It may be hard to believe that 10 years have passed since FSMA became law. The risk-based preventive approach to growing, manufacturing and processing, packing, storing and transporting food has transformed the industry and the nation’s food system. Today, on the anniversary of FSMA, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas takes a look at where it all began and walks us through progress, accomplishments and what the future holds.
Global partnerships (Canada, Mexico, Europe, and China) to strengthen safety of imported food
Investment in cooperative agreement programs to support compliance with FSMA rules at the state level
Looking forward: New Era of Smarter Food Safety, with blueprint released in July 2020 creates a 10-year roadmap for a more “digital, traceable and safer food system”
Incentivizing industry to adopt new technologies that facilitate full traceability
Emphasis on food safety culture on farms and in food facilities
Improving root cause analysis when preventive control measures fail
“Have we accomplished everything we wanted to help ensure that the food you serve your family is safe? The honest answer is that we’re still working on that. We are working diligently to ensure that remaining FSMA rules and related guidance documents are finalized and implemented,” said Yiannas in the FDA Voices blog. “But even when we have reached all of those milestones, we will always be working with industry on continuous improvement based on the latest science and the application of new technologies. Every day we will do our utmost to make our nation’s food as safe as it can be.”
FDA has released an outbreak investigation table that aims to disseminate information about foodborne illness outbreaks right when the agency begins an investigation. The table, published by the FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, will be updated with important information before a public health advisory or food recall is issued.
“The outbreak investigation table is a demonstration of our continued commitment to more frequent and transparent communication with stakeholders and consumers about outbreaks we’re investigating,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency statement. “We have already taken steps to release information early, in some cases prior to a specific food being linked to an outbreak, including in our recent communications on investigations into three ongoing E. coli O157:H7 outbreaks.”
As of November 18, the table listed seven outbreak investigations, only one of which identified a product linked to illnesses. Yiannas pointed out that during the early stages of an investigation, there may not be any action that a consumer can take—however, the tool is in line with the New Era of Smarter Food Safety initiative, which commits to releasing outbreak information in the “earliest stages of an investigation”.
One year ago the FDA held an at-capacity public meeting to discuss its latest initiative, the New Era of Smarter Food Safety. At the time, the agency was planning to release the blueprint for the New Era in the spring of 2020. In fact, the FDA was just days away from unveiling it when the COVID-19 pandemic hit in March. The blueprint was put aside and it was all hands on deck, as the agency worked with the food industry to ensure companies continued operating, as they were deemed a part of America’s critical infrastructure. From there, the agency navigated through uncharted waters with the food industry and its stakeholders. It signed an MOU with USDA in an effort to prevent disruptions at FDA-regulated food facilities and address shortages of PPE, disinfection and sanitation supplies. It announced that it would conduct remote inspections and extended the comment period for the Laboratory Accreditation Program Proposed Rule. It released a COVID-19 food safety checklist with OSHA to help guide companies through employee health, social distancing, and the operational issues that have entered into play as a result of the pandemic. Food companies and the supply chain were facing an enormous challenge.
“I always thought we had one of the best food systems in the world… by and large we have an amazing food system,” said Frank Yiannas deputy commissioner for food policy and response during last week’s keynote address at the 2020 Food Safety Consortium Virtual Conference Series. “We just experienced the biggest test on the food system in 100 years. Have we passed the test? I don’t think anyone would say we scored 100%… but by and large we passed the test.” Yiannas added that COVID-19 has exposed some strengths and weaknesses in the food system as well. He also emphasized a point that he has been driving home throughout the pandemic: “The virus that causes COVID-19 is not a virus that is transmitted by food. It is a respiratory virus and generally transmitted in very different ways.”
The FDA released the blueprint for the New Era of Smarter Food Safety, which incorporated some lessons learned from COVID-19, in July. Traceability is a big part of agency’s new era initiative, and the pandemic further put a spotlight on the need for better tracking and tracing in the food industry. And under FSMA, FDA is required to “establish a system that will enhance its ability to track and trace both domestic and imported foods”. In working to meet this requirement, FDA proposed the FSMA rule on food traceability last month.
Yiannas said the proposed rule has the potential to lay the foundation for meaningful harmonization and called aspects of the proposed rule game changing. It establishes two critical components that are the leading edge of food traceability: It defines critical tracking events (i.e., what are the types of events in the food system that required those events to be kept) and key data elements (i.e., the data elements that must be captured at those critical tracking events). “These two things are big ideas for traceability,” said Yiannas. “They will allow us to harmonize how traceability is to be done, allow us to scale and allow for greater interoperability.” The proposed rule also creates a traceability list that identifies foods based on a risk-ranking model for food tracing.
