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HQ 964562




December 22, 2000

CLA-2 RR:CR:GC 964562 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 5601.21.0090

Mr. Arthur K. Purcell
Sandler, Travis & Rosenberg, P.A.
551 Fifth Avenue
New York, NY 10176

RE: HQ 963875 reconsidered; Cotton Tip Applicators

Dear Mr. Purcell:

This is in reference to your letter of October 4, 2000, on behalf of Graham Professional, A Division of Little Rapids Corp., requesting reconsideration of HQ 963875 dated August 3, 2000, concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of cotton tip applicators. In HQ 963875, we determined that these goods were classifiable in subheading 5601.21.0090, HTSUS, which provides for "[W]adding of textile materials and articles thereof; textile fibers, not exceeding 5 mm in length (flock), textile dust and mill neps: [W]adding; other articles of wadding: [O]f cotton: [O]ther." We have thoroughly reconsidered HQ 963875, and all of your submissions, and find the classification for the subject merchandise in HQ 963875 to be correct. In reaching this conclusion careful consideration was given to your submission of December 15, 2000, as well as arguments you presented in a meeting with representatives of my staff on December 20, 2000.

FACTS:

The subject merchandise is cotton tipped applicators (“CTAs”) imported from China. The CTA consists of a finished, thin wooden stick in either 3 or 6 inch lengths to which a small amount of cotton has been glued to one end. The cotton head is tightly wound so that it will not fray. The wooden stick is made from white birch wood.

You state that these particular CTAs will be marketed and sold only to the medical profession and will be imported in bulk to be put in dispensers before being sold and distributed. As such, the CTAs will be imported in both sterile and non-sterile packaging. You state that in the clinical setting, CTAs are used to apply ointments or antiseptics to a wound, to cleanse or remove exudate and debris from a wound, or to remove organisms from the nasopharynx, throat, ear, vagina, cervix, urethra, other orifice or lesion for culture. CTAs are "Class I Exempt medical devices" and must be registered with the U.S. Food and Drug Administration (FDA).

Our research shows that 3 and 6 inch long, wood handled cotton tipped swabs or applicators have pharmaceutical, electronic and industrial applications as well. In addition to being used in the clinical setting they are used in laboratories to apply substances to a slide or other medium for analysis. CTAs are also used to lift debris from camera lenses and other mechanical equipment. Hence, CTAs are multi-purpose goods. Similar goods have been classified in heading 5601, HTSUS. See HQ 963875 for cites of previous Customs rulings.

ISSUE:

Whether CTAs are classified in heading 3005, HTSUS, the provision for "[W]adding, gauze, bandages and similar articles . . .," in heading 9018, HTSUS, the provision for "[I]nstruments and appliances used in medical, surgical, dental or veterinary sciences, . . . ," in heading 4421, HTSUS, the provision for "[O]ther articles of wood,"or in heading 5106, HTSUS, the provision for "[W]adding of textile materials and articles thereof; . . . ."

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 that 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 interpreting 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 (official interpretation of the Harmonized System at the international level) generally indicative of the proper interpretation of the HTSUS. See T.D. 8980, 54 Fed. Reg. 35127 (August 23, 1989).

Additional U.S. Rule of Interpretation 1(a) requires that "a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use".

GRI 2(b) requires that goods consisting of different materials be classified according to the principles of GRI 3. GRI 3(a) requires that amongst competing headings, the most specific heading be used, but headings which refer to part only of the goods are equally specific. GRI 3(b), provides that composite goods consisting of different materials or made up of different components, 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)(VIII) to GRI 3(b) states that essential character may 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 following headings and subheadings are relevant to the classification of this product:

3005: Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:

4421 Other articles of wood:

5601 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

5601.21.0090 Other (369)

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 (con.):

The EN for heading 3005, HTSUS, states in pertinent part, as follows:

Wadding and gauze for dressings (usually of absorbent cotton) and bandages, etc., not impregnated or coated with pharmaceutical substances, are also classified in this heading, provided they are exclusively intended (e.g., because of the labels affixed or special folding) for sale directly without re-packing, to users (private persons, hospitals, etc.) for use for medical, surgical, dental or veterinary purposes.

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, characterised 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)." EN 90.18, HTSUS, states in pertinent part that: "[T]his 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." (emphasis added). The EN then lists instruments for human medicine or surgery included under the heading. Following are the categories listed in EN 90.18 pertinent to the medical uses for CTAs that you cite:

Instruments which may be used under the same names for several purposes, (B) Special diagnostic instruments and apparatus . . . , Instruments for nose, throat or tonsil treatment . . . , (H) Urinary canal or bladder instruments . . . , (K) Gynaecological or obstetrical instruments . . . .

