Modification of HQ 558009; Silicone part

HQ H314649 March 3, 2022 OT:RR:CTF:EMAIN H314649 NVF CATEGORY: Classification TARIFF NO.: 3926.90.99 Brian J. O'Shea, Esq. McKenna & Cuneo 1575 Eye Street, N.W. Washington, D.C. 20005 RE:  Modification of HQ 558009; Silicone part Dear Mr. O’Shea: This ruling is in reference to Headquarters Ruling Letter (“HQ”) 558009, dated November 10, 1994, regarding the country of origin marking of an Aerochamber device under the North American Free Trade Agreement ("NAFTA"). In HQ 558009, U.S. Customs and Border Protection (“CBP”) classified the component parts of the Aerochamber under subheading 9019.20, HTSUS which provides for, “Mechano-therapy appliance; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” We have since reviewed HQ 558009 and determined that the portion of the ruling pertaining to the classification of the silicone valve is in error. Therefore, CBP is modifying HQ 558009 according to the analysis set forth below. Notice of the proposed action was published in the Customs Bulletin, Vol. 56, No. 3, on January 26, 2022. No comments were received in response to that notice. FACTS: In HQ 558009, the Aerochamber is described as: {A}n aerosol therapy device which is marketed under the trademark "Aerochamber. According to your submission, the Aerochamber is an FDA-approved medical device that is used with a metered dose inhaler ("MDI") to deliver aerosol medication. It was designed to simplify delivery of medication to patients suffering from asthma who are unable to properly coordinate an MDI (due to age or ill-health), to reduce undesirable side effects that result from use of a MDI alone in the delivery of medication, such as oral candidiasis, and to enhance the therapeutic value of the medication. The device is described as a temporary holding chamber for MDI-dispersed medication . . . . {T}he basic model ("Aerochamber with FLOWSIGnal") is in the shape of a tube measuring approximately 4 1/2 inches in length and 1 1/2 inches in diameter. At one end of the holding chamber is a plastic mouthpiece containing a one-way silicone inhalation "flapper" valve and exhalation ports. At the other end of the device is a rubber end cap with a port into which a standard MDI may be inserted. Imbedded in the rim of the end cap is what you refer to as a FLOWSIGnal, a plastic whistle-like device, which sounds if the patient fails to inhale at a slow and even pace . . . . {E}xcept for the silicone flapper valve, the Aerochamber is made entirely of plastic. {A} second model Aerochamber, which is referred to as Aerochamber with Mask, is nearly identical to the basic model, but is fitted with a permanently-attached silicone mask. This model is particularly designed for infants and the infirm who may not have the strength or ability to hold the device and coordinate inhalation and delivery of the medication. The Aerochamber with FLOWSIGnal consists of the following six components: mouthpiece cap, mouthpiece, die-cut silicon diaphragm valve, aerochamber body, thermoplastic MDI-end, and polycarbonate reed whistle . . . . The Aerochamber with Mask consists of the following seven components: die-cut silicon diaphragm valve, aerochamber body, thermoplastic MDI-end, polycarbonate reed whistle, silicon mask, mask adaptor, and mask lock ring. In HQ 558009, CBP stated without explanation that all the component parts of the Aerochamber are classified under subheading 9019.20, HTSUS which provides for, “Mechano-therapy appliance; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” CBP next determined the NAFTA country of origin marking of two models of Aerochamber and found that, pursuant to Section 102.11 of the interim NAFTA regulations, the Aerochamber devices became goods of the U.S. and were excepted from marking pursuant to Section 134.35(b) and because the goods were processed by the importer, the outermost container of the goods were also excepted from marking. ISSUE: Whether the silicone valve is classified as an other article of plastic of heading 3926, HTSUS, or as a part of heading 9019, HTSUS. LAW AND ANALYSIS: Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (“GRIs”) and, in the absence of special language or context which requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all classification purposes. GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relevant section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the heading and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. The HTSUS provisions under consideration in this case are as follows: 3926 Other articles of plastics and articles of other materials of headings 3901 to 3914. 9019 Mechano-therapy appliance; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof. Note 2(u) to Chapter 39 states that Chapter 39 does not cover articles of chapter 90. Therefore we must first determine whether the silicone valve is classified under heading 9019, HTSUS, which provides for, “Mechano-therapy appliance; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The term “part” is not defined in the HTSUS. In the absence of a statutory definition, the courts have fashioned two distinct but reconcilable tests for determining whether a particular item qualifies as a part for tariff classification purposes. See Bauerhin Technologies Limited Partnership, & John V. Carr & Son, Inc. v. United States, 110 F.3d 774 (Fed. Cir. 1997). Under the first test, articulated in United States v. Willoughby Camera Stores, 21 C.C.P.A. 322 (1933), an imported item qualifies as a part only if can be