Chocolate

Chocolate and Big Data: The Recipe for Food Safety Is Changing

By Steven Sklare
No Comments
Chocolate

Almost everybody loves chocolate, an ancient, basic, almost universal and primal source of pleasure. “The story of chocolate beings with cocoa trees that grew wild in the tropical rainforests of the Amazon basin and other areas in Central and South America for thousands of years… Christopher Columbus is said to have brought the first cocoa beans back to Europe from his fourth visit to the New World” between 1502 and 1504.1

Unfortunately, the production of chocolate and chocolate products today is as complex as any other global food product with supply chains that reach from one end of the world to the other. The complexity of the supply chain and production, along with the universal demand for the finished product, exposes chocolate to increasing pressure from numerous hazards, both unintentional and intentional. For example, we know that more than 70% of cocoa production takes place in West African countries, particularly the Ivory Coast and Ghana. These regions are politically unstable, and production is frequently disrupted by fighting. While production has started to expand into more stable regions, it has not yet become diversified enough to normalize the supply. About 17% of production takes place in the Americas (primarily South America) and 9% from Asia and Oceania.2

In today’s world of global commerce these pressures are not unique to chocolate. Food quality and safety experts should be armed with tools and innovations that can help them examine specific hazards and fraud pertaining to chocolate and chocolate products. In fact, the global nature of the chocolate market, requires fast reflexes that protect brand integrity and dynamic quality processes supported by informed decisions. Digital tools have become a necessity when a fast interpretation of dynamic data is needed. If a food organization is going to effectively protect the public’s health, protect their brand and comply with various governmental regulations and non-governmental standards such as GFSI, horizon scanning, along with the use of food safety intelligent digital tools, needs to be incorporated into food company’s core FSQA program.

This article pulls information from a recent industry report about chocolate products that presents an examination of the specific hazards and fraud pertaining to chocolate and chocolate products along with ways to utilize this information.

Cocoa and chocolate products rely on high quality ingredients and raw materials, strict supplier partnership schemes and conformity to clearly defined quality and safety standards. During the past 10 years there have been a significant number of food safety incidents associated with chocolate products. The presence of Salmonella enterica, Listeria monocytogenes, allergens and foreign materials in cocoa/chocolate products have been reported on a global scale. Today, information on food safety incidents and potential risks is quickly and widely available by way of the internet. However, because the pertinent data is frequently siloed, food safety professionals are unable to take full advantage of it.

Top Emerging Hazards: Chocolate Products (2013-2018)

Publicly available data, from sources such as European Union RASFF, Australian Competition and Consumer Commission, UK Food Standards Agency, FDA, Food Standards Australia New Zealand (FSANZ), shows a significant increase in identified food safety incidents for cocoa/chocolate products from 2013 to 2018. For this same time period, the top emerging hazards that were identified for chocolate products were the following:

  • Allergens: 51.60%
  • Biological: 16.49%
  • Foreign bodies: 13.83%
  • Chemical: 7.45%
  • Fraud: 6.38%
  • Food additives & flavorings: 4.26%
  • Other hazards: 2.66%

By using such information to identify critical food safety protection trends, which we define to include food safety (unintentional adulteration) and food fraud (intentional adulteration, inclusive of authenticity/intentional misrepresentation) we can better construct our food protection systems to focus on the areas that present the greatest threats to public health, brand protection and compliance.

A Data Driven Approach

Monitoring Incoming Raw Materials
Assessment and identification of potential food protection issues, including food safety and fraud, at the stage of incoming raw materials is of vital importance for food manufacturers. Knowledge of the associated risks and vulnerabilities allows for timely actions and appropriate measures that may ultimately prevent an incident from occurring.

Specifically, the efficient utilization of global food safety and fraud information should allow for:

  • Identification of prevalent, increasing and/or emerging risks and vulnerabilities associated with raw materials
  • Comparative evaluation of the risk profile for different raw materials’ origins
  • Critical evaluation and risk-based selection of raw materials’ suppliers

A comprehensive risk assessment must start with the consideration of the identified food safety incidents of the raw material, which include the inherent characteristics of the raw material. Next, the origin-related risks must be taken into account and then the supplier-related risks must be examined. The full risk assessment is driven by the appropriate food safety data, its analysis and application of risk assessment scientific models on top of the data.

Using food safety intelligent digital tools to analyze almost 400 unique, chocolate product related food safety incidents around the globe provides us with important, useful insights about cocoa as a raw material, as a raw material from a specific origin and as a raw material being provided by specific suppliers. The graph below represents the results of the analysis illustrating the trend of incidents reported between 2002 and 2018. It can be observed that after a significant rise between 2009 and 2010, the number of incidents approximately doubled and remained at that level for the rest of the evaluated period (i.e., from 2010 to 2018), compared to the period from 2002 to 2005.

Cocoa incidents, FOODAKAI
Graph from Case Study: Chocolate Products: lessons learned from global food safety and fraud data and the guidance it can provide to the food industry,
an industry report from FOODAKAI. Used with permission.

By further analyzing the data stemming from the 400 food safety incidents and breaking them down into more defined hazards, for incoming raw materials, we can clearly see that chemical hazards represent the major hazard category for cocoa.

