Attend the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREAccording to the CDC’s Foodborne Outbreak Online Database (FOOD Tool), there were 29 Listeria outbreaks between 2010 and 2014, resulting in 325 illnesses and 68 deaths (nearly a 21% fatality rate). In light of the recent reports that the U.S. Department of Justice is looking into Blue Bell Creameries following the Listeria outbreak in its facilities that killed three people, food companies need to have a strong mitigation and control program before it’s too late. The government is placing is a higher level of accountability on employees at all levels within food organizations and no one, including company executives, are immune to it.
“It’s extremely important that we understand how deadly Listeria is,” said Gina Nicholson-Kramer, founder and executive director at Savour Food Safety International, Inc. during a Listeria workshop at the 2015 Food Safety Consortium. “We’re put here to protect our consumer.”
Containing what may be growing (and rapidly spreading) within the nooks and crannies of a facility is a challenge. To learn more about how to prevent product contamination within all areas of food production, read the column by Nicholson-Kramer and Jeff Mitchell, vice president of food safety at Chemstar, Activate Your Listeria Mitigation and Control Program.
Several news outlets have reported that the U.S. Department of Justice (DOJ) is investigating Blue Bell Creameries following the Listeria outbreak that resulted in three deaths in Kansas and 10 illnesses in Arizona, Kansas, Oklahoma and Texas between January 2010 and January 2015.
According to The Wall Street Journal, the DOJ is mainly interested in the involvement of company executives—did they know about the Listeria contamination? If so, what did they do about it?
Last April Blue Bell recalled all of its products over concerns of Listeria contamination and shut down the production line where the products were manufactured.
Blue Bell started a limited-release of its ice cream products last August. The company has not yet issued a response to the reports about the DOJ investigation, but last week it announced that it would begin a “bonus phase” of product re-entry in El Paso, Texas, Little Rock, Arkansas, and Memphis, Tennessee. This is scheduled to be followed by phase five of market re-entry in parts of Tennessee, Alabama, Georgia, Kentucky, North Carolina, South Carolina, and Virginia the week of January 18, and then shipment into all of Florida, southern Georgia and southern South Carolina the week of January 25.
The company stated in a press release that after phase five is completed, all of Blue Bell’s furloughed employees will have returned to work.
With FDA’s limited resources, it’s important for the agency to work smarter, not necessarily harder, when it comes to implementing FSMA. During an FDA Town Hall at the Food Safety Consortium last fall, Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, briefly touched on the agency’s strategy for working with foreign parties to ensure compliance related to importing foods into the United States, including the Food Safety Systems Recognition Agreement with New Zealand.
It’s safe to say that 2015 has been one of the worst years in recent history when it comes to food contamination. Everyone from global food manufacturers to major restaurant chains and grocery stores perpetuated or experienced outbreaks of foodborne illnesses like E. coli, Listeria, Salmonella and Norovirus. From farm to fork, the food industry needs to evalutate and improve its processes to deliver the utmost health and safety to consumers.
With FSMA and tougher industry standards in place, there will be much more emphasis on preventative measures—especially for food manufacturers. FSMA establishes a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
Even though most of the regulations affiliated with the FSMA have just gone into effect, or will go into effect in 2016, food manufacturers are already feeling the heat. A recent survey found that the majority (81%) of food manufacturers are experiencing some level of impact from current and impending regulations. Processes pertaining to traceability, supplier and facility audits, HACCP and product recalls are causing the most concern. While most food manufacturers support FSMA’s mission to put prevention at the forefront, the reality is that many aren’t equipped to handle growing compliance demands.
There are still a sizeable number of food manufacturers that manually record their processes for identifying, evaluating and controlling food safety hazards. In fact, more than 30% of food manufacturers document their HACCP plan in this manner.
With FSMA, there isn’t any room for human error. Although technology with track and trace capabilities has been available long before FSMA came into play, obstacles such as complicated interfaces, lack of interoperability and resources deterred wide-spread adoption among food manufacturers. The tide is changing here. Advanced enterprise resource planning (ERP) solutions have built in track and trace functionality that is more intuitive and integrates seamlessly with vital manufacturing execution systems (MES).
