RR:CTM:CPMMR H283893 MG
Mr. Mathew Mermigousis
PricewaterhouseCoopers LLP
One North Wacker, Chicago, IL, 60606
RE: Request for Binding Ruling; Classification; TIDI Products, LLC (“TIDI”), drapes, covers, and miscellaneous disposables
Dear Mr. Mermigousis:
This is in response to your request dated November 3, 2015, on behalf of your client, TIDI Products, LLC (“TIDI”), concerning the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of drapes, covers, and miscellaneous disposables (collectively, “drapes”, “covers”, or “urology disposables”). Your request has been forwarded by the National Commodity Specialist Division (NCSD) in New York to this office for a response. Product samples and specifications have been forwarded along with the request. Our decision follows multiple teleconferences between you and your client, and staff of the Office of Regulations and Rulings, and receipt of additional submissions on behalf of TIDI.
FACTS:
The merchandise at issue consists of sterilized and packaged disposable drapes, covers, and urology disposables of low density polyethylene to be used as barriers between equipment and patients during medical or surgical procedures. The purpose of such barriers is to prevent contamination of equipment and the subsequent transfer of germs to another patient, which could cause infection. Only the drapes, covers, and urology disposables are being imported and none of the articles have any mechanical or electrical parts.
Representative samples were provided. The C-Armor drape is a flat piece of plastic folded over and connected with hook and loop closures to form a pouch. It is adhered to the existing sterile drapes at the level of the sterile field line during surgery. It maintains its position when opened to cover suction tubing and other equipment. The C-Arm cover fits the profile of a mobile x-ray machine in order to cover it. The Microscope drape fits the profile of a surgical microscope. The Ultrasound probe cover fits the profile of an ultrasound transducer. Urology disposables are sealed to the shape of a funnel and typically include an expandable hose for covering a fluid containment device. Other covers, such as the Band Bag, the Wireless Mouse Bag, and The Slush Drape, are similarly loosely shaped for the device they are meant to cover.
ISSUE:
Whether the disposable drapes, covers, and urology disposables at issue are classified as other articles of plastic in heading 3926, HTSUS, or as other instruments and appliances used in medical, surgical science in heading 9018, HTSUS.
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods 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.
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:
* * *
3926.90 Other:
* * *
3926.90.99 Other.
* * *
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:
Other instruments and appliances, used in dental sciences, and parts and accessories thereof:
* * *
9018.90 Other instruments and appliances and parts
and accessories thereof:
Optical instruments and appliances and parts and accessories thereof:
Other:
* * *
9018.90.80 Other.
* * *
The relevant section and chapter Notes are as follows:
Note 2(u) to chapter 39 states, in relevant part:
This chapter does not cover:
(u) Articles of chapter 90. . .;
Note 2 to chapter 90, HTSUS, provides, in relevant part:
Subject to note 1 above, parts and accessories for machines, apparatus, instruments or articles of this chapter are to be classified according to the following rules:
* * *
(b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus … are to be classified with the machines, instruments or apparatus of that kind[.]
Note 2(u) to chapter 39 states that this chapter does not cover the “[a]rticles of chapter 90. . .”. In effect, instruments and apparatus of chapter 90, HTSUS, are excluded from chapter 39. Therefore, if the drapes, covers, and urology disposables are classifiable under chapter 90 and specifically, under heading 9018, HTSUS, they are not classifiable under heading 3926, HTSUS.
The EN to heading 3926, states, in relevant part:
This heading covers articles, not elsewhere specified or included ,of plastics (as defined in Note 1 to the Chapter) or of other materials of headings 3901 to 3914.
The EN to heading 9018, states, in relevant part:
This heading covers a very 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.
The Harmonized Commodity Description and Coding System Explanatory Notes ("EN’s") constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the EN’s provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127-28 (Aug. 23, 1989).
You explain that the drapes, covers, and urology disposables at issue are used in the medical field to cover various electrical and hand-held medical instruments. You also explain that they are medical devices as deemed by the Food and Drug Administration (FDA). In Amersham Corp v. United States, 5 C.I.T. 49, 56, 564 F.Supp. 813, 817 (1983), the court noted that “statutes, regulations and administrative interpretations relating to, ‘other than tariff purposes’ are not determinative of [CBP] classification disputes.” Therefore, FDA designation as a medical device does not dictate classification in heading 9018, HTSUS. See HQ H265244, dated June 1, 2015, (finding FDA approval has no bearing on classification of a knee protector). See also, HQ 085064, dated August 24, 1990 and HQ 962181, dated January 13, 1999 (Articles are classified by FDA to protect public safety, not as guidance for classification).
You claim that the drapes, covers, and urology disposables are classified under heading 9018, HTSUS, by application of Note 2(b) to chapter 90, because they are specifically designed and used as accessories of the medical instruments and appliances of heading 9018, HTSUS.
We note that drapes for medical equipment have consistently been classified by their material makeup in numerous CBP rulings. For instance, in New York Ruling Letter (NY) NY 883919, dated April 13, 1993, CBP classified plastic disposable banded bags used to cover non-sterile items in the operating room and surgical drapes as other articles of plastic in heading 3926, HTSUS. See also NY C81283, dated November 28, 1997 (a mayo stand cover used to cover equipment in an operating room made from blue polyethylene film); NY N041298, dated November 3, 2008 (a general purpose probe cover used to cover medical apparatus composed of plastic sheeting); NY 870868, dated February 13, 1992 (patient isolation drapes, C-arm and mobile X-ray drapes, microscope, laser and video camera drapes, and X-ray cassette drapes).
