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FSMA Implementation Challenges, Illness Investigation Logistics Feature at the Food Safety Summit

By Holly Mockus   |   

1,700 attendees and nearly 200 exhibitors converged on suburban Chicago’s Stevens Convention Center May 8–11 for the 2017 Food Safety Summit. Alchemy participated in force, meeting with fellow food safety advocates to emphasize the need for food companies to provide their employees with the knowledge and confidence to take smart action and prevent food safety incidents.

Several sessions focused on the industry shift from a reactive past to an active, aggressive, preventive present and future. The summit’s keynote presentation was centered around what food companies are actually experiencing in their work to implement new FSMA rules in light of the new emphasis on legal ramifications of noncompliance.


FSMA implementation challenges

Keynote speaker Kathy Gombas, formerly with FDA, remarked that many companies don’t know where to start in their compliance efforts and aren’t sure what the FDA expects them to show when administration investigators show up at their door. She mentioned supply chain concerns—most small processors and importers, for example, probably aren’t aware that the rules apply to them—and that “affordable” and “timely” resources were needed to help food companies meet FSMA requirements. She referenced helpful tools including model plans and food safety templates soon to become available.

Dave Gombas, formerly of United Fresh Produce Association, spoke about the FSMA Produce Safety Rule and the fact that it aligns “90%” to well-established Good Agricultural Practices. Despite this alignment, he warned, challenges continue to arise around foreign supplier verification and a lack of clarity concerning enforcement details—just who will enforce the rule, and how will they enforce it? He recommended using universities and auditors as ready sources of information.

Costco Wholesale Corporation’s Craig Wilson acknowledged that the implementation process was confusing for small and medium companies and called FSMA “the elephant in the room,” but he attempted to reassure small processors that potential recalls were the top concern of wholesale suppliers and promised that they would “figure it out.”

Jeffery Steger, Assistant Director and Senior Counsel for the Consumer Protection branch of the U.S. Department of Justice, explained the DOJ’s growing role in enforcement of food regulations and assured those in attendance that that role was unlikely to diminish in the future. He stated that the DOJ gets involved in cases where significant harm has come to consumers and in which company management had prior knowledge of potentially dangerous food safety issues.

Shawn Stevens of Food Industry Counsel, LLC reiterated his belief that FSMA represents the Food and Drug Administration’s absolute commitment to stop foodborne illness, and that companies should enthusiastically merge FSMA precepts into their operations. He cited aggressive pathogen control and shifting from “root cause” to “root source” sampling as critical, and he pushed the need to insist on such practices among suppliers. He emphasized that food company executives need to realize the seriousness of personal criminal liability and to take steps to protect both their companies and themselves.


Logistics of foodborne illness investigations

Laura Dunn Nelson, VP of Food Safety and Global Alliances for Alchemy, introduced an important session on foodborne illness outbreaks and investigations.  She reminded attendees that smart action by their employees—timely and appropriate action resulting from thorough training, reinforcement, and coaching—is the first line of defense against food safety incidents and potential spread of foodborne illnesses.

Matthew Wise, Outbreak Response Team Lead for the Centers for Disease Control and Prevention, walked the audience through a “typical” foodborne illness outbreak and investigation. He explained how recent technological advances—especially DNA fingerprinting, genome sequencing, and the PulseNet database— had dramatically increased the ability of investigators and researchers to pinpoint both specific pathogens and their contamination points. But, he cautioned, the techniques still have limitations. Even when combined with food testing and trace-back exercises, processes cannot generally determine exactly how contamination occurred.

The CDC’s Health Communications Specialist, Laura Burnworth, admitted that foodborne illness outbreaks are complex and much of the public has difficulty understanding many of the details. But she observed that the CDC is a non-regulatory agency, and as such, usually plays a significant communications role. These communications are often limited to posting notices both at the beginning and, importantly, at the end of an outbreak. These announcements allow state and local agencies and individuals among the public to take action, avoid or control exposure, or seek help.

For obvious reasons, Burnworth said, CDC communications must be fast, accurate, and expressed in both plain language for the public and precise scientific language for government and medical entities. Multistate or multiregional outbreaks continue to be huge challenges for the CDC.

The Food Safety Summit once again proved invaluable to food industry professionals engaged in protecting both the integrity of the food supply and the health and safety of consumers. Alchemy looks forward to 2018 and yet another opportunity to network with food safety leaders in the continuing fight for pathogen- and adulterant-free food.


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