Tag Archives: Focus Article

February 23, 2016

Veterinary Drugs Analysis to Ensure Food Safety

By Olga I. Shimelis

Monitoring for veterinary drug residues is conducted to ensure food safety and compliance with approved veterinary medicine practices. Veterinary drugs are used in animal husbandry for a variety of reasons, including as a curative/preventive of disease in herd and flock, to improve meat quality, and to promote growth. The chemical classes of drugs that may be used are broad, but major classes include antibiotics, anti-parasitics, and hormones. While risk-modifiers are used to minimize risk for consumption, residues from these drugs, their breakdown metabolites, or associated impurities of the drug may persist in animal tissue, necessitating the requirement that contaminant testing be undertaken.

In the United States, trace analysis of contaminants in food products began in the early 1970s following amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1968. Worldwide, the regulatory requirements for contaminants in food have seen significant tightening due to a number of high-profile contamination crises and increased trade of food across country borders. From the technology standpoint, lower detection limits have been made possible by improvement of the detection capabilities of the analytical methods and instruments. Some of the most stringent requirements for contaminants in food are found in the European Union, where the levels of contamination should be below Minimum Residue Limits (MRLs), whereas in the United States, such limits are called U.S. tolerances.

When analyzing for drug residues, the choice of tissue has historically been the liver and kidney tissues, as these organs serve to remove the contaminants from the body and, as a result, the concentration of contaminants there is higher and easier to detect. Muscle tissue now often is added to the target list, as its contamination would have a direct impact on consumers.

With regards to veterinary drugs testing, one can distinguish between screening methods and confirmatory methods. The former should be fast and high-throughput and used to detect the presence of an analyte. The confirmatory methods should be able to provide confirmation of an analyte’s identity and quantitation at the levels of interest. Microbiological methods were popular for screening of antimicrobial drugs since these drugs inhibit growth of microorganisms, but suffer from a lack of specificity since not all microorganisms are equally sensitive to all antibiotics. Rapid screening methods include immunoassay-based testing kits, which are specific, fast, and can include multiple antibiotic classes in one test. Confirmatory methods typically include chemical analysis techniques with LC-MS detection, which provides the best ionization for most classes of veterinary drugs, along with better selectivity for focused analysis and lower detection limits. LC-MS can provide specific analysis of compounds from multiple classes in the same run through either targeted MS/MS or non-targeted analysis of unknowns through high mass resolution methods. The speed of LC-MS analysis has improved with the introduction of ultra-high pressure liquid chromatography-MS (UHPLC-MS) instruments. In the last few years, UHPLC-MS methods simultaneously serve as screening and confirmation methods for multiple classes, so called “multi-residue methods”. Some of these methods use MS/MS detectors and some use high-resolution mass spectrometers utilizing time-of-flight and ion trap detectors. These methods now can provide fast turn-around time and better accuracy in comparison to microbiological methods. They may be preferentially used by testing laboratories that are equipped and capable of utilizing the latest MS instrument technologies.

The 4th Annual Food Labs conference provides practical solutions and best practices on running, managing and equipping a food lab. | March 7–8, 2016, Atlanta, GA | LEARN MOREAll mass spectrometry methods that strive to perform simultaneous analysis of multiple veterinary drug classes are prone to the same drawbacks. Due to the differences in the analytes’ polarity, acidity and hydrophobicity, the quantitative extraction of analytes from tissue samples could be difficult. Ideally, the sample preparation methods should be compatible for compounds with varying physico-chemical properties but still provide selective separation from the matrix components to avoid occurrence of matrix effects during quantitation. The co-extracted matrix impurities are undesirable since they can affect the ionization of targeted analytes and result in under- or over-estimation of their concentration (ion suppression or enhancement). Due to the difficulty in designing a method that works for a wide variety of analytes, cleanup is often omitted for multi-class multi-analytes methods, and the stable isotope internal standards are used to correct for ionization effects during quantitation. However, omitting the sample cleanup could lead to other methodology problems.

