Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.
“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”
Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation
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.”
2020 has taken a lot away from us, but it has also taught us the importance of being able to quickly adapt (can you say…“pivot”?) to rapidly changing, dire circumstances. For Food Safety Tech, that meant shifting our in-person annual Food Safety Consortium to a virtual event. I really look forward to the Consortium each year, because we are a virtual company, and this is the one time of year that most of the Food Safety Tech and Innovative Publishing Company team are together. When we made the decision to move the event online, we really wanted to be considerate of our attendees, who more than likely were quickly developing webinar and Zoom fatigue. So we created a series of 14 Episodes that spanned from September until last week. I am not going to single out one episode or speaker/session in particular, because I think that all of our speakers and sponsors brought a tremendous amount of education to the food safety community. Thank you.
COVID-19 has served as the springboard for digital transformation, more of which we have seen in the past nine months than in the last several years or even decade. Tech advances are increasing efficiencies, adding the ability to be more predictive, giving more visibility and traceability in the supply chain and offering increased accessibility. These include: IoT; Advanced analytics; Artificial intelligence (FDA has been piloting AI technology); Graph technology used in supply chain visibility; blockchain; mixed reality; and remote monitoring.
There are new responsibilities that come with being a part of America’s critical infrastructure and protecting essential frontline workers.
Companies must have a strong relationship (or work to build one) with local health departments and authorities
Name a COVID Czarat your company: This is a designated person, located both within a production facility as well as at the corporate location, who manages the bulk of the requirements and precautions that companies should be undertaking to address the pandemic.
Every company should have an emergency risk management plan that centers around good communication.
The COVID-19 pandemic is a reminder to us that the threat for viruses is always lurking beneath the surface. There is still work to be done on the food labs side regarding more rapid assays, leveling the playing field regarding conducting viral testing, and technology that enables labs to get safe, effective and consistent results.
Lessons in sanitation: Investment in sanitation is critical, there are no shortcuts, and empower your sanitation employees, give them the tools they need to effectively do their jobs.
Know your suppliers, know your suppliers, know your suppliers!
Biofilms are ubiquitous, and the process of detecting and eliminating Listeria in your facility is a marathon with no finish line.
Food Safety Culture is a profit center, not an overhead department.
“If I’m not well, I can’t do well.” Making sure your needs are met personally and professionally plays an important role in being a better contributor to your company’s success.
As part of a special offering, we are making four episodes of the 2020 Food Safety Consortium Virtual Conference Series available on demand for free. Head to our Events & Webinars page to register to view the sessions on or after January 2021.
While COVID-19 exposed disconnects in the food supply chain, it also served as an overdue catalyst for rapid technology adoption. Food manufacturers, distributors and retailers were forced to grapple with consumer behaviors that—previously expected to occur over five years— changed within about five weeks. Faced with unprecedented demand, channel shifts and rapidly changing consumer purchasing behaviors, forward-looking brands and retailers have started to transform their business models to become highly responsive and agile.
A new approach called “programmatic commerce” may be the key to faster market insights and pivots. Taking cues from past attempts to digitize the supply chain from end-to-end, programmatic commerce uses artificial intelligence (AI) and machine learning (ML) to connect and unify critical business data across food manufacturers, distributors and retailers using common retail portals, BI and CRM tools as well as other data resources and platforms.
With a real-time unified view of channels and activity, programmatic commerce has the potential to create fully automated trade processes to optimize production, inventory management, logistics, promotions and more for both upstream and downstream supply chain activities.
To achieve the potential of programmatic commerce, real-time or near real-time data sources must be easily integrated, unified and displayed. This is in stark contrast to previous attempts to create end-to-end supply chain visibility, which often required custom or manual integrations, had costly and lengthy implementation requirements and necessitated custom reporting.
The programmatic approach is already gaining traction, enabling retailers to leverage AI and ML technology to optimize supply chains. But the real value is in taking it one step further—to tap into rich customer data, understand rapidly changing consumer behaviors and ultimately—to predict and personalize shopping experiences at scale.
Tracking and Adapting to Evolving Consumer Journeys
Consumers increasingly demand greater choice, control, personalization and transparency and companies must continuously create, track and manage a 360º view of customers’ shopping journeys to stay ahead of these trends. Fortunately, real-time data and analytical capabilities are available to supply the critical information they need to implement a programmatic commerce approach.