Although the FDA does not have the legal authority to require companies to use computerized traceability solutions, implementing track and trace technology is one of the most effective measures a food manufacturer can take when it comes to FSMA compliance. It can help create a more systematic and reliable account throughout the lifecycle of a food product, and also establish preventative measures, including automated product checkpoints and quality tests throughout the supply chain. Ultimately, this gives food manufacturers the opportunity to identify and prevent issues before they become epidemics.
In addition to taking strong measures to prevent contamination, under FSMA the FDA now has authority to initiate mandatory recalls. Although mandatory recalls are anticipated to be rare, food manufacturers should use track and trace technology to make recall preparation routine. When used properly, these tools can pinpoint specifics about a product in real time, streamline quality reporting, and launch mock recalls.
Of course, technology is not only the vessel for improvement—to actually see change, food manufacturers need to take a critical look at their processes and make adjustments. Automating poor processes will only accelerate poor results, therefore approaching FSMA compliance and implementing track and trace technology requires time and strategy.
Ultimately, your company’s reputation is on the line as well as the safety of consumers. Dedicating necessary resources toward compliance planning and technology implementation is always well worth the investment. Many of the companies and suppliers that were in this year’s spotlight for contamination will look back on 2015 with regret because safety wasn’t at the forefront. Let’s learn from the hard lessons they provided and make 2016 the year that food manufacturers win back consumer trust and focus on quality.
At last the new Produce Rule is out, issued on November 13, 2015. For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.
The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act. It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.
The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.
For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along. For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).
This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.
The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.
However, some key requirements of the new rule not noted in existing third-party standards include:
Water testing of untreated water, sample collection and survey creation for agricultural water.
Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.
This rule does not apply to:
Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
Produce for personal or on-the farm consumption
If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
A food grain such as wheat or oats
The rule provides also for exemptions:
Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.
Under certain conditions the FDA may withdraw a farm’s qualified exemption.
The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.
This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.
FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.
The compliance dates for the new rule are staggered and based on business size.
After much anticipation, FDA has finally published the FSMA final rules. If you’ve had time to dig into the details, you most likely noted the new initiative that requires companies to measure food safety culture. The industry is also seeing SQF, BRC and other GFSI audit schemes ramping up discussions around measuring food safety culture. However, FDA and GFSI audits aside, how do you create a culture for sustained compliance with this initiative? Follow these 10 tips to ensure your food safety culture is constant and in line with the new requirements
1: Create a solid foundation of programs, procedures and policies
Have a preset annual schedule for review and update of all programs, procedures and policies. Don’t let the schedule slide because there are competing priorities. A small pebble is all it takes to start ripple effect in the company, making it difficult to recover.
2: Set clear expectations, driven from the top down
Everyone should follow the rules and guidelines—from visitors to the CEO to the plant manager to the hourly employee. A “no exceptions” policy will drive a culture that is sustainable and drive a “this-is-just-how-we-do-things” mindset.
3: Use record keeping to ensure that food safety culture is well documented and data-driven
Collect the data that is measureable and non-subjective to help drive continuous improvement. If you collect it, you must do something with it. Good documentation is imperative to proving you did what you said you were going to do, especially in the event of an audit. Be stringent in training, and review all documentation before it hits the file cabinet to ensure it is accurate and appropriate.
4: Implement a robust continuous improvement process
Forward momentum through a continuous improvement process cannot be achieved unless management nurtures the program. If you are not continuously improving, you are falling behind.
5: Have a 360-degree approach to employee engagement with 24/7 awareness and communication
Top-down communication is critical to highlighting the priorities and needs of an organization and will not be effective unless an organized program is in place. Organizations that are not making the necessary pivots to communicate with the multiple generations within their workplace today will struggle to sustain change.
6: Foster an atmosphere of mutual respect
Treat people as you would like to be treated, turn the other cheek, etc. There may be lots of adages you quote, but which one best describes your facility and the relationships with management and peers on a daily basis?
