More Guidance and More Questions: Initial Oversight of Animal Cell Culture Technology
By Robert Hibbert and Amaru Sanchez
On March 7, 2019, as promised and on time, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued an agreement describing in some detail the division of responsibility between the two agencies over the emerging and much-talked-about category of human food produced using cell culture technology derived from cell lines of USDA-amenable species of meat and poultry. The document contains no real surprises and, as is often the case with such materials, tends to raise as many questions as it answers. Nonetheless, it provides the clearest delineation to date on the particulars of just how the safety, suitability and marketing of such products is to be overseen by the two agencies.
At the outset, it may be useful to start with some basics. While FDA at the federal level maintains jurisdiction over the safety and labeling of most food products, primary jurisdiction over meat and poultry falls to USDA’s Food Safety and Inspection Service (FSIS). There are fundamental differences between the two systems of oversight, the most significant being that FSIS is required to maintain a continuous, day-to-day presence in meat and poultry production facilities, while no such requirement applies to FDA-regulated foods. The issue of agency jurisdiction for the emerging cell culture industry thereby hinges upon whether the products in question can be said to conform with those established definitions of meat, poultry, and other related terms, as overseen by FSIS.
Controversy surrounding such questions broke the surface this past summer when FDA took steps, including the initiation of a public meeting, to assert itself in this area with a limited reference to any role for FSIS. Ensuing pushback, rooted in the livestock in meat and poultry processing industries, began moving the issue in a different direction, and, after additional public meetings, comment and passage of the recent Farm Bill, the process leading to the March 7 publication took shape. As the March 7 document indicates, the agencies have set forth their shared commitment to ongoing cooperation, to provide for comprehensive and coordinated oversight, and for a joint process to identify any changes needed to statutory or regulatory authority.
To properly assess the March 7 document, it may be useful to separate pending issues into three separate areas: 1) premarket review (how such products are to be evaluated before being allowed to move into production for human food purposes); 2) ongoing oversight (supervision of actual food-processing operations); and 3) marketing (how the product is to be labeled and advertised in commerce).
Under the agreement, FDA takes the lead in this area. The agreement specifies that FDA will be responsible for conducting a premarket consultation process to evaluate production materials and processes in manufacturing controls, including the oversight of tissue collection, cell lines and banks, and all components and inputs. Further, FDA will oversee proliferation and differentiation of cells through the time of harvest. Within this area, it reserves the right to conduct appropriate inspections and follow-up activities, initiate enforcement actions, and provide addition regulation and guidance as appropriate. Finally, at harvest, FDA will be responsible for coordinating transfer of oversight to FSIS, including providing information necessary for USDA to determine whether such materials are eligible to be processed into meat or poultry products.
Once this transfer has occurred, USDA takes over and presumably incorporates the oversight of production of these foods into its established inspection system. As noted above, this entails the requirement of continuous inspection, as overseen by the daily presence of a federal inspector, as well as the establishment and application of an effective Hazard Analysis and Critical Control Points (HACCP) program. Products that successfully move through such systems are to be eligible for the USDA mark of inspection identical to that being applied today to traditional meat and poultry products available in the marketplace. Note, however, that this regime will not be applicable to all cell-cultured protein products. With limited exception, all seafood products remain under FDA jurisdiction, which mandates its own HACCP requirement but does not require or provide continuous inspection.
Last, but by no means least, FSIS commits itself in the document to develop, as needed, additional requirements to ensure the accurate labeling of the human food products derived from the cultured cells of livestock and poultry.
Where Things Stand
While the initial clarification of FDA’s premarket gatekeeper role is welcomed and not surprising, it opens the door to another layer of specific, yet-to-be answered questions. A few would be: What is the specific nature of the premarket evaluation process? What will be the time line for any review? Will FDA be issuing any sort of affirmative sanction of such product as opposed to the absence of any objections? Will any type of acceptance, either through an active or passive process, be attached to a particular production facility, a particular class of product, or some other distinction? Will new regulations need to be promulgated before any of this takes place?
In prior discussions, FDA has pointed to existing procedures such as the Generally Recognized as Safe notification program, food contact notification procedures, and new technology guidelines as points of reference, while also suggesting that a new process, focusing upon variables unique to this industry, needs to be crafted.
Inspection Oversight Issues
Once the transfer of eligible cell material has occurred and what is deemed to be meat and poultry processing begins, the FSIS inspection will presumably apply to all forms of further food processing of these materials. The constants in this equation thus include continuous inspection and mandatory HACCP. But there are clearly underlying complications and nuances. It is noteworthy, for example, that FDA’s statement of responsibilities includes providing FSIS with information necessary to determine whether harvested materials are eligible to be processed into the meat and poultry products. This suggests the need for some affirmative endorsement of safety by the agency, which is something FDA does not typically do. It also bears mention that all meat and poultry items for further processing subject to FSIS inspection must be derived from the carcasses of animals that have also been subject to both pre- and antemortem inspection by that same agency. If, when, and how this particular issue is to be addressed in the cell cultured arena raises, and by no means answers, its own set of scientific and legal riddles.
What has probably engendered the most debate in this area are questions about how these products are to be identified and labeled within the marketplace, more specifically, whether they can maintain access to the traditional terminology (i.e., “ground beef” or “sliced turkey”) applied to such products, as well as whether they should be further differentiated in some other fashion. At one extreme, some proponents of the new technology have asserted that the finished product itself will ultimately have characteristics identical to traditional items and thus can be identically labeled. At the other extreme, it is argued that traditional meat and poultry items are apples, and cell cultured products are oranges, and they need to be fully differentiated as such.
Another underlying question is whether, independent of any determinations by FSIS on such question, different policies will be advanced at the state level. As has been widely reported, there has been a spate of recent legislative activity centered in states with significant local livestock industries, advancing the view that such traditional terminology should only be applicable to products derived from the carcasses of live animals. While activity will doubtlessly continue, it appears directly contrary to the clear federal preemption that attaches to the labeling of any meat and poultry products under FSIS jurisdiction. Once again, seafood products are a bit of a wildcard in this area, since they do not enjoy the benefits of such clear statutory protection.
Issuance of the March 7 document is a useful and valuable step forward on this issue. It commits both agencies to a cooperative approach to these issues, drawing upon their respective areas of expertise and jurisdiction. As this article indicates, however, a host of additional details must be resolved prior to the marketing of this much-discussed new category of food products.
Morgan, Lewis & Bockius LLP partner Robert Hibbert, Esq., and associate Amaru Sanchez, Esq., advise clients in the food and agricultural industries on federal regulation. This article is provided as a general informational service and should not be construed as imparting legal advice on any specific matter.
2. 21 U.S.C. Chapter 9, Subchapter IV.
4. 21 U.S.C. §§ 455, 602-606.