EXTENSION OF REMARKS
OF
THE HONORABLE JOHN D. DINGELL

June 18, 1998

Mr. Speaker, today I am introducing the Imported Food Safety Act of 1998 which will give the Food and Drug Administration (FDA) new authority and much needed resources to protect American consumers from unsafe imported food. I am very pleased to have 15 of my Democratic colleagues on the Commerce Committee joining me as original cosponsors in introducing this important legislation. It is my sincere hope that many more Members, including my Republican colleagues, will soon join us in responding to consumer concerns over the safety of the food we eat.

U.S. food safety standards are among the highest in the world. In spite of this fact, millions of Americans each year are unknowing victims of illness attributable to food-borne bacteria, viruses, parasites, and pesticides. According to a recent General Accounting Office (GAO) report as many as 33 million Americans each year become ill from the foods they eat. We also know that many cases of food-borne illness are not reported. GAO, therefore, estimates the total number of food-borne illnesses to exceed 81 million each year. Among these cases, more than 9,100 result in death. The U.S. Department of Agriculture's Economic Research Service estimates "the costs for medical treatment and productivity losses associated with these illnesses and deaths range from $6.6 billion to $37.1 billion."

Increased media attention on food-borne illness outbreaks has turned, once unfamiliar scientific names, into household words. Recently, an outbreak of food poisoning from salmonella in cereal was reported in 11 states. E. coli 0157 has been found in apple juice and hamburger, Cyclospora in raspberries, Listeria in ice cream, Cryptosporidium in water, and viral Hepatitis A in frozen strawberries served in the school lunch program.

The population of our country is growing and changing. Exposure to food-borne pathogens is particularly dangerous for the most vulnerable members of the public, such as children, pregnant women, the elderly, HIV/AIDS, cancer and other persons whose immune systems are compromised.

The number of food-borne illness outbreaks has increased in recent years, and so has the volume of foreign food imports coming into our country. In its recent report, GAO said that the Federal Government cannot ensure that imported foods are safe. The FDA itself has acknowledged that it is "in danger of being overwhelmed by the volume of products reaching U.S. ports."

The volume of imported food has doubled over the last five years, while the frequency of FDA inspections has declined sharply during this same period of time. More than 38 percent of the fresh fruit and more than 12 percent of the fresh vegetables that Americans now consume each year are imported.

Most Americans would be alarmed to learn that just a small fraction, less than two per cent, of the 2.7 million food entries coming into this country are ever inspected or tested by the FDA. Even fewer, only 0.2 percent of food entries, are tested for microbiological contamination.

In a recent letter, however, FDA said that it "has NO assignments for monitoring imported fresh fruits and vegetable for presence of pathogenic microorganisms." [emphasis added]. In fiscal year 1997, ALL of the 251 microbiological samples FDA collected that year, were in response to food-borne illness outbreaks. NONE were for preventive detection.

The outrageous and wholly intolerable conclusion one must draw is that American consumers are being used as guinea pigs.

FDA has stated that there is a "critical need for rapid, accurate methods to detect, identify and quantify pathogens...." The testing methods currently being used at FDA can take up to two weeks to isolate and identify pathogens in food samples. What is needed are quicker detection methods, or "real time tests" that yield results in approximately 60 minutes, to identify pathogenic contamination, especially at busy ports of entry. But currently, FDA is not funding research to develop these tests, nor do they have plans to develop these tests in the future.

It is clear that FDA is lacking the necessary resources to regulate the global food marketplace. Unlike the U.S. Department of Agriculture (USDA), FDA does not have the authority to deny product entry at the border or to permit imports only from agency approved suppliers in foreign countries. The GAO reported that FDA's procedures for ensuring that unsafe imported foods do not reach consumers are vulnerable to abuse by unscrupulous importers. According to GAO, some importers ignore FDA's orders to return, to destroy or to re-export their shipments. By the time FDA decides to inspect shipments, in some cases, the importers have already marketed the goods.

In response to this crisis, the President has said FDA needs increased resources, more authority, and improved research and technology. The Imported Food Safety Act of 1998 addresses each of these points.

This legislation provides additional resources in the form of a modest user fee on imported foods to increase the number of FDA inspectors at ports of entry in the U.S. Proceeds from the user fee would also be used for a "Manhattan Project" to develop "real time" tests (results within 60 minutes) to detect E. coli, salmonella, and other microbial and pesticide contaminants in imported food. Without tests that produce quick results, there is no way FDA inspectors can detect pathogens in imported food before it is distributed to consumers. Finally, the legislation gives FDA authority, comparable to that of the U.S. Department of Agriculture (USDA) with respect to imported poultry and meat, to stop unsafe food at the border and to assure that its ultimate disposition is not America's dinner table.

