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HQ 732844

Febuary 12, 1990

MAR-2-05 CO:R:C:V 732844 NL


Dr. Lewis B. Udis, Chairman
United Instrument Corporation
P.O. Box 20924
Philadelphia, PA 19141-0855

RE: Country of Origin Marking of Surgical Instruments

Dear Dr. Udis:

This is in response to your letter of September 18, 1989, and subsequent correspondence in which you seek a ruling concerning the country of origin marking of surgical instruments to be sold by United Instrument and its Alan Scott Division to the U.S. government and other entities. Specifically, you ask whether the marking "United Instrument U.S. Forged Stainless Steel" is acceptable in light of the fact that the instruments are to undergo processing and assembly in Pakistan.


United Instrument plans to import surgical instruments from Pakistan. The instruments will be machined, finished and assembled in Pakistan from stainless steel forged instrument blanks produced in the U.S. by Schilling Forge. The blanks are rough forgings consisting of the unassembled halves of pairs of forceps. From examination of the submitted samples it is evident that in Pakistan they are machined, cut, curved, riveted, assembled and polished. The articles as imported from Pakistan are substantially finished products which, as you state, require only testing for conformity with FDA, ASTM and federal government specifications, passivization (anticorrosion treatment) and packing to be marketable.

The objective of United Instrument is to arrange for the production of surgical instruments which satisfy the requirements of the Preference for Domestic Specialty Metals of the Department of Defense Acquisition Regulations (48 CFR 252.225-7012). That provision requires a contractor to certify that specialty metals furnished to the federal government were melted in the U.S., its possessions or Puerto Rico. Accordingly, United Instrument proposes to mark each article with the legend, "United Instrument U.S. Forged Stainless Steel."

Samples were submitted of three instruments to demonstrate their condition as blanks produced by Schilling Forge and as finished and assembled articles as imported from Pakistan. Cost
data also was submitted indicating that the F.O.B. prices of the instrument blanks from Schilling Forge range from $1.09 to $2.50, while the F.O.B. prices from Pakistan range from $1.60 to $3.35. United Instrument's costs in the U.S. for final testing and preparation for the three sample instruments are between $1.50 and $2.00.


For country of origin marking purposes, does the machining, finishing and assembly in Pakistan substantially transform the U.S. forgings into products of Pakistan?

How may the U.S. origin of the forgings be indicated?


Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin 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 manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article.

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)), provides that "country of origin" means 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". The term "foreign origin" is defined in section 134.1(c), Customs Regulations (19 CFR 134.1(c)), as a country of origin other than the U.S.

As provided in section 134.32(m), Customs Regulations (19 CFR 134.32(m), products of the U.S. exported and returned are specifically excepted from country of origin marking requirements. If a U.S. product is sent abroad for processing, the article remains a product of the U.S. excepted from the country of origin marking requirements unless prior to its return it is substantially transformed into an article of foreign origin. This exception from country of origin marking does not apply to articles assembled abroad in whole or in part from U.S.- made components and eligible for entry under subheading 9802.00.80 of the Harmonized Tariff Schedule of the United States. See section 10.22, Customs Regulations (19 C.F.R. 10.22). They are considered products of the country of assembly for purposes of 19 U.S.C. 1304, whether or not the assembly constitutes a substantial transformation.

If the U.S. product is substantially transformed abroad, it becomes an article of foreign origin and must be marked with its country of origin. In order for a substantial transformation to be found, a new and different article having a distinctive name, character, or use must emerge from the processing. See, Anheuser-Busch Brewing Ass'n v. United States, 207 U.S. 556 (1908).

