Congress appears poised to pass food safety reform this year, but FDA Commissioner Margaret Hamburg points out the pending Senate legislation lacks provisions included in a House bill regarding essential funding and authority for the agency.

"We intend to move ahead with a markup as soon as possible and get this to the floor," said Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin during an Oct. 22 hearing on the FDA Food Safety Modernization Act, ¹ S. 510.

"Hopefully we can get this bill passed and on down to the White House before year's end," the Iowa Democrat added, citing the bill's broad support in the chamber.

Harkin, until recently chair of the Senate Agriculture, Nutrition and Forestry Committee, had said he would prioritize food safety as HELP chair (² Also see "FDA Stresses Preventive Food Safety As Senate Readies To Move Legislation" - Pink Sheet, 21 September, 2009.).

Should S. 510 clear the Senate, its differences with ³ H.R. 2749, the Food Safety Enhancement Act, would need to be smoothed over in conference committee. The House bill passed in late July (⁴ Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 August, 2009.).

While Hamburg offered support for the Senate bill, introduced in March by Dick Durbin, D-Ill., she pointed out areas where it could be stronger. The lack of general facility registration fees, which could fund the agency's enhanced inspection mandate, is a glaring omission from S. 510, Hamburg said in her ⁵ testimony.

H.R. 2749, offered by Rep. John Dingell, D-Mich., includes both general and targeted user fees. Durbin, however, has said the general user fees will not attract bipartisan support in the Senate.

"Our concern is that [S. 510] does not provide a guaranteed, consistent funding source to help FDA fulfill its new responsibilities," Hamburg said.

Hamburg also raised the issue of inspector access to manufacturer records, what she called "one of the most significant gaps in FDA's existing authority."

While H.R. 2749 would allow FDA inspectors access to view and copy food records "at reasonable times and within reasonable limits and in a reasonable manner," the Senate bill offers no such explicit authority during routine inspections.

In contrast, FDA already has routine records access for certain other regulated products, as does the Department of Agriculture for its products, the commissioner's testimony says.

"Such access is critical to our ability to assure the ongoing implementation of appropriate preventive measures and safety standards," Hamburg said.

Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, ⁶ testified that, despite the group's support of the bill, it too recommends amendments to further reinforce FDA oversight of the food supply.

Inspecting high-risk facilities once a year is insufficient, DeWaal said, adding S. 510 should institute more specific categories of risk level and inspect the highest-risk plants a minimum of once every six months to a year.

Language regarding testing and reporting requirements should also be strengthened, with facilities obligated to test for contamination as part of its preventive control plan and to report promptly any positive results to FDA, DeWaal said.

Hungry For Food Safety Reform

Harkin noted the "pretty impressive" list of consumer advocacy and industry groups that formally back S. 510. In addition to CSPI, supporters include the Consumer Federation of America, Consumers Union, Food Marketing Institute, Grocery Manufacturers Association and American Frozen Food Institute.

Though the dietary supplement industry is concerned food safety reform could saddle firms with redundant requirements on top of existing good manufacturing practices, the Council for Responsible Nutrition joined in support of S. 510.

"To date, this legislation represents what may be the best opportunity to lead a national, if not global, agreement on food-borne illness protection," said CRN President and CEO Steve Mister in an Oct. 22 statement.

- Dan Schiff ( ⁷ d.schiff@elsevier.com )

FDA Requests More Funding, Authority As Senate Preps To Move Food Safety

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