Tag Archives: Focus Article

USP Food Fraud Database

Why Include Food Fraud Records in Your Hazard Analysis?

By Karen Everstine, Ph.D.
2 Comments
USP Food Fraud Database

Food fraud is a recognized threat to the quality of food ingredients and finished food products. There are also instances where food fraud presents a safety risk to consumers, such as when perpetrators add hazardous substances to foods (e.g., melamine in milk, industrial dyes in spices, known allergens, etc.).

FSMA’s Preventive Controls Rules require food manufacturers to identify and evaluate all “known or reasonably foreseeable hazards” related to foods produced at their facilities to determine if any hazards require a preventive control. The rules apply both to adulterants that are unintentionally occurring and those that may be intentionally added for economically motivated or fraudulent purposes. The FDA HARPC Draft Guidance for Industry includes, in Appendix 1, tables of “Potential Hazards for Foods and Processes.” As noted during the recent GMA Science Forum, FDA investigators conducting Preventive Controls inspections are using Appendix 1 “extensively.”

The tables in Appendix 1 include 17 food categories and are presented in three series:

  • Information that you should consider for potential food-related biological hazards
  • Information that you should consider for potential food-related chemical hazards
  • Information that you should consider for potential process-related hazards

According to the FDA draft guidance, chemical hazards can include undeclared allergens, drug residues, heavy metals, industrial chemicals, mycotoxins/natural toxins, pesticides, unapproved colors and additives, and radiological hazards.

USP develops tools and resources that help ensure the quality and authenticity of food ingredients and, by extension, manufactured food products. More importantly, however, these same resources can help ensure the safety of food products by reducing the risk of fraudulent adulteration with hazardous substances.

Incidents for dairy ingredients, food fraud
Geographic Distribution of Incidents for Dairy Ingredients. Graphic courtesy of USP.

Data from food fraud records from sources such as USP’s Food Fraud Database (USP FFD) contain important information related to potential chemical hazards and should be incorporated into manufacturers’ hazard analyses. USP FFD currently has data directly related to the identification of six of the chemical hazards identified by FDA: Undeclared allergens, drug residues, heavy metals, industrial chemicals, pesticides, and unapproved colors and additives. The following are some examples of information found in food fraud records for these chemical hazards.

Undeclared allergens: In addition to the widely publicized incident of peanuts in cumin, peanut products can be fraudulently added to a variety of food ingredients, including ground hazelnuts, olive oils, ground almonds, and milk powder. There have also been reports of the presence of cow’s milk protein in coconut-based beverages.

Drug residues: Seafood and honey have repeatedly been fraudulently adulterated with antibiotics that are not permitted for use in foods. Recently, beef pet food adulterated with pentobarbital was recalled in the United States.

Heavy metals: Lead, often in the form of lead chromate or lead oxide which add color to spices, is a persistent problem in the industry, particularly with turmeric.

Industrial Chemicals: Industrial dyes have been associated with a variety of food products, including palm oil, chili powder, curry sauce, and soft drinks. Melamine was added to both milk and wheat gluten to fraudulently increase the apparent protein content and industrial grade soybean oil sold as food-grade oil caused the deaths of thousands of turkeys.

Pesticides: Fraud in organic labeling has been in the news recently. Also concerning is the detection of illegal pesticides in foods such as oregano due to fraudulent substitution with myrtle or olive leaves.

Unapproved colors/additives: Examples include undeclared sulfites in unrefined cane sugar and ginger, food dyes in wine, and tartrazine (Yellow No. 5) in tea powder.

Adulteration, chili powder, skim milk powder, olive oil
Time Series Plot of Records for Chili Powder (blue), Skim Milk Powder (green), and Olive Oil (orange)

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Sabrett hot dog recall

More than 7 Million Pounds of Hot Dogs Recalled Nationwide

By Food Safety Tech Staff
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Sabrett hot dog recall

On Saturday the USDA announced a Class I nationwide recall of 7,196,084 pounds of hot dog products from Marathon Enterprises, Inc. Produced between March 17, 2017 and July 4, 2017, the certain beef and pork hot dog and sausage items may contain bone fragments.

