Friday, July 13, 2007

The Food and Drug Administration, the agency responsible for most of the food that comes into the U.S., inspects between 1 percent and 2 percent of that food.

The agency is drawing criticism as concerns rise about tainted imports of Chinese food and drugs, from toothpaste to seafood to pet food that is blamed for the deaths of dogs and cats.

Former Associate FDA Commissioner William K. Hubbard said the recent problems with Chinese food imports “should be a wake-up call to official Washington.”

“If they don’t get it at this point, that a weak FDA threatens us all, then they’re really blind to the facts,” said Mr. Hubbard, who worked at the FDA from the Jimmy Carter through the George W. Bush administrations.

FDA inspections of animal, infant and human food from 2002 to 2006 varied between 1.15 percent and 1.88 percent, according to Domenic Veneziano, the FDA’s director of import inspections and policy.

Inspections of all products that the FDA supervises, including such products as drugs, cosmetics, medical devices and electronic products that emit radiation, range from 0.8 percent to 1.3 percent.

The FDA regulates all foods except most meat and poultry — limiting its regulation in this category to game, such as venison, ostrich and snake, which is the only meat not already regulated by the Agriculture Department. Altogether, the FDA oversees 80 percent of the U.S. food supply, a percentage that FDA spokeswoman Julie Zawisza said is “probably similar” for food imports.

The percentage of inspections is somewhat misleading, however, because the FDA tracks “import lines,” which are products in one shipment, rather than import volume. A truck containing 500 bags of flour, 300 cases of tomatoes and 10 boxes of cantaloupes would have three such “lines.”

The amount of lines FDA inspectors are responsible for has jumped from just under 2 million in 1991 to an estimated 16.3 million this year.

Food imports have risen 15 percent annually over the last 10 years.

The FDA’s budget, although it has climbed, is not keeping up.

FDA money and staffing for inspection of food imports rose after the September 11, 2001, terrorist attacks. Spending on inspections after that initial jump has increased from $63.1 million in fiscal 2003 to an estimated $67.2 million for fiscal 2007, which ends Oct. 1, but critics say food safety increases have not kept up with inflation.

The number of full-time inspection positions has dropped. Although the number of jobs jumped from 217 in fiscal 2002 to 536 in fiscal 2003, it has since dropped to an estimated 463 in fiscal 2007.

Ms. Zawisza said the FDA is “very committed to food safety” and has “dedicated many staff hours and resources toward this program area.”

“Actually, the systems we have in place are working very well to identify unsafe food products, whether imported or domestically produced, and we have acted extremely quickly to resolve the problems we have seen,” she said.

An estimated 76 millions Americans get sick each year from food-borne illnesses, according to the Centers for Disease Control and Prevention. Of those, more than 300,000 are hospitalized and 5,000 people die.

Mr. Hubbard said it would be fair to say that a significant portion of food-borne diseases can be tied to imports, “but to try to then burrow down to the next level, which is, show me, give me a number, I think is really hard.”

Sen. Richard J. Durbin, Illinois Democrat, yesterday introduced legislation that would generate revenue for the FDA’s import inspection program by charging fees to companies and countries sending food to the U.S.

“One of the biggest obstacles FDA faces in the struggle to ensure food safety is the lack of funding they need to get the job done right,” he said. “While the volume of imports has nearly doubled over the last three years, the number of FDA inspectors has been steadily decreasing. … The system needs to be fixed immediately.”

FDA critics say the rate of food inspections is too low and that the inspection program is badly focused.

They also say FDA inspectors make their initial screening decisions only on the basis of imports’ invoice data, which is limited to the seller, a description of the goods and identification of the buyer.

Recall information, laboratory results, facility inspection histories and publicly available information related to possibly adulterated products from specific regions is not used to make decisions on which shipments to inspect, said consultant Carl Nielsen, a former director of the FDA’s Division of Import Operations who also worked for the agency from the Carter through George W. Bush administrations — although it would be used in a system that the FDA is testing.

Much of that information is available from open sources, third parties, foreign governments or other U.S. agencies, said Benjamin L. England, former FDA regulatory counsel.

“Virtually none of it is used in the entry screening process,” according to Mr. England, who worked for the agency during the Ronald Reagan through the George W. Bush administrations and is now a lawyer in the Washington offices of Jones Walker. He founded the consulting organization with Mr. Nielsen.

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