Tag Archives: Focus Article

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

FDA’s Tactics to Reduce Outbreaks and Recalls

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

The advent of PulseNet in the late 1990s enabled more effective identification of outbreaks, even as many of them overlapped. The database brought to light the fact that many of the products sold in commerce nationwide contained ingredients that were at risk of contamination with dangerous pathogens. In many instances, these ingredients were in products from a single lot or batch and then sold by a single supplier to dozens of customers. From there, they were used in hundreds of products that would be distributed into thousands of retail locations.

Attend Food Safety Tech‘s Listeria Detection & Control Workshop | May 31–June 1 in St. Paul, MN | LEARN MOREFDA created the Reportable Food Registry (RFR) as a way to prevent the shipment of contaminated ingredients into the food supply. If received ingredients or products test positive for contaminants, the RFR requires that the company inform FDA. The agency uses the reports to take regulatory action against the original supplier and requires that all ingredients or products from all potentially affected lots be recalled from commerce. Because the RFR allows FDA to immediately begin tracking and containing ingredients testing positive for pathogens, its introduction in 2009 resulted in a significant spike in recalls.

Driven by the recalls triggered by PulseNet and the RFR, a national perception about an extremely unsafe U.S. food supply began to emerge. The public and media demanded that Congress take action, and so FSMA was born. The regulations require all FDA-regulated food companies to develop and implement written preventative control programs designed to control pathogens and other hazards in food. As a result, food companies will face heightened regulatory risk, scrutiny and exposure.

To further decrease the incidence of outbreaks and recalls, FDA is implementing regulatory enforcement initiatives that include sampling food products at retail for the presence of pathogens; conducting microbiological profiling of food processing facilities during routine inspections; and exploring criminal sanctions against companies that have been linked to positive samples in food products or production facilities associated with an outbreak or foodborne illness.

Microbiological Sampling in Retail

FDA is sampling products intended for human consumption as well as those for animal consumption. As testing continues at the retail level, the likelihood of more food products testing positive for the presence of pathogens is much higher. When positive product samples are found, FDA will take immediate action against the company that processed the product and require the company to recall all affected product. The agency will also demand access to the production facility at issue and conduct extensive environmental sampling, including from drains, floors, walls, production equipment, and finished products, in an effort to find the same strain as the sample testing positive at retail.  If product or environmental samples test positive, FDA will perform genetic DNA testing on the isolates and compare the DNA fingerprints against those of the isolates collected from sick case patients in PulseNet over the past 15 years. If a match between the DNA fingerprint and an illness(es) in PulseNet is found, the agency will presume that these illnesses were caused by product originating from that particular facility. FDA will also demand access to all food production and microbiological testing records from previous months, or years, and critique those records.

Microbiological Sampling in Food Production Facilities

In accordance with FSMA, FDA will inspect all food production facilities (drains, floors, walls, food processing equipment, and finished products) that process high-risk ingredients or food products within the next three years (lower risk facilities will be inspected within the next five years). The agency is also performing extensive microbiological profiling of the food processing environment in all production facilities during routine inspections. If a positive sample is found, FDA may require the company to recall the affected product. It is expected that the level of sampling will intensity in the coming months and years as a result of FSMA mandates. And as the extensive microbiological sampling in food production facilities continues, FDA will perform genetic DNA testing on any positive samples collected, once again comparing the DNA fingerprints of samples against those of sick case patients over the last two decades. If a match is found, FDA will take the same course of action as in retail and presume all illnesses were caused by a food product originating from that specific facility. When that occurs, in addition to the potential recalls that may be required, the food companies at issue may become the target of a criminal investigation as well.

My next column will cite recent examples of FDA’s criminal offensive against food companies.

Steven Guterman, InstantLabs
In the Food Lab

Save Seafood with Digital Tracking

By Steven Guterman, Sarah McMullin, Steve Phelan
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Steven Guterman, InstantLabs

The combination of improved digital tracking along the food supply chain, as well as fast, accurate DNA testing will provide modern, state-of-the-art tools essential to guarantee accurate labeling for the ever-increasing quantities of foods and ingredients shipped globally.

