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NY M80122

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February 24, 2006

MAR-2 RR:NC:MM:114 M80122

CATEGORY: MARKING

Mr. Robert Basinski
CooperVision
370 Woodcliff Drive
Suite 200
Fairport, New York 14450

RE: COUNTRY OF ORIGIN MARKING FOR CONTACT LENSES

Dear Mr. Basinski:

This is in response to your letter dated January 20, 2006 requesting a ruling on the country of origin marking requirements for contact lenses that are imported from the United Kingdom. Samples were submitted with your letter for review. In your letter, you requested that confidential treatment be given. Your request for confidential treatment was reviewed and denied. A letter regarding this matter was sent to you on February 9, 2006. In a letter dated February 14, 2006, you stated that your request for confidential treatment has been withdrawn.

CooperVision, Inc. produces dry contact lenses in a manufacturing facility in Norfolk, Virginia. The dry contact lenses are produced from a polypropylene monomer solution. A specially designed injection-molding machine produces a plastic male and female mold. The monomer solution is poured between the plastic male and female mold to produce the dry contact lens on the end of the male mold. This is referred to as “cast molding”. The cast molded dry contact lenses have the required optical properties of contact lenses. No polishing procedures are required.

Once the molding process is completed, the plastic molds containing the dry contact lenses are shipped to a manufacturing facility in the United Kingdom. In the United Kingdom, the male mold will be removed from the female mold, and the dry contact lens will be removed from the end of the male mold. The plastic molds are then discarded. The dry lenses are placed on trays and hydrated in a special solution which gives the contact lenses a soft, pliable consistency and reacts with the dry plastic lens to allow for oxygen admissibility. The hydrated lenses are heated to a specified temperature for sterilization purposes and placed in plastic blister tubs that contain a saline solution to keep the lenses hydrated. The blister tubs are sealed and placed in cardboard packages of three or six.

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. AnheuserBusch Brewing Association v. The United States, 207 U.S. 556 (1908) and Uniroyal Inc. v. United States, 542 F. Supp. 1026 (1982).

In this case, the processing in the United Kingdom does not result in a substantial transformation. The finished contact lenses do not have a distinctive name, character or use different from the dry contact lenses, and therefore the contact lenses are a product of the United States for marking purposes. Accordingly, the contact lenses will not be required to have any country of origin marking pursuant to 19 U.S.C. 1304 when imported into the United States.

For your information, the Federal Trade Commission has jurisdiction over whether or not goods can be marked “Made in the U.S.A.” and should be contacted in regard to that question.

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 Barbara Kiefer at 646-733-3019.

Sincerely,

Robert B. Swierupski
Director,

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