In several previous rulings Customs has considered the circumstances under which the processing of forged blanks into finished or semifinished surgical instruments is a substantial transformation. In HRL 055703 (September 24, 1979), we ruled that German forgings sent to Malaysia for milling and machining, including widening the holes for joining matching pieces, machining small ridges for locking or gripping, and machining to define the edges and surfaces, substantially transformed the forgings into surgical instruments whose country of origin was Malaysia. In C.S.D. 80-15 (June 25, 1979), we determined that machining in the U.S. of United Kingdom forged blanks substantially transformed them into products of the U.S. In that same ruling we found that the subsequent finishing, polishing, assembly and passivization (anticorrosive treatment) of the instruments in Pakistan did not substantially transform them into products of Pakistan. In HRL 553197 (February 11, 1985), we determined that machining of forged blanks in the U.S., consisting of deburring, milling, assembly and riveting, constituted a substantial transformation. Correspondingly, we found that the subsequent rough polishing, hand shaping and curving, heat treatment and final polishing of the instruments in Pakistan was not a substantial transformation. It was our opinion that all the key machining operations were performed in the U.S. and the articles imported from Pakistan were eligible for treatment as articles of the U.S. returned after further processing.

Guidance is also offered by a recent ruling on rough forgings imported into the U.S. for processing into parts of a socket set. HQ 731572 (C.S.D. 89-121)(July 25, 1989). The processing consisted of lathing, drilling, centerless grinding, marking, heat treatment, hardness and torque testing, sand blasting, tumbling, chemical vibration, acid dipping, plating, painting and quality control. We distinguished the machining operations of lathing, drilling, and grinding to achieve a specified diameter and wall thickness from the other more cosmetic or minor processing operations on the basis that the former change the forgings to sockets and enable the products to be used as tools. This significant amount of machining was needed before the finishing operations could be accomplished. The ruling followed the rationale of Midwood Industries v. United States, 64 Cust. Ct. 449, C.D. 4026, 313 F.Supp. 951(1970), in which a finding of substantial transformation was based on the numerous machining operations performed in the U.S. on forgings
which imparted the essential characteristics enabling them to be used as fittings and flanges. Under Midwood the transition from "producers' goods" to "consumers' goods" is recognized as a change in the utility of the product and is indicative of a substantial transformation.

On the basis of these precedents and upon examination of the sample instruments submitted, it is our conclusion that the processing of the U.S.-made forgings in Pakistan into surgical instruments substantially transforms them into products of that country. While the U.S.-made forgings resemble the size and shape of the finished articles, they are not yet machined to their actual dimensions and and lack essential characteristics such as the capacities to grip, close, lock in place and be adjusted. Without the machining, bending, cutting, riveting, assembly and polishing the articles cannot be used as surgical instruments and do not have the characteristics thereof. The final quality control, inspection and processing operations conducted in the U.S. do not substantially transform the Pakistan-made products into U.S.-made articles, but are minor finishing processes.

As articles produced in Pakistan, the instruments must be marked with their country of origin, in accordance with 19 U.S.C. 1304 and 19 CFR Part 134.

Since United Instrument wishes to indicate the U.S. origin of the forgings on the instruments, the requirements of section 134.46, Customs Regulations (19 CFR 134.46), are applicable. That section provides that in any case in which the words "U.S.," or "American," or the letters "U.S.A.," appear on an imported article or its container, the name of the article's country of origin must appear in close proximity, in lettering of at least comparable size, preceded by "Made in," "Product of," or other words of similar meaning. The purpose of 19 CFR 134.46 is to avoid misleading or possible deception of the ultimate purchaser in the U.S.

In this case, you propose to mark the instruments "United Instrument U.S. Forged Stainless Steel." To accomplish the purposes of 19 CFR 134.46 and of 19 U.S.C. 1304 generally, it is necessary that the ultimate purchaser be given an unambiguous marking which plainly discloses that the instruments are manufactured in Pakistan. To that end, we would approve markings such as "Made in Pakistan of U.S. Forged Stainless Steel for United Instrument", or "Made in Pakistan by United Instrument of U.S. Forged Stainless Steel". Other markings may also be acceptable, provided that they are equally plain and clearly indicate that the instruments are made in Pakistan. The marking must be located in close proximity to the reference to the U.S. and in lettering of comparable size.


1) The processing in Pakistan of the U.S.-origin forged blanks into surgical instruments is a substantial transformation of the blanks into products of Pakistan which must be marked, for purposes of 19 U.S.C. 1304, as originating in that country.

2) Indicating that the forging is of U.S. origin is acceptable, provided that the requirements of 19 CFR 134.46 are satisfied.


Marvin M. Amernick
Chief, Value, Special Programs

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