§ 510.521 Exportation or reexportation to North Korea of certain agricultural commodities, medicine, medical devices, and replacement parts and components. ( a ) All transactions prohibited by § 510.206 that are related to the exportation or reexportation to North Korea of agricultural commodities, medicine, medical devices, or replacement parts or components for medical devices, in each case that are not subject to the Export Administration Regulations (15 CFR parts 730 through 774) (EAR), are authorized, provided that the agricultural commodities, medicine, medical devices, or replacement parts or components: ( 1 ) Would be designated as EAR99 if they were located in the United States;
( 2 ) Are not luxury goods as set forth in 15 CFR 746.4(b)(1), including identified as examples of luxury goods in 17 CFR part 746, supplement no. 1;
( 3 ) Are approved for exportation or reexportation to North Korea by the Security Council Committee established pursuant to United Nations Security Council resolution 1718 (2006), to the extent such approval is required;
( 4 ) Are not exported or reexported to any military, intelligence, or law enforcement purchaser or importer; and
( 5 ) Replacement parts are limited to a one-for-one export or reexport basis (*i.e.,* only one replacement part can be exported or reexported to replace a broken or non-operational part). Note 1 to paragraph ( a
).
Separate authorization from OFAC is required for export or reexport by a U.S. person to North Korea of items that are not subject to the EAR, other than agricultural commodities, medicine, medical devices, or replacement parts or components for medical devices as described in this paragraph. *See* § 510.512 for a general license authorizing certain transactions by nongovernmental organizations, including exports and reexports of certain items that are not subject to the EAR.
( b ) For the purposes of this section, agricultural commodities, medicine, and medical devices are defined as follows: ( 1 ) *Agricultural commodities.* The term *agricultural commodities* means products: ( i ) That fall within the term “agricultural commodity” as defined in section 102 of the Agricultural Trade Act of 1978 (7 U.S.C. 5602); and
( ii ) That are intended for ultimate use as: ( A ) Food for humans (including raw, processed, and packaged foods; live animals; vitamins and minerals; food additives or supplements; and bottled drinking water) or animals (including animal feeds);
( B ) Seeds for food crops;
( C ) Fertilizers for the purposes of food production; or
( D ) Reproductive materials (such as live animals, fertilized eggs, embryos, and semen) for the production of food animals.
( 2 ) *Medicine.* The term *medicine* means an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
( 3 ) *Medical device.* The term *medical device* means an item that: ( i ) Falls within the definition of “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); and
( ii ) Is not on the List of Medical Devices Requiring Specific Authorization, which is maintained on OFAC's website (*www.treasury.gov/ofac*) on the North Korea Sanctions page.
Note 2 to § 510.521 .
Pursuant to 17 CFR 746.4(a), a license from the Department of Commerce is required to export or reexport any item subject to the EAR to North Korea, except food and medicine designated as EAR99, unless a license exception applies.
[89 FR 12235, Feb. 16, 2024]