Tag Archives: risk

Risk, food safety

Does Your Risk Control Program Meet FSMA’s Demands?

By Food Safety Tech Staff
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Risk, food safety

Identifying, prioritizing and managing supply chain risks is critical to maintaining FSMA compliance. Under the Preventive Controls rules, food companies must implement a hazard identification system for any known or foreseeable hazards. During an upcoming webinar, David Acheson, Ph.D. and Miles Thomas will discuss how data can help companies manage supply chain risk, methods for analyzing and prioritizing hazards, and mitigating risk to achieve FSMA compliance. They will also shine a spotlight on global trends in food safety and authenticity threats.

Learn more during the webinar, Don’t Get Blindsided by FSMA! April 27, 2017, 1 pm ET.

Sean Crossey, arc-net
FST Soapbox

5 Problems Facing the Global Food Supply Chain

By Sean Crossey
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Sean Crossey, arc-net

The food we eat is a lot less secure than we would like to imagine. According to PricewaterhouseCoopers, food fraud is estimated to be a $40 billion a year problem, with instances of fraud becoming worryingly frequent—from wood shavings discovered in our parmesan to the 2013 horsemeat scandal in the UK.1-3 Not only do these incidents damage the faith consumers have in their food, but as seen in the 2009 salmonella peanut butter outbreak, which resulted in the death of 9 Americans and sickening of 714, they can have fatal consequences.4 Indeed, the World Health Organization estimates that nearly 1 in 10 people become ill every year from eating contaminated food.5

While it may be uncomfortable to imagine our food supply can be susceptible to such high profile attacks, what is more unsettling is that our food supply chain has grown so complex that it has become almost impossible for food producers to guarantee the provenance of their products—meaning consumers can never entirely trust in the food they eat. In this article I will identify five main issues the global food supply chain faces, and what steps can be taken to address them.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE1. Consumer demand for traceability

Traceability is no longer a request from consumers, but a demand, and one that is only growing stronger. A recent transparency survey found that consumers want to see everything from a complete ingredient breakdown to sourcing information, with 94% of respondents saying they are likely to be more loyal to a brand that offers complete transparency.6 While a new study discovered that more than half of Canadians are concerned about food fraud.7

If we take seafood products as an example, almost half (46%) of respondents to an independent research survey conducted by the Marine Stewardship Council (MSC) agreed that they trust brands that use ecolabels (a form of third-party certification) more than those that do not.8 The survey also found that 66% of respondents felt that traceability of the product was the primary factor determining seafood purchasing decisions.

This kind of consumer driven, high-quality information opens up a world of possibilities for companies that recognize the significance of its demand. Brand protection, demand forecasting and consumer loyalty all becomes possible for early adapters who show themselves to be taking practical steps to guarantee the authenticity of their products.

2. Lack of communication between actors

One of the biggest challenges preventing full traceability of our food is the fragmented nature of the supply chain. For even the most seemingly simple of food items there can be a huge number of actors involved that are spread around the globe with little to no knowledge of one another’s actions.

For instance, to trace your hamburger from farm to fork may involve tracing your lettuce back to the farm in which it was grown (but not what happens to it before it reaches your supermarkets shelves), tracing the beef back to the cattle (with no guarantee, as seen with the horsemeat scandal, that the end product is 100% beef) and any number of logistical barriers.

It is vital then that stakeholders within the chain prioritize communication with their suppliers, either through the implementation of traceability solutions, or the commitment to engage only with suppliers they know they can trust. Not only is this beneficial to the end consumer, but to the food producers themselves, allowing them to ensure that their organizational reputation remains solely their responsibility and not left in the hands of unknown and uncontrollable third parties.

3. Influence of organized crime

When one thinks of the Mafia, it’s rare that olive oil is the first thing that comes to mind. Currently, however, it is the fraudulent manufacture of this and many other Italian exports (cheese, wine, etc.) that is fueling organized crime and ending up on our shelves.9

High-scale food fraud is not a naturally occurring phenomenon but rather exists as a result of highly organized criminal activity. In his 2014 UK government report, Professor Chris Elliot notes that “food fraud becomes food crime when it no longer involves random acts by “rogues” within the food industry, but becomes an organized activity by groups that knowingly set out to deceive and or injure, those purchasing food”.10

This is not just a problem for Italy; counterfeit food and drink occurs on a massive scale throughout the whole of Europe. A joint initiative by EUROPOL and INTERPOL last year led to the largest ever seizure of fake and adulterated projects. This project, known as OPSON V resulted in 11,000 tons and 1,440,000 liters of hazardous fake food and drink seized across 57 countries.11

In order to combat the growing threat organized crime has on our food supply, it is vital that governments devote resources to organizations with the sole responsibility of identifying food crime. In response to the horsemeat scandal, the UK government launched its National Food Crime Unit within the Food Standards Agency in London, while the FDA has a special focus on food defense.

