OT:RR:BSTC:CCR H348215 MF
Fabian Walt
Supplier & Procurement Manager
HAMELIRAINSTRASSE 11
Kloten 8302
Switzerland
RE: Instruments of International Traffic; 19 U.S.C. § 1332(a); § 10.41a(a)(1),
SkyCell AG; Temperature Controlled Pharmaceutical Containers.
Dear Mr. Walt:
This is in response to your April 25, 2025, ruling request on behalf of SkyCell AG
(“SkyCell”). In your request you inquire whether 1500X temperature controlled pharmaceutical
containers qualify as “instruments of international traffic” (“IIT") within the meaning of 19
U.S.C. § 1332(a). Our decision follows.
FACTS:
The following facts are from your ruling request and supplements thereto. The subject
item is a pharmaceutical container, specifically, the “1500X” model. The subject item is
designed to transport pharmaceuticals through international air traffic in a temperature-controlled
environment and be returned to the United States empty for refill and re-exportation. The subject
containers are comprised of: (1) a 5-sided shell constructed of Aluminum insulated with a
proprietary multi-layer technology based on composite materials and including refrigerant; (2) an
outer door constructed of Aluminum insulated with a proprietary multi-layer technology based
on composite materials; (3) a refrigerant constructed of organic phase change materials (PCMs);
(4) inner doors constructed of Aluminum composite panels, including refrigerant; and (5) shipper
feet constructed of Aluminum with an elastomer layer at the bottom of the feet.
The subject container is 1456 mm x 1170 mm x 1600 mm. The subject containers are
depicted below:
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There are a total of approximately three thousand 1500X containers in circulation globally at
present. Units in service since SkyCell’s founding twelve years ago are still in use and the
company estimates that these containers have a likely lifespan of twenty years.
SkyCell’s internally developed transportation management system enables the firm to
track every movement of their containers and identify all imports and re-exports down to the
exact date. If a container approaches the 365-day limit on the presence of IITs within the United
States specified in 19 C.F.R. § 10.41a(g)(1), SkyCell will organize a stock-to-stock transfer to
another service center country. SkyCell’s customers are not involved in the movement of their
empty containers and only retain them at their warehouse for a few days. Either after unloading
or loading, the containers are picked up by a freight forwarder. As a result, the conduct of
SkyCell’s customers is precluded from resulting in violations of 19 C.F.R. § 10.41a(g)(1).
ISSUE:
Whether the subject containers qualify for consideration as IIT 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. See 19
C.F.R. § 141.4(b)(3).
Subheading 9803.00.0, 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
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duty (if any) thereon paid, or if of a class specified by the Secretary of the Treasury 1
as instruments of international traffic, repair components for containers 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
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 are 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 the 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
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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).
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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
CBP has previously ruled on whether temperature-controlled cargo containers are IITs.
In HQ H225100 (Sept. 17, 2012), for example, CBP held that temperature-controlled cargo
containers used for transporting pharmaceuticals qualified as IITs within the meaning of 19
U.S.C. §1322(a) and 19 CFR § 10.41a. See also HQ H167475 (July 20, 2011) and HQ H218509
(July 30, 2012), both holding that temperature control containers used for shipping various
articles for the pharmaceutical, biotech and genetic research industries are IITs. More recently,
CBP determined that similar temperature-controlled containers for pharmaceuticals from
SkyCell constituted IITs. See HQ H302868 (Apr. 4, 2019).
Based upon review of the submission and information provided, the subject
pharmaceutical 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 steel 3 and aluminum 4. They are used in significant numbers in international commerce,
given that approximately three thousand of the subject items are currently used in international
traffic. Lastly, the subject items are suitable for and capable of reuse given that they are
designed to be refilled and have been used for periods of up to twelve years with an apparent
lifespan of up to twenty years. Based on the foregoing, the subject pharmaceutical containers are
designated as IITs; therefore, they qualify for entry-free and duty-free treatment as IITs pursuant
to 19 C.F.R. § 10.41a(a)(1).
HOLDING:
The subject pharmaceutical containers qualify for treatment as instruments of
international 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
incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
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
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.
3
See HQ 114733 (Nov. 17, 1999); H116376 (Jan. 11, 2005) (CBP determined steel bins and steel chains were
substantial); HQ 303170 (Apr. 9, 2019) (CBP held steel container racks were substantial); and H339996 (October
11, 2024) (CBP found that steel cargo support structures were substantial).
4
See HQ 340856 (November 27, 2024) (finding that aluminum frames designed to surround CB5 Carbon LED tiles
were substantial).
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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 terms
of the import or export contracts and results of the sampling records 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(b)(1),
(2) and (4), and § 177.9(b)(1) and (2).
Sincerely,
W. Richmond Beevers, Chief,
Cargo Security, Carriers, and Restricted
Merchandise Branch
Office of Trade, Regulations & Rulings
U.S. Customs and Border Protection
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