Tag Archives: Focus Article

Palmer Orlandi, FDA, Food Labs conference

March 15, 2016

FDA Pushing Proactive, Real-Time Analysis

By Maria Fontanazza

Over the past year, FDA has been emphasizing the level of collaboration necessary with industry to drive a more preventive culture of food safety. Much of these efforts surround closely integrated partnerships between federal, state and local stakeholders, including a larger role that laboratories will play in FSMA implementation.

There will be greater reliance on the responsibilities and capabilities of laboratories as a result of the proactive movement in finding points of contamination, before they invade the home of the consumer, in real time. With the convergence of more laboratory analysis and the responsibilities that the FSMA regulations warrant, industry will be relying on the establishment of uniform and standardized lab-related processes and policies in order to bring uniformity and trust to the quality of data being generated and shared, according to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine. Orlandi, speaking at the Food Labs Conference last week, said that FDA is moving in this direction. “The oversights we’re mandating moving forward for data sharing, data reporting and data acceptance are completely equivalent across the board,” he said. FDA is working toward providing more transparency in terms of laboratory oversight and how it intends on working with industry.

Within the five published final FSMA rules there is at least some component of lab support that is necessary. The rule that deals the most with lab involvement, especially laboratory accreditation, is the foreign supplier verification program, because the responsibility falls on the importer to assure and verify safety of the commodity, and this requires the submission of laboratory analysis, said Orlandi.

Palmer Orlandi, FDA, Food Safety Consortium — Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium. WATCH NOW

Currently the majority of FDA’s work effort in the laboratory category falls under compliance program driven sampling, with domestic activities (i.e., inspections) and import activities coming in second and third respectively. Moving forward, environmental driven sampling will play a much larger role, as FSMA places greater emphasis on a risk-based approach and finding issues in real time, directly in the environment.

“We don’t want to be the agency that is just is responding to foodborne outbreaks or responding to problems with industry or farms or any of the commodities,” said Orlandi. “We want to work and become less of an enforcement agency and one of a partner so we can stop problems where they may occur. That involves making partners and leveraging our resources.”

FDA is expanding its responsibility for testing and sampling in the area of surveillance, verification (i.e., preventive controls and import controls), and compliance (i.e., removing adulterated products from the market, enforcement actions, and environmental assessment). The agency is taking a risk-based approach to deploying its resources, and where it does not have the capacity it will be relying on partners for assistance. It is also investing more resources in import testing and the criteria that go into accepting data for import testing, and will be preparing guidance for submission of data.

FDA Vs. USDA: Who Regulates What?
FDA Responsibilities	USDA Responsibilities
Manufacturers, processers, packers, holders, distributors, food transporters Growers of fresh fruits and vegetables, tree nuts and sprouts Dairy products Plant products and spices Grain-based products Seafood (except catfish) Beverages and bottled water Food and color additives Dietary supplements	Meat Poultry Frozen, dried and liquid eggs (FDA regulates whole eggs) Catfish
FDA tests foods for the presence of pesticides, toxic elements, mycotoxins, chemotherapeutics in seafood, and microbial hazards (bacterial, parasitic, viral)

March 14, 2016

Food Safety Culture Series: 2016 Outlook

By Maria Fontanazza

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In the final article in Food Safety Tech’s Q&A series on food safety culture, Lone Jespersen, director of food safety at Maple Leaf Foods, and Brian Bedard, executive director of the GMA Science and Education Foundation sound off on the development of food safety culture this year.

Food Safety Tech: Where are we headed in the food safety culture landscape in 2016?

The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MORELone Jespersen: I think we’re going down a path of standardizing or at least agreeing on a set of definitions for food safety culture. Some of this will come out of the GFSI technical working group on food safety culture. That will lead us to better guidelines for what the different components of food safety culture are. That’s going to be strongly science based and collectively agreed upon. I think we’ll see a lot of that work done in 2016.

I think we’re also going to see a greater focus on connecting food safety culture to organizational culture. Many organizations are looking at integrating food safety and quality assessments into their organizational culture assessments and I think for larger organizations this makes sense.

I hope we’ll get closer to having compared measurement systems and be able to publish work around that so we don’t fall into a trap of a fragmented and independent approach, but rather building on each other as we work [together] and have a common definition.

