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Safety of Imported Foods


Statement of

William B. Schultz
Deputy Commissioner for Policy
Food and Drug Administration
Department of Health and Human Services

before

the Permanent Subcommittee on Investigations
Senate Committee on Government Affairs

September 24, 1998

INTRODUCTION

Good morning, Madam Chairman, Members of the Committee. I am William B. Schultz, Deputy Commissioner for Policy, Food and Drug Administration (FDA or the Agency). With me today are Joseph Levitt, Director, Center for Food Safety and Applied Nutrition (CFSAN), and Gary Dykstra, Deputy Associate Commissioner for Regulatory Affairs (ORA). We appreciate the opportunity to participate in this hearing, and we thank you for the leadership and concern you have demonstrated on the issue of the safety of imported foods.

BACKGROUND

As you know, food safety has been a high priority of this Administration, as evidenced by the President's Food Safety Initiative and Produce Initiatives. We believe the reports you have requested from the General Accounting Office (GAO) and the three previous hearings you have held have provided added focus and clarity to this important issue.

Even though Americans enjoy one of the safest food supplies in the world, every year tens of millions of Americans become sick and thousands die from illnesses caused by both domestic and imported food. The increasing quantities of food that are imported into the United States has raised some significant questions about our ability to protect consumers from potential hazards. We agree with those who believe that our approach to the regulation of food imports needs to be updated to meet the demands of modern society. We also know that improving FDA's import program will be a serious challenge. FDA's current program relies at the turn of the century because relatively few foods were imported, today, we are seeing changes in food imports that necessitate changes in our approach. We believe that dramatic new approaches are called for, including improvements in the existing imported food program, new authorities to more efficiently implement the program, and a significant infusion of resources, as reflected in the Administration's budget for FY 1999.

In the remainder of my testimony I will describe our current import program and give some background on the President's two food safety initiatives, both of which strengthen our imported foods program. I then will move on to the GAO Report and the Agency's recommendations for improving how we fulfill our responsibility to assure the safety of imported foods.

FDA'S IMPORT PROGRAM

During the past 12 years, food imports have grown dramatically. In 1985, only approximately 950,000 line items were offered for import into the United States. As the attached chart shows, that number more than tripled to over 3 million line item entries by 1998, and is expected to continue to increase.

In addition, the nature of imported foods has changed. In the past, most imported products consisted of raw or bulk materials which were further processed into finished products in the United States. Currently, more and more food imports consist of finished, value added foods (e.g., cooked, ready-to-eat, quick frozen shrimp as opposed to raw shrimp for cooking/processing in this country). As products receive additional processing, the potential for the product becoming contaminated and a potential public health hazard increases. For example, the hazard associated with a microbial pathogen, such as Salmonella, in a ready-to-eat food is potentially greater than in a product that will be cooked before eaten. As we all know, fresh produce and seafood can pose additional risks, particularly with emerging pathogens. Today, 38 percent of fruit consumed by Americans, 12 percent of vegetables, and 50 percent of seafood are imported. As noted by the August 1998 report by the Institute of Medicine/National Research Council, Ensuring Safe Food: From Production To Consumption, (IOM/NRC Report), sample analysis is not adequate to detect many of the more serious risks from these microbiological hazards. To monitor adequately the safety of many imported foods, it has become necessary to understand and be able to evaluate the conditions under which they are grown, manufactured, and transported.

Meanwhile, the resources allocated to the inspection of imported foods have actually decreased. In 1992, we received approximately 1.1 million line items of imported foods and had 631 supported Full Time Equivalent employees (FTEs) to look at those items. By 1997, our line items more than doubled to approximately 2.7 million but budget limitations caused us to cut our supported FTEs to 565. Of these 565 FTEs, only 314 are what we refer to as "operational," with 112 actual investigators and 202 analyzing samples in the laboratories. (The others are support staff, including those at headquarters.) In practice, this means that in 1992 we were able to physically inspect 8 percent of all imported foods. Today, the Agency physically inspects only 1.6 percent of imported food. A single entry may contain multiple line items of food offered for import. Each line item corresponds to a specific item on the invoice or shipping papers.A single entry may contain multiple line items of food offered for import. Each line item corresponds to a specific item on the invoice or shipping papers.

