Institute for Food Laws and Regulations

Scott Haskell teaches the online course “Animal Health, World Trade, and Food Safety” each fall semester, and "The Law of the Preventive Controls for Human Food Rule" each spring semester.

Plant-based ‘meats’, ‘meat’ analogues, cell-based cultured ‘meat’, and edible insects/worms, can be major meat alternatives in our food supply as well as in pet foods. These meat replacement alternatives reflect an ever-changing consumer palate. ‘Meat’ replacements are the wave of the future for many human and pet foods. Within this new industry, technical difficulties of mass production, cost of product development, quality control and palatability, legal and regulatory guidance are key impediments for the pet food industry. With an ever-growing global vegetarian and vegan human consumer base, pets are next in line for the consumption of meat alternatives. Plant-based (‘meat’ analogues derived from plant proteins) and cultured cell-based (‘meat’ derived from cell cultures) products will provide new and advanced industry alternatives requiring regulatory alternatives to enhance our current system of production.

Plant-based ‘meat’ (PBM) and cell-based ‘meat’ (CBM) are new and/or revitalized approaches to human and animal ‘meat’ production. Novel food alternatives are being commercialized with improved and enhanced sensory characteristics reflecting consumer attitudes and demands for the final product.

“Cellular Agriculture” is at the forefront in developing sustainable animal meat alternatives.  Cellular agriculture has opened an entirely new industry producing ‘meat’ and protein commodities based on both animal and plant cellular components. Though industry evidence suggests a ‘healthier’ final product, it is necessary to evaluate the impacts of PBMs and CBMs comprehensively and scientifically on human and pet health, potential cell-culture issues and the environmental effects of these novel production processes.

The Pet Food Institute estimates that more than 180 million dogs and cats live within U.S. households. Additionally, the American Pet Products Association reports that Americans spent more than $42 billion on pet foods and treats in 2020. With this vast economic base, expansion of meat alternatives is in part the future of global pet foods.

Many individuals within the animal food industry believe that the production of meat alternatives will continue to increase within the pet food market share. Currently, marketed ‘meat’ analogue products are generally plant-based ‘meat’ which has been engineered to have similar tastes and textures of meat. It is most often prepared from a soy protein base with additional novel ingredients added for taste and texture (e.g., mycoproteins and soy leghemoglobin).

Five current protein rich alternatives to natural meat are utilized in the pet food industry: tofu (curd product made from mashed or processed soybeans), legumes and plant byproducts, seitan (wheat gluten), lab-grown or cultured ‘meat’ of animal tissue cells (CBM), and potentially insects.

Existing technology is also expanding lab-grown or cultured meat alternatives into our pet foods. Consideration of current limitations include cost-effectiveness, unknown government regulations, public acceptance, reproducible quality, current culture techniques and reliable production are issues that will need to be addressed for large scale commercial production to expand. However, food safety should be a top priority with each production step from cellular collection to marketing of the final product. Therefore, as a necessary step, regulatory frameworks need to be developed and put in place alongside these production and marketing goals.

The current process for growing/cultivating CBM is a complex procedure. Animal cells are either harvested from recently slaughtered or live animals. These cells are then scientifically cultured and grown in the laboratory as they mature and differentiate. This differentiation allows the ‘meat’ to develop defined textures and recognizable cellular formation. The cellular maturation process requires the cells to be placed into a nutrient-rich broth supported by ‘scaffolding’ which allows the support in a growth promoting medium. This ‘meat’ will then be harvested at a designated end stage of growth.

How do we regulate pet food CBM which can contain precursor cells from any commercial species (e.g., beef, swine, poultry, and fish/shellfish)? For PBM and CBM ‘meat’ to be successful in both human and animal food, there must be an efficient and comprehensive regulatory pathway developed on a domestic as well as global basis. In 2019, “the United States Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) released a formal agreement outlining their respective regulatory roles for livestock and poultry ‘meat’: FDA will oversee the earlier stages of cultivated ‘meat’ production and the USDA will ensure safety in the later stages.”

CBM oversight will involve the monitoring of actual production practices, labeling, packaging, and marketing of the products. The USDA and the FDA will jointly regulate CBM products. Additionally, the FDA will regulate the culture process (e.g., cell collection and isolation, cell storage, growth and culture and final maturation of the final product). Post-production harvested cells and tissues will be monitored by the USDA. Cellular scaffold materials should be controlled by the FDA food additive provisions. Additionally, three interagency working groups have been developed specifically addressing CBM and PBM production.

