Search results for: blueprint

  • On July 13, the FDA announced its New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint represents achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. The Blueprint builds on the work that FDA has already implemented through FSMA and also outlines a partnership between government, industry, and public health advocates to create a modern approach to food safety.
  • The Blueprint is centered around four core elements:
    • Tech-enabled Traceability – FDA wants to utilize new technologies and integrate data streams to identify outbreaks and trace the origin of contaminated food to its source in minutes.
    • Smarter Tools and Approaches for Prevention and Outbreak Response – The Blueprint includes plans to strengthen the FDA’s procedures and protocols for conducting root cause analyses that can identify how a food became contaminated and figure out how to help prevent contamination from happening again. The need for greater traceability and predictive analytics is seen in the Agency’s most recent efforts to improve the safety of romaine and other leafy greens.
    • New Business Models and Retail Modernization – FDA is also examining new business models for the production and delivery of food, while ensuring that those foods continue to be safe for consumers. New business models include novel ways of producing foods and ingredients, such as cell-cultured food products. FDA is also committed to exploring new approaches of food safety that go beyond traditional training and inspection for retail establishments and restaurants.
    • Food Safety Culture – The Blueprint also focuses on fostering the growth of and strengthening the food safety culture on farms and in food facilities all over the world. For instance, in order to make dramatic reductions in foodborne disease, the Agency believes they must do more to influence and change human behavior, as well as to address how employees think about food safety and educating consumers.
  • FDA originally intended to publish the Blueprint in March, but was forced to postpone and turn attention to addressing the public health emergency posed by the COVID-19 pandemic. However, as explained by the FDA, the pandemic has made it even more clear that the actions outlined in the Blueprint are essential to protect and promote food safety.
  • James Jones, the newly appointed Deputy Commissioner for Human Foods, released a statement on October 19 outlining his commitment to Commissioner Robert Califf’s framework for the proposed Human Foods Program (HFP). Jones said that he is “committed to upholding and executing this framework guided by the principle of protecting and promoting the health and wellness of all U.S. consumers.” The framework contains three priority areas: preventing foodborne illness, decreasing diet-related chronic disease, and safeguarding the food supply.
  • Under the foodborne illness prevention prong of the framework, FDA is proposing to set up an Office of Critical Foods, which will regulate infant formula and medical foods. This office is intended to work with industry to avoid recalls and shutdowns, particularly in infant formula manufacturing. The HFP will also use FDA’s New Era of Smarter Food Safety blueprint to further progress to regulate the food supply under the Food Safety Modernization Act.
  • To aid in decreasing diet-related chronic diseases, the HFP will prioritize reducing sodium in food, creating more accessible food labels, promoting healthy habits, and supporting innovation. On November 16, the Agency is co-hosting a public meeting with the Reagan-Udall foundation to hear input on front-of-package labeling and from November 6-8 will hold virtual public meeting and listening sessions regarding strategies to reduce added sugar consumption.
  • The HFP will also work to safeguard the food supply by reducing exposure to contaminants and other harmful chemicals in foods. FDA is working on a proposed rule regarding Brominated Vegetable Oil in food, as well as continuing its work on the Closer to Zero initiative, which we have covered previously, to reduce exposure to heavy metals in foods for babies and young children.
  • Keller and Heckman will continue to follow and report on the HFP.
  • On August 31, FDA announced its 8th webinar in its ongoing series “Collaborating on Culture in the New Era of Smarter Food Safety” which explores food safety culture in partnership with the non-profit public health organization Stop Foodborne Illness. The upcoming webinar “Facing Food Safety Challenges through Culture and Persistence” will focus on the importance of a strong food safety culture and how it can help organizations address food safety challenges they may face. Guest speakers include representatives from the food industry and Conrad Choiniere, Director of the Office of Analytics and Outreach at the Center for Food Safety and Applied Nutrition, FDA.
  • FDA’s webinar series brings together experts from both the public and private sectors to exchange ideas and experiences regarding the importance of cultivating a robust food safety culture, ultimately contributing to safer food production. According to the FDA, food safety culture stands as a cornerstone in the FDA’s New Era of Smarter Food Safety blueprint which states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs, attitudes, and the behaviors of people and the actions of organizations.
  • The webinar will take place on September 13, 2023, from 12 noon to 1:00 pm EST. Registration is available through the FDA website here.
  • Keller and Heckman will continue to report on FDA activities impacting food safety.
  • On December 12, the FDA published a systematic review of the scientific literature on food safety culture (FSC) as part of the Agency’s New Era of Smarter Food Safety blueprint. As our readers know, the FDA launched the blueprint in July 2020 as a means to outline the Agency’s plan to create a safer food system over the next decade. The FDA commissioned the systematic literature review to produce a synthesis of the published literature to answer three overarching questions:
    1. What is FSC?
    2. How is FSC developed and maintained?
    3. How is FSC assessed?
  • As discussed in the literature review, while FSC is defined in various ways, the most frequently cited definition defined FSC as “the aggregation of the prevailing, relatively constant, learned, shared attitudes, values and beliefs contributing to the hygiene behaviors used within a particular food handling environment (Griffith, Livesey, and Clayton 2010).”