Since resources are limited, FDA sets its priorities by focusing on risk, and therefore, by placing an emphasis on the analysis of foods upon import for a variety of hazards, which include heavy metals, pesticides, chemical contaminants, natural toxins, allergens, pathogens, histamine in seafood, etc. The presence of some of these hazards can lead to illness or death. Given our risk-based strategy, FDA focuses its import activities on problem, product, and country. For example, a higher priority is given to low-acid canned foods to protect against potentially fatal botulism, as well as other ready-to-eat foods susceptible to pathogen contamination (such as Listeria monocytogenes and Salmonella), while a lower priority is given to issues less directly related to public health, such as minor labeling violations.

In recent years, FDA has implemented several enhancements to its program in response to the increase in imported foods. We have developed an automated screening system, which receives data via United States Custom Service (USCS) system, capable of electronically reviewing information submitted by filers. This system, Operational and Administrative System for Import Support (OASIS), has been operating in all FDA districts since October 1997. FDA uses OASIS to screen shipment information using a variety of risk-based criteria. These criteria include the type of product, the country of origin, the foreign manufacturer, and the foreign shipper. Criteria used in screening always includes a default examination rate, so that products that might otherwise not meet any criteria triggering FDA review could randomly be considered for review. This default system ensures that every product offered for import has some possibility of being examined. OASIS determines whether a shipment may proceed into domestic commerce, needs further review, or must be detained.

Let me now explain briefly how the Agency's current import program works. Using the relatively new OASIS system, FDA reviews all food entries offered for import, either electronically or by staff evaluation. Based on this review, each entry is designated either a "May Proceed without FDA examination" or "FDA Review". After an "FDA Review," the product may be redesignated "May Proceed," selected for "Examination," identified for "Detention Without Physical Examination," or the filer can be told to submit additional documents before FDA can make an entry determination. Through this electronic review, approximately 55 percent of all FDA food line items are categorized as "May Proceed" and are admitted into domestic commerce within minutes. In FY 1997, of the 2.7 million food line items, approximately 1.5 million were categorized as "May Proceed" based on electronic screening.

The entries that do not receive a "May Proceed" are subject to additional review, and the filer may be required to submit paper documentation for the entry. FDA inspectors verify whether certain information submitted by the filer is accurate and determine if the product, country, shipper, importer, and/or manufacturer are the subject of an Import Alert. The inspector will make a decision to release or detain the entry or to sample or conduct a field examination. When FDA detects the appearance of a violation, the Agency detains the product. Detention is intended to prevent the products from entering domestic commerce until the importer submits information to FDA that overcomes the appearance of a violation, or the products are brought into compliance with the law through reconditioning if this is appropriate. Where the importer fails to overcome the appearance of a violation or where detained products cannot be brought into compliance, FDA refuses admission of the products into the United States, and the products must be destroyed or re-exported, according to USCS regulations. FDA also can seize violative imported products, which involves a formal judicial action.

In addition to having the authority to refuse entry of an apparently violative import, FDA may detain products without physical examination when they consistently violate FDA requirements or when FDA has information that they are health hazards. The products of importers who frequently have presented violative products for import or who have tried to evade the law may be detained without physical examination. Under this control measure, all subsequent shipments of the suspect product may be detained upon import (not distributed in domestic commerce) until either the importer, shipper, producer, or a responsible agency of the exporting country provides information establishing, to FDA's satisfaction, that the shipment is in compliance.

By providing uniform entry screening to all districts, the OASIS system helps to ensure that problem products will be recognized as such at whatever port they enter. The review criteria can be revised within minutes to respond to emerging problems. The OASIS system accomplishes in minutes what used to take days.

ENHANCEMENTS UNDERWAY TO THE CURRENT IMPORT PROGRAM

FDA currently is updating OASIS to make it a more efficient and effective tool. We are enhancing the system to link various Agency databases to OASIS, which will allow inspectors easy access to additional Agency databases (such as Import Alerts and Low-Acid Canned Food registrations) that might have risk information relevant to the decision about how a particular shipment should be handled. This improvement to the existing system will reduce the amount of time needed to determine what action to take on individual entries and is expected to be operational by the end of the year.