described as an “integral, constituent, or component part, without which the article to which it is to be joined, could not function as such article.” Bauerhin, 110 F.3d at 779. Pursuant to the second test, set forth in United States v. Pompeo, 43 C.C.P.A. 9 (1955), a good is a “part” if it is “dedicated solely for use” with a particular article and, “when applied to that use…meets the Willoughby test.” Bauerhin, 110 F.3d at 779 (citing Pompeo, 43 C.C.P.A. at 14); Ludvig Svensson, Inc. v. United States, 63 F. Supp. 2d 1171, 1178 (Ct. Int'l Trade 1999) (holding that a purported part must satisfy both the Willoughby and Pompeo tests). An item is not a part if it is “a separate and distinct commercial entity.” Bauerhin, 110 F.3d at.779. The term “accessory” is not defined in the HTSUS or in the Harmonized Commodity Description and Coding Explanatory Notes (ENs). However, this office has previously stated that the term “accessory” is generally understood to mean an article which is not necessary to enable the goods with which they are intended to function. They are of secondary importance, but must, however, contribute to the effectiveness of the principal article (e.g., facilitate the use or handling of the particular article, widen the range of its uses, or improve its operation). See HQ 958710 (Apr 8, 1996); HQ 950166 (Nov. 8, 1991). We also employ the common and commercial meanings of the term “accessory,” as the courts did in Rollerblade v. United States, wherein the Court of International Trade derived from various dictionaries that an accessory must relate directly to the thing accessorized. See Rollerblade, Inc. v. United States, 116 F.Supp. 2d 1247 (Ct. Int'l Trade 2000), aff’d, 282 F.3d 1349 (Fed. Cir. 2002) (holding that inline roller-skating protective gear is not an accessory because the protective gear does not directly act on or contact the roller skates in any way); see also HQ 966216 (May 27, 2003), HQ H061738 (May 5, 2010). Before we can classify the silicone valve, we must first determine the proper classification of the Aerochamber. As stated above and in HQ 558009, the Aerochamber is used with an MDI (a portable metered dose inhaler, typically used by asthma sufferers) that delivers medication. The Aerochamber cannot be used on its own to provide any sort of aerosol therapy or relief to a patient, therefore it is not an aerosol therapy device of heading 9019, HTSUS. Rather, the MDI, which administers medication, is the aerosol therapy device because it aerosolizes and releases a set amount of medicine. The Aerochamber is an accessory of an MDI. It is a separate commercial entity that facilitates the use of an MDI by providing a chamber that holds the dispensed medication and allows the user to inhale the medication at his or her own pace. Thus, the Aerochamber improves and enhances the use of the MDI, particularly for young users or those who otherwise may have difficulty using an MDI. The Aerochamber is not an MDI part because an MDI does not need an Aerochamber in order to aerosolize and deliver medication. An MDI can be used effectively, with the proper technique by a patient, without an Aerochamber. Because the Aerochamber is an accessory to a good of heading 9019, HTSUS, it is classified as an accessory under subheading 9019.20.00, HTSUS which provides for “Mechano-therapy appliance; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” We observe that heading 9019, HTSUS, does not provide for parts of accessories. Furthermore, we must consider Mitsubishi Electronics America v. United States, 19 CIT 378, 383 n.3 (1995), in which the Court of International Trade stated that: The Court notes that if the subject merchandise is not a clutch, but rather a part of a starter motor, then it cannot be classified as part of an automobile, even though it is used solely in automobiles. This is because a subpart of a particular part of an article is more specifically provided for as a part of the part than as a part of the whole. C.F. Liebert v. United States, 60 Cust. Ct. 677, 686-87, 287 F. Supp. 1008, 1014 (1968) (holding that parts of clutches which are parts of winches are more specifically provided for as parts of clutches than as parts of winches). Therefore, regardless of whether the instant valve is considered a part of the Aerochamber, it cannot be classified under heading 9019, HTSUS. The legal text of the heading does not provide for parts of accessories and Mitsubishi bars the valve from being classified as a part of an MDI. Because no other heading provides for the silicone article (referred to as a “valve”), it therefore is classified by constituent material as an other article of plastic of heading 3926, HTSUS. In light of the foregoing, we conclude that the silicone valve is classified under heading 3926, HTSUS as an other article of plastic. Our analysis in HQ 558009 pertaining to NAFTA country of origin marking requirements remains the same. HOLDING: By application of GRIs 1 and 6, the silicone valve is classified in heading 3926, HTSUS specifically subheading 3926.90.99, HTSUS, which provides for, “Other articles of plastics and articles of other materials of headings 3901 to 3914: Other: Other.” The general, column one rate of duty for goods of subheading 3926.90.99, HTSUS, is 5.3% ad valorem. Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov/tata/hts/. EFFECT ON OTHER RULINGS: HQ 558009 is hereby MODIFIED. In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin. Sincerely, Craig T. Clark, Director Commercial and Trade Facilitation Division