MAR-02 RR:TC:SM 560561 MLR
Richard O. Wood, Esq.
Burditt & Radzius, Chartered
333 West Wacker Drive
Suite 2600
Chicago, IL 60606-1218
RE: Country of origin marking for convenience kits of medical devices; container labels; numerical code
Dear Mr. Wood:
This is in reference to your letter of July 11, 1997, requesting a ruling on behalf of your client, concerning the country of origin marking requirements for certain convenience kits of medical devices.
FACTS:
The goods at issue are convenience kits containing medical devices. It is stated that your client purchases various medical components needed for a given medical procedure and assembles them into a single tray which is sealed, sterilized, and sold to hospitals or health-related institutions. The components for these kits may be more than 100 in number and may originate in many different countries. Furthermore, the source of the components may change depending on price, availability, etc.
On the outside of the sealed kit, a label will list the components included inside the kit, for example syringe, needle holder, needle, scalpel, gauze sponges, etc. For those components which are not of U.S. origin, your client wishes to identify the country of origin of the component by placing a number after the description of the component. A chart on the outside of the kit will match the number to a particular country.
For example:
1 Needle Holder
1 Needle
2 Gauze Sponges
Some countries that are listed in the chart, however, will not be represented by the components included in a particular kit depending on price, availability, etc. Additionally, the countries listed in the chart may change from time to time. It also appears from the submitted photocopy of the proposed packaging that the list, chart, and distributor's address will be on the same side and surface of the packaging.
ISSUE:
Whether it is acceptable to indicate the country of origin of the components of the kit by using numbers which represent a particular country as indicated on a chart on the outside of the convenience kits.
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. Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.
Pursuant to 19 U.S.C. 1304 (a)(3)(D) and 19 CFR 134.32(d), an exception from individual marking is applicable where the marking of a container of such article will reasonably indicate the origin of the article. This exception is normally applied 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 the original unopened marked container. Relevant factors regarding whether an article is likely to remain in its original container include the chain of distribution, the type of container, and the nature of the article.
In this case, we find that an exception from marking the individual components should be allowed pursuant to 19 CFR 134.32(d), as it is highly unlikely that the components will be removed from their sterile trays before they reach the ultimate purchaser.
In regard to whether the coding system proposed is an acceptable means of identifying the foreign country of origin of the components in the marking of the containers, in HRL 735268 dated October 1, 1993, Customs considered intravenous sets packaged one set to a plastic pouch, forty pouches to a master carton, and four master cartons to a shipping carton. Both the shipping cartons and the master cartons were marked with the country of origin. The individual intravenous pouches indicated a U.S. address, and pointed to a lot code for the country of origin. The intravenous sets were only to be sold to the ultimate purchasers in the master cartons, and no intravenous sets were supposed to be taken out of the master carton and sold separately. It was found that since the master cartons were properly marked to indicate the country of origin of the intravenous sets, the ultimate purchaser would be advised of the country of origin, and, therefore, the individual intravenous sets were excepted from marking under 19 U.S.C. 1304(a)(3)(D) and 19 CFR 134.32(d). Furthermore the reference on the individual pouches to the lot number for the country of origin was determined to satisfy the requirements of 19 U.S.C. 1304 and 19 CFR Part 134 because the ultimate purchasers would not be misled by the U.S. address as the intravenous sets were only received in the properly marked master carton and the lot code printed on the individual pouches explained how to determine the country of origin.
In this case, it is our opinion that the proposed numerical coding system satisfies the requirements of 19 U.S.C. 1304 as the ultimate purchaser will be able to identify where each component originates by referring to the list of components and the numerical chart. Furthermore, since it also appears that the list of components and chart will be on the same side and surface as the distributor's address, we find that the requirements of 19 CFR 134.46 will be satisfied, provided the chart is in the same size as the distributor information. Section 134.46, Customs Regulations (19 CFR 134.46) requires the name of the country of origin preceded by "Made in," "Product of", or other words of similar meaning to be in close proximity and in at least a comparable size to the name of any city or locality appearing on the article which is not the country of origin of the article. Customs has ruled that in order to satisfy the close proximity requirement, the country of origin marking must generally appear on the same side(s) or surface(s) in which the name of the geographical reference other than the country of origin appears. Please note that 19 U.S.C. 1304 does not require labeling of U.S. origin articles; however, whether and how retail containers may be marked to indicate the U.S. origin of an article is a matter to be decided by the Federal Trade Commission and we suggest that you contact that agency for a determination concerning the use of the phrase "Product of U.S. origin." Customs, however, has no objection over the use of this phrase.
HOLDING:
Based on the facts presented, we find that the an exception from marking the individual components should be allowed pursuant to 19 CFR 134.32(d), as it is highly unlikely that the components will be removed from their sterile trays before they reach the ultimate purchaser. Moreover, it is our opinion that the proposed coding system will satisfy the requirements of 19 U.S.C. 1304 as the ultimate purchaser will be able to identify where each component originates by referring to the list of components and the numerical chart.
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
Tariff Classification Appeals Division