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HQ 965203

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May 8, 2002

CLA-2 RR: CR: GC 965203 TPB

CATEGORY: CLASSIFICATION

TARIFF NO.: 7616.99.5090

T.L. Le
SteriCorp
11424 Biona Drive
Los Angeles, CA
90066-3308

RE: Stericup; Drug Paraphernalia

Dear Mr. Le:

This is in response to your letter dated July 8, 2000, to the Director, Customs National Commodity Specialist Division, New York, requesting classification of the “Stericup”, under the Harmonized Tariff Schedule of the United States (“HTSUS”). Your letter, together with a sample, was referred to this office for reply. We regret the delay in responding.

FACTS:

The “Stericup” is a small, single-use metal cup fabricated and packaged in France. It has a diameter of 27 mm, a capacity of 4.0 cubic centimeters and is formed by stamping 200 micron (0.000002m) natural 8011H12 Isothorpe Aluminum. It is supplied with a small filter element made of compressed 100% cotton and a 100% cotton swab measuring 25mm square with rounded corners.

The three elements are placed in a plastic container measuring 64mm x 48mm x 13mm depth and the entire ensemble is then sterilized in ethylene oxide gas. The manufacturing lot number and the date after which sterility can no longer be guaranteed are printed on the package label which also serves to seal the package.

The Stericup was created as a response to the growing public health problem of the propagation of diseases such as AIDS and Hepatitis C through the behavior of intravenous drug users. The Stericup itself is intended to replace the typical unsterile and frequently shared household spoon used to prepare the drug for injection with a sterile, disposable, one-time usage device that won’t contribute to the transmission of blood-borne diseases. The included filter replaces the typical improvised unsanitary filter and the swab is used post injection to keep the site clean.

ISSUE:

Is the Stericup set classified pursuant to GRI 1 under heading 9018, HTSUS, which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences.; or as a GRI 3(b) set put up for retail sale, under heading 7616, HTSUS, which provides for other articles of aluminum?

LAW AND ANALYSIS:

Classification

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 may then be applied.

At GRI 1, the HTSUS provision under consideration is:

Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments.

You indicate in your submission that the Stericup set is used in conjunction with intravenous drug use and that it is properly classified under heading 9018, HTSUS, as either an accessory to a syringe or other instrument or appliance and accessory thereof.

The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor 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. See T.D. 89-80.

In describing the general content and arrangement of Chapter 90, the EN states in pertinent part that: "[T]his Chapter covers a wide variety of instruments and apparatus which are, as a rule, characterized by their high finish and high precision."

The EN also lists the following exceptions to the general rule that the instruments and apparatus of this Chapter are high precision types: "ordinary goggles (heading 90.04), simple magnifying glasses and non-magnifying periscopes (heading 90.13), divided scales and school rules (heading 90.17) and fancy hygrometers, irrespective of their accuracy (heading 90.25)."

The ENs to heading 90.18 continue, in pertinent part, as follows:

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 language of the heading and the EN indicate that 9018, HTSUS, is a “use” provision. The court in E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996 Ct. Intl. Trade) explained the application of these types of HTSUS provisions thus:

The principal use of the class or kind of goods to which an import belongs is controlling, not the principal use of the specific import. Group Italglass U.S.A., Inc. v. United States, 17 C.I.T. 1177, 1177, 839 F. Supp. 866, 867 (1993). "Principal use" is defined as the use "which exceeds any other single use." Conversion of the Tariff Schedules of the United States Annotated Into the Nomenclature Structure of the Harmonized System: Submitting Report at 34-35 (USITC Pub. No. 1400) (June 1983). As a result, "the fact that the merchandise may have numerous significant uses does not prevent the Court from classifying the merchandise according to the principal use of the class or kind to which the merchandise belongs." Lenox Coll. v. United States, 20 C.I.T. 194.

When applying a "principal use" provision, the Court must ascertain the class or kind of goods which are involved and decide whether the subject merchandise is a member of that class. In determining the class or kind of goods, the Court examines factors which may include: (1) the general physical characteristics of the merchandise; (2) the expectation of the ultimate purchasers; (3) the channels of trade in which the merchandise moves; (4) the environment of the sale (e.g., the manner in which the merchandise is advertised and displayed); (5) the usage of the merchandise; (6) the economic practicality of so using the import; and (7) the recognition in the trade of this use. United States v. Carborundum Co., 63 C.C.P.A. 98, 102, 536 F.2d 373, 377, cert. denied, 429 U.S. 979, 50 L. Ed. 2d 587, 97 S. Ct. 490 (1976).

Therefore, Customs must make the determination as to whether the Stericup is of the class or kind of good that is principally used as instruments and appliances used in (human) medical sciences.

In this case, the importer would have to proffer evidence that the Stericup set was of a class or kind of instruments principally used as an accessory to a syringe that is used by a doctor, surgeon, dentist, etc., in order to prevent an illness; or that it is some other instrument or appliance or part or accessory thereof used by the above said group.

