Export Controls

If you have export-related questions, assistance and guidance are available from the ECU Office of Export Controls at (252)744-2395, or ECUExportControls@ecu.edu. We're here to help demystify the export process and we can work with you 1:1, in small teams, or in larger teams. Look for website enhancements in the coming months; meanwhile, please send us any comments.

In simplistic terms, US export controls collectively are federal regulations that govern what we can export from the US, or what we can disclose in writing or orally, regardless of the medium, to people who are not US citizens, US permanent resident aliens, or some other protected classes of individuals. These regulations exist to promote US foreign policy, national security, and economic goals.

While there are many carve outs that exempt some activities at US universities, ECU still is subject to the various US export regulations. So, in our various ECU roles, we have some obligations. Keep in mind that violating US export control regulations can result in significant fines for not only ECU, but for you. Both criminal and civil penalties can apply, including imprisonment. Think it cannot happen to you? Universities in various US states, faculty, and students have been convicted for various violations.

See the following US Department of Commerce summary table for fiscal year 2016 criminal fines and imprisonment, as well as administrative actions, issued for violations of the Export Administration Regulations. 

 FY Criminal Administrative
 201632 individuals and businesses convicted
$274,500 in criminal fines
$79,077,400 in forfeitures
883 months of imprisonment
35 administrative cases
$23,055,000 in administrative penalties

Criminal penalties can reach $1,000,000 and 20 years imprisonment per violation and the administrative penalties can reach the greater of $250,000 per violation or twice the amount of the transaction that is the basis of the violation. 

Source: https://www.bis.doc.gov/index.php/enforcement/oee/penalties

While you might think of these regulations as restrictive, keep in mind that regulations also create, allow for, and protect, the spaces that allow free-thought and expression so commonplace on university campuses. Regardless of your perspective, following are some common university activities where export controls often apply. If you have questions about any of these, please reach out to us!

  • International travel to attend conferences, to meet with research sponsors, to meet with foreign-university collaborators, or to conduct research;
  • Employment of foreign nationals;
  • Research agreements or collaborations with foreign companies;
  • Working or conducting research in ECU offices or laboratories containing export-controlled information, materials, or equipment.

 

Some Export Essentials to Know

While many regulations may affect exports, we focus here on those that are most typical for ECU activities here, and we also are opting to give a somewhat oversimplified view. 

OFAC - US Office of Foreign Assets Control - Think of OFAC's regulations as top-level restrictions or prohibitions, aka sanctions, that can prohibit engaging in activities with certain countries, but also with specific individuals, regardless of country, because of the individual's role in some undesired activity. 

  • Country Example: The US views various policies of the Government of Syria as a threat to US national security, foreign policy, and to the US economy. Thus, one of the most comprehensive set of sanctions exists for interactions with Syria. Other highly sanctioned countries include CUBA, IRAN, NORTH KOREA, SUDAN, and SYRIA.
  • Individual Example: The US views narcotics trafficking as a threat to national security, foreign policy, and the US economy. So, engaging in activities with individual Colombian narcotics traffickers and narcotics-related organizations is prohibited.

ITAR - International Traffic in Arms Regulations - ITAR focuses on regulating defense articles and services. So, whereas OFAC sanctions are broad in the sense that any engagement in certain activities might be restricted, ITAR regulates only defense-related activities. So, if you're working on research for an item that is to be incorporated into, say a military missile, the ITAR might restrict who can have access to design drawings, or where we can ship prototypes.

EAR - Export Administration Regulations - The collective EAR has a broader scope than the ITAR. For example, nearly any physical shipment is subject to the EAR, and various levels of controls exist depending on the item or activity, the destination, and the intended end use. Despite being subject to the EAR, an item might not require any license. On the other hand, an item might require a license only to certain destinations. Or, the item might require a license if it is intended to be used in a specific way, such as for military end use. 

Other regulations with Reporting and Recordkeeping Requirements

While the OFAC regulations, the ITAR, and the EAR are the primary purview of export controls, other US agencies sometimes have requirements for the physical movement of goods. 

