Tag Archives: adulteration

Integrated informatics and food labs

Using Data to Ensure Food Chain Security

By Maria Fontanazza
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Integrated informatics and food labs
Integrated informatics and food labs
Integrated informatics enable labs to execute and manage all lab processes easily, with the data rigor and intelligence that lab managers require to drive efficiency and profitability, for the lab and for the business. Image courtesy of Thermo Fisher Scientific. (Click to enlarge)

Moving forward, if food manufacturers, suppliers and distributors want to be ahead of the game, they’ll need to have the ability to view their product throughout the supply chain. During a discussion with Food Safety Tech, Trish Meek, director of product strategy at Thermo Fisher Scientific, explains the importance of product traceability in the food chain, from both a consumer and food producer’s perspective.

Food Safety Tech: In your recent article about Integrated Informatics, you cite it as an ideal solution to modernizing a highly distributed food chain. What are the challenges you see companies facing in managing their global supply chain?

Trish Meek: We’ve seen the issues related to intentional adulteration documented throughout the media, and they extend to traceability. For example, what Tesco experienced during the horsemeat scandal wasn’t necessarily intentional adulteration, but rather a matter of not understanding the supply chain. Horsemeat was introduced in France as legitimate meat and then it ended up in the UK. In this case, you have a lack of traceability and thus a lack of understanding of what has happened to your product in its lifecycle.

Trish Meek, Thermo Fisher Scientific
“With consumer demand for foods that are free of gluten, GMOs and antibiotics, it’s becoming more important to customers that they understand everything that has happened to the animal and the food source.” –Trish Meek

In this complex world of suppliers, distributors and food producers, having the ability to pull in analytical data and manage it regardless of the source (whether it’s from the initial ingredient supplier or the final manufacturer) is a critical piece in understanding the overall lifecycle picture. An integrated informatics solution provides a single source of truth for that information: From the technician operating the lab process to the lab manager who is overseeing to the integration into the enterprise-level system. It provides a complete view on everything that has happened to your data, while also enabling the management of regional specifications.

FST: What are the biggest concerns in the area of food chain security?

Meek: Traceability is key, and the common denominator is food chain security: Ensuring that you’re providing security and with an understanding of everything that happened to your product, which leads to quality assurance and brand security.

FST: What are the concerns related to food chain security?

Meek: There are a few concerns:

  1. Adulteration
  2. Correct label claims. For example, 30% of the populous is trying to avoid gluten. While 1% is truly allergic to it, there’s a lot of gluten intolerance. Take, for example, recent commercials from Cheerios saying they are ensuring traceability and can say with confidence that their product no longer comes into contact with wheat in any part of the process. There’s an understanding that consumers want to believe what’s on the label, from both a health and allergy perspective as well as a concern in the public around unhealthy ingredients added or antibiotics used. As a food producer, you want to make sure you can honestly state what has happened to the food and that what you’ve put on your label is true. People are willing to pay a premium, and so there’s a drive towards the premium of being able to claim no GMOs on a label or an organic product.
  3. From a food producer’s point of view, having traceability from all suppliers is key. They want to ensure that any raw materials have been handled and managed with all the same scrutiny and adherence to regulatory requirements as their own processes. With ingredients coming from all over the world, manufacturers are relying on multi-sourcing ingredients from places they don’t necessarily control, so they need to have the traceability before the ingredients appear in the final product.

Using an Integrated Informatics Platform

Trish Meek: Through an integrated informatics platform, users can manage the entire lab process and integrate it into the enterprise system. Having the ability to incorporate the lab data is critical to ensuring product safety, quality and traceability throughout the entire supply chain. Because the solution encompasses lab processes and required lab functionalities, it enables efficiency both in the laboratory as well as across the entire operation. The solution provides an opportunity not just to the top-tier food producers but also the regionally based middle-tier companies that want to set themselves up for future growth.

The reality of the regulations today is that you must look towards the future. Twenty years ago, we weren’t including information about what nuts were present in the labeling. Now there’s consumer awareness and a change in labeling. And five years from now, there could be a different allergy that needs to be documented in the labeling. Integrated informatics gives you the business agility to take on that next step of analysis and adapt to the marketplace.

