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HQ 965845




November 7, 2002

CLA-2 RR:CR:GC 965845 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.90.80

Mr. Peter J. Fitch
Fitch, King and Caffentzis
35 Beach Road
Monmouth Beach, NJ 07750

RE: HQ 089373 revoked: sterile and non-sterile sutures with or without needles

Dear Mr. Fitch:

This is in reference to Headquarters Ruling Letter (HQ) 089373, issued to you on October 25, 2002, on behalf of Davis & Geck, a Division of American Cyanamid Company, concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of sterile and non-sterile sutures with or without needles. In HQ 089373, we determined that: sterile needled sutures are classified under subheading 3006.10.00, HTSUS, the provision for Pharmaceutical goods specified in note 4 to this chapter: Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental hemostatics.” Non-sterile suture material of catgut with and without needles is classified under subheading 4206.10.30, HTSUS, the provision for Articles of gut (other than silkworm gut), of goldbeater's skin, of bladders or of tendons: Of catgut: If imported for use in the manufacture of sterile surgical sutures.” Other non-sterile suture material with and without needles is classified according to the type of material used in the suture in heading 5609, HTSUS, the provisions for "articles of yarn, strip or the like . . . ."

In the process of reviewing a similar matter, we have determined that HQ 089373 must be revoked. In addition, New York Ruling (NY) H80134 dated April 26, 2001, HQ 560914, dated October 22, 1998, NY 869236, dated December 17, 1991 are revoked in HQs 965318, 965847 and 965846 of this date.

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. L. 103-82, 107 Stat. 2057, 2186), notice of the proposed revocation of that HQ 089373 was published on October 2, 2002, in the CUSTOMS BULLETIN, Volume 36, Number 40. No comments were received in response to this notice.

FACTS:

As stated in HQ 089373, the subject merchandise consists of sterile and non-sterile sutures with and without needles. The Trade and Tariff Act of 1984 (P.L. 98-573) replaced item 792.22, of the Tariff Schedules of the United States (TSUS), the provision for articles of gut, with two new items. Item 792.24 provided the same preferential duty rate for “articles of gut imported for use in the manufacture of surgical sutures” as that accorded to item 495.10, TSUS, the provision for sterile surgical sutures and materials. New item 792.26, TSUS, provides for “other articles of gut.” In so doing, the House of Representatives Ways and Means Committee used the following language in recommending the bill:

When used in the manufacture of sutures, the gut is cut to the appropriate length and a needle is added, resulting in a nonsterile suture, classified in item 792.22 [“articles of gut”]. If sterilized and sterile-packed in inner and outer packages prior to importation, the suture would be classified in item 495.10 [“articles of gut imported for use in the manufacture of surgical sutures”]. House Report No. 98-1015, to accompany H.R. 6064, Sept. 18, 1984.

Specifically disregarding the legislative history cited above, HQ 082498, dated March 14, 1989, held that a sterile needle with suture attached was classified in item 709.27, TSUS, the provision for medical instruments. HQ 087660, dated November 5, 1990, modified HQ 082498, in accordance with the legislative history, classifying sterile needles with suture attached in item 495.10, the provision for surgical sutures, and non-sterile suture with a needle attached in item 792.24,TSUS, the provision for "articles . . . of gut, if imported for use in the manufacture of sterile surgical sutures."

In 1988, the HTSUS was adopted. However, rulings on the instant matter continued to discuss the legislative history of the Tariff Act of 1984. For instance, HQ 089373, dated October 25, 1991, cited the sentence above that “[W]hen used in the manufacture of sutures, the gut is cut to the appropriate length and a needle is added, resulting in a non-sterile suture, . . . .” There, Customs ruled that sterile needled sutures are classified in subheading 3006.10.00, HTSUS as “sterile suture material” and non-sterile needled sutures are classified according to the material of the suture thread, such as in subheading 4206.10.30, HTSUS, for “articles of gut.”

ISSUE:

Whether non-sterile suture attached to a needle is classifiable as a medical instrument or according to the material of the suture?

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 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. 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 generally indicative of the proper interpretation of the HTSUS. See T.D. 8980, 54 Fed. Reg. 35127 (August 23, 1989).

The EN to GRI 1 part (V) explains that the expression “provided such headings or Notes do not otherwise require” makes it clear that “the terms of the headings and any relative Section or Chapter Notes are paramount, i.e., they are the first consideration in determining classification. For example, in Chapter 31, the Notes provide that certain headings relate only to particular goods. Consequently those headings cannot be extended to include goods which otherwise might fall there by reason of the operation of Rule 2 (b).” 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." GRI 3(c) requires that if the essential character can not be determined, the good is classified in the latter heading.

