CLA-2 RR:CR:GC 966676 AM
Mr. Jeffrey A. Meeks
Meeks & Sheppard
1735 Post Road, Ste. 4
Fairfield, CT 06824
Re: Non-Sterile Suture
Dear Mr. Meeks:
This is in reference to your letter of July 24, 2003, on behalf of Tyco Healthcare Group LP, to the National Commodity Specialist Division, requesting a ruling on the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of non-sterile sutures without needles. Your letter was forwarded to this office for reply. We have also considered the claims put forward by you in the telephone conference of November 17, 2003.
FACTS:
The subject merchandise consists of the following material assembled into surgical sutures in the Dominican Republic: (1) gut suture sourced from Australia and Mexico; (2) monofilament nylon suture sourced from the U.S.; (3) nylon suture sourced from the U.S. and England; (4) Dacron® suture with attached pledget sourced from the U.S.; and (5) silk suture sourced from England. Assembly in the Dominican Republic consists of cutting the suture material to length and packaging in pouches and display boxes noting the sterility of the contents. Additionally, the gut sutures are treated with alcohol, the Dacron® sutures are treated with a tipping solution and the silk suture is stripped of wax before packaging. The sutures, however, are not sterilized until after entry into the United States.
ISSUES:
1. Whether non-sterile suture, ready for sterilization and sale as sterile suture, is classified as sterile suture or according to the material of the suture.
2. What is the country of origin of the merchandise?
LAW AND ANALYSIS:
Classification
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(a) states, in pertinent part, that "any reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article. . . ." GRI 5(b) states, in pertinent part, that ". . . packing materials and packing containers entered with the goods therein shall be classified with the goods if they are of a kind normally used for packing such goods. . . ." 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).
The following headings and subheadings are relevant to the classification of this product:
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:
4206.90.00 Other
* * * * * * * * * * * *
5004.00.00 Silk yarn (other than yarn spun from silk waste) not put up
for retail sale
* * * * * * * * * * * *
5402 Synthetic filament yarn (other than sewing thread), not put up for retail sale, including synthetic monofilament of less than 67 decitex:
Other yarn, single, untwisted or with a twist, not exceeding 50 turns/m:
5402.41 Of nylon or other polyamides:
5402.41.90 Other
* * * * * * * * * * *
5607 Twine, cordage, ropes and cables, whether or not plaited or braided and whether or not impregnated, coated, covered or sheathed with rubber or plastics:
5607.50 Of other synthetic fibers:
Other
Chapter 30, Note 4, HTSUS, states, in pertinent part, that "Heading 3006 applies only to the following, which are to be classified in that heading and in no other heading of the tariff schedule: (a) Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure; . . . . "
The ENs to heading 3006 state, in pertinent part, the following:
This heading covers only the following goods:
(1) Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure.
This item covers all kinds of ligatures for surgical sutures, provided they are sterile. These ligatures are usually put up in antiseptic solutions or in sealed sterile containers.
The materials used for such ligatures include:
catgut (processed collagen from the intestines of cattle, sheep or other animals);
(b) natural fibres (cotton, silk, linen);
(c) synthetic polymer fibres, such as polyamides (nylons), polyesters;
(d) metals (stainless steel, tantalum, silver, bronze).
The item also covers tissue adhesives such as those consisting of butyl cyanoacrylate and a dye; after application, the monomer polymerises and the product is therefore used in place of conventional suture materials for closing internal or external wounds of the human body.
The heading excludes non-sterile suture materials. These are classified according to their nature, e.g., catgut (heading 42.06), silkworm gut, textile yarns, etc. (Section XI), metal wire (Chapter 71 or Section XV) (emphasis added).
Goods are to be classified in their condition as imported. Heartland By-Products, Inc., v. U.S., 23 C.I.T. 754; 74 F. Supp. 2d 1324 (1999). The instant merchandise consists of non-sterile suture material cut to length and packaged as sterile sutures. However, the articles are not sterile when entered.
The terms of heading 3006, Note 4 to Chapter 30, HTSUS, and EN 30.06 make clear that the suture material classified there is sterile. The sterility of the suture material is paramount to the classification determination in that heading. The fact that sterilization in the U.S. does not substantially transform the article under marking rules (HQ 730306, dated October 23, 1987, and HQ 561167, dated December 14, 1998) is not determinative of the classification determination.
You contend that the instant merchandise is not just non-sterile suture materials explicitly excluded from classification in heading 3006, but rather, unfinished sterile sutures already packaged, and thus transformed from suture material into sutures. We disagree.
First, GRI 2(a) requires that the reference to the article include a reference to the unfinished article. Here, neither the referenced suture material, nor the referenced sterility of the suture material, is unfinished. The suture material is fully finished and packaged as suture material, and the sterilization process has not yet begun. The sutures are not partially, incompletely, or almost sterile. They are simply not sterile and cannot therefore be classified as sterile sutures.
Second, GRI 5(b) allows for products entered in their usual packing material to be classified in the provision for the product under GRI 1. The packing material is not germane to the classification. While we agree that the instant yarns are packed for the specific purpose of surgical ligature and will not be used to sew cloth, they are nevertheless non-sterile suture materials. Since suture materials have long been packaged before the sterilization procedure via gamma radiation, this is the usual packing for non-sterile suture materials that will become sterile sutures. Suture materials, even when packaged as sterile suture materials, do not become classifiable as sterile suture materials until they are actually sterile.