Brian Bedard: The measurement tools and the gap analysis for which these tools are being developed needs to be done. In terms of operationalizing and actually getting food safety embedded in companies, I would envision a roadmap that looks at a four-tiered framework of who the targets are for changing behaviors. That would be focused around senior leaders in an organization, mid-level managers, supervisors in operations, and at the fourth level, the operators on the plant floor. At GMA’s Science & Education Foundation, we have a group of companies investing in this to roll out a portfolio of training programs. We’re trying to consolidate them under the umbrella of food safety culture and dealing with the full spectrum, from entry level and plant operators through to senior leadership.

March 10, 2016

Microanalytical Methods Identify Foreign Materials for FSMA Compliance

By Debra L. Joslin, Ph.D

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Implementation of FSMA will result in greater scrutiny of foreign material in food products at every stage of production, as well an entirely new pressure to locate and eliminate the source of contamination from the supply and production chain. Identifying foreign materials found in food products is the first step in determining their source, and therefore in determining how to prevent a given foreign material from being introduced into the product. For identification of small particles ranging from 1–1000 µm, microanalytical techniques are essential.

Examining and Isolating Foreign Material

Before the foreign material is prepared for analysis, the material is examined under a stereomicroscope. Ideally, isolation of the foreign particles from the host matrix and preparation of the foreign particles for microanalysis is performed in a cleanroom, which mitigates the introduction of environmental contamination not related to the initial contamination problem.

Under the stereoscope, the foreign material is isolated from the product matrix using a tungsten needle probe. It is photographed and the physical characteristics of the material (color, elasticity, magnetic properties, etc.) are observed and documented. Figure 1 shows particles filtered from a liquid product. In this case, the particles are approximately 100 μm and smaller. Most of the particles appear black to dark brown/orange in color. Some are brittle, while others are not. All are magnet responsive.

Only a few particles must be picked and prepared for analysis in this case because the particles are roughly similar. The coloration of the particles, along with their mechanical properties (magnetic, brittle, hard) indicate that the material is likely inorganic; scanning electron microscopy with energy dispersive X-ray microspectrometry (SEM-EDS) could be used to determine the elemental makeup of the material. The coloration and mechanical properties imply the source of the particles could be production machinery.

Figure 2. Corrosion — Figure 2 (click to enlarge)

Identifying Inorganic Compounds with SEM-EDS

In a scanning electron microscope, a beam of electrons is scanned over the particle producing several signals, some of which are used for imaging, and some that are used for elemental analysis. For this discussion, the signals of interest for elemental analysis are X-rays. The energies of the X-rays are characteristic of the elements found in the sample. By counting these X-rays and arranging them according to their energies, a spectrum is produced, and elements in the sample can be identified and quantified.

Corrosion inclusions — Figure 3 (click to enlarge)

Figures 2 and 3 are SEM-EDS data from one of the brittle particles from the filter. The particle is steel corrosion (iron, chromium, and nickel), possibly with brass corrosion (copper and zinc) and some silicate material (elevated silicon and aluminum). Residues of corrosive agents (chlorine and sulfur) are present. The inclusions analyzed are 300 series stainless steel (see Figure 2). SEM-EDS data from one of the harder dark particles is shown in Figure 4. This particle is oxidized 300 series stainless steel, likely Type 316. 300 series stainless steels are not generally magnetic, but magnetism can be induced during wear processes.

Harder dark particles — Figure 4. SEM-EDS data from harder dark particles. (click to enlarge)

Stainless steels, particularly Type 304 and Type 316 are common in food manufacturing environments. Pinpointing the source of these materials as contaminants can be frustrating due to the number of pieces of equipment made from these alloys. However, other metals are less common, such as Waukesha 88, a bismuth containing nickel-based alloy that is used in pump rotors and other moving parts because of its wear properties. Another less-common alloy is Type 321 stainless steel, a titanium stabilized stainless steel that is used in high temperature equipment where corrosion resistance is needed. Materials such as these are more easily traceable to their source, and therefore more easily repaired and thus eliminated as a source of foreign particles.

Other inorganic materials, such as glass, are also amenable to identification by SEM/EDS. SEM-EDS data from a glass particle is shown in Figure 5. Often, the glass can be identified as soda-lime glass or borosilicate glass. Soda-lime glass is commonly used for glass containers and bakeware; it is a mixture of oxides, mostly silicon dioxide, sodium oxide, and calcium oxide with smaller amounts of other oxide compounds. Borosilicate glass, commonly used in heat-resistant labware, contains silicon dioxide with a few weight percent boron trioxide, along with other oxide compounds; its composition results in a low coefficient of thermal expansion, and it is used in applications where its chemical and heat resistance are necessary. Identifying the glass type is helpful in determining the source of glass particles.

