The country of origin marking for laboratory instruments to be assembled in the U.S.

N246387 October 24, 2013 CLA-2-90:OT:RR:NC:N4:414 CATEGORY: Marking Mr. Randall L. Smith Aplegen, Inc. 5880 West Las Positas Blvd. Suite 34 Pleasanton, CA 94588 RE: The country of origin marking for laboratory instruments to be assembled in the U.S. Dear Mr. Smith: In your letter dated September 17, 2013, you requested a ruling whether U.S. Country of Origin could be claimed for your Omega Lum C imaging instrument. You state that most components are sourced from Asia, but final assembly and quality control testing is performed in the U.S. The Omega Lum C is a laboratory instrument used in life science laboratories to photograph and analyze samples of proteins or DNA that have been separated into individual sub-samples by applying an electric current. Unable to be seen with the naked eye, the samples are stained with a dye visible under white light and “labeled” with dye that fluoresces under colored UV light or luminescent molecules that glow faintly. The Omega Lum C has various lighting capabilities, a highly sensitive camera and a light-tight darkroom cabinet so that samples marked as described above can be photographed and analyzed. The researcher can crop, contrast, view and save the image to a USB or a network directly from the Omega Lum C. Aplegen purchases components (camera, lens, computer, and cabinet with integrated illumination) from various parties outside the United States. The analysis software, labor, overhead, packaging and instrument accessories are said to all be U.S. elements. U.S. labor consists of assembling the motorized lens onto the camera, attaching the camera to the cabinet, loading software onto the computer, attaching the computer to the cabinet, back-focusing the camera, constructing dark master, performing burn-in and other quality control tests, and final packaging for shipment to customer. Concerning the individual imported components, 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. Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain. Section 134.1(d) defines the ultimate purchaser as generally the last person in the U.S. who will receive the article in the form in which it was imported. 19 CFR 134.1(d)(1) states that if an imported article will be used in manufacture, the manufacturer may be the ultimate purchaser if he subjects the imported article to a process which results in a substantial transformation of the article. The case of U.S. v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940), provides that an article used in manufacture which results in an article having a name, character or use differing from that of the constituent article will be considered substantially transformed and that the manufacturer or processor will be considered the ultimate purchaser of the constituent materials. In such circumstances, the imported article is excepted from marking and only the outermost container is required to be marked. See, 19 CFR 134.35.In this case, the assembly of the Omega Lum C that occurs in the United States, along with the installation of analysis software developed in the U.S. into the device, transforms the imported foreign components into a product with a new name, character and use. Therefore, the U.S. manufacturer is the ultimate purchaser of the imported components and under 19 CFR 134.35 the imported articles would be exempt from marking. Only the outermost containers in which the components are imported must be marked with the country of origin of the country in which they are manufactured. Regarding your question whether Aplegen may claim U. S. country of Origin for this item, please note, the Federal Trade Commission has jurisdiction concerning the use of the phrase “Made in the USA” and similar claims of U.S. origin. Whether an article, in this case, the Omega Lum C, may be marked with the phrase "Made in the USA" or similar words denoting U.S. origin, is an issue under their authority. Inquiries should be directed to the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580 regarding the propriety of marking indicating that the article is made in the U.S. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Barbara Kiefer at (646) 733-3019. Sincerely,  Gwenn Klein Kirschner Acting Director National Commodity Specialist Division