• 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.
  • 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.

 

  • FDA’s regulations implementing the FDA Food Safety Modernization Act (FSMA) requirements for Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), and Foreign Supplier Verification Programs (FSVP) permit the use of third-party audits as supplier verification activities.  Additionally, FDA’s July 13, 2020 New Era of Smarter Food Safety Blueprint (discussed on our blog) indicates that to the extent third-party audit data are reliable and align with FDA’s regulatory food safety standards, FDA may use such data in risk-prioritization for FDA regulatory activities, such as inspections of both imported and domestically produced foods.  In this regard, FDA has developed templates that may help determine how well third-party audit standards align with the requirements under the PCHF, PCAF, and FSVP rules.
  • On October 26, 2020, FDA published notice and invited requests for participation from owners of third-party human food safety standards and others interested in participating in a voluntary pilot program for assessing third-party food safety standards for alignment with FDA’s PCHF and/or FSVP rules.  Under the pilot program, FDA plans to select and assess up to five third-party food safety standards.  FDA will evaluate:
    • The resources required to review and assess third-party standards for alignment with the PCHF and FSVP;
    • The ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment; and
    • Whether the audit standard comparison templates that FDA developed are helpful in making alignment determinations.
  • The pilot program will run through October 26, 2021 or longer, as needed.  Applications to participate are due by November 25, 2020.  FDA will publish information on its website regarding the third-party standards that FDA determines to be in alignment with FDA regulations.
  • The FDA and two Mexican regulatory agencies, the National Service of Agro-Alimentary Public Health Safety and Quality (SENASICA) and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), have signed a statement of intent (SOI) that strengthens and expands upon their 2014 Produce SOI.
  • The most recent SOI broadens the scope of the partnership to cover all foods that are traded between the U.S. and Mexico. Furthermore, it encourages the development and use of new technologies to prevent and respond to foodborne illness outbreaks and also encourages collaboration with other governmental agencies and non-governmental entities including industry, consumer groups, and academia.
  • This partnership, including its emphasis on the development new technologies, is an important step in furthering the goals laid out this past summer by the FDA in their New Era of Smarter Food Safety Blueprint. And, it is an impactful one for U.S. consumers, as approximately one third of all food and sixty percent of produce in the U.S. is imported from Mexico. Keller and Heckman will continue to monitor and report on food safety issues.
  • In the United States between 2009 and 2018, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) identified 40 outbreaks of food-borne illness with a confirmed or suspected link to leafy greens and Shiga toxin-producing E. coli (STEC).  Although agricultural water is one of the main vehicles through which leafy greens and other produce can become contaminated with E. coli O157:H7 and other foodborne pathogens, there are no antimicrobial treatment products registered with the Environmental Protection Agency (EPA) for use in agricultural water sources.
  • On July 30, 2020, FDA announced the release of a new testing protocol, formed in partnership with EPA, to facilitate companies’ efforts to develop and register antimicrobial products designed to treat preharvest agricultural water.  The protocol was first revealed during an FDA Center for Food Safety and Applied Nutrition webinar on its 2020 Leafy Greens STEC Action Plan, and was introduced as a way to address the identified need to further protect agricultural water sources from pathogen contamination.  The new protocol establishes an agricultural water panel assay that companies can use to test the capability of their water treatment products to combat strains of Listeria, Salmonella, and E. coli frequently responsible for foodborne illnesses.  EPA’s endorsement of this protocol enables companies that follow its steps to use the testing data generated to support an application for registration of new products or to revise the labels of existing products as being for use against microbial contamination in preharvest agricultural water.
  • FDA cites the new EPA-approved protocol for evaluating the efficacy of antimicrobial pesticides in agricultural water as an important prevention step towards food safety, taken as part of its Leafy Greens STEC Action Plan and New Era of Smarter Food Safety Initiative (which includes a 10-year blueprint released on July 13, 2020, as discussed here).
