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Clean meat staking its claim amid regulatory uncertainty

Clean meat staking its claim amid regulatory uncertainty
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As the world’s population balloons, agriculture and science have converged to create sustainable, innovative solutions to food production. The fruits of this “Ag Tech” evolution includes groundbreaking technology that has fomented the production of “clean meat” via cellular agriculture as a viable alternative to conventional animal agriculture. Given the novelty of how clean meat is produced, a key question is which federal agency will take the lead in regulatory oversight.

Clean meatClean or cultured meat refers to meat produced ex vivo, or grown outside the animal, from cell cultures sourced from healthy livestock or poultry. The finished product replicates the characteristics of muscle harvested from food-producing animals.

Product development efforts are well underway across the globe. In 2016, for example, San Francisco-based Memphis Meats unveiled the first meatball produced with clean meat technology. In 2017, Memphis Meats debuted its “clean” chicken nuggets and duck à l’orange. Significant investments from Tyson Foods’ venture capital arm Tyson Ventures, Cargill, Bill Gates and Richard Branson — among others — are helping clean meat start-ups to reduce cost and scale up production.

Clean meat could hit supermarket shelves as early as 2021. Before that happens, clean meat stakeholders must confront regulatory realities. In recent days, both the U.S. Department of Agriculture and the Food and Drug Administration have been on record stating that they think clean meat falls within their regulatory purview. The White House Domestic Policy Council is set to hash out the Administration’s approach in the coming weeks, and the FDA has scheduled a public meeting on July 12 to kickstart the conversation.

Regardless of which agency takes the lead, developing a regulatory pathway for clean meat — preferably one that falls within the existing federal framework — is essential to providing this burgeoning industry with regulatory certainty.

Jurisdiction
USDA’s Food Safety and Inspection Service (FSIS) has jurisdiction over meat, poultry, and certain egg products pursuant to the Federal Meat Inspection Act (FMIA) (21 U.S.C. § 621, et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. § 451, et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. § 1031, et seq.). FDA has jurisdiction over all other food products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301, et seq.). Importantly, the FDCA authorizes the FDA to oversee the safety of all food ingredients used in both FDA and USDA-regulated foods.

Clean meat may be said to qualify as “meat” as USDA currently defines it. At the same time, FDA has significant experience with regulating the introduction of novel foods. Irrespective of whether FDA or USDA takes the lead on clean meat, these foods can be managed within the current statutory framework in a manner that ensures consumer safety and confidence.

USDA-FSIS
Any product that meets the definition of “meat” or “poultry” as defined under current USDA law triggers USDA-FSIS jurisdiction.

In the case of “meat,” USDA adheres to the following definition (9 C.F.R. § 301.2.):

“The 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.”

For USDA’s purposes, meat does not include “the muscle found in the lips, snout, or ears.” Also, the definition specifies meat may not include “significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia.”

Stem cells cultured to produce clean meat are sourced from the species of livestock and authorized parts of the animal enumerated above. Likewise, the stem cells cultured to produce poultry are sourced from the species of domestic birds that qualify as poultry under current USDA regulation (9 C.F.R. § 381.1). The definitions of meat and poultry assume that the finished product sold to consumers is non-living. Clean meat satisfies this “non-living” criterion. On these bases, meat and poultry produced via clean meat technology could be construed as meeting USDA definitions for meat and poultry.

Clean meat may also be said to qualify as “meat food product” under the FMIA. 21 U.S.C. § 601(j) of the FMIA provides:

“[A]ny product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products.”

The definition excludes products that have not historically been considered by consumers as products of the meat industry. The definition does not speak to production method per se. Rather, the key question is whether a reasonable consumer would perceive clean meat to be a product of the meat industry. Analogous reasoning applies to fitting poultry produced with clean meat technology within USDA’s definition for “poultry product” (defined at 21 U.S.C. § 453(f)).

Does the production method matter?
Notwithstanding the novel production method, a case can be made that clean meat and poultry qualifies as “meat,” “meat food products” and “poultry products.” At the genetic and cellular level, clean beef and beef derived from a slaughtered cow share a common source. Unlike plant-based meat substitutes that mimic the appearance and taste of meat but are compositionally directly produced from plants, clean meat is actual animal meat and would be expected to be perceived by consumers as such.

The U.S. Cattlemen’s Association (USCA) disagrees. The USCA contends that clean meat is notmeat within the meaning of the FMIA, and in a recent petition asked the USDA to limit the term “meat” to mean the “tissue of flesh of animals that have been harvested in the traditional manner.”

