CLA-2 RR:CR:GC 965847 AM
Port Director
U.S. Customs Service
#1 La Puntilla
San Juan, PR 00901
Re: HQ 560914 modified; non-sterile suture attached to a suture needle
Dear Port Director:
This is in reference Headquarters ruling (HQ) 560914, dated October 22, 1998, responding to a request for Internal Advice (I.A. 32/97), on behalf of Davis & Gech, Inc. and U.S. Surgical Corporation, concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of non-sterile suture attached to a suture needle. In HQ 560914, we determined that these goods were eligible for duty free treatment under U.S. Note 2(b), subchapter II, Chapter 98, HTSUS, provided all the components and materials thereof are of U.S. origin and the materials are exported directly from the U.S. to the B.C. and the assembled goods were imported directly to the U.S. from the B.C. This decision was based on classification in subheading 5609.00.40, HTSUS, which provides for "[a]rticles of yarn, strip or the like of heading 5404 or 5405, twine, cordage, rope or cables, not elsewhere specified or included: [o]ther."
In reviewing like merchandise in another matter, we have determined that HQ 560914 must be modified to reflect the correct classification of the merchandise irrespective of the duty determination. In addition, New York Ruling (NY) H80134, dated April 26, 2001, NY 869236, dated December 17, 1991 and HQ 089373, dated October 25, 1991, are modified in HQs 965318, 965846 and 965845 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 modification of HQ 560914 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 560914, the subject merchandise consists of silk and man-made yarns and needles of U.S. or foreign origin. The different type of yarns used include: catgut; man-made absorbable gut; nylon dacron and silk. The yarns are cut to length and dressed in Puerto Rico and sent to the Domincan Republic for assembly with the needles (by threading) and retail packaging. The assembled sutures and needles are returned non-sterilized.
ISSUE:
Whether unsterile 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 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. 89 80, 54 Fed. Reg. 35127 (August 23, 1989).
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." 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 product:
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
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)."
The instant merchandise consists of two different materials prima facie classified in two different provisions: the needle of heading 9018, HTSUS, and the thread of headings 4206 and 5609, HTSUS. Neither heading can be considered more specific as they both describe the good in part. The needle constitutes the item with the most value and weight.
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:
Non-sterile suture material attached to a needle is 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." This is a duty free provision not subject to textile agreements. Further analysis of U.S. Note 2(b), subchapter II, Chapter 98, HTSUS is otherwise unchanged. Specifically, The imported sutures with needles are eligible for duty-free treatment under U.S. Note 2(b), subchapter II, Chapter 98, HTSUS, provided all the components and materials thereof are of U.S. origin and the materials were exported directly from the U.S. to the B.C. and the assembled goods were imported directly to the U.S. from the B.C.
EFFECT ON OTHER RULINGS:
HQ 560914 is modified in accordance with this ruling on the classification of non-sterile suture attached to a needle.
In accordance with 19 U.S.C. ยง1625(c)(1), this ruling will become effective 60 days after its publication in the CUSTOMS BULLETIN.
Sincerely,
Myles B. Harmon, Acting Director
Commercial Rulings Division