Call 2018 the year of the food recall.
By the end of October, the federal government had ordered more than 535 recalls on fresh or processed food for a safety precaution, and the number was expected to jump higher by year’s end.
“The rules have changed. Awareness has increased, and this trend will continue,” said Shawn Stevens, an attorney with Food Industry Counsel, a Milwaukee, Wisconsin-based firm that provides food safety legal and regulatory consulting services exclusively for the food industry.
Earlier this year, during a food safety meeting sponsored by the Northwest Horticultural Council, Stevens offered tips on preventing and responding to a recall, and he provided a few more thoughts during a follow-up call with Good Fruit Grower.
Too often, Stevens said, companies have “silo vision” and believe that because they’ve never had a problem, there isn’t the potential for one.
“I don’t want to say the risk is high, but I think about it as high. What scenario could conceivably happen? What company could conceivably use my product in a way that could increase risk? That’s how we need to be thinking,” he said.
Lesson 1: Listeria is out there.
Listeria is more prevalent and persistent than once thought. Rough welds, cracks, framed conveyor belts, wooden bars that are not easily sanitized, condensation dripping onto food contact surfaces — these all easily harbor listeria, he said. “If you want to find contamination, sample more. It’s really easy,” Stevens said.
Lesson 2: The FDA can track better than before.
The Food and Drug Administration’s ability to detect emergency outbreaks is expanding drastically.
During the course of a foodborne illness, a person eats contaminated food and gets so sick, he or she ends up at a hospital. A physician might be concerned enough to order a culture. “Whole genome sequencing is the shiny new car, and they’re getting really good at being able to link illnesses to isolates in a database,” Stevens said.
Today, about 85,000 human isolates are uploaded each year to this database — that’s 85,000 people for whom the Centers for Disease Control has determined the vast majority of their illness was caused by exposure to food. That database now tops 1 million human isolates.
How many of those cases have been solved? Only about 30,000 at most, he said. “That means there’s nearly 1 million people out there who got sick from eating food, and we don’t know what made them sick. We don’t know the source, and these are just people in the hospital,” he said. “There are lots of food companies, making lots of food that’s making lots of people sick. All of us, no matter what segment of the industry we’re in, need to wonder if we are one of those companies.”
Lesson 3: The FDA is hunting.
The Food Safety Modernization Act has given FDA new powers. The new FDA is loaded with listeria hunters and salmonella hunters. “They have swab kits on their hips. A new image, new aura, new responsibility: Make foodborne illness stop,” he said. “And they’re serious about it.”
Those hunters are intentionally looking at places that are difficult to clean or sanitize. If they find something, they will conduct whole genome sequencing on that strain that was found in the drain, for instance, and if it matches a human illness in the database, they “will descend.”
Lesson 4: Criminal charges are possible.
FDA and the Department of Justice may initiate criminal investigations when contamination in facilities or food is linked to human illness.
“I guarantee you, if children throughout the U.S. started getting sick and dying from taking ibuprofen, the FDA would initiate a criminal investigation. So why not do it for food?” Stevens asked. “That’s the direction we’re moving.”
There also could be enhanced liability, he said. A food company executive or food safety manager who was aware of a situation that could lead to contamination, and was in a position to eliminate the condition, could face a misdemeanor charge of up to a $250,000 fine and a year in prison for each illness.
Lesson 5: FDA guidance can help.
Does FDA’s listeria control guidance protect your company? Stevens recommended highlighting anything in the guidance that could apply to your facility and that you can fit in to show you’re following through on it. But remember, one free pass is not really one free pass, he said.
Aggressive cleaning and negative test results, following the find of a positive sample in April, after product has shipped, may mean nothing if illnesses turn up over the course of the next few months and more positive test results occur later.
Lesson 6: Prepare for an FDA inspection.
Prepare now for an FDA inspection. Stevens offers a checklist for companies to ensure they’re prepared. (See the accompanying list: “Tips to be prepared for an FDA inspection.”)
Overall, Stevens said, companies have immunized themselves to the concept that pathogens should be in the environment.
A recall is a situation where the airliner has left the runway, it’s climbing, it’s full of passengers and the one defect on the aircraft that could have been identified and fixed to prevent disaster wasn’t, he said.
What would the reaction be in the United States if airlines collectively had more than 535 airliner crashes each year?
“It’s not accepted. It’s intolerable, and I think the industry needs to start thinking of recalls in those terms,” he said. “There is a need for a philosophical reset or shift for the food industry as a whole.” •
–by Shannon Dininny