FDA is encouraging comments on the proposed rule and is holding three meetings (November 6, November 18 and December 2) to discuss the proposed traceability rule. “We are going to create the final rule together,” said Yiannas.
FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.
The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.
In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”
One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.
It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.
The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.
Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.
In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.
The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.
In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.
Today FDA released the New Era of Smarter Food Safety Blueprint. The much-anticipated document was originally scheduled for release in March but was delayed due to the agency’s response to COVID-19. Although the agency’s plan places a lot of focus on the use of new technology, FDA Commissioner Stephen Hahn, M.D., stressed that it is also about enabling more effective methods and processes.
Tech-Enabled Traceability. A lesson learned during the coronavirus pandemic was that there is a need for greater traceability and visibility in the supply chain. “One of the challenges we’ve faced over the years is recurring outbreaks of illnesses associated with the consumption of certain foods,” said Hahn. “What this daunting problem underscores is the critical importance of the FDA working with industry so that we can rapidly trace a contaminated food to its source. And when I say rapidly, I mean minutes, not days, weeks, or even longer.
Smarter Tools and Approaches for Prevention and Outbreak Response. Here, the FDA is emphasizing the “power of data”. “The plans embraced by the blueprint include strengthening our procedures and protocols for conducting the root cause analyses that can identify how a food became contaminated and inform our understanding of how to help prevent that from happening again,” said Hahn.
New Business Models and Retail Modernization. This element address food production and delivery, as well as food safety in restaurants and the retail setting.
Food Safety Culture. “The pandemic has given us a new perspective on what we mean by food safety culture,” said Hahn. He stated that beyond influencing human behavior, food safety culture must also address worker safety and consumer education.
On October 1, Frank Yiannas will be the keynote speaker for the 2020 Food Safety Consortium Virtual Series || The series takes place during the weeks of September 3 through December 17Expect the much-anticipated blueprint for FDA’s New Era of Food Safetyto be released soon. The agency has not provided an exact date but in an update prior to the July 4th holiday, FDA stated it would be rolled it out “in the coming weeks”.
“The challenges we’ve faced during the pandemic have made it clear that the goals we set forth in the New Era blueprint are more important now than ever. Some of them, like enhanced traceability, are particularly meaningful in light of recent events,” Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, stated in an agency consumer update. “What we have learned from the pandemic is that we’re on the right track with the New Era of Smarter Food Safety. The steps that we’ll take will prepare us to protect the safety of our food supply, no matter what challenges we face.”
In addition to the focus on emerging digital technologies, traceability in the supply chain, ensuring safety in the home delivery of food (e-commerce), and food safety culture, FDA will be including the lessons learned from the COVID-19 pandemic as part of the blueprint structure.
EDGARTOWN, MA, January 22, 2020 – Innovative Publishing Company Inc., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker for the 2020 Food Safety Consortium Conference & Expo on October 21. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 21–23 in Schaumburg, IL (just outside Chicago).
“At last year’s Food Safety Consortium, Frank Yiannas spoke about the ‘sea change’ happening at FDA and the increased efforts on the part of the agency to drive more transparency and traceability. We look forward to his insights, as well as learning more about FDA’s progress on its initiatives, especially the New Era of Smarter Food Safety,” says Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference & Expo.
This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Food Safety, chaired by Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation; Food Integrity, chaired by Steven Sklare, president of The Food Safety Academy; and Food Defense, chaired by Jason Bashura, senior manager, global food defense at PepsiCo.
Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
About the Food Safety Consortium Conference and Expo
Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy. The Food Safety Consortium Conference and Expo is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.
With the passage of the Farm Bill, there has been a great deal of interest from the food industry in cannabis-infused foods and beverages, which includes hemp and CBD. The Food Safety Consortium is co-located with The Cannabis Quality Conference & Expo, an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the Cannabis Quality Conference enables attendees to engage in conversations that are critical in finding solutions to improve regulatory compliance, quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace. Both conference programs run concurrently, thus, Food Safety Consortium registrants can attend any of the Cannabis Quality Conference presentations and vice versa. This year’s event takes place October 21–23 in Schaumburg, IL and is co-located with the Cannabis Quality Conference & Expo.
Going digital is a hot topic in the food industry, but making the investment can be a tough choice for organizations. Jeremy Schneider, business development director, food safety and quality assurance at Controlant, reviews some of the factors that food companies should consider when making the decision, along with the value that digital technologies can bring from the perspective of ROI and improving food safety culture.
Food Safety Tech: For businesses that have been historically paper-driven, where do they start on the technology adoption journey?
