Institute for Food Laws and Regulations

Kris DeAngelo is an attorney and educator with MSU's Institute for Food Laws and Regulations. 

Is a ribeye still a ribeye if it’s made in a factory instead of on a farm? Although meat and poultry have up to this point been products of animals born, raised, and slaughtered, new technologies are challenging that paradigm.  Now cells can be grown or cultured in nutrients and harvested as food.  Enter “cultured meat,” “bio meat,” “clean meat,” “in vitro meat,” “cell-based meat,” “artificial meat,” “fake meat,” “slaughter-free meat,” or “lab meat.”  The question is does it matter to YOU, the consumer, where the actual cells that make up your steak were grown, and should we label them differently?

The concept of cultured meat has been around since 1931, with Winston Churchill predicting industry moving away from the “absurdity of growing and whole chicken in order to eat a breast or wing...” the vision has become a reality.[1]  Industry has been able to transform the creation of beef, lamb, goat, pork, chicken, and various species of fish.  And in the future, it claims it will create cell-based shrimp, breast milk, and foie gras in addition to making blends of these meats with plant-based proteins.

Consumers, traditional meat producers, and emerging meat producers continue to spar over what to call this new technology meat.  The US government has joined the naming and labeling battle, and it wants consumer and industry input.  The question is are these cultured cells the same as traditional cells, and therefore should the government permit identical labeling, or does the methodology of growing and harvesting necessitate an alternate naming scheme. 

You might be asking “What’s the beef?”  Why deliberate about a name?  But the debate regarding naming is similar to that of the cattle carcass trimmings that are heated to separate the fat, and hit with ammonium gas to create a product “lean finely textured beef” or LFTB, objectionably known as “pink slime,” which was found to meet the regulatory definition of ground beef and is now permitted to be labeled as such.[2]   Now, when LFTN is added to ground beef, you would never know by looking at the label.  But should “cultured meat” be labeled identically to traditional meat?  Or do the benefits and costs require or permit differences?

Those that advocate for cultured meat claim numerous benefits which are sometimes difficult to quantify. Most often cited is the fact that the demand for animal-based food is increasing at an alarming rate, estimates of an 80% increase from 2006 to 2050, with demand for beef increasing by 95%.[3]  The amount of pastureland, water and other natural resources needed to grow these entire animals for food is grossly disproportionate to the number of calories produced.[4]  Cultured meat would fill the need while reducing the environmental impact. Similarly, without the need for entire animals, ancillary use of pesticides, fungicides, and fertilizers for crops decrease. In addition, cultured meat eliminates much of the discussion regarding animal welfare issues of living on factory farms in close confinement, the subsequent use of vaccinations and antibiotics to reduce disease outbreaks, as well as the possibility of zoonotic pandemics.[5]  Likewise, cultured meat eliminates potential pathogenic contamination from microbes living in animal intestines such as E. coli, Salmonella, and Campylobacter during slaughter.  It also lacks the bacteria found in the digestive tract which create trans fats.[6]  Ultimately, cultured meat offers socially conscious consumers a way to “feel good” about their food choices without requiring a change in diet, the ultimate “having a steak and eating it too.”

Opponents to cultured meat argue it will negatively impact farmers, ranchers, processors, transporters, and the chemical and pharmaceutical industries financially. They disagree that less resources will be used in the production of cultured meat, because animals eat plants that covert energy from the sun, while bioreactors need their own input for cultured meat to grow.[7]  Moreover, cultured meat technology has focused on muscle cells but continues to struggle to incorporate fat cells, blood vessels, nerves and connective tissue, which alter the taste, mouth feel, juiciness, nutrition, and appearance.[8]  One vitamin in particular, B12, which is a product of specific bacteria that colonize the intestines, would be absent.[9]  Difficulties also arise when attempting to create various cuts of meat from various anatomical locations, a chunk roast versus a tenderloin.[10] Likewise, opponents argue that the various types of cells used are difficult to obtain, difficult to keep dividing, and sensitive to changes in the culture media.  Also, the favored culture media is fetal bovine serum, otherwise known as calf blood, which is unacceptable to vegetarians and seemingly unpalatable. These consumer perception and acceptance issues will be difficult to overcome. Various studies are conflicting in terms of whether the technology of cultured meat will be able to overcome notions of unnaturalness, health concerns, food safety, and price.[11]  The arguments for and against are just the tip of the naming dilemma, because the goal in a name is to inform consumers about the nature of the product.

The United States Department of Agriculture Food Safety Inspection Service (USDA FSIS), is the agency in charge of ensuring that meat and poultry products are wholesome, not adulterated, and properly labeled, marked, and packaged.  Specifically, FSIS is tasked with reviewing and approving labels before products enter the stream of commerce, including claims that would say “No Animals Harmed in Creating this Pork Sausage!” And FSIS is, once again, asking for consumer and industry input on naming these various meat products.  The goal is to collect information to enable USDA to promulgate regulations for labeling these products that are based on science, as well as consumer and industry input.  Ultimately these regulations will provide guidance to industry so that it can create labels that are “not false or misleading in any particular” pursuant to current law. This includes conforming to standards of identity (legislatively proscribed recipes or percentages to comply with a specified name[12]) or requiring language and claims on labels that prevent misleading of consumers.