  • Last year we reported on FDA’s announcement on the “New Era of Smarter Food Safety”, an effort intended to combine the implementation of Food Safety Modernization Act (FSMA) with new and emerging technologies. The effort was set to begin with the development of the “Blueprint for a New Era of Smarter Food Safety.”
  • On June 2, 2020, FDA released an update on the effort titled “Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety,” in which they announced that—due to the COVID-19 pandemic—plans to announce the Safety Blueprint had been delayed.
  • FDA announced that it will release the blueprint in the coming weeks that will outline its plan to create a safer food system over the next decade.  In light of lessons learned during the pandemic, FDA has revised and accelerated measures in the blueprint, including enhanced traceability, smarter tools for protecting food ordered online, and promotion of a food safety culture, as described below:
    • Food Traceability – FDA has noted that enhanced traceability could help FDA and the food industry anticipate marketplace imbalances, such as those that resulted in shortages of certain commodities during the pandemic.
    • Smarter Tools for Foods Ordered Online – Online food ordering and delivery have skyrocketed in recent months due to COVID-19 and are likely to continue in popularity; the blueprint will discuss tools like root cause analyses to understand how foods were contaminated and use data to anticipate the likelihood of contamination.
    • Food Safety Culture – the plan addresses the establishment and support of food safety cultures on farms, food facilities, and at home—primarily through education initiatives.

 

  • Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response, answered questions regarding the current state of the U.S. food supply in a conversation published here. While acknowledging the new challenges faced by the industry during the COVID-19 pandemic, he reassured consumers that the U.S. food supply remained safe and robust.
  • Mr. Yiannis stated that shortages consumers are facing are a result of increased demand rather than a decrease in supply. He assured consumers that there was “plenty of food,” that despite some food facility closures, U.S. food production and manufacturing are widely dispersed, and that the primary challenge was diverting food to the retail market. He noted the FDA’s efforts to redirect food to the retail market including: (1) affording industry temporary labelling flexibility (blogged about here and here), (2) temporarily modifying shell egg regulation (blogged about here), and (3) providing guidance for safely distributing unused human food for use in animal food (blogged about here).
  • Mr. Yiannis also reminded consumers that there was still no evidence that food or food packaging had resulted in the transmission of COVID-19. Further, while most domestic and foreign in-person inspections have been halted (blogged about here and here), he assured consumers that the FDA was still ensuring that food was safe, including through remote inspections under the Foreign Supplier Verification Program (blogged about here) and monitoring of potential outbreaks of food-born illness.
  • Finally, while the pandemic has delayed the FDA’s plans to release a “New Era of Smarter Food Safety” blueprint in March, the FDA will continue to work toward the blueprint’s release. Indeed, the value of the blueprint’s goals —including to establish a more digital and traceable food system—will be of paramount importance in the post-pandemic world.  Keller and Heckman will continue to monitor and report on the impact of the pandemic on the food industry.
  • FDA will hold a public meeting on October 21, 2019 to hear from a broad cross-section of stakeholders on their new food safety approach, called “A New Era of Smarter Food Safety.” The new approach is intended to combine the implementation of FSMA with the use of new and emerging technologies, like blockchain, sensor technology, the Internet of Things, and artificial intelligence.  FDA is working towards enhancing its ongoing efforts to implement FSMA by creating a more digital, traceable, and safer system to help protect consumers from contaminated food.
  • At the meeting, the public will have a chance to discuss and comment on FDA’s new approach to food safety and the input received both at the meeting and in comments submitted to the accompanying Federal Register docket will help shape the FDA Blueprint for a New Era of Smarter Food Safety. As our readers may remember, the Blueprint will outline how FDA plans to address several areas of food safety, including traceability, digital technologies, and evolving food business models. FDA intends for the strategic plan to outline how this new approach will address public health challenges, including being able to trace sources of contaminated foods and using new predictive analytics tools to assess risks and prioritize the agency’s work and resources.
