Tag Archives: investigation

General Mills

FDA Investigating Consumer Illness Complaints from Lucky Charms

By Food Safety Tech Staff
No Comments
General Mills

Following a surge in consumers reporting illnesses that range from nausea to vomiting to diarrhea after eating Lucky Charms, FDA has initiated an investigation into the product and the claims. Iwaspoisoned.com is a nationwide consumer food safety platform that allows people to report their illnesses immediately. The complaints of food poisoning connected to consuming the popular cereal began trending late last year, with more than 1300 reports of illnesses to date, according to the website.

Patrick Quade, founder of iwaspoisoned.com, called the volume of consumer complaints related to this single product “unprecedented”.

FDA has not released an official statement on the matter.

General Mills spokesperson Andrea Williamson told Consumer Reports the following: “After a thorough internal investigation, we have not found any evidence that these complaints are attributed to our products. We encourage consumers to please share any concerns directly with General Mills to ensure they can be appropriately addressed.”

Recall

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

By Food Safety Tech Staff
No Comments
Recall

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

–END UPDATE–

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

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

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

Select Subcommittee on the Coronavirus Crisis

OSHA, Tyson, Smithfield and JBS Under Investigation for COVID Outbreaks

By Food Safety Tech Staff
No Comments
Select Subcommittee on the Coronavirus Crisis

Last week U.S. Congressman and chairman of the Select Subcommittee on the Coronavirus Crisis James E. Clyburn (D-SC) launched an investigation into OSHA, Tyson Foods, Smithfield Foods and JBS USA over the nationwide coronavirus outbreaks at meatpacking plants that have led to the deaths of at least 270 employees. Nearly 54,000 workers at 569 U.S. meatpacking plants have tested positive for COVID-19, according to the Subcommittee and media reports.

Select Subcommittee on the Coronavirus Crisis“Public reports indicate that under the Trump Administration, the Occupational Safety and Health Administration (OSHA) failed to adequately carry out its responsibility for enforcing worker safety laws at meatpacking plants across the country, resulting in preventable infections and deaths. It is imperative that the previous Administration’s shortcomings are swiftly identified and rectified to save lives in the months before coronavirus vaccinations are available for all Americans,” the letter to James Frederick, deputy assistant secretary of labor for OSHA stated. “The Select Subcommittee strongly encourages you to take all necessary steps, including under President Biden’s Executive Order on Protecting Worker Health and Safety1and your other existing statutory authorities, to protect workers from the risks of the coronavirus by issuing clear guidance to employers, enacting an emergency temporary standard, and enhancing enforcement efforts.”

Clyburn and the Subcommittee issued a letter to Dean Banks, president and CEO of Tyson Foods, Dennis Organ, president and CEO of Smithfield Foods, and Andre Nogueira, president and CEO of JBS USA. Each letter pointed out the shortcomings of each company in adequately addressing the outbreaks that occurred among its workers.

“Public reports indicate that meatpacking companies … have refused to take basic precautions to protect their workers, many of whom earn extremely low wages and lack adequate paid leave, and have shown a callous disregard for workers’ health,” Clyburn stated in the letter. “These actions appear to have resulted in thousands of meatpacking workers getting infected with the virus and hundreds dying. Outbreaks at meatpacking plants have also spread to surrounding communities, killing many more Americans.”

The Subcommittee has asked OSHA and each company for documentation related to the COVID infections and deaths, as well as their enforcement of worker protections under the Trump administration.

Manuel Orozco, AIB International
FST Soapbox

Detecting Foreign Material Will Protect Your Customers and Brand

By Manuel Orozco
No Comments
Manuel Orozco, AIB International

During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.

As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.

The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.

The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.

To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.

But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.

Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.

It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.

Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.

The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.

The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.

Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.

