Classification Details
| Category | 1 — Materials, Chemicals, Microorganisms & Toxins |
| Product Group | C — Materials |
| Description | Genetic elements and genetically modified organisms, as follows (see List of Items Controlled). |
| Control Reasons | AT |
| License Exceptions | GBSLVS |
Items Controlled
a. Any genetically modified organism that contains, or any genetic element that codes for, any of the following: a.1. Any gene, genes, translated product or translated products specific to any virus controlled by 1C351.a or .b or 1C354.c; a.2. Any gene or genes specific to any bacterium controlled by 1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b, and which; a.2.a. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health;
Related Controls
(1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, maintain controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN, including (but not limited to) certain genetic elements, recombinant nucleic acids, and recombinant organisms associated with the agents or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42 CFR 73.4(c)). (2) See USML Category XIV for modified biological agents and biologically derived substances that are "subject to the ITAR" (see 22 CFR parts 120 through 130).
Items may also be controlled under the ITAR (22 CFR 121) administered by the State Department Directorate of Defense Trade Controls (DDTC).
Related ECCNs
Export Control Context
Category 1 covers advanced materials, chemicals, microorganisms, and toxins. Many items are controlled under the Chemical Weapons Convention (CWC) and Australia Group commitments. Chemical precursors and biological agents require careful screening of end-use and end-user.
Source: BIS Commerce Control List, eCFR Title 15 Part 774. This reference is for informational purposes only. For licensing determinations, consult BIS.doc.gov or a licensed export compliance attorney.
Cross-Source Intelligence
Fed Reg Amendments
5
CSL Entities
3221
Recent BIS Amendments
Implementation of Certain Australia Group Decisions
Allied Governments Favorable Treatment: Revisions to Certain Australia Group Controls; Revisions to Certain Crime Control and Detection Controls
Proposed Enhancements and Simplification of License Exception Strategic Trade Authorization (STA)
Implementation of Australia Group Decisions From 2021 and 2022 Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and Biological Equipment
Commerce Control List: Controls on Certain Marine Toxins
Related Export Codes (Schedule B)
Sources: BIS Commerce Control List (eCFR), Census Schedule B, Federal Register (BIS), BIS Consolidated Screening List