The Agency also has safeguards against importers who continue to submit erroneous entry data. As part of FDA's implementation of the OASIS system, FDA conducts evaluations of all filers, and strives to evaluate every filer once a year. FDA randomly selects entries of a given filer that were designated as "May Proceed" and requests that the filer provide the paper documentation for these entries. The information on the paper documentation is compared to the electronic documentation for accuracy and consistency. When a filer is identified with an error rate in excess of 10 percent and the errors do not appear to be deliberate, FDA will work with the filer to correct the problem. This effort could include providing guidance on how to submit their data correctly, or simply taking greater care to avoid typographical errors. If the filer still cannot achieve an error rate of 10 percent or less, the filer will be required to submit paper documentation for every entry until their error rate is reduced to an acceptable rate. If the pattern of errors indicates deliberate submission of erroneous data in order to facilitate entry of violative food, the filer must immediately submit paper documents for all entries, and FDA may refer the matter for criminal investigation. As of August 1998, out of 2,293 electronic filers, 1,315 were evaluated within a nine month period and 247 were found to have an error rate in excess of 10 percent. Of the 247 filers with an error rate in excess of 10 percent, only one was removed from electronic status after efforts were made to assist the filers in making corrections to reduce their error rate.

Since implementation of the OASIS system began in all districts in 1997, FDA has been working with the filers to help them learn the system in order to submit correct data consistently. FDA continues to conduct product code training and other types of data entry training around the country. We believe this has been an appropriate approach in light of the recent implementation and complexity of the system.

THE TWO PRESIDENTIAL FOOD SAFETY INITIATIVES

As the Committee is well aware, improving the overall safety of food has been a focus of the Clinton Administration. In the past 16 months, the Administration has announced two major initiatives to improve the safety of the food supply. The first is the President's May 1997 National Food Safety Initiative, a multi-agency approach involving FDA, the Centers for Disease Control and Prevention (CDC), the U. S. Department of Agriculture (USDA), and the Environmental Protection Agency to reduce the incidence of foodborne illnesses by enhancing the safety of both domestic and imported foods. Some of the measures being implemented include an expanded early warning surveillance system for foodborne illnesses, strengthened communication between State and Federal agencies to coordinate the response to foodborne disease outbreaks, education campaigns directed at consumers and retail food service establishments to improve food handling practices, focused research on better risk assessment techniques for foodborne pathogens, and research to develop new methods to detect and prevent foodborne pathogens. This initiative is described in greater detail in Food Safety From Farm To Table: A National Food-Safety Initiative, A Report to the President, May 1997.

In addition, in October 1997, President Clinton issued a two-part directive specifically to improve the safety of imported and domestic fresh produce. The first part was a directive to the Secretary of Health and Human Services and the Secretary of Agriculture to work together and in close cooperation with the agricultural community to develop voluntary guidance, regarding good agricultural practices and good manufacturing practices (GAPs and GMPs). The voluntary guidance targeted towards both the domestic and foreign industry recommends various approaches to reduce the risk of microbial contamination of fresh produce throughout the production and distribution system. We have received a great deal of public input and worked with the states on this guidance and are revising the guidance based on this input. We expect to publish the final voluntary guidance in early October 1998.

The second part of the produce initiative is legislation aimed at ensuring imported foods are as safe as domestic foods. Because this legislation directly addresses one of the recommendations in the GAO report, I will defer my remarks on this topic until after I discuss the report.

