The following infographic is a snapshot of the hazard trends in poultry and poultry products from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.
Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”
FDA held breakout sessions centered on areas critical to the initiative:
During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.
The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”
Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.
“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”
FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.
The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.
The food industry is undergoing considerable change, especially as consumers become increasingly more vocal about their preferences and concerns, and as technology improvement and adoption plays a larger role in the conversation. In a recent Q&A with Food Safety Tech, Laura Dunn Nelson, vice president of food safety at Alchemy, shares her thoughts about current industry trends and how they are impacting food companies, where more help is needed, as well as ways in which companies can help advance food safety culture internally.
Food Safety Tech: The food industry is rapidly evolving. What are some of the trends you’re seeing and are these posing different challenges to food manufacturers?
Laura Dunn Nelson: The food industry is rapidly evolving in three key areas: Who produces our food, the variety of our food, and how consumers access our food.
As consumers continue to shift their food preferences toward an increase in healthy ingredients, locally sourced products, and clean labels, companies in turn continue to innovate and reformulate. Mergers and acquisitions continue as larger companies look to partner with niche companies that are focused on products marketed to the health-conscious consumer. Companies like Impossible Foods and Beyond Meat are expanding rapidly, reaching both vegans and meat eaters in the United States and expanding into international markets. Ever-changing consumer preferences create challenges for the industry to accelerate their research and development processes in order to remain competitive in the marketplace.
Changes in product formulas and increases in product lines create the need for new ingredient procurement, changes in production schedules, and new operating procedures. There has been a proliferation of start-up companies using CBD as an ingredient for food and beverages despite the lagging food safety regulations forcing some city and state regulators like New York City to create their own ban of CBD products. As the FDA explores future regulations, producers and consumers are left to determine the safety of these products.
Home delivery of food continues to be a hot trend as the market continues to grow for companies like UberEats, Grubhub, retailers and foodservice companies like Domino’s Pizza where you can Tweet your pizza order. The home delivery service area presents new considerations for food safety including monitoring appropriate product temperatures.
Finally, discussion around blockchain technology continues to gain prominence as companies work to develop transparency within their supply chain. For many companies, this will translate into a significant shift in technology adoption and a move away from disparate data sources and therefore an investment in not only the technology but in revising their procurement processes.
FST: What are the areas in which you feel companies need a bit more guidance?
Nelson: How we effectively train our employees to ensure learning and comprehension is paramount to our success in the future. IBM Institute for Business Value recently completed their study “The Enterprise Guide to Closing the Skills Gap,” and noted “120 million workers in the world’s biggest economies may need to be retrained as a result of artificial intelligence (AI) and automation in the workplace.” Reskilling will be the new norm as new technologies and automation of equipment disrupt the current state.
Deloitte noted that “reinventing the way people learn” was the number one trend in the 2019 Global Human Capital Trends Report. Many companies are focused almost exclusively on mandatory compliance training and conducting the training the same way they have for years. Typically, orientation food safety training is provided during the employee’s first week of work and annual refreshers are given every year. In the Global Food Safety Training Survey that Alchemy provides to the global industry with Campden BRI, we consistently find that 67% of responding QA managers report that employees do not follow their food safety programs, despite their food safety training. Unfortunately, the emphasis on food safety is often relegated to that one day a year of refresher training with little reinforcement the remaining 364 days of the year. The ‘noise’ of competing priorities of production and customer expectations often distracts employees from their food safety responsibilities.
Some companies still define training as classroom training when, in fact, employees are being trained each and every day by their supervisors and peers. Companies that put additional emphasis in not only their training but validation of training through observations of employees’ food safety behaviors achieve higher food safety compliance. The power of two-way conversations between the employee and the supervisor as a coach creates an environment of communication and trust.
Alchemy worked with independent researchers to determine the effect of active coaching with prescribed behavior feedback on the plant floor. The results were conclusive: every facility included in the study revealed a 38% improvement in aligned employee behaviors.
