Tag Archives: FDA

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FDA’s Traceability Tech Challenges Goes Live

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

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

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

Food Safety Consortium Virtual Conference Series

2021 FSC Episode 4 Preview: Food Safety Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium Virtual Conference Series

This week’s episode of the 2021 Food Safety Consortium Virtual Conference Series will discuss the challenges that the industry faces in managing the supply chain, including in the realm of audits. The following is the agenda for this Thursday’s session:

  • Food Safety as a Supply Chain Management Problem, with John Spink, Ph.D., Michigan State University
  • Supplier Certification in Today’s Supplier Quality Management Programs: A Discussion with Gary van Breda, McDonald’s; Jorge Hernandez, Wendy’s; and moderated by Kari Hensien, RizePoint; Sponsored by RizePoint
  • What Needs to Change in Food Safety Certification: A GFSI Panel Discussion moderated by Erica Sheward, GFSI
  • Auditing Update in the Age of COVID: FDA Standards and Regulations Alignment Pilot, with Trish Wester, AFSAP

This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.

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 Virtual Conference Series

2021 FSC Episode 1 Preview: FDA on New Era, Experts Discuss Digital Transformation and Consumer Focus

By Food Safety Tech Staff
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Food Safety Consortium Virtual Conference Series

Thursday, May 6, marks the first episode of the 2021 Food Safety Consortium Virtual Conference Series. The following are highlights for this week’s session:

  • FSMA-Based & Technology-Enabled: FDA Advances into New Era of Smarter Food Safety, a special keynote with Frank Yiannas, FDA
  • Digital Transformation in Food Safety, with Natasa Matyasova and Matt Dofoo, Nestlé
  • Consumer-focused Food Safety, with Mitzi Baum, STOP Foodborne Illness
  • TechTalks from Controlant, Veeva and Primority

This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.

FDA

FDA’s ‘Closer to Zero’ Action Plan to Reduce Exposure to Toxic Elements in Baby Food

By Food Safety Tech Staff
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FDA

Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:

  • Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
  • Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
  • Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.

“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.

FDA

FDA Publishes Report on Fall 2020 E. Coli Outbreak in Leafy Greens

By Food Safety Tech Staff
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Today the FDA released a report on its investigation into the E. coli O157:H7 outbreak involving leafy greens during the Fall 2020. The report also identified three reoccurring trends in the contamination of leafy greens grown in the Central Coast of California related to the outbreak strain, region and issues with activities on adjacent land.

In January, FDA released preliminary findings, which linked cattle feces to the outbreak strain—located uphill from where contaminated leafy greens were grown.

“In the investigation, the FDA recommends that growers of leafy greens in the California Central Coast Growing Region consider this reoccurring E. coli strain a reasonably foreseeable hazard, and specifically of concern in the South Monterey County area of the Salinas Valley,” stated Frank Yiannas, deputy commissioner for food policy and response, in an agency news release. “It is important to note that farms covered by the Food Safety Modernization Act (FSMA) Produce Safety Rule are required to implement science and risk-based preventive measures in the rule, which includes practices that prevent the introduction of known or reasonably foreseeable hazards into or onto produce.”

The 2021 Food Safety Consortium Virtual Conference Series kicks off on May 6 with a keynote address from Frank Yiannas, deputy commissioner of food policy and response at FDA The FDA also recommends that the region’s agricultural community work to determine where the reoccurring strain of the pathogenic E. coli is persisting, along with the probable contamination route(s).

“Although the FDA is keenly focused on taking steps to help mitigate recurring leafy green contamination events, we alone cannot fix this issue. Industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community is critical to reducing foodborne illnesses,” Yiannas stated. “At the FDA, the safety of leafy greens remains a top priority, and we are committed to working with all stakeholders to address this significant public health issue and further protect consumers.”

The Report, “Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli O157:H7”, can be downloaded from FDA’s website.

Recall

Sabra Recalls Hummus After Salmonella Discovered During FDA Routine Screening

By Food Safety Tech Staff
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Recall

On Monday Sabra Dipping Company, LLC and the FDA announced a voluntary recall of the company’s Classic Hummus due to potential Salmonella contamination. The discovery was made when the FDA conducted a routine screen of one tub. Sabra has recalled about 2100 cases of its 10 oz Classic Hummus (1 SKU), which was produced on February 10 and has a “Best Before” date of April 26. The product was distributed to 16 states, but according to the company announcement posted on FDA’s website, since the hummus is more than halfway through its shelf life, “it’s unlikely you’ll find this product on the shelf.”

Thus far no illnesses have been reported in connection with this recall.

Recall

FDA and CDC Investigating Non-Viral Hepatitis Potentially Linked to ‘Real Water’ Brand Alkaline Water

By Food Safety Tech Staff
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Recall

–UPDATE April 19, 2021 — The FDA continues to investigate reports of acute non-viral hepatitis in Nevada associate with consumption of “Real Water” brand alkaline water. “The FDA has become aware that “Real Water” brand alkaline water is still being offered for sale through online retailers. The agency is working to locate any remaining products to ensure they are no longer available to consumers,” FDA stated in an email update. “The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale.”

–END UPDATE–

The FDA and CDC are investigating reports of acute non-viral hepatitis in consumers that has a common link to “Real Water” brand alkaline water. The agency is in the beginning stages of the investigation and notes that more products could be connected to the outbreak. The acute non-viral hepatitis cases affected infants and children, resulted in acute liver failure and occurred in November 2020, but FDA was alerted to the cases on March 13, 2021.

The manufacturer, Arizona-based Real Water, Inc., stated that the issue occurred in Las Vegas and is recalling the product. FDA pulled information from the company’s website stating that the five-gallon containers are delivered to homes in Honolulu; Orange County, Ventura and Santa Barbara, California; St. George, Utah; and Tucson, Arizona. The agency also states that Real Water is packaged and sold in various sizes including 1 gallon, 1 liter and 1.5 liter plastic bottles.

FDA is urging consumers, restaurants and retailers against drinking, cooking with, selling or serving the “Real Water” alkaline water until more information is revealed about the illnesses.

Angel Suarez, EAS Consulting Group
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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.

FDA

FDA Issues Letter to Industry Addressing Efforts to Reduce Chemical Hazards in Foods for Babies and Young Children

By Food Safety Tech Staff
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FDA

A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.

In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.

“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”

The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:

  • “Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.

  • Focused compliance and enforcement activities, including inspections.

  • Providing guidance to industry on how to meet their obligations under current regulations.”

The agency will also continue its surveillance sampling assignment that focuses on these products.