Debadeep Bhattacharyya, Thermo Fisher Scientific
In the Food Lab

Pushing The Limits Of Targeted Pesticide Residue Quantitation: Part 2

By Debadeep Bhattacharyya, Ph.D.
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Debadeep Bhattacharyya, Thermo Fisher Scientific

Detection and quantitation of pesticide residues in food is extremely important in food safety. Given the challenge of evaluating multiple pesticides at low levels across various samples, laboratories are in constant need of robust, reliable and sensitive analytical methods.

The risk of unauthorized pesticide overuse can increase residue concentrations in food, thereby, causing severe health issues. Global food safety bodies strictly regulate the levels of pesticides allowed in food products. In the European Union for instance, legislation in the form of Directive No 752/2014 sets statutory maximum residue limits (MRLs) for more than 1000 pesticides in food products of plant or animal origin.1 The number of pesticides and their allowed concentrations are necessary to ensure consumer safety, and are amongst the strictest in the world, permitting concentrations in products at levels typically as low as several parts-per-billion (ppb).

The requirements to achieve such low limits of quantitation for all analytes in a complex matrix present a significant analytical challenge for the food safety laboratories tasked with making a confident assessment of every sample. With perishable products such as fresh fruits and vegetables under routine analysis, these results need to be achieved within very short turnaround times and at a low cost per sample to meet lab managers’ budgets.

Advances in LC-MS/MS Technology

Recent advances in triple quadrupole technology have offered an additional boost to the existing analytical capabilities of liquid chromatography tandem mass spectrometry (LC-MS/MS). The segmented quadrupoles, faster rod drivers and more powerful electron multipliers can enable analysts to achieve the desired levels of robustness, mass accuracy, precision and sensitivity required to meet this challenge.

Improvements in instrument detection capability are pushing the limits of quantitation even further. Figure 1 highlights the amplified sensitivity of a triple quadrupole spectrometer for the determination of two pesticides in a leek sample—a particularly complex matrix with a high moisture content. For both chlormequat and 2-methyl-4-chlorophenoxyacetic acid (MCPA), the spectrometer delivers enhanced performance, giving analysts the ability to quantify residues far beyond the current limits required for MRL determination.

mass spectrometers
Figure 1. Representative chromatograms of chlormequat (positive ionization mode) and 2-methyl-4-chlorophenoxyacetic acid (negative ionization mode), in leek extract monitored using the TSQ Quantis MS (blue trace) and the TSQ Endura triple quadrupole MS (red trace) mass spectrometers.

Robust, Reliable and Reproducible

With potentially hundreds of perishable samples to analyze each day, food testing laboratories not only require the ultimate sensitivity, but sensitivity should be supported by speed and robustness.

One way in which analysts are achieving higher analytical throughput is through the use of shorter instrument dwell times. Although short dwell times in the past enabled productivity of sample analysis (more samples at the same time), they often came at the expense of robustness and sensitivity of the results. With the latest advances in triple quadrupole technology, short dwell times no longer compromise analysis.

Very effective quantitation of pesticide residues can be achieved using timed selection reaction monitoring (SRM). With the timed SRM approach, data acquisition is performed within a short retention time window around each compound of interest. This approach reduces the number of transitions that are monitored in parallel within the retention time window, while ensuring consistent quantitation even at low concentrations (see Figure 2).

Pesticide Residue Quantitation
Figure 2. Comparison of azoxystrobin peak areas (1 μg/kg in leek) obtained on 10th injection and 410th injection. Peak areas are consistent even when a low dwell time of 2.5 ms is used. The 410th injection demonstrates an adequate number of data points across the peak.

Another important point to consider is workflow robustness. For busy laboratories with large workloads and tight turnaround times, time-consuming daily instrument recalibration and frequent maintenance simply isn’t a viable option.

Triple quadrupole instruments are renowned for their experimental reliability that is delivered for every fast-paced environment, and the latest instruments are pushing expectations even further. Figure 3 demonstrates the precise levels of measurement reproducibility that can be achieved using a triple quadrupole MS. Peak areas for the pesticide residue atrazine, added to a leek sample at a concentration of 10 μg/kg, remained well within the expected ±20% range over 400 injections. Even when the system was placed into standby mode for 12 hours and subsequently restarted, consistent measurements could be obtained without any additional maintenance.

Pesticide Residue Quantitation
Figure 3. Atrazine peak areas (10 μg/kg in leek) monitored over 400 injections. Red lines represent ±20% atrazine response. Yellow lines show the point at which the system was placed in standby mode for 12 h. No system maintenance was performed between injections.

Conclusion

Technical advances in instrumentation and improvements in procedures have generated more robust LC-MS/MS processes to definitively detect trace pesticide residues. With limits of quantitation growing increasingly stringent year on year, such advances in technology are not only helping laboratories meet the quantitation challenges of today, but also prepare for those of tomorrow.

References

1. Commission Regulation (EU) No 752/2014 of 24 June 2014 replacing Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council, 2014.

