Tag Archives: Focus Article

Jennifer van de Ligt, Food Protection and Defense Institute, University of Minnesota
FST Soapbox

Hot Topics in Intentional Adulteration, Food Fraud and Food Crime

By Jennifer van de Ligt, Ph.D.
No Comments
Jennifer van de Ligt, Food Protection and Defense Institute, University of Minnesota

The Food Protection and Defense Institute held its annual Food Defense Conference on May 3 and 4. This unique conference focused on food fraud detection, food crime, intentional adulteration FSMA updates, advocacy for food protection and defense, and big data and how to use it. The event garnered active discussion and collaboration among speakers and attendees representing six international government agencies, 11 domestic federal, state and local government agencies, 33 private food sector partners, and many academic partners.

The keynote address by Andy Morling, head of the UK National Food Crime Unit, led off the conference with discussion on food fraud and food crime. He profiled the tremendous work being taken to bridge the food regulatory and criminal systems to curb food crime in the UK. The UK response to food crime is guided by the 4P approach: Prevent, Protect, Prepare and Pursue. The Protect (reducing vulnerabilities) and Prepare (investing in capacity and capability building) components of the 4P approach embody key concepts of successful food defense plans.

Economically Motivated Adulteration and Food Fraud will be discussed at the Food Safety Supply Chain Conference | June 5–6, 2017 | Learn moreThe food crime discussion was followed by insight on food fraud detection in the European Union from Franz Ulberth, Ph.D., head of the Fraud Detection and Prevention Unit at the European Commission’s Joint Research Centre. This included results from Operation Opson in which Europol and INTERPOL coordinated with 61 countries. The goal of Operation Opson is to protect public health and safety through international cooperation to combat counterfeit and substandard food and drink. In Operation Opson VI, more than 9,800 tons, 26.4 million liters, and 13 million units/items of potentially hazardous food worth an estimated €230 million were seized between December 2016 and March 2017. The scope of products seized spans the range of all foods and beverages such as mineral water, alcohol, olive oil, seasonings, seafood and caviar, and includes both every day and luxury items. In addition, Dr. Ulberth outlined key characteristics of food fraud, the most common foods susceptible to fraud, and types of vulnerability and mitigation in the food fraud area.

Defense against food fraud through the use of genomics and ingredient supply chain understanding were presented by Robert Hanner of the Biodiversity Institute of Ontario at the University of Guelph and Cheryl Deem, executive director of the American Spice Trade Association, respectively. Genomics have been particularly helpful in identifying and quantifying the prevalence of seafood fraud. The most common seafood fraud is when one species of seafood is marketed and sold as a different species. The primary driver for this deception is to promote lower quality or illegal seafood species as a species of higher quality, premium location, or simply allowed in commerce. The genomics technique has been used successfully in the food fraud arena. It identified puffer fish, which produces a toxin, being deceptively marketed as monkfish. The accurate identification allowed public health officials to confirm that consumer illnesses accompanying this deception were caused by puffer fish toxin consumption. Similar to analytical techniques, supply chain understanding can help protect food manufacturers and consumers from food fraud. For example, major spice providers worked together to develop a guide to identification and prevention of adulteration because spices are often a target for adulteration. One aspect of the guide is a decision tree used to protect against supply chain vulnerabilities.

The conference also featured the authors of the FSMA Mitigation Strategies to Protect Against Intentional Adulteration Rule. They are part of the Food Defense and Emergency Coordination Staff at CFSAN. The author of the Intentional Adulteration rule discussed updated information on FDA efforts to develop both guidance for industry and training materials to support implementation of the regulation. In addition, they provided insight on the use of key activity types as an appropriate method for vulnerability assessments. For inspection and compliance, the authors indicated a two-step approach will be taken. The two-step approach will include a quick check at all registered facilities that is followed by a food defense inspection at a limited number of prioritized facilities. Inspection will occur in a tiered and staged approach after compliance dates pass. The FDA presentation at the Food Defense Conference was the launch of the new information campaign with additional detail and insight on guidance, training, inspection and vulnerability assessment approaches.

