Tag Archives: FDA

Food Safety Consortium

2020 FSC Episode 11 Preview: Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium

This week’s episode of the 2020 Food Safety Consortium Virtual Conference Series will address how food companies can navigate supply chain complexities. The following are highlights for Thursday’s session:

  • Disruptions in the Supply Chain and the Government Response, with Brian Ravitch and Benjamin England, FDA Imports
  • Food Safety Risks and the Cold Supply Chain, with Jeremy Schneider, Controlant
  • A panel discussion on the Third-Party Certification Program, moderated by Trish Wester, AFSAP and featuring Doriliz De Leon and Clinton Priestly of FDA
  • TechTalk on How Restaurant Brands International has Digital Transformed Its Supply Chain to Ensure Food Safety, Quality & Consistency, with Jim Hardeman, CMX

The event begins at 12 pm ET on Thursday, November 19. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Tucson Tamale

USDA Issues Public Health Alert for Tamales Due to Potential Foreign Matter Contamination

By Food Safety Tech Staff
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Tucson Tamale

Yesterday USDA’s FSIS issued a public health alert for ready-to-eat chicken and pork tamales because they contain recalled diced tomatoes in puree that have been recalled by the producer due to foreign matter contamination. The puree product is FDA regulated. The RTE tamales were produced by Tucson Tamale Wholesale Co., LLC between October 22 and November 9, 2020, and have the establishment number “EST. 45860” inside the USDA mark of inspection. The products were sold online and shipped for retail and restaurant distribution nationwide.

Tucson Tamale
Tucson Tamale recalled the above-pictured ready-to-eat tamales due to potential contamination with hard plastic.

Tucson Tamale uncovered the issue upon identifying pieces of hard plastic in the cans of diced tomatoes that they received from their ingredients supplier. FSIS is urging consumers who purchased the product to throw them away or return them to the place of purchase.

Tanimura & Antle romaine lettuce

Romaine Lettuce Recall Due to Possible E. Coli Contamination

By Food Safety Tech Staff
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Tanimura & Antle romaine lettuce
Tanimura & Antle romaine lettuce
Tanimura & Antle issued a voluntary recall of single-head packaged romaine lettuce.

Tanimura & Antle, Inc. is voluntarily recalling its packaged single head romaine lettuce, out of an abundance of caution, due to possible E. Coli 0157:H7 contamination. The product has a packaged date of 10/15/2020 or 10/16/2020, and the UPC number 0-27918-20314-9.

Although no illnesses have been reported, the recall is based on the test result of a random sample taken and analyzed by the Michigan Department of Agriculture and Rural Development. The company distributed 3,396 cartons to 20 states. Retailers and distributors can identify the affected products using the Product Traceability Initiative stickers (571280289SRS1 and 571280290SRS1) that are attached to the exterior of the case.

FDA

FDA Releases More Resources for Food Traceability Proposed Rule, Risk-Ranking Model for Food Tracing

By Food Safety Tech Staff
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FDA

Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].

The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.

Other resources include a flowchart to assist with determining who is subject to the rule and a glossary of key terms.

FDA

FDA Starts Voluntary Pilot Program to Assess Third-Party Food Safety Audit Standards Against FSMA

By Food Safety Tech Staff
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FDA

On Friday FDA announced a voluntary pilot program to help the agency and industry better understand whether private third-party food safety audit standards align with the requirements in FSMA’s Preventive Controls for Human Food and Produce Safety Rules. The program, which will be conducted over one year, is part of the goals established under the New Era of Smarter Food Safety Blueprint, which states that FDA is exploring the reliability of third-party audits in ensuring food safety.

“The FDA understands that determinations that third-party audit standards align with the FSMA regulations could provide importers and receiving facilities with confidence that the standards used to audit their suppliers adequately consider FDA’s food safety requirements,” the agency stated in a constituent email update. “In addition, alignment determinations could help the FDA’s investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supplier verification requirements.”

During the pilot, FDA will assess up to five third-party food safety standards for alignment with the above-mentioned FSMA rules—including what resources are needed to review and assess those standards, and whether the pilot participants can provide adequate information allow FDA to determine alignment. “Alignment determinations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits,” FDA stated. “In addition, the pilot will enable FDA to gain information and experience that will allow the Agency to evaluate the resources and tools required to conduct alignment reviews.”

FDA is requesting those who want to participate in the program, both the public as well as owners of third-party food safety standards, submit requests in the Federal Register within 30 days.

