Food additive petition best regulatory route for cultivated/cell-cultured meat production, argues EDF
In a document released today, the EDF says startups in the space “should demonstrate leadership” by adopting the following principles:
- Ensure cell-cultured meat and seafood products are safe for human consumption: "Companies must ensure that a government agency with expertise and authority to regulate the product conducts a thorough review and affirms that the manufacturing process is indeed safe. The agency conducting the review must make its decision public by a credible means that is sufficiently transparent to allow public and scientific review and input."
- Continuously improve the overall environmental footprint of cell-cultured meat and seafood products as compared to the foods they are intended to replace: “As manufacturing technology is likely to evolve rapidly leading up to, and after, commercialization, life cycle assessments should be revisited and refined periodically with appropriate acknowledgement of uncertainties and data gaps;"
- Advocate for programs that maximize the net societal benefits of cell-cultured meat and seafood products; and
- Enable consumers to make informed choices about cell-cultured meat and seafood products with accurate labeling and marketing. (The EDF favors ‘cell-cultured’ as a descriptor and says that, “Where cell-cultured and conventional meat and seafood are blended, companies should identify the percentage of each... Labels should also include nutritional and food safety handling differences. "Moreover, all environmental and health claims should be easily accessible, reviewed by the appropriate government agency and supported by scientific evidence."
Food additive petition preferred route
As for regulatory pathways, the food additive process is its preferred route, argues the EDF, which believes self-certifying products as GRAS (Generally Recognized as Safe) is inherently problematic (as there’s no requirement to inform the FDA), while the review process for new genetically modified crops “raises serious concerns because it lacks the transparency and rigorous review by external experts, stakeholders, and the public necessary to ensure products are not only safe but also that consumers can trust they have been adequately evaluated.”
Ideally, it says: “The agency conducting the [pre-market] review makes its decision public by a credible means that is sufficiently transparent to allow public and scientific scrutiny.
“EDF recommends that companies use this [food additive petition] route since it provides protection for trade secrets while offering a meaningful opportunity for public and third-party scientific scrutiny as well as accountability.”
Technology-neutral
Jenny Ahlen, senior director for sustainable food & products at the EDF, told FoodNavigator-USA: “We’re technology neutral, so we don't pick a technology as a favorite; what we care about is that the technologies out there are safe and can demonstrate environmental and human health benefits.
“Do we know enough about them [cell-cultured or cultivated meat and seafood products] to make sure that they're actually going to have less of an environmental impact [vs conventional meat production] given the energy-intensive nature of the manufacturing process and the feedstocks needed and the growth cultures needed to grow them?”
FDA ‘intends to issue draft guidance on the pre-market consultation process’
Under a joint agreement addressing the regulatory framework for cell-cultured meat announced in March 2019, the FDA will oversee cell collection, cell banks, and cell growth and differentiation, with a transition to FSIS (USDA) oversight to occur during the cell harvest stage. FSIS will then oversee the production and labeling of meat and poultry derived from these cells.
An FDA spokesperson told FoodNavigator-USA in August that it “intends to issue draft guidance on the pre-market consultation process,” although it did not provide a timeline, adding: “The FDA is actively working in this space and consulting with a number of companies interested in bringing cultured animal cell food products to the US market.
"We cannot comment on the status of individual consultations that are in progress. However, FDA intends to communicate publicly once the FDA consultation is complete.”
'We do not expect there will be a need for any detailed public announcement of particular procedures'
Asked about the transfer of jurisdiction from FDA to USDA at the cell harvest stage, the spokesperson said: “FDA and USDA-FSIS continue to work together to prepare for shared oversight of cell culture facilities involving cultured livestock or poultry cells used for human food.
"Given that the agencies currently coordinate on oversight in the field in a number of situations, and that both agencies intend to use existing authorities and tools, we do not expect there will be a need for any detailed public announcement of particular procedures.”
USDA: ‘Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable’
In a recent advance notice of proposed rulemaking (ANPR) about the labeling of cell-cultured meat, the USDA said that, “Other than new labeling regulations concerning this product, FSIS does not intend to issue any other new food safety regulations for the cell-cultured food products under its jurisdiction. Current FSIS regulations requiring sanitation and HACCP systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.”
