HQ 562632 - Request for binding ruling regarding country of origin marking requirements applicable to imported surgical instruments; sealed containers; adhesive stickers; 19 CFR 134.43(a); 19 CFR 134.32(d); - United States International Trade Commision Rulings

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HQ 562632

February 26, 2003

MAR-05 RR:CR:SM 562632 KKV

CATEGORY: MARKING

Kimberly A. Carlson, Esq.
Mark S. Zolno, Esq.
Katten Muchin Zavis Rosenman
525 West Monroe Street
Suite 1600
Chicago, IL 60661-3693

RE: Request for binding ruling regarding country of origin marking requirements applicable to imported surgical instruments; sealed containers; adhesive stickers; 19 CFR 134.43(a); 19 CFR 134.32(d);

Dear Ms. Carlson and Mr. Zolno:

This is in response to your letter dated January 15, 2003, on behalf of Cardinal Health 200, Inc. (hereinafter “Cardinal”), which requests a binding ruling regarding the country of origin marking requirements applicable to imported surgical instruments.

FACTS:

You state that Cardinal intends to produce stainless steel surgical instruments abroad and sell them to hospitals in the U.S. in clear polybags, clam shells or cardboard boxes. Rather than permanently etching the country of origin on each instrument, Cardinal proposes to mark the sealed container in which the instruments will be sold with an adhesive label marked with the country of origin. No information has been provided regarding the manner in which the instruments are packaged and/or marked upon importation into the U.S.

LAW AND ANALYSIS:

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 United States 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 United States 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., 27 C.C.P.A. 297, 302 (1940).

Part 134 of the Customs Regulations implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates that the ultimate purchaser in the United States must be able to find the marking easily and read it without strain.

Articles for which the marking of the containers will reasonably indicate the origin of the article are excepted from marking under 19 U.S.C. 1304(a)(3)(D). For an exception to be granted under 19 U.S.C. 1304(a)(3)(D), generally the article must be imported in a marked retail container which will reach the ultimate purchaser unopened. See also 19 CFR 134.32(d). 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.

In the facts presented here, the surgical instruments are sold in their imported form by distributors solely to hospitals for their own use. In such circumstances, Customs has held that it is the hospital, not the employees or patients, that is the ultimate purchaser of such articles. See Headquarters Ruling Letter (HRL) 733678, dated August 30, 1990 (hospitals and hospital supply distributors were the ultimate purchasers of imported surgical towels to be used by them) and HRL 734742, dated December 9, 1992 (hospital prcurement office, not hospital employees, was the ultimate purchasers of imported latex gloves used on the premises).

Section 134.43(a) requires that certain types of articles be marked in a specified manner. Surgical instruments are specifically identified in this regulatory provision as articles that shall be marked legibly and conspicuously by die stamping, castinthemold lettering, etching, or engraving. Although surgical instruments are subject to the special marking requirements of 19 CFR 134.43(a), Customs has previously ruled that such articles may be excepted from individual marking if the marking of their containers will satisfy the requirements of 19 CFR 134.32(d). See Headquarters Ruling Letter (HRL) 559588, dated March 6, 1996; and HRL 559388, dated February 13, 1996. See also, HRL 735378, dated February 10, 1995; HRL 558800, dated January 26, 1995; HRL 734703, dated December 2, 1992; HRL 733301, dated August 8, 1990; and HRL 732437, dated October 4, 1989.

No information has been provided regarding the marking of the containers in which the surgical instruments will be imported into the U.S. In the event that the instruments are imported into the U.S. in bulk in properly marked containers, and subsequently repackaged into polybags, clam shells or cardboard boxes for sale to hospitals, the certification procedures of 19 CFR 134.26 will be applicable. However, if the outermost containers are not properly marked with the country of origin of the surgical instruments contained within, the procedures of 19 CFR 134.34 will apply.

HOLDING:

Based upon the information provided, the surgical instruments may be excepted from individual marking and the special marking requirements of 19 CFR 134.43 pursuant to 19 CFR 134.32(d), provided that Customs officials at the port of entry are satisfied that the surgical instruments will reach the ultimate purchaser, the hospitals, in sealed polybags, clam shells or cardboard boxes that are properly marked with an adhesive sticker that indicates the country of origin of the instruments contained within.

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

Sincerely,

Myles B. Harmon

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