Tag Archives: FDA

FDA

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

By Food Safety Tech Staff
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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.

Food Safety Consortium

2020 FSC Episode 4 Preview: FDA’s Frank Yiannas to Discuss Proposed FSMA Traceability Rule, Updates on New Era of Smarter Food Safety

By Food Safety Tech Staff
No Comments
Food Safety Consortium

Episode 4 of the 2020 Food Safety Consortium Virtual Conference Series features more important conversations about COVID-19 and its impact on the food industry. The event kicks off with a special presentation by FDA’s Frank Yiannas. Highlights include:

  • FDA Keynote Address by Frank Yiannas, deputy commissioner for food policy and response
  • COVID-19 Lessons Learned Panel Discussion with Mitzi Baum, STOP Foodborne Illness; Stephanie Dragatsis, Feeding America; Carletta Ooten, Amazon; Spir Marinakis, Maple Leaf Foods; and Craig Wilson, Costco Wholesale
  • Rumor vs. Reality: How to Cope with the Trends of Food Safety During a Pandemic, with Ge Song, Benjamin L. England & Associates, LLC
  • Tech Talk by sponsor Rizepoint and program partner AOAC

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.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium
Although there will be no physical handshaking this year, Frank Yiannas, deputy commission for food policy and response at FDA (left), will join Rick Biros, president of the Food Safety Consortium, for this year’s Virtual Conference Series on October 1. (Photo credit: amyBcreative)
FDA

FDA Proposes FSMA Rule on Food Traceability

By Food Safety Tech Staff
No Comments
FDA

Keeping in line with commitments made under FDA’s New Era of Smarter Food Safety, the FDA has announced a food traceability proposed rule to create more recordkeeping requirements for specific foods. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods”, puts additional requirements on companies that manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain records related to critical tracking events (i.e., growing, receiving, transforming, creating and shipping).

Foods on the proposed traceability list have been selected based on a risk-ranking model for food tracing and include:

  • Cheese
  • Shell eggs
  • Nut butter
  • Cucumbers
  • Herbs
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Finfish
  • Crusteaceans
  • Mollusks
  • Ready-to-eat deli salads

The requirements of the proposed rule pertain to the above-foods as a standalone product as well as when an ingredient in a product.

 

Department of Justice seal

Blue Bell Hit with Record $17.25 Million in Criminal Penalties for 2015 Listeria Outbreak

By Maria Fontanazza
No Comments
Department of Justice seal

Remember the 2015 Listeria outbreak linked to Blue Bell Creameries? The outbreak led to three deaths and 10 illnesses between January 2010 and January 2015. On Thursday the Department of Justice ordered the company to pay $17.25 million in criminal penalties for shipping contaminated products linked to that outbreak. The sentence, enforced by U.S. District Judge Robert Pitman (Austin, Texas), is the largest fine and forfeiture ever imposed in a conviction involving a food safety case.

“American consumers must be able to trust that the foods they purchase are safe to eat,” stated – Acting Assistant Attorney General Jeffrey Bossert Clark, Justice Department’s Civil Division in an agency news release. “The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”

In May 2020 Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream. The following is an excerpt from the Department of Justice news release:

“The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act. According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination. Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional state-led testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.”

Checklist

2020 FSC Episode 1 Wrap: Food Defense & Food Safety Culture Go Hand-in-Hand

By Maria Fontanazza
No Comments
Checklist

Yesterday marked the beginning of the 2020 Food Safety Consortium Virtual Conference Series. Episode 1 featured Food Defense Foundational Planning Elements: Strategies, Insights and Best Practices. Led by Jason Bashura, senior manager, global defense at PepsiCo, food defense experts from manufacturing, retail and the government shared different perspectives on the FSMA Intentional Adulteration rule; how to develop a food defense plan; the key role that food safety culture plays in food defense; education and training; and establishing awareness of and combating various threats to the food supply, including the insider threat.

Especially eye-opening was the information presented by Robert Norton, Ph.D. of Auburn University about the threats against the food supply (a “target-rich environment”) and the range of adversaries and their motivation for disrupting the food supply.