As of April 21, there have been 67 FDA-posted food or beverage recalls since the start of the year. However, the issuance of a recall does not, in and of itself, stop consumers from becoming ill from the implicated food. The Association of Food and Drug Officials (AFDO) sees the primary reasons for that as being that consumers continue to consume products even after their recall is announced because recalls and related communication are typically issued too late to prevent additional illnesses.
Providing solutions for the causes of this was the main driver behind AFDO’s recently issued white paper: Recall Modernization: Accelerated Partnering for Effective Recalls. The paper – the result of a three-year, ongoing AFDO recall modernization project review of data and information – provides recommendations for regulatory bodies and industry “related to not only recall policy, but foundational practices that are integral to working with others to carry out quick and effective recalls.” The report highlights key areas of improvement as being the establishment of a clear, common purpose in the implementation of recalls for both FDA and its state, local, tribal, and territorial (SLTT) partners; communication and coordination between partners; and training at all levels – both regulatory and industry.
With a key pain point discussed by industry and states being the delay or misclassification of recalls, AFDO attributes this as due, in part, to the scattered recall roles and responsibilities across FDA offices, which can delay a recall. Although FDA’s response to a 2017 OIG report included a reorganization of the recall system at FDA, further steps need to be taken. Thus AFDO’s report recommends that clear expectations and roles/responsibilities with partners be established with unrestricted information sharing to limit duplication and maximize speed.
The report also cites recommendations from a STOP Foodborne Illness working group engaged by FDA to focus on recall process improvement. Citing the current recall processes as “a patchwork of approaches,” the working group recommended a strategic approach to modernize the entire recall system to enhance its effectiveness to “quicker, more coordinated, better utilize technology, and ensure consumers better understand and act in response to recall communications by disposing of or returning recalled products.”
As points of confusion and potential steps for resolution, AFDO cites three primary areas:
- Information Sharing. The current recall system is encumbered by federal requirements that limit the ability for FDA to fully and freely share information with state and local public health agencies; and the “fear of prosecution for the disclosure of confidential information” holds FDA back from sharing information. Because states then tend to seek distribution information from industry instead of FDA, state and federal informational sharing laws need to be reviewed and updated.
- Policy. While legislative change is a long, arduous process, FDA is able to adjust existing recall communication and process policies within the agency. AFDO recommends it consider harmonizing the language between all recall communications procedures and include the roles and responsibilities of CFSAN in this communication, to ease state misunderstandings and confusion.
- Training. While food businesses use FDA recall tools and guidance to build their plans, they are not receiving FDA training or exercising the plans once they have been developed. Thus, AFDO recommends that FDA consider providing both internal and external training on its guidance, internal policies, and field directives. AFDO provides the example that most companies know what the RFR is, but they don’t include filing a report as part of their recall plan – potentially due to the lack of this being stated specifically as the required element in 21 CFR 117.139. Thus, training is needed (internally and externally) not just on official statute, but for the interpretation of FDA guidance, directives, and internal policies.
The 19-page report includes a number of other specific items for improving the recall process, and welcomes FDA to work with it and other stakeholders on its overarching recommendations to “take constructive steps to: update its policies, align its staff, develop novel approaches to information sharing that works for all partners, adopt new recall coordination technologies, provide training on both law and guidance, and enhance the transparency of its communications with partners to successfully conduct recalls in a new era of smarter food safety.”
The AFDO report is focused on improving the regulatory recall process, but how far this report will go to change foundational recall practices, or the speed of communication is yet to be seen, but even small steps in the direction advocated by AFDO and STOP can only be positive for the industry, and more importantly, for consumer safety.
From an industry perspective, recalls are always stressful and challenging with a need to move fast and often with limited information. Being prepared for a recall is one of the best things a company working in the food industry can do – this includes maintaining current databases and having fast electronic ways of communicating information to customers. Regulatory agencies will expect you to move fast when there is a threat or potential threat to public health and being recall ready is key to success. If you are not sure what recall ready means, or if you want to test your system, give TAG a call.
