Tag Archives: FSMA

Rick Biros
Biros' Blog

In Defense of FSMA

By Rick Biros
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Rick Biros

The lead (pardon the pun) headline in Tuesday’s New York Times digital edition is “Lead-Tainted Applesauce Sailed Through Gaps in Food-Safety System: Hundreds of American children were poisoned last year. Records show how, time and again, the contamination went unnoticed.

The headline is misleading. The article says the cinnamon originated in Sri Lanka and was shipped to Ecuador, where it was ground into a powder. It was probably there, the FDA has said, that the cinnamon was likely contaminated with lead chromate, a powder that is sometimes illegally used to tint or bulk up spices.

The ground cinnamon was then sold, bagged, and sold again to a company called Austrofood, which blended it into applesauce and shipped pouches to the U.S. It was sold under the brand name WanaBana and various generic store labels.

The article states that Austrofood was last inspected five years ago, implying that this is the gap in the Food Safety System.

The authors did not look into the reasons why there are reductions in FDA inspections, which by the way, the FDA is ramping up again. FDA has seen huge budget cuts year after year reducing its ability to hire new inspectors. The Covid-19 pandemic reduced the number of inspectors and inspections dramatically.

The Food Safety Modernization Act (FSMA) is not perfect, but it is a huge step up from the past. The new powers and resulting responsibilities for FDA personnel, combined with the public’s expectation for the agency to do more (to protect the public) but with less resources must be part of the discussion as we dissect contamination events.

 

Frank Yiannas, Walmart

Frank Yiannas Joins iFoodDS Board of Directors

By Food Safety Tech Staff
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Frank Yiannas, Walmart

Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the FDA, has joined the iFoodDS Board of Directors. iFoodDS is a provider of connected traceability, quality and food safety solutions. Yiannas will advise the company on strategy.

During his time at the FDA, Yiannas was responsible for a broad range of priorities, including implementing the Food Traceability Rule under the Food Safety Modernization Act (FSMA). Prior to joining the FDA, he spent more than 30 years in food safety leadership roles with Walmart and the Walt Disney Company.

Yiannas has long been a champion of supply chain innovation and technology, making technology-enabled food traceability in the global supply chain a priority in the FDA’s New Era of Smarter Food Safety initiative.

“Frank is a visionary in the food supply chain, using his insight, knowledge and passion for innovation to enhance food safety and safeguard public health,” said Scott Mathews, CEO of iFoodDS. “We are excited to welcome him to the iFoodDS board of directors. His insights will be invaluable as we pursue our vision of a connected food value chain, enabling better collaboration between trading partners and providing insights on product safety, quality and freshness, ultimately reducing food waste and benefiting food companies and consumers alike.”

“I believe that technology will transform the food supply chain, making it safer for consumers, optimizing it, and creating shared value for all supply chain participants,” said Yiannas. “I’m excited to join the iFoodDS board of directors, and to be part of a company that has the food industry expertise, solution capabilities, and vision to not only help companies comply with FSMA 204 regulation, but to help them ensure continued business success by enabling a safer, more predictable food supply and transparency that protects brands and consumers.”

 

Matt Brown
FST Soapbox

Technology in the Food Chain: Insights from the IFT 2023 Traceability Challenge Report

By Matt Brown
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Matt Brown

In a report released in May of 2023, the Institute of Food Technologists (IFT) offered an encouraging and attainable outlook for cooperative and effective functionality throughout the global food supply chain. And with traceability as the primary goal in this diverse landscape of users, challenges and solutions abound. Less a snapshot of where we have been, this report is a helpful guide to where we are going and how best the industry will achieve compliance to the Food Safety Modernization Act (FSMA) by January 20, 2026.

Traceability Challenges in a Global Food Supply Chain

Traceability is a common goal in all industries. But when food and beverage is your bread and butter, the ability to trace a single ingredient can be a matter of life and death. Based on findings in a 2006 study, the Center for Disease Control (CDC) reported the following yearly totals: 37.2 million cases of foodborne illnesses; 228,744 resulting hospitalizations; and 2,612 deaths.[1] In order to improve the landscape of health and safety in the food and beverage industry, the IFT in conjunction with the FDA embarked on a study[2] of how low- or no-cost technology could improve traceability for businesses within the global food supply chain.

