NEW ERA OF SMARTER 

FOOD SAFETY

FDA’s Blueprint for the Future
NEW ERA OF SMARTER FOOD SAFETY - FDA’S BLUEPRINT FOR THE FUTURE

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Table of Contents

I. Executive Summary ........................................................................................................... 1

II. Introduction...................................................................................................................... 2

III. Our Principles ................................................................................................................. 4

IV. Our Process ..................................................................................................................... 5

V. The Four Core Elements .................................................................................................... 6

Core Element 1: Tech-Enabled Traceability ..........................................................................8

1.1 Develop Foundational Components ....................................................................................8

1.2 Encourage and Incentivize Industry Adoption of New Technologies ...................................8

1.3 Leveraging the Digital Transformation ..............................................................................9

Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response.... 10

2.1 Invigorate Root Cause Analyses....................................................................................... 10

2.2 Strengthen Predictive Analytics Capabilities ................................................................... 10

2.3 Domestic Mutual Reliance ............................................................................................... 11

2.4 Inspection, Training, and Compliance Tools..................................................................... 11

2.5 Outbreak Response ......................................................................................................... 12

2.6 Recall Modernization....................................................................................................... 12

Core Element 3: New Business Models and Retail Modernization ....................................... 13

3.1 Ensure Safety of Food Produced or Delivered Using New Business Models ..................... 13

3.2 Modernize Traditional Retail Food Safety Approaches..................................................... 13

Core Element 4: Food Safety Culture.................................................................................. 15

4.1 Promote Food Safety Culture Throughout the Food System............................................. 15

4.2 Further Promote Food Safety Culture Throughout the Agency ........................................ 15

4.3 Develop and Promote a Smarter Food Safety Consumer Education Campaign ................ 16

VI. Conclusion..................................................................................................................... 17
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I. Executive Summary 

The world around us is changing rapidly, and we are in the midst of a food revolution. Many believe we will 

see more changes in the food system over the next 10 years than we have over the past several decades. 

Foods are being reformulated, new foods and new food production methods are being realized, and the 

food system is becoming increasingly digitized. At the U.S. Food and Drug Administration (FDA), we 

believe modern times require modern approaches.

While we had originally planned to unveil the blueprint in the spring of 2020, our plans were placed on 

pause so the FDA could focus on COVID-19 pandemic response efforts. This crisis has highlighted some 

challenges and has underscored the need for modern approaches as we respond to unique demands on our 

food system and work to ensure that the food supply remains safe and strong, now more than ever. With 

the pandemic have come unprecedented imbalances in the marketplace, changing consumer behaviors and 

a rise in e-commerce, and challenges in performing inspection and compliance work in FDA’s traditional 

manner. It has demonstrated 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.

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. Smarter food safety is about more 

than just technology. It’s also about simpler, more effective, and modern approaches and processes. It’s 

about leadership, creativity, and culture.

This blueprint outlines the approach FDA will take over the next decade to usher in the New Era of 

Smarter Food Safety. It will evolve as food technologies and the food system evolve. It builds on work that 

FDA has done to implement the FDA Food Safety Modernization Act (FSMA), which established science 

and risk-based protections.

This document represents the thinking of FDA food safety experts, consumers, the food industry, 

technology firms, federal and state regulatory partners, our regulatory counterparts in other nations, and 

academia. Together, we envision a framework that will enable food to be traced to its source in seconds 

and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting 

consumers in real time before contaminated or misbranded foods are consumed. We envision a framework 

in which education, communication, and democratization of data will enable industry, public health 

advocates, and government to work in concert to keep the food supply safe.

This document represents 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 a food safety culture. It outlines a partnership between government, industry and public 

health advocates based on a commitment to create a more modern approach to food safety. There is an 

opportunity to drive the changes needed to create a digital and safer food system. We’re in this together.

