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Name: Export Controls Policy - Interim
Responsible Office: College Services

Applies to: (examples; Faculty,Staff, Students, etc)

Faculty , Staff , Students , Contractors_Vendors

Policy Overview:

Issued: 05-01-2017
Next Review Date: 05-01-2019
Frequency of Reviews: Every 2 Years

Export control laws govern the transfer of controlled technology and information to foreign countries and to foreign nationals within the U.S. (“deemed exports”). The purpose of export control laws is to provide for the national security of the United States.

St. Louis College of Pharmacy (“STLCOP” or “the College”) recognizes the importance of maintaining an effective and comprehensive export compliance program. The purpose of the Export Control Policy is to affirm the College’s commitment to compliance with the Export Control Laws; to promote faculty and staff awareness of the Export Control Laws as they relate to the College’s activities; to provide general guidance on the College’s obligations under the Export Control Laws; and to establish procedures to assist faculty and staff in meeting the objectives of this policy statement.

Applies to all STLCOP investigators, faculty, staff, visiting scientists, postdoctoral fellows, students, scholars, and any other person working at or for STLCOP.


Definitions:

See Appendix A, Glossary of Terms.

Details:

Applicable Regulations

The export control laws govern the transfer and proliferation of certain defense-related technologies and the dissemination of technical data relating to those technologies. The regulations enacted by the federal government in furtherance of these interests include the Export Administration Regulations (“EAR”), 22 CFR 120-130, the International Traffic in Arms Regulations (“IRAR”), 15 CFR 730-774, and the various embargo and sanctions administered by the Treasury Department’s Office of Foreign Assets Control (“OFAC”) (collectively, the “Export Control Laws”). Of particular importance in the College setting, the Export Control Laws apply not only to the physical export of technology overseas, but also to the deemed export of controlled technical information to foreign nationals within the United States.

International Traffic in Arms Regulations (ITAR)

The International Traffic in Arms Regulations (ITAR) (22 CFR 120-130) are regulations administered and enforced by the U.S. Department of State that govern the export of defense articles, defense services, and related technical data of an inherently military nature. The United States Munitions List (USML) defines twenty-one broad Categories of technologies controlled under ITAR (22 CFR 121.1). In assessing the export control status of technologies potentially subject to the ITAR, covered individuals should be mindful that the USML Categories define ITAR controlled technologies in broad enough terms to encompass virtually any technology designed, modified, configured, or adapted for military use (as well as certain sensitive technologies that are controlled without regard to their intended use).

Export Administration Regulations

The Export Administration Regulations (EAR) (15 CFR 730-774) are administered and enforced by the U.S. Department of Commerce and govern the export of dual use technologies having both military and civilian applications. The technologies controlled under the EAR are listed in the Commerce Control List (CCL) (15CFR 738, Supp. 1). Unlike the broad Categories of technology controlled under the ITAR, the CCL defines EAR controlled technologies with detailed specifications and assigns to each an Export Control Classification Number (ECCN), which must then be compared to the Commerce Department’s Country Chart (15 CFR 738, Supp. 1) to determine the controls applicable to a given country. In assessing the export control status of dual use technologies, faculty and staff should be mindful that the CCL controls a variety of technologies (such as lasers, optical lenses, biological agents and imaging devices) whose military application may not be immediately apparent.

Office of Foreign Asset Control (OFAC)

The U.S. Department of the Treasury’s Office of Foreign Asset Control administers and enforces economic and trade sanctions against certain foreign countries, organizations, persons, and regimes designated by Congress as threats to the national security, foreign policy or economy of the United States. A current list of nations subject to U.S. sanctions (along with regulatory guidance) is available at the OFAC website. Although U.S. sanctions vary by country, virtually all transactions with (and, in some cases, travel to) the comprehensively embargoed countries such as Iran, North Korea, Sudan, and Syria are prohibited. In addition, the Department of the Treasury publishes lists of Specially Designated Nationals (SDN) with whom virtually all transactions are prohibited.

