- Determining the purpose of FDA, state and local engagement in recalls. While the purpose should be to mitigate and prevent illness by ensuring immediate removal of product, others would argue it’s to evaluate the effectiveness of recalls
- Classifying recalls very early in the process – nearly immediately – since this impacts the response of everyone in government and industry
- Readily and openly sharing information among all regulatory and public health partners so industry isn’t overly burdened with dozens of requests for the same information
- Implementing a regulatory technology that shows in near real time the progress of recall implementation to better focus the work of removing product and listing locations where more product continues to be found.
A highly functioning, efficient integrated food safety system
AFDO has been focused on using this post-COVID period to examine the barriers to an integrated food safety system. In this area, the work with many industry and consumer stakeholders is key. A consistent theme has emerged in conversations I’ve had across the food safety community: There is a need for an empowered, expert food safety leader at the FDA with direct authority over the key components of the foods programme – The Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA).
Much of the FDA’s food inspection work is accomplished by state inspectors under contract by the FDA
Under the current structure, Deputy Commissioner Frank Yiannas is a leader among equals. He and the Associate Commissioner for Regulatory Affairs, and the Center Directors all report to the Commissioner.
The coalition (behind the aforementioned three‑year study) believes this decentralised structure results in slow decision-making, limited coordination across the functional areas, and inconsistent approaches – or silos – which reduce effectiveness.
The food safety community has great confidence in the Deputy Commissioner for Food Policy and Response and the other food leaders. Yet, unlike previous deputy commissioners for Food Safety, Yiannas has not been empowered in all aspects of food safety, including budget and supervisory authority over CVM and CFSAN.
The FDA does not have regulatory authority in retail foods, including food services (restaurants, caterers, etc), grocery stores and supermarkets, as well as convenience stores
While the commissioner and other leaders at FDA are admired and respected, most commissioners come to the agency as experts in medical products and, unlike Yiannas, have little knowledge, interest, or experience with food safety. Consequently, their attention tends to gravitate to those areas they know. This creates a situation where each component of the food programme can move in different directions and various speeds.
An excerpt from an AFDO executive report, ‘Recall Modernization: Accelerated Partnering for Effective Recalls’ underscores this point:
“Furthering the organizational complications are the recall activities that take place in an entirely different center at FDA: the Center for Food Safety and Applied Nutrition (CFSAN). With CFSAN, three different offices are directly involved in making critical decisions on recall activities (ie, classification, determination, hazard analysis, and product reconditioning). The decentralization of recall activities continues to slow the effectiveness of the overall recall response.”
Imagine your CEO has 30-plus direct reports with a huge portfolio of divergent subject matters. Naturally, that creates a challenging situation.
we know that the culture must be implemented by those leaders at the individual store or unit, but perhaps we haven’t successfully empowered them with the tools?
At least one previous commissioner recognised this and strategically moved all human and animal food safety under an empowered leader. As many will know, 30 consumer groups, trade associations and AFDO recently sent a letter to the Commissioner requesting a return to an empowered leader who is an expert in food safety.
Group members believe this could streamline, enhance and make the FDA even more effective at meeting its food safety mandate.
Historically, every 10 years, the federal government sets goals for foodborne illness reduction, but it does not develop a comprehensive strategy. Past AFDO President, Ernie Julian, led an effort to bring the entire food safety community together to develop strategy and work in lock step to bend the foodborne illness curve and meet the Healthy People 2030 goals.
As of today, two large meetings, and numerous work groups with AFDO’s support and leadership, continue to work together to develop strategies and coordinated approach to meeting these.
Retail food safety
Another significant area of food safety is retail food safety in restaurants, grocery stores, convenience stores, among other locations.
Part of AFDO’s continued work on food safety, through FDA funding, involves extensive work in retail food safety in conjunction with other association partners.
AFDO has focused on four areas in the past 18 months: active managerial control; retail data analytics; benchmarking the brand-based retail industry in active managerial control, food safety management systems, employee health, and food safety culture; and root cause analysis for retail regulators.
How to improve your food safety culture
As I travelled to industry meetings, I heard a similar message repeated: “We know how to measure many of our goals, such as revenue, drive-through speed, etc, but we find food safety foreign.”
Thinking back to Yiannas’ book on food safety culture, we know that the culture must be implemented by those leaders at the individual store or unit, but perhaps we haven’t successfully empowered them with the tools?
AFDO has worked with a group of SMEs, including food safety experts from brands in the food service, grocery and convenience store segments, and also some owners and operations folks to help these boots-on-the-ground leaders become food safety leaders too.
This pilot programme for about 40 leaders began in early summer 2022; by the fall, a train-the-trainer programme will be available for use by brands and their suppliers.
Retail inspections
Over the past two years, a mapping project has brought together complete datasets of retail inspections data. The AFDO has successfully mapped and brought together data from eight states and a very large local jurisdiction.
We have brought in more than 400,000 routine inspections and soon will add one more state for just under a half million inspections. The project has also mapped data across the 400 largest retail brands.
The dataset leads to some important questions and serves as a tool for participating states:
- Why is there a variance in inspection times? Two groups have emerged: one with an average retail inspection time of 50 minutes and another with an average of 95 minutes
- Why are processes like cooling, reheating only rarely observed during inspection? It seems fairly obvious that these most common contributors to foodborne illness at retail should be routinely observed.
We’re only beginning the work on this data, but we can see huge promise in better understanding retail food safety, and, ultimately, improving both inspections and compliance at the establishment level. Over time, I expect the data will provide trending and even predicative work to assist in allocating resources and prioritising inspections.
About the author
Steven Mandernach is the Executive Director of the Association of Food and Drug Officials (AFDO). Prior to becoming executive director in 2018, Mandernach was the Bureau Chief for Food and Consumer Safety at the Iowa Department of Inspections. Mandernach is a past president of AFDO and current co-chair of the Association’s Laws and Regulations committee. He has served as the chair and co-chair for the Manufactured Food Regulatory Program Alliance (MFRPA). He is a past president of the Mid‑Continental Association of Food and Drug Officials (MCAFDO). Mandernach has a J.D. from Drake University Law School. He has completed graduate work in Food Safety at Michigan State University.