Identifying Organic Compounds using Fourier Transform Infrared Micro Spectroscopy (Micro-FTIR) Analysis

Figure 6. Reference spectrum for Viton. (click to enlarge)

The SEM-EDS method cannot uniquely identify organic compounds, as it provides only elemental information—an EDS spectrum of organic material shows major carbon, and if it is degraded, oxygen. Protein will contain nitrogen as well.

Figure 7. Cellulose IR spectrum. (click to enlarge)

FTIR analysis can identify most organic and a few inorganic materials. For small particles, micro-FTIR (an FTIR system with a microscope coupled to it) is used. Micro-FTIR analysis requires that the sample be thin enough to transmit light, since the system passes a beam of infrared radiation through the sample and records the frequencies at which the sample absorbs infrared radiation. The spectrum from a given material is unique, and even mixtures of materials can often be identified by comparison to known spectra from a reference library using an automated computer search.

Figure 8. Cardboard IR spectrum. (click to enlarge)

In this way, organic materials such as Viton O-rings can be identified (Figure 6 is a reference spectrum for Viton). Other organic material may be present in the product, such as cellulose (see Figure 7) or cardboard (see Figure 8). While these materials are not dangerous as small particles, they are not desirable in food products. When these kinds of things are found, tracing them to their source may be simple (as in the case of the O-ring material) or hard (cellulose can come from paper or cotton clothing, for example).

If the organic material found has inorganic fillers like titanium dioxide or silicon dioxide, then SEM-EDS can be used in concert with the micro-FTIR to refine the material description and simplify the process of identifying the source of the foreign material.

When used in tandem, SEM-EDS to identify inorganic materials and micro-FTIR to identify organic materials can be powerful tools for determining the origin of foreign particles. These microanalysis methods are essential tools for identifying and tracing the source of contaminant particles in food.

March 8, 2016

Mike Taylor Leaving FDA, Stephen Ostroff to Step In

By Food Safety Tech Staff

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FDA has announced that FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor is leaving the agency on June 1, 2016. Dr. Stephen Ostroff (most recently served as acting commissioner) will become the second Deputy Commissioner for Foods and Veterinary Medicine.

According to an FDA release:

Mr. Taylor joined FDA in July 2009 and was named to this position in 2010. Since that time, he has led the implementation of the FDA Food Safety Modernization Act, the most sweeping food safety reform in more than 70 years, and guided nutrition-related initiatives to reduce the risk factors for chronic disease and other adverse diet-related outcomes. He has overseen the move to eliminate the use of certain antibiotics that can contribute to the development of antimicrobial-resistant bacteria. Understanding the importance of dialogue, partnership, and active stakeholder engagement in effecting change, Mr. Taylor has sought to ensure everyone had a place at the table in designing rules and taking actions to protect Americans and contribute to a safer, more wholesome food supply.

A nationally recognized food safety expert, Mr. Taylor has served in numerous high-level positions at FDA, as a research professor in the academic community, and on several National Academy of Sciences expert committees studying food-related issues. He also served as administrator of USDA’s Food Safety and Inspection Service (FSIS) and acting under secretary for food safety at USDA, where he spearheaded public health-oriented reform of FSIS, guided the development of new safety requirements for meat and poultry products, and addressed the hazard associated with E. coli O157:H7 in beef products.

Mr. Taylor plans to continue working on in the food safety arena, focusing on those settings where people lack regular access to sufficient, nutritious and safe food.

Prior to serving as acting FDA commissioner, Dr. Ostroff was named the agency’s chief scientist in 2014, and was responsible for leading and coordinating FDA’s cross-cutting scientific and public health efforts. Dr. Ostroff joined FDA in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to Mr. Taylor. Prior to that, he served as deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), and as Director of the Bureau of Epidemiology and Acting Physician General at the Pennsylvania Department of Health. He is a graduate of the University of Pennsylvania of Medicine and completed residencies in internal medicine at the University of Colorado Health Sciences Center and in preventive medicine at CDC.