The knowledge and passion of the professionals gathered at the conference allowed appreciation of and connection between the incredible global efforts dedicated to improving defense and protection of the food system. The future of food defense to protect and create a resilient food system will be assured by continued efforts and expertise shared like those at this conference.

Hot dog recall

Recall: Metal May Have Contaminated 210,000 Pounds of Hot Dogs

By Food Safety Tech Staff
No Comments
Hot dog recall

Following three complaints of metal objects found in product packages, John Morrell and Co. has recalled about 210,606 pounds of ready-to-eat hot dog products. The following franks subject to the Class II recall were distributed to retail locations nationwide and produced on January 26, 2017: 14-oz sealed film packages containing Nathans Skinless 8 Beef Franks (use by date of August 19, 2017) and 16-oz sealed film packages of Curtis Beef Master Beef Franks (use by date June 15, 2017).

Thus far there have been no reports of adverse reactions or injury as a result of consuming these products.

FSMA, Food Safety Tech, FDA

FDA Releases New Guidance on Foreign Supplier Verification Program

By Food Safety Tech Staff
No Comments
FSMA, Food Safety Tech, FDA

With the first FSVP compliance rule just two weeks away, FDA has published a new guidance to help importers that are subject to the rule. “Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation” specifically provides information on the following:

  • How an organization identifies itself as an importer of food at entry into the United States
  • Requirement to provide a unique facility identifier that is acceptable by FDA
  • Information on what to do if the importer cannot obtain a Dun & Bradstreet Data Universal Numbering System number in time for the compliance date

FDA also identified the importers that fall under the May 30, 2017 compliance date. The foreign supplier would fall into one of the following categories:

  • The supplier will not be covered by the FSMA PC or Produce Safety rules
  • The supplier is subject to the Preventive Controls for Human Food rule and is not a small business, qualified facility or subject to the Pasteurized Milk Ordinance
  • The supplier is subject to CGMP requirements in the FSMA Preventive Controls for Animal Food rule and is not a small business or qualified facility

For importers that are unsure as to whether they are required to comply with the FSVP rule, the agency released a one-page chart, “Am I Subject to FSVP?”, along with a fact sheet about the final rule and the requirements under it, compliance dates and additional information.

Judy Black, Rentokil
FST Soapbox

What Is the Internet of Things and How Does It Impact Food Safety?

By Judy Black
No Comments
Judy Black, Rentokil

The Internet of Things (IoT) is a category of objects or devices—things—equipped with electronics and online capabilities that let them communicate data to computers and other networked devices. In the home, this may take the form of smart locks that can be controlled via the homeowner’s work computer or a Wi-Fi-enabled thermostat, allowing the user to monitor and control the temperature of their home from a smartphone app. While the in-home applications of IoT may get more consumer attention, many of its most interesting applications are happening in the business and industrial world.

You may have seen TV ads from General Electric or IBM promoting their work on networks of connected trains, semi-trucks and warehouses that communicate precise tracking of cargo and packages in shipping. As more industries begin to see how big data and instant communication can improve their efficiency, IoT is quickly catching on in many fields, including the food business. Indeed, those involved in shipping raw materials or finished food products are likely familiar with the IoT’s impact on the supply chain. The rest of the food industry isn’t far behind, as more than 57% of respondents to a recent survey of food professionals conducted by Quocirca indicated IoT has already impacted their organization.

Judy Black will be hosting a webinar on the applications of IoT in the food supply chain on Wednesday, May 24 at 1 pm ET/10 am PT. Register now

From farm to fork, connected devices are collecting data and sharing it through centralized networks that help the industry better manage supplies and finished food products. Sensors in the ground can measure moisture levels and regulate irrigation systems to ensure no crops receive too much or too little water and keep farmers informed on soil conditions in real time. At the warehouse level, incoming and outgoing food products can be tagged and scanned to automatically track data like the farm of origin or any other information required by law. In any phase of the supply chain, IoT may take the form of smart pest control devices specifying when they need service or when something has been captured in a trap.

