Editor's Plate: Where's the FDA's New Funding?

The Food Safety Modernizaton Act has become one of the victims of feuding in Washington. Is good enough good enough?

By Dave Fusaro, Editor in Chief

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August 18 was an historic day. On that date, the FDA issued a detention order for spices, tamarinds and chili products at a food storage warehouse owned and operated by Bonaterra Products Inc. of Maywood, Calif., after inspectors found evidence of live and dead insects in food products. Why historic? The action was the first use of the detention authority as revised by the Food Safety Modernization Act, signed into law by President Obama in January.

Where the agency will get funding for future enforcement actions is anybody's guess, however.

FSMA has become one of the victims of the budget crisis and partisan feuding in Washington. The original act was passed by both houses of Congress in late 2009, riding a wave of bipartisan support and urgency, given some then-recent food recalls. Then health care reform and a sagging economy got in the way of reconciliation of the House and Senate bills.

But the final bill got passed, just before Republicans took control of the House. FSMA was rightly heralded as the biggest change in food safety laws since the FDA was created as part of the Food, Drug and Cosmetic Act of 1938. At least the bill as passed fits that lofty description. What gets enacted looks like it will fall far short.

The biggest changes in 70-some years don't come without price tags; in this case, it was $1.5 billion over the next five years. Now, as Cuba Gooding Jr. said in the movie: Show me the money.

Part of the money was to come from the larger food industry, from fees assessed not just on processors but also on grocers, foodservice and especially importers. But at least part of the funding, and certainly the seed money, was to come from Congress. Meaning it was to come from taxpayers. And a Republican-controlled House (filled with or frightened by Tea Party members) doesn't appear keen on that idea.

[The} FDA is likely to push forward on the regulation-writing -- they are not exactly free but they can be accomplished with current resources. The inspection mandate is certainly dependent on new funding and so will lag behind until new funding is available.

– David Acheson

Even recalls of cantaloupes, ground turkey and romaine lettuce have not moved Congress to open the checkbook for FSMA.

For better or worse, it does increase the size of government – a heretical thing to say these days (although not so bad in 2009). Probably the biggest change was giving FDA the power to order a recall, rather than strongly suggest one. That little deficiency shocked most consumers as they followed reporting on the food safety act. But as we said in the first paragraph, the agency now has that authority at little or no cost. Is that alone enough change?

An equal headline-grabber was the legions of new FDA inspectors who were going to make our country's food supply safer. Those 2,000 new bodies are nowhere to be found, as invisible as the money to pay them.

But the agency does seem to have stepped up scrutiny of imported foods. One of the new rules the agency declared for itself is the requirement that anyone importing food into the U.S. must inform the FDA if any country has refused entry to the same product, including food for animals. This should help the FDA to target foods that may pose a significant risk to public health. This new reporting requirement will be administered through the FDA's prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Gone is the idea of full supply chain visibility. Simple one-up, one down track-and-trace systems were supposed to be gradually replaced. Pilot systems were supposed to be tested, with full visibility coming down the road. That road appears to be closed now.

Is this good enough? It'll have to be, says David Acheson, who as associate commissioner for foods was FDA's highest-ranking food safety czar and an architect of FSMA. He left the agency and is now at a consulting firm, Leavitt Partners (www.leavittpartners.com), where he advises on food and import safety. He spoke at Pack Expo Las Vegas in September.

I caught up with him in the booth of Plex Systems and pushed him for an assessment of FSMA. "FDA is likely to push forward on the regulation-writing -- they are not exactly free but they can be accomplished with current resources," he told me. But "the inspection mandate is certainly dependent on new funding and so will lag behind until new funding is available.

"Overall, yes, we are better off than we were last year," he concluded. "The ball is moving forward but not at a fast rate with regard to the total solution -- regs and enforcement capacity."

Better than we were. But not as good as we can be. Is that good enough for you … and your customers and consumers?

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