The country of origin of plastic medical syringes

N343161 November 7, 2024 OT:RR:NC:N3:135 CATEGORY: Origin Frank Kaliner Avanos Medical 5405 Windward Parkway, Suite 100Alpharetta, GA 30004 RE:  The country of origin of plastic medical syringes Dear Mr. Kaliner: In your letter dated October 9, 2024, you requested a country of origin ruling on plastic medical syringes.  Additional information was provided by email, dated October 14 and October 16, 2024.   The plastic medical syringes are produced under three scenarios. Scenario 1: The products under consideration are plastic medical syringes without a needle.  Each syringe consists of three parts: (1) a barrel with measurement markings, which is a cylindrical part of the syringe that holds the fluid; (2) a plunger, which is a rod that fits tightly inside the barrel; and (3) a rubber gasket (plunger seal) that ensures a tight seal within the barrel to prevent leakage.  The barrel also includes a specific tip, such as a luer lok tip,  a slip tip, or a catheter tip.  Each barrel and tip design has a specific medical function/purpose depending on its shape and size.  The tip is formed with the barrel as a “molded” plastic on the barrel.  This syringe does not include a needle.  The barrels with measurement markings and tips originate in Thailand.  The plungers and rubber gaskets originate in Vietnam.  They are purchased and shipped to the Philippines, where the rubber gasket is fixed to the plunger with adhesive and the syringe is assembled by inserting the plunger with the affixed gasket into the barrel.  The syringe is then sterilized, packaged, and shipped in this condition to the U.S. Scenario 2: The products under consideration are plastic medical syringes with a needle.  All the same facts from scenario 1 apply except that there is also a stainless-steel needle that originates in Japan.  The assembly process occurring in the Philippines includes an additional step: the needle is fixed to the barrel with adhesive.  The other processes are the same as scenario 1.  Scenario 3: The products under consideration are plastic medical syringes with a needle.  All the same facts from scenario 1 apply except that there is also a stainless-steel needle that originates in Japan and the barrel originates in the Philippines.  The assembly process performed in the Philippines includes an additional step: the needle is fixed to the barrel with adhesive.  The other processes are the same as scenario 1.  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. Under scenario 1, the syringe assembly is a simple operation.  It does not change the name, character, and use of the barrel, plunger, or rubber gasket imported from Thailand and Vietnam, respectively.  There is no substantial transformation occurring in the Philippines.  You explain that the barrel is the essential component because it performs the “essential function” of holding the fluid, whether it is injected or ejected.  In addition, the barrel makes up the bulk size of the syringe.  The specialized tip of the barrel designates the specific function of the syringe.  Moreover, the barrel has the measurement markings on it to gauge the amount of fluid in the barrel.  The barrel guides the plunger, enabling the controlled movement necessary to draw in or expel fluid.  The barrel is what integrates the other components, like the tip, which is essential for the syringe’s specific medical function.  The barrel is transparent, allowing the user to see the fluid level and check for air bubbles, which is important for safe and accurate administration.  Based on the above, we agree the barrel is the dominant component that provides the character and essence of the syringe and determines the country of origin of the syringe.  Therefore, the country of origin of the plastic medical syringes is Thailand. Under scenario 2, there is also no substantial transformation occurring in the Philippines.  You state that the essential component is the needle imported from Japan.  Its name, individual identity, and ability to perform its intended function do not change upon the simple assembly.  Online research indicates that the needle is essential for the functionality of the syringe when it comes to injections or blood draws as it is the part that actually punctures the skin or other tissues to deliver or withdraw fluids; while the Thailand barrel and Vietnamese plungers and rubber gaskets are designed primarily as parts of a delivery system for administering fluids, medications, or other substances into or out of the body.  Moreover, the needle accounts for more than fifty percent of the total cost.  Accordingly, the essence of the syringe is the needle in this case.  Therefore, the country of origin of the plastic medical syringes with a needle is Japan. Under scenario 3, the barrel is produced in the Philippines, in addition to the complete assembly of the syringe in the Philippines.  In H033395, dated July 22, 2009, CBP reviewed the country of origin marking of ball point pens.  The ball point pens consist of multiple components including a plunger, plunger spring, dome, clip, and mechanism (a base, piston, and actuator), band, tip, plastic grip refill, refill spring, and upper barrel.  All the components except the upper barrel are produced in a country that is not a party to the DR-CAFTA. The processing in the DR-CAFTA country includes the production of the upper barrel of the pen and the assembly of the various components listed above.  CBP determined that “the assembly of the various components and the manufacture of the upper barrel in the DR CAFTA country would create a new article with a new name, use and character and would constitute a substantial transformation.  When both the assembly operation and the manufacture of the upper barrel are considered together, the processing would be more than a simple assembly.”  It ruled that “[t]he country of origin for marking purposes would be the DR CAFTA country where the upper barrel is produced and the pens are assembled.”  Likewise, in this case, the assembly of the syringe and the manufacture of the syringe barrel in the Philippines creates a new article with a new name, use, and character, and constitutes a substantial transformation.  It could be argued that the essence of the plastic medical syringes in this scenario is the needle similar to scenario 2; however, the essence test is deemed irrelevant in this scenario due to the operations performed in the Philippines causing a substantial transformation.  As such, in this scenario, the country of origin of the plastic medical syringes with a needle is the Philippines. Although you included a six-digit tariff number for each component of the syringes, for the purposes of this ruling we will only focus on the country of origin of the syringes.  If you would like us to verify the classification, please send a separate ruling request. 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