As noted in the veterinary drug analysis session during the 2015 AOAC Annual meeting, sample cleanliness can result not only in matrix effects and impact quantitation, but it can also have an effect on the mass accuracy when high-resolution mass spectrometry is used and, therefore, can affect the identification of the analytes and lead to false negatives.

The most often used methodologies for sample cleanup during analysis of veterinary drugs in tissues is solid-phase extraction (SPE), both in cartridge and dispersive formats. C18 SPE proved to be a very versatile sorbent that often resulted in the best cleanup and best precision of analysis, closely followed by polymeric sorbents when applied to multi-class LC-MS analysis.

Aminoglycosides Antibiotics

Aminoglycosides is one class of veterinary antibiotics that is hard to include into multi-class methods. The aminoglycoside structures include connected modified sugars with different number of substituents including hydroxy- and amino-groups. The higher degree of polarity for aminoglycosides contributes to their solubility properties: these compounds are freely soluble in water and to some extent are soluble in lower alcohols, but are not soluble in common organic solvents and have solubility issues in solvent-water mixtures with high organic contents. Therefore, the normal extraction conditions that include organic solvents and are frequently applied to most other classes of veterinary drugs do not work well for aminoglycosides. A separate method is often used to extract and analyze these antibiotics.

Most often aminoglycosides are detected by mass spectrometry through the formation of positive ions during electrospray ionization. The LC separation of aminoglycosides could be done by either a reversed-phase (RP) method with ion-pair mobile phase additive to insure the retention of compounds or by HILIC chromatography. We have investigated both methods and looked at the sensitivity for detection of these compounds. The use of ion-pair is most often presented as a disadvantage, as it can reduce the analyte signal through the decrease of ionization efficiency and fouling the LC-MS instrument. While the use of ion-pair in our study decreased the ionization for some of the lighter compounds in this class (streptomycin, puromycin), ionization efficiency increased for the heavier mass compounds (gentamycin, neomycin). RP chromatography resulted in improved separation of the analytes compared to HILIC. LC-MS fouling from the use of HFBA was not observed in our investigation that spanned the course of a couple of years. In the HILIC mode with use of formic acid as a mobile phase additive, the detection of neomycin was problematic due to very low sensitivity. It was as low as one seventh of the sensitivity obtained by RP method.

The instrument response for aminoglycosides also depends on sample extraction and cleanup and the accompanying matrix ionization effects. The extraction from animal tissues has been traditionally done using the McIlvaine buffer that includes 2% Tricloroacetic acid (TCA) to precipitate proteins and release any bound analytes and 0.4 mM EDTA to prevent the binding of the analytes to cations and/or glass. Then the extract undergoes cleanup steps using SPE. The SPE sorbent most often used is a cation exchange phase, as the aminoglycosides have ionizable amino-groups and can be retained from the extract through ion-exchange interactions. Another option for the SPE cleanup became recently available—molecularly imprinted polymeric (MIP) SPE. MIPs, which are sometimes called “chemical antibodies”, mimic the performance of immunoaffinity sorbents. MIPs have binding sites that conform to the shape and functionality of a specific compound or a compound class. Strong binding of the analyte to the MIP makes it possible to perform intensive SPE washes that lead to very clean samples. Unlike immunoaffinity sorbents, MIPs are compatible with organic solvents and strong acids and bases.

