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NY I85913

September 18, 2002

CLA-2-30:RR:NC:2:238 I85913


TARIFF NO.: 3002.10.0190; 9802.00.8066

S. Richard Shostak, Esq.
Stein Shostak Shostak & O’Hara
515 South Figueroa Street, Suite 1200
Los Angeles, CA 90071-3329

RE: The tariff classification, country of origin, and country of origin marking of FIRST RESPONSE® 1-Step Ovulation Predictor Test, First Response® Early Result Pregnancy Test, and ANSWER QUICK & SIMPLE® Early Result Pregnancy Test, assembled in and imported from Mexico; ARTICLE 509

Dear Mr. Shostak:

This is in response to your letter dated September 5, 2002, on behalf of your client, Scantibodies Laboratory, Inc., requesting a ruling on the tariff classification and country of origin of FIRST RESPONSE® 1-Step Ovulation Predictor Test, FIRST RESPONSE® Early Result Pregnancy Test, and ANSWER QUICK & SIMPLE® Early Result Pregnancy Test. A sample of each item was submitted with your request.

The three submitted samples consist of in-vitro diagnostic test devices designed for home use and purchased over the counter from most food, drug or mass retailers. The FIRST RESPONSE® 1-Step Ovulation Predictor Test predicts the two days during a woman’s menstrual cycle when she is most likely to become pregnant. According to the product literature, the device detects, by means of antibodies present in the device’s chromatographic test strip, the increased concentration or “surge” of LH (luteinizing hormone) in the urine, which precedes ovulation by 24-36 hours. Since the two most fertile days begin with this LH surge, having intercourse within the next 24-36 hours maximizes the chances of becoming pregnant. The FIRST RESPONSE® Early Result Pregnancy Test, and ANSWER QUICK & SIMPLE® Early Result Pregnancy Test are designed to detect, also by means of antibodies present in the device’s chromatographic test strip, the presence of hCG (human chorionic gonadotropin) in the urine as early as three days before a woman’s expected period. A positive (i.e., “pregnant”) test result indicates that hCG has been detected in the urine, and that the individual should see a physician to confirm that she is, in fact, pregnant. Your client indicates that all the components comprising each test device, namely: the plastic housing and over-cap: the chromatographic test strip containing the (U.S.-produced) antibodies and other reagents; the urine collector (“wick”); the cotton pad (used to collect excess urine not absorbed by the test strip); the dessicant tablet (used to keep the test strip from absorbing moisture from the air during storage); and the foil pouch are fabricated in the United States. §10.12(d) of the Customs Regulations. With respect to the test strip, it is our determination that it is of U.S. origin, since each of the non-originating materials (in this case, the German- or Irish-manufactured nitrocellulose membrane material) has satisfied the changes in tariff classification required under HTSUSA General Note 12(t)/30.3.

Your client further indicates that the aforementioned components are shipped to Mexico, where they undergo a “packaging process” which consists of “placement” of the components into the plastic housings and then sealing the completed devices into the foil pouches for return to the United States for packaging into Scantibodies’ retail packages. Finally, your client indicates that “[I]n the near future, the foil pouches will be placed into the retail packages in Mexico for distribution in the U.S.”

Although you state in your letter that the operations performed in Mexico “[c]learly constitute permissible packaging operations under Subh. 9801.00.10, HTSUS,” it is our determination, pursuant to §10.12 (b) & (d) of the Customs Regulations, that the operations performed in Mexico, namely: the fitting of the test strip, urine collector (“wick”), upstream absorbent (cotton pad), and dessicant tablet into the plastic housing, plus the fitting of the over-cap onto the plastic housing, clearly constitute an assembly operation. Furthermore, in light of this determination, we find that the joining or fitting together of the fabricated U.S. components in Mexico is a qualified assembly operation under subheading 9802.00.80, HTS and, as such, an allowance may be made for the cost or value of the U.S. components, upon compliance with the documentation requirements of §10.24 of the Customs Regulations.

In a letter dated June 10, 2002, marked by you as “Exhibit A,” your client states the following: “The active ingredient of the PTK (Pregnancy Test Kits) and OV (Ovulation Test Kits) products is the test strip covered with a series of reagents. The test strip is composed of a nitrocellulose membrane and a protein-coated paper, which are adhered to a polyester material. A series of four reagents are laid on the strip in a linear fashion and allowed to dry. The reagents include antibodies, which are specific to and bind with the hormone molecules of choice (either hCG or LH). When urine is introduced to one end of the strip, the urine soaks into the paper and allows the molecules to react with the antibody reagents dried onto the strip. The outcome is the appearance of the visual result on the strip. Without the antibody reagent on the test strip, the product would not function” (emphasis added). Accordingly, pursuant to General Rule of Interpretation 3(b), Harmonized Tariff Schedule of the United States (HTS), and Explanatory Notes 3822 and 3002, HTS, the applicable subheading for all three products will be 3002.10.0190, HTS, which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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 of the Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. §134.1(c) of the Customs Regulations defines “Foreign origin” as referring to “[a] country of origin other than the United States .“ Therefore, since an article of U.S. origin is not of foreign origin, it is not subject to the country of origin marking requirements of Part 134 of the Customs Regulations.

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 of the Customs Regulations. The marking requirements of these goods are set forth in Part 134 of the Customs Regulations.

Section 134.45(a)(2) of the Customs 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.

Applying the NAFTA Marking Rules set forth in Part 102 of the Customs Regulations to the facts of this case, we find that §102.11(c) is the rule which must be applied to the imported products. Under this rule, the country of origin of the imported products is the country or countries of origin of all materials that merit equal consideration for determining the essential character of the good. In this case, we find that the essential character is imparted by the (U.S.-produced) antibody reagents. It is, therefore, our determination that the country of origin of the subject products is the United States. As such, they are not subject to the country of origin marking requirements of Part 134 of the Customs Regulations. Finally, you request this office to confirm that the retail packages of the subject products can continue to be marked with your client’s company name and its Santee, California address. Presumably, this is a consequence of compliance with U.S. Food & Drug Administration (FDA) mandates which, pursuant to 21 C.F.R. 201.1, require the identification of the manufacturer or distributor of these products. With respect to any questions you may have concerning the satisfaction of any statutory labelling requirements imposed by and under the jurisdiction of the FDA, we advise you to consult with the FDA on this matter. Accordingly, this ruling is limited solely to a determination of the country of origin and country of origin marking requirements (as determined above), for Customs’ purposes, for the subject products.

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 646-733-3033.


Robert B. Swierupski

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