The issue was uncovered via the FSIS Complaint Monitoring System on July 10, which stated that pieces of bone were found in the product. No injuries have been reported yet.

USDA Recall Classification of Class I Recall: “This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.”

FSIS has posted a full list of the recalled items on its website.

Keep It Simple: New Software Tool Cuts through Data Clutter

By Maria Fontanazza
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As companies are hit with a massive amount of information as a result of new technology, proper management of data intelligence can be difficult. The key is to be able to translate the data into useable information to drive improvements in processes, products and business operations. A new tool aims to do just that—help companies boost operational margins using real-time data intelligence, from supplier performance to trends to safety and quality processes, across an organization.

Launched earlier this week, SafetyChain Analytics can also help companies spot problems before they balloon into larger issues that affect product quality. Barry Maxon, CEO of SafetyChain, explains why the company developed the tool and how it can help food companies save money by being more efficient.

Food Safety Tech: What was the impetus behind developing this tool?

Barry Maxon, SafetyChain
Barry Maxon, CEO of SafetyChain

Barry Maxon: The food and beverage industry historically is a business that has tight operating margins. At the same time, companies spend a tremendous amount of money every year collecting compliance data. If you walk through any food and beverage facility, you’ll see people writing down data on paper and putting it in filing cabinets or a spreadsheet. There’s already a tremendous amount of data being collected. We wanted to help companies go beyond collecting compliance data to satisfy their records for their auditors; we wanted to harness that data so they can begin to use it to drive operational excellence. That’s what’s going to make the difference in moving the needle on a company’s bottom line and their operating margins—the ability to leverage all the data they’re collecting to gain insights into how their business is operating and use it to improve their processes, products and operations.

FST: How does it address challenges that food businesses experience? How does it streamline their workflow?

Maxon: Companies are being squeezed from all directions—they need to do more with less, perform at the speed of business today, and remain up to date with all the different compliance standards—be it regulatory, industry standards from GFSI, and even down to customer specific compliance level. There’s a tremendous amount of demand being put on food companies. Yet at the same time, all of these demands typically require greater cost, and they’re being challenged to do more with less and achieve greater economy with their businesses to actually improve their bottom line. It’s a double whammy—improve your bottom while also having greater demand placed on your business—competitively, and from a regulatory and compliance perspective.

There are a lot of processes that have been fundamentally manual in the past, on paper and spreadsheets and in filing cabinets. We’ve talked to companies that say they have people spending hours a day just billing out paperwork and putting numbers into spreadsheets. And we have multi-billion-dollar industries still running on spreadsheets. As nice as a spreadsheet is, it’s a 40-year old software technology that came out in 70s. We’re trying to use new and innovative tools so companies can perform in this new era of technology and use it to benefit their business in multiple ways.

Food Safety Tech: Who are the main product users?

Maxon: Your user base is anyone in the organization who touches safety, quality or compliance from an operational standpoint.

Often the front-end users are collecting and reviewing the sets of data. One of the key elements of the tool is to deliver the right data to the right user in real time. In the past, one of biggest challenges for food companies is that they may run for many hours before realizing they are out of compliance. The idea is to give front-line users have an immediate access to data that prompts them when they’re trending into a direction where they need to take preventive action.

At the same time, managers and executives have access to the tool so they can mine the data, run the reports, and see process control charts.

Screenshot of SafetyChain Analytics tool. “One of the key elements of the tool is to deliver the right data to the right user in real time.” – Barry Maxon

FST: Are there different security controls for this software?

Maxon: Absolutely. You can organize it so users only see what matters to them. That’s really the key to keeping it simple. Data can very quickly become overwhelming. We’re trying to deliver prebuilt dashboards and reports, and organize the data to make it intuitive. We’re also trying to leverage data on an exception-based management principle. It used to be, in more manual paper-based processes, that a supervisor had to review every single record and sign off on it. Here, with automation in software, everything that passes compliance goes through the system; you don’t need to look at it—it will immediately highlight where you have exceptions in your process so you can quickly take corrective action and make sure everything is resolved before it gets further downstream.