The FDA also has sole regulatory authority over most cultivated seafood, they have released a request for information seeking input on cultivated seafood labeling.

Check out this 20-minute overview presentation of FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products.

Industry needs governmental assurances that cultured ‘meat’ will be regulated responsibility to allow for global competition and expansion.

Cell-based ‘meat’ companies argue that their product is meat and should be regulated just like commercial meat. (This 2018 Wired Magazine article summarizes the perspective of various stakeholders: What is meat?)

The USDA Food Safety Inspection Service (USDA-FSIS) defines meat as “part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing.

Additionally, the FSIS clarifies that meat or meat products are ‘misbranded’ if: “labeling is false or misleading in any particular; if it is offered for sale under the name of another food; [or] if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word ‘imitation’ and immediately thereafter, the name of the food imitated.”

7 C.F.R. § 66.1 (proposed), defining “bioengineered food” to mean “a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature”. 7 CFR § 66.1

Canada, Australia, and New Zealand have each introduced legislation and regulations concerning guiding and regulating the production of novel foods. Within the EU, regulations and policies are supportive of “alternative proteins”. The 2018 “EU Protein Plan” presented by the European Commission to encourage the creation and production of alternative protein sources that “provide options for strengthening the development of EU-grown plant proteins”. Many of these novel PBM and CBM products are classified under the EU Novel Food Regulation which regulates “food that has not been consumed or do not exist in the EU before 15 May 1997”.

There are lots of potential scientific issues associated with PBM and CBM products to be successful within the pet food industry. These challenges include developing improved laboratory production techniques. ‘Scaffolding materials’ are important in the tissue culture process of CBMs. These scaffolding materials are essential to ‘shape’ the ‘meat’ into the final palatable tissue product. Additionally, improved cell lines and nutrient media for cell growth are essential to continued success. ‘Bioreactor platforms’ are also necessary for large scale cellular production. The safety of each stage within this process must be assessed by the FDA to ensure the product is safe for final human and pet consumption. Finally, will our pets consume these end products at a cost that is affordable to the consumer? This appears likely thus far.

How about regulatory issues? A lack of federal guidance, indeterminate legal definitions and minimal industry inclusion surround this production process. The big question concerning food safety: are harvested animal cells adequately covered by existing regulatory definitions of meat or will new rule-making and definitions be required for human and pet foods? How will appropriate product labeling be addressed for pet food products? Will CBM products be monitored the same as existing animal feeds through FSMA (Food Safety Modernization Act)?  

The FDA through FSMA has established necessary ‘baseline’ current pet food industry standards; how do CBM products fit into these existing standards? How will the AFFACO (The Association of American Feed Control Officials) Safety and Utility Standards (“Any ingredient or additive used must have its nutritional or technical purpose established through a legally-recognized due process. An ingredient must be used within the limits of its established safety and utility.”) apply to these new novel foods?

Will the USDA’s authority over the culture, production, harvesting and labeling of cell-cultured products reflect global standards as well? Currently the USDA-FSIS is the regulatory body overseeing and regulating most aspects of the food safety and labeling of poultry, certain egg products and traditional (non-game) meats under its authority through the Federal Meat Inspection Act (FMIA). The USDA-FSIS does define the term “meat”; however, FMIA does not. Although FMIA does defines a “meat food product” as “any article capable for use as human food which is made wholly or in substantial part from meat or other portion of the carcass of any cattle, sheep, swine, or goats.” Additionally, it defines “prepared” meat as a product that has been “slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.” A food product is “misbranded” under FMIA if its “labeling is false or misleading in any particular.” In this case, the FMIA definition represents differing terminology from that of the USDA-FSIS.

There is currently an effort to prevent CBM products from being labeled as meat by livestock organizations and processors. Based on the FMIA, there may be justification for CBM to retain its wording as meat. The North American Meat Institute has concluded that CBM products most likely fall into the definitions of either “meat” or “meat byproduct”. Within the European Union, CBM is most probably included within the European Union Novel Food Regulation pathway, 32015R2283 - EN - EUR-Lex - European Union

As with the role of facilities inspection by the USDA-FSIS, will they be required to inspect laboratories culturing ‘meat’ cells for food safety on a regular basis suggesting the current inspections of slaughter plants? The USDA-FSIS currently has existing rules applying only to establishments “in which any products of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale as articles of commerce, which are intended for use as human food.” Will this apply to cell-cultured ‘meat’ products?  Will a new provision be developed and implemented? How will this relate to animal feed? However, this current USDA-FSIS provision appears that it cannot be utilized or applied to cell-cultured products in the current form. It seems evident however, that food safety inspection of CBM laboratories growing, and handling facilities should be less involved and more readily transparent than conventional processing.