Granulated sugar with dark foreign particles

Food Investigations: Microanalytical Methods Find Foreign Matter in Granular Food Products

By Mary Stellmack
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Granulated sugar with dark foreign particles

The upcoming implementation of FSMA will likely result in increased scrutiny of contaminants in food products. If the foreign matter can be identified, steps can be taken to eliminate the source of contamination and avoid future losses of product. Small foreign particles are sometimes observed in drums of bulk granular or powdered raw materials. While these foreign particles may be seen as dark specks in the product, they are often too small for standard QA/QC methods of analysis. Microanalytical techniques, however, can be used to isolate and identify the specks. This article describes a case study of dark particles in a granulated sugar sample.

Microscope Exam

Ideally, when conducting contaminant analysis, all sample manipulations take place in a cleanroom to eliminate the chance for contamination by extraneous environmental debris. This is especially important when working with small contaminant particles, which may consist of environmental debris such as metal particles, fibers and other types of dirt. If the unknown particles are identified as common environmental debris, the analyst must be certain that he or she did not introduce any debris while handling the unknown sample.

Granulated sugar with dark foreign particles
Figure 1. Granulated sugar with dark foreign particles, 13X (Click to enlarge)

The first step in the identification process involves examination of the sample under a stereomicroscope. Figure 1 is a photomicrograph of dark brown particles, less than 1 mm in size, in the sugar sample. Particles of this size must be isolated from the bulk product prior to analysis in order to correctly identify them.

Since all of the dark particles are visually similar, only a few representative particles need to be isolated. The contaminants can be isolated by removing a small glob of tacky adhesive (50 µm or smaller) from a piece of tape with the pointed tip of a fine tungsten needle. The adhesive-coated needle tip is gently touched to the surface of one of the dark particles, causing the particle to adhere to the needle, and the particle is transferred to a glass slide or other substrate for further examination.

Isolated dark foreign particles
Figure 2. Isolated dark foreign particles, 63X. (Click to enlarge)

Figure 2 is a photomicrograph of three dark particles, isolated from the sugar granulation. The dark brown particles have a smooth, shiny appearance with conchoidal (shell-shaped) fracture surfaces, and are visually consistent with glass. However, when probed with the tungsten needle, the particles are found to be brittle and fragile, and this texture is not consistent with glass. Therefore, chemical analysis is needed to identify the brown particles.

Micro-FTIR Analysis to Identify Organic Components

Most organic compounds (and some inorganic materials) can be identified by Fourier transform infrared (FTIR) spectroscopy. For the analysis of small particles, a microscope is coupled with a standard FTIR system; this method of analysis is known as micro-FTIR analysis. The micro-FTIR system passes a beam of infrared radiation through the sample and records the different frequencies at which the sample absorbs the light, producing a unique infrared spectrum, which is a chemical fingerprint of the material. By comparing the spectrum of the sample with spectra of known compounds from a reference library through an automated computer search, the sample can often be identified.

In order for the FTIR analysis to work, the sample must be transparent, or thin enough to transmit light. In the case of the particles from this case study, this is achieved by applying pressure to a ~50 µm portion of the sample until it forms a thin transparent film. This film is placed on a salt crystal for micro-FTIR analysis.

An FTIR spectrum of crystalline sugar is shown in Figure 3, and a spectrum of a brown particle is shown in Figure 4. The spectrum of the brown particle has some similarities to sugar, but there are fewer peaks, and the remaining peaks are rounded, consistent with a loss of crystallinity. The loss of crystallinity, coupled with the brown color of the particles, suggests charred sugar.

FTIR spectrum of granulated sugar
Figure 3. FTIR spectrum of granulated sugar. (Click to enlarge)

Figure 4. FTIR spectrum of a dark foreign particle, microanalysis
Figure 4. FTIR spectrum of a dark foreign particle. (Click to enlarge)

SEM/EDS to Identify Inorganic Compounds

The FTIR method does not provide complete information about the presence or absence of inorganic materials in the contaminant. To complete the analysis of the brown particles, scanning electron microscopy (SEM) combined with an energy dispersive X-ray spectrometer (EDS) detector is needed. Using the SEM/EDS method, two types of information are obtained: SEM provides images of the sample, and the EDS identifies the elements that are present.

