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Ensuring Safe FDA-regulated Products at the Port of Tampa

Statement of

Gary J. Dykstra
Regional Food and Drug Director
Southeast Regional Office, Office of Regulatory Affairs
Food and Drug Administration

before

the Subcommittee on National Security, Veterans' Affairs, and International Relations
House Committee on Government Reform

August 5, 2002

INTRODUCTION

Good morning Mr. Chairman and members of the Subcommittee; I am Gary Dykstra, Director of the Food and Drug Administration's (FDA or the Agency) Southeast Region, which includes Louisiana and the states east of the Mississippi and south of Tennessee and North Carolina. I welcome the opportunity to inform the Subcommittee of FDA's efforts to help ensure that FDA-regulated products coming through the port of Tampa are safe and not used as potential vehicles for terrorist acts while minimizing the impact on the free flow of trade.

Before I address your specific questions, let me briefly describe FDA's general procedures for handling imports at the Port of Tampa.

Every FDA office that has responsibilities for reviewing import entries or conducting investigations related to imported articles works through the local Customs office, which has the primary responsibility for border security. FDA is very pleased with the level of cooperation we have been able to achieve with Customs. FDA continues to attempt, whenever feasible, to physically co-locate import personnel with Customs. Our FDA Tampa resident post enjoys a good working relationship with the U.S. Customs Service representatives at the port of Tampa.

Since September 11th and subsequent events, there is even closer communication with Customs, especially to target suspect terrorist activities particularly using imported products. There is a greater sensitivity and review of potential terror vehicles or contaminated products by FDA. Following September 11th, FDA's port security concerns also have been focused on the deliberate contamination of FDA products -either at the port, enroute to, or at, the importer's premises.

FDA's RESPONSIBILITY CONCERNING ECONOMIC ACTIVITY AT THE SEAPORT

FDA is responsible for all foods, drugs, cosmetics, medical devices and radiological products with the exception of meat, poultry and processed egg products, which are the responsibility of the Department of Agriculture. FDA monitors the production and, in some cases, the development, import, transport, and storage of more than one trillion dollars worth of consumer goods each year. This amounts to more than 20 percent of the total dollars spent by U.S. consumers. In general, we believe that the value of imported products coming through the port of Tampa is consistent with these nationwide figures. Medical devices and radiological products and pharmaceuticals predominately enter through Tampa, while foods predominately enter through other Florida ports. The entries coming through Tampa tend to be more technologically complex, and generally require more time to review than do foods.

As you may know, FDA's import computer system, the Operational and Administrative System for Import Support (OASIS), helps screen most of FDA-regulated products within minutes so products can move into domestic commerce with little delay.

OASIS is an automated system for processing and making admissibility determinations to ensure the safety, efficacy and quality of the foreign-origin products for which FDA has regulatory responsibility under the Federal Food, Drug and Cosmetic (FD&C) Act. OASIS enables FDA to handle more efficiently and effectively the burgeoning volume of shipments (now over eight million entries per year -- up by 50 percent in the last four years) of imported products. OASIS brings consistency to FDA enforcement decisions at the 350 U.S. ports-of-entry nationwide, where FDA-regulated products arrive, to an extent that was not possible with the manual system. System security controls protect the confidentiality of the proprietary trade information involved in these government-industry electronic transactions.

OASIS is complementary to FDA's regulatory system of approvals, and domestic and foreign inspections, which all protect American consumers in relation to imported goods. FDA evaluates 100 percent of the import filers annually to ensure that they are properly reporting the Customs codes for the products they are importing, and the integrity of the reporting system.

The Port of Tampa receives approximately 25-30 FDA-related entries per day. Most of these entries are medical devices or drugs. These types of entries are more complicated than food entries, and they require more review and data checking. To further enhance the efficiency of FDA import operations in the Port of Tampa and in our Florida District, beginning this October, the Florida District will reorganize its investigations branch. Currently, the Tampa-based consumer safety officers working in imports routinely travel to Orlando and Port Canaveral. After the reorganization, they will cover the port of Tampa exclusively. This will result in these consumer safety officers having additional time to examine more incoming products and collect additional samples.

