Biotech in BIS Crosshairs
1.16.25
BIS’ latest interim final rule to control exports of certain U.S. biotechnology (new ECCN 3A069) is a nod to the “inherently dual-use” nature of biotechnology. It’s also a recognition that the potent combination of AI, bio design and biotech can present an “asymmetric threat” to the United States.
The geographic scope of the rule goes far beyond China and the product scope includes technology used to “develop” or “produce” the newly controlled items (new ECCN 3E069).
Covered by this interim final rule are two equipment categories:
* High parameter flow cytometers that simultaneously measure characteristics of cells and particles and are “specially designed” for spectral analysis or contain 26 or greater detectors or channels; and
* Liquid chromatography mass spectrometers specially designed to “elucidate and quantify unknown biomolecular structures, characterize molecules and aid in the study of molecular interactions.”
While BIS recognizes the equipment’s contributions to important innovations in health, agriculture, climate change, health and energy, its concerns regarding the misuse of the instruments’ ability to generate large amounts of high-quality biological datasets by “countries of concern” prompted the rule. “Countries of concern,” for which the license policy is a presumption of denial, include D1 countries, D5 countries, Macau and Country Group E[i]. Full list below. For all other destinations, applications are subject to a case-by-case review. However, no licenses are required for Country Group A:1. The rule does restrict, however, reexport or release to Group B countries with written assurances required from the importer. For a full list of BIS Part 740 Country Groups, see here.
Shipments en route on January 16 may proceed to destinations without licenses before February 18, 2025. Also, certain flow cytometers and mass spectrometers defined in Section 201(h) of the Federal Food Drug and Cosmetic Act and authorized for marketing by FDA are excluded from the rule’s scope.
While the rule goes into effect upon its publication today (1.16.25), BIS will receive comments until March 17, 2025, at regulations.gov, ID BIS-2024-0050.
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D1 Countries (National Security): Armenia, Azerbaijan, Belarus, Burma, Cambodia, PRC, Georgia, Iraq, Kazakhstan, North Korea, Kyrgyzstan, Laos, Libya, Macau, Moldova, Mongolia, Nicaragua, Russia, Tajikistan, Turkmenistan, Uzbekistan, Venezuela, Vietnam and Yemen); D5 Countries (U.S. Arms Embargoed Countries): Belarus, Burma, Cambodia, Central African Republic, PRC, Congo, Cuba, Eritrea, Haiti, Iran Iraq, North Korea, Lebanon, Libya, Nicaragua, Russia, Somalia, South Sudan, Sudan, Syria, Venezuela, Zimbabwe; Macau; and Country Group E: (Terrorist Supporting Countries) Iran, North Korea and Syria; and (Unilateral Embargo) Cuba.
