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Since the present isn’t looking so peachy, today we distract ourselves with a peek into the future, where cell-cultured meat may help save the planet from environmental destruction and nourish the multitudes with safe, high-quality protein. Or maybe just feed us a $600 burger.

The U.S. Government Accountability Office (GAO) recently issued a report to Congress detailing the ways the GAO believes the “FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat“. We’ll leave the bureaucratic details of the GAO’s regulatory recommendations to those who like to study that sort of thing. Instead, we’ll take a look at the facts of, and opinions about, the current state of the cell-cultured meat industry, it’s uncertain potential, and unresolved issues (including safety and nutritional value), reported by the GAO after what appears to be a fairly exhaustive, 2-year information-collecting mission conducted in the service of making its recommendations.

No company is actually selling cell-cultured meat to the public yet, but there are about two dozen firms worldwide, 11 in the U.S., working to bring it to market. There are varying estimates as to when that might actually happen: some suggest as soon as this year, others say 2-4 years. Hence, the Fed’s efforts to try to figure out just how to regulate cell-cultured meat, including whether it should be called “meat” at all. So far, the FDA and USDA have preliminarily agreed that the FDA will oversee the early phases of growing cell-culture meat through the point of harvest (processes we’ll get to in a moment). During harvest, the FDA will transfer regulatory oversight to the USDA, which will assume regulatory control of cell-cultured meat through the food-processing phase (making cell-cultured meat into, say, a sausage or a fish stick), including labeling.

Making “meat”

Whatever the ultimate regulatory decision is on a name, for its purposes the GAO calls the product “cell-cultured meat” (so we will too), defined as

food derived from animal cells grown in an environment outside the animal. . . [C]ell-cultured seafood is a subcategory of cell-cultured meat.

According to the GAO, general information about the process of making cell-cultured meat is available, but specific information about the technology being used, eventual commercial production methods, and the final products are unknown, partly because companies fear competitors getting ahold of their trade secrets and partly because these processes are still in development.

Here’s what we do know, per the GAO. The general process of cell-cultured meat production, which sounds both scientifically fascinating and a bit dystopian, includes five phases:

Cell-cultured meat production

Biopsy: Collecting rice-sized tissue samples from an animal following “specific laboratory sanitation procedures”, which may involve antibiotics. As best I can tell, the plan is to use slaughtered animals for biopsy, although that is not specifically stated.

Cell-banking: Biopsied cells “with the most desirable traits” are selected from existing cells for use either as is or in genetic engineering, either immediately or frozen for later use. “Desirable traits” can include reduced cholesterol or fat content or other nutritional traits, as well as those resilient to environmental factors like temperature. This phase gives producers an opportunity (according to them) to ensure that source cells are free of pathogens and other contaminants.

Growth: Cells are placed into a bioreactor to divide and differentiate in a growth medium that may include glucose, amino acids, hormones, and other growth factors. It also includes nutrients to “feed” the cells. Cells may require attachment to a structure to grow on, called a “scaffold”. (With no scientific background, “bioreactor” sounds to me like something from Star Trek.)

Harvest: Once a piece of cell-cultured meat reaches the desired size, it is harvested. If the scaffold is edible, the product can be left attached; otherwise it must be separated from the scaffold.

Food processing: The cell-cultured meat is prepared into a product “such as meatballs or chicken nuggets” or perhaps, as the technology becomes more sophisticated, chicken breasts or steak.

As they say, the proof is in the pudding, so I’ll withhold judgment until I’ve actually tasted cell-cultured meat, but at this point: Yuck!

The known unknowns

In an (ironically) chicken-and-egg situation, the FDA and the USDA are somewhat hamstrung by their lack of knowledge about cell-cultured meat manufacturing in deciding how to regulate the industry. On the other hand, the industry says it needs guidance from the agencies on how they intend to regulate in order to adapt their processes accordingly.

According to the GAO, many questions remain unanswered.