We’re still in the early stages of IoT’s deployment throughout the food industry, but its benefits are already showing up in better food safety practices and a more efficient supply chain, both of which help to cut down on waste and reduce risk. This network of connected devices and centralized hubs for data analysis will only grow in importance as the technology develops and drives innovation in how we can use this data to improve every aspect of the business.

Scott Gottlieb, FDA

Scott Gottlieb Confirmed to Lead FDA

By Food Safety Tech Staff
No Comments
Scott Gottlieb, FDA

Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner. The vote was 57 to 42.

Gottlieb has extensive experience in healthcare and has been outspoke about the long approval process, along with the Medicare coverage process. However, he has not been vocal about food safety issues, so his impact on the food industry remains to be seen.

He previously served as deputy commissioner for medical and scientific affairs during the George W. Bush administration and was most recently a fellow at the American Enterprise Institute, a venture fund that invests in life sciences, medical technology and healthcare services.

Randy Fields, Repositrak
FST Soapbox

Food Safety Technology Disrupters

By Randy Fields
No Comments
Randy Fields, Repositrak

We’ve all heard about the latest disrupters in the retail supply chain, like the Internet of Things, wearable computers, cognitive analytics, machine learning and even the new value chain in which these technologies intercede to provide a better and more accurate shopping experience for consumers. There are also developments like digital fabrication that interacts with both the consumer and appliances to improve the way product gets to the consumer from the point of production.

Technology disrupters can fundamentally change supply chains, destroying existing ones and creating new ones. Other disruptions can be caused by not a single technology but by several new and existing technologies that come together in innovative ways. Smart retailers and their trading partners are working to judge the impact of these technology disrupters before or at least as they occur. They need to be more proactive by investing in key areas of strategy, culture and partnership.

A company’s supply chain can be the weakest link in its food safety program. Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 2017

Many of the technology disrupters in food safety are based on the growing ability to apply analytics, including machine learning, to drive a better understanding of and increase the personalized relationships with the consumer, and to glean insight from all the data being collected. Knowing exactly what information shoppers require to feel safe with the products they are buying from you can only help build and maintain a great reputation. Further, analytics help companies predict and address the weakest links on the production floor and in their own extended supply chain to keep those customers free from potentially deadly pathogens.

Cloud computing for the delivery of IT and business processes as digital services is transforming the food safety world through the unprecedented speed and agility it enables for mobile and social engagement. Telling your customers that a recalled product could cause an illness used to require lots of phone calls or even snail mail, but now technologies in the cloud facilitate almost instantaneous messaging of the warning to whole or subsets of a population. This is just one of the ways that everyone from shoppers to business people are changing the way they interact with each other and the way we all do business due to the cloud.

Security in general and cybersecurity specifically are disrupters for companies concerned with food safety, because they can fall prey to sophisticated hackers and other crooks that try to ransom a business’ reputation in the digital world. Think how important it is to protect your own information as well as that of your consumers and customers for payment details and personal data. Now add health data to the mix and you’ll recognize the critical nature of the issue.

All of these technology disrupters have the potential to seriously impair your food safety plans and procedures, but they can also help you better deploy resources to address individual food safety emergencies and ongoing issues. Knowing the impact of the disruption is the first step in addressing it; then you need to develop a plan that helps you take advantage of the positive sides of the disruption and eliminate the negative ones.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

How Do We Incentivize Behavior Change?

By Deirdre Schlunegger
No Comments
Deirdre Schlunegger, CEO of STOP Foodborne Illness

In March, I presented and participated in a session regarding produce safety at The Global Food Safety Conference in Houston. In April, I was the keynote speaker at the BRC conference in Orlando, Florida. I asked: What incentivizes the human spirit and how do we draw on people’s creativity and their ability to have empathy and to solve problems?  Which interventions are more or less likely to stimulate one’s ability to care about food safety as it relates to human beings? Knowledge alone seldom changes behavior. The imagination benefits from stimulation—for example, listening to personal stories. For change to happen, there must be an emotional connection to the idea of achievable outcomes.