7: Be sure employees have consumer awareness for the products they produce
Do your employees know who the end consumer is of the product that they are producing every day? Does your culture include a review of consumer complaints and customer complaints with your frontline workers? Listening in to a call center is a very powerful way to help employees understand what affects consumers and how their job is critical to avoiding a food safety or quality issue.
8: Create accountability across the board
Hold folks who do not support the culture in which you are striving to develop or maintain accountable, regardless of their position or stature.
9: Provide positive reinforcement. It’s the best motivator
Work to catch people doing things right and make a big fuss when you do. Positive reinforcement for a job well done is the most powerful motivator. It helps keep every team member on board with food safety commitments.
10: Celebrate often
We spend too much time at work not to celebrate all the good things that are accomplished. Whether it’s a cake and recognition for those that served in the armed forces on Veterans Day or a successful launch of a new product—celebrations are a great way to recognize and reinforce your employees’ hard work. Identifying and correcting mistakes should also be celebrated; they are fertile ground for making changes and provide great nutrients for continuous improvement.
Millions of aluminum and tin-plated steel cans enter the marketplace every day, yet despite the extensive efforts of manufacturing plant quality control systems, a small percentage of the cans may have defects that can result in loss of the can integrity and subsequent contamination of the food products. Quality control operations within manufacturing plants typically have limited analytical chemistry capabilities and must rely on the manufacturer’s laboratory or independent laboratories to help identify and characterize the defects and troubleshoot the operations to eliminate the root cause of the defects. This article will present some of the current technology utilized for evaluating metal can defects.
Metal cans made from aluminum for beer and beverage products have been in use for about 50 years, whereas tin-plated steel cans for food products, have been in use for more than 100 years. Throughout that time, many improvements have been made to the design of the cans, the materials used for the cans (metal and internal/external protective organic coatings), the manufacturing equipment, chemical process monitoring, and quality control methods/instrumentation. The can manufacturing plants and their material suppliers are responsible for product integrity prior to distribution of the cans to food and beverage manufacturing operations throughout the world. Incoming quality control and internal quality control are also quite extensive at those manufacturing locations. Many of the can defects that would result in potential consumer issues are quickly eliminated from the consumer pipeline as a result of the rigorous quality control procedures. Occasionally, defective cans find their way into the marketplace, resulting in consumer complaints that must be addressed by the manufacturers.
The cause of the defects must be determined quickly, even if it means shutting down production lines while waiting for answers and corrective actions. Anything that results in a major product recall will have a high priority for the manufacturers to determine the root cause and take corrective actions. Major manufacturers have extensive analytical laboratories with a vast array of instrumentation and technical expertise for troubleshooting the defects. Smaller manufacturers usually have to rely on a network of independent laboratories to assist with their troubleshooting analyses.
Instrumentation and Methodology
Most major can manufacturing plants produce several hundred thousand to several million cans per day, and any can defects detected during quality control inspections will obviously have major implications. Most aluminum and tin-plated steel cans have an organic protective coating applied on the interior surface. One of the major quality control tests is to determine the amount of metal exposure inside the cans. This is done through the use of Enamel Rater instrumentation in which a sampling of cans are filled with an electrolyte. An electrode is immersed into the liquid and external contact is made with the can’s bottom or side wall. When a voltage is applied to the system, the current generated is directly proportional to the amount of exposed metal; a very small amount of exposed metal is acceptable. By reversing the polarity of the system, exposed metal regions produce gas bubbles as a result of the electrochemical reactions. This allows the inspector to identify the location of the exposed metal. When too much metal exposure is encountered, the troubleshooting process begins immediately.
Visual examination of additional cans from the production line is done, followed by examination with a low-power microscope, typically a stereo microscope, in order to characterize metal exposure defects. Typical defects are craters and/or fisheyes, which are seen as circular dewetting (also known as pullback) of the coating from a solid contaminant on the metal (see Figure 1) or an incompatible liquid, such as machine oil mist (fisheye). Additionally, broken blisters in the coating, known as solvent pops, can occur in the curing oven for the coating, resulting in exposed metal. The metal exposure produces two main problems for the filled food product: Metal migration into the product and corrosion of the metal, which eventually results in perforation and product leakage. Manufacturing plants typically do not have the necessary analytical instrumentation available to identify the contaminants and must send selected samples to the laboratory for the analysis.
