Stating that it believes a large volume of shipments containing biological materials are imported with missing, conflicting, or improper documentation and packaging, U.S. Customs and Border Protection has issued the following guidance on the procedures and requirements to appropriately import such goods. 

(For purposes of this guidance the term “biological materials” refers to any microorganism (e.g., bacteria, viruses, fungi, helminths, protozoa), materials derived from a living source (e.g., cell lines [human or animal, natural or cultured]), genomic materials, clinical materials (tissues/organs; body fluids), biological toxins, allergens, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or materials. Biological materials may or may not be infectious (e.g., prions, recombinant DNA).)

- Biological materials must be shipped with a description that accurately describes the shipment’s contents.

- All imported biological materials must be documented, labeled, packaged, placarded, and declared in accordance with relevant international, federal, and state regulations.

- Importations must be accompanied with all required documents, such as import permits, letters of no jurisdiction, health certificates, official statements, and/or accurate invoices upon arrival at a CBP port of entry.

- If utilizing the Document Image System, 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 non-infectious.

- For documents required by the Department of Agriculture’s 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 certificates of inspection, certificates of origin, etc.

- 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.

CBP states that shipments that fail to comply with U.S. import requirements may be refused or denied entry.

For more information on import requirements for biological products, please contact attorney Andrea Jeglum at (781) 559-0140 or via email.

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