AGW Comments to USDA on Cell-Cultured Protein

October 27, 2021

U.S Department of Agriculture
Food Safety and Inspection Service
1400 Independence Ave. S.W.,
Washington, D.C. 20250

Re: Request for comment pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals subject to the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et. seq.) or the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.)

[Docket No. FSIS-2020-0036] [Agency: Food Safety and Inspection Service]

To Whom it May Concern,

On behalf of A Greener World (AGW), we appreciate the opportunity to submit comments to the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) on “Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells.”

As a nonprofit organization working with farmers and ranchers, slaughter plants, further processors and businesses across the country, AGW identifies, audits, certifies and promotes practical, sustainable farming systems by supporting producers and informing consumers. AGW’s growing family of trusted certifications, independently validated on-farm by third-party audits, includes Certified Animal Welfare Approved by AGW, Certified Grassfed by AGW, Certified Non-GMO by AGW and Salmon Welfare Certified by AGW, with Certified Regenerative by AGW now in pilot. We work with over 6,000 farms and ranches across 3 million acres globally, including producers of all scales and backgrounds.

Our farmers are leaders in their field, practicing genuinely high-welfare, sustainable stewardship and responsible management—and like all farmers, continuing to produce in the face of significantly challenging economic and environmental conditions. These conditions will not be improved with the introduction of a poorly labeled, techno-industrial protein product that undermines their markets while offering few if any of the benefits they currently provide to families and communities across the country and beyond.

As FSIS considers how to ensure that products comprised of or containing cultured cells derived from amenable species are truthfully labeled, we appreciate the opportunity to comment on how to best address challenges and provide recommendations to ensure fair and transparent markets for farmers and consumers. Please find below our responses to those questions that most directly relate to our expertise in this sector and the potential impacts on our key stakeholders:

• Question 1: Should the product name of a meat or poultry product comprised of or containing cultured animal cells differentiate the product from slaughtered meat or poultry by informing consumers the product was made using animal cell culture technology? If yes, what criteria should the agency consider or use to differentiate the products? If no, why not?

Yes. Research by Consumer Reports shows that consumers already experience significant confusion when considering food label claims they read on slaughtered meat and poultry product packaging, such as “natural,” which are widely misunderstood and not independently verified.[1] Introducing products comprised of cultured animal cells that are not clearly differentiated from slaughtered meat will only add to this confusion. Since FSIS regulates the labeling of all meat and poultry products under its jurisdiction to ensure products are not misbranded, the agency must take great caution to ensure products comprised of and/or containing cultured animal cells are clearly labeled to avoid consumer confusion and mistrust, and to ensure consumers are able to choose which food production systems they support. A primary method for differentiation is whether the product came from a slaughtered animal or from cultured protein using cells derived from livestock.

Consumers are increasingly interested in purchasing healthy products with known benefits for the environment, animal welfare and rural communities, benefits which our certifications validate through independent, third-party audits. These qualities have yet to be validated in animal cell culture technology, and in fact may never be validated. Farmers and consumers deserve transparent markets that allow fair competition and informed choices. Any product which did not originate from a live animal, born from another live animal and raised on a farm, should not be labeled as meat or poultry (or their equivalent) and should be clearly identified as animal cell culture technology. Importantly from both a transparency and food safety/allergenic perspective, the product should also clearly specify any and all species of animal cells it derives from.

This should be clearly communicated in text the same size and visibility as the product name on the Principal Display Panel. The label should also list all ingredients and materials used in the manufacturing process. This should be disclosed transparently and should not be allowed to be classified as proprietary information, as it has the very real potential to impact the health and purchasing choices of anyone considering consuming such a product. QR codes should not be permitted for use in conveying information about source material, as this represents an additional and dissuasive step for consumers to obtaining information and risks misleading consumers. Further, this information should not be permitted to be communicated solely through a website, or any other means dependent on technology or resources beyond a visual assessment of the packaging. The labeling guidance of bioengineered foods should NOT be used as a precedent. This approach is already failing consumers who seek information about foods containing genetically engineered ingredients—it is inadequate, confusing, obfuscates rather than informs, and further exacerbates existing inequities in access to information which should be readily and publicly available. The challenges above will only grow if similar approaches are permitted as the delivery mechanism for information about cell-cultured protein products.

• Question 2: What term(s), if any, should be in the product name of a food comprised of or containing cultured animal cells to convey the nature or source of the food to consumers? (e.g., ‘‘cell cultured’’ or ‘‘cell cultivated.’’) a. How do these terms inform consumers of the nature or source of the product? b. What are the benefits or costs to industry and consumers associated with these terms? c. If meat or poultry products comprised of or containing cultured animal cells were to be labeled with the term ‘‘culture’’ or ‘‘cultured’’ in their product names or standards of identity (e.g., ‘‘cell culture[d]’’), would labeling differentiation be necessary to distinguish these products from other types of foods where the term ‘‘culture’’ or ‘‘cultured’’ is used (such as ‘‘cultured celery powder’’)?