SEM/EDS analysis of a dark foreign particle
Figure 5. SEM/EDS analysis of a dark foreign particle

A brown particle was mounted on a beryllium stub with a small amount of adhesive, and submitted for SEM/EDS analysis. Figure 5 includes an SEM image of the particle, and a table of EDS data. The SEM image provides some information about the composition of the particle. This image was acquired using backscattered electron mode, in which heavier elements appear lighter in color. The image displays light colored specks scattered across the surface of the particle, indicating that more than one type of material is present. The light-colored circle on the SEM image shows the area that was included in the EDS analysis (the entire particle was analyzed). Looking at the column in the table for weight percent (Wt%), the particle consists primarily of carbon and oxygen, with small amounts of chlorine and iron. Carbon and oxygen are chemical constituents of sugar, but chlorine and iron are not.

SEM/EDS analysis of specks on a dark foreign particle
Figure 6. SEM/EDS analysis of specks on a dark foreign particle

The EDS system can also be used to focus on individual small areas on the particle. Figure 6 includes EDS data from five specific light-colored specks on the surface of the brown particle. The specks contain major amounts of iron with small amounts of chlorine, and sometimes chromium and silicon, plus contributions from carbon and oxygen from the surrounding sugar matrix. The composition of the specks indicates steel corrosion, likely from low alloy steel. The presence of chlorine suggests that a chlorinated substance was the initiator for the corrosion process.

In some cases, steel corrosion can be the sole cause of brown or dark discoloration of small particles. In the case of this brown particle, the SEM image shows that the iron-rich particles are not evenly distributed throughout the particle, but are only scattered on the surface. Charring is the most likely cause of the overall brown color of the particle.

Conclusion

When examined under the microscope, the dark particles in the sugar sample had the visual appearance of glass. However, chemical microanalysis of the particles revealed that they were not glass at all, highlighting the importance of microanalytical methods in determining the identity of the foreign matter. The brown particles were ultimately identified as charred sugar particles with scattered specks of steel corrosion (likely from low alloy steel) on the surface. This information can be used to narrow down the search for possible sources of the brown particles in the bulk sugar sample. As part of a root cause investigation, samples of dark particles from various locations in the manufacturing and packaging processes can be studied by the same techniques to look for a match.

More information about FTIR analysis is available in the webinar, Preparation of Polymer Samples for Microspectroscopy

Steps to Avoid a Food Crisis

By Maria Fontanazza
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Part two of Food Safety Tech’s interview with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, discusses how companies can reduce their chances of having a food crisis. “Sometimes we forget that part of our crisis management team is part of food defense,” says Baumfalk.

Food Safety Tech: Can you discuss the importance of the food defense plan within crisis management?

Alan Baumfalk: We need to defend the product within our facility, and we need to determine as part of the food defense plan the methods that we’re going to implement to prevent adulteration of product.

We need to step up and watch this: The process literally travels from farm to fork; from the crop through processing through distribution and to the final consumer. As part of our food defense plan we need to protect sensitive processing points from intentional adulteration, and we must watch for potential accidental adulteration.

It is important to carefully control the activities in the plant. Part of that involves limiting employee, subcontractor and visitor access to production equipment, manufacturing, and storage areas by designating access points.

These steps can help to eliminate issues involved in causing a crisis:

  • Secure the storage of raw materials, packaging equipment and hazardous chemicals
  •  Control all chemicals within the facility, because they can be used to deliberately or accidentally contaminate food.
  •  Hold finished products in secure storage.
  •  Control transportation. Apply seals to the full truckload.
  •  Monitor all points of distribution.

Is Your Company Prepared to Fight Food Fraud and Product Adulteration?

By Maria Fontanazza
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Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.

Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?

Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.

FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?

Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.

FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?

Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.

Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.

FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?

Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.

In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.

Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:

  • When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
  • Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.

FST: What factors are contributing to under-use of microscopy-based methods?

Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.

FST: What industry partnerships/collaborations are essential in testing and analysis?

Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.

