Tag Archives: Frank Yiannas

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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.
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Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:

FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.

Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.

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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.”

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2020 FSC Episode 4 Wrap: FDA: There’s a Strong Business and Public Health Case for Better Traceability

By Maria Fontanazza
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One year ago the FDA held an at-capacity public meeting to discuss its latest initiative, the New Era of Smarter Food Safety. At the time, the agency was planning to release the blueprint for the New Era in the spring of 2020. In fact, the FDA was just days away from unveiling it when the COVID-19 pandemic hit in March. The blueprint was put aside and it was all hands on deck, as the agency worked with the food industry to ensure companies continued operating, as they were deemed a part of America’s critical infrastructure. From there, the agency navigated through uncharted waters with the food industry and its stakeholders. It signed an MOU with USDA in an effort to prevent disruptions at FDA-regulated food facilities and address shortages of PPE, disinfection and sanitation supplies. It announced that it would conduct remote inspections and extended the comment period for the Laboratory Accreditation Program Proposed Rule. It released a COVID-19 food safety checklist with OSHA to help guide companies through employee health, social distancing, and the operational issues that have entered into play as a result of the pandemic. Food companies and the supply chain were facing an enormous challenge.

“I always thought we had one of the best food systems in the world… by and large we have an amazing food system,” said Frank Yiannas deputy commissioner for food policy and response during last week’s keynote address at the 2020 Food Safety Consortium Virtual Conference Series. “We just experienced the biggest test on the food system in 100 years. Have we passed the test? I don’t think anyone would say we scored 100%… but by and large we passed the test.” Yiannas added that COVID-19 has exposed some strengths and weaknesses in the food system as well. He also emphasized a point that he has been driving home throughout the pandemic: “The virus that causes COVID-19 is not a virus that is transmitted by food. It is a respiratory virus and generally transmitted in very different ways.”

The FDA released the blueprint for the New Era of Smarter Food Safety, which incorporated some lessons learned from COVID-19, in July. Traceability is a big part of agency’s new era initiative, and the pandemic further put a spotlight on the need for better tracking and tracing in the food industry. And under FSMA, FDA is required to “establish a system that will enhance its ability to track and trace both domestic and imported foods”. In working to meet this requirement, FDA proposed the FSMA rule on food traceability last month.

Yiannas said the proposed rule has the potential to lay the foundation for meaningful harmonization and called aspects of the proposed rule game changing. It establishes two critical components that are the leading edge of food traceability: It defines critical tracking events (i.e., what are the types of events in the food system that required those events to be kept) and key data elements (i.e., the data elements that must be captured at those critical tracking events). “These two things are big ideas for traceability,” said Yiannas. “They will allow us to harmonize how traceability is to be done, allow us to scale and allow for greater interoperability.” The proposed rule also creates a traceability list that identifies foods based on a risk-ranking model for food tracing.

FDA is encouraging comments on the proposed rule and is holding three meetings (November 6, November 18 and December 2) to discuss the proposed traceability rule. “We are going to create the final rule together,” said Yiannas.

As part of a special offering, Episode 4 has been made available for viewing on demand for free. Register to view the on-demand recording.

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2020 FSC Episode 4 Preview: FDA’s Frank Yiannas to Discuss Proposed FSMA Traceability Rule, Updates on New Era of Smarter Food Safety

By Food Safety Tech Staff
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Episode 4 of the 2020 Food Safety Consortium Virtual Conference Series features more important conversations about COVID-19 and its impact on the food industry. The event kicks off with a special presentation by FDA’s Frank Yiannas. Highlights include:

  • FDA Keynote Address by Frank Yiannas, deputy commissioner for food policy and response
  • COVID-19 Lessons Learned Panel Discussion with Mitzi Baum, STOP Foodborne Illness; Stephanie Dragatsis, Feeding America; Carletta Ooten, Amazon; Spir Marinakis, Maple Leaf Foods; and Craig Wilson, Costco Wholesale
  • Rumor vs. Reality: How to Cope with the Trends of Food Safety During a Pandemic, with Ge Song, Benjamin L. England & Associates, LLC
  • Tech Talk by sponsor Rizepoint and program partner AOAC

