PORTLAND — In 2015, federal regulators will pivot from writing food safety rules to implementing them, experts say.
The U.S. Food and Drug Administration must finish key rules for food manufacturing and produce safety by this autumn to comply with a court order.
Agency officials are preparing to “hit the ground running” when the rules are completed, said Miriam Burbach, FDA’s Seattle district compliance director.
This year will mark “phase two” of the FDA’s implementation of the Food Safety Modernization Act, which was enacted in 2011, Burbach said during the Northwest Food Processors Association’s annual conference here Jan. 12.
Until now, during “phase one,” the agency has focused on developing food safety standards, which have been revised due to feedback from the food industry, she said.
Implementation of these rules will be gradual for farmers and processors, who will be given at least a year to comply with the final regulations after they’re published.
Enforcement will be rolled out over time, with the largest firms expected to be ready the earliest, Burbach said. “Compliance dates are staggered based on business size.”
The FDA plans to “educate before and while we regulate,” providing companies with technical assistance in their food safety practices, she said.
Companies will be given “regulatory incentives” to comply with the rules — firms with a solid history of following the rules will be rewarded with shorter or less frequent inspections, Burbach said.
Those with poorer records will receive more scrutiny “until we’re on the same page regarding public health,” she said.
Food manufacturers are generally well prepared for rules aimed at preventing contamination, said Stephanie Page, food safety and animal welfare program director for the Oregon Department of Agriculture.
Farmers, however, will largely be new to federal oversight of their food safety practices, Page said.
“Our greatest implementation challenge is going to be the produce rules,” she said, referring to pending regulations aimed at fruits and vegetables that are typically eaten raw.
The ODA and other state farm agencies expect to help implement the Food Safety Modernization Act, but their role will depend on federal funding, Page said.
“It’s not something we can take on without federal resources to support that work,” she said. “Our existing food safety staff has very full plates.”
Discussions about the level of federal funding and the additional duties required of ODA are still ongoing, Page said.
It’s heartening the FDA has been willing to revise controversial provisions such as requirements for irrigation water testing, which some farmers said were too burdensome, she said.
“The FDA has really listened to those concerns,” she said.
The original water testing rules required weekly testing and set a hard limit for bacteria levels, Page said.
Water that exceeded that microbial standard would have to be treated or irrigation would have to cease, she said.
Now, the FDA has changed its approach by allowing farmers to sample water over a longer period of time and conduct a statistical analysis to determine its safety for irrigation, she said.
Growers will also have more options for ensuring safety, like waiting for a certain period of time after the final irrigation before harvest, Page said.
While the rules are more flexible, they’re also more complicated than the previous proposal, she said. “Just because FDA has backed off a little bit, they’re not giving you a free pass.”
Charles Breen, a food safety consultant and former FDA official, has urged software companies to devise programs to assist farmers with such statistical computations.
“It’s more than grade school math,” he said. “I’m telling them there may be a market for growers to have a handy tool.”
The change in FDA’s water testing strategy was influenced by dry bulb onion producers, who feared they would not be able to economically comply with the agency’s original proposal, Breen said.
The agency is wrestling with trying to ensure the safety of food while ensuring that producers can make a living growing it, he said.
In the case of dry bulb onions, the FDA recognized that the interval between final irrigation and harvest can act as a kill step for diseases, Breen said.
FDA is giving the food industry latitude in its food safety practices rather than being overly prescriptive, said Donna Garren, vice president of regulatory and technical affairs at the American Frozen Food Institute.
In exchange, the agency expects companies to understand their safety systems and be able to defend them, she said.
“It requires more work and more decisions based on science,” Garren said. “You’re going to create your program. You’re going to have the science to support your decisions.”