The country of origin of water and blood filters

N351307
August 7, 2025
OT:RR:NC:N1:105
CATEGORY: Origin Elizabeth Lowe Venable LLP 600 Massachusetts Avenue NW Washington, DC 20001 RE: The country of origin of water and blood filters Dear Ms. Lowe: In your letter dated July 14, 2025, on behalf of your client, Medica USA Inc., you requested a country of origin ruling on water and blood filters. Descriptive literature was provided for our review. The items under consideration are described as water and blood filters. The water filter products are used to filter dialysis water, pharmaceutical water, domestic water, and wastewater. The blood filter products are used to filter blood and plasma. The items come in a range of sizes with different fiber membrane filtration ranges to suit the specific filtration needs of the various applications. For each of the filters, the manufacturing process is substantially similar. U.S.-origin Fiber Bundles and Tunisian-origin plastic parts and components are exported to Italy for further processing into the finished merchandise. Once these components are received in Italy, the local team begins prepping the materials by putting Fiber Bundles into filter cases and cutting off excess fiber ends. The Fiber Bundles undergo a potting process, which is the procedure where urethane is added to the ends of the units and then cut. The products then undergo leak testing to ensure integrity before final packaging. For blood filters, there is an additional sterilization step followed by an aeration step. The Fiber Bundles are the component that imparts the filtration capabilities and are manufactured in the United States through a specialized process that involves using a blend of solvents, polymers, and additives, and use a unique spinneret to form the semi-permeable hollow fiber membranes with the right pore sizes for filtration. The solvents, polymers, and additives are blended to create a dope (or casting) solution. This solution is then extruded by specialized pumps through a manufacturing process known as “spinning capillary membranes by phase inversion” to produce ultrafiltration and microfiltration membranes with microscopic or nanoscale pores for filtering. The dope solution extruded by the pumps is passed through the spinneret along with a specified diluent (or precipitating) solution using a dry-wet spinning phase-inversion technique. The forming hollow-fiber membranes are then passed through an air gap (i.e., the space between the spinneret and a temperature-controlled coagulating bath) and then dropped into a coagulation bath. After this bath, the hollow-fiber membranes are transported by rollers and put through a solvent removal and

drying process and then wound to specified fiber counts to form the finished Fiber Bundles. The resulting Fiber Bundles have the micro or nano pore size specifications necessary for the specific filtration application. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter H301619, dated November 6, 2018. 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, 681 F.2d 778 (C.C.P.A. 1982). This 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). Regarding the origin of the water and blood filters, the assembly process performed in Italy predominantly involves placing the U.S.-origin Fiber Bundles into Tunisian-origin plastic parts and components. The simple combining of these parts in Italy does not create a new and different article of commerce with a name, character, and use distinct from the individual components. Therefore, to determine the country of origin of the water and blood filters, we rely on the origin of the Fiber Bundles, which provides the essential function of the filters. It is the Fiber Bundles from the United States which requires considerable technical expertise and customized equipment to produce. It is also the most expensive portion of the filter, and it is the item performing the filtering of the water or blood. Accordingly, the country of origin of the water and blood filters will be the United States, which is where the Fiber Bundles are manufactured. 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 [email protected].
Sincerely,
(for) James Forkan Acting Director National Commodity Specialist Division