It also noted that to avoid holding up the commercialization process, it would review labels submitted by cell-cultured meat brands before the rulemaking process is completed on the understanding that they may need to be changed down the road to comply with its final regulations.
Vaporware?
EDF’s principles were released following the publication of a lengthy article in The Counter (that draws heavily on two techno-economic analyses of cell-cultured meat - CE Delft 2021, and Humbird 2020) arguing that cell-cultured meat faces "intractable technical challenges at food scale,” echoing comments made by Impossible Foods founder Dr Pat Brown, who has described cell-cultured meat as "vaporware" in a recent interview.
Startups in the field have - unsurprisingly - challenged the notion that the obstacles to industrial-scale cell-cultured meat production are insurmountable, but acknowledge that higher-density cell cultures, more efficient use of food-grade media, food-grade equipment in facilities, and dramatic cost reductions in recombinant protein and growth factor production are needed for this technology to be commercially viable at scale.
Friederike Grosse-Holz, director at private equity firm Blue Horizon, which has invested in multiple startups in the alternative protein space, told attendees at the recent Good Food Conference that investors are taking something of a leap of faith at this juncture, adding: "We still need technical advances. We need the technology to evolve in ways that we don't exactly understand yet...
"But do we believe it [costs] will come down? Yes. Do we know exactly how? Of course not, because we're jumping off a cliff and building the engine [for the plane we don't know how to fly yet] as we go, right?”
'GFI has no vested interest in any particular alternative protein technology'
The Good Food Institute has addressed many of these issues in a new post on its website, noting that, "Modeling a process on public data from parallel but distinct cell culture processes that are also necessarily out of date (biopharma companies are typically not publishing their most recent innovations on process or cell line improvements, preferring to retain them as intellectual property) will lead to a muddled understanding of the state of the art, which can be particularly misleading in such a rapidly-progressing field."
It added: "GFI has no vested interest in any particular alternative protein technology. We support innovations that have the greatest potential for impact, and we’re strongly motivated to not divert precious resources toward endeavors that seem clearly incapable of success — we’d like to be the first to know if cultivated meat were incontrovertibly a futile exercise!
"In fact, some members of our Science & Technology team entered the alt protein field as skeptics about the ultimate economic or technical viability of cultivated meat. Had that stance continued to hold as we dug deeper, we would have happily advocated for resource allocation exclusively into plant-based and fermentation-derived alternatives. But the more we have dug in, with an open-minded approach and enough humility to not presume that our starting assumptions are indefinitely true, the more optimistic we have become."
'Commodity meats will not stay as cheap as they are today'
Elliot Swartz, PhD, lead scientist, cultivated meat, at the Good Food Institute also noted in a twitter thread that many cell-cultured meat companies are initially focusing on higher-value products.
“Commodity meats will not stay as cheap as they are today and there are other impactful business models with more premium meat products [tuna, foie gras, Wagyu beef etc] to give time for costs to come down.”
Conventional meat, meanwhile, is “subsidized in various ways and its externalities are not priced in,” he added. “This has been said before but it's very possible conventional meat prices will rise over time.”
What’s in a name? Growing consensus around term 'cultivated meat' within nascent industry
“In the regulatory realm, we've used [the terms] cell cultured or cell based, because it really says these are animal cells being grown, and let’s not mistake it for a meat alternative… but 'cultured' and 'cultivated' seem to be the most common preferred names for consumers.
“My personal preference is ‘cultivated’ in front of a consumer… I think that's where most of the arrows are pointing at the moment.”
Dr Uma Valeti, founder and CEO, UPSIDE FOODS
“So on one hand you want to call this ‘meat’ because that's what it is, and calling it something else would be, in my mind, misleading. At the same time, you want to make clear to consumers that it's grown in a different way… so some sort of qualifier does make sense.
“For the moment, I think just to avoid confusion we should settle on something like ‘cultivated meat’ or ‘cultured meat’… at least to be unified on what we're talking about.”
Dr Mark Post, founder and CSO, Mosa Meat
"In September 2021, we polled company CEOs on their preferences and found a significant shift [vs a 2020 poll], with 75% of the 44 companies that replied preferring 'cultivated.' 'Cultured meat' comes in second at 20%, and everything else trails by quite a lot.
"One of the previous favorites, 'cell-based,' is preferred by just one company."
Bruce Friedrich, executive director, The Good Food Institute