Lastly, you believe the reasoning in HQ 054988, dated June 21, 1978, a ruling classifying braided nylon rope specifically designed and packaged for mountain climbing, as sporting equipment rather than as rope, under the Tariff Schedule of the United States (TSUS), should be applied in the instant case. We disagree. In that case there was nothing in the legal text for sporting equipment that excluded the classification of the rope as sporting equipment. We believe the situation here is much more analogous to that in HQs 084273, 082076, and 083193, dated June 14 and June 21, 1989, and January 19, 1990, respectively, where comforter shells could not be classified as "bedding internally filled with any material" because the comforter shells, unlike comforters themselves, are not filled. The covers are not "unfinished filled bedding" because they are not "filled" at all. Here, the finished non-sterile suture material cannot be classified as unfinished sterile suture material because the legal text itself does not allow it and there is nothing "unfinished" about the sterility of the article.
Hence, gut suture is classified in subheading 4206.90.00, HTSUS, the provision for "Articles of gut (other than silkworm gut), of goldbeater's skin, of bladders or of tendons: Other." Silk suture is classified in 5004.00.00, HTSUS, the provision for "Silk yarn (other than yarn spun from silk waste) not put up for retail sale." Monofilament nylon suture is classified in 5402.41.90, HTSUS, the provision for "Synthetic filament yarn (other than sewing thread), not put up for retail sale, including synthetic monofilament of less than 67 decitex: Other yarn, single, untwisted or with a twist, not exceeding 50 turns/m: Of nylon or other polyamides: Other." Braided nylon suture is classified in subheading 5607.50.40, HTSUS, the provision for "Twine, cordage, ropes and cables, whether or not plaited or braided and whether or not impregnated, coated, covered or sheathed with rubber or plastics: Of other synthetic fibers: Other."
We are unable to classify the Dacron® suture with attached pledget at this time because no sample was enclosed. You may request a ruling from the National Commodity Specialist Division, 1 Penn Plaza, New York, NY, 10003. If you do so, please include a sample such that we may determine whether the suture is yarn or cordage and whether the pledget changes the essential character of the good.
Furthermore, the entry of this merchandise may involve oversight by the Food and Drug Administration. You can reach them at U. S. Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857-0001.
Country of Origin
Section 334 of the Uruguay Round Agreements Act (codified at 19 U.S.C. 3592), enacted on December 8, 1994, provided rules of origin for textiles and apparel entered, or withdrawn from warehouse for consumption, on and after July 1, 1996. Section 102.21, Customs Regulations (19 C.F.R. 102.21), published September 5, 1995, in the Federal Register, implements Section 334 (60 FR 46188). Section 334 of the URAA was amended by section 405 of the Trade and Development Act of 2000, enacted on May 18, 2000, and accordingly, section 102.21 was amended (68 FR 8711). Section 102.21 states, in pertinent part, the following: " . . . the country of origin of a textile or apparel product shall be determined by the sequential application of the general rules set forth in paragraphs (c)(1) through (5) of this section and, where appropriate to the specific context, by application of the additional requirements or conditions of §§102.12 through §§102.19 of this part." 19 C.F.R. 102.21(c). Section 102.15 (a)(1) instructs Customs to disregard packaging materials and containers in which a good is packaged for retail sale that are classified with the good when determining whether the good undergoes the applicable change in tariff classification set out in §102.21. Section 102.17(c) excludes from consideration retail packaging without more than minor processing in determining whether applicable requirements of a change in tariff classification specified in §102.21 are met. Therefore, under §102.15(a)(1) and §102.17(c), the cutting, finishing and packaging operations in the Dominican Republic are not considered in determining the origin of the suture materials.
19 CFR §102.21(c)(1) states: "The country of origin of a textile or apparel product is the single country, territory, or insular possession in which the good was wholly obtained or produced." Assuming the "source country" is where the suture material was wholly obtained or produced, the country of origin of suture material is the source country of the textile material. The cutting, finishing and packaging operations in the Dominican Republic do not support a change in tariff classification necessary for the country of origin to be considered the Dominican Republic under sections 102.15 and 102.17. Specifically, the country of origin of the monofilament nylon suture is the U.S., the country of origin of the nylon suture is the U.S. or England, and the country of origin of the silk suture is England.
With regard to the gut sutures cut and packaged in the Dominican Republic, the substantial transformation standard is applied to determine the country of origin. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)) provides that: " 'country of origin' means the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part."
A substantial transformation occurs when a new and different article of commerce emerges from a process with a new name, character or use different from that possessed by the article prior to processing. United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940).
Customs ruled in New York Ruling Letter (NY) 810501, dated June 2, 1995, that non-sterile suture braid was not substantially transformed abroad by simply having been packaged there. The assembly operations involved in this case require little more than packaging the suture material. It is cut to length and undergoes minor processing which does not substantially transform the thread into a new and different article. Hence, the source country is the country of origin for marking purposes. Specifically, the country of origin for the gut sutures is Australia or Mexico.
HOLDINGS:
Gut suture not made of catgut is classified in subheading 4206.90.00, HTSUS. Silk suture is classified in 5004.00.00, HTSUS. Monofilament nylon suture is classified in 5402.41.90, HTSUS. Braided nylon suture is classified in subheading 5607.50.40, HTSUS.
The country of origin for textile non-sterile suture material cut to length, treated with alcohol, a tipping solution or wax stripper, or untreated and packaged in the Dominican Republic is the respective source country. Specifically, the country of origin of the monofilament nylon suture is the U.S.; the country of origin of the nylon suture is the U.S. or England, and the country of origin of the silk suture is England.
The country of origin for marking purposes of the gut non-sterile suture material cut to length, treated with alcohol, a tipping solution or wax stripper, or untreated and packaged in the Dominican Republic is the respective source country, either Australia or Mexico.
Sincerely,
Myles B. Harmon, Director
Commercial Rulings Division