NEW ORLEANS — A revelation at a fresh-cut seminars at United Fresh 2011 should give those in the produce industry some measure of comfort in relation to the Food Safety Modernization Act.

During a teleconference May 2 with the Produce Traceability Initiative task force the deputy director of the Food and Drug Administration said the agency will likely take its lead from private industry in terms of what kind of traceability regulations to adopt.

“Mike Taylor said during the teleconference that ‘A food safety system is one big information system,’” said David Durkin, general counsel for United Fresh. “And he also said ‘In the end we are going to have to rely on what industry does.’”

Both Durkin and Robert Guenther, senior vice president for public policy for United Fresh, said that was good news for the industry. They also said it is an excellent reason to keep moving forward with PTI.

“There is no reason to slow down on PTI,” said Durkin who is with the law firm of Olsson, Frank & Weeda. “Traceability will be a core operating function for people in the produce business.”

Much of the focus of the seminar was on traceability, but other key points included the timeline set for the FDA by the legislation and how the agency might pay for its new responsibilities.

Durkin also said one area of concern related to the Act is the FDA’s plan to pursue criminal prosecution if businesses fail to meet requirements of new regulations that aren’t even written yet. He said FDA officials have recently stated that they plan to “reinvigorate the Park Doctrine,” which related to a Supreme Court case about a man named Park who owned a warehouse in Chicago and lived in New York.

The bottom line of the case law related to the Park case is that business owners can be held criminally liable for a first-time misdemeanor — and possible subsequent felonies — under the Federal Food, Drug, and Cosmetic Act, and there does not have to be proof that corporate officials acted with intent or even negligence, even if they did not have any actual knowledge of, or participation in, the specific offense.

In discussing the impact of the FSMA, United’s Guenther likened the situation to that of a “firetruck model.” He said the way it has been, something happens and the FDA responds. Under the FSMA, the agency is required to take a preventive approach.

FDA to take PTI cues from industry
FDA to take PTI cues from industry


While there will be new requirements regarding a variety of business-related activities, such as record keeping and providing FDA access to more company records than is currently required, the area of traceability is not cut and dried.

“I will be very surprised if they ever get to traceability,” Guenther said. “There is no requirement (in the FSMA) for a final rule on traceability. It is my view that this will be the last thing they do.”

Guenther and Durkin discussed other details of the law, and their presentations should be available to United Fresh members on the association’s website within the next two weeks.

In the meantime, both experts suggested that produce industry business people step up and participate in FDA’s process as it works during the next two to three years to meet its obligations under the FSMA.

“You must participate,” Durkin said. “United Fresh will be predicting what’s coming up next and you need to get involved.

“Industry groups had a lot of input into the law and it could have been a lot worse. If the House version would have passed it would be a much darker day. It could have been much, much worse.”