Tag Archives: new era of smarter food safety

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FDA To Host Virtual Meeting on Data and Tech in New Era of Smarter Food Safety

By Food Safety Tech Staff
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The FDA is hosting a one-day virtual public meeting on “Data and Technology in the New Era of Smarter Food Safety” on April 24, 2024, from 10:00 am – 4:00 pm EDT. The meeting is designed to help the agency improve its understanding of how regulators and industry can leverage data and technology to exponentially advance food safety and achieve better health outcomes.

The morning session of the public meeting will consist of presentations from FDA to explain the agency’s current thinking on the potential for new, innovative or different data and technology activities that could be leveraged by both government and industry to exponentially advance food safety. The afternoon session will be reserved for public comments to provide an opportunity for stakeholders to share feedback on how and where advances in data and technology can be leveraged to significantly accelerate FDA’s ability to improve public health outcomes. Beginning on April 24, 2024, a Regulations.gov docket will open for 60 days to collect comments related to the event topic.

Topics for consideration during the public meeting include:

  • Tech-enabled traceability
  • Predictive analytics
  • Data sharing
  • Whole genome sequencing (i.e., GenomeTrakr)
  • Ways to use technology to monitor and gather data

Technological innovation in equipment design, digital tools, and training methods

The FDA will also welcome feedback on new and emerging areas of innovation (e.g., use of virtual reality in food safety training) that were not addressed in the initial New Era of Smarter Food Safety Blueprint.

Feedback received from this meeting, as well as comments submitted to the accompanying docket, will help the FDA prioritize its activities within the New Era of Smarter Food Safety framework and shape further stakeholder engagement opportunities.

There is no cost to attend the virtual public meeting, but registration is required. Participants who wish to speak during the afternoon public comment session must register as indicated on the meeting page.

 

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FDA Announces Publication of Final Traceability Rule and Informational Webinar

By Food Safety Tech Staff
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The FSMA Final Rule on Traceability was published in the Federal Register on November 21, meaning the rule will go into effect on January 20, 2023 (60 days after the publication date). The FDA will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm – 5:00 pm (ET) to provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and to discuss the recordkeeping requirements of the rule.  The FDA will answer pre-submitted questions and take questions during the webinar.

The final rule establishes additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables and ready-to-eat deli salads. In collaboration with industry, the FDA will be able to more rapidly and effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.

“This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future.”

Foods subject to the final rule requirements appear on the Food Traceability List (FTL). To determine which foods should be included on the FTL, the FDA developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act (FSMA). These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, and tropical tree fruits, as well as shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish and crustaceans.

The FDA released a proposed rule in 2020 and held a public comment period where comments were received from food producers and other stakeholders through early 2021. In response, the agency has made several changes to the final rule so that it better aligns with current industry approaches to food traceability and harmonizes points in the supply chain where records must be maintained.

Key features of the final rule include:

  • Critical Tracking Events: at specific points in the supply chain—such as harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods—records containing Key Data Elements are required.
  • Traceability Plan: information essential to help regulators understand an entity’s traceability program. These include a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan and a farm map for those that grow or raise a food on the FTL.
  • Additional Requirements: maintenance of records as original paper or electronic records, or true copies; providing requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist the FDA during an outbreak, recall or other threat to public health.
Derek Stangle, Squadle
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A Check on Food Service Safety

By Derek Stangle
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Derek Stangle, Squadle

Food safety is a primary concern worldwide. On a national scale, the U.S. Food and Drug Administration earmarked $44.8M for food safety in the President’s FY2022 Budget Request, with more than half of that funding going to the New Era of Smarter Food Safety initiative—a blueprint for the use of new and emerging technologies and approaches.

The New Era of Smarter Food Safety is centered around four core elements:

  • Tech-enabled Traceability
  • Smarter Tools and Approaches for Prevention and Outbreak Response
  • New Business Models and Retail Modernization
  • Food Safety Culture

These foundational pillars cover a range of technologies, analytics, business models and values. Working together, these elements help create a safer and more traceable food system.