ADDITIONAL RESOURCES REQUESTED BY THE ADMINISTRATION

The Administration also has sought additional funding to implement these initiatives. With strong support from the Congress, we received the first installment for the President's Food Safety Initiative in FY 1998 of $24 million, the full increase for food safety sought by the Administration that year for FDA. This funding has allowed us to lay a foundation for improving the safety of foods through implementation of Hazard Analysis Critical Control Points (HACCP) in the seafood industry, as well as develop activities in the areas of surveillance, research, risk assessment, coordinating more response to food borne outbreaks at the federal, state, and local levels, and education. We are proud of a number of significant accomplishments that have already occurred with this funding. For example, we are using FoodNet and PulseNet data to identify and contain more quickly outbreaks before large numbers of people become ill. We have developed new and improved methods for detection of pathogens, such as Cyclosporasis. Educational efforts are changing consumers' unsafe food practices; surveys indicate that fewer consumers are eating raw oysters, improperly cooked eggs, and rare hamburger. The interagency Risk Assessment Consortium has been formed as a forum for the development and use of uniform and consistent approaches to risk assessment in food safety. These are only a few of the accomplishments made possible by the President's Initiatives.

For FY 1999, the Administration is requesting $101 million for the Food Safety Initiative. Our FY 1999 request builds upon this foundation by targeting the areas of imports and produce. Of the Administration's total request, $50 million is for FDA. Of this amount, $25 million would be devoted toward activities to improve the safety of imports. This funding would be used not only to put additional inspectors at the borders, but also to take a very proactive approach to imports by evaluating the food production systems of other countries wishing to export to the U.S. With this funding, our goals are to conduct such activities as these overseas evaluations, provide educational outreach and technical assistance to promote use of GAPs, promote use of Mutual Recognition Agreements and other agreements, increase the accuracy of import entry data, and increase sampling of high risk food at the border.

THE GAO REPORT

While FDA is implementing important measures to improve the safety of food imports, additional improvements must be made. In this regard, the April 1998 GAO Report makes several observations and recommendations. The Report's recommendations fall into three main areas:

  • First, the Report recommends that Congress require that all foods imported into the U.S. be produced under equivalent food safety systems. USDA already has such authority to control imported meat and poultry products in this manner.
  • Second, GAO recommends several improvements to more effectively target resources on high risk imported foods. These improvements include altering our work plan to provide better guidance to our inspectors, enabling our inspectors to access all health risk databases from OASIS, and ensuring that importers submit accurate data into our electronic entry system.
  • Third, the Report recommends that FDA improve its control over food imports prior to a decision that such food may proceed in domestic commerce. These improvements include re-evaluating the use of private laboratory tests by importers, retaining better control over questionable products, marking refused items, and imposing stiffer penalties for those who ship unsafe products.

We agree with many of GAO's findings and recommendations and would like to address them in turn.

AUTHORITY TO REQUIRE THAT FOOD IMPORTS ARE PRODUCED UNDER A SYSTEM THAT MEETS THE U.S. LEVEL OF PROTECTION

I first would like to address the recommendation that FDA be given statutory authority that would enable us to ensure that products imported into the United States have been produced under a system that provides the same protection as domestically produced foods. As I have stated previously, there is no doubt our current system to protect Americans against unsafe imported products is in need of revision. We simply cannot rely solely on catching problems at the border through inspection. The GAO Report has made this a priority and devoted a substantial portion of the report to this recommendation.

The issue of FDA's support of this proposed authority was questioned at the May 14 hearing. We fully endorse this recommendation, and the Administration has requested legislation to give FDA explicit statutory authority to require that all imported foods are produced under a system that meets the level of protection applicable to domestic foods. FDA's only concern has been over GAO's use of the word "equivalent". This concern arises because the term "equivalent" has a particular meaning in the context of the World Trade Organization's SPS agreement; it has been interpreted by some of our trading partners to always require formal agreements. These agreements involve a lengthy and resource intensive process, which, in our view, should not be required as part of the statutory authorities that GAO has recommended.

As you know, S. 1707, introduced by Senators Barbara Mikulski and Ted Kennedy, (and its companion bill H.R. 3052 introduced by Representatives Anna Eshoo and Frank Pallone) would add a new provision to section 402 of the Act that would deem imported foods to be adulterated if the Secretary (and by delegation FDA) determines that the imported products were not prepared, packed, or held under a system or subject to conditions that either meet the requirements of our Act or "otherwise achieve the level of protection" required by our Act for domestic foods. In making that determination, the Secretary could consider whether the country, firm, or establishment has allowed FDA access (including sample collection) upon our request.