The establishment of these organizations is important, as police forces traditionally have struggled to combat food fraud, either through a lack of time, resources, or simply understanding of the complexities of how fraud affects the supply chain. The creation of specialist taskforces not only legitimizes the fight against food fraud, but allows for easier intelligence share.

4. Lack of transparency throughout the supply chain

In her work on trust for the digital age, Racheal Botsman tells us that trust has evolved from an institutional based system to a distributed system. Nowhere has this more potential than with our food supply.

In such a complex system it becomes necessary to consider how the food industry can begin to move away from traditional systems of centralized trust. As Botsman points out, “institutional trust is not designed for the digital age”, the emergence of new technologies, most notably the blockchain, highlights the potential to introduce more trust in our food.12

Originally the technology underpinning Bitcoin, the blockchain has wide ranging applications beyond the world of FinTech. Blockchain is a transformative tool in the fight against food fraud, allowing an open and transparent ledger of our food products journey. This allows unalterable trust to be introduced into an untrustworthy system, ensuring every actor in the chain records and shares their interactions with our food.

This represents a huge opportunity for those companies who see the advantage of early adoption of blockchain infused traceability systems. Indeed by 2022, Gartner estimates an innovative business built on a blockchain will be worth $10 billion.13

5. Need for strong legislation

Steps have already been made in legislation to allow for earlier prevention of food safety incidents occurring, such as FSMA. While it is important that lawmakers are proactive in their response, the focus has primarily been on food safety, and there is still a difficulty in treating food fraud as its own separate entity.

Legislation regarding food labelling could also be more stringent, especially in Europe. At present only olive oil, fish (unless it’s canned or prepared), beef (fresh, chilled, frozen or minced), fresh or frozen poultry of non-EU origin, wine, most fresh fruit and vegetables, honey and eggs are required to be labelled. This means that origin information is largely missing on foods such as meat products (e.g., ham and sausages), yogurts and cheese, kitchen staples (e.g., oil, flour, sugar and pasta), biscuits and confectionery, or ready-meals.

Tighter legislation, leading to significant punitive measures taken against actors found to be committing fraud, would be a vital catalyst in ensuring that food in our supply chain is as secure as possible.

Conclusion

The growth of the global food supply chain may bring with it complexity and challenges, but also great opportunities. If actors can interject their processes with the kind of joined up thinking outlined above, with the help of technological tools that are becoming more and more accessible, the benefits will be significant, not just for them, but for all of us.