As part of a special offering, Episode 4 has been made available for viewing on demand for free. Register to view the on-demand recording.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium
Although there will be no physical handshaking this year, Frank Yiannas, deputy commission for food policy and response at FDA (left), will join Rick Biros, president of the Food Safety Consortium, for this year’s Virtual Conference Series on October 1. (Photo credit: amyBcreative)
Food Safety Consortium

2020 Food Safety Consortium Virtual Conference Series Agenda Announced

By Food Safety Tech Staff
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The agenda for the 2020 Food Safety Consortium Virtual Conference Series has been released. The announcement about the annual Food Safety Consortium being converted to a virtual series due to the COVID-19 pandemic was made last month. Due to a demand to provide attendees with even more content, the event has been extended a full month and is running into December. Food Safety Tech is the media sponsor.

The event will begin every Thursday at 12 pm ET, beginning on September 3 and continue through December 17. Each week will feature three educational presentations, two Tech Talks, and a panel discussion. Weekly episodes include food defense, food labs, pest management, sanitation, food fraud, listeria detection, mitigation & control, professional development, women in food safety, supply chain management, COVID-19’s impact and food safety culture.

Frank Yiannas, FDA deputy commissioner for food policy and response, will serve as the keynote speaker on Thursday, October 1 at 12 pm ET.

“Human connection is so important for events, and we know we’re not the only game in town. That’s why we’ve invested in a Conference Virtual Platform that can facilitate discussions, discovery, and connection that can continue whether our event is offline or online—and not end with the live streaming,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “Simply, the experience other food safety conferences are offering is not conducive to learning, staying engaged or take into consideration that you have a job to do during that week. This is why we have designed the Consortium’s program with short, manageable episodes that are highly educational.”

Registration for the 2020 Food Safety Consortium Virtual Conference Series is open. Keeping in mind that registrants may not be able to attend every week due to scheduling conflicts, there is an option to watch the each session on demand.

Tech Talk Sponsorship

Companies that are interested in sponsoring a 10-minute technical presentation during the series can also submit their abstract through the portal. For pricing information, contact IPC Sales Director RJ Palermo.

Innovative Publishing has also converted the Cannabis Quality Conference to a virtual event. More information is available at Cannabis Industry Journal.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo (The live event)

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy.

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 conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

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FDA Expects to Release Blueprint for New Era of Smarter Food Safety Soon

By Food Safety Tech Staff
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On October 1, Frank Yiannas will be the keynote speaker for the 2020 Food Safety Consortium Virtual Series || The series takes place during the weeks of September 3 through December 17Expect the much-anticipated blueprint for FDA’s New Era of Food Safetyto be released soon. The agency has not provided an exact date but in an update prior to the July 4th holiday, FDA stated it would be rolled it out “in the coming weeks”.

“The challenges we’ve faced during the pandemic have made it clear that the goals we set forth in the New Era blueprint are more important now than ever. Some of them, like enhanced traceability, are particularly meaningful in light of recent events,” Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, stated in an agency consumer update. “What we have learned from the pandemic is that we’re on the right track with the New Era of Smarter Food Safety. The steps that we’ll take will prepare us to protect the safety of our food supply, no matter what challenges we face.”

In addition to the focus on emerging digital technologies, traceability in the supply chain, ensuring safety in the home delivery of food (e-commerce), and food safety culture, FDA will be including the lessons learned from the COVID-19 pandemic as part of the blueprint structure.

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2020 Food Safety Consortium Keynote Speaker Announced: Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

By Food Safety Tech Staff
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Frank Yiannas, FDA, food safety

EDGARTOWN, MA, January 22, 2020 – Innovative Publishing Company Inc., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker for the 2020 Food Safety Consortium Conference & Expo on October 21. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 21–23 in Schaumburg, IL (just outside Chicago).

“At last year’s Food Safety Consortium, Frank Yiannas spoke about the ‘sea change’ happening at FDA and the increased efforts on the part of the agency to drive more transparency and traceability. We look forward to his insights, as well as learning more about FDA’s progress on its initiatives, especially the New Era of Smarter Food Safety,” says Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference & Expo.

This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Food Safety, chaired by Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation; Food Integrity, chaired by Steven Sklare, president of The Food Safety Academy; and Food Defense, chaired by Jason Bashura, senior manager, global food defense at PepsiCo.

The call for abstracts is open until March 2, 2020.

