CLA-2-73:OT:RR:NC:N1:113
Ms. Toni Dembski-Brandl
Stryker
1901 Romence Road Parkway
Portage, MI 49002
RE: The country of origin of instrument sterilization trays
Dear Ms. Dembski-Brandl:
In your letter dated January 30, 2017, you requested a country of origin ruling on instrument sterilization trays. Photographs of the tray and laser punched metal pieces were provided for our review.
The merchandise is identified as surgical instrument sterilization trays used to organize, store and sterilize surgical instruments and implants. In your letter you stated that “The sterilization trays are composed of a metal tray body with plastic dividers to keep surgical instruments in place during sterilization and operating room use. The tray consists of four sides, two handles, instrument holding brackets, and laser engraved diagrams with the name and model number of each instrument necessary for the utility and intended purpose of the surgical tray...The primary utility of the tray is imparted by its final form and shape, a configuration designed to afford maximum utility in the sterilization process and subsequently in the operating room. The tray is covered on all surfaces with holes, which are there primarily for sterilization purposes.” The manufacturing processes performed on the subject merchandise in China include cutting the sheet metal into outlines and laser punching to create holes. The laser punched metal pieces are then deburred, or buffed, to smoothen the sides and the resulting metal pieces are exported to Poland. The manufacturing processes performed on the flat metal pieces in Poland include bending each of the sides upwards into a 90 degree angle, placing the plastic handles on the sides of the tray, and spot welding the handles and bent sides together. The tray body is then e-polished in Germany. The tray is returned to Poland where plastic corners and shields are assembled onto the tray with rivets. The bottom base of the tray is engraved to mark the outlines and labels of the instrument placements. The plastic brackets are inserted into the tray body and secured in place with screws. The tray is inspected to ensure that the brackets are properly positioned and the tray is then exported back to Germany, where it is assembled with a lid, packaged, and labeled for sale.
As stated in HQ 735009 dated July 30, 1993, “The country of origin is the country where the article last underwent a substantial transformation, that is, processing which results in a change in the article's name, character, or use.” Customs and Border Protection (CBP) maintains, based on United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (C.A.D. 98) (1940), that “A substantial transformation occurs when an article emerges from a manufacturing process with a name, character, and use that differs from the original material subjected to the processing.”
You noted in your ruling request that Customs has generally held that bending materials to defined shapes suitable for use in making finished articles constitutes substantial transformation. In HQ 557159 dated January. 11, 1994, Customs stated that “merely cutting to length and width, as opposed to cutting to length and/or width and bending and/or forming to shape, does not constitute a substantial transformation.” In HQ 555811 dated March 20, 1992, Customs determined that die cutting, stamping and shaping operations transform aluminum flat stock into new and different articles of commerce. In HQ H119218 dated October 13, 2010, where further manufacturing involved bending and a further assembly of parts, CBP concluded that the combination of processes constituted substantial transformation.
With regard to the merchandise at issue, it is the opinion of our office that the laser punched metal pieces that are exported from China to Poland lack the functionality that are present in the completed trays and do not have the essential character of the surgical instrument sterilization trays. We believe that the further manufacturing processes performed in Poland constitute a substantial transformation of the article into a new or different article of commerce. The bending, welding, assembly and marking operations that are performed in Poland result in new articles in which the name changes from flat metal pieces/plates to surgical instrument sterilization trays. Therefore, it is our opinion that the country of origin of the