  • Chemical: 73.46%
  • Biological: 16.49%
  • Organoleptic aspects: 5.93%
  • Other Hazards: 4.38%
  • Fraud: 2.32%
  • Foreign bodies: 2.06%
  • Food additives and flavorings: .77%
  • Allergens: .52%
  • Food contact materials: .52%

Using the appropriate analytical tools, someone can drill down into the data and identify the specific incidents within the different hazard categories. For example, within the “chemical hazard” category specific hazards such as organophosphates, neonicotinoids, pyrethroids and organochlorines were identified.

Comparative Evaluation of Risk Profiles for Different Origins of Raw Materials
The main regions of origin for cocoa globally are Africa, Asia and South America. After collecting and analyzing all relevant data from recalls and border rejections and the frequency of pertinent incidents, we can accurately identify the top hazards for cocoa by region.

The top five specific hazards for the regions under discussion are listed in Table I.

Africa South America Asia
1 Organophosphate 2,4-dinitrophenol (DNP) 2,4-dinitrophenol (DNP)
2 Molds Pyrethroid Poor or insufficient controls
3 Neonicotinoid Aflatoxin Aflatoxin
4 Pyrethroid Cadmium Spoilage
5 Organochlorine Anilinopyrimidine Salmonella
Table I.  Top Five Hazards By Region

After the first level of analysis, a further interpretation of the data using the appropriate data intelligence tools can help to reach to very specific information on the nature of the incidents. This provides additional detail that is helpful in understanding how the regional risk profiles compare. For example, the prevalence of chemical contamination, as either industrial contaminants or pesticides, has been a commonly observed pattern for all three of the regions in Table I. However, beyond the general hazard category level, there are also different trends with regard to specific hazards for the three different regions. One such example is the increased presence of mold in cocoa beans coming from Africa.

The primary hazard categories for cocoa, as a raw ingredient were identified and a comparison among the primary hazards for cocoa by region (origin-specific) should take place. The next step in a data-powered supplier assessment workflow would be to incorporate our use of global food safety data in evaluating the suppliers of the raw materials.

The Role of Global Food Safety Data

This article has been focused on chocolate products but has only touched the surface in terms of the information available in the complete report, which also includes specific information about key raw materials. Let’s also be clear, that the techniques and tools used to generate this information are applicable to all food products and ingredients. As we strive to produce food safely in the 21st Century and beyond, we must adapt our methods or be left behind.

The regulatory environment the food industry must operate in has never been more intense. The threats to an organization’s brand have never been greater. This is not going to change. What must change is the way in which food companies confront these challenges.

Global food safety data can contribute to the establishment of an adaptive food safety/QA process that will provide time savings and improve a quality team’s efficiency and performance.

Based on the continuous analysis of food recalls and rejections by key national and international food authorities, a food safety / quality assurance manager could establish an adaptive supplier verification process and risk assessment process by utilizing the knowledge provided by such data. In that way, QA, procurement, food safety and quality departments can be empowered with critical supplier data that will inform the internal procedures for incoming materials and ingredients (e.g., raw materials, packaging materials) and allow for adaptive laboratory testing routines and compliance protocols. Moreover, food safety systems can become adaptive, enabling quality assurance and safety professionals to quickly update points of critical control when needed, and intervene in important stages of the chocolate manufacturing process.

References

  1. Discovering Chocolate. The Great Chocolate Discovery. Cadbury website. Retrieved from https://www.cadbury.com.au/About-Chocolate/Discovering-Chocolate.aspx.
  2. Chocolate Industry Analysis 2020 – Cost & Trends. Retrieved from https://www.franchisehelp.com/industry-reports/chocolate-industry-analysis-2020-cost-trends/.
Production line, NiceLabel

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

By Lee Patty
No Comments
Production line, NiceLabel

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

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

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

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

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

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

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

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

Disorganized Sprawl: A Major Hurdle to Effective Labeling

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

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

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

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

Implementing Modernized Labeling to Improve QA

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

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

Centralized Labeling is Easily Delivered Through Cloud

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

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

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

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

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

Futureproofing and Ensuring Consumer Safety with Allergen Labeling

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

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

Salami, plastic packaging

Using Raman Spectroscopy to Evaluate Laminated Food Packaging Films

By Ellen Link, Gary Johnson, Ph.D.
No Comments
Salami, plastic packaging

Laminated plastics are common and popular food packaging options. They are strong and flexible, making them ideal for both packing and presentation, and can be used for cooking, frozen foods, drink pouches, snack products and even pet food. Yet, unreliable plastics can create a problem for food packaging and the safety of a product.

If a grade of plastic is not what was promised or needed, there can be issues that lead to spoilage, spills and messes, crystallization, mold or other risks. Additionally, there may be concerns about how laminated films will interact with the product itself, as it could impact food safety or lifecycle. For these reasons, it is critical to have accurate information when evaluating the plastics films used in food packaging.

Raman Spectroscopy

Raman spectroscopy (RS) is a powerful method of identifying and characterizing chemical compounds based on light scattering by a sample. It can be used to identify layers in food packaging films to accurately understand the chemical makeup of the laminated plastic. The effect is named for its inventor, C.V. Raman, who was awarded the Nobel prize in physics for its discovery in 1930. It is a non-destructive method that uses an induced-dipole mechanism to probe the vibrations of the chemical bonds in a molecule. The Raman spectrum shows a pattern of molecular vibrations that represents a detailed chemical fingerprint of a material, providing insights into the product composition.