We have tested the MIP SPE versus the traditional weak cation exchange (WCX) SPE cleanup for aminoglycosides spiked into pork tissue. The resulting ionization effects were compared as an indication of samples cleanliness. The quantitation in both cases was done using matrix-matched calibration curves and in both cases the recoveries for most of the ten tested aminoglycosides were above 70% (with exception of spectinomycin at 33% in case of WCX cleanup and tobramycin at 55% in case of MIP cleanup). For the two cleanup methods, there was a significant difference in matrix effects. In Figure 1, matrix factors close to 1.0 indicate little to no matrix influence for analyte detection: the ionization of the analyte in mass spectrometer is not influenced by co-extracted matrix impurities and quantitation values are not skewed. Values for matrix factors that are significantly greater than 1.0 suggest matrix enhancement for the analyte and values less than 1.0 are considered to be the result of matrix suppression. Significant matrix suppression was observed for all analytes when WCX SPE was used for cleanup. The ion suppression effect was significantly less for samples cleaned using MIP SPE. In addition, we observed significant time savings when using the MIP SPE cleanup method, as it did not require sample evaporation after using water-containing elution solvent.

Figure 1. Matrix factors close to 1.0 indicate little to no matrix influence for analyte detection

Conclusions

While improvement in the laboratory instrumentation allows the simultaneous and fast analysis of multiple contaminants, sample preparation remains important for reliable identification of contaminants in screening methods and error-free quantitation in confirmatory methods. Both the extraction and sample cleanup methods can contribute to accurate multi-class methods analyzing wide variety of veterinary drugs. New and upcoming technologies such as molecularly-imprinted polymers could be used for more targeted analysis of specific classes of analytes via instrumental methods.

February 22, 2016

Contamination, Adulteration Remain Highest Priority

By Maria Fontanazza

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Increased media attention and consumer awareness of verifying ingredients, detecting allergens and effectively tracing the source of outbreaks has placed much higher scrutiny on food processors and manufacturers. With the anticipated FSMA final rule on intention adulteration (Focused Mitigation Strategies to Product Food Against Intentional Adulteration) expected in late spring, having the ability to effectively detect and address product contamination and adulteration will be of significant importance to manufacturers. In preparation for the upcoming Food Labs Conference March 7–8, Food Safety Tech sat down with Craig Schwandt, Ph.D., director of industrial services at McCrone Associates, to learn how contamination is currently affecting food companies and what they should be doing to protect their products and ensure consumer safety.

Craig Schwandt will be presenting “Contaminant Particle Identification: Establishing Provenance and Complying with FSMA” at this year’s Food Labs Conference | March 7–8 | LEARN MOREFood Safety Tech: What are the big issues facing the food industry related to product contamination?

Craig Schwandt: I think the biggest issue facing the food safety industry is realizing that FSMA, in its final ruling, comes with requirements to ensure food safety from farm to table. In the past, many [ingredients] were GRAs, or generally recognized as safe, so when there was a contaminant, [food companies] had a lot of liberty in disposing of the batch and weren’t too concerned about where it came from.

FSMA is going to require that [food companies] keep records of what contaminants are found, how they address it and whether it’s a recurring problem, and [that they] have a procedure in place to track back and [conduct] forensic analysis. In the analytical services industry we call it investigational analysis, which is a description of what actually takes place for ascertaining what the contaminant is and how it got there. That information is provided to clients so they can track back in their production process—all the way to the raw materials and then ascertain where the contaminants came from in that production chain.

The big challenge will be in recognizing that they have to start keeping records and then actually doing the investigation to determine what contaminants are there and determine where they’re coming in.

FST: Are companies taking the right steps to detect and identify contaminants in food?

Schwandt: Some of them do and some don’t. At last year’s Institute of Food Technologist’s conference in Chicago, there was a session on FSMA in which there were representatives from FDA, the Grocery Manufacturers Association and a major food company. I was a little bit shocked by the food company’s position. They felt they didn’t need to take all of the steps required by FSMA because they dealt directly with producers from all over the world. They felt removing intermediaries from their supply chain sufficiently protected their products from adulteration. This seems to be oversimplifying the production and supply chain process. Even though they may directly deal with farmers, there’s still opportunity from the time food stuff is harvested to being dried, placed in containers, and shipped from overseas to the U.S.—there are several steps where unintentional contaminants can arise. So to say they didn’t need to look at the potential for contamination because they dealt directly [with farmers] is a bit oversimplified. I think this perspective typifies some of the industry’s viewpoint at the moment.