Among the shifts companies must track as a result of COVID-19 is the explosion in online grocery shopping. In November 2020, U.S. grocery delivery and pickup sales totaled $5.9 billion and a record high 83% of consumers intend to purchase groceries online again, signaling this trend continues as the pandemic lingers on.1 By 2025, online grocery sales are predicted to account for 21.5% of total grocery sales, representing more than a 60% increase over pre-pandemic estimates.2 A permanent shift toward online grocery shopping can be expected as consumers’ shopping and fulfillment experience continues to improve.
For consumers still shopping in stores, the pandemic also drove switches in primary physical store locations. In the United States, an estimated 17% of consumers shifted away from their primary store since the start of the pandemic.3 This was driven by increased work-from-home, which eliminated commuting routes and made different store locations more convenient, including ones closer to home.
Given the multitude of changes impacting consumer journeys during the pandemic, it is imperative that companies track relevant purchase drivers and considerations of each purchase occasion, while also taking into account their recent shopping experience. This creates the need for consistent, seamless and relevant experiences across both digital and physical channels that aligns all touchpoints with the consumer as part of their “total commerce experience.”
Multiple retailers are already pursuing this approach in the hope of retaining their “primary store” status across the totality of their consumers’ shopping experiences. Walmart recently launched a new store format to help achieve “seamless omni-shopping experiences” for its customers through a digitally enabled shopping environment. Customers can use the Walmart app to efficiently find what they’re looking for, discover new products, check pricing, and complete contactless checkout.4 Data tracked on these customers can eventually be used to create personalized recommendations and in-store activations and assistance based on their purchase history and in-store experience.
Conversely, the “digital store” is also being reimagined to align with consumers’ in-store experience to create a seamless shopping experience. For example, personalized meal planning service The Dinner Daily now offers the ability for its members to order recipe ingredients directly from Kroger and other Kroger-owned stores through The Dinner Daily app.5 Integrated data from multiple shopping platforms and consumer touchpoints can provide food manufacturers and retailers with shopper profiles, consumer experiences, and purchase history along with inventory status and other inputs to ultimately build personalized customer experiences and enhance shopper loyalty.
Applying Programmatic Commerce to Deliver Personalization to Consumers
Once armed with real-time data in a uniform format from sources ranging from consumer search analytics to retailer promotional pricing, a programmatic commerce approach can provide companies with predictive understanding of demand and supply to optimize decision making from raw materials through production through retail or direct-to-consumer.
Using online grocery shopping as an example, consumer personalization can be delivered through the accurate prediction and display of items relevant to each shopper based on shopping history, preferences, current cart selections, and other inputs such as real-time availability, marketing promotions and more.
Innovations are already in the market, including Halla, a data science company that developed a grocery-specific personalization algorithm that works with grocery retailer e-commerce platforms to create smart recommendations based on understanding of individual shoppers’ product usage and preferences.6 Another example is the Locai Solutions digital grocery platform, which applies AI to personalize recipe recommendations based on consumer preferences and purchase history and determines ingredients and quantities needed for easy incorporation into their shopping cart.7
The Path Ahead: Accelerating Technology Adoption in the Food Industry
AI and ML are already reducing waste across supply chains and enabling consumer personalization. However, currently only about 12% of retail decision-makers feel they are very effective at providing these experiences to customers and only 10% have access to the real-time data needed to achieve this goal.8
Modern programmatic commerce platforms (see Figure 1) can effectively bridge information gaps, improve inventory and distribution to prevent shortages or overages and help companies be data-ready to meet actual demand. Beyond this, a programmatic approach unlocks the next stage of customer satisfaction and loyalty, personalizing the experience during and after the pandemic.
Food Safety Recalls – Digging Deeper into FDA, CDC, USDA & Food Industry Data, with Allen Sayler, EAS Consulting
Preparing for Blockchain in “A New Era of Smarter Food Safety”, with Kathy Barbeire, CAT Squared
The Road to Traceability is Paved with Standards, with Lucelena Angarita, IPC/Subway and Liz Serti, GS1 US
TechTalk from Controlant
The event begins at 12 pm ET on Thursday, December 10. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! We look forward to your joining us virtually.