A Raman spectrum is obtained by illuminating the sample with a laser and collecting and measuring the scattered light with a spectrometer. The molecular vibrational modes vary depending on the geometry and electronic structure of the chemical compound present in the sample. By controlling the position of the laser focus point on a sample, a map of the composition can be created. This provides valuable information on the plastic film related to its composition, such as number of layers, thickness of each layer and overall make-up.

In the food packaging and safety industry, this technique can be used to evaluate laminated plastic films by examining polymers, minerals, and/or inorganic fillers and pigments present in the film. Specific food packaging products that can benefit from RS assessments include heat seals, containers, lids, films and wrappers both for durability and performance and for diffusion, permeation or other concerns.

Benefits and Limitations

There are numerous benefits to using the RS method. A major advantage is that there is virtually no sample preparation necessary; spectra can be obtained without direct contact, such as through the sides of glass vials or through windows in reaction cells. As a non-destructive technique, it allows an easy, highly accurate way to take a sample, create a chemical composition map and better understand films’ barrier properties, structural integrity and layers. It has broad applicability and works using conventional microscope optics.

There are, of course, limitations to the approach, as well. Fluorescent components or impurities in a sample can emit a photoluminescent background that overwhelms the Raman scattering. Samples can also be damaged by the laser if too much power is used, or the sample absorbs light at the laser wavelength. Samples that do fluoresce and samples that are photolabile act as common interferences for the RS method. In many cases, these interferences can be overcome with the proper choice of laser and sampling techniques. Additionally, while RS provides an accurate analysis of laminated films, the technique cannot be used on metals or metallic compounds (which can be assessed using scanning electron microscopy or light optical microscopy) or organic pigments or ink layers (which can be assessed with other infrared techniques).

Using RS for Food Packaging

RS can offer a variety of insights for food packaging films:

  • Failure analysis. If a plastic used for a heat seal in a fruit or yogurt cup fails, it could result in a mess for manufacturers, stores or the consumer. Exposure to air or elements could also lead to spoilage, particularly for refrigerated foods. Inconsistent plastic packaging could result in weak points that break, crack or puncture, which could also result in mold, mess or other spoilage concerns. If a manufacturer experiences a failure in a heat seal or packaging leading to leakage or spoilage, RS analysis can help determine why the failure occurred (was in the plastic film or something else) to help prevent future issues.
  • Supply chain validation. It is extremely important that the plastic films coming from suppliers are what they are promising and what the manufacturer needs. RS analysis can be used to determine the chemical make-up and morphology of packaging to confirm a supplier’s claims before proceeding with use of the film in food packaging and products.
  • Simple decision making. If a manufacturer is trying to decide which material to use, RS can provide answers. For example, if there is a need for moisture non-permeating films and there are multiple options available, an RS chemical map can illustrate what to expect with each option, aiding in the decision-making process when combined with other known factors such as cost or timing. If there is an additive in the food product that may diffuse into the film, RS can determine which material might best resist the potential problem.
  • Packaging appearance. If there is a swirl or haze in the packaging, RS can compare the area with the issue to a clear section to determine if the defect in the film is a foreign polymer or an inorganic pigment or filler, identifying the source of the problem.

RS analysis provides a wealth of information in a manner that is non-destructive. Giving a chemical fingerprint to identify composition with extremely good spatial resolution gives manufacturers valuable information that can be used to mitigate issues, correct problems or make important decisions. These actions in turn can help ensure food safety, which builds brand image and manufacturer equity. Ultimately, RS analysis can play an important role in the success of a product, a brand or a company.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part II)

By Frank Pisciotta, Spence Lane
No Comments

Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.

Average Cost Per Covered Facility Initial Recurring Total Annualized
Prohibit after hours key drop deliveries of raw materials $ $1070 $1070
Electronic access controls for employees $1122 $82 $242
Secured storage of finished products $1999 $– $285
Secured storage of raw materials $3571 $– $508
Cameras with video recording in storage rooms $3144 $– $448
Peer monitoring of access to exposed product (not used) $47 $1122 $1129
Physical inspection of cleaned equipment $– $303 $22
Prohibit staff from bringing personal equipment $157 $– $22
Total $9993 $1455 $2878
Table I. Costs of Mitigation

In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.

Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.

Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:

  • Is the perimeter maintained?
  • Are cameras pointed correctly?
  • Are doors secure?
  • Are vehicles screened?
  • Are guards and guard tours effective?
  • Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
  • Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
    • Access control
    • Visitor controls
    • Use of identification measures
    • Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
    • Effectiveness of buddy systems
    • Employee presence

Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.

Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.

Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.

Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.

Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.

Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification. Read the final installment of this series on Lessons Learned from Intentional Adulteration Vulnerability Assessments, Part III.

magnifying glass

Food Fraud and Adulteration Detection Using FTIR Spectroscopy

By Ryan Smith, Ph.D.
No Comments
magnifying glass

Producers of food-based products are faced with challenges of maintaining the safety and quality of their products, while also managing rapid screening of raw materials and ingredients. Failure to adequately address both challenges can be costly, with estimated recall costs alone starting around $10 million, in addition to any litigation costs.1 Long-term costs can accumulate further as a result of damage to brand reputation. A vast array of methods has been employed to meet these challenges, and adoption continues to increase as technology becomes smaller, cheaper and more user friendly. One such technique is Fourier transform infrared (FTIR) spectroscopy, an analytical technique that is widely used for quick (typically 20–60 seconds per measurement) and non-destructive testing of both man-made and natural materials in food products. The uniformity and physical state of the sample (solid vs. liquid) will dictate the specifics of the hardware used to perform such analyses, and the algorithm applied to the identification task will depend, in part, on the expected variability of the ingredient.

