New Era year-one achievements [1]

Traceability

The FDA notes that one if its priorities under the FDA Food Safety Modernization Act (FSMA) and as part of the New Era initiative is end-to-end traceability throughout the food supply chain to help identify contaminated foods sources and speed recalls. The FDA is encouraging food manufacturers of all sizes to develop traceability programs that allow entities to track and trace throughout the supply chain.

The FDA’s traceability accomplishments over the last year include publishing the Proposed Rule on Food Traceability and a proposed list of foods to which the rule’s additional recordkeeping requirements would apply.[2] The FDA also held three public meetings on the proposed rule discussing the key data elements and critical tracking elements for enhanced traceability. The FDA anticipates issuing a Final Rule in late 2022, consistent with the timing required under a Consent Decree.

Predictive analytics

Another key FDA initiative is to use data analysis to strengthen predictive capabilities (and by extension, support food safety). To support this goal, the FDA created 21 Forward, a data analysis tool to help identify where there could be disruptions in food supply continuity due to food worker absences because of the pandemic. 21 Forward uses COVID-19 human transmission forecast data from the Centers for Disease Control and Prevention (CDC) to identify areas where COVID-19 could impact key segments of the food system (among other data in-feeds). The FDA believes 21 Forward can also help states with vaccine distribution to food and agriculture workers.

Import screening

The FDA has been leveraging artificial intelligence via a pilot study to help predict when imported food will pose a greater risk of violation. The FDA believes it will be able to use this information to allocate import review resources to the highest risk products. The second phase of this pilot was launched in February, and is designed to use machine learning to rapidly analyze data and automatically identify connections and patterns that are difficult to determine using other tools.[3]

Inspections

The New Era Blueprint calls for the FDA to explore alternative ways to conduct inspections. Due to COVID-19, the FDA began conducting remote inspections of importers subject to the Foreign Supplier Verification Programs rule, which provides the FDA with authority to request records electronically. The FDA conducted a record number of FSVP inspections (more than 1,600) since March 2020 through this remote approach.

Priorities Going Forward

The FDA says that many of its priorities have been executed by industry with “an impressive level of engagement by organizations representing farmers, manufacturers, retailers, and other stakeholders.” The FDA plans to bring on additional new partners like technology companies as it continues to move forward.

In the newly-issued “New Era of Smarter Food Safety Select Activities for 2021,”[4] the FDA outlines additional work planned under the previously-identified four Core Elements:[5]

• Core Element 1: Tech-Enabled Traceability. This work includes advancing traceability fundamentals as the FDA moves to finalize the regulation, working with international partners to create common traceability language based on harmonized data elements and standards, and developing a pilot program for the FDA to receive traceability data in digital form.
• Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response. This work includes continuing pilot programs and feasibility studies to assess how artificial intelligence can assist with identifying public health threats, and entering into mutual reliance agreements with states to leverage each other’s data and analytics to ensure optimal use of resources and maximize their food safety reach.
• Core Element 3: New Business Models and Retail Modernization. This work includes continued collaboration with national retail regulatory associations, the CDC, and food e-commerce stakeholders to advance food safety and identify potential food safety vulnerabilities.
• Core Element 4: Food Safety Culture. This work includes conducting a literature review on challenges, barriers, and opportunities to influence attitudes and behaviors related to desired food safety practices, and educating the FDA inspectional staff, state partners, and consumers on the principles that make up food safety culture.

Next steps

We will continue to monitor FDA’s progress in implementing the New Era of Smarter Food Safety. 

References

1 FDA Voices Update, New Era of Smarter Food Safety Select Activities for 2021 (13 July 2021), https://www.fda.gov/news-events/fda-voices/one-year-later-new-era-smarter-food-safety-blueprint-makes-inroads-fdas-public-health-mission.

2 85 Fed. Reg. 59984 (23 Sept. 2021); FDA Proposed Food Traceability List (content current as of 12 Jan. 2012), https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

3 FDA Moves into Second Phase of AI Imported Seafood Pilot Program (8 Feb. 2021), https://www.fda.gov/food/cfsan-constituent-updates/fda-moves-second-phase-ai-imported-seafood-pilot-program.

4 FDA New Era of Smarter Food Safety Select Activities for 2021 (July 2021), https://www.fda.gov/media/150619/download.

5 FDA New Era of Smarter Food Safety Blueprint (15 July 2021), https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint; see also Hogan Lovells Update - FDA Releases Blueprint for the New Era of Smarter Food Safety (15 July 2020).