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Export" target="_blank">http://www.chenab.com/Emssite/aboutems2.htm">Export Management

EXPORT MANAGEMENT SYSTEM

Table of Contents

Introduction and Background 3

Export Control Regulations 4

Important concepts: 5

Management Policy 7

Responsible Officials 9

Recordkeeping 11

Training 12

Internal Reviews 13

Notification 14

Request Processing System 15

Screening: 17

Denied Persons Screen 17

Product Classification/Licensing Determination Screen 18

Diversion-Risk Screen 18

Sensitive Nuclear Screen 18

Missile Screen 19

Chemical and Biological Weapons Screen 19

Anti-Boycott Screen 19

Informed Letter/Entity List Screen 19

Shipping/Packaging Requirements Screen: 20

Material Transfer Screen 22

Appendix I: Other Agencies List: 24

Appendix II: UC Forms: 26

Chapter

2

Export Control Regulations

The United States export control regulations have generally arisen from the goals of protecting the US and its citizens from the proliferation of weapons and their means of delivery, and from the attempt to satisfy US treaty obligations.

Our Export Management System is built upon a coordinated management of the shipment of tangible materials and upon the exemptions provided in the export control regulations for intangible information.

The two main export Control Regulations applicable to the University are the International Traffic in Arms Regulation and the Export Administration Regulations .

The Export Administration Regulations (EAR), Title 15, sections 730-774 of the Code of Federal Regulations (CFR) are promulgated and implemented by the Department of Commerce. The EAR regulates the export of ‘dual use’ goods and services (goods and services having both military and civilian uses) identified on the Commodity Control List (CCL). The complete text of the EAR and CCL are available online at http://www.access.gpo.gov/nara/cfr.

The International Traffic in Arms Regulations (ITAR), 22 CFR §§ 120-130 are promulgated and implemented by the Department of State and regulate defense articles and services and related technical data. Regulated items are identified on the Munitions Control List (MCL), 22 CFR § 121. Complete, on-line versions of ITAR and MCL are available online at http://www.access.gpo.gov/nara/cfr (Gov’t Printing Office site) and at http://www.fas.org/spp/starwars/offdocs/itar (Website for the Federation of American Scientists).

There are a number of other Export Control regulations, as well as shipping and packaging regulations and permit requirements, discussed in this manual, which may be applicable to University shipments.

Important concepts:

The term export, as used in export control regulations has an expansive meaning. Generally, an export includes any: a) shipment of commodity, technical data, source code or software out of the US, or b)release of technical data or source code to a foreign national inside the US (so-called “deemed export”).

It is particularly important to understand the concept: “deemed export” because the export control regulations prohibit an unlicensed deemed export of ‘technical data’, or source code even within the US. Disclosure of technical data or information on export-controlled items to a foreign person (e.g., a graduate student) in the United States is considered a deemed export, and requires a license.

Exceptions

There are two significant exemptions or exceptions from the export control laws that apply to the University setting. It is of utmost importance that the University and its employees take no actions that would defeat these exclusions. These exclusions provide a “safe harbor” within the law.

Fundamental research, as used in the export control regulations, includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the U.S. where the resulting information either is ordinarily published and shared broadly in the scientific community or where the resulting information has been or is about to be published.

Fundamental research is distinguished from research that results in information that is restricted for proprietary reasons or pursuant to specific U.S. government access and dissemination controls.

It is important to note that no University research will qualify as fundamental research if:

§ the institution accepts any restrictions on the publication of the information resulting from the research (other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information or to insure that publication will not compromise patent rights of the sponsor); or

§ the research is extramurally funded and the university or the researcher has accepted specific access or dissemination controls regarding the resulting information.

The educational exclusion exempts from export controls the sharing of general scientific, mathematical or engineering information commonly taught in colleges and universities as well as exempting information in the public domain.

Chapter

3

Management Policy

The University of California will comply with all applicable United States export-control laws and regulations. It is each employee’s responsibility to understand any export control requirements related to his or her work and to ensure that no exports are made contrary to those requirements. The University is establishing procedures and administrative support to aid UC personnel in complying with these laws and regulations.

