WASHINGTON, Sept. 16, 2015 - Increased funding that Food and Drug Administration officials say is critical to implementing sweeping new food-safety regulations will be at stake in this fall’s budget negotiations.
A key Senate budget writer assured FDA officials on Wednesday that he will make it a priority to give the agency more money if the White House and congressional Republicans reach an agreement to raise budget caps.
The White House asked Congress for $109 million in additional spending, a 9 percent increase, in fiscal 2016 to implement a series of major new rules needed to carry out the Food Safety Modernization Act. Bills pending in the House and Senate would provide at most $45 million of that amount.
“Successful implementation does not come without a cost,” the chairman of the Senate Agriculture Appropriations Subcommittee, Kansas Republican Jerry Moran, said at a special hearing Wednesday on implementation of the law. He said extra funding for FSMA implementation would be a “significant” priority for appropriators if they have extra money to spend. Moran’s home state was hit the hardest by a recent listeria outbreak linked to ice cream produced by Texas-based Blue Bell Creameries. Kansas had five of the 10 cases blamed on the product, and three of the Kansas patients died, according to the U.S. Centers for Disease Control and Prevention.
FDA released the first two major rules last week and five more will be released in coming months under court-ordered deadlines. The first two rules set standards for preventive controls that must be in place for the manufacture of human food and animal feed. Regulations for growing and packing produce are due out in October, as is a rule for foreign supplier verification. The extra $109 million is needed to hire additional personnel and provide the training and other resources that will be needed to carry out the increased inspections and auditing that the rule requires, FDA officials told the subcommittee. “Unless we receive the total amount of the request something is going to have to give,” said Stephen Ostroff, the FDA’s acting commissioner. About $50 million of the spending request is needed for implementing the preventive control rules, the agency has told Agri-Pulse. That funding would be focused on ramping up FDA and state inspection programs and for training. An additional $30 million is needed to pay state agencies to enforce the produce standards. The rest of the money is earmarked for increasing oversight of imports. FSMA is fundamentally changing the way the agency operates. For example, FDA inspectors are being re-trained to specialize in specific food commodities rather than trying to oversee the broad spectrum of FDA-regulated products. The Senate’s Agriculture appropriations bill, which funds USDA and FDA, would provide an extra $45 million for FSMA implementation, while the House version contains $41.5 million more. Fiscal 2016 begins Oct. 1 but Congress has yet to pass any funding bills for the new year because Democrats insist on raising the spending limits imposed as part of a 2011 budget agreement. Republican leaders say they are willing to discuss a deal but it isn’t expected to be finished before December. FSMA was enacted in early 2011 without a source of funding after the Congress, then under Democratic control, couldn’t agree on a revenue source. That left the funding for the law to the whim of appropriators. Members of the Senate subcommittee sought assurance that FDA would ramp up its regulation of imported foods at the same time that it increases its inspections and oversight of domestic farmers and processors. Oregon Sen. Jeff Merkley, the panel’s top Democrat, noted that FDA was supposed to conduct 19,000 foreign inspections in 2016 but would actually do as few as 1,200. “This law will not successfully work,” said Ostroff, “unless we can assure total equity between food that is produced overseas with food that is produced domestically.” Mike Taylor, FDA’s deputy commissioner of foods, told reporters after the hearing that the 2016 funding request included money for hiring the field staff needed to carry out the foreign supplier rule. It will take effect in fiscal 2017, but the additional personnel need to be hired in fiscal 2016, he said. #30
