Collaborating to advance a safety research agenda for cell-cultured meat and seafood products

Over the past year, we at Vireo Advisors, an expert advisory consultancy focused on the safe and sustainable commercialization of new technologies, worked with New Harvest, a nonprofit focused on advancing cellular agriculture through research, to prepare a landmark manuscript about the safety of cultured meat — co-created with cultured meat companies from around the world. What we originally intended to be one half-day during the 2020 New Harvest Annual Conference transformed into a weeks long series of virtual gatherings where academic and industry experts came together to weigh in on a manufacturing process diagram and a systematic analysis of safety questions that form the basis of a forward-looking research strategy.

This initiative — a multi-party collaboration among 49 leading cell agriculture companies — yielded a process diagram adaptable to more than 80% of current cell ag technologies, a safety research strategy, a manuscript outlining potential safety issues, available strategies for addressing them, and outstanding questions to address by a global research community. All without any non-disclosure agreements or other intellectual property protection.

This all transpired while the cellular agriculture industry passed a critical milestone: the first cell-cultured meat product, by Eat Just, received regulatory authorization from the Singapore Food Agency.

Not only did the initiative advance the safety conversation in cellular agriculture, but it also brought together companies from around the world to unite around a critical pre-commercial topic of shared interest. In doing so, it set the stage for future efforts. Critical to our success was the strategic and technical guidance of Allen Gunn and Aspiration Tech, the celebrity and support of Robert Downey Jr. and his FootPrint Coalition along with many other funders, and the visionary leadership of Isha Datar and her expert team at New Harvest.

Several cultured meat companies hope to put products on the market within the next five years. However, given the lack of adequate publicly available information and regulatory agencies’ heavy emphasis on third party data, a key need is data to demonstrate the safety of cultured meat products. This was our first target since it is a critical need in advance of shaping the policy and regulatory side, and also because New Harvest focuses exclusively on public, academic research. We see the creation of credible information in the public domain as a critical first step toward reducing uncertainty and demonstrating safety. The initiative deliberately goes beyond compliance and takes a proactive approach.

Cellular agriculture technologies are still under development. This means that here are not many final products to assess for safety at the present time. The products are meant to be safer than conventional alternatives, but as new products, they may be subject to a great deal of scrutiny until regulators and consumers feel comfortable.

Our initiative aimed to limit the possibility that a lack of available safety information would slow commercialization. We addressed three key issues:

● Lack of credible public data to inform how cultured meat is made

● Lack of credible public data to inform a path forward for safety demonstration

● Lack of scientifically-informed recommendations for safety assessment

The cellular agriculture industry is growing rapidly. If those growing the field do not address safety issues early and thoroughly, they might face slowed growth and limited success. Transparency about how the products are made, and what goes into them, is crucial for both regulatory and commercial acceptance of these products.

It’s not that we have concerns that cell ag products are not safe. Rather, with new technologies it is especially important to share the data as proof of their safety. To show people how and why we know they are safe. Here, public data goes further than privately-generated data since it can be scrutinized. In short, transparency creates trust.

Being proactive about safety can inform product manufacturing design. Community supported safety research conducted now to address safety gaps means that in the future, when companies are ready to commercialize, they have data ready and available to use. Collaborations like ours are thus an efficient way to develop information that benefits start-ups as well as larger organizations, for whom methods and data can be a significant hurdle.

As we begin to address research priorities, we might need to adapt methods to assess safety. That takes time. As we conduct safety studies and validate methods, we might have to come up with new analytical tools. That is expensive. Peer reviewed safety data in the public domain helps everyone — especially smaller companies that don’t have the in-house resources or expertise. The whole field benefits from the cost-sharing and trust-building of transparency and collaboration

The New Harvest/Vireo Advisors safety collaboration focused on identifying and characterizing the critical safety research needs up front. We identified potential hazards in a model manufacturing process, and then analyzed them for issues that might affect the final products. What resulted is a list of research needs prioritized by industry participants to fill current knowledge gaps in safety. The manuscript is now in peer review, and will be shared in open access format once published.

Industry leaders identified these priorities for future research:

1) Identify the concentration of inputs in the product, compared to conventional foods. For example, growth factors, antibiotics, scaffold, novel inputs.

2) Develop industry-wide standards for safe residue levels.

3) Assess the range of genetic modification approaches and outcomes that affect safety.

4) Assess whether media recycling concentrates hazardous inputs/residues.

5) Evaluate the comparative approach for the safety assessment of the final product.

We have demonstrated the power of collaboration and look forward to continued efforts to address these and other critical priorities.