  • The literature review identifies key determinants that contribute to a FSC, such as leadership and communication, and also describes some best practices to promote FSC, including promoting FSC as a necessary and critical business matter for all employees. However, the authors found that there is a gap in the literature about what a strong and effective FSC would look like among general consumers and about how FSC is defined in a regulatory agency. Similarly, the literature does not take into account employees’ diverse political, familial, racial, and other cultural identities or how these identities may influence FSC.
  • The FDA intends to use this research to inform its continued efforts in support of food safety culture and as a means to implement effective food safety management.
  • On November 15, FDA announced a finalized rule to more effectively trace contaminated food through the food supply sourced both domestically and internationally. Foodborne illness affects millions of Americans each year. FDA’s action progresses its commitment to better protect the public by ensuring a safe and wholesome food supply through enhanced recordkeeping requirements which will allow for fast identification and removal of contaminated food from the US market.
  • The final rule, entitled “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types.
  • Working closely with industry, FDA will be able to more effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.
  • “This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” shared Frank Yiannas, FDA’s duty commissioner for food policy and response.
  • The traceability recordkeeping requirements purport to create a universal and harmonized approach to tracing certain foods included on the Food Traceability List (FTL). In determining what foods to include on the FTL, FDA has developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act. Examples of identified food categories include, but are not limited to, fresh leafy greens, melons, peppers, nut butters, fresh fruits, and crustaceans.
  • The final rule, which will go into effect on November 21, 2022, includes the following key features:
    • Tracking specific points in the supply chain – such as the harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods;
    • Instituting traceability plans that contain information essential to help regulators understand an entity’s traceability program, including a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise a FTL product;
    • Requiring industry to maintain records as original paper or electronic records, or true copies, provide requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed), and offer records in an electronic spreadsheet when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
  • Keller and Heckman will continue to provide updates on this final rule and its applications to the food industry
  •  FDA launched the New Era of Smarter Food Safety in 2019 to combine the implementation of the FDA Food Safety Modernization Act (FSMA) with the use of new and emerging technologies.  As discussed here, FDA’s blueprint for the New Era of Smarter Food Safety initiative is centered on four core elements: (1) Tech-enabled Traceability, (2) Smarter Tools and Approaches for Prevention and Outbreak Response, (3) New Business Models and Retail Modernization, and (4) Food Safety Culture.
  • In a January 27, 2022 Constituent Update, FDA announced the second webinar in a series, “Collaborating on Culture in the New Era of Smarter Food Safety,” which began in November 4, 2021 and features experts from the public and private sector discussing the value of fostering, supporting, and strengthening food safety cultures to help ensure the safe production of food, and the role of science-based metrics in assessing their effectiveness.  The quarterly webinar series is sponsored by FDA and the nonprofit, Stop Foodborne Illness.  The second webinar, “Making Leaders Risk Aware and Push to Reduce Risk,” will take place on February 16, 2022 from 12:30 to 1:15 p.m. ET and will feature Nancy Wilson, Director of Quality Assurance, Risk Management and Safety at Wawa, and Randall Huffman, Chief Food Safety and Sustainability Officer at Maple Leaf Foods.
  • FDA recommends the series for both those well-versed on, and those just learning about, food safety culture.  Participants must register for the second webinar and may listen to a recording of the first webinar.  Keller and Heckman will continue to monitor and report on developments related to the New Era of Smarter Food Safety.
  • FDA announced it plans to host a three-day virtual event on October 19–21 , 2021. The agency seeks to discuss and exchange perspectives with industry stakeholders and interested parties about the safety of human and animal foods ordered online and delivered directly to consumers.
  • The agency has expressed interest in past updates about the role of e-commerce in food and how foods produced, manufactured, sold, and delivered to consumers without involving traditional supply chains and brick and mortar stores may fit into current regulatory frameworks and present new challenges for tracking food products. Considerations for e-commerce operations will be key components of FDA’s New Era of Smarter Food Safety initiative to modernize the agency’s approach to food traceability and improving responses to foodborne illness.
  • More information on registration and event times will be available on FDA’s website and in the Federal Register. All of FDA’s upcoming public meetings, conferences, and workshops are listed here. Information on past events is available here.
  • Last year we reported on FDA’s New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint focused on tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and promotion of food safety culture.
  • On June 1, the FDA launched a public challenge in tangent with the New Era of Smarter Food Safety initiative to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods.  The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge aims to develop scalable traceability hardware, software, or data analytics platforms that are low- or no-cost to the end user, while promoting innovation.  Entries will be evaluated on the following criteria:
    • Ability to address the needs of the targeted segment of the food supply chain.