The focus on food safety culture is particularly interesting. The FDA calls upon restaurants and food service providers to define food safety culture goals, and to develop and launch internal training on the principles of food safety, starting with education on the tools available for food safety with a particular focus on tools that assess and measure progress.

Creating that safety culture is critical to any brand in food service. Employees, equipped with the proper tools and procedures, are on the front lines of food safety: from ensuring proper food storage and refrigeration, to keeping food prep areas and utensils clearly marked, clean and sanitary, and cooking food to safe temperatures.

According to the Safe Food Alliance, food safety culture refers to the specific culture of a facility: the attitudes, beliefs, practices and values that determine what is happening when no one is watching. A strong culture of food safety helps a facility both prevent and catch deviations in their processes that can impact the safety, quality and legality of their products.

How to Maintain Cleanliness and Service Standards

Yet a food safety culture alone is not enough. Equip your employees for success by providing the proper tools and training. For new employees, training should include: education of the restaurant’s cleanliness and service standards, where these standards are derived from (i.e. FDA Food Code), the purpose of restaurant inspections and the consequences of receiving a food code violation.

Starting with the basics, employees should carefully inspect the kitchen, eating and dining areas, as well as restrooms, to make sure the restaurant meets legal health requirements and store-implemented standards. Implementation of the FDA food code ensures cleanliness and food safety practices, including the most current science, technology and legal precedents. Adhering to these guidelines enhances the customer and employee experience by reducing the risk of foodborne illnesses, and the likelihood of physical injury.

Maintaining cleanliness and service standards can be difficult, and the tasks required for food safety can be cumbersome for employees. Manual checklists can help ensure tasks are completed. Newer technologies, such as digital checklists, can further streamline food safety tasks, with compliance and visibility into whether procedures are being diligently followed and completed.

One major challenge of using manual/paper checklists is the lack of transparency in completion rates and quality of tasks. This is especially true for operators of multiple locations. Digital checklists can require employees to provide managers with evidence of task completion—signing a form or capturing a task completion photo.

A manager also can assess the state of restaurant cleanliness and predict threats to food safety and customer satisfaction remotely. For example, if a manager identifies that the tables in the customer seating area are overdue to be wiped down, they can alert employees to this issue.

Having a digital record of completion provides managers confidence that their procedures are being followed, especially when it comes time for restaurant inspection. These insights also allow managers to refine employee education. With effective implementation, these good habits will become routine.

Without an accurate view of operations, food safety and restaurant cleanliness standards cannot be accurately assessed. Eventually, these inconsistencies may cause unforeseen customer service conflicts and food code violations.

Establishing a food safety culture, backed by routine and technology tools, will help your team develop the habits needed to achieve and maintain the high level of cleanliness and service standards required to prevent foodborne illness and increase customer satisfaction.

 

FDA

Online Food Shopping Becomes New Normal for Consumers, FDA to Ramp Up Food Safety Efforts

By Food Safety Tech Staff
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Online grocery shopping became essential during the early months of the COVID-19 pandemic. While many consumers have returned to the brick and mortar stores, many others have completely changed how they shop for food, opting for online shopping, whether out of convenience or for safety. The FDA has seen and recognizes this shift and even held a three-day virtual summit last month, “The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers”, to discuss and gain insights into the world of business to consumer e-commerce involving food.

“It is now clear that this is not a trend that will be completely reversed in time but one likely to lead to a new normal in how consumers shop for food, whether it’s from restaurants, grocery stores, or companies providing meal kits and other products,” state Frank Yiannas, deputy commissioner for food policy and response at FDA and Andreas Keller, director, multi-commodity foods, Office of Food Safety at CFSAN on the FDA Voices blog. “Thus, the U.S. Food and Drug Administration is actively working with partners in federal, state, and local government and industry in the U.S. and other nations, as well as with consumer advocates, to help ensure that consumers aren’t ever unwittingly trading food safety for convenience.”