The sheer scale of the international food supply chain creates opportunities for unscrupulous parties to substitute cheaper products with false labels. We know fraud is obviously a part of the problem. Some suppliers and distributors engage in economically motivated substitution. That is certain.

It’s equally true, however, that some seafood misidentification is inadvertent. In fact, some species identification challenges are inevitable, particularly at the end of the chain after processing. We believe most providers want to act in an ethical manner.

Virtually all seafood fraud involves the falsification or manipulation of documents created to guarantee that the label on the outside of the box matches the seafood on the inside. Unfortunately, the documents are too often vague, misleading or deliberately fraudulent.

Oceana, an international non-profit focused solely on protecting oceans and ocean resources, has published extensively on seafood fraud and continues to educate the public and government through science-based campaigns.

Seafood fraud is not just an economic issue. If the product source is unknown, it is possible to introduce harmful contamination into the food supply. By deploying two actions simultaneously, we can help address this problem and reduce mistakes and mishandling:

  • Improved digital tracking technologies deployed along the supply chain
  • Faster, DNA-based in-house testing to generate results in hours

Strategic collaborations can help industry respond to broad challenges such as seafood fraud. We partner with the University of Guelph to develop DNA-based tests for quick and accurate species identification. The accuracy and portability produced by this partnership allow companies to deploy tests conveniently at many points in the supply chain and get accurate species identification results in hours.

Our new collaboration with SAP, the largest global enterprise digital partner in the world, will help ensure that test results can be integrated with a company’s supply chain data for instant visibility and action throughout the enterprise. In fact, SAP provides enterprise-level software to customers who distribute 78% of the world’s food and accordingly its supply chain validation features have earned global acceptance.

The food fraud and safety digital tracking innovations being developed by SAP will be critical in attacking fraud. Linking paper documents with definitive test results at all points in the supply chain is no longer a realistic solution. Paper trails in use today do not go far enough. Product volume has rendered paper unworkable. Frustrated retailers voice concerns that their customers believe they are doing more testing and validation than they can actually undertake.

We must generate more reliable data and make it available everywhere in seconds in order to protect and strengthen the global seafood supply chain.

Catfish will become the first seafood species to be covered by United States regulations as a result of recent Congressional legislation. This change will immediately challenge the capability of supply chain accuracy. Catfish are but one species among thousands.

Increasingly, researchers and academics in the food industry recognize fast and reliable in-house and on-site testing as the most effective method to resolve the challenges of seafood authentication.

DNA-based analyses have proven repeatedly to be the most effective process to ensure accurate species identification across all food products. Unfortunately, verifying a species using DNA sequencing techniques typically takes one to two weeks to go from sample to result. With many products, and especially with seafood, speed on the production line is essential. In many cases, waiting two weeks for results is just not an acceptable solution.

Furthermore, “dipstick” or lateral-flow tests may work on unprocessed food at the species level, however, DNA testing provides the only accurate test method to differentiate species and sub-species in both raw and processed foods.

Polymerase chain reaction (PCR), which analyzes the sample DNA, can provide accurate results in two to three hours, which in turn enhances the confidence of producers, wholesalers and retailers in the products they sell and minimizes their risk of recalls and brand damage.

New technology eliminates multi-day delays for test results that slow down the process unnecessarily. Traditional testing options require sending samples to commercial laboratories that usually require weeks to return results. These delays can be expensive and cumbersome. Worse, they may prevent fast, accurate testing to monitor problems before they reach a retail environment, where brand and reputational risk are higher.

Rapid DNA-based testing conducted in-house and supported by sophisticated digital tracking technologies will improve seafood identification with the seafood supply chain. This technological combination will improve our global food chain and allow us to do business with safety and confidence in the accuracy and reliability of seafood shipments.

