export controls: how to stay compliant in an academic medical setting

34
Chad Copeland Research Compliance Officer Texas Tech Health Sciences Center

Upload: kristy

Post on 14-Jan-2016

35 views

Category:

Documents


0 download

DESCRIPTION

Export Controls: How to stay compliant in an academic medical setting. Chad Copeland Research Compliance Officer Texas Tech Health Sciences Center. The export controls maze: How do I get my research done and stay compliant with the regulations?. What is an Export”?. - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: Export Controls: How to stay compliant in an academic medical setting

Chad CopelandResearch Compliance Officer

Texas Tech Health Sciences Center

Page 2: Export Controls: How to stay compliant in an academic medical setting
Page 3: Export Controls: How to stay compliant in an academic medical setting

Transfer of controlled technology, information, equipment, software, or services to a foreign person in the U.S. or abroad by any means. For example:

Actual shipment outside the U.S. Visual inspection in or outside of the U.S. Written or oral disclosure.

Page 4: Export Controls: How to stay compliant in an academic medical setting

All researchers are ultimately responsible for their own individual compliance.

At a minimum, researchers need to know how to recognize that an export control issue may exist, and then whom to contact for assistance.

This presentation is a summary designed to provide sufficient information for researchers to be able to spot export control issues.

Page 5: Export Controls: How to stay compliant in an academic medical setting

Restrict exports of goods and technology that could contribute to the military potential of adversaries

Prevent proliferation of weapons of mass destruction (nuclear, biological, chemical)

Prevent terrorism Comply with U.S. trade agreements and trade

sanctions against other nations

Page 6: Export Controls: How to stay compliant in an academic medical setting

State Department: International Traffic in Arms Regulations (ITAR), which pertain to inherently military technologies

Commerce Department: Export Administration Regulations (EAR), which pertain to “dual use” technologies (civilian or military use)

Treasury Department, Office of Foreign Assets Control (OFAC): Prohibits certain transactions with countries subject to boycotts, trade sanctions and embargoes

Page 7: Export Controls: How to stay compliant in an academic medical setting

Covers military items found on the United States Munitions List (USML) - munitions and defense articles

Includes most space related technologies because of application to missile technology

Includes technical data related to defense articles and services

Page 8: Export Controls: How to stay compliant in an academic medical setting

Covers dual use items found on the Commerce Control List (CCL)

Regulates items designed for commercial purposes but also have military applications (computers, pathogens, civilian aircraft, etc.)

Covers goods, test equipment, materials and the software and technology

Each item has an export controls classification number (ECCN)

Page 9: Export Controls: How to stay compliant in an academic medical setting

OFAC enforces economic and trade sanctions against specific foreign countries, terrorists, international narcotics traffickers, and those engaged in weapons of mass destruction proliferation.

Countries include: Cuba, Iran, Iraq, Libya, North Korea, and Sudan.

Page 10: Export Controls: How to stay compliant in an academic medical setting

Export controls cover◦ Any item in U.S. trade (goods, technology,

information)◦ U.S. items wherever located, even

internationally◦ “Deemed exports” (access to controlled

technology and source code by a foreign national in the U.S.)

◦ Providing defense information or ITAR technical data to a foreign national in the U.S. or abroad

Excludes◦ Items in the public domain◦ Artistic or non-technical publications

Page 11: Export Controls: How to stay compliant in an academic medical setting

Public Domain “Deemed” Exports Fundamental Research Exclusion (FRE) Situations that invalidate the FRE Faculty start-up funds and non-sponsored

research Equipment “Use” Shipping and payments to foreign persons

outside the U.S. Travel

Page 12: Export Controls: How to stay compliant in an academic medical setting

Includes information that is published and generally available to the public:◦ Through sales at bookstands and stores◦ At libraries open or available to the public◦ Through patents◦ Through unlimited distribution at a conference,

meeting seminar, trade show, generally accessible to the public in the U.S.