Policy Statement

It is STLCOP’s policy, as stated in its Code of Conduct, to comply with all relevant laws and regulations applicable to the College or its activities, including the Export Control Laws. No College personnel, including faculty, staff, visiting scientist, postdoctoral fellows, student, scholars, or any other person working for or at STLCOP, may transfer any controlled items, services, information or technology in violation of the Export Control Laws or in violation of the policies and procedures implemented by the College as part of its export compliance program.

It is the College’s policy to assure compliance with the Export Control Laws by conducting its research and other activities under the Fundamental Research Exclusion to the Export Control Laws. The College may therefore decline any research project or other activity that would involve contractual restrictions on the College’s right to publish its research, or that would restrict participation by a foreign national, or that would otherwise jeopardize the College’s right to conduct its research and other activities under the Fundamental Research Exclusion. All projects subject to such restrictions will be reviewed on a case-by-case basis by the Export Control Manager, the General Counsel, and the Dean of the relevant School to determine whether the risk of an export control violation can be adequately managed by obtaining an export license from the appropriate federal agency or by implementing physical and informational safeguards to prevent unlicensed foreign nationals from accessing the export controlled technology. Under these specific conditions, a restricted research project or other activity may be acceptable to the College. Such exceptions must be approved in advance by the Dean and the President.

For those activities that fall to qualify for an exception or exclusion to the Export Control Laws, it is the policy of St. Louis College of Pharmacy to take all reasonable precautions necessary to prevent unlawful access to ITAR- and EAR- controlled technologies by non-U.S. persons. Investigators will take all measures prescribed by law or required by the College’s Export Control Manager to prevent unlicensed foreign nationals from gaining access to ITAR- and EAR- controlled technology, including, when appropriate, the development and implementation of a Technology Control Plan to document the safeguards the College has put in place to prevent such access. When an export-control license is required by law, no research or other activity will commence until the license is obtained.

Procedures:

Roles and Responsibilities

Export Control Manager

The Vice President, College Services serves as the College’s Export Control Manager (ECM) responsible for administration of this policy.  This includes the development of training, education and assessment tools, and the implementation of procedures to assure the College’s ongoing compliance with the Export Control Laws. The ECM will work in partnership with faculty and administrators, including without limitation, the General Counsel & Chief Compliance Officer, the Director of Human Resources, Chief Technology Officer, research administration, and the Deans to assure that the College’s export compliance procedures adequately address the College’s obligations under the Export Control Laws. When appropriate, the ECM or his/her designee will assist faculty in obtaining export control licenses for foreign nationals working on export controlled projects, or assist them in developing a Technology Control Plan (TCP) to restrict unlawful access to such technologies.

Faculty & Investigators

STLCOP investigators and faculty, in consultation with the ECM, bear primary responsibility for assuring export compliance for all their research, teaching, clinical, or other College activities.

General Counsel and Chief Compliance Officer

The General Counsel and Chief Compliance Officer will provide legal advice and assistance to comply with the Export Control Laws.

 

Additional Considerations

Export Control Licenses

Faculty and staff may on occasion engage in research or other activities that require foreign nationals to have access to ITAR- or EAR- controlled technologies. In all such cases an export license must be obtained from the Department of State or Department of Commerce prior to allowing foreign nationals access to the controlled technology or controlled technical information. Faculty and staff should be aware that the application process can take from three to six months, depending on which agency has jurisdiction, the nature of the technology, and the foreign national’s country of origin. There are no guarantees that a license will be granted. Inquiries about the licensing of foreign nationals should be directed to the ECM at 446-8375 or Eric.Knoll@stlcop.edu.

Transactions with Sanctioned and Other Countries

U.S. Trade sanctions may limit the College’s ability to collaborate with persons and entities in certain embargoed countries. In particular, covered individuals will consult with the ECM prior to dealing with any persons or entities in comprehensively embargoed nations such as Iran, Syria, North Sudan, and North Korea. The shipping of items or transmittal of technical information to persons or entities in the embargoed countries is almost categorically prohibited and should not be undertaken without consulting the College’s Export Control Manager. Travel to embargoed countries is allowed, if at all, only under exceptional circumstances. Further guidance on specific embargoes and sanctions can be found on the OFAC website.