This request for comments originated with a 2018 petition from industry, specifically the United States Cattlemen’s Association, who requested that FSIS limit the name “beef” to those products that “originated from cattle born, raised, and harvested in the traditional manner,” in other words, not cells grown and harvested in a factory.  The petition and subsequent FSIS action garnered over 6000 comments including support positions and comments from national and local Farm Bureau Federations, numerous Cattlemen’s Associations, and many businesses as well as independent farmers and ranchers.  Opponents to the petition argued such points as the fact that new technologies emerge in all areas, but new technologies do not necessitate new naming schemes or standards of identity.  After receiving comments on the petition and conducting a joint public meeting with FDA, additional comments flooded FSIS expressing concerns over lack of guidance for claims on associated packages. In 2020, a secondary petition was filed by Harvard Law School asserting that FSIS should continue to investigate safety, and review proposed labels prior to limiting companies’ first amendment right to speech.  Most recently, the US Governmental Accountability office assessed the information collected and determined that FSIS has collected insufficient evidence to make necessary regulations.

So now FSIS is asking for your thoughts on the following issues for comment:

(Read the full Proposed Rule and request for input at https://www.regulations.gov/document/FSIS-2020-0036-0001)

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?
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? (g.,“cell cultured” or “cell cultivated.”)
   1. How do these terms inform consumers of the nature or source of the product?
   2. What are the benefits or costs to industry and consumers associated with these terms?
   3. 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 (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”)?
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?
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.
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.
6. Should names for slaughtered meat and poultry products established by common usage (g.,Pork Loin), statute, or regulation be included in the names or standards of identity of such products derived from cultured animal cells?
   1. If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate?
   2. Do these names, with or without qualifying language, clearly distinguish foods comprised of or containing cultured animal cells from slaughtered products?
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?
   1. Under what circumstances should these terms be used?
   2. What information would these terms convey to consumers?
8. Should FSIS establish a regulatory standard of identity under its authorities in the FMIA and the PPIA (21 U.S.C. 607(c) and 457(b)) for foods comprised of or containing cultured animal cells?
   1. If so, what would be the standard and how might compliance with the standard be verified?
   2. If so, what would be the labeling terminology for products that do and do not meet a formal standard of identity? What would be the anticipated categories of use? For example, mechanically separated poultry that does not meet the standards of identity outlined in 9 CFR 381.173 may be diverted for production in broths and bases, as well as reaction flavors, e.,flavors produced by the heating of the protein source in the presence of a reducing sugar.
   3. If so, what are the benefits and costs to industry if the standard of identity is established? Please provide quantitative and qualitative feedback in your response and explain the basis of any quantitative estimates.
   4. If so, what are the consumer benefits and costs to the standard of identity recommended?
9. What nutritional, organoleptic (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?
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?
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?
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 sub-listing, or elsewhere on the label?
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?
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?

Be part of the decision-making process before the products are on your table. Go to https://www.regulations.gov/document/FSIS-2020-0036-0001 to read more about the request and click comment on the left side of the page.  USDA-FSIS wants to hear your beef now or forever hold your piece (of meat).

And if cultured meat, labeling, standards of identity, claims, adulteration, GMOs, FSMA, FDA and USDA compliance and enforcement or food laws and regulations in various countries are things you want to or need to learn more about, come find us at IFLR.msu.edu and take our asynchronous semester-long classes, designed for working professionals.  It’s as easy as signing up for a conference.

Disclaimer.

References

[1] https://www.smithsonianmag.com/smart-news/winston-churchill-imagined-lab-grown-hamburger-180967349/#:~:text=Churchill%20wrote%3A%20%22With%20a,separately%20under%20a%20suitable%20medium.%22

[2] https://www.gpo.gov/fdsys/pkg/CFR-2012-title9-vol2/pdf/CFR-2012-title9-vol2-sec319-15.pdf

[3] https://www.wri.org/food

[4] https://gfi.org/cultivated/

[5] https://gfi.org/cultivated/ and https://www.frontiersin.org/articles/10.3389/fnut.2020.00007/full

[6] https://www.sciencedirect.com/science/article/pii/S0924224419310568

[7] https://www.agweek.com/business/4890450-Cultured-meat-Good-or-bad-promise-or-peril

[8] https://www.sciencedirect.com/science/article/pii/S0924224419310568  

[9]https://reader.elsevier.com/reader/sd/pii/S2095311914608819?token=B66193657F7264ADEC92C4C9341DD8221622102D60C120A9F0E6EBA888636A6DC004460157E0C5575BA3B9D91C48D9BA&originRegion=us-east-1&originCreation=20210909093822

[10] https://www.frontiersin.org/articles/10.3389/fnut.2020.00007/full#B10

[11] https://www.sciencedirect.com/science/article/pii/S0924224419310568 (citing other studies)

[12] E.g. to label a product bacon it must be the cured belly of a swine carcass unless qualified and properly identified such as ‘Pork Shoulder Bacon” and “Beef Stroganoff must include 45% beef (or 30% cooked beef), at least 10% sour cream, or 7.5% sour cream and 5% wine, or 9.5% whole milk and 2% sour cream and 2.5% wine.