MONTEREY, Calif. — Enhanced record-keeping regulations for fresh produce may be a compelling option for the Food and Drug Administration after the E. coli/romaine lettuce outbreak this year, former FDA associate commissioner of foods David Acheson said.
Speaking May 22 at the 2018 Cal Poly freshPACKmoves event, Acheson, president and CEO of the Acheson Group, reviewed current challenges of food safety regulators moving from education to enforcement and the possibility of greater traceback regulations on high-risk foods.
The 2011 Food Safety Modernization Act allows the FDA to establish a product tracing system to effectively and rapidly track and trace U.S. and imported food, Acheson said.
So far, the FDA not yet created any regulations on enhanced tracking traceability requirements for high risk-foods, nor has it yet created a list that identifies what foods fit that description.
Acheson said the agency may be compelled to do.
“If we’re going to look at what’s the driver for making some changes around product tracking, it will be the romaine situation going on right now because clearly tracking systems failed us in terms of getting to the bottom of this one quickly,” he said.
While the FDA doesn’t have the authority to require farm-to-retail traceability or a particular technology, the agency could issue regulations that would increase demands on suppliers related to record keeping, with potentially more specificity mandated record keeping on lot codes and dates of receipt.
“In my crystal ball, I could see this coming back on the surface and I think it needs to,” he said.
“One of one of the things that break my heart is going back to spinach which I was involved with as regulator,” he said, noting the severe impact on spinach growers in 2006. Twelve years later, it happened again, he said.
“Here we are today where a commodity is being thrown under the bus and that’s my fear that we are still doing that because our systems are letting us down,” he said. While there are many cost and logistic challenges to make it work, Acheson said something has to change.
On-site inspections
In other remarks, Acheson spoke about what firms need to do in preparing for preventive controls inspections by FDA and what approach is needed for environmental monitoring of food safety risks and ensuring the safety of produce supply chains.
Acheson said the FDA is heavily focused environmental food safety issues and the supply chain because those are two big industry vulnerabilities.
“Consumers want what they want fast and they want it inexpensive, they want it 100% safe and they want exotic flavors,” Acheson said. “That’s driving the complexity of the supply chain.”
Acheson said the FDA is progressively moving from education to enforcement on the preventive controls regulations for value-added fruit and vegetable operations. Companies have been cited for their lack of a foreign supplier verification program, he said.
“The (FDA) wants the food industry to be understanding that reacting to a problem isn’t the answer — prevention is the answer,” he said. “An approach that works is essentially is to create a list of everything you’re using the ingredients, products, the primary packaging, do an analysis on every hazard analysis on every single item.”
Fresh produce marketers who are marketing a ready-to-eat food need to have environmental controls to detect pathogens, he said.
In monitoring the environment of produce facilities, Acheson said the biggest pathogen concerns are salmonella and listeria monocytogenes.
Environmental controls combined with environmental monitoring equals maximum protection, he said. That means managing hygienic zoning, air flow, drains, traffic, people, hand-washing, equipment, produce and more.
Acheson said companies should look for trends in their monitoring results and react both to too many negatives or too many positives.
“I think agency has got to the point where if you’re not finding listeria and salmonella somewhere in your plant, than you are probably not doing a good enough job,” he said.
Reacting to evidence of pathogens is key, he said, and companies must seek answers with root cause analysis and retesting.
Acheson said large firms will be expected to comply with the food defense rule starting in July 2019. The regulation is geared toward preventing wide-scale and intentional contamination of food, with particular attention to processes where mixing of liquids is involved.
Acheson said companies may be tempted to cut back on food safety spending and maintenance but he said that is a wrong direction.
“People will say, ‘Why do you need more money to make this work?’” he said. “Because if we don’t, we are going to wind up with violations,” he said.