Similarly, CBP has classified drapes of other materials outside of heading 9018. In NY I88352, dated December 6, 2002, CBP classified polyethylene or polyester film coated drapes with a strip of adhesive in subheading 3919.90.50, HTSUS. In NY N108695, dated June 10, 2010 CBP classified a magnetic surgical drape in subheading 8505.19.20, HTSUS. In Headquarters Ruling Letter (HQ) 961683, dated August 13, 2002, CBP classified a surgical drape used primarily in cardiac procedures and comprised of four layers of four different materials, two of which are plastic (polyethylene film), paper (wood pulp), and textile (bonded polyester) in subheading 4818.90.00, HTSUS, which provides for other sanitary or hospital articles of paper. In NY N254836, dated July 17, 2014, CBP classified single-use, sterile-packaged surgical drapes, which were constructed of different materials in subheading 6307.90.68, HTSUS, which provides for surgical drapes, of man-made fibers and in subheading 4818.90.00, HTSUS, which provides for other household, sanitary or hospital articles, of paper pulp, paper, cellulose wadding or webs of cellulose fibers.
In support of classification as a medical device in heading 9018, HTSUS, you cite to NY N245526, dated September 6, 2013, for the proposition that CBP has classified surgical drapes in this heading. However, the item at issue in that ruling is not a surgical drape, but a flexible, tubular, plastic article measuring approximately ten feet in length, with a plastic tray attached to one end. The tray has several electronic connectors which attach to an electrical circuit that will sound an alarm if the item is not used properly. The article in NY N245526 has greater functionality, and is thus distinguishable, from the merchandise at issue in this ruling request.
You have indicated that the urology disposables are sealed to the shape of a funnel and typically include an expandable hose for connecting to a fluid containment device. These products are configured to fit surgical tables that will be utilized in procedures involving large amounts of fluid. They are used in procedures including but not limited to urology and cystoscopy. You claim that the utility of a urology disposable in a medical procedure makes it more specialized than an ordinary disposable and reference HQ 556798, dated September 23, 1993, where CBP classified catheter drainage bags with plastics materials in Chapter 90. We note, however, that the drainage bags at issue in this ruling were connected to a catheter unlike the instant urology disposables, which are configured to fit surgical tables. CBP has ruled that a medical fluid collection pouch designed to hang below an operating table is not classified in heading 9018, HTSUS. See NY N028698, dated Jun 13, 2008. You further cite to HQ 966911, dated April 1, 2004, which classified a fleece lined covers for an exercise machine. The covers at issue in this ruling provide padding during the exercise, which is integral to the purpose and function of the machine as used for exercise. However, the articles at issue in this ruling request are covers and serve no purpose (i.e., to accessorize or assist) in relation to the purpose or functionality of the apparatus, which they cover.
The term “accessory”, as used in Note 2(b) to Chapter 90, is not defined in the HTSUS or in the Harmonized Commodity Description and Coding Explanatory Notes (ENs). However, this office has 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, dated April 8, 1996; HQ 950166, dated November 8, 1991. We also employ the common and commercial meanings of the term “accessory”, as the courts did in Rollerblade, Inc. 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 (CIT 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, dated May 27, 2003.
Although the instant drapes, covers, and urology disposables may come in contact with the equipment, their function as a barrier has nothing to do with the operation of the equipment. The drapes, covers, and urology disposables do not facilitate the use or handling of the equipment, widen the range of its uses, or improve its operation and they are used to simply provide a barrier between the equipment and the patient. For these reasons, we find that the drapes, covers, and urology disposables are not accessories to the equipment. Furthermore, because the drapes, covers, and urology disposables are not accessories of the instruments of heading 9018, HTSUS, Note 2(b) to Chapter 90 does not apply. Similarly, because the drapes, covers, and urology disposables are not classifiable in Chapter 90, they are not excluded by Note 2(u) to Chapter 39.
The drapes, covers, and urology disposables at issue are made of plastic as defined in Note 1 to Chapter 39, and are not described more specifically elsewhere in the tariff schedule. We conclude, in accordance with GRI 1, that the articles at issue are properly classified under heading 3926, HTSUS, which provides for “Other articles of plastics and articles of other materials of headings 3901 to 3914”. Specifically, classification is under subheading 3926.90.99, HTSUS, the provision for "Other articles of plastics and articles of other materials of heading 3901 to 3914: Other: Other."
HOLDING:
In accordance with GRI I, the drapes, covers, and urology disposables are classified in heading 3926, HTSUS. It is specifically provided for in subheading 3926.90.99, HTSUS as: "Other articles of plastics and articles of other materials of heading 3901 to 3914: Other: Other." The 2019 general, column one rate of duty is 5.3 percent ad valorem.
Duty rates are provided for convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
Sincerely,
Allyson Mattanah, Chief
Chemicals, Petroleum, Metals and Miscellaneous Articles Branch