A fundamental principle of the University is that the teaching and research environment should be open so that ideas can be exchanged freely among faculty and students. The University’s research activities are conducted as an integral part of the presentations at professional meetings, student dissertations and theses. The University recognizes that instances may arise in which the University’s research involves the dissemination of certain ‘technical data’, information, materials or equipment that are subject to federal export control regulations.

In such situations, UC and its employees must be responsible exporters. This includes abiding by the export rules and regulations set forth by the various agencies of the United States Government. It also includes understanding the export implications of the research undertaken at UC and obtaining the proper licenses prior to the export of any work, whether abroad or within the US. Particularly, UC employees must ensure that:

§ No item is exported without first determining if an export license is required; and

§ All domestic and international shipments are in conformance with applicable regulations governing the licensing, packaging, and shipment of the material.

§ Before shipping non-documentary items, a Request for Transfer of Material form is filled out and submitted to the Export Manager, and the transfer must be reviewed and approved.

Penalties for Non-Compliance:

Failure of any UC employee to comply with this Policy and/or the requirements of any applicable federal export control regulations may result in the imposition of sanctions by appropriate University officials up to and including termination, as well the possibility of prosecution by the federal government and the imposition of federal civil, criminal and/or administrative penalties or sanctions.

Contact Information: For additional information regarding this policy or export control requirements contact: UC Export Manager @ XXX-XXXX

Chapter

4

Responsible Officials

Empowered Official:

As a part of its compliance efforts, the University has designated the Export Manager as its “Empowered Official” for all purposes relating to applicable federal export control regulations. It should be noted, however, that for the purposes of ITAR compliance, the University of California has designated the Director of Research Administration, at the UC Office of the President (UCOP) as the “Empowered Official.”

Under the applicable regulations, the Empowered Official shall be a United States citizen, corporation or lawful permanent resident. The Export Manager is hereby designated and empowered by the University to oversee any of the University’s export licensing or approval activities and to sign license applications or other documentation relating to such licensing or to export approval.

The Export Manager is familiar with the provisions of export licensing and approval controls, including the provisions regarding criminal, civil and administrative penalties for violating such provisions. The University hereby explicitly recognizes that the Export Manager shall have the independent authority to:

1. inquire into any aspect of a proposed export, temporary import or any other transaction within the scope of export control regulations;

2. verify the legality of the transaction and the accuracy of any information to be submitted to a licensing or approval authority; and

3. refuse to sign any license application or other request for approval without prejudice or other adverse recourse being taken by the University.

4. refer ITAR license requests to the UCOP ‘Empowered Official,” the Director of Research Administration.

Duties of Principal Investigators, Researchers and Staff:

All campus Principal Investigators, Researchers and Staff shall have the opportunity and responsibility to:

§ Prior to commencing any research, shipping, or exchange of materials that may be subject to federal regulatory export licensing controls, consult with the Export Manager to determine whether and how their research may be impacted by such controls.

§ Re-evaluate any decision that was made regarding the applicability of such controls at any time that the scope of the project or project staff changes.

§ Undertake consultation in a timely fashion to permit the Export Manager and all other appropriate University personnel to review and evaluate the research in question and obtain any necessary license or authorization.

§ Refrain from entering into any agreements applicable to their University employment or research that would defeat the fundamental research exemptions. Examples of such agreements would be non-disclosure agreements and confidentiality agreements related to University research.

§ Refrain from bringing items; ‘technical data’ or information onto the campus or into UC research that is not part of campus research or educational activities, or that may subject research or educational activities to export controls. Examples of this type of activity would be a researcher using a proprietary software package obtained from an outside consulting job in a UC research project.

§ Contact the Export Manager if the researcher knows or is aware that there is a high probability that an item will be used directly or indirectly in activities related to missiles, chemical/biological weapons, or sensitive nuclear activities.

§ Coordinate with the recipient of all materials to make sure that he or she has obtained the proper importation permits.

§ Ensure that all materials sent from the campus are packaged according to applicable regulations.

Chapter

5

Recordkeeping

The Export Manager shall maintain a file of all applicable Export Records, including, but not limited to: all Applications for Export permits (BXA 748P, 748P-A, 748P-B and accompanying attachments, riders, or conditions); all other Bureau of Industry and Security (BIS) Forms related to the transfer, International Import Certificates, End User Certificates, License Exception TSR Written Assurance, and UC internal Material Transfer Request forms.