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Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy. The Food Safety Consortium Conference and Expo 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 conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

With the passage of the Farm Bill, there has been a great deal of interest from the food industry in cannabis-infused foods and beverages, which includes hemp and CBD. The Food Safety Consortium is co-located with The Cannabis Quality Conference & Expo, an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the Cannabis Quality Conference enables attendees to engage in conversations that are critical in finding solutions to improve regulatory compliance, quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace. Both conference programs run concurrently, thus, Food Safety Consortium registrants can attend any of the Cannabis Quality Conference presentations and vice versa. This year’s event takes place October 21–23 in Schaumburg, IL and is co-located with the Cannabis Quality Conference & Expo.

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E. Coli Outbreaks Linked to Salinas-Grown Romaine Lettuce Over, Deputy Commissioner Yiannas Releases Statement

By Food Safety Tech Staff
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Yesterday the CDC reported that the E.coli outbreak linked to romaine lettuce grown in the Salinas, CA growing region is over. The contaminated lettuce should no longer be available, and FDA states that consumers do not need to avoid romaine lettuce from Salinas. The agency will continue its investigation into the potential factors and sources that led to the outbreak.

The FDA did identify a common grower link to the E.coli O157:H7 contamination as a result of its traceback investigation. However, a statement released yesterday by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas points out that “this grower does not explain all of the illnesses seen in these outbreaks.”

To be specific, the FDA, CDC and other public health agencies were tracking three outbreaks involving three separate strains of E.coli O157:H7 linked to romaine lettuce. During the course of the investigation FDA, CDC, the California Department of Food and Agriculture and the California Department of Public Health conducted sampling of the water, soil and compost of several of the fields in the lower Salinas Valley that were connected to the outbreak. “So far, sample results have come back negative for all of the three outbreak strains of E. coli O157:H7. However, we did find a strain of E. coli that is unrelated to any illnesses in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze,” Yiannas said in the agency statement. “This could be an important clue that will be further examined as our investigation continues. However, this clue does not explain the illnesses seen in these outbreaks.”

Finding the contamination source(s) is critical, as it will aid romaine growers in putting safeguards in place to help prevent future contamination.

As for the final case count (with last illness onset on December 21, 2019) of this outbreak, there were 167 total illnesses and 85 hospitalizations across the United States. No deaths were reported.

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FDA Receives Record Turnout As Industry Eager to Discuss New Era of Smarter Food Safety

By Maria Fontanazza
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Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”

FDA held breakout sessions centered on areas critical to the initiative:

  • Tech-enabled traceability and outbreak response
  • Smarter tools and approaches for prevention
  • Adapting to new business models and retail modernization
  • Food safety culture

During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.

Tech-Enabled Traceability and Outbreak Response

  • FDA should consider all parts of the supply chain when thinking about traceability
  • Take into account considerations for sharing sensitive data along the supply chain
  • Speaking a common language and creating data standards, along with necessary minimum data elements for traceability is critical
  • Better communication related to data sharing as well as more meetings with FDA and stakeholders, especially during outbreaks
  • Show industry the ROI of the data
  • Provide a roadmap or recommendation for companies on where they can begin on their traceability journey
  • Request for unity across government agencies (i.e., FDA, USDA), as it would provide more clarity during an outbreak

Smarter Tools and Approaches for Prevention

  • Trust and transparency are key
  • Safeguards that address privacy concerns and liability
  • Data
    • Data sharing: Concern about retroactive investigations
    • Types of data: With the “treasure trove” of existing data out there, which is the most important and helpful in improving food safety?
  • Environmental assessments and root cause analysis—more dialogue between FDA and industry

Adapting to New Business Models and Retail Food Safety Modernization

  • More need for collaboration
  • Globalization and use of best practices
  • Establishing a common standard to level the playing field
  • Establish best practices for tamper resistance
  • The last mile: Food safety training for food delivery personnel as well as harmonization for last mile delivery
  • More consumer education

Food Safety Culture

  • Emphasis on behavior and humanizing the work: Focusing on what happens within organizations at all levels
  • Clarity and communication are important
  • Leveraging current food safety culture best practices as well as any relevant existing standards (i.e., ISO, Codex)
  • Partnerships are critical, finding the balance between compliance and collaboration

Other Factors FDA Must Consider

The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”

Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.

“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”

FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.

The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.