Acknowledgements

This article is based on research by Katerina Bousova, Michal Godula, Claudia Martins, Charles Yang, Ed Georg, Neloni Wijeratne & Richard J. Fussell Thermo Fisher Scientific, Dreieich, Germany, Thermo Fisher Scientific, California, USA, Thermo Fisher Scientific, Hemel Hempstead, UK.

Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
1 Comment
Lance Roberie, D.L. Newslow

As a food safety plan manager, do you ever get asked these questions regarding your food safety plan: What was your thought process for making this decision? Why do you do it this way? How do you answer this?

And, do you ever answer with one of the following statements:

  • I’m not sure? What do you mean?
  • That’s the way it has always been.
  • Our customer asked us to do it that way.
  • That’s what our last auditor recommended.
  • We make a low-risk product.

If this is one of your answers, defending your food safety plan may be a challenge. There is a major shift taking place in the world of food safety. With the implementation of FSMA Preventive Controls, the widespread adoption of GFSI audits, along with advanced technologies such as rapid pathogen and allergen detection, whole genome sequencing, and transparency efforts such as Blockchain, as well as with the increasing use of social media and access of information via the internet, food industry professionals are more educated and informed than ever before and ready to challenge your every move. As a food safety plan manager, you and your team must be ready! Being prepared to defend your food safety plan can be the difference between a recall and a routine audit. If you cannot fully explain the reasoning behind your decision-making, then how will you be able to prove that you are in complete control and are being proactive against food safety hazards? It will not be easy.

You must be ready to defend each and every part of your food safety plan. You must be able to defend questions and challenges with certainty and facts. Every decision made in your hazard analysis should be written down and backed with factual evidence whenever possible. Even the “none identified” areas should be backed by strong reasoning if no other factual evidence is available. You can use the data that you collect daily to help justify your decisions. Data collected from your prerequisite programs (ATP swab results, allergen cleaning validations, GMP audit findings, pest control trends, etc.) and food safety plan (CCP’s, validations, verifications) is all support for your decisions. Have this on file and ready to review when necessary.

If something looks out of the ordinary in your plan, make sure you can fully explain it and can back it with solid justification. If not, auditors, regulators, customers, etc. may start to become suspicious, which can lead to unwanted questions. You will then oftentimes start to get suggestions for change based on others’ individual expertise. Regulators may make “strong suggestions” for changes, for instance, and some people will just go along with it to avoid the pushback or because they simply don’t have a better solution. If this happens, soon your plan is no longer yours—it’s everyone’s. Some of these suggestions may be good, but is it really the right change for your plan? If not, it will often make the plan less rational and often difficult to defend.

The following are tips to help you avoid this situation.

  1. Meet with your food safety team regularly. Go through each part of your food safety plan and figure out how to answer the “why’s”. Why are things done this way? Why did we decide if this hazard was significant or not? Have annual reviews to make sure your plan is still functioning as originally intended and review new industry trends to be proactive regarding new potential hazards.
  2. Write a process narrative. Writing a process narrative documenting what happens at each step of your process and explaining your “thought process” for making decisions is a great support tool. It gives your team a chance to elaborate on the “justification” column in the hazard analysis, providing more decision-making details without crowding the hazard analysis form.
  3. Gather supporting documents. Scientific studies, guidance documents, expert opinions, etc. are vital pieces to have in your supporting documents library. Make sure it is appropriate for your individual products and the documents are from reputable sources, such as FDA, USDA, universities, process authorities, etc. Oh, and don’t forget about history! A reputable supplier with a long track record of safe product, a low history of recalls for the products you produce, etc. can help justify your decision-making.
  4. Conduct Internal Audits. Having an internal audit schedule and well-trained internal auditors help with finding inconsistencies within your program and allow you to make corrections before outside parties find these issues.
  5. Prepare. Have a “mock audit” and prepare for questions that are commonly asked during audits. Practice your answers and make sure you have supporting evidence when needed. Stay up-to-date with industry trends, especially common audit non-conformances.
  6. Be organized. It’s great to have all the supporting documents that you need, but if you cannot find them, then you just as well have nothing.
  7. Be confident. People, especially experienced auditors and inspectors, can quickly sense fear and lack of confidence. This often prompts more questions. Knowledge is power, and knowledge also builds confidence. Simply put, the more knowledgeable you are about your food safety plan, the more confident you will be when someone is trying to test you.
  8. Continuously Improve. It’s understandable that mistakes will be made. However, the next logical question you will be asked is: What did you do about it? Remember, for every nonconformance you find in your system, there should be a correction or corrective and preventive action to address it. It must not simply restate the problem, but legitimately correct the issue. This will give regulators, auditors, customers and anyone else looking at your system confidence that you are in control and can provide a consistently safe product.
Debadeep Bhattacharyya, Thermo Fisher Scientific
In the Food Lab

Pushing The Limits Of Targeted Pesticide Residue Quantitation: Part 1

By Debadeep Bhattacharyya, Ph.D.
2 Comments
Debadeep Bhattacharyya, Thermo Fisher Scientific

Robust, reproducible quantitation of pesticide residues in food is the most important step in ensuring food safety, and hence, forms one of the most important responsibilities of every food safety laboratories. The analytical process involves characterization and identification followed by quantitation of pesticides across different food matrices. Considering the growing list of pesticides and their adverse effects even for very low concentrations, quantitation with confidence for every sample can pose some significant challenges to the analytical scientist.

