Request to reconsider NY N306102; Classification of Pill Crusher and Plastic Pouch

U.S. Customs and Border Protection HQ H306368 November 13, 2020 CLA-2 OT:RR:CTF:EMAIN H306368 NVF CATEGORY: Classification TARIFF NOs.: 3926.90.99; 8479.82.00 Aaron Collett Resolve Designs LLC 1447 North 1000 W Mapleton, UT 84664 RE: Request to reconsider NY N306102; Classification of Pill Crusher and Plastic Pouch Dear Mr. Collett: This letter is in response to your request, dated April 6, 2020, for reconsideration of New York Ruling Letter (“NY”) N306102, which was issued to your firm on October 1, 2019. In NY N306102, U.S. Customs and Border Protection (“CBP”) classified a pill crusher under heading 8479 of the Harmonized Tariff Schedule of the United States (“HTSUS”), which provides for “Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter, parts thereof” and a plastic pill pouch under heading 3926, HTSUS which provides for “Other articles of plastics and articles of other materials of headings 3901 to 3914.” We have reviewed NY N306102, determined that it is correct, and for the reasons set forth below, are affirming that ruling. FACTS: As described in NY N306102, the subject merchandise is used to crush and pulverize hard medicament pills so the powder can be easily dissolved into a liquid and dispensed to a patient through a feeding tube. To operate, the user inserts the pill into a plastic pill pouch, which is in turn positioned under the crush block. A manual process of moving the handle up and down breaks the pill. The plastic pill pouch is then moved under the roller and the handle is moved side to side to pulverize the pill into powder. The crusher is imported in an incomplete, unassembled condition. The critical components necessary to perform the crushing function are: the Crush Block made of cast and machined aluminum with powder coating the Pivot Block made of cast and machined stainless steel the Handle made of machined stainless steel the Roller made of machined polyvinyl chloride (PVC) the Base Plate made of machined aluminum with powder coating the Link made of machined stainless steel the Anti-Rotation Plate made of cast stainless steel After importation, the RxCrush Pill Crushing System is assembled with components sourced in the United States such as 1-1/2” snap ring, 2-5/8” snap rings, a PVC grip, 4-5/16” stainless steel press pins, 5-suction cups feet, 2-1/4” stainless steel screws, and a “locktite”. The plastic pouch is used with the pill crusher device. It is intended to completely contain medicament dust while crushing hard pills. The pouch is about three inches by five inches and made of two clear plastic sheets that are 0.005 inches thick, sealed together on the sides. One end of the pouch is fitted with an ENFit syringe connection, and the other end is sealed with a zip seal. The pill is inserted in the pouch through the zip seal and then closed. The pouch with pill is then placed in the crusher machine to pulverize the pill into powder. After the pill is crushed, liquid is inserted into the pouch to dissolve the pill powder, the contents of drawn out with a syringe, and the syringe is then used to inject the contents into a feeding tube of a patient. The pouch is imported separately and is not reusable. In our original ruling, we determined that the pill crusher was not classifiable in heading 9018, HTSUS, because it is not used by practitioners in direct contact with a patient and not used directly in a professional practice to make a diagnosis, prevent or treat an illness, or perform surgery. We concluded that the pill crusher was classified under heading 8479, HTSUS. We also determined that the plastic pill pouch was classified under heading 3926, HTSUS. ISSUE: Whether the pill crusher is properly classified under heading 9018, HTSUS, as instruments and appliances used in medical, surgical, dental or veterinary sciences or under heading 8479, HTSUS as machines or machinery having individual functions not specified elsewhere. Whether the pill pouch is classified under heading 9018, HTSUS, as instruments and appliances used in medical, surgical, dental or veterinary sciences, or under heading 3926, HTSUS as other articles of plastic. LAW AND ANALYSIS: Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. PILL CRUSHER: The HTSUS provisions under consideration are as follows: 8479 Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof: 9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Note 1(m) to Section XVI, which encompasses Chapter 84, states that articles of Chapter 90 are not covered by Section XVI. Therefore, we must first determine whether the pill crusher is classified in heading 9018, HTSUS. The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the HTSUS. While not legally binding or dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings at the international level. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989). EN 90.18 states that heading 9018, HTSUS covers a “wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc.” We observe that the pill crusher is not used by a doctor to make a diagnosis, to prevent or treat an illness or to operate. While it is used to prepare pills for the eventual dispensation of the medicaments they contain, any treatment effect is derived from dispensing of the medication, not the pill crusher. Therefore, the pill crusher is not an instrument or appliance used in medical, surgical, dental or veterinary sciences and therefore does not fall under the scope of heading 9018, HTSUS. You argue that the pill crusher is only used alongside enteral feeding systems, which administer medication to a patient, and that the pill crusher is therefore as much a medical device as the feeding tube and feeding syringe. However, in making this argument, you do not provide additional details about the enteral system nor any support for your assertion that a feeding tube and feeding syringe are medical instruments of heading 9018, HTSUS. Even assuming arguendo that the enteral feeding system is an article of heading 9018, and noting that the pill crusher is not itself an article of heading 9018, HTSUS, the pill crusher is not a part or accessory to such a system. 