bioMérieux Opens a Molecular and Genomic Innovation Center at the Navy Yard in Philadelphia

By Food Safety Tech Staff
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bioMérieux selected to open the site at the Navy Yard, which serves the region as an innovation Life Sciences hub focused on research and development, commercialization and manufacturing, and boasts a roster of regional and global companies currently occupying more than one-million square feet of life sciences and advanced manufacturing space.

The new 32,000 sq. ft. facility is home to the xPRO™ Program, which has rapidly changed the landscape of food safety diagnostic capabilities by partnering directly with industry leaders to address unmet needs to streamline operational efficiencies and further public health. bioMérieux’s global leadership team was on-site for the ribbon cutting event, as Philadelphia continues to fortify its reputation as a hotbed of innovation in Life Sciences across North America.

Global leadership from bioMérieux and Philadelphia dignitaries commemorate the opening of the company’s Molecular Genomic Innovation Center in Philadelphia, Wednesday, Sept. 18, 2024. (Ryan Collerd/AP Content Services for bioMérieux)

“We couldn’t be more excited to deepen our roots in Philadelphia, which has long supported our organization through its commitment to fostering an entrepreneurial environment that promotes innovation and collaboration,” said Ben Pascal, global head of the xPRO™ Program, “As the innovation leader in the market and with our focus on maintaining a culture of entrepreneurship, the new site bolsters our ability to rapidly respond and develop breakthrough innovations that change the paradigm for global food safety.”

bioMérieux selected to open the site at the Navy Yard, which serves the region as an innovation Life Sciences hub focused on research and development, commercialization and manufacturing, and boasts a roster of regional and global companies currently occupying more than one-million square feet of life sciences and advanced manufacturing space. The opening of bioMérieux at the Navy Yard strengthens the sites reputation as a foremost innovation hub across the US.

“The opening of the Molecular and Genomic Innovation Center at the Navy Yard is an important milestone in bioMérieux’s storied legacy, as we continue to provide game changing diagnostic solutions that solve the food safety industry’s most persistent and urgent challenges,” said Miguel Villa, Sr. Vice President, Industrial Applications, Americas, and xPRO™ sponsor, “This facility – in conjunction with our unique Augmented Diagnostics approach to food safety – allows us to continue redefining the role and capabilities of diagnostic testing to further ensure public health and fortify brand reputations.” 

Food Safety Tech Content Director, Rick Biros tours bioMérieux’s Molecular Genomic Innovation Center in Philadelphia. (Ryan Collerd/AP Content Services for bioMérieux)

 

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FDA’s new Human Foods Program (HFP) kick’s off October 1

By Food Safety Tech Staff
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The U.S. Food and Drug Administration’s reorganization implementation involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts are scheduled for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.

Jim Jones, FDALead by Jim Jones, Deputy Commissioner for Human Foods at FDA, the reorganization establishes the HFP by realigning the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) under one program.

Additionally, the restructuring of ORA will enable the field operations unit to focus on inspections, investigations and imports as its core mission. The FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real time insights and science-based evidence necessary to ensure the safety and quality of products Americans depend on.

Jim Jones will Keynote the Food Safety Consortium Conference, October 20-22 in Washington DC. During this session Mr. Jones will delve into the agency’s recent reorganizational changes, key regulatory policy priorities, and commitment to stakeholder transparency. Doug Stearns, Deputy Associate Commissioner of Regulatory Affairs, will discuss how these changes will shape investigations and inspections for both domestic and foreign facilities. Attendees will gain valuable perspectives on regulatory shifts, emerging challenges, and collaborative opportunities shaping the landscape of food safety and compliance. Discover how the new Deputy Commissioner’s strategic vision will drive innovation, enhance public health outcomes, and foster trust within the food industry. Attendees will have the opportunity to gain deep insights into emerging challenges, innovative strategies, and collaborative approaches to advancing food safety.

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The Alliance to Stop Foodborne Illness Announces 2024 Class of 40 Under 40

By Food Safety Tech Staff
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This yearly initiative highlights exceptional young professionals making significant contributions to food safety and food safety culture worldwide.

The Alliance to Stop Foodborne Illness — an arm of the national nonprofit consumer advocacy group Stop Foodborne Illness — proudly announces its “2024 40 Food Safety Professionals Under 40.”

This yearly initiative highlights exceptional young professionals making significant contributions to food safety and food safety culture worldwide.

The class of 2024 represents 35 universities and organizations — including PepsiCo., Aramark, and Wegmans.

Public-Private Partnership Aims to Fill Gaps in Supply Chain Interoperability

Partnership for Food Traceability seeking members to play key roles in decision-making.