During last month’s meeting, many challenges and questions came up, from how to further prevent food tampering to labeling issues, especially related to allergens, to ensuring that food safety values are shared across all parties involved in producing, transporting and selling food in the e-commerce setting.

FDA announced that it will be reviewing and assessing the information it received during the meeting and is inviting industry to submit public comments now through November 20, 2021 (Docket FDA-2021-N-0929). From there, the agency will determine the critical issues that need to be addressed first.

The daily recordings of the virtual summit are available on FDA’s website.

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FDA Announces 12 Winners of Traceability Challenge

By Food Safety Tech Staff
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Back in May, FDA launched a technology traceability challenge with the goal of promoting innovation in the development of scalable and affordable traceability technology tools for food operations of all sizes. Today, the agency announced the winning teams and their technologies:

  • FarmTabs. Free, downloadable software run on Microsoft Excel to aid small and mid-size farmers manage records for traceability/ farm-related metrics.
  • Freshly. Traceability and batch-tracking software for small businesses (including retailers, manufacturers and distributors).
  • HeavyConnect. Cloud-based digital traceability and compliance documentation solutions, including a mobile app for producers to capture data in the field and share it across the supply chain.
  • ItemChain. Item-level traceability to each party in the supply chain.
  • Kezzler. Solution uses self-service portals to generate item-level identifiers and associate homogenized datasets at the grower level through mobile applications.
  • Mojix. Uses industry standards to link traceability events for each item or lot throughout the supply chain in an open data network.
  • OpsSmart. Cloud-based traceability software solution for food safety, recall management, and traceability in a complex supply chain.
  • Precise’s. Traceability Suite that provides end-to-end supply chain tracking to all segments of the food market, using geospatial, machine learning and IoT technologies.
  • Roambee/GSM/Wiliot’s. Solution uses low-cost IoT sensor tags in with shipment visibility and verification technologies for end-to-end traceability.
  • Rfider. Software-as-a-service that captures, secures and shares critical event data along supply chains to consumers.
  • TagOne. A role-based data capture framework that updates an open source blockchain platform, and uses industry standards to ensure interoperability, and ease of use and data security.
  • Wholechain. Supply chain traceability system that uses blockchain technology to trace products back to the original source.

The videos submitted by each winning company are available on FDA’s webpage that announces the winners.

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FDA’s Traceability Tech Challenges Goes Live

By Food Safety Tech Staff
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Today FDA launched its latest initiative set forth as part of the New Era of Smarter Food Safety blueprint: The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. The agency is asking technology providers, entrepreneurs and innovators to come forward and develop traceability technology tools that are scalable and affordable for food operations of all sizes.

“Too many Americans suffer from foodborne illnesses every year. Making the food supply more digitally enabled and food more traceable will speed the response to outbreaks and deepen our understanding of what causes them and how to prevent them from happening again,” said Acting FDA Commissioner Janet Woodcock, M.D. in an agency release “One of the FDA’s highest priorities is protecting consumers from foodborne illnesses. We hope to find new, innovative ways to encourage firms of all sizes to voluntarily adopt tracing technologies that can help our nation modernize the way we work together to determine possible sources of foodborne illnesses as quickly as possible to keep Americans safe.”

Additional information about the challenge, which ends on July 30, can be found on the precisionFDA website.

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FDA Requests $6.5 Billion for FY 2022 Budget, 8% More than Last Year

By Food Safety Tech Staff
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The FDA is asking for $6.5 billion, about an 8% increase over the previous year, for its FY 2022 budget. The budget includes a $185 investment in the agency’s critical public health infrastructure, which addresses enterprise-wide data modernization and enhanced technology to ensure that labs and facilities are safe and integrated with program needs, and capacity building. FDA is asking for $97 million to increase the development of its food and medical product safety programs. Specific areas of investment within food safety include boosting funding given to programs that address maternal and infant nutrition ($18 million); providing funds that tackle emerging food-related chemical and toxicological issues ($19.7 million); and improving the oversight of animal foods and supporting the implementation of the New Era of Smarter Food Safety Blueprint ($22 million). Accompanying FDA’s budget request are legislative proposals to enhance the agency’s authorities to protect and promote public health.