If you’ve heard FDA leaders talk about the New Era of Smarter Food Safety, you might understandably be 

asking yourself how we plan to bring about this sea change. Read on.
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II. Introduction

What is the New Era of Smarter Food Safety? While we 

have made advancements in food safety over the past 

decade, rates of foodborne disease in the U.S have not 

changed significantly. Our ultimate goal is to bend the 

curve of foodborne illness in this country by reducing 

the number of illnesses. Essentially, we are building on 

the work we’re doing to create a modernized food safety 

regulatory framework while also leveraging the use of new 

and emerging technologies and approaches to strengthen 

our predictive capabilities, accelerate prevention, speed 

outbreak response, and enhance our ability to swiftly adapt 

to crises that could affect the food supply.

When we look at how industries track, through digital 

means, the real-time movement of planes, ride sharing, and 

packaged goods or how firms are harnessing big data to 

identify trends, it is clear FDA and our stakeholders should 

be looking at how to tap into new technologies that include, 

but are not limited to, artificial intelligence, the Internet of 

Things, sensor technologies, and blockchain.

That said, while technology is an important part of the New 

Era of Smarter Food Safety, it’s more than that. It’s about 

simpler, more effective, modern approaches and processes. 

It’s about leadership and creativity. It’s about fostering a 

food safety culture that transcends borders between the 

public and private sectors. This New Era of Smarter Food 

Safety is people-led, FSMA-based and technology-enabled. 

The tools and authorities granted by FSMA create a 

flexible framework that is adaptable to the changing food 

safety environment. We continue to make progress in 

implementing the seven foundational rules that are the 

FSMA building blocks, which created standards for the 

production, transportation and importation of human 

and animal food. Major compliance dates have arrived, 

inspections are being conducted, and challenges are being 

addressed. 

Fully implementing the remaining FSMA-mandated 

requirements will help to further prevent contamination. 

Yet, our prevention framework must continue to evolve. 

Advances in detection technologies (e.g., whole genome 

sequencing and enhanced analytics) mean that more 

outbreaks are being detected than would have been possible 

to detect in the past. Recognizing this reality, FDA aims 

to focus on further modernizing prevention, quickly 

identifying contaminated food, and helping to ensure that it 

is removed from the marketplace. 

Smarter Food Safety 

to me means always 

looking to the future. Our 

destination − safe food for 

our families, our children, 

and our animals − is 

unchanged. But how do 

we get there more quickly 

and effectively using 

modern tools as the world 

transforms around us?

Stephen Hahn,

FDA Commissioner
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Collectively, FDA and all stakeholders should strive to 

ensure that we are doing everything possible to quickly 

incorporate the lessons learned from contamination 

events into prevention efforts, and to complete our work as 

expeditiously as possible.

Our world is evolving at a breakneck pace. With this 

evolution comes new technologies, ranging from new digital 

tools to new sources of food ingredients. It also comes 

with new business models, like e-commerce and omnichannel food distribution, which covers a range of online, 

mobile device, telephone, and brick-and-mortar store 

shopping platforms. These advances provide new tools and 

approaches for tackling food safety issues, but also present 

new issues to consider in determining how to regulate food 

safety. 

FDA has determined that it’s time to look to the future of 

food safety once again, with an approach that builds on 

the progress that FSMA has made in creating a risk-based, 

prevention-oriented regulatory framework, but that also 

leverages the use of new and emerging technologies to create 

a safer and a more digital, traceable system.

We plan to engage a broad expanse of stakeholders in 

industry, academia, trade associations, and consumer 

groups, as well as our state, federal, international and 

other regulatory partners, and groups that we had not 

traditionally engaged with before, such as technology 

companies.

We recognize that building on our food safety approach 

in a rapidly evolving and interconnected world will 

require resources and innovation. Continued investments 

throughout FDA and the food safety system will be critical 

to improving public health and reducing supply chain 

disruption.

The New Era of Smarter 

Food Safety is an 

approach to bending 

the curve of foodborne 

illness through the use 

of new technologies and 

approaches. 

Frank Yiannas,

Deputy FDA Commissioner
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III. Our Principles

People-Focused and Led

Enhancing the safety of the foods 

consumers eat each day, as well as 

improving consumer trust in the food 

system, will require heightened focus 

on prevention, advancements in food traceability, and 

continued efforts to provide consumers with actionable 

and accurate information about the foods they consume.