  • APHIS - Animal Plant Health Inspection Service
  • FWS - US Fish & Wildlife Service
  • Census - US Census Reporting
  • Recordkeeping
Anyone, whether student, faculty, staff, or any other individual with any conceivable label, who travels with an ECU-owned laptop or other university-owned equipment, should be aware of these basics:
  • Almost all laptops, tablets, iPhones, Androids, and similar devices are considered mass market encryption devices. While these items ARE subject to US export controls, the devices, as well as installed mass market encryption software, typically do not require export licenses. Microsoft Office products, such as Outlook and Skype, that are common on ECU laptops, are examples of mass market encryption software.
    • Some destination countries might require import licenses. While this is rare, check with us if you are uncertain. Quantity exemptions often exist. 
    • Remember to comply with ECU policies regarding password and encryption protection in order to protect ECU data. 
    • As a best practice, remove data unnecessary for your travel.
    • Technical data on your laptop must be evaluated for export controls separately from the laptop and software evaluations.
  • If you're traveling with equipment, the physical movement to another country does constitute an export. It's likely that the equipment either....
    • Requires no export license, or
    • Qualifies for what is known as a TMP, or temporary export, license exception as a "Tool of Trade".
      • TMP-eligible equipment that you also take with you (either in the flight cabin or in checked luggage), does not require reporting in AES
      • TMP-eligible equipment that you ship separately requires reporting to AES and/or recordkeeping demonstrating why the reporting was not required.
Question 1a: What is required of me if I am only temporarily removing ECU-owned equipment from the US?

Answer: You must notify the ECU Office of Export Controls. (You might also need to notify other areas, such as Materials Management, for asset tracking.) In turn, the Office of Export Controls will assess the complete scenario. If an export license is required, we will file with the appropriate authority to obtain the license. If no license is required, we will inform you. If a license would otherwise be required except that the equipment is to be removed only temporarily, we will provide you a temporary license exception letter. The letter outlines your obligations. In brief, as the traveler, and if a temporary license exception applies, you must:
  • Maintain "effective control" of the item. The regulations define this as, "You maintain effective control over an item when you either retain physical possession of the item, or secure the item in such an environment as a hotel safe, a bonded warehouse, or a locked or guarded exhibition facility. Retention of effective control over an item is a condition of certain temporary exports and reexports."
  • Not take the item to any of the following countries:
    • Cuba
    • Iran
    • North Korea
    • Sudan
    • Syria
  • Protect your software. Directly from the regulations, "Software used as a tool of trade must be protected against unauthorized access. Examples of security precautions to help prevent unauthorized access include the following:
    • (i) Use of secure connections, such as Virtual Private Network connections, when accessing IT networks for activities that involve transmission and use of the software authorized under this license exception;
    • (ii) Use of password systems on electronic devices that store the software authorized under this license exception; and
    • (iii) Use of personal firewalls on electronic devices that store the software authorized under this license exception."
  • Return the item within twelve months.
Question 1b: C'mon, this is a university and I am taking this equipment to help my fundamental research! I am loaning it to another university for only thirteen months. Why do I need to notify anyone?

Answer: By leaving the equipment at another university, "effective control" is not maintained. Additionally, the item isn't planned to be returned within twelve months. In this case, a license might be required, but with a little planning, the Office of Export Controls can help make the process as easy as possible. Additionally, because the equipment does not qualify for the temporary exception, the equipment's value might trigger an export reporting requirement.

Question 1c: There is no commercial value. In fact, I am providing the item free of charge, on loan, to the other university. The book value is zero. Why would it have to be reported?

Answer: Valuation for Customs purposes follows a defined methodology. Where there is no commercial transaction value, the ECU Office of Export Controls can help determine the appropriate Customs value.
Many researchers believe that fundamental research is exempt from export control regulations. While the regulations say, ""Technology" or "software" that arises during, or results from, fundamental research and is intended to be published is not subject to the EAR," it's essential to note that technology or software released (say, from a project sponsor to the research team) is not automatically exempted.
 
First, consider what constitutes fundamental research...
Fundamental research means research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons. 

Second, even if your research meets the definition above, release of technology, such as technical data provided to the research team, may be subject to export controls. If the technical data are not already published, it's likely those data are subject to export control regulations. Whether or not data release to a non-US person requires a license is dependent on what the data are, and the nationality of the non-US person. The ECU Office of Export Controls can work with researchers to implement appropriate technology control plans. These might include physical access controls and/or data security access controls, for example. 

Last, all physical shipments from ECU to another country are subject to export control regulations. The exemption for the defined terms "technology" and "software" does not apply to tangible exports.

Practical Example: Campus Laboratory Working with Viruses

Suppose you know your overall research is fundamental. A project sponsor will release technical data to you that will be shared with the campus research team. One member of the research team is a graduate student working in your lab. The graduate student is in the US on a J1 student visa and she was born in Iran. She most recently lived in Vietnam before coming to ECU's campus. In fact, she even became a Vietnam citizen! The project sponsor will supply your ECU lab with Brucella abortus virus from its local laboratory in Raleigh. 

Question 2a: Is this fundamental research project subject to US export controls?

