Background

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.

This communication serves to provide the procedures and requirements to appropriately import shipments of biological materials.  For the purpose of this guidance, the term “biological materials”  refers to any 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. Biological materials may or may not be infectious (e.g., prions, recombinant DNA).

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.

• If utilizing the CBP Automated Commercial Environment Document Image System (DIS), filers should consider using the appropriate document type and label.
• For documents required by the Centers for Disease Control and Prevention, document label “CDC_NONINFECTIOUS MATERIAL” is appropriate for document uploads related to biological materials that are noninfectious. 
• For documents required by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, document label “APH_CERT_STAT_DOCS” may be appropriate for certificates issued by foreign governments, phytosanitary certificates, health certificates, meat certificates, sanitary certificates, treatment certificates, Foreign Certificate of Inspection, Certificate of Origin, etc.
• Additional information is available in the DIS XML Implementation Guide (cbp.gov)

Supporting documentation for non-ABI (i.e., paper) importers/filers should be submitted to the Entry Unit at the Port of Entry and made available to CBP at the time of examination. 

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