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Lester M. Crawford, D.V.M., Ph.D. - State Departments of Agriculture

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

National Association of
State Departments of Agriculture

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
February 3, 2003
Good morning. As most of you know the FDA, just like your state departments and the U.S. Department of Agriculture, is very much involved in protecting the safety and security of imported food.

Our agency regulates about 80 percent of the national food supply -- practically everything we eat except for meat and poultry --, and the responsibility for the safety and wholesomeness of these many foodstuffs in interstate commerce is a traditional part of our job.

The additional need to safeguard food security became urgent, of course, in the aftermath of September 11, 2001, when we had to consider the various ways in which our enemies might strike next. Food -- as a commodity used by virtually everyone -- had to be placed high on the list of potential targets of bioterrorism.

Introducing serious contaminants into thousands of food articles might not be easiest way to strike a blow at the United States, but there are other reasons why it could be attempted -- the biggest of which is our dependence on imports. One-third of fresh fruit and 55 percent of seafood consumed in the U.S. comes from abroad -- from countries where we have no regulatory authority.

Moreover, controlling imports in a continent-size country is notoriously difficult. We share a mostly porous, 7500-mile land and air border with Canada and Mexico, which is crossed each year by 11.2 million trucks and 2.2 million rail cars. During the same period, 7,500 foreign flag ships make 51,000 calls at U.S. ports. Last year, almost five million shipments of imported food poured into the U.S. through more than 300 ports of entry.

Recognizing that monitoring food security is a herculean job, Congress, since September 11, has provided our agency with $154 million in supplemental appropriations, $97 million of which has been earmarked for the food counter-terrorism program, which covers both domestic and imported food, but is mostly focused on the latter.

In addition to increased resources, Congress last spring passed the Public Health Security and Bioterrorism Preparedness and Response Act that bolstered our agency's legal authority for protecting the security of all our food, both imported and domestic. As I discussed at your conference last October, the teeth of the bioterrorism act are four provisions that require FDA regulation.

These four measures are so central to our food security program that -- at the risk of repeating familiar material -- I'll recap their main points:

One of the provisions requires registration of domestic or foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. Exempted are farms, restaurants, retail food establishments, non-profit establishments that prepare or serve food, and fishing vessels not engaged in processing. The final regulation is to be issued no later than December 12, 2003, but facilities must register by this date even if the regulation is not finalized.

The second key provision requires that FDA receives prior notice of all imported food shipments. The notice must include a description of the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. The FDA's final regulation is due December 12, 2003, but even if it is not finalized, the Act requires that after that date the FDA must be notified about arriving imports no less than 8 hours and no more than 5 days prior to shipment.

Next, the law requires all businesses that manufacture, process, pack, transport, distribute, receive, hold or import food to create and maintain records that may be needed to determine the immediate previous sources and the immediate subsequent recipients of food -- in other words, records that would facilitate quick tracing of suspicious shipments of human or animal food. Farms and restaurants are exempt from this requirement, and FDA must develop a regulation specifying how this is requirement is to be implemented, again, by December 12 of this year.

Finally, the law authorizes the detention of food if an FDA officer or qualified employee finds credible evidence or information indicating that the food poses a serious threat to humans or animals. The Act requires the FDA to develop regulations to expedite court actions on perishable foods, but for this measure, there is no deadline.

In addition to these four provisions, the bioterrorism act authorizes, among others, debarment of persons who have been involved in importing adulterated food; restricts and controls port shopping; and authorizes the marking -- at the owner's expense -- of foods refused admission into the U.S.

Now, what have we done with these added resources and new powers?

Starting with the most recent development, last week, our agency proposed two of the regulations required by the bioterrorism act -- one on the prior notice of food imports, and the other on the registration of food facilities. The proposed rule on prior notification requires that FDA be advised of the intended shipment by noon of the calendar day before the day of the shipment's arrival, and it lists the type of information that must be included for each imported entry. The proposed notification requirement applies to all beverages and all foods except for meat, poultry and egg products.

The information that must be submitted in prior notice is fairly detailed -- for example, the quantities must be described from the smallest package size to the largest container -- but we believe that all of the data would or could be known by the time the notice has to be submitted. We expect to get on the average about 20,000 of such notifications each day.

