Tag Archives: contamination

magnifying glass

Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

Dollar

Pathogens Drive More Than Half of $12 Billion Global Food Safety Testing Market

By Maria Fontanazza
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Dollar

The importance of food safety testing technologies continues to grow, as companies are increasingly testing their products for GMOs and pesticides, and pathogens and contamination. Last year the global food safety testing market had an estimated value of $12 billion, according to a recent report by Esticast Research & Consulting. Driven by pathogen testing technologies, the global food safety testing market is expected to experience a 7.4% CAGR from 2017–2024, hitting $21.4 billion in revenue in 2024, said Vishal Rawat, research analyst with Esticast.

With a CAGR of 9.3% from 2017–2024, rapid testing technologies are anticipated to lead the market. Testing methods responsible for this growth include immunoassays (ELISA), latex agglutination, impedance microbiology, immune-magnetic separation, and luminescence and gene probes linked to the polymerase chain reaction, said Rawat, who shared further insights about the firm’s market projections with Food Safety Tech.

Food Safety Tech: With the GMO food product testing market expected to experience the highest growth in the upcoming future, can you estimate the projected growth?

Vishal Rawat: The GMO food product testing market is estimated to generate a revenue of approximately $5.2 billion in 2016. The market segment is expected to witness a compound annual growth rate of 8.3% during the forecast period of 2017–2024. This is a global market estimation.

FST: What innovations are occurring in product testing?

Rawat: Nanomaterials and nanobased technologies are attracting interest for rapid pathogen testing. Sustainable technologies such as edible coatings or edible pathogen detection composition can attain a trend in the near future. Also, new rapid allergen testing kits are now emerging out as the latest food testing technology in the market, which are portable and easy to use.

FST: Which rapid pathogen detection testing technologies will experience the most growth from 2017–2024?

Rawat: New and emerging optical, nano-technological, spectroscopic and electrochemical technologies for pathogen detection, including label-free and high-throughput methods would experience the highest growth.

FST: What pathogen testing technologies are leading the way for meat and poultry in the United States?

Rawat: The presence of a microbial hazard, such as pathogenic bacteria or a microbial toxin, in ready-to-eat (RTE) meat or poultry products is one basis on which these products may be found adulterated. The FSIS is especially concerned with the presence of Listeria monocytogenes, Salmonella, Escherichia coli O157: H7, and staphylococcal enterotoxins in RTE meat and poultry products. Rapid pathogen testing for E. coli O157:H7 and Salmonella, for ground beef, steak and pork sausages is going to lead the U.S. market.

An overview of the report, “Food Safety Testing Market By Contaminant Tested (Pathogens, GMOs, Pesticides, Toxins), By Technology (Conventional, Rapid), Industry Trends, Estimation & Forecast, 2015– 2024” is available on Esticast’s website.

FSMA

FDA Releases Chapter 6 of Draft Guidance for PC Rule

By Food Safety Tech Staff
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FSMA

Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.

Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.

FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).

Thomas Tarantelli
In the Food Lab

Lead Found in Recalled Ground Cumin

By Thomas Tarantelli
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Thomas Tarantelli

Laboratory reports recently acquired by the Freedom of Information Law from the New York State Department of Agriculture and Markets show the Sol Andino brand ground cumin to contain 1090 ppm lead as well as 259 ppm chromium. The spice was also analyzed by IS:2446, 1980 method, “Detection of Lead Chromate in Chillies, Curry Powder and Turmeric by diphenyl carbizide.” A positive result was given, indicating the presence of hexavalent chromium, which is a component of lead chromate. Lead chromate is a yellow pigment, not allowed in food anywhere in the world as it is toxic, containing both lead and hexavalent chromium. The New York State Department of Agriculture and Markets posted a Class I recall of the Sol Andino ground cumin on July 10, 2017, without mention of the extremely high concentration of lead in the product.

Sol Andino, ground cumin
Sol Andino ground cumin recalled

The author could find no record of an FDA recall for the Sol Andino brand cumin powder containing excessive lead.

Some of us remember the four FDA Class I recalls of Pran brand turmeric for excessive lead in October 2013. These recalls were initiated by the New York State Health Department due to an illness complaint—most likely a child with high blood lead levels. The recalled Pran brand turmeric contained 28–53 ppm lead.

Also worthy of mention is the FDA/Illinois Class I recall of Nabelsi brand Thyme (actually a spice mix containing Thyme) on March 17, 2017.

