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HQ 089373


October 25, 1991

CLA-2 CO:R:C:M 089373 KCC

CATEGORY: CLASSIFICATION

TARIFF NO.: 3006.10.00; 4206.10.30

Peter J. Fitch, Esq.
Fitch, King and Caffentzis
35 Beach Road
Monmouth Beach, New Jersey 07750

RE: Sterile and Non-Sterile Sutures, With or Without Needles; Of-Gut and Other Materials; GRI 1; 087660; 849025; 9018.90.80; Chapter Note 3, Chapter 30, Section VI; EN 30.06; EN 90.18; Nippon Kogasku (USA), Inc.; C.J. Tower & Sons; House Report No. 98-1015; Dorland's Illustrated Medical Dictionary; suture; 730999

Dear Mr. Fitch:

This is in response to your letter dated May 10, 1991, on behalf of Davis & Geck, a Division of American Cyanamid Company, concerning the tariff classification of sterile and non-sterile sutures with or without needles under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).

FACTS:

Davis & Geck, a Division of American Cyanamid Company, imports sterile and non-sterile sutures with and without needles into the U.S. These importations are made on a continuing basis primarily at the port of New York.

Until Headquarters Ruling Letter (HRL) 087660 dated November 5, 1990, we had held that sterile and non-sterile needled sutures were classified in item 709.27, Tariff Schedules of the United States (TSUS), as medical, dental, surgical, and veterinary instruments, including parts thereof...Other...Needles...Other... Other. See, C.I.E. 894/55 dated September 6, 1955; TC 426.85 dated May 21, 1965; HRL 079455 dated March 5, 1987; and HRL 082498 dated March 14, 1989.

However, HRL 087660 found that sterile needled sutures were classified in item 495.10, TSUS, as surgical sutures, surgical suture materials, all the foregoing which are sterile, and that non-sterile needled sutures were classified in item 792.24, TSUS (formerly item 792.22, TSUS), which provides for articles not specially provided for of gut...if imported for use in the manufacture of sterile surgical sutures. We based our opinion on the descriptive language in the legislative history provided in the Trade and Tariff Act of 1984, which amended the TSUS, in part by changing the duty rates applicable to articles of gut, if imported for use in the manufacture of surgical sutures. The House Report No. 98-1015 stated in pertinent part:

...Raw catgut is generally sold in coils of varying lengths. When used in the manufacture of sutures, the gut is cut to the appropriate length and a needle is added, resulting in a nonsterilized suture classified in item 792.22. If sterilized and sterile-packed in inner and outer packages prior to importation, the suture would be classified in item 495.10...

The Senate Report (No. 98-308) contains virtually identical language. The language cited above, plus Headnote 1(i) of Schedule 7, Part 2, Subpart B, TSUS, excluding from that subpart articles falling within the medical supplies provision of part 13C of Schedule 4, make it patently obvious that sterile sutures are properly classifiable under item 495.10, TSUS, whether with or without needles.

However, New York Ruling (NYR) 849025 dated February 6, 1990, held that needles with attached sutures are classified in the HTSUSA under subheading 9018.90.80, HTSUSA, as other instruments used in medical, surgical or veterinary sciences.

You are requesting that sterile sutures, whether or not needled, are classified under subheading 3006.10.30, HTSUSA, and that non-sterile needled sutures "of gut" be classified under subheading 4206.10.30, HTSUSA. Additionally, you request that non-sterile needled sutures consisting of other materials are classified according to the material of the suture ligature present in each suture.

ISSUE:

What is the proper tariff classification of sterile and un- sterile sutures with or without needles under the HTSUSA?

LAW AND ANALYSIS:

The classification of merchandise under the HTSUSA is governed by the General Rules of Interpretation (GRI's). GRI 1, HTSUSA, states in part that "for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes and...according to the following provisions..." In this case, it appears that the sterile needled sutures are classifiable under two headings:

3006 Pharmaceutical products specified in note 3 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.

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...

9018.90.80 Other instruments and appliances and parts and accessories thereof...Other.

The non-sterile needled sutures appear to be classifiable under subheading 9018.90.80, HTSUSA, and:

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

4206.10.30 Of catgut...If imported for use in the manufacture of sterile surgical sutures.

Chapter Note 3, Chapter 30, Section VI, HTSUSA, states that heading 3006, HTSUSA, "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 Explanatory Note 30.06 of the Harmonized Commodity Description and Coding System (HCDCS), states that sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure in heading 3006, HTSUSA, covers all kinds of ligatures for surgical sutures, provided they are sterile. The materials used for such ligatures include:

(a) 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).

This heading excludes non-sterile suture material. Non-sterile suture material is classified according to its nature, i.e., catgut (heading 42.06). HCDCS, Vol. 2, p. 440-441. Additionally, Explanatory Note 90.18 states that heading 9018 does not cover sterile catgut and other sterile material for surgical sutures, sterile laminaria and sterile laminaria tents (heading 30.06). HCDCS, Vol. 4, p. 1488. The Explanatory Notes, although not dispositive, are to be looked to for the proper interpretation of the HTSUSA. 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The term "suture material" is not defined in the HTSUSA or the HCDCS. Tariff terms are construed in accordance with their common and commercial meaning. Nippon Kogasku (USA), Inc. v. United States, 69 CCPA 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 69 CCPA 128, 673 F.2d 1268 (1982).

The descriptive language in the legislative history states that nonsterilized sutures are cut to length catgut with an attached needle. See, House Report No. 98-1015. Moreover, Dorland's Illustrated Medical Dictionary, 27th Edition defines a suture as "material used in closing a surgical or traumatic wound with stitches; a stitch or series of stitches made to secure apposition of the edges of a surgical or accidental wound; used also as a verb to indicate the application of such stitches." Dorland's Illustrated Medical Dictionary, 27th Edition, p. 1620 (1988). Dorland's Illustrated Medical Dictionary, 27th Edition defines a ligature as "any substance, such as catgut, cotton, silk, or wire, used to tie a vessel or strangulate a part." Id, p. 935. Additionally, we have held that the addition of surgical thread to a needle creates an article known as a suture which is suitable for use in surgery to bind body tissue. See, HRL 730999 dated December 12, 1988 (regarding the country of origin marking requirements for sutures).

Based 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. Therefore, the sterile needled sutures of any type of material would be classified under subheading 3006.10.00, HTSUSA, as "...similar sterile suture materials...." This tariff provision covers all types of suturing material which is sterile. HCDCS, Vol. 2, p. 440. Additionally, sterile surgical catgut and similar sterile suture material without needles is also classified in subheading 3006.10.00, HTSUSA.

Based on Explanatory Note 30.06, it appears that non-sterile suture material without needles is classified according to the nature of the material. HCDCS, Vol. 2, p. 441. Non-sterile suture material with and without needles will be classified under different tariff provisions depending on the type of material used, i.e., non-sterile suture material of catgut will be classified under subheading 4206.10.30, HTSUSA, as Articles of gut...Of catgut...If imported for use in the manufacture of sterile surgical sutures.

HOLDING:

Sterile needled sutures are classified under subheading 3006.10.00, HTSUSA. Sterile ligature suturing material without needles is also classified under subheading 3006.10.00, HTSUSA.

Non-sterile suture material of catgut with and without needles is classified under subheading 4206.10.30, HTSUSA. Additionally, other non-sterile suture material with and without needles should be classified according to the type of material used in the suture.

Accordingly, NYR 849025 is revoked pursuant to section 177.9, Customs Regulations (19 CFR 177.9).

Sincerely,

John Durant, Director
Commercial Rulings Division

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