CLA-2-39:OT:RR:NC:N4:415
Steve Fodor
Customs Services & Solutions, Inc.
6576 Church Street
Douglasville, GA 30134
RE: The country of origin of medical instrument covers from Cambodia.
Dear Mr. Fodor:
In your letter dated November 14, 2023, you requested a country of origin ruling on behalf of your client, Advance Medical Designs.
Images were provided in lieu of samples. There are three articles under consideration. They are all medical instrument covers made from polyethylene plastic film/sheeting.
The first product is described as a “C-Arm drape,” item number 07-CA104STF. It measures 42 inches in width by 72 inches in length. This item will serve as a cover for a C-arm medical instrument.
The second and third products are both described as a “PE probe cover,” item numbers 20-P3D548ST and 20-P3D648ST, respectively. Item 20-P3D548ST measures 5 inches in width by 48 inches in length and 20-P3D648ST measures 6 inches in width by 48 inches in length. These will serve as covers for optical telescopic medical instruments.
Per your submission and follow up correspondence, the polyethylene covers/bags are manufactured in Cambodia with the Cambodian origin film/sheeting produced from colloidal material sourced from China. Assorted tape, stickers, and packaging are also produced in China and sent to Cambodia to be applied to the covers/bags and package them for sterilization, which occurs in China.
Pursuant to Part 134, Customs Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 USC 1304. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines “country of origin” as: “[t]he 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.” A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
In order to determine whether a substantial transformation occurs when components are assembled into completed products, all factors such as the components used to create the product and manufacturing processes that these components undergo are considered in order to determine whether a product with a new name, character, and use has been produced. No one factor is decisive, and assembly/manufacturing operations that are minimal will generally not result in a substantial transformation.
This office reviewed the provided documentation, including the step-by-step assembly guide, and is of the opinion that no substantial transformation is required as the covers are manufactured in Cambodia from Cambodian produced plastic film/sheeting, thus, these covers would be products of Cambodia. The assorted Chinese components merely enhance the covers and would not alter the essential character that they impart, General Rule of Interpretation 3(b) noted.
Further, you questioned whether the sterilization process in China would alter the country-of-origin of these products. We point you to HQ 561167, dated December 14, 1998, which stated those articles “do not undergo a substantial transformation as a result of the sterilization process ….” As such, despite these being sterilized in China, they would remain Cambodian in origin and we would hold no objections if you decided to mark these products “Made in Cambodia, Sterilized in China.”
With regard to the appropriate country of origin marking of these medical instrument covers, section 304, Tariff Act of 1930, as amended (19 USC 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.
As provided in 19 CFR 134.41(b), the country-of-origin marking is considered conspicuous if the ultimate purchaser in the U.S. can find the marking easily and read it without strain.
Regarding the permanency of a marking, 19 CFR 134.41(a) provides that, as a general rule, marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, 19 CFR 134.44 generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser, unless deliberately removed, is acceptable.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR 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 Kristopher Burton at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division