To address the growing complexity of the food system we 

need actions informed by the best expertise. Scientific 

and regulatory expertise is at the root of our public health 

mission, and the people of FDA and our stakeholders are 

critical to future success. FDA will bring diverse groups 

together to find common ground and identify smart 

solutions. Together, we can implement better solutions to 

protect public health in a way that creates shared value.

FSMA-Based

The prevention-based system that FSMA 

created is the foundation of the work 

going forward. Digital innovation and a 

complex, dynamic global supply chain are 

re-shaping the future of food and food safety. Realizing the 

opportunities that come with change will depend on our 

collective vision and commitment. This approach will layer 

informational and technological advancements onto the 

FSMA foundation to further strengthen food safety.

Technology-Enabled

The world is rapidly becoming more digital. 

Advances in artificial intelligence, the 

Internet of Things, sensor technologies, 

and blockchain are improving business 

processes. New digital technologies offer the potential 

to help us predict and prevent food safety problems and 

better detect and respond to problems when they do occur. 

Whenever possible, we will work with stakeholders to 

explore low- or no-cost options so that our approaches are 

inclusive of and viable for food operations of all sizes. As 

we learned with the FSMA rules, there’s no such thing as 

one-size-fits-all when it comes to protecting a diverse food 

system and flexibility in approaches is critical.

We are not walking 

away from, nor are we 

replacing, FSMA. Instead 

we are building on the 

progress we have made 

in implementing this 

landmark law.

Susan Mayne,

Director of FDA’s Center for Food 

Safety and Applied Nutrition
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IV. Our Process

In April 2019, FDA announced the New Era of Smarter Food Safety initiative. In July, FDA’s Foods 

Program leadership took the first step, selecting experts within the agency to provide their insights on how 

we can really make this happen, starting with ideas and continuing with a vision of how their ideas could 

potentially be realized. The experts represented the Office of Food Policy and Response, the Center for 

Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Regulatory Affairs, 

and the Office of the Commissioner. More than 100 experts participated in brainstorming sessions on 

these core elements.

• Tech-enabled Traceability

• Smarter Tools and Approaches for Prevention and Outbreak Response

• New Business Models and Retail Modernization

• Food Safety Culture

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.

In October 2019, FDA conducted a public meeting to engage 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. FDA also opened a docket in the Federal Register 

inviting public comment. The comment period closed on December 5, after which an FDA team compiled 

and reviewed all of the input for consideration during our planning.

The release of this blueprint, initially planned in spring 2020, was delayed by the COVID-19 pandemic 

response, but our experiences thus far in our ongoing response efforts have only reinforced that the New 

Era of Smarter Food Safety is the right approach for the future. The lessons we are learning are helping us 

prioritize our goals by highlighting the areas in greatest need of new technologies, tools, and approaches.

This blueprint reflects input from a variety of stakeholders and offers a vision for the new decade, with 

short and long-term goals that will evolve as we move forward in implementation. Priorities will inform 

the deployment of resources and can be adapted based on food safety performance metrics and ongoing 

stakeholder input.

Science, technology, and innovation continue 

to evolve, and we must constantly think about 

how we evolve along with them.

Judy McMeekin,

FDA Associate Commissioner for Regulatory Affairs
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V. The Four Core Elements

These are the foundational pillars of the New Era of Smarter Food 

Safety, covering the range of technologies, analytics, business 

models, modernization and values that are its building blocks. 

There is a lot of synergy; an idea in one element may be 

relevant to one or more others. For example, analytics crosses 

over into traceability and new business models. The themes 

of mutual reliance between federal and state partners and 

the importance of food safety culture are woven throughout. 

There are common needs for metrics and reliable third-party 

audits. These elements, working together, will bring us into 

the New Era of Smarter Food Safety.

Tech-Enabled Traceability

The records involved in moving food through the supply chain 

are still largely paper-based. This creates a system in which it is 

necessary to take one step forward to identify where the food has 

gone and one step back to identify the previous source. This, along with 

insufficient data identifying the product along the supply chain, creates an 

inability to rapidly track and trace food. During an outbreak, this can cost lives, millions of dollars in 

avoidable product loss, and damage to consumer trust. As has been seen with outbreaks in fresh leafy 

greens and other foods over the past decade, anonymity and lack of traceability in the food system are an 

Achilles heel that hinders more significant progress in rapid traceback efforts to identify contaminated 

foods. It also stands in the way of the transparency needed to better understand the supply chain in the 

event of public health crises, such as the COVID-19 pandemic, and to create a more nimble, resilient, and 

interoperable food system.

