MAR-2 OT:RR:NC:1:105
Ms. Iliana Fuller
Manager, Global Trade Compliance
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92612
RE: COUNTRY OF ORIGIN MARKING OF IMPORTED LAP BAND SYSTEM AP
Dear Ms. Fuller:
This is in response to your letters, dated August 4 and October 28, 2008, requesting a ruling on the country of origin marking requirements for the imported Lap Band System AP, Standard AP with Low Profile Access Port II, which are sterilized/inspected/assembled/packed almost entirely from U.S. components in Costa Rica. A marked sample was submitted with your letter for review. The marking does not claim “Made in USA.”
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.
The “country of origin” is defined in 19 CFR 134.1(b) as “the country of manufacture, production, or growth of any article of foreign origin entering the United States. 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; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin.” For tariff purposes, the courts have held that a substantial transformation occurs if a new and different article emerges having a distinctive name, character or use. Anheuser Busch Brewing Association v. The United States, 207 U.S. 556 (1908) and Uniroyal Inc. v. United States, 542 F. Supp. 1026 (1982).
Headquarters non-binding informational letter H021027 ADK, 2-7-08, (not in CROSS), held that preconditioning, sterilization, inspecting, vacuum drying (to stabilize the suture material) and repacking of needled sutures is not a substantial transformation.
From the information in your October 28, 2008 letter, all of the components of the System have been confirmed as being manufactured in the USA with the possible exception of a “Needle, Band Priming.” You show a cost for it that is far below one percent of the total for the components of the System, and it is clear that has a relatively minor function taking the System as a whole.
In this case, the sterilization/inspection/assembly/packing process does not result in a substantial transformation. The assembled Lap Band System AP does not have a distinctive name, character or use different from the unassembled Lap Band System AP , and therefore is a good of the United States for marking purposes. Accordingly, it will not be required to have any country of origin marking pursuant to 19 U.S.C. 1304 when imported into the United States.
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 James Sheridan at (646) 733-3012.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division