Dick Durbin: Durbin Calls for Immediate Reform of FDA Import Program

July 12, 2007 -- [WASHINGTON, DC] –U.S. Senator Dick Durbin (D-IL) today introduced legislation to strengthen the Food and Drug Administration’s (FDA) ability to monitor and inspect goods that enter the United States from abroad by imposing a fee on companies and countries exporting food products to the United States. These fees would generate revenues for inspections of imported foods and food safety research. The legislation would also require foreign firms and governments to apply for certification with FDA; only those that met standards equivalent to those of the United States would be eligible.
“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,” said Durbin. “While the volume of imports has nearly doubled over the last three years, the number of FDA inspectors has been steadily decreasing. Meanwhile, seventy six million Americans are getting sick each year from food borne illnesses. The system needs to be fixed immediately.”

Durbin noted that under the current system, any country and any company can export food products to the United States as long as they inform regulators of the shipment. There are currently no checks done to ensure that our trading partners have adequate regulatory systems. The FDA does not ensure that trading partners have equivalent standards or inspect overseas plants when problems arise. When the FDA needs to investigate an outbreak, it can be delayed by uncooperative foreign governments. During the recent pet food recall, U.S. regulators were delayed three weeks in their request for visas to inspect Chinese facilities.

Durbin added, “If you want to sell in America, you have to meet American standards.” His legislation would:

* Require FDA to collect user fees on imported food products. Revenues would be used for inspections of food imports and food safety research. While the bill would give the Administration the responsibility for determining the dollar amount of the fee, it would limit it to a maximum of $20 per line item.

o Require FDA to dedicate a portion of this funding for research on testing technologies and methods that would accurately detect the presence of pervasive contaminants such as E. Coli and listeria.
o Require FDA to establish an Imported Food Certification Program. Under this program, foreign governments and firms interested in exporting food products to the United States would be required to apply for certification. Entities would only be certified if they meet standards equivalent to those of the United States for food safety, inspection, labeling, and consumer protection and agree to allow regulators to inspect foreign facilities. Regulators would have the ability to pull certifications if companies or countries failed to comply and detain products if they failed to meet U.S. standards.

TIMELINE OF RECENT FOOD SAFETY ACTIONS:

Two weeks ago, Sen. Durbin and Congresswoman Rosa DeLauro (D-CT) sent a letter urging the FDA Commissioner, the Secretary of Agriculture, and the Secretary of the Department of Health and Human Services to establish a food safety Memorandum of Understanding (MOU) between the U.S. and China. An MOU is a legal document describing a bilateral agreement between parties.

On June 1st, Durbin sent a letter to FDA Commissioner, Andrew von Eschenbach, asking for answers to recent reports that a number of domestic feed manufacturers announced voluntary recalls of their products which contain melamine.

On May 10th, Durbin and DeLauro called for the U.S. Trade Representative, Susan Schwab, to examine the U.S. trade relationship with China in light of the questions being raised in connection with the pet food recall about China’s poor sanitary conditions and lax food safety regulations. Two companies in China were identified as the source of the contaminated wheat gluten and rice protein concentrate in the pet food recall. In the letter, Durbin and DeLauro requested that Ambassador Schwab provide information about food safety standards included in current free trade agreements and other permanent trade relations, as well as what recourse is taken when imports threaten public health.

On May 9th, Durbin and DeLauro met with FDA Commissioner, Andrew von Eschenbach, and Ambassador Zhou Wenzhong, of the People’s Republic of China, to discuss the recent food safety problems, including several contaminated shipments of food products imported from China. During the meeting, Durbin also learned of a second importer of rice protein concentrate that had received shipments of contaminated product from China. According to Commissioner von Eschenbach, Cereal Byproducts located in Mt. Prospect, Illinois, had imported contaminated rice protein concentrate from Binzhou Futian in China, and issued a recall on May 4, 2007 of all products it distributed.

On May 2nd, the Senate passed, by a vote of 94-0 as part of the FDA Reauthorization bill, the amendment introduced by Durbin that will strengthen the nation’s food safety system. Durbin’s amendment establishes an early warning and notification system for human food, as well as pet food, establishes fines for companies that don’t promptly report contaminated products, improves inspections/monitoring of imports, and provides better, more uniform pet food safety standards. Durbin’s amendment passed, as part of the FDA Reauthorization bill, by a vote of 94-0.

On May 1st, Durbin and DeLauro introduced a food safety bill in anticipation of the FDA Reauthorization bill, S.1082, coming to the floor. Durbin worked with Senators Kennedy and Enzi, and negotiated to offer a version of the bill as an amendment to the FDA reauthorization bill.

On April 23, Durbin learned that a second, unnamed, company had imported rice protein from China. Durbin asked for full disclosure of the names of all companies involved.

On April 18th, Durbin met with FDA Commissioner, Andrew von Eschenbach. At the meeting, Eschenbach told Durbin that his inspectors were having trouble acquiring visas to go inspect plants in China. Durbin wrote to the Chinese Embassy that day, asking that they expedite the process. The letter was sent on the 18th and the Chinese Embassy granted the visas on the 22nd.

On April 12th, Durbin held a Senate Appropriations Subcommittee hearing with FDA officials and industry experts to address problems in federal regulation of the pet food industry. Durbin called for the hearing on April 5th, as the wake of a widespread recall of contaminated pet food grew.

On March 26th, shortly after the first pet food recall, Durbin wrote to FDA, asking them for an analysis of their oversight of pet food manufacturing facilities and a report of actions taken since the recent pet food recall.

Senator Durbin and Congresswoman Rosa DeLauro have been actively engaged on food safety issues for over a decade. Currently, there are at least 12 different federal agencies and 35 different laws governing food safety. With overlapping jurisdictions, federal agencies often lack accountability on food safety-related issues.

Source: Senator Dick Durbin

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