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Getting-to-Market barriers for cell-cultured meat discussed in new GAO report

Getting-to-Market barriers for cell-cultured meat discussed in new GAO report
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A new report from the U.S. Government Accountability Office (GAO) says federal food safety agencies “could strengthen existing efforts to prepare for oversight of cell-cultured meat.”

However, the most interesting part of this latest GAO report on cell-cultured meat, which is grown in labs, is the vast number of questions the fledgling industry has to answer before it will ever reach commercial significance.

The GAO depicts the cell-cultured meat game as competing for business ventures that are all still stuck in the research and development (R&D) phase and reluctant to share information with one another or with the public’s food safety agencies.

“Specific information about the technology being used, eventual commercial production methods, and composition of the final products are not yet known,” the GAO reports. It found the technology and methods “still in development” and said FDA and USDA “do not have clarity” about what’s going on with the secretive R&D projects.

Here are some of the issues and questions the cell-cultured meat ventures are going to have to answer for the product to be commercially viable, according to the GAO, which interviewed some in the industry as part of the review:

Tissue collection — How often will producers need to collect biopsy samples from animals, and what animals will be used? Some stakeholders have stated concerns about whether, and how, regulators will ensure that biopsies are collected from healthy animals. For example, one cell-cultured meat firm stated that tissue samples would be taken from slaughtered donor animals that met federal standards for conventional processing at the time of slaughter. However, the USDA and FDA have not indicated whether they would require cell-cultured meat firms to do so. Additionally, representatives from cell-cultured meat firms stated that they did not yet know how frequently they would need to collect biopsies from animals for commercial-level production. Additionally, according to researchers, there are too many unknowns to accurately estimate how much cell-cultured meat could be produced from a single biopsy of animal tissue.

Genetic engineering — Will commercial production methods involve genetic engineering? Some stakeholders expressed concern that the use of genetic engineering in cell-cultured meat production could cause the product to experience a lengthy wait for regulatory approval, similar to that for genetically engineered salmon, which took approximately 20 years. One representative from a cell-cultured meat firm noted that uncertainty about pending government regulations could negatively affect firms’ ability to attract and retain investors. Representatives from some firms said understanding what regulatory requirements will look like might influence which scientific pathways they pursue as they continue to develop their commercial production methods. According to FDA officials and representatives from one cell-cultured meat firm, it is likely that some firms will use genetic engineering in their commercial cell-cultured meat production methods. However, representatives from two other cell-cultured meat firms said they were undecided as to whether they would use genetic engineering in their commercial production methods.

Antibiotics — Will antibiotics be used to make cell-cultured meat, and will residues be present in the final product? According to agency officials, the presence of antibiotics in commercial production and the potential for residues in the resulting product would represent a significant potential concern for food safety and public health. Officials stated that they would not expect antibiotics to be used past the cell- banking phase. Representatives from cell-cultured meat firms differed on whether they planned to use antibiotics in their commercial production process, but they had not finalized their decisions. According to one firm, if antibiotics are used, the user would be limited both in quantity and duration.

Growth medium — What type of growth medium will producers use, and how might variations in the media affect the final product? According to agency officials and other stakeholders, the ingredients used in the growth medium could affect the end product’s composition and raise potential safety concerns. For example, FDA officials stated that residual growth factors, such as hormones, in the final product would be something they would likely evaluate in premarket consultations. However, representatives from cell-cultured meat firms stated that their firms have not finalized the medium they plan to use. In addition, the formulation of the medium firms use could be an important piece of intellectual property or confidential corporate information (CCI).

Scaffold — What type of scaffold will producers use to grow the meat, if any, and will it be edible or inedible? The use of edible or food-grade scaffolds, where they are used, will affect the composition of the product and may need to be evaluated by federal agencies for safety. According to USDA officials, the composition of edible scaffolding may also create labeling and jurisdictional concerns. For example, USDA officials stated that the addition of edible scaffolding may require significant additional aspects of production to be subject to USDA jurisdiction. Additionally, researchers have commented that a chemical separation technique needed to separate some inedible scaffolds may also need to be evaluated for potential safety concerns.

Point of harvest — How will the FDA and USDA define the point of harvest? The point of harvest is the point at which FDA will transfer oversight responsibilities, including inspections, to USDA. Stakeholders have raised concerns that not having a clear definition of the point of harvest could lead to challenges such as overlapping inspection requirements or a gap in the inspection. Representatives from several cell-cultured meat firms said in the spring of 2019 said it was ambiguous how FDA and USDA intended to define the point of harvest. These representatives also said it is unclear how often each agency plans to conduct inspections during the phases for which it is responsible. Agency officials stated that they are working to develop a detailed process for the transfer of jurisdiction, including defining the point of harvest.

Scaling up production — How will firms scale up production to commercial levels? One 2018 study conducted by researchers in the United Kingdom stated that to produce one pound of cell-cultured meat, firms would need bioreactors at least two and a half times larger than what is currently available. Similarly, a senior FDA official stated that the capacity of existing production equipment is a challenge for firms seeking to produce cell-cultured meat products at a commercial scale. As a result, the firms themselves may have to develop the equipment or custom order such equipment. Representatives from one cell-cultured meat firm said that they are interacting with equipment providers to identify commercial-scale production equipment.

