The country of origin of a gas chromatograph

N340153 June 6, 2024 OT:RR:NC:N1:105 CATEGORY: Origin Kelsey LallensackThermo Electron North America LLC5225 Verona RdMadison, WI 53711 RE:  The country of origin of a gas chromatograph Dear Ms. Lallensack: In your letter dated May 15, 2024, you requested a country of origin ruling on a gas chromatograph. The item under consideration is a Gas Chromatography (GC) instrument, which is an analytical instrument designed to vaporize gas, liquid or solid samples, through the application of heat, during an analysis. Upon importation, the instrument can function either as a standalone unit or in conjunction with Mass Spectrometry (MS). When used as a standalone instrument, the customer installs detectors onto the gas chromatography unit. These detectors are responsible for detecting compounds within the vaporized samples and outputting their concentrations. Alternatively, the instrument can be used in tandem with mass spectrometry, where the gas chromatography unit sends vaporized samples to the mass spectrometry unit for plotting into a mass spectrum for further analysis. The gas chromatograph is to be manufactured in Singapore using components and subassemblies produced in China and other countries. The main components, including the electronics box and oven are manufactured in China. The motor is manufactured in the United States. The electronic box contains the controller that collects, processes, and analyzes the signals from the detector to generate the chromatograms (which are graphical representations of the separated components). It also allows for data storage, manipulation, and interpretation. The oven maintains a constant temperature in the column, which is crucial for reproducible separations. Temperature programming can also be used to optimize separation efficiency. The motor serves a critical purpose in facilitating the movement of components within the instrument. Specifically, the motor is responsible for driving the flow of the carrier gas through the chromatographic column. Additionally, the software embedded within these instruments, crucial for their operation and analytical capabilities, is designed and developed in Italy. The software controls instrument operation, data acquisition and analysis.  It allows users to set instrument parameters, run analytical methods, and interpret results. The software/firmware is first programmed into the electronic box in China, to enable some quality control functional testing, however, the Singapore factory will load the latest software for end use into the instrument during the oven calibration phase.  In Singapore, the process starts with integrating electronic and mechanical parts, meticulously calibrating the instrument to precise performance specifications, and subjecting it to thorough quality assurance testing. The manufacturing operation begins with the base assembly. During the base assembly, various components, and subassemblies, which originate from different countries, are brought together onto the chassis of the gas chromatograph. This integration involves assembling the oven, cables, tubings, and other loose components onto the chassis. The combination of these components into a cohesive unit creates the foundation of the gas chromatograph. The oven fan and motor are installed during the base assembly, which is a crucial step for reproducible separations. Furthermore, the electronic box is installed, which not only controls and coordinates all components, but also collects signals used to generate chromatograms. Without the electronic box, none of the features of the gas chromatograph would operate. Finally, the oven baffle assembly, which includes the heating elements and sensors that are heating air and measuring temperature in the area of the oven, are installed. Once all components have been installed, the fully assembled instrument has the firmware and software installed. Next, in Singapore, the product is ready for calibration and testing, which allows all components to work together to perform the required functions of a gas chromatography instrument. This includes calibrating temperature probes, installing and testing software, and conducting operational tests to verify that the instrument meets required parameters. These calibration procedures not only ensure quality but also tailor the performance of the instrument to specific analytical requirements. Throughout the assembly process, various quality assurance checks are conducted to verify that the gas chromatograph meets manufacturing standards and regulatory requirements. These checks encompass safety tests, vibration tests, communication bus tests, and outgoing checks to ensure that the instrument functions as intended and complies with relevant regulations. Finally, the complete gas chromatograph is ready for packaging and shipping. 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.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.”The courts have held that 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); Anheuser Busch Brewing Association v. The United States, 207 U.S. 556 (1908) and Uniroyal Inc. v. United States, 542 F. Supp. 1026 (1982).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, dated January 17, 2007, citing Ferrostaal Metals Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987).Regarding the country of origin of the gas chromatograph, in our view, the manufacturing process performed in Singapore would be considered complex. Many different components and subassemblies are garnered from numerous countries and combined in order to generate a functional gas chromatograph. Each of the individual components such as the electrical box, oven, motor, fan, tubing, etc., lose their identity during the manufacturing process. Therefore, the manufacturing and assembly process creates a new name, character and use different from the individual components. Accordingly, for origin and marking purposes, the gas chromatograph would be considered a product of Singapore at the time of importation into the United States. 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 Jason Christie at jason.m.christie@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division