Checklist

2020 FSC Episode 6 Wrap: Lessons in Sanitation

By Maria Fontanazza
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Checklist

COVID-19 has put a spotlight on the importance of proper handwashing and overall hygiene. In addition to focusing on worker and operational safety, it has also pushed food manufacturers and processors to pay more attention to the location of high-touch areas and how they should be cleaned, sanitized, disinfected and sterilized. During last week’s Food Safety Consortium episode on sanitation, there was discussion about the need to have the right sanitation plan and properly trained people in place. “When it comes to food safety, who are the most important people in the plant? It’s the sanitation crew and employees. They are on the frontlines, ” said Shawn Stevens, founder of Food Industry Counsel, LLC. “If they don’t do their job or are not given the tools to do their jobs, that’s where the failures occur. We need to empower them. We have to invest in sanitation and not be complacent.”

Investing in a sanitation plan is where it all begins, said Elise Forward, president of Forward Food Solutions. Within the plan, companies need to include items such as PPE and sanitation equipment, along with what resources will be needed and what chemicals will be required. “What would it look like in our manufacturing facilities if we had a plan for the pandemic?” asked Forward. “There was so much scrambling: ‘How do we do this and what do we do’. We need to plan for these events.” Forward, along with David Shelep, microbiologist and consultant for Paramount Sciences and Bill Leverich, president of Microbiologics, Inc., offered a strong overview of the right components of a sanitation plan and the common products and technologies used in the process (quaternary ammoniums, sodium hypochlorite, ethyl alcohol, peracetic acid, hydrogen peroxide, and chlorine dioxide). They also provided insight on some of the products and technologies that are being explored in the face of COVID-19—UV-C and hypochlorous acid, which has applications in cleaning biofilms, hand sanitizing, fogging, and surface application (i.e., electrostatic spraying, mopping).

“Cleaning and sanitizing is setting up your production team(s) for success.” – Elise Forward, Forward Food Solutions

View the list of EPA-registered COVID-19 disinfectants.

Beyond sanitation methods, companies need to invest in employee training and be committed to their safety. This means giving employees sick days and not incentivizing them to come to work when they are sick.

Rob Mommsen, senior director, global quality assurance and food safety for Sabra Dipping Company, shared a candid perspective on how Sabra developed an effective and validated Listeria environmental monitoring program (LEMP) following an FDA inspection that led to a swab-a-thon, findings of resident Listeria in the plant, and a huge product recall as a result of the Listeria contamination in the plant (Mommsen stated that Listeria was never found in product samples). “We had to severely alter the way we cleaned our plant,” he said. And the company did, with a number of changes that included taking the plant apart and cleaning it; removing all high pressure water nozzles; changing areas in the plant from low care to high care; keeping movable equipment to certain areas in the plant; changing employee and equipment traffic patterns; and retraining staff on GMPs. The company also changed its microbiological strategy, conducting daily swabbing in certain zones, increasing testing on samples, and implementing a weekly environmental meeting that was attended by senior and department managers. “Fast forward” to 2019: FDA conducted an unannounced audit and noted that Sabra’s environmental monitoring program was one of the best they’ve seen and that the company’s culture was clearly driven by food safety, according to Mommsen.

Fast forward again to 2020 and the pandemic: With work-from-home orders in place and other frontline workers staying home for various reasons, the company saw a change GMP adherence, employee training and the frequency of environmental monitoring, said Mommsen. So Sabra had some work to do once again to re-right the ship, and Mommsen presented it as a lessons learned for folks in the food industry: In addition to employee safety, food safety must be the number one priority, and having the support of senior management is critical; the turnaround time for environmental swabs is also critical and an effective LEMP should consist of both conventional testing as well as rapid detection technology; and an environmental monitoring program requires persistence—it is not self sustaining and there are no shortcuts.

The watch the presentations discussed in this article, register for the 2020 Food Safety Consortium Virtual Conference Series, and view the session on demand.

Karil Kochenderfer, LINKAGES
FST Soapbox

GFSI at 20 YEARS: Time for a Reboot?

By Karil Kochenderfer
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Karil Kochenderfer, LINKAGES

The marketplace has experienced dramatic changes that were barely on the horizon 20 years ago—by that, I mean mobile phones, Instagram, Facebook, climate change, consumer transparency, globalization, novel new products delivered to your doorstep and now COVID-19, too.

I write from a perspective of both pride and concern. I had the privilege of representing GFSI in North America and helping the organization expand beyond Europe as new food safety laws were implemented in both the United States and Canada.

Questionable Utility of Multiple, Redundant and Costly Certifications

However, I also sympathized with small and medium food companies that struggled with minimal resources and food safety expertise to understand GFSI and then to become certified not once, but multiple times for multiple customers. GFSI’s mantra, “Once Certified, Accepted Everywhere,” was far from their GFSI reality…or, frankly, the reality of many food companies. My concern was not insignificant. The food industry is populated by a majority of small businesses, each seeking that one big break that could possibly, maybe open up access to retail shelves. Their confusion about being audited and certified to one standard was significant. Certification to multiple and redundant standards presented a daunting and costly endeavor for these start-ups. I heard their anxiety in their voices as I served as GFSI’s 1.800 “customer service rep” in North America for years.

