Develop an action plan that can be implemented by federal agencies (FDA, USDA-FSIS, CDC), state and local regulators, the food industry, consumer advocacy organizations, and public health organizations to improve recall execution and consumer communications to protect public health.
RESEARCHING RECALL COMMUNICATIONS
examining consumer and industry responses to develop recall notification language which is clear and actionable.
FACILITATING OPPORTUNITIES FOR FEEDBACK AND COLLABORATION
between STOP constituents, industry partners, and policy makers to address federal recall language and systematic modernization.
LAUNCHING A ROOT CAUSE DATABASE
to share learnings across the industry and help companies prepare for and prevent potential issues.
PUBLISHING COMMENTARY FROM THOUGHT LEADERS
including a white paper outlining issues and next steps for recall modernization.
To learn more about policy-related initiatives of Stop Foodborne Illness, visit our Policy Work page.
The Team
Rutgers University
William K. Hallman, PhD
Kathering Ognyanova, PhD
Stop Foodborne Illness
Thanks to the generous support of the Association of Food and Drug Officials (AFDO) and an anonymous donor, we have raised 13% of our total funding goal.
We are actively seeking additional supporters for this work. If you or your organization would like to contribute, contact Vanessa Coffman today.
Project Goal and Summary
Our goal is to create templates for communicating essential information to consumers about recalls, market withdrawals, and public health alerts that work in the current communications environment.
Research will occur in three phases. Phase One will be a needs assessment including key-informant interviews, focus groups, and surveys with stakeholders. Phase Two will be the development of new written templates based on the learnings from Phase One and feedback from FDA/USDA, journalists, and consumer organizations. Finally, Phase Three will be the testing of the new templates across multiple media outlets, including press releases, Facebook, and Google.
Project Objectives
We will create templates written in “plain language” that are harmonized across the FDA and USDA, meeting any specific agency requirements, which can be tailored to incidents involving pathogens, allergens, chemical contamination, or foreign objects. Templates are needed that are appropriate for initial recalls and that are appropriate for a “rolling recall,” involving additional products over time.
These templates must meet the needs of consumers to receive timely notifications of recalls, easily recognize that they may have purchased, consumed, or own an affected product, and have ready access to key information necessary to identify affected products and to distinguish these from products that are not affected. The recall communications must also help consumers understand what to do if they find an affected product, have consumed an affected product, believe they have been made ill by an affected product, or are seeking additional information.
The information captured in the templates must be easily distributed through press releases, social media platforms, RSS feeds, emails, text messages, point-of-sale terminals, robocalls, local radio, and short videos. To do this, the templates must be structured to facilitate easy extraction of key information (e.g., data, metadata, formatted photos) by responsible third-party amplifiers of recall notifications (i.e., media, producers, distributers, and retailers, consumer organizations, and non-profit food distribution entities such as food banks and emergency feeding programs).
Finally, the templates should be readily translated into multiple languages, beginning with Spanish, but also other languages spoken by large populations of Americans.
The Alliance convenes a working group dedicated to recall modernization at a regular cadence. The group includes industry members and partners, current and former regulators from state and federal agencies, STOP constituents, and public relations experts. In addition to these meetings, the working group has met with a team from USDA-FSIS and meets regularly with a team at FDA to facilitate discussion and collaborative efforts towards improving recall systems.
The FDA is opening the regulations on recalls. On September 29, 2023, the FDA will host a hybrid public meeting: “Modernizing Food and Drug Administration Recalls Listening Session.” Find additional details at the FDA website.
The Alliance has engaged several STOP constituents to tell their stories in person at this session. By sharing their life-altering experiences with foodborne illness, due in many cases to products later recalled, they hope to drive meaningful change as FDA updates the recall regulations.
Develop and launch an online, interactive, sustainable, and externally funded system that can compile and visually communicate these data for large and small firms.
There is no single place where firms can deposit or see root cause data trends across industry. This leads to the same mistakes and problems happening repeatedly throughout the food system and no decrease in the number of recalls. Collecting data in this manner would indicate where mitigation strategies can be identified and deployed and could help identify research gaps to be filled.
This database will collect and visualize industry data regarding food safety contamination events that result in recalls (Class I, II, or III) for collective learning, identification of mitigation strategies to prevent reoccurrence, and ultimately, a reduction human illness and injury.
The database will be anonymous, private sector to private sector to allow for collective approaches to reducing recall incidents, tacking the issues industry-wide instead of company by company.
On August 20, 2020, the Alliance to Stop Foodborne Illness convened a group of food safety experts (working group) to outline how food recall processes in the United States can be improved. This working group recognized that there is a need for fundamental change in food recall processes to protect consumers from harmful products and decrease the burden of foodborne illness. With as many as 500 food recalls a year impacting suppliers, retailers, food service, and consumers, the working group recommends a strategic approach to modernize the entire recall system and enhance its overall effectiveness for the consumer.
The working group benchmarked the current system and defined an effective product recall as an item rapidly identified, traced, and removed from the supply chain, commerce by downstream businesses and organizations, and ultimately, communicated to consumers. Currently, there is not a singular federal or state agency, stakeholder, or node in the food chain that controls these processes. This has been identified as a major problem, as the current recall processes of the U.S. evolved due to a patchwork of approaches based on learnings from previous recall events.
Recalls are preventable. Although industry has become more proactive and there have been advances in technology and techniques to identify issues that require a product recall, the number of annual recalls has not decreased. The working group’s philosophy is to have an action-focused plan for modernizing the U.S. food recall system; specifically, to not rely on consumers’ vigilance.
