Tag Archives: new era of smarter food safety

FDA

FDA Announces 12 Winners of Traceability Challenge

By Food Safety Tech Staff
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FDA

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.

magnifying glass

FDA’s Traceability Tech Challenges Goes Live

By Food Safety Tech Staff
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magnifying glass

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.

FDA

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

By Food Safety Tech Staff
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FDA

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.

FDA

FDA to Launch Technology Traceability Challenge

By Food Safety Tech Staff
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FDA

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.

2021 Food Safety Consortium

FDA to Take Questions in Advance of 2021 Food Safety Consortium

By Food Safety Tech Staff
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2021 Food Safety Consortium

This year’s Food Safety Consortium Virtual Conference Series kicks off on Thursday, May 6 with a keynote presentation from Frank Yiannas, FDA deputy commissioner for food policy and response. This year we are extending the Q&A period with Yiannas to 30 minutes, and we are providing attendees the opportunity to bring their questions to the top of the list by filling out the below form. We had a lot of questions during last year’s FDA Town Hall, and we’d love to be able to get to more of them this year.

The Spring Program will run every Thursday in May, with each episode starting at 12 pm ET. The weekly episodes will tackle a range of critical topics in foods safety, including FSMA and traceability, food protection strategies, COVID-19’s lasting impact on the food industry by segment, audits and supply chain management. Registration is open now.

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About the Food Safety Consortium Conference

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in sessions that are critical for advancing careers and organizations alike. Over the past 9 years the Food Safety Consortium has built a reputation for delivering the most knowledgeable and influential perspectives in food safety. The speaker line-up has driven key food safety decision-makers to the event (both in-person and virtually)—facilitating an environment for vendors, suppliers, food industry professionals, and consultants to network and build long-lasting business relationships.

Due to COVID-19, the 2020 Food Safety Consortium was converted to a virtual conference series that featured specific topics in a weekly episode series. The 2021 Food Safety Consortium Virtual Conference Series will feature a Spring and Fall program, running in May and October, respectively.

FDA

In a Year of ‘Unprecedented Challenges’ FDA’s Food Program Achieved So Much

By Food Safety Tech Staff
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FDA

Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.

“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”

  • Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
  • Release of the New Era of Smarter Food Safety Blueprint
  • Release of the 2020 Leafy Greens STEC Action Plan with a focus on prevention, response and research gaps
  • Artificial Intelligence pilot program to strengthen the screening of imported foods
  • Proposed Food Traceability Rule issued in an effort to create more recordkeeping requirements for specific foods
  • New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
  • Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation
Frank Yiannas, FDA, food safety

Ten Years Later, a Reflection on FSMA’s Accomplishments

Frank Yiannas, FDA, food safety

It may be hard to believe that 10 years have passed since FSMA became law. The risk-based preventive approach to growing, manufacturing and processing, packing, storing and transporting food has transformed the industry and the nation’s food system. Today, on the anniversary of FSMA, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas takes a look at where it all began and walks us through progress, accomplishments and what the future holds.

  • Seven foundational rules established, and the proposed Food Traceability Rule (September 2020) positioned to harmonized traceability
  • Global partnerships (Canada, Mexico, Europe, and China) to strengthen safety of imported food
  • Investment in cooperative agreement programs to support compliance with FSMA rules at the state level
  • Looking forward: New Era of Smarter Food Safety, with blueprint released in July 2020 creates a 10-year roadmap for a more “digital, traceable and safer food system”
    • Incentivizing industry to adopt new technologies that facilitate full traceability
    • Emphasis on food safety culture on farms and in food facilities
    • Improving root cause analysis when preventive control measures fail

“Have we accomplished everything we wanted to help ensure that the food you serve your family is safe? The honest answer is that we’re still working on that. We are working diligently to ensure that remaining FSMA rules and related guidance documents are finalized and implemented,” said Yiannas in the FDA Voices blog. “But even when we have reached all of those milestones, we will always be working with industry on continuous improvement based on the latest science and the application of new technologies. Every day we will do our utmost to make our nation’s food as safe as it can be.”

FDA

FDA’s New Outbreak Table an Effort Toward Earlier Transparency about Outbreaks

By Food Safety Tech Staff
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FDA

FDA has released an outbreak investigation table that aims to disseminate information about foodborne illness outbreaks right when the agency begins an investigation. The table, published by the FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, will be updated with important information before a public health advisory or food recall is issued.

“The outbreak investigation table is a demonstration of our continued commitment to more frequent and transparent communication with stakeholders and consumers about outbreaks we’re investigating,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency statement. “We have already taken steps to release information early, in some cases prior to a specific food being linked to an outbreak, including in our recent communications on investigations into three ongoing E. coli O157:H7 outbreaks.”

As of November 18, the table listed seven outbreak investigations, only one of which identified a product linked to illnesses. Yiannas pointed out that during the early stages of an investigation, there may not be any action that a consumer can take—however, the tool is in line with the New Era of Smarter Food Safety initiative, which commits to releasing outbreak information in the “earliest stages of an investigation”.

The FDA’s outbreak investigation table is available on the agency’s website.