Food Defense Culture is Coming

By Maria Fontanazza
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FSMA’s proposed rule on intentional adulteration isn’t the only reason companies should be paying attention to food defense.

Establishing metrics in food defense, similar to the growing awareness around the importance of measuring behaviors in a food safety culture, was a topic recently brought up at FDA’s FSMA public meeting in the spring. The agency acknowledged that it will need to both clearly define what exactly is intentional adulteration and how it can be measured.

While food safety involves assessing and mitigating hazards, food defense is all about the threat and protection against intentional contamination. “The threat of fraud is a growing problem as supply chains get more complex, resources grow scarcer and the cost of food increases. All this provides more opportunity and potential reward for food adulterers,” stated a recent PwC report on food trust.

The FSMA final rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration is scheduled to be published in spring 2016, and companies need to be revisiting and revamping their food defense plans to prepare.

Prevention is the key word and on the most fundamental level of a food defense plan, businesses need to have management commitment before building, or even revisiting, a food defense plan—do they understand the resources, time and cost involved?

Conducting a vulnerability assessment is the first step in finding the gaps and examining whether a facility is secure. Beyond the standard questions that companies may ask when embarking on this assessment, businesses should identify potential attackers, asking how an attacker could have access to a product or process and what would be the outcome of an attack. Then look at the protective measures that are already in place—would these act as a deterrent? And if deterred, would the attacker proceed to the next target or would he or she stop? What measures are in place to find the attacker before there is an effect on the product?

When developing a food defense plan, there are several areas of potential vulnerability:

  • Shipping and receiving and packaging
  • Laboratories and testing sites
  • Recall and traceability programs and processes
  • Water used in processing/manufacturing—what is its origin?
  • Employees—what are the health risks? Is there a process for employee health reporting? Is there a process for reporting disgruntled employees?
  • Security personnel

With food fraud on the rise, it’s important for companies to continue to revisit and update their food defense plans, considering changes to facility designs or strategies, packaging changes, security improvements, etc. Companies should also be proactive in monitoring their employees both from a satisfaction (reducing the incidence of a disgruntled employee) and awareness perspective. FDA has initiatives to help companies build a food defense culture and employee awareness, including the ALERT training course for owners and operators of food facilities and Employees FIRST, and the National Center for Food Protection and Defense has programs aimed at workforce training as well as undergraduate and graduate curriculum on food defense.

Paul Dewsbury, B.Sc.
In the Food Lab

Is that Pricey Wine the Real Deal? Using IRMS to Detect Fraud

By Paul Dewsbury
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Paul Dewsbury, B.Sc.

By Paul Dewsbury, B.Sc.

Upon conducting some online research to find a nice bottle of wine to bring to a party, I became distracted by a story about the world’s most expensive wine, priced at an eye-watering $195,000. With just a few clicks, I uncovered stories about auctioning a single bottle of wine for more than $300,000, and a case of 114 bottles selling for a record $1.6 million. Some of the reasons for the huge sums invested in pricey wines include rarity, social status of owner (aka famous), vintage, and perhaps most importantly, region and vineyard.

Ever the analytical chemist, I wondered, how do buyers identify whether that the extravagant bottle of wine they’re purchasing is the real thing? Perhaps the serious wine collectors out there could benefit from having an isotope ratio mass spectrometer (IRMS) in their cellar! But seriously, could IRMS play a role in authenticity testing?

Testing for Authenticity and Geographic Origin of Wine

Increasingly, fraud surrounding the provenance of wine has become a problem. Last year, a man was sentenced to 10 years in prison for selling millions of dollars of counterfeit wine. He not only created fake labels, but he also mixed and blended lower-priced wines to imitate the taste and character of rare and much more expensive wines.

An article published last year about the authenticity and geographic origin of wine discusses the results of investigating the stable isotope composition (C and O) of wine samples.1 The authors claim to have found significant isotope variations within samples from the same country as well as between samples from different countries.