◦ Includes technology and software that are educational and released by instruction in catalog courses and associated labs and universities

Page 13: Export Controls: How to stay compliant in an academic medical setting

The EAR defines a deemed export as the release of technology to a foreign national (no green card) in the U.S.◦ Applies to a foreign or visiting faculty, research

assistants, and students Can effect tours of laboratories phone calls, emails, visual inspections

Transferring ITAR technical data to or performing a defense service (includes training) on behalf of a foreign person in the U.S. or abroad

Does not apply to U.S. Citizens, permanent residents and those with U.S. asylum protection

Page 14: Export Controls: How to stay compliant in an academic medical setting

General Rule: Research faculty and employees may not send or take export-controlled equipment, chemicals or technologies to foreign persons without a license from the U.S. Government, unless an exclusion applies.

What are the exclusions?

Page 15: Export Controls: How to stay compliant in an academic medical setting

Public Domain Exclusion (ITAR, EAR) Education Exclusion (ITAR, EAR) Fundamental Research Exclusion (ITAR, EAR)

Page 16: Export Controls: How to stay compliant in an academic medical setting

No license is required to export or transfer information and research results that are generally available to the interested public through:◦ Libraries, bookstores, or newsstands,◦ Trade shows, meetings, seminars in the U.S.

open to the public, ◦ Published in certain patent applications, or◦ Websites accessible to the public.

Note: the public domain exclusion applies to information and research results -- not physical equipment, substances, etc.

Page 17: Export Controls: How to stay compliant in an academic medical setting

No license is required for fundamental research, defined as basic or applied research in science or engineering◦ at an accredited institution of higher learning in

the U.S.; and ◦ resulting information is ordinarily published and

shared broadly in the scientific community. Fundamental research is to be

distinguished from research the results of which are restricted for proprietary reasons.

Page 18: Export Controls: How to stay compliant in an academic medical setting

University based research is not considered “fundamental research” if …

You accept restrictions on the publication of the results of the project◦ Pertains to many industry contracts and testing

agreements◦ EAR/ITAR have a carve-out for delay of

publication for a pending patent application

Page 19: Export Controls: How to stay compliant in an academic medical setting

The agreement requires sponsor approval prior to publication◦ Sponsor “Review” vs “Approval”◦ Okay to review and comment, but not approve

Page 20: Export Controls: How to stay compliant in an academic medical setting

Foreign persons who are full-time regular employees of US institutions of higher education with permanent abodes in U.S. throughout employment

Applies to unclassified technical data directly related to defense articles

◦ Does not apply to foreign nationals from prohibited countries (22 CFR 126.1)

◦ Does not apply to foreign graduate students ◦ Must be informed in writing and agree not to

transfer technology to another foreign national without a license

Page 21: Export Controls: How to stay compliant in an academic medical setting

Unless the fundamental research exclusion applies, a university’s transfer of controlled (on the CCL or the USML) technology to a non-permanent resident foreign national may require a license from Commerce or the State Department.

Page 22: Export Controls: How to stay compliant in an academic medical setting

Could have export control issues depending on the nature of the research and if you plan on releasing to the public domain◦ proprietary research could have export control

implications◦ if not run through sponsored projects office, may

not get an export controls review◦ foreign nationals on project could be an issue◦ Nondisclosure agreements

Page 23: Export Controls: How to stay compliant in an academic medical setting

Shipping equipment, technology, software, computers, goods, outside the U.S. may require a license

Payment to foreign entity outside the U.S. should raise a red flag!

Page 24: Export Controls: How to stay compliant in an academic medical setting

Commerce and State have regulations that affect:

Physically taking items with you on a trip such as◦ Laptop◦Encryption products on your laptop◦Blackberry (cell phone)◦Data/technology◦Blueprints, drawings, schematics◦Other “tools of the trade”

Giving controlled technology/data to a foreign person outside the U.S.

Page 25: Export Controls: How to stay compliant in an academic medical setting

Travel to most countries does not usually constitute an export control problem!

Taking a laptop with only Microsoft Office Suite, Internet Explorer, etc. okay to most countries – no license required◦ Export issue if taking to Cuba, Syria, Iran, North

Korea, or Sudan

Page 26: Export Controls: How to stay compliant in an academic medical setting

In most cases, if you are taking or need to work with export controlled info abroad, a license exception or exemption is available!◦ An exception/exemption is not needed if you are

taking a “clean” laptop to countries other than Cuba, Syria, Iran, North Korea, or Sudan

◦ There are some items you can take that are controlled but don’t require a license to most countries; i.e., you don’t need to use the exception Items, software should be evaluated before travel

Page 27: Export Controls: How to stay compliant in an academic medical setting

EAR – not too complicated, can apply electronically, no fee◦ Deemed Export license required for foreign national

working with certain controlled proprietary technology

◦ License needed to ship certain goods/technologies outside the U.S.

ITAR – very complicated and expensive◦ DSP-5/Technical Assistance Agreement required for

foreign nationals working with export controlled technology/defense service

◦ Technology Control Plan required

Page 28: Export Controls: How to stay compliant in an academic medical setting

28

1. Public domain, and

a) No equipment, encrypted software, listed-controlled chemicals, bio-agents or toxins, or other restricted technologies are involved, and

b) Information/software is already published, and

c) There is no contractual restriction on export, or

2. Fundamental Research

(note definitions and caveats associated with this exemption)

1. Equipment or encrypted software is involved, or

2. Technology is not in the public domain, and

3. Technology may be exposed to foreign nations (even on campus) or foreign travel is involved, and

a) The equipment, software or technology is on the Commerce Control List, or

b) Information or instruction is provided about software, technology, or equipment on the CCL, or

c) The foreign nationals are from or the travel is to an embargoed country

4. The contract has terms e.g. a publication restriction that effect the Fundamental Research Exemption

NO

1. Equipment, software, chemical, bio-agent, or technology is on the US Munitions List (ITAR), or

2. Equipment, software, chemical, bio-agent or technology is designed or modified for military use, use in outer space, or there is reason to know it will be used for or in weapons of mass destruction, or

3. Chemicals, bio-agents or toxins on the Commerce Control List are involved, or

4. The contract contains a restriction on export or access by foreign nationals

YES

License Will Be Required

Probably(further review is required)

License May Be Required

Page 29: Export Controls: How to stay compliant in an academic medical setting

If you realize you have violated the regulations, notify State, Commerce, or OFAC◦ Procedures are spelled out in ITAR and

EAR

Honest errors are acceptable but gross negligence is punishable

It is better to self-disclose than not say anything

Violations are civil and criminal---Fines and jail time!!!

Page 30: Export Controls: How to stay compliant in an academic medical setting

EAR◦ Criminal: $50K to $1 million or 5 times value of

export, whichever is greater, per violation, 10 years imprisonment

◦ Civil: revocation of exporting privilege, fines $10K-$120K per violation

◦ Examples Bass-Pro - $510K for shipping guns without a license ITT fined $100M for exporting night vision materials

without license

Page 31: Export Controls: How to stay compliant in an academic medical setting

ITAR◦ Criminal: Up to $1 million per violation and 10

years imprisonment◦ Civil: seizure and forfeiture of article, revocation

of exporting privilege, up to $500,000 fine per violation Professor Roth (Univ. TN) convicted on 9/3/08 and

recently sentenced to four years Raytheon fined $25M Hughes Electronics and Boeing Satellite Systems -

$32M Boeing - $4.2M Lockheed Martin - $13M

Page 32: Export Controls: How to stay compliant in an academic medical setting

Professor John Roth, University of Tennessee, was sentenced to 48 months for violating the Arms Export Control Act by illegally exporting technical information relating to USAF research contracts.◦ He was developing plasma technology for use on an

advanced form of an unmanned air vehicle (UAV)◦ Roth gave ITAR technical data to a Chinese and an

Iranian student ◦ Downloaded his project from a Chinese colleague’s

computer while in China◦ His laptop and flash drive were confiscated

The university export control officer warned Roth

Interesting article; indictment, and trial brief:

http://www.patentbaristas.com/archives/2009/09/17/professor-gets-4-years-in-prison-for-exporting-technical-information-on-uavs/

Page 33: Export Controls: How to stay compliant in an academic medical setting

BIS - BIS - http://www.bis.doc.gov

◦ EAR database – Commerce Control ListEAR database – Commerce Control Listhttp://www.access.gpo.gov/bis/ear/ear_data.html

ITAR - ITAR - http://www.pmddtc.state.gov/regulations_laws/itar.html

Page 34: Export Controls: How to stay compliant in an academic medical setting

Chad Copeland [email protected]

806-743-4752