Resources

  1. PWC. (2016). Fighting $40bn food fraud to protect food supply [Press Release]. Retrieved from http://press.pwc.com/News-releases/fighting–40bn-food-fraud-to-protect-food-supply/s/44fd6210-10f7-46c7-8431-e55983286e22
  2. Mulvany, L. (February 16, 2016). The Parmesan Cheese You Sprinkle on Your Penne Could Be Wood. Retrieved from https://www.bloomberg.com/news/articles/2016-02-16/the-parmesan-cheese-you-sprinkle-on-your-penne-could-be-wood
  3. Grierson, J. (August 26, 2016). Three men charged over UK horsemeat scandal. Retrieved from https://www.theguardian.com/uk-news/2016/aug/26/three-men-charged-over-uk-horsemeat-scandal
  4. Andrews, J. (April 16, 2016). 2009 Peanut Butter Outbreak: Three Years On, Still No Resolution for Some. Retrieved from http://www.foodsafetynews.com/2012/04/2009-peanut-butter-outbreak-three-years-on-still-no-resolution-for-some/#.WD7tE6KLTpJ
  5. World Health Organization. (2015). WHO’s first ever global estimates of foodborne diseases find children under 5 account for almost one third of deaths [Press Release] Retrieved from http://www.who.int/mediacentre/news/releases/2015/foodborne-disease-estimates/en/
  6. Label Insight (2016). The 2016 Label Insight Transparency ROI Study. Retrieved from https://www.labelinsight.com/hubf /2016_Transparency_ROI_Study_Label_Insight.pdf?t=1486676060862
  7. Sagan, A. (February 21, 2017). Study finds 63 per cent of Canadians are concerned about food fraud. Retrieved from http://www.theglobeandmail.com/news/national/study-finds-63-per-cent-of-canadians-are-concerned-about-food-fraud/article34094664/
  8. MSC (2014). MSC Consumer Survey 2014. Retrieved from https://www.msc.org/newsroom/news/new-research-shows-increasing-appetite-for-sustainable-seafood
    Bacchi, U. (February 21, 2017). Italian police break mafia ring exporting fake olive oil to U.S. Retrieved from http://www.reuters.com/article/us-italy-crime-food-idUSKBN1602BD
  9. HM Government (2015) Elliot Review into Integrity and Assurance of Food Supply Networks. Retrieved from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/350726/elliot-review-final-report-july2014.pdf
    EUROPOL (2016) largest ever seizures of fake food and drink in INTERPOL-EUROPOL operation [Press Release]. Retrieved from https://www.europol.europa.eu/newsroom/news/largest-ever-seizures-of-fake-food-and-drink-in-interpol-europol-operation
  10. Botsman, R. (October 20, 2015). The Changing Rules of Trust in the Digital Age. Retrieved from https://hbr.org/2015/10/the-changing-rules-of-trust-in-the-digital-age
  11. Panetta, K. (October 18, 2016) Gartner’s Top 10 Strategic Technology Trends for 2017. Retrieved from http://linkis.com/www.econotimes.com/Zk8mh
Elise Forward, Forward Food Solutions
FST Soapbox

Take Food Defense Concepts Beyond Your Four Walls

By Elise Forward
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Elise Forward, Forward Food Solutions

The new food defense regulations have caused quite a stir in the food industry and have left many scratching their heads. Many companies are worried about how to implement these programs. The regulations have created a format and structure in which many companies can adapt within their existing food defense programs to comply with the new law. Still, one of the biggest challenges of food defense is merely the idea of developing the food defense plan and coming into compliance with the FDA’s new Food Defense rule. The FDA received many comments from industry in response to the draft guidance. Many of these comments asked the agency for additional time to come into compliance, and the FDA responded by delaying the compliance dates well beyond what was proposed in the draft rules.

According to the regulations, companies are required to implement a food defense plan that focuses on the vulnerabilities in their facility. If you follow the FDA’s template, a food defense plan will look very similar to the traditional HACCP plan. The term, VACCP, Vulnerability Analysis Critical Control Points, is a term that is being tossed around as of late. The FDA wants companies to make sure that they consider an internal attacker, one that has inside access to the buildings, processes and products that are being produced. For many companies, this is stretching them beyond their current paradigms and may force some to implement new procedures. In reality, this paradigm shift is not insurmountable when the items to be controlled are within the four walls of their facility. Even subcontractors, such as pest control providers, maintenance subcontractors, auditors, etc., can be included in these programs. However, is this enough to ensure the safety of the product you are selling, the one you are putting your name on, and the one you are personally standing behind?

The goal of current risk-based thinking is to find the weakest link in the process, evaluate the risk and likelihood of a threat to food safety, and respond appropriately to control the risk. Unlike the Preventive Controls rule and the FSVP rule, the Food Defense rule focuses on the processes occurring in a facility and does not take into account the processes involved in the supply chain.  CargoNet Command Center found that there were 1500 security breaches in the transportation industry in the United States and Canada in 2015. The data was categorized by types of product and the highest percentage of any group of products was the food and beverage products which comprised 28% of the cargo thefts.  On average, that is greater than one food or beverage cargo theft per day. CargoNet Command Center provides a nice map on their website showing the location of these instances and I encourage you to review this map.  If your product passes along the hot spots of cargo theft, as well as having risk factors such as being valuable or in limited supply, it would be very beneficial to build systems and programs in place to address these additional risks to your product.

In another study presented at the Food Defense conference, there was a statistically significant link between breaches in IT systems to a follow-up cargo theft. Many quality and food safety professionals, much less executives, fully understand the interdependence of all business units on food safety. Many companies have problems with siloed departments, and unfortunately, this increases the vulnerabilities to attacks on the food we are trying to protect. This is a great example of how food safety is everyone’s job, and having this mentality is key to the success of food safety programs.

