MAR-2-05 RR:TC:SM 560613 MLR

Stewart K. Hall, Esq.
Selfcare, Inc.
200 Prospect Street
Waltham, MA 02154

RE: Country of Origin Marking on pregnancy test kit; Assembly; Antibodies; Ireland

Dear Mr. Hall:

This is in reference to your letter of July 23, 1997, to Customs in New York requesting a ruling regarding the country of origin marking on an early pregnancy test kit ("test kit"). A sample of the article and test kit literature were submitted with your request.

FACTS:

It is stated that the test kit is designed for home use and indicates whether the user is pregnant by producing a reaction when it comes in contact with a urine sample. The test kit consists of a plastic housing that holds a cellulose strip which is connected to a media that is impregnated with certain antibodies. If the user is pregnant, the antibodies react with the human chorionic gonadotropic hormone present in the woman's urine.

It is stated that the test kit consists of the following components:

Component Origin (1) top housing........................................................U.S. (2) bottom housing..................................................U.S (3) cap..................................................................... U.S. (4) wick....................................................................U.S. (5) 939 paper............................................................U.S. (6) 901 paper............................................................U.S. (7) monoclonal antibody 107 ("MAb 107").............U.S. (an anti-human chorionic gonadotropic monoclonal antibody) (8) monoclonal antibody 105 ("MAb 105").............U.S. (an anti-human chorionic gonadotropic monoclonal antibody (9) control antibody (goat anti-mouse antibody)......U.S. (10) laminate.............................................................U.S. (11) nitrocellulose.....................................................U.S. (12) splash guard.......................................................Ireland (13) 8 millimeter rayon.............................................Germany (14) hydrogen tetra chlorauric hydrate......................U.S.

All of the components are shipped to Ireland for assembly.

It is stated that the critical components of the test kit are the three antibodies which are produced in the U.S. In addition to the assembly, the antibodies shipped to Ireland in liquid form are placed on a solid material. The MAb 105 and control antibody are sprayed onto the nitrocellulose in two thin lines and dried. In a telephone conversation with a member of my staff on October 28, 1997, it was stated that in Ireland the hydrogen tetra chlorauric hydrate is diluted with water to result in chlorauric acid which is then boiled in water and sodium citric acid to result in gold solution of pinkish/purple color. This gold solution is coated with the MAb 107 and dried onto the rayon membrane. It is stated that the purpose of the gold solution is to impart color so that the pregnancy test may be read once the urine reacts with the antibody. The nitrocellulose and rayon are then placed on a laminated paper with the 901 and 939 paper which has been soaked in a detergent solution and dried. These laminates are then cut into 6.9 mm strips. The strips are then assembled into the housing which consists of a top part, a bottom part, and a cap. A wick is added, and the completed sticks are then placed in a foil pouch with a desiccant (both of Irish origin) and sealed.

It is stated that the function of the antibody, to detect the presence of the human pregnancy hormone, is not transformed in the process, but its handling characteristics are merely simplified. It is stated that the antibody in its native state still reacts with the pregnancy hormone in the same way, and the addition of a solid material only simplifies consumer handling.

ISSUE:

Whether the test kit components are substantially transformed by the processes performed in Ireland.

LAW AND ANALYSIS:

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. Congressional intent in enacting 19 U.S.C. 1304 was "that the ultimate purchaser should be able to know by an inspection of the marking on the 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." United States v. Friedlaender & Co. Inc., 27 CCPA 297, 302, C.A.D. 104 (1940).

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 "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 the marking laws and regulations.

For country of origin marking purposes, a substantial transformation of an imported article in the U.S. occurs when it is used in manufacture, which results in an article having a name, character, or use differing from that of the imported article. If such substantial transformation occurs, then the manufacturer is the "ultimate purchaser" of the imported article, and the article is excepted from marking and only the outermost container is required to be marked. See 19 CFR 134.35. On the other hand, if the manufacturing or combining process is merely a minor one which leaves the identity of the imported article intact, a substantial transformation has not occurred and an appropriate marking must appear on the imported article so that the consumer can know the country of origin. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff'd, 702 F.2d 1022 (Fed. Cir. 1983).

In this case it is claimed that placing the MAb 105 and the Control antibody onto the nitrocellulose and the MAb 107 onto a rayon membrane, which are both placed on a laminated paper, and the subsequent assembly of the strips into a plastic housing does not result in a substantial transformation in Ireland. It is alleged that while the antibodies are placed on a solid material, the critical components are the antibodies of U.S. origin that react with the pregnancy hormone.

In National Juice Products Association v. United States, 628 F. Supp. 978 (CIT 1986), the court upheld Customs ruling that manufacturing concentrate used to make frozen concentrated orange juice and reconstituted orange juice was not substantially transformed. The manufacturing concentrate is the "major part of the end product, when measured by cost, value or quantity" and the further processing in the U.S. to make the manufacturing concentrate into frozen concentrated orange juice was considered a minor manufacturing process. The court noted that the imported product was the very essence of the retail product and that the addition of water, orange essences and oils to the concentrate, while making it suitable for retail sale, did not change the fundamental character of the product.

In Headquarters Ruling Letter (HRL) 733248 dated August 22, 1990, Customs considered whether immune serum globulin intravenous ("IGIV"), a human blood fraction, was substantially transformed in Belgium. The IGIV was first made from human blood, collected from U.S. donors, which underwent various precipitating, centrifuging, and filter processes. During these processes, proteins were removed and reagents were added to the plasma, to result in a product known as Immune Globulin (Human) Fraction II paste. It was noted that in this form, with the addition of a diluent, it could be used for intramuscular injection in patients. The Fraction II was then sent to Belgium where it underwent additional filtering, buffering, and other processes to change it from bulk into dosage form which rendered the IGIV fit to be administered intravenously. In HRL 733248, Customs found that while the Belgian processes were necessary to make the product useable in intravenous form, the Fraction II was the major part of the end product and the Belgian processes did not change the fundamental character of the product.

Similarly, in this case it is our opinion that the processes performed before the antibodies are shipped to Ireland are the processes which are more fundamental in creating the function of the pregnancy test kit. It is also stated that the antibody in its native state still reacts with the pregnancy hormone in the same way, and that the addition of the solid material in Ireland only simplifies consumer handling. Additionally, while the gold solution is used to impart color once the test is used so that the user may read the result of the test, we agree that the antibody of U.S. origin itself reacts with the urine sample to yield the result. Accordingly, we find that since the essential character of the test kit is imparted by the antibodies which are of U.S. origin, the placement of the antibodies onto solid materials and the simple assembly thereof into the housing in Ireland do not result in a substantial transformation. Accordingly, since the antibodies are of U.S. origin, we find that the imported test kits are not subject to the country of origin marking requirements of 19 U.S.C. 1304. See also 19 CFR 134.32(m). However, the determination of whether the test kits may be marked "Made in U.S.A." is within the jurisdiction of the Federal Trade Commission, Division of Enforcement, located at Suite 4636, 601 Pennsylvania Ave., NW, Washington, D.C. 20580.

HOLDING:

Based upon the information and sample provided, we find that the placement of U.S.-origin antibodies on solid material and the simple assembly of components does not result in a substantial transformation in Ireland since we find that the U.S.-origin antibodies represent the essential character of the finished test kits. Accordingly, no marking under 19 U.S.C. 1304 will be required on the finished test kits. However, the Federal Trade Commission should be contacted regarding the use of U.S. origin claims.

A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.

Sincerely,

John Durant, Director
Commercial Rulings Division