The pet food industry represents a strong, growing, and robust global economy. As pet food PBM and CBM technology advances, expands, and consumer interest of cell-cultured ‘meat’ escalate, global regulatory authorities are being asked to address key questions and develop and implement novel regulations. Is the PBM and CBM regulatory status under existing governmental oversight statutory authorities adequate? Are global cell-culture ‘meat’ safety issues different than current concerns? Appropriate cooperative federal approaches to support and monitor cell-cultured pet foods are essential. We need to help avoid conflicting regulatory requirements to ensure that this new industry remains competitive and productive. Industry scientists, product developers, manufacturers, marketers, and consumers all are awaiting regulatory guidance. Cooperation between FDA and USDA is a start in this process. Improved legal guidance is essential for all connected parties. As policy direction for CBM and PBM ‘meat’ products enter the pet food industry now is the time to direct safety and quality assurances. Well planned regulations are the key to industry success.

Disclaimer.

References

Kettenmann, S, Lamb, B. (2020) New Regulatory Frameworks for Cell-Cultured Meat. American Bar Association https://www.americanbar.org/groups/environment_energy_resources/publications/natural_resources_environment/2019-20/spring/new-regulatory-frameworks-cellcultured-meat/

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 doi: 10.5187/jast.2020.62.2.111. Epub 2020 Mar 31. https://pubmed.ncbi.nlm.nih.gov/32292920/

USDA 7 C.F.R. § 66.1 (proposed), defining “bioengineered food” to mean “a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” https://www.law.cornell.edu/cfr/text/7/66.1

Possidonio, C., et al. (2021) Consumer perceptions of conventional and alternative protein sources: A mixed-methods approach with meal and product framing Appetite 2021 Jan 1;156:104860. doi: 10.1016/j.appet.2020.104860. Epub 2020 Sep 8. https://pubmed.ncbi.nlm.nih.gov/32916208/

Dolgin, E. (2019) Sizzling interest in lab-grown meat belies lack of basic research Nature 2019 Feb;566(7743):161-162.doi: 10.1038/d41586-019-00373-w. https://www.nature.com/articles/d41586-019-00373-w

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Dodd, S, et al., (2019) Plant-based (vegan) diets for pets: A survey of pet owner attitudes and feeding practices. PLOS ONE https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0210806

YouTube Cleaner, safer, more responsible pet foods. https://www.youtube.com/watch?v=s36v9wPUong

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https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181301

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U.S. Dep’t Agric., Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the Regulation of Cell-Cultured Food Products from Cell Lines of Livestock and Poultry, Release No. 0248.18, Nov. 16, 2018, available at https://www.usda.gov/media/press-releases/2018/11/16/statement-usda-secretary-perdue-and-fda-commissioner-gottlieb.

Kumar, P. et al. (2017) Meat analogues: health promising sustainable meat substitutes. Crit. Rev. Food Sci. Nutr. 57, 923–932 (2017). https://www.researchgate.net/publication/274705760_Meat_Analogues_Health_Promising_Meat_Substitutes

Khandpur, N., Martinex-Steele, E (2012) Plant-Based Meat and Dairy Substitutes as Appropriate Alternatives to Animal-Based Products? J Nutr 2021 Jan 4;151(1):3-4.

doi: 10.1093/jn/nxaa351. https://academic.oup.com/jn/article-abstract/151/1/3/6029136?redirectedFrom=fulltext

FSMA Final Rule for Preventive Controls for Animal Food https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food#:~:text=This%20rule%20requires%20animal%20food,minimize%20or%20prevent%20those%20hazards.

Draft Guidance for Industry #239 entitled "Human Food By-Products for Use as Animal Food" https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM49 9201.pdf

https://www.fda.gov/food/guidanceregulation/fsma/ucm253380.htm

CFR - Code of Federal Regulations Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=507.3