Infrared spectral measurements provide a “compositional snapshot”— capturing information related to the chemical bonds present in the material. Figure 1 shows an example of a mid-infrared spectrum of peppermint oil. Typically, the position of a peak along the x-axis (wavenumber) is indicative of the type of chemical bond, while the peak height is related either to the identity of the material, or to the concentration of the material in a mixture. In the case of peppermint oil, a complex set of spectral peaks is observed due to multiple individual naturally occurring molecular species in the oil.

Mid-infrared spectrum, peppermint oil
Figure 1. Mid-infrared spectrum of peppermint oil. The spectrum represents a “chemical snapshot” of the oil, as different peaks are produced as a result of different chemical bonds in the oil.

Once the infrared spectrum of an ingredient is measured, it is then compared to a reference set of known good ingredients. It is important that the reference spectrum or spectra are measured with ingredients or materials that are known to be good (or pure)—otherwise the measurements will only represent lot-to-lot variation. The comparative analysis can assist lab personnel in gaining valuable information—such as whether the correct ingredient was received, whether the ingredient was adulterated or replaced for dishonest gain, or whether the product is of acceptable quality for use. The use of comparative algorithms for ingredient identification also decreases subjectivity by reducing the need for visual inspection and interpretation of the measured spectrum.

Correlation is perhaps the most widely used algorithm for material identification with infrared spectroscopy and has been utilized with infrared spectra for identification purposes at least as early as the 1970s.2 When using this approach, the correlation coefficient is calculated between the spectrum of the test sample and each spectrum of the known good set. Calculated values will range from 0, which represents absolutely no match (wrong or unexpected material), to 1, representing a perfect match. These values are typically sorted from highest to lowest, and the material is accepted or rejected based on whether the calculated correlation lies above or below an identified threshold. Due to the one-to-one nature of this comparison, it is best suited to identification of materials that have little or no expected variability. For example, Figure 2 shows an overlay of a mid-infrared spectrum of an ingredient compared to a spectrum of sucrose. The correlation calculated between the two spectra is 0.998, so the incoming ingredient is determined to be sucrose. Figure 3 shows an overlay of the same mid-infrared spectrum of sucrose with a spectrum of citric acid. Notable differences are observed between the two spectra, and a significant change in the correlation is observed, with a coefficient of 0.040 calculated between the two spectra. The citric acid sample would not pass as sucrose with the measurement and algorithm settings used in this example.

Mid-infrared spectrum, sucrose
Figure 2. An overlay of the mid-infrared spectrum of sucrose and a spectrum of a different sample of sucrose.
Mid-infrared spectrium, sucrose, citric acid
Figure 3: An overlay of the mid-infrared spectrum of sucrose and a spectrum of citric acid.

When testing samples with modest or high natural variability, acceptable materials can produce a wider range of infrared spectral features, which result in a correspondingly broad range of calculated correlation values. The spread in correlation values could be of concern as it may lead to modification of algorithm parameters or procedures to “work around” this variation. Resulting compromises can increase the potential for false positives, meaning the incorrect ingredient or adulterated material might be judged as passing. Multivariate algorithms provide a robust means for evaluating ingredient identity for samples with high natural variability.

Click below to continue to page 2.

Pages: 1 2
Data protection, security

The Digital Transformation of Global Food Security

By Katie Evans
No Comments
Data protection, security

Modern food supply chains are inherently complex, with products typically passing through multiple suppliers and distributors, as well as countries and continents, before they end up on the supermarket shelf. While global supply chains offer consumers greater choice and convenience, they also make protecting the security of food products more challenging. With additional stakeholders between farm and fork, products are exposed to an elevated risk of biological or chemical contamination, as well as food counterfeiting and adulteration challenges—potentially putting consumer health and brand reputation in jeopardy.

Given the importance of maintaining the safety, quality and provenance of food products, global regulatory bodies are placing the integrity of supply chains under increased scrutiny. In the United States, for example, the adoption of FSMA moved the focus from responding to foodborne illnesses to preventing them by prioritizing comprehensive food testing measures, enforcing inspections and checks, and enabling authorities to react appropriately to safety issues through fines, recalls or permit suspensions.1 Similarly, China’s revised Food Safety Law (known as FSL 2015) is widely considered to be the strictest in the country’s history, and seeks to drive up quality standards by empowering regulators, and enhancing traceability and accountability through robust record-keeping. 2 The European Union continues to closely regulate and monitor food safety through its General Food Law, which is independently overseen by the European Food Safety Authority from a scientific perspective.

Achieving the Highest Standards of Food Security, Integrity and Traceability

For producers, manufacturers and distributors, the heightened regulatory focus on the security and integrity of the food supply chain has placed additional emphasis on accurate record-keeping, transparent accountability and end-to-end traceability. To meet the needs of the modern regulatory landscape, food chain stakeholders require robust systems and tools to manage their quality control (QC), environmental monitoring and chain of custody data. Despite this, many businesses still handle this information using paper-based approaches or localized spreadsheets, which can compromise operational efficiency and regulatory compliance.

