{"id":10371,"date":"2021-06-17T08:12:10","date_gmt":"2021-06-17T13:12:10","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=10371"},"modified":"2021-06-17T08:12:10","modified_gmt":"2021-06-17T13:12:10","slug":"fdas-short-sighted-approach-to-building-trust-in-the-safety-of-cell-cultured-meat-and-seafood-products","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2021\/06\/17\/fdas-short-sighted-approach-to-building-trust-in-the-safety-of-cell-cultured-meat-and-seafood-products\/","title":{"rendered":"FDA\u2019s short-sighted approach to building trust in the safety of cell-cultured meat and seafood products"},"content":{"rendered":"

Tom Neltner, J.D.<\/em><\/a>,\u00a0<\/em>is Chemicals Policy Director<\/p>\n

Consumer trust that products are safe to eat is essential to acceptance<\/a> of any innovative food product.<\/em><\/p><\/blockquote>\n

One of the most innovative food products expected to enter U.S. markets in coming years is cell-cultured meat and seafood<\/a>. Producing these products by culturing cells in tanks and forming them into foods that look and taste like their conventionally produced counterparts is a technological achievement. Proponents enthusiastically tout<\/a> these products as climate-friendly alternatives that provide real hope to meet the world\u2019s growing demand for animal protein in a sustainable way that also minimizes animal welfare concerns.<\/p>\n

Consumer trust that products are safe to eat is essential to acceptance<\/a> of any innovative food product. That trust is built through a rigorous, transparent, and independent scientific review to ensure safety. Without that, questions linger that undermine widespread consumer adoption.<\/p>\n

Unfortunately, we have serious concerns that the process the Food and Drug Administration (FDA) may be planning to use to review the safety of cell-cultured meat and seafood is inadequate and will undermine consumer trust. From our perspective, the manufacturing process for cell-cultured meat and seafood is a significant departure from current practice and warrants careful scrutiny. FDA guidance<\/a> is clear that, for these types of changes, the appropriate review options are a food additive petitions<\/a> or the voluntary Generally Recognized as Safe (GRAS)<\/a> notification process. We strongly recommend FDA rely on these existing options existing options rather than create a new approach.<\/p>\n

<\/p>\n

FDA\u2019s agreement on cell-cultured meat and seafood<\/strong><\/p>\n

In March 2019, the FDA and U.S. Department of Agriculture announced<\/a> a formal agreement to jointly oversee the production of cell-cultured meat and seafood. Overall, the plan was a positive step, especially for the agencies with overlapping jurisdiction for these food products.<\/p>\n

A key FDA commitment<\/a> in the agreement was to \u201cconduct premarket consultation processes to evaluate production materials\/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs.\u201d This evaluation will be critical to ensuring safety because much of the agencies\u2019 oversight and inspection programs will rely on it.<\/p>\n

We presumed that FDA\u2019s review of these technologies would be conducted through the two pathways designed for products like these that involve an innovative technology, especially made through a process that is such a dramatic departure from conventional practices. The two pathways are food additive petitions<\/a> and voluntary GRAS notifications<\/a>.<\/p>\n

However, it has become increasingly clear to us from discussions with some in industry that FDA is seriously considering creating a third pathway modeled on how it reviews genetically modified new plant varieties. Such an approach raises serious concerns because it lacks the transparency and rigorous review by external experts, stakeholders, and the public necessary to ensure products are not only safe but also that consumers can trust they have been adequately evaluated. The technology involved in producing cell-cultured meat and seafood bears little semblance to the targeted gene editing for new plant varieties that are grown using conventional methods and, like all innovative food ingredients, warrants careful review and public scrutiny.<\/p>\n

In addition, nowhere does FDA make clear that companies will be required\u00a0<\/em>to seek agency review of these innovative products. This is important because the agency explicitly allows companies to make GRAS safety determinations in secret without notifying FDA for many novel food ingredients, a decision we are currently challenging in court<\/a>. This practice poses additional serious food safety problems due to conflicts of interest and bias concerns<\/a> when a company or its consultants make the decision and fails to evaluate the cumulative effect<\/a> of this and related substances in the diet on our health.<\/p>\n

Rather than create a new alternative review system that is likely to raise safety concerns and undermine consumers\u2019 trust because it lacks transparency and rigorous external review, we encourage FDA to invest in addressing legitimate concerns that companies have with the two existing pathways. And the agency should explicitly prohibit secret GRAS determinations for cell-cultured meat and seafood products.<\/p>\n

FDA\u2019s biotech consultation process for new plant varieties has three significant weaknesses<\/strong><\/p>\n

FDA established its biotech consultation process<\/a> for genetically-modified new plant varieties<\/a> in 1992. The process narrowly focuses on ensuring that \u201cfoods from genetically engineered plant varieties don\u2019t present different or greater safety concerns than their non-genetically engineered counterparts.\u201d<\/p>\n

The outcome of a positive review<\/a> is a letter from the agency to the plant developer that \u201cexplains that FDA has no questions about the developer\u2019s safety and regulatory assessment and reminds the developer that they remain legally obligated to ensure the safety of the food products they bring to market.\u201d With the letter is a staff memo assessing the product. The information provided by the company is not publicly available. In 2006, FDA extended the program \u201cnew non-pesticidal proteins<\/a> produced by new plant varieties\u201d and also included a heavily redacted version<\/a> of the information provided by the company.<\/p>\n

There are several aspects to FDA\u2019s approach that undermine the credibility of the new plant varieties process and, therefore, the products made from ingredients evaluated by the process:<\/p>\n