The Foreign Supplier Verification Program specifically addresses this concern. Even companies that deal directly with producers and supplies in the country of the product’s origin will be required to demonstrate that they tested it and verified it as uncontaminated.

The understanding and recognition by suppliers of these new regulations is the biggest issue facing the food industry right now—especially now that the final rulings have been issued and we’re in the grace period before compliance with the regulation is required.

FST: What technologies are helping in the effort to fight product adulteration, especially as it relates to FSMA compliance?

Schwandt: Handheld instrumentation is making headway at identifying, at a gross scale, screening capabilities—handheld x-ray fluorescence instrumentation and handheld infrared spectroscopy, to identify things at the bulk level. Mass spectrometry methods and chromatography are exceptional at their ability to do really fast general screening for chemical adulterants. I think many of the food laboratories and food companies have in-house laboratories and screen in that general way.

In terms of some of the solid phase contaminants, I think there’s a lack of in-house capability at the moment where one can use simpler [methods] like optical microscopy and another microscopy-based methods to identify the physical solid phase contaminants.

A good example is the use of magnetometers. Many companies use large-scale process line magnetometers to highlight the presence of metal pieces in their product. A magnetometer tells you that there are metal contaminants in your product, it does not provide a specific alloy identification. Whether one needs to go further to use additional methods and actually ascertain the composition of the alloy, is the question. That’s a new requirement—to identify what it is and then to try and assess where in the process it may have occurred. Using a microscopy-based method is advantageous because metal pieces are easily isolated and identified. Once food industry clients have an idea of what the alloy is, they can compare it to the metal alloys that make up their machinery along the way, whether it’s packaging or sorting machinery, [and] essentially establish where the particles enter into the food process.

Gary Smith, Eurofins’ Food Safety Systems

February 15, 2016

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza

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Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

February 11, 2016

Food Safety Think Tank

Listeria, the Pesky Bug is Everywhere!

By Gina R. Nicholson-Kramer

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“When a flower doesn’t bloom you fix the environment in which it grows, not the flower.” A quote, by Alexander Den Heijer, trainer, speaker, purposologist, that rings true in food safety. When there is a contamination issue in food processing, one must fix the environment in which food is being processed. Safe food is a product of a clean environment.

We have better environmental sampling programs in our food manufacturing plants and processing facilities, and we have sanitation standard operating procedures, so why are we seeing a prevalence of Listeria, and in rising numbers? I recently sat down with Jeff Mitchell, vice president of food safety at Chemstar, about the recent increase in Listeria outbreaks and how you can rid your facility of the dangerous pathogen.

We’re seeing Listeria—in product recalls and outbreaks—over the last couple of years, and in multiple numbers. Why do you think this is happening?

Jeff Mitchell, Gina Kramer, Listeria — My interview with Jeff Mitchell about the increase in *Listeria* recalls. Watch the video

Jeff Mitchell: The distribution of Listeria in the environment has not changed, and the processes that we use for processing food really haven’t changed. What’s changed is the way that we collect data. We have PulseNet now, which gathers information. If someone goes to a medical treatment facility with a foodborne illness, they’re going to investigate that and they’re going to get the whole genome sequencing on the pathogen.

There’s a difference between understanding what transient Listeria is and resident Listeria. I think there are a lot of sanitation efforts being put forth to eliminate the resident populations—those are the populations we’re most concerned about, and they’re the ones that are being related back to a lot of these recalls.

If I have resident Listeria in my facility, why can’t I find it?

Food Safety Tech is organizing a Listeria Detection & Control Workshop, May 31 – June 1, 2016 in St. Paul, MN. LEARN MOREMitchell: Resident populations of Listeria are found in a biofilm—most bacteria aggregate within a biofilm. A biofilm is a survival mode for the bacteria; it protects it from sanitizer penetration. That layer actually masks it from sampling. You could swab a surface or an area and not pick it up, because the biofilm is masking it.