Of course, the requirement to the Food Defense rule must be addressed, but I challenge the industry to look beyond the walls of our facilities and instead, take a whole business approach and apply the principals of food defense to all inputs of the process that impacts the finished product. As food safety professionals, we need to work with our suppliers and our customers to ensure that the whole supply chain is protected from an attack.

Resources

Melanie Neumann, Neumann Risk Services

Risk Mitigation and Compliance Management Strategies – Tightly Intertwined but Very Different!

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Melanie Neumann, Neumann Risk Services

Melanie Neumann of Neumann Risk Services, LLC, (NRS) a global food safety and compliance law firm shares her thoughts on the similarities and differences of risk mitigation and compliance management, as well as the year ahead and what companies should be focusing on with regard to these key risk management topics.

Q.  Risk Mitigation and Compliance Management are often grouped together – in your view what is the key distinction between the two?

A.  The two are very much linked and very much codependent yet they are separate topics that need to be identified, implemented and managed differently.  Independent strategies need to be put together that are different, separate and apart based upon a company’s strategy and risk tolerance.  [more]

Q. What risk mitigation approach is most realistic, and typically deployed by the food & beverage industry?

A.  With risk management, there are 4 types of risk mitigation strategies that are typical. I’ll break down to how you can manage risk very simply – 1) avoid it, 2) limit it, 3) transfer it, and 4) if you can’t do any of these 3, you can accept it.  [more]

Q.  How does your risk management strategy tie into compliance management?

A. Tying it together, risk management identifies the risk, and establishes a way to manage that risk appropriately. Compliance management is assessing whether the process of managing that risk is actually working the way you intended it, and is meeting laws or regulatory requirements if there are any that apply.  [more]

Q.  What are some of the key risk mitigation and compliance management considerations and initiatives companies should be thinking about in 2017?

A.  As companies continue to develop and execute upon their risk mitigation and compliance management strategies – they should be focusing on: 1- Showing your work; and 2 – leveraging your data for positive outcomes.  [more]

Q. Any parting thoughts on what you’ve shared today?

A. Right now, frankly, the stakes are higher than ever.  Liability concerns are greater than ever, too.  “knowledge” is being imputed on companies more than ever before for food safety issues that occurred in the past and rear its head again in the future.  [more]

Learn how SafetyChain’s solutions can help you more effectively reduce risk and ensure program compliance – www.SafetyChain.com

Scott Mahloch, FBI, Food Safety Consortium

FBI Says Terrorists May Target Food Sector

By Maria Fontanazza
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Scott Mahloch, FBI, Food Safety Consortium

Many people associate terrorism with spectacular attacks such as those that occurred on September 11. However, lone wolf attacks are far more likely to happen in what has unfortunately become the new normal. “The last thing on your mind is a terrorist being interested in food. It does exist, and bad guys do have an interest in this area,” said Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI during the Food Safety Consortium last week. What does this mean for the food industry?

SA Scott Mahloch will present FBI’s Role in Food Defense on November 29 at the 2017 Food Safety Consortium | Learn moreAccording to the Department of Homeland Security, with 2.2 million farms and 900,000 restaurants in the United States, the food and agricultural sector accounts for 1/5 of the national economic activity. There are several industry targets for terrorism: Food processing facilities; food storage and distribution; restaurants, grocery stores and markets; commercial facilities; and cruise lines.

While Mahloch emphasized that there is no imminent threat to the food sector, one of the biggest areas of concern for this particular industry is the insider threat. “The insider threat is that person [who] knows the facilities, processes, distribution network and can cause the greatest impact,” said Mahloch. This can be in the form of a disgruntled employee who has or can gain access to equipment or other areas of a facility that would otherwise be secure and then introduce contaminants into food products. Mahloch stressed the important role that a food company plays in monitoring employees and reporting any deviation from normal behavior. This is not an easy task—in fact, it is the most difficult threat to detect, and the most difficult threat to protect against, Mahloch pointed out.

Insider Threat: The threat posed by an individual who exploits his/her position, credentials or employment to achieve trusted access to the means, processes, equipment, material, location, facility and/or target necessary to carry out a terrorist action.