The following headings and subheadings are relevant to the classification of this merchandise:

Pharmaceutical goods specified in note 4 to this chapter:

3006.10.00 Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental hemostatics

4206 Articles of gut (other than silkworm gut), of goldbeater's skin, of bladders or of tendons:

5609 Articles of yarn, strip or the like of heading 5404 or 5405, twine, cordage, rope or cables, not elsewhere specified or included:

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:

9018.90 Other instruments and appliances and parts and accessories thereof:

9018.90.80 Other

Note 4 to Chapter 30, HTSUS, specifies, inter alia: “[S]terile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure . . . .” EN 30.06 states, in pertinent part, "This item covers all kinds of ligatures for surgical sutures, provided they are sterile. . . ." The materials used for such ligatures include catgut, natural fibers, synthetic fibers and metals.

Subheading 3006.10.00, HTSUS specifies “Sterile surgical catgut” and “similar sterile suture materials.” Item 495.10, TSUS, was the provision for “articles of gut imported for use in the manufacture of surgical sutures”. HQ 087660, which classified sterile needles with suture attached in item 495.10, TSUS, interpreted the phrase “articles of gut” to include the suture material with a needle.

In an attempt to follow the history of classifying sterile suture and needle in the provision for suture material, HQ 089373 ruled that sterile suture and needle is classified in subheading 3006.10.00, HTSUS, the provision for “sterile suture materials.” There, we stated “[B]ased on the legislative history and above cited definitions, we are of the opinion that “suture material” is suturing material such as catgut, synthetic polymer fibres, metal, etc. and an attached needle.” This statement is incorrect. The terms “similar suture material” can not be twisted to refer to anything but materials, ie. catgut, synthetic polymer fibres, metal, etc. The sterile needle combination can not be classified in heading 3006, HTSUS, by the terms of the heading itself. EN 30.06, which defines the scope of the heading as covering all kinds of “ligatures for surgical sutures,” supports this view. Ligatures are “any substance, such as catgut, cotton, silk, or wire, used to tie a vessel or strangulate a part.” Dorland’s Illustrated Medical Dictionary, 27th Edition, p. 935. Furthermore, the EN to GRI 1 warns against expanding a heading clearly limited in this manner. Here, the heading is clearly limited, by its terms and by Chapter note 4, to sterile suture material. It does not include needled sutures because needles are not "suture materials" in the way that gut is suture material.

EN 90.18(I)(A), lists needles under "[I]nstruments 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)."

Sterile and non-sterile needled sutures consist of two different materials prima facie classified in three different provisions: the needle of heading 9018, HTSUS, and the thread of headings 3006, 4206 and 5609, HTSUS. Neither heading can be considered more specific as they both describe the good in part. The needle may have greater value and weight than the thread.

However, the role of the suture material to the item as a whole outweighs the role of the needle. The raison d'etre of the merchandise is to keep a wound closed. The thread is the portion of the merchandise that holds the wound together; the needle is simply the vehicle for placing the thread where it needs to go. Furthermore, the trade recognizes that the role of the suture is paramount. For instance, completed sterilized suture and needle is listed in the 2001 Medical Device Register, Medical Economics, Inc., under "Sutures." The listings include "monofiliment suture with needle of same diameter as suture and non-absorbable, synthetic, polyamide suture in 8 sizes with full range of needle types." The listing for "Needles-Suture" describes only disposable and re-usable suture needles. Commercially, the completed and sterilized item is known as a suture. Some sutures are packaged attached to a needle and some are not. Each component of the instant merchandise appears to be equally "essential" under GRI 3(b). Hence, the merchandise is classifiable in heading 9018, HTSUS under GRI 3(c).

HOLDING:

Sterile and non-sterile suture material attached to a needle will be classified in subheading 9018.90.80, HTSUS, as "[I]nstruments 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: [O]ther instruments and appliances and parts and accessories thereof: [O]ther." Sterile suture material continues to be classified in subheading 3006.10.00, HTSUS, and non-sterile suture materials continue to be classified according to the nature of the material.

EFFECT ON OTHER RULINGS:

HQ 089373 is revoked.

In accordance with 19 U.S.C. §1625(c)(1), this ruling will become effective 60 days after its publication in the CUSTOMS BULLETIN.

Sincerely,

Myles B. Harmon, Acting Director

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