Technology already assists outbreak response: Whole genome sequencing allows us to identify illness 

clusters when they are smaller. Public health agencies increasingly rely on electronic data in outbreak 

investigations—e.g., shopper card data; the bar code from a food package; supplier-customer data; 

purchase orders; bills of lading for shipments of goods. Yet the quality and compatibility of this data is 

highly variable. We want to tap into new technologies and integrate data streams to identify outbreaks and 

trace the origin of a contaminated food to its source in minutes, or even seconds, speeding our response 

when public health is at risk. 

Smarter Tools and Approaches for Prevention and Outbreak Response

With better traceback, our ability to conduct root-cause analyses will be greater, and findings from this 

work can be used to better inform the prevention-based framework that FSMA established. To fully 

realize a preventive controls system that rapidly incorporates new knowledge, it is important to ask 

how we can make processes and communications more effective, efficient, and in some cases, simpler. 

This will be particularly valuable in our collaborations with the public and private sectors to mitigate 

the risks presented by foods that are especially vulnerable to contamination. As more data streams 

and tools for rapidly analyzing data become available, we should also think about how we can best 

use predictive analytics tools to identify when and where contamination might be likely to occur, to 

prevent contaminated products from entering the food supply, and target efforts to remove potentially 

contaminated product from the market. It’s also important for us to work with others in new and creative 

ways, such as leveraging reliable third-party audits and the expertise of our state and local regulatory 

partners to advance food safety. We must also have alternate approaches when traditional methods cannot 

be carried out during a public health crisis.
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New Business Models and Retail Modernization

Industry is inventing new ways to produce and distribute food, 

and we strive to prepare for new business models. Before the 

COVID-19 pandemic, research indicated that online grocery 

shopping would have a 20 percent share of consumer food 

spending within the next few years.1 However, online shopping 

took on a new importance for consumers sheltering in place, 

with one survey reporting that 31 percent of U.S. households 

are already using online grocery services.2 What approaches 

can FDA take to help ensure food safety? How do we educate 

distributers, manufacturers, and retailers on the importance 

of temperature control, cross-contamination, and other safety 

issues? We will also explore how to adapt our oversight to help 

ensure the safety of novel ingredients, new foods, and new 

food production methods. 

Progress should also be made in advancing the safety of foods 

sold in traditional retail establishments. According to the 

Centers for Disease Control and Prevention (CDC), restaurants 

and other retail establishments remain the most common 

nexus of foodborne illness outbreaks. We will focus on known 

risk factors to change behaviors and practices.

Food Safety Culture

Last, but not least, we should foster, support, and strengthen 

food safety culture on farms, in food facilities, and in homes. 

We will not make dramatic improvements in reducing the 

burden of foodborne disease without doing more to influence 

and change human behavior, addressing how employees think 

about food safety and how they demonstrate a commitment 

to this goal in how they do their job. The importance of a food 

safety culture has been highlighted during the COVID-19 

pandemic with its focus on keeping food workers safe and 

educating consumers cooking more at home on safe food 

handling practices. We should also look within to ensure that 

we, as regulators, are promoting the development of a global 

food safety culture.

1 FMI/Nielsen: The Digitally Engaged Food Shopper; January 2018 (https://

www.fmi.org/digital-shopper)

2 Brick Meets Click/ShopperKit Online Grocery Shopping Survey conducted 

March 23-25, 2020

Whether you’re working 

on the safety of human or 

animal food, we will all 

benefit from being able 

to more rapidly trace a 

contaminated food to its 

source.

Steven Solomon,

Director of FDA’s Center for 

Veterinary Medicine
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Core Element 1: Tech-Enabled Traceability

We are advancing 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. The 

first step in our work will be completing FSMA Section 

204 rulemaking to harmonize the key data elements and 

critical tracking events needed for enhanced traceability. 

