Tag Archives: foodborne illness

Cantaloupe

Adapted QRA Model with Epidemic Curve Enhances Root Cause Analysis

By Food Safety Tech Staff
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Cantaloupe

A new Quantitative Risk Analysis (QRA) model using epidemic curve (EC) prediction (QRA-EC) could become a valuable new tool in root cause analyses of foodborne illness outbreaks. Researchers with the FDA Center for Food Safety and Applied Nutrition developed a QRA-EC model and evaluated it in a case study of a 2019 multistate Salmonella outbreak linked to melons. The study was published in Risk Analysis.

Amir Mokhtari, et al, modified the traditional QRA model to track illness timing (epidemic curves). They then compared the predicted number of illnesses and timing of illnesses identified by their model—the FDA-Melon QRA-EC—with the 2019 Salmonella melon outbreak epidemic curve.

The authors explain that QRA models are traditionally used to predict the number of illnesses associated with given food-pathogen pairs and to simulate previous foodborne illness outbreaks by comparing model estimates with observed outbreak size. The QRA-EC model extends that framework to include prediction on the timeline of illnesses associated with consumption of contaminated food products.

“This additional feature yields two-dimensional risk predictions that provide investigators with a more nuanced quantitative evaluation of potential/hypothesized illness outbreak root cause, as the shape and/or span of epidemic curves can give clues about potential sources and/or patterns of spread for an outbreak,” the authors wrote.

They found that contamination niches on the equipment were the most likely cause of the 2019 outbreak, as illnesses were linked to one processor of fresh-cut melons, while the contaminated melons (linked back to one supplier) had been sent to several processing facilities.

“Compared to the efficiency of whole melon washing, proper sanitation of contamination niches had a more pronounced impact on the predicted epidemic curves,” the authors wrote. Furthermore, the model and case study found that risk was greater when food was exposed to contamination niches on the assembly line versus in scrubbers and bins, likely due to the larger surface area of the assembly line and the potential for several contamination niches along the line.

“Using an Agent-Based Modeling approach, FDA Melon QRA-EC explicitly tracked the temporal and spatial movement of contaminated melons throughout the supply chain, which allowed us to predict both the total number and timeline of illnesses for various scenarios, which enabled us to identify conditions that can lead to an outbreak of certain magnitude and with a certain span of the epidemic curve,” the authors concluded.

While this particular model was developed specifically for Salmonella outbreaks linked to melons, the authors note that their model can be adapted for other food-pathogen pairings.

 

 

FDA logo

FDA and CDC Sign MOU for Enhanced Collaboration To Reduce Foodborne Illness

By Food Safety Tech Staff
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FDA logo

The FDA and CDC have entered into a Memorandum of Understanding (MOU) to strengthen food safety in retail environments. The goal of the renewed partnership is to help reduce the occurrence of foodborne illness in retail and foodservice establishments.

This MOU, which was signed on September 21, was developed to help increase the consistency and capacity of retail food protection programs across the country, promote a general culture of food safety and facilitate continued communication between the FDA and CDC to assist state, tribal, local, territorial (SLTL) and industry partners.

The three primary goals of the MOU include:

  1. Increase uniformity, consistency and capacity of STLT retail food protection programs
  2. Promote industry’s active managerial control (AMC) of foodborne illness risk factors and promote a culture of food safety
  3. Maintain a strong FDA National Retail Food Team (NRFT) and CDC National Center for Environmental Health (NCEH) workforce to assist STLT partners.

The agencies are seeking to: improve STLT’s effectiveness in conducting risk-based inspections and foodborne illness investigations; promote a culture of food safety and food safety management systems within retail and foodservice establishments; and improve research in support of foodborne illness risk factor reduction.

To accomplish these objectives, the FDA and CDC are both tasked with establishing metrics to measure the success of collaborations as well as establishing direct and consistent relationships at multiple organizational levels, sharing best practices, and identifying opportunities for leveraging the resources of both agencies to more efficiently and effectively support STLT retail regulatory programs as well as both FDA and CDC retail food protection initiatives.

In its announcement of the MOU, the FDA notes that it has historically worked with CDC to help control the risk factors for foodborne illness outbreaks in retail settings. “This MOU will ensure enhanced continued collaboration on this important work,” the agency wrote.

Brie Cheese

FDA Links Listeria monocytogenes Outbreak to Old Europe Cheese Brie and Camembert Soft Cheese Products

By Food Safety Tech Staff
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Brie Cheese

A multistate outbreak of Listeria monocytogenes infections has been linked to Brie and Camembert soft cheese products manufactured by Old Europe Cheese, Inc. of Benton Harbor, Michigan. The products are sold at various retailers under multiple labels and brands. Six cases of illness have been reported in patients in California, Georgia, Massachusetts, Michigan, New Jersey and Texas.