Typical practices of using pesticides to control pests and improve yields can often pose a serious risk to human health if and when used inappropriately. Improper use of pesticides in breach of approved procedures, or those that are applied to crops for which their use has not been authorized, unacceptable amounts of these potentially dangerous compounds can find their way onto the plates of consumers.

In order to ensure food is safe for consumption, laboratories require robust, reliable and cost-effective workflows, incorporating highly effective sample preparation steps, separation methods and detection techniques. Owing to its selectivity, specificity, sensitivity, robustness and universal approach, liquid chromatography coupled to triple quadrupole mass spectrometers (LC-MS/MS) are widely used for quantitation of pesticides in food.

Food standards are growing increasingly stringent, so leading laboratories must ensure they consistently meet the requirements of regulators. Thankfully, the latest comprehensive pesticide workflow solutions are helping laboratories deliver the very highest quality of pesticide quantitation, on time and on budget.

Optimizing Sample Preparation

Regardless of the food product that is being tested, pesticide residue workflows typically start with sample preparation, following homogenization and residue extraction steps. This stage is one of the most important parts of the workflow, however, very often they are not highlighted.

The heterogeneity of the sample matrix, as well as the wide variety of pesticide compounds that must be extracted, can significantly add to the complexity of this task. For example, pesticide residues can be lost during sample grinding, compromising the accuracy of quantitative analysis. Loss of critical pesticides can also occur through hydrolysis by water or enzymatic degradation as enzymes are released from cells, or by the formation of insoluble complexes due to interaction of the analyte with matrix components. Each of these factors can impact the quantitation of pesticide residues in food.

Homogenization is followed by solvent extraction and cleanup. Extraction could traditionally be a time-consuming process, often requiring relatively large amounts of sample, and involving use of multiple solvents and work-up steps. In addition, results from this step can vary based on matrix type and pesticides that are being monitored. Time-consuming sample cleanup steps, based on separation techniques such as gel permeation chromatography, could also be necessary, thereby adding another layer of complexity.

The widespread adoption of sample preparation strategies based on QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) methods has significantly simplified the process of residue extraction for a wide range of food types, especially for high-moisture content samples. These generic extraction approaches, coupled with “quick and easy” cleanup techniques such as dispersive solid phase extraction, are able to comprehensively extract residues with a range of different chemical properties, resulting in more consistent and reliable quantitation.

The universal and easy-to-implement nature of QuEChERS methods has also allowed laboratories to reduce the complexity of their workflows. Their simplicity is such that many suppliers are now offering all-in-one kits containing all of the necessary pre-weighted reagents and supplies, which laboratories can use straight from the box. And as they require very little sample material, solvent or equipment, and eliminate the need for time-intensive homogenization steps, they are also helping to reduce laboratory waste and cut operational costs.

The Need for LC-MS/MS Technology

Once analytes are extracted from the matrix, food safety laboratories require reliable, sensitive and precise separation, detection and quantitation technologies to determine their concentration.

As indicated above, LC-MS/MS technology with triple quadrupole mass spectrometers are often the go-to choice for quantitation applications. The high selectivity and sensitivity of these instruments allow analysts to confidently identify pesticides against target lists and accurately quantify even trace levels. Figure 1 shows the distinct separation obtained for a leek sample spiked with more than 250 pesticides at a concentration of 100 µg/kg. The mass range, robustness, specificity, selectivity of the triple quadrupole instrument ensures the ability to handle a wide variety of sample types and deliver reliable results in a cost-effective manner.

Pesticide Residue Quantitation
Figure 1. LC-MS/MS chromatogram of leek extract spiked with more than 250 pesticides at 100 μg/kg. Results were obtained using a UHPLC system coupled with a triple quadrupole MS.

Conclusion

To ensure the food on our plates does not contain potentially harmful levels of pesticides, laboratories require robust workflows for their analysis and targeted quantitation. Improvements in the sample preparation methods that are used to extract pesticide residues from food samples, as well as in the sensitivity, accuracy, robustness and reliability of the triple quadrupole instruments used for analyte detection, are helping food safety laboratories confidently quantify these compounds even in trace amounts.

Acknowledgements

This article is based on research by Katerina Bousova, Michal Godula, Claudia Martins, Charles Yang, Ed Georg, Neloni Wijeratne & Richard J. Fussell, Thermo Fisher Scientific, Dreieich, Germany,  Thermo Fisher Scientific, California, USA, Thermo Fisher Scientific, Hemel Hempstead, UK.

Adam Serfas, R.S. Quality
FST Soapbox

Color Coding Helps Brewers Button Up QA Procedures

By Adam Serfas
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Adam Serfas, R.S. Quality

The passage of FSMA sparked industry-wide tightening of food safety standards. Perhaps one industry that has been affected more than others is brewing. Prior to the passage of this sweeping legislation, brewers weren’t held to the same standards as other food manufacturers and food processors. The act’s new categorization for brewers as “food” means that the FDA now has some jurisdiction over the industry in conjunction with the Alcohol and Tobacco Tax and Trade Bureau (TTB).

