Implementing Global Best Practices for Quality and Safety of Cell-Cultured Seafood

By Noreen Hobayan

Director of Quality Assurance and Regulatory Affairs

Cell-cultured foods are a newly emerging field of products produced directly from animal cells. This nascent industry has been growing considerably, with over 70 companies around the world developing inputs or end products for cell-cultured meat, poultry and seafood. Approximately a third, like BlueNalu, are working exclusively on seafood.

While the benefits of producing meat, poultry and seafood directly from cells are promising, how do we ensure that these novel food products are safe to eat? As companies in this space approach commercialization, food safety agencies worldwide are working to understand the application of cell-culture technology to food production and determine how to ensure its safety through regulatory oversight.

FDA and USDA’s Regulatory Oversight of Cell-Cultured Foods

In the United States, the FDA has extensive experience applying its existing authority flexibly and effectively to evolving food technology areas to ensure the safety of the food supply. In cooperation with the USDA, the FDA has been proactive in its approach to regulating food produced using animal cell-culture technology. Starting in 2018, they held a public meeting to share experiences with novel foods and gather stakeholder input. In 2019, the FDA and USDA-Food Safety Inspection Service (FSIS) established a formal agreement on how they would use regulatory tools to help ensure that foods comprising or containing cultured animal cells entering the U.S. market are safe and properly labeled. In 2020, they held a joint webinar to discuss their roles and responsibilities for cell-cultured food products. They agreed that the FDA will be responsible for regulating cells cultured for use as food up until cell harvest, including through cell collection, cell banks, and cell growth and differentiation. Once processing begins, they will divide their oversight to match that of conventional meat and seafood products. USDA-FSIS will regulate meat and poultry products during post-harvest processing, packaging, and labeling and the FDA will regulate foods made from the cultured cells of fish (other than Siluriformes, including catfish, which are under USDA inspection).

Safety and quality, while of paramount importance, are not the only areas where U.S. regulatory agencies have been proactive. To distinguish cell-cultured products from conventional seafood, meat and poultry, FDA and USDA are also evaluating labeling of these products. Last October, FDA issued a request for information (RFI) to gather public input on cell-cultured seafood labeling that closed in March (our CEO wrote about it here). In June, USDA-FSIS announced their intent to publish an advanced notice of proposed rulemaking seeking public comments on the labeling of meat and poultry products made using animal cell culture technology.

My Food Safety and Quality Assurance Recommendations for Cell-Cultured Seafood

The U.S. is not the only nation developing a regulatory framework for cell-cultured protein products as global challenges with food security, climate change and other factors are catalyzing the development of regulatory frameworks around the world. Once final regulations and guidance are issued, they will likely vary from country to country. This lack of standardization will be a hurdle for cell-cultured food companies that want to expand rapidly into global markets. Given this environment, a comprehensive food safety strategy that focuses on globally recognized best practices will be critical to success.

After 20+ years of working in quality management, I have a few recommendations to help cell-cultured food manufacturers get such a food safety strategy in place. As processes vary by product, I will focus on cell-cultured seafood, although many of my recommendations can apply to the whole category of cell-cultured meat, poultry, and seafood products.

Think globally

As stated above, regulatory compliance for cell-cultured seafood may look different around the world, so, aiming for independent, third-party certifications that demonstrate compliance to globally recognized food safety standards can fill the gap. Working towards Global Food Safety Initiative (GFSI) standards should begin very early in the commercialization process — long before plant design, engineering and food production has started. Doing so will expedite the global marketability and consumer adoption of cell-cultured seafood products and complement regulatory requirements that will be needed at the national level.

GFSI is a coalition that brings together retailers and manufacturers from around the globe, and the extended food safety community, to oversee standards for food processors. They collaborate across borders to strengthen and harmonize food safety standards, going above and beyond local regulations. As a result, foodservice operators and retailers worldwide recognize and trust GFSI certification to keep customers safe and protect their brand. Achieving certification to a GFSI benchmarked program, like Safe Quality Foods (SQF), or the British Retail Consortium (BRC) is the equivalent of gaining a passport to the global market.