As the food supply chain has become evermore global, the tracing of foodborne illness has become evermore complex. Although the Traceability Rule (FSMA 204) was enacted to mitigate that complexity, it has no provisions for interoperability between supply chains, primarily because FDA was not given the authority to require that.

So the Partnership for Food Traceability (PFT) has stepped up the plate to fill that gap. PFT is a public-private partnership between FDA, state officials, and all sectors of the food industry founded to help streamline the implementation of compliant traceability systems – accommodating both electronic and alternate/non-electronic methods to represent both large and small businesses.

A membership-based, sector-neutral organization, PFT provides a forum for stakeholders to come together with an equal voice to advance enhanced traceability. Companies that manufacture, process, pack, or hold foods and their trade associations can join as voting members; technology vendors and technical experts as non-voting members; and FDA and other officials will have formal, non-voting participation in full membership meetings, committees, and work groups. With the government officials serving as technical advisors to provide perspectives on regulations, guidance documents, policies, and practices, the membership will work to establish a comprehensive vision for enhanced food traceability in the U.S.

Understanding that it can be difficult for small stakeholders and businesses to have a voice in industry forums, “PFT has been designed to provide a level playing field so that everyone, regardless of your size, your sector, your business model, has an equal voice in the process of defining that vision,” said Leavitt Partners Principal Eric Marshall.

There’s also recognition that the implementation of traceability is difficult and dependent on a lot of people, companies, and sectors of the industry. “You can’t simply flip a switch and turn it on, Marshall said. “You need a clear, coordinated plan for how you get from here to compliance; and then not just to compliance, but how you get from basic compliance to actual optimization and interoperability. We think that the PFT can fill that role and provide that kind of a vision.”

“Today, traceability is the foundation for business growth,” said Kevin Edwards, Vice President of Global Market Development for the Global Dialogue on Seafood Traceability (GDST). “The key to global digital traceability is a common data language and an interoperable approach; advancing our mission cannot be done alone.”

Echoing a similar sentiment The Acheson Group Executive Vice President of Regulatory and Scientific Affairs Ben Miller said, “Our goal is to create that overarching vision and plan for traceability, but we are not intending to displace any of the work that’s come before, rather to extend it and bring it together in a town square concept. Importantly,” he added, “we don’t want to hinder innovation or efficiency.” In fact, Miller sees that as the principal return on investment of the group: “The more we can arrive at standardized approaches, the greater efficiency we will realize across the supply chain,” he said.

Additionally, the partnership is not starting from a blank slate. Rather, Miller said, “We have the benefit of standing on the shoulders of the success of the Partnership for DSCSA Governance developed by the drug industry. So we know this structure, based on previous experience, is one that can work well.”

The primary charges of PFT are to:
• Define open-source consensus business requirements and functional requirements for food traceability. The specific technical vision will be determined through decision-making mechanisms that promote balance, sector neutrality, and equitability, leveraging and incorporating existing work from various sectors.
• Coordinate pilots and share pilot learnings to advance electronic traceability. PFT will provide a forum to consolidate learnings from private and public pilots; identify and support new pilots; and promote industry/regulator interactions through pilot activity.
• Provide a forum for the sharing of common practices in supplier requirements for data sharing. Through a dedicated work group, PFT will strive to ensure its consensus business and functional requirements build on, and limit disruption to, supplier requirements, with each company free to establish its own standards. PFT will promote consistent and interoperable requirements by providing a forum for the discussion of promising practices.

With regulators also playing an essential role both in helping to define requirements for food traceability and as a recipient of food traceability information, FDA has formally agreed to collaborate with industry through the PFT to coordinate approaches across diverse supply chain sectors and help to more rapidly remove contaminated products from the market. Although interoperability is not a requirement of the Traceability Rule, it is becoming increasingly more important to how food traceability is operationalized within the broader food supply chain, and better food traceability means faster, more accurate, and more efficient outbreak investigations; and that requires FDA having a seat at the table with the broader food industry.

“PFT enables the ability to create an industry ‘town square’ that can bring the best thinking together from different functions and types of companies,” stated John Phillips, Pepsico Senior Vice President of Customer Supply Chain and Go-To-Market. “We have been involved in the planning group, and even in those sessions we have had great conversations on some of the challenges that we need to solve, and even came up with some creative ideas for many of them,” he said. Companies will benefit and help the industry by being engaged in this forum and ensuring their input helps craft the industry path forward.