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FDA to Launch Technology Traceability Challenge

By Food Safety Tech Staff
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The FDA is asking technology providers, entrepreneurs and innovators to come forward and develop traceability technology tools that are scalable and affordable for food operations of all sizes. The FDA New Era of Smarter Food Safety Low or No-Cost Tech-enabled Traceability Challenge will launch on June 1.

“Achieving end-to-end food traceability will involve everyone in the supply chain – from source to table. To achieve that level of participation, we need accessible tracing solutions for human and animal food companies of all sizes. That means that we must help ensure that even small companies can use and benefit from new tracing technologies,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency blog post. “Digitizing data at no or low cost through the use of creative financial models may allow the entire food system to get smarter together.”

The challenge will be administered by precisionFDA and overseen by the agency’s Office of Food Policy and Response. On June 1 at 8 am ET, the FDA’s pre-registration page will be updated with the submission information. The deadline for the challenge is July 30 at 5 pm ET.

Up to 12 winners will be selected and although there is no cash prize, the winners will have the chance to discuss their technology solution during an FDA public forum. “The food industry will gain new insights into how to solve traceability challenges, and the FDA will open the door to a conversation about finding new ways to overcome obstacles in the road to farm-to-fork traceability,” stated Yiannas.

The challenge is part of the goals outlined in the FDA’s New Era of Smarter Food Safety blueprint, which specifies tech-enabled traceability as a core element.

Food Safety Consortium

FDA Focusing on Fostering Food Safety Culture, Truly Bending the Curve of Foodborne Illness

By Maria Fontanazza
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Food Safety Consortium

The past year has tested and stressed the food system, putting tremendous pressure on worker safety and supply chain resilience. Despite the challenges, the industry continued to work day in and day out to meet the needs of Americans. “Consumers could still go then and now to their favorite supermarket or online platform and have access to thousands of food SKUs that are available,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “We have the people in the food and agriculture sector to thank, and that’s you.”

Last week Yiannas gave his third Food Safety Consortium keynote address as deputy commissioner, reflecting on the past year and recognizing the progress and the work ahead. “I appreciate the larger conversation that the Consortium facilitates on food safety.” The Spring program of the Food Safety Consortium Virtual Conference Series takes place every Thursday in May.

Since the Fall of 2020, FDA has made advances in several areas, all of which take steps to advance the agency’s New Era of Smarter Food Safety initiative. The goals set as part of the New Era aim to help the agency more efficiently and efficiently respond to outbreaks and contamination, and other food safety challenges. The intent is to go beyond creating food safety programs into fostering a culture of food safety and truly bending the curve of foodborne illness, said Yiannas. In September the FDA issued the proposed FSMA rule on food traceability with the intent on laying the groundwork for meaningful harmonization. Nearly 6200 comments were submitted to the docket on the Federal Register, and the agency held three public meetings about the proposed rule in the fall, hosting more than 1800 people virtually. Yiannas anticipates the final rule will be published in early 2022.

The pandemic has shown how enhanced traceability might have helped prevent supply chain disruptions during a public health emergency, and the FDA continues its efforts to establish greater transparency and traceability. It is supporting the development of low-cost traceability technology solutions that are accessible to companies of all sizes. The agency also continues to explore the role of predictive analytics via the use of artificial intelligence. It has moved its AI program involving imported seafood from proof of concept into the field. Based on the results, it is expected that AI will help the FDA better manage the ever-increasing amount of imported foods by targeting inspectional resources in a more informed manner.

Efforts to strengthen food safety culture within organizations include collaborating with partners, industry, academia and consumers to define food safety culture in a transparent way. The agency will also be developing and launching internal training modules for FDA inspectional staff to introduce them to important concepts such as behavioral sciences. “We want to make food safety culture part of the dialogue and part of the social norm,” said Yiannas.