Plan for food safety

In the United States, the Food Safety Modernization Act (FSMA) provides robust but flexible food safety planning methods, ensuring that a wide variety of food products are safe for consumption. Cell-cultured seafood companies can readily adapt the food safety planning tools published by FDA to their upstream processes and products. Similar to FSMA, the Seafood Hazard Analysis Critical Control Point (HACCP) regulations have been in place since 1995 to ensure the safe and sanitary processing of fish and fishery products. Since cell-cultured companies produce seafood products from actual fish cells, the same Seafood HACCP principles will assure their safety and quality.

Drafting a food safety plan and conducting a hazard analysis early in the development process can help cell-cultured seafood companies understand potential hazards and determine the controls required to assure safety. A continuous process of refining the plan as companies approach commercialization will enable them to get food safety controls in place effectively and efficiently.

Build a foundation of food safety culture

Food safety “culture” — not for cells but for people — is also critical to the success of cell-cultured seafood. Culture drives behavior, and safe behavior results in safe food. Cell-cultured seafood companies can demonstrate their commitment to food safety by embedding it at all levels of the organization from the executive suite to the plant floor. A best-in-class food safety culture does not happen on its own or overnight. Instead, it is a journey that requires commitment from top leadership and a comprehensive plan covering things like the company vision and mission regarding food safety, the goals and expectations for food safety, prioritization and alignment strategies, training on food safety hazards, and continuous improvement processes.

Partner with capable and committed suppliers

There is an African proverb that states, “If you want to go quickly, go alone. If you want to go far, go together.” When it comes to commercializing cell-cultured seafood, we want to move quickly and go far. Therefore, we rely on various skillsets, internal and external to our organizations, to collectively reach our goals. Identifying supply chain partners who can adapt to meet the demands of this budding industry is a vital piece of the puzzle. Cell-cultured seafood companies require a secure supply chain for cell-culture media, food-grade ingredients, components, and packaging. Partnering with capable suppliers can add critical know-how to product development and expedite the production of a scalable, consistent, safe, and quality product.

Invest in scalable electronic systems

Supply chain traceability and transparency are important for all food products. Due to complexities in the conventional seafood supply chain, knowing where your seafood came from or the path it took to your plate is difficult at best. In contrast, traceability, and transparency for cell-cultured seafood, which will be produced, from start to finish, in Good Manufacturing Practices (GMP) compliant food production facilities and shipped with full identification, will be far easier to demonstrate. That is, if companies have the right systems in place.

To verify with complete confidence that these new products comply with top safety standards, state-of-the-art tools and analytical systems provide real-time insights and visibility as to what is happening at every stage, from raw material receipt to manufacturing and product distribution. Solid electronic quality management systems can scale seamlessly and document every step of the process, making compliance with high caliber, third-party certifications much easier down the line. Cell-cultured seafood companies should consider what systems they need for resource planning, quality systems, learning management, laboratory management, and data collection and analysis. While there is an upfront investment, these best-in-class tools are worth every penny. As an added plus, they reduce waste by eliminating the need for paper records.

Transforming the food system

Cell-cultured seafood can provide people worldwide with access to nutritious seafood, a critical protein source that millions around the world already rely upon. At the same time, it creates a holistic third seafood option that alleviates stresses on fish populations and our planet. We have the chance to transform the food system with safe and high-quality cell-cultured seafood products.

In this transformation, food safety and quality assurance are too important to be an afterthought. In fact, the highest possible safety and quality standards are the only acceptable option. Therefore, companies in this space should be laying a solid foundation of food safety from the beginning, collaborating closely across all departments to manage risks before they have the remotest chance of going to production.

You can learn more about our food safety and quality framework in our recent announcement.

For more information about BlueNalu, visit www.BlueNalu.com

Lou CooperhouseJuly 22, 2021