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Food Safety Consortium 2017

Update: 2017 Food Safety Consortium Date Change

By Food Safety Tech Staff
2 Comments
Food Safety Consortium 2017
FBI, food safety, terrorism
Watch Food Safety Tech’s exclusive video interview with FBI Special Agent Scott Mahloch at last year’s Food Safety Consortium

This year’s annual Food Safety Consortium will take place November 29 at 1 pm until December 1, concluding at noon. The main conference kicks off on Wednesday, November 29 at 1 pm with a plenary presentation by Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by a town hall meeting where he will answer audience questions. General sessions for the afternoon include a presentation on food defense given by Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI.

During the final session of the day, industry experts will gather for an engaging reflection on Food Safety: Past, Present and Future. Stay tuned for more details on this special event.

On Thursday, attendees will be treated to an interactive court case:

  • Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham, represented by Shawn Stevens vs. Food Safety victims, represented by Bill Marler. Stevens and Marler will be present their case to the honorable Judge Steve Sklare

In addition to the general event, there will be pre- and post-conference workshops. Pre-conference workshops take place on Tuesday, November 28, beginning at 9 am and run for the first half of the morning on Wednesday, November 29. Post-conference workshops take place during the afternoon of Friday, December 1, following the conclusion of the main event.

For more information, visit the Food Safety Consortium website: http://www.foodsafetyconsortium.org/ .

The super early bird discount ends September 8, 2017!

Big data

Embracing Big Data as an Asset to Your Company

By Maria Fontanazza
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Big data

Big data has become a fairly common term used across industries. It refers to large, complex volumes of data that are generated from multiple sources. The challenge may not be so much in gathering the data but more so in what to do with the information. Although it can be a bear to manage, if able to harness data correctly, food companies could have a leg up on their competition.

“The food industry is behind. As an example, the aerospace industry has the ability to monitor engines on a transatlantic flight to ensure they are operating at the optimal conditions. This data is being used by engineers within different organizations to make improvements,” says Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL. “Just having the ability to collect information in real time will shift the industry from reactive to proactive. This will require the industry to fit the pieces together to collect information. As an example, you could reject a product at the supplier site, even before it leaves the supplier—you would have all that information at the tips of your fingers.” In a Q&A with Food Safety Tech, Wybourn discusses how the food industry can benefit from the proper use of big data.

Food Safety Tech: What does the term “big data” mean to the food industry?

Kathy Wybourn, DNV-GL
Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL

Kathy Wybourn: Large volumes of data that is collected from both internal and external sources, used to make smarter business decisions. The supply chain in the food industry is very complex—receiving supplies from all over the globe. [Big data can identify] trends in different regions of the world and assist food companies make better risk decisions about their supply chain. Big data will ultimately improve the safety and quality of products for consumers. Improved supply chain management [and] traceability of products will also lower the risk of food fraud.

We’ve moved from an analog to digital age. The internet has provided the connectivity to link data from raw materials to end users. Using social media data, GPS, photos, videos and data sensors can provide real-time data about raw materials through manufacturing, distribution and retail, which will allow an organization to have better insights into information and decision making along the entire supply chain.

DNV GL recently conducted a survey called “ViewPoint” about the application of Big data. The survey found that 50% of the respondents already have been doing something with Big Data in different ways. Interesting enough, Big Data has different meanings and importance to the respondents, but what is common, is the fact that data will be used differently in the future than what is currently in their tool box. Big Data will allow better insight and enable companies to make fact-based decisions and better manage both performance and risks. The respondents may have different definitions for Big Data, but they all agree that data will be used differently than today for making both internal and external business decisions.

“A higher number of food and beverage companies indicate that big data will have a high or fairly high impact on their business in the next 2¬–3 years. The companies in this industry indicate fewer barriers, even today, in taking advantage of big data concepts. Already, 21% say that their management team is preparing for the new reality and seemingly more food and beverage companies plan to invest in big data.” – DNV-GL Viewpoint Report

FST: How can the industry use big data to make food safer and more sustainable?

Wybourn: Big data will allow the food industry to become even more transparent, which will help improve food safety. Big data will improve supply chain management and allow organizations to make more informed decisions regarding processes, both internally and externally. Food manufacturers can improve efficiency and quality of their own manufacturing processes: Increasing output and solving operational problems faster, which will both have a positive effect on an organization’s bottom line.

