HQ 0731002 - Country of origin marking requirements applicable to orthopedic implants and fixators - United States International Trade Commision Rulings

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HQ 731002

October 31, 1989

MAR-2-05 CO:R:C:V 731002 jd

CATEGORY: MARKING

Ms. Loredana Pollonio-Lister
President
Lima International Corporation
44 Amaral Street
East Providence, Rhode Island 02915

RE: Country of origin marking requirements applicable to orthopedic implants and fixators

Dear Ms. Pollonio-Lister:

This is in response to your letter of January 14, 1988 (resubmitted on November 15, 1988), requesting a ruling on the application of country of origin marking requirements to orthopedic implants and fixators. We regret the delay in responding and your patience has been much appreciated.

FACTS:

Your company imports orthopedic products from Italy. Sample catalog pages depict various products such as prosthetic devices for resectioning bones, and fixators for properly aligning and holding in place broken bones being repaired. Where possible, the manufacturer's name and stock number are marked on pieces by means of a laser beam. It appears from the catalog pages that these articles are grouped according to their intended application, e.g., all pieces necessary to set a broken leg bone are assembled on a metal tray, and the metal tray is contained in a metal box. Some small pieces are in plastic pouches and the pouch is imprinted with the country of origin of its contents.

You have asked several questions relative to the marking of these articles: is laser beam marking of the word "ITALY" on these articles an acceptable method of marking; would it be appropriate to mark "ITALY" only on the boxes holding the trays; must all the items be marked;and where marking of small pieces would be impossible or present significant difficulties, may an exception from marking be granted?

We add to this list of issues an inquiry into who is the ultimate purchaser of these articles. Our resolution to that issue makes it clear that the question of the sufficiency of marking the metal box holding the trays is the only remaining point needing attention.

ISSUES:

Who is the ultimate purchaser of orthopedic implants and fixator devices?

If various pieces of an orthopedic implant kit are grouped together and packaged on a metal tray, such metal tray then placed in a metal box, is country of origin marking on the metal box sufficient for purposes of 19 U.S.C. 1304?

LAW AND ANALYSIS:

Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), requires that, unless excepted, every article of foreign origin (or its container) 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. Section 134.1(d), Customs Regulations (19 CFR 134.1(d)), defines ultimate purchaser as "generally the last person in the U.S. who will receive the article in the form in which it was imported."

Section 134.32, Customs Regulations (19 CFR 134.32), sets forth a list of circumstances which except articles from the requirement that they be individually marked. One such circumstance of relevance to the implants and fixators under consideration is { 134.32(d), "[a]rticles for which the marking of the containers will reasonably indicate the origin of the articles".

Section 134.43, Customs Regulations (19 CFR 134.43), lists various classes and kinds of articles which under provisions of the Tariff Act of 1930 were required to be marked by certain methods. One class of articles listed is "surgical instruments." The current Customs Regulations do not list Harmonized Tariff Schedule heading numbers, but previous editions of the regulations listed Tariff Schedules of the United States (TSUS) item number 709.56, "Bone and joint prostheses, bone plates, screws, and nails, and other internal fixation devices and appliances" as surgical instruments subject to specific marking method requirements. We mention these provisions here for sake of completeness, and for instances in the future when orthopedic implants and fixators might be imported not packaged as in the present circumstance. However, the special marking provisions of { 134.43 are subject to the general statutory exception available under 19 U.S.C 1304(a)(3)(D), implemented as { 134.32(d), Customs Regulations.

Congressional intent in enacting the marking law, as explained in United States v. Friedlander & Co., 27 C.C.P.A. 297 at 302 (1940), 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."

It is the opinion of this office that the doctor, surgeon or other medical professional that implants or affixes these medical appliances in or on a patient is the ultimate purchaser of the implant or fixator. These professionals are the parties involved capable of using the disclosure of country of origin of a medical appliance in making an informed decision to use or not use a particular implant or fixator. Provided the metal box will remain with the appliance until receipt by the ultimate purchaser (which appears very likely since the box is made of metal and is customized to securely hold its contents), country of origin marking appearing on the outside of the box indicating the contents are of Italian origin is sufficient for purposes of 19 U.S.C. 1304.

This determination is supported by resort to { 134.1(d), Customs Regulations which states the ultimate purchaser of an article is the last person in the U.S. to receive it in the form in which it was imported. By the time a patient "receives" an implant or fixator it has been subjected to a highly sophisticated assembly process and the separate pieces have been merged into a functioning medical appliance.

HOLDING:

Country of origin marking on the outside of a metal box indicating the origin of the orthopedic implants or fixators contained in the box will satisfy the requirements of 19 U.S.C. 1304. If the U.S. address of the distributor of these products appears anywhere on the box, the country of origin disclosure must appear in close proximity and in comparable size lettering to that U.S. address.

Sincerely,

Marvin M. Amernick

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