There are two sets of export control regulation that govern the biological agents and shipments. The Export Administration Regulations (EAR) govern dual-use items, technologies and software with commercial and military applications. The International Traffic in Arms Regulations (ITAR) govern materials, technologies and software specifically designed for military applications. Most research at the University of Colorado Denver | Anschutz Medical Campus is considered unrestricted and considered fundamental research, which is basic or applied research in science and engineering, where the resulting information is ordinarily published and shared broadly with the scientific community. However, in certain situations, the fundamental research exemption may not apply and further analysis of the planned project is required. Persons who plan to work with biological agents governed by the export control regulations are required to contact the export control officer in advance of planned research. A license or other authorization maybe needed before work can commence. Contact the Export Control Office with any questions. Christine.Ahearn@cuanschutz.edu 303-724-0245
$The following forms of saxitoxin are CWC Schedule 1 chemicals (see 742.18 of the EAR) and require a license for CW reasons to export and reexport to all destinations including Canada:
i. Saxitoxin identified by C.A.S. #35523-89-8 #While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g., neosaxitoxin) are designated EAR99 (see below).
ii. The US Government must provide advance notification and annual reports to the OPWC of all exports of Schedule 1 chemicals (see 745.0 of the EAR for notification procedures).
#While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g. neosaxitoxin) are designated EAR99.
As a result of recent changes to the CDC/APHIS list of Select Agents and Toxins, the following select agents that were formerly controlled by ECCN 1C360 are no longer listed on the CCL and are now classified as EAR99 instead:
Items designated as EAR99 may be exported using the license exception "NLR", specifying "no license required", as long ALL of the following criteria are met:
Category XIV: Toxicological Agents including Chemical, Biological Agents, and Associated Equipment
MULTIPLE Export Controls, INCLUDING a License will be required to use or possess the following:
(b) 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.
(f) Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment as follows:
Additional items associated with, or specific to, the biological agents listed in paragraph (b) are also controlled under the ITAR including medical countermeasures (pre- and post-treatments, vaccines, antidotes, medical diagnostics); modeling or simulation tools; equipment, components, parts, accessories and attachments, exclusive of incinerators specifically designed/modified for the destruction of biological agents in paragraph (b); technical data and defense services. For more information on these items please refer to Category XIV – Toxicological Agents, including Chemical Agents, Biological Agents and Associated Equipment sections (g) through (m), page 486