This past year we spoke at a large food company. During a pre-call to discuss what the presentation might look like, one man said that nearly 20 years ago, he heard Nancy Donley speak about her son Alex, who died at the age of six from a foodborne illness. He said since that time, he has never looked at food safety the same way, and he takes every single infraction dealing with food safety as a possible consequence for someone’s life. A rational understanding of what a better outcome might look like will often involve a deeper understanding and a connection with an issue and with the individuals related to that issue. Change is difficult. We often don’t learn until we risk collapse or fail. In a moment of crisis, we are presented with a unique opportunity for change. This idea could stand to be finely calibrated, as there are moments that are too painful to activate learning as one struggles with a deep sense of hopelessness, and there are moments when change lies outside the realm of possibilities. An analytic perspective without access to emotional content is unlikely to provide the conditions for change, but a link between the head and the heart may initiate transformation.

I met Will Daniels, formerly of Earthbound Farms after an emotional presentation he made at a conference. He spoke about a young boy who died from the spinach outbreak and he referred to his children of nearly the same age. He also presented the sequence of events that led to and followed the outbreak in a very factual and logical way. This link between his head and his heart delivered a presentation that was impactful, emotional, factual and sincere. A cold analysis of a problem is seldom sufficient, nor is the condition of people when they are stuck in an overwhelming emotional state. The challenge is to find middle ground and put together thinking and feeling in a context where a coherent narrative will be created. For individuals to change their behavior, we must influence not only their environment, but their hearts and their minds. What we do know about change and people’s readiness to change is that it has much to do with timing and ripeness. The crucial question is whether issues are close enough to the surface to break into the public discourse or to have an impact on a system. As a protective mechanism, people resist the pain of engagement and hold onto old assumptions, often adopting a deluded narrative. People may find that blaming others, scapegoating, externalizing the other party, denying the problem, jumping to conclusions, or launching a distracting issue might restore stability and feel less stressful than facing and taking responsibility for a complex challenge.

We often see change in companies and their policies after they have experienced an outbreak, not before. Over the years we have seen this with several companies whose confidence was high prior to an outbreak, as they had never had a problem before and felt as if they were immune. The challenge is to allow for conditions in that there is sufficient pressure to change but there is also a safety net in place. There is a real tension between the pressure to change and the conditions that allow for necessary creativity, flexibility and imagination to get us through a crisis.   Businesses that are transparent in their admittance to a problem often are better able to create change in a safe environment. In other words, “yes, we have a problem and what are we going to do to change course?” Crisis isn’t necessary but in reality, catastrophic events often precede modifications in policy and practice. Creating a head/heart connection during planning and training may deliver a sense of urgency to help individuals remember “the why” behind food safety.

Until we prepare for a future with a sense of urgency and commitment and fully integrate “the why behind food safety”, we will merely repeat errors of the past. It takes courage and true leadership to carry out a vision, a future that doesn’t deny or divorce itself from the past but uses it in such a way that opens the door to progress. We have improved our narratives and are better at risk analysis and detection, and I believe we will continue to improve.

GFSI

GFSI Releases Version 7.1 to Incorporate More Harmonization

By Food Safety Tech Staff
No Comments
GFSI

GFSI has just released a new benchmarking requirements version that was developed for food safety certification schemes. Following stakeholder input, Version 7.1 intends to reflect changes happening in the market. The new version includes the addition of clauses for each scope under Food Safety Management requirements, including purchasing from non-approved suppliers and compliance with food safety legislation.

The previous version, Version 7, was released in February and introduced requirements to combat food fraud, incorporate unannounced audits, and increase transparency in the benchmarking process. It also included a new scope of supply chain food brokers and agents.

Department of Justice seal

Seeking Deterrent Effect, DOJ Targets Cases that Have Big Influence

By Maria Fontanazza
No Comments
Department of Justice seal

As the Department of Justice (DOJ) continues to prioritize prosecution against food companies that have been involved in recalls and foodborne illnesses, many often wonder how exactly the department decides which companies it will pursue and why. The most notorious recent example is the case against the Peanut Corporation of America (PCA) in which the sentencing of the company’s executives was said to have set a precedent for the industry. One of the reasons the DOJ went after PCA was due to its widespread distribution of food and the fact that the illnesses and deaths were all over the country, according to Michael Blume, director of the consumer protection branch of the DOJ.