Answer: Yes

Explanation: The unpublished technical data released from the project sponsor to a non-US person, even a graduate student working in the lab on ECU's campus, are subject to export control regulations. The technical data release to a non-US person may or may not require an export control license, however. This depends on both WHAT the technical data are, and the person's most recent country of citizenship.

Additionally, Brucella abortus virus is controlled because of its potential use in chemical and biological weapons, as well as for anti-terrorism reasons. The technological know-how of how to dispose of Brucella abortus also is controlled. Because the non-US graduate student will work directly with the virus, likely will be taught how to dispose of the virus, and holds a citizenship of Vietnam, an export license is required because of the chemical and biological weapons controls.  

Question 2b: Suppose the graduate student held a Canadian citizenship. Would an export license really be required?

Answer: Yes

Explanation: Brucella abortus, as well as a number of other viruses, require export licenses for release to any non-US person. 

Question 2c: Suppose the appropriate export licenses for Questions 2a and/or 2b have been issued. The project sponsor asks that ECU ship a dormant form of the Brucella abortus virus to the sponsor's lab in Austria. The virus has been modified, and again, it is dormant. The lab needs only a small amount, and in fact, the researcher is aware that APHIS (Animal and Plant Health Inspection Service) and the CDC (Centers for Disease Control and Prevention) have no reporting requirements. There is no commercial value because this is essentially a tiny sample. Do we need an export license to ship this small amount of dormant virus?

Answer: Yes

Explanation: Regardless of value, and regardless of quantity, a shipment of Brucella abortus virus requires an export license. 

Question 2d: Suppose you worked with the ECU Office of Export Controls and now have the export license to ship the dormant virus to Austria. There is no commercial value, and the sample fits into a standard FedEx International Letter sleeve. FedEx is asking for a value and won't let you proceed. Given there is no commercial value, should you just say $1?

Answer: No

Explanation: While there is no commercial value, and therefore, there is no selling price to use as the transaction value of the virus, the export regulations require that the value be recorded as the cost to produce, plus the cost to transport to the port of export. Assuming that you will use FedEx, UPS, DHL, or the USPS to move the virus to Austria, simply provide the cost to produce. (Reach out to the ECU Office of Export Controls if you do not know how to determine the cost to produce.)

Question 2e: Suppose that you determined the value is $750. The express courier's site is asking for an AES exemption. Should you just select LVS because this is still as Low Value Shipment less than $2,500?

Answer: No

Explanation: All exports that require an export license, regardless of value, must be reported via AES to the US Census. 

Question 2f: Ok, then who is authorized to report the shipment to Census?

Answer: Only the ECU Office of Export Controls is authorized to report an export shipment to Census. After submission, Census will return a government-assigned ITN (International Transaction Number). We will provide this number to you. Express couriers have fields where the ITN can be input when no AES Exemption is appropriate. AES simply refers to Census' Automated Export System. Export data are reported in AES via US Customs & Border Protection's ACE portal. ACE is the Automated Commercial Environment; it can most easily be thought of as a central data gathering, processing, and reporting application that can be accessed by various government and non-government parties to import and export shipments and their related transactions. 

Practical Example: Campus Laboratory Working with Tissue Specimens

Suppose you need to ship a few paraffin-embedded specimens to a project sponsor's laboratory in France. The specimens fit easily into a standard express courier's international letter package. These rodent tissues are to be provided to the project sponsor so the sponsor can perform histology analysis. Even correctly valued, these would cost no more than $100. 

Question 3a: Is an export filing required?

Answer: Yes. While the shipment may qualify for an AES filing exemption, the US Fish & Wildlife (FWS) requires that form 3-177 be filed with the local FWS office prior to export for some species, such as those that appear in the CITES regulation, or within 180 days of export for others. IF the rodent tissue is from common laboratory mice of the genus and species Mus musculus, it must be reported within 180 days of export. The Office of Export Controls can work with you to ensure this reporting is completed. 

While most educational activities are not subject to export controls, OFAC sanctions sometimes limit what we can do with sanctioned countries, restricted persons and entities. In many cases, OFAC authorizes certain activities via general licenses. For these, if you're engaging in the activity, say with a professor at a university in a restricted country, it's better to understand that the activity is initially prohibited, yet OFAC authorizes the activity via general license. For activities not already authorized by general license, a specific license might be required. The ECU Office of Export Controls can work with you to determine whether a license is required, and if so, whether the activity is authorized already by general license, or if we need to request a license. 

What's an example?

Question 4a: I am a professor who simply wants to work with foreign graduate students who have a passion for may fundamental research topic. What license could I possibly need?