To ensure fair and transparent markets for farmers and clarity for consumers, terminology should clearly differentiate this new technology from traditional meat and poultry products. “Cell-cultured protein” should be the generic product name, with the product specifying which animal cells it derives from. For example, “Made with cell-cultured protein derived from bovine cells.” “Cell-cultured” would not risk confusion with other cultured products.

• Question 3: If a meat or poultry product were comprised of both slaughtered meat or poultry and cultured animal cells, what unique labeling requirements, if any, should be required for such products?

Labeling requirements should ensure that consumers can clearly identify if a meat or poultry product is comprised of both slaughtered meat or poultry and cultured animal cells, with percentages of each clearly listed and prominence on front of package according to the recommendations in these comments.

• Question 4: What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would be potentially false or misleading to consumers? For each term, please provide your reasoning.

Terms which would be false or misleading and should be prohibited in the product name of a food comprised of or containing cultured animal cells include (but are certainly not limited to):

• Grassfed – Due to the absence of grass and pasture in the production system–a key component of consumer expectation regarding grassfed meat products–as well as the lack of traceability in determining whether original cells were derived from animals which consumed solely grass.
• Humane – This term implies a level of attention to animal welfare. While subjective, poorly defined and often unverified, there is an established and growing market for animal products with animal welfare claims. Where no animals are raised, there can be no assessment of animal husbandry. Furthermore, the animal welfare impacts of cell-cultured protein could very well be negative, making this claim potentially even more misleading on such a product.
• Natural – Consumer perception of this technology as “unnatural” and “disgusting” has been identified as a key barrier to growth in the cell-cultured protein industry.[2] This creates a powerful incentive to label such products as “natural” when most consumers would disagree. According to research by Consumer Reports, a majority of consumers expect a “natural” claim to mean: no artificial ingredients or colors were added to the meat or poultry (65%), no artificial growth hormones were used (64%), the animals’ feed contained no artificial ingredients or colors (61%), the animals’ feed contained no GMOs (59%), and no antibiotics or other drugs were used (57%). A greater percentage feel that this label should mean that no artificial ingredients or colors were added to the meat or poultry (85%), no artificial growth hormones were used (87%), the animals’ feed contained no artificial ingredients or colors (83%), the animals’ feed contained no GMOs (81%), and no antibiotics or other drugs were used (82%).[3] As this process is inherently artificial and there are no prohibitions on the inputs listed, a majority of consumers would find this claim misleading when applied to cell-cultured protein derived from animal products.
• Non-GMO – due to the lack of traceability in determining whether original cells were derived from animals which consumed GMO feed, or animals which were genetically modified themselves.
• Organic – While “Organic” is defined in the Code of Federal Regulations and does not currently address cell-cultured protein derived from animal cells, it is not impossible to imagine attempts to produce cell-cultured protein derived from animal cells using “Organic” inputs. This would fly in the face of the spirit of Organic production, and dramatically undermine the market created by Organic producers over many decades. Defined by the National Organic Standards Board as “an ecological production management system that promotes and enhances biodiversity, biological cycles and soil biological activity,” Organic production is intended to be based on “minimal use of off-farm inputs and on management practices that restore, maintain and enhance ecological harmony.” Cell-cultured protein derived from animal cells, produced in a tightly controlled laboratory or factory environment, would fail any reasonable expectation of this intent.
• Sustainable – This claim is already widely misused and rarely validated. To-date there is no evidence that cell-cultured protein derived from animal cells is “sustainable” along any metric; in fact, its production is significantly more resource-intensive than, for instance, cattle grazing established pasture consuming only sunlight, rainwater and grass.

We firmly believe that should FSIS not allow any animal raising claim, including breed claims, as they would be false and misleading as no animals were raised in the production of this product. Because no animals were raised, bred, handled, fed, or cared for in any way, there can be no truthful statement made about their production. Further, breed claims are not based on a cellular level but rather an actual breed of animal that has adapted to a specific environment and place over an extended period of time, often due to diligent animal husbandry and stewardship over thousands of years. Animal raising claims currently under the jurisdiction of FSIS, and which should not be allowed on these products, is available here: https://www.fsis.usda.gov/sites/default/files/media_file/2021-02/RaisingClaims.pdf

• Question 5: What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would potentially have a negative impact on industry or consumers? For each term, please provide your reasoning.

