CDC Noninfectious Certification Statement

Recently the Centers for Disease Control (CDC) reminded the trade community that shipments of noninfectious diagnostic specimens must be accompanied by a noninfectious certification statement.

Providing CDC with a non-infectious certification statement is not a “new” requirement. Title 42 part 71 The Foreign Quarantine regulations state that noninfectious diagnostic specimens may be imported without an import permit but must be accompanied by a non-infectious certification statement. In addition, the FAQ section available on CDC’s website specifically addresses the issue of providing certification statements for noninfectious materials.

The noninfectious certification statement may be declared on the shipment invoice or provided on a separate document but must be on official company letterhead, be signed by the person responsible for and with knowledge of the shipment and must include:

  1. A detailed description of the material including how the material was obtained (e.g, obtained from healthy patients, etc.)
  2. A statement certifying that the material is not known or suspected to contain an infectious biological agent or,
  3. A description of how the material was rendered noninfectious (e.g., heated, treated, etc.)

The CDC monitors import shipments closely to make sure shipments of non-infectious materials are accompanied by the required noninfectious certification statement. Failure to provide the CDC noninfectious certification statement or alternatively obtain a CDC import permit may result in clearance delays or shipment holds.

Any questions regarding CDC import regulations or to obtain a template of the CDC infectious statement may be addressed to Marken’s trade compliance team at tradecompliance@marken.com

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