Gina Kramer
Food Safety Think Tank

Mobile Technology Could Help Your Business in an Outbreak

By Gina R. Nicholson-Kramer
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Gina Kramer

Join Gina Kramer at the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREI recently spoke with Wes Billingslea, one of the co-founder’s of Till Mobile Corp., a company founded because its team realized large brands needed to connect all the way down to the smallholder and grower level. There are more than 6 billion mobile devices on earth and only a small percentage of them are smartphones. Till uses voice, text, and SMS-mobile to enable two-way communication with smallholders, and to deliver visibility and traceability. The company is able to collect massive amounts of data from growers because there is no resistance to using mobile phones. It works with your existing systems to identify and fill data gaps that create risk. The big brands access detailed analytics and can communicate directly throughout their supply chain to accelerate supplier onboarding, support local and alternate sourcing, and check inventory, pricing, and food safety standards.

I asked Wes, as a food company, how could this technology save me money? To start, it allows you to check inventory and pricing, and helps you adhere to your food safety standards beyond the packinghouse or distributor. It can also help you get more out of your existing systems to protect your IT infrastructure.

In the following video, we discuss the Salmonella outbreak in cucumbers that occurred last summer. In such a scenario, this new technology could help save food retailers money during an outbreak or recall by giving them greater visibility and real-time data, and help them source alternatives directly.

Sanitation in Retail

Out with the Old: From Dirty Rags to Cleaner, Safer Technology in Retail

By Maria Fontanazza
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Sanitation in Retail

Across the board, increased employee awareness and training has become a big issue in food safety. The foodborne illness outbreaks that hit Chipotle Mexican Grill has put retail and restaurant establishments on high alert, yet this is just another example of the reactive culture in which we operate, according to Matt Schiering, vice president and general manager at Sani Professional.

Matt Schiering, Sani Professional
“Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean,” says Matt Schiering of Sani Professional.
Food Safety Tech recently hit the road with Schiering and John Caton, regional sales manager at Sani Professional, to experience first hand how one company is communicating its message to customers. Breaking with tradition has been an important part of promoting cleaner technology: The use of the rag and bucket as a means to clean both the front of the house (tables, chairs, counters, etc.) as well as the back of restaurants and retail establishments, while still fairly common, has outlived its effectiveness, and frankly, says Schiering, “screams unclean”. Caton and Schiering continued the conversation with their customers about how using disposable wipes for cleaning, sanitizing and disinfection helps prevent the spread of contamination, along with the cost savings associated with using such products. The company takes a multi-prong approach to promoting awareness among its current and potential clients, from deploying a sales force that directly interacts with quality assurance and food safety professionals in establishments to offering how advances in sustainable technology can help them stay ahead of the curve to driving consumer advocacy.

Food Safety Tech: How is Sani Professional raising the level awareness of the disadvantages of the traditional cleaning method (the rag and bucket method) in the retail environment?

Matt Schiering: There are a few ways to raise the level of awareness. The first and foremost is “feet on the street”. We’ve deliberately moved toward a direct-to-customer sales force, which gives us the opportunity to interface directly with QA, food safety and operations to show them a simpler, more efficient, more effective, and guest appealing way versus the traditional rag and bucket. The first win is one for the user (the employees of a given establishment), because associates have shown us time and time again that they do not like the mixing and measuring, and the errors that are often associated with that process. They don’t like the dirty rag itself—having to fish it out of the bowl and then present it or be seen with it in the front of the establishment. It’s a win for the operator (the manager), because with our system, there’s no longer any heightened heart rate when the health inspector shows up. One of the most common violations is the water in the buckets being out of spec or the rags themselves not being inside the bucket per regulation. And perhaps most importantly, it’s a win for the guest. Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean.

As we talk about the evolution in perception, away from traditional methods, we believe that speaking directly to the consumer has to play a role. There has to be a degree of consumer-driven advocacy for a better way. – Matt Schiering

FST: Regarding employee training, how should retailers be more proactive in ensuring their employees are engaging in proper food safety practices and aren’t spreading foodborne illnesses?