The fundamental flaw of these traditional data management approaches is their reliance on manual data entry and transcription steps, leaving information vulnerable to human error. To ensure the accuracy of data, some companies implement resource-intensive verification or review checks. However, these steps inevitably extend workflows and delay decision-making, ultimately holding up the release of products at a high cost to businesses. Moreover, as paper and spreadsheet-based data management systems must be updated by hand, they often serve merely as a record of past events and are unable to provide insight into ongoing activities. The time lag associated with recording and accessing supply chain information means that vital insight is typically unavailable until the end of a process, and data cannot be used to optimize operations in real-time.

Furthermore, using traditional data management approaches, gathering information in the event of an audit or food safety incident can be extremely challenging. Trawling through paperwork or requesting information contained in spreadsheets saved on local computers is time-consuming and resource-intensive. When it comes to establishing accountability for actions, these systems are often unable to provide a complete audit trail of events.

Digital Solutions Transform Food Security and Compliance

Given the limitations of traditional workflows, food supply chain stakeholders are increasingly seeking more robust data management solutions that will allow them to drive efficiency, while meeting the latest regulatory expectations. For many businesses, laboratory information management systems (LIMS) are proving to be a highly effective solution for collecting, storing and sharing their QC, environmental monitoring and chain of custody data.

One of the most significant advantages of managing data using LIMS is the way in which they bring together people, instruments, workflows and data in a single integrated system. When it comes to managing the receipt of raw materials, for example, LIMS can improve overall workflow visibility, and help to make processes faster and more efficient. By using barcodes, radiofrequency identification (RFID) tags or near-field communication, samples can be tracked by the system throughout various laboratory and storage locations. With LIMS tracking samples at every stage, ingredients and other materials can be automatically released into production as soon as the QC results have been authorized, streamlining processes and eliminating costly delays.

By storing the standard operating procedures (SOPs) used for raw material testing or QC centrally in a LIMS, worklists, protocols and instrument methods can be automatically downloaded directly to equipment. In this way, LIMS are able to eliminate time-consuming data entry steps, reducing the potential for human error and improving data integrity. When integrated with laboratory execution systems (LES), these solutions can even guide operators step-by-step through procedures, ensuring SOPs are executed consistently, and in a regulatory compliant manner. Not only can these integrated solutions improve the reliability and consistency of data by making sure tests are performed in a standardized way across multiple sites and testing teams, they can also boost operational efficiency by simplifying set-up procedures and accelerating the delivery of results. What’s more, because LIMS can provide a detailed audit trail of all user interactions within the system, this centralized approach to data management is a robust way of ensuring full traceability and accountability.

This high level of operational efficiency and usability also extends to the way in which data is processed, analyzed and reported. LIMS platforms can support multi-level parameter review and can rapidly perform calculations and check results against specifications for relevant customers. In this way, LIMS can ensure pathogens, pesticides and veterinary drug residues are within specifications for specific markets. With all data stored centrally, certificates of analysis can be automatically delivered to enterprise resource planning (ERP) software or process information management systems (PIMS) to facilitate rapid decision-making and batch release. Furthermore, the sophisticated data analysis tools built into the most advanced LIMS software enable users to monitor the way in which instruments are used and how they are performing, helping businesses to manage their assets more efficiently. Using predictive algorithms to warn users when principal QC instruments are showing early signs of deterioration, the latest LIMS can help companies take preventative action before small issues turn into much bigger problems. As a result, these powerful tools can help to reduce unplanned maintenance, keep supply chains moving, and better maintain the quality and integrity of goods.

While LIMS are very effective at building more resilient supply chains and preventing food security issues, they also make responding to potential threats much faster, easier and more efficient. With real-time access to QC, environmental monitoring and chain of custody data, food contamination or adulteration issues can be detected early, triggering the prompt isolation of affected batches before they are released. And in the event of a recall or audit, batch traceability in modern LIMS enables the rapid retrieval of relevant results and metadata associated with suspect products through all stages of production. This allows the determination of affected batches and swift action to be taken, which can be instrumental in protecting consumer safety as well as brand value.

Using LIMS to Protect Security and Integrity of the Food Supply Chain

Increasingly, LIMS are helping businesses transform food security by bringing people, instruments and workflows into a single integrated system. By simplifying and automating processes, providing end-to-end visibility across the food supply chain, and protecting the integrity of data at every stage, these robust digital solutions are not only helping food supply chain stakeholders to ensure full compliance with the latest regulations; they are enabling businesses to operate more efficiently, too.

References

  1. FDA. (2011). FDA Food Safety Modernization Act. Accessed October 3, 2019. Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma.
  2. Balzano, J. (2015). “Revised Food Safety Law In China Signals Many Changes And Some Surprises”. Forbes. Accessed October 3, 2019. Retrieved from https://www.forbes.com/sites/johnbalzano/2015/05/03/revised-food-safety-law-in-china-signals-many-changes-and-some-surprises/#624b72db6e59.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

By Frank Pisciotta, Spence Lane
No Comments

Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class OSHA Workplace Violence Offender Description Motivation Translated to the Food and Beverage Industry
1 The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame. Behavioral Health Patient *
Social Media Fame Seeker *
Copycat *
Extortion *
Economic motivation *
2 The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category. My load isn’t ready, you are costing me money
3 The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace. I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
Youthful stupidity
I am not paid enough *
4 The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim. I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5 Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs. Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more. Read Part II of this series on intentional adulteration.