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 Headquarters Ruling Letter (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). A pill crusher is not an integral, constituent part of an enteral feeding system because a patient can be fed with a feeding tube without the pill crusher. Similarly, the pill crusher does not enhance the effectiveness of a feeding tube or a syringe, but rather, prepares the contents for the enteral system. Therefore, the pill crusher is not a part or an accessory of an article of heading 9018, HTSUS. In light of the above, the pill crusher cannot be classified under heading 9018, HTSUS. As no heading in the HTSUS provides for pill crushers, and the instant pill crusher performs the individual function of crushing pills, they are properly classified in heading 8479, HTSUS as a mechanical appliance having individual functions, not specified or included elsewhere. PILL POUCH: The HTSUS provisions under consideration are as follows: 3926 Other articles of plastics and articles of other materials of headings 3901 to 3914: 9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; 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 plastic pill pouch is an article of heading 9018, HTSUS. As stated above, articles of heading 9018, HTSUS are used only in professional practice either to make a diagnosis, to prevent or treat an illness or to operate. In this case, the plastic pill pouch is not used to make a diagnosis or to operate on a patient. Similarly, any treatment or preventative effect that may be obtained during use is derived from the pills that are crushed by the pill crusher, and not directly from the plastic pill pouch. Therefore, the plastic pill pouch is not an instrument or appliance used in medical sciences to diagnose, prevent, or treat an illness, or to operate and cannot be classified under heading 9018, HTSUS. You argue that the pill pouch is directly attached to an ENFit syringe which then extracts the crushed pill and liquid. The syringe is then attached to the feeding tubes for administration. Therefore, you contend, the pill pouch is a medical device in the same way that an enteral feeding system is a medical device. As we discuss above, even assuming that the enteral feeding system is an instrument or appliance of heading 9018, HTSUS, the plastic pouch is neither a part nor accessory of such a system. The pouch connects to the syringe, which sends liquid into the pouch, dissolves its contents, and liquid is then extracted with the syringe. The pouch is not an integral constituent part of the syringe because the syringe can function without being connected to a plastic pouch. Similarly, the pouch is not an accessory of an enteral feeding system because it does not enhance the performance or effectiveness of the syringe. Rather, the pouch merely serves as a vessel for holding liquid and mixing contents. The syringe and any enteral feeding system are not enhanced or made more effective by the plastic pouch. In light of the above, the plastic pill pouch is not classified under heading 9018, HTSUS. It is properly classified under heading 3926, HTSUS, as an other article of plastic. HOLDING: By application of GRIs 1, 2(a), and 6, the pill crusher is correctly classified under subheading 8479.82.00, HTSUS which provides for “Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter, parts thereof: Other machines and mechanical appliances: Mixing, kneading, crushing, grinding, screening, sifting, homogenizing, emulsifying or stirring machines.” The column one, general rate of duty is free. By application of GRIs 1 and 6, the plastic pouch is correctly classified under 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 column one, general rate of duty is 5.3 percent ad valorem. Effective July 6, 2018, the Office of the United States Trade Representative (USTR) imposed an additional tariff on certain products of China classified in the subheadings enumerated in Section XXII, Chapter 99, Subchapter III U.S. Note 20(b), HTSUS. The USTR imposed additional tariffs, effective August 23, 2018, on products classified under the subheadings enumerated in Section XXII, Chapter 99, Subchapter III U.S. Note 20(d), HTSUS. Subsequently, the USTR imposed further tariffs, effective September 24, 2018, on products classified under the subheadings enumerated in Section XXII, Chapter 99, Subchapter III U.S. Note 20(f) and U.S. Note 20(g), HTSUS. For additional information, please see the relevant Federal Register notices dated June 20, 2018 (83 Fed. Reg. 28710), August 16, 2018 (83 Fed. Reg. 40823), and September 21, 2018 (83 Fed. Reg. 47974). Products of China that are provided for in subheading 9903.88.01, 9903.88.02, 9903.88.03, or 9903.88.04 and classified in one of the subheadings enumerated in U.S. Note 20(b), U.S. Note 20(d), U.S. Note 20(f) or U.S. Note 20(g) to subchapter III shall continue to be subject to antidumping, countervailing, or other duties, fees and charges that apply to such products, as well as to those imposed by the aforementioned Chapter 99 subheadings. Products of China classified under subheading 8479.82.00, HTSUS, unless specifically excluded, are subject to the additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 8479.82.00, HTSUS, listed above. See U.S. Note 20 to Subchapter III, Chapter 99, HTSUS. Products of China classified under subheading 3926.90.99, HTSUS, unless specifically excluded, are subject to the additional 15 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.15, in addition to subheading 3926.90.99, HTSUS, listed above. See U.S. Note 20 to Subchapter III, Chapter 99, HTSUS. 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: NY N306102, dated October 1, 2019, is hereby affirmed. Sincerely, Craig T. Clark, Director Commercial and Trade Facilitation Division