CLA-2 RR:CR:GC 962506 MGM
Port Director
U.S. Customs Service
9777 Via de la Amistad
San Diego, CA 92173
Re: Protest 2501-98-100027; “Anesthesia Trays”
Dear Port Director:
This is our decision regarding Protest 2501-98-100027, concerning your classification of “anesthesia trays” under the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
The items to be classified consist of anesthetic medications packaged in trays with goods ancillary to the administration of such medications. The trays are divided into two categories according to the way in which the medication is administered, spinally or epidurally. According to materials submitted by the protestant, spinal anesthesia differs from epidural anesthesia in that the anesthetic agent is injected into the subarachnoid space, while in epidural procedures the needle penetrates only to the epidural space.
There are 63 different types of spinal and epidural trays. The trays vary as to the specific anesthesia and in the type and size of the needle. In addition to the needles and the drugs, each tray contains syringes, iodine, fenestrated drape, prep applicators, gauze sponges, an adhesive bandage, underpad and drug information sheets. The value of the anesthesia ranges from 3.6% to 33.3% of the value of the anesthesia tray.
The merchandise was entered in April and May of 1997, under subheading 9018.90.30, HTSUS, which provides for anesthetic instruments and appliances. The entries were liquidated under the same provision in the period from February to April of 1998. This classification was timely protested on April 22, 1998.
ISSUE:
What component of the anesthesia tray kits supplies the essential character of the merchandise?
LAW AND ANALYSIS:
Merchandise imported into the U.S. 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.
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).
The anesthesia is bundled in trays or kits which each contain numerous items. GRI 3(b) states that:
Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable.
Explanatory Note 3(b)(X) states that goods are classified as “goods put up in sets for retail sale,” if they:
(a) consist of at least two different articles which are, prima facie, classifiable in different headings. Therefore, for example, six fondue forks cannot be regarded as a set within the meaning of this Rule;
(b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and
(c) are put up in a manner suitable for sale directly to users without repacking (e.g., in boxes or cases or on boards).
The anesthesia tray kits meet each of these three criteria. They contain several articles that are classifiable under different subheadings. For example, a measured dose of local anesthesia is classified in heading 3004, HTSUS, syringes fall in heading 9018, HTSUS, and bandages fall in heading 3005, HTSUS. Further, these items are put up for a particular purpose - the administration of anesthesia to a human being. Finally, they are sold directly to users (hospitals) without repacking.
Thus, the anesthesia tray kits are sets within the meaning of GRI 3(b) and should be classified as if they consisted of the component which gives them their essential character.
Explanatory Note (VIII) to GRI 3(b) states as follows:
The factor which determines essential character will vary as between kinds of goods. It may, for example, be determined by the nature of the material or component, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods.
The anesthesia does not predominate in bulk, weight or value of the kits. Nonetheless, the purpose of the kits is to provide the equipment necessary to administer a dose of anesthesia to a patient. The anesthesia is the raison d’etre of the sets. Thus, it is the anesthesia which provides the essential character of the sets and the sets will be classified as though they consisted only of measured doses of anesthesia.
Heading 3004, HTSUS, provides as follows:
3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale:
3004.90 Other:
3004.90.90 Other:
Other:
3004.90.9045 Dermatological agents and local anesthetics.
The anesthetics included in the sets are tetracaine HCl, bupivacaine and lidocaine. Each of these is a recognized anesthetic medication. Merck Index, 12th edition. Further, the anesthetics in the sets are put up in measured doses. Thus they fall under heading 3004, HTSUS. Within this heading, these anesthetics are classified in subheading 3004.90.9045, HTSUS (Annotated), which provides for local anesthetics.
HOLDING:
The instant merchandise is classified in subheading 3004.90.9045, HTSUS (Annotated). Since reclassification of the merchandise as indicated above will result in a lower rate of duty than claimed you should ALLOW the protest in full.
In accordance with Section 3A(11)(b) of Customs Directive 099 3550 065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.ustreas.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
John Durant, Director
Commercial Rulings Division