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Invitrogen and the Bureau of Industry and Security (“BIS”) recently signed a settlement agreement pursuant to which Invitrogen agreed to pay $30,000 for three shipments and one attempted shipment of human leukocyte antigen tissue typing trays to Syria without a license. The shipments and attempted shipments had been made, and voluntarily disclosed, by Dynal Biotech, which Invitrogen acquired in 2005. The charging documents allege that these shipments and alleged shipments violate General Order No. 2 of Part 736 of the Export Administration Regulations which forbids exports of all items “except food and medicine” to Syria.
HLA tissue typing trays are used, among other things, to determine whether tissue or organs are compatible for transplantation into a particular individual. Clearly this product isn’t food or medicine within the exemptions provided by General Order No. 2.
But the trays are arguably medical devices under the Trade Sanctions Reform Act of 2000 (“TSRA”) which prohibits unilateral sanctions affecting medical devices. TSRA defines “medical devices” by referencing the definition of “medical devices” under the Federal Food, Drug and Cosmetic Act. Section 201 of that Act defines a medical device to include:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … (2) intended for use in the … the cure, mitigation, treatment, or prevention of disease, in man or other animals … .
This, of course, raises the question as to why General Order No. 2 exempts food and medicine but not medical devices. By failing to exempt medical devices it appears to run afoul of TSRA’s prohibition on unilateral sanctions on exports of medical devices. This is even more clear in this case because section 906(a)(2) notes that medical devices can be shipped to Syria notwithstanding any determination that Syria is a state sponsor of terrorism.
Of course, this was not the case to litigate the issue with BIS. Counsel for Invitrogen wisely decided that it would cost much more than the $30,000 agreed fine to litigate the matter. But BIS should know better.
Of course, perhaps there’s a reason I’ve missed for not including medical devices in the General Order No. 2 exemption. I haven’t had the time to fully research the matter, so if you can explain the mysterious case of the missing medical devices, please leave a comment enlightening everyone.
UPDATE: A reader points out that Section 5(a)(2)(A) of the Syria Accountability and Lebanese Sovereignty Restoration Act of 2003 permits the President to impose, as one of the sanctions on Syria, a prohibition on “the export of products of the United States (other than food and medicine) to Syria.” However, there is nothing in the legislation that suggests that Congress explicitly intended to overturn the language of TSRA which permits the unlicensed export of medical devices to Syria. There is no reference at all in the Syria Accountability Act to TSRA. In that context, then, “food and medicine” should be seen as referring to the “agricultural commodities,” “medicines,” and “medical devices” as defined in TSRA.
Of course, I am not recommending that this argument be used by anyone as a basis for not applying for a license for a medical device to be exported to Syria, since BIS will certainly seek to penalize such an export. Rather, I am suggesting that BIS should amend General Order No. 2 to make it consistent with TSRA.
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