Ultimately, companies need to evaluate their current learning organization for effectiveness and focus on job competencies and their ongoing assessment of compliant employee behaviors.
FST: What maturity level are you seeing in the industry related to food safety culture and the related implementation of best practices?
Nelson: The food industry is still relatively new to the concept of a mature food safety culture, and even how to define that. The industry focus of this topic has largely been driven by efforts within the GFSI community, particularly with the publication of the position paper “A Culture of Food Safety.” Pioneers in food safety culture research, like Dr. Lone Jespersen, and emerging training assessment tools are working toward pushing these newer concepts to the mainstream of our industry.
As with many important constructs, the QA/QC team is typically tasked with introducing this concept to their organization, defining their company’s level of food safety culture maturity, and establishing a continuous improvement plan. This is a tough ask from individuals who typically have a technical education background with little experience in behavioral science. To address these challenges, there are a growing number of consultants, books, and resources to help define a company’s food safety culture maturity and establish improvement strategies.
To help frame the benefits of a mature culture, a recent publication by Lone Jespersen et al, “The Impact of Maturing Food Safety Culture and a Pathway to Economic Gain,” notes the value of a mature food safety culture in reducing the cost of poor quality and food safety risks. Research indicates that many companies are currently in mid-maturity of their food safety culture. Suggested best practices to help an organization mature their food safety culture include:
The first step is an assessment to understand the company’s unique performance gaps, either through an internal review or an external assessment. Once the specific gaps are identified, companies can develop their food safety culture improvement plan and execute. It’s helpful to conduct a reassessment over time to ensure the established improvement strategies are successful.
The effort can be challenging but research confirms that a more mature food safety culture will deliver improved food safety performance of food safety behaviors, improved product quality, and a reduction in food safety risks.
“As food safety leaders, it is our responsibility to actively investigate the newest technologies in the market with the goal of providing the highest level of safety for our customers. The regulatory environment is rapidly evolving from a position of hazard management to preventative control, which challenges the status quo while promoting innovation. In addition, we are actively working to build food safety cultures within our operations,” says Jeremy Schneider, business development director, food safety and quality assurance at Controlant. “On top of these mandates, we are consistently being challenged to find ways to improve quality, reduce waste, and assure supply. When taken as a collective mandate, this can be considered a challenge that allows the industry to solve previously unsolvable business problems in new and exciting ways. Utilizing the newest technologies for enhanced supply chain visibility is the solution to some of our most challenging industry-wide problems.”
Schneider has more than 15 years of experience in the food quality, safety, and regulatory sector. His experience spans managing food safety and quality systems within several fast-casual restaurant chains as well as food manufacturing. In a Q&A with Food Safety Tech, Schneider discusses some of the issues that food companies are experiencing surrounding traceability in their supply chain.
Food Safety Tech: What challenges are food companies and retailers facing when it comes to real-time monitoring of their supply chain?
Jeremy Schneider: One of the biggest challenges that the industry faces when it comes to real-time monitoring of the supply chain is where to start. As you can imagine, implementing a program that allows for an organization to monitor all shipments, including those that are shipped internationally, by ship, air freight, over the road or by rail, can be daunting.
As with all food safety programs, it is advised to take a risk-based approach to the project. Begin with the highest-risk items within your supply chain and work to your second- and third-tier items or suppliers. When implemented by category over time, you will find implementation less challenging. It is important to remember that when you begin a real-time program, you will start to discover eye-opening information about your supply chain. It’s important that you develop strategies to deal effectively with these incidents.
Another primary concern for the food industry is the cost of implementation, as well as the return on investment. We have found that, by implementing a real-time monitoring solution, an organization is able to dramatically reduce shipping loss because of temperature abuse. Oftentimes, the program provides a net savings for the organization. When considering the cost of wasted food, freight, liability, lost sales and labor, a real-time supply chain visibility solution becomes a cost-effective program very quickly.
FST: Are there any lessons learned from recent outbreaks or recalls regarding traceability?