Travel & Shipping

It is the responsibility of faculty and departmental personnel to assure that all International travel and physical shipments abroad comply with the Export Control Laws. In assessing the export control implications of such activities, covered individuals should remain mindful that seemingly routine activities, such as carrying controlled technical data at a closed conference abroad, may constitute a violation of the Export Control Laws. Any doubts about the export-control status of a proposed trip or export should be resolved in favor of contacting the ECM.

International Communications and Deemed Exports

It is the responsibility of all College personnel to assure that all communications of technical information comply with the Export Control Laws. In assessing the export compliance implications of such communications, faculty should remain mindful that even informal communications of controlled technical information to collaborators abroad can constitute a violation of the Export Control Laws, as can communications of controlled export-control status of a proposed communication should be resolved in favor of contacting the ECM.

Education and Audits

The ECM will develop and make available educational material to assist covered individuals in meeting their obligations under the Export Control Laws. The ECM may also require formal export control education and training for covered individuals who will have access to export controlled technologies in the course of their work. The ECM and other appropriate offices will conduct periodic audits of College research and other activities to assure the College’s ongoing compliance with the Export Control Laws.

Restricted Party Screening 

To prevent transactions with restricted entities or persons, shipping destinations, travel destinations, visitors, and international collaborators should be screened against the restricted parties lists discussed above (Restricted Party Screening).  

Any interactions with foreign persons or entities should undergo RPS. Examples include:

  • International shipment destinations
    • ​sending or carrying equipment, biologicals, or controlled technical information overseas 
  • Visa applicants 
  • Foreign visitors
  • International sponsors 
  • International travel destinations 

Please contact the ECM at STLCOP to have restricted party screening conducted for you. Examples of situations where RPS should be requested:

  • Faculty member receives a request to give a talk at a foreign College or institute (request screening before travel arrangements are made)
  • An unsolicited request is received by a foreign national to tour a high technology facility (request screening before letter of invitation is sent).
  • Items are being shipped to a foreign destination 
  • Visa application for employer
  • Transfer of material to a foreign country or foreign material in the United States.

EXCLUSIONS FROM EXPORT CONTROLS

Both the ITAR and the EAR recognize a number of important exemptions and exclusions to the Export Control Laws. Of particular relevance to the College community are the Fundamental Research Exclusion (FRE), the Public Domain Exclusion, and the Educational Information Exclusion. 

Fundamental Research Exclusion

Information from "fundamental research" is excluded from export control laws. It is the College’s policy, whenever possible, to conduct its research activities under the Fundamental Research Exclusion. Although the definitions of “fundamental research” vary slightly between the ITAR (22 CFR § 120.11(a)(8)​) and the EAR (15 CFR § 734.8​), both are based upon the Reagan Administration’s National Security Directive 189​, which defines fundamental research as:

"Basic or applied research in science and engineering at an accredited institution of higher learning, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons."

The Fundamental Research Exclusion is NOT available when:

  • Publication restrictions are accepted from the sponsor (beyond a brief review for proprietary information)
  • Access or participation restrictions are accepted from the sponsor

Even if the basic project is determined to be fundamental research, the following aspects are still subject to export controls:

  • Work done outside the U.S.
  • Shipping of tangible items
  • Encryption software/source code
  • Export controlled proprietary information
  • Development or "Use" of equipment (operation, installation, maintenance, repair, overhaul AND refurbishing)
  • Foreign National access to technologies, equipment, or technical data controlled under the ITAR

Though broadly defined, faculty and investigators should be mindful that the FRE does not apply to all College activities. Many clinical activities (such as patient care), for example, would not qualify as "research" in “science” or “engineering” and would therefore be ineligible for the FRE.

