IFT Comments to FDA on the Draft Guidance for Industry on Good Importer Practices

March 30, 2009

Re: Draft Guidance for Industry on Good Importer Practices
Docket FDA-2009-D-0675

To: Dr. Jeffrey Shuren
Associate Commissioner for Policy and Planning
Division of Dockets Management (HFA-305)
Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852

The Institute of Food Technologists (IFT), the not-for-profit international, scientific society with 20000 members working in food science, technology, and related professions in industry, academia, and government appreciates the opportunity to provide comments pertinent to the Draft Guidance for Industry on Good Importer Practices published in the Federal Register on January 12, 2009.

Ensuring that imported products are in compliance with applicable U.S. statutes and regulations is a shared responsibility between the public and private sectors. It is critical that practices be in place to prevent or detect potential problems at key points along a product’s life cycle in the food system. The Good Importer Practices guidance document provides broad recommendations to importers on procedures that could increase the likelihood that imported products comply with applicable U.S. safety and security requirements. Beyond this, IFT recommends that the Agency consider the following:

• Accreditation of laboratories could be difficult for importers. Thus, we recommended that the accreditation process and its expectations be clearly defined, for the following reasons:

o Although accreditation is important, good laboratory practices are vital for the efficient sampling and testing of product. There are several models for good laboratory practices including guidelines and methods published by the FDA. The agency should be commended on its transparency and willingness to make available at no cost testing methods and laboratory operations manuals, which are excellent models upon which food testing laboratories could base their own programs. rams.

o An accreditation provides some indication that a laboratory conducts its overall operations according to best laboratory practices, but not necessarily that it is competent to do any specific test that it is asked to do on any given day. As with a food safety audit, a lab accreditation audit provides only a snapshot in time and does not provide any guarantees over time for a particular testing procedure or particular facility.

o Moreover, in many countries, a functional accreditation body does not exist or may not be qualified to conduct accreditation activities. This could subsequently increase the cost of accreditation for a laboratory in the exporting country since a ‘third party’ would need to fulfill this role.

o Many foreign food safety and inspection agencies operate under systems that are not fully independent and thus create conflict of interest that diminishes credibility.

o Many labs are fully competent but would not be able to obtain accreditation for financial reasons. For example, it would be difficult for most university laboratories, and state and local agencies to become accredited because no funding is available that would allow them to participate in such a program. It is recommended that the testing facilities of these entities be considered acceptable for use as long as the laboratory demonstrates to the satisfaction of the importer and the regulatory agency official that the requested testing is conducted appropriately.

• It is also suggested that the FDA recognizes the need for expedited sample collection and analyses at its laboratories. Most industry members would agree that test results presently take a significant amount of time, while products are held at the port of entry at considerable cost for the importer. In the case of perishable goods, this delay becomes critical, since product quality decreases very rapidly. If analytical results cannot be obtained within a suitably short timeframe then an alternative process should be evaluated, or procedures be in place to discard the sample without analysis.

• To facilitate the reach of pertinent information to the interested parties, we also recommend that the FDA include an appendix that provides the following information: a list of all agency web links of enforcement information or action items such as warning letters, enforcement reports, import alerts or a reportable food registry, procedural guidelines or recommendations for importers as well as contact information for the competent authority in exporting countries and copies of export certificates and fee schedules per country or region.

We appreciate the opportunity to provide these comments. We would be pleased to address our comments further or any questions you may have about recommendations.


Sheri Schellhaass, Ph.D. President

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