Schiering: It varies by chain. Unfortunately, we live in a reactive culture—and that goes well beyond the restaurant industry.

Oftentimes a problem precedes a protocol or other means of addressing said problem. Chipotle is one example: They’ve taken an exhaustive look at restructuring their food safety protocols as a result of a myriad of foodborne illness-related issues that they suffered in the preceding months. The [retailers] who are doing it best are the ones who build it into their establishment in the first place where it’s not predicated by some sort of problem. That involves training materials, in-service lessons, and online training (i.e., ServSafe certifications). Waffle House, for example, has Waffle House University where food safety is a key component to that system.

We envision ourselves as part of that process. We take a microcosm—the notion of proper food handling, prevention of cross contamination related foodborne illness—and provide an innovative and easy-to-use solution, and all the training and collateral materials associated with the solution that explain the proper use. We also provide test kits so that if the health inspector wants an in-the-moment proof that our product is doing what the label says it does, [the retailer] can provide that at a moments notice. It becomes more of a service proposition than simply a product-driven solution.

Sanitation in Retail
Using disposable wipes for cleaning, sanitizing and disinfection can help prevent the spread of cross contamination and foodborne illness.

FST: Where do you see sustainable products fitting into the space?

Schiering: This also boils down to education, because the perception of disposables is that they’re wasteful, when in fact they needn’t be any more costly than existing solutions.

If you’re using a linen service, there’s a cost associated with renting towels, but there’s a higher cost associated with wasting towels. So if a towel ends up in a gym bag or in the trash because of overuse and/or abuse, there’s a significant upcharge for not returning that towel to the rental agency. That’s what we call the hidden cost or the dirty little secret of rag and bucket sanitizing. When you factor that in, and everyone [retailers] experiences that type of loss, and you look at the fact that sanitizing wipes kill pathogens trapped in the wipe as well as whatever it is coming into contact with at the surface, thereby enabling it to be used on multiple surfaces without causing cross contamination—the cost aligns very closely. And of course it’s a more value-added guest experience than a dirty rag being used from table to table, which is not preventing cross contamination.

Speaking to the environmental piece: At the moment, we’re actually fairly well ahead of the industry. It varies chain to chain—some chains are doing a better job than others, because it’s part of their corporate culture. But by providing solutions that are leveraging either recyclable substrates or compostable substrates, we provide greater opportunity to reduce the environmental impact often associated with disposable products. If a retailer is working with a waste management partner that can handle industrial compostable products or non-solid state recyclables, we have solutions that are appropriate for those operations, so that we’re not just adding to landfills but rather essentially recycling and/or regenerating the products that are being used, and at no greater cost.

Most retailers haven’t gotten there yet. It speaks directly to corporate culture and corporate mission of the end user. We deliberately target customers who are a little bit ahead of the curve when it comes to “green technology or “green behavior”. And so when the rest of the industry catches up, we’re more than ready to serve them with products that meet those needs.

FST: Where do consumers fit into the picture, especially has industry moves away from traditional methods in food safety?

Schiering: About a decade ago, consumers started demanding that retailers like Walmart, Target, and local grocers provide a means of sanitizing shopping carts when they walk into their local retail establishments. There were myriad news reports about the germs and potential for contamination and illness arising from the often used and rarely cleaned implements—these vehicles for placing your groceries. We answered the call a decade ago, and at one time it was a significant piece of our business.  It continues to be a marketplace we serve, albeit a much commoditized one. But the rise in that solution would not have taken place if not for consumers advocating for a better way.

