U.S. Customs and Border Protection (CBP) and partner government agencies (PGAs) regulate the importation of biological materials that can pose a threat to agriculture, public health, and natural resources. 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. Importers are responsible for knowing and adhering to these regulations, and noncompliance with any regulation may result in importation delays, civil or criminal penalties, and/or seizure of the biological materials.
Examples of Biological Materials
Biological materials can include the following:
- Cell or tissue cultures: such as nonrecombinant or recombinant products, hybridomas, or tissue culture supernatants
- Genetic materials: such as synthesized, inactivated, or recombinant chromosomes, genomes, plasmids, DNA/RNA, or transposons
- Genetically modified or engineered organisms: such as insects, seeds, plants, or other organisms
- Human and veterinary products: such as monoclonal or polyclonal antibodies, antitoxins, antivenom, antisera, vaccines, toxoids, test kits, ascitic fluid, proteins, peptides, enzymes, extracts, blood, plasma, clotting factors, histopathological slides, or diagnostic specimens of urine, feces, or saliva
- Infectious substances: such as cultures of hepatitis B virus, rabies virus, or poliovirus
- Microorganisms: such as live, killed, or inactivated and nonrecombinant or recombinant bacteria, fungi, yeast, protozoa, viruses, prions, and helminths
- Select agents and toxins: such as anthrax, botulinum neurotoxins, ricin, African swine fever virus, Ebola virus, Rift Valley fever virus, or Xanthomonas oryzae disease
- Vectors and hosts: such as ticks, mosquitoes, or laboratory and scientific research animals
Documentation Requirements for Biological Materials
PGAs, such as the U.S. Department of Agriculture, Centers for Disease Control and Prevention, U.S. Environmental Protection Agency, U.S. Fish and Wildlife Services, and U.S. Food and Drug Administration, may require documents or permits for biological materials. Importations must be accompanied with all the required documents or permits upon arrival at a CBP port of entry. If the biological materials require a permit, the importer is responsible for ensuring that the biological materials follow the permit’s conditions.
Biological materials can be regulated and permitted according to a variety of factors, including: the material’s source; the quantity, weight, or amount; the method of production or synthesis; the packaging (as bulk ingredients or in final dosage form); the end use in humans, animals, or research; the state of infectiousness; the potential as a vector of human, animal, or plant disease; and the status as an endangered species (if applicable).
Biological materials transported via culture or transport media may require additional documents or permits if the media contains animal ingredients, such as fetal bovine serum, bovine serum albumin, or porcine trypsin.
Hazardous Material Requirements for Biological Materials
Biological materials that are dangerous goods or hazardous materials, such as infectious substances or select agents and toxins, must be packaged, placarded, and transported according to the regulations of the Department of Transportation’s Pipeline and Hazardous Materials Safety Administration and the Federal Aviation Administration. These regulations also include dry ice used to maintain a temperature range for the biological materials.
Importing Biological Materials by Passenger Travel
Biological materials imported through passenger or pedestrian travel must be presented to CBP for inspection. The biological materials must be declared by either providing an oral declaration or by using a mobile application (such as Mobile Passport Control), self-service kiosk (such as Global Entry or Automated Passport Control), or CBP Form 6059B. More information on these requirements can be found in the following Code of Federal Regulations (C.F.R.): 19 C.F.R. § 122.27, 19 C.F.R. § 148.11, 19 C.F.R. § 148.12, and 19 C.F.R. § 148.13.
Prior to travel, passengers using CBP Preclearance locations should verify import requirements by directly contacting the Preclearance location or by calling the CBP Info Center at either 1-877-227-5511 (general inquiries) or 202-325-8000 (international callers). Biological materials may be subject to preclearance agreements and host country limitations.
The CBP inspection process may be expedited by scheduling an appointment via the CBP One™ mobile application, which can be used to facilitate the importation of compliant biological materials at select ports of entry.
If the biological material requires a permit, the permit must specifically authorize hand-carry as a condition of importation. Importers are responsible for knowing and adhering to the permit’s importation conditions. Most select agents and toxins cannot be hand-carried since these are hazardous materials.
Importing Biological Materials by Cargo or Mail Shipments
Biological materials imported by cargo, including express couriers, and mail shipments must be shipped with a description that accurately describes the shipment’s contents. All shipments must include the paperwork needed for the CBP clearance process, such as invoices and/or PGA required documents.
Certain biological materials, if hazardous materials, cannot be imported in mail shipments due to international mail agreements and U.S. Postal Service regulations.
Entry Requirements for Biological Materials
CBP and PGA regulations apply regardless of whether the biological materials are goods for research or personal use or are commercial goods for profit or resale. A formal entry, which requires a bond and the payment of duties, taxes, or fees, may be required if the biological materials are commercial goods that exceed $2,500 in value, it is deemed necessary by the port of entry for the purposes of enforcing entry or admissibility requirements, or the port of entry has deemed it necessary to support the efficient conduct of customs business.
Some importations of biological materials may not require a formal entry with a bond, but may require the payment of duties, taxes, or fees. If the biological materials are below a value of $800, importers of these shipments can voluntarily participate in the optional Entry Type 86 Test program, which allows for the electronic filing of an entry in the Automated Commercial Environment system for shipments subject to PGA requirements.
Using a licensed Customs Brokers can assist importers with the entry filing process, since Customs Brokers are licensed by CBP to conduct customs business on behalf of importers. Customs Brokers can also interact with CBP’s Centers of Excellence and Expertise (Center). Certain biological materials requiring an entry may be assigned to the Pharmaceuticals, Health & Chemicals Center, which specializes in pharmaceuticals, health-related equipment, and products of the chemical and allied industries.
There is no legal requirement to hire a licensed Customs Broker. Many importers opt to do so for convenience, since Customs Brokers are familiar with CBP systems and are knowledgeable in entry and document submission, bonds, and the payment of duties, taxes, or fees.
Contact Information for Biological Materials
It is strongly recommended that you visit the following PGA websites for additional guidance on importing biological materials into the United States:
- Centers for Disease Control and Prevention
- Federal Aviation Administration
- Pipeline and Hazardous Materials Safety Administration
- U.S. Department of Agriculture
- U.S. Environmental Protection Agency
- U.S. Fish and Wildlife Services
- U.S. Food and Drug Administration
- U.S. Postal Service
For further information or clarification on the CBP clearance process, please contact your intended CBP port of entry or email email@example.com.