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.

  • Pat

    No hurry on finalizing FSMA since Tester-Hagen exempts about 95% of producers anyway (except they may have to put up a sign). It would save a lot of time and trouble if we just had the remaining 5% of producers hang a sign too, and leave it at that. Then all that’s left to wrangle over is how big the signs should be…because one size doesn’t fit all, as we have learned.

  • Ray Webb

    In March 2012-03-01, the FDA now has mandatory records access and will be able to also detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace while the agency determines whether an enforcement action, such as seizure or federal injunction against distribution of the product in commerce, is necessary.
    FDA’s Mike Taylor said to the trade;Rules took effect July 3, 2011
    The first rule strengthens the FDA’s ability to prevent potentially unsafe food from entering commerce by allowing the agency to administratively detain food the agency believes has been produced under unsanitary or unsafe conditions.
    “This authority strengthens significantly the FDA’s ability to keep potentially harmful food from reaching U.S. consumers,” said Mike Taylor, FDA Deputy Commissioner for Foods.
    After FSMA was signed into law, FDA posted on their website the section about the Park Doctrine a must-read for all owners and executives of food, feed, ingredient or beverage facilities.
    FDA has clearly signaled repeatedly that they are ramping up on enforcement actions and are actively pursuing new avenues for prosecuting individuals involved in food safety violations. Here is a link to an easy understanding explanation we found in the internet:
    Taylor also sent this response to the trade in June this year after he received letters complaining about OMB hold up the new parts of FSMA;
    Other food safety preventive controls provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations for human and animal food continue in effect. If we find a food that poses a public health risk to humans or animals, or if an inspection reveals a facility operating under insanitary conditions or otherwise failing to operate safely, we will continue to take action as appropriate under the FD&C Act.
    Michael R. Taylor
    Deputy Commissioner for Foods
    Gorny didn’t reveal the whole story!