Non-conformity data is powerful and can be collected through advanced analytics throughout the supply chain. This data can be further sorted by regions of the world, which will improve knowledge and insight about suppliers. Big data brings further insight beyond what is gained from one audit, which will allow organizations to be confident about making better risk decisions.

Additionally, big data can be used to assess your organization’s performance by benchmarking against other companies’ performance in the areas of nonconformities to food safety standards in their own or different regions.

FST: Can you give some examples of where food companies are or should be leveraging big data to help them in the compliance phase of FSMA?

Wybourn: Both large as well as small companies are struggling with FSMA preventive controls. FSMA mandates that a manufacturing facility have a risk-based supply chain program for raw materials and ingredients for hazards that require a supply chain applied control. Manufacturing sites may rely on a supplier or customer to control a hazard. An organization’s ability to manage big data to improve the organization’s tools to capture, store and analyze this data can greatly improve the monitoring of hazards and lower risk to the supply chain.

FST: Do you have examples of how some companies are leveraging technology to make the best use of their data?

Wybourn: DNV GL has new digital platforms, which can be used to benchmark your own organization to the performance of others.

eAdvantage is a customer portal that provides customers with a complete overview of their former and future audit activities. Through the portal they can see upcoming activities, work with findings and close non-conformities, communicate with an auditor, share audit information, access certificates and monitor their overall progress.

Lumina is a set of tools that provides better insight into a company’s management system. It analyses information hidden in the company’s audit data and allows to benchmark that company against thousands of others worldwide based on more than 1.6 million audit findings. It allows an organization to obtain an overview of their own sites performance, spot warning signs at an early stage and see how they compare to similar companies in the industry, giving confidence to make the right decisions.

Veracity is an open industry data platform, ideal for integrating data in a secure way. The Veracity eco-system handles asset data, manages data quality and applies advanced analytics, connecting industry players for frictionless data aggregation, sharing and benchmarking. In the aquaculture industry, this will lay the foundation for predictive analyses, decision support, indication warning, and simulation capabilities unlocking substantial growth potential in the global aquaculture industry. All the while, we make sure fish farmers and other data providers retain ownership and control of their data.

I believe we are only at the tip of an iceberg of where big data can take the food & beverage Industry.

FST: Is it possible to get too much data? Are food companies going to be bombarded with too much info that they don’t know how to use?

Wybourn: The answer is simple, yes. We live in a world of data abundance and information overload each day. Data sets are growing rapidly, and the ability to store and analyze data is daunting. The tools we have today will become obsolete tomorrow. One only can sort through data with the tools he/she has today to understand even the simplest of processes.

Honey, adulteration

The Honey Trap: Analytical Technology Makes Food Fraud Easier to Catch

By Christopher Brodie
1 Comment
Honey, adulteration

Because of its high nutritional value and distinctive flavor, natural honey is a premium product with a price tag significantly higher than that of other sweeteners. As a result, honey is often the target of adulteration using low-cost invert sugar syrups. This article looks at two analytical approaches based on isotope fingerprint analysis using isotope ratio mass spectrometry (IRMS) that can be used to detect honey adulteration and safeguard product integrity.

Honey is a complex mixture of sugars, proteins and other compounds, produced in nature by honeybees from flower nectar or honeydew. The extent to which its sugars are present is heavily dependent on the floral source and differs significantly between honeys produced in different regions. Climate, processing and storage conditions can also have an effect on the amounts of these sugars.1

Fructose and glucose are the major components of honey, and account for 85–95% of the total sugars present. The remaining carbohydrates are a mixture of disaccharides, trisaccharides, and larger oligosaccharides, which give individual honeys their own characteristic taste.

These distinctive flavors, combined with honey’s renowned nutritional benefits and a growing consumer demand for natural, healthy ingredients, have contributed to a substantial increase in honey sales over the past few decades. However, this demand has also helped to raise costs, with some varieties, such as Manuka honey, reportedly selling for as much as $35 for a 250 gm jar.