“There have been two cases of high blood levels of lead associated with this product to date. Both cases have been reported through the Illinois Department of Public Health, Environmental Health Protection.”

According to the recall, the “Thyme” was found to contain 422 ppm lead.

Wondering if the 422 ppm lead was caused by adulteration of the “Thyme” with lead chromate or another lead pigment, a food chemist at the New York State Food Laboratory (a Division of NYS Dept. of Agriculture and Markets) requested from Illinois a sub-sample of the “Thyme” for analysis. Lab analysis of the spice found 323 ppm lead, 109 ppm chromium and a positive result for the chromate test. Thus, this recalled “Thyme” contains lead chromate.

In both cases, Pran turmeric and Nabelsi Thyme, illness complaints led to the recall of lead adulterated spices.

The New York State Department of Agriculture and Markets has a proactive program. Random samples of spices are sampled from retail markets and subsequently analyzed for unallowed colorants, undeclared allergens and heavy metals. In 2016 this resulted in the Oriental Packing Class I recall of 377,000 lb. of turmeric containing spices for excessive lead. (A typo in the FDA recall attributes the recall to the New York State Health Department, instead of the New York State Dept. of Agriculture and Markets.)

Still, it’s even better to analyze spices being imported into the country at receiving warehouses before the product reaches retail markets. Lead concentrations above 10 ppm can be determined instantaneously with a handheld XRF analyzer.

Adulteration with Sudan Dye Has Triggered Several Spice Recalls

Sprouts

FDA Releases Sampling Report on Sprout Contamination

By Food Safety Tech Staff
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Sprouts

In an effort to determine the prevalence of Salmonella, Listeria and E. coli O157:H7 in sprouts, FDA conducted a large sampling study of sprouts, the results of which were released last week.

The agency collected 825 samples from 37 states, Puerto Rico and the District of Columbia and found 14 positive samples at eight of the 94 growers (10 samples came from four growers). Samples were collected from three production process points: Seeds, finished product and spent irrigation water, and tested for contamination. FDA found the following contamination:

  • Salmonella on 2.35% of seed samples, 0.21% in finished sprouts and 0.53% in spent irrigation water
  • Listeria monocytogenes on 1.28% of finished sprouts
  • No positive E. coli O157:H7 results in finished sprout or spent irrigation. Due to limitations of the test method, FDA didn’t test seed samples.

“Sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States linked to sprouts. These outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths.” – CFSAN

In the event that contaminated sprout samples were uncovered, FDA worked with the firms that own or released the affect sprouts to conduct voluntary recalls or destroy them. FDA inspections also followed.

The full report, FY 2014 – 2016 Microbiological Sampling Assignment, is available on FDA’s website.

Erin Mann, Food Protection and Defense Institute
FST Soapbox

Targeting Agent Detection with Horizon Scanning of Food System Disruptions

By Erin Mann, MPH
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Erin Mann, Food Protection and Defense Institute

Agent detection to identify contamination of food products is required in food safety and defense programs. Detection typically involves laboratory methods or technologies, such as biosensors, that are used in close physical contact with food products. While the field of food protection has benefited from the development of novel agent detection methods in recent years, the challenge of determining which food products to test remains. The sheer volume of food produced within and traded across U.S. borders makes agent detection a daunting, time-consuming and expensive task. The decision of when to utilize detection methods depends on the risk of a particular product being contaminated. Contamination may be unintentional or intentional, including economically motivated adulteration (EMA).

The risk of contamination fluctuates over time and is a function of several factors. Risk depends on the biochemical makeup of the product, supply chain characteristics such as complexity and transport distance, and a wide range of natural or manmade events that may disrupt supply and potentially incentivize intentional adulteration. This is particularly true in the case of EMA. Events include but are not limited to natural disasters that destroy or reduce the usual supply of an ingredient, political instability that disrupts usual trade patterns, interruptions of routine food safety inspections, and market fluctuations that impact global prices. While data exists to monitor these risk factors of contamination, optimal use of this information by government and private industry is hindered by several challenges. For example, valuable data often exists across multiple data systems with data across systems appearing in inconsistent formats. In addition, the amount of data that must be reviewed to find a signal within the noise is frequently overwhelming.