Production cost — How will firms sell their product at a price point that is both profitable to the firms and affordable to the consumer? Some studies and stakeholders, including representatives from cell-cultured meat firms, said that the high production cost of cell-cultured meat is a key industry challenge. For example, in the past two years, one firm reported that it cost $600 to make a cell-cultured meat hamburger patty and reported that it cost about $1,200 to produce a single cell-cultured meatball. One of the biggest cost drivers in the production of cell-cultured meat is the growth medium, according to some studies and some cell-cultured meat firms. To address issues of cost and scale, some firms may develop their own, less expensive growth media.

Safety consideration — Are potential safety hazards in commercial production methods for cell-cultured meat different from those for conventional meat, and how will eventual commercial production methods affect the overall safety of the product? According to agency officials, cell-cultured meat may present different safety challenges than conventional meat. For example, according to agency officials, residues, and constituents in harvested cell-cultured meat would be expected to be different from those in conventional meat, depending on the details of the production process. Representatives from one cell-cultured meat firm said that they likely will use food processing techniques similar to those used for conventional meat, abide by similar health and safety standards, and possibly share food processing facilities. However, because specific information about commercial production methods and final products is not yet known, it is unclear whether cell-cultured meat produced on a commercial scale will pose any hazards not present in conventional meat.

Product composition — What will be the composition of any eventual products? Agency officials said that without knowing the composition of a cell-cultured meat product, it is impossible to predict how food safety and labeling requirements will apply. According to representatives from some cell-cultured meat firms, initial cell-cultured meat products most likely will not be composed entirely of cell-cultured meat but, rather, a mixture of cell-cultured meat and other ingredients such as binding and flavoring ingredients, and plant-based materials used in conventional food products. Some firms have developed prototypes of cell-cultured meat products as part of their research and development. In April 2019, representatives from one firm said that their prototype included about 90 percent plant-based ingredients and 10 percent cell-cultured meat. However, representatives from cell-cultured meat firms stated that they aim to produce products that contain more cell-cultured meat than other ingredients. For example, some cell-cultured meat firms have stated that a long-term goal is to commercially produce cell-cultured meat products that are similar to intact cuts of meat, such as steaks. As of December 2019, these firms had not provided regulators with specific information detailing the composition of their cell-cultured meat prototypes, according to FDA and USDA officials.

Environmental, animal welfare, and health impacts — How will cell-cultured meat impact the environment, animal welfare, or human health, if at all? Cell-cultured meat firms and researchers have made various claims about the potential environmental, animal welfare, and health advantages of cell-cultured meat over conventionally produced meat. For example, some cell-cultured meat firms have claimed that cell-cultured meat production would use less water and emit less greenhouse gases than conventional meat production. Some cell-cultured meat firms have also claimed that cell-cultured meat will improve animal welfare because slaughter will be unnecessary. Additionally, some stakeholders stated that because there is less opportunity for contamination from animal feces — a potential source of contamination for conventional meat — cell-cultured meat would be less likely than conventional meat to contain foodborne pathogens. However, there are disagreements regarding the accuracy of these claims. Stakeholders said that until commercial production methods and final products are established, these claims about impacts on the environment, animal welfare, and human health will remain unsubstantiated.

Timeline to market — When will cell-cultured meat products reach consumers? As of December 2019, no cell-cultured meat products were available for retail sale in the United States. Stakeholders give varying estimates for when cell-cultured meat may be commercially available. Some estimates suggested that firms may be able to commercially produce some form of cell-cultured meat product as soon as this year, while others estimate that such products may not be available for two to four years.

Labeling — How will cell-cultured meat be labeled? 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 a bias for, or against, certain products, potentially affecting consumer acceptance of these products. Additionally, stakeholders, as well as agency officials, have emphasized the importance of labeling to ensure consumers have accurate information about what they are buying. For example, in February 2018 the United States Cattlemen’s Association submitted a petition to USDA requesting that the agency limit the term “beef” to products “born, raised, and harvested in a traditional manner” and “meat” to mean the “tissue or flesh of animals that have been harvested in the traditional manner.” USDA received more than 6,000 comments on the petition, and the agency has not responded to the petition. However, according to agency officials, USDA has committed to a public process, likely rulemaking, for the development of labeling requirements for cell-cultured meat and poultry. In addition, in recent years, a number of states have passed laws that could affect the labeling of cell-cultured meat when it comes to the market. For example, in 2018, Missouri enacted a law to prohibit plant-based products and cell-cultured meat from being labeled as “meat.”

Consumer Acceptance — How will consumers respond to cell-cultured meat? It remains unclear whether consumers will embrace and purchase cell-cultured meat products. Stakeholders and studies cited consumer acceptance as a challenge for commercializing cell-cultured meat. One study noted that consumers have both positive and negative views toward cell-cultured meat, which could impact their willingness to purchase and consume such products.

The GAO report says federal oversight will observe five phases of cell-cultured meat production: biopsy, cell-banking, growth, harvest, and food processing. Th FDA and USDA’s Food Safety and Inspection Service will jointly provide oversight.

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