House Committee On Energy And Commerce, Subcommittee On Oversight And Investigations: Can The FDA Assure The Safety And Security Of The Nation's Food

Statement

House Committee On Energy And Commerce, Subcommittee On Oversight And Investigations: Can The FDA Assure The Safety And Security Of The Nation's Food Supply? --Part 2

REP. ED WHITFIELD (R-KY): Chairman Stupak, thank you very much for holding this important hearing on the ability of the FDA to protect the safety and security of America's food supply.

Recent problems with imports in our food supply have been making national headlines, and I must say that a lot of those headlines comes from China. Tainted wheat gluten originating in China was found to be killing animals in America. Since then, China shipments of -- Chinese shipments of toxic toothpaste, toys and seafoods have caused safety scares in America.

In 2004, bogus baby formulas killed dozens of infants in China. More recently, the Chinese media have reported half a dozen dead and many ill from a flawed antibiotic, 11 dead from tainted injections, 56 people ill from contaminated meat, toxic snacks pulled off shelves, and fake blood protein discovered in hospitals. Now, that's all domestic in China.

And in May, the head of the agency that regulates Chinese food and drugs was sentenced to death and was executed for abruptly -- for accepting bribes in exchange for licenses, produced fake drugs and medical devices. He was executed, but we don't know what happened to those people who did the bribing.

The general administrator of inspections and quarantines in China, China's standard watchdog, said that 20 percent of their domestic products have failed to meet safety standards. That kind of information should cause us pause to what's coming into America from China.

Now, the FDA has the responsibility of regulating the safety of all domestic and imported articles used for food and drink, except for meat and poultry. And these include both animal and human foods. This means that FDA oversees 80 percent of the nation's food supply. But the information I have, they only have 20 percent of the U.S. food safety budget. The U.S. Department of Agriculture has the biggest part of that budget.

And over the past 35 years, as biotechnology became a focus of FDA regulation, the food safety share of FDA's budget declined from about half of FDA's budget to about a quarter. As FDA's resources for food safety have declined, America has become more of an importer of food products.

Food imports have risen 15 percent annually over the last 10 years. And it is suggested that today, literally 50 percent of our food supply is imported. And so FDA has received more than 10 million imported food entries in fiscal year 2006. And just over 1 percent of those shipments were physically examined.

FDA's main mission in food imports is, if possible, to prevent or lessen the chance of public health risks from FDA-regulated imports. FDA has relied upon border operations as a primary line of defense. The surge in volume, variety and complexity of imports as well as threats of terrorism are good reasons to overhaul FDA's system for the 21st century.

Dr. Mark McClellan, when he was FDA commissioner, was right, I believe, when he said that FDA needed to adopt a risk-based import system to replace the current import program.

Unfortunately, in 2007, FDA lacks the health and safety information to make systematic risk-based decisions. FDA makes initial screening decisions based only on the import's invoiced data, which is limited to seller, a description of the goods, and identification of the buyer. Recall information, laboratory results, facility inspection histories and publicly available information related to possible adulterated products from specific regions are not used to make decisions on which shipments to inspect.

FDA needs also to profile food control agencies in foreign countries, understand what they do and where they are developing new programs. Such a systems approach was recommended by the GAO in 1983 for the Department of Agriculture's food safety and inspection service.

Second, FDA should establish an online training course for foreign regulators and food processors on good manufacturing practices.

FDA may not be effectively using the authority even that it has today.

While the Bioterrorism Act of 2002 gave FDA dramatically more authority over imported food, it took FDA five years before it invoked the act's authority for the first and only time in the pet food investigation.

There may also be gaps in FDA's law. Congress should pass legislation to make clear that FDA has the authority to prosecute foreign food producers who tamper with food bound for the U.S., even when these acts occur outside U.S. territory.

I would like to thank at the outset all of our witnesses today, including FDA Commissioner von Eschenbach, who have come this morning to talk about the steps that FDA has taken and will take in the future to further increase the safety of our food supply.

We appreciate the witnesses' testimony. We look forward to it.

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