Establishing this foundation for traceability will allow 

stakeholders in the supply chain to adopt and leverage 

digitally-enabled technologies, enable data sharing, and 

introduce approaches that greatly reduce the time it takes to 

identify the origin of a contaminated food tied to a recall and/

or outbreak. This will also create the transparency needed to 

anticipate and help prevent supply chain disruptions in a public 

health emergency, such as a pandemic.

Ultimately, we want to have end-to-end traceability throughout 

the food safety system. We want to 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.

1.1 Develop Foundational Components

• Help the food system to speak the same traceability language through the use and standardization 

of critical tracking events and key data elements. 

• Strive to enable industry compliance with FDA’s traceability regulation using existing consensus 

standards, where possible.

• Expand FDA’s capacity to process data quickly for all food commodities, encouraging the expansion 

of traceability to cover the broadest range of commodities on a voluntary basis.

• Play a lead role in promoting and participating in governance and harmonization with U.S. and 

international regulatory counterparts through bodies such as GS1 and Codex.

• Develop ways to achieve interoperability. Specifically, work with standards bodies, technology 

providers, and users to help ensure systems are designed with interoperability as a foundational 

component.

1.2 Encourage and Incentivize Industry Adoption of New Technologies

• Demonstrate FDA’s commitment to promote industry adoption by highlighting the wide-ranging 

benefits of tech-enabled traceability in outreach to the food industry and engaging in conversation with 

non-traditional stakeholders (e.g. financial industry, technology firms, insurance companies).

• Consider how to address concerns about how to disclose actions related to traceability in a way that 

provides any necessary protection of confidentiality and proprietary interests while advancing 

transparency.

• Explore ways for FDA to recognize adoption of strong traceability systems in how we approach 

our food safety oversight activities (e.g., taking traceability into account in risk-based planning for 

inspections).

Tech-enabled Traceability and Outbreak 
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• Encourage food traceability technology providers to develop creative financial models that are lowto no-cost solutions, proportional to benefits derived from participating, and enabling food producers 

of all sizes to participate in a scalable, cost-effective way.

1.3 Leveraging the Digital Transformation

• Conduct a review of FDA’s current outbreak response and recall protocols to optimize how the 

agency makes traceback requests of firms and receives information in digital form.

• Collaborate with federal, state, local, tribal and territorial partners on new ways of conducting 

accelerated tracebacks and trace forwards in a tech-enabled food traceability world.

• Harmonize, where possible, traceability work already underway at the agency related to other 

FDA-regulated products (e.g., drugs and medical devices).

• Work with stakeholders to design and execute pilots on concepts needed for traceability to 

further scale, such as testing interoperability and public-private data sharing. Select commodities 

that have been subject of recent outbreaks, specifically leafy greens, will be given a high priority.

• Implement an internal digital technology system, such as blockchain, to receive critical tracking 

events and key data elements from industry and regulatory partners.
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Core Element 2: Smarter Tools and Approaches for 

Prevention and Outbreak Response

As modern food safety approaches generate new data streams 

- and tools for rapidly analyzing big data become available – 

we are exploring their preventive value. We are looking to 

enhance and strengthen root cause analyses and predictive 

analytics. Findings of root cause analyses can be an 

important step in helping industry modify practices to 

avoid identified risks and can provide more robust data for 

predictive analytics.

It’s also important for us to work with others in new and 

creative ways. These include the domestic mutual reliance 

initiative, in which 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 FDA and our regulatory partners’ approach to inspections, 

outbreak response and recall modernization.

2.1 Invigorate Root Cause Analyses

• Collaborate with federal, state, industry, consumer, and academic stakeholders to advance, 

standardize, and socialize root cause analysis protocols for food safety.

• Consider how to address concerns about how to disclose actions related to data analyses in a way that 

provides any necessary protection of confidentiality and proprietary interests while advancing 

transparency.

• Strengthen root cause analysis procedures – coordinating with federal, state, local, tribal, and 

territorial partners – to ensure rapid deployment as soon as an outbreak is traced to a specific site.

• Standardize criteria and format for producing reports on root cause analyses of outbreaks 

and determine the most expedited process for disseminating information and required actions to 

prevent a reoccurrence.

