Tag Archives: labeling

FDA

FDA on How to Return Refrigerated Transport Vehicles and Storage Units to Food Use After Holding Human Remains

By Food Safety Tech Staff
2 Comments
FDA

The increase in deaths during the COVID-19 pandemic has pushed funeral homes and morgues beyond capacity, and other measures have been taken to store the bodies of victims. As a result, refrigerated food transport vehicles and food storage units have been temporarily used for this purpose. Now, FDA has released the guidance document, “Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic” because when those additional storage units are no longer needed to store bodies, “industry may wish to return the trailers and storage units to use for food transport and storage”.

Returning these vehicles and storage units to use for food is possible—but only with thorough cleaning and disinfection. The agency recommends the use of EPA-registered disinfectants that are suitable for the material being disinfected. It also recommends these disinfectants be effective against SARS-CoV-2 and foodborne pathogens. When disinfecting, it is important to adhere to the instructions for use for guidance on how many times application is required, the contact time needed, and effectiveness at refrigeration temperatures. For instances in which the interior surfaces have been in direct contact with blood or bodily fluids, the FDA guidance provides the scenarios in which the vehicles and storage units should not be returned to use for transporting or storing food for humans or animals.

OSHA has also stated that compressed air or water sprays should not be used to clean contaminated surfaces due to the risk of aerosolizing infectious material.

Due to the public health emergency, the guidance has been issued without the agency’s usual 60-day comment period.

April Kates, EAS Consulting
Retail Food Safety Forum

Labeling Impact of FDA’s Nutrition Innovation Strategy

By April Kates
No Comments
April Kates, EAS Consulting

On March 29, 2018, FDA announced the Nutrition Innovation Strategy, which signaled their intention to take a fresh look at what can be done to “reduce the burden of chronic disease through improved public nutrition.” The agency wants to facilitate consumers making better food choices to improve their health. At the same time, FDA has acknowledged that in many cases, changes in food processing technology has rendered outdated certain provisions of the regulations once written to both inform and protect the public. Therefore, FDA has developed a plan to move ahead to update its policy toolkit.

This multi-pronged approach includes modernizing food labeling, including food standards, health claims policy, ingredient labeling requirements and continuing implementation of the updated nutrition facts label, menu labeling, and reducing sodium in processed food products.

In particular, in trying to gather information to help determine the best approach to revising food standards of identity, FDA held a public meeting on September 27, 2019. FDA is attempting to provide room in the regulations for industry to be able to use modern and hopefully more healthful manufacturing methods while at the same time retaining the traditional characteristics and nutritional value of standardized food products.

During the public meeting, consumer advocacy groups, food industry trade groups and medical associations expressed many points of view as to what FDA should do to make the more than 250 food standards of identity more applicable to the modern food supply. FDA also took comments on updating food ingredient labeling requirements, including simplifying terms for ingredients such as vitamins. Because each food standard of identity is a regulation, it will be no small effort for the agency to update, remove or add standards of identity as needed. This meeting was a way to get input to help guide their decisions and priority—making for food standards and ingredient labeling revisions.

Obviously, with such a broad-based effort, the revisions and changes will be incremental. But the thing to keep in mind is that it all points to an effort to improve public health through the food supply as well as an effort to impactfully modernize the regulations. What follows is a very brief summary of some of FDA’s recent actions in this regard.

On December 30, 2019, FDA announced the final guidance on Serving Sizes, Dual-Column Labeling, which provided additional information about when dual column labeling for nutrition is required and what exemptions are in place to provide relief for certain products or package sizes.

On December 27, 2019, FDA reopened the comment period on the use of ultrafiltered (UF) milk in certain cheeses. When the proposed rule for UF milk in cheeses originally published in 2005, FDA received many comments. Essentially, ultrafiltration was a means to enhance the speed of cheese production, and the standard of identity cheeses were written before this technology was common and did not permit this type of process. FDA seeks to modernize the cheese standards while keeping intact the nature of these cheeses, and so the agency is eager to learn about what can be done to accommodate the new technology without losing the essence of the standards that consumers have come to expect. Because of the time lapse since the previous comment period, FDA is seeking more information to inform their rulemaking.

On October 25, 2019, FDA released a final rule revising the type size for calorie declarations on front of pack labeling for glass-front vending machines. The 2014 rule establishing calorie labeling for products sold from vending machines had provisions that were difficult for certain products to meet. This new rule recognizes those challenges and was an attempt by the agency to provide a middle ground for the industry to meet the requirements of visible calorie labeling on small packages sold in vending machines.