This increased scrutiny, particularly in the event of a recall, has caused many brewers to look to color-coding as a measure to tighten up their quality assurance protocols. Fortunately for brewers, there are many benefits to incorporating color-coding, making the process a worthwhile one.

Happy Inspectors

Perhaps the most immediate effect of incorporating color-coding in a facility is delighting any inspectors that may drop in. A color-coding plan is a documented method for evaluating potential hazards and implementing precautionary measures to preventing contamination—all things inspectors want to see. Failure to live up to these standards can result in follow up inspections and, in some cases, fines.

Proper Tool Usage

A color-coding plan indicates where and when a tool is to be used. While mistakes can still be made, a clear plan that is reflected in all tools and paired with adequate signage and training makes it much more likely that a tool will be used properly. Much of the equipment in a brewery is very expensive and can be easily damaged by using the wrong tool. For example, if an abrasive brush were to be used on a stainless steel tank, there can be irreparable damage.

Higher-Quality Tools

Tools that are color-coded are generally made at a food-grade, FDA-approved quality. This means they are much less likely to leave behind bristles, a potential contaminant you wouldn’t want finding its way into the product. Additionally, many breweries make use of caustics and acids followed by sanitizers in the cleaning process. A low-quality tool will degrade at a much higher rate as a result of coming into contact with these chemicals than a higher quality tool will. Simply put, higher quality tools last longer, saving you money in the long run.

Less Tool Wandering

A color-coding plan should indicate where a tool is used and where it is stored when it is not being used. When tools have this designated storage area they are much less likely to be carelessly misplaced. And in the event of a lost tool, it becomes much easier to recognize these tool gaps and replace as necessary sooner rather than later to ensure that the proper tool is always used for the task at hand.

Higher Efficiency

When protocols are in place for tool usage, time isn’t wasted finding the correct tool for the job. This may seem insignificant, but over time those lost minutes can add up.

Removal of Language Barriers

For facilities that employ foreign speakers, color-coding is extremely helpful in breaking down language barriers. A brewery production area can be a busy, fast-paced environment, so it is helpful to have a plan in place that is easily recognizable and understood by all employees.

It is however important to consider the fact that you may need to keep in mind the visibility of these colors for colorblind employees. It’s best to try to use high contrast colors in your plan.

Greater Traceability

Finally, in the unfortunate event of a recall, a color-coding plan helps add traceability potentially decreasing the amount of product that needs to be pulled from shelves. Certainly color-coding helps to prevent contamination issues that can cause a recall.

A well thought out color-coding plan that is carefully implemented can have numerous benefits in breweries both small and large. For questions related to drafting a color-coding plan from scratch or updating an existing plan, contacting a color-coding specialist is recommended.

Megan Nichols
FST Soapbox

Blockchain Improves Visibility In the Food Supply Chain

By Megan Ray Nichols
2 Comments
Megan Nichols

Cryptocurrency is a favorite topic in the business world currently, but it’s not the coins or currency that are the star of the show. Bitcoin in and of itself is exciting and promising from several perspectives. However, the foundation of what these technologies run on is much more important. You likely already know what we’re going to talk about next: Blockchain.

To understand why blockchain is considered so crucial, you first need to delve into the core components of the technology. It’s basically a digital ledger, except it has some incredibly useful properties that make it uniquely lucrative. For starters, it’s public and transparent, so anyone with access to the network can see what’s happening in the moment, or what has been happening while they were away. However, the parties involved in a transaction or entry remain private, as do the materials or items exchanging hands.

Finally, because of the nature of blockchain, it’s secured and valid. The ledger itself is thoroughly protected, and no one can alter data save the parties involved. Even then, the relevant parties only weigh in with pertinent information such as time and date of the transaction and the amount transferred.

Most of what we’re talking about here is in reference to currencies and more traditional transactions. But it’s important to remember that we’re merely scratching the surface. As we speak, various organizations are working to adapt this technology for alternate industries and applications.

Still, what does any of this have to do with your average food supply chain?

Blockchain May Evolve the Food Supply Chain As We Know It

Believe it or not, blockchain can help improve the transparency and management of the food supply chain. It’s definitely needed. The world’s population continues to grow, and it’s expected to reach 10 billion by 2050. In food requirements, that means we’ll need to be increasing food production by as much as 70% to keep up. This puts a demand on the food supply chain to evolve and become more efficient, more accurate and more reliable.

The following are several ways blockchain can help achieve better transparency in and management of the food supply chain.

Preventing Foodborne Outbreaks, Enabling Fresher Goods

IBM has teamed up with several major suppliers including Wal-Mart, Dole and Nestle to come up with a blockchain-powered system that can be used to track a product’s journey from farm to store shelves. The goal is to create a more transparent deployment and transportation process so that interested parties can see exactly when and where certain foods might become contaminated.