Please see responses to Question 4. These are all popular claims sought by consumers and in many cases confer a market premium for producers. Consumers would be negatively impacted by undermining their own choices, failing to impact food production as intended and being denied the benefits they would reasonably expect with such claims. Farmers, ranchers, further processors and other producers offering validated claims from the above list would be negatively impacted by lost markets and unfair competition.

Popular claims such as “natural,” “sustainable,” or “humane” are already widely misunderstood and rarely independently verified. Producers who are genuinely delivering these attributes, like those certified by A Greener World, are already at a disadvantage due to misleading marketing, or “greenwashing” by producers who promise sustainability rather than delivering it. Adding additional opacity to the protein space will only increase consolidation and further undermine existing markets for value-added, sustainable products, threatening the viability of independent, sustainable farmers and ranchers. As the challenges of climate change grow, we need more sustainable producers—not fewer.

• Question 6: Should names for slaughtered meat and poultry products established by common usage (e.g., Pork Loin), statute, or regulation be included in the names or standards of identity of such products derived from cultured animal cells? a. If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate? b. Do these names, with or without qualifying language, clearly distinguish foods comprised of or containing cultured animal cells from slaughtered products?

Names or standards of identity of such products derived from cultured animal cells should NOT include names for products established by common usage. If this is permitted, additional qualifying language is absolutely necessary to distinguish these products. Please see responses to previous questions for further recommendations.

• Question 7: Should terms that specify the form of meat or poultry products (such as ‘‘fillet’’, ‘‘patty’’, or ‘‘steak’’) be allowed to be included in or to accompany the name or standard of identity of foods comprised of or containing cultured animal cells? a. Under what circumstances should these terms be used? b. What information would these terms convey to consumers?

If terms that specify the form of meat or poultry products are allowed to be included in or to accompany the name or standard of identity of foods comprised of or containing cultured animal cells, these terms should be used in quotation marks to underscore their difference from their genuine analog, and follow the specifications outlined in previous responses, for example:

• Ready-to-Eat “Steak” Made with Cell-Cultured Protein Derived from Bovine Cells
• Cell-Cultured Protein “Patties” Derived from Turkey Cells

This could also be accomplished with a phrase such as, “Imitation [Product] Made with Cell-Cultured Protein Derived from [Species] Cells.” Per recommendations above, these full product names should be listed in the same size text and clearly labeled on the Principal Display Panel.

• Question 9: What nutritional, organoleptic (e.g., appearance, odor, taste), biological, chemical, or other characteristics, material to consumers’ purchasing and consumption decisions, vary between slaughtered meat or poultry products and those comprised of or containing cultured animal cells?

Significant questions and uncertainties remain about many aspects of the (still theoretical) production at any significant scale of cultured protein using cells derived from livestock, including whether cultured “meat” can ever be economically viable – even if it is technically feasible. At this stage, it is not possible to say with any certainty that products comprised of cultured animal cells will, for example, have the same nutritional benefits of slaughtered meat, let alone appearance, taste, texture, smell and other qualities.

According to Chriki S and Hocquette J-F (2020),[4] current cultured animal cell technology produces muscle fibers that are “significantly different from real muscle.” This represents “a huge limitation when seeking to reproduce the wide range of meats representing the diversity of animal species and breeds, as well as muscles or cuts. Moreover, the role of blood vessels and blood, nerve tissue, intramuscular fats, and connective tissue affect both taste of meat.” In addition, while the nutritional quality of cell-cultured products can be “theoretically controlled” by adjusting the fat composites used in the medium of production, Chriki and Hocquette (2020) argue that “controlling the micronutrient composition of cultured meat is still a research issue.” As Fassler (2021)[5] reveals, significant concerns exist about the food safety of producing cell-cultured protein safely at any scale, where sterility and biosecurity are absolutely paramount. On this basis, the impact of cultured “meat” consumption on human health will need to be carefully monitored.

Regarding other characteristics which are material to consumers’ purchasing and consumption decisions, there are a wide range of production, quality and animal raising claims at risk of being made on cell-cultured animal protein and have no place on these products. Consumers increasingly seek products which have been verified to deliver positive benefits to the environment, animals and rural communities. As stated in our response to Question 1, no such benefits have been demonstrated for cell-cultured protein derived from animal cells.

As Chriki and Hocquette (2020) argue, consumer acceptance of food products comprised of or containing cultured cells derived from animals and choice will be strongly influenced by many other factors beyond that of basic appearance, odor or taste that must also be fully considered: “Consumers seem to dislike unnatural food. Ethically, cultured meat aims to use considerably fewer animals than conventional livestock farming. However, some animals will still have to be reared to harvest cells for the production of in vitro meat … [R]eligious authorities are still debating the question of whether in vitro meat is Kosher or Halal (e.g., compliant with Jewish or Islamic dietary laws).”