Dr. Ostroff’s expertise in public health and knowledge of food safety, nutrition and veterinary medicine programs will ensure a smooth and seamless transition. Between now and June 1, Mr. Taylor and Dr. Ostroff will work closely together, with FDA Commissioner Califf’s strong support, to manage a transition that sustains the program’s momentum on the many challenges and opportunities that lie ahead for FDA.

March 7, 2016

Retail Food Safety Forum

Break the Pencil: Goodbye Paper, Hello Technology

By John Sammon III

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With the passage of FSMA, any location that handles food for public consumption must implement Hazard Analysis and Critical Control Points (HACCP) plans to reduce food safety risks across the food chain. Many businesses with multiple locations in the restaurant and retail industries are finding that traditional paper-based methods of record keeping are no longer adequate to comply with the FSMA. By abandoning paper-based systems and adopting cloud-based technology, restaurant and retail locations can embrace and enforce stronger food safety cultures and help eliminate human error.

According to the CDC, each year an estimated 48 million Americans get sick, 128,000 are hospitalized and 3,000 die from foodborne disease.

Why? The process of purchasing, transporting, preparing and serving food heavily revolves around individual human behaviors related to cooking, cleaning, handling and refrigerating food. When employees do not follow the correct processes and procedures, it can lead to accidental food safety issues.

FSMA & HACCP Plans

In an effort to shift from responding to food contamination incidents after the fact to proactively preventing them, the FDA introduced FSMA in 2011. To allow businesses time to adjust to new rules and regulations, the FSMA requirements are implemented in phases, which began in September 2015 and will continue through May 2016.

As part of a larger food safety initiative, FSMA requires any business that handles food for public consumption to implement a HACCP plan. The purpose of the plan and its procedures is to identify potential hazards in any food-related processes where a lapse in attention or failure to complete a task could turn a potential hazard into an actual one.

The three main components of an HACCP plan that are required to be documented are:

Hazards: Evaluate potential hazards that exist in the enterprise. For example, how, when and why Salmonella or Listeria could migrate into a finished product
Critical Control Points: Identify critical control points where failures could occur, such as when products are moved from preparation to the sales floor
Preventative Steps: Establish the preventative steps that must be followed at each critical control point to reduce hazards, for example, interval checks to make sure correct temperatures, whether hot or cold, are consistently maintained

FSMA also mandates a record of food safety compliance to ensure a company follows its HACCP plan. Every location must document all actions, including ongoing monitoring of when a problem was spotted and corrective actions taken. These records, which have traditionally been created and maintained with pen or pencil and paper logs, must be kept for a minimum of two years.

Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.

Compliance Challenges

With multiple locations and an ever-changing labor force, it is difficult for companies to be confident that the food they sell is safe and that every employee is acting diligently when it comes to food safety across the entire enterprise.

In a busy restaurant or retail environment with ever-changing customer demands for a variety of different products and services, a food safety culture and plan can unintentionally become compromised.

With local farmers to international food manufacturers supplying fresh, frozen and prepared foods and a variety of workers in contact with each for different reasons, it can be difficult to track food safety procedures.

Add an inefficient, manual, paper-based food safety record-keeping system that does not proactively remind employees to complete tasks or prompt corrective actions when needed, and you are opening the door to potential problems.

It’s Time to Break the Pencil

Companies must implement the highest standards of food safety processes at all levels and locations. Once a food safety culture is defined, it needs to be enforced every day. Employees should be well trained on policies, feel empowered and mandated to behave consistently.

A major part of the solution is abandoning traditional pen or pencil and paper-based record-keeping systems. By adopting technology, restaurants and retail locations can embrace and enforce stronger a food safety culture and help eliminate human error.

Electronic and intelligent checklists and digital record keeping on mobile, handheld solutions that are integrated into the Internet of Things (IoT) represent a major technological advancement over what was previously possible, and can manage and dynamically influence food safety processes. Through connectivity to the cloud, mobile, digital solutions can be deployed anywhere throughout a business, from warehouses to sales floors, to prompt the desired behaviors and provide a detailed, accurate audit trail of completion. Devices can also keep track of relevant safety alerts and recalls to improve efficiencies and initiate steps that may not be part of a typical routine.

Daily employee work schedules can be preloaded and custom electronic-based checklists and templates can be built specifically around potential hazards to manage employee tasks and processes. Any missed steps or violations are flagged for easy correction.

As tasks are completed, data is electronically gathered and transmitted directly to the cloud where it can be stored, analyzed and reported for compliance.