The early deadline for their receipt adds a significant security layer to our existing screening process, which is based on entry data that's sent by the U.S. Customs to our electronic system, called OASIS -- that's acronym for Operational and Administrative System for Import Support. We usually get this information when the shipment is already in the port or even later, whereupon OASIS automatically releases all low risk products that do not require additional scrutiny. Under the proposed rule -- and we are still working on the details -- the prior notice will have to be sent directly to a new, stand-alone, Internet-connected FDA system to be checked for any indication that the shipment might present a serious health hazard.

The other proposed rule we issued last week covers the requirements for registering food facilities. Under this proposal, all domestic food facilities would be required to register whether or not their products -- including dietary supplements, infant formulas, beverages and food additives -- enter interstate commerce. For a foreign firm, the registration would have to include the name of its U.S. agent, and all facilities, domestic or foreign, would have to notify the FDA within 30 days if there is any change in the submitted data.

These are just the highlights. The proposed regulations were discussed last week at a public meeting that was broadcast in English, French and Spanish via an interactive satellite downlink, and they are published in the Federal Register. The comment period on the two proposals is open until April 4, and we urge all interested parties to give us their ideas for possible improvements.

We're committed to finalize all four rules for implementing the bioterrorism act by October 12 of this year, three months before the statutory deadline. Incidentally, we're planning another satellite downlink for March in order to discuss the upcoming proposals for the other two required regulations, which will deal with record keeping and administrative detention.

I should also add that already a year ago, before the passage of the bioterrorism act, our agency published two guidances on food security preventive measures, advising domestic producers and importers on measures they can take to minimize the risk that food they control will be tampered with by criminals and terrorists. In addition, we also established a special committee to overhaul our import policies and operations to ensure they are based on risk assessment.

In addition to the proposed counter-terrorism rules, our agency has so far hired 655 new field personnel, 463 of whom are consumer safety officers whose primary job will be monitoring food security. The new hires include also 149 laboratory analysts, 33 criminal investigators, 6 supervisors and 4 compliance officers. Three hundred of the consumer safety officers are being assigned to the ports of entry, both big and small. For example, we are assigning 49 of these new hires each to the ports of New York and Los Angeles, 25 to the Southwest import district that monitors imports from Mexico, and we're sending four new employees to Port Huron in Michigan, and two to Virgin Islands.

To get these new arrivals on the job as soon as possible -- within three months after they come on board -- our Office of Regulatory Affairs has intensified and retooled its training program for new hires by using a combination of Web-based courses, classroom, and on-the job training. The first, and longer, phase of this program takes place in the FDA district offices, and it is followed by a two-week national course. By the time they complete the first year of their FDA employment, the new hires will have to pass a standardized audit of their competence.

By the end of last year, 250 of the new hires had completed their two-week national training, and the first consumer safety officer the FDA had hired under the counter-terrorism program completed her field audit. We expect that by the end of this year, when the bioterrorism act is due to be fully implemented, all of the new hires will have completed the required field audit and most of them will start a more advanced training to bring up their level of skills. Eventually, each consumer safety officer will be capable of performing import and domestic inspection procedures, as well as foreign inspections.

Now, what have been the results of this buildup? At present, we are in the awkward stage when the new hires are learning their job and some of the old staff is busy providing the training, which means that the bioterrorism program is only beginning to get off the ground. But the data on monitoring of food imports in the last fiscal year already show some significant improvements over fiscal year 2001.

For example: total food imports in fiscal 2002 increased only 10 percent over fiscal 2001 -- from 4.5 million shipments to 4.9 million -- but our visual examinations of the imported products -- what we call field exams -- tripled, from 9500 in fiscal 2001 to 27,500 in fiscal 2002. Our field exams of imported seafood during the same period went up from 2,000 to more than 7,000, and field exams of vegetables and some vegetable products increased from less than 1,000 to more than 2,700. The number of samples examined in laboratories increased 14 percent, and the number of detained shipments went up by the same percentage.

Yet, despite this heightened vigilance, the number of imported food shipments that were denied entry during the last fiscal year was less than 4,700 -- about 7 percent below the 5,000 in fiscal 2001 -- a sign that the system is sophisticated, and distinguishes between apparent and real threat to the public health. And let me just add that in the future, we plan to strengthen the targeting of our border operations, and increase their efficiency, by utilizing the results of our domestic and foreign inspections, recall monitoring, and consumer complaint reporting.

On this positive note, I think I best stop to give you a chance to ask questions.