“Did any of you hear about [PCA] before the outbreak?” Blume asked the audience at the GMA Science Forum last week. “Consumers have very little ability to protect themselves from foodborne illness. PCA was in all kinds of brands—crackers, Kelloggs, [etc]. For those reasons, we were much more concerned about preventing these kinds of outbreaks and what could the DOJ do about it.”

When assessing contenders for criminal prosecution, there are several common factors that encourages the DOJ to dig deeper:

  • The amount of harm. Has the sale of contaminated food has led to a great deal of illnesses or deaths?
  • Has the company had problems in the past? If it is a first time occurrence, the DOJ is less likely to pursue a case, but if there is a history, “we’re going to look harder,” said Blume. For example, if a government agency or another party has identified a problem, and then the FDA also sees the problem and issues a 483. Then five years later, the company still has not fixed the problem.
  • Similarly, if the DOJ sees that the company has identified internal problems and has chosen not to fix them, and as a consequence, these actions lead to the sale of contaminated food.
  • Where does the company sit in the market? “We can’t [pursue] every case, we have to think about what case will be most impactful,” said Blume. “What case will signal to the rest of industry that there are things they need to think about? If it is a company that people think have a good reputation, etc—to give a signal to industry—there are things that even the very best in industry can run afoul.”
  • If there’s evidence that the company has misled any party. This doesn’t apply to a government body only—it could also be the company’s vendors.
  • The general culture. Although this concept is intangible, the DOJ considers a company’s reputation in the industry and the relationship it has with regulators. Are they trying to fix issues and maintain compliance? That will make a difference and will be weighed in the company’s favor versus companies that choose to ignore problems.

“The DOJ thinks very hard about charging individuals. If there’s a criminal investigation targeting a company, you have to be concerned about who acted within the company and what their role was.” ­– Michael Blume, DOJ

Of course, food companies would like to avoid the heavy hand of the DOJ and for that, Doug Fellman, partner at Hogan Lovells US, LLP, offered several points of advice:

  • Be on guard for red flags that suggest a compliance-related environment in which the company is at risk for having problems. If employees are raising concerns at the facility or about the manufacturing process, don’t let people write those individuals off.
  • Be careful about how any decisions will look in hindsight. Stop on a real-time basis and look at how it will appear in retrospect.
  • If in a recall situation, decisions must be made quickly. Be careful that any decision making won’t to come back and bite the company when someone looks at it with the benefit of time.
  • Always be truthful and candid with the regulators.
  • Ask yourself whether you really know the conditions at the facility. Do people have visibility to what’s happening there?
  • Beware of emails. “Emails form the basis of almost every case I have,” cautioned Fellman.

Should the DOJ show up at your facility, it’s important to be polite and act professional towards agents. Although this may seem obvious, whether or not the agents immediately encounter pushback makes a difference, advised Blume. That said, it’s important to have protocols in place in the event that the DOJ shows up either at a company facility or even at an employee’s doorstep. “We get great evidence from a knock at someone’s door who doesn’t know what to say or when we do an inspection and people don’t know what to do,” said Blume. It’s prudent to discuss in advance when to seek the advice of a lawyer, because the more prepared a company is in handling such an issue, the less likely it is to make incriminating statements.

DNA sequencing

Whole Sample Next-Generation DNA Sequencing Method: An Alternative to DNA Barcoding

By Casey Schlenker, Jenna Brooks, Kent Oostra, Ryan McLaughlin
No Comments
DNA sequencing

This article discusses a non-targeted method for whole sample next generation DNA sequencing (NGS) that does not rely on DNA barcoding. DNA barcoding requires amplification of a specific gene region, which introduces bias. Our non-targeted method removes this bias by eliminating the amplification step. The applications of this method are broad and we have begun optimizing workflows for numerous materials, both processed and unprocessed. Some of the materials we have been able to successfully identify at the species level are fish tissue, fish meal, unrefined fish oil, unrefined plant-based oils (nuts, seeds, and fruits), specific components of cooked and processed products such as cookies and powders, and processed meats. Non-targeted NGS is also a very powerful tool to comprehensively identify constituents of microbial communities in probiotics and fermented products like kombucha. Additionally, this non-targeted technique is applicable to detection and identification of microbial contamination at various levels of manufacturing including equipment surfaces, processing water and assaying intermediate processing steps. In this communication we briefly review a current issue in the botanicals industry, discuss the methods that have been used in the past to tackle that problem, and present preliminary results from a pilot study we performed to determine the utility of non-targeted NGS in high-throughput identification of botanical raw materials.