On August 15, 2019, FDA announced final guidance on converting units of measure for Folate, Niacin, and Vitamins A, D and E on the nutrition and supplement facts labels. The guidance provides help to the industry in meeting the requirements of the revised nutrition facts label.

Regarding updating the “healthy” claim on food products, when this term was originally defined by the agency, saturated fat was the nutrient of focus for these claims. However, since then, there are new focuses on health, such as added sugar and calories. In September 2016, FDA sought to modernize the claim, and provided an interim policy to guide its use.

In May 2019, FDA published a draft guidance to provide enforcement discretion for the use of the term “potassium chloride salt” on ingredient statements. In addition, in April 2019, FDA provided a draft guidance for the calculation of calories from a newer sweetener, Allulose.

As you can see, there are a lot of moving parts to FDA’s effort. What will be the impact on the food industry? Changes will most likely be gradual. Over time, there will be modifications to food standards of identity, and potentially claims, and both of these will cause label revisions. And, typically, there may be enforcement discretion by FDA to allow the industry time to revise their products and /or labeling as needed.

You will see FDA requests for information from the public and the industry on various related topics to the Nutrition Innovation Strategy, and guidance documents will be updated.

Karen Everstine, Decernis
Food Fraud Quick Bites

Fraud in Alcoholic Beverages

By Karen Everstine, Ph.D.
No Comments
Karen Everstine, Decernis

Recently, a group of researchers published a paper that documented unique chemical “fingerprints” left by whiskies after evaporation that could be used to identify the origin (specifically, American whiskeys in relation to Scotch and Irish whiskies.) Authentication of value-added label attributes in wine and spirits is important for protection of producers, brands and markets. Other examples include varietal fraud and geographic indication misrepresentation with wines and counterfeit production (intellectual property infringement) of a variety of spirits.

Food Fraud, wine
The Food Fraud Database has captured 220 incidents of fraud involving all alcoholic beverages and 63 specifically involving wines. (Source: Grape Wall of China)

Unfortunately, alcoholic beverages are also prone to fraud involving the addition of substances that can cause illness or death. This often happens at the local level, with the production of “moonshine” or other unlicensed spirits. Some of the substances used have included methanol, isopropyl alcohol and industrial-grade alcohol.
One notable incident from the 1980s had global implications and severe market effects. Diethylene glycol was added to Austrian wines, resulting in recalls around the world when the adulteration was detected. Fortunately, no illnesses or deaths were reported. Just a year later, methanol added to Italian wine caused both hospitalizations and deaths. More recently, incidents involving the addition of methanol to spirits have caused deaths in India, China and Malaysia.

Authentication and traceability for alcoholic beverages, and specifically wines, lend themselves to technology-enabled solutions such as blockchain. On a lighter note, take a look at some of the labels documented by reporters covering the wine market in China. In a high value marketplace such as the wine business, there is no end to creativity in labeling.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

In That Wine, There Is No Truth

By Susanne Kuehne
No Comments
Susanne Kuehne, Decernis
Wine, Decernis Food Fraud database
Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne.

Booze bootleggers are still quite active since there is a lot of money exchanging hands in the high-end wine and liquor business. Fake premium Penfolds wines, which can fetch several hundred dollars per bottle, as well as acclaimed brands of adulterated whisky, were discovered and seized in a liquor store in Cambodia. Besides the fake beverages, the raid also uncovered fake labels and packaging materials.

Resource

  1. Australian Associated Press (November 28, 2019). “Fake Penfolds wine seized in raid on bootlegging operation in Cambodia”.The Guardian.

 

 

Production line, NiceLabel

Farm-to-Fork Transparency: How Digitized Labeling Can Prevent a Major Allergen Recall

By Lee Patty
No Comments
Production line, NiceLabel

For consumers and brands alike, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal. Therefore, to prevent a health and business disaster, best practices around allergen labeling must be top of mind. Luckily, technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

No one wants to face a recall, but have you done enough to prevent one from happening to you? More than 650 food products were recalled last year in the United States alone. And one of the leading causes might just be the easiest to prevent: Undeclared allergens.

According to the Q2 2019 Stericycle Recall Index, undeclared allergens are the leading cause of U.S. food recalls, accounting for 48.4% of food recalls from the FDA and 62.9% of food pounds recalled by the USDA. This statistic becomes more alarming considering that roughly 11% of US adults have a food allergy, according to JAMA.