Yesterday FDA released more resources to help stakeholders in understanding the FSMA Food Traceability proposed rule. The Risk-Ranking Model for Food Tracing is designed to help users learn more about the methods and criteria for scoring commodity-hazard pairs, along with the results of the scoring that are used to determine the foods included on the Food Traceability List [https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list].
The agency also published a pre-recorded webinar about the proposed rule, featuring Frank Yiannas, deputy commissioner for food policy and response, and Angela Fields, a traceability expert with FDA’s Coordinated Outbreak Response and Evaluation Network.
With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.
With a global marketplace and complex supply chain, the food industry continues to face increasing risks for both unintentional and intentional food contamination or adulteration.1 To mitigate the risk of contaminated products reaching consumers, the International Organization for Standardization (ISO), using a consensus-based approval process, developed the first global laboratory standard in 1999 (ISO/IEC 17025:1999). Since publication, the standard has been updated twice, once in 2005 and most recently in 2017, and provides general requirements for the competence of testing and calibration laboratories.2
In the recent revision, four key updates were identified:
A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
The introduction of the concept of a risk-based approach used in production quality management systems.2
A stronger focus on information technologies/management systems, specifically Laboratory Information Management System (LIMS).4
As modern-day laboratories reduce their reliance on hard copy documents and transition to electronic records, additional emphasis and guidance for ISO 17025 accreditation in food testing labs using LIMS was greatly needed. Food testing laboratories have increased reliance on LIMS to successfully meet the requirements of accreditation. Food and beverage LIMS has evolved to increase a laboratory’s ability to meet all aspects of ISO 17025.
Chain of Custody
A key element for ISO 17025 accredited laboratories is the traceability of samples from accession to disposal.5 Sometimes referred to as chain of custody, properly documented traceability allows a laboratory to tell the story of each sample from the time it arrives until the time it is disposed of.
LIMS software allows for seamless tracking of samples by employing unique sample accession numbers through barcoding processes. At each step of sample analysis, a laboratory technician updates data in a LIMS by scanning the sample barcode, establishing time and date signatures for the analysis. During an ISO 17025 audit, this information can be quickly obtained for review by the auditor.
Procurement and Laboratory Supplies
ISO 17025 requires the traceability of all supplies or inventory items from purchase to usage.6 This includes using approved vendors, documentation of receipt, traceability of supply usage to an associated sample, and for certain products, preparation of supply to working conditions within the laboratory. Supply traceability impacts multiple departments and coordinating this process can be overwhelming. A LIMS for food testing labs helps manage laboratory inventory, track usage of inventory items, and automatically alerts laboratory managers to restock inventory once the quantity falls below a threshold level.
A food LIMS can ensure that materials are ordered from approved vendors only, flagging items purchased outside this group. As supplies are inventoried into LIMS, the barcoding process can ensure accurate storage. A LIMS can track the supply through its usage and associate it with specific analytical tests for which inventory items are utilized. As products begin to expire, a LIMS can notify technicians to discard the obsolete products.
One unique advantage of a fully integrated LIMS software is the preparation and traceability of working laboratory standards. A software solution for food labs can assist a technician in preparing standards by determining the concentration of solvents needed based on the input weight from a balance. Once prepared, LIMS prints out a label with barcodes and begins the supply traceability process as previously discussed.
Quality Assurance of Test and Calibration Data
This section of ISO 17025 pertains to the validity of a laboratory’s quality system including demonstrating that appropriate tests were performed, testing was conducted on properly maintained and calibrated equipment by qualified personnel, and with appropriate quality control checks.
Laboratory Personnel Competency
Laboratory personnel are assigned to a specific scope of work based upon qualifications (education, training and experience) and with clearly defined duties.7 This process adds another layer to the validity of data generated during analysis by ensuring only appropriate personnel are performing the testing. However, training within a laboratory can be one of the most difficult components of the accreditation process to capture due to the rapid nature in which laboratories operate.
With a food LIMS, management can ensure employees meet requirements (qualifications, competency) as specified in job descriptions, have up-to-date training records (both onboarding and ongoing), and verify that only qualified, trained individuals are performing certain tests.
