Anyone who has ever worked in or with food processing facilities knows that many of the tasks can be rote and become monotonous over time. And monotony can all-too-easily result in “shortcuts.” But a number of recent occurrences have shown the consequences of cutting corners at all levels of the food industry: from FDA’s newly released guidance on FSMA-granted authority to mandate recalls (https://bit.ly/2RYmgd3), the Interagency Food Safety Analytics Collaboration (IFSAC) foodborne illness source report, and the allergen contamination-related manslaughter convictions (https://bit.ly/2RYmgd3). As these show, the consequences can be extremely serious for a business and life-altering for individuals.
With FSMA’s new mandatory-recall authority, FDA can order the recall of a food if there is a reasonable probability that it is adulterated or misbranded and could cause serious illnesses or death. The rule does provide that the responsible party first be given the opportunity to do a voluntary recall, and at least two producers have taken the option to do so when they were served with the written notice of FDA’s intent. In addition to that partial use of its authority, FDA has used it once to its full extent, issuing a mandatory recall order in April 2018 for food products containing powdered kratom, after several were found to contain Salmonella.
On November 5, FDA released final guidance on the use of mandatory recalls. As noted in a statement from FDA Commissioner Scott Gottlieb M.D., the guidance is part of FDA efforts “to be as robust and transparent as possible and provide answers to questions that many have asked about the FDA’s mandatory recall processes. Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products.”
That same week, the IFSAC report, “Foodborne Illness Source Attribution Estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter,” was released. According to the report, for which IFSAC analyzed data from just over 1,000 foodborne disease outbreaks from 1998-2016:
- Salmonella illnesses came from a wide variety of foods.
- E. coli O157 illnesses were most often linked to vegetable row crops (e.g., leafy greens) and beef. The estimated attribution of Listeria illnesses to the row crops increased from 3.4% in 2013 to 12.5% in 2016 due to the 2015 multi-state lettuce outbreak.
- Lm illnesses were most often linked to dairy products and fruits — which also remain the top two categories with the highest estimated attribution percentages.
- Campylobacter illnesses were most often linked to chicken and unpasteurized milk.
Attention to this report is important, not only for industry to increase its focus in these areas and ensure it is not cutting corners, but also because the report notes that the estimates may help shape agency priorities and support the development of regulations and performance standards and measures, and other activities. (Read the full report at https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2016-report-TriAgency-508.pdf.)
While the recall mandate and IFSAC estimates are significant and serious, it is the mention of a manslaughter conviction for lack of allergen controls that likely most caught your attention. And if it didn’t, it should have.
Although it occurred in England, there’s nothing saying that such a judgment and conviction couldn’t, and won’t, be declared in the U.S., particularly because undeclared allergens continue to be a top cause for recalls by both FDA- and USDA-regulated facilities.
In the case, two food business managers in England were found guilty of manslaughter in the death of a 15-year-old girl who died after eating supposedly nut-free food from an Indian restaurant. The food was found to contain peanut protein to which she had a life-threatening allergy. The restaurant’s owner/chef and the take-out manager were convicted of manslaughter, not only because of the allergen presence, but because of the lack of food safety standards in the operation that could have prevented the teen’s death.
It can be tempting to take shortcuts, cut corners, and make allowances for “minor” mistakes here and there. But as these all show, there can be grave consequences to food safety concessions — both for your business and you, as an individual.