Is Your Food Safety Program Protecting Your Business or Litigators' Retirements Plans?
Updated: Nov 22, 2018
If there is anything in the food industry that would "scare me straight" if I were an executive of a food facility, it would be the recent blog posted by Food Poisoning Attorney Bill Marler titled: "My business was up in late 2015 through 2016 and the same so far in 2017." If you're thinking, "Oh sure, he's probably just out outbreak chasing," think again. I don't have any insider information on Marler's business, but I can tell you that the most recent CDC data does, indeed, show that the "business" of foodborne disease incidence has increased.
According to CDC's April 21 FoodNET report, focused on Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food and the Effect of Increasing Use of Culture-Independent Diagnostic Tests (CIDT) on Surveillance, the incidences of infections increased for nearly every foodborne-illness causing bacteria.
But is this increase real, or is it a reflection of changing technology? As the FoodNet report points out, there is a large increase in the use of clinical microbiology tests that are not dependent on cultures. So these tests, called Culture Independent Diagnostic Tests (CIDT), may use DNA, such as PCR technology, or enzyme immunoassay tests. As the report also points out, the use of these tests is increasing, and this may reflect an actual increase in testing, rather than a real increase in the number of cases. But whatever the explanation, the data clearly show more cases of major foodborne pathogens.
A few facts from CDC's 2016 data for specific bacteria:
The largest number of confirmed or CIDT positive–only infections was reported for Campylobacter (8,547), followed by Salmonella (8,172), Shigella (2,913), STEC (1,845), Cryptosporidium (1,816), Yersinia (302), Vibrio (252), Listeria (127), and Cyclospora (55).
The proportion of infections that were CIDT positive without culture confirmation in 2016 was largest for Campylobacter (32%) and Yersinia (32%), followed by STEC (24%), Shigella (23%), Vibrio (13%), and Salmonella (8%).
The overall increase in CIDT positive–only infections for these six pathogens in 2016 was 114% compared with 2013–2015.
Among infections for which reflex culture was performed, the proportion of infections that were positive was highest for Salmonella (88%) and STEC (87%), followed by Shigella (64%), Yersinia (59%), Campylobacter (52%), and Vibrio (46%).
As noted above there is a suggestion that some of the increase is likely due to the increased use of culture-independent diagnostic tests (CIDTs) by clinical laboratories rather than being caused by increased contamination in the food supply chain. As CDC states, "Because of the ease and increasing availability of CIDTs, testing for some pathogens might be increasing as health care provider behaviors and laboratory practices evolve." Additionally, results are more quickly obtained using CIDTs than traditional culture methods, so health care providers might be more likely to order a CIDT, and increased testing could identify infections that previously would have remained undiagnosed.
Thus, all of this complicates the interpretation of surveillance data, not only because of the increased ability to detect the bacteria, but because some information about the bacteria causing infections, such as subtype and antimicrobial susceptibility, can only be obtained if a reflex culture is performed, which is not done in CIDT testing.
However, regardless of the reason for the increase; regardless of the means, ease, or frequency of tests and detection; and regardless of your opinion on the interpretation of statistics, an enteric infection – or foodborne illness – is still that, and it is a basic responsibility of the food industry to mitigate or prevent its potential. As the CDC report concludes, "Foodborne illness remains a substantial public health concern in the United States." And, while CIDTs may be making infections more visible, "previous analyses have indicated that the number of infections far exceeds those diagnosed."
When you then add to this FDA's new Preventive Controls inspection "swab-a-thons" for environmental sampling(with 150-200 swabs being reported as typical regardless of plant size); the agency's increasing use of whole genome sequencing (WGS) to link illnesses to their source (present and past); and DOJ's increased investigations into food safety activity, it should come as no surprise that business is good for foodborne illness litigators.
And if, even with all this, you're still thinking it's just a matter of "outbreak chasing" or the interpretation of statistics, you may want to take heed of the closing remark on Marler's blog: "The entire food chain, both foreign and domestic, as well as government, academia and consumers, clearly have more to do to drive me into retirement." It's nice that he does include consumers in the list, as he should. However, while I've known Marler to make a case against numerous food suppliers, manufacturers and retailers, I don't believe (though correct me if I'm wrong) I've seen him take a consumer to court over a foodborne illness incident. Be it the deep-pocket theory or not, the food industry, and particularly the food manufacturer, is generally the first to be presumed guilty, investigated, and made to prove its innocence, when an incident occurs.
As I have said in the past the food safety landscape is highly complex and getting more complex by the day. Risks are going up, threats to brands are going up, and the most recent CDC report suggests that the diagnosis of foodborne illness is going up. My advice: Take another look at your food safety programs and environmental controls, not just to ensure they meet the new FSMA requirements and protect the consumer, but to be sure you are protecting your own business rather than adding to Marler's retirement plan.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com