Cannabis, gavel

CBD Marketplace: How Should We Navigate It?

By Richard Blau
1 Comment
Cannabis, gavel

Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.

Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.

Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.

Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.

Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.

Cannabis, gavel
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.

Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”

Is CBD legal in America? The answer is: “It’s complicated.”

The Details Behind CBD, Legalization and Marketing

CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”

The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.

The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.

Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.

According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.

Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.

Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.

In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.

Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.

Pages: 1 2
magnifying glass

Advances in GC-MS/MS Enhance Routine Detection of Dioxins and Dioxin-like Compounds in Food and Animal Feed

By Richard Law
1 Comment
magnifying glass

Dioxins are highly toxic organic compounds that can remain in the environment for extended periods. These persistent organic pollutants (POPs), which include polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), are mainly generated by the combustion or manufacture of chlorine-containing materials such as plastics. Dioxins and other closely related POPs, such as polychlorinated biphenyls (PCBs), are classed as carcinogenic by the United States Environmental Protection Agency, and present a significant threat to human health even at low levels.

Dioxins and PCBs can enter the food chain when livestock consume contaminated animal feed, and can accumulate in the fatty tissues of animals due to their high fat-solubility. As a result, over 90% of human exposure to dioxins and PCBs is through the consumption of meat, fish, dairy and other foods of animal origin.1 Given the health risks posed by dioxins and PCBs, effective food testing workflows are essential to ensure products do not exceed regulatory-defined safe levels.

GC-MS/MS: A Robust Technique for Analyzing Dioxins and PCBs in Food and Animal Feed

To control human exposure to PCDDs, PCDFs and PCBs from the food chain, global regulatory bodies have established maximum levels (MLs) and action levels (ALs) for various POPs in food products, as well as approved analytical methods for food testing laboratories to enforce these standards. In the European Union (EU), for example, European Commission regulations 2017/644 and 2017/771 outline sampling, sample preparation and analysis protocols for the detection of dioxins and other dioxin-like compounds in food and animal feedstuffs.2,3

With food testing laboratories tasked with handling potentially hundreds of samples every day, these workflows must be supported by robust and reliable analytical technologies that can confidently identify and accurately quantify dioxins and PCBs with minimal maintenance requirements in order to minimize downtime and maximize throughput.

Thanks to ongoing improvements in the robustness and sensitivity of gas chromatography-triple quadrupole mass spectrometry (GC-MS/MS) systems, regulations were updated in 2014 to permit this technique as an alternative to gas chromatography-high resolution mass spectrometry (GC-HRMS) for confirmatory analysis and for the control of MLs and ALs. The latest GC-MS/MS systems are capable of exceptionally reliable performance for the routine analysis of dioxins and PCBs, providing accurate and sensitive quantification of these compounds even at trace levels.

Case Study: Sensitive and Reliable Determination of Dioxins Using GC-MS/MS

The performance of modern GC-MS/MS systems was evaluated in a recent study involving the confirmatory analysis and quantification of 17 PCDDs and PCDFs, and 18 dioxin-like and non-dioxin-like PCBs in solvent standards and various food and feedstuff samples. The samples were analyzed using a triple quadrupole GC-MS/MS system equipped with the advanced electron ionization source (AEI) and a TG-Dioxin capillary GC column. Two identical GC-MS/MS systems in two separate laboratories were used to assess the reproducibility of the method.

Extraction was performed by Twisselmann hot extraction or pressurized liquid extraction. The automated clean-up of the extracts was performed using a three-column setup, comprising multi-layered acidic silica, alumina and carbon columns. Two fractions were generated per sample (the first containing non-ortho PCBs, PCDDs and PCDFs, and the second containing mono-ortho and di-ortho PCBs and indicator PCBs) and these were analyzed separately. The analytical method gave excellent separation of all the PCDD, PCDF and PCB congeners in less than 45 minutes.

Given the high sensitivity of modern GC-MS/MS instruments, a calibration-based approach was used to determine limits of quantitation (LOQs) of the analytical system. Using calibration standards at the LOQ and subsequent check standards at this level enabled the performance of the method to be assessed throughout the analytical sequence. This also allowed LOQs for the individual congeners to be determined, assuming a fixed sample weight. Individual congener LOQs could be applied to upper-bound, middle-bound and lower-bound toxicity equivalence (TEQ) results by substituting the result of any congener that fell below the lowest calibration point with this value multiplied by the toxicity equivalence factor (TEF) of the congener.

To evaluate the response factor deviation over the course of the analytical sequences, standards at the specified LOQ were analyzed at the start, during and end of each run. Using a nominal weight of 2 g, and assuming 100% 13C-labeled standard recovery and all natives were less than the LOQ in the sample, a minimum upper-bound value of 0.152 pg/g WHO-PCDD/F-TEQ was determined. This met regulatory requirements for reporting at 1/5th of the ML upper-bound sum TEQ for all food and feedstuffs with a nominal intake of 2 g, with the exception of guidance associated with liver of terrestrial animals and food for infants or young children, which both have legal limits defined on a fresh weight basis. In these cases, either a larger sample intake or a magnetic sector instrument would be required. All of the calibration sequences demonstrated response factor %RSDs within EU regulations, highlighting the suitability of the method.