• Question 10: Should any of the definitions for ‘‘meat’’, ‘‘meat byproduct’’, or ‘‘meat food product’’ found in 9 CFR 301.2 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?

Foods comprised of or containing cultured animal cells should be distinct from meat products at all points in the supply chain and specifically excluded from any definition of a meat product, including ‘‘meat’’, ‘‘meat byproduct’’, or ‘‘meat food product.’’

• Question 11: Should any of the definitions for ‘‘poultry product’’ or ‘‘poultry food product’’ found in 9 CFR 381.1 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?

Foods comprised of or containing cultured animal cells should be distinct from meat products at all points in the supply chain and specifically excluded from any definition of a poultry product, including ‘‘poultry product’’ or ‘‘poultry food product.’’

• Question 12: Should FSIS-regulated broths, bases, and reaction flavors produced from cultured animal cells be required to declare the source material in the product name, ingredient sublisting, or elsewhere on the label?

Yes. Just as FSIS requires traceability statements for labels making animal raising claims, traceability should be upheld in the case of FSIS-broths, bases and reaction flavors produced from cultured animal cells. The source material should be clearly included on front of package according to the recommendations in our response to Question 3.

• Question 13: Should the presence of cultured animal cells in further processed products regulated by FSIS, such as a lasagna made with cell cultured beef cells as an ingredient, be qualified on the product label? If so, how should this be qualified?

Yes. Just as FSIS requires traceability statements for labels making animal raising claims, traceability should be upheld in the case of FSIS-regulated products containing any ingredients from cultured animal cells. Language along the lines of “Contains protein made from cultured animal cells” along with the source material should be clearly included on front of package according to previous recommendations.

• Question 14: What label claims are likely to appear on FSIS-regulated products comprised of or containing cultured animal cells? Should FSIS develop new regulations or guidance on such claims to ensure they are neither false nor misleading?

Based on our role as a certifier, we have decades of experience helping producers identify meaningful label claims that reflect – and protect – their farming practices, while helping consumers understand more about the farming practices behind the products they are purchasing. In a context where many label claims have now been co-opted by major corporations, or where claims are used that are often misleading (such as “natural”), we believe there is a real need for strict regulations and requirements for the use of claims for products comprised of or containing cultured animal cells.

In this context, we anticipate seeing the full gamut of animal raising claims on packaging of products comprised of or containing cultured animal cells, including (but not limited to) regenerative, breed claims such as Wagyu beef or Berkshire pork, antibiotic free and/or raised without antibiotics, sustainable/sustainably produced and more.  Please see our responses to previous questions for more detail on the vast range of potentially misleading food labels and our recommendations to prevent this.

Finally, AGW would also like to comment on an additional point raised by this comment process. USDA’s primary function is to promote agriculture that nourishes people, and this means promoting farmers and ranchers growing food and raising animals to feed their communities. Products comprised of or containing cultured animal cells are processed products. Unless products made from cultured animal cells are clearly labeled – thus enabling consumers to make informed purchasing decisions – the USDA simply becomes a marketing agency for food processors, thereby undermining the very people and businesses the agency was established to serve.

Thank you for your consideration. The stakes for farmers, ranchers and independent food producers couldn’t be higher and we urge you to ensure they are not casualties of this quickly evolving market.  Please contact us if we can address any additional questions or support these recommendations for clarity and transparency in any way.

 

Sincerely,

Emily Moose
Executive Director
A Greener World

 

[1] Consumer Reports ® National Research Center. Decoding the Labels on Meat Packaging. Nationally-Representative Survey, June 2016. https://www.consumerreports.org/food/decoding-the-labels-on-meat-packages/ [Accessed 10.19.2021]

[2] Bryant, C and Barnett and Consumer Acceptance of Cultured Meat: An Updated Review (2018-2020). https://www.mdpi.com/2076-3417/10/15/5201/htm

[3] Consumer Reports ® National Research Center. Decoding the Labels on Meat Packaging. Nationally-Representative Survey, June 2016. https://www.consumerreports.org/food/decoding-the-labels-on-meat-packages/ [Accessed 10.19.2021]

[4] Chriki, S and Hocquette, J-F (2020) The Myth of Cultured Meat: A Review. Front. Nutr. 7:7. doi: 10.3389/fnut.2020.00007

[5] Fassler, J (2021) Lab-grown meat is supposed to be inevitable. The science tells a different story. The Counter.  https://thecounter.org/lab-grown-cultivated-meat-cost-at-scale/ [Accessed 10.13.2021]

This post has been updated to correct a typo in Question 4 regarding Organic production.