The Imported Food Safety Act of 1998 focuses on these three key areas: authority; research; and resources.

Increased Regulatory Authority for FDA

The recent GAO study of the imported food safety program points out that: "In some cases, when the Food and Drug Administration decides to inspect shipments, the importers have already marketed the goods." "[W]hen the [FDA] finds contamination and calls for importers to return shipments to the Customs Service for destruction or reexport, importers ignore this requirement or substitute other goods for the original shipment. Such cases of noncompliance seldom result in a significant penalty."

FDA currently lacks the authority to impose criminal penalties on importers that circumvent FDA's import procedures. FDA reliance on the importer's bond agreement with Customs, has left the agency without an adequate economic deterrent to the distribution of adulterated products . Current penalties, namely the forfeiture of a bond, are inadequate and are regarded as a cost of doing business. Under the current bond system, GAO reports that " even if the maximum damages had been collected, the importer would have still made a profit on the sale of the shipment." This bill would subject such behavior to tough penalties that will be a strong deterrent to circumventing the current regulatory system. These penalties are the same as those used by USDA in their imported meat inspection program.

The bill would also prohibit an importer from commercially distributing foreign-produced food, without FDA approval. An importer whose food is refused entry by FDA would be responsible for the disposition or re-exportation of such food products. Failing to do so would make the importer subject to penalties under the Federal Food Drug and Cosmetic Act.

Development of "Real-Time" Laboratory Methods to Test for Pathogens to be Used in Border Inspections

FDA wrote in a January 16, 1998 letter that there is a "critical need for rapid, accurate methods to detect, identify and quantify pathogens in a wide variety of environments..." "

The methods for detecting a wide range of bacterial, viral, and parasitic pathogens in or on fresh fruits and vegetables are limited ..."

This bill would provide additional funds for research and development on test methods to detect E. coli, salmonella and other disease-causing microorganisms and pesticide residues in imported food, as it enters the U.S. and before it is distributed to the public. The bill requires FDA to devote resources to developing such tests within three years of the date of enactment. This funding will be in addition to FDA appropriated funds and will be collected through a modest, $20 per entry, user fee on imported food.

User Fee for Imported Food

This legislation also provides for a modest user fee be paid to the FDA for each entry of foreign food imported into the U.S. It is clear that the current majority in Congress is not prepared to appropriate funds needed to protect Americans from unsafe food. Funds for the President's food safety initiative were recently zeroed out at the Senate Appropriations Committee and in the House, the President's initiative received only a token funding level.

A user fee on imported food, like the user fee in the Imported Food Safety Act, would ensure that FDA has much needed resources to protect American consumers from unsafe imported food. The proceeds from this user fee would be used to fund much needed research efforts on "real time" test methods for detecting pathogenic contaminants in food and to fund increased FDA efforts to inspect foreign fresh and packaged foods coming into the country.

The U.S. imports approximately 2.7 million entries of food each year that are valued at approximately $36 billion. The bill provides that a per entry fee of no more than $20 would be imposed on food imports. This fee is not based on the value of a shipment of imported food. Instead, it is an amount based on the cost of processing and approving food imports, including the cost of sampling and testing.

Country-of-Origin Labeling

Finally, this bill requires country-of-origin labeling of all imported foods. Restaurants and other prepared-food service establishments are exempted from complying with the country- of-origin labeling requirement. We often forget that the toughest, and many times the best, regulators are America's consumers. This bill gives consumers information that allows them to make informed choices with respect to the conditions under which the food they buy is produced.

Maintaining public confidence in the safety of the food supply is of paramount importance. People must be confident that the food they purchase and provide for themselves and their families is safe. Country-of-origin labeling will empower consumers, giving them greater information on which to base their food purchasing decisions. This is especially important in view of the now all too frequent outbreaks of food-borne illness.

We need to focus our efforts on eradicating food-borne illness in this country. As our consumption of imported food continues to grow, we must find ways of ensuring that foreign produced food meets our health and safety standards. It simply is no longer acceptable for government to blame its failures on the increased volume of imports or the fact that detection methods are not available.

FDA must be given the authority, the resources, and the responsibility to ensure that foreign produced foods get to the consumers of this country, if, and only if, they meet U.S. health and safety standards.

The Imported Food Safety Act of 1998 would give FDA, for the first time, the authority, resources, and responsibility it needs to tackle this problem in a meaningful way. This is good public health policy, and the American people deserve no less. I urge my colleagues to support this important legislation. Thank you.