Instruments of International Traffic; 19 U.S.C. § 1322(a); 19 C.F.R. § 10.41a(a)(1); BioKeeper.

H354915
June 5, 2026
OT:RR:BSTC:CCR H354915 JLE
CATEGORY: Carriers Chae Hwa You Assistant Manager Temp Chain Company Ltd. 204, Convensia-daero, Yeonsu-gu Incheon, South Korea, 22004 RE: Instruments of International Traffic; 19 U.S.C. § 1322(a); 19 C.F.R. § 10.41a(a)(1); BioKeeper. Dear Ms. You: This is in response to your October 23, 2025, ruling request on behalf of Temp Chain Company Ltd. In your request you inquire whether BioKeeper 1800 containers qualify as “instruments of international traffic” within the meaning of 19 U.S.C. § 1332(a). Our ruling is set forth below. Facts The following facts are from your ruling request and supplements thereto. The subject BioKeeper 1800 is used to transport pharmaceuticals internationally. The subject BioKeeper is manufactured in South Korea and constructed from glass fiber reinforced plastic, aluminum alloy, and vacuum insulated panel insulation. Phase change material is used to maintain temperature. The subject BioKeeper is equipped with forklift slots, stacking pins, and stacking holes. Additionally, each subject item has a unique serial number and an external data logger. The subject BioKeeper has a lifespan of ten to fifteen years and is used repeatedly each year. Currently dozens of the subject items are in use, however, it is expected that hundreds will be used in international traffic annually.
Issue Whether the subject BioKeeper qualifies for consideration as instrument of international traffic within the meaning of 19 U.S.C. § 1322(a) and 19 C.F.R. § 10.41a(a)(1). Law and Analysis Per 19 C.F.R. § 141.4(a), “all merchandise imported into the United States is required to be entered, unless specifically excepted.” The four exceptions to the requirement of entry are listed under 19 C.F.R. § 141.4(b), one of which is instruments of international traffic (“IIT”). 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 returned as boxes or barrels containing merchandise), or if of foreign production and previously imported and duty (if any) thereon paid, or if of a class specified by the Secretary of the Treasury1 as instruments of international traffic, repair components for containers of foreign 1 Customs revenue functions have been delegated to the Secretary of Homeland Security by the Secretary of Treasury, with exceptions herein not applicable, under the authority of the Homeland Security Act of 2002, Pub. L. 107-296. See Treas. Dep't Order 100-16 (May 15, 2003). BioKeeper 1800
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 separately to be reexported with a container. (Footnote and 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: (i) Imported empty and not within the purview of a provision which specifically exempts them from duty; or (ii) 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. See U.S. Note 1, et seq., Chapter 98, HTSUS. Pursuant to 19 U.S.C. § 1322(a), IITs shall be excepted from the application of the Customs laws to the extent that such terms and conditions are prescribed in regulations or instructions. The relevant CBP regulations implementing that statute is found at 19 C.F.R. § 10.41a(a)(1) which provides in pertinent part: 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 traffic are hereby designated as “instruments of international traffic” [. . .] The Commissioner of Customs [now CBP] is authorized to designate as instruments of international traffic […] such additional articles or classes of articles as he shall find should be so designated. 19 C.F.R. § 10.41a(a)(1) (emphasis added). Such instruments may be released without entry or payment of duty, subject to the provisions of this section. To qualify for entry-free and duty-free treatment as IITs under the aforementioned statutory 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) suitable 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. 533, No. 56247 (Aug. 26, 1964).2 2 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
CBP has reviewed similar items. In HQ H348215, CBP determined certain temperature-controlled pharmaceutical containers made from aluminum, using phase change materials to maintain temperature, qualified as IITs. See HQ H348215 (Aug. 20, 2025). In HQ H409432, CBP ruled that certain temperature-controlled containers that were made, in part, from fiberglass and aluminum, possessed a lifespan of ten years, with a hundred containers used in international traffic per year, qualified as IITs. See HQ H409432 (Apr. 28, 2022). In the present matter, the subject BioKeeper is substantial in it is constructed from glass fiber reinforced plastic, aluminum alloy, and vacuum insulated panel insulation. The subject item is suitable for and capable of repeated use as it can be used multiple times per year over the course of ten to fifteen years. Finally, the subject BioKeeper is used in significant numbers as over one hundred will be in circulation. Based upon the information above, the subject item qualifies as an instrument of international traffic under 19 C.F.R. 10.41a(a)(1) and is eligible for duty-free admittance. Holding The subject BioKeeper is an IIT within the meaning of 19 U.S.C. § 1322(a) and 19 C.F.R. § 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 incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and complete 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 articles vary from the facts stipulated to herein, or CBP ascertains discrepancies based upon a review of any other pertinent information, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§ 177.2(b), 177.9(b). Sincerely yours, W. Richmond Beevers, Chief Cargo Security, Carriers, and Restricted Merchandise Branch Office of Trade, Regulations and Rulings U.S. Customs and Border Protection Schedule of the United States (1963) (TSUS), the predecessor provision to 9803.00.50, HTSUS. Likewise, the criterion that an article be “suitable for and capable of repeated use” is found in Schedule 8, Item 808.00, TSUS, Headnote 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 under 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.