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NY N025454

April 22, 2008

MAR-2 OT:RR:E:NC:2:238


Ms. Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury
1735 Post Road, Suite 4
Fairfield, CT 06824


Dear Ms. Abraham:

This is in response to your letter dated March 31, 2008, requesting a ruling on behalf of your client, Johnson & Johnson Consumer Product Company, on the acceptable country of origin marking for imported E.P.T. Pregnancy Test Kits. A marked sample was not submitted with your letter for review.

The E.P.T. Pregnancy Test Kit is designed for home use and indicates whether the user is pregnant by producing a reaction when certain antibodies contained in the test kit come into contact with the “pregnancy hormone” (human chorionic gonadotropic hormone, “HCG”) contained in the urine. The kit consists of a digital optical reader and plastic housing that holds a strip of nitrocellulose membrane that is impregnated with the antibodies.

According to your submission, the antibodies are produced in the United Kingdom. They are shipped to China where they are applied to the nitrocellulose membrane and made into strips. The strips, digital reader and plastic housing are manufactured in China and hand assembled together. They are placed in foil pouches (foil made in Sweden) and shipped from China to the United States where they are further packaged, wrapped and labeled. The secondary packaging components (cartons, shippers, inserts, labels and individual wrap) are all made in the United States.

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 United States 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.

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) 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." A substantial transformation occurs when articles lose their identity and become articles having a new name, character or use. United States v. Gibson-Thomsen Co., 27 CCPA 267 at 270 (1940), National Juice Products v. United States, 10 CIT 48, 628 F. Supp. 978 (CIT 1986).

Section 134.1(d) defines the ultimate purchaser as the last person in the United States who will receive the article in the form in which it was imported. Furthermore, at Section 134.1(d)(3): “If an article is to be sold at retail in its imported form, the purchaser at retail is the “ultimate purchaser.”

We agree with your contention that the essential character of the E.P.T. Pregnancy Test Kit is imparted by the antibodies made in the United Kingdom. You also suggest in your letter that the placing of the antibodies on the nitrocellulose membrane strips and the subsequent assembly of the strips into the plastic housing does not constitute a substantial transformation. The antibodies are not altered in any way and are not transformed into a new article with a new name or a new use. They do not lose their identity. They are simply assembled into a housing that is primarily provided to allow ease of handling for the user. The history of administrative and court decisions regarding substantial transformation supports your contention that the antibodies are not transformed enough or at all during the assembly process in China to render them products of China. We agree that the country of origin of the E.P.T. Pregnancy Test Kit is the United Kingdom. Since the individual test kits will be imported in a foil pouch, marking the pouches with the correct country of origin of the contents in accordance with the general provisions of C.R. 134.41 would be sufficient to satisfy the conditions of C.R. 134.11.

In the scenario you describe, the foil pouches will be further packed in the United States by the importer. The wrapping, packing and labeling undertaken in the United States is also not associated with any substantial transformation. There is no effect on the country of origin. The nature of the imported merchandise is such that the ultimate purchaser will be the purchaser at retail (C.R. 134.1(d)(3)). Therefore, it is our opinion that, if the foil pouches are properly marked at the time of importation, the repacking triggers the requirements of 19 C.F.R. 134.26(a), which states that: “If an article subject to these requirements is intended to be repacked in retail containers after its release from CBP’s custody, or if the port director having custody of the article, has reason to believe that such article will be repacked after its release, the importer shall certify to the port director that, if the importer does the repacking, he shall not obscure or conceal the country of origin marking appearing on the article, or else the new container shall be marked to indicate the country of origin of the article, or, if the article is intended to be sold or transferred to a subsequent purchaser or repacker, the importer shall notify such purchaser or transferee, in writing, at the time of sale or transfer, that any repacking of the article must conform to these requirements.”

Finally, should the repacking in the United States result in the use of labels containing any reference to a geographic location (e.g., the address of the importer) other than the actual country of origin of the kits, the special provisions of C.R. 134.46 may apply. Section 134.46 provides that: “In any case in which the words ‘United States,’ or ‘American,’ the letters ‘U.S.A.,’ any variation of such words or letters, or the name of any city or location in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced appear on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin of the article, there shall appear legibly and permanently in close proximity to such words, letters or name, and in at least a comparable size, the name of the country of origin preceded by ‘Made in,’ ‘Product of,’ or other words of similar meaning.” CBP has previously ruled that in order to satisfy the "close proximity" requirement, the country of origin marking must appear on the same sides(s) or surface(s) in which the name of the locality other than the country of origin appears.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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