Enacted in 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) stipulates that all packaged food regulated under the Federal Food Drug and Cosmetic Act (FFD&C) comply by listing major food allergens. “Major allergens” refers to milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans, and for nuts and shellfish, the species must be declared.

For brands, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal, resulting in costly recalls or litigation. However, the impact to consumers can be even greater when one small mistake can cause serious illness, or worse, death. To prevent a health and business nightmare, best practices around allergen labeling must be top of mind.

However, with constantly changing legislation, this can be easier said than done. For instance, in a move that outpaced the FDA, Illinois issued a state law requiring sesame labeling. And in the UK, Natasha’s Law was recently introduced, requiring companies to label all food ingredients on fresh pre-packaged food after 15-year-old Natasha Ednan-Laperouse died of a sesame allergy from a sandwich that didn’t list all the ingredients.

The need for optimal allergen labeling is clear, so how can organizations ensure allergens are clearly labeled on their products and meet existing standards while preparing for future requirements?

Though the underlying principle behind a clear label is simple, the process of designing such labels can be multifaceted and difficult to streamline—especially if labels are designed, printed and managed by separate users across a franchise or store network. And this challenge is multiplied further when products reach across international boundaries. But technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

Disorganized Sprawl: A Major Hurdle to Effective Labeling

When implemented properly, modern label management can cost-effectively centralize labeling, reducing inefficiencies and human error. However, before this can happen, there are a few common roadblocks that may make standardizing the labeling process challenging.

One issue may be a sprawl of legacy equipment that is not integrated into a cohesive network. For instance, a legacy labeling system may only support certain label printers while certain manufacturers of direct marking equipment may only support their own propriety brand of printers. In another sense, a lack of standardization can also make it difficult to efficiently integrate labeling with other business solutions like manufacturing execution systems (MES) and enterprise resource planning (ERP) systems.

A damaging impact of sprawl is adoption of a wide range of different labeling applications across various facilities. This will result in inconsistent label formatting, the need to create the same label multiple times, and the need to accommodate different systems and printers. Consequences of this may be a lack of centralized storage when everything is saved locally, complex user training encompassing many software programs, an increased burden on IT, and a great deal of extra administration and human intervention to maintain and update labels.

Another problem with a disorganized ecosystem for labeling is that quality assurance inevitably suffers because tracing a label’s history or implementing standardized approval processes can be difficult or impossible. To accurately track labeling, it’s necessary to have a production log stating where and when labels were produced and who produced them. Having such a log and using it effectively requires centralization or else it can become difficult to track different versions or enforce universal approval processes for altering templates.

Implementing Modernized Labeling to Improve QA

Modern label management systems can help suppliers and manufacturers standardize and control marking packaging or label production across an entire organizational ecosystem. These solutions feature a central, web-based document management system and provide a reliable storage space for label templates and label history. This will enable changes and updates to be tracked centrally, so local facilities can access uniform and accurate templates to produce labels.

An ideal label management system can also interface with a multitude of direct marking and labeling printers, even if they are from different manufacturers, and it can integrate labeling and direct marking with a business system’s master data, which eliminates manual data entry errors. This decreases upfront capital expenditures in more costly efforts to standardize equipment, provides a system that is easy to integrate with partners, saves costs generated from having to discard product or rework labels, and increases a company’s ability to implement unified, organization-wide labeling processes.

Centralized Labeling is Easily Delivered Through Cloud

To many, the thought of migrating legacy labeling to a centralized system or investing a large sum of resources into centralizing labeling may seem inordinate or daunting. However, cloud technology makes migrating to a modern label management system feasible for organizations of all sizes.

With the cloud, designing labels and ensuring quality assurance becomes far more accessible. Additionally, the software-as-a-service (SaaS) model doesn’t require the capital investments or operations and maintenance upkeep associated with costly IT infrastructure and is easily scalable depending on business needs. This is a game changer for small to medium sized businesses who can now benefit from a centralized labeling system because of the cloud.

The Benefits of a “Single-source-of-truth”

In addition to other benefits, integrating a modern label management solution with other business systems allows users to access a “single-source-of-truth.” This allows for enforceable, specific user roles with logins for each user as well as traceability and transparency across all factories that produce products. The traceability from being able to monitor a “single-source-of-truth” is a critical component to farm-to-fork transparency because it can provide an accurate production log overviewing label versions and changes, so companies can pinpoint the locations and causes of labeling inaccuracies and fix them instantly.