Schneider: Over the last several years, the industry has made real progress towards a transparent supply chain. However, it must be said that much work is needed to meet regulatory standards and consumer expectations when it comes to traceability. As we have become accustomed to having information that provides insights into all facets of our life, the same is becoming true of the supply chain.
Being able to have business-critical data immediately, such as real-time supply chain and traceability data, is revolutionizing the industry and is allowing enterprise-wide improvements. During a crisis situation, being able to have insights into your supply chain is paramount. Unfortunately, it has become all too common for organizations to take the ‘’out of an abundance of caution’’ approach and remove all products from the supply chain, regardless of lot code or other data, to ensure consumer safety.
The consequence of such an approach is that much more product is removed than necessary, which compounds the effects of the incident. Having had the appropriate traceability information allows organizations to take a precision-focused approach, allowing for organizations to minimize the impact as much as is safely possible.
To help organizations solve this dilemma, there are a variety of technology offerings available to help companies collect and transform data so that it can be easily used. In addition, layering rich data, such as that which is created from real-time Internet-of-Things (IoT) devices and cloud-enabled software technology, helps provide dimensional insights into your supply chain information.
FST: How can companies leverage technology to be proactive in maintaining consistent tracking and tracing throughout the supply chain?
Schneider: As we enter an era of smarter food safety, each organization will be challenged to solve some of the most pressing concerns using state-of-the-art technology. The great thing about having actionable traceability data, beyond its uses to support food safety, is that it allows an organization the ability to gain insights into their supply chain at both the micro- and macro-levels.
As an example, when an organization implements a real-time temperature monitoring program, not only are they able to identify and resolve temperature deviations before they become food safety or quality incidents, logistics can then utilize the data to optimize the shipping lane to reduce costs, and purchasing is able to know exactly where a truck is located on its route. Being able to show the value that location traceability data provides across an enterprise helps to improve the organization at every level.
Last week’s seventh annual Food Safety Consortium brought together a variety of industry experts to discuss key topics around regulation, compliance, leadership, testing, foodborne illness, food defense and more. The following are just a few sound bytes from what we heard at the event. (Click on any photo to enlarge)
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“The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency.” – Frank Yiannas, deputy commissioner for food policy & response, FDA. Read the full article on Yiannas’ keynote session |
“A typical food company only has about 5% visibility into known supply chain threats.” – Ron Stakland, senior business development, FoodChain ID, Inc.
“For most of us, our supply chain is a big black hole. Why are we so fearful of technology? Is it the implementation itself? What if technology could help us solve some of those perennial problems? There are resources available to help us get there.” – ¬ Jeremy Schneider, business development director, food safety and quality assurance, Controlant
| “The records tell the story of how well the facility is being managed. It’s the first thing the regulators are going to look at.” – Glenn Black, Ph.D., associate director for research, CFSAN, FDA, on validation considerations and regulations for processing technologies in the food industry | |
“We’ll see more robotics enter the food space.” – Gina Nicholson Kramer, executive director, Savour Food Safety International
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“Changes are happening; you can choose to face it or ignore it. We’re at least 10 years behind on technology. Automation/technology is not a new term in aerospace, etc., but to us [the food industry], it is. We will get there.” – Melody Ge, head of compliance, Corvium, Inc., on how industry should prepare for the data-driven transformation occurring in the smarter era of food safety |
It’s okay to risk and fail, but how are going to remediate that with your employee? The more learners practice in different scenarios, the less they rely on specific examples. [They] become more adept with dealing with decision making.” – Kathryn Birmingham, Ph.D., VP for research and development, ImEpik, on employee training
“As a contract lab with the vision of testing for foodborne viruses for about 10 years—it wasn’t until about three or four years ago that we had the test kits to turn that into a reality. We also didn’t have a reference method.” – Erin Crowley, chief scientific officer, Q Laboratories, on the viral landscape of testing in the food industry
| “You have to be strong and you have to believe in yourself before you get into any situation—especially as a food safety professional.” – Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory, on what it takes to earn respect as a food safety professional |  |
“’See something, say something’ is likely not enough. We recommend that companies develop a formal detection program that includes management buy-in, HR and governance, and policy documents, formal training and an awareness program…While FDA focuses on the insider threat, we feel that using a broader mitigation approach works best.” – R. Spencer Lane, senior security advisor, Business Protection Specialists, Inc. on lessons learned from food defense intentional adulteration vulnerability assessments
“Food safety is a profession, a vocation, [and] a way of life.” – Bob Pudlock, president of Gulf Stream Search
Food safety professionals are underappreciated. This statement was met with a round of applause last week at the seventh annual Food Safety Consortium. It was made by Bob Pudlock, president of Gulf Stream Search, who has heard the remark from folks working in this demanding field many times, as his firm works to place them in food safety and quality positions within the industry. Pudlock shared his advice on how you, the food safety professional, can better market yourself and earn the respect of peers and higher-ups, as well as how those who are doing the hiring should approach the process.