One of the greatest challenges in achieving uniform traceability lies in the vastness within the food supply chain itself. Those beholden to compliance are defined as “all persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List (FTL).[3]” And this rule applies to all foods that are consumed in the U.S. market, not just those grown in the U.S. All laborers—planters, harvesters, processors, handlers, packers, distributors, shippers and retailers—who interact with any item on the FTL[4] must be recorded and tracked according to FDA guidelines. These guidelines include procedural protocol for food handling as well as timelines for processing and documentation. Whether the starting point of a single ingredient is stateside or overseas, it generally travels several places before arriving on a grocery store shelf or appearing on a restaurant’s menu.

Within this huge network of players lies the next challenge: economic and technological diversity. While economy and technology are not always one and the same, the typical overlap is demonstrated in the specific case of a head of lettuce. On one end of the supply chain continuum, a head of lettuce begins its journey in a field. There are no handheld scanners or databases in this lettuce’s origin story. There is only the hot sun, an irrigation system, and hard-working people laboring up and down the rows of lettuce. Now flash forward to Aisle 1 of your local grocery store. By now this lettuce has been inspected, washed, shrink-wrapped, labeled, UPC-ed, shipped, received and shelved. With each new set of hands it has passed through—both human and mechanical—it has likely experienced an ascending economic stratum with advancing technological features at each step. Sophistication and automation often increase exponentially as the number of places on the continuum increases. A head of lettuce purchased at your local farmers market, for instance, may have only changed hands once or not at all, while a vacuum-sealed carton of greens at your regional mega-outlet has likely seen many locales as well as top-of-the-line technology and automation.

In addition to a variety of technologies, it is likely that this head of lettuce has also passed through the hands of people speaking multiple languages. The laborers at the beginning of the continuum are often non-native English speakers. And regardless of a laborer’s native tongue, lower rates of literacy are common in entry level food industry jobs. According to statistics published by the Department of Labor in 2018, 77% of U.S. farmworkers report Spanish as their primary language. And the same report states that the average level of formal education completed was eighth grade.[5] Therefore, compliance across the continuum must be translatable and comprehendible to all levels of experience and available in all languages of users.

The challenge of complete supply chain compliance from one end of the spectrum to the other warrants cooperation across many lines: state, national, linguistic, cultural and economic to name a few. The need for intuitive solutions and an easy to implement process is paramount.

Technology as the Traceability Solution

With a better understanding of the global food supply chain itself, it is not hard to see why solutions can be found in the tech sector. When the food supply chain existed primarily in a local economy, keeping paper records was a viable process. Now the food supply chain is a global enterprise, and as such, processes must also operate on a global scale.

Tech solutions offer ready-made customization. Language translations, infographics, flowcharts and videos are easily incorporated into platforms for ease of use across all segments of the supply chain. This is beneficial to both domestic and international operations, and it is especially advantageous to those whose operations span both.

The availability of cloud-based platforms has elevated technological capabilities. No longer does every physical operation need its own dedicated server; rather, information is stored and remains accessible anywhere—from a single lettuce field all the way to the grocery store aisle across the world.

“It used to be common that shipments would arrive without necessary paperwork such as invoices, bills of lading or certificates of analysis. Even shipping labels would commonly be ripped off or illegible,” says Geoff Ellis, COO of Wherefour. “Things get lost in the mail. But when all pertinent information is stored in the cloud, it’s unquestionably accessible to the receiver, the shipper and the transport company.”

Not only does the use of cloud-based technology streamline operations for shipping and receiving, but it does the work ahead of time for quality assurance and regulatory compliance. Documentation does not have to be intentionally gathered and prepared for audits. Everything is already in order when a cloud-based tech platform is employed.