However, nothing in the submission you have provided gives such evidence. To the contrary, you have indicated that the Stericup would be distributed through various public health services and governmental organizations to the end users. Heading 9018, HTSUS, covers certain goods used in professional practice by a medical professional. The Stericup is merely distributed by health practitioners for use by an end user not contemplated by this provision. Various other articles, such as medicaments, distributed by medical professionals in professional practice are provided for outside this heading. This article is no exception. The distribution of the set to an end user does not indicate “use” in professional practice as required by the heading. The “use” is, in fact, by the drug addict. For these reasons, the Stericup set is not of a class or kind of instrument that is used in professional practice.

In the absence of a more specific provision, the merchandise falls to be classified under heading 7616, which provides for other articles of aluminum, as the Stericup itself is composed of natural 8011H12 Isohorpe Aluminum.

The Stericup comes packaged as a set which includes the Stericup itself, a cotton filter and a cotton swab. Both the filter and the swab are made up textile articles composed of 100% cotton wadding. Heading 7616, HTSUS, provides for other articles of aluminum. Heading 5601, HTSUS, provides, in pertinent part, for wadding of textile materials and articles thereof. GRI 3(a) indicates that when goods are classifiable in more than one heading, headings which refer to part only of the items put up for retail sale, the headings are to be regarded as equally specific. The EN to GRI 3(b) states that to meet the criteria of a set put together for retail sale, articles must:
consist of at least two different articles which are, prima facie, classifiable in different headings;
consist of product or articles put up together to meet a particular need or carry out a specific activity; and
are put up in a manner suitable for sale directly to users without repackaging (e.g. put in boxes or cases or on boards).

In applying the GRI 3(b) criteria above, the instant goods are several different goods classifiable in different headings. Criteria (a). The items work together to carry out the specific activity of providing a sanitary intravenous drug injection. Criteria (b). The goods are put up in a manner suitable for distribution directly to users without repacking in boxes, in a sealed plastic tray. Criteria (c). You indicate that the goods would be sold by the manufacturer to the importer after the importer has received purchase orders from buyers which are various public service and governmental agencies in the U.S. The importer would then import the goods and forward them to the purchasers. You then indicate that these agencies will distribute the items to the end users gratis, at no cost to them, for the sake of protecting the public health. Although the merchandise at issue is not “sold” to consumers, it is, nonetheless put up in a manner suitable for distribution directly to the ultimate user. Customs has previously held that this type of merchandise can still be considered “goods put up for retail sale.” See HQ 954616, dated May 10, 1994; HQ 962339, dated June 29, 1999.

To be classified at GRI 3(b), the set must be classifiable as if the set consisted of the one article which gives the whole its essential character, insofar as this criterion is applicable. The ENs indicate that the characteristic which gives the set its essential character 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.

In this case, the Stericup, which heats the drug prior to injection, plays the primary role in this set. It is the item which provides the raison d’être for the set. It also constitutes the bulk of the set, by both weight and value. Therefore, the entire Stericup set is classifiable under subheading 7616.99.5090, HTSUS, which provides for other items of aluminum.

Quotas

The filter and swab that come packaged in the Stericup set are made up of cotton, a textile. Where a textile article is part of a set found to be a GRI 3(b) set put up for retail sale, the textile article remains subject to quota and/or visa requirements, regardless of where the set is classified. 54 F.R. 35223 (1989). See also Reconfirmation of a Previous Directive Concerning Visa and Quota Requirements for Textiles and Textile Products Entered as Sets, 67 Fed. Reg. 12,977 (March 20, 2002). As we have held above that the Stericup qualifies as a GRI 3(b) set, we must, nonetheless, classify the filter and cotton swab separately, for quota requirements. For that reason, the cotton filter and cotton swab are each classified under subheading 5601.21.0090, HTSUS, which provides for wadding of textile materials and articles thereof; textile fibers, not exceeding 5 mm in length (flock), textile dust and mill neps.

HOLDING:

For the reasons stated above, the Stericup set is to be classified under subheading 7616.99.5090, HTSUS, as: other articles of aluminum: other: other: other. For quota requirements, the cotton filter and cotton swab are classifiable under subheading 5601.21.0090, HTSUS, which provides for wadding of textile materials and articles thereof; textile fibers, not exceeding 5 mm in length (flock), textile dust and mill neps: wadding; other articles of wadding: of cotton: other. The textile category number is 369.

The designated textile category may be subdivided into parts. If so, visa and quota requirements applicable to the subject merchandise may be affected. Since part categories are the result of international bilateral agreements which are subject to frequent renegotiations and changes, to obtain the most current information available, we suggest that you check, close to the time of shipment, the Status Report on Current Import Quotas (Restraint Levels), an internal issuance of the U.S. Customs Service, which is available for inspection at your local Customs office. The Status Report on Current Import Quotas (Restraint Levels) is also available on the Customs Electronic Bulletin Board (CEBB) which can be found on the U.S. Customs Service Website at .

Due to the changeable nature of the statistical annotation (the ninth and tenth digits of the classification) and the restraint (quota/visa) categories applicable to textile merchandise, you should contact your local Customs office prior to importation of this merchandise to determine the current status of any import restraints or requirements.

Finally, this merchandise may be subject to additional requirements administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

Sincerely,

John Durant, Director

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See also:

• Tariff No.: 5601.21.00 - Wadding of cotton and other articles of cotton wadding nesoi
• Tariff No.: 7616.99.50 - Aluminum, articles, nesoi