Calibration and Maintenance of Equipment
Within the scope of ISO 17025, food testing laboratories must ensure that data obtained from analytical instruments is reliable and valid.5 Facilities must maintain that instruments are in correct operating condition and that calibration data (whether performed daily, weekly, or monthly) is valid. As with laboratory personnel requirements, this element to the standard adds an additional layer of credibility that sample data is precise, accurate, and valid.
A fully integrated software solution for food labs sends a notification when instrument calibration is out of specification or expired and can keep track of both routine internal and external maintenance on instruments, ensuring that instruments are calibrated and maintained regularly. Auditors often ask for instrument maintenance and calibration records upon the initiation of an audit, and LIMS can swiftly provide this information with minimal effort.
Measurement of Uncertainty (UM)
Accredited food testing laboratories must measure and report the uncertainty associated with each test result.8 This is accomplished by using certified reference materials (CRM), or known spiked blanks. UM data is trended using control charts, which can be prepared using labor-intensive manual input or performed automatically using LIMS software. A fully integrated food LIMS can populate control data from the instrument into the control chart and determine if sample data analyzed in that batch can be approved for release.
Valid Test Methods and Results
Accurate test and calibration results can only be obtained with methods that are validated for the intended use.5 Accredited food laboratories should use test methods that are current and contain embedded quality control standards.
A LIMS for food testing labs can ensure correct method selection by technicians by comparing data from the sample accession input with the test method selected for analysis. Specific product identifiers can indicate if methods have been validated. As testing is performed, a LIMS can track time signatures to ensure protocols are properly performed. At the end of the analysis, results of the quality control samples are linked to the test samples to ensure only valid results are available for clients. Instilling checks at each step of the process allows a LIMS to auto-generate Certificates of Analysis (CoA) knowing that the testing was performed accurately.
The foundation of a laboratory’s reputation is based on its ability to provide reliable and accurate data. ISO 17025:2017 includes specific references to data protection and integrity.10 Laboratories often claim within their quality manuals that they ensure the integrity of their data but provide limited details on how it is accomplished making this a high priority review for auditors. Data integrity is easily captured in laboratories that have fully integrated their instrumentation into LIMS software. Through the integration process, data is automatically populated from analytical instruments into a LIMS. This eliminates unintentional transcription errors or potential intentional data manipulation. A LIMS for food testing labs restricts access to changing or modifying data, allowing only those with high-level access this ability. To control data manipulation even further, changes to data auto-populated in LIMS by integrated instrumentation are tracked with date, time, and user signatures. This allows an auditor to review any changes made to data within LIMS and determine if appropriate documentation was included on why the change was made.
ISO 17025:2017 requires all food testing laboratories to have a documented sampling plan for the preparation of test portions prior to analysis. Within the plan, the laboratory must determine if factors are addressed that will ensure the validity of the testing, ensure that the sampling plan is available to the laboratory (or the site where sampling is performed), and identify any preparation or pre-treatment of samples prior to analysis. This can include storage, homogenization (grinding/blending) or chemical treatments.9
As sample information is entered into LIMS, the software can specify the correct sampling method to be performed, indicate appropriate sample storage conditions, restrict the testing to approved personnel and provide electronic signatures for each step.
Monitoring and Maintenance of the Quality System
Organization within a laboratory’s quality system is a key indicator to assessors during the audit process that the facility is prepared to handle the rigors that come with accreditation.10 Assessors are keenly aware of the benefits that a food LIMS provides to operators as a single, well-organized source for quality and technical documents.
An ISO 17025 accredited laboratory must demonstrate document control throughout its facility.6 Only approved documents are available for use in the testing facility, and the access to these documents is restricted through quality control. This reduces the risk of document access or modification by unauthorized personnel.
LIMS software efficiently facilitates this process in several ways. A food LIMS can restrict access to controlled documents (both electronic and paper) and require electronic signatures each time approved personnel access, modify or print them. This digital signature provides a chain of custody to the document, ensuring that only approved controlled documents are used during analyses and that these documents are not modified.
Corrective Actions/Non-Conforming Work
A fundamental requirement for quality systems is the documentation of non-conforming work, and subsequent corrective action plans established to reduce their future occurrence.5
A software solution for food labs can automatically maintain electronic records of deviations in testing, flagging them for review by quality departments or management. After a corrective action plan has been established, LIMS software can monitor the effectiveness of the corrective action by identifying similar non-conforming work items.
