Guidance for Importers of Biological Materials
By NNR USA In USA Trade Alerts On 23rd February 2023
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.
- 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.