• Enhance communication tools, for quickly and transparently relaying the outcomes of root cause 

analyses, both internally and externally, in a timely manner.

• Incorporate root cause analysis data into the agency’s risk ranking and predictive analytical 

systems to increase the likelihood of predicting and mitigating future contamination events.

2.2 Strengthen Predictive Analytics Capabilities

• Advance FDA’s predictive analytics capabilities through expanded use of artificial intelligence 

and machine learning tools, beginning with expanding the proof of concept completed by the 

agency on using AI for screening of imported foods at ports of entry.

• Increase the amount and quality of data FDA has through mechanisms that include expanded use 

of information-sharing agreements with regulatory and public health partners, academic 

institutions, industry and others.

Smarter Tools and Approaches for Pre

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• Explore methods to create public-private “data trusts,” a bank of large volumes of data generated 

by industry that can be accessed for analytical work to further strengthen preventive approaches. 

Begin by working with stakeholders to create a “leafy greens data trust.”

• Work with industry to find the balance between the need for transparency and concerns about 

the confidentiality of business data in advancing predictive analytics, including the development 

of protocols to establish that requests for data are targeted for a specific purpose.

• Explore technologies to enhance predictive toxicology tools that identify and characterize 

food chemical hazards to further strengthen preventive approaches and to support safe innovative 

food ingredient and production technologies.

• Working with stakeholders, develop processes to analyze big data and non-traditional data 

sources of information, such as environmental conditions (rain, temperature, wind, etc.), that 

could be used by the public and private sectors to strengthen foodborne predictive capabilities and 

make more informed risk management decisions.

2.3 Domestic Mutual Reliance

• Consistent with our legal framework, develop and implement a plan for state and federal mutual 

reliance, which will build on existing efforts to provide an effective approach for FDA and its 

state regulatory counterparts to work in partnership, one defined by sharing, collaboration and 

harmonization, as well as supporting activities during a public health crisis.

• Further develop and enhance the mechanisms for appropriate data and information sharing to 

enable FDA and states with comparable regulatory and public health systems to more fully rely on, 

coordinate with, and leverage one another’s work, data, and actions.

• Advance an integrated approach to work planning and risk prioritization/categorization, 

including inspection frequency mandates, comparison/reconciliation of inventories, and sample 

collection.

• Advance an integrated, public health focused approach to emergency and incident response 

coordination by further expanding our federal-state rapid response teams, including recall oversight, 

investigations of outbreaks and complaints, and supply chain disruptions.

• Collaborate on training and education, including training of field staff and industry and consumer 

education.

• Harmonize food testing methodologies used by state and federal laboratories, including sample 

collection, analysis, and reporting.

2.4 Inspection, Training, and Compliance Tools

• Conduct proof-of-concepts to evaluate the feasibility of using remote, virtual, and/or 

component inspections of foreign and domestic firms with a demonstrated history of compliance 

for agency prioritization purposes. FDA conducted remote inspections of certain importers during the 

COVID-19 pandemic.

• Encourage, support, and evaluate the use of sensor technology by industry to strengthen monitoring 

of critical and preventive control points.

• Expand the availability of industry and regulatory training to include, where appropriate, computerbased and distance learning models.
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• Increase the use of reliable third-party audits to help ensure safer food, including exploring the 

use of reliable audit data in risk-prioritization for FDA regulatory activities, for example, with respect 

to inspections of both imported and domestically produced foods.

• Develop online tools to assist growers in evaluating the risk of their water sources and determine 

potential management options to help ensure compliance with the Produce Safety Rule.

• Modernize the agency’s inspectional and reporting process by leveraging mobile inspection 

technology and digital reporting tools.

2.5 Outbreak Response

• Working with federal partners, explore mechanisms to accelerate the submission of reports of 

foodborne illnesses from state health departments and state departments of agriculture to federal 

authorities.

• Work with international, federal, state and academic partners to increase the number of laboratories 

that can submit sequences of parasites, pathogens and viruses isolated from food samples via FDA’s 

GenomeTrakr.

• Continue building capacity to upload FDA’s food and environmental sample sequence data to 

PulseNet to facilitate investigations of foodborne outbreaks.