The likelihood of an employee becoming an insider threat increases with a variety of personal factors, including financial need, feelings of anger or revenge, being a sympathizer with terrorist ideology, having problems at work, compulsive and destructive behavior, ego and family issues. Food organizations also open themselves up to vulnerabilities via the following:

  • Allowing easy access to restricted or sensitive areas within a facility (i.e., not limiting personnel access to certain areas or clearly labeling access controls)
  • Failure to have physical security controls over personal items that are either brought into or taken from the workplace
  • Vague security policies/Lax security perception
  • High employee turnover
  • Lack of proper employee vetting
  • Failure to train employees in proper security protocols
  • Failure to have consequences for violating security policy

Surveillance

When assessing the insider threat, what should food companies look for in an effort to protect their facility and products? “You’re the first line of defense,” said Mahloch. “We get a lot of phone calls where people run things by us. If something doesn’t seem right, say something.” He provided several key behaviors that may be characterized as suspicious in some instances:

  • Someone taking a photograph or video, or notes/sketches, of food processing operations or sensitive areas
  • Someone attempting to gain information about company operations, especially related to security and personnel, in person, or by phone or email
  • Someone conducting surveillance of self services areas such as salad bars, condiment stands or open bulk containers
  • Shipping area: Unscheduled deliveries, driver who is unfamiliar with facility delivery protocols, items left on dock at unusual hours, illegally parked or unattended vehicles, or shipping documents that don’t match

Be Proactive

Companies can take several preventive steps to protect their facilities, products and personnel. Proactive measures include:

  • Monitoring products for evidence of tampering, resealing or damage
  • Securing open containers of food or ingredients in storage areas
  • Controlling access to specific areas of facility by delivery personnel, employees, vendors and contractors, and general visitors
  • Securing loading dock area, and standardize delivery and pickup protocol
  • Developing a written food defense plan
  • Training employees, contractors and vendors to recognize suspicious activity and report it accordingly

Take Action

It’s important to stay alert and be aware—employee observations are critical, said Mahloch. Once suspicious activity is observed, the facility security officer or manager should be notified, and from there a decision can be made on whether external parties need to be involved. In general, state and local partners investigate an incident before the FBI gets involved.

“When it comes to intentional contamination [or a] terrorist incident—that’s an area that we investigate and ultimately prosecute,” said Mahloch. He emphasized the FBI is not a regulatory agency, so it would not show up at a facility due to a company’s lack of compliance to FSMA, for example. The agency is interested in food defense and intentional contamination that has the purpose of causing harm.

For more information about the FBI’s role in food defense, the agency has a document on its website that summarizes food defense for the industry, including some of the above-mentioned factors to look for when trying to identifying suspicious behavior. If a company wants to report suspicious activity that is not an emergency, it can call 1-855-TELL-FBI (1-855-835-5324).

Food Safety Law Firm Neumann Risk Services, LLC at the Food Safety Consortium

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Neumann Risk Services, LLC (NRS), IL, a law firm where law, food, and science converge—founded by global food safety attorney Melanie Neumann, J.D., M.S., will be participating in the 2016 Food Safety Consortium. Melanie Neumann will moderate and speak at “Ask the Experts” Panel and Discussion Group on the topic of Post-FSMA Compliance Challenges and Risk Management on Thursday, December 8th at 10:30 – 11:15 am at this year’s Food Safety Consortium. NRS focuses on food law and regulatory compliance and offers a dynamic combination of food safety and food law skills to provide a unique, specialized approach to understanding and implementing the changing global food safety regulations.

Visit our exhibit and meet with NRS to explore your needs and how NRS can help—especially regarding legal, regulatory, business and brand counsel and consulting topics such as: recall and crisis management, responses to regulatory actions,  advertising/labeling regulations, supply chain management optimization, FSMA compliance and implementation, supplier and customer contract matters, and other matters that require regulatory interpretation, legal assistance, and preservation of attorney/client privilege.

Let NRS advise your company on how to build holistic, global food safety programs integrated into enterprise risk management programs—all to protect and preserve the public health, business efficiencies, and brand reputation.

If you would like more information, please email info@neumannriskservices.com or call 507-828-4536.

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
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FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.
Randy Fields, Repositrak
FST Soapbox

Insurance and Food Safety: A Primer for the C-Suite

By Randy Fields
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Randy Fields, Repositrak

Food safety risk is now a greater concern for retailers and manufacturers than ever before due to the combination of FSMA and increased consumer concerns. Supply chains are more complex, product recalls and foodborne illness outbreaks occur more frequently, and the new normal is prevention rather than inspection. Wrap that all up with advanced technology and the 24-hour news cycle, and consumers are acutely becoming aware of food safety issues as soon as they occur.