The FDA reports that epidemiologic information provided by CDC found that, of the five patients with information available, four reported eating Brie or Camembert cheese prior to their illnesses. An FDA inspection of the Old Europe Cheese, Inc. facility in Michigan, performed with assistance from the Michigan Department of Agriculture and Rural Development, showed the presence of Listeria monocytogenes. Whole Genome Sequencing (WGS) analysis determined that the Listeria strain found in the facility matches the Listeria strain causing illness in this outbreak.

The company has voluntarily recalled multiple brands of its Brie and Camembert cheeses produced at the facility in response to the investigation findings. The firm has also halted production and distribution of its Brie and Camembert products from the Michigan facility and is working with FDA on corrective actions.

Consumers, restaurants and retailers should not eat, sell or serve recalled products and should throw them away; this includes Best By Dates ranging from September 28, 2022 to December 14, 2022—all flavors and quantities. A full list of recalled products and stores that potentially sold these products is available on the firm’s recall.

Romaine Lettuce

Wendy’s Pulls Romaine Lettuce Over E. Coli Concerns

By Food Safety Tech Staff
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Romaine Lettuce

A multi-state outbreak of E. coli led Wendy’s to take the precautionary measure of removing romaine lettuce being used in sandwiches from restaurants in the region of the outbreak.

The CDC reports that as of August 18, 2022, a total of 37 people infected with the outbreak strain of E. coli O157:H7 have been reported from Michigan, Indiana, Ohio and Pennsylvania. The illnesses started on dates ranging from July 26, 2022, to August 8, 2022.

A specific food has not yet been confirmed as the source of this outbreak, but among 26 people who have been interviewed, 22 (86%) reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Michigan, Ohio or Pennsylvania in the week before their illness started. Based on this information, Wendy’s removed the romaine lettuce being used in sandwiches from restaurants in those regions.

A spokesperson for Wendy’s released the following statement: “We are fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states. While the CDC has not yet confirmed a specific food as the source of that outbreak, we have taken the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region. The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality.”

The CDC emphasized that it is not advising that people avoid eating at Wendy’s restaurants or that people stop eating romaine lettuce.

The CDC, public health and regulatory officials in several states, the FDA and the USDA-FSIS are collecting and analyzing data at the ingredient level to identify the food source of the outbreak, confirm whether romaine lettuce is the source and determine if there are any other possible foods that could be the source of the outbreak.

 

Gary Nowacki
FST Soapbox

It’s Time To Embrace Ingredient Agility

By Gary Nowacki
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Gary Nowacki

In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.

Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.

Food Safety and Supply Chain Issues Challenge CPGs

As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]

While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]

In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.

Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.

Pandemic Uncertainty and New Legislation

As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]

The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.

If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.

Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.

Nimble Access to Ingredient Data is Crucial

On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]

The bill would direct the FDA to revise the GRAS Rule to include provisions that:

  • Prohibit manufacturers from designating substances as safe without supplying proper notice and supporting information to the Secretary of Health and Human Services
  • Require safety information to be publicly available on the FDA website and subject to a 90-day public review period
  • Prohibit carcinogenic substances from receiving GRAS designation
  • Prohibit substances that show reproductive or developmental toxicity from receiving GRAS designation
  • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations

Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]

With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.

Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.

References:

[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.

[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.

[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.

[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.

[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.

[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.

[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.

[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.

[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.

 

FDA

Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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FDA

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.

CDC, FDA, USDA logos

IFSAC to Continue Focus on Finding Sources of Foodborne Illnesses

By Food Safety Tech Staff
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CDC, FDA, USDA logos

The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:

  • Analysis of trends related to foodborne disease outbreak-associated illnesses over the past two decades, with a subsequent peer-reviewed journal article that reveals results.
  • Development and improvement of machine-learning methods used to predict food sources of illnesses that have an unknown source. WGS will be used to compare Salmonella isolates of known and unknown sources.
  • Collaboration with FoodNet when assessing key food sources for sporadic Salmonella Enteritidis and Campylobacter illnesses. The group will develop case-control studies using specific FoodNet data.

Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.

Food Safety in 2022: Sustainability, Supply Chain Issues, Consumer Preferences and Technology at the Forefront

By Maria Fontanazza
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The ongoing pandemic, food fraud, food insecurity, supply chain disruptions and shortages, maintaining and fostering a robust food safety culture, and foodborne illness outbreaks kept the food industry very busy last year. Looking ahead to 2022, these challenges will continue, but many food companies are becoming better at forecasting and course correcting. During a recent interview with Food Safety Tech, Waylon Sharp, vice president and chief operating officer at Bureau Veritas, discussed trends affecting food safety this year, along with how companies should respond to incoming challenges.