To demonstrate the performance of the GC-MS/MS system, six replicate extractions of a mixed fat quality control sample (QK1) were prepared, split between the two sites and analyzed at regular intervals throughout the analytical sequences (14 injections in total). The measured WHO-PCDD/F-TEQ values for congener were in excellent agreement with the reference value provided by the EU Reference Laboratory for Halogenated POPs in Feed and Food, and the upper bound WHO-PCDD/F-TEQ value did not deviate by more than 6% from the reference value for all 14 measurements (Figure 1). The deviation between the upper-bound and lower-bound WHO-PCDD/F-TEQ for each measurement was consistently less than 1.2%, well below the maximum limit of 20% necessary to support compliance with EU regulations.

pper- and lower-bound WHO-PCDD/F-TEQ values
Figure 1. Upper- and lower-bound WHO-PCDD/F-TEQ values for all 14 measurements of the QK1 mixed animal fat quality control sample, for six replicate extractions.

Robust Routine Analysis of Dioxin and Dioxin-like Compounds

To assess the robustness of the GC-MS/MS system, the PCDD, PCDF and non-ortho PCB extracts were pooled into a mixed matrix sample and analyzed more than 161 injection sequences across a period of approximately two weeks. Each sequence consisted of 40 matrix injections and 40 LOQ standards, interspersed with nonane blanks. No system maintenance, tuning or user intervention was undertaken throughout the two-week study. Figure 2 highlights the exceptional peak area stability achieved for selected PCDD and PCDF congeners.

Peak area repeatability
Figure 2. Absolute peak area repeatability over two weeks of analysis for selected PCDD and PCDF congeners in a pooled matrix sample (%RSD and amounts on column are shown for each congener).

These results highlight the exceptional levels of day-to-day measurement repeatability offered by the latest GC-MS/MS systems. By delivering consistently high performance without the need for extensive maintenance steps, modern GC-MS/MS systems are maximizing instrument uptime and increasing sample throughput for routine POP analysis workflows.

Conclusion

Developments in GC-MS/MS technology, namely the advanced electron ionization source, are pushing the limits of measurement sensitivity, repeatability and robustness to support the needs of routine dioxin and PCBs analysis in food and feed samples. By minimizing instrument downtime while maintaining exceptional levels of analytical performance, these advanced systems are helping high-throughput food testing laboratories to analyze more samples and ultimately better protect consumers from these harmful pollutants.

References

  1. Malisch, R. and Kotz, A. (2014) Dioxins and PCBs in feed and food – Review from European perspective. Sci Total Environ, 491, 2-10.
  2. European Commission. Commission Regulation (EU) 2017/644, Off J Eur Union, 2017, L92 9-34.
  3. European Commission. Commission Regulation (EU) 2017/771, Off J Eur Union, 2017, L115 22-42.

Acknowledgements

This article is based on research by Richard Law and Cristian Cojocariu (Thermo Fisher Scientific, Runcorn, UK), Alexander Schaechtele (EU Reference Laboratory for Halogenated POPs in Feed and Food, Freiburg, Germany), Amit Gujar (Thermo Fisher Scientific, Austin, US), and Jiangtao Xing (Thermo Fisher Scientific, Beijing, China).

How Do Canadian Food Industries Perceive Food Fraud, and How Do They Manage the Threat?

By Virginie Barrere, Ph.D.
No Comments

Food fraud has been at the center of attention recently and has highlighted inconsistencies in the food industry and supply chain management. Both consumers and regulators are demanding or imposing new standards for assuring the authenticity of food products. In such a context, food industries have to use their knowledge, perceptions and experience to answer and comply with regulators, consumers, and (for some) GFSI requirements regarding food fraud management. However, one can ask how ready and aware food industry players are to understand, mitigate and tackle food fraud. With those questions in mind, the research team of the CIRANO at Montreal, Canada led by Professor Nathalie de Marcellis-Warin and the research team of the PARERA platform at Laval University, Quebec, Canada led by Professor Samuel Godefroy had developed a survey of 52 closed questions to assess the awareness and the perceptions of Canadian food industries toward food fraud and what actions they had already implemented to mitigate their risks. The survey included six main sections:

  1. Food fraud definition
  2. Perceptions of food fraud burden globally and locally
  3. Food fraud regulations
  4. Food industry responsibility towards food fraud
  5. Their capacities to prevent and manage this aspect of food quality and safety
  6. Food fraud prevention practices, detection methods and their implementation.

A total of 398 Canadian food industries took the survey; they were food processors, producers (crop, livestock, and fisheries), and distributors (agricultural wholesalers, wholesaler-merchants, and retailers). They will be referred to as Food Business Operators (FBOs) or processors, producers, and distributors when a difference was highlighted between sectors.

What Is the Level of Knowledge of Food Fraud?