Another critical test that is conducted in the can manufacturing plants looks for adhesion characteristics of the internal coatings and external coatings (inks and over varnish). A typical adhesion test involves cutting open the sidewalls and immersing the cans into hot water for a period of time. Upon removal from the water, the cans are dried and a tool is used to scribe the coatings. A tape is applied over the scribe marks and rapidly pulled off. If any coating comes up with the tape, the troubleshooting process must begin. Often, over-cure and under-cure conditions can result in coating adhesion failure. The failure can also be caused by a contaminant on the surface of the metal. Loss of internal coating adhesion can result in flakes of the coating contaminating the product and also metal exposure issues. Adhesion failure analysis is typically conducted in the analytical laboratories.
Analytical laboratories are well equipped with a vast array of instrumentation used to identify and characterize various can defects, including:
Optical microscopes, both stereomicroscopes and compound microscopes, are used with a variety of lighting conditions and filters to observe/photograph the defects and in some cases perform microchemical tests to help characterize contaminants. They are also used to examine metal fractures and polished cross sections of metals looking for defects in the metal that may have caused the fractures.
Scanning electron microscope (SEM) equipped with the accessory for energy dispersive X-ray spectrometry (EDS) are used, in conjunction with the optical microscopes, to observe/photograph the defects in the SEM and then obtain the elemental composition of the defect material with the EDS system. This method is typically used for characterizing inorganic materials. Imaging can be done at much higher magnifications compared to the optical microscopes, which is particularly useful for analysis of fractures.
Infrared spectroscopy, commonly referred to as Fourier Transform Infrared (FTIR) spectroscopy, is used mainly to identify organic materials, such as, oils, inks, varnishes, cleaning chemical surfactants that are commonly found in the can manufacturing operations. Solvent extractions from adhesion failure metal surfaces and the mating back side of the coating are often done to look for very thin films of organic contamination.
Differential scanning calorimetry (DSC) instrumentation is often used to determine the degree of cure for protective coatings on cans exhibiting adhesion failure issues.
Other more specialized instrumentation that is more likely available in independent analytical laboratories includes:
X-ray photoelectron spectroscopy (XPS), also known as electron spectroscopy for chemical analysis (ESCA), is used to analyze the outermost molecular layers of materials. The technique is particularly useful for detecting minute quantities of contaminants, typically thin films involved in adhesion failures. Depth profiles can also be done on the metal to determine thickness of oxidation or the presence/absence of surface enhancement chemical treatments. High-resolution binding energy measurements on various elements can provide some chemical compound information as part of the characterization.
Secondary ion mass spectrometry (SIMS) is also an outer molecular layer type of analysis method. Depth profiling also be accomplished with this instrumentation, but one of the major advantages is the ability to detect boron and lithium which are found in some greases and other materials in the manufacturing facility. To help identify organic films that may have resulted in the adhesion failures, it is often crucial to know if boron or lithium is present, which helps identify a potential source.
X-ray diffraction (XRD) instrumentation is used to identify crystalline compounds, mainly inorganic materials but can also be used for certain organic materials. Inorganic materials, isolated from coating craters, are often identified with a combination of SEM/EDS and XRD analyses.
Three case studies are presented to show how analytical lab instruments can be used to identify and characterize metal can defects.Metal can defects can take on numerous forms, some of which have been discussed in this article. Extensive quality control activities in can manufacturing plants often prevent defective cans from entering the marketplace. Characterizing the cause of the defects often requires major troubleshooting activities within the production plants, supplemented by the analytical laboratories with a vast array of instrumentation and personnel expertise. Due to the huge quantities of metal cans produced each day, it is inevitable that some defective cans will make it to the marketplace, resulting in consumer complaints. High priorities must be assigned to consumer complaints to not only identify and characterize the defects, but also to determine how widespread the defective cans are within the marketplace. In this way, decisions can be made regarding product recalls.