¹³C and Simultaneous ¹⁸O and ²H Isotope Analysis in Ethanol with Thermo Scientific DELTA V Isotope Ratio Mass Spectrometers is also a useful resource, as it defines the configuration required for such testing. The method demonstrates excellent results and could be quite suitable for origin testing of wine. Isotopic analysis of wine has become a widespread tool to evaluate the quality, authenticity and origin of labeled products. This application note shows the ability and performance of the analysis of ethanol with combustion and with a high temperature carbon reduction technique in combination with a DELTA V IRMS. With this configuration, the ethanol can be analyzed for oxygen and carbon isotope composition. The analysis allows for the quantification of exogenous sugar added during the fermentation process, which is used to increase the alcohol content of the wine. This control is also needed for the detection of frauds, such as mislabeling regarding both ingredients and origin.

Most laboratories will seek alternative or complimentary techniques for authenticating wine. A few months ago, I blogged about using an ion chromatography method to verify the authenticity of your wine. I was also captivated by the poster, Related Seasonal and Geographical Differences in Wine from California’s Central Coast, which describes how a high performance liquid chromatography coupled to mass spectrometry (LC-MS) configuration was successfully implemented to analyze several wine varieties from different areas to show simultaneous detection and relative quantification of the wine’s components.

Wine authenticity is a fascinating subject, and I will leave you with this unbelievable but true story. In 1989, a bottle of 1787 Château Margaux from Thomas Jefferson’s wine collection was valued at more than $500,000 by its owner, William Sokolin, a New York wine merchant. At a dinner, it was accidentally knocked over and broke. What’s more,  the insurers paid $225,000 for the loss of the wine.

And to get back to where I started—I went to the supermarket and picked up a cheap bottle of wine. I don’t think anyone was the wiser, either.

References

1. Horacek, M., Papesch, W., Ogrinc, N., Magdas, A., Wunderlin, D., and
Misurovic, A. (2014). Control of Authenticity and Geographic Origin of Austrian, Slovenian,Romanian, Montenegrin and Argentinean wine, Geophysical Research Abstracts, 14. Retrieved from: http://www.josephinum.at/fileadmin/content/BLT/Puplikationen/1444-00_E.pdf.

Paul Dewsbury, B.Sc.

Honey Laundering: Food Fraud That’s Not So Sweet

By Paul Dewsbury
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Paul Dewsbury, B.Sc.

ThermoFisherpodcastAs a result of my research, I found two fantastic resources describing the background of food fraud, the first is an excellent 3-minute podcast on our website, titled, Food Fraud by Dr. Jennifer McEntire, who at the time was VP and Chief Science Officer at The Acheson Group and is now the newly appointed VP of Science Operations at the GMA. Dr. McEntire succinctly gets to the crux of the reasons pertaining to food fraud and it is well worth a listen.

The second is a 3-minute slide deck narrated by renowned food safety expert Professor Chris Elliot, Director of the Institute of Global Food Safety at Queens University Belfast. Professor Elliot highlights the impact of various food frauds including melamine adulteration in milk, spices, meat and he specifically expands on the topic of honey laundering.

There are too many honey adulteration frauds to list here and while some have resulted in huge fines and criminal charges, there is one that will not go away is the mislabeling of Manuka honey. This premium product (and premium price) is a rare honey from New Zealand produced by bees that pollinate the manuka bush and has numerous claimed medicinal properties that can be extremely profitable for the fraudsters through substitution with a basic product. As food fraud is an international issue, various organizations likeInterpol and Europol have food fraud units and here in the UK the government has committed to, and is setting up a dedicated Food Crime Unit.

Moving into the science, one of the best literature resources I would like to share is the Food Fraud Resources website which has some highly cited articles including reviews, thought leadership and analytical methods that are available for download. There are various techniques for honey analysis in the journals and I want to briefly focus on one of the most powerful for authentication, the use of isotope analysis. In our Application Note 30177, Detection of Honey Adulteration with FlashEA Elemental Analyzer and DELTA V Isotope Ratio Mass Spectrometer, we describe a fully automated system for the detection of honey adulteration with C4-syrups according to the AOAC 998.12 guidelines and is routinely used in many laboratories.

Is honey analysis or food fraud of interest to your laboratory? If so, share your thoughts and experiences in the comments below. 

Check out Thermo Fisher’s Food Community page for more resources, on-demand webinars, videos, and application notes.

 

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.

TACCP

FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.

Communication

Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.