Just like many other food products that have a premium price tag, intentional adulteration is a significant concern for the honey industry. The fraudulent addition of cheaper sweeteners, such as sugar derived from cane, corn and beet sources, to extend product sales, is unfortunately common within the marketplace.

Honey producers and suppliers therefore require reliable and accurate analytical techniques to profile the composition of honey to identify cases of adulteration. Using analytical data, honey adulteration and counterfeiting can be routinely identified and product integrity can be maintained.

Carbon Isotope Fingerprints of Honey

Analysis of honey is commonly undertaken using isotope ratio mass spectrometry (IRMS) for the detection of adulteration. Honey has a fingerprint, a unique chemical signature that allows it to be identified. To visualize this fingerprint, IRMS can be used to identify the botanical origin of its constituent sugars.

Two ways that carbon can be incorporated into plants by photosynthetic CO2 fixation are the Calvin cycle (also known as the C3 cycle) and Hatch-Slack cycle (the C4 cycle). The nectar used by bees to produce honey comes from plants that produce sugars via the C3 pathway, while the sugars derived from sugar cane and corn are produced by the C4 pathway.

Carbon naturally exists as two stable isotopes that behave in the same way, but possess different atomic mass numbers. Carbon-12 is the most abundant in nature (98.9%), whereas carbon-13 is far less common (1.1%). By measuring the ratio of carbon-13 to carbon-12 (13C/12C) using IRMS, the carbon isotope fingerprint of the honey can be determined. As more carbon-13 is incorporated in sugars produced by the C4 pathway, the adulteration of honey with sugar cane and fructose corn syrups, rich in C4 sugars, can be detected.

In unadulterated honey, the carbon isotope fingerprint will be similar to that of the natural protein precipitated from the honey. However, if cane sugar or high fructose corn syrup has been added, the isotope fingerprint of honey and protein will be significantly different.

Detection of Adulteration by EA-IRMS

One approach that has traditionally been used for the detection of honey adulteration is elemental analysis interfaced with IRMS (EA-IRMS).2 This highly robust, rapid and cost-effective technique is able to reliably detect the addition of C4 sugars in honey at levels down to 7%.3 The analytical approach complies with the official method for the analysis of C4 sugars in honey, AOAC method 998.12.4

In EA-IRMS, bulk honey is combusted in the presence of pure oxygen to form CO2 for analysis. The CO2 produced from the combustion of the bulk honey, including all sugars and the protein fraction, is analyzed by IRMS. Figure 1 shows carbon isotope fingerprints of four unique samples, including bulk honey and the proteins extracted from those honeys, determined using an EA-IRMS system. In each case of adulteration, shown in the grey columns, the honey δ13C value becomes more positive relative to the protein value, moving towards the carbon isotope fingerprint of C4 plants. The natural variation of δ13C in honey is shown by the red lines.5

Figure 1. Carbon isotope fingerprints of bulk honey and protein fractions from those honeys. The red lines show the natural variation of δ13C in honey.2

Detection of Adulteration by LC-IRMS

While EA-IRMS can be used to identify cases of honey adulteration using the bulk sample, the analysis of low levels of added C4 sugars and C3 sugars (i.e., beet sugars) to honey reveal that a compound specific technique with more powerful separation capabilities is needed. Furthermore, as fraudsters develop more sophisticated adulteration techniques and effective ways of concealing their actions, it can be necessary to utilize other IRMS techniques.

Much lower limits of adulteration detection can be obtained from liquid chromatography interfaced with IRMS (LC-IRMS). This technique permits the analysis of very small sample amounts without the need for extensive preparation or derivatization, and can also identify C3 sugar adulteration, which EA-IRMS cannot readily achieve, and therefore serves as a strong, complimentary isotope fingerprint technique. There are IRMS portfolios available that allow for sequential automated analysis of both analytical techniques.

Using LC-IRMS, the sample is oxidized within the aqueous solvent eluting from the HPLC column. The oxidation reagent consists of two solutions: The oxidizing agent itself and phosphoric acid. Both are pumped separately and added to the mobile phase. Within this mixture, all individual organic compounds eluting from the HPLC column are oxidized quantitatively into CO2 upon passing through a heated reactor. In a downstream separation unit, the generated CO2 is then separated from the liquid phase and carried by a stream of helium gas. The individual CO2 peaks in the helium are subsequently dried in an on-line gas drying unit and admitted to the isotope ratio mass spectrometer via an open split interface.