Clean meat is certainly distinguished by its production method, i.e., it is produced ex vivo rather than via conventional animal agriculture. But new meat production methods do not, per se, alter a products’ status as meat within the meaning of the FMIA. As noted by the Good Food Institute and Memphis Meats in recent comments on the USCA petition, “the methods used to raise and kill animals for food have significantly evolved over time, and current production today would have been unthinkable to previous generations.”

Over the years, USDA has deemed various new technologies as acceptable to produce meat for food, effectively interpreting its existing regulatory framework as one which accommodates innovations in meat production practices. Perhaps the clearest example is cloning technology. The FDA collaborated with USDA using existing authorities to evaluate the safety and suitability of cloning technology. The end result was that FDA found meat derived from cloned animals to be safe and USDA accepted the product as meat within the meaning of the FMIA. The FDA and USDA worked together. FDA assessed the safety of meat derived from cloned animals. Once the science was settled, the labeling and marketing of clone-derived meat landed at USDA’s doorstep.

USDA did initially recommend a voluntary moratorium to support consumer acceptance of meat derived from animal clones and clone progeny, but this had no bearing on the agency’s acceptance of the product as meat. The use of cloning and clone progeny for meat production of course differs from conventional animal agriculture production. But FDA aptly explains that “cloning could be thought of as an extension of the assisted reproductive technologies that livestock breeders have been using for centuries.” Importantly, both USDA and FDA have found that meat sourced from cattle, swine and goat clones are no different than food from conventionally bred animals, “and therefore do not require special or different labeling.” USDA has not issued new rules specifically tailored to the production and marketing of clone-derived meat and poultry.

USDA could apply this thinking to clean meat — that is, clean meat is no different from meat from conventionally bred animals. Doing so would represent a consistent approach to regulation that fosters innovation.

Historically, it has been possible to regulate the products of biotechnology within the existing federal framework. One example is federal regulation of plant-based food products developed using novel tools of biotechnology. FDA’s Biotechnology Policy, published in the Federal Register in 1992, was created to clarify FDA’s interpretation of the FDCA for food products developed using novel tools of biotechnology. Rather than issue a new set of rules expressly for biotech foods, FDA simply chose to develop this policy to support an innovative approach to food production. Core to FDA’s policy is the agency’s stance that foods produced via the novel tools of biotechnology, including products of intentional genetic alteration, have the same objective characteristics and are just as safe as conventionally produced foods.

Clean meat is certainly distinct from plant-based biotech foods with respect to how the food is produced and its fundamental identity. But like plant-based biotech foods which are equivalent to their non-biotech counterparts, clean meat possesses the food and nutritional characteristics of slaughtered meat. Cellular agriculture has no adverse bearing on product quality or safety. Assuming USDA concurs that clean meat is safe and equivalent to traditionally sourced meat, the agency could conceivably interpret the FMIA and the PPIA to encompass clean meat and poultry.

Challenges with a USDA approach to regulationThe challenge for this emerging industry — insofar as a USDA-managed approach is concerned — lies primarily in the breadth of USDA’s inspection requirements.

Inspection oversight forms a key aspect of USDA regulation. FSIS maintains an ongoing inspection presence in meat packing and processing facilities.

Pre-market inspection for clean meat could be construed as an unnecessary regulatory burden, particularly because many of the safety concerns present in traditional meat slaughter and processing do not apply to the clean meat production paradigm. Nevertheless, clean meat producers may find it desirable from a marketing standpoint to have their products bear the USDA inspection legend like traditionally sourced meats. Due to the manner in which clean meat is produced, if USDA moves forward with pre-market inspection for clean meat, new, science-based inspection standards to ensure safety and facilitate innovation should be developed in consultation with industry and the FDA. This could mean undertaking an administrative rulemaking for requirements tailored to clean meat.

FDA
FDA appears poised to take the lead on clean meat. In announcing the upcoming public meeting, FDA noted that it “has extensive experience applying its existing authority flexibly and effectively to rapidly evolving areas of technological innovation such as plant biotechnology” and looks forward to sharing its “experiences in evaluating and ensuring the safety of novel technologies in the food sector at this upcoming public meeting, while … also discuss[ing] these issues with, and gather[ing] relevant data and information from stakeholders.” Along similar lines, this past spring, FDA stated that “it seems reasonable to think that cultured [i.e., clean] meat, if manufactured in accordance with appropriate safety standards and all relevant regulations, could be consumed safely.”

The FDA’s June 18 press release announcing the July 12 meeting states that “[u]nder the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article. Thus, as a starting point, both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to the FDA’s jurisdiction.” Pronouncements like this could be an early indication that FDA will seek to place clean meat squarely under its jurisdiction.