It is important to understand that the PFT is for the entire supply chain through to retail foods and restaurants – large and small. “I think a lot of people assume that traceability is going to impact only the big restaurants. And that’s not true. We’ve done the math on this; we believe FSMA 204 will directly impact more than 85% of all restaurants across the United States – including mobile food trucks and food carts,” said National Restaurant Association Vice President of Food Science Patrick Guzzle. “We believe the impact will be great to the industry, so the importance of hearing from small vendors from small restaurants is really important as this all comes together.”

Whether a producer, manufacturer, processor, distributor, retailer or restaurant, becoming a member of PFT offers a strategic advantage that goes beyond compliance with the FSMA Traceability Rule. Members gain direct influence on how traceability systems are developed and implemented, a unique access to collaboration with the FDA, and the opportunity to network and collaborate with a diverse group of stakeholders across the food supply chain. Sharing best practices and learning from industry-wide approaches, can help a company innovate and improve its traceability processes, leading to greater operational efficiency, reducing duplication of efforts and lowering compliance costs, and ultimately providing long-term cost savings.

“In essence, PFT membership is an investment in your company’s future, ensuring that you play a key role in advancing safer, more transparent food supply chains that align with your company’s needs,” Marshall said.

Over the next few months, PFT will finalize the organizational details, begin an initial member sign-on period, and hold Board Member elections with a goal of holding its first Board Meeting on October 23. For more information and membership application, visit pftraceability.org.

 

Editors Note: the key leaders of the PFT are guests of Rick Biros’ webinar series, It’s 5 o’clock somewhere… A happy hour conversation about Food Safety & Quality, December 18 at 4pm EST. Register Here

 

 

Forma Foods uses 3D printing technologies to produce plant-based meat

By Food Safety Tech Staff
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Forma Foods, a startup company incubated at Tecnologico de Monterrey, the top Mexican university in engineering and technology according to the QS World Ranking 2024, is leveraging cutting-edge 3D printing technologies to produce plant-based meat that not only looks and tastes like real meat, but also promotes a more sustainable and ethical approach to future food.

Lab-developed meat from Forma Foods emulates the texture, consistency, and flavor of traditional “carne asada”, offering a viable and attractive alternative for meat lovers and vegan consumers.

To this end, Grissel Trujillo de Santiago and Mario Moises Alvarez, researchers and academics from the School of Engineering and Sciences at Tec de Monterrey, experts in tissue engineering, and co-founders of the company, are applying a technique that both have invented and perfected: chaotic printing.

“These chaotic flows have nothing to do with disorder or turbulence, they produce microstructures in a fast and mathematically predictable way; they generate very fine thin layers that mimic the architecture of animal tissues,” explains Trujillo, Chief Scientific Officer (CSO) at Forma Foods.

Forma Foods not only mimics skeletal muscle tissue, but also fat and connective tissue, using pea protein to simulate muscle tissue, an oriental prebiotic fiber for connective tissue, and coconut oil for fat tissue.

The team has created products very similar to arrachera and carne al pastor, staples in dishes representative of Mexican culture. “Eating an arrachera taco is not the same as eating a sausage or ground beef taco,” Trujillo says, emphasizing how their product authentically integrates into Mexican cuisine.

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Survey Says… 48% of F&B Suppliers Rely on Spreadsheets

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From June 24, 2024 through July 15, 2024, TraceGains conducted an online survey of 483 food
and beverage industry suppliers to better understand supplier readiness and drivers for change and found
most suppliers stuck in the past, unprepared for change with legacy processes despite a
willingness and understanding on the benefits for modernizing.

To quantify the problem, a new report “Old Habits, New Challenges: The Critical Need for
Modernization in Food and Beverage Supply Chains” found nearly half (48%) of all suppliers
commonly rely on legacy approaches to manage communications with F&B buyers.

These legacy approaches hinder efficiency, with more than two-thirds (71%) of respondents
admitting these methods often cause issues such as data entry errors (39%) and
miscommunication (32%), negatively impacting their ability to operate effectively.

As the regulatory landscape becomes more complex, manual processes will be pushed to the
edge. In fact, compliance with regulatory change made the top-3 list of reasons
suppliers want to modernize their software. Requirements such as the U.S. Food Safety
Modernization Act (FSMA) Rule for Traceability (204), set to take effect in January 2026, will
impose stricter traceability requirements for certain food materials. And, in Europe existing
mandates such as the Corporate Sustainability Due Diligence Directive (CSDDD) already
require time-based sustainability reporting, adding further compliance challenges.

Sustainability continues to be a priority for almost all suppliers, with nine in ten (89%) saying it’s
at least somewhat important for new technologies to align with their company’s corporate
sustainability objectives.