To realize significant improvements for recall effectiveness, they must be timely, coordinated, technology must be deployed appropriately, and outcomes must be consumer focused. Providing language that consumers understand and measuring whether they take appropriate action responding to recalls is essential.
The working group is focused on taking evidence-based action to identify and assess the current U.S. recall system. The existing structure depends on the consumers’ internal motivation to monitor recalled products. This deems the recall system as dysfunctional due to its reliance on consumers’ diligence to determine whether a product has been recalled.
We identified research gaps needing to be filled and evaluated the current system. This work is critical to create the political will to improve the broken aspects in the recall structure. This applied research may be used to develop better metrics and mechanisms for measuring success. There is potential to specifically create an educational framework to support the food systems and identify who is best suited to conduct this research.
These challenges, gaps, and issues need to be addressed to achieve real modernization of the recall system. This group sees the opportunity to work collaboratively with industry partners, consumer advocacy organizations, federal agencies (CDC, USDA-FSIS, FDA) and state and local regulators to attain this goal. The group is particularly interested in working jointly to meet the needs of consumers to identify effective methods of communication to limit the consumption of recalled foods.
Communication
Recall Execution
The major research gap is understanding how the consumer is receiving and reacting to information about food recalls. The following research must be conducted:
Consumer Motivations
Consumer Data Privacy and Trust
Additional Opportunities to Explore
Consumer Messaging
Consumer Tools, Technology, and Response
The release of the U.S. Food and Drug Administration’s (FDA) New Era for Smarter Food Safety catalyzed discussions among the working group.
In this blueprint, the FDA has stated the way the Agency addresses recalls should be modernized.
The working group recognizes that Core Element 2.6: Recall Modernization calls for the Food Safety and Inspection Service (FSIS) and FDA to harmonize communications of recall information and develop guidance documents on notification processes for consumers.
The following opportunity areas directly align and support multiple topics identified in FDA New Era for Smarter Food Safety- FDA’s Blueprint for the Future listed according to the Blueprint Core Element.
Element 1.1 Develop Foundational Components related to Tech Enabled Traceability
Element 1.3 Leveraging the Digital Transformation
Element 2.3 Domestic Mutual Reliance
Element 2.6 Recall Modernization
The blueprint encouraged the use of register lockdowns. This is a widely used practice at the point of sale. The action blocks sale of any product sharing the same SKU. Lot specific blocking is not currently supported. This is often one of the first steps in recall execution and happens within minutes to hours of recall notification from suppliers. FDA and FSIS should work with the food industry and support commonly adopted practices.
Additionally, there are opportunity areas that fall outside the scope or are not directly addressed in the New Era for Smarter Food Safety- FDA’s Blueprint for the Future.
The following are the top three topics for action accompanied by proposed plans to support the New Era Blueprint.
I. Conduct an evaluation of recall effectiveness (including consumer actions) across federal agencies. Standardize recall coordination and execution across federal agencies.
FDA should lead an effort to gather data specific to recall effectiveness beginning at firm decision-making through consumer actions. FDA and FSIS should develop an interagency team to discuss best practices and align on recall policies and procedures. FDA to provide leadership in developing consistency in recall management, policies, and communications across FDA, FSIS and state and local regulators. The agencies currently use different models (decentralized and centralized) and there are valuable parts of each that can be shared and implemented. Consistent policies are needed for timely recall classifications that apply across jurisdictions. This applies to recall identification and initiation as well as communications.
Who: FDA and FSIS co-lead this initiative related with significant stakeholder input.
Timeline: Evaluation begins immediately . Interagency recall modernization team begins immediately.
II. Support technology application in recall execution, management, and communications with a specific focus on SME.
FDA should continue the New Era-supported focus on collaborating on implementing new technologies to support the timely identification, tracking and tracing of food to support recall systems. FDA should be focused on helping SMEs to implement low-cost technologies and support programs that lead to education, toolkits and practical application of technology in the food systems. Integration of systems is needed for the RFR and the division recall coordinators. Toolkits for food businesses of various sizes to be created, shared and implemented.
Who: FDA leads this initiative related to the blueprint with significant stakeholder input from industry partners and service providers.
Timeline: FDA has already begun this work with the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-enabled Traceability Challenge, continue through 2022.
III. Develop and implement a risk communication strategy for regulator and industry partners. Drive programs resulting in timely, accessible, and effective information to protect consumers.
Sometimes these are simple actions (changes in language used in recall notices) and some will require more complex development (policy changes across agencies and guidance to the food industry).
Who: A regulatory coalition, FDA/FSIS and outside experts in risk communication
Timeline: Evaluation of evidence-based risk communications should begin immediately with an ORISE Fellow and consumer research.
Collaboration Tools
Working groups or task forces should be established to collaborate among agencies, industry and public health organizations through meetings, forums, webinars, and research/surveys. Ideas include initiating a special project with a focus on evaluation, implementation, communication, and continuous improvement to implement changes in recall initiation and management.
Next Steps
Summary
The working group of the Alliance to STOP Foodborne Illness with external stakeholders recognizes that FDA’s New Era for Smarter Food Safety, Core Element 2.6: Recall Modernization calls for harmonization in communications of recall information to consumers for both FSIS and FDA. This document provides guidance on future research and priorities to achieve this goal and aligns with the blueprint.
Stop Foodborne Illness is a 501(c)(3) tax-exempt organization. Donations are tax-deductible to the extent the law allows.