The Principal Use Provisions

Both headings 3005 and 9018, HTSUS, are principal use provisions. 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., Slip Op. 96-30 (Feb. 2, 1996).

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. See supra Additional US Rule of Interpretation 1 to the HTSUS. 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); see also Lenox Coll., 20 C.I.T., Slip Op. 96-30, at page 5.

Therefore, the first determinative issue is whether the CTAs as imported in bulk sterile and non-sterile packaging, are of the class or kind of good that is used as wadding, gauze, bandages and similar articles put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes or whether CTAs are of the class or kind of good that is principally used as instruments and appliances used in medical, surgical, dental or veterinary sciences.

Wadding, gauze, bandages and similar articles put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes are packaged in sterile and non-sterile forms. (There is no indication that the instant merchandise is impregnated or coated with pharmaceutical substances. Accordingly, this ruling will not discuss that aspect of the heading). The ultimate purchaser expects that the merchandise will clean and dress a wound or surgical site, pack an excision, or absorb exudate over the course of several hours or days. The merchandise is typically sold in pharmacies or used in hospitals, clinics, or practitioners' offices. The merchandise is capable of lying on the wound and is usually wrapped around the wound or adhered to the skin surrounding the wound in order to protect the wound and absorb blood, serum, pus or other exudate. The merchandise consists of the wadding or gauze alone, or surrounded by an adhesive material. Removing the merchandise may also serve to debride (remove devitalized tissue from) the wound. The merchandise is used almost exclusively in a clinical setting on patients.

CTAs are not simply wadding or gauze. They are a piece of wadding glued to a stick. As such, they can not, by the explicit language of the heading, be included as "wadding." If included, CTAs would fall under the "and similar articles" language which explicitly lists the examples dressings, adhesive plasters, poultices. Using the principle of ejusdem generis, CTAs do not "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)). Likewise, CTAs are not of the class or kind of good that is principally used as medical wadding or gauze. Unlike dressings, adhesive plasters, poultices, medical wadding or gauze, CTAs do not lie on the wound for protection, absorption of exudate, or debridement of the wound. In wound treatment CTAs are simply used to apply an antiseptic or antibacterial ointment or other substance to the wound. Furthermore, they are not exclusively used in a clinical setting to treat patients. In the medical arena alone, they are used in the laboratory to apply substances to slides or culture media. They are also used in the electronic and other industries. Hence, CTAs are not provided for in heading 3005, HTSUS.

The instruments and appliances used in medical, surgical, dental or veterinary sciences described in EN 90.18 are placed in different categories. Instruments which may be used under the same names for several purposes (e.g., needles, lancets, trocars, surgical knives and scalpels of all kinds, sounds, specula, mirrors and reflectors, scissors, shears, forceps, pliers, chisels, gouges, mallets, hammers, saws, scrapers, spatulae, cannulae, catheters, suction tubes, etc., cauteries, tweezers, dressing, swab, sponge or needle holders, retractors, dilators, clips, syringes of all kinds) are characterized by their hardy construction and reusability in the clinical setting. Even those items that are not typically reused are of a type of merchandise that could withstand sterilization and reuse. For instance, most needles, catheters, cannulae and syringes are currently disposed of after use, but some are sterilized for reuse depending on the material of which they are constructed (i.e., plastic syringes are disposed of after use, but glass or metal syringes are sterilized and reused). Further, these items are only used in hospitals, clinics and by practitioners in direct contact with a patient. Those that are common tools or cutlery, such as saws, scissors, pliers, scrapers, knives and the like, must be "clearly identifiable as being for medical or surgical use." EN 90.18.

Special diagnostic instruments and apparatus (eg.: stethoscopes, instruments to measure rate of breathing, sphygmomanometers, tensiometers and oscillometers, spirometers, cephalometers and pelvimeters) are also characterized by their sturdy construction and reusability. With the exception of stethoscopes, they are all items used to measure something related to a patient's treatment (ie., vital signs, lung capacity, or cranial or pelvic circumference). Stethoscopes also help a practitioner measure the heart rate and breathing rate of a patient as well as to discern the presence of excess fluid or masses in various organs. These items are all unique to clinical diagnosis and are only found in hospitals, clinics, and practitioners' offices.