Answer: An OFAC license. If, for example, the graduate student is located in Iran, providing research assistance without a specific OFAC license likely is prohibited. The most highly sanctioned countries where specific licenses might be required to engage in certain activities with students ordinarily resident of those countries include, for example, CUBA, IRAN, NORTH KOREA, SUDAN, and SYRIA.

Question 4b: In my role as a journal editor, I routinely receive submissions from researchers who live in these highly-sanctioned countries. this activity is okay, right?

Answer: Peer review, including substantive editing, typically is allowed. But, be certain not to provide individualized services above routine peer review. These could require specific OFAC licenses. If you're in doubt, please reach out to the ECU Office of Export Controls.

Question 4c: We have many full-time faculty who are from other countries. These have no restrictions, right?

Answer: While full-time university employees generally do not require export licenses to have access to restricted technology, this does not always hold true. For example, some technology and source code releases require that the university employee, including full-time faculty, be a permanent resident of the US throughout employment, be informed in writing that the technology or source code may not be transferred to other foreign nationals without prior US Government authorization even after the tenure of employment at the university, AND the employee cannot be from any of the following countries: AFGHANISTAN, BELARUS, BURMA, CENTRAL AFRICA REPUBLIC, CHINA (PRC), CONGO (DEMOCRATIC REPUBLIC OF), CUBA, CYPRUS, ERITREA, HAITI, IRAN, IRAQ, NORTH KOREA, LEBANON, LIBYA, SOMALIA, SUDAN, SYRIA, VENEZUELA, ZIMBABWE. If you think you might be working with restricted technology, please reach out to us.

Interesting...or not-so-interesting...export control tidbits for faculty

 OK? ACTIVITY DESCRIPTION COMMENTS
 YesNon-US persons on ECU's campus participating in undergraduate and graduate level catalog courses and their teaching laboratoriesAssuming the student has a student visa, they are authorized to study!
 YesNon-US persons taking online undergraduate courses in the humanities, social sciences, law, or business OK 
 NoNon-US persons taking online undergraduate courses in health sciences, physical sciences For some sanctioned countries, ok only if typical introductory courses and equivalent of courses ordinarily required for completion of undergraduate degree program
 NoNon-US persons taking online graduate courses For some sanctioned countries, this might require a specific OFAC license 

The most highly sanctioned countries where specific licenses might be required to engage in certain online courses include, for example, CUBA, IRAN, NORTH KOREA, SUDAN, AND SYRIA.

Keep in mind that the specific license requirement does not prohibit ECU from offering the course if we obtain the specific license first. However, doing so without notifying OFAC and obtaining the specific license may subject ECU, the faculty member, or both, to penalties and event imprisonment depending on the violation. Reach out to the ECU Office of Export Controls if you have any doubts about the course, lecture, or seminar you wish to offer. 

 

We realize that staff routinely are asked to send items internationally either via Mail Services (who leverages USPS), or via Materials Management's Central Stores & Receiving service (who leverages UPS, FedEX, or DHL). Please reach out to the ECU Office of Export Controls if you have any questions about how to complete the customs information or if you need us to vet the recipient.

Recordkeeping requirements apply to all physical exports.

Records must be kept for 5 years after the Date of Export.

Export Compliance Requirement Violations Carry Civil and Criminal Penalties

Knowingly violating US export control regulations can trigger serious civil and criminal penalties.

Sending Routine Documents Internationally

Most staff who send routine admissions documents or contracts internationally appear to be using the USPS. Regardless of carrier, you'll find some helpful information in this section.

First, OFAC regulations prohibit engaging in activities with various persons and entities. Because the lists are routinely updated, you must screen international recipients each time you send a shipment. For routine document shipments, search the list at https://sanctionssearch.ofac.treas.gov/ to ensure you do not send shipments to prohibited persons or entities. While the vast majority of foreign university destinations are benign, keep in mind that some universities in highly sanctioned countries are prohibited (generally because they have engaged in activities that support the development of weapons of mass destruction, including chemical, biological, and/or nuclear weapons, or terrorist activities). For example, various universities in China and Iran, as well as others, appear on the restricted parties lists. 

Next, where you're using the USPS First-Class Mail International service because you're sending only non-negotiable documents and correspondence that weigh under 16 ounces, a customs form is not required. Assuming you really are sending only admissions or similar documents, and for where this service class is not appropriate, please ensure you input the following when completing the Customs Form on USPS.com.

