§ 589.513 Exportation or reexportation of agricultural commodities, medicine, medical supplies, and replacement parts to the Crimea region of Ukraine.

(a)

(1) Agricultural commodities, medicine, and medical supplies. Except as provided in paragraphs (b)(1) through (3) of this section, the exportation or reexportation, from the United States or by a U.S. person, wherever located, of agricultural commodities, medicine, and medical supplies to the Crimea region of Ukraine, or to persons in third countries purchasing specifically for resale to the Crimea region of Ukraine, and the conduct of related transactions are authorized.

(2) Replacement parts. Except as provided in paragraph (b)(1) of this section, the exportation or reexportation, from the United States or by a U.S. person, wherever located, of replacement parts for medical supplies exported or reexported pursuant to paragraph (a)(1) of this section, and the conduct of related transactions are authorized, provided that such replacement parts are designated as EAR99, or, in the case of replacement parts that are not subject to the Export Administration Regulations, 15 CFR parts 730 through 744 (EAR), are not listed under any multilateral export control regime; and further provided that such 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 component).

(b)

(1) Excluded persons. Paragraphs (a)(1) and (2) of this section do not authorize the exportation or reexportation of agricultural commodities, medicine, medical supplies, or replacement parts to military or law enforcement purchasers or importers.

(2) Excluded agricultural commodities. Paragraph (a)(1) of this section does not authorize the exportation or reexportation of the following items: Castor beans, castor bean seeds, certified pathogen-free eggs (unfertilized or fertilized), dried egg albumin, live animals (excluding live cattle), embryos (excluding cattle embryos), Rosary/Jequirity peas, non-food-grade gelatin powder, peptones and their derivatives, super absorbent polymers, western red cedar, or all fertilizers.

(3) Excluded medicines. Paragraph (a)(1) of this section does not authorize the exportation or reexportation of the following medicines: Non-NSAID analgesics, cholinergics, anticholinergics, opioids, narcotics, benzodiazapenes, and bioactive peptides.

(c)

(1) Other excluded items agricultural commodities. For the purposes of this section, agricultural commodities do not include furniture made from wood; clothing manufactured from plant or animal materials; agricultural equipment (whether hand tools or motorized equipment); pesticides, insecticides, or herbicides; or cosmetics (unless derived entirely from plant materials).

(2) Other excluded medicine. For the purposes of this section, medicine does not include cosmetics.

(d) Nothing in this section relieves the exporter from compliance with the export license application requirements of another Federal agency.

(e) Nothing in this section authorizes the exportation or reexportation of any agricultural commodity, medicine, or medical device controlled on the United States Munitions List established under section 38 of the Arms Export Control Act (22 U.S.C. 2778); controlled on any control list established under the Export Administration Act of 1979 or any successor statute (50 U.S.C. App. 2401 et seq.); or used to facilitate the development or production of a chemical or biological weapon or weapon of mass destruction.

(f) Nothing in this section affects prohibitions on the sale or supply of U.S. technology or software used to manufacture agricultural commodities, medicine, or medical devices, such as technology to design or produce biotechnological items or medical devices.

(g) Nothing in this section affects U.S. nonproliferation export controls, including the end-user and end-use controls maintained under Part 744 of the EAR, 15 CFR part 744.

(h) Nothing in this section authorizes any transaction or dealing with a person whose property and interests in property are blocked pursuant to 31 CFR 536.201, 544.201, 594.201, 597.201, or 598.202, or with any foreign organization, group, or person subject to any restriction for its involvement in weapons of mass destruction or missile proliferation, or involving property blocked pursuant to this chapter or any other activity prohibited by this chapter not otherwise authorized in or pursuant to this part.

(i) Nothing in this section authorizes the exportation or reexportation of any agricultural commodity, medicine, or medical device that is not designated as EAR99 or, in the case of any agricultural commodity, medicine, or medical device not subject to the EAR, is not listed under any multilateral export control regime.

(j) For the purposes of this section, agricultural commodities, medicine, medical devices, and medical supplies are defined below.

(1) Agricultural commodities. For the purposes of this section, agricultural commodities are:

(i) In the case of products subject to the EAR, products that are designated as EAR99, and, in the case of products not subject to the EAR, products that are not listed under any multilateral export control regime, in each case 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) In the case of products subject to the EAR, products that are designated as EAR99, and in the case of products not subject to the EAR, products that are not listed under any multilateral export control regime, in each case that are intended for ultimate use in the Crimea region of Ukraine as: 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); seeds for food crops; fertilizers or organic fertilizers; or reproductive materials (such as live animals, fertilized eggs, embryos, and semen) for the production of food animals;

(2) Medicine. For the purposes of this section, medicine is 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) and that, in the case of an item subject to the EAR, is designated as EAR99 or, in the case of an item not subject to the EAR, is not listed under any multilateral export control regime.

(3) Medical devices. For the purposes of this section, a medical device is an item that falls within the definition of “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and that, in the case of an item subject to the EAR, is designated as EAR99, or in the case of an item not subject to the EAR, is not listed under any multilateral export control regime.

(4) Medical supplies. For purposes of this section, the term medical supplies means those medical devices, as defined in paragraph (j)(3) of this section, that are included on the List of Medical Supplies on OFAC's website (www.treas.gov/ofac) on the Ukraine-/Russia-Related Sanctions page.

(k) Specific licenses may be issued on a case-by-case basis to authorize the export or reexport of medical devices that are not medical supplies (and therefore not authorized pursuant to paragraph (a)(1) of this section) to the Crimea region of Ukraine, or to persons in third countries purchasing specifically for resale to the Crimea region of Ukraine.