This legislation puts the emphasis on underlying systems of control at their source rather than finding contaminated food shipments at our border or, worse yet, after people get sick. In other words, it is a move from reaction to prevention. If enacted, this legislation would achieve a better allocation of FDA resources by taking into account the production, processing, and handling of food products rather than only focussing on products when they are offered for import, a focus we can no longer afford to rely on solely given the dramatic rise in imported foods and our current level of resources. This legislation is consistent not only with GAO's recommendation, but also with the August 1998 IOM/NRC Report.

Let me make one other point. FDA plans to undertake the activities identified in the President's Food Safety Initiative and Produce Initiative. While enactment of this legislation would enhance our ability to improve the safety of imported foods, in the absence of such legislative authority, we can, and if the additional funds that have been requested are provided, still move ahead to meet each of the goals listed previously.

TARGETING RESOURCES ON HIGH RISK IMPORTED FOODS

While there is no doubt we must begin to focus on prevention, we cannot ignore the continued importance of inspection at the border. The GAO Report made several recommendations involving the Agency's ability to target our inspectional resources on high risk imported food products. We agree that, given current resources, we must focus on those entries that pose the greatest threat to public health. As I have mentioned, FDA already has been taking many of the steps recommended by GAO. More specifically, the Agency has been and will continue to work to link the OASIS system to other databases, as well as our efforts to work with filers to prevent the entry of errors into the electronic entry system. In addition, we are reviewing the tools we use to assist field staff in prioritizing their work.

FDA supplies guidance to its field staff to target their work. The primary mechanisms for doing this are Compliance Programs, Assignments, and Import Alerts and Bulletins. Compliance Programs reflect Agency priorities based on anticipated risk associated with a product and list individual products and the problems that can be associated with those products, as well as countries and or regions from which samples could be collected. They also contain other guidance based on FDA's past accomplishments and surveillance information to guide the field force in selecting imported products to sample. Assignments, containing information similar to that in Compliance Programs, usually are issued to gather information on new or emerging problems. Import Alerts and Bulletins identify known or potential problem foods (by country and manufacturer) and contain guidance to our field offices as to appropriate actions.

FDA's Workplan, on the other hand, is a management tool used to assign the number of operations (field examinations, sample collections and analysis) that the Agency will perform on a national basis. Each district then is assigned its proportionate share of operations to perform during the year. The Workplan reflects the Agency priorities contained in Compliance Programs, but is not the only reflection of overall Agency import priorities. The GAO report noted that FDA did not meet the goals set forth in the Workplan, principally because the Workplan did not factor in the time required to investigate emergencies and consumer complaints. FDA does not disagree. Consequently, we have established an internal working group of both field and headquarters personnel to examine how to factor in emergencies and consumer complaints in order to better plan import work and report activities. We hope to implement recommendations from this group in FY 1999.

IMPROVING CONTROL OVER IMPORTED FOODS PRIOR TO RELEASE BY FDA

GAO also recommended that FDA improve its control over imported foods prior to a decision by the Agency that the goods be allowed to enter into domestic commerce. I would like to respond to this category of recommendations by highlighting controls that FDA is currently considering, some of which can be achieved administratively.

Independent Laboratories

FDA generally agrees with GAO's observation that FDA needs to exercise better control when permitting importers of foods subject to detention without physical examination to select a laboratory to analyze their products, to certify that the labs sampled the product once, and that the information provided is true and correct. To this end, we plan to revise our internal laboratory procedures manual to offer additional guidance for our district offices regarding the submission by private laboratories to FDA of analytical packages in post-detention sampling.

Improved Cargo Control

The GAO Report criticized the Agency for allowing the importer to retain control over imports and GAO observed problems such as substitution of cargo and failure to redeliver the goods after FDA has refused admission. This is a serious criticism, and FDA agrees that better controls over incoming cargo are necessary. We are evaluating new ways to require importers to securely hold articles identified for detention without physical examination. One option would be requiring that the goods be held in a bonded warehouse, at the importer's expense, until FDA makes a final entry decision. Certain exemptions from any new requirement may apply in some instances, such as if the Agency has an agreement with the country of origin establishing that the foreign food safety system meets our level of protection or if the articles are highly perishable.

