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USDA to solicit information on cell-based meat and poultry products prior to rulemaking

22 October 2020 Jonathan Pegg

USDA's Food Safety and Inspection Service (FSIS) plans to gather more information about cell-based meat and poultry products before it issues labeling regulations.

The agency on Thursday (Oct. 22) told IHS Markit that it intends to publish an Advanced Notice of Proposed Rulemaking (ANPR) seeking public comments to inform future labeling rules for cell-based meat and poultry products.

"The ANPR will help ensure that a public process, allowing stakeholder comments, is used to develop labeling regulations," according to FSIS.

The agency did not provide specifics on when it would release an ANPR but said the rulemaking will be listed in the fall Unified Regulatory and Deregulatory Agenda and then published in the Federal Register.

Industry call

USDA's move to gather more information will be welcomed by many industry stakeholders - earlier this week the North American Meat Institute (NAMI) and a coalition of cell-based meat and seafood developers called for it to issue an ANPR rather than a proposed labeling regulation.

Information solicited through an ANPR will provide FSIS with "substantive data" needed to better inform mandatory labeling rules for cell-based meat and poultry products, NAMI and the Alliance for Meat, Poultry and Seafood Innovation (AMPS Innovation) said in their October 19 letter to USDA Under Secretary for Food Safety Mindy Brashears.

Issuing an ANPR would appear to complement a decision made earlier this month by FDA, which put out its own request for information on labeling of cell-based seafood and is working with FSIS to develop a joint regulatory framework for cell-based products.

Under the terms of a Memorandum of Understanding (MOU) signed in March 2019, FDA is set to serve as the primary regulator at the beginning of the process and will oversee premarket consultations as well as cell collection, development and production through the time of harvest. Once the cells are harvested, oversight will likely shift to FSIS, which will regulate the production and labeling of cell-based meat and poultry products. The MOU gives FDA sole authority over any cell-based seafood except for catfish, which is under USDA's jurisdiction, but FDA is expected to develop its labeling rules in tandem with FSIS.

The agencies have set up three working groups to iron out specifics - one led by FDA is focused on pre-market safety and a second is exploring jurisdictional issues related to inspection oversight. The third group, led by FSIS, is tasked with developing joint principles for product labeling. In its comments to IHS Markit, FSIS said the groups are still completing their reviews and there is no timeframe for when their work will be completed.

Uncertainties abound

The effort to construct a regulatory regime for cell-based products comes amid uncertainty about the actual state of the industry.

At least 20 US companies are developing cell-based products and while none are yet commercially available, developers claim that could change in the next year or so. But sizeable issues related to scaling up production and crafting final products remain and the bullish claims by companies may not match reality.

A Government Accountability Office (GAO) report issued in May honed in on the difficulty facing regulators, highlighting the lack of knowledge about commercial production methods and the composition of final products.

FDA and USDA officials told GAO they "have limited information" and "need more to regulate this new food."

With regards to labeling, GAO reported officials say that without knowing the composition of a cell-based product "it is impossible to predict how food safety and labeling requirements will apply."

GAO also noted that the agencies will have to sort out label claims and may need to define specific terms.

"Labeling was an area of concern for representatives from both conventional and cell-cultured meat firms who explained that the specific terminology, such as 'clean meat' or 'lab-grown meat,' can sometimes reflect bias for, or against, certain products, potentially affecting consumer acceptance of these products," GAO reported. "Additionally, stakeholders, as well as agency officials, have emphasized the importance of labeling to ensure consumers have accurate information about what they are buying."

Labeling characteristics

The letter from NAMI and AMPS Innovation noted that FSIS has previously issued ANPRs to obtain data and information on labeling standards that could affect an entire category of products.

"The labeling of cell-based/cultured products is no different," the groups said. "FSIS has indicated that careful consideration of additional information relating to product characteristics is needed to inform labeling decisions for such products, and any proposed labeling standards would have industry-wide effects."

The industry groups noted that soliciting for information through an ANPR "can be time consuming," adding that it is "possible and likely" cell-based products may be ready to come to market before the rulemaking process concludes. But those products would still be subject to prior label approval by FSIS and any claims must be adequately substantiated, according to the letter from NAMI and AMPS Innovation.

"The companies developing these products are committed to supporting and complying with principles that ensure labeling is truthful and not misleading, does not disparage cell-based/cultured or conventional products, enables consumers to distinguish between such products, and is consistent with the safety and nutritional qualities of the product," the groups told FSIS.

Posted 22 October 2020 by Jonathan Pegg, US Correspondent, IHS Markit



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