  • Persons interested in attending the public meeting either in-person or by webcast must register online by October 11, 2019. The deadline to submit written/electronic comments is November 20, 2019. Keller and Heckman attorneys are well-versed in FSMA and food safety requirements and stand ready to assist interested parities in preparing comments for submission to FDA.
  • On April 30, 2019, Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas announced a “New Era of Smarter Food Safety,” an effort intended to combine the implementation of FSMA with the use of new and emerging technologies. This new approach will start with the development of a “Blueprint for a New Era of Smarter Food Safety,” which will address several areas of food safety, including traceability, digital technologies, and evolving food business models.
    • Food Traceability – According to FDA, food safety is a “never-ending race to detect and respond to problems, while continually assessing better ways to prevent them.” Currently, many in the food system utilize paper-based traceability systems. FDA’s new era of smarter food safety will explore and evaluate new technologies that may upgrade our abilities to rapidly track and trace food through the supply chain. FDA intends for this work to support and align with other trace and track agency efforts, such as the pilot programs focused on tracking the movement of medicines throughout the supply chain.
    • Digital Technologies – FDA intends to also look at how to leverage emerging technologies that are currently being used in other business sectors, such as distributed ledgers, sensors, the Internet of Things, and artificial intelligence. For example, FDA plans to conduct a new pilot that will leverage artificial intelligence and machine learning to explore new ways to enhance the agency’s review of imported foods at ports of entry.
    • Evolving Food Business Models – With the rise of e-commerce food business models, FDA intends to explore areas for collaboration in this space in order to identify the appropriate standard when it comes to food safety challenges and regulatory oversight.
  • The FDA announcement emphasized the importance of collaboration between the private and public sectors to ensure food safety. FDA intends to hold a public meeting later this year to discuss smarter food safety efforts and to seek stakeholder input on FDA’s overall strategy and initiatives. We will continue to monitor and report on any updates regarding the “New Era of Smarter Food Safety.”
  • On July 31, 2018, FDA announced that it was working on a five-year blueprint to combat antimicrobial resistance in animals.  On September 14, 2018, FDA published Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023.
  • FDA provides action items to promote three goals; we summarize several major steps for each;
  • Align Antimicrobial Drug Product Use with the Principles of Antimicrobial Stewardship
    • Update list of medically important antimicrobial drugs administered in the feed or water of food producing animals;
    • Issue draft strategies to ensure that all medically important antimicrobial drugs have appropriate durations of use when used in food or feed and all medically important antimicrobial drugs are under the supervision of a licensed veterinarian;
    • Engage stakeholders on improvement of labeling to support antimicrobial stewardship;
    • Obtain public input on antimicrobial use practices in companion animals, ensure that all dosage forms are used under the oversight of a licensed veterinarian, and develop and implement a strategy for promoting antimicrobial stewardship in companion animals; and
    • Collaborate with stakeholders to identify ways to encourage development of antimicrobial alternatives.
  • Foster Antimicrobial Stewardship in Veterinary Settings
    • In consultation with USDA, work with stakeholders to identify ways to develop, update, and disseminate information on antimicrobial stewardship and assist academic and federal partners to develop educational materials that address antimicrobial stewardship;
    • Increase access to antimicrobial label information; and
    • Develop position to promote international antimicrobial stewardship and provide technical assistance to developing countries.
  • Enhance Monitoring of Antimicrobial Resistance and Antimicrobial Drug Use in Animals
    • Continue collecting data on on-farm antimicrobial use in U.S. animal agriculture in poultry, swine, and cattle first funded in 2016;
    • Expand antimicrobial resistance screening for additional bacteria species and to characterize resistance in bacteria;
    • Expand information technology systems to promote coordination;
    • Expand surveillance to retail meat sampling; and
    • Characterize and include genomic information in reports.
  • Please contact Keller and Heckman at fooddrug@khlaw.com for assistance preparing comments on the goals document or in engaging in FDA’s policy development.