Food and beverage testing laboratories are increasingly becoming accredited to ISO 17025. With recent changes to ISO 17025, the importance of LIMS for the food and beverage industry has only amplified. A software solution for food labs can integrate all parts of the accreditation process from personnel qualification, equipment calibration and maintenance, to testing and methodologies.11 Fully automated LIMS increases laboratory efficiency, productivity, and is an indispensable tool for achieving and maintaining ISO 17025 accreditation.
The theme of better traceability and more transparency is a theme that will only grow stronger in the food industry. Just last week we heard FDA Deputy Commissioner for Food Policy and Response Frank Yiannas talk about the agency’s recently proposed FSMA rule on food traceability during the 2020 Food Safety Consortium Virtual Conference Series. In a recent Q&A with Food Safety Tech, Mikael Bengtsson, industry & solution strategy director for food & beverage at Infor, explains yet another role that technology can play in helping companies maintain agility during changes that affect the supply chain such as the coronavirus pandemic.
Food Safety Tech: How can food suppliers mitigate the risks of foodborne illness outbreaks under the stress of the COVID-19 pandemic and with limited resources?
Mikael Bengtsson: Food safety must always be a top priority for any food and beverage company. The risks associated with contamination can have a severe impact for public health, brand and company reputation. Safety routines are therefore always of the highest priority. In today’s situation with COVID-19, the stress on safety is further increased. Now, it’s not only about keeping products safe but also keeping employees healthy. One progression and resource that all food suppliers must follow is the FDA [FSMA rules], which require suppliers to be diligent and document their compliance. Especially now, while suppliers are faced with limited resources and additional stress during the pandemic, they must rely on the basics—ensuring masks are worn in and out of the workplace, washing hands for at least 20 seconds prior to touching any food, and remaining six feet apart from co-workers. When it comes to a crisis like COVID, take solace in knowing suppliers can rely on the basics—even when conditions are strained.
This year we have seen many companies having to adapt and change quickly. Demand has shifted between products, ingredients have been in shortage and many employees have had to work from home. Some were better prepared than others in adapting to the new situation. Technology plays a big role when it comes to agility. Regarding food safety, there are many proactive measures to be taken. The industry leaders establish transparency in their supply chain both upstream and downstream, use big data analysis to identify inefficiencies, as well as couple IoT with asset management systems to foresee issues before they happen.
FST: How can technology help suppliers meet the growing consumer demand for transparency in an end-to-end supply chain and improve consumer trust?
Bengtsson: Communication with consumers is changing. It is not only about marketing products, but also to educate and interact with consumers. This requires a different approach. Of course, consumers are loyal to brands, but are also tempted to try something new when grocery shopping. After a new study is published or a new story is written, consumers are likely to shift their shopping preferences.
It is therefore important to build a closer connection with consumers. Companies who have full supply chain visibility, transparency and traceability have detailed stories to tell their consumers. One way they can build these stories is by including QR codes on their packages. The consumer can then easily scan the code and be brought to a website that shows more product details—e.g. who was the farmer, how were the animals cared for and what sustainability efforts were involved. These are all important aspects to build consumer trust. According to researchers at MIT Sloan School of Management, investing in supply chain visibility is the optimal way to gain consumer trust, and can lead to increased sales.
FST: What technologies should suppliers leverage to better collaborate with trading partners and ensure consistent food safety procedures?
Bengtsson: When a food safety problem arises, batches, lots, and shipments need to be identified within minutes. Manufacturers must be able to trace all aspects of products throughout the entire supply chain—with complete visibility at the ingredient level—from farm to table, and everything in-between. An efficient and transparent food supply chain requires extensive collaboration and coordination between stakeholders. New technologies can extend both amount of collaboration possibilities and the impact of those collaborations. In order to maintain a transparent, efficient food supply chain, companies need to invest in modern cloud-based ERP and supply chain systems that incorporate the increased visibility of the Internet of Things (IoT) with data sharing, supplier and customer portals, and direct links between systems—all aimed at facilitating joint awareness and coordinated decision-making. Modern technologies that enable transparency will also have the added benefits of meeting consumer demand for product information, identifying and responding to food safety issues, reducing food waste, and supporting sustainability claims.
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.
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