 SECTIONFIELD SELECTION/INPUT 
 Non-delivery optionsNon-delivery Option Return to Sender 
 Enter package informationContents Documents 
 Enter item informationDetailed Description <Describe your documents> 
 Enter item informationItem Value <$1, or appropriate value> 
 Enter item informationQuantity <1, or appropriate number> 
 Enter item informationWeight <Appropriate weight> 
 Enter export informationAES Exemption NOEEI 30.37(a): Package
value is less than $2500
(if truly less than $2500)
<Otherwise, ask ECU
Office of Export Controls>

Sending Non-Routine Documents or Emails Internationally

If you are asked to send technical data related to research, engineering designs, etc. physically or via email, send the following information to the ECU Office of Export Controls for further guidance:

  • Destination Recipient
    • Institution's Name, if applicable
    • Person's Name (First and Last)
    • Destination Address (Street Number and Name, City, State/Province, Country)
  • Brief Description of Contents

Sending Items Internationally

If you are asked to send items internationally, send the following information to the ECU Office of Export Controls for further guidance:

  • Destination Recipient
    • Institution's Name, if applicable
    • Person's Name (First and Last)
    • Destination Address (Street Number and Name, City, State/Province, Country)
    • Recipient's Telephone Number
  • Brief Description of Contents

The ECU Office of Export Controls will reach out to you for any additional required information, such as...

  • Helping you prepare a proforma invoice for shipment of items not being sold. Examples include specimens being provided to research sponsors, university-owned equipment being sent to support faculty member research internationally where the items are being shipped separately from the traveler, equipment being loaned to other universities, equipment or materials being given to another university.
  • Obtaining any required US export licenses from OFAC, Department of State, or Department of Commerce.
  • US government agency reporting. Examples include US APHIS or FWS reporting for biological specimens.
  • Ensuring that export recordkeeping requirements are met. 
If you're an international student, thank you for being a part of ECU! We're delighted you are here. We realize that some information on this site for US export controls might not be perceived as being as open and free as one might think otherwise. Still, it is helpful to know these points:

Catalogue courses taken at ECU's campus or in teaching laboratories, such as in ECU's on-campus labs and our study abroad programs that also are part of catalogue courses, are authorized and require no further concern.

Research conducted at ECU that is also recorded in RAMSeS is routinely screened for export control requirements. While this applies mostly to graduate students, we realize that some undergraduate students participate in research, too! If your research is not recorded in RAMSeS for any reason, please reach out to the ECU Office of Export Controls so we can review. 

Quick Links

Announcements

East Carolina University is co-sponsoring an OHRP (Office for Human Research Protections) Research Community Forum titled "Community Engagement: Current Challenges and New Directions". The Forum will be held September 25-26, 2018 in Greenville, NC. The workshop day will feature interactive presentations on applying the HHS regulations, with a focus on the revised Common Rule. The conference day will focus on thought-provoking topics related to community engagement, and include breakout sessions on research with vulnerable populations and the role of patient advocates. Check out the agenda and view the full program!

You can find the agenda and more information about registration here

The following UMCIRB informed consent templates have been revised:

Consent Letter for Expedited Survey Research v. 02.05.18

Consent for More than Minimal Risk Research v. 02.16.18

Consent for No More than Minimal Risk Research v. 02.05.18

Genetic Testing Addendum v. 02.05.18

Language for Use in a Sponsor's Consent Template v. 02.08.15

Parent Permission Form Template: No More than Minimal Risk Research v. 02.05.18

Please begin using these templates immediately and discard any old templates you may have stored on your desktop. 

The revisions involve primarily changes to Vidant Health contact information and minor grammatical/editorial changes as needed. These revised templates can be found on our website as well as in ePIRATE. 

The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.

This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.

Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).

You may review the NIH posting regarding sIRB review by clicking here

If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your questions to umcirb@ecu.edu. 

  • Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect July 19, 2018. 
  • The changes to the Common rule do not apply to FDA-regulated studies. 
  • ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source for information and updates about the revised Common Rule roll out. 
  • Studies submitted on or after July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements. 
  • The revisions to the Common Rule go into effect July 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date. 
  • New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 07.19.18. 
  • Revised SOPs will be posted on the UMCIRB website.
  • Existing expedited studies approved prior to July 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
  • Keep our website and the ePIRATE homepage checked for continuing and updated information.
  • Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu
  • Remember, the revised Common Rule does not apply to FDA-regulated studies. 

If you will be traveling internationally on behalf of ECU, please submit a completed International Travel form for export control review and approval. Please submit this form as soon as you become aware that you will be traveling internationally. Click here to access the form.

Staff Contacts

Norma Epley
Director
252-744-1971

Sierra Fountain
University Program Associate, COI
252-328-9473

Tony Rowe
Director of Export Controls
(252) 744-2395

RGS Road Map