Tom Neltner, J.D., is Chemicals Policy Director
Consumer trust that products are safe to eat is essential to acceptance of any innovative food product.
One of the most innovative food products expected to enter U.S. markets in coming years is cell-cultured meat and seafood. 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 these products as climate-friendly alternatives that provide real hope to meet the world’s growing demand for animal protein in a sustainable way that also minimizes animal welfare concerns.
Consumer trust that products are safe to eat is essential to acceptance 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.
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 is clear that, for these types of changes, the appropriate review options are a food additive petitions or the voluntary Generally Recognized as Safe (GRAS) notification process. We strongly recommend FDA rely on these existing options existing options rather than create a new approach.
FDA’s agreement on cell-cultured meat and seafood
In March 2019, the FDA and U.S. Department of Agriculture announced 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.
A key FDA commitment in the agreement was to “conduct 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.” This evaluation will be critical to ensuring safety because much of the agencies’ oversight and inspection programs will rely on it.
We presumed that FDA’s 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 and voluntary GRAS notifications.
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.
In addition, nowhere does FDA make clear that companies will be required 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. This practice poses additional serious food safety problems due to conflicts of interest and bias concerns when a company or its consultants make the decision and fails to evaluate the cumulative effect of this and related substances in the diet on our health.
Rather than create a new alternative review system that is likely to raise safety concerns and undermine consumers’ 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.
FDA’s biotech consultation process for new plant varieties has three significant weaknesses
FDA established its biotech consultation process for genetically-modified new plant varieties in 1992. The process narrowly focuses on ensuring that “foods from genetically engineered plant varieties don’t present different or greater safety concerns than their non-genetically engineered counterparts.”
The outcome of a positive review is a letter from the agency to the plant developer that “explains that FDA has no questions about the developer’s 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.” 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 “new non-pesticidal proteins produced by new plant varieties” and also included a heavily redacted version of the information provided by the company.
There are several aspects to FDA’s approach that undermine the credibility of the new plant varieties process and, therefore, the products made from ingredients evaluated by the process:
- Lack of transparency: The information in the searchable inventories is limited. For new plant varieties, the information provided by the company is only publicly available through a Freedom of Information Act (FOIA) request. The available information provides extensive protection for trade secrets and, therefore, has limited usefulness.
- No opportunity for public comment: There is no way to know that FDA was reviewing the substance until the “no questions” letter is posted, no process to solicit or submit comments, and no responsibility for the agency to respond to comments received. The opportunity to comment provides FDA with a chance to learn from experts outside of the agency and the company, such as academia, public interest community, or others in industry, to get different views that may alter its assessment of the safety.
- No option to challenge the decision: FDA does not consider the “no questions” letter to be a final agency action that can be challenged by the public or competitors. There is not even a formal option to appeal to the Commissioner for a reassessment. As a result, unsafe products that could harm the public may enter the market with no recourse for those who have concerns.
The food additive petition and GRAS notice alternatives are more appropriate pathways
Congress established the food additive petition requirement in 1958 for new substances added to food that were not GRAS. The petition process protects trade secrets from disclosure but provides notice to the public when the review begin and allows anyone to comment when the review commences and after a final decision is made. Congress gave FDA 180 days to complete the review process for each new substance.
If someone objects to a final decision, the agency has a rigorous administrative public meeting process to reconsider the decision. If objections remain, the public can seek legal review in federal court. The agency also created a similar process – but without the statutory deadlines – for substances whose use FDA affirmed as GRAS.
Until the 1990s, these options were the primary routes for industry to get innovative ingredients onto the market. Unfortunately, rather than the 180 days mandated by Congress, the agency took years to complete the reviews, which left the ingredients in limbo.
Frustration mounted and rather than securing the necessary resources to make timely decisions, the agency created the voluntary GRAS notification alternative. Companies could voluntarily submit notices to the agency they believe demonstrated safety. Positive reviews received a “no questions” letter. The process has been popular: from 1997 to June 2021 the agency has posted 968 notices in an online searchable inventory and issued 755 “no questions” letters.[1]
The GRAS notice provides transparency because the company’s notice is posted online while review is pending and trade secret claims are strictly limited because they are antithetical to the general recognition claim. Like the new plant variety consultations, there is no opportunity for public comment or option to challenge the decision.
Cell-cultured meat and seafood are unlike new plant varieties
For typical new plant varieties, FDA reviews seed products that will be grown by farmers. That is radically different than cell-cultured meat and seafood where the products consumers eat are grown in tanks and formed, with or without other ingredients, into products using extrusion, 3-D printing or other processes commonly used in the food industry. This makes them highly engineered processed foods.
FDA’s short-sighted approach to cell-cultured meat and seafood
To succeed in the marketplace, cell-cultured meat and seafood must first and foremost be safe while also meeting consumer expectations for taste, nutrition, convenience, cost, and sustainability. A misstep by the product developer or marketer regarding safety can jeopardize public health and undermine both the industry’s credibility and the company’s reputation.
While we anticipate that product developers will make safety a top priority, the potential for mistakes is too great and the conflicts of interest too strong for them to unilaterally make the decisions without independent oversight and public scrutiny.
We recommend the agency use the food additive petition pathway and reject the creation of a new option adapted from new plant varieties. The food additive petition is best because it protects trade secrets while ensuring:
- FDA makes the safety determination after considering the cumulative effect on our health rather than simply saying it has “no questions”;
- Provides opportunity for rigorous review by external experts, stakeholders, and the public through public comment; and
- Allows for a decision that responds to those comments and can be appealed.
While we acknowledge that the GRAS notification process is currently allowed by FDA, we maintain that the 2016 GRAS rule on which it is based is contrary to law, and, represented by Earthjustice and Center for Food Safety, have challenged the rule in court and are awaiting a court decision.
As appealing as a new biotech consultation program may be, it is a shortcut that will eventually undermine consumers’ trust. We strongly recommend FDA improve the available options rather than creating a new approach. The agency should focus on solving its problems in making timely decisions on food additive petitions or get Congressional approval of a new process.
[1] The balance of notices were either withdrawn, pending, or rejected.