Is there a microbiologist in the house?
With the exception of deep-pocketed corporations in the food industry, the answer most likely is no. “Very few companies have a microbiologist on staff,” observes Dane Bernard, a microbiologist and former vice president-food safety and quality assurance at Keystone Foods, who now provides food safety consulting under the name Bold Bear Food Safety, Annapolis, Pa.
Not many more have a microbiologist on call, either. For decades, environmental swabs have been routine at plants under the auspices of USDA’s Food Safety and Inspection Service. With implementation of the Food Safety Modernization Act (FSMA) under way, similar routines are beginning at some FDA-regulated facilities.
The swabs are taken by quality assurance personnel, the boots on the ground for any science-based food safety program. At November’s Food Safety Consortium, Eddie Richter, chief science officer at Matrix Sciences, related the story of a client who offered a $100 bounty for every QA worker who delivered a positive result from a Listeria-detection swab.
That’s not difficult to do—a floor drain is a good place to start—but Richter’s point was that many FSMA-affected processors are taking a "don’t find, don’t tell" approach to environmental monitoring. The sin isn’t finding pathogens, it’s a lack of diligence in looking for them.
At last year’s Food Safety Summit, industry professionals were aghast when peers in FDA’s first wave of preventive-controls inspections under FSMA described teams of regulators descending on their facilities to take hundreds of environmental swabs, giving rise to the term “swab-a-thons.” The regulators expected they would find some pathogens, and rarely were they disappointed. Better that QA staffers should find those microbes before the FDA, and the point of Richter’s tale was that a few positive results against a backdrop of many negatives are not necessarily a bad thing.
“We expect you to find positives,” Joann Givens, director of FDA’s food and feed program, told Food Safety Summit attendees. What’s important, she indicated, is what action is taken when a swab yields a positive result.
FDA had conducted only a handful of plant inspections for compliance with FSMA’s preventive controls rules at the time of that conference. A former quality systems director for McDonald’s Corp. said 130-150 environmental swabs were typical in those inspections for allergen and pathogen detection.
While undeclared allergens trigger a recall just as quickly as the presence of Salmonella or any other pathogen, they are unlikely to sicken as many individuals as microbially contaminated products. They also are unlikely to generate the level of brand damage and civil-suit settlements.
Beginning with the 1992 E. coli O157:H7 deaths and illnesses attributed to Jack in the Box hamburgers, attorney William Marler has represented many people affected by food contamination. Since then, he has been involved in most of the high-profile events, collecting more than $600 million from food companies on behalf of his clients, all of it involving pathogenic contaminants.
“If there’s one common denominator in those cases, it’s that there are always warning signs -- but people either chose not to react or make themselves aware of the problem,” says Marler, the managing partner of Marler Clark LLP (marlerclark.com), Seattle, who bills himself as the food poisoning attorney.
The heads of quality assurance at defendant companies are usually deposed in those suits. Many of them resisted product testing out of cost concerns, says Marler. “A lot came up the ranks through public relations or a background in the arts,” he grimaces. “They should have a science background and know what they don’t know” and seek expert counsel where necessary to fortify food safety programs.
History repeats itself
Germ theory dates to the 19th Century, but an understanding of the link between microscopic life forms in food and human illness is a more recent development.
The Pure Food and Drug Act and the Federal Meat Inspection Act of 1906 mandated sanitary conditions in the production of food, but almost 70 years would pass before regulators started cracking down on bacterial contaminants. Clostridium botulinum deaths tied to canned foods were the trigger for the low-acid foods regulations that came into being in the 1970s.