Shipments of bio-agents
University of Pittsburgh
Office of Export Controls Services – [email protected]
Overview
Shipments of bio-agents and materials outside of the U.S. may require an export authorization, called an
export license, from a U.S. Governmental agency. Prior to exporting materials, you shall review your
obligations under export laws and regulations 1. If you determine that your transfer may be controlled
under any of those regulations, please contact the Office of Export Controls Services with as much
advance notice as possible. Until approval is received from the Office of Export Controls Services, you
are not allowed to transfer the material to a foreign destination. Note that you can be held personally
liable for failure to comply with the U.S. export regulations, which may result in significant criminal and
civil liabilities.
Export Requirements
Any individual who intends to send, take, transfer or disclose any biological and chemical materials to a
foreign country, shall check if their item is controlled by the export regulations.
The Office of Export Controls Services has developed 2 matrices to help you determine if your items are
controlled under the Export Administration Regulations (EAR) or the International Traffic in Arms
Regulations (ITAR). Since the regulations can and do change over time, you should directly consult the
EAR - Commerce Control List (CCL), category 1 - and the ITAR - part 121, category XIV - every time
you intend to transfer a bio-agent to a foreign country. If your item appears on one of those lists, you
must contact the Office of Export Controls Services as soon as possible and not transfer the material
until approval is granted.
If your item is listed in the Commerce Control List (CCL) of the EAR, you must contact the Office of
Export Controls Services in order to determine if an export authorization is required, prior to exporting
the bio-agent outside of the U.S.
If your item falls under the ITAR, any export (direct or “deemed”) or import will require a license.
Contact the Office of Export Controls Services before exporting and/or importing any items listed on the
United States Munitions List (USML).
In addition, and beyond the EAR and ITAR regulations, exports of bio-agents may be restricted
depending on the destinations, purpose, and parties involved. Imports/exports without a license to
embargoed countries are prohibited: this includes Cuba, Iran, and Syria. Other countries and territories
are subject to targeted sanctions and will also require immediate notification to the Office of Export
Controls Services before any shipments are made to: Afghanistan, Balkans, Belarus, Myanmar
(Burma), Cote d’Ivoire, Cyprus, Democratic Republic of Congo, Eritrea, Fiji, Haiti, Iraq, Lebanon,
Liberia, Libya, North Korea, People's Republic of China (PRC), Somalia, Sudan, Venezuela,
Vietnam, Yemen, and Zimbabwe 2.
1
- Export Administration Regulations (EAR), administered by the Bureau of Industry and Security (BIS) Department of Commerce;
- International Traffic in Arms Regulations (ITAR), administered by the Directorate of Defense Trade Controls
(DDTC) - Department of State;
- regulations administered by the Bureau of Alcohol, Tobacco, Firearms and Explosives (BATFE);
- regulations administered by the Office of Foreign Assets Controls (OFAC) - Department of Treasury.
2
For complete and updated lists of the countries that may trigger an export controls authorization, please consult:
- EAR Part 746 : http://www.bis.doc.gov/policiesandregulations/ear/index.htm
- ITAR Part 126.1: https://www.pmddtc.state.gov/
- OFAC: http://www.treasury.gov/resource-center/sanctions/Programs/Pages/Programs.aspx
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Shipments of bio-agents
University of Pittsburgh
Office of Export Controls Services – [email protected]
Finally, when exporting, you must conduct a screening of the parties receiving your items. Various
U.S. Government agencies maintain a number of lists that include individuals or entities barred or
otherwise restricted from entering into certain types of transactions with U.S. persons 3. The Office of
Research routinely conducts those screenings via global trade compliance software. Contact the Office
of Export Controls Services to have Restricted Parties Screening (RPS) done before exporting any
controlled materials.
Liability
You can be held personally liable for violations of the export controls laws and regulations. The penalties
for unlawful transfer to a foreign person or to a foreign country are up to a prison time of 20 years, fines
of $1,000,000 and a denial of export controls privileges 4.
E.g.: In 2004, Dr. Thomas Campbell Butler, M.D., a professor of Texas Tech University received a 2 year
prison sentence for illegally exported the Yersinia pestis (human plague), which is a controlled item
under the EAR and cannot be exported without the required export licenses. Dr. T. C. Butler had to
resign from Texas Tech, agreed to pay a $37,400 civil penalty and accept a denial of his export privileges
for a period of ten years.
