APPENDIX 3: FDA's IMPORT STRATEGY

The goal of FDA's import program is to assure that all FDA-regulated imports available to U.S. consumers are safe. The scope of the program is broad, covering all FDA-regulated products, which represent 30 percent of all imports into the U.S. The number of FDA-related import shipments reached nearly 4 million in 1997, continuing a 4 percent annual growth rate in the last decade. And the complexity is increasing--the reality of a truly global economy is adding significant regulatory challenges for FDA.

FDA's challenges include assuring safety of products from increasingly diverse countries of origin, with wide variation in technological capability of production sources; dealing with a higher percentage of semi-finished or finished goods; detecting known and emerging pathogens; and working in an evolving system of international trade and regulatory agreements. FDA's imports activities are focused on the establishment of a safety net that extends from the point of production in source countries through their entry into the U.S. To ensure that its safety net works, the Agency employs three strategies:

• Reduce the probability that violative products will be exported to the U.S. This is accomplished through multiple strategies, including educational and technical assistance targeted to foreign producers and governments, foreign inspections, development of mutual recognition agreements (MRAs), participation in international standard-setting forums, and establishment of international data bases that adopt a global focus on health risks. In public meetings conducted during the summer of 1998 as part of the FDA Modernization Act planning process, FDA's stakeholders expressed strong support for FDA's international activities. They were particularly vocal in advocating FDA's presence at the prevention end of the import chain. For example, stakeholders felt that FDA should have a prominent "seat at the table" in standard-setting bodies such as Codex Alimentarius (for foods), and should negotiate MRAs that promulgate high safety and quality standards while promoting trade. Proactive stances taken by FDA in these settings will raise the probability that imports reaching the U.S. are safe. Stakeholders encouraged FDA to staunchly defend the U.S. standard of health and safety both in determining standards equivalency and in assuring that foreign nations have the regulatory systems in place to meet those standards. FDA will view high public health standards as its highest priority as it participates in the ongoing development of international agreements and multi-national standard setting.

• At the border, make rapid and reliable decisions on product entry. In order to operate at high confidence levels, FDA has established a system that prioritizes entries based on degree of presumed risk. More than half of all entries are now allowed to proceed into the U.S. within minutes of their arrival without direct examination of the product. This is possible because information on the history of the product, importer and source country is collected and used to screen for potential risk. These rapid entry decisions are called "immediate may proceed" decisions and are based on screening criteria developed by FDA. The remainder of entries are reviewed by Agency staff, using more sophisticated screening criteria and more detailed product information. Most of these are allowed entry within hours. Thus, a majority of all import entries are allowed entry without visual or physical examination, and with high levels of confidence of their safety.

• Target violative products at the border and prevent their entry. A small percent of import entries (approximately 2 percent) are directly assessed, through field examinations, and, in less than 1 percent of the cases, through laboratory analysis. The need to directly examine this small portion of imports is based on empirical evidence that selected product categories from certain source countries or shippers have shown significant violation rates. In addition, surveillance examination of imported products is necessary to identify new problem firms or emerging health concerns. Certain violative firms and products with poor histories of compliance are subject to detention without physical examination at the border until the importer can prove the product complies with FDA standards. FDA will continue to refine and standardize its risk-based criteria for screening imports as more comprehensive information concerning the product and country of origin are entered into the automated review system.

Performance goals for FY 2000 support the continued implementation of the above three strategies. To reduce the probability that violative products will be exported to the United States, FDA will continue to participate in international negotiations and establishment of mutual recognition agreements with other nations. A specific target for the medical device program in FY 2000 is to implement a Mutual Recognition Agreement with the European Union. These activities will assure that products from those nations are meeting FDA standards. The Agency has also planned for an increasing number of foreign inspections, particularly for food and medical device establishments. These inspections will be focused on those establishments that represent major sources of imports to the U.S. and/or that produce higher-risk products.

To maintain high assurance that the vast majority of imports are safe upon entry, FDA will continue to strengthen the automated import information system so that more robust information can be brought to bear on the decision to allow imports to proceed. FDA will also focus on the accuracy of the information used in the system. In order to assure that import entry information is being accurately recorded the agency will evaluate filers of electronic import data to determine error rates. Once baseline data are established, FDA will establish an error reduction goal and embark on intervention strategies to reduce the error rate.

To support the targeting of suspect products, FDA will continue to conduct laboratory analysis on a small percentage of products with potential problems (less than 1 percent of entries). It will, however, be extremely difficult to maintain even that percentage, given no increase in import resources coupled with continued rapid growth in the volume of import entries. The Agency has established an FY 2000 performance goal to evaluate the variation in criteria used to screen import entries in different product areas, and to aim for an efficient system that applies consistent, risk-based decision rules across import categories. This will provide the potential for greater convergence in determining what represents high risk to the U.S. consumer.

Performance Goals, Data Sources, and Baselines:

Goal Statement: Implement the Mutual Recognition Agreement (MRA) with the European Union (EU). (See Devices program section in Plan.)

Goal Statement: Expand the geographical scope and capacity of NARMS by the establishment of an international resistance database. (See Veterinary Medicine program section in Plan.)

Goal Statement: Improve inspection coverage for Class II and Class III foreign medical device manufacturers from 12 percent in FY 1999 to 19 percent in FY 2000, and increase the number of inspections/evaluations of foreign food establishments from 100 to 250. (See Devices and Foods program sections in Plan.)

Goal Statement: Complete survey of filers that submit import entry data electronically to FDA, and determine the error rates and error types that are representative of the population of filers.

Data Source: ORA, Division of Import Operations and Policy

Baseline Data:
FY 1998:
Preliminary checks done on number of filers to determine need for more complete filer evaluation.

FY 1999:
Complete survey design intended to determine the accuracy rate of import entry data submitted to FDA.

Goal Statement: Complete analysis of variations in criteria used by FDA programs to screen import entries. Establish Agency screening guidelines that emphasize risk-based decisions through program information.

Data Sources: ORA, Operational and Administrative System for Import Support (OASIS) records

Baseline Data:
FY 1999:
Complete design specifications for an analysis that is intended to profile variations in criteria used by different FDA programs in screening import entries.

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