Tracking this information will achieve a couple of things. For starters, public health officials, suppliers and management teams can help limit and prevent contagions from spreading. After the detection of Salmonella, for instance, they could mark all related goods as a risk and stop both stores from selling them and consumers from buying faster than ever before.

Second, it will help identify problematic systems and processes, hopefully cutting down on the risk of contamination in the future. If they know certain foods are going bad in transport, they can discern that it’s something to do with how they’re handled or stored along that segment of the journey. This would further enable them to identify and fix or optimize the issue. In other words, suppliers and retailers will use blockchain to keep food fresh. This is especially important since FSMA calls for reliable hygiene and storage methods during transportation.

More Accurate Inventory Tracking for Distributors

Unexpected shortages pose significant challenges to the food supply chain. A variety of external factors can contribute to a supply block, including inclement weather, poor soil, insect infestations, equipment failures and much more. When this happens, distributors are left to pick up the slack, but sadly, they often can’t do much to fix the problem.

Blockchain technologies, however, make the supply chain more transparent, which helps distributors get the information they need to address shortages. Through the use of blockchain, they’ll know exactly how much supply is available and what they need to do to ramp up their offerings.

For example, in the event of a shortage, they might connect with local farmers to make up the difference. Gathering the information needed to find the right partner, however, can take a long time when using traditional methods. Through blockchain, though, distributors could easily see product types, farming practices, harvest dates and amounts, treatment info, fair-trade certifications and other information. This would allow them ample time to find a suitable replacement or additional partner.

Transparent Safety Protocols

The food supply chain is lengthy, includes a lot of different parties and involves a lot of metrics and details that need to be recorded and monitored. The problem with having so many factors is that it can muddy the waters. It’s hard to keep track of what every party is doing, where problems exist and what improvements can be made.

Many modern food supply providers are as transparent as they can be with partners and colleagues, but it’s not an element you would describe as streamlined or accessible to all. Blockchain can completely alter and disrupt this for the better.

Since food safety is an enormous concern for suppliers, distributors and retailers, blockchain can offer more than just peace of mind. It can help organizations perfect the entire process, improving safety for consumers and even enhancing the freshness or quality of the products provided. Improper storage or transport, for instance, can have a detrimental effect on quality, before the goods even reach store shelves. Blockchain will enable better tracking and monitoring, and make the resulting details much more accessible and transparent.

It’s Time for the Food Supply Chain to Evolve

The coming change is warranted and welcomed by many. A more transparent process means a much more accessible system. Suppliers can better communicate with farmers and food sources. Distributors and retailers can keep a close eye on the goods they’re acquiring and offering to consumers. Furthermore, safety, quality and quantity can be more accurately monitored and measured by everyone along the way. It’s time for the food supply chain to evolve in this way — it’s been a long time coming.

Amy Kircher, Food Protection and Defense Institute
FST Soapbox

2018 Food Defense Outlook

By Amy Kircher, DrPH
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Amy Kircher, Food Protection and Defense Institute

As we look to 2018, the need for food defense activity remains. Increased adulteration incidents in 2017, consumer purchasing trends and FSMA rules implementation drive this need and the work necessary to complete it in 2018.

Intentional Adulteration of Food. It was evident that intentional adulteration of food did not diminish over the past year and likely increased. Adulteration cases of spices with undeclared ingredients to extend the product or boost color were documented. Terrorists plans and food adulteration tests were uncovered and publicized. In Germany, a man threatened to put antifreeze in the nation’s baby formula supply chain. And disgruntled employees continued to adulterate food to get revenge on their employer or co-workers. Given the complexity of our food system and the limited transparency of supply chains from farm to fork, those willing and able to adulterate will continue to do so in 2018.

Consumer Demands. Look in your local grocery aisles and you will find an ever-increasing section of “freedom foods”. These are foods that claim to be free of something whether it be gluten, lactose, pesticides or GMOs. With increasing frequency consumers are also asking questions about the sustainability and agriculture practices of the food they buy. How have the oceans been fished? Are my eggs from cage-free chickens? Does the food I buy protect the environment. Based on current trends, consumers will continue to spend their food dollars on organic, free-of, and sustainability produced food. This means food defense needs to have a keen eye on where fraudsters could adulterate products representing these food trends.

Company Food Defense. Two things have increased in the requests we are getting from companies: New incidents and the nearing deadline for compliance of the FSMA Intentional Adulteration (IA) rule. First, adulteration incidents that affect your product or the ingredients you use changes the lens you see food defense through. Even an adulteration in an ingredient or product similar to yours makes you look twice at how protected you are. With the continued incidents, companies are taking a hard look at how they are affected. Second, food companies have completed their work to prepare for the early FSMA rules such as Preventive Controls and Foreign Supplier Verification moving their attention to the next rules. The IA rule compliance dates begin in July 2019, and we anticipate increased activities, questions and food defense efforts in 2018.

As you can see, there is a nexus of need to accomplish defense work in our food system. Perhaps 2018 will be “the” year of food defense where individually and collectively we close vulnerability gaps.

