1C991 Category 1C
Vaccines, immunotoxins, medical products, diagnostic and food testing kits, as follows (see List of Items Controlled).
Category 1: Special Materials and Related Equipment, Chemicals, “Microorganisms,” and “Toxins”
Reasons for control
- CB: Chemical and biological weapons
- AT: Anti-terrorism
Country chart
List-based license exceptions
Items
- (a) Ricinus communis AgglutininII (RCAII), also known as ricin D, or Ricinus Communis LectinIII (RCLIII);
- (b) Ricinus communis LectinIV (RCLIV), also known as ricin E; or
- (c) Saxitoxin identified by C.A.S. #35523-89-8.
- (2) The export of a “medical product” that is an “Investigational New Drug” (IND), as defined in 21 CFR 312.3, is subject to certain U.S. Food and Drug Administration (FDA) requirements that are independent of the export requirements specified in this ECCN or elsewhere in the EAR. These FDA requirements are described in 21 CFR 312.110 and must be satisfied in addition to any requirements specified in the EAR.
- (3) Also see 21 CFR 314.410 for FDA requirements concerning exports of new drugs and new drug substances.
- a. Vaccines containing, or designed for use against, items controlled by ECCN 1C351, 1C353 or 1C354.
- b. Immunotoxins containing toxins controlled by 1C351.d;
- c. Medical products that contain any of the following:
- c.1. Toxins controlled by ECCN 1C351.d (except for botulinum neurotoxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.15 or .d.16); or
- c.2. Genetically modified organisms or genetic elements controlled by ECCN 1C353.a.3 (except for those that contain, or code for, botulinum neurotoxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6);
- d. Medical products not controlled by 1C991.c that contain any of the following:
- d.1. Botulinum neurotoxins controlled by ECCN 1C351.d.3;
- d.2. Conotoxins controlled by ECCN 1C351.d.6; or
- d.3. Genetically modified organisms or genetic elements controlled by ECCN 1C353.a.3 that contain, or code for, botulinum neurotoxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6;
- e. Diagnostic and food testing kits containing toxins controlled by ECCN 1C351.d (except for items controlled for CW reasons under ECCN 1C351.d.15 or .d.16).
Related controls
(1) Medical products containing ricin or saxitoxin, as follows, are controlled for CW reasons under ECCN 1C351:
Notes
Technical Note: For purposes of the controls described in this ECCN, 'toxins' refers to those toxins, or their subunits, controlled under ECCN 1C351.d.
Source: eCFR, version
2026-08-01, retrieved
2026-08-20T04:04:59+00:00.