On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency's initiative, "A New Era of Smarter Food Safety," to build on the advances that have been and are being made in FDA's implementation of the FDA Food Safety Modernization Act (FSMA). 1 FDA will use input from the meeting and written comments to the docket to develop a Blueprint for a New Era of Smarter Food Safety, which the agency plans to release in early 2020. The Blueprint will outline the agency's vision for a modern approach to food safety that includes technology-enabled traceability and the use of predictive analytic tools to assess risk and set agency priorities. FDA has opened a docket for written comments, which are due by November 20, 2019. 2 The specific questions on which FDA has requested input are included as an appendix to this memo and provide insight into FDA's current thinking on these issues. The discussion below provides a high-level summary of the agency statements and stakeholder comments made during the meeting.
Through this initiative, FDA is exploring the use of new and emerging technologies to strengthen predictive capabilities, support the implementation of preventive controls, and increase the speed of outbreak response. The impetus for the initiative is rooted in the rapid innovation in food products, processes, and delivery modes alongside the emergence of transformational technologies such as blockchain, machine learning, sensors, and the Internet of Things. FDA believes that these technologies offer the potential to dramatically alter the speed and effectiveness of preventing, tracing, and responding to outbreaks.
There are four priority areas that will be the focus of FDA's efforts:
- Tech-Enabled Traceability and Foodborne Outbreak Response: Looking at technologies, data streams, and processes that will greatly reduce the time it takes to track and trace the origin of a contaminated food and respond to public health risks.
- Smarter Tools and Approaches for Prevention: Enhancing the use of new knowledge from traceback, data streams, and other tools for rapidly analyzing data. The ability to use new data analysis tools and predictive analytics will help FDA and stakeholders better identify and mitigate potential food safety risks and advance the preventive controls framework that FSMA established.
- Adapting to New Business Models and Retail Food Safety Modernization: Advancing the safety of both new business models, such as e-commerce and home delivery of foods, and traditional business models, such as retail food establishments.
- Food Safety Culture: Promoting and recognizing the role of food safety culture on farms and in facilities. This involves doing more to influence what employees and companies think about food safety and how they demonstrate a commitment to this work. Strengthening food safety cultures also extends to the home and FDA is working to educate consumers on safe food handling practices.
Prior to the meeting, groups of FDA experts were asked to generate big-picture ideas and proposals, without considering practical constraints such as staffing and resources, on how the agency can leverage new technologies, as well as new approaches to the food system's safety challenges. The results of these discussions are found in "Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety," which was released as background information prior to the public meeting. 3 In his opening remarks, FDA's Deputy Commissioner for Food Policy and Response, Frank Yiannas, charged the assembled stakeholders to contribute to these brainstorming efforts using "imagination" to ask "what if" as part of an ongoing dialogue to eventually reach actionable solutions. Yiannas emphasized that the initiative is FSMA-based and reported that the agency is making significant progress on a proposed rule on traceability under FSMA § 204, which is expected sometime next year. 4
In his remarks, Yiannas flagged traceability as a critical issue. The challenges around devising a scalable, flexible, interoperable system based on effective data management practices elicited commentary throughout the day. FDA is not planning on building its own platform, but does see a role for the agency in creating the conditions for interoperability, industry adoption, and scale.
The at-capacity meeting (both in-person and webcast) included representatives from food and technology companies, public officials from other government agencies (including state, local, and international), media, and consumer advocates. Two all-inclusive sessions offered "Visions for" and "Perspectives on" a "New Era of Smarter Food Safety," which were then followed by repeat breakout sessions on the four topics for discussion, which are discussed in more detail below.
1. See our memo on FDA's notice of the public meeting at https://www.hoganlovells.com/en/publications/fda-announces-public-meeting-and-docket-forcomments-on-a-new-era-of-smarter-food-safety-to-facilitate-fsma-implementation.
2. Comments can be submitted to FDA docket number FDA-2019-N-4187.
3. "Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety," available at https://www.fda.gov/media/131682/download.
4. Section 204 of FSMA requires FDA to 1) establish and publish a list of high-risk foods; and 2) engage in rulemaking setting forth additional traceability recordkeeping requirements related to such foods. Two consumer groups brought a lawsuit against FDA for failing to implement these provisions within the statutorily prescribed timeframe. FDA ultimately entered into a settlement agreement committing to issuing a proposed rule establishing recordkeeping requirements for highrisk foods. For a summary of the settlement agreement regarding FSMA Section 204, see our memo at https://www.hlfoodlaw.com/wp-content/uploads/sites/357/2019/06/HL-Memo-SettlementReached-in-Lawsuit-Seeking-to-Compel-FDA-to-Implement-FSMA-Traceability-Provisions.pdf.
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