The retention period for records shall be 5 years from the date of the export, re-export, or any other termination of the transaction as defined in Section 762.6 of the EAR.

Additionally, the Empowered Official is responsible for maintaining:

§ A log or database of items exported from the campus

§ A current copy of the EAR with all Export Administration Bulletin (EAB) updates filed.

§ A current copy of the ITAR regulations, with all updates.

§ A written copy of this manual and updates.

§ A copy of the most current Denied Persons List and all Federal Register notices identifying persons added to, or deleted from the list.

Chapter

5

Training

The Export Manager shall be given sufficient resources and training to obtain a degree of expertise in applicable export regulations sufficient to provide basic training to individuals in Material Management, Shipping, and Laboratory support. These should include, at a minimum, courses offered by the Department of Commerce related to EAR requirements, as well as IATA training and certification.

Additionally, the Export Manager shall develop, maintain, and disseminate source documents for providing notification to researchers and staff of the existence and potential applicability of US Export Regulations, and the campus policies regarding Material Transfer and Export, including the Export Management System Policy.

Chapter

6

Internal Reviews

At appropriate intervals, but not less than annually, the Export Management System will be reviewed by the campus Research Compliance Office for verification of compliance with the Export Management System Plan. The reviewer should verify that all applicable documents and records are maintained, that suggested training and dissemination of materials are taking place, and that sufficient resources have been directed towards the process to make compliance feasible.

The reviewer shall prepare a written report documenting findings from the review. This report shall include a description of the review processes used and the results of the review. Appropriate managers should be notified of the results of the review and the corrective actions needed. The reviewer should prepare a written confirmation of follow-up and corrective actions taken as a result of the review.

Additionally, a review of the entire Export Management System, including a review of the annual reviews, should be included in the periodic audit of the Research Compliance program performed by Internal Audit at 3 to 5 year intervals.

Chapter

7

Notification

The Export Manager shall consult with the Bureau of Industry and Security (BIS) Office of Export Services and BIS local field offices when questions arise concerning the appropriateness of specific end users or end uses for exports, or when campus personnel suspect that questionable, unauthorized or illegal activities may have taken place or that they have been asked to participate in such activities.

Chapter

8

Request Processing System

To be more fully developed by the Export Manager. Here is an example of a possible business process: A researcher has an item and notifies the Mailroom, Office for Management of Intellectual Property (OMIP) or the Export Manager:

Sample decision tree for Export Manager’s determination of Export Control Applicability:

Chapter

9

Screening:

The following screens must be performed or coordinated by the Export Manager prior to the export of materials:

Denied Persons Screens:

These screens are designed to identify parties with revoked export privileges, and need to be conducted for all international shipments. The Export Manager should refer to the Denied Persons List. The list is located here: http://www.bis.doc.gov/dpl/thedeniallist.asp

The U.S. Department of the Treasury Office of Foreign Assets Control (OFAC) Specially Designated Nationals List should also be consulted. The list is available here: http://www.treas.gov/offices/eotffc/ofac/sdn/index.html

The Export manager should keep in the transaction file a record of:

§ the date the searches were performed,

§ how they were performed (database or hard copy), and

§ the name of the person who performed the search.

The Export Manager should look for reasonable combinations of the name, not just the entire name as listed (e.g., search for “Skylark” rather than ‘Skylark Communications, Incorporated’) and should contact the BIS Office of Export Enforcement for assistance if unsure or if there is a close match to the name.

In order to remain current, the online version of the list should be consulted for each party. The Export Manager may wish to keep a matrix of all persons he or she has looked up, and subscribe to the BIS email updates in order to determine whether a person not previously listed has been added the list.

Product Classification/Licensing Determination Screen

This screen is intended to determine whether the item being shipped is subject to ITAR, EAR, or other regulations, and to determine whether a license is needed to export the item. Under the Export Administration Regulations, each category of item is given an ECCN, or Export Control Classification Number. Items that do not fall under one of the 9 main categories of controlled items are designated as EAR99, and must still undergo the other screens. Items that do fall under the 9 main categories will indicate the reasons for control. Reference is then made to the Commerce Country chart, which indicates by country, whether a license is needed for items based on the reasons for control.