Jeff goes on to discuss the type of sanitation program that companies should have in place to get rid of resident Listeria. You can learn about the steps you need to take in my video interview.

February 10, 2016

The Multi-Step Process of Third-Party Accreditation

By Charles Breen

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The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.

An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.

The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:

FDA is responsible for officially recognizing accreditation bodies.
An officially recognized accreditation body will accredit third-party certification bodies.
The accredited third-party certification body will certify third-party auditors.
The certified auditors will conduct consultative and regulatory audits of food facilities.

If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.

In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.

FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.

Recognized accreditation bodies under TPA will be required to:

Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
Self-evaluate and correct any problems in their own performance
Submit monitoring and self-assessment reports and other notifications to the FDA
Maintain and provide the FDA access to records required to be kept under the program

Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.

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February 8, 2016

Trends in Digital Learning

By Holly Mockus

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The food industry is becoming increasingly fast-paced. Regulations are changing, the supply chain is becoming more transparent, and resources are harder to access. To meet the needs of an ever-changing industry, digital learning is becoming the go-to solution for training managers and frontline food handlers alike, as it can be done quickly and efficiently. Now that most people have smartphones and mobile devices, there are multiple ways to make learning accessible.

The “Mind of the Food Worker” study conducted by the Center for Research and Public Policy (CRPP) points out that food workers have developed a preference for digital training over traditional classroom or instructor-conducted training. There are many new approaches to learning, including web-based eLearning, kiosk, gamification/competition, social media, digital signage, and coordinated communication programs. Let’s take a closer look at each of these.

eLearning

eLearning is no longer about reading through a PowerPoint presentation or watching a pre-recorded video. The number of companies offering eLearning continues to increase, as do the topics, content and format of the content. In addition, eLearning carries the added benefit of being affordable. For many companies, saving on the cost of travel when an individual attends a workshop provides an attractive incentive.

The ability to learn at one’s own pace at the time and place of one’s choosing has special appeal for today’s learners. The availability of eLearning via mobile devices is meeting that desire. It can be seen everywhere—people glued to their mobile devices while waiting in line, taking a lunch break, or in the evenings on their own time. This is multitasking at its finest.

Kiosks

The ability to take a device to a quiet environment helps with concentration and efficiency in training. Kiosks can be set up in an area that is conducive to learning with no traffic, noise or other distractions and are popping up at workplaces more and more. Learners can come and go at their convenience. A learning lab set up in a manufacturing facility will pay for itself very quickly. Sending workers to the lab one at a time is much more cost effective than shutting down a line or area of the plant for group or classroom training.

Gamification

Gamification, the use of interactive tools in conjunction with learning, is a term being used more often in training industry vocabulary. For example, it can involve the addition of a word and a definition-matching exercise in conjunction with a training module to encourage learners to retain what they have just learned. It also makes the education process more fun—and it seems to be working.

Gone are the days of sitting through hours and hours of dry lectures or reading textbooks that simply do not resonate. This method has always been especially difficult for employees working in a food plant. Sitting in a warm darkened room listening to a droning presentation is an invitation to sleep. Gamification eliminates the droning, and requires attention and participation.

The Association for Psychological Science has confirmed that competition engages learners, drives retention, and leads to higher test scores. Got a boring topic for training? Get your game on! A great example of gamified learning that is readily available is Merriam-Webster’s Word of the Day. Sign up for free and receive a daily email with a new word, along with its pronunciation, definition(s), use and history. The email also links to several great games that provide word calisthenics for the brain.

Social Media

Leveraging social media helps to expand and continuously improve training programs. This mode of technology will ensure that every employee in a company has timely, consistent answers to questions. Using private company social media provides a safe environment for posting questions and answers while complementing a training program and filling any knowledge gaps. The CRPP study points out that 80% of workers regularly use public social media platforms such as Facebook and LinkedIn.

