Strengthening Scientific Cooperation Between FDA and the European Food Safety Authority From a Global Perspective By Ritu Nalubola and Steve Musser February 1, 2021 From whole genome sequencing to risk communication science, the Food and Drug Administration has been stepping up its collaboration with the European Union on a host of scientific issues involving food safety. Our cooperative efforts with the European Food Safety Authority (EFSA) have flourished under the concerted efforts of the FDA's Europe Office and the Center for Food Safety and Applied Nutrition. EFSA is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (Commission, Council, Parliament) and EU Member States. It was set up in 2002 following a series of food crises in the late 1990s to be a source of scientific advice and communication on risks associated with the food chain. EFSA produces scientific opinions and advice that sometimes form the basis for European policies and legislation regarding food safety that are set by other European agencies. The FDA's Europe Office is responsible for outreach to both the European Union and other non-member European countries. While the Office may be better known for its activities regarding medical products, it has enjoyed a long collaborative history with EFSA's risk assessment and risk communication endeavors for both human and animal foods.   Building cooperation The FDA and EFSA first began their scientific relationship after signing a confidentiality commitment in 2007 and from 2009-2013 they even placed a liaison within each other's offices. Interactions between the two agencies have been varied and have included exchanging information, monitoring developments related to human and animal food safety, and collaborating in international forums. The FDA sees great value in continuing to foster scientific and technical cooperation in areas of mutual benefit with EFSA, and so over the past year and a half, we have worked on further enhancing our relations with the agency. In 2019, the FDA's and EFSA's executive leadership held a pivotal day-long meeting at the FDA's White Oak campus where we agreed to explore opportunities for convergence on science policy and collaboration in key areas, including the value and promotion of whole genome sequencing, potential alternatives to animal testing, the challenges of effectively communicating risk to the public, and food safety research funding; and also discussed procedures for routine and robust scientific exchanges between the two agencies. We have now begun to implement some of the items we touched on at that meeting. In October 2020 we co-sponsored a webinar with policy makers and communications experts from food safety regulatory authorities across the globe to identify shared interests, challenges, and opportunities for international engagement in the areas of risk communication and food safety literacy. While it's a topic not often addressed at the global level, the FDA and EFSA both have a wealth of experience in public communication on a range of food safety topics and, thus, are aptly suited to provide international leadership for a global dialogue on how to effectively communicate food safety information to the public and maintain consumer confidence in the regulatory system. We are also working together to advance the science and increase our understanding of the risks from food contaminants, such as per- and polyfluoroalkyl substances (better known as PFAS). These manmade chemicals have been used in many products throughout various industries, and over the years have found their way into the soil, air, and water, providing different routes of exposure; PFAS's persistence in the environment and ability for bioaccumulation has prompted study by the FDA and EFSA. In addition, we are expanding our use of whole genome sequencing technology, an efficient molecular-typing method that reveals the complete DNA sequence of an organism, to identify and characterize pathogen risks in our food supply. Let's examine this last area more closely. Promoting technology for outbreak tracing In 2012, the FDA spearheaded the creation of GenomeTrakr, a network of laboratories that use WGS to identify pathogens. The sequence data are housed in a publicly available database and the network now includes the FDA's federal and state public health partners. Initially, the GenomeTrakr network consisted of 10 FDA and four state laboratories. Since 2012, the network has seen rapid growth to its current level of more than 60 domestic and international laboratories, including government, university, and private laboratories. Participating laboratories around the globe share WGS analytical data regarding pathogen identification and information about sample collection locations and dates. Mining these data in GenomeTrakr can reveal patterns and anomalies that can characterize the range and virulence of specific pathogen strains linked to specific outbreaks. This helps public health officials see connections that are useful in locating an outbreak source or to better understand the dynamics of human-pathogen interaction — in other words, to characterize risks informed by product, location, or strain of organism. The public health benefit of this technology — and such partnership to further it — is significant, and prominently falls within the FDA's New Era of Smarter Food Safety blueprint for the future. In October 2020, in coordination with EFSA, the Europe Office and CFSAN launched the WGS "Cluster," or working group, to advance the use of this technology in food traceability and outbreak investigations after establishing the terms of reference and a two-year work plan, consistent with FDA priorities and objectives. The group's work will explore different aspects related to WGS, such as interoperability, data sharing, bioinformatic tools, harmonization across methodologies, and novel sequencing technologies. Initially the work group will explore the exchange of information to better understand each other's experiences and implementation practices. We hope the lessons learned will ultimately help facilitate the expansion of the GenomeTrakr network. Going forward Our renewed commitments to collaboration with EFSA, built on a longstanding foundation of scientific cooperation, will continue to pave the way for mutually beneficial scientific advancement and cooperation in key areas. The FDA and EFSA plan to follow-up on their successful webinar on risk communication by jointly hosting a larger and virtual risk communication workshop in 2021. In this global conversation, we intend to explore the fragility of trust in regulatory decision-making, and the challenges, opportunities, and prospects for effectively communicating important scientific concepts related to food safety and risk, to stakeholders and the public. In addition, both the FDA and EFSA share a similar vision of a more modern food safety system enabled by new digital tools. In September EFSA issued a report on data collection and modeling that complements the objectives of the FDA's New Era blueprint. Both agencies have now begun to discuss how to collaborate in this area. They also aspire to create a global food safety community where technical staff can participate in exchanges or fellowships, allowing for more active and targeted risk assessment collaborations, developing data strategies, and fostering discourse on the topics of scientific credibility and public trust. Finally, we're looking ahead to the changes in store in 2021, when new provisions to the EU's General Food Law will be implemented; changes that will call for increased transparency of the EU risk assessments that are intended to strengthen the reliability, objectivity, and independence of the studies used by EFSA. Both CFSAN and the Europe Office intend to closely monitor these developments to determine how they might impact our established interests and engagements with EFSA.   Ritu Nalubola, Ph.D., is the Director of the Europe Office in the FDA's Office of Global Policy and Strategy Steve Musser, Ph.D., is the Deputy Director of Scientific Operations in the FDA's Center for Food Safety and Applied Nutrition

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