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NY C88992

July 1, 1998

MAR-2 RR:NC:2:238 C88992


Judith A. Lee, Esq.

Gibson, Dunn & Crutcher LLP

1050 Connecticut Avenue, N.W.

Washington, DC 20036-5306


Dear Ms. Lee:

This is in response to your letter dated June 8, 1998, requesting a ruling, on behalf of your clients, Continental Lab Products, Inc., and Quidel Corporation, on the country of origin marking requirements for two imported pregnancy tests, namely: Precise® One-Step Pregnancy Test and RapidVue® 1-Step Pregnancy Test, which are assembled from U.S. components in a NAFTA country. A marked sample of each test was submitted with your letter for review. It is noted that this office ruled, in NY C86217, dated April 22, 1998, that, pursuant to Note 3(b) of the General Rules of Interpretation, HTSUS, the two subject products were properly classifiable within subheading 3002.10.0090, HTS, which provides for: "Antisera and other blood fractions, and modified immunological products, whether or not obtained by means of biotechnological processes: Other," with a general rate of duty of free.

The two submitted samples, Precise® One-Step Pregnancy Test and RapidVue® 1-Step Pregnancy Test, consist of in-vitro diagnostic test kits, designed for home use, which indicate whether the user is pregnant, by producing a reaction when it comes in contact with a urine sample. According to the product literature, the tests are designed to detect, by means of various antibodies contained in the kits, the presence of hCG (Human Chorionic Gonadotropin), which begins to appear in the urine as early as the first day of a missed period. If the test result is positive, hCG has been detected in the urine, and the individual can assume that she is pregnant. The Precise® test kit contains two test cassettes (each in a sealed foil packet); two droppers; and two plastic cups (i.e., supplies needed to carry out two tests). The RapidVue® test kit contains one test device, put up in a sealed, foil packet.

You state in your letter that all the components of both pregnancy tests, namely: (1) the coded test strip, (2) the drying agent, (3) the plastic housing enclosing the test strip and the drying agent, (4) the foil pouch enclosing the plastic housing, and, (5) in the case of the Precise® test kit, the droppers and plastic cups, are manufactured in the United States. You also state that, under the proposed NAFTA transaction, all of the components, including the final retail packaging material of the test kits, would be sent to Mexico, where: (1) the coded strip and drying agent would be inserted into the plastic housing, (2) the plastic housing covering the strip would be inserted into the foil pouch, and (3) the foil pouch would be inserted into the final (i.e., outer) retail packaging material for shipment to the United States. With respect to the Precise® test kit, you state that the droppers and plastic cups would also be included in the outer retail packaging as part of the kit. Finally, you indicate that, although, in general, the pregnancy test kits will be imported into the United States completely assembled and packaged in the outer retail packaging material, on occasion, the tests may be shipped to the United States in bulk in the foil pouches, where they will then be put up into the final packaging material.

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 the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134, Customs Regulations (19 C.F.R. Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. §1304.

The country of origin marking requirements for a "good of a NAFTA country" are also determined in accordance with Annex 311 of the North American Free Trade Agreement ("NAFTA"), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102, Customs Regulations. The marking requirements of these goods are set forth in Part 134, Customs Regulations.

Section 134.45(a)(2) of the regulations, provides that "a good of a NAFTA country may be marked with the name of the country of origin in English, French or Spanish. Section 134.1(g) of the regulations, defines a "good of a NAFTA country" as an article for which the country of origin is Canada, Mexico or the United States as determined under the NAFTA Marking Rules.

In this case, you state that U.S. components are exported to a NAFTA country where they are assembled prior to being re-
imported into the U.S.

The rules for determining when, for marking purposes, the country of origin of an imported good is one of the parties to "NAFTA" are set forth in Part 102, Customs Regulations.

Part 102 of the regulations, sets forth the "NAFTA Marking Rules" for purposes of determining whether a good is a good of a NAFTA country for marking purposes. Section 102.11 of the regulations, sets forth the required hierarchy for determining country of origin for marking purposes.

Applying the NAFTA Marking Rules set forth in Part 102 of the regulations to the facts of this case, we find that the imported products are goods of the United States for marking purposes. Accordingly, they 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 181 of the Customs Regulations (19 C.F.R. Part 181).

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 212-466-5770.


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