Companies can take full advantage of this familiarity with social media by providing an internal forum that encourages open discussion and group learning. This approach enables the workforce to engage in an interactive learning path that is continually up to date. Internal social media also encourages networking, which fosters a sense of camaraderie between individuals, along with company loyalty. One major food company that has used this approach has seen employee questions flourish from 3,000 entries in the first year to more than 15,000 the following year. What an incredible way to keep the workforce updated minute by minute with appropriate, relevant answers to their inquiries.

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February 3, 2016

The Future of Technology, Compliance and Food Safety

By Jason Dea

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There is no question that we are in the midst of a unique time period in history. Technology is continuing to innovate at an increasingly rapid rate, which has led to drastic changes that affect nearly every corner of day-to-day life. From the way we find information to our food choices, technology is influencing our lives in new ways.

The Rise of the Internet

Mary Meeker, the venture capitalist who was dubbed the “Queen of the Internet” more than 15 years ago, has described the current Internet age as a period of reimagining. At the heart of this reimagining has been the rapid growth, maturity and adoption of the Internet and Internet-enabled technologies.

In her most recent 2015 research, Meeker published some fascinating statistics. The number of people online has ballooned more 80 times, from a user base of a mere 35 million in 1995 to a staggering 2.8 billion users in less than 20 years. This figure translates into nearly 40% of the total global population.

It hasn’t just been the volume of usage that has evolved radically. The nature by which those billions of users are signing online has also changed. It’s hard to believe that the original iPhone was released in 2007, less than 10 years ago. In that time, the mobile Internet has gone from a novelty to a necessity for many of us in our daily lives. This smartphone adoption has fueled Internet use and has drastically increased the ease with which consumers can get online.

Reimagining Communication and Compliance

The result of our new “always-on,” globally connected world (to borrow Meeker’s term) is a complete reimagining of communication. Consumers expect a velocity and volume of communication that the world has never before experienced. We now take for granted that we can reach friends, family and acquaintances anywhere in the world—at any time—in an instant. This has also drastically changed our expectations of business relationships.

Consumers in an ever-connected world have an expectation of availability and transparency of information from the brands with which they interact and the establishments they frequent. What this means for businesses is that customers expect to have a degree of access to business data that they’ve never asked for previously.

A tangible side effect of this desire for data transparency can be seen within the regulatory environment that organizations operate. Governments and regulatory bodies have increased their expectations of data access and availability over time, resulting in more stringent regulations across the board.

Research from Enhesa shows that the regulatory growth rate is nearly as staggering as Internet growth rates. According to the firm’s research, from 2007–2014 regulatory increases by region were as follows:

North America: +146%
Europe: +206%
Asia: +104%

Impact on Food Safety: Consumer Engagement and Regulatory Growth

One particular area of regulatory growth has occurred within the food and beverage sector. Arguably no product category has a more direct impact on consumers than food, as it literally fuels us each day. It’s no wonder that in an environment of increasing regulations and more empowered consumers that food quality and food safety are under increased scrutiny.

In today’s environment, it becomes much more challenging to brush aside product recalls and food safety incidents or bury these stories in specialized media. The latest news is not just a fleeting negative headline. In a worst-case scenario these incidents are viral, voracious and more shareable than ever before. From Listeria outbreaks to contaminated meat to questionable farming practices—when fueled by the Internet, the negative branding impact of these stories can be staggering. Consumers are paying attention and engaging with these stories—for example, during a Listeria or Salmonella outbreak, online searches for these terms significantly rise.

The rise of hyper-aware consumers has had a measurable impact. As a result, governments have been quick to respond and have beefed up existing regulations for the food and beverage sector via FSMA and GFSI.