News concerning the safety of food seems to be everywhere these days. On a daily basis there’s a story about a salmonella outbreak or a company initiating a product recall due to possible contamination. Why is this the case?
If you visit most food businesses, whether it’s a restaurant, grocery store, manufacturer or foodservice operator, chances are you’ll see the same thing: Employees using pen and paper checklists, forms and log books to manage their food safety operations.
The recent E. coli outbreak traced to Chipotle Mexican Grill infected more than 50 people and led the company to shut down several restaurants. The outbreak was also a PR disaster for the company and damaged its reputation as a reliable provider of safe meals. Chipotle lost out on potential revenue and probably spent a good amount of money on hiring outside food safety consultants to examine its safety standards.
Since starting the business, Chipotle has remained focused on a core mission: Make great-tasting food, and more recently, food that is not modified with GMOs. While its goal has not changed, running a food company is vastly different today than in the past.
Modern Food Safety Isn’t So Modern
For one thing, there is a lot more paper to manage in today’s world. Between time and temperature controls, HACCP and HARPC requirements, and a whole host of industry certifications and brand standards, food businesses implement several safety processes. Even with advancements in technology, food safety operations are often run manually and therefore are error-prone.
In the early 1990s, food companies could handle the volume of paperwork themselves. Today, they’re swamped. Visit a food business, and you’ll see the same thing everywhere: Stacks of documents that need to be typed up and sent to food agencies. As one quality assurance manager recently stated, “We can barely keep track of them all.”
Surrounded by stacks of paper in their office, quality assurance (QA) managers explain that much of the pileup is due to more rules and regulations related to food safety. Food companies must comply with a growing number of local, state and federal laws that regulate food safety. The focus of recent laws such as FSMA is toward prevention of foodborne illness, placing even more emphasis on internal audits and recordkeeping. In addition to these laws, food companies must compete with the wealth of information available to customers about how their food safety operations work. Especially in the realm of social media, as Taco Bell has learned, one photo of an employee playing with food can lead to a PR nightmare.
A Day in the Life of a QA Manager
Complying with food safety laws often falls on a company’s QA manager who supervises food safety. She walks through the facility several times a day with clipboard in hand, reviewing a list of safety and quality measures.
The QA manager will then manually key this data into a spreadsheet, create reports, and file the results with industry partners and government regulators. These seemingly routine and time-consuming compliance tasks matter. Failing to comply with the appropriate laws can lead to costly penalties, permitting delays, loss of business from industry partners (such as retailers with strict requirements), and even legal action.
The legal requirements are often complex, overlapping, and they change every couple of years. The laws are designed, of course, to ensure that food preparation and delivery is safe, thereby protecting consumers. But an expanding body of regulations and fear of litigation have increased the time, cost and stress that play into compliance.
Improve Food Safety with Technology
So how can companies improve their food safety operations? By using food safety technology, particularly mobile software tools, to improve their processes. Since food safety operations are still manual, they tend to be hard to standardize and difficult to track—especially at larger companies where employees are working in multiple shifts across dozens of locations. Mobile food safety software offers several major benefits:
No More Pen and Paper. Replacing paper-and-pencil clipboards with digital tools saves time and money. Digital audits and task-lists can be logged and tracked, ensuring that staff are performing tasks in real-time. Digital entries are more accountable; managers can confirm when and where tasks where conducted and completed (including requiring photos to be taken). And digital clipboards can be loaded with reference materials like images and training videos, which helps staff learn best practices and prepare for real inspections by government agencies.
Quality and Safety Checklists. Instead of letting employees complete tasks ad hoc and make notes on clipboards and log books, companies can use quality and safety checklists to ensure that key tasks are standardized across the organization. For example, data can be collected to show that a company is always forgetting to label produce with an expiration date. Digital food safety and quality checklists that are loaded on smartphones or tablets makes it easier to ensure that all employees are following brand standards and best practices.
Automated Reports. Instead of sifting through binders filled with audit logs, food safety software captures and stores data in a structured format, making it easy to search and analyze. Why waste hours at the end of every week or month sifting through binders full of paper, when software lets you generate insights with the click of a button?