A modern label management system also enables organizations to nimbly respond to new regulatory requirements because alterations only need to be made in one location, new templates can be previewed before going to production, and nutrition and allergen functionality can be easily formatted so that it is clear and stands out to the consumer. This increases labeling consistency and accuracy, and saves time when rules change and when new products need to be incorporated during a merger or acquisition.

Futureproofing and Ensuring Consumer Safety with Allergen Labeling

In today’s world, food and beverage manufacturers must rise to the challenge of changing regulations while meeting the call of shifting customer demands and integrating themselves within greater business ecosystems and extended supply chains. In the case of allergen labeling, this may mean preparing labels for different countries, which have varying standards for labeling allergens like sesame, royal jelly, bee pollen, buckwheat and latex, or ensuring labels can be altered quickly when new products are rolled out or when bodies like the FDA revamp standards.

Companies that implement modern label management solutions position themselves to adapt to competition and regulations quickly, implement solutions that can easily be integrated with partners in a supply chain, and streamline quality control. This can help improve productivity, reduce labeling errors, increase collaboration, and prevent product recalls. But most importantly, it helps ensure the safety of consumers everywhere.

Doug MacDonald, Oracle Retail
Retail Food Safety Forum

To Protect Food Quality, Start With the Data

By Doug Macdonald
No Comments
Doug MacDonald, Oracle Retail

Last month, the FDA held a public meeting to discuss its New Era of Smarter Food Safety initiative, with a rallying call to create a more “digital, traceable and safer food system.”

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas made it clear that the FDA is not replacing FSMA. Rather, the goal is to build on it, recognizing changes in the food industry over the last 10 years and the technologies available to tackle new challenges.

This isn’t surprising given continuing quality issues resulting in food recalls and shelf withdrawals. Last year, two major outbreaks of E. coli that were tied to consumption of romaine lettuce made a mark on industry perceptions, impacting customer trust, brand loyalty and the bottom line of companies involved were affected. Research by Allianz found recall costs could reach $10,000,000 for significant events.

To achieve the FDA’s goal of end-to-end traceability, the amount of information carried by every food item needs to increase, as will information about its location and condition in the supply chain. Grocers are at the sharp end of the food chain, meaning everything the FDA is proposing will impact them. As well as being merchandisers, they are brand-owners in their own right. They work directly with farmers and growers, they are directly involved in food safety, storage and distribution, and they feel the impact of recalls more than most. Unlike others in the food chain, they interact with consumers daily. This is important to note, since consumers are expecting communication on recalls immediately. In a recent study of more than 15,800 global consumers, 66% of respondents noted that they expect immediate notification of a product recall and another 28% stated they expect notification within a week.1 Furthermore, 88% said if a retailer immediately informed them of an issue, they would be more likely or slightly likely to trust them. The study also found that only 16% of consumers completely trust the product information provided to them from retailers today. In short, the impact of recalls extends far beyond the empty store shelf, and gives the industry even more reason to strive for safety.

High-Tech Next Steps

The FDA plans to publish a strategic blueprint early in 2020 of planned actions to meet its goal, but food brands and grocers need not wait to act. Proven technologies like brand compliance solutions, combined with emerging blockchain track and trace solutions and Internet of Things (IoT) sensors can add new depth and detail to traceability in the food supply chain, and these new technologies are already helping grocers and retailers keep consumers safe.

As retailers have sought a better means to track supply chain movements, blockchain technology has emerged as a potential way forward. Originally developed to manage financial transactions involving cryptocurrency, blockchain has proven to be capable of providing a verifiable record of the movement of goods through a supply chain. In fact, one major retailer has been piloting blockchain for more than a year and has already proven its value on produce items, cutting traceability times from more than a week to a matter of seconds. Some want to go even further and use IoT sensors to monitor the condition (e.g., temperature) of food products in the supply chain. Together, blockchain can help trace the path a product took through the supply chain and IoT can monitor the environmental conditions en route, providing a more cohesive picture of its supply chain journey.

But while supporting a few simple products with one ingredient and a one-step supply chain, such as fruits or vegetables, is one thing, scaling to address the needs of the average private brand retailer—now handling more than 10,000 active products from 2,000 production sites globally—is another. Managing the complexity of a product like tiramisu or a ready-made meal with dozens of ingredients, all coming from different sources, needs a different approach. To address the complexity, many are turning to brand compliance solutions—trusted, real-time repositories of information spanning the entire supply chain. For example, those using brand compliance solutions now have complete visibility of the ingredients in their private label products, helping them ensure labeling accuracy and transparency for consumers. Brand compliance tools also bring improved visibility of the food supply chain, enabling them to verify the status of manufacturing sites and respond quickly to food quality issues.

