By John Reichard, CQ HealthBeat Editor

Calling a new report on under-funding of the Food and Drug Administration “about as fierce an indictment in terms of a government agency as I’ve seen in 45 years of being in the United States Senate,” Sen. Edward M. Kennedy , D-Mass., challenged the Bush administration Tuesday on the urgency of its response to gaps in the U.S. food safety system.

“The FDA does not have the capacity to assure the safety of food for the nation,” the Senate Health, Education, Labor and Pensions Committee Chairman said during his panel’s hearing, and repeatedly reminded Health and Human Services Secretary Michael O. Leavitt of that conclusion made in the report, released Monday by the FDA Science Advisory Board (See related story, CQ HealthBeat, Dec. 3, 2007).

“Instead of improving matters, the White House is poised to make them worse by threatening to veto the very bill that funds FDA,” Kennedy said.

“We could not be responding more rapidly,” replied Leavitt, asserting that FDA is already implementing elements of a new food safety plan and saying he wants to work with Congress to give the agency new legislative authority to respond to food hazards.

Leavitt also said he is seeking “substantial” added resources for federal food safety efforts, but acknowledged the limits of his power. “History tells me I usually don’t get as much as I ask for, but I expect there will be more in this budget,” he said of the administration’s upcoming budget request.

Meanwhile, he deflected Kennedy’s attack by simply acknowledging that the current food safety system needs major improvements. “We have a good system,” Leavitt said, but “it is not adequate for the future.”

But Kennedy differed with Leavitt over the adequacy of the administration’s response, which includes a trip Friday by Leavitt to China to sign agreements on the standards Chinese products must meet to be sold in the U.S. market. Kennedy said those treaties don’t protect the American people if basic computer equipment at FDA is too antiquated to coordinate with the various players needed to assure food safety in the United States. The report cited several inadequacies in the agency’s IT infrastructure.

Leavitt also acknowledged that FDA’s information systems are deficient. “There are times the FDA can’t get the information it needs from the Department of Agriculture,” he said.

Other Democrats also challenged the “FDA Food Protection Plan.” Sen. Tom Harkin , D-Iowa, said “I’m very encouraged by some of it,” he said, but voiced concern about inconsistent standards governing imports for meat, poultry, and eggs on the hand and other foods on the other.

The Department of Agriculture requires that meat, poultry and eggs brought into the country must be produced under safety standards equivalent to those in the United States, but no such standards exist for other food products, whose safety is overseen by FDA, Harkin said. He added that not only are those foods subject to less stringent standards, very few of them — under five percent, he said — are inspected when they come into the United States.

“Maybe it is time to think about a single food inspection agency,” Harkin said. He also expressed support for legislation that would sunset FDA’s food safety program, in effect forcing the creation of an entirely new food safety system. “Maybe by sunsetting everything it would force Congress to finally do something,” he said.

But Leavitt said “We will never inspect ourselves to safety,” noting that the volume of food imports is much too large for that to happen. And he sought to put safety concerns about the rising tide of imported foods into a larger context, observing that with globalization, many countries are struggling to find new ways to assure safety.

Leavitt said the focus needs to be on preventing food safety threats from occurring in the first place. “We need to build quality in every step of the way,” he said. He called for a voluntary certification process in which products could be certified as meeting U.S. safety standards by “trusted” organizations.

“In addition, if HHS is provided the necessary authority, importers of certain high risk products could be required to certify that those products meet certain standards before they are exported to the U.S.” Leavitt said in his written testimony. He added that more U.S. inspection personnel are needed in ports abroad, and that stronger penalties are needed for unsafe imports.

Leavitt also confessed his surprise at learning that FDA lacks the authority to mandate recalls of unsafe foods. The agency has relied on the power to publicize unsafe foods to force manufacturers to recall unsafe products, but in some cases that hasn’t worked. The administration’s new food safety plan calls for giving the agency the power to mandate recalls if food concerns don’t agree to do so voluntarily.

Sen. Patty Murray , D-Wash, said there are too many voluntary elements to the administration’s plan, however.

Republicans on the panel agreed with Democrats on the need for legislation, but warned against exaggerating food safety concerns. “Hysteria and massive recalls based on incomplete information cost small producers hard-earned profits,” said Sen. Michael B. Enzi of Wyoming, the panel’s top Republican. “That’s not the answer. We must improve coordination among all the agencies and businesses responsible for producing, testing, and inspecting food before it arrives at the kitchen table.”

Enzi added that improvements are needed in testing and inspection capabilities and that “new authorities” for FDA should be considered.

Cal Dooley, president of the Grocery Manufacturers Association, said that such authorities are needed. “We urge you to provide FDA authority to mandate that produce be produced following good agricultural practices,” he said. FDA also should be given the power to mandate recalls when a company refuses a voluntary recall and “there is significant risk to the public health.” Dooley also urged a requirement that “every food importer of record institute a foreign supplier quality assurance program that assures that all imported ingredients and products meet FDA food safety and quality requirements.”

Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a consumer group, said the new food safety plan has a number of shortcomings. “It is not enough to ask for new authority to mandate recalls but fail to ask for authority to require traceability standards and impose civil penalties so that recalls are effective,” she said.

Another shortcoming of the plan is that it fails to seek authority to “implement programs on the farm or in the country of origin,” she said.