FDA “New Era of Smarter Food Safety” – Comments from Steve Mandernach, AFDO Executive Director

Comments delivered by
Steven Mandernach
AFDO Executive Director
FDA “New Era of Smarter Food Safety”
10/21/19

Thank you for the opportunity to participate in this meeting on behalf of the Association of Food and Drug Officials or AFDO.  AFDO represents federal, state, and local food regulatory programs across the United States.

We are excited to be embarking as partners in the Era of Smarter Food Safety.  We believe some of the best practices from our state and local agencies may model how we can move forward.  This provides an opportunity to think as a food safety community—industry, consumers, and regulators.

Retail:  We recognize the emphasis FDA has placed on the retail sector for this program.  Food service continues to be the sources of over fifty percent of the outbreaks each year.  We see many opportunities for in this area including the following:

•  Improving Outbreak Investigations.  Modernizing foodborne illness investigation with the largest portions of outbreaks this year resulting from the food service industry.  AFDO has been actively working with CDC and several states on some of these techniques.  By developing an environmental sampling training for retail regulators, they will be better able to find the cause of outbreaks and assist industry in eliminating the source of illness.  We believe WGS and CIDTs will only increase the number of outbreaks at retail many of which were previously unidentified or considered background.
•  Using Routine Inspectional Findings.  Second, we see opportunities to use routine inspectional findings to help us identify challenging areas for industry and use this information to provide more timely assistance to the retail industry.  This information can be nearly real time and show what is being improved or not improved.  We’re eager to work collaboratively with FDA to help use real time data to identify brand challenges and assist brands in addressing them.
• Addressing the last mile.  Third, we believe addressing the new emerging methods providing Americans with food in their homes is important.  We have to address how to ensure food is safety delivered without temperature abuse and tampering.  We may have to rethink the traditional dividing lines between retail and manufacturing in this process and determine the right methods of regulation. The traditional thoughts may no longer be appropriate.

Agility to address new issues quickly.  Further, we also believe the food regulatory system must become more agile in this era.  Today new food items can spread across the country in a very short period of time making it very challenging to change course.  Spending years to determine how to address emerging issues through a regulatory system is simply no longer an appropriate response to consumers or industry.  Further, more and more products blur the regulatory lines such as CBD and Kratom.  We have to find ways to more quickly address these challenging items that may have significant public health impacts and may cross multiple regulatory lines.

Improving inspection techniques and compliance.  Root cause analysis.  Historically we have taught inspectors and investigators to make observations and not go the next step in determining and accessing the why is this happening.  FSMA begins moving toward systems assessment, but we must go further and teach investigators to be skilled in root cause analysis.  This is a fundamental change from how they have been historically trained. Through root cause analysis we ask investigators and inspectors to use their professional judgement to assess likely causes of problems.  This may be the single most important change in the inspectional food safety culture.

Quicker Follow Up.  We also need to get beyond the concept of the appropriate actions toward quicker follow up of those violations with the potential to cause illness.  This has historically happened more commonly at the retail level, but in manufactured foods we must move forward too.

Recalls Must Improve.  It’s time to rethink recalls.  AFDO has been working with industry to rethink the recall system and what might improve the system.  The first thing we heard, was why are the FSIS and FDA systems not similar if not complimentary and why do they not work similarly.  A major event that could cause illness is not the time to be trying to discern the difference between regulatory schemes.  Secondly, we have to move toward the public health purpose and ensure product is indeed off the market during class 1 recalls.  We have technology today that can quickly get recall data out to all health agencies with only the product delivered into their jurisdiction.  We should not see product involved in these recalls available for months or years afterward.

Moving toward Smart Metrics and Performance Criteria.    We as regulators can use new terminology and new ideas, but until we change the metrics and measures to match the smarter era, we will not be successful.  If we continue to only focus on numbers of inspections, the future goals we are discussing here will not be supported be supported by our regulatory organizations. 

Every single person with a food safety mission in all of our public health agencies needs to have foodborne illness prevention and mitigation as a part of their performance evaluation.  I don’t think we have the exact solutions on how to do this, but talking about smarter food safety and not evolving in the metrics to support that will limit our ability to change all of organizations to really embrace the era of smarter food safety.  Embracing food safety culture can’t be limited to only industry but must also be incorporated into regulatory agencies. Our measures and metrics must match what we are saying in a smarter era of food safety.

We believe the era of smarter food safety can only be effective if strategies are collaboratively developed with the key stakeholders —  regulators at all levels, industry, and consumer groups — we all agree on the common purpose.  AFDO and the regulators we represent look forward to working with FDA in this process.