The country of origin of bulb irrigation syringes

N342838 October 18, 2024 OT:RR:NC:N3:135 CATEGORY: Origin Lawrence Pilon Rock Trade Law LLC 134 N LaSalle Street, Suite 1800Chicago, IL 60602 RE:  The country of origin of bulb irrigation syringes Dear Mr. Pilon: In your letter dated September 25, 2024, on behalf of Medline Industries, LP, you requested a country of origin ruling on bulb irrigation syringes.  Additional information was provided by email dated October 4, 2024. The products under consideration are two styles of finished bulb irrigation syringes: Item 47394 having a 50 ml barrel capacity and Item 00943 having a 60 ml barrel capacity.  Both styles consist of (1) a molded hard PVC plastic body (the barrel) with raised liquid volume graduations molded into the clear barrel body; (2) a detachable soft plastic (TPE) bulb; and (3) a thin molded PVC plastic sealing ring between the barrel and the bulb.  You state that the clear plastic barrel body and graduations molded into the barrel body allow the medical professional to draw up measured volumes of liquid and to visually confirm the liquid in the barrel.  By squeezing the bulb, the medical professional is able to take up or expel the liquid contents of the barrel.  The sealing ring seals the joint where the barrel and bulb meet, preventing leakage at the joint.  The irrigation syringes are designed and intended for the irrigation of wounds and surgical sites with liquids (water or saline solution) during medical/surgical procedures and will be included as components in various surgical/medical procedure kits.  The bulb irrigation syringes will not be sold to the general public. The barrels and the sealing rings will be injection molded in Vietnam from PVC resin, ready for assembly into the finished irrigation syringe.  The soft plastic bulbs will be injection molded in China, then shipped to Vietnam in bulk, and assembled into finished irrigation syringes.  The assembly operation is relatively simple, consisting of placing a sealing ring at the top neck of a barrel, then press fitting a bulb into the top neck of the barrel.  After assembly, the syringes will be cleaned, inspected, and tested for leaks.  They will then be packaged for shipment to the United States or Mexico where they will be included in medical/surgical procedure kits. 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 test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character or use, different from that possessed by the article prior to processing.  See Texas Instruments Inc. v. United States, 69 C.C.P.A. 151 (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).  A substantial transformation determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993).  The issue of whether a substantial transformation occurs is determined on a case by case basis.  See HQ 561353, dated September 19, 2002. As described above, the assembly operation that occurs in Vietnam is a simple and minor operation.  It does not change the name, character, and use of the Chinese bulbs.  Despite being assembled with the Vietnamese barrels and sealing rings, the Chinese bulbs retain their name “bulb” upon production of the finished bulb irrigation syringes.  Moreover, the character and uses of the Chinese bulbs are pre-determined and are not altered as a result of the aforementioned Vietnamese assembly, cleaning, inspecting, and testing processes.  The use of the bulbs is to create suction to draw in an irrigating fluid by squeezing the bulbs or expel the fluid by releasing the pressure on the bulbs.  This use remains unchanged in the finished bulb irrigation syringes.  By squeezing and releasing the bulb, the medical professional can irrigate a wound or incision.  In our opinion, the essence of the finished bulb irrigation syringes is imparted by the bulbs while the barrels and sealing rings complement the use of the bulbs by holding the liquid irrigation fluid, gauging the amount of fluid, and preventing leakage.  Additionally, the cost of the bulb accounts for more than fifty percent of each finished bulb irrigation syringe.  Accordingly, we find that the Chinese bulbs determine the origin of the finished bulb irrigation syringes and the country of origin for both bulb irrigation syringes is China for the purposes of marking and the assessment of both the normal trade relations duty rate and Section 301 duties. 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