FDA Discusses Whole Genome Sequencing in the New Era of Smarter Food Safety
August 12, 2021, Covington Alert
Yesterday, the Food and Drug Administration (FDA) released the second installment of its quarterly TechTalk podcast series. FDA’s TechTalk podcast series explores the use of novel technologies to support the core objectives of FDA’s New Era of Smarter Food Safety. This quarter’s episode focused on the use of Whole Genome Sequencing (WGS) to advance the New Era’s core objective of “exploring smarter tools and approaches for prevention and outbreak response.”
WGS is a technology that allows laboratories to sequence the genetic material in bacteria and capture that information in an analyzable and shareable data format. Using WGS, scientists can differentiate between different strains of foodborne pathogens with a degree of precision generally not possible using older analytical tools. WGS can thus play a key role in detecting and preventing foodborne illness outbreaks.
Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, kicked-off the episode by identifying WGS as one of the most important developments in food safety in the 21st century. Yiannas explained that WGS allows FDA and industry to “make the invisible visible” by identifying commonalities among seemingly unrelated illnesses and discovering outbreaks that may have previously gone undetected.
Representatives of FDA’s Center for Food Safety and Applied Nutrition then led a discussion with stakeholders from the New York State Department of Health, the Association of Public Health Laboratories, and Western Growers. These stakeholders agreed that WGS can play a crucial role in conducting pathogen surveillance and performing root cause analysis. They also noted that resources such as FDA’s GenomeTrakr—which provides a distributed network of laboratories that use WGS to identify foodborne outbreaks—have supported the implementation of WGS over the past decade. The participants expressed their intent to expand the use of WGS in the coming years to further enhance detection and prevention efforts.
But, while the participants agreed that WGS is a valuable tool, they also identified existing legal, regulatory, and technological barriers that could limit the adoption of WGS. These barriers include the high cost of transitioning to WGS and the time and resources required to develop in-house expertise. To alleviate these burdens and promote the adoption of WGS, FDA should collaborate with industry and other stakeholders to address these issues in the coming years.
Frank Yiannas concluded the episode by identifying three key takeaways from the discussion:
1. WGS is a game changer for prevention. Yiannas emphasized that WGS can support both pathogen detection and outbreak prevention, and noted that coupling WGS with new technologies such as real-time traceability could further enhance prevention efforts.
2. Food safety is a race. Yiannas noted that while FDA and other stakeholders have made significant recent progress in pathogen detection, new technologies like WGS are necessary to accelerate prevention efforts and “win the race” against foodborne illness.
3. WGS is a useful tool for both the private and public sector. Yiannas stressed the potential for industry to use WGS for special applications like root cause analysis and encouraged industry to learn more about WGS and how it can supplement existing efforts to detect and prevent foodborne illnesses.
What can you do?
FDA will continue to solicit input from stakeholders as it implements the New Era for Smarter Food Safety Blueprint and explores the potential benefits of WGS and other novel technologies. Companies should continue to monitor these developments and identify opportunities to meaningfully engage with the agency on these issues.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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