Importer Certification Statement

Purpose

Any noninfectious biological agent or biological substance that is being imported must be accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent or has been rendered noninfectious.

Certification statement

We recommend that the Importer Certification Statement includes the following:

  • A statement the material is not known or suspected of containing an infectious biological agent or has been rendered non-infectious.
  • A detailed description of the material being imported.
  • One of the following:
    • Why you believe the material is not known or suspected to contain an infectious biological agent
    • How you know the material is not known or suspected to contain an infectious biological agent
    • A description of how the material was rendered non-infectious

The template form below has been created as a resource for importers and includes all the fields that should be included in the Importer Certification Statement to facilitate the importation.

Importer Certification Statement Form
Importer Certification Statement Form
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Content Source:
Office of Readiness and Response; Division of Regulatory Science and Compliance