Read Bob Pudlock’s insights on recruiting in the food safety and quality field in his column series, Architect the Perfect Food Safety TeamCompany cultures change, the popularity of products (and their safety) ebbs and flows, company leadership fluctuates and a company may even move its corporate headquarters. Amidst all of these changes, the only things that a professional can control are his or her reputation, professional acumen, and enhancing one’s education, said Pudlock. “Focus your energy on improving parts of you. Invest in your brand,” he said. “You never know how you’re being perceived and who’s out there in the crowd.” He added that it’s important to take a moment to do some deep digging and ask questions that can help draw out greater meaning:
“Get yourself in a position where you’re personally responsible for getting yourself in the right lane,” said Pudlock, emphasizing the importance of accountability. He also advises that professionals take a moment each day to work through organizational issues via journaling. Writing serves as a cathartic exercise and can help as one is going through the problem-solving process. “Work through your overwhelm with journaling,” he said.
On the final day of the Food Safety Consortium, Pudlock led a panel of industry stakeholders who shared their insights on how to remain motivated and earn the respect of peers and superiors in the industry.
Pudlock: As a food safety professional, what has contributed to your ability earn respect from the peers who you’ve worked with over the years?
Jorge Hernandez, vice president, quality assurance at The Wendy’s Company
“What I’ve learned throughout my career is the fact that you have to understand why you are doing this. You have to reach inside and figure out for yourself, and then build your brand around that. It has to be honest; it has to be true to you. Why are you doing this? Is it to get a paycheck? Is it to get away from the kids? There are multiple reasons. There will be times in this field that you have to make the tough decisions. As you build your career, try to figure out why you really want to do this.”
April Bishop, senior director of food safety at TreeHouse Foods/Bay Valley Foods
“The ‘why’ is for those around me: We [speak] a lot of scientific jargon, and we know what we’re talking about. But the folks on the other side—in sanitation [for example], doing the most miserable job at the worst hours and in the worst condition, [for them] I need to translate all the way to the top on why we need so much time to clean the plants. Simplify the scientific jargon down to the facts that people can understand. Sell them on the ‘why’ of what they’re doing.
Marcus Burgess, senior food safety and quality systems specialist at The Cheesecake Factory
“A lot of it is communication and being able to relate at all levels from [in the field] to the top. It’s the 30-second conversation with the server or the dishwasher about why food safety is important. Being able to connect with the front line employees goes a long way. Approach the job with professionalism and sincerity. Have integrity and know the reason why you’re doing what you’re doing. It’s easy to see the pot of gold. Be selfless and know that ultimately our obligations is to customers.”
The industry has evolved quite a bit since FSMA was passed eight years ago, and there’s been an overarching recognition that more modern methods to addressing food safety challenges—especially traceability—are essential. “The agency is at the threshold of a sea change in how we’re going to oversee food safety in the nation’s food supply,” said Frank Yiannas, deputy commissioner for food policy & response at FDA at the 2019 Food Safety Consortium. The first driver is the FDA’s new initiative announced earlier this year, coined the “New Era of Smarter Food Safety”. The agency will be looking at how new and emerging technologies can help advance food safety.