This combination of detailed product and supplier information makes brand compliance a foundational enabler for any blockchain/IoT-based initiative to improve supply chain visibility and traceability. For example, using brand compliance solutions, grocers can:

  • Confirm the ethical compliance of the supply chain at the point of selection or review, while using blockchain/IoT to monitor the ongoing conformance to these standards
  • Validate shelf life claims during formulation, while blockchain/IoT monitors logistical movement and environments to optimise products’ freshness
  • Record products’ formulation and ingredients to ensure safety, legal compliance and labeling accuracy, with blockchain/IoT monitoring the ongoing conformance to these standards
  • Rapidly identify potential risks across the entire formulation and supply chain, while tracking the affected batches to stores using blockchain and IoT

This convergence of static factual data (e.g., formulation, nutrition and allergens) linked to near real-time traceability and checking offers grocers confidence in the data and supports the consumer’s confidence of an actual product in their basket.

Looking Ahead

It seems clear that the food business is moving in the same direction as airlines and banks and becoming much more data driven. For grocers looking to keep pace, they will need to:

  • Treat data as a core competency. This means hiring information experts, investing for the future, and using data to identify ways to deliver better, safer products.
  • Create a customer-centric value promise. Grocers must go beyond regulatory compliance and use data to improve consumer transparency, support ethical sourcing initiatives, expand sustainable packaging and speed innovation.
  • Go above and beyond. Rather than waiting for FDA direction or simply complying with requirements, brands should take matters into their own hands, hold themselves to high markers and get started now.

In the future, improving the way that we manage the food supply chain is not just about how well we work with trucks and warehouses; it’s about how use information. The FDA’s initiative makes a clear statement that now is the time to modernize our food supply chains. As we look ahead to a new decade, the industry can come together to improve food safety and protect consumers, and we need not wait for the FDA’s blueprint or even the new year to get started.

Reference

  1. Setting the Bar: Global Customer Experience Trends 2019. (2019). Oracle Retail. Retrieved from https://go.oracle.com/LP=86024.
Susanne Kuehne, Decernis
Food Fraud Quick Bites

In France, Appellation Matters, Not Just for Wine

By Susanne Kuehne
No Comments
Susanne Kuehne, Decernis
Food fraud, Decernis, Strawberries
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

The 2013 horse meat and lasagna scandal, and the 2018 kiwi fraud issue are just some of the product traceability cases that are under public scrutiny in France. For the second time in France’s Lot-et-Garonne region, strawberries labeled French turned out to originate in Spain. Part of the harvesting labor was outsourced and was therefore more difficult to track. This makes it easier for mislabeling and food fraud to enter smaller-scale agricultural and agricultural cooperative businesses.

Resource

  1. Annick Berger (June 22, 2019). “Apres les faux kiwis, voici les fausses fraises francaises”. Capital.fr Retrieved from https://www.capital.fr/entreprises-marches/apres-les-faux-kiwis-voici-les-fausses-fraises-francaises-1342718
Daniel Erickson, ProcessPro
FST Soapbox

Establishing Preparedness Initiatives to Mitigate the Effects of Recalls

By Daniel Erickson
No Comments
Daniel Erickson, ProcessPro

Despite manufacturers’ best intentions to provide safe products for consumers, notifications about recalled products appear in news headlines with increasing regularity. The CDC reports that each year, 48 million Americans experience foodborne illnesses, resulting in a reported 128,000 hospitalizations and 3,000 deaths. Behind these statistics are recall trends that can lead to operational and financial instability, and a loss of reputation for companies in the marketplace. Proactive measures and tools adopted by experienced food and beverage manufacturers can help mitigate the potentially harmful effects of these product recalls by establishing preparedness initiatives.

Recall Essential Facts

A recall is defined as a request for the return of a product from the market due to a defect or safety concern resulting from a variety of issues including improper labeling or contamination, which places the manufacturer at risk of legal action. Product recalls can be issued by either the manufacturer or a governmental agency, but it is the sole responsibility of the company to properly recall and notify consumers of unsafe products. Recalls are categorized as either voluntary or mandatory, with the majority falling under the voluntary classification. In the case of a voluntary recall, a manufacturer has greater control over the process with less stringent procedures, review and paperwork. While both have the same potential for negative effects and significant legal costs, a voluntary recall is preferred by manufacturers. Implementing an industry-specific ERP solution with a documented recall preparedness plan and mock recall capabilities provide the necessary tools for either scenario, as recalls are inevitable in today’s manufacturing environment.

