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What You Need to Know About the FDA's 'New Era of Smarter Food Safety' Blueprint

The FDA’s "New Era of Smarter Food Safety Blueprint" builds upon the foundation created by the Food Safety Modernization Act (FSMA), which established both risk- and science-based protections in the food supply chain by focusing on and implementing a preventative approach to foodborne illnesses, rather than a reactive one.

The FDA’s approach to food safety, as outlined, aims to reduce the number of foodborne illnesses through a modernized, more digital, traceable, and safer food system using technology and other tools over the next decade. The ultimate goal, as described in the blueprint, is to strengthen the framework that enables the prevention of foodborne illnesses, leveraging a robust digital network that allows food to be traced to its source in seconds, alerting consumers in real time before the consumption of contaminated or misbranded foods. Additionally, the FDA “envisions a framework in which education, communication and democratization of data will enable industry, public health advocates and government to work in concert to keep the food supply safe.”

The FDA had originally planned to release the blueprint in spring 2020, but plans were paused when COVID-19 pandemic response efforts took priority. The COVID-19 crisis highlighted challenges and unique demands on the food supply chain and food system, further solidifying the need for a robust, nimble and data-driven approach to ensure a strong and resilient food system. Food laboratories with a deep bench of expertise and experience are fundamental to the FDA’s data-driven, proactive and preventative approach to foodborne illness, employing a wide range of analytical methodology and partnering with stakeholders along the food supply chain to offer insights into best practices, process optimization and routine quality control measures.

Four Core Elements

The blueprint is built upon four pillars, also referred to as “the four core elements,” which include tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and food safety culture. Common themes throughout the core elements include a mutual reliance on state and federal partners, the need for reliable reporting and metrics as well as third-party audits, and the importance of a strong food safety culture. By bringing these four core elements together, the FDA believes the goals set within the blueprint can be achieved, ushering in a new era of smarter food safety.

Element partners with companies along the food supply chain, enabling organizations to achieve smarter food safety by implementing, maintaining and enriching a proactive, preventative and scientifically driven approach to foodborne illness and outbreaks. Our industry-leading experts have decades of experience in food safety, and actively partner with customers to build, sustain and strengthen robust food safety systems.

Tech-Enabled Traceability

When there is an outbreak of a foodborne illness, the stakes are high, and can include loss of life, millions of dollars in lost product and a breakdown in consumer trust. At this time, it is not possible to rapidly track and trace food that has moved through the supply chain, as most records are paper-based and there is a lack of data identifying products. Furthermore, as observed during the COVID-19 pandemic, the lack of immediate visibility impedes the ability to understand the supply chain amid public health crises.

The FDA plans to lay the foundation for enhanced traceability by completing FSMA Section 204 rulemaking to harmonize both key data elements and critical tracking events. By standardizing these foundational components, data sharing can be enabled across stakeholders in the supply chain who make use of digital technologies, significantly reducing the time it takes to identify the source of food contamination and/or outbreaks of foodborne illness. Additionally, the FDA intends to leverage the digital transformation, optimizing tech-enabled outbreak response and recall protocols, collaborating with federal, state, local, tribal and territorial stakeholders. Traceability work is already underway at FDA for other regulated products, e.g. medical devices and drugs, and where possible, the FDA is looking to harmonize the traceability work being done for the food supply chain with these other products.

Partnerships with trusted food testing labs are critical to ensuring the source of food contamination is properly tracked and identified. Partner food testing laboratories should be equipped with modern laboratory information management systems, a deep bench of expertise and the ability to rapidly deliver results to identify the source of foodborne illness and/or contamination. Furthermore, laboratories must have a thorough understanding of the current regulatory landscape, including the FDA’s modernization and traceability efforts to facilitate and support the reporting of scientific data needed to carry out tech-enabled outbreak responses.

Smarter Tools and Approaches for Prevention and Outbreak Response

As part of their commitment to modernizing their approach to foodborne illness outbreak responses and recalls, the FDA is looking to build upon existing state-level partnerships where comparable regulatory and public health systems are in place, maximizing food safety reach and ensuring the optimal use of resources. By collaborating with federal, state, industry, consumer and academic stakeholders, the FDA can further the standardization and advancement of root cause analysis protocols specific to food safety. Additionally, the FDA believes that concerns regarding confidentiality and protection of proprietary information can be addressed while all parties work together to advance transparency. By standardizing the reporting format and criteria for root cause analyses, improving communication tools and integrating root cause data into the Agency’s risk ranking and predictive analytical systems, the FDA aims to increase the probability of predicting and mitigating future instances of food supply contamination and foodborne illnesses.

The FDA’s modernized food safety approach is supported by independent food testing labs that employ a variety of analytical tools and methodology, as the Agency looks to leverage private lab capabilities to identify potential outbreaks. Element’s risk-based approach to furthering food safety aligns with the FDA’s approach for prevention and outbreak response, with a strong focus on root cause analysis, quality control measures and process optimization. Partner with Element and together, we can be at the forefront of modernization within the food industry, working with the FDA to achieve a more robust and proactive approach to food safety.

