Cargill, CALS and the Center for Business Law and Innovation (CBLI) hosted a symposium in February 2022 to explore the legal, business, and ethical dimensions of the industry. The goal, Frasch said, was to encourage students, alumni, and other interested parties to get informed and involved. The conference is the latest in a series of annual conferences produced by the law school on food law.
Lewis & Clark has deep expertise in all of these areas, which uniquely positions our graduates to become important contributors to this rapidly growing field.
Panelists discussed topics ranging from investments and entrepreneurship to regulatory compliance and IP strategy.
“Intellectual property is such an important area where these companies need legal help,” said George Foster, professor of law and CBLI codirector. “Many times, the creators of these innovations are professors at research universities or other scientists who want to publish their results to enhance their careers. But that could undermine their ability to claim a patent, because the technology’s been disclosed before they filed their application.” Lawyers, he said, can help preserve the inventor’s right to patent protection by filing a provisional application, securing nondisclosure agreements, and ensuring that they communicate appropriately with investors. Legal advisors also help startups determine their overall IP strategy, including when to use trade secrets, patents, or a combination of the two.
The recent high-profile dispute between Impossible Foods and Motif FoodWorks Inc., helps illustrate the significance of IP counsel for alt-protein companies. In a lawsuit filed in March, Impossible Foods sought unspecified damages for Motif’s alleged infringement on several of its patents, including one related to an ingredient that lends plant-based burgers a beeflike flavor and color. Both companies created their additives using a genetically engineered strain of the yeast Pichia pastoris. Impossible Foods secured a patent for its “heme” protein (soy leghemoglobin) in 2020. Motif obtained patent protection for its HEMAMI protein (myoglobin) in 2021. While Motif contends that its ingredient is a different protein, former Impossible Foods CFO David Lee was quoted in a March 10, 2022, FoodNavigator-USA article as stating the Impossible Food patents “cover the use of heme, any heme, in plant-based meat.”
Lawyers can help preserve the inventor’s right to patent protection by filing a provisional application, securing nondisclosure agreements, and ensuring that they communicate appropriately with investors. Legal advisors also help startups determine their overall IP strategy, including when to use trade secrets, patents, or a combination of the two.
To understand some of the key regulatory issues around these novel foods, you need look no further than their labels. Legislation and litigation abound over what is or isn’t on a food label, including what a product can be called, the accuracy of its protein content, and any nutrient or health claims, or “green marketing” that suggests the product is better for you or the environment.
“Even though the Food and Drug Administration sets national food labeling requirements for most foods, actions by state legislatures and private plaintiffs can conflict with our interpretation of the FDA regulations. With different requirements for food products sold across the country, assessing labeling risks can get a little tricky,” said Allison Condra, a food law attorney with Davis Wright Tremaine in Portland. “I feel like I work in the cracks of the FDA rules with state legislation and private litigation adding a complicating layer. That’s the fun part, but it also can be maddening. So, I’ve learned to say to clients, ‘This is our best interpretation of the regulations and, in light of known litigation and state legislation, here are the potential risks.’”
Legislation and litigation abound over what is or isn’t on a food label, including what a product can be called, the accuracy of its protein content, and any nutrient or health claims, or ‘green marketing’ that suggests the product is better for you or the environment.
One of the most common challenges for a new product is developing a Statement of Identity, reflected in its name and influenced by the descriptive text found on its label and in its marketing materials, that doesn’t run afoul of rapidly changing laws.
Alt-protein foods often use terms traditionally associated with meat products. To comply with federal law and FDA requirements, however, they should avoid descriptions and imagery that could mislead or confuse consumers.
A meatless pork chop made from soy, for example, might need to ensure that the words plant-based are more prominent than the words pork chop. It also would be wise to avoid using the image of a pig, which might suggest the product contains meat.
But even these measures cannot guarantee protection from class-action lawsuits or individual state laws, Condra said.