Schneider: There are a number of questions that firms, both small and large, should consider when deciding to move to a paperless operation. Have you considered what moving away from a paper-based system would mean for your enterprise? What are the perceived challenges to making this move? Or perhaps, what are the risks of not moving to digital? How would utilizing systems provide your organization with the ability to access data in transformative ways?
For organizations that are making the transition from paper documentation to digital, it is critical to develop a roadmap with tangible milestones and objectives. Although there are a variety of reasons to make the switch to digital, what is most important for your organization will determine what those are, as they will play a critical role in developing a roadmap of priorities. We often find that organizations identify a ‘’pain-point’’ in their current process, and this is a leading driver to wanting to make a change in their process. Perhaps this is the inability to easily access information in a timely manner, or the challenges with making sense of the data that you are currently collecting. Whatever your challenges may be, begin by developing a plan, and prioritize this, as it will provide you with early positive results that will keep you working towards the goal. As you experience these early benefits from going digital, you will begin to see the value that this will bring your organization at scale.
One significant issue that many organizations face when beginning this journey is not bringing the appropriate stakeholders into a program early enough. It is critical for the success of new supply chain programs to make sure you bring in members of purchasing, logistics, quality, finance, IT, and others as early as possible so that any questions or concerns are properly vetted early in the process. In addition to this, getting buy-in from these teams at the earliest phase of a project will allow others to vet the system in their own way, potentially helping them solve challenges they have been
FST: Talk about measuring the success of a technology: How do the metrics translate into ROI?
Schneider: A question that is often raised is how to measure the success of the technology. Simply put, does the program make your life easier and solve the problem you set out to, or not? Does it meet the concise objectives that you outlined in the beginning of the process, or does it fall short in some way? If your answer to any of these questions is yes, and it does meet the objectives, then you are well on your way to defining success of your program.
Read Food Safety Tech’s previous discussion with Schneider, Using Technology for Traceability Adds Dimension to Supply Chain, Promises ROIIt is critical that programs are able to show their value through their return on investment, but how do you measure this? If you have recently implemented a real-time supply chain temperature monitoring program, for instance, you may want to consider metrics such as reduced loss, spoilage, shortages, or restaurant-level outages as metrics of success. Or perhaps you would want to translate this into a dollar figure. For instance, in the previous year, your organization counted 10 rejected shipments due to suspected temperature abuse, at a loss of $500,000. In the year following your implementation, your new system was able to help the organization intervene and minimize that loss to just one rejected shipment at a cost of $50,000, thus leading to a reduced loss rate of $450,000.
In collaboration with other stakeholders in your organization, you may be able to identify additional metrics, such as reduced freight rates from optimized shipping lanes, reduced insurance premiums from reduced losses, or reduced quantities of on-hand inventories as you are able to truly manage a just-in-time supply chain. If your organization actively measures your Cost to Serve, savings within your supply chain would likely be an important data point to consider.
Beyond the identifiable money savings, consider some of the soft ROI attributes, such as enhanced collaboration with supply chain and supplier partners, improved customer loyalty, brand protection generally, and sustainability initiatives. Does your organization have goals to reduce food waste? If so, perhaps waste minimization is an important attribute to measure. When evaluated holistically, significant savings can be realized.
FST: How does technology facilitate a more effective food safety culture?
Schneider: Building an effective food safety culture is a process that requires commitment from every level of your organization. The ways that we promote food safety culture within each organization differs, from rewarding team members when they identify an unsafe practice, to actively promoting food safety throughout the organization, to encouraging quality assurance teams to identify state-of-the-art technologies and implementing them to improve the systems, programs, and processes throughout the company.
As food safety professionals, our toolboxes are filled with a variety of tools for the job, and technology as a tool is no exception. Technology should enable our organizations to be more efficient, allowing them to focus their attention on high-priority projects while minimizing work that can be automated. An example of this is setting parameters to allow organizations to work based on exception instead of requiring a review of all documentation.
As we enter the New Era of Smarter Food Safety, and the tenants of it being people-led, technology-enabled, and FSMA-based, we have a mandate to try new technologies to help solve previously unsolvable supply chain challenges. Organizations are actively pursuing real-time supply chain temperature monitoring as a way to provide insights into their cold chain and allowing them to move from reaction to a position of prevention.
Organizations are finding that investments in food safety technologies pay dividends in customer commitment over the long term. It is no longer acceptable to only meet regulatory standards. It is now an expectation that companies do anything possible within their power to assure customer safety and, per the FDA’s new mandate, to help create a more digital, traceable, and safer food system.
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