N351844

N351844 August 13, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification; Origin TARIFF NO.: 9023.00.0000; 9903.01.14; 9903.01.25; 9903.02.20; 9903.01.26 Ross Seeley Alden Dimensional Media Inc. 70 Denison Street Markham, ON L3R1B6 Canada RE: The tariff classification, country of origin, marking, and eligibility under the United States-Mexico-Canada Agreement (USMCA) of nasal spray training units Dear Mr. Seeley: In your letter dated July 30, 2025, you requested a tariff classification, country of origin, and USMCA applicability determination ruling. Descriptive literature was provided for our review. The items under consideration are described as reusable nasal spray training units, which are designed specifically to support patient and public education in two distinct therapeutic areas. The first is Opioid Overdose Response, which is for training in the recognition and reversal of opioid overdose using intranasal naloxone. The second is Anaphylaxis Preparedness, which is for training individuals at risk of severe allergic reactions in the use of intranasal epinephrine. The devices come in two different kits. The NS-T1 is a single trainer-in-sleeve item that includes a labeled demo trainer and is inserted into a printed educational sleeve. The NS-T2K is a two-trainer awareness kit that includes 2 labeled demo trainers, 2 educational sleeves, additional printed inserts and awareness stickers, and is all housed in a custom-printed folding carton. The printed sleeves and inserts contain clearly illustrated step-by-step instructions. The user reads the inserts and then uses the trainer to practice, which reinforces the technique described in the printed instructions. The nasal spray trainer devices are non-functional, demonstration-only units, intentionally designed to simulate the form and actuation of real therapeutic delivery devices. They contain no active pharmaceutical ingredient, do not deliver any spray, and are unsuitable for any clinical or therapeutic use. They are used to build confidence and competence in medication administration, particularly among first responders, educators, caregivers, and laypersons. In operation, when actuated, the device emits a tactile or audible “click,” simulating the deployment of a real intranasal spray without releasing any substance. It is designed to help users practice hand positioning, aiming, and pressure needed to administer a real dose. The nasal spray training units are shipped to public health units, emergency medical services (EMS), fire departments, police services, addiction services and community harm reduction programs, schools and universities, corporate wellness programs, and pharmacies and health clinics. In your letter, you state that the plastic demonstrational devices are produced entirely in either Canada, Germany, or China from a proprietary mold. This process would include molding the plastic article into shape to produce the finished item. Once the demonstrational devices are produced, they are moved to the assembly plant in Canada. In Canada, the Canadian-origin instructional adhesive labels are attached to the demonstrational devices. Different labels are used for the Epinephrine items and the Naloxone items. Then, the labeled demonstrational devices are paired with Canadian-origin printed educational materials (sleeves, inserts, etc.), and finally assembled into kits for distribution. The applicable subheading for the NS-T1 and NS-T2K reusable nasal spray training units will be 9023.00.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments, apparatus and models, designed for demonstrational purposes (for example, in education or exhibitions), unsuitable for other uses, and parts and accessories thereof.” The general rate of duty will be free. COUNTRY OF ORIGIN When determining the country of origin for purposes of applying current trade remedies under Section 301 and additional duties, 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 NS-T1 and NS-T2K reusable nasal spray training units, the assembly process predominantly involves placing the stickers onto the plastic units and combining with the educational materials and packaging. The combining of these articles in Canada 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 NS-T1 and NS-T2K reusable nasal spray training units, we rely on the origin of the plastic demonstrational trainer. It is the plastic demonstrational trainer that provides the practice required to administer real nasal sprays in the field. It is the plastic demonstrational trainer produced in China, Canada or Germany which provides the essence of the entire kit without which the user would not be able to physically practice as intended. Accordingly, the country of origin for trade remedy purposes of the NS-T1 and NS-T2K reusable nasal spray training units will be China, Canada or Germany, depending on where the plastic demo trainer is produced. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States 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 United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” 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 to render such other country the “country of origin” within the meaning of the marking laws and regulations. Pursuant to section 102.0, interim regulations, related to the marking rules, tariff-rate quotas, and other United States-Mexico-Canada Agreement (USMCA) provisions, published in the Federal Register on July 6, 2021 (86 FR 35566), the rules set forth in sections 102.1 through 102.18 and 102.20 determine the country of origin for marking purposes with respect to goods imported from Canada and Mexico. Section 102.11 provides a required hierarchy for determining the country of origin of a good for marking purposes, apart from textile and apparel goods which are subject to the provisions of 19 CFR 102.21. See 19 CFR 102.11. Applied in sequential order, 19 CFR 102.11(a) provides that the country of origin of a good is the country in which: (1) The good is wholly obtained or produced; (2) The good is produced exclusively from domestic materials; or (3) Each foreign material incorporated in that good undergoes an applicable change in tariff classification set out in Part 102.20 and

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 NS-T1 and NS-T2K reusable nasal spray training units, the assembly process predominantly involves placing the stickers onto the plastic units and combining with the educational materials and packaging. The combining of these articles in Canada 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 NS-T1 and NS-T2K reusable nasal spray training units, we rely on the origin of the plastic demonstrational trainer. It is the plastic demonstrational trainer that provides the practice required to administer real nasal sprays in the field. It is the plastic demonstrational trainer produced in China, Canada or Germany which provides the essence of the entire kit without which the user would not be able to physically practice as intended. Accordingly, the country of origin for trade remedy purposes of the NS-T1 and NS-T2K reusable nasal spray training units will be China, Canada or Germany, depending on where the plastic demo trainer is produced. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States 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 ul