We’re starting to create a presence on Facebook and other social media outlets to remind consumers that it’s up to them in many cases to ask for, if not demand a more effective, more pleasing way of ensuring their safety in dining establishments. Unfortunately, incidents like what we saw at the large Mexican food service retailer do ultimately play a part in that consumer advocacy, albeit a negative one, because we are a reactive society. But by presenting a positive message and sharing alternatives in the absence of citing examples or shaming retailers through the problem, we believe that will be one of the keys to changing perceptions at the retail level.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Federal Government Takes Regulatory and Criminal Offensive Against Food Industry

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

There was been a significant uptick in the amount of foodborne illness outbreaks and food product recalls (there were more than 500 food product recalls last year), many of which have been caused by dangerous pathogens. As FSMA plays a role in addressing this alarming trend, FDA is making several policy changes that will only continue to intensify. The agency is conducting microbiological profiling both inside food processing facilities during routine inspections and testing large amounts of food at the retail level. In addition, it has launched criminal investigations against food companies distributing products that have the potential to cause human illness. In many of these cases, company executives did not have direct knowledge that their products were causing, or had the potential to cause, illness. Many investigations involve Listeria monocytogenes (LM) found in food processing environments or in food products in commerce. Under FDA’s new approach, the failure to eliminate sporadic LM findings in the environment can subject companies to criminal liability. The immediate challenge to the food industry is to find a more effective solution to identify and reduce pervasive pathogens in the processing environment using pathogen-reduction technologies, while simultaneously employing written food safety protocols that can provide additional protection against criminal sanctions.

PulseNet Makes Foodborne Illness Link

Following the conclusion of the infamous the Jack-In-The Box outbreak that sickened 600 and killed four people more than two decades ago, the federal government recognized that similar outbreaks were probably occurring throughout the country, but there were no viable means of detection. As a result, the CDC created the PulseNet database, a mandatory foodborne illness reporting system to detect and track outbreaks in real time. From there, when a patient tested positive for a pathogen of concern (such as Listeria Monocytogenes, Salmonella or E. coli O157:H7), his or her doctor had to report that finding to the state health department. Each state requests copies of the isolates and tests them for the specific genetic DNA fingerprint of the pathogen of interest. These fingerprints are uploaded to PulseNet, and when indistinguishable genetic DNA fingerprints are uploaded from multiple victims, the CDC can recognize that an outbreak is emerging. The agency shares this information with FDA and other federal, state and local health departments as they work to determine a common source. Despite the fact that most illnesses uploaded to PulseNet remain unsolved, the database has helped CDC and FDA solve hundreds of outbreaks that have affected thousands of victims.

My subsequent columns will look at the emerging challenges faced by the food industry, including recent federal criminal investigations, some solutions designed to assess environmental contamination and reduce pathogens, and strategies that you can employ to reduce criminal liability.

Palmer Orlandi, FDA, Food Labs conference

FDA Pushing Proactive, Real-Time Analysis

By Maria Fontanazza
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Palmer Orlandi, FDA, Food Labs conference

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.

Palmer Orlandi, FDA, Food Labs conference
“We can’t test our way to food safety. It’s just not possible,” said Orlandi. He added that industry can work together to develop a testing program that leads to safer foods.

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)

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.

Lone Jespersen of Maple Leaf Foods debates food safety culture at the 2015 Food Safety Consortium.
Lone Jespersen of Maple Leaf Foods debates food safety culture at the 2015 Food Safety Consortium.

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.

Particles on filter

Microanalytical Methods Identify Foreign Materials for FSMA Compliance

By Debra L. Joslin, Ph.D
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Particles on filter

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.

Particles on filter
Figure 1. Particles filtered from a liquid product.

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.

Glass particle
Figure 5. Glass particle. (click to enlarge)

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

Reference spectrum for Viton
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.

Cellulose IR spectrum
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.

Cardboard IR spectrum
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.

Michael Taylor FDA

Mike Taylor Leaving FDA, Stephen Ostroff to Step In

By Food Safety Tech Staff
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Michael Taylor FDA

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.

John Sammon, ParTech
Retail Food Safety Forum

Break the Pencil: Goodbye Paper, Hello Technology

By John Sammon III
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John Sammon, ParTech

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.
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

  1. 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