OT:RR:NC:N3:135
Will Planert
Morris, Manning & Martin, LLP
1333 New Hampshire Avenue, NW, Suite 800Washington, DC 20036
RE: The country of origin of dental syringe brush tips
Dear Mr. Planert:
In your letter dated November 5, 2024, on behalf of Inter-Med, Inc. (d/b/a “Vista Apex”), you requested a country of origin ruling on dental syringe brush tips. Additional information was provided by email, dated November 13, and November 15, 2024.
The products under consideration are Sol-u-Flo Applicator Tips and Stat-Flo Hemostatic Brush Tips. When attached to a syringe, these tips serve as delivery tips to deliver dental solutions and materials in the oral cavity. Each dental syringe brush tip will consist of three parts: (1) a thin hollow stainless-steel tube (also referred to as "cannula” or “needle” in your letter), (2) a fiber brush, and (3) a plastic hub adapter (“hub”). The tubes are pre-bent at a fixed angle.
The tubes will be manufactured in Japan, South Korea, or India. The fibers will be made in the United States. The plastic hubs will be sourced in China. Assembly of the finished dental syringe brush tips will be performed in China. The processing to produce the complete dental syringe brush tips is described in your letter as follows:
Manufacture of Cannula in Japan, South Korea, or India:
A flat strip of stainless steel will be rolled and laser welded into a tube shape. The tube will be cold-worked through a die several times to toughen it and reduce the size down to the specified 19ga tubing. An electric blade will cut the tubing to individual cannulas at specified lengths with a blunt end without burrs or sharp edges. Next, the cannula will undergo heat treatment, either tempering or annealing to give the cannula its desired ductility, electropolishing to remove any burrs and give it luster, and citric acid passivation for rust prevention. All of the aforementioned processing requires highly specialized machinery and skilled labor and inspections are performed at each step.
Manufacture and Optional Coating of Fibers in the United States:
A bundle of fibers, either polypropylene or nylon, will be combined into a roll of thread. This process will be done by highly specialized equipment by contracted manufacturers to the specifications set by Vista Apex. Select fibers will be further processed at Vista Apex’s facility in the United States to apply a polymer coating. This process will be carried out by custom-built specialized equipment that Vista Apex has independently constructed at its facility. To add the polymer coating to select fibers, a slurry will be batched and mixed to Vista Apex specifications. The fibers will be then loaded into Vista Apex’s equipment which dips the fibers through this slurry at a specific rate to add a uniform coating of the slurry to the fibers. The coated fibers will then progress through a die and various heating elements to dry the coating onto the fibers. The coated fibers in rolls of thread will then be packaged and shipped to China for assembly of the fibers within the tips.
Assembly and Packing in China:
To complete the assembly of a dental syringe brush tip using the cannula and hub, an automated assembly machine will be utilized. The machine will be loaded with components, and automatically take the plastic hub, insert a cannula, apply an epoxy, cure the epoxy with flashes of ultraviolet radiation, and bend the cannula. The fiber thread will be cut to length and manually inserted into the cannula end and crimped in place at the end of the assembly line. No further processing will be performed to the cannulas, fiber, or hubs at the facility other than this assembly. After assembly, the tips will be packaged in multiple configurations to match SKUs specified by Vista Apex. The tips will be packaged in cups, bags, or blister packs at various quantities. These cups, bags, or packs will be placed in corrugated boxes for 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 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.
In this case, the assembly and packaging performed in China are simple and minor processes. Specifically, the assembly of the dental brush syringe tips will be done via a mechanically automated process that solely consists of adhering the components together with an epoxy solution and flashes of ultraviolet radiation. The tubes will be pre-bent to a fixed angle for the user’s convenience. The fiber threads are cut to length and manually inserted into the tube end and crimped in place. The mechanized assembly of the components will be a highly repetitive, low-skill function that merely requires the assembly line be switched on, that the fiber thread be cut, inserted, and crimped, and that adhesive epoxy be utilized. The additional processing of the dental brush syringe tips will merely consist of packaging. These processes do not change the name, character, and use of the pre-cut, pre-processed stainless steel tubes and fibers. We find that no substantial transformation occurs in China. You explain that the fiber brush enhances the functionality of the dental brush syringe tip by allowing the dental material being delivered through the cannula to be painted/scrubbed onto the application site during material delivery. The brush syringe tip can still deliver dental material to the application site without the brush. Also, the fibers only account for three percent of the product cost. Based on the above, in our opinion, the essence of the dental syringe brush tips will be imparted by the tubes, which determine the origin of the products. Accordingly, the country of origin of the dental syringe brush tips will be Japan, South Korea, or India depending on the country of origin of the pre-cut, pre-processed tubes.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division