CLA-2 RR:CR:GC 962361 MGM
Jack D. Mlawski, Esq.
Galvin & Mlawski
440 Park Avenue South - 9th Floor
New York, NY 10016-8067
RE: “Bio-Set” Infusion Device; NY D81573
Dear Mr. Mlawski:
This is in response to your letter, dated November 4, 1998, on behalf of Merck & Co., Inc., in which you seek review of NY D81573 issued to you by the Customs National Commodity Specialist Division, New York. In NY D81573, dated September 29, 1998, the “Bio-Set” infusion device was classified in subheading 7326.90.85, Harmonized Tariff Schedule of the United States (HTSUS), as an article of steel.
Pursuant to section 625(c)(1). Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by section 623 of Title VI (Customs Modernization), of the North American Free Trade Agreement Implementation Act (Pub. Law 103-182, 107 Stat. 2057), notice of the proposed revocation of NY D81573 was published on August 18, 1999, in the CUSTOMS BULLETIN, Volume 33, Number 33. No comments were received in response to this notice.
FACTS:
The “Bio-Set”infusion device is designed to aid in the administration of drugs to patients. It functions by acting as a conduit between the vial in which drugs are packaged and an infusion bag which is attached to a catheter which is in turn connected to the patient. The “Bio-Set” infusion device consists of a hollow metal needle in a plastic casing. One end of the device is designed such that it can be affixed to a standard size vial so that the metal needle protrudes through the rubber stopper of the vial while the other end attaches to an infusion bag. In this way the contents of the vial can be transferred to the infusion bag and administered to the patient.
ISSUE:
Is the “Bio-Set”infusion device an instrument or appliance used in medical science?
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 purposes.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs. In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See, T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
NY D81573 held that the “Bio-Set” infusion device was classified as an article of steel. This classification is based on GRI 3 which applies to goods which are prima facie classifiable under two or more headings. However, where merchandise can be classified according to GRI 1, that is, according to the headings, section notes or chapter notes, GRI 3 is inapplicable.
Heading 9018, HTSUS, provides for “[i]nstruments and appliances used in medical...sciences.” “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.” EN 90.18. Here the merchandise is an instrument or appliance used in the administration of pharmaceutical substances, that is, to prevent or treat an illness. Thus, it is an instrument used in medical science and is classified in heading 9018, HTSUS, pursuant to GRI 1.
One might argue that the “Bio-Set” infusion device is too far removed from the patient to be considered an instrument used in medical science. That is, the “Bio-Set” infusion device might be considered as merely an accessory for use with an intravenous (I.V.) administration apparatus. However, accessories suitable for use solely or principally with a particular kind of apparatus are to be classified with the apparatus of that kind. Note 2 (b), Chapter 90, HTSUS. Therefore the “Bio-Set” infusion device, even if considered merely an accessory, is classifed with apparati for the administration of I.V. fluids. Such apparati are classified as “other” instruments or appliances used in medical science in subheading 9018.90.80, HTSUS. See NY 869994, dated January 14, 1992; NY 804233, dated December 1, 1994; NY 811806, dated July 18, 1995; NY A83725, dated June 11, 1996.
Within heading 9018, you argue that the “Bio-Set” infusion device falls within subheading 9018.31.00, HTSUS, which provides for “[s]yringes, needles, catheters, cannulae, and the like; parts and accessories thereof.” It is your position that although the instant merchandise is not a syringe or cannulae, it is sufficiently similar in form and function to qualify as a “like” good. Under the rule of ejusdem generis, the phrase “and the like” is limited to goods which “possess the essential characteristics or purposes that unite the articles enumerated eo nomine.” Totes, Inc. v. U.S., 69 F.3d 495, 498 (Fed. Cir. 1995) (citing Sports Graphics, Inc. v. United States, 24 F.3d 1390 (Fed. Cir. 1994)). The characteristic which unites the exemplars of this subheading is their direct application to the body. The “Bio-Set” infusion device is further removed from the patient than syringes, needles, catheters or cannulae. Those devices are each used in administering fluids directly to the body while the “Bio-Set” infusion device transfers fluids only to an infusion bag. Thus, it does not share the characteristic which unites the exemplars of subheading 9018.31.00, HTSUS, and is not a “like” good. However, the merchandise remains an instrument used in medical science of heading 9018, HTSUS. As none of the more specific subheadings of heading 9018, describe the “Bio-Set” infusion device, it falls to the residual or “other” provision.
This is consistent with NY 882361, dated February 24, 1993, which classified a “Drug Infusion Balloon Catheter.” In that ruling, a device which acted as a conduit between a medicinal preparation and a tube connected to a catheter was classified as an “other” instrument or appliance used in medical science.
HOLDING:
The “Bio-Set” infusion device is classified in subheading 9018.90.80, HTSUS, which provides for “[o]ther instruments and appliances and parts and accessories thereof: other: other.” NY D81573 is revoked.
In accordance with 19 U.S.C. 1625 (c), this ruling will become effective 60 days after its publication in the CUSTOMS BULLETIN.
Sincerely,
John Durant, Director
Commercial Rulings Division