Dana Johnson Downing, TraceGains
FST Soapbox

Six Signs Your Quality Department Is Still in the Dark Ages

By Dana Johnson Downing
1 Comment
Dana Johnson Downing, TraceGains

Increasingly, we turn to technology to simplify tasks in our personal and business lives. Platforms like Facebook and Twitter allow us to connect, shop, advertise and publish with just a few clicks. LinkedIn is where people turn to prospect for new business, publish articles, discuss issues within industry groups, and look for a job. Need a ride? Apps like Uber and Lyft can usually get you where you’re going cheaper and more easily than a taxi. Devices like Google Home and Amazon Echo can listen to your voice commands to play music, manage your shopping list, adjust your lights, or tell a joke. And experiments are underway for driverless cars, which could make us the last car-owning generation.

Food safety documentation

With technology automating and solving so many tasks, how is it possible that food production is still dependent on paper-driven and manual processes?

The current way of doing things in the food and beverage industry is outdated, labor intensive, and—most importantly—error-prone. Under FSMA, companies need to be able to justify their decisions and processes, and of course, document them. It’s not only critical for brand protection—it’s a regulatory requirement. Ignorance is not bliss. Now, senior management is obligated to demonstrate their commitment to food safety and they risk criminal prosecution if their operations don’t measure up. There’s too much at risk to keep doing things the same old way. The following are some signs that your quality department is still in the Dark Ages.

1. You’re using clipboards.

In defense of clipboards, they were a wonderful invention. They are quite well suited for gathering signatures on petitions to save the whales or signing up for a PTA bake sale. But if you’re still using clipboards to log temperatures or document sanitation procedures, then your food safety records are not as current and organized as they could be. Inputting data later is not an effective use of time. Processes like these not only take away from the core competencies of your quality team, but they also make staff spend more time analyzing everything manually, which could lead to costly mistakes or inaccuracies. Tablets and PCs have replaced paper-based logs and other quality recordkeeping. Why make your staff do a task twice? By digitizing these records, you can ensure that your records are up-to-date in real time and reduce the likelihood of errors made during transcription. Trust me, your staff will thank you for rescuing them from extra data entry. Plus, the modern workforce expects digital solutions.

Filing cabinet, food safety documentation
Still using a filing cabinet to store documentation? All images courtesy of TraceGains

2. You’re still using a physical filing cabinet to store food safety documentation.

If you’re putting your food safety plan, supplier documents and certificates of authenticity (COAs) in a filing cabinet, you have a transparency problem. Your department isn’t the only one that needs access to those critical documents. And if everyone has their own paper copy, then you are going to have problems with version control. Solve your transparency and version control problems by keeping critical documents in the cloud where the data can be extracted, analyzed and shared internally and externally across your supply chain.

Food safety documentation
Three-ring binders are no longer an appropriate place to store important information.

3. Three-ring binders are for middle school, not food safety.

If your idea of ensuring compliance involves keeping COAs in a three-ring binder, you probably still have a flip phone, too. Seriously, 1980 called and they want their Trapper Keeper back. Whether your documents are in filing cabinets or binders, you still don’t have the transparency you need to efficiently share that information with your peers and other departments. Plus, your audits are sure to drag on longer than necessary if you are doing audits with stacks of three-ring binder instead of using an online platform where you can show the auditor any documentation they need with just a few clicks of a mouse.

4. Your suppliers send critical food safety documents to you via e-mail.

Email is a great way to communicate. It’s just not the best way to gather and manage supplier documents. Admit it; we all get behind on email, and sometimes things slip through the cracks. What happens if an out-of-spec allergen declaration gets buried under the 586 emails you receive each day? I can tell you, it’s certainly not good. The alternative is allowing your suppliers to upload those documents into a platform, so they are immediately available to you and anyone else in the company that you’ve given access to the system. Leveraging a platform, you also have access to a dashboard that can quickly show you which suppliers are in compliance and which ones have issues that need to be addressed. And if you have incoming certificates of authenticity (COAs), you can sit back and rely on software to read those documents for you and spot anything that doesn’t match your specifications or purchase order details. Isn’t it time that you not only collected supplier documents, but really use that data within the documents to better manage your incoming material to ensure food safety and quality?

5. You rely on file sharing to store your food safety and quality documentation.

SharePoint and other file sharing systems may look more modern than the paper alternative, but they weren’t designed specifically for vendor management or supply chain transparency. They can file and retrieve, but it’s not automated document management. Ask yourself how long do you or fellow employees spend searching for requested documents? Perhaps you need certain documentation for your GFSI/FDA audit, but different pieces of information are stored in various locations, either in a shared drive like SharePoint or a custom vendor portal. Every minute counts when it comes to document retrieval. These systems are often a little more than an electronic filing cabinet. They can store the information electronically, but unless it’s gathering, analyzing, validating and sharing that data across all departments, you still don’t have an automated system.

Spreadsheets, food safety documentation
If you’re still using spreadsheets, consider moving data to the cloud.