    • Uniqueness and innovativeness of the technology developed.
    • Likelihood of utilization and ease of navigation.
    • Affordability to enable inclusive and viable traceability approaches.
    • Scalability and interoperability for the solution to be used by a majority of the targeted segment of the food supply chain.
  • FDA’s Office of Food Policy and Response is overseeing the public challenge, which runs from June 1, 2021 to July 30, 2021.  Up to 12 entrants will be announced as challenge winners, with their respective video submissions posted to FDA’s website and shared at an FDA webinar.  Entrants are not required to transfer any intellectual property rights to FDA nor provide an open source code.
  • On November 18, 2020, FDA released the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table, a tool to publish early information on all foodborne outbreaks that the FDA is investigating.  While FDA issues public health advisories or recalls for any outbreak that results in specific, actionable steps for consumers to protect themselves against an unsafe food or product, this new table allows FDA to share information at the earliest phases of an investigation, before actionable steps have been identified.
  • In the press release announcing the table, FDA emphasized that releasing early information about investigations in their beginning stages does not mean FDA will announce early actions for consumers to take.  Rather, the table furthers FDA’s goal of improving transparency in outbreak investigations and complements its New Era of Smarter Food Safety initiative and implementation of the FDA Food Safety Modernization Act (FSMA).  The investigation table will be rolled out as a six-month pilot after which FDA may adjust the table per stakeholder feedback.
  • The table lists the outbreak investigation’s FDA Reference Number, the pathogen involved, the products linked to the outbreak, case count, investigation and outbreak status, and whether any additional steps have been initiated, including recall, traceback, on-site inspection, and sample collection and analysis.  The table is updated weekly with data from both the Center for Disease Control (CDC) and FDA’s CORE Response Teams and tracks outbreaks from beginning to end.  Upon its release, and as of the date of this post, the table listed seven ongoing investigations at various stages of development, including three recently announced investigations into ongoing E. coli O157:H7 outbreaks.  Keller and Heckman will continue to monitor and report on developments in foodborne illness outbreaks.
  • On October 26, 2020, the FDA held a webinar in which it discussed its progress in implementing the blueprint for the New Era of Smarter Food Safety and its vision for the path forward. The webinar focused on the four Core Elements of the blueprint with leaders of the teams assigned to each Core Element addressing their respective contributions and visions. Additionally, Frank Yiannas, the Deputy Commissioner for Food Policy and Response at the FDA, delivered the opening and closing remarks in which he discussed the need to build upon the Food Safety Modernization Act (FSMA) and leverage new technologies to improve food safety and adapt to changes in the industry. He stressed that while the FDA was leading the charge, it was a collaborative effort that could not be done without the assistance of a wide variety of stakeholders, and that the FDA was committed to transparency throughout the process.
  • Kari Irvin, Deputy Director of the Office of Coordinated Outbreak Response and Evaluation, in the Center for Food Safety and Applied Nutrition (CFSAN) addressing Core Element 1: Tech Traceability, discussed the importance of creating a foundational language in this space. She stated that the Proposed Rule for Food Traceability is an effort to establish the common language and encouraged all stakeholders to comment on the proposed rule and participate in the coming public meetings on the proposed rule. Comments on this proposed rule are due on January 21, 2021.  She further stated that the FDA is not looking at any single technology and stated that one goal of creating a common language is to allow multiple systems to operate together.
  • Mark Moorman, Director of the Office of Food Safety, CFSAN, addressing Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response, emphasized the importance of information sharing, both within industry and government, in order to learn from adverse effects. In particular, he discussed the importance of data analysis to predict future outbreaks, the need to conduct root cause analysis of outbreaks, and the importance of clear communication to consumers.
  • Andreas Keller, director, Multi-Commodity Foods, Office of Food Safety, CFSAN, addressing Core Element 3: New Business Models and Retail Modernization, discussed the FDA’s efforts to evaluate the effectiveness of retail food regulatory programs, encourage the development and implementation of new systems and technologies to promote food safety, and study the impact of changing consumer behaviors, especially in light of the COVID-19 pandemic.
  • Conrad Choiniere, Director, Office of Analytics and Outreach, CFSAN, addressing Core Element 4: Food Safety Culture, stated that the blueprint seeks to develop a food safety culture within the FDA and among industry and consumers. Furthermore, he stated that the FDA’s role is not to mandate a predetermined food safety culture, but rather to study the issues and provide advice so that industry, and other stakeholders, can each develop their own unique food safety culture tailored their particular needs. He also noted that the Global Food Safety Initiative (GSFI) food culture safety standard is among the sources of information that the FDA was considering in developing its approach.
  • Keller and Heckman will continue to monitor and report on developments related to the New Era of Smarter Food Safety.