In addition, through the cloud and IoT, employees at various levels of an organization, from corporate headquarters to store managers, can view and access real-time data from each location. New information can be uploaded from any location and automatically distributed to a particular store, region or all locations across an enterprise. Enterprise-wide access helps ensure all locations are practicing the most up-to-date HACCP plan and procedures.

Digital food safety solutions have many benefits for a business:

Overall Food Safety: Ensures critical control points are monitored and proper corrective actions are taken when necessary
Higher Performance: Employees are reminded to complete assigned tasks, so more tasks are completed on time with fewer misses
Audit Trail: Detailed, automated audit trail of who completed the action, what time it was completed and the data retrieved from the action
Process Improvement: A single database of comprehensive information detailing timing, missed checklists, commonly missed items and top violations to help improve overall processes
Cost Savings: Fewer resources are needed to complete food safety inspections, a 60% reduction in time compared to pen or pencil and paper-based systems¹
Quality Improvement: In addition to HACCP compliance, the information gathered can be used for quality control. For example identifying where there has been over- or under-cooking in the food preparation process

Handheld, wireless and cloud-based technologies can serve as more accurate, reliable and efficient systems. Electronic systems are part of the solution for businesses to comply with new FSMA regulations and improve food safety procedures. When implemented properly, these technologies can help turn food safety in a positive direction and potentially avoid the next foodborne illness outbreak.

Reference

National Grocers Innovation Center, Center for Advancing Retail Technology. Intelligent Checklist for Quality and Safety in the Supermarket. Retrieved from http://info.partech.com/whitepaper-intelligent-checklist-for-food-safety

Brian Bedard, GMA, Food Safety Consortium

March 2, 2016

Food Safety Culture Series: Where the Leaders Are

By Maria Fontanazza

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Most industries face issues with breaking down silos and promoting cross-functional collaboration. For the next class of leaders to be well equipped to promote and practice a strong food safety culture, more work needs to be done on alignment within organizations and across industry. In part II of Food Safety Tech’s series on food safety culture, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen weigh in on leadership.

Food Safety Tech: Food Safety Culture requires strong professional leaders. How can industry work together to develop the leadership that is needed?

The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MORELone Jespersen: We start by acknowledging that we have an abundance of strong leaders in the food industry. We don’t need to build from the ground up or something new. We need to look at what makes [these leaders] strong. Why are some leaders more successful than others? Identify the companies that have strong food safety leaders that are not within food safety—those that come from finance, HR, procurement, and the CEO—and formally acknowledge their technical and leadership competencies.

I’m aware of three organizations that are actively looking at what constitutes a food safety professional and its competencies—IFPTI (International Food Protection Training Institute) in the United States, Safe Food Canada, and the International Union of Food Science and Technology. Alignment between the work conducted by each of these organizations is important to shorten the time between development and business impact. It’s really important to get this alignment. The more we keep working in small subgroups while not comparing notes and agreeing on those competencies, the more we’re going to see the cost of developing leaders going up. And we’ll have fewer strong leaders, because it will be hard for individuals to move on in their career if it is not clear what it means to be a competent, strong food safety leader.

There’s a very large group of food safety leaders, the ‘Malcolms-in-the-Middle’ who are excellent leaders and are one or two steps down from the head of food safety in an organization. Sometimes we forget that we have strong leaders at this level, and they have a much stronger handle on food safety culture because they’re the ones who have to make sure programs work for frontline associates, supervisors, and managers. Letting that level become more visible to what their competencies are or should be and making sure that they contribute and are heard in the conversations [is important].

Brian Bedard: We need to collaborate and get some alignment around what we think leaders need. Unfortunately, this is creating a competitive space among service providers and training entities that can work with leaders.

There are a couple of fundamental principles that need to be addressed:

The leaders at the top need to recognize and drive it down through their entire system so that everyone is responsible in terms of their annual work and development plans, including metrics and the deliverables in their annual evaluations
The ‘Malcolms-in-the-Middle’ who, in most cases, manage the budget. It’s critical to get them on board to ensure that, when making investments, they’re spending money on driving food safety culture throughout an organization
Several specific opportunities now exist to promote food safety culture leadership, including the Food Safety Leadership Workshop being offered by the GMA Science and Education Foundation at the upcoming GMA Science Forum (April 18, Washington, DC).

February 29, 2016

FST Soapbox

Substituted Ingredients Are Only the Tip of the Iceberg

By John M. Ryan, Ph.D.

