The country of origin of an angiographic syringe kit

N341969 September 6, 2024 OT:RR:NC:N3:135 CATEGORY: Origin Alexander Ruben DARCO International Corporation 510 Shotgun Rd. Suite 520Sunrise, FL 33326 RE:  The country of origin of an angiographic syringe kit Dear Mr. Ruben: In your letter dated August 9, 2024, you requested a country of origin ruling on an angiographic syringe kit. Additional information was provided via email on August 10, 2024. The imported product is a sterile angiographic syringe kit housed in a high-impact polystyrene tray, which consists of one or two angiographic syringes, tubing with two Luer connectors and two dust caps (a tubing assembly), a filling spike (spike body and spike sheath) with a dust cap and an air filter cap (a spike assembly), and a J straw.  The syringe is composed of a protective cap, a helical Luer nut, a blue umbrella, a plunger, a plunger holder, and a syringe barrel.  The syringe components are all injection molded individually and assembled together in the Dominican Republic.  The tubing with two Luer connectors, tubing dust caps, spike body, spike sheath, spike air filter cap, and spike duct cap are made in China.  The packaging materials (tray, Tyvek pouch, Tyvek label, master carton, and inner carton) are made in the Dominican Republic.  In the Dominican Republic, the dust caps are threaded onto tubing by hand to become a tubing assembly.  The spike sheath, spike body, the air filter cap, and the duct cap are connected together by hand to become a spike assembly.  The syringe (s), tubing assembly, spike assembly, and J straw are put into a blister tray and sealed with a Tyvek label or Tyvek pouch with PE film printed with manufacturing information.  The assembled syringe kits are then packed into corrugated fiberboard cartons which may or may not contain an inner carton in a master carton.  The corrugated fiberboard cartons' artwork is printed on at a previous point in the process. Then the master carton is wrapped in PE film and sterilized.  The finished goods are then inspected for compliance with specifications. The "country of origin" is defined in 19 CFR 134.1(b) as "the country of manufacture, production, or growth of any article of foreign origin entering the United States.  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 the meaning of this part." A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing.  United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993).  However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred.  Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983).  Substantial transformation determinations are based on the totality of the evidence.  See Headquarters Ruling (HQ) W968434, date January 17, 2007, citing Ferrostaal Metals Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987).  The issue of whether a substantial transformation occurs is determined on a case by case basis.  See HQ 561353, dated September 19, 2002. In this case, the attaching of the Chinese tubing components and spike components, and the packing, sterilization, and inspection processes performed in the Dominican Republic do not constitute a complex and meaningful operation, and therefore, do not result in a substantial transformation.  The name, character, and use of the tubing components and spike components remains unchanged after the processing occurs in the Dominican Republic.  The Chinese J straw is merely packaged in the kit without further process and does not undergo a substantial transformation.  The syringe is made in the Dominican Republic.  All four components are packaged into a blister tray for retail sale with each component retaining their individual countries of origin.  The angiographic syringe kit is a set consisting of multiple components with each component retaining their individual countries of origin.  Therefore, the countries of origin of the imported sterile angiographic syringe kit will be the Dominican Republic and China. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request.  This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1).  This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect.  In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.  Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 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, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division