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Campbell Soup Company

In Move to Expand into Organic Food, Campbell’s Buys Pacific Foods

By Food Safety Tech Staff
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Campbell Soup Company

As consumer preferences continue the shift toward organic food, Campbell Soup Co. announced its $700 million acquisition of Pacific Foods today. The cash deal will help Campbell Soup expand into the organic and functional food spaces, according to company president and CEO Denise Morrison.

“Pacific Foods is an excellent fit with Campbell — strategically, culturally and philosophically,” said Morrison in a company press release. “It advances our strategic imperatives around real food, transparency, sustainability and health and well-being. Culturally, Campbell and Pacific Foods share similar values and a commitment to a purpose-driven approach. Philosophically, both companies believe in making food that we are proud to serve at our own tables using simple, recognizable ingredients.”

Pacific Foods produces organic broth and soup, as well as shelf-stable plant-based beverages and other meals. The Oregon-based company, which employees 540 people, will become part of Campbell’s Americas Simple Meals and Beverages division. Pacific Foods CEO and co-founder Chuck Eggert will remain a supplier of key ingredients through his family farms, which will help the company continue its farm-to-table philosophy. “We’ve spent the past 30 years focused on making nourishing foods with an emphasis on simple, organic ingredients and authentic, rich flavors,” said Eggert. “Looking ahead, a future with Campbell means we can maintain what we value while accelerating growth of the brand in a way that we couldn’t do alone, reaching more people while increasing our impact on sustainable agriculture.”

Randy Fields, Repositrak
FST Soapbox

Update: Non-FSMA Food Safety Litigation

By Randy Fields
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Randy Fields, Repositrak

The keynote panel at the 2017 Food Safety Summit in May had, as any food safety professional would expect, a focus on how companies are coping with FSMA and the increased scrutiny they may face. There was unanimous belief on the panel that enforcement is coming and all trading partners need to be prepared, but there was also a look beyond FSMA adoption to what will come next.

First, though, where do we stand with FSMA-related litigation?

Shawn Stevens, one of the leading food industry lawyers, told attendees that it’s important for all retailers, wholesalers, suppliers and affiliates to understand that FDA was commanded by Congress to stop foodborne illness and the impact it has on Americans, plain and simple. His advice is for food pros to learn all aspects of FSMA and do it quickly, saying the goal now is to avoid making the operational mistakes that may result in criminal exposure for the company and its executive leadership team.

Going forward, the industry will not only have to comply with FSMA, but it will also need to address recalls, risk mitigation and other complex food safety issues not directly related to FSMA. Foodborne illness outbreaks will still cause legal claims that can be compounded by personal injury suits and potentially impact a retailer’s reputation negatively. Also, there are trends in organic foods, GMOs, gluten-free items and more that will impact the retailer, supplier and ultimately may result in more litigation.

Jeffrey Steger, assistant director of the Consumer Division at the U.S. Department of Justice (DOJ), reported that companies shouldn’t expect a waning of the federal government’s support of non-FSMA enforcement actions. The DOJ gets involved in cases where there is significant harm to consumers, where food company executives had prior knowledge, and where legal action will protect the integrity of the regulatory system and prevent future harm. It has pursued many high-profile food industry prosecutions to date and he believes this trend will continue.

The importance of the FSMA regulations and the responsibilities placed on the food industry shouldn’t be understated in the context of food-related litigation. But there are other new developments in the marketplace and the extended supply chain that are impacting retailers like transparency in packaging, labeling of social responsibility programs, the move toward clean labels and facility auditing requirements.

Recent research by the Food Marketing Institute indicates retailers and suppliers that connect with shoppers in support of food safety are well positioned to build shopper trust and loyalty. The converse must also be true—companies that have their reputation dragged down due to involvement in food safety litigation will surely be poorly positioned to build shopper trust and loyalty.