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While the United States has no legal definition of food fraud, current thinking tends to be focused primarily on companies and products involved in the illegal substitution of one ingredient for another in a product. Such substitution generally involves substituting a cheap filler in the place of the labeled ingredient. In recent news, Parmesan and Romano cheeses have captured news headlines because of illegal “misbranding” of foods meaning that the label on shredded cheeses from companies like the Castle Cheese, Inc. company in Slippery Rock, PA include ingredients found through FDA testing that are included in percentages beyond allowable levels. In the case of shredded cheeses, so called “imitation” cheese better is known as wood pulp. The labels stated that the ingredients were 100% cheese.

Perhaps Slippery Rock is an apt name for the Castle Cheese operation where the inclusion of wood pulp was cheaper than the inclusion of real parmesan cheese. Such activities are becoming increasingly known as “economically motivated” and the practice is one of economically motivated adulteration. The FSMA final rule, Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, will make these practices illegal.

Such intentional cheating has a long record in the history of food. No one really knows the extent of such food fraud activities, when they started (perhaps at the beginning of time?), or who could claim to be the first person to win an international award for creativity.

There are so many ways to commit food fraud that it boggles the mind and creates an almost complete inability on the part of governments, testing laboratories, food processors, retailers and the public to identify, let alone fully prevent and capture the guilty every single time.

Think about a few things. Is it fraudulent to leave the identification of GMO ingredients off of labels? If a packer knowingly packs a product in dirty packaging, is that practice fraudulent? If the food safety part of the government knows how high the levels of fecal coliform are on most of the produce we eat but does not acknowledge the problems or inform the public, is this practice fraudulent? How about the idea that a retail outlet replaces an “expired” label on hamburger with a new unexpired label? Or how about the time Sysco was shipping perishable foods in refrigerated trucks and storing eggs, milk, meat, chicken and other products in the same storage sheds where you might keep leftover junk from your garage? Do “Good Things Come From Sysco”?

But none of those examples have anything to do with intentionally substituting a cheaper ingredient for an ingredient on the label. Honey, olive oil, coffee, juices, fish, alcohol, milk and dairy products, fish, vitamins, meat, spices, organic foods, maple syrup, peanut product, flavorings, preserves, cereals, colorings, wines, vinegar, purees, sweeteners ,and other ingredients are involved. And food fraud occurs in manufacturing, processing, packing and food holding operations. Such large opportunities for all foods in all operations means the entire food chain is—at one time or another, in one place or another—suspect.

The Grocery Manufacturers Association (GMA) estimates that food fraud may cost the global food industry between $10 billion and $15 billion annually with lost sales between 2% and 15%. They estimate that approximately 10% of all commercial food products are impacted.

Considering the fact that the food industry claims their profit margins are only a few percent, it would seem that if they wanted to reduce food costs, food fraud would surely be a prime business improvement target. And GMA, unfortunately, is also focused on economically motivated adulteration such as unapproved additives, mislabeling, counterfeit ingredients, transshipment (shipping from one country to another to repackage and relabel in order to avoid taxes), and dilution.

When a consumer enters a supermarket in search of fresh meat, poultry or fish to cook for dinner, he or she knows little about how those products were packaged. Adding water to the pad that is often inserted under the meat to soak up blood, adds weight to the scale and money to the price. Packing the meat using carbon monoxide is common in order to “preserve” the product color. Red meat should look red, right? While the FDA considers this practice generally recognized as safe (GRAS), studies regarding how carbon monoxide interacts with the foam packaging and the clear plastic wrap covering the package are nonexistent. What makes the practice deceptive is the lack of information on the label that tells consumers carbon monoxide is used to preserve color. Of equal importance are recent studies that clearly show that many of the plastics used in today’s food packaging operations contain toxic chemicals shown to be dangerous to humans.

Interestingly enough, the European Union has a definition of food fraud:

‘Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain’.

After the monster European horsemeat scandal (remember that one?) in which horse meat was substituted for beef to the embarrassment of many companies, such as Burger King and Ikea, the United Kingdom promised proactive solutions from food laboratories and improving supply chain audits in an effort to slow and diminish the number of incidents reported annually.

In the United States, we frequently point to the melamine (milk substitution) in baby formula or the pet food problems that came out of China as evidence that foreign companies are primarily to blame for food fraud. Coupled with governmental trade agreements and the attitude that other countries are dumping substandard product on American consumers, it seems easy to blame others for food fraud –except for the fact that we in America are dealing with so many incidents.