Real-Time, Centralized Management. Food companies often have multiple locations in which employees are conducting food safety operations in their own way. For companies that have multiple locations, mobile software being used by employees at each location can help corporate managers track performance by location, provide critical alerts, and give employees real-time feedback to help standardize food safety operations.
Here’s an example of a QA manager running a food safety audit using mobile software. During a random spot check, the manager shows up on the line with a smartphone in hand. As she walks around, she pulls up a food safety application and answers a series of pre-set multiple choices questions that cover key criteria, dictates comments into the device using the built-in voice recognition, and takes high-resolution color photos of several problematic issues. If a QA manager is unsure about food safety requirements, she can use her mobile device to quickly pull up a reference document (or even the official code citation) from state, FDA, USDA or other agencies.
After running a digital audit with food safety software, the QA manager can immediately print or e-mail a report that shows all of the items out of compliance, creating actionable intelligence for her team. The QA manager can then share this with line workers during their weekly team meeting, which help to train staff on best practices in food safety.
The data the QA manager collected through her mobile device is immediately stored in the cloud. From there it can be easily accessed by a colleague (i.e., her manager at corporate headquarters) at any time. Over time, the data from each of these spot checks is stored in a central database that a manager can analyze, looking for trends in performance, issues that keep arising, or locations that may need extra training and attention. Mobile software makes it easier to generate insights that can drive major improvements in an organization’s safety and performance.
By using software to help manage food safety audits, logs and line checks, businesses can save time and money on compliance, train staff on best practices, and most importantly, keep customers safe and satisfied.
Today, food safety technology, especially mobile software, should be a critical part of any modern food company’s operations. Mobile audit and task-management software allows QA managers to streamline and standardize quality and safety operations across large teams and multiple locations, helping save valuable time and money. Whether you’re a mobile food vendor or a large-scale food processor, modern software tools can help food businesses of all sizes effectively manage time-consuming tasks around food safety and compliance, from digitizing audit logs for analysis to created automated filings for supply chain partners.
Economically motivated adulteration (EMA) of food, or food fraud, has been estimated to cost the food industry $30–40 billion per year. The 2008 incident of melamine adulteration of milk powder has cost billions of dollars to companies and invaluable loss of consumer confidence. Even more significant than the economic cost or loss of confidence, the impact on public health was enormous. An estimated 290,000 consumers were affected with more than 50,000 hospitalizations including at least six deaths. There is also collateral damage caused by incidences of EMA, including the loss of confidence in government regulatory systems around food safety. Although major incidents like the melamine scandal happen infrequently, food fraud commonly occurs under the radar. According to a 2014 report by the Congressional Research Service, it is estimated that up to 10% of the food supply could be affected by food fraud Thus, the costs of fraud food are borne by industry, regulators and, ultimately, consumers.
Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREFood fraud is not a new phenomenon. During the time of the Roman Empire, Pliny the Elder wrote in Natural History about the adulteration of wine, bread and pepper, and tracked the fluctuation of their prices with the appearance of adulteration. In Medieval Germany, the adulteration of saffron was such a problem that the Safranschou Code was enacted, which described standards for saffron and allowed convicted adulterators to be executed.1 When there is an opportunity for economic gain, adulterators tend to come out of the woodwork.
As recently as the 1980s, food fraud was mostly an event confined to local markets. In 1981 the adulteration of olive oil with an industrial lubricant injured thousands and killed hundreds, but because the oil was not widely distributed, the primary effects were limited to Spain. Similarly, when apple juice adulteration occurred in the United States in the 1980s, the consequences were basically confined to the United States.
However, with the increasing globalization of the food supply chain and freer movement of foods and ingredients among countries, the opportunities for food fraud not only increased, but the consequences also now more easily have a global impact. By the late 1990s, the global consequences of food fraud became more evident with the contamination of fats intended for animal feed with industrial oils containing PCBs and dioxins. This scandal, which started with an oil recycler in Belgium, led to massive recalls of products throughout Europe and concerns about contaminated products reaching the United States. The impact of this episode arguably changed the food safety environment in Europe and led to the formation of the European Food Safety Authority. Likewise, the fallout from the adulteration of wheat gluten with melamine in 2008 likely contributed to the passage of new food safety legislation in the United States, including FSMA.