Public Domain Exclusion

Both the ITAR and the EAR exclude from their export licensing requirements any information that is already in the public domain. (22 CFR §120.11 (a)​ (ITAR)); (15 CFR §734.9​ (EAR)​)

Information may be considered “published” and hence in the “public domain” when it is generally accessible to the interested public through:

  • Libraries (public or College)
  • Periodicals, books, print, or other media
  • Patents and patent applications
  • Conferences, meetings, seminars, trade shows, or exhibits open to the public or technically qualified public.
  • Websites accessible to the public

Educational Information Exclusion

Both the ITAR and the EAR recognize a related exclusion for "educational information" that has become part of the public domain through academic instruction. Under the EAR, the exclusion applies to information that is publicly released through instruction in catalog courses and associated teaching laboratories (15 CFR §734.9​​). Under the ITAR, the exclusion applies to information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges and universities. (22 CFR § 120.10(b)).​​

TECHNOLOGY CONTROL PLANS

In cases where it has been determined that items, information, or technology are exports controlled under the ITAR or the EAR and no exemptions or exclusions are available, the ECM will assist the Principle Investigator (PI) to develop a Technology Control Plan (TCP) (See Appendix B). A TCP is a customized management plan which outlines the procedures in place to prevent access to export-controlled items, technologies, data, or information by unauthorized individuals.

The TCP will include a description of the export-controlled information, a physical and informational security plan, and personnel screening and briefing procedures. All project personnel will be required to read, understand, and sign the TCP prior to working on the project. All project personnel must also sign the Briefing and Certification on the Handling and Protection of Export Controlled Information. The PI must notify Export Control of personnel changes so that the TCP can be updated and approved.

The exact terms of the TCP will depend upon the nature of the technology and safeguards available in a given laboratory. A general template along with suggested security requirements is attached to its policy. Original signed TCPs and Certification forms must be retained in the Department or Division in which the project is administered. Copies of all signed forms must also be sent to the ECM.

VISA PETITIONS

​The transfer of controlled information to a foreign national within the United States is considered to be an export to the home country of that foreign national under both the EAR and the ITAR. This is called a "deemed export." The deemed export of controlled technology or information may be prohibited without a license, depending on the technology and the country involved. The deemed export rule has implications for College personnel sponsoring foreign student and scholar visa applications.  


For H1-B visa applications, the required USCIS Form I-129 Visa Petition effectively requires the College to certify that its foreign employees will not have access to any ITAR- or EAR-controlled technologies during the course of their employment. In order to make this determination, the ECM ​or his/her designee will collect information from the department through the H-1B and O-1 Export Control Questionnaire​ (See Attachment C) and follow up interviews. After review, the ECM will make a recommendation as to whether a license will be needed.  

For other classes of visa applicants from countries with extensive embargoes (Iran, Syria, Sudan, North Korea) a similar questionnaire will be used to assess export control risk.

 

Requests for export control information from consulates or embassies:

In some cases the consulate will request information about the applicant's intended activities and whether or not export controlled information will be shared with them.  Please contact the ECM at STLCOP for an assessment before sending any statements regarding access to export controlled items, technology, or information. 

Sanctions

Violations of the Export Control Laws carry significant criminal and civil penalties for both the College’s and its investigators. Criminal penalties include up to ten (10) years incarceration and fines ranging up to $1,000,000 per violation. Violations may also debar the College from receiving future federal funding. In addition to governmental penalties, the failure by College personnel to comply with the Export Control Laws, or with the College’s export compliance procedures, may result in a recommendation for sanctions by the College.

Responsibilities:

Position/Office/Department

Responsibility

Export Control Manager

Administration, compliance, and oversight of export control disclosure, Technology Control Plans, and permitting

General Counsel & Chief Compliance Officer

Provide advice to the ECM and College managers and personnel on compliance with Export Control Laws

Director, Human Resources

Coordinate completion and management of Export Control Certification for H-1B and O-1 employees, and in consultation with the Export Control Manager implement procedures to ensure compliance with Export Control restrictions applicable to foreign nationals

Chief Research Administrator

Coordinate compliance with the Export Control Manager and Director, Human Resources

Resources:

Appendix A, Glossary of Export Control Terms

Appendix B, St. Louis College of Pharmacy Technology Control Plan Template

Appendix C, Questionnaire for Export Control Certification for H-1B and 0-1 Employees