The traceability alphabet: Seeking to create an ‘integrated whole’
The Food Safety Modernization Act (FSMA) has the undivided attention of the food industry right now.
The legislation was signed into law by President Obama on Jan. 4, 2011. Since then, FDA has been seeking input from the food industry as it prepares to write rules for four main areas of concern: food facilities, animal feed facilities, foreign supplier verification programs and produce safety rules.
A recent editorial in The New York Times criticized the administration and the Office of Management Budget (OMB) for failing to meet a January 2012 deadline to publish drafts of proposed rules to allow for public comment. Joseph Levitt, a partner at Hogan Lovells US LLP in Washington, D.C., said it's not surprising that it has taken FDA a long time to promulgate the proposed rules for the four main areas of concern.
"I think that FDA is trying to presentthemasanintegrated whole," said Levitt, who worked at FDA for 25 years before joining Hogan Lovells in 2004. "The common theme throughout all four of these is how to put in place strong preventative controls, so that we can prevent food safety incidences from occurring and not just react after they happen."
Levitt anticipates that the proposed rules for FSMA will be released this summer. A period of public comment would follow. The norm is 90 days for public comments, sometimes longer depending on the complexity of the information.
"The new regulations will inevitably result in higher costs," Levitt said. "The FDA is required to do an economic analysis and show that the proposed benefits outweigh any proposed costs. When the regulations come out, it's something that the industry should pay particular attention to and comment on."
Levitt said that traceability was a late addition to FSMA, and FDA is having traceability pilot projects conducted by the Institute of Food Technologists (IFT).
"This is particularly challenging for products that get co-mingled along the way," Levitt said. "So what the law did on traceability, it recognized that nobody knows the perfect way to do this yet. So Congress told the FDA to conduct some pilot projects. They're actually being done by the IFT.
"When the law was developed, traceability was one of the last things that got figured out," he said. "So it was the most recent topic on people's minds when the law got passed, so a lot of people thought that's what FDA would then do first. So the reality is, it's going to be prevention first, traceability second."
Levitt said it probably will be at least another year before we see the final rules and regulations of the FSMA take effect.
Meanwhile, some sections of FSMA are already in effect without regulations. Following a poor inspection, companies will be required to reimburse the FDA for follow-up inspections at a rate of $224 per hour.
"Staying in compliance is important from an economic standpoint as well," Levitt said.
Dan Vache, vice president of supply chain management for United Fresh Produce Association, sits on the Institute of Food Technologists panel that's doing pilots for FDA. Vache had returned from an IFT review meeting in Washington, D.C., in the middle of April and said IFT had to present a report to FDA in the next 45 days. Vache said that it's difficult to predict what FDA is going to do.
"They have to report back to Congress after July 4 and they have to be prepared to present to the Senate what they're going to do with the FMSA," he said. "That includes a number of different variables. One of them is traceability in foodstuffs."
Vache's advice to growers:
"Wait and watch," he said. "That's what we're all doing, and as soon as we can get that released, that's when we start doing the work to look at it and see what they've put out there."
Vache said the Produce Traceability Initiative continues to gain deliberate and methodical support within the food industry.
"We've probably got 20 percent of the industry that is now labeling their cases as we put out on the recommendations and best practices from the PTI," he said. "That's continuing to gain traction."
Vache said FDA has taken notice of the trend and wants input from business on the best path to traceability practices.
Eli Wollman, farm manager for Warden Hutterian Brethren Farms in Washington state, said traceability is of the utmost importance on his farm, and should be for every farmer.
"The reason why is because of all the different chemicals being used on crops," he said. "All the records have to be kept on what is put on each circle every year."
Wollman said that his farm works with his inputs supplier, Simplot, to keep an accounting of all fertilizer, fungicides and herbicides used. He said traceability practices lead to a more efficient and cost-effective farming operation.
His advice to farmers is to get with the program.
"It's here to stay," Wollman said. "Avoiding the issue isn't going to solve or conquer the problem. That's a necessity that they're going to have to adapt to, or else they'll be out of business."