Cost, however, remains the largest factor influencing software purchasing decisions, with 77%
of suppliers citing it as their top consideration, followed by ease of implementation (65%) and
customer support (56%).

FSSC 22000 Version 6 Achieves GFSI Recognition

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FSSC 22000 has completed the Consumer Goods Forum’s GFSI Benchmarking process for Version 6 of the Scheme and achieved recognition against the GFSI Benchmarking Requirements v2020 on 23 August 2024.

The Global Food Safety Initiative (GFSI), The Consumer Goods Forum’s Coalition of Action on food safety, compared FSSC 22000 Version 6 to the GFSI Benchmarking Requirements for evidence of alignment and verified that Version 6 fully meets the benchmarking standards.

The FSSC 22000 Scheme is owned and governed by the independent non-profit Foundation FSSC and outlines the requirements for the audit and certification of an organization’s Food Safety Management System. Version 6 of the Scheme was published on 31 March 2023 and became mandatory on 1 April 2024. Foundation FSSC developed the Version 6 Scheme update to integrate the latest requirements of ISO 22003-1:2022 and strengthen the framework to better support organizations in aligning their operations with the United Nations Sustainable Development Goals (SDGs), ensuring the Scheme continues to meet evolving global food safety standards and sustainability objectives.

“We are pleased with the continued GFSI recognition of our updated FSSC 22000 Scheme Version 6. It confirms that we continue to provide trust to the food industry and create impact by contributing to the implementation of the United Nations Sustainable Development Goals,” said Aldin Hilbrands, CEO of Foundation FSSC. “This has also demonstrated our commitment to food safety excellence through the unique ISO-based management system certification approach adopted by an increasingly growing number of organizations globally.”

Attend the FSSC Insights Event, North America 2024 at the Food Safety Consortium Conference, October 22, 2024, Washington DC, Topics covered include FSSC 22000 Update and Version 6, FSSC 24000 and FSSC in Practice – Transport and Storage; Benefits of Certification and ROI. More Info at https://foodsafetyconsortium.org/ > Agenda > Tuesday 10/22

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Heavy metals found in 72 dark chocolate and cocoa products in the USA

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New research published in the journal, Frontiers in Nutrition found heavy metals in dark chocolate and cocoa products.

The researchers reported that 43, 35, and 0% of the products tested exceed Prop 65 MADLs for heavy metal concentrations, respectively, of Pb, Cd, and As, while 97.2% (70 of 72) fall below US FDA IRL limits established for Pb. Median concentrations of each metal tested were lower than even the conservative Prop 65 MADLs, indicating a potentially large effect of product outliers.

This indicates that heavy metal contamination—in more than half of products tested—may not pose any appreciable risk for the average person when consumed as a single serving; however, consuming some of the products tested, or more than one serving per day in combination with non-cocoa derived sources heavy metals, may add up to exposure that would exceed the Prop 65 MADLs. Notably, “organic” products were significantly more likely to demonstrate higher levels of both Cd and Pb.

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Beltway Beat

More Ground Cinnamon Products Added to FDA Public Health Alert Due to Presence of Elevated Levels of Lead

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Through product testing, the FDA has determined that the ground cinnamon products listed on their website contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. According to the FDA’s website, the FDA has been unable to reach MTCI to share their findings and request that the company initiate a recall. No illnesses or adverse events have been reported to date in association with these products.

Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium.

Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon.

FDA Actions

The FDA announced it is continuing its Toxic Elements monitoring program, which includes testing of a variety of foods including colored spices offered for sale in the U.S. According to their website, sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of FDA surveillance activities, these monitoring programs only evaluate a subset of the commodity being imported. FDA will follow-up on these findings as well as continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including by adding firms and products to import alert where appropriate. Ultimately, FDA says, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market.

The FDA also sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.

 

 

 

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USDA Proposes New Policy to Reduce Salmonella in Raw Poultry Products

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On July 29, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. According to the USDA’s website, this is the culmination of FSIS’ three-year effort to reevaluate their strategy for controlling Salmonella rates in poultry and protect American consumers from foodborne illness linked to consumption of poultry products.

The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I,4,[5],12:I:- ; and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.

“The proposed Salmonella framework is grounded in data and rigorous scientific evaluation, and it reflects feedback from extensive stakeholder engagement,” said USDA Under Secretary for Food Safety Dr. Emilio Esteban. “We encourage all interested stakeholders to submit comments and relevant data on the proposal as we work to finalize data-driven, science-based regulatory policies to address Salmonella in poultry.”