Retailers and suppliers need to address all food safety-related issues or risk becoming defendants in a lawsuit or further government regulation. To accomplish this goal and, more importantly, to keep their customers safe, food companies need to nurture an enterprise-wide food safety culture that extends from the executive suite to store personnel –all retail employees must be responsible for food safety. Only then will customers recognize the company as being committed to food safety, and only then will the company get ahead of any potential food safety-related litigation.

Sudan dye

Adulteration with Sudan Dye Has Triggered Several Spice Recalls

By Thomas Tarantelli
4 Comments
Sudan dye

In the following article, the author reports finding Sudan dye in spices in New York State, making the argument for Class I recalls.

In New York State (NYS), Department of Agriculture and Markets food inspectors routinely sample domestic and imported food from retail markets for food dye determination. For decades, the NYS Food Lab has examined both domestic and imported food for undeclared allowed food dyes and unallowed food dyes utilizing a paper chromatography method. This method works well with water-soluble acid dyes, of which food dyes are a subset.

The NYS Food Lab has participated in four sets of the FAPAS proficiency tests: Artificial Colours in Soft Drinks and Artificial Colours in Sugar Confectionary (Boiled Sweets). The qualitative analysis was by paper, thin layer silica and thin layer cellulose chromatography. Satisfactory results were obtained.

The paper/thin layer chromatography method is a qualitative non-targeted method and has a limit of detection of approximately 1 to 5 ppm (parts per million) depending on the dye. If an unallowed dye is detected, the food product is violated as adulterated and results are forwarded to the FDA.

Some countries have a maximum concentration of allowed food dye in a food product. For example India has a 100 ppm to 200 ppm maximum for their allowed food dyes, in some food, singly or in combination.1

Sesame seeds, Rhodamine B
Early 2011, sesame seeds were found to contain Rhodamine B.

In early 2011, a food sample of pink colored sugar coated sesame seed from Pakistan was sent to the lab for color determination. The paper chromatography method could not determine any dyes. (As found out later, the unknown pink dye was not an acid dye.) From research it was found that Rhodamine B was a pink water soluble basic dye commonly used as a food adulterant.  A standard was ordered and then a qualitative high performance Liquid chromatography-tandem mass spectrometry (HPLC/MS/MS) method was developed (Waters UPLC Aquity w/Waters Premier XE triple quadrapole) to determine Rhodamine B. After utilizing this new method, Rhodamine B was found in the sugar coated sesame seed.

Rhodamine B is an industrial dye and is not allowed in food anywhere in the world. Industrial dyes are not allowed in food because they are toxic; in fact, some industrial dyes are used for suicide.2,3,4 In addition, industrial dyes are not made to “food grade” specifications with regard to dye purity, heavy metal (i.e., arsenic and lead) concentrations, subsidiary dye concentrations and concentrations of unreacted precursors. From additional research of news articles and research papers, more industrial dyes were identified as common food adulterants; more dye standards were ordered and incorporated into the HPLC/MS/MS method. The NYS Food Lab’s current HPLC/MS/MS surveillance method includes 36 compounds: Water soluble “acid dyes” and “basic dyes”, organic solvent soluble “solvent dyes”, and several pigments.

The HPLC/MS/MS method has a limit of detection in the ppb (parts per billion) range for some dyes and parts per trillion for other dyes. The FDA has an action level of 1 ppb for certain water-soluble basic dyes (such as Malachite Green) when used as a fish antibiotic. However, due to concern that unallowed dyes might be present due to contamination from packaging, the food lab subsequently set an action level of 1 ppm for unallowed dyes determined by the HPLC/MS/MS method. At levels over 1 ppm, detection of dyes in food would indicate intentional dye usage for coloring food.

The food lab has participated in three rounds of the FAPAS proficiency test, “Illegal Dyes found in Hot Pepper Sauce”. The qualitative analysis was by LC/MS/MS. Satisfactory results were obtained.