Firstly, there is no current data on knowledge of food industry operators on food fraud, hence, the research team proposed definitions and the respondents had to identify which ones could refer to food fraud (1) An intentional and deliberate act (2) False or misleading statements for economic gain and (3) An act aimed at misleading the consumer. More than nine FBOs assigned the definitions to food fraud, hence showing a good understanding of what food fraud is. In an additional question some examples of food fraud were proposed:

  1. Hidden mix of a liquid with another liquid of lower quality
  2. Hidden information about a product or one of its ingredients
  3. Hidden replacement of a product or one of its ingredients by a product of lower quality
  4. Labeling containing false claims
  5. Addition of a non-approved or illegal ingredient.

Again, more than 90% of the FBOs were able to identify those cases as food fraud. The answers to the first questions suggested that Canadian FBOs understand what food fraud is.

Was Your Company a Victim of Fraud?

The authors asked the respondents if they think or know that their company has already been the victim of food fraud in the past or recently. Besides, the respondents were asked to assess how safe their company is towards food fraud. More than a third of the respondents reported to have been a victim of fraud in the past, but sectors answered differently. In fact, while 40% of processors and 48% of the distributors answered it was likely or very likely that their company had been a victim, only 24% of the producers gave this answer. In parallel, one third of the respondents agreed that their business is safe from food fraud, however, the results per sector were statistically different: 42% of the producers agreed while only a quarter of the processors and the distributors felt safe from food fraud. Those results indicated a shift between producers and the two other sectors; the producers seem to feel less impacted and concerned by food fraud.

Who Is Responsible for Managing Food Fraud?

Depending on where the FBO is in the supply chain, one can make the hypothesis that this company might not feel responsible for the authenticity of the products it buys or sells. The survey authors asked respondents if they considered themselves as responsible for the products’ authenticity they would buy or sell to consumers or an intermediate. Among the three sectors, 82% of the respondents considered themselves as responsible for the products they received from the suppliers, and 80% for the authenticity of the products they sell to consumers. However, only half consider they are responsible for the product authenticity once it is processed or sold by a client. It was reassuring to see that FBOs understand fraud and consider themselves as responsible for ensuring food authenticity. One can argue that this perception will positively impact the robustness of their mitigation measures and the controls of food fraud.

Which Measures Have Canadian FBOs Implemented to Prevent Food Fraud?

FBOs mainly implemented a supply chain traceability system to mitigate food fraud. This result was not surprising, as traceability has to be in place to comply with current requirements for food safety and food quality. The vulnerability assessment is a recommended (or required) procedure to implement in food industries to comply with regulations and certifications such as GFSI, and 36% of the FBOs have implemented this measure (half of the processors). Finally, detection methods were implemented by only 27% of respondents. Interestingly, through another question, those three measures were seen as the more efficient way to fight food fraud according to the respondents. Also, FBOs would rely on a stable and long-term relationship based on trust with their supplier to mitigate food fraud and rated this measure as an efficient way to fight food fraud. Audits of suppliers and ingredient authenticity checking were also perceived as efficient but were not implemented as frequently. The lack of human resources, financial means, training, and time were the reasons why processors and distributors did not implement more measures to counter food fraud. Interestingly, the primary reason producers selected was “the system in place was enough” followed by lack of financial means, human resources and time and “food fraud is not an essential stake for our company.” One can relate this difference between the sectors with the observation made earlier on how safe the producers feel compared to the two other groups. Regarding detection methods, 88% of the FBOs rated their knowledge of those technologies as moderate or low, and 77% of the respondents rated the frequency of food fraud detection technologies as “never to rarely”. The reason why detection methods are not applied more was the lack of financial means, and the system in place is adequate to control food fraud.

Also, If They Identify Fraud, What’s Next?

Lastly, the authors asked what the respondent would do if their company identified an incident of fraud. Most of the respondents (69%) said they would speak to their supplier; this affirmation can be associated with the strong and long-term relationship the company would have with the supplier. The second option chosen was to change the supplier and then inform the authorities. The respondents could answer several questions, and one can hypothesize that their actions following the identification of fraud would depend on the severity of the fraud and its impacts on both the consumers and the company.

Conclusion

In summary, this survey is the first to assess the knowledge, perception and readiness of FBOs to fight food fraud. Results have indicated that Canadian FBOs understand what food fraud is but data is missing to support their perception that fraud is more present abroad than in Canada. Two third of the respondents feel unsafe towards food fraud which should be seen as positive point; in fact, FBOs would be keener to implement measures to protect themselves if they feel unsafe. Besides, a majority feels responsible for the authenticity of the products they sell to consumers. Respondents tend to implement preventive measures but perceive other measures as more efficient to counter fraud. Apparently, those measures seem to be too expensive, time-consuming and resource-consuming. Besides, lack of training on food fraud management was also reported as an impediment to fight fraud. Finally, differences have been highlighted along the survey between producers and the two others sectors: Processors and distributors. One can hypothesize that producers might feel less concerned by food fraud being at the very beginning of the food chain supply and that most food fraud cases involve their clients and not the producers directly.

Footnotes

  1. More details and more results are presented in a manuscript submitted by the research team: Food industry perceptions and actions towards food fraud: Insights from a pan Canadian study.
  2. Researchers involved in the project from the CIRANO: Yoann Guntzburger, Ingrid Peignier and Nathalie de Marcellis-Warin and from the PARERA platform Jeremie Theolier, Virginie Barrere and Samuel Godefroy. Partners: r-Biopharm, EnvironeX, the Quebec consortium for industrial bioprocess research and innovation (CRIBIQ), NSF, Transbiotech, and Olymel.