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February 2, 2016

Chipotle Outbreaks Over, but Origin Remains Unknown

By Maria Fontanazza

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The CDC has declared the Chipotle E. coli outbreaks over. As for its origin(s), we may never know. Yesterday the CDC provided its latest and final update regarding the two outbreaks, stating that investigators used whole genome sequencing to dig a bit deeper, and isolates tested from those sickened in the second outbreak (sickened five people in three states) were not genetically related to isolates from the people who fell ill in the initial outbreak (55 sickened in 11 states, with 21 hospitalizations).

“We are pleased to have this behind us and can place our full energies to implementing our enhanced food safety plan that will establish Chipotle as an industry leader in food safety,” said Steve Ells, founder, chairman and co-CEO of Chipotle in a company statement. “We are extremely focused on executing this program, which designs layers of redundancy and enhanced safety measures to reduce the food safety risk to a level as near to zero as is possible. By adding these programs to an already strong and proven food culture, we strongly believe that we can establish Chipotle as a leader in food safety just as we have become a leader in our quest for the very best ingredients we can find.”

While the outbreaks “appear” to be over, the fact that the source will remain a mystery is a bit unsettling. All the CDC can tell us is that the “likely” source was a common meal item or ingredient served at Chipotle Mexican Grill. Regulatory officials simply cannot trace a food or ingredient to the outbreak. “When a restaurant serves foods with several ingredients that are mixed or cooked together and then used in multiple menu items, it can be more difficult for epidemiologic studies to identity the specific ingredient that is contaminated,” according to the CDC’s final update on the outbreak.

The most recent reported illness started on December 1, 2015. No deaths were reported as a result of either of the outbreaks.

Today Chipotle released its Q4 2015 earnings, reporting a 6.8% decrease in revenue ($997.5 million) compared to Q4 2014. However, 2015 revenue increased 9.6% over 2014.

The problems are not over for the restaurant chain either. On January 28, Chipotle was served another subpoena that broadened the scope of the existing DOJ investigation. The company stated the following in a release, “The new subpoena requires us to produce documents and information related to company-wide food safety matters dating back to January 1, 2013, and supersedes the subpoena served in December 2015 that was limited to a single Chipotle restaurant in Simi Valley, California. We intend to fully cooperate in the investigation.”

February 2, 2016

FDA Makes FSMA Education and Training Available

By Food Safety Tech Staff

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As part of FDA’s FSMA training vision, the agency has announced two funding opportunities aimed at providing outreach, education and training on the FSMA preventive controls rules.

The Native American Tribes Outreach, Education and Training cooperative agreement will provide up to $750,000 annually for three years. “FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations,” according to an FDA release.

The Local Food Producer Outreach, Education, and Training agreement will award local food producers $1.5 million this fiscal year with the potential for two more years if federal funds are available. It aims to assist small and mid-size producers/processors with particular practices related to their scale of production and management practices. The agreement will focus on those involved in local food systems while considering “account diversified, sustainable, organic and identity-preserved agricultural production and processing.”

February 1, 2016

FDA Traces Three More Listeria Cases to Dole’s Bagged Salad

By Food Safety Tech Staff

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Dole’s bagged salad was the culprit of three more Listeria cases last month. Last week the FDA released the latest figures on the outbreak, which began in July 2015. An investigation was not initiated until September, and the source of Listeria—a Dole processing facility in Springfield, Ohio—was not known until January 2016. The CDC reports that 15 people, all which were hospitalized, in eight states have been infected with Listeria traced back to the Dole facility since July.

On January 21 Dole told the FDA and CDC that it both stopped producing all packaged salads at the Springfield facility and stated that it would be withdrawing all packaged salads on the market that were produced there. The company initiated the recall of the salads, which were sold under the brand names Dole, Fresh Selections, Simple Truth, Marketside, The Little Salad Bar, and President’s Choice Organics, last week. The bagged salads were distributed in 24 states.

The Public Health Agency of Canada also issued a food recall warning for products made at the Springfield facility. The products were shipped to six Canadian provinces.

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