However, this year, the number of shipments is expected to grow to 25 million! It means that  2/3 of all fruits and vegetables and 3/4 of all seafood consumed in the United States now come from outside the country!
WASHINGTON — In her first two years as Food and Drug Administration commissioner, Dr. Margaret A. Hamburg has repeatedly expressed alarm about waves of imported food and drugs overwhelming her organization’s ability to monitor them. But she had not provided a strategy to deal comprehensively with this problem — until now.On Monday, the F.D.A. released a rare special report titled “Pathway to Global Product Safety and Quality”that is likely to win praise not so much for the four “building blocks” it outlines for dealing with imports but for the open and direct way it acknowledges the problem opening the gate fo rthe solutions. The  world has changed significantly, and the F.D.A. has to raise up to the challenge transforming itself. Just look at basic numbers  that show a scary picture:A decade ago, the F.D.A. was responsible for inspecting about five million shipments annually coming through a few hundreds ports! However, this year, the number of shipments is expected to grow to 25 million! It means that  2/3 of all fruits and vegetables and 3/4 of all seafood consumed in the United States now come from outside the country.

Government investigators estimated in 2008 that the F.D.A. would need 13 years to check every foreign drug manufacturing plant, 27 years to check every foreign medical device plant and 1,900 years to check every foreign food plant at its rate of inspections at the time. And with imports growing faster than the agency’s inspection force, those numbers have only mounted.

Many popular over-the-counter medicines and vitamins are made almost entirely in Chinese plants that the F.D.A. has never inspected. Domestic suppliers often maintain that they test their imported ingredients rigorously, but such sampling is akin to testing a bucket of soil from a mountain, then declaring the entire mountain free of pollutants.

And once these products reach American shores, almost nothing is done. The F.D.A. has a few hundred inspectors — not even enough for every port. The most they know about the vast majority of imports is a brief description on a computer screen. They crack open a tiny fraction of all shipments and send to the agency’s laboratories an even tinier fraction. Less than one pound in a million of imported seafood even gets a visual inspection.

Monday’s report acknowledges that “the safety of America’s food and medical products remains under serious threat.” It lists a few recent and deadly scares: contaminated heparin, a blood-thinning drug, from China; counterfeit glucose monitoring strips; andtainted pet food from China.

The F.D.A. won new powers to police foreign foods in legislation signed by President Obama in January, but with those new powers came new responsibilities. The law directed the agency to inspect at least 600 foreign food facilities within a year, then increase that number every year afterward. But instead of increasing the agency’s budget to perform those inspections, House Republicans voted last week to cut it.

“While the goal may be attainable in the first year, it would be impossible for F.D.A. to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the report notes.

Many in the food industry, angered by contamination scares that have cost hundreds of millions of dollars, have volunteered to pay fees directly to the F.D.A. to underwrite more inspections. Consumer groups have cheered this suggestion. But some Republicans in the Senate have so far refused to consider such fees, calling them an unacceptable tax. Polls have shown overwhelming and bipartisan support among voters for strengthened federal oversight of the food system.

So in the absence of the people and money needed to perform the agency’s functions adequately today, Dr. Hamburg has proposed creating “global coalitions of regulators dedicated to building and strengthening the product safety net around the world,” the report states. To support this network, “F.D.A. intends to develop a global data information system” so regulators can talk to one another.

The F.D.A. already has some limited cooperation agreements with regulators in Europe and elsewhere, and it has recently stationed employees in China, India and Central America. Closer cooperation between the F.D.A. and European authorities, for instance, could spare manufacturers and governments the expense of repeated inspections of the same plants. And better sharing could allow the findings of an alarming audit by one country to alert others to problems.

But Chinese authorities have in some instances refused to cooperate with F.D.A. investigations of counterfeit ingredients, and other countries have corrupt or largely nonexistent regulatory authorities with which to cooperate.

Carl R. Nielsen, who retired as the director of the agency’s import operations in 2005, said the plan sounded reasonable as far as it went. But before the F.D.A. can consider communicating regularly with Brussels or Beijing, he said, it needs to start talking with its offices in Texas and California.

“Until you repair the in-house computer system, how are you going to create an international one?” Mr. Nielsen asked.

Indeed, a computerized alert system for imports that was started at the F.D.A. in 2001 is still not complete. But Dr. Hamburg said in the interview that despite possible budget cuts and challenges domestically, the agency has no choice in becoming more globally engaged. And just stepping up inspections at the border will not be enough, she said.

“It’s all very nice for people to feel that we have one of the safest food supplies in the world,” she said, repeating a phrase that House Republicans used to justify cutting the agency’s budget. “But we really need to recognize that our food is increasingly coming from this complex supply chain and coming from parts of the world where there are not as robust standards and practice. And we cannot be complacent.”