The country of origin of plastic urinary bags from the Dominican Republic.

N339518 May 7, 2024 CLA-2-39:OT:RR:NC:N4:415 CATEGORY: Country of Origin Lisa Murrin Expeditors Tradewin, LLC 795 Jubilee Drive Peabody, MA 01960 RE:      The country of origin of plastic urinary bags from the Dominican Republic. Dear Ms. Murrin: In your letter dated April 12, 2024, you requested a country of origin ruling on behalf of your client, Global Resources International. Images were provided in lieu of samples. There are two types of bags under consideration, a 24-hour style and a single specimen style. The bags are used to collect urine specimens. The opening of the bags contains a pressure-sensitive adhesive which affixes the bag to the skin. The 24-hour style urinary bags have a permanently attached connecting tube to drain the urine from the bag to prevent overflow. They have the following part numbers: 7533 (Pediatric, 200 milliliters) and 7537 (Newborn, 100 milliliters). The single specimen style urinary bag includes the bag only and does not include the tubing. These bags have the following part numbers: 7531 (Pediatric, 200 milliliters), 7535 (Newborn, 100 milliliters), and 7540 (Preemie, 10 milliliters). Per your submission, you indicate that except for certain packaging materials, all components of the urinary bag are of Chinese origin. For the 24-hour style, the following steps are performed within the Dominican Republic: 1. Cutting the film for the bag 2. Hole punching the film 3. Printing the film 4. Heat bonding and punching the film and non-woven adhesive 5. Heat bonding the junction to the bag 6. Connecting the tubing to the junction 7. Packing and labeling For the single specimen style, the following steps are performed within the Dominican Republic: 1. Cutting the film to shape for the bag 2. Hole punching the film opening 3. Printing the film 4. Punching and heat bonding the non-woven adhesive to the film 5. Heat bonding the blue film to the bag 6. Total heat bonding to seal the bag 7. Packing and labeling Pursuant to Part 134, Customs Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 USC 1304. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines “country of origin” as: “[t]he 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.” A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In Energizer Battery, Inc. v. United States, 190 F. Supp. 3d 1308 (2016), the Court of International Trade interpreted the meaning of “substantial transformation” as used in the Trade Agreements Act of 1979 (“TAA”) for purposes of government procurement. In Energizer, the court reviewed the “name, character and use” test in determining whether a substantial transformation had occurred in determining the origin of a flashlight and reviewed various court decisions involving substantial transformation determinations. The court noted, citing Uniroyal, Inc. v. United States, 3 C.I.T. 220, 226, 542 F. Supp. 1026, 1031, aff’d, 702 F.2d 1022 (Fed. Cir. 1983), that when “the post-importation processing consists of assembly, courts have been reluctant to find a change in character, particularly when the imported articles do not undergo a physical change.” Energizer at 1318. In addition, the court noted that “when the end-use was pre-determined at the time of importation, courts have generally not found a change in use.” Energizer at 1319, citing as an example, National Hand Tool Corp. v. United States, 16 C.I.T. 308, 310, aff’d 989 F.2d 1201 (Fed. Cir. 1993). Furthermore, courts have considered the nature of the assembly, i.e., whether it is a simple assembly or more complex, such that individual parts lose their separate identities and become integral parts of a new article. In order to determine whether a substantial transformation occurs when components are assembled into completed products, all factors such as the components used to create the product and manufacturing processes that these components undergo are considered in order to determine whether a product with a new name, character, and use has been produced. No one factor is decisive, and assembly/manufacturing operations that are minimal will generally not result in a substantial transformation. This office reviewed the provided documentation and is of the opinion that the Chinese plastic film, along with the other components, have a different name, character, and use when substantially transform into the urinary specimen bags in the Dominican Republic. Therefore, we hold the opinion that both the 24-hour style and single specimen style urinary bags would have a country-of-origin of the Dominican Republic. 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 Regulations (19 CFR 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 Kristopher Burton at kristopher.burton@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division