• Explore barriers and mechanisms to better leverage industry food testing results to identify 

possible outbreaks.

• Enhance early warning mechanisms by facilitating information exchange with and between other 

countries on reported foodborne illnesses and pathogens isolated from food samples.

• Increase awareness and training to facilitate opportunities to speed whole genome sequencing of 

pathogens by public and private labs.

• Explore using artificial intelligence to mine nontraditional sources of information, such as 

customer online reviews, medication sales trends, and dining apps to detect outbreaks and as an adjunct 

to traditional health reporting.

2.6 Recall Modernization

• Explore mechanisms to harmonize how FDA and USDA communicate recall information to 

consumers. 

• Develop best practices guidance on various consumer notification processes ranging from 

web and social media postings, text messages, email, alerts, and digital scan prompts to ensure that 

consumers know if they purchased recalled product.

• Explore the use of a broad spectrum of technologies to enhance external communications and the 

effectiveness of recalls.

−	 Create a United States Government (USG) app for alerting consumers about food recalls and 

advisories to empower them with actionable information in real time.

−	 Explore the ability to create and incentivize the widespread use of protocols and standards to 

enable register lockdown capabilities to prevent sales of recalled food products.

• Enhance connectivity of data from Reportable Food Registry submissions and food recalls. 
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Core Element 3: New Business Models and Retail Modernization

We are looking 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, we’re 

exploring the best ways to further modernize and help 

ensure the safety of foods sold at restaurants and other 

retail establishments.

3.1 Ensure Safety of Food Produced or Delivered Using 

New Business Models

• In collaboration with regulatory partners, and including a 

broad array of stakeholders, convene a new food business model 

summit to identify future courses of action to address potential food safety 

vulnerabilities.

• Work with regulatory partners to address new business models that may not be currently covered by 

FSMA (e.g. address who “owns” the food in the last mile).

• Partner with food delivery companies to provide education on the importance of proper food 

handling, including outreach to delivery services such as the U.S. Postal Service, UPS, FedEx, Uber, 

Lyft, DoorDash, etc.

• In partnership with the U.S. Department of Agriculture, CDC, industry and consumer stakeholders, 

develop educational materials for consumers on the handling of food delivered to their 

home including time/temperature considerations, looking for tamper-resistant packaging, and 

reducing potential for cross-contamination. These materials are also relevant to creating a food safety 

culture in the home.

• Encourage the use of technology that automatically monitors product risk factors associated 

with new business models, such as time, temperature, tamper resistance, and traceability information.

• Facilitate the safe development of new food ingredients and production technologies to foster 

product innovation and market access in a safe and timely way.

3.2 Modernize Traditional Retail Food Safety Approaches

• Conduct an independent review of the traditional retail food safety program’s 

effectiveness in preventing foodborne illness and communicating effectively across partners.

• Further advance the importance of facility and equipment design as preventive controls for retail 

food safety management (i.e., engineering controls). In particular, encourage the development and use 

of commercial smart kitchen equipment capable of automatically monitoring time and temperature 

processes.

New Business Models and Retail Moder

WWW
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• Work with the Conference for Food Protection to:

−	 increase uniform adoption of the FDA Food Code by state, local, tribal, and territorial retail 

food protection programs, and

−	 explore more fully incorporating into the Food Code a food safety management systems

approach for retail establishments.

• Encourage and explore use of new digital tools and incentives that prompt desired 

behaviors, such as handwashing and manual temperature monitoring (i.e., managerial controls).

• Work with partners to enhance existing manager certification and food handler education and 

training requirements to include principles proven to better influence human behavior.

• Enhance training curricula for federal, state, local, tribal, and territorial retail regulators 

and staff, while increasing engagement with industry and regulatory partners, to target food safety 

practices most effective in preventing foodborne illness.

• Increase the use of risk-based inspectional approaches that are consistent with the principles of 

Annex 5 of the Food Code, which provides guidance on planning, conducting and evaluating risk-based 

inspections.

• Advance research related to strengthening retail food safety, encouraging academic research 

to fill knowledge gaps in this area.