The agency will also be proposing new agricultural water requirements, a move as a result of feedback that FDA received in response to the Produce Rule. “Produce safety is one of the last frontiers because of product being grown outside,” said Yiannas.

In addition, FDA continues to review and evaluate feedback from proposed lab accreditation rule. It is expected that the FDA will issue the final rule early next year.

“We just lived through a historic year and historic challenges. These have been the most difficult of times in my profession. We have been able to move forward nonetheless,” said Yiannas. “We’re going to get through this stronger and more resilient than ever.”

Angel Suarez, EAS Consulting Group
FST Soapbox

Regulatory Cross Cutting with Artificial Intelligence and Imported Seafood

By Angel M. Suarez
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Angel Suarez, EAS Consulting Group

Since 2019 the FDA’s crosscutting work has implemented artificial intelligence (AI) as part of the its New Era of Smarter Food Safety initiative. This new application of available data sources can strengthen the agency’s public health mission with the goal using AI to improve capabilities to quickly and efficiently identify products that may pose a threat to public health by impeding their entry into the U.S. market.

On February 8 the FDA reported the initiation of their succeeding phase for AI activity with the Imported Seafood Pilot program. Running from February 1 through July 31, 2021, the pilot will allow FDA to study and evaluate the utility of AI in support of import targeting, ultimately assisting with the implementation of an AI model to target high-risk seafood products—a critical strategy, as the United States imports nearly 94% of its seafood, according to the FDA.

Where in the past, reliance on human intervention and/or trend analysis drove scrutiny of seafood shipments such as field exams, label exams or laboratory analysis of samples, with the use of AI technologies, FDA surveillance and regulatory efforts might be improved. The use of Artificial intelligence will allow for processing large amount of data at a faster rate and accuracy giving the capability for revamping FDA regulatory compliance and facilitate importers knowledge of compliance carrying through correct activity. FDA compliance officers would also get actionable insights faster, ensuring that operations can keep up with emerging compliance requirements.

Predictive Risk-based Evaluation for Dynamic Imports Compliance (PREDICT) is the current electronic tracking system that FDA uses to evaluate risk using a database screening system. It combs through every distribution line of imported food and ranks risk based on human inputs of historical data classifying foods as higher or lower risk. Higher-risk foods get more scrutiny at ports of entry. It is worth noting that AI is not intended to replace those noticeable PREDICT trends, but rather augment them. AI will be part of a wider toolset for regulators who want to figure out how and why certain trends happen so that they can make informed decisions.

AI’s focus in this regard is to strengthen food safety through the use of machine learning and identification of complex patterns in large data sets to order to detect and predict risk. AI combined with PREDICT has the potential to be the tool that expedites the clearance of lower risk seafood shipments, and identifies those that are higher risk.

The unleashing of data through this sophisticated mechanism can expedite sample collection, review and analysis with a focus on prevention and action-oriented information.

American consumers want safe food, whether it is domestically produced or imported from abroad. FDA needs to transform its computing and technology infrastructure to close the gap between rapid advances in product and process technology solutions to ensure that advances translate into meaningful results for these consumers.

There is a lot we humans can learn from data generated by machine learning and because of that learning curve, FDA is not expecting to see a reduction of FDA import enforcement action during the pilot program. Inputs will need to be adjusted, as well as performance and targets for violative seafood shipments, and the building of smart machines capable of performing tasks that typically require human interaction, optimizing workplans, planning and logistics will be prioritized.

In the future, AI will assist FDA in making regulatory decisions about which facilities must be inspected, what foods are most likely to make people sick, and other risk prioritization factors. As times and technologies change, FDA is changing with them, but its objective remains in protecting public health. There is much promise in AI, but developing a food safety algorithm takes time. FDA’s pilot program focusing on AI’s capabilities to strengthen the safety of U.S. seafood imports is a strong next step in predictive analytics in support of FDA’s New Era of Smarter Food Safety.