Instruments for nose, throat or tonsil treatment (eg.: clamps, transillumination apparatus, tonsilotomes and guillotines, direct laryngoscopes, and laryngeal brushes), urinary canal or bladder instruments (eg: urethrotomes, lithotrity instruments, bladder-grit suction apparatus, and instruments for prostatectomy), and gynecological or obstetrical instruments (eg.: vaginal retractors; hysterectomy instruments; obstetrical stethoscopes; specialised optical instruments for examination of the genital organs; forceps; perforators; embryotomy instruments, cephalotribes and cranioclasts, and instruments for taking internal measurements) include only instruments that are reusable items for clinical practice specific to diagnosing and treating the ailments of patients. Conspicuously missing from these items are the supplies used in obtaining specimens from the vaginal orifice. You cite NY 838689, dated April 10, 1989, which places a plastic cervical scraper in heading 9018, HTSUS, as support for the view that CTAs are medical instruments. The plastic cervical scraper, however, may be distinguished from the CTAs in its unique use only for scraping a cervix. Unlike the CTAs, it is not used to clean camera lenses or other equipment or to transfer fluids onto a slide or into a Petri dish. Furthermore, we note that a wooden scraper entered as part of a laboratory specimen collection kit was classified in heading 4421, HTSUS, as an article of wood, (See NY 814041, dated September 11, 1995), lending support for classification of such supply items as to their material component(s).

CTAs are not reusable, nor are they of a type of merchandise that is reuseable. They are not exclusively used in the clinical setting by practitioners to treat or diagnose disease. CTAs (defined here as 3 to 6 inch sticks of wood, paper or plastic with cotton wadding glued to one end) are found in use in laboratories in medical, biotechnical and other industries, as well as in camera shops, machine shops and hobby stores. They are not clearly recognizable as articles used specifically for the diagnosis or treatment of a patient in a clinical setting.

Furthermore, the chapter notes to Chapter 90 explicitly state that the articles listed in this section are "characterised by their high finish and high precision " and notes the exceptions to this general rule. We decline to add to this careful list of exceptions in order to classify CTAs in a heading designated for high precision articles. You argue that CTAs are "high precision" instruments because they are a Class I medical device under FDA regulations. Class I medical devices are those which "present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process." Exempted Class I devices, are those for which "a premarket notification application and FDA clearance is not required before marketing the device in the U.S. . . .Examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans." General Information on Medical Device Regulation-510(k) and Premarket Approval (PMA), http:// www.fda.gov/ cedrh/ consumer/geninfo/ html (updated August 2, 1999). While the FDA classification is irrelevant to Customs classification decisions, in this case, it does not even support the argument that the CTA is a precision instrument. Enema kits, bandages, thermometers and bedpans, some of the examples of Class I medical devices listed in this general information piece prepared by the FDA, are certainly not classified in heading 9018, HTSUS. Likewise, CTAs are not classified in heading 9018, HTSUS.

Lastly, even if CTAs are encased by or packaged with a culture medium such that they are only useable to collect organisms for culture, they are not classified in heading 9018, HTSUS, as medical instruments. Instead, they are classified in heading 3821, HTSUS, the provision for "culture medium" because the swab, arguably an instrument used to obtain microorganisms for culture, may be used to do so in a clinical setting on patients, or in a meat packing plant on chickens. (See NY 894596, dated February 14, 1994 and NY 808648, dated April 10, 1995). The swab is not uniquely a medical instrument, even when packaged for sterilization. Hence, CTAs are not of the class or kind of good listed in EN 90.18 which are unique to the clinical setting and are principally used as medical instruments.

The Material Article Provisions

At GRI 1, the terms of the headings and the legal notes do not resolve the classification issue. At GRI 3(a), the CTAs are a composite good, consisting of a wood handle and a cotton wadding tip. Heading 4421, HTSUS, the provision for articles of wood, and heading 5601, HTSUS, the provision for wadding and articles thereof, are under consideration, as they each describe the good in part.

At GRI 3(b), we must determine the essential character of the composite good. The purpose of the CTA, to cleanse an area, remove debris, apply a substance, or collect or smear a specimen, is accomplished with the cotton tip. For a number of these tasks the handle could be made of some other material such as plastic, paper, or metal. A handle is necessary to place the cotton tip in the correct area of the body or of a machine. While wood may be the best choice to accomplish some of the tasks, it is not the only choice. Therefore, CTAs are classified in heading 5601, HTSUS, because the role of the cotton wadding material in relation to the use of the goods far outweighs the role of the wooden handle.

Applying GRI 6, CTAs are classified in subheading 5601.21.0090, HTSUS, the provision for "[W]adding of textile materials and articles thereof; textile fibers, not exceeding 5 mm in length (flock), textile dust and mill neps: [W]adding; other articles of wadding: [O]f cotton: [O]ther."

HOLDING:

HQ 963875 is reaffirmed. CTAs are classified in subheading 5601.21.0090, the provision 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 general column one duty rate is 5 percent ad valorem. The designated textile category number is 369.

The designated textile and apparel category may be subdivided into parts. If so, visa and quota requirements applicable to 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 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.

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

Sincerely,

John Durant, Director

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