Karil Kochenderfer will present “GFSI at 20 Years: Time for a Reboot?” during the 2020 Food Safety Consortium Virtual Conference Series | Her session takes place on December 17Transparency

In the 20 years since GFSI was established, the world has become much more transparent. Today, entire industries operate on open, international, consensus-based ISO management standards in far bigger and more complex sectors than the food sector (e.g., the automotive, airline and medical device sectors). And, in the 20 years since GFSI was established, an ISO food safety management system standard has been developed that is now used widely throughout the world with more than 36,000 certifications (i.e., ISO 22000).

Auditing and certifying a facility to a single, international, public standard would enhance GFSI transparency. It also would help to hurdle government concerns related to the lack of public input into the development of private standards, enabling private certifications like GFSI to be used efficiently as a compliance tool—a benefit to both government and food interests and to consumer health, safety and trade.

New Technologies

Many new technologies, such blockchain, artificial intelligence, sensors and the Internet of Things are being heralded widely now as well, particularly for businesses with complex supply-chains like those in like the fast-moving food and retail sectors. The benefits of these technologies are predicated on the use of a common digital language…or standard. Multiple and diverse standards, like GFSI, complicate the use of these new technologies, which is why FDA is examining the harmonizing role of standards and data management in its proposed New Era of Smarter Food Safety.

Sustainable Development

Today, food safety often is managed in tandem with other corporate environment, health and safety programs. The Consumer Goods Forum, which oversees GFSI, should take a similar approach and merge GFSI with its sustainability, and health and wellness programs to help CGF members meet their existing commitments to the United Nations’ Sustainable Development Goals (SDGs) and to encourage others to do the same. Here, once again, adoption of a single, transparent ISO standard can help. Adoption of ISO 22000 as the single and foundational standard for GFSI makes it easy to layer on and comply with other ISO standards—for example, for the environment (ISO 14000), worker protection (ISO 45001), energy efficiency (ISO 50001) and information/data security (ISO 27001)— and to simultaneously meet multiple SDGs.

Globalization

As I write, the COVID pandemic rages. It may re-align global supply chains and set back global trade temporarily, but the unprecedented rise in consumer incomes and corresponding decrease in poverty around the world attests to the importance of the global trade rules established by the World Trade Organization (WTO). Among these rules is a directive to governments (and businesses) to use common standards to facilitate trade, which uniquely recognizes ISO standards as well as those of Codex and OIE. When trade disputes arise, food interests that use ISO 22000 are hands-down winners, no questions asked. So, why use many and conflicting private standards?

Supply Chain Efficiency

Finally, ISO 22005, part of the ISO 22000 family of food management standards, also is aligned with GS1 Standards for supply-chain management, used throughout the food and retail sectors in North America and globally to share information between customers and suppliers. GS1 is most well known for being the administrators of the familiar U.P.C. barcode. The barcode and other “data carriers” provide visibility into the movement of products as well as information about select attributes about those products—including whether they have been certified under GFSI. Both GS1 and ISO GS1 standards are foundational to the new technologies that are being adopted in the fast-moving food, consumer products, healthcare and retail sectors both in the United States and globally. That alignment puts a spotlight on safety, sustainability, mobility, efficiency and so much more.

Focus Less on the Change, More on the Outcome

My proposal will surely set tongues in motion. Proposals to switch things up generally do. Disruption has become the norm, however, and food businesses are prized for their agility and responsiveness to the endless changes in today’s fast-moving marketplace. Still, ISO and Codex standards already are embedded in the GFSI benchmark so what I’m proposing should not be so disruptive and no one scheme or CPO should benefit disproportionately. And, less differentiation in the standard of industry performance will compel scheme or certification owners to shift their focus away from compliance with their standards and audit checklists to working with customers to truly enhance and establish “food safety-oriented cultures.” If they do, all of us emerge as winners.

The New Normal?

Around us new food businesses are emerging just as old businesses reinvent theirs. Trucks now operate as restaurants and athletes deliver dinner on bicycles. For a long time, we’ve operated businesses based on 20th century models that don’t resonate in the 21st century world. Are we at an inflection point, with both small and large businesses paying for costly and inefficient practices that no longer apply, and is it time for GFSI to change?

I welcome your thoughts. I truly do. Better, let’s discuss on a webinar or video call of your choosing. I look forward to connecting.

Submit questions you want Karil to answer during her session at the 2020 Food Safety Consortium Virtual Conference Series in the Comments section below.

