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HQ 732498

October 3, 1989

MAR-2-05 CO:R:C:V 732498 KG


Lewis Stein
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, N.J. 08933-7002

RE: Country of origin marking of disposable suture removal kit and shave prep pack

Dear Mr. Stein:

This is in response to your letter of June 19, 1989, requesting a ruling on the country of origin marking of a imported disposable suture removal kit and a imported shave prep pack. You submitted a sample of the disposable suture removal kit for examination.


The disposable suture removal kit contains a Littauer scissors, forceps and gauze sponge. The scissors will be made in Israel. Although you state that they will be marked with the country of origin, the sample was unmarked. The forceps and gauze sponge will be manufactured in the U.S. The plastic container will be molded in Mexico of U.S. origin materials. The paper cover on the plastic container is marked "Made in U.S.A." without any specification as to what is made in the U.S.A.

The shave prep pack will contain two disposable razors, a soap sponge, two linen protectors, two towels and two cotton- tipped applicator packed in a twin compartment tray. The tray will be molded in Mexico and the disposable razors will be assembled in Mexico of U.S. components sent to Mexico ready for assembly.

The suture removal kits and the shave prep packs will be packed into shipping containers, with 48 units in each container. The suture removal kits are sold through distributors to hospitals, emergency clinics and physicians only. The shave prep packs are sold through distributors only to hospitals. In both cases the smallest unit of sale is the container of 48 units. You state that the containers will be marked to show the country of origin of the scissors, the country of assembly of the razors and the country of origin of the plastic containers.


What is the proper country of origin marking for imported disposable suture removal kits and shave prep kits.


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 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. The U.S. Court of International Trade stated in Koru North America v. United States, 701 F.Supp. 229, 12 CIT (CIT 1988), "In ascertaining what constitutes the country of origin under the marking statute, a court must look at the sense in which the term is used in the statute, giving reference to the purpose of the particular legislation involved. The purpose of the marking statute is outlined in United States v. Friedlaender & Co., 27 CCPA 297, 302, C.A.D. 104 (1940), where the court stated that: 'Congress intended that the ultimate purchaser should be able to know by an inspection of the marking on 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."

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 the 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 this part. Therefore, pursuant to 19 CFR 134.1(b), each piece within a kit maintains its own country of origin which must be marked if it is of foreign origin unless the packaging of the pieces together effects a substantial transformation. A substantial transformation occurs when articles lose their identity and become new articles having a new name, character or use. United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 at 270 (1940), National Juice Products Association v. United States, 10 CIT ___, 628 F.Supp. 978 (Ct. Int'l Trade 1986), Koru North America v. United States, 12 CIT ___, 701 F.Supp. 229 (Ct. Intl Trade 1988).

In the case of the suture removal kit, the packaging together of the scissors and forceps and gauze sponge is similar to HQ ruling 731460 (May 26, 1989), which involved the repackaging of imported screwdriver bits with U.S. made screws. In that ruling, the repackaging was held not to be a substantial transformation because the separate items are in their finished form, are not modified or affixed to each other, or combined in a permanent manner. In this case, the scissors and forceps are not permanently changed or combined in any way. The packaging together of the scissors, forceps and gauze is not a substantial transformation. Since the forceps and gauze are not imported, they are not required by 19 U.S.C. 1304 to be marked. However, the scissors are imported and must be marked with their country of origin.

Because the scissors are packaged in a sealed sterile container which is not transparent, the country of origin must be marked so as to inform the ultimate purchaser of the country of origin prior to their making a purchase. Pursuant to 19 U.S.C. 1304(a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR 134.32(d)), Customs excepts from individual marking requirements imported articles for which the marking of the containers will reasonably indicate the origin of the articles. In this case, the suture kits are sold in containers of 48 packaged units only and are not individually sold. Therefore, marking the shipping containers holding 48 units will satisfy 19 U.S.C. 1304 and 19 CFR Part 134.

The shave prep kit is also not substantially transformed by packaging. The disposable razors which are assembled in Mexico of U.S. components must be marked in accordance with section 10.22, Customs Regulations (19 CFR 10.22), which states that assembled articles are considered products of the country of assembly for country of origin marking purposes. Therefore, the disposable razors are considered to be made in Mexico. If the assembled article is made entirely of U.S. materials, the legend "Assembled in ____ from material of U.S. origin" or a similar phrase may be used. For the reasons discussed above in relation to the suture kit, the shave prep kits are entitled to the exception set forth in 19 U.S.C. 1304(a)(3)(D) and 19 CFR 134.32(d) and marking the shipping container will satisfy the marking requirements. The phrase "Assembled in Mexico from material of U.S. origin or a similar phrase will satisfy 19 CFR 10.22.

The plastic container for the suture kits and the shave prep kits, if imported empty to be filled, may be excepted from individual marking pursuant to section 134.24(c)(1), Customs Regulations (19 CFR 134.24(c)(1)), if the outside wrapping or packages containing the containers is clearly marked to indicate the country of origin.


The suture removal kit must be marked to inform the ultimate purchaser of the country of origin of the scissors. Marking the shipping container which contains 48 units which reach the ultimate purchaser will satisfy 19 U.S.C. 1304 and 19 CFR Part 134.

The shave prep kit must be marked to inform the ultimate purchaser of the country of origin of the disposable razors. Marking the shipping container which contains 48 units which will reach the ultimate purchaser will satisfy 19 U.S.C. 1304 and 19 CFR Part 134. The phrase used to mark the shipping container may indicate the razors are made in Mexico of components of U.S. origin.


John Durant

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