Legally Speaking By Shawn Stevens
Shawn Stevens is the founding member of Food Industry Counsel LLC, the only law firm in the U.S. that represents the food industry exclusively. Stevens works with to help them protect their brand by complying with FDA and USDA regulations, reducing risk, managing recalls, and defending high-profile foodborne illness claims.

FSIS using Whole Genome Sequencing could link you to unsolved outbreak

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(The views and opinions expressed in this blog are strictly those of the author.)

It wasn’t long ago that the FDA took the lead from FSIS, modeling the agency’s new preventive control regulations on FSIS’ historic HACCP rules. Now, it’s FDA’s turn to return the favor, showing FSIS that, with the use of Whole Genome Sequencing (“WGS”), it is now possible to solve past foodborne illnesses and outbreaks that remain unsolved.

The technologies now available to the government to quickly detect dangerous pathogens lurking in food facilities or finished products are becoming more effective with every passing moment. The days of judging the sanitary conditions of an establishment by looking for product residue are long gone. Today, with a single swab collected from a food processing facility, the government can see the genetic makeup of a pathogen and, by comparing it to CDC’s PulseNet Database, everyone it has made sick.

It is no secret that FDA has been aggressively swabbing food facilities and comparing the genetic strains of any pathogens found in those facilities to the library of genetic strains stored in the government’s database. And, they have been doing it quite successfully. While conducting this testing has allowed FDA to verify the effectiveness of sanitation programs, it has also allowed FDA to find pathogens that have been making people sick or causing outbreaks. Notably, there are approximately 1,000,000 human isolates in the PulseNet database representing human beings who got sick from eating contaminated foods, where the offending food product or facility remain unsolved.

Until now, FSIS’ primary method of analyzing and characterizing bacteria found in establishments has been through pulsed-field gel electrophoresis (PFGE). In partnership with the National Antimicrobial Resistance Monitoring System (NARMS) they have done a great job identifying genes associated with resistance to antibiotics that are commonly used in the production of meat and poultry products.

But, now, FSIS is considering following lead of FDA and using WGS to begin comparing the genetic makeup of pathogens isolated from regulated establishments or food products with the genetic makeup of pathogens stored in the CDC’s database. According to the USDA, the agency plans to use WGS “to aid in accurately identifying and responding to outbreaks, conducting efficient traceback, and studying environmental harborage and movement of pathogens in regulated establishments.” Once this happens, any positive sample collected from the environment or food products in your establishment could link your company to illnesses or outbreaks that occurred weeks, months or even years ago.

If adopted, I predict that this shift in FSIS policy will have a substantial impact upon industry. Moving forward, an increasing number of establishments will likely be linked to outbreaks or illnesses that currently remain unsolved. To the shock of implicated food companies, this scenario has played out repeatedly in FDA regulated facilities.

Fortunately, there are a number of strategies you can implement to help protect your company from the consequences of these new regulatory enforcement initiatives. But, act quickly, because you never know when the next positive sample taken from your facility will be linked to an illness or outbreak.

10/9/2017