Mikael Bengtsson, Infor

As COVID-19 Stresses Food Suppliers, Technology Steps In

By Maria Fontanazza
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Mikael Bengtsson, Infor

The theme of better traceability and more transparency is a theme that will only grow stronger in the food industry. Just last week we heard FDA Deputy Commissioner for Food Policy and Response Frank Yiannas talk about the agency’s recently proposed FSMA rule on food traceability during the 2020 Food Safety Consortium Virtual Conference Series. In a recent Q&A with Food Safety Tech, Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor, explains yet another role that technology can play in helping companies maintain agility during changes that affect the supply chain such as the coronavirus pandemic.

Food Safety Tech: How can food suppliers mitigate the risks of foodborne illness outbreaks under the stress of the COVID-19 pandemic and with limited resources?

Mikael Bengtsson: Food safety must always be a top priority for any food and beverage company. The risks associated with contamination can have a severe impact for public health, brand and company reputation. Safety routines are therefore always of the highest priority. In today’s situation with COVID-19, the stress on safety is further increased. Now, it’s not only about keeping products safe but also keeping employees healthy. One progression and resource that all food suppliers must follow is the FDA [FSMA rules], which require suppliers to be diligent and document their compliance. Especially now, while suppliers are faced with limited resources and additional stress during the pandemic, they must rely on the basics—ensuring masks are worn in and out of the workplace, washing hands for at least 20 seconds prior to touching any food, and remaining six feet apart from co-workers. When it comes to a crisis like COVID, take solace in knowing suppliers can rely on the basics—even when conditions are strained.

This year we have seen many companies having to adapt and change quickly. Demand has shifted between products, ingredients have been in shortage and many employees have had to work from home. Some were better prepared than others in adapting to the new situation. Technology plays a big role when it comes to agility. Regarding food safety, there are many proactive measures to be taken. The industry leaders establish transparency in their supply chain both upstream and downstream, use big data analysis to identify inefficiencies, as well as couple IoT with asset management systems to foresee issues before they happen.

FST: How can technology help suppliers meet the growing consumer demand for transparency in an end-to-end supply chain and improve consumer trust?

Mikael Bengtsson, Infor
Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor

Bengtsson: Communication with consumers is changing. It is not only about marketing products, but also to educate and interact with consumers. This requires a different approach. Of course, consumers are loyal to brands, but are also tempted to try something new when grocery shopping. After a new study is published or a new story is written, consumers are likely to shift their shopping preferences.

It is therefore important to build a closer connection with consumers. Companies who have full supply chain visibility, transparency and traceability have detailed stories to tell their consumers. One way they can build these stories is by including QR codes on their packages. The consumer can then easily scan the code and be brought to a website that shows more product details—e.g. who was the farmer, how were the animals cared for and what sustainability efforts were involved. These are all important aspects to build consumer trust. According to researchers at MIT Sloan School of Management, investing in supply chain visibility is the optimal way to gain consumer trust, and can lead to increased sales.

FST: What technologies should suppliers leverage to better collaborate with trading partners and ensure consistent food safety procedures?

Bengtsson: When a food safety problem arises, batches, lots, and shipments need to be identified within minutes. Manufacturers must be able to trace all aspects of products throughout the entire supply chain—with complete visibility at the ingredient level—from farm to table, and everything in-between. An efficient and transparent food supply chain requires extensive collaboration and coordination between stakeholders. New technologies can extend both amount of collaboration possibilities and the impact of those collaborations. In order to maintain a transparent, efficient food supply chain, companies need to invest in modern cloud-based ERP and supply chain systems that incorporate the increased visibility of the Internet of Things (IoT) with data sharing, supplier and customer portals, and direct links between systems—all aimed at facilitating joint awareness and coordinated decision-making. Modern technologies that enable transparency will also have the added benefits of meeting consumer demand for product information, identifying and responding to food safety issues, reducing food waste, and supporting sustainability claims.

Checklist

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

By Maria Fontanazza
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Checklist

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

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

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

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

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

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

FDA

FDA Asks for Comments and Evidence to Aid in Labeling of Cultured Seafood Cells

By Food Safety Tech Staff
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FDA

FDA has issued a Request for Information in an effort to gain information and data about how to properly label foods made with cultured seafood cells. The goal is to help FDA determine next steps in ensuring that products derived from cultured seafood cells are labeled consistently and transparently. The “Request for Information: Labeling of Foods Comprised of or Containing Cultured Seafood Cells” will be published on the Federal Register on October 7, and there is a 150-day comment period.

“The FDA invites comment, particularly data and other evidence, about names or statements of identity for foods made with cultured seafood cells. The agency is also interested in information on consumer understanding of those terms and how to determine material differences between cell cultured and conventionally produced seafood,” FDA stated in an email constituent update.

The labeling of foods derived from cultured seafood cells falls under FDA jurisdiction. In March the USDA and FDA entered into a formal agreement regarding the oversight of human food made from cells of livestock and poultry.