Marking Refused Goods

An additional control tool would be to require that such products be marked "refused" or "refused admission" if the articles were rejected under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), or the applicable regulations. FDA currently does not have explicit authority to mark goods or to require the marking of goods refused entry. Consistent with the observations made by GAO in the April report, as well as at the September 10 hearing, however, the Agency is considering a regulation based upon its implicit authority in the FD&C Act and the PHS Act. Such a regulation could require the marking of refused goods to aid the Agency in identifying these products should the importer attempt to reenter them without reconditioning.

Partnership with U.S. Customs Service

An additional theme throughout this section of the GAO report is FDA's relationship with USCS. We believe that this is a close, cooperative relationship as shown by our cooperation in investigating criminal activities; our joint efforts in linking OASIS with the USCS system; and, our daily contacts in monitoring imports at the over 330 ports-of-entry where FDA-regulated products enter the U.S. But like any relationship, there always is room for improvement. USCS and FDA already have established a working group to explore the issue of cargo control and a second working group to develop mechanisms to improve the sharing of valuable information. The efforts of these two groups will hopefully enhance the partnership we have with USCS.

IMPROVING FDA'S ABILITY TO TRACE BACK FOOD PRODUCTS TO THE SOURCE OF PRODUCTION

Although the GAO Report did not address our ability to trace food products back to their production source, the Agency believes such ability can be a key element of public health protection. For that reason, I would like to address this issue.

FDA and the food industry share an interest in improving the ability to trace back and to identify the source of foods that pose health hazards to the American public, including fresh produce. For FDA (and CDC), a trace back to the source of production allows us to conduct more thorough investigations more quickly (before evidence gets lost or spoils). For industry, more precise identification of the source of production can reduce instances where consumers believe an entire category of products is unsafe, when the problem is associated with the products of just one or a small number of manufacturers, distributors, or growers.

Because of our shared interest in utilizing a trace back, FDA and industry have had a number of discussions about steps that industry could take to improve traceability. For packaged food, a trace back can usually be established because food packages or labels are required to include information that allows FDA to trace the foods at least to the distributing firm. Fresh produce presents a very different situation. Many small producers are involved, and when their products enter our country's vast and complex distribution system, the information that links a farm to the product in the supermarket display case can easily be lost. Product marking seems to be a more pragmatic approach than requiring detailed distribution records, but even product marking is a complex issue for products typically sold in bulk, products commingled with products from other sources, and products sold to the consumer unpackaged. Industry is increasing its use of stickers or tags, and our investigators have found some of the bar codes being used on certain wrapped produce an especially efficient source of information, but these practices are not yet widespread or economically efficient.

FDA will continue to discuss this issue with the industry. At this time, we see many practical problems to imposing a trace back requirement. We are quite hopeful that the industry's keen interest in finding workable solutions will lead to enhanced product marking practices.

CONCLUSION

Madam Chairman and Members of the Committee, FDA is serious about significant reforms of its import program. But we believe that neither the current approach nor the current level of resources to handle the increasing quantities of foods that are being imported into this country are sufficient. Instead, as both the President and GAO have recognized, we must change our approach. Rather than relying solely on inspections at the border, we must place a greater emphasis on the regulatory systems of the foreign countries that are exporting to us. In addition, without a significant increase in resources, as requested in the President's FY 1999 budget, a strong import program is not possible.

We appreciate and welcome the Committee's interest in this important subject, and we look forward to working with the Committee to find ways to improve the Agency's imported food program.

My colleagues and I would be pleased to answer any questions. Thank you.

1. A single entry may contain multiple line items of food offered for import. Each line item corresponds to a specific item on the invoice or shipping papers.

2. Products for which there is a basis to detain without physical examination are placed on an Import Alert. Import Alerts identify problem commodities, countries, and/or shippers and provide guidance to FDA field staff. Occasionally, FDA places products from an entire country or region of a country on detention without physical examination when the violative conditions appear to be geographically widespread. Recent examples of country-wide Import Alerts include cheese from El Salvador due to a history of contamination with Salmonella, Escherichia coli, and Staphylococci aureus, and raspberries from Guatemala due to past outbreaks of Cyclosporasis.