THE COUNTRY OF ORIGIN MARKING OF Dental Aligners

N308939 February 12, 2020 MAR-2 OT:RR:NC:N3:135 CATEGORY: MARKING Mr. Elvis A Morales Ortho Organizers Inc. 1822 Aston Ave. Carlsbad, CA 92008 RE: THE COUNTRY OF ORIGIN MARKING OF Dental Aligners Dear Mr. Morales: This is in response to your letter dated January 14, 2020 requesting a ruling on the country of origin marking requirements for Dental Aligners imported from Pakistan via a consumption entry to be inspected for quality control, and then re-exported. A marked sample was not submitted with your letter for review. Additional information was provided via email on January 29 and 30, 2020. You state that the Dental Aligners manufactured in Pakistan for sale in the European Union must be brought into the United States temporarily via a consumption entry to conduct a quality control inspection before being re-exported. Each packaging container will hold several boxes each containing one dental aligner custom fitted to a patient. The packaging containers are not marked with the country of origin. These dental aligners and boxes lack the country of origin because the intended market is not the United States and will not be made available to the U.S. market. The EU items will have separate labeling and item numbers ensuring they cannot be provided to the U.S. market for sale. Additionally, each import will be assigned to a patient proving the international location of the user. Ortho Organizers Inc. is the importer who has a direct contract with the foreign supplier and will control the shipment. It will receive the dental aligners in the form as imported and conduct the quality control inspection in the U.S. You are requesting the imports be exempted from the country of origin marking requirements in order to conduct the quality control function before re-exporting. The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Section 134.1(b) of U.S. Customs and Border Protection (“CBP”) Regulations (19 C.F.R.), defines "country of origin" as: the country of manufacture, production, or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within this Part; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin. The “ultimate purchaser” is defined in section 134.1(d) as the “last person in the U.S. to receive the article in the form in which it was imported.” The general exceptions to the marking are set forth in section 134.32, which states, in pertinent part: The articles described or meeting the specified conditions set forth below are excepted from marking requirements…: * * * (h) Articles for which the ultimate purchaser must necessarily know, or in the case of a good of a NAFTA country, must reasonably know, the country of origin by reason of the circumstances of their importation or by reason of the character of the articles even though they are not marked to indicate their origin Headquarters Ruling Letter (HQ) H250459, dated October 7, 2014, states: The special “circumstances of importation” for an exception from marking under this provision [19 C.F.R. §134.32(h)] generally refers to a situation where the importer is the ultimate purchaser of the imported article and there is a direct contract with the foreign supplier in which the supplier insures that the order will be filled only with articles manufactured in a named country. Informing customers either through advertising or personally or both of the country of origin of imported articles is not sufficient to satisfy the requirements of 19 C.F.R. 134.32(h). See U.S. Wolfson Bros. Corp. v. United States, 52 Cust. Ct. 86, 91 (1964); see also HQ 968083, dated April 10, 2006. The applicability of this exception depends upon the identity of the ultimate purchaser. See HQ 968083. Containers or holders of articles within the exception set forth in 19 C.F.R. §134.32(h) are not required to be marked to indicate the origin of the contents. See 19 C.F.R. §134.22(e)(1). Given the facts presented, we find that Ortho Organizers Inc. is the “ultimate purchaser” and Ortho Organizers Inc. “must necessarily know” the country of origin of these products. As a result, the marking exception of 19 C.F.R. §134.32(h) and 134.22(e)(1) apply; under these provisions, the dental aligners, boxes, and packaging containers do not need to be marked with the country of origin as long as Ortho Organizers Inc. certifies to CBP that the subject Dental Aligners will be re-exported. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov Sincerely, Steven A. Mack Director National Commodity Specialist Division