In any novel biotech space, the largest threat is regulatory uncertainty. FDA’s willingness to hear from novel product producers directly, consider their input, and offer reasonable pathways to market using existing authority is incredibly innovative and welcome.

FDA premarket oversight compared to USDA
A key difference between FDA and USDA-FSIS oversight is the level of premarket inspection. For FDA, the Food Safety Modernization Act (FSMA) mandates inspection frequency based on risk for food facilities. Rather than risk, USDA-FSIS interprets its statutory mandate to mean that FSIS inspectors must be physically present at every FSIS-regulated establishment during that establishment’s operating hours regardless of risk. FDA-regulated producers are not subject to the same level of premarket inspection as USDA-FSIS regulated establishments.

What an FDA program might look like
Under the traditional FDA approaches to regulation, producers can opt to engage in voluntary premarket reviews to assure consumer confidence. FDA’s Biotechnology Policy could serve as a blueprint for FDA’s approach to regulating clean meat. This policy provides for a voluntary consultation process through which developers may consult with FDA to address safety, nutritional, and related issues for a given bioengineered food. This voluntary mechanism affords developers the opportunity to have FDA review its scientific and regulatory assessment. If the review does not raise any safety or regulatory concerns, FDA issues a “No Questions” letter. FDA maintains a publicly available database of all biotech foods that have been the subject of this voluntary review. Applying this approach to clean meat could be a prudent step from a consumer relations standpoint to demonstrate that clean meat is just as safe as traditionally sourced meat.

In any event, FDA will have to develop a regulatory approach for clean meat additives, i.e., the cell culture medium constituents. Because FDA is charged with regulating food additives for all foods — subject to USDA or FDA jurisdiction — industry should engage with the FDA early on and establish the safety of the cell culture medium constituent additives required to promote the growth of clean meat to the extent any such constituents are not approved as food additives or deemed generally recognized as safe (GRAS). Clean meat producers may consider a voluntary submission to FDA via the GRAS Notice review process to support the safety of the culture medium feedstock that promotes the growth of the clean meat product. This assumes, of course, that FDA will not require the submission of a food additive petition to establish the safe use of the culture medium constituents.

Skirting regulatory uncertainty
Assuming clean meat and poultry fit within the existing statutory definitions, USDA-FSIS would be charged with regulatory oversight.

But given the novelty of clean meat and poultry and FDA’s extensive experience with regulating novel foods and production methods closely analogous to the clean meat paradigm, FDA and USDA could enter into a Memorandum of Understanding (MOU) transferring regulatory oversight to FDA.

Such an MOU would not be without precedent, but could require limited congressional action. In a reverse scenario transferring jurisdiction from the FDA to USDA, catfish became subject to USDA-FSIS jurisdiction due to congressional mandates in the 2008 and 2014 Farm Bills. The 2008 Farm Bill amended the FMIA to make “catfish” a species amenable to the FMIA and, thus, subject to FSIS inspection. The 2014 Farm Bill amended the FMIA to remove the term “catfish” and to subject “all fish of the order Siluriformes” to FSIS jurisdiction and inspection. A subsequent MOU between the USDA and FDA facilitated the transfer of jurisdiction from FDA to USDA-FSIS. Seafood is otherwise subject to FDA oversight. It remains to be seen whether the regulators will follow a similar path for clean meat – but, in this case, to transfer jurisdiction to FDA.

Conclusion
Clean meat is set to stake out its place in the American marketplace. Before it hits American grocery shelves and dinner plates, industry must work with FDA and USDA to map out an appropriately tailored regulatory approach that gleans insights from prior collaborations between these agencies that is both transparent and readily understood.

Assuming clean meat and poultry are accepted as fitting within USDA’s regulatory definitions, narrowly tailored congressional action could transfer oversight to FDA. On the other hand, if USDA takes the lead, to avoid the criticism that USDA jurisdiction sets an unnecessarily high pre-market inspection bar, USDA could design an inspection program in consultation with FDA and industry that is tailored to clean meat production.

The question of jurisdiction cannot properly be addressed without stakeholder feedback as some legislators recently sought to do via an Agriculture Appropriations bill. Rather, FDA, USDA, policymakers and industry must work together to develop a science-based solution within established legal frameworks as has been done in past cases involving novel foods. Any legislative alternative should be expressly designed to foster continued innovation in this burgeoning sector.

About the author: Brian P. Sylvester, former USDA regulatory lawyer and special counsel in Wiley Rein’s Food, Drug and Medical Device Law Practice, advises emerging and established companies in the food, beverage, and agricultural biotechnology sectors, with an emphasis on innovative foods.

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