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HQ 733325

August 8, 1990

MAR-2-05 CO:R:C:V 733325 KG


Dale O. Torrence, Esq.
1331 Pennsylvania Avenue, N.W.
Suite 1200F
Washington, D.C. 200004

RE: Country of origin marking of imported intravenous drip sets; sterilized containers; 19 CFR 134.32(d); 19 CFR 134.36(b).

Dear Mr. Torrence:

This is in response to your letter of May 1, 1990, requesting a country of origin ruling on behalf of Abbott Laboratories, regarding imported intravenous drip sets assembled in the Dominican Republic.


The various components, subassemblies and packing materials that are used to make this product will be of U.S. origin. The following operations are performed in the Dominican Republic:

(1) A predetermined length of tubing is dispensed into a coiling cup and the paper band is used to keep the coiled piece of tubing in proper configuration.

(2) The CAIR clamp is then manually assembled to the tubing.

(3) The piercing pin assembly is solvent bonded to the previous assembly.

(4) The flashback assembly is solvent bonded to the other end of the PVC tubing.

(5) The finished I.V. set is then placed into a pre-printed 2 1/2 by 5 3/4 inch individual carton.

The individual cartons containing one I.V. set each will be labeled "Abbott Laboratories" or "Abbott Laboratories, North Chicago, IL 60054, USA." Forty eight individual sets are packaged in a corrugated box (the outer container) which is labeled "Abbott Laboratories, North Chicago, Il. 60064, USA" and "Assembled in the Dominican Republic." The outer containers are then shipped to Puerto Rico where the I.V. sets are sterilized by an irradiation process while still in the outer containers.

After sterilization, the outer containers are shipped to the U.S. where the 48 unit I.V. sets will be sold to U.S. hospitals and clinics in their outer containers marked as described above. The I.V. sets will be used by the hospitals and clinics and disposed of following their one-time use.


Whether the I.V. sets, described above, satisfy the country of origin marking requirements.


Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or 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 Court of International Trade stated in Koru North America v. United States, 701 F.Supp. 229, 12 CIT (CIT 1988), that: "In ascertaining what constitutes the country of origin under the marking statute, a court must look at the sense in which the term is used in the statute, giving reference to the purpose of the particular legislation involved. The purpose of the marking statute is outlined in United States v. Friedlaender & Co., 27 CCPA 297 at 302, C.A.D. 104 (1940), where the court stated that: "Congress intended 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."

Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. If the words "United States," or "America," the letters "U.S.A.," any variation of such words or letters, or the name of any city or locality in the U.S., or the name of any foreign country or locality other than the country of origin, appears on an imported article in such a way as to be misleading to the ultimate purchaser, special marking requirements are triggered. Section 134.46, Customs Regulations (19 CFR 134.46), requires that in such case, the name of the country of origin must appear legibly, permanently, and in close proximity to such words, letters, or name, and in at least a comparable size, preceded by "Made in,""Product of," or other words of similar meaning. Further, section 10.22, Customs Regulations (19 CFR 10.22), provides that assembled articles entitled to the exemption set forth at subheading 9802.00.80, Harmonized Tariff Schedule of the United States ("Subheading 9802.00.80"), are considered products of the country of assembly for the purposes of the country of origin marking requirements. If an imported assembled article is made entirely of American-made materials, the U.S. origin of the material may be disclosed by using a legend such as "Assembled in _____ from material of U.S. origin," or a similar phrase.

It appears from the facts presented, that the imported I.V. sets may be entitled to the exemption set forth at subheading 9802.00.80. If these I.V. sets are entitled to the exemption set forth at subheading 9802.00.80, the marking "Assembled in the Dominican Republic" would be in accordance with 19 CFR 10.22. Further, if the marking "Assembled in the Dominican Republic" appears conspicuously and in close proximity everywhere that the U.S. address appears on the outer containers in which the 48 I.V. sets are packaged, the provisions of 19 CFR 134.46 would be satisfied.

Section 134.1(d), Customs Regulations (19 CFR 134.1(d)), defines the ultimate purchaser as generally the last person in the U.S. who will receive the article in the form in which it was imported. The definition then gives examples of who might be the ultimate purchaser if the imported article is used in manufacture, if the imported article is sold at retail in its imported form and if an imported article is distributed as a gift. If an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser.

In this case, the hospitals and clinics purchase these I.V. drip sets at retail in their imported form for their own use. Therefore, these hospitals and clinics are the ultimate purchasers of the imported I.V. drip sets. They purchase them in the corrugated boxes which contain 48 units of the I.V. drip sets.

Pursuant to 19 U.S.C. 1304(a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR 134.32(d)), Customs excepts from individual marking requirements imported articles for which the marking of the containers will reasonably indicate the origin of the articles. The exception set forth in 19 U.S.C. 1304(a)(3)(D) and 19 CFR 134.32(d) applies in cases where the article is imported in a properly marked container and Customs officials at the port of entry are satisfied that the ultimate purchaser will receive it in its original unopened marked container.

The hospitals and clinics receive the 48-unit containers in sealed sterilized boxes which are marked with the country of origin. Particularly in this case where it is necessary that the imported item be sterile and the item is sterilized within the Customs territory of the U.S. in the sealed box in which it is imported, the imported article is entitled to the exception set forth at 19 U.S.C. 1304(a)(3)(D) and 19 CFR 134.32(d). However, section 134.36(b), Customs Regulations (19 CFR 134.36(b)), states that an exception from marking shall not apply to any article or retail container bearing any words, letters, names, or symbols described in 19 CFR 134.46 or 19 CFR 134.47 which imply that an article was made or produced in a country other than the actual country of origin. Therefore, if the U.S. address of Abbott Laboratories is printed on the individual cartons containing each I.V. set, the country of origin must also appear on the individual carton.


The proposed marking described above for the imported I.V. sets assembled in the Dominican Republic would satisfy the provisions of 19 U.S.C. 1304 and 19 CFR Part 134. However, if the U.S. address of Abbott Laboratories is printed on the individual carton containing each I.V. set, in accordance with 19 CFR 134.36(b), the country of origin must also appear on the individual carton.


Marvin M. Amernick
Chief, Value, Special Programs

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