Tissue collection: Researchers don’t know enough to accurately estimate how much cell-cultured meat can be produced from a single biopsy of animal tissue. The Feds haven’t told industry what standards the animals will have to meet to be eligible for tissue biopsies. For example, will an animal meeting government standards for conventional processing be sufficient for tissue biopsy, or will there be additional, or altogether different, requirements?

Genetic engineering: The FDA and some industry reps say it’s “likely” that firms will use genetic engineering in production. Other industry reps told the GAO that they are undecided. Part of the problem is the lengthy wait for regulatory approval where genetic engineering is involved; genetically engineered salmon took approximately 20 years. This regulatory uncertainty, in turn, affects the ability to attract and retain investors.

Antibiotics: According to the Feds, use of antibiotics in commercial production and the potential for residues in the final product represents “a significant concern for food safety and public health”, although they felt antibiotics would not be used beyond the cell-banking phase. Industry reps differ on whether they’ll use antibiotics and some have not made a decision.

Growth medium: Although industry reps say they have not finalized the medium they will use in cell production, the ingredients used could affect the end product’s composition and raise safety concerns. The FDA, for example, says that it would likely do a premarket evaluation of some residual growth factors, like hormones.

Scaffold: If the scaffolding is edible, its composition may need to be evaluated for safety. Chemically separating the product from inedible scaffolding during production may also require a safety evaluation.

Production costs: Industry reps told the GAO that the “high production cost of cell-cultured meat is a key industry challenge”, the growth medium being one of the biggest cost drivers. One firm said it cost $600 to make a cell-cultured hamburger patty and some $1,200 to produce a single cell-cultured meatball.

Safety considerations: According to federal officials, “residues and constituents in harvested cell-cultured meat would be expected to be different from those in conventional meat, depending on the details of the production process” although no one yet knows whether any of this will pose hazards not present in conventional meat.

Product composition: Cell-cultured meat products, at least initially, won’t likely be composed entirely of cell-cultured meat. Instead, they will include binding, flavorings, and plant-based materials used in conventional foods. In fact, one firm’s prototype was 90% plant-based, although the aim is to “produce products that contain more cell-cultured meat than other ingredients” and, long term, produce something similar to conventional cuts of meat, like steaks.

Environmental, animal welfare, and health impacts: Some companies and researchers have made as-yet unsubstantiated claims that cell-cultured meat offers environmental, animal welfare, and health advantages over conventional meat. These include using less water and emitting less greenhouse gasses (although that certainly seems logical), eliminating animal slaughter (except those needed for biopsy), and providing fewer opportunities for contamination with foodborne pathogens.

Labeling: Industry is concerned that what you call cell-cultured meat can reflect bias for or against the product which, in turn, affects consumer response. For instance, would you likely buy “clean meat”? How about “lab-grown meat”? “In-vitro meat”? This has put conventional meat producers on the offense. In 2018, the U.S. Cattlemen’s Association petitioned the USDA to limit the terms “beef” to products “born, raised, and harvested in a traditional manner” and “meat” to “tissue or flesh of animals that have been harvested in the traditional manner”. (I suppose they didn’t want to use the terms “killed” or “slaughtered”, hence “harvested in the traditional manner”.) Although it has yet to respond to the petition, which received over 6,000 public comments, the USDA says it’s committed to a public process, likely rulemaking (which can take years), for developing labeling requirements. To confuse matters (as happened with “Right-to-Try” laws), some states are enacting their own requirements, Missouri, for example, prohibits both plant-based and cell-cultured products from being labeled as “meat”.

Consumer acceptance: Finally, according to the GAO, people it interviewed and studies it reviewed “cited consumer acceptance as a challenge for commercializing cell-cultured meat.”

For my part, I will not be ordering the $600 hamburger. However, if and when a reasonably-priced cell-cultured meat product comes to market, I will sample it, but only with an appropriately matched wine.

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Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.