There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Novel Foods, Novel Frauds

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

The popularity of plant-based protein powders has skyrocketed, and so has fraudulent activity with so-called protein boosting adulterants. Examples are a variety of beans, such as fava beans, as well as wheat, maize, alfalfa and more. Due to the rapid innovation and development of novelty supplements, regulatory standards are in urgent need of overhaul. Correct ingredient investigation in commercial plant-based protein powders is therefore a must and was investigated in this study with three different diagnostic tools.

Resource

  1. Faller, A.C., et. al. (August 20, 2019). “Investigating appropriate molecular and chemical methods for ingredient identity testing of plant-based protein powder dietary supplements”. Scientific Reports.

Learn more about food fraud and testing technologies at the Food Labs/Cannabis Labs Conference | June 2–4, 2020

Peter Jardine, Bayer
Bug Bytes

What’s the Most Important Tool for Proper IPM Inspection?

By Peter Jardine
No Comments
Peter Jardine, Bayer

As technologies become more and more advanced, the best pest technicians are often those willing to use the latest and greatest, most advanced tools on the market to provide superior service. However, if your technician is not carrying this one basic item in their toolkit, there is a good chance you’re not getting the quality of service you deserve. Any guesses at what that tool might be?

Register now for the complimentary webinar: New Technology’s Impact on Pest Management in the FSMA Regulated World | March 5, 2020 | 12 pm ETIf you guessed flashlight, you’re correct. Whether or not your technician carries a flashlight with them when they perform the inspection speaks volumes about the quality of service you are getting. A flashlight tells you two important things. First, that your technician is not just checking traps, but performing an investigation. He or she is looking for conditions that attract and foster pests. Second, a flashlight sends the message that your technician is willing to inspect dark or difficult-to-reach places. This is the type of technician willing to get on hands and knees to check under equipment. They will climb and crouch in order to reach the places pests are likely hiding. They value a pest-free environment more than their own convenience.

In short, the most important work your pest technician can provide is a thorough investigation to help prevent pest problems before they occur. If your pest technician is not performing an investigation each time they enter your facility, you’re not getting the value you need and should expect from your service provider.

Recall

Almark Foods Expands Hard Boiled Egg Recall As Listeria Outbreak Continues

By Food Safety Tech Staff
No Comments
Recall

Today FDA provided an update about its outbreak investigation of Listeria monocytogenes linked to hard-boiled eggs manufactured by Almark Foods’ facility in Gainesville, Georgia. On December 23, Almark expanded its recall to include all eggs manufactured at the Gainesville plant. In addition, the company is not producing products at this facility.

Thus far, four companies have recalled products containing the eggs from Almark Foods, as they have the potential to be contaminated with Listeria monocytogenes:

As of December 17, seven infections were reported, with four hospitalizations and one death across five states. The hard-boiled eggs were sold both in bulk pails to food processors, restaurants and retailers, as well as directly to consumers at the retail level, and have “Best If Used By Dates” through March 2, 2020.

FDA used whole genome sequencing to find a genetic match in the outbreak strain from samples collected at Almark’s facility during agency inspections in February and December of this year.

The agency investigation is ongoing.

FST Soapbox

A Digital Approach to Environmental Monitoring: Let’s Get Proactive!

No Comments

Technology and automation for safety and surveillance have already impacted nearly every industry in the world. For example, in the United States and many other developed regions, we have just lived through the transformation to electronic health records within the healthcare industry. Prior to that, we lived through the digital transformation of all of our banking information to an online banking platform—now the norm across the world.

However, the food and beverage industry is still learning how technology can improve their organizations. The food safety segment of this market is particularly in need of a digital transformation, as the risk associated with foodborne illness is potentially catastrophic to food companies, and moreso, to the end consumers who are impacted by preventable pathogenic outbreaks.

Along with regulation advancements, such as the timed roll-out of FSMA, the industry continues to work towards a more effective approach to food safety. But most regulations, and advancements in the industry are pointed toward a reactive stance to food safety issues, rather than a preventive stance. For example, although traceability is important in leading investigations to the source and taking remediation steps sooner, a more proactive approach to prevention should be considered when investing in food safety programs.