• Identify and develop intervention strategies known to be effective at reducing the occurrence of 

foodborne illness risk factors and tie incorporation of these strategies to FDA’s funding of state and 

local retail programs to incentivize implementation. 
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Core Element 4: Food Safety Culture

We should foster, support and strengthen food safety 

cultures on farms, in food facilities, and in homes. We 

will not make dramatic improvements in reducing 

the burden of foodborne disease without 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.

4.1 Promote Food Safety Culture Throughout 

the Food System

• Review literature and conduct and support

research on challenges, barriers, and 

opportunities to influence attitudes and modify 

behaviors related to food safety culture.

• Develop an FDA food safety culture social marketing 

plan to strengthen a culture of food safety in the establishments 

we regulate and in turn, influence and sustain widespread safe-food behavior changes.

• Encourage influencers, such as chefs, bloggers, cooking shows, celebrities, and industry leaders to 

model desired safe-food behaviors and make smarter food safety part of the national dialogue and 

social norm.

• Ensure FDA education, training, and inspectional tools incorporate established behavioral 

science principles that foster a food safety culture.

• Enhance food safety culture and behavioral science principles as a critical component of the food 

safety work we do with federal, state, local, tribal, territorial and international regulatory partners.

• Support the development and harmonization of tools that companies can use to assess their 

food safety culture, working in concert with industry and academia.

4.2 Further Promote Food Safety Culture Throughout the Agency

• Ensure consideration of the central role of food safety culture as a core tenet in advancing the 

agency’s food safety mission.

−	 Develop procedures to further strengthen and measure the internal understanding of food 

safety culture, including the role of public health and regulatory partners as essential members of 

our food safety team.

• Strengthen communications from FDA leadership on the importance of food safety culture as 

part of FDA’s Foods Program.

• Consider how companies’ positive food safety culture can factor into reduced inspection 

frequencies.

−	 Educate investigators on the characteristics that indicate a facility has a strong food safety 

culture.

Food Safety Culture
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4.3 Develop and Promote a Smarter Food Safety Consumer Education Campaign

• Develop strategies to help consumers access, understand and utilize new technologies relevant to 

food safety and facilitate their adoption of new tools (e.g., apps).

• Engage new partners in a broad coalition (consumer groups, industry groups such as technology 

companies, other government partners, and media groups) to promote food safety culture.

• Use new, tech-enabled popular mediums and tools, such as Smart Home devices, smart phones, 

digital platforms, and more to reach consumers with Smarter Food Safety messages.
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VI. Conclusion

We know that FDA cannot embark upon this journey alone and, to be successful, it’s equally important for 

food companies and technology firms, as well as government agencies and consumers, to join us in this 

effort.

Imagine how different our work and lives would be if we could leverage tools and technologies, as well as 

modern approaches, to fundamentally change how we keep food safe. 

No matter whether you’re a food producer or a food regulator, or whether you are in the government, 

industry or academia, at the end of the day we’re all consumers. So, imagine these aspirations becoming 

the norm:

• Scanning a bag of lettuce and being able to immediately know where it came from to determine if it’s 

tied to an outbreak of foodborne illness.

• Receiving a text message that lets you know you’ve purchased something that’s been recalled.

• Having greater confidence in the safety of the food you share with your family because artificial 

intelligence has enabled FDA to significantly increase its predictive capability of finding contaminated 

food.

• Knowing the potential impact of weather events, like hurricanes or floods, on the safety of foods 

hundreds of miles or more away because of big data analytics.

• Knowing that the water used to grow the produce you’re buying is safe because it was monitored by the 

farmer in real-time using sensor monitoring on a smart device.

• Receiving alerts on your smart phone when your dinner has reached a safe temperature.

• Knowing that the workers in your favorite restaurant use safe-food handling practices, not because 

they’re required to but because the workplace culture has made it second nature for them.

In putting forth the concepts in this blueprint, we’re not talking about things that can’t be done. We’re 

talking about doing our work differently. 

Working together and thinking outside the box, we’ll create a more digital, traceable and safer food system 

that advances food safety, improves the quality of life for consumers in this country and all over the world, 

and better prepares us for unexpected events that could impact the food supply. 
U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

July 2020