The problem with our inability to tackle food fraud in part comes from the gap between our ability to identify and develop appropriate and targeted food ingredient testing capabilities. So many types of food, so many types of tests, so many types of ingredients, and so many types of ways to intentionally or accidentally cheat the system all combine to confuse and confound our efforts to quickly and economically establish detection systems.

In most food distribution arenas, food traceability systems are slowly being agreed upon and implemented. However, the FDA does not seem to be able to help with establishing data and other standards that would help establish traceability requirements designed to quickly and accurately get to the source suppliers in food fraud events. Other industries under FDA medical device and drug laws have worked to establish solid chain of custody systems. Chain of custody implies that the suppliers and handlers are legally responsible and clearly identified. Leadership in this area is clearly needed.

While there are many good resources evolving both within and outside of the United States, those resources are scarce and relatively immature. It seems that without some basics, such as legal definitions, standardized testing practices, and an agreement that food fraud is much more than substitution of one ingredient for another, we have a very long way to go if we expect to get the food fraud system under control.

February 25, 2016

Food Safety Culture Series: What’s the Controversy?

By Maria Fontanazza

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From measurement tools to a shift in mindset and leadership, a recent debate at the Food Safety Consortium brought to light the varying levels of opinion and understanding about food safety culture. In a four-part series with Food Safety Tech, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen, director of food safety at Maple Leaf Foods continue the conversation about food safety culture and where it’s headed in 2016.

Food Safety Tech: What is the most controversial aspect to the concept of Food Safety Culture?

Lone Jespersen: I don’t think there are a lot of controversial aspects. I think the debate in Chicago [at the Food Safety Consortium] showed exactly that—companies understand the importance of food safety culture. The challenges that we collectively face lies in what food safety culture is and how we can best measure improvements within our organization to sustain a strong and effective food safety culture. That, by definition, requires that we know what food safety culture is and what we are going to measure. That is where the lack of clarity, understanding, and alignment is.

Over the last few months, I’ve done a lot of comparisons between the measurement tools, and they’re actually not terribly different, but as usual, we get confused by words. As long as we have a clear understanding of how tools are different and what they actually measure, it will be possible for each of us to select the best method for our organization. It’s more confusion than controversy. If we speak of controversy, I think it is with manufacturers and processors who are increasingly worried about what FDA is going to do when they talk about the food safety culture—will investigators come and look for food safety culture without a clear understanding of what it is? Again, it requires that we have a common understanding, which we don’t have today.

Brian Bedard: I agree. It’s not really controversy; it’s more of confusion and misunderstanding. We’re seeing some alignment and a better understanding that food safety culture is not something totally different and out in left field; it’s a new way of looking at food safety that is all-encompassing and gets around what was happening in the past, which was an ad-hoc, disjointed approach to dealing with food safety issues. It gives companies a more refined process to drive food safety that everyone can understand, from senior managers right on down.

Regulators around the world are looking at food safety culture as one way to help them do their work better. Our concern is that food safety culture shouldn’t become a regulatory tool per se but should be awareness and [an] appreciation that food safety culture at a company can help regulators better understand the risks they are supposed to be evaluating in a preventive manner.

The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MOREJespersen: It’s also about looking at food safety culture and the discussion today, which largely takes place in the forum of food scientists, food safety leaders, heads of food safety at large organizations—in other words, between individuals who are educated and experienced food safety professionals. Their experience is in developing microbiological environmental testing programs, full-scale food safety management systems that go across manufacturing facilities—very complex and technical issues, all of which couldn’t be more different than that required of a professional within an organizational where it’s about behaviors and consequences. The same goes for investigators and auditors [and their roles]—they’re good at assessing written systems, etc. What about behavioural observations and assessments? This stakeholder assessment hasn’t been a part of the debate, and we need to bring it in.

February 23, 2016

Veterinary Drugs Analysis to Ensure Food Safety

By Olga I. Shimelis

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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.

Examining and Isolating Foreign Material

Identifying Inorganic Compounds with SEM-EDS

Identifying Organic Compounds using Fourier Transform Infrared Micro Spectroscopy (Micro-FTIR) Analysis

FSMA & HACCP Plans

Compliance Challenges

It’s Time to Break the Pencil

Reference

Aminoglycosides Antibiotics

Conclusions

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