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WILLIAM HUBBARD

The overwhelmed FDA

(John Overmyer Illustration)

THOUSANDS OF pet deaths from spiked wheat gluten, raising fears that humans could be next. Millions of shipments of imported foods from China, Vietnam, and other developing countries flooding into the country each year with no inspection by US authorities. Repeated foodborne outbreaks often resulting in deaths and severe illnesses -- from US-produced spinach, sprouts, peanut butter, and other common foods. A plummeting drop in public confidence in the government's ability to protect our food supply.

The bad news about our food seems to keep on coming, and it all points to the inevitable conclusion that the Food and Drug Administration cannot provide the protections for which it was created. What has happened to this century-old consumer protection agency that has led the way in establishing a safety net for consumer products on which Americans have so long relied?

The most common thread in FDA's declining ability to carry out its responsibilities is a steady, debilitating drop in funding. The agency is simply overwhelmed by an ever-increasing workload, constant congressional demands to do more with less, and righteous indignation when the agency fails to meet unreasonable expectations.

With the exception of FDA's drug review program, which is funded increasingly by industry "user fees," FDA's budget has been declining for a decade. Just as our schools cannot educate our children without teachers and fires cannot be extinguished without a fire department, our food supply cannot be inspected and monitored without the highly skilled scientists at the FDA.

What's the evidence that FDA is experiencing a budget crisis? The FDA is located in Montgomery County, Md. , a suburb of the nation's capital; the suburb's school board has a bigger budget than the FDA; the county's budget is twice that size. Ten years ago, Congress appropriated funds to support 9,100 scientists, but today there are 1,000 fewer, at a time in which the demands on the agency have grown and grown. The number of scientists at FDA's food headquarters office has dropped from 1,000 to 800 in just the past three years.

The story of the inspection force is even more troubling. After the 9/11 attacks, Tommy Thompson, then Health and Human Services secretary, demanded that the food inspection force at the nation's ports be improved, and 600 more inspectors were rapidly put in place to examine the burgeoning imports of food. Today, they are all gone, the victims of year-by-year budget cuts that cripple the agency's ability to do even rudimentary screening of our food.

So where are we today? There are 13 million food imports this year, with FDA able to inspect only about 1 percent. The system is so weak that many FDA professionals fear the word is out in the international community you can send virtually anything, of any quality, regardless of risk, to the United States, because no one's looking.

But exporting countries take some responsibility for what companies in their countries send to us, right? If you believe that, I have a nice bridge to sell to you. And the picture's not much better domestically. The FDA is responsible for inspecting over 200,000 food processing facilities in the United States, but because their staffing is so inadequate, they can get to most only once every 10 to 15 years.

OK, so there's no "there there" anymore at the FDA. Is there really a threat? Well, let's see. Incidences of foodborne disease, from new and lethal pathogens like E coli 0157:H7 and salmonella enteriditis , have been climbing, and the Centers for Disease Control and Prevention count 5,000 deaths annually (and millions of illnesses).

Conditions in many countries exporting food to the United States are often described as "primitive," illegal drug residues are commonly found in imported seafood, and "filth" is a routine finding when imported foods do get inspected by the FDA. China has aggressively captured much of the world's market for many of our most common food ingredients -- ascorbic and citric acid, soy lecithin, wheat gluten, propionate -- that are found every day in our cereals, candy bars, frozen dinners, bread, and baby food.

Yet China leads all other countries in the incidence of contaminated food found by FDA inspectors. One of the most common food ingredients, used in thousands of different foods, gum Arabic, comes from such unstable countries in sub-Saharan Africa as Somalia and Sudan.

Congress is scheduling hearings on food safety over the summer, and many ideas will be proposed for "fixing" the FDA. But if reversing the hollowing out of that agency does not lead the list of solutions, the safety of our food supply will not improve.

If the past is an indication, members will muster up their finest moral outrage and accuse the FDA of failing us. Wouldn't it be refreshing if, just once, the White House and Congress fessed up to the real truth -- that by letting the FDA wither away, the real failure has been theirs?

William Hubbard is a former associate commissioner of the Food and Drug Administration.

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