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FDA Report May Herald Increase in Authority

In the wake of a report that describes the Food and Drug Administration's ability to protect the food supply as alarmingly inadequate, the agency may soon find its powers will be expanded to help it tackle issues of food safety. A report by an FDA subcommittee titled FDA Science and Mission at Risk declared that the agency does not have the resources to fulfill its mission of protecting

WASHINGTON — In the wake of a report that describes the Food and Drug Administration's ability to protect the food supply as alarmingly inadequate, the agency may soon find its powers will be expanded to help it tackle issues of food safety.

A report by an FDA subcommittee titled “FDA Science and Mission at Risk” declared that the agency does not have the resources to fulfill its mission of protecting the nation's food supply, and that it was bogged down with antiquated technology that may have interfered with its communications efforts during some of the product recalls of the past year.

“In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk,” the FDA report concluded.

The report came as the industry expects additional Congressional action on the issue of protecting the nation's food supply, which could include granting the FDA the power to mandate product recalls and other expansions of its authority.

“The FDA is likely to get some more funding, and with more funding comes more enforcement,” said Robert Hahn, a principal in the law firm of Olsson, Frank and Weeda, Washington, during a seminar on food imports last week (see Page 20).

The FDA, with a 2007 budget of $1.6 billion, has more resources than the U.S. Department of Agriculture, with which it shares responsibility for food safety, but the FDA oversees a much larger universe of products and companies. That budget figure, when adjusted for inflation, is actually $300 million less than it was 20 years ago, the FDA report stated.

“I think [the FDA report] will certainly strengthen the case on Capitol Hill that additional funding needs to be provided in some form,” said Tim Hammonds, president and chief executive officer, Food Marketing Institute, Arlington, Va.

FMI supports some broader regulatory authority for the FDA and an increase in the agency's funding, he said, provided the funds appropriated for improving food safety are actually applied to that purpose and not shifted “over to the drug side.”

Hammonds said FMI looks to the FDA to provide guidelines that producers should follow, while its retail members can help ensure that their vendors adhere to those guidelines by incorporating them into their buying specifications.

“It's not just a government job, it's a farm-to-table problem that needs a farm-to-table solution, and private industry has to play an increasingly important role in that whole process,” he said.

Cal Dooley, president and CEO, Grocery Manu-facturers Association, Washington, said GMA “welcomes the conclusion of this report: Science is FDA's most important tool, and it cannot be fully effective without the resources to support science, hire trained people and use information technology to support food safety.”

GMA has recommended adding $450 million over the next five years to the FDA's budget for food safety, according to the FDA report.

Congress this year introduced several pieces of legislation that included calls for broader powers for the FDA, and Hammonds said additional legislation could be introduced by year-end and early next year.

The FDA report, originally developed by a subcommittee of the FDA's science advisory committee, was said to be one of the more harshly worded of its type and follows a year in which a series of product recalls, from pet food to peanut butter, overwhelmed the agency's capabilities.

“The nation's food supply is at risk,” the report concludes. “Crisis management in the FDA's two food safety centers, Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), has drawn attention and resources away from the FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance and conduct emergency outbreak investigation activities to protect the food supply.”

The report states that the FDA's antiquated methods of keeping paper records in warehouses slows its communications efforts and often results in data being lost.

“Many of the FDA systems reside on technology that has been in service beyond the usual life cycle,” the report states. “Systems fail frequently, and even email systems are unstable — most recently during an E. coli food contamination investigation. More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt).”

The FDA itself published a “Food Protection Plan” last month in which it seeks to add several powers to the scope of its authority, such as empowering it to issue mandatory recalls, which is supported by FMI.