Sudan Dyes Considered to be Carcinogenic

“Sudan dyes are not allowed to be added to food. There has been worldwide concern about the contamination of chili powder, other spices, and baked foods with Sudan dyes since they may have genotoxic and carcinogenic effects (according to the International Agency for Research on Cancer)”.5

“There have been several documented cases of spices being contaminated with carcinogenic dyes such as Sudan I or lead oxide. We therefore assume that the presence of these chemicals in spice ingredients will be considered a reasonably foreseeable hazard under this rule.”6

“Sudan red dyes have been used to color paprika, chili powders, and curries, but are also known carcinogens and are banned for use in foods.” 7

Sudan Dyes are a family of more than 10 synthetic industrial “solvent dyes”. Solvent dyes are typically used to color oils and waxes, including shoe polish. Sudan dyes that the food lab has found in spices include Sudan 1 (Sudan I), and Sudan 4 (Sudan IV). Sudan 1, also known as Solvent Yellow 14, is an orange colored dye. Sudan 4, also known as Solvent Red 24, is a blue shade red colored dye.

Positive identification of Sudan 4 is often hindered by the existence of a positional isomer, Sudan Red B (Solvent Red 25). This problem was addressed by using the HPLC/MS/MS method with a transition unique to Sudan 4 (381.2 > 276.0). This information was obtained from one of the two corroborating labs. The food lab has recently identified a transition unique to Sudan Red B (381.2 > 366.1).

Sudan Dyes Found in Spices in Europe

In March 2001, Europe began discovering Sudan dyes in spices. A February 2017 search of Europe’s Rapid Alert System for Food and Feed (RASFF) for “unauthorised colour” and “sudan” in the “herbs and spices” food category resulted in 429 notifications.

The 429 RASFF notifications arranged by year and by maximum concentration reported of Sudan 1 and Sudan 4 during that year are listed in Table I.

Sudan dye
Table I.

In a search of the FDA’s Import Alert 45-02 (Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors) the author could find no record of spices violated for Sudan dye adulteration.

In a search of the FDA’s Enforcement Reports the author could find no record of spices violated for Sudan dye adulteration.

Industrial Dyes in Food: Class II or Class I Recall?

The NYS Food Lab and the FDA routinely find imported food containing unallowed food dyes such as Ponceau 4R, Amaranth and Carmoisine. These unallowed food dyes are allowed for use in food in other parts of the world, while not allowed in the USA. Foods containing unallowed food dyes are violated as adulterated and a Class II recall will occur. Sudan dyes are not allowed as food dyes anywhere in the world. They are industrial dyes, used in coloring oils and waxes, such as shoe polish.

“Class I recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”8

With a Class II recall, there is no consumer notification. In contrast, as part of a Class I recall, a press release is issued. Consumers who have purchased the product might be informed and may discard the product or return it for a refund.

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Minimizing Hazards and Fraud in Milk, IBM Research Partners with Cornell University

By Food Safety Tech Staff
1 Comment

Americans consume an estimated 600 pounds of milk and milk-based products annually, according to the USDA. In an effort to minimize the hazards in the milk supply and prevent food fraud, IBM Research and Cornell University are joining forces. Combining next-generation sequencing with bioinformatics, the research project will collect genetic data from the microbiome of raw milk samples in a real-world situation at the Cornell University dairy plant and farm in Ithaca, New York.

Specifically, IBM and Cornell will sequence and analyze the DNA and RNA of food microbiomes, which will serve as a raw milk baseline, to develop tools that monitor raw milk and detect abnormalities that could indicate safety hazards and potential fraud. The data collected may also be used to expand existing bioinformatics analytical tools used by the Consortium for Sequencing the Food Supply Chain, a project that was launched by IBM Research and Mars, Inc. at the beginning of 2015.

“As nature’s most perfect food, milk is an excellent model for studying the genetics of food. As a leader in genomics research, the Department of Food Science expects this research collaboration with IBM will lead to exciting opportunities to apply findings to multiple food products in locations worldwide.” – Martin Wiedmann, Gellert Family Professor in Food Safety, Cornell University.

“Characterizing what is ‘normal’ for a food ingredient can better allow the observation of when something goes awry,” said Geraud Dubois, director of the Consortium for Sequencing the Food Supply Chain, IBM Research – Almaden, in a press release. “Detecting unknown anomalies is a challenge in food safety and serious repercussions may arise due to contaminants that may never have been seen in the food supply chain before.”

Cornell University is the first academic institution to join the Consortium for Sequencing the Food Supply Chain.