Erin Mann, Food Protection and Defense Institute
Read our recent Q&A with Erin Mann, “As Food Fraud Grows, More Comprehensive Tools Emerge”

To address finding signals within vast quantities of data sources and systems, the Food Protection and Defense Institute (FPDI) developed technology to curate and help make sense of this data. With support from both the FDA and the Department of Homeland Security, FPDI developed FIDES or Focused Integration of Data for Early Signals to perform “horizon scanning” of food system disruptions in support of food protection efforts, including agent detection. FIDES was designed to help users forecast, monitor and identify food system risk factors and adverse food events. The FIDES web application fuses multiple streams of data from disparate sources and displays information in the form of an online dashboard where users browse, search and layer both dynamic and reference data sets related to food system disruption events. Examples of data currently included in FIDES are import refusals, global disasters, animal health alerts, food defense incidents, historical food safety incidents, import data, price alerts and reference data on food production worldwide.

Events in recent years illustrate the value of gathering intelligence and utilizing data related to food system risks to inform decisions regarding product targeting. Tsunamis, crop failures and disease outbreaks in humans and animals around the globe have threatened supply of products such as shrimp, spices, cocoa and eggs. When supply is disrupted, companies are often forced to quickly identify new and sometimes previously unvetted suppliers, including spot market purchasing. Likewise, supply disruptions often lead to price increases. As prices increase in the absence of adequate supply, concerns about EMA also increase. In both of these instances, the risk of product contamination—both unintentional and intentional—may rise and an increase in product screening or a change in agent detection methods may be appropriate.

For example, the 2014–2016 Ebola outbreak had a significant impact on West Africa, the primary production region for the world’s cocoa supply. Disruptions from the outbreak, including border closures and other trade interference, led to uncertainty about supply availability and prices. This raised concern for EMA, particularly given that many cocoa products are sold as powders, butters and liquors— forms that are more vulnerable to EMA than raw ingredients. As a test case, FPDI reviewed FIDES data streams during the peak of the outbreak. Real-time data on the outbreak was layered with data on global cocoa production and import patterns. Import refusal data from multiple global systems was assessed to identify any concerning patterns. Historical food defense and food safety incidents were also reviewed to determine which cocoa products had been previously contaminated. A similar approach could be used by the food and agriculture sector to guide decisions about targeted inspections—which product(s) and region(s) to monitor, which method(s) to use and which contaminant(s) to test. FIDES could support targeted screening and enhanced awareness of product risk profile that would allow the food industry to assure continued supply of authentic and quality products.

Michael Taylor FDA

Food Safety Over Past 25 Years: ‘Everything Has Changed’

By Maria Fontanazza
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Michael Taylor FDA

The effect that the 1993 E. coli O157:H7 outbreak had on the food industry was tremendous. Responsible for more than 600 illnesses and the deaths of four children, the outbreak led to significant changes in the industry’s approach to food safety. “[It] drove a shift in food safety that many had been working toward for years,” said Rima Khabbaz, M.D., acting deputy director for infectious diseases at CDC during the “We Were There” CDC lecture series, adding that the focus moved to food suppliers and how they could make their products safer. “The outbreak drove a paradigm shift that opened the door to food safety,” said Patricia Griffin, M.D., chief of the CDC’s enteric diseases epidemiology branch during the lecture.

Deirdre Schlunegger and Michael Taylor
Deirdre Schlunegger, CEO of Stop Foodborne Illness, and Michael Taylor at Stop event celebrating Food Safety Heroes during the 2015 Food Safety Consortium.

Within a few years, several actions and initiatives paved the way for notable progress. In 1994, Mike Taylor, who was administrator of USDA’s FSIS at the time, made a speech that “shocked and outraged the industry,” said Griffin, where he stated, “we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.” From there, the USDA worked on the first major advance in meat regulation. In 1996 the agency established the Pathogen Reduction Rule to improve meat inspection. The same year CDC’s PulseNet was born, the nationwide lab network that uses DNA fingerprinting to help identify outbreaks early, along with the Foodborne Diseases Active Surveillance Network (FoodNet), an epidemiological system that tracks incidents and trends related to food.

In a Q&A with Food Safety Tech, Mike Taylor, most recently the former FDA commissioner for foods and veterinary medicine, discusses the dramatic change that industry has undergone during the past 25 years, from FSMA to technology advancements to food safety culture.