The Export Manager should keep a record of all such determinations, including:

§ the date performed,

§ the name of the person performing the screen

§ a copy of supporting information or notes used to make the determination

§ the category number, ECCN, or EAR99, and the reasons for control

§ the result of the Commerce Country chart review-is a license required?

§ if a license is required based on the Commerce Country chart, is a license exception available?

§ If no exception is available, does the investigator wish to apply for a license?

The Export Manager may decide to keep a matrix of all determinations made, in order to refer to it for repetitive shipments. If so, he or she should subscribe to the BIS email update service or otherwise keep abreast of all changes in the regulations, in order to ensure that the ECCN and Commerce Country Chart have not changed since the determination was made.

Diversion-Risk Screen

This screen is intended to screen shipments for the risk of diversion to countries or persons for which an export license is required, but has not been obtained. The Export Manager should refer to the BIS publication: “Know Your Customer” for further information. The Export Manager should decide whether there are any “Red Flags” for diversion.

Sensitive Nuclear Screen

Under EAR Section 744.2(a) an export license is required if the exporter knows or is aware that there is a high probability that an item will be used for

§ Nuclear explosive activities

§ Unsafeguarded nuclear activities

§ Safeguarded and unsafeguarded nuclear fuel cycle activities

The Export Manager should determine whether any of these situations might apply before moving forward with the export.

Missile Screen

Under EAR Section 744.3, an export license is required if an item:

§ Is destined to or for countries listed in the footnote to BIS Country Group D:4

§ If the item will be used in the design, development production or use of missiles in or by a country listed in BIS Country Group D:4

If an item is destined for one of these locations, the Export Manager should determine whether a license is required.

Chemical and Biological Weapons Screen

Under EAR Section 744.4 an export license is required if the exporter knows or is aware that there is a high probability that an item:

§ will be used in the design, development, production, stockpiling, or use of chemical or biological weapons in or by country listed in BIS Country Group D:3

Anti-Boycott Screen

Antiboycott laws require U.S. corporations to refuse to participate in foreign boycotts that the U.S. does not sanction.

We are required to report each boycott-related request we receive to:

Office of Antiboycott Compliance

Phone: (202) 482-2381

Website: bis.doc.gov/AntiboycottCompliance

Embargoed Country Screen

A license is required for exports to all embargoed countries. The Export Manager should maintain a list of all embargoed countries and screen for any shipments to those countries.

Informed Letter/Entity List Screen

This screen is designed to ensure that transactions involving certain entities are subject to export license requirements. BIS maintains an entity list in EAR Section 744, Supplement 4. The Export Manager should refer to this list for all transactions.

Most of these screens involve comparing the package contents, destination, or recipient with a list of entities or items controlled. The Shipping and Material Transfer Screens require special processes.

Shipping/Packaging Requirements Screen:

Shipping hazardous materials is regulated by several governmental and non-governmental, consensus development organizations. Penalties for non-compliance with the rules are significant and could result in the following fines:

§ Up to $250,000 and up to a year jail sentence for individuals.

§ Up to $500,000 per incident for organizations.

Hazardous materials shipping regulations administered by the International Air Transport Association (IATA) and the US Department of Transportation (DOT) are the most comprehensive and widely applicable. Some shipping companies have developed specific rules, which are stricter than DOT and/or IATA regulations. Examples of these companies include the US Postal Service (USPS), Federal Express (FedEx) and United Postal Service (UPS).

Hazardous material regulations are extremely complex; a minimum of 24 hours of professional training, repeated every three years, is required to be certified to ship hazardous materials. EHS personnel have received this training and are available to assist University offices in their shipping needs.

DEFINITION OF HAZARDOUS MATERIAL

Hazardous material is generally defined as any substance that could adversely affect the safety of the public, handlers or carriers during transportation. Hazardous material, as defined by the DOT, is any substance that appears in the 49 CFR Hazardous Materials Table. This table is searchable by clicking on the following link: Searchable HazMat Table.

