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HQ 561189

November 5, 1998

MAR-2-05 RR:CR:SM 561189 MLR


Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Avenue
39th Floor
New York, NY 10017

RE: Country of origin of surgical instruments; forging; forceps; surgical scissors; clamps; substantial transformation

Dear Mr. Leo:

This is in reference to your letter of October 15, 1998, requesting a ruling on behalf of Miltex, Inc., concerning the country of origin of certain surgical instruments. Samples were submitted with your request.


It is stated that the surgical instruments are forged in Germany from stainless steel made in Germany. The forgings are for various surgical instruments, including forceps, surgical scissors, and clamps. It is stated that the forged articles are shaped to the required, specified shape for the particular instrument. The following forgings and their respective finished products of various surgical instruments were submitted with this request:

(1) a forging which is made into serrated adson forceps; (2) a forging which is made into adson forceps with 1x2 teeth;
(3) a forging which is made into 5 1/2" straight Kelly forceps or 5 1/2" curved forceps;
(4) a forging which is made into straight mosquito forceps or curved mosquito forceps;
(5) a forging which is made into 4 1/2" straight iris scissors or 4 1/2" curved iris scissors; and (6) a forging which is made into 5 1/4" backhaus towel clamps.

It is stated that the forgings are inspected in Germany and shipped to Pakistan for further working and finishing. In Pakistan, the processing will include milling, assembling (by welding for forceps), bending of jaws or blades (if curved patterns are made), grinding and filing, hardening and annealing, polishing and buffing, electro-polishing, etching, and cleaning. Each instrument will also be stamped "Stainless" and "Germany." It is also stated that there are instances where one forging can be used to produce instruments with different lengths through the addition of tungsten carbide inserts at the working ends. It is claimed that the inserts do not change the instrument other than its length, and give it more durable working ends.


Whether the surgical instruments are products of Germany or Pakistan.


The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was "that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will." United States v. Friedlaender & Co. Inc., 27 CCPA 297, 302, C.A.D. 104 (1940).

Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), Customs Regulations {19 CFR 134.1(b)}, defines "country of origin" as the country of manufacture, production or growth of any article of foreign origin entering the U.S. 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 the marking laws and regulations.

For country of origin marking purposes, a substantial transformation of an imported article occurs when it is used in manufacture, which results in an article having a name, character, or use differing from that of the imported article. On the other hand, if the manufacturing or combining process is merely a minor one which leaves the identity of the imported article intact, a substantial transformation has not occurred and an appropriate marking must appear on the imported article so that the consumer can know the country of origin. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff'd, 702 F.2d 1022 (Fed. Cir. 1983).

It is claimed that the surgical instruments are products of Germany based on National Hand Tool Corp. v. United States, 3 CIT 308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993), and Headquarters Ruling Letter (HRL) 561002 dated May 21, 1998; HRL 560441 dated November 18, 1997; HRL 560239 dated June 17, 1997; and HRL 559847 dated January 2, 1997.

In National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993), the court considered sockets and flex handles which were either cold formed or hot forged into their final shape prior to importation, speeder handles which were reshaped by a power press after importation, and the grip of flex handles which were knurled in the U.S. The imported articles were then heat treated which strengthened the surface of the steel, and cleaned by sandblasting, tumbling, and/or chemical vibration before being electroplated. In certain instances, various components were assembled together which the court stated required some skill and dexterity. The court determined that the imported articles were not substantially transformed and that they remained products of Taiwan. In making its determination, the court focused on the fact that the components had been cold-formed or hot-forged "into their final shape before importation," and that "the form of the components remained the same" after the assembly and heat-treatment processes performed in the U.S. Although the court stated that a predetermined use would not necessarily preclude a finding of a substantial transformation, it noted that such determination must be based on the totality of the evidence. The court then concluded that no substantial change in name, character or use occurred as a result of the processing performed in the U.S.

In HRL 559847 January 2, 1997, Customs considered U.S.-origin stainless steel sheets cut into strips of suitable width, which were further cut into blanks. The blanks were then heated and hammer forged. The forgings were annealed and trimmed, and cold stamped to straighten the trimmed forgings. The forgings were then shipped to Pakistan where they underwent milling operations to cut the box, rachet, and jaw serrations into the forceps; assembled; ground; filed; heat treated, including tempering and testing for hardness; acid pickled; polished; chemical cleaned; and buffed. It was held that inasmuch as the forgings resembled the shape and size of the completed instruments upon importation into Pakistan, the operations performed in Pakistan did not substantially transform the forgings into a new and different article of Pakistani origin. Accordingly, the origin of the finished instruments was the U.S. In HRL 560441 dated November 18, 1997, it was held that German rough forgings sent to Hungary where they were machined, assembled, and finished by removing a layer of impurities from the forgings did not undergo a substantial transformation in Hungary.

We find the processes in this case to be similar to the ones considered in HRL 559847 and HRL 560441. Accordingly, pursuant to those rulings and National Hand Tool, we find that there is no substantial transformation of the forgings in Pakistan, and the country of origin of the finished instruments will be Germany. We note that each forging is shaped in the final shape of the finished surgical instrument. For example, the forging for the iris scissors contains a flatter tip on one side. The tip of the forging for the kelly forcep is straighter than the forging for the mosquito forceps, and the tip of the backhaus towel clamp is more curved. While we also note that some forgings may be used to produce instruments with different lengths and some will be made into either a curved or straight surgical instrument, in National Hand Tool, the reshaping of the speeder handle was found not to be extensive enough to result in a substantial transformation. Therefore, we do not find that minor lengthening or bending is extensive enough to hold that the forging undergoes a substantial transformation. As in HRL 560441 and HRL 559847, the surgical instrument forging is not changed in shape to such a degree to result in a substantial transformation. Accordingly, we find that the country of origin of the finished surgical instruments will be Germany -- where the forgings are made.


Based on the facts and samples presented, we find that the processing in Pakistan does not result in a substantial transformation of the German forgings. Therefore, the country of origin of the finished surgical instruments is Germany and they may be marked "Product of Germany," "Made in Germany," or "Stainless Germany."

A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.


John Durant, Director
Commercial Rulings Division

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