What this means for all of the participants in the global food supply chain is that you should review your insurance policies and look for gaps in coverage where you may be exposed. While no two recalls are the same, and foodborne illness outbreaks impact affected companies in different ways, certain trends have emerged to help better understand the claim friction points that frustrate companies after a food safety event.

Two of the most important tools to mitigate food safety risk are contaminated product insurance (CPI) and product recall insurance (PRI). Inventory, cost of refunds and recall expenses are three of the largest recall loss items suffered by companies. Combined, they are the largest percentage of loss (nearly 50%) and represent a substantial portion of uncovered loss for any insured under CPI/PRI. The sole basis for this frustrating friction point is simple—lack of traceability.

CPI/PRI only covers losses that result directly from a covered insured event. If a company is unable to support its claim that costs are directly related to the event and the resulting recall or outbreak, it will not be reimbursed under a CPI/PRI policy. And, as such, loss amounts are generally not covered under general liability and property policies either, so a significant portion of a company’s loss remains uncovered.

Here’s a recent claim example to illustrate the impact on a company that lacked the capability to properly trace its products. An insured purchased a CPI policy with a $2 million Accidental Contamination limit. An event occurred involving a contaminated food product, which triggered that coverage. During the review, the insured provided spreadsheets supporting nearly $1.1 million in customer credits for product shipped and either returned by the customer for disposal or destroyed by the customer. Unfortunately, based on a review of the information provided in support of the spreadsheets, the accountants found that the insured was unable to properly trace and support its claim that the returned or destroyed product was affected by the insured event recall. Under these circumstances, the accountants were only able to confirm $187,000 in losses. The result: The company was unable to recover nearly $1 million in potentially covered losses because it lacked traceability. These outcomes are not uncommon.

The insurance industry understands food safety risks and the need to evolve products to meet the needs of food industry clients. Companies can’t totally mitigate all food safety issues, but understanding the risks is the best way for a business to protect itself. Insurance industry leaders are working in partnership with their food sector clients to ensure that risks are better understood and that the client has appropriate systems in place to help mitigate them.

Insurance companies are tailoring their products to ensure that policies are developed to address the recall risks caused by regulatory changes and help companies ensure compliance as well as an understanding of the regulatory requirements. However, food companies may increasingly find coverage and limits adjusted lower for government recalls in high-risk environments. Insurers are also a key player in the promotion of food safety standards, and some offer favorable rates to food industry clients who are graded top tier for safety.

Some insurers go a step further, allowing clients to allocate a portion of their premium for pre-incident risk-analysis and crisis-response services. Top insurers provide clients access to a network of crisis management specialists as part of their food safety coverage. They should offer risk management guidance in areas such as food safety risk, regulatory compliance, supply chain management and product security.

One of the most critical risk mitigation tactics is developing long-term relationships with trusted, but verified, suppliers, distributors and other key partners. It is also important for companies to undertake regular site visits to their manufacturers or suppliers, and commission third-party audits to maintain reliability and transparency.

Not if, but when a product recall occurs, a company faces a myriad of risks. As with food safety, preventive planning can pay off significantly. By proactively working with insurers, trading partners and technology vendors you can reduce if not eliminate the negative impact of the event.

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.

Food Fraud

PwC Partnership Fights Food Fraudsters

By Food Safety Tech Staff
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Food Fraud

Each year, food fraud costs the industry $30–$40 million worldwide, according to Michigan State University. In an effort to help food companies combat vulnerabilities in their supply chain, PricewaterhouseCoopers (PwC) and non-profit organization SSAFE have created a free tool to help detect food fraud. Developed in partnership with Wageningen University (The Netherlands), VU University Amsterdam and other industry experts, the tool consists of 50 questions and is available via a downloadable app or Excel spreadsheet. Upon completion, the tool provides a profile of the company’s potential for food fraud vulnerability in the form of a report that can be added to food safety documentation.  According to PwC, the assessment is confidential, and while the profile doesn’t offer any mitigation techniques, it provides links on where and how a company can find solutions to the issues mentioned.  

“Beyond the economic cost, food fraud can harm public health and damage consumer trust,” said Craig Armitage, PwC’s Global Leader of Food Supply and Integrity Services in a press release. “Food frauds, such as horse meat being passed off as minced beef or the addition of melamine in dairy, have increased the urgency with which the food industry is taking action.”

Companies can begin using the Excel spreadsheet, which is available on PwC’s website. The app will be available in February.