Recall Trends

In the USDA- and FDA-regulated markets, comparatively, there have been a slightly higher number of recall incidents in the beginning months of 2019 versus 2018. Mispackaging is identified as one of the primary recall issues, involving packaging a finished good into the wrong container. Another trending recall cause involves not properly identifying an ingredient on the packaging label. Both of these manufacturing errors resulted in the labels not providing an accurate reflection of the product, which could be potentially harmful to consumers if the undeclared ingredient(s) include one of the common allergens. Well-documented and properly executed internal manufacturing processes, in addition to an automated ERP solution, create checks and balances and assist in generating accurate, compliant packaging and nutrition fact panels to meet the requirements of consumers and regulatory bodies.

A third recall trend of 2019 is being driven by consumer complaints in regards to foreign materials such as metal fragments, plastics or rubber pieces in finished goods. This is caused by incomplete testing, lack of or faulty material detection equipment, including metal detectors, x-rays and other devices used during manufacturing. Due to an increasing number of these types of incidents, the USDA has issued a guidance document requiring manufacturers to maintain updated documentation of their internal procedures in their hazard analysis and critical control point (HACCP) plan. This guidance necessitates follow up with federal inspectors regarding any adjustments made to the plan. HACCP information recorded within an ERP solution helps to identify and control potential hazards before food safety is compromised—providing quality, consistent and safe consumables for the public.

Progress towards fewer FDA food and beverage recalls continues due to an increase in FDA inspections as well as manufacturers’ success in proactive measures to stay abreast of FDA requirements. However, bacterial pathogenic concerns including Listeria, Salmonella and E. coli continue to be prevalent recall culprits. This has resulted in the FDA utilizing the Whole Genome Sequencing (WGS) Program in an attempt to protect consumers from foodborne illness. By swabbing manufacturing environments and sending samples to WGS, the DNA strains are documented in a centralized public database—holding manufacturer’s accountable for processing and sanitation control. When an outbreak occurs, the database is able to locate possible matches that help health officials identify the source of contamination, and stop outbreaks more quickly, thereby avoiding additional widespread illnesses. As the database grows in size, so will the speed of investigations to determine the root causes of illnesses. This program has the potential to not only stop outbreaks from spreading but also includes proactive applications for increasing the safety of the food and beverage industry as a whole.

ERP’s Role in Recall Preparedness

An industry-specific ERP’s real-time forward and backward lot traceability, detailed record keeping, allergen/attribute tracking and efficient, documented processes support end-to-end recall management functionality to maintain compliance. With preventative measures such as establishing supplier relationships, conducting quality control testing and documenting quarantine procedures, an ERP solution works to identify gaps and prevent future recalls. Accurate product labeling is one of the key factors of recall prevention and food and beverage ERP software handles the intricacies of packaging and label creation, such as ingredient and allergen statements, nutrient analysis, expiration dates and lot and batch numbers—creating an audit trail that allows items to be located promptly in the event of a recall. As part of a sound food safety plan, mock recalls conducted regularly encourages familiarity with internal recall processes, as well as allows for adjustments to be made as needed. With a comprehensive ERP to generate lot tracking reports, manufacturers are able to identify and locate contaminated products in order to notify clients, vendors, consumers and government agencies quickly in the event of a recall—helping to minimize harmful effects in the marketplace as well as legal action.

The trends identified in recent recalls issued by the FDA and the USDA, thus far in 2019, demonstrate that manufacturers need to be proactive in how they respond in order to mitigate the detrimental effects that recalls can have on companies and to public health. With the increasing scrutiny from the FDA and USDA, along with an aware consumer base, it’s important for forward-thinking businesses to address the eventuality of a product recall with sound food safety and HACCP plans and an industry-focused ERP software solution that promotes, supports and helps manage preparedness and responsive action, if needed.

magnifying glass

FDA, USDA Formally Agree to Regulate Human Food Made from Cells of Livestock and Poultry

By Food Safety Tech Staff
No Comments
magnifying glass

Today FSIS and FDA announced a formal agreement regarding the regulatory oversight of human food products derived from the cell lines of livestock and poultry. The agencies will jointly oversee regulation of these cell-cultured products to ensure both safe production as well as accurate labeling.

The agreement involves a joint regulatory framework in which the FDA will manage cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, FDA will transition oversight to FSIS and from there, FSIS will oversee production and labeling of the human food products that are derived from the cells of livestock and poultry.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a USDA press release.

magnifying glass

FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
No Comments
magnifying glass

The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce