RE: Instruments of International Traffic; 19 U.S.C. § 1322(a); 19 C.F.R. § 10.41a; Skycell AG; Temperature Controlled Pharmaceutical Containers

HQ H359606 August 18, 2026 OT:RR:BSTC:CCR H359606 CBC CATEGORY: Carriers SkyCell AG Benito Domínguez Rodríguez Bahnhofplatz 6300 Zug Switzerland VIA EMAIL: benito.dominguez@skycell.ch RE: Instruments of International Traffic; 19 U.S.C. § 1322(a); 19 C.F.R. § 10.41a; Skycell AG; Temperature Controlled Pharmaceutical Containers Dear Mr. Domínguez Rodríguez: This is in response to your March 12, 2026, request for a ruling pursuant to 19 C.F.R. § 177.2, on behalf of SkyCell AG (“SkyCell”), that 6500X temperature controlled pharmaceutical containers qualify for treatment as an Instruments of International Traffic (“IIT”), properly clas- sified under subheading 9803.00.50 of the Harmonized Tariff Schedule of the United States (“HTSUS”). FACTS: The following facts are from your ruling request and supplements thereto. The subject item is a pharmaceutical container, specifically the “6500X” model. The subject item is de- signed to transport pharmaceuticals through international air traffic in a temperature-controlled environment and be returned empty for refill and re-exportation. The subject containers are comprised of: (1) a five-sided shell constructed of aluminum insulated with a proprietary multi- layer technology based on composite materials and including refrigerant; (2) outer doors con- structed of aluminum insulated with a proprietary multi-layer technology based on composite materials; (3) a non-lithium battery-powered active cooling system using refrigerant composed of organic phase change materials (“PCMs”); and (4) shipper feet constructed of aluminum. The subject containers are 2,865 mm x 2,200 mm x 1,600 mm. They are equipped with L-tracks, also known as logistics or airline tracks, sized for a PMC (pallet, medium capacity) 1 pallet. Four of the subject containers can be fit inside of a reefer container, and the 6500X has 2 been adopted by multiple international airlines. The subject containers are depicted below. LAW AND ANALYSIS: Instruments of International Traffic “All merchandise imported into the United States is required to be entered, unless specifi- cally excepted.” 19 C.F.R. § 141.4(a); see 19 U.S.C. § 1484(c) (“The Customs Service may per- mit the entry and release of merchandise from customs custody in accordance with such regula- 3 The four exceptions to the requirement of entry are tions as the Secretary may prescribe.”). listed under 19 C.F.R. § 141.4(b), one of which is instruments of international traffic. See 19 C.F.R. § 141.4(b)(3). Subheading 9803.00.50, HTSUS, provides for the duty-free treatment of: Substantial containers and holders, if products of the United States (including shooks and staves of United States production when 1 https://skycell.ch/6500x-use-cases (July 15, 2026). 2 https://skycell.ch/products/6500x (July 15, 2026). 3 Customs revenue functions have been delegated to the Secretary of Homeland Security by the Secretary of Treas- ury, with exceptions herein not applicable, under the authority of the Homeland Security Act of 2002, Pub. L. 107- 296, §§ 401–19, 116 Stat. 2135, 2177–82; see Treas. Dep’t Order 100-16 (May 15, 2003). 2 returned as boxes or barrels containing merchandise), or if of for- eign production and previously imported and duty (if any) thereon paid, or if of a class specified by the Secretary of the Treasury as instruments of international traffic, repair components for contain- ers of foreign production which are instruments of international traffic, and accessories and equipment for such containers, whether the accessories and equipment are imported with a container to be reexported separately or with another container, or imported sepa- rately to be reexported with a container. (Emphasis added). Subchapter 98 of the HTSUS only applies to: (a) Substantial containers or holders which are subject to tariff treatment as imported articles and are: (1) Imported empty and not within the purview of a provi- sion which specifically exempts them from duty; or (2) Imported containing or holding articles, and which are not of a kind normally sold therewith or are entered separately therefrom; and (b) Certain repair components, accessories and equipment. U.S. Note 1 et seq., Subchapter 98-III, HTSUS. Section 322(a) of the Tariff Act of 1930, added by the Customs Simplification Act of 1953, codified the “customary exemptions from the application of the customs laws” for “instru- ments of international traffic to such extent and subject to such terms and conditions as may be prescribed in regulations or instructions of the Secretary of the Treasury.” Pub. L. No. 243-397, 4 § 14, 67 Stat. 507, 516; see 19 U.S.C. § 1322(a). “These ‘customary’ exemptions had an estab- lished legal existence long before the Congress first recognized them in § 1322(a).” Inter-City 5 Truck Lines, Ltd. v. United States, 408 F.2d 686, 689 (Ct. Claims 1969) (Nichols, J. dissenting). As empowered by Section 322(a), the Secretary has delegated authorization to CBP “to designate as instruments of international traffic, in decisions to be published in the weekly Cus- toms Bulletin, such additional articles or classes of articles as he shall find should be so desig- nated.” 19 C.F.R. § 10.41a(a). Lift vans, cargo vans, shipping tanks, skids, pallets, caul boards, and cores for textile fabrics, arriving (whether loaded or empty) in use or to be used in the shipment of merchandise in international 4 While “instruments of international traffic” include “containers” and “accessories,” they are subject to entry once “diverted into domestic use.” Sea-Land Serv. v. United States, 920 F.2d 922, 923 (Fed. Cir. 1990); 19 C.F.R. § 10.41a(d). 5 Section 127 of the Trade and Tariff Act of 1984, Implementation of the customs convention on containers, 1972, removed the qualification that the “exemption” in Section 322(a) was “traditional,” and revised duty-free treatment of “accessories” in the tariff schedules. Pub. L. No. 98-573, 98 Stat. 2948, 2959. 3 traffic are [t]hereby designated as “instruments of international traffic” within the meaning of section 322(a). In so designating, “‘instruments of international traffic’ includes the normal accessories and equipment imported with any such instrument which is a ‘container’ as defined in Article 1 6 of the Customs Convention on Containers.” Id. (“Convention”). So defined: [T]he term “container” shall mean an article of transport equip- ment (lift-van, movable tank or other similar structure): (i) fully or partially enclosed to constitute a compartment in- tended for containing goods; (ii) of a permanent character and accordingly strong enough to be suitable for repeated use; (iii)specially designed to facilitate the carriage of goods, by one or more modes of transport, without intermediate reloading; (iv) designed for ready handling, particularly when being trans- ferred from one mode of transport to another; (v) designed to be easy to fill and to empty; and (vi) having an internal volume of one cubic metre or more; ↳ the term “container” shall include the accessories and equipment of the container, appropriate for the type concerned, provided that such accessories and equipment are carried with the container. The term “container” shall not include vehicles, accessories or spare parts of vehicles, or packaging. Demountable bodies, are to be 7 treated as containers. The term “accessories and equipment of the container” shall cover in particular the following devices, even if they are removable: (a) equipment for controlling, modifying or maintaining the temperature inside the container; (b) small appliances, such as temperature or impact recorders, designed to indicate or record variations in environmental condi- tions and impact; (c) internal partitions, pallets, shelves, supports, hooks, and 8 similar devices used for stowing goods. “The Convention reflects a national policy to remove impediments to the use of contain- ers as instruments of international traffic.” Japan Line, Ltd. v. County of Los Angeles, 441 U.S. 434, 453 (1979). The “consistent practice” “of the other signatory nations” “is persuasive evi- dence of the Conventions’ meaning.” Itel Containers Int’l Corp. v. Huddleston, 507 U.S. 60, 84 (1993) (Blackmun, J. dissenting). “Such instruments may be released without entry or the pay- ment of duty, subject to the provisions of this section.” 19 C.F.R. § 10.41a(a)(1). 6 Customs Convention on Containers, 1972, 988 U.N.T.S. 43. 7 Art. 1, 338 U.N.T.S. at 104–05. 8 Annex 6, 988 U.N.T.S. at 68. 4 To qualify for entry-free and duty-free treatment as IITs under the aforementioned statu- tory and regulatory authority, the article must be a substantial container or holder. As stated above, CBP is authorized to designate as an IIT such additional articles not specifically noted in 19 C.F.R. § 10.41a(a)(1). To qualify as an IIT within the meaning of 19 U.S.C. § 1322(a) and 19 C.F.R. § 10.41a(a)(1), an article used as a container or holder must be: (1) substantial; (2) suita- ble for and capable of repeated use; and (3) used in significant numbers in international traffic. See HQ H291037 (Jan. 9, 2018); HQ H016491 (Oct. 1, 2007); HQ 114150 (Dec. 12, 1997); HQ 107545 (May 7, 1985); Treas. Dec. 71-159, Cust. B. & Dec. 296 (June 18, 1971); 99 Treas. Dec. 9 533, No. 56247 (Aug. 26, 1964). The 6500X Containers CBP has previously ruled on whether refrigerated pharmaceutical containers are IITs. See, e.g., HQ H167475 (July 20, 2011) (“Kodiak” containers); HQ H186596 (Nov. 2, 2011) (“Envirotainer” containers); HQ H218509 (July 30, 2012) (“Intelligent Thermal Solutions Reus- able Shipping Containers”). More recently, CBP determined that similar temperature-controlled pharmaceutical containers from SkyCell constituted IITs. See HQ H265208 (July 22, 2015) (SkyCell 1500 and 770 models); HQ H302868 (April 4, 2019) (SkyCell 1500C/CRT and 2500C/CRT models); HQ H348215 (Aug. 10, 2025) (SkyCell 1500X models). Based upon review of the submission and information provided, the subject pharmaceuti- cal containers are containers that are substantial, suitable for and capable of repeated use, and used in significant numbers in international traffic. They are substantial in that they are made of 10 aluminum. They are used in significant numbers in international commerce, given that they have been adopted by multiple international air cargo carriers. Lastly, the subject items are suit- 11 Moreo- able for and capable of reuse given that they are designed to be returned and refilled. ver, they also have the additional characteristics of a “container” under the Convention, having a fully enclosed internal volume of one cubic meter or more and being specifically designed for intermodal transport. Based on the foregoing, the subject pharmaceutical containers are desig- nated as IITs; therefore, they qualify for entry-free and duty-free treatment as IITs pursuant to 19 C.F.R. § 10.41a(a)(1). 9 The requirement that an article be “substantial” is not only a threshold requirement under 9803.00.50, but also a requirement for an article to be an instrument of international traffic pursuant to CBP decisions. The origin for the criterion found in CBP decisions that an article be “substantial” is found in Schedule 8, Item 808.00 of the Tariff Schedule of the United States (1963) (TSUS), the predecessor provision to 9803.00.50, HTSUS. Likewise, the crite- rion that an article be “suitable for and capable of repeated use” is found in Schedule 8, Item 808.00, TSUS, Head- note 6(b)(ii), stating that the article must be capable of “reuse.” Although the requirement that an article be capable of reuse is no longer in subheading 9803.00.50, HTSUS (the successor provision to Item 808.00, TSUS), to receive duty-free treatment thereunder, nevertheless, “reuse” is still required, pursuant to CBP decisions, for an article to be considered an instrument of international traffic. 10 See, e.g., T.D. 56411 (May 13, 1965) (finding that aluminum barrels were substantial); T.D. 68-56, 2 Cust. B. & Dec. 107 (Feb. 9, 1968) (aluminum trays); T.D. 73-94, 7 Cust. B. & Dec. 247 (April 3, 1973) (aluminum film cores); HQ 114187 (April 23, 1998) (aluminum shipping racks); HQ 116573 (Dec. 19, 2005) (aluminum carrying cases); HQ H005408 (Jan. 25, 2007) (aluminum compressed gas containers); HQ H044815 (Dec. 18, 2008) (alumi- num boxes for the carriage of isotopes); HQ H155142 (July 20, 2011) (aluminum cryogenic shipping containers); HQ H236467 (July 2, 2013) (aluminum temperature-controlled air cargo containers); HQ H262230 (April 29, 2015) (refrigerated aluminum containers). 11 https://skycell.ch/services/pharma-containers/end-to-end (July 16, 2026). 5 HOLDING: The subject pharmaceutical containers qualify for treatment as instruments of interna- tional trade within the meaning of 19 U.S.C. § 1322(a) and § 10.41a(a)(1). Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the assumption that all of the information furnished in connection with the ruling request and incor- porated in the ruling letter, either directly, by reference, or by implication, is accurate and com- plete in every material respect. The application of a ruling letter by a CBP field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based.” If the facts at hand vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. § 177.2(b)(1), (2), and (4), and § 177.9(b)(1) and (4). Sincerely yours, W. Richmond Beevers, Chief Cargo Security, Carriers, and Restricted Merchandise Branch Office of Trade, Regulations & Rulings U.S. Customs and Border Protection 6