On September 2, 2021, the Food Safety Inspection Service (“FSIS”), an agency housed within the United States Department of Agriculture, released an Advanced Notice of Proposed Rulemaking (“Notice”) requesting comments to help guide FSIS in drafting a proposed rulemaking on the labeling of cell cultured meat and poultry products.
Background
Cell cultured meat, also known as “lab-grown” or “slaughter free” meat, is a product created from animal cells in a laboratory. FSIS, in the Notice, refers to such foods as cultured meat and poultry products or as products comprised of or containing cultured animal cells. Production of cell cultured meat involves taking muscle, fat, or stem cells from an adult animal and placing them in nutrient-rich fluid. Within the fluid, the cells begin to multiply. These groups of cells then start to grow around a structure known as “scaffolding” which helps the cells take on a particular shape. The desired result is a product made from animal cells that looks and tastes like traditionally harvested meat and poultry. On December 19, 2020, the first cell cultured chicken product was sold and served at a restaurant in Singapore. Cell cultured beef on the other hand, has yet to hit the market and generally resembles ground meat products. However, a study published on August 24, 2021, announced a research team at Osaka University was successful at 3D-printing Wagyu beef. Before cell cultured meat and poultry products can be sold in the United States, however, FSIS must finalize federal regulations on how to label such products.
Labels on meat and poultry products sold across state lines in the United States must first be approved by FSIS. Depending on the label type, that approval may be either generic or specific. Generic labeling approval is allowed in situations where there is widespread industry understanding for what certain terms mean. Products containing cultured animal cells would not be eligible for generic approval, because, as the Notice explains, “[n]o widespread industry understanding of the labeling requirements for cell cultured meat and poultry products currently exists.” As a result, FSIS would have to specifically approval all cell cultured meat and poultry labels before those products could be marketed across state lines.
FSIS has previously sought and received public comments regarding cell cultured meat and poultry product labeling. On February 9, 2018, the United States Cattlemen’s Association (“USCA”) filed a petition with FSIS. USCA requested that FSIS limit the definition of “beef” to those products derived from cattle born, raised, and traditionally harvested. Similarly, USCA requested that FSIS limit the definition of “meat” to the tissue or flesh of traditionally harvested animals. Both proposed definitions would prohibit products derived from cultured animal cells from being labeled as beef and meat. FSIS received over 6,000 comments in response to the USCA petition. According to the Notice, commenters “generally agreed that cultured meat and beef should be labeled in a manner that indicates how it was produced and differentiates it from slaughtered meat products.”
FSIS also received around 315 comments regarding cell cultured meat and poultry product labeling in October 2018 in response to a joint meeting between FSIS and the Food and Drug Administration (“FDA”). Following the joint meeting, FSIS and FDA announced in November 2018 that the agencies had come to an agreement to jointly regulate cell cultured meat and poultry. The agencies agreed on a regulatory framework where “FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to [FSIS] oversight will occur during the cell harvest stage. [FSIS] will then oversee the production and labeling of food products derived from the cells of livestock and poultry.” However, in the case of cell cultured seafood, other than catfish, FDA will retain all regulatory authority. This agreement was formalized on March 7th, 2019, in a memorandum signed by FSIS and FDA officials.
Both the FDA and FSIS agree that they have the statutory authority to regulate these types of products. However, some members of Congress have attempted to make the agencies’ agreed upon jurisdiction more explicit. During the 116th Congress, three bills were introduced to codify the jurisdictional divide laid out in the agreement and memorandum. All three bills went to committee, but not any farther. The 117th Congress has yet to introduce any similar bills. To read more about the bills introduced in the 116th Congress, click here.
On October 7, 2020, FDA published a Request For Information (“RFI”) seeking comments on how to regulate the labeling of foods containing cell cultured seafood. FDA received 35 comments to the RFI. FSIS said in the Notice that, when relevant, it will take the comments FDA received in response to the RFI into consideration when drafting a proposed rule.
The advanced notice of proposed rulemaking
Agencies are not required to publish advanced notices of proposed rulemaking but may choose to. Agencies may publish an advance notice when the agency needs more information to determine whether a rule is needed, what is the best way to regulate a certain action, or the agency wants ideas and suggestions before drafting a proposed rule. As for cell cultured meat labeling, FSIS published the Notice to gather information and ideas for how it should regulate the labeling of cell cultured meat and poultry.
The Notice references a Government Accountability Office report and states that FDA and FSIS “lack specific information on the technology being used, eventual commercial production methods, and composition of final products.” Thus, FSIS asks commenters to offer such information. Additionally, the Notice asks fourteen specific questions regarding how cell cultured meat and poultry products should be labeled and marketed. In submitting comments, FSIS asks commenters to indicate which question they are answering or whether they are commenting on a subject not listed. To submit a comment or read already submitted comments, click here. Comments must be submitted on or before November 2, 2021.
Moving Forward
After considering the comments received from the Notice, FSIS will likely draft and publish a proposed rule. However, FSIS has not announced when it plans to publish a proposed rule nor is FSIS required to publish a proposed rule within a certain timeframe. When the proposal is published, part of the rulemaking process is that FSIS will again seek public comments on how to improve the proposed rule or whether the rule is actually necessary. After the comment period for the proposed rule concludes, FSIS will read the comments and take them into consideration when drafting a final rule. Once effective, the final rule will govern the labeling requirements of cell cultured meat and poultry products introduced in interstate commerce.
To read the Notice in full, click here.
To submit a comment or read already submitted comments to the Notice, click here.
To read more about the history of cell cultured meat regulations, click here.
For more information on how FSIS evaluates meat and poultry labels, click here.
For more information about state laws regulating cell cultured meat and potential federal preemption, watch this National Agricultural Law Center webinar.
For more National Agricultural Law Center resources on food labeling, click here.
**This article was written by former NALC Staff Attorney Jana Caracciolo.