Federal Agencies Issue Draft Guidance on Good Importer Practices; Retailers and Manufacturers Should Take Note

By Ricardo Carvajal –      

Several federal agencies, including FDA, have jointly issued a draft guidance for comment purposes only that recommends a wide range of practices intended to help ensure that imported products comply with applicable federal laws.  The action was taken pursuant to a recommendation in the Action Plan for Import Safety: A Roadmap for Continual Improvement, which was released in November 2007 by the Interagency Working Group on Import Safety (which was established by Executive Order 13439).  Although primarily directed at importers, the draft guidance states that retailers and manufacturers also should “carefully consider” the draft guidance.  Furthermore, “the principles and the non-customs related recommendations” that it sets forth “are also applicable to helping ensure the safety and security of products that are domestically produced.” 

The practices in the draft guidance are organized under four “guiding principles.”  The first of these is “Establishing a Product Safety Management Program.”  This principle focuses on establishing an organizational structure to facilitate implementation of the recommended practices and to ensure corporate responsibility.  That structure would provide for the establishment of appropriate policies, specifications, and procedures, training of personnel, effective communication within and outside the organization, and establishment of a formal quality assurance program. 

The second principle is “Knowing the Product and Applicable U.S. Requirements.”  This principle calls for importers to understand which regulatory requirements apply to a product and its producer, know the risks and compliance history associated with a product and any firms involved in that product’s life cycle, and be alert to information that suggests fraudulent activities, such as prices that are significantly below market value. 

The third principle is “Verifying Product and Firm Compliance with U.S. Requirements Throughout the Supply Chain and Product Life Cycle.”  This principle calls for importers to make significant efforts to ensure that products and their producers comply with applicable requirements, and contains the most extensive recommendations of all of the principles addressed in the draft guidance.  In general, importers are expected to take numerous steps to “control, monitor, and verify” product and producer compliance prior to the arrival of the product, during the product’s entry, and afterward when the product is in distribution. 

The fourth principle is “Taking Corrective and Preventive Action When the Imported Product or Firm Is Not Compliant with U.S. Requirements.”  Importers are expected to establish procedures for the development of corrective action plans, engage in root cause analysis when there is non-compliance by products or producers, and take steps to prevent recurrence.

The draft guidance acknowledges that importers may be using other practices that ensure that products comply with applicable federal laws.  Nonetheless, it offers a potential carrot to those who adhere to the recommended practices: such adherence “may, in some cases, facilitate admissibility determinations.”  Comments on the draft guidance should be submitted by April 12, 2009 to Docket No. FDA-2009-D-0675 at www.regulations.gov.