The FSMA’s Traceability Plan guide[6] mandates specific controls and standards for record keeping, all of which are reliant on lot codes. Lot code traceability is easily achievable with a comprehensive software solution. And data sharing is significantly improved with a cloud-based system. All involved parties can be in separate parts of one building or in different parts of the world, and they can still be on the same page operationally.

Expertise in the Tech Sector

With the FDA’s commitment to increased traceability, a shift in focus from response to prevention is apparent. And tech solutions have the unique ability to measure efficacy in procedural implementation across the supply chain continuum. Records are created, stored and shared in perpetuity, and those records can be instantly accessed from any location. Leaders in the tech industry are interested in creating solutions that are scalable and transferable. It is not uncommon for a platform whose original design was to address problems in one industry to end up solving a problem in a different industry altogether. Software solutions are by nature about operational functionality and can be applied to any operation therein.

Furthermore, evolution in the tech sector is rapid and collaborative. Expert insights and advancements drive competitors to continually improve and increase productivity and efficiency. “The tech sector is driven by a healthy sense of collaboration and competition,” says Ellis. “It’s exciting to watch the bar being raised by our competitors. It really motivates us to raise it even further with each new feature we develop.”

In order to achieve FSMA compliance within the diverse global food supply chain, implementing low- or no-cost tech-enabled traceability solutions is essential. It is in everyone’s best interest to remove any barriers that would otherwise prevent viable and nutritious food from getting to market.

References

[1] Scallan, E., Hoekstra, R. M., Angulo, F. J., Tauxe, R. V., Widdowson, M., Roy, S. L….Griffin, P. M. (2011). Foodborne Illness Acquired in the United States—Major Pathogens. Emerging Infectious Diseases, 17(1), 7-15. https://doi.org/10.3201/eid1701.p11101

[2] Bratager, Sarah…Grantham, Alison. (2023, May 17). IFT’s Tech-Enabled Traceability Insights Based on the FDA’s Low- or No-Cost Traceability Challenge Submissions. Retrieved from https://www.ift.org/-/media/gftc/pdfs/ift-tech-insights-fda-nolowcost-traceability-report-2023.pdf

[3] FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. (2023, June 26). Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

[4] Food Traceability List. (2023, June 26). Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

[5] Hernandez, Trish and Gabbard, Susan. (2018, January). Findings from the National Agricultural Workers Survey (NAWS) 2015-2016: A Demographic and Employment Profile of United State Farmworkers. 10-14. Retrieved from https://www.dol.gov/sites/dolgov/files/ETA/naws/pdfs/NAWS_Research_Report_13.pdf

[6] Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry. Small Entity Compliance Guide. (2023, May). Retrieved from https://www.fda.gov/media/168142/download

 

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FDA Publishes New FAQs and Tools for the Food Traceability Rule

By Food Safety Tech Staff
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The FDA has posted new frequently asked questions and additional tools related to the FSMA Food Traceability Rule to help clarify how the rule applies to specific situations and commodities.

The new FAQs address are largely based on questions received during the FDA’s regular interactions with industry and on questions sent via the Technical Assistance Network, a central source of information for questions related to the FSMA rules, programs, and implementation strategies.

Along with the FAQs, additional tools developed to help further educate and inform industry subject to the Food Traceability Rule are accessible from the FDA’s traceability website, including:

  • Addition of the results for all foods and associated commodity-hazard pairs included in the Risk-Ranking Model for Food Tracing—beyond what appear on the food traceability list
  • Additional description on the Food Traceability List webpage to clarify that “nut butters” include all forms of nut butters—shelf-stable, refrigerated, and frozen products
  • Eight new supply chain examples that illustrate how the rule is applied in different scenarios for different commodities
  • What you need to know about the Food Traceability Rule fact sheets on “Recordkeeping Information for Produce Farms” and “Coverage and Exemption for Produce Farms”
  • Guide to Getting Started with the Food Traceability Rule
  • Additional foreign language translations of the Critical Tracking Event and Key Data Elements interactive tool and supply chain examples.

The compliance date for the Food Traceability Rule is January 20, 2026.