Hazardous material regulations may apply to commercial products, chemical mixtures, and newly synthesized compounds. Various types of batteries, fuel containers and cleaning products are examples of materials that are regulated for shipment. There are nine classes of hazardous materials (see Appendix B for more information):

(1) Explosives

(2) Gases

(3) Flammable Liquids

(4) Flammable Solids

(5) Oxidizing Substances and Organic Peroxides

(6) Toxic and Infectious Substances

(7) Radioactive Material

(8) Corrosives

(9) Miscellaneous Dangerous Goods

SCOPE OF REGULATIONS

Shipments of hazardous material must comply with regulations any time they are transported by air. Shipments by ground are regulated when they are considered to be “in commerce.” Material carried by any commercial transport company such as FedEx or through U.S. Mail is considered to be “in commerce.” However, hazardous material transported in a university vehicle by university personnel for use in a university project is not considered to be “in commerce.” However, this material is required to meet DOT packaging requirements. EHS will provide guidance on how to package hazardous material transported by university vehicles. Fill out a Request to Ship UC Research Materials form (Appendix A) whenever you wish to transport hazardous material. For shipments of biological materials or dry ice, refer to the UC Shipment of Biological Materials and Dry Ice Manual.

If you are shipping a hazardous material that is a commercially available product, it is more cost-effective in many cases to purchase the material at the location to which you wish to ship it. For example, if you are planning fieldwork that requires the use of hazardous chemicals, you may find it easiest to have a vendor ship the chemicals directly to (or near) the location where you will be working. If this is not an option or if you will be shipping very small quantities of hazardous materials, fill out the Intent to Ship Hazardous Materials form.

Certain hazardous materials are exempt from shipping regulations when shipped in small quantities. These excepted quantity limits vary by material. EHS will determine the regulatory status of your material, including any possible exceptions, based on information submitted in the Intent form.

PLANNING A SHIPMENT

Due to the complicated nature of hazardous material shipments, you must submit a Request form for your material at least two weeks prior to your expected shipping date. EHS will determine what regulations, if any, apply to your shipment and notify you of what shipping materials you will need to ship your material. Each department will be responsible for providing all packaging materials required for your shipment.

TRAINING REQUIREMENTS

Federal rules require that anyone wishing to ship biological materials or dry ice must first have shipping training. If you are going to package biological materials or dry ice for shipment or fill out a Declaration for Dangerous Goods form you must be certified.

Shipping regulations change frequently so it is necessary to repeat training certification every two years.

Material Transfer Screen

The Office for Management of Intellectual Property (OMIP) is responsible for monitoring and administrating the Intellectual Property aspects of incoming and outgoing Material Transfer. OMIP will receive a cc copy of each Request to Transfer UC Research Materials from the Export Manager, and will contact shippers as applicable. OMIP will notify the Export Manager when a Material Transfer or licensing request involving the transfer of research materials is in process in order for the Export Manager to make the proper determinations regarding export licensing and packaging.

Other Permits and Shippers Export Declaration

A variety of other permits and documentation are required for transportation of certain materials, as well as Shipper’s Export Declarations for many items. The Principal Investigator is responsible for coordinating with the receiving party to confirm that they have obtained all required permits and other documents required for importation of the shipment. The Export Manager is responsible for filling out the Shipper’s Export Declaration, if required.

Appendix I: Other Agencies List:

Certain federal agencies other than the Dept. of Commerce or Dept. of State may have jurisdiction with regard to export controls concerning certain items. Some of these federal agencies and the items they regulate are listed below. Their jurisdiction may in some cases be exclusive, and in other cases, jurisdiction may reside in more than one federal agency, in which case both agencies regulatory requirements must be satisfied.

(a) Drug Enforcement Administration, Int’l Chemical Control Unit

Type of Items Regulated: drugs, chemicals and precursors.

Pertinent Federal Regulations: 21 CFR Parts 1311 through 1313.

(b) Drug Enforcement Administration, Int’l Drug Unit

Type of Items Regulated: controlled substances.

Pertinent Federal Regulations: 21 CFR Parts 1311 through 1313.

(c) Food & Drug Administration, Import/Export Div.

Type of Items Regulated: drugs and biologics.

Pertinent Federal Regulations: 21 U.S.C. Sections 301, et. seq.

(d) Food & Drug Administration, Int’l Affairs

Type of Items Regulated: investigational drugs.

