Guidance for Importers of Biological Materials

U.S. Customs and Border Protection (CBP) estimates that a large volume of shipments containing biological materials are imported with missing, conflicting, or improper documentation and packaging.  

Biological Materials  

 – Microorganism (including but not limited to bacteria, viruses, fungi, helminths, protozoa);  

 – Materials derived from a living source (including but not limited to cell lines [human or animal, natural or cultured]);  

 – Genomic materials;  

 – Clinical materials (tissues/organs; body fluids), biological toxins, or allergens; or  

 – Any naturally occurring, bioengineered or synthesized component of any such microorganism/materials as mentioned above.  

On February, 13, 2023, CBP issued CSMS # 55083113 – Guidance: Clearance of Biological Materials by U.S. Customs and Border Protection-Procedures and Requirements highlighting key requirements for import.

Procedures and Requirements 

• Biological materials must be shipped with a description that accurately describes the shipment’s contents.  
• All biological materials imported into the United States must be documented, labeled, packaged, placarded, and declared in accordance with relevant international, federal, and state regulations.  
• Importations must be accompanied with all the required documents, such as import permits, letters of no jurisdiction, health certificates, or official statements, and/or accurate invoices, upon arrival at a CBP port of entry.

 Importations that fail to comply with U.S. import requirements may be refused/denied entry.