Procedure
1. Will you send, take, or transfer any biological or chemical material to a foreign country?
NO.
YES -> Please answer the following questions:
2. Is your item listed on the EAR or on the ITAR?
You may consult the matrices called “Bio-agents controlled under the EAR” and “Toxicological agents
controlled under the ITAR” developed by the Office of Export Controls Services. Those lists are provided
as a reference and may not reflect the most current information. Check the Category 1 of the Commerce
Control List in the EAR and the ITAR part 121, category XIV to see the most updated version.
3. Is there any military application or use for your sample/material?
4. Will you export your material to one of the restricted/sanctioned/embargoed destination
listed above?
5. Does the end-user/recipient intend to re-export the material?
6. Does the name of the recipient appear on a Restricted Party list?
Note: ALL PROSPECTIVE RECIPIENTS SHOULD BE SCREENED REGARDLESS OF THEIR LOCATION (U.S
OR FOREIGN) OR ENTITY STATUS (PERSON OR COMPANY).
If you answer positively to any of those questions, please contact the Office of Export Controls Services
before making any export. Obtaining an export authorization can take up to several weeks so please plan
accordingly. Until approval is received, you should not transfer the material.
3
E.g. Specially Designated Nationals and Blocked Persons List, Denied Persons List, Entity List, Unverified List,
Excluded Parties List etc.
4
See Penalties for Export Violations guidance document.
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Shipments of bio-agents
University of Pittsburgh
Office of Export Controls Services – [email protected]
Contacts
Office of Export Controls Services: [email protected]
Allen A. DiPalma
Kelly Downing
Director of the Office of Research
Export Controls Official
Primary Empowered Official
Associate Director
Export Controls Officer
Secondary Empowered Official
Jacquelyn Correll
Export Controls Manager
Additional documents
•
•
Matrix: “Bio-agents controlled under the EAR” -> EAR - Commerce Control List (CCL),
category 1 (ECCN 1C351 to 1C354).
Matrix: “Toxicological agents controlled under the ITAR” -> ITAR - part 121, category XIV.
Other Procedures
•
International shipments may require other licenses or permits for items entering or leaving
the United States.
All shipments entering the United States are processed by the U.S. Bureau of Customs and
Border Protection (CBP). An import permit may be required under U.S. regulations to deliver the package
even if a permit is not required by the originating/shipping country.
When exporting your package from the United States, depending on the nature of the shipment, a
U.S. export permit may be required. Additionally, an import permit may be required in the country of
destination where the package is being shipped. If your shipment requires an export permit, it must be
completed and approved by the appropriate government agency prior to shipment.
Some examples of Permits:
- U.S. DHHS/CDC Permits (42CFR, Part 71.54)
http://www.cdc.gov/od/eaipp/
The Etiologic Agent Import Permit Program (EAIPP) of the CDC requires an import permit for all
etiologic agents, biological materials, and hosts and/or vectors entering the U.S.
- USDA Animal and Plant Health Inspection Service (APHIS) Permits
http://www.aphis.usda.gov/plant_health/permits/index.shtml
Animal and Plant Health Inspection Service (APHIS) permits are required to import, domestically transfer
or export a plant pest, plant, biological agents or other material.
- U.S. Fish & Wildlife Service Permits (50 CFR, Part 13)
http://www.fws.gov/
Fish & Wildlife Service Permits cover a wide range of import/export regulations including the trapping,
buying, selling, and trading of live animals (non-agricultural), preserved animal trophies, animal hides,
and animal tissues.
- Food and Drug Administration (FDA)
http://www.fda.gov/ForIndustry/ImportProgram/default.htm
The Food and Drug Administration controls most food and other products that enter the U.S.
Foods, drugs (human, animal and biological), cosmetics, medical devices and radiation emitting devices,
etc. offered for entry into the United States require a permit or registration.
- Canadian Import Regulations
http://www.tc.gc.ca/eng/tdg/clear-tofc-211.htm
Shipments of human, animal, or plant pathogens to Canada will require a Canadian import permit.
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Shipments of bio-agents
University of Pittsburgh
Office of Export Controls Services – [email protected]
•
Many biological materials fall into the federal category of “dangerous goods” for shipping
purposes.
You MUST package and label the material according to the requirements pertaining to those items and
you MUST have documented training for shipping dangerous goods.
Contact the Pitt Environmental Health and Safety department (EH&S) for assistance and training.
http://www.ehs.pitt.edu/
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