6. Spreadsheets are the main source of tracking your data.

While quality managers at competing companies are investing in the latest technology, other food companies are still inputting supplier lists and data in spreadsheets. Often, managers are reluctant to move their data to the cloud, opting instead to stick with what they know by using a spreadsheet that lacks a comprehensive system to track supplier performance in real time. This is a major disadvantage when different departments need one source of the truth about supplier performance and trend data about incoming material. Not only are spreadsheets hard to share and keep up-to-date, but the majority of them also contain errors.

  • A report by Ray Panko, a professor of IT management at the University of Hawaii, found that 88% of spreadsheets contained errors.
  • Coopers & Lybrand found that 91% of spreadsheets with 150 rows or more produced results that were off by more than 5%.
  • In a sample of 22 spreadsheets, KPMG found that 91% contained serious errors.

If your executives think automated supplier, compliance and quality systems are a “nice-to-have,” chances are you are still operating in the Dark Ages. This final advice is true no matter what software your business is thinking of implementing. Whatever the aims of the system, you must choose a long-term partner. Make sure your vendor can solve these six problems and meet the needs of your business now and in the future.

Gregory Siragusa, Eurofins
Food Genomics

What’s in a Name? Probiotic Analysis and Genomics

By Gregory Siragusa, Douglas Marshall, Ph.D.
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Gregory Siragusa, Eurofins

In short, in the world of regulatory and probiotic microbiology the “name” is critical. Whether you are a probiotics manufacturer, blender or user, we are all likely aware that usage and sales of probiotic strains of bacteria and yeasts is burgeoning. Estimates of sales growth are impressive, with $24 billion and $5 billion in human and animal markets respectively projected by the year 2024.1,2Although the organisms approved as human and animal probiotic are a huge list, it is quite large and varied. Prove it to yourself by visiting your local grocery store or pharmacy and take a trip down the aisle where probiotic supplements are displayed. Read content labels and see if you recognize the microbe names. There are many probiotic organisms’ names that you are likely to be familiar with, most of which are lactic acid bacteria (LAB). However, we are quickly entering an age of more novel or even new probiotic organisms that may be unfamiliar to you. Some of which are not always as easy to culture as the LAB.3 On the same labels you may see claims of viability and cell population declarations (usually in CFU’s or colony forming units). Also, many probiotics are retailed in dry form, while others are marketed as liquids. As food safety scientists and practitioners, questions are probably popping into your head as to how probiotic species and populations are verified and how these various preparations survive expected shelf life.

Most will agree that before anyone starts consuming pills or eating foods with billions of viable bacteria, it is obviously a prudent idea that the manufacturer has the means to assure safety and quality. The details and scope of probiotic safety and microbial analysis are much too complex and broad to deal with in a few pages. For more details we direct the reader to two key publications.4,5

Identity, viability and populations are attributes largely measurable by methods that rely on culture, phenotypic analysis, genomics and combinations thereof. Here we will share a primer on genomic methods for probiotic analysis starting with a very basic aspect critical to all of microbiology—taxonomy and asking the “right” questions.

Why Not Just Perform a Plate Count? Revisiting Taxonomy

The process of identifying or classifying organisms, also known as the science of taxonomy or systematics, has sometimes been given less-than-stellar treatment among the community of microbiologists. We are frustrated when taxonomists change genus or species names just as people learned the old existing names. But every dog will have its day, and for microbial systematists, that day has arrived since application of genomic tools to the taxonomist toolbox has coincided with growth of the probiotics industry. Practically speaking, for the probiotic microbiologist, there is a lot more to a name than just nomenclature. Microbial taxonomy, and specifically bacterial taxonomy, becomes vitally important as more and more products are produced and as regulations increase in scope. Bacterial nomenclature is an ever-changing field, but at least naming has become more centralized with its own website.6

For the probiotic manufacturer, some important questions require answers: “Is it ‘my’ strain?”, “What’s in the mixture?”, “Is the label accurate?”, and “Are they alive?”. So why are we addressing this topic as a subject for Food Genomics? Confronted with the shear variety of bacterial types, it is easy to see why and how genomic tools offer a solution to this complexity. We now have tools that augment, complement, or even in some cases, replace cultural microbiology as a means to classify, identify and analyze probiotics (see Table I).7

 General Method Application Notes
 Targeted microbiome Genus/Species level resolution
Bacterial or fungal profiles (16S/ITS gene)
Suitable for multi-strain probiotic products
Unknown or QA analysis
 Shotgun metagenome Species/Possible Strain level resolution
Bacterial and fungal profiles in same assay
Well suited for multi-strain probiotic products
 Qualitative microarray Species/Possible Strain level resolution
Non-quantitative, descriptive only
Well suited for multi-strain probiotic products
 PCR Species/Strain, probe designed specificity
Qualitative
 qPCR Species/strain probe designed specificity
Quantitative against CFU standard curve
Can be designed to detect viability
 Flow Cytometry
(Gene Probe-Based)		 Probe designed specificity
Quantitative against CFU standard curve
Viable, injured, dead cell detection possible
High throughput
Table I. Genomic Tools for Probiotic Analysis

“Why not just perform a plate count?”. Obviously plate counts have a pivotal role in the analytical microbiology of probiotics and will likely remain a gold standard for enumeration of viable counts. In fact, the unit of viable cell counts, CFU is the recommendation for use to verify probiotic populations.8 Unfortunately, most plate count methods do not name or identify the microbes we count as colonies. Occasionally, with precise selective and differential media the identity of the colonies growing on the plate can be reliably called, but misidentification is common. Other tools, such as PCR, are the tool of choice for amplifying specific genes from an organism’s DNA. Quantitative PCR (qPCR) and flow cytometry both rely on a probe specific for a species or even a strain in order to estimate cell numbers, including viable cell counts.7, 9,10,11, 12

So how will modern genomics help you with the analysis of your probiotics? The following are some questions, examples and comments that illustrate genomic applications for probiotic analysis that you should be familiar with. These methods, whether sequencing-based, PCR-based or flow cytometry-based (using gene probes not antibodies), all require some form of sequence determination, detection/hybridization and analysis.

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Randy Fields, Repositrak
FST Soapbox

Technology’s Role In The Future Of Food Safety

By Randy Fields
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Randy Fields, Repositrak

As we have all read in the media, when a food safety emergency occurs, a company’s reputation stands to take a significant hit that may be unrecoverable. This phenomenon isn’t going away soon, nor are compliance requirements that pose a threat to the personal freedom of executives. If these aren’t enough reasons to get busy automating your food safety programs, read on.

Learn more about the future of food safety and technology at this year’s Food Safety Consortium, November 12–16 in Schaumburg, IL

The trends toward social and health-related product claims, like organic, the ‘free-froms’ and locally-grown, have had the impact of adding dozens if not hundreds of new suppliers to a retailer’s procurement list. And, it’s important to note, that these generally smaller suppliers are just now approaching their compliance deadlines for FSMA, and if they are very small, still have another year. New trends appear every year, and they will compound the challenge for retailers and wholesalers of knowing exactly who all of their suppliers are, which in turn will worsen compliance issues.

Our studies show that at least 12% of documents that certify organic, ‘free-froms’ and other product label claims have some level of discrepancy or inaccuracy making them invalid, and rendering the systems that rely on vendor self-disclosure near useless. With sales expected to skyrocket within these categories during the next few years, companies need to leverage technology to protect the supply chain, and consider having the system hold purchase orders generated for vendors who are not compliant with requirements.

An alternative is to have the system add a compliance fee to the purchase order that escalates over time or swiftly replace suppliers if they are not willing or not able to comply. That also speeds compliance as news travels quickly if there is a hard-hitting consequence for non-compliance. Either way, it’s important to be able to substantiate any claims to the consumer, since if those assertions are deemed unreliable, retailers and their suppliers risk a breach in consumer confidence and will suffer economically when shoppers turn away from them at the shelf.

And while retailers and wholesalers have begun to turn the Titanic on regulatory and business compliance, they need to continue to diligently find the risks in their supply chain, working even more aggressively to automate their current food safety and quality programs using new technology and procedures. Otherwise, their reputation and their existence are in jeopardy.

Cloud-based compliance management solutions that help retailers, wholesalers and suppliers meet the new food safety requirements can be configured to manage documentation requirements by supplier type vs. requiring the same documents from all suppliers. These systems also go beyond just storing digital copies of documents, and actually manage any form of compliance by reading inside the document to confirm it meets requirements. The benefits of these compliance management tools extend to streamlining new vendor approvals, which can save time and enable the redeployment of resources to more productive business-building activities.

Make no mistake: business and regulatory compliance will continue to be a focal point in the future. This includes addressing potential safety, certification and quality challenges throughout the extended supply chain as nearly one-third of all recalls are due to ingredient suppliers. We believe that in less than three years, retailers will require supply chain visibility from the shelf all the way back to “dirt”. It’s been proven too risky not to have that kind of visibility for ultimately everyone’s customer – the consumer. And now technology companies are on the hook to deliver it.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

FSMA Checklist: Intentional Adulteration Rule

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The FSMA Intentional Adulteration rule is focused on preventing intentional adulteration from acts intended to cause wide-scale food safety impacts to public health, including acts of terrorism, economic adulteration and disgruntled employees. Such acts, while unlikely, could cause illness, death and economic disruption of the food supply absent mitigation strategies. This rule requires mitigation strategies to reduce risk versus specific food hazards.

How much do you know about the Intentional Adulteration Rule? Test your smarts by taking the FSMA IQ Test here The Intentional Adulteration rule is established to address large companies with products that reach many people, while exempting smaller companies. This rule requires covered facilities to conduct a “vulnerability assessment” to identify vulnerabilities and actions to take for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these vulnerabilities must be identified and evaluated. Covered facilities must also prepare and implement a Food Defense Plan. This written plan must identify the vulnerabilities and actionable process steps; mitigation strategies; and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA Intentional Adulteration requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA, Intentional Adulteration
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Intentional Adulteration program for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Intentional Adulteration requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their program. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.