A quick search of the Brooks Animal Law Digest reveals an abundance of recent laws and pending legislation that ban either the use of the terms meat or milk—as in the case of plant-based oat, almond, and soy milk—on labels for food products that do not come from animal sources.
The state of Vermont has even proposed two bills (S.206 and S.207) that, if passed, carry a potential two-year imprisonment and a civil liability of $10,000 for each product in violation.
Sustainability claims can also expose alt-protein companies to risk.
“Often, part of the story a brand wants to tell is why their product is better for the environment. It’s important to tread carefully, because they need to ensure that the claims are truthful and not misleading, and that they have adequate substantiation for those claims,” Condra said. “It can be tricky to counsel clients through that. They want to tell this wonderful story about their product and, in the pursuit of mitigating the legal risks, sometimes it feels like you’re raining on their parade.”
Some alt-protein foods are so novel that federal agencies are creating new regulatory frameworks to address them. Case in point: cell-based, lab-grown meat. Lab-grown chicken graces restaurant menus in Singapore and Israel, but is not yet commercially available in the United States. These foods are cultivated using animal cells that are extracted, sometimes reengineered, and grown into “meat” using large bioreactors.
In March 2019, the FDA and the U.S. Department of Agriculture entered a memorandum of understanding that proposed a joint regulation arrangement: the FDA would oversee the stages from cell collection through growth into the various meat products, and the USDA would oversee the harvesting, packaging, and inspection of the cultivated meat.
However, the framework is not set in stone. “We’re at a critical moment of influence where in the next year the USDA and FDA will propose regulations and invite comments,” said George Kimbrell ’04, legal director for the Center for Food Safety, a nationwide nonprofit supporting sustainable agriculture, and adjunct professor of food and agricultural law. Kimbrell’s concerns about lab-grown meat include potential harms from genetically engineered organisms, possible environmental hazards contained in the growth medium, and a genuine need for trustworthy oversight.
“We’re talking about introducing something into the food system that we’ve never eaten before. Whenever you do that, you’re looking at an experiment, essentially,” Kimbrell said. “As for the environment, those bioreactors are huge vats of contaminant. It reminds me of confined animal operations and lagoon manure pits. For me, it sets off alarm bells.”
Often, part of the story a brand wants to tell is why their product is better for the environment. It’s important to tread carefully, because they need to ensure that the claims are truthful and not misleading, and that they have adequate substantiation for those claims.
Issues spawning from the birth and rapid development of the alt-protein industry have also highlighted the need for new laws or amendments to existing ones. Such legislation could create definitions for these novel foods, address the technology involved, and potentially establish an independent regulatory agency to determine their impacts on food safety, human health, animal welfare, and the environment. Until then, said Kimbrell, advocates and litigators must creatively use tools such as the National Environmental Policy Act, the Clean Air Act, and other laws that “never foresaw the challenges we face now.”
Call to Arms
Foster and Frasch view these challenges as opportunities for those versed in business, animal, food, and environmental law to bring their expertise to the table. Together, they can ensure key issues are addressed.
“The industry is still at an early stage and questions remain,” Foster said. “To what extent will these alternatives contribute to sustainability? Will they be more environmentally friendly and affordable, or will they only be available for the rich in advanced industrial economies? If they’re sustainable and accessible to the broader population, that could be a real game changer.”
Equally filled with potential and problems, the alt-protein industry presents a clarion call to attorneys and advocates who possess the courage to explore new horizons.
We’re at a critical moment of influence where in the next year the USDA and FDA will propose regulations and invite comments.
“What makes this space so interesting is that it’s uncharted territory. This creates new and exciting opportunities for those who care about these issues to get in on the ground floor,” Frasch said. “The industry is experiencing tremendous growth and we hope to see more people get involved.”
Alt-Protein Investments in 2021
Cultivated (cell-based meat)
|Source: Good Food Institute, gfi.org/investment.|