The FDA plans to employ artificial intelligence and machine learning to bolster its predictive analytics capabilities, and the Agency has successfully performed proof of concept testing on artificial intelligence (AI) screening of imported foods at ports of entry. The FDA is also exploring the use of technology for inspection, training and compliance, including remote, virtual and/or component inspections of foreign and domestic firms, building on their experience conducting remote inspections of specific importers during the COVID-19 pandemic. Element’s food testing labs have extensive experience working with border authorities and the FDA to test and address imported goods that have been flagged for further inspection. Leading organizations trust Element’s import hold testing and consulting services for on-site sampling, rapid testing and coordination of reporting to regulatory authorities.

New Business Models and Retail Modernization

E-commerce and delivery models, in addition to the development of novel ingredients, new foods and new food production systems, are evolving that farm to table pathway for food. A more digital, traceable food system is the answer to diminishing foodborne illnesses and keeping consumers as safe as possible.

The FDA is exploring ways to modernize traditional business models and ensure the safety of food sold through new and emerging markets. To support new business models, the FDA is collaborating with multiple stakeholders, including regulatory partners, to identify potential food safety vulnerabilities and determine how to build systems and processes to best address them in the future. Food testing laboratories will continue to be critical in addressing and detecting food safety vulnerabilities. By partnering with a trusted food testing lab to identify potential points of failure or susceptibility throughout the food system, stakeholders can implement a proactive approach to preventing foodborne illness and outbreaks.

Leveraging digital infrastructure is woven throughout the FDA’s plan to modernize the traditional approach to retail food safety, which includes digital incentivization to prompt and reward desired behaviors, including handwashing and monitoring temperatures manually. The Agency is also exploring the use of technology to enhance facility and equipment design, including developing and using smart commercial kitchen equipment with built-in automatic monitoring of time and temperature processes. In instances where smart commercial equipment is employed, routine lab testing will be essential to validate that baking and other temperature-controlled processes are lethal against foodborne pathogens such as salmonella.

Food Safety Culture

The "New Era of Smarter Food Safety" Blueprint emphasizes the FDA’s commitment to food safety culture, which extends to upholding food safety culture throughout the food system as well as further promoting food safety culture throughout the Agency. The FDA plans to develop a social marketing plan to strengthen the culture of food safety, as well as influence and sustain desired behavior changes. Additionally, the Agency will support the harmonization and development of tools that can be used by companies to assess their current food safety culture, partnering with both industry and academia. Consumer education is a high priority for the FDA, relying upon the use of prevalent technical tools, including smart phones, smart home devices and digital platforms to engage and reach consumers with Smarter Food Safety communications.

Within Element’s network of food testing labs, food safety is paramount. Ensuring the highest standard of food safety is at the core of our service offerings and approach. Our comprehensive suite of service offerings promote and strengthen food safety throughout the food supply chain, from routine testing to inspection and consulting services.

How the Right Food Testing Lab Can Help You Achieve Smarter Food Safety

By partnering with an independent laboratory with extensive expertise in food safety testing and deep regulatory knowledge, you can enhance your food safety programs and initiatives, implementing a preventative approach to foodborne illness, rather than a reactive one. With Element’s acquisition of Avomeen in 2021 and Analytical Lab Group (ALG) in 2020, Element has combined complementary capabilities to offer an even wider array of services and value to stakeholders along the food supply chain, with an unwavering commitment to scientific excellence and quality, as well as exceptional client service and partnership.

Element’s broad network of food labs offer a comprehensive suite of food testing and consulting services, including food chemistry and microbiology testingnutrition label and shelf life studiesfood contact testing and submissions, and a wide of supply chain consulting support services.

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Andrew Kolbert, Ph.D., M.T.M.

Avomeen’s President & Chief Technical Officer has 20 years of experience executing and managing analytical and product development programs, both internally and in external organizations. Clients regularly benefit from his expertise in analytical chemistry and product development, particularly in highly regulated areas, including pharmaceutical development and testing, food contact migration studies, extractables and leachables studies, food additive and food contact notification testing and registration, and pesticide and insecticide testing under FIFRA. With his sound perspective, Andrew has been sought out as an expert witness for industry litigation cases and has participated in FDA pre-notification conferences, FDA site audits and trained FDA inspectors on analytical technology.

James Black

James Black joined Element in June 2021 as the Technical Director of Food Microbiology. Element’s customers benefit greatly from James’ expertise in food microbiology, food safety, food plant sanitation, food plant environmental testing, HACCP, FSMA, product shelf-life testing, challenge study design, sanitary design of food processing equipment, and process validation. James holds a B.S. in Biology from Mount Vernon Nazarene University. Throughout his career, James has worked within the food, cosmetics and pharmaceutical industries, and has over nine years’ experience in third-party microbiological testing.

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