Federal, international, and state laws strictly regulate shipping, transport, and import of biological materials. Federal and international regulations pertaining to the shipment of dangerous goods or hazardous materials may also apply to biological materials. Import of biological materials must be clearly marked, labeled, packaged and/or placarded in accordance with the requirements of all international, Federal and state agencies.
Biological materials are categorized, permitted, and regulated according to a variety of factors. Factors to consider include the source of the biological material; method of production or synthesis; packaging (bulk or final dosage form); terminal use in humans, animals, or research; state of infectiousness; potential as a vector of human, animal, or plant disease; and status as an endangered species (if applicable).
Examples of biological materials include (but are not limited to):
- Cell or tissue culture (includes primary cell/tissue cultures, recombinant cell lines, non-recombinant cell lines, hybridomas).
- Cell/tissue culture product (includes monoclonal antibodies, ascitic fluid, tissue culture supernatants, used/conditioned culture media, enzymes, other proteins, extracts, nucleic acids [DNA/RNA]).
- Histopathological slides (fixed in formalin).
- Micro-organisms (includes recombinant or non-recombinant, bacteria, fungi, yeast, protozoa, viruses, prions), live or killed.
- Products of micro-organisms (includes plasmids, nucleic acids (DNA/RNA), toxins, enzymes, recombinant human insulin, other proteins and extracts).
- Test kits
- Unused culture media
- Tissue/organ extracts and samples
- Blood, plasma, blood cells, clotting factors
- Polyclonal antibodies
- Antisera, anti-venom, antitoxins
- Fetal Bovine Serum (FBS), other sera, Bovine Serum Albumin (BSA), enzymes, hormones
- Urine, feces, saliva
- Materials collected from endangered species
U.S. Customs and Border Protection (CBP) regulations apply specifically to import. Importers should adhere to entry requirements under CBP regulations for commercial or noncommercial importation; depending on the mode of importation, different regulations apply. The importer is responsible for ensuring that shipments of biologicals meet all entry requirements.
If the biological materials are hand carried or in checked baggage, they must be declared in accordance with CBP regulations, using CBP Form 6059B, an oral declaration to a CBP officer or at an Automated Passport Control kiosk or Global Entry Kiosk (if applicable).
If the biological materials are imported through baggage, applicable regulations include, but are not limited to:
- 19 C.F.R. § 122.27 applies to private aircraft;
- 19 C.F.R §§§ 148.111 (applies to personal declarations and exemptions). All articles brought into the United States by any individual must be declared to a CBP officer at the port of first arrival in the United States, on a conveyance en route to the United States on which a CBP officer is assigned for that purpose;
- 148.12 is for oral declarations; and
- 148.13 is for written declarations.
Certain federal agencies, such as the Department of Transportation (DOT), Centers for Disease Control & Prevention (CDC), Department of Agriculture (USDA), and Fish and Wildlife Services (FWS), as well as certain individual states, may require import permits for entry. Imports of biological materials must be accompanied by all the required permits and entry documents upon arrival at the port and be properly packaged and labeled per applicable state, federal, and international requirements.
- Import permits must be secured prior to the importation of any material.
- A permit and label are not required if the package is accompanied by either a USDA Letter of No Jurisdiction (LNJ) or a CDC Informational Letter for Non-Infectious Material.
- The importer is legally responsible to ensure that the infectious biological materials are packaged, labeled, and shipped according to federal and international regulations.
- Shipping labels with the universal biohazard symbol, the importer name and address, permit number, and expiration date are issued with the permit.
- The importer must send the labels and one or more copies of the permit to the shipper.
- The permit and labels inform the carrier and CBP of the package contents.
Note: Biological materials requiring a permit under federal or state law must have a permit that specifically authorizes hand-carry on the permit. Certain select agents and toxins may not be permitted to be hand-carried due to the level of biological hazard; verify handling conditions as stated in the permit. Hand carrying biological material without, or in violation of, a permit may result in delays, seizure, and civil or criminal penalties.
A formal entry may be required at the port of arrival if, any of the following conditions apply:
- It is deemed necessary by the port for the purposes of enforcing entry or admissibility requirements. Such requirements may be determined by one or more partner government agency (e.g., U.S. Food and Drug Administration, USDA, CDC, etc.); or
- Commercial shipments of biological materials that exceed $2,500 in value; or
- The port has deemed it necessary to support efficient conduct of customs business.
Note: There is no legal requirement to hire a licensed Customs Broker. Many importers opt to do so for convenience, as brokers are versed in all required CBP systems, paperwork and bonds. Customs Brokers are licensed by the U.S. Customs and Border Protection to conduct customs business on behalf of importers. The importer is ultimately responsible for knowing CBP requirements and for ensuring their importation complies with all federal rules and regulations.
Using a licensed Customs Broker can save importers from making costly mistakes and can assist with filing an entry on items in hand carried bags. Importers of biological materials are encouraged to participate in the new Entry Type 86 pilot. On September 28, 2019, U.S. Customs and Border Protection (CBP) will deploy the new Entry Type 86 for entry of Section 321 low-valued shipments through ACE. This new entry type will improve import safety and security by providing greater visibility into low value shipments. Please note that this new entry type is a test and is not mandatory for users. For more information, select this link: Entry Type 86. A list of licensed customs brokers may also be found here: Licensed Customs Brokers.
Many U.S.-based research institutions have a preferred Licensed Customs Broker. Please check with your local Director of Research Compliance or equivalent to see if your institution has retained a Licensed Customs Broker for university business.
Partner Government Agency permitting websites: