Lab Biosafety Focus Forum - PowerPoint Presentation

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Lab Biosafety Focus Forum

--Export Controls and Trade Sanctions--

Eileen Nielsen

Director of Research Administration EducationOffice of Research AdministrationHarvard T.H. Chan School of Public Health

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U.S. Export Controls

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Exports defined

Any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, technology, information, technical data, assistance or software codes to

Anyone outside the US (including US citizen)A non-US individual (wherever they are)A foreign embassy or affiliate

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U.S. Export Controls

Cover

any item in U.S. trade (goods, tech, info)Extend

to U.S. origin items wherever located, including U.S. (Jurisdiction follows the item world wide)Restrict export of goods and technology that could contribute to the military potential of adversariesPrevent proliferation of weapons of mass destruction (nuclear, biological, chemical)

Image Source: Export Results,

Brixham

Chamber of Commerce

, http://

www.brixhamchamb

er.co.uk

/positive-q1-export-results/?

doing_wp_cron

=

1405618752.1919538974761962890625

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U.S. Export Controls

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U.S. Export Control Authorities

Department of Treasury

Department of CommerceDepartment of State

Office of Foreign Assets Control (OFAC)Bureau of Industry and Security (BIS)Directorate of Defense Trade Controls (DDTC)

Foreign

Assets Control Regulations

Export

Administration Regulations (EAR)

International

Traffic in Arms Regulations (ITAR)

Sanction

Programs

Commerce Control List (CCL)

United States

Munitions List (USML)

Transactions with sanctioned countries,

entities and persons

Exports and re-exports of dual-use commodities,

software, equipment and technology

Transfers

of defense articles and provision of defense services

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Department of Commerce

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EAR: Dual-use and biologicals…

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Commerce Control List

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Information needed to determine export control requirements for a transaction

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Biological Agents Controlled under EAR

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Equipment capable of handling biological materials controlled by EAR

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The Violation:

On January 14, 2003, Dr. Thomas Campbell Butler, M.D., a professor at Texas Tech University in Lubbock, Texas reported to the FBI that thirty vials of a potentially deadly plague bacteria, Yersinia pestis(the causative agent of human plague), were

missing and presumed stolen from his research lab. The report sparked a bioterrorism alert in west Texas and the President was informed of the incident. An

investigation ultimately proved that Dr. Butler had illegally exported Yersinia pestis to Tanzania. The bacteria s a controlled under ECCN 1C351 and cannot be exported to Tanzania without an export license from BIS. On January 15, 2003, Dr. Butler was arrested. Dr. Butler was found guilty of numerous charges at trial, two of

which were export

control-related

: making false, fraudulent and fictitious statements regarding the export to

federal

agents, and making an unauthorized export to Tanzania. This case resulted from a joint investigation

by

BIS’s Dallas Field Office, the FBI, IRS, and Department of

Transportation

.

The Penalty

:

Dr. Butler was convicted of

forty-seven

counts of a

sixty-nine

count indictment. He was

sentenced

to two years in prison on March 10, 2004, and he resigned from Texas Tech. On October 24, 2005,

the

U.S. Court of Appeals

for

the Fifth Circuit affirmed his conviction. In the administrative case, on

September

1, 2006, Dr. Butler agreed to pay a $37,400 civil penalty and accept a denial of his export

privileges

for a period of ten years

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Technology capable of handling biological material controlled by EAR

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Definition of “release” of technology or software

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FUNDAMENTAL RESEARCH

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Fundamental Research

Basic and applied research in science and engineering, 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 applies only to the dissemination of research data and information, not to the transmission of material goods.

http://www.fas.org/irp/offdocs/nsdd/nsdd-189.htm

Image Source: At Work, Harvard School of

Public Health, http://

wordpress.sph.harvard.e

du

/vid-new/

wp

-content

/uploads/sites/35/2012/04/atwork1.jpg

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FUNDAMENTAL RESEARCH EXCLUSION IS DESTROYED IF

“Side deals” between a PI and Sponsor destroy the fundamental research exclusion and may also violate university policies on openness in research

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“Deemed” Export

An export to the country of nationality is “deemed” to have occurred at time of access – even if the technology/source code never goes there (e.g., never leaves the US.)

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Department of State

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International Traffic in Arms Control (ITAR)

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Biologics controlled under ITAR

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Deemed exports under ITAR

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Deemed exports under ITAR

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Department of Treasury

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http://www.ustreas.gov/offices/enforcement/ofac/

29

Image Source: US Sanctions, 06.04.14, Redadder123, http://commons.wikimedia.org/wiki/

File:US_Sanctions.svg, CCBY

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Office of Foreign Asset Control (OFAC)

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Sanctions - Examples

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According to this

article in the San Diego Union Tribune, Mohamad Nazemzadeh, who was a Research Fellow in the Neurology Department of the University of Michigan at the time of his arrest, is being prosecuted for sending a medical device to Iran. At issue is a coil for a magnetic resonance imaging (MRI) machine. The coil is the assembly of wires that generates the necessary radio signals when electricity flows through them to permit imaging the part of the body within the coil. Mr.

Nazemzadeh is currently a researcher at the Henry Ford hospital in Detroit and his area of specialty is, not surprisingly, magnetic resonance imaging.A part for an MRI machine would, under the Trade Sanctions Reform and Export Enhancement Act of 2000, be eligible for an export license notwithstanding the embargo on Iran.

Nazemzadeh’s failure to obtain a license would, of course, be a violation of the embargo. Even assuming that it was a criminal violation in his case, one has to wonder why prosecutorial resources are being consumed to prosecute a researcher for trying to send life-saving medical equipment to Iran. Aren’t there dangerous people out there with guns and bombs who might warrant the attention instead?An affidavit in support of a search warrant for Nazemzadeh’s mobile phone provides more detail on the case than the

Union-Tribune

article and casts some doubt on whether

Nazemzadeh

actually had the criminal intent necessary to support a criminal prosecution for the attempted export of the MRI part. According to the affidavit,

Nazemzadeh

was negotiating with the undercover federal agent (who had been tipped off by the used medical device company that

Nazemzadeh

had contacted) to ship the MRI coil to Iran through a company in the Netherlands. As is often the case, it is not uncommon for people to believe (incorrectly) that if it is legal to ship an item to a particular country, no laws are broken if the item is then re-exported to a prohibited destination. Here, according to the affidavit, Mr.

Nazemzadeh

continued to say to the undercover agent that he believed the transaction was legal and says this is true because the export from the United States is to the Netherlands, not Iran.

Just tell that, you sold that item to some company in the Netherlands, and you have the request so you’re, you issued pro forma form for them and they sent money from the bank account to you, everything is legal between you[r] two companies …. [T]here’s nothing to do with Iran. You actually have sold that coil to one company in Netherland [sic], ok?

Granted that isn’t a true statement of the law, but a good faith legal mistake is not a criminal act. Instead, this is precisely the sort of case that ought to be handled as an administrative matter by OFAC. Such a proceeding could result in the imposition of substantial civil penalties on Mr.

Nazemzadeh

notwithstanding his mistaken belief that the transaction did not violate U.S. law.

Scientist charged in Iran export case

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Resources

SPH Export Control websitehttp://www.hsph.harvard.edu/export-controls/ Harvard Global Support Services: International Programs Planning Guide

https://www.globalsupport.harvard.edu/ Harvard University Information Security Advisory for Travelers

http://security.harvard.edu/pages/travel-advisory

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CONTACT INFORMATION