Waylon Sharp, Bureau Veritas
Waylon Sharp leads North American food and agriculture testing, inspection and certification operations at Bureau Veritas.

Food Safety Tech: What challenges did food companies face in 2021 and how can they apply their lessons learned in the new year?

Waylon Sharp: Supply chain disruptions were a big challenge for food companies in 2021, as much of the North American food system is reliant on production or raw materials from international locations. This theme will continue into 2022, as logistics become more costly and challenging from a labor perspective, food companies will naturally gravitate to exploring alternatives. This shift in supply will increase the need for verification of product quality and safety of new suppliers. In addition to, or alternatively, some producers may choose more local options to reduce delays and increase stability of supply.

FST: What are the key trends impacting food safety in 2022?

Sharp: This year we’ll see food safety impacted by sustainability, consumer preferences and health and wellness:

  • Sustainability: Connecting with a purpose will be a key driver for both attracting new customers and enticing top talent to join food organizations. All aspects are critical, including sourcing raw materials, the packaging used, and minimizing the CO2 footprint in production and logistics. Consequently, I suspect there will be bad actors that see the advantage of appearing to be responsible but not doing what they say. Services that hold these organizations accountable will likely continue to grow.
  • Consumer Preferences: Migration to hyper-local, community supporting businesses can be directly correlated to the COVID financial fallout. Buying local helps support the areas we reside in, and this trend will likely persist. The feel-good support should also result in fresher product with less supply chain challenges for consumers.
  • Health & Wellness: Sustainable, plant-based products are expanding in prevalence. Traditional meat alternatives witnessed an increase in volume and new entrants such as seafood alternatives also grew in consumer acceptance. I expect more to launch in 2022 to meet the rising demand for healthy and environmentally conscious alternatives.

FST: What technologies will play a role in helping food companies tackle their biggest hurdles this year?

Sharp: Technology will continue to play an important role in the industry this year. Additional automation and digital tools to manufacture, assess food quality and safety, and distribute food are all likely to grow. Staffing challenges will continue to impact those highly manual production environments and the more work that can be performed without human intervention will gain favor over labor-intensive functions. In addition, remote audits and inspections allow for an experienced individual to assess a situation without traveling and being present on-site to limit human contact.

Recall

FDA Continues Investigation of Listeria Outbreak in Packaged Salad

By Food Safety Tech Staff
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Recall

— UPDATE — January 12, 2022

Dole Fresh Vegetables, Inc. has now issued a voluntary recall of Dole-branded and private label packaged salads processed at its Springfield, OH (product ID lot code “W” and “Best if Used By” date December 22, 2021–January 9, 2022) and Soledad, CA production facilities containing iceberg lettuce.

–END UPDATE —

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes illnesses linked to Fresh Express Packaged Salad and Dole Packaged Salad.

Last month Dole Fresh Vegetables issued a voluntary recall for salads processed at its facilities in Bessemer City, NC and Yuma, AZ due to the health risk. The company also temporarily suspended operations at both facilities. The brand names in which the salads were sold under include Dole, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise and Simply Nature. The products have “Best if Used By” dates between November 30, 2021 and January 8, 2022.

The agencies’ investigation of Fresh Express Packaged Salad resulted in the company stopping production at its Streamwood, IL facility. It also initiated a recall of certain varieties of its branded and private-label salads that were produced at this facility.

The FDA’s investigation into the Listeria monocytogenes outbreak linked to both Dole and Fresh Express is ongoing. Thus far, no deaths linked to the outbreak have been reported.

FDA

FDA’s Foodborne Outbreak Response Improvement Plan Seeks to Expedite Investigations

By Food Safety Tech Staff
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FDA

Today FDA released a plan to help the agency and its partners improve the “speed, effectiveness, coordination and communication” of investigations surrounding foodborne illness outbreaks.

“We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network in an agency news release. “We also recognize that today’s U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products. That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.”

The Foodborne Outbreak Response Improvement Plan targets four areas that, if improved, will have the greatest effect on foodborne illness outbreaks:

  • Tech-enabled product traceback: Being smarter about using digital technology, regularly, to streamline traceback investigations
  • Root-cause investigations: Adapting and strengthening procedures for conducting root-cause investigations
  • Working with the CDC, USDA’s FSIS and other partners to improve the analysis and distribution of outbreak data (including identifying recurring, emerging and persistent strains of pathogens)
  • Enhancing performance measures across the agency’s food programs to enable better evaluation of the timeless and effectiveness of outbreak and regulatory investigation activities

In addition to this improvement plan, the agency also released “An Independent Review of FDA’s Foodborne Outbreak Response Processes”, which was contracted with the University of Minnesota’s School of Public Health. The independent report played an important role in the development of FDA’s improvement plan.