I. General Questions on the New Era of Smarter Food Safety
II. COVID and the New Era of Smarter Food Safety
III. New Era’s Impact on Other FDA Work
IV. The Four Core Elements
V. Process for Developing the Blueprint
VI. Accomplishing the Blueprint’s Goals
VII. Working with FDA
What is the New Era of Smarter Food Safety?
The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system. It seeks out simpler, more effective, and modern approaches and processes. Its ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.
What is the purpose of the New Era blueprint?
The blueprint outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.
Is the blueprint a strategic plan? If so, how long will it take to reach these goals?
This blueprint frames a vision for the next decade with short- and long-term activities that will evolve as we pursue the goals it outlines. It is a living document that is intended to keep pace with new food technologies, methods of food production and delivery, and new tools for oversight.
What aspects of food safety does the blueprint focuses on?
The blueprint focuses on four Core Elements, or themes, that we believe hold the power to significantly reduce foodborne illness in this country: Tech-Enabled Traceability, Smarter Tools and Approaches for Prevention and Outbreak Response, New Business Models and Retail Modernization, and Food Safety Culture.
Why did the agency decide on these Core Elements?
In thinking about the challenges and opportunities over the next decade, the FDA leadership identified these four foundational pillars of the New Era of Smarter Food Safety to cover the range of technologies, analytics, business models, modernization, and values that are its building blocks. There is a lot of synergy among them; an idea in one element may be relevant to one or more others. These elements, working together, will bring us into the New Era of Smarter Food Safety.
How will FDA monitor progress toward desired outcomes?
We have assigned leads for each Core Element, and they will be monitoring progress toward desired outcomes. FDA recently established the Food Safety Dashboard, a performance management reporting tool designed to track the impact of the seven foundational rules of the FDA Food Safety Modernization Act (FSMA) and help us continue to refine our implementation. As the New Era of Smarter Food Safety initiative is technology-enabled and aims to build on the work that FDA has accomplished under the FSMA rules, we also expect this dashboard to be one of the ways we could monitor progress.
What is the significance of the New Era relative to the COVID-19 pandemic?
The COVID-19 pandemic underscores the need for modern approaches as we respond to unique demands on our food system, from unprecedented imbalances in the marketplace, to changing consumer behaviors and a rise in e-commerce, to challenges to performing inspection and compliance work in FDA’s traditional manner. The pandemic has highlighted the need for more real-time, data-driven, nimble approaches to help ensure a strong and resilient food system and keep all Americans safe during a crisis, whether they are federal employees, food industry workers, or consumers.
What food safety and security needs did the pandemic highlight and/or accelerate?
The pandemic made clear that enhanced traceability, coupled with advanced analytical tools, could provide greater supply chain visibility and potentially help the FDA and industry anticipate the kind of marketplace imbalances experienced during the pandemic.
The need for best practices to help ensure the safety of foods ordered online and delivered directly to consumers has been accelerated by COVID-19. We’ve seen this trend steadily increase over the years, but it has skyrocketed as families hunkered down at home order foods from restaurants and grocery stores online and by phone, often for the first time. It made the question of how we ensure that these foods are produced, packed, and transported safely directly to consumers more important than ever.
In addition, public health concerns and associated travel considerations have highlighted the need to find new and innovative ways to carry out our oversight activities. We must consider ways to do virtual and remote inspections and to use enhanced predictive analytics to determine the farms and facilities that pose the greatest risks .
Further, the pandemic shined a light on what it truly means to have strong food safety cultures, which is all about the people who work on farms and in facilities accepting responsibility for producing safe foods and keeping those people safe when co-workers are sick. Food safety culture is also about educating consumers on the best food safety practices when cooking at home, which more people have been doing during the pandemic.
Q: How is the blueprint different from FSMA?
FSMA provides FDA with the authority to establish modern, science- and risk-based requirements, and its full implementation will remain a key priority for the FDA. The blueprint will identify ways to further FDA’s modernization goals and will help ensure that the FDA evolves with the food industry and available technology to reduce foodborne illness.
Q. How will the New Era of Smarter Food Safety blueprint incorporate the upcoming implementation of FSMA Section 204 (“Enhancing tracking and tracing of food and recordkeeping”)?
The New Era of Smarter Food Safety incorporates some work that is already underway, such as our current rulemaking on FSMA section 204, which will serve as a foundation for traceability throughout the food system. Implementation of 204 is a key component of the Blueprint. We anticipate that the proposed rule will publish in early September.
How is the New Era of Smarter Food Safety initiative related to the FDA’s Leafy Greens STEC Action Plan?
The FDA’s Leafy Greens STEC Action Plan is a commodity-specific action plan developed to outline actions the FDA plans to take in 2020 to advance work in the areas of prevention, response and addressing gaps in knowledge about leafy greens safety. The plan is in response to numerous foodborne outbreaks of Shigatoxin-producing E. coli (STEC) infections with a confirmed or suspected link to leafy greens in the U.S.