Food Safety Past, Present and Future at the 2017 Food Safety Consortium: Recognizing the 1993 Jack In the Box E. coli outbreak as the event that propelled the current food safety movement. Mike Taylor, Bill Marler, Esq. and Ann Marie McNamara (Target Corp.), who took the reins from the late David Theno at Jack In the Box, will discuss Theno’s impact on the industry. The session continues through a timeline of the evolution of food safety from 1993 to present, and then the future, where we will cover the IoT, social media, food safety culture and technology. It will be followed by the STOP Foodborne Illness Award Ceremony. Wednesday, November 29, 2017, 4:00–5:30 pm | LEARN MORE

Food Safety Tech: Reflecting on how far the industry has come since the E.coli O157:H7 outbreak involving Jack in the Box in 1993, what key areas of progress have been made since?

Michael Taylor: I think there are very major ones obviously. You have to remember where things were when the Jack-in-the-Box [outbreak] happened. We were in a place where USDA programs said it was not responsible for pathogens in raw meat and that consumers are supposed to cook the product; [and] industry was operating under traditional methods. Microbial methods were typically conducted for quality not for safety; you had the loss of public confidence and a terrible situation in which consumers were pointing at industry, and industry was pointing at consumers, and no one was taking clear responsibility for safety of the product.

Now we are in a completely different environment where not only is there clarity about industry’s responsibility for monitoring pathogens, there’s also been enormous progress by industry to put in place microbial testing, something David Theno pioneered and is now a central part of food safety management systems for meat safety.

Everything has changed.

These [institutional] arrangements exist not only in the meat industry, but now across the whole food industry. There’s the emergence of GFSI taking responsibility for managing the supply chain for food safety, food safety culture taking hold broadly across leading companies in the industry, and FSMA codifying for 80% of the food supply that FDA regulates the principles of risk-based prevention and continuous improvement on food safety.

I think it’s rather dramatic how far the industry’s food safety regulatory system has come since [the] Jack in the Box [outbreak].

FST: How has FSMA helped to align industry priorities?

Michael Taylor FDA
Mike Taylor was on the front lines of change in the meat industry.

Taylor: Let’s focus on the events first leading up to FSMA—for example, the outbreaks or illnesses associated with leafy greens [and] peanut butter, and problems with imported products—those events in the world aligned industry priorities around the need to modernize the food safety laws and to enact FSMA. It was the coming together of industry and consumer interests, and the expert community around the principles of comprehensive risk-based prevention that vaporized into FSMA. Now FSMA is the framework within which companies are organizing their food safety systems in accordance with these modern principles of prevention.

And clearly what’s been codified in FSMA and some of the key elements are becoming organizing principles where industry is aligning our priorities for food safety. Environmental monitoring where that’s an appropriate verification control for a company’s hygiene and pathogen control—that’s clearly a priority that folks are aligning on. The issue of supplier verification for domestic and foreign supply is a priority that has been elevated by FSMA, and so has the whole issue of training and employee capacity, whether it’s in processing facilities or on farms, as well as food safety culture. If you’re going to be effectively preventive you need to deal with the human dimension of your food safety system.

These are examples of ways in which FSMA is aligning industry priorities.

Read the rest of the interview on page 2 (link below).

Egg

Egg Contamination Spreads Across Europe

By Food Safety Tech Staff
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Egg

At least 17 countries have been hit with the European egg scandal involving insecticide contamination. Ground zero of the problem has not been definitively identified, as Belgium, the Netherlands and Germany are reportedly pointing fingers over which country is to blame and how long they knew about the problem. Dutch authorities may have known about the problem as far back as November 2016.

The eggs have been tainted with the pesticide Fipronil, doses of which are not harmful to humans engaging in short-term consumption. When consumed in large doses, it can cause damage to the kidneys, liver and thyroid glands.

Farmers in the Netherlands used a company, Chickfriend, to delouse their chickens, but this company reportedly mixed fipronil into the cleaning solution and could have contaminated nearly 180 farms in the country as a result, according to The New York Times. As many as 20% of Dutch egg-laying chickens could be affected. Chickfriend was recently raided by authorities and two of its directors were arrested. Antwerp-based Poultry-Vision stated that it provided Chickfriend with fipronil via a source in Romania, according to The Guardian.

Contaminated eggs, which have been distributed to at least 17 countries (mainly in Europe) have also been found at producers in Belgium, France and Germany, and as a result, millions of eggs have either been destroyed or removed from store shelves.

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.

Sudan dye

Adulteration with Sudan Dye Has Triggered Several Spice Recalls

By Thomas Tarantelli
2 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.

Continue to page 2 below.