 

 

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FDA Releases Small Entity Compliance Guide for the Food Traceability Rule

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The FDA has released a Small Entity Compliance Guide for the FSMA Food Traceability Rule. This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule. It offers recommendations—unless specific regulatory or statutory requirements are cited—on how small entities can comply with the new regulations, which were issued in November 2022. The compliance date for recordkeeping requirements is Jan. 20, 2026.

The guidance document covers:

  • Who is subject to the traceability rule
  • Who is exempt
  • What records must be kept, and for how long
  • How to apply for a modification or exemption
  • How to petition the FDA for waivers
  • Consequences of failure to comply

Download the compliance guide here.

 

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FDA Releases List of 2023 Priority Guidance Topics for Foods Program

By Food Safety Tech Staff
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The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.

The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.

The priority list of draft and final guidance topics include (by category):

Allergens

  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
  • Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
  • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders

Food Additives

  • Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
  • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry

Food Safety

  • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
  • Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
  • Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
  • Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff

FSMA

  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
  • Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry

Labeling

  • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
  • Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry

Public comments on the list of guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.

 

Frank Yiannas, Walmart

Frank Yiannas Announces Resignation from FDA

By Food Safety Tech Staff
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Frank Yiannas, Walmart

Frank Yiannas is stepping down from his position as FDA Deputy Commissioner for the Office of Food Policy and Response effective February 24. In his resignation letter, Yiannas cited concerns about the decentralized structure of the FDA foods program and urged the Commissioner to consider “creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods.”

During his tenure, Yiannis oversaw several efforts to modernize and improve food safety, including issuing the FSMA Final Food Traceability Rule and a new, proposed Agricultural Water Standard.

During his tenure, Yiannis has taken an active role engaging regularly with both industry and consumer groups to advance food safety and the prevention of foodborne illness. We at Food Safety Tech thank him for his service to the FDA and American consumers.

 

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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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FDA Commits $41M to Support the Joint Institute for Food Safety and Applied Nutrition

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The University of Maryland has announced a five-year, $41 million cooperative agreement with the FDA to expand the University’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

Established in 1996, JIFSAN is an FDA Center of Excellence combining the expertise of the federal agency with UMD researchers. It promotes research, education and outreach in food safety, security and applied nutrition and has developed partnerships across industry, government and other stakeholders in support of the 2011 Food Safety Modernization Act (FSMA).

“This enduring partnership and funding will allow us to continue our collaborative research efforts between UMD and the FDA,” said Jianghong Meng, professor of nutrition and food science and JIFSAN director. “We are in a new era of food safety where better protections and preventative measures are more important than ever. The last few years have shown that as a community we must all work together to eradicate illness and disease.”

The new award will be used to grow several programs, including a congressional mandate on imported aquacultured shrimp, which supports the FDA in regulating the sourcing and importing of shrimp to the United States.

JIFSAN will continue to provide graduate and undergraduate internship opportunities to UMD students who work with and are mentored by FDA scientists. In its first quarter century, the institute has provided more than 300 undergraduate internships, graduate assistantships and postdoctoral research appointments that have contributed to a variety of food safety initiatives and programs.

The institute will also conduct multi-institutional, multidisciplinary research projects and develop mechanisms for the exchange of technical information and scientific concepts. Additionally, it will continue to advance the development of educational and outreach programs designed to enhance the FDA’s efforts with other nations to improve U.S. and global health.

The funding will also help support JIFSAN as it prepares to move its offices to a new location at 5825 University Research Court in UMD’s Discovery District. The new facility includes a microbiology laboratory for research and training in whole genome sequencing as well as other advanced technologies for detecting and tracing the source of foodborne pathogens.

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FDA Submits Final FSMA Rule for Food Traceability

By Food Safety Tech Staff
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On November 7, the FDA sent the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR).

The final rule includes a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The FDA notes that while the proposed requirements only apply to those foods on the FTL, “they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”

The final rule will become effective 60 days after it is published in the Federal Register, which the FDA anticipated would happen within one to two weeks. The compliance date for all persons subject to the recordkeeping requirements is two years after the effective date.