“I believe that we’re in the midst of a food revolution,” said Yiannas, pointing to the level of investment in food globally. “Products will be reformulated… new food sources and production approaches will be realized, and the food system will become increasingly digitized.” It will be the job of food safety professionals to adapt to this changing landscape and to ensure that innovation does in fact happen (and safely) in order to feed the growing population.
FDA is taking a new mindset that builds on the success of FSMA but also leverages a people-led, technology enabled method to get there. Just a few days ago the agency launched FDA-TRACK, a new food safety dashboard through which FDA intends to track and measure the performance of the seven FSMA rules—and these measurements will be publicized and available for all stakeholders. Initial available metrics will be tracking outcomes for the FSMA Preventive Controls and the Foreign Supplier Verification Program related to inspections and recalls.
The second driver of this sea change at the FDA involves a shift in its current approach to FSMA and the evolution of the regulation. While the agency continues to educate while it regulates, this past summer FDA took actions that are indicating a shift in its approach to FSMA compliance. On July 30, FDA issued its first warning letter using FSVP authorities to a tahini importer for lack of FSVP compliance. This was followed a month later by actions surrounding the most recent Salmonella outbreak linked to imported papaya. “If you pause and look back, there have been eight outbreaks in eight years,” said Yiannas. The outbreak involved 500 documented cases, 100 hospitalizations and two deaths. “I thought, enough is enough,” he added, and this prompted Acting FDA Commissioner Ned Sharpless, M.D. and Yiannas to issue a statement asking the papaya industry to do more—and urged them to work together to review their practices and make necessary changes to ensure that the papayas they’re offering to the public are safe. The FDA also issued a warning letter to the papaya importer, with the possibility of barring the company for the next five years. “When there’s a public health hazard, FDA will act decisively,” said Yiannas, stating that parity and oversight is important, and domestic and imported food must be safe. “We regulators, we’re going to strike the right balance, and are committed and as passionate as ever in trying to bend the foodborne illness curve.”
Yiannas added that over the next eight years, the trajectory of papaya-related illness will look very different from the last eight years, thanks to the adoption of better technologies—and that’s part of what the FDA’s New Era of Smarter Food Safety is about. “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency,” said Yiannas. There’s a lack of knowledge in where food comes from, where it’s produced, and the fact that many companies simply don’t know as much about their supply chains as they think. With FSMA, Congress anticipated the need to track and trace food, and now the agency is exploring how new technology can enhance tracking and tracing. With regards to tracking foodborne illnesses, the food industry has been in a race between detection and prevention. “We’re getting so good at finding the needle in the haystack, but we can’t find the haystack,” said Yiannas. “We have to provide the same level of investment for technologies for trace backs….we will do that together.”
When looking at implementing smarter tools and approaches for prevention, the industry needs to work together at not just collecting the data but also converting this data into actionable information. Yiannas emphasized that the agency is not chasing the shiny object—new technology will not be a distraction; it will help solve industry problems and address the new issues that arise with the evolving food system (i.e., cell-cultured meat, plant-based meat, etc.). The agency is also holding a public meeting on October 21 to encourage discussion between the public and private sector, all surrounding this new initiative on smarter food safety.
“What’s become clear to me is [that] there’s so much we an do working together—the public and private sector… Think. Think about how you can do your work differently,” said Yiannas. “We’re all working for the same boss, the consumer. [We have the] same mission and they’re counting on us.”
The 7th annual Food Safety Consortium Conference & Expo featured dynamic discussions both in the sessions as well as on the exhibit floor. A special thank you to our Advisory Board, who contributed tremendously to the educational content, as well as our sponsors and exhibitors. (Click on the images to enlarge)
All image credit: amyBcreative
Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:
The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.
The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.
The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.
July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.
“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA
“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA
Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.
FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.
The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.
