DDTC

ITAR Control of Medical Research?

The International Traffic in Arms Regulations (“ITAR”) presently controls “Biological agents and biologically derived substances specifically developed, configured, adapted, or modified for the purpose of increasing their capability to produce casualties in humans or livestock, degrade equipment or damage crops.” However, subparagraph (n)(2) of U.S. Munitions List Category XIV(b) presently excludes biological agents subjected to “modifications made only for civil applications (e.g., medical or environmental use)” from ITAR control.

Under the subparagraph (n)(2) exclusion, the Department of Commerce Export Administration Regulations and the Federal Select Agent Program have historically served the public interest by imposing intelligent restrictions on biomedical research that balances Defense Department concerns with the need to foster university and private industry research vital to our nations’ ability to combat infectious diseases.

In a recently proposed amendment to U.S. Munitions List Category XIV(b), the State Department now seeks to remove the subparagraph (n)(2) exclusion and, at the same time, subject certain genetically modified biological agents and related technical information to ITAR control. [F/N 1]

Specifically, among other things, the State Department rule seeks ITAR control over a list of genetically modified biological agents where the agents are subjected to non-naturally occurring genetic modifications which result in an increase in “[p]ersistence in a field environment (e.g., resistance to oxygen, UV damage, temperature extremes, or arid conditions).”  Although these types of modifications may sound scary, they are often necessary steps to the preparation of test samples used in laboratories for the development of vaccines and new drugs. As noted by Kathryn Nixdorff and Welcome Bender, distinguished professors in the fields of microbiology and genetics:

“Some of the most intensive research concerns the elucidation of the mechanisms of pathogenesis. This work is essential for combating infectious diseases. It is hoped that the production of more effective vaccines with [fewer] side effects, better diagnostics and new therapeutic drugs will result from this research.” [F/N 2]

The State Department’s proposed rule further seeks to impose ITAR control over technical information directly related to the agents at issue. This control, in turn, results in ITAR license requirements for the involvement of foreign nationals in related biomedical research activities and altogether prohibits the involvement of foreign nationals from China and over twenty other ITAR-embargoed countries in such research.

A key question is how the State Department will interpret the term “persistence in a field environment” under the new rule.  Considering the high percentage of foreign national graduate students and other foreign researchers involved in biomedical research, an expansive interpretation can substantially impact public health research and the consequent ability to respond to threats posed by the listed agents.

Public comments to the proposed rule must be submitted by August 17, 2015 and may be emailed to the State Department at mailto:DDTCPublicComments@state.gov ATTN: ITAR Amendment—USML Categories XIV and XVIII.

.   .   .

[1] 80 Fed. Reg. 34,572 (June 17, 2015).  Among other things, this rule proposes to subject ITAR control to the following:

*(b) Biological agents and biologically derived substances and genetic elements thereof as follows

(1) Genetically modified biological agents:

(i) Having non-naturally occurring genetic modifications which result in an increase in any of the following:

(A) Persistence in a field environment (e.g., resistance to oxygen, UV damage, temperature extremes, or arid conditions); or (B) The ability to defeat or overcome standard detection methods, personnel protection, natural or acquired host immunity, host immune response, or response to standard medical countermeasures; and

(ii) Being any micro-organisms/toxins or their non-naturally occurring genetic elements as listed below:

(A) Bacillus anthracis; (B) Botulinum neurotoxin producing species of Clostridium; (C) Burkholderia mallei; (D) Burkholderia pseudomallei;  (E) Ebola virus; (F) Foot-and-mouth disease virus; (G) Francisella tularensis; (H) Marburg virus; (I) Variola major virus (Smallpox virus); (J) Variola minor virus (Alastrim); (K) Yersinia pestis; or (L) Rinderpest virus.

[2] Nixdorff, K., and W. Bender. 2002. “Biotechnology, Ethics of Research, and Potential Spin-off,” INESAP Information Bulletin, 19 (March): p. 19-22.

___________________

*The above is not intended as an exhaustive list of restrictions that may apply to a particular transaction nor advice for a specific transaction because the specifics of an individual case may implicate application of other U.S. laws as well as foreign laws that carry added or different requirements.  In addition, U.S. export control and sanctions laws are frequently subject to change.  Such changes can affect the continued validity of the information above, which is based on U.S. law existing as of June 18, 2015. For these reasons, assistance from a qualified attorney competent to advise on such matters is highly recommended. Matthew A. Goldstein is an International Trade Attorney in Washington D.C. licensed to practice in the District of Columbia.  He can be reached at (202) 550-0040 and Matthew@GoldsteinPLLC.com

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