The Leafy Greens STEC Action plan and the blueprint share common goals. Both focus on the shared role of government and industry in helping to prevent foodborne illness and stress the importance of technology and data in responding to outbreaks. Key activities outlined in the Leafy Greens STEC Action Plan reflect the underlying goals of the New Era of Smarter Food Safety initiative: leveraging technology and other tools to create a more digital, traceable, and safer food system.
Can you briefly describe each of the four Core Elements?
Core Element 1: Tech-enabled Traceability seeks to advance traceability to help protect consumers from contaminated products by doing rapid tracebacks, identifying specific sources and helping to remove products from the marketplace as quickly as possible when necessary.
Ultimately, the goal is to support end-to-end traceability throughout the food safety system. The FDA will explore ways to encourage firms to voluntarily adopt tracing technologies and ways to harmonize tracing activities, which will support interoperability across a variety of technology solutions, working towards outcomes that are achievable for all sectors.
Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response seeks to explore the preventive value of modern food safety approaches that generate new data streams as well as tools for rapidly analyzing big data. The FDA is looking to enhance and strengthen root cause analyses and predictive analytics. Findings of root cause analyses can be an important step in helping to modify practices to avoid identified risks and can provide more robust data for predictive analytics.
It is also important for the FDA to work with others in new and creative ways. These include the domestic mutual reliance initiative, in which the FDA seeks to build on existing efforts to partner with states that have comparable regulatory and public health systems, leveraging each other’s data and analytics to ensure optimal use of resources and maximize our food safety reach. They also include leveraging reliable third-party audits to advance food safety and having alternate approaches when traditional methods are not feasible.
These tools and approaches will also inform the FDA and our regulatory partners’ approach to inspections, outbreak response, and recall modernization.
Core Element 3: New Business Models and Retail Food Modernization is intended to address how to protect foods from contamination as new business models emerge and change to meet the needs of the modern consumer. The evolution of how food gets from farm to table continues with the emergence of e-commerce and new delivery models. The evolution of how food gets produced continues with the emergence of new business models that advance innovations in novel ingredients, new foods, and new food production systems. These new models include online shopping for meals and groceries, a practice that has surged during the COVID-19 pandemic. Looking at more traditional business models, the FDA is exploring ways to further modernize and help ensure the safety of foods sold at restaurants and other retail establishments.
Core Element 4: Food Safety Culture seeks to foster, support and strengthen food safety cultures on farms, in food facilities, and in homes. Dramatic improvements in reducing the burden of foodborne disease depends on everyone doing more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations. A strong food safety culture is a prerequisite to effective food safety management.
When was the New Era of Smarter Food Safety Initiative launched?
In April 2019, the FDA announced the New Era of Smarter Food Safety initiative. In July 2019, FDA’s Foods Program leadership took the first step, selecting experts within the agency to provide their insights on how to develop the initiative, starting with ideas and continuing with a vision of how their ideas could potentially be realized.
How were food safety experts within the FDA involved in the development of the blueprint?
More than 100 experts participated in brainstorming sessions on the Core Elements. In the first round of brainstorming sessions, participants were asked to unleash their ideas, unfettered by practical considerations like staff and resources. The time for practicality came in a second round of sessions, when these experts looked at their ideas with new eyes, considering feasibility and recommending realistic goals for the next decade.
How was the public involved in the development of the blueprint?
In October 2019, the FDA conducted a public meeting to engage external stakeholders and foster a dialogue with our domestic and international regulatory partners, industry, consumer advocates, and others. More than 1,300 people participated in person or via Webcast. The FDA also opened a docket in the Federal Register inviting public comment. The comment period closed on December 5, 2019, after which an FDA team compiled and reviewed all of the input for consideration during our planning.
What are FDA’s plans to accomplish the goals of the blueprint?
We have identified senior foods program leaders to oversee each of the four Core Elements identified in the blueprint and an overall implementation lead. These Core Element leads will help to identify the short and long-term actions to fulfill the goals laid out in the blueprint over the next decade, working in partnership with stakeholders.
Will the FDA continue to create mechanisms for receiving feedback from stakeholders, as well as for informing the public about the importance of food safety?
Yes. The blueprint was developed with valuable input provided by a variety of internal and external experts and the FDA remains committed to listening and learning from stakeholders. We will continue to travel and talk with people across the country to the extent feasible.
How can I learn about new developments as they occur?
The FDA has created the New Era of Smarter Food Safety webpage, which we are continually updating. The best way to stay abreast of new developments is to visit this webpage and subscribe to automatically receive e-mail updates.
How can I contact the agency regarding the New Era for Smarter Food Safety?
If you wish to contact the agency regarding the blueprint or other matters related to this initiative, please send an email to email@example.com. This address can be found on the New Era of Smarter Food Safety website. If you access this email through the website, you will be provided a form with options related to your inquiry (e.g., speaker request, meeting request, general information).