CHALLENGES FDA FACES IN PLANNING FOR AND IMPLEMENTING SEAPORT SECURITY ENHANCEMENT MEASURE

As noted, FDA is in a supporting role to Customs and other Federal agencies in ensuring seaport security. Our focus is on FDA-regulated products that enter through these ports. While our public health mission has not changed since September 11th, it has certainly been redirected and heightened with respect to imported products. FDA is hiring additional personnel to carry out its responsibilities. Also, FDA will implement new authorities provided to facilitate monitoring and control the entry of suspect products into the United States. New authorities include the registration and listing of firms exporting products to this country and requiring additional information from importers.

The Fiscal Year 2002 counter-terrorism budget supplemental authorized 655 new hires for FDA's Office of Regulatory Affairs (ORA). Of these, 600 were authorized for the food program, 35 for the animal drug and feed program and the remaining 20 were authorized for the drug, biologic and device programs. When all these new hires are on board, ORA anticipates that approximately 420 will either be stationed at border locations, or will be working specifically on imports. Regardless of their physical location, ORA anticipates that all new hires will be trained in both import and domestic operations.

As you know, on June 12 of this year the Public Health Security and Bioterrrorism Preparedness and Response Act of 2002 (P.L. 107-188) was signed into law. This new law provides authority and requirements that will enhance FDA's ability to ensure the safety of FDA-regulated products entering the country.

Some of the law's provisions took effect upon enactment. Others will require regulations and other implementation activity. Let me briefly highlight some of the law's provisions. To help prevent "port shopping," a process unscrupulous importers use to attempt to get refused goods into the country through another port when refused entry at one port, the law authorizes FDA to require the marking of refused food with the statement "UNITED STATES: REFUSED ENTRY." The law also provides penalties for "port shopping" by deeming food adulterated if offered for import after having previously refused admission.

The law also will give FDA new administrative authority to detain food if there is credible evidence that it presents a threat of serious adverse health consequences to humans or animals. This enables FDA to take immediate control of a possibly hazardous food without having to go to court first; a process that can take several days.

Under this new law, both domestic and foreign food manufacturing facilities will be required to register with FDA. Foods offered for import from unregistered foreign facilities will be held at the port of entry until the facility complies with the registration requirement. The registration requirement will provide FDA a more complete inventory of the firms involved in food production. It will also enable FDA to quickly notify the appropriate firms when FDA has information about a potentially hazardous food or ingredient of a food.

Foreign manufacturers of drugs and medical devices will be required to register with FDA. This would include supplying their name and place of business, name of their U.S. agent, the name of each importer of a drug or device that is known to the establishment, and the name of each person who imports or offers a drug or device for import. This new requirement will supply FDA with more information on foreign manufacturers and aid in keeping unapproved drugs and devices from entering through U.S. ports-of-entry. In addition, this legislation requires that importers supply pertinent information regarding import components intended for use in export products. This information will assist the Agency in deterring the entry of components not intended for further processing for products solely manufactured for export.

There are many other provisions in this legislation that will help ensure the safety of imported products. The Agency has established working groups for all FDA-related provisions and is in the process of implementing the law. Many provisions require regulations, and FDA is conducting a transparent implementation process. Meetings with stakeholders already have taken place, and dockets for public comment already have been established for various provisions.

FDA's mission is to protect the public health and to ensure the safety and effectiveness of FDA-regulated products entering the country. We will work to ensure that FDA assists in expediting the flow of imported goods into the country. FDA is striving to ensure that FDA-regulated goods move through the import system in an expeditious manner without compromising the safety of these products.

I would be pleased to answer any questions the committee may have.