The value of the global herbal dietary supplement (botanical) market was estimated to be greater than $90 billion in 2016, with a projected compound annual growth rate of 5-6%. Currently, regulators and manufacturers in this rapidly expanding market seek to confirm the veracity of label claims, investigate fraud, identify adulterants and ensure product quality.1 These products are often dried and ground, making visual identification difficult, time consuming and sometimes impossible.2 It is critical to this market that botanical identification be high-throughput, accurate and cost effective. Historically, various chromatography techniques have been used to meet this need, but those techniques rely on identification of molecules that can vary significantly due to storage conditions, which has led to the use of DNA barcoding as an analytical technique. However, DNA barcoding is not without significant challenges.1

For quite some time, scientists have had the ability to identify biological samples by sequencing their DNA.3 Currently DNA sequencing-based identification methods rely heavily on a technique called DNA barcoding, which functions analogously to the barcodes found on products in a grocery store. DNA barcoding amplifies a distinct small gene region that serves as a unique identifier and “scans” it by DNA sequencing.4 The advantages of this amplification are high sensitivity and simplification of data analysis. However, this amplification is not completely reliable and in practice can create biases and false positives.5 There is also the possibility that the amplification may fail, causing false negatives.6 When using DNA barcoding to identify botanical raw materials, numerous labs have observed notably high levels of apparent contamination.7 While it is certainly likely that some or even many botanical raw material samples contain contamination, it is also possible that the amplification-based method of DNA barcoding is itself contributing to the levels of contamination that are being observed.

We have partnered with Practical Informatics and Pacific Northwest Genomics to develop comprehensive whole sample DNA screening methods that don’t rely on amplification. To achieve this we are utilizing a non-targeted metagenomics workflow. Non-targeted metagenomic analysis is a powerful tool for examining the entire genetic content of a sample, instead of just one particular gene region (if a gene is a word or phrase, then a genome is the entire book, and the metagenome is the library). Unlike DNA barcoding, which requires PCR amplification, non-targeted metagenomic analysis requires no prior knowledge of a sample’s source and does not introduce the biases that plague PCR initiated methods. All of the DNA extracted from a sample is analyzed without targeting any particular gene region, relying instead on complex data analysis to identify the constituents (Figure 1). This is accomplished with the use of advanced molecular biology techniques and sophisticated computational methods, combined with a highly-curated database of species-identifying DNA sequences. Our research and development team has completed several experiments demonstrating the utility of a non-targeted DNA sequencing method.

DNA sequencing
Figure 1. The traditional targeted method, or DNA barcoding uses a PCR amplification step prior to sequencing. Non-target whole sample sequencing skips the amplification step and all present DNA is sequenced and used in analysis.

Our research endeavors to solve the issues of DNA sequence analysis that originate with the PCR step by simply eliminating amplification from our process entirely. PCR amplification as a prelude to DNA sequencing traces to traditional technologies that were lower throughput and required large amounts of material. Current generation high-throughput DNA sequencing technologies do not require large amounts of starting material, and therefore amplification can be avoided. Many DNA barcoding methods require universal primers, which, during PCR, can amplify some products but not others, leading to false negatives. A solution to that issue is to use specific primers, however this is also inherently problematic as a certain foreknowledge of the sample identity is required. What is the advantage to our non-targeted sequencing method? There is no need to direct the analysis to any particular identification before sequencing, decreasing the introduction of bias and false negatives. As an added bonus, we don’t need to know what the sample is prior to analysis—we can tell you what it is rather than you telling us.

Continue to page 2 below.