PROVIDENCE–With implementing regulations held up at the White House’s Executive Office of Management and Budget (OMB), officials at the U.S. Food and Drug Administration (FDA) are finding themselves able to talk only in generalities about the nation’s new food safety law.
That’s disappointing to some attending the International Association for Food Protection (IAFP) meeting this week at the Rhode Island State Convention Center.
The new U.S. Food Safety Modernization Act (FSMA) was passed by bipartisan majorities in Congress and signed by President Obama in January 2011, but implementation details have not been widely shared outside the federal government.
FDA’s James Gorny Tuesday spoke to IAFP on “preventive controls to local produce” under FSMA, but he had to start out by acknowledging that everything remains in a “deliberative phase.”
For the time being, Gorny said, there is “no implementing regulation for produce.” He said OMB’s job is to coordinate federal regulations across the federal government and he suggested in this case the issue might be lining up FDA’s newly proposed regulations with USDA and the U.S. Trade Representative.
The produce safety rule should have taken effect last January, one year after Obama signed FSMA into law. It’s been in limbo at OMB ever since along with other implementing regulations.
Gorny says the draft is intended to be the “rules of the road” for the produce industry with three overall goals: reducing the public health burden of produce-related foodborne illness, eliminating disruptions for farmers and shippers and increasing consumer confidence.
“We understand that one size is not going to fit all,” Gorny said.
The so-called Tester-Hagen amendment language included in the new food safety law exempts small producers selling directly to the public through farmer’s markets, roadside stands and the like so long as those transactions are in the same state or within a 275 miles radius.
Small is defined as an operation with gross sales under $500,000 a year.
“We have no leeway,” Gorny said of the exemption. “It is what it is and it is nothing other than that.”
He did says that small producers will have to pay attention to labeling requirements because they are not exempt from those. Depending on the situation, these producers will be required to label packages and in other instances they will be required to provide signage.
FDA’s produce regulations are going to be flexible, according to Gorny. He said they would focus on setting standards in a structure much like that used by the USDA Organic program. They will also target the coastal areas where most fruits and vegetables in the U.S. are grown.
Gorny said fruit and vegetable producers would not have to worry about the FDA produce rule conflicting with other laws. “We cannot be in conflict with other federal rules,” he said
There will be some focus on specific commodities, in part to exclude some low risk produce from oversight.
In addition to the produce rule, OMB is holding up the final rule for foreign supplier verification, another rule covering preventive controls, and one concerning animal feed. All are now well past the deadlines established in the new law.© Food Safety News