Pertinent Federal Regulations: 21 CFR Section 312.1106

(e) Food & Drug Administration, Office of Compliance

Type of Items Regulated: medical devices

Pertinent Federal Regulations: 21 U.S.C. Section 301, et. seq.

(f) Dept. of the Interior

Type of Items Regulated: endangered species.

Pertinent Federal Regulations: 50 CFR Sections 17.21 - .22; l7.31 - .32.

(g) Nuclear Regulatory Commission, Office of Int’l Programs

Type of Items Regulated: nuclear materials and equipment.

Pertinent Federal Regulations: 10 CFR Part 110.

(h) Dept. of Energy, Office of Arms Control & Non-Proliferation, Export Control Div.

Type of Items Regulated: nuclear commodities, technical data for nuclear weapons and special nuclear materials.

Pertinent Federal Regulations: 10 CFR Part 810.

(i) Dept. of Commerce, Patent and Trademark Office, Licensing & Review

Type of Items Regulated: patent filing data sent abroad.

Pertinent Federal Regulations: 37 CFR Part 5.

(j) Dept. of Treasury, Office of Foreign Assets Control, Licensing

Type of Items Regulated: foreign assets and transactions control (including regulation of exports and imports and funds sent to and financial dealings with certain other counties).

Pertinent Federal Regulations 31 CFR Parts 500 to 590.

Appendix II: UC Forms:

REQUEST TO SHIP RESEARCH MATERIALS

PI:_____________________________Telephone:__________________ Mail Stop:______

PI Signature:___________________________ Date:___________email: _____________________

Describe the material to be transferred. The description should include the name of the material, the type of material, what it is, and what it is for or does. (If applicable, please also provide the grant name and number and the name of the sponsor that has supported your research in this material, or reference other contracts affecting the material. Use additional sheets, if necessary).

Recipient Organization: ______________________________________________________________

Please indicate whether this is a o for-profit organization; o not-for-profit organization; or o not sure.

Contact person at the Recipient Organization:______________________________________________

Address: _________________________________________________________________________

_

Telephone___________________ Fax No:_____________________Email:______________________

If the material is being shipped internationally, has the recipient been notified that they must obtain the proper importation licenses and permits? Yo No If the material requires US export licenses, additional information and documentation may be required.

Anticipated use of material by Recipient: (Please provide a concise description of the intended use of the material. Please do not use terms such as “research” or “basic research” since they are non-specific. If available, please attach a copy of the recipient’s email or letter that indicates the intended use of the material.)

__________________________________________________________________________________

__________________________________________________________________________________

1) Has the material been disclosed to the Office for Management of Intellectual Property(OMIP)? Yo No

If “N” please attach brief description of the material’s uses and/or furnish OMIP with a paper or manuscript that describes the material if available. If applicable, please attach a Record of Invention form, available at the UCOP website at: http://www.ucop.edu/ott/disclose.html. Please contact OMIP if you have any questions regarding disclosure of tangible research property.

2) Did you receive the material from others and is this a re-transfer? Yo No

3) Does the material contain materials received from others? Yo No

4) Is the material derived from or related to materials received from others? Yo No

5) Is the material or "material received from others" governed by an existing agreement with a third party? Yo No

6) Do you want to charge the Recipient for the costs associated with the material? Yo No

If your answer is “Y” to any of the above, OMIP will contact you to obtain additional information to make sure we have the legal right to transfer the Material.

PI Signature:___________________________ Date:___________email:

Appendix III: Definitions

Export: a)shipment of commodity, technical data, source code or software out of the US, or b)release of technical data or source code to a foreign national inside the US.

Commodity: Any article, material, or supply except technology and software.

Deemed Export: Any release of technology or source code subject to the EAR to a foreign national. Such release is deemed to be an export to the home country or countries of the foreign national. This deemed export rule does not apply to persons lawfully admitted for permanent residence in the United States and does not apply to persons who are protected individuals under the Immigration and Naturalization Act (8 U.S.C. 1324b(a)(3)).

Source Code (or source language): A convenient expression of one or more processes that may be turned by a programming system into equipment executable form (object code (or object language)).

Software: A collection of one or more "programs" or "microprograms" fixed in any tangible medium of expression.

Technical data: May take forms such as blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disk, tape, read-only memories.

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