Research materials shipped domestically and internationally are subject to a number of Federal, State and Local regulations. If these regulations are not followed, shipping will be delayed and the package will be returned to the sender or destroyed and the individual cited for non-compliance and subject to civil and/or criminal penalties.
Import Biological Materials to the NIH
Export Biological Materials from the NIH
Quarantine Permit Service Officer Forms
Obtaining Additional Permits
Instructions for Submitting Applications
Complying with Federal Regulations
Resources for Shipping Biological Materials
An application for importation must be submitted to the NIH Quarantine Permit Service Officer (QPSO) when importing biological products, diagnostic, or infectious materials into the United States. An application for importation must be submitted for the transfer of previously permitted imported material. When sending any and all biological material from NIH facilities to an overseas destination, an export declaration must be signed by an NIH QPSO.
All packaging must comply with the
Department of Transportation (DOT) , the
Federal Aviation Authority (FAA) and the
International Air Transport Association (IATA) dangerous goods regulations. Federal and international regulations require that the packager successfully complete job-specific training and be certified to ship biological products, diagnostic or infectious materials.
Questions should be directed to the
NIH QPSO at (301) 496-2960.
back to the top
Individuals wishing to import any biological material (infectious or non-infectious) to the NIH must submit an "Application for Permit to Import Biological Agents or Vectors of Human Disease into the United States" (CDC 0.753) to QPSO. Upon review, QPSO will determine whether the intended importation requires the issuance of a CDC import permit and label or a NIH Letter for Non-Infectious Importation. QPSO will provide the required documentation to the applicant.
Domestic shipments may require the issuance of a transfer permit. For example, select agents and toxins may only be transferred after authorization from the CDC Division of Select Agents and Toxins. The CDC or U.S. Department of Agriculture (USDA) may also require transfer permits for the domestic transport of other etiologic agents or vectors (e.g. Influenza A virus H7N9; MERS-CoV Virus). Please contact QPSO for guidance before transporting etiologic agents or vectors that may be subject to permitting restrictions.
Individuals wishing to export any biological material (infectious or non-infectious) from the NIH to a destination outside of the United States must submit a "Declaration for Exportation of Biological Materials" (NIH 2388) to QPSO. Note: Please use Adobe Professional or Adobe Reader when completing the form. It is not compatible with Mac Previewer. Following successful review of the Export Administration Regulations and a restricted party screening, QPSO will provide export declaration approval to the applicant. The export declaration is valid for the date of shipment.
Application for Permit to Import Biological Agents or Vectors of Human Disease into the United States (CDC 0.753)
back to the top
In some cases, more than one permit may be required for the import, transfer, or export of biological material(s). Although QPSO does not issue Animal and Plant Health Inspection Service (APHIS) or U.S. Fish and Wildlife Service (FWS) permits, the office will provide assistance in obtaining these permits.
Please submit completed applications or inquiries to
email@example.com. Applications may also be sent to QPSO via fax at (301) 480-0671. Please allow at least ten business days to process import applications and five business days to process export declarations. Turn-around time is workload dependent and contingent upon receiving complete information. In general, QPSO officers endeavor to process import applications within five business days and export declarations within two business days. Copies of all import permits and labels, exemption letters, or declarations must accompany the shipping manifest.
Note: All persons must comply with applicable Department of Transportation (DOT), Federal Aviation Administration (FAA), and International Air Transport Association (IATA) regulations pertaining to the transport of hazardous materials. Only individuals who maintain a current certificate that authorizes them to prepare infectious substances and dry ice for shipment may offer such materials for transport. The Division of Occupational Health and Safety (DOHS) offers a one-day training course on shipping biological materials. Additional information and registration for biological materials shipper training can be found on the
DOHS Training Website.
There are regulations concerning the importation of any animal-derived material or any biological material that has been in contact with materials of animal origin. These materials generally come under the jurisdiction of the U.S. Department of Agriculture (USDA). The QPSO can provide clarification of these restrictions. For more information about the USDA animal and animal product import and export, please visit the
USDA Animal and Plant Health Inspection Service website.
The United States Fish and Wildlife Service (FWS) has the authority under Federal regulations to control the import and export of all wildlife and specimens coming into or leaving the United States. Of particular concern are the non-human primate specimens. Researchers must contact a biologist at the FWS for clarification.
You may contact the FWS at (703) 358-2104. For more information, please visit the
back to the top
Biological products are divided into two subcategories:
Those which contain pathogens in Risk Group 1; those which contain pathogens under such conditions that their ability to produce disease is very low to none; and those known not to contain pathogens.
Those products, derived from living organisms, which are manufactured and packaged in accordance with the requirements of national health authorities and transported for the purpose of final packaging or distribution and used for personal health care by medical professionals or individuals.
These materials are NOT restricted and are not considered Dangerous Goods. Contact the
Freight Forwarding Section to receive information on how to package these materials. Your laboratory sample may never arrive at its destination if it is improperly packaged, labeled or declared. Freight Forwarding Section can be reached at (301) 496-5921.
The total package should be brought to the
Freight Forwarding Sectionin Building 13, Room 1759. At the Freight Forwarding Section, they will inspect the package to make sure that it is packed correctly. The Freight Forwarding Section will provide any stickers and labels that are needed. The Freight Forwarding Section will fill out the shipping manifest.
back to the top
Diagnostic packages (UN 650) must be packaged by a trained and certified shipper using approved packing materials.
When packaging liquids, there must be sufficient absorbent material placed between the primary container and the secondary container to contain a leak from the primary container.
CAUTION, if dry ice is used, the package must permit the release of carbon-dioxide gas. Dry ice is a Dangerous Good and must be properly declared and packaged.
The package should be brought to the
Freight Forwarding Section in Building 13, Room 1759. Freight Forwarding Section can be reached at (301) 496-5921. The Freight Forwarding Section will provide any stickers and labels that are needed to correctly mark and label the package as a diagnostic specimen. They will also complete the shipping manifest. Your laboratory sample may never arrive at its destination if it is improperly packaged, labeled or declared.
Your laboratory sample may never arrive at its destination if it is improperly packaged, labeled or declared. All infectious materials must be packaged by a trained and certified individual according to IATA regulations using specific packaging, labeling, markings and documentation.
All packages must go through the
Freight Forwarding Section located in Building 13, Room 1759. Freight Forwarding Section can be reached at (301) 496-5921. Proper packaging supplies may be purchased through any vendor selling United Nations (UN 6.2) certified packaging materials.
*Disclaimer:The Office of Research Services (ORS), Division of Occupational Health and Safety (DOHS) does not endorse or recommend any commercial products, processes, or services. The DOHS website provides links to other Internet sites for informational purposes. When users select a link to an external web site, they are leaving the DOHS website and are subject to the privacy and security policies of the owners/sponsors of the external site.