This is where the importance of an automated environmental monitoring program comes in. To be proactive requires a commitment to embracing data and digital technology. Knowing where to start to effectively pivot your digital approach can be a challenge.

Understanding the following thought process can help you to recognize areas of potential improvement and growth within your environmental monitoring program.

  • Define Your Business Objectives. Ask how profitability and production uptime is connected to food safety issues.
  • Verify Suppliers. Establish protocols for incoming product from external suppliers and validate their food safety performance and ability to maintain a clean facility.
  • Modernize Your Environmental Monitoring Program (EMP). Are you able to confirm that your EMP is being executed consistently? Across all facilities?
  • Understand Data Exhaust. See how your organization’s valuable data can be used to identify trends and accelerate root cause analysis that impact decision-making processes.

Define Your Business Objectives

Food companies large and small are being challenged to implement required processes and procedures to meet the demands of FSMA, and ultimately achieve a more proactive and preventative food safety stance. Transformation in this arena, led by government regulation, and enhanced by standards certification requirements, has highlighted the responsibility of suppliers and manufacturers to protect consumers.

Many organizations are not aware that a single failure in their food safety program could actually be the most devastating profitability risk that the organization faces today. When your organization is focused on production uptime and profitability, it can be easy to overlook the details involved in maintaining a strong food safety program. In reality, though, food safety and profitability are inextricably linked due to the risk of production interruptions that can be caused by safety issues.

Whenever a food recall occurs, it has the potential to start the dominoes falling, with major implications regarding costs, reputational damage, compliance penalties, supply chain interruption, and sales declines. Worse yet, these impacts can last for years after the actual event. By delaying both the importance of recognizing the seriousness of this risk as well as taking necessary steps to prevent it, your organization’s reputation could be on the line.

Unfortunately, planning is often sacrificed when managers fail to implement the proper technological solutions. Fulfilling fundamental documentation requirements involves a smart, automated approach. This is the best way to optimize recall prevention. By incorporating an automated EMP process, a supplier management system, and other FSMA Preventive Controls measures, suppliers ultimately improve the strength of the entire chain for their partners, consumers and themselves.

There are many other facets to food safety, but the EMP is where inspectors and auditors will look to see the indicators of contamination and the efficacy of your sanitation controls. Therefore, it is critical that your organization exhibit not only that you are on top of things and are following your EMP procedures consistently, but that you can analyze and pinpoint issues as they arise, and that you have a track record of corrective actions in response to those issues. This, in-turn, allows you to see where your business objectives are most at-risk.

Regardless of which specific food industry segment your company operates in, or which governing body it reports to, it’s essential to stay informed and compliant with changing regulations in order to reduce the risk of experiencing a recall. In a strategic operational role, intelligent environmental monitoring allows companies to not only proactively work to avoid public health issues, but is vital to retaining a consistent bottom line.

Verify Suppliers

Earlier this year, the FDA heralded what they call a “New Era of Smarter Food Safety”. As technology becomes increasingly accessible, more and more companies are investigating how technology can be used to harness and control the growing complexity of supply chain implications.

The challenge of making sure your organization is doing its due diligence to prevent recalls is further complicated when incorporating outside suppliers. For example, 15% of the United State’s overall food supply is imported from more than 200 other countries, according to the FDA. Making sure the product coming into a facility is also meeting your standards is vital to preventing pathogens from entering your supply chain either through containers, people, or the incoming product itself.

The complexity grows exponentially when we contemplate what this means for tracking food safety across a supply chain of this scope. Generally suppliers are asked to provide verification for the cleanliness of the product they are bringing into your facility. However, by going a step further and establishing test points for the product when it comes in, you will be better equipped to catch pathogens before they can enter into your own supply chain and potentially contaminate other products. While you may already have a good relationship with your suppliers, being able to independently verify the safety of their products and that their own processes are working, creates a mutually beneficial relationship.

Modernize Your Environmental Monitoring Program

Food experts at the World Health Organization headquarters in Geneva discussed the critical nature of ensuring food safety across geographic boundaries, as it is an issue that affects everyone. Incidents of pathogen outbreaks around the world have a direct impact on the health of global citizens, with one in 10 people falling ill due to food contamination.

A traditional EMP allows organizations to continuously verify that their sanitation programs are working by scheduling testing, monitoring results for any signs of pathogens, and maintaining compliance with regulatory bodies. Historically, this type of program is documented in spreadsheets and three-ring binders, but today the acceptance of new tools being offered by vendors and labs are expanding offerings to modernize the monitoring process.

Food safety professionals, many of whom are trained microbiologists, should have better tools at their disposal than spreadsheets that force them to manually sift through data. All regulatory bodies in the food industry have guidelines when it comes to where, what, and when you should be testing in your facilities. Ensuring that this is happening is a basic requirement for meeting regulatory mandates.

By choosing an automated EMP, FSQA teams are able to schedule testing plans including randomization and test point coverage rules, see what testing is being performed when, and obtain all testing data in one system for ease of access before or during an audit. This offers an “always-on” source of audit data and more importantly, trending and root-cause analysis capabilities to find and define actions to remediate recurring problems.

Further, an automated EMP that is integrated with your food safety plan allows you to set up workflows and automatically notify appropriate team members according to your organization’s policies. Each remediation step can be recorded and time stamped as the corrective action moves towards completion.

Understand Data Exhaust

A dominant theme pushed forward by FSMA is the need to document all aspects of your food safety plan, from the written outline to the records indicating proper implementation. Today’s manufacturers face a time of heightened regulation, and with stricter enforcement comes greater requirements for documentation. Automated EMPs not only provide your organization insight into what is happening within your facilities for documentation, it also gives time back to your FSQA team who, instead of spending their days with three ring binders, can analyze and investigate recurring issues in your facility to look for new, innovative ways for the organization to maintain a high standard of quality.

However, effective testing also means reading, understanding and responding to results. It is not enough to simply meet the required volume and frequency of environmental testing metrics. You need to use the resulting information to effect change and improvements by lowering the likeliness of pathogens, allergens and contaminants from entering the food supply chain. The more data collected, the more it leads to true understandings. What testing might show is just the symptoms of the problem—not the root cause of a far bigger problem. As more data is available, it becomes more valuable through the insights that can be gained through trend analysis. This, in turn, moves the conversation to higher levels within the organization who care about ensuring productivity and reducing avoidable risk.

Incorporating your lab into the equation is essential. Find a lab partner that offers an automated testing program that is integrated with their LIMS. Your organization will then be in a better position to ensure results are being responded to in an appropriate time frame.

There are many diagnostic tools in use today, both in-plant and at the lab. Each of these tools generates “data exhaust” in the form of a diagnostic result. But are your data streams being integrated and analyzed to find correlations and potential cause/effect relationships? Or does your ATP device simply record its data to a dedicated laptop or spreadsheet?

Testing, combined with an automated EMP, can allow you to combine data from various diagnostic systems (on-premise or from your lab partner) to identify trends and therefore a more holistic path to remediation. For this to occur, data must be accessible, aggregated and actionable, which an automated EMP achieves.

Forward-thinking companies and facility managers are leveraging valuable software solutions to improve processes, protect reputations, minimize inefficiencies, and simplify multifaceted compliance and audit tasks. Over the next three to five years, numerous organizations will reduce their risk of food recalls by combining their EMPs with analytics capabilities to reduce food risk and improve quality using diagnostic solutions and data assets. This change will be arduous, as all digital transformations in other industries have shown. But, in the end, they have shown the value and long-term success that the food industry now needs to experience.