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.
Dane Bernard was beginning his career with the National Canners Assn. as those regulations were rolling out. Beginning in 1907, the Canners served as the industry’s principal scientific organization; it would later become the National Food Processors Assn., which was absorbed into the Grocery Manufacturers Assn. in 2007.
It took a decade before canners achieved steady state with the new regulations, Bernard recalls, and the time lag repeated in fresh meat processors in the wake of 1996’s HACCP mandate by USDA. Massive recalls that destroyed companies like Hudson Foods and Topps Meat Co. and drove Conagra out of the beef slaughter business attest to the difficulty in implementing effective controls. That history likely will be repeated with FSMA implementation, Bernard believes.
“If you have a good food safety culture, the food safety voice is heard at the production table,” he says, “but it takes time before it’s steady state.” Not until meat processors embraced product and environmental pathogen testing did food safety professionals have enough data points to effectively control invisible contaminants in their facilities.
Listeria monocytogenes in cheese in the mid-1980s and E. coli in apple juice in the mid-1990s somehow managed to surprise processors, though in hindsight they shouldn’t have.
Al Baroudi, a food scientist with a focus on technology and microbiology, was a quality assurance specialist for 98 Borden Foods dairies in the mid-'80s when he developed a HACCP-lite program that included 10-20 environmental swabs at each dairy. When news of 61 listeriosis deaths attributed to Jalisco Mexican Products’ cheese broke, “we knew exactly where it came from,” he says, because the dairy swabs already had flagged floor drains as a Listeria harborage.
Likewise, 66 illnesses and the death of a 16-month-old child from pathogenic E. coli in unpasteurized Odwalla apple juice in 1996 was predictable, Marler maintains. “Odwalla was told that its juice was unfit for the military, yet they continued selling it to pregnant women and kids,” he says. Conventional wisdom held that bacteria couldn’t survive in acidic juice; convention was proven wrong.
Quicker test results, better interventions
Technical advances provide quicker test results and greater accountability than ever before, points out Baroudi. E. coli tests that used to take a week now deliver results “within a couple of hours,” he says. Whole genome sequencing holds processors to account for illnesses that occurred years ago. A recent example is Listeria in Blue Bell ice cream: After comparing the genome fingerprint of 2015 illnesses with its DNA library, the Centers for Disease Control matched the pathogen with victims from a decade earlier.
A longtime proponent of ozonated water as an antibacterial intervention, Baroudi championed the technology at Calabasas Hills, Calif.-based Cheesecake Factory Inc. when he joined the organization 10 years ago as vice president of food safety and quality assurance. The company already had installed ozone generators at its two bakeries in the wake of a safety incident, and his advocacy resulted in deployment of ozone cleaning systems in the prep kitchens of Cheesecake Factory’s 214 restaurants.
An effective contact-surface sanitizer, ozonated water was approved by FDA for direct food contact 15 years ago. “Knowing the benefits of this technology, I wanted to make sure we had this killer step for supplies coming in our back doors,” explains Baroudi. Vendors, particularly poultry and seafood suppliers, receive additional rating points when they use the technology.
Fresh produce is one of the ready-to-eat categories that fall under FDA regulation and are receiving more scrutiny with FSMA. When romaine lettuce was implicated in December in multiple foodborne illnesses, kitchen ozone systems spared Cheesecake Factory’s restaurants. Some raw materials are packed in frozen ozonated water, providing timed release of the antioxidant during shipment.
Between ozone and PCR tests, Baroudi has leveraged his educational training and work experience into a comprehensive food safety program for his employer. His competitors can’t say the same, he believes. “All the big companies think of food safety and quality assurance as an overhead expense until they have a catastrophic event. Then food safety is Job No. 1, but by then it’s too late.”
The Jack in the Box poisonings of a quarter century ago were a seminal event in processors’ war against pathogenic E. coli. The gap between awareness and effective control, however, was measured in many years. “Ninety percent of my revenue used to come from E. coli cases,” says attorney Marler. “Now it’s close to zero.”
Listeria events, on the other hand, now account for the lion’s share of his cases. Whole genome sequencing will be the bridge between the bacterium’s long incubation period and the human illnesses it causes. That should be cause for concern for makers of snack foods, baked goods, leafy greens and other ready-to-eat products not regulated by USDA.
There was a lag of several years between Jack in the Box and “the recalls of the late '90s to the early 2000s, when the wheels came off,” Marler points out. “But once they started doing the testing, E. coli came under control. Whether or not there will be the same painful learning curve with leafy greens and other foods will depend on companies’ willingness to spend money on testing and HACCP enforcement.”
“Almost everybody knows it’s mandatory to have some kind of preventive controls in place,” says Gary Acuff, a microbiologist and nutrition & food science professor at Texas A&M University (nfs.tamu.edu) in College Station. “FSMA has a lofty goal, but implementation is going to take time.”
It’s also complicated by a shorter bench of science trainers. Land grant colleges like Texas A&M have diminishing staffs for their extension services, and FDA was counting on those personnel to get small and mid-sized food companies up to speed on the continuous improvement approach to food safety that underpins FSMA.
His advice: Start forging relationships with microbial testing labs, scientific consultants and others with expertise in this new form of germ warfare. “Zoning and environmental sampling is new to a lot of people,” Acuff allows. “There will be initial pain and eventual gain. There will be surprises, for sure.”
Food microbiologists are in short supply and high demand. That level of in-house expertise isn’t necessary for the vast majority of food and beverage companies, but cognizance of its importance and access to it when necessary can make the transition to steady state less painful.