During the recent Good Food Institute conference on cell-cultured meat, an industry executive remarked that he tries to stay away from politics and focus on his company and developing the technology. That certainly is an understandable approach, especially given the turbulent political climate we are experiencing.
However, considering that this emerging industry is the focus of so much attention and investment, and is attempting to disrupt the status quo while incurring the ire of traditional agriculture groups, politics has a way of finding you in these situations.
Much is being made of this upcoming joint USDA-FDA meeting on cell-cultured meat. While very useful information and data will be exchanged, the meeting likely is being convened mostly as a pro forma exercise. Reportedly, the joint meeting had long been planned, but then FDA jump-started the debate by convening the recent public meeting without inviting USDA to participate. This upset some stakeholder groups and USDA, which supposedly led to a very tense White House meeting in an attempt to broker a truce.
Regardless of the veracity of these rumors, one can only hope that the source of the tension at the White House meeting centered on which agency is better equipped to prevent food-borne illness and protect consumers. However, as we all are aware, when it comes to jurisdictional skirmishes between federal agencies, history tells us otherwise.
The USDA-FDA tension notwithstanding, the FDA public meeting was very informative, and the message from FDA was clear – the agency has the expertise and the infrastructure to oversee these products.
As the process for working through the jurisdictional dilemma continues, stakeholder groups also seem to be trying to sort out their respective issue management strategies in determining how to advocate for their positions.
For instance, while the cell-cultured meat industry mostly appears to support FDA jurisdiction over the technology, there is a thought among the companies that it would be acceptable if jurisdiction fell to USDA’s Food Safety and Inspection Service (FSIS). The rationale for this position is that it would provide them with preemption under the Federal Meat Inspection Act, thus preventing states from imposing barriers to entry for their products.
However, it is very likely that states that strongly support traditional agriculture will create other hurdles for the cell-cultured meat industry. Therefore, the question for them to deliberate is whether these markets should factor into their thought process as they consider their position on jurisdictional authority. If a high concentration of their market will be in states that would be supportive of the technology, then they should consider whether preemption is a legitimate concern, especially if it is their view that FDA is better equipped to oversee this industry.
As for the traditional agriculture stakeholder groups, they have been clear in their belief that cell-cultured meat should be regulated by FSIS, arguing that this type of product should be subject to the same regulations as animal protein products. Just as catfish jurisdiction was a passive-aggressive attempt at imposing non-tariff trade barriers, FSIS jurisdiction over cell-cultured meat would be a passive-aggressive approach to imposing potential barriers to market entry.
Nevertheless, some of the traditional agriculture groups also have asserted that cell-cultured meat should not be labeled as meat, which would be incongruent with FSIS jurisdiction; the more this labeling argument is made, the more it plays into the hands of those who believe FDA is the more appropriate agency of jurisdiction. You cannot help but wonder whether Commissioner Gottlieb’s recent announcement on modernizing FDA’s standards of identity was made with the jurisdictional debate over cell-cultured meat products in mind.
Consumer/food safety watchdog groups have remained somewhat silent on the issue so far. While Food & Water Watch has urged federal agencies, including FDA, to update their existing frameworks for regulating this technology, the group, along with other members of the Safe Food Coalition, have not declared a particular agency preference. It makes sense strategically for these groups to avoid expending resources on a nascent issue, but if the technology reaches the commercialization point, expect these watchdog groups to become more engaged.
Antibiotic resistance – under the radar?
One issue not yet receiving as much attention in this debate is antimicrobial resistance. Proponents of cell-cultured meat argue that these products eliminate the threat of antimicrobial resistance by virtue of being produced in a sterile environment free of antibiotic use.
However, one industry presenter at the FDA public meeting explained that to remove antibiotics and ensure safety of cell-cultured meat, it is important that a facility has a closed system that eliminates the possibility of microbial growth, and limits human interaction within the system. Additionally, the design of the facility must allow for sterilization, as well as constant and regular in-process sampling of cultures to ensure no microbial growth is possible.
This might signal to policy-makers that the threat of antimicrobial resistance is not completely eliminated under this process. If so, the question becomes whether this process would have the potential of creating antibiotic resistant strains of pathogens through overuse if the design of a facility is not perfect. Although this may seem to be an unlikely scenario, the cell-cultured meat industry should prepare in the event policy-makers develop this type of interpretation.
If the focus on antimicrobial resistance issues is elevated in this debate, it might provide additional validation to those who argue that FDA as being the more appropriate overseer of these products. While USDA certainly has a role in the consideration of antimicrobial resistance issues, the FDA has primary jurisdiction.
Congressional action forecast
There has been thought given to the notion that USDA and FDA should be allowed to figure out the jurisdictional issue, thus obviating the need for Congressional involvement. In addition to being highly unlikely that it would happen, it already is too late since House and Senate agriculture appropriations subcommittee members are negotiating a final FY 2019 spending bill that may include language asserting that USDA should have jurisdiction over cell-cultured meat.
If this language does pass, it is unlikely that it will be Congress’ final declaration on the issue; the authorizing committees probably have some strong beliefs and will want some formal input. Another school of thought among a number of congressional staffers that I have spoken with is questioning the eagerness for legislative action given that the technology is far from reaching mass production. It likely speaks to the influence of livestock groups that Congress is seeking to address the jurisdictional issue so early in the technology’s development.
Also, there is another dynamic involving USDA-FDA jurisdictional entanglements in play that has the potential of playing a role in any future negotiations over cell-cultured meat regulations.
Although it may not receive as much attention as the debate over cell-cultured meat products, another jurisdictional dispute being discussed relates to gene-editing in animals. The FDA considers this process to be subject to the statutory and regulatory requirements for new drug applications. However, segments of the biotechnology industry, with support from some livestock groups, believe that, in addition to FDA jurisdiction, the gene-editing process should include an enhanced role for USDA’s Animal and Plant Health Inspection Service (APHIS).
As this debate on jurisdiction over gene-editing in animals progresses, it likely will converge with the escalation of deliberations over cell-cultured meat. If this happens, it is difficult not to envision a scenario within Congress where negotiations and deal-making among engaged and motivated stakeholder groups results in split jurisdictions among the agencies over both issues. For cell-cultured meat products, the recent proposal by Memphis Meats and the North American Meat Institute (NAMI) might provide a starting point for discussions.
The farm bill offers Congress a natural legislative vehicle for this debate. While the opportunity for language to be included in this year’s farm bill may appear closed, an opening may appear if Congress fails to pass it in time and extends current farm bill programs for one year; the additional time might allow for consideration of this issue, especially if the development of the technology, along with the discussion over jurisdictional authority, continues to accelerate.
We are likely years away, if ever, from witnessing the wide-spread commercialization of cell-cultured meat products. However, it behooves stakeholders to position themselves such that they can pivot accordingly as the debate progresses and shifts. Ultimately, the end of this process over determining jurisdictional authority will demonstrate that there is space on the hamburger bun for cell-cultured meat products. It also will demonstrate that there is no avoiding politics either.
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