FDA has always acted against food fraud whenever there was an indication of public health hazards. With the passage of FSMA and the Preventive Controls for Human Food rule (published in September 2015), the agency has come full circle to its roots with Harvey W. Wiley, M.D. and his famous Poison Squad. Dr. Wiley formed his famous group to go after adulterators of foods. The Poison Squad was famously known for their willingness to consume suspect foods to test for adulteration. FDA’s history of Dr. Wiley states that “In the 1880s, when Wiley began his 50-year crusade for pure foods, America’s marketplace was flooded with poor, often harmful products. With almost no government controls, unscrupulous manufacturers tampered with products, substituting cheap ingredients for those represented on labels: Honey was diluted with glucose syrup; olive oil was made with cottonseed; and “soothing syrups” given to babies were laced with morphine. The country was ready for reform…” While the opportunities for fraud have not changed, luckily we no longer have to rely on human volunteers to detect adulterated food.
The new Preventive Controls rule published in September addresses EMA when there is a reasonable possibility that adulteration could result in a public health hazard. Companies are required to conduct a written hazard analysis, which should include hazards identification and evaluation. Companies are expected to identify “…known or reasonably foreseeable hazards that may be present in the food…The hazard may be intentionally introduced for the purposes of economic gain.”[i] While companies were previously expected to be knowledgeable about microbiological hazards in their products, it appears that they now also have the responsibility to be knowledgeable about known or reasonably foreseeable hazards from EMA.
How can organizations identify potential EMA threats as part of hazards analysis? One way is via the Food Fraud Database, which is designed to help answer this question by taking a look into the past. Launched in 2012, the database provides the information necessary to identify ingredients with a past pattern or history of adulteration and the adulterants used—a perfect fit for the EMA requirement in FSMA. The database has more than 140,000 users from 194 countries documented.
After identifying an ingredient with a pattern/history of EMA, companies need to determine whether the ingredient may introduce potential food safety hazards and how to develop a control plan in response. To address those issues, USP undertook a project in 2013 to take a more holistic approach to identifying EMA vulnerable ingredients by looking at factors beyond history. It assembled a group of leading food adulteration experts to develop a first-of-its-kind guidance document that offers a framework for the food industry to help develop and implement preventive management systems to deal specifically with EMA.
The Food Fraud Mitigation Guidance became official in the Food Chemicals Codex (FCC) in September 2015, just as FSMA’s Preventive Rule for Human Food was published. The aim of the guidance is to assist manufacturers and regulators with identifying the ingredients most vulnerable to fraud in their supply chains and how to choose effective mitigation tools to combat EMA. This is a significant leap forward in the battle against food fraud—and a way to get ahead of criminals engaging in EMA. The guidance provides not only a solution to deal with FSMA’s EMA provision, but goes beyond FSMA to help organizations fulfill GFSI requirements to conduct a food fraud vulnerability assessment and control plan.
Thenadier (The innkeeper), in Les Miserables said in the lyrics of Master of the House:
watering the wine and making up the weight
Food beyond compare. Food beyond belief
Mix it in a mincer and pretend it’s beef
Kidney of a horse, liver of a cat
Filling up the sausages with this and that”
While deceiving the unwary can seem humorous in fiction, in real-life food fraud can have extremely serious consequences to consumers and everyone involved with the production of safe food. There are multiple large-scale efforts in many regions and countries to address food fraud. The attention that is now focused on food fraud and the development of new tools such as Food Fraud Database cast a bright light that will hopefully make it more difficult for food fraudsters to operate.
Willard, P. (2002), Secrets of Saffron: The Vagabond Life of the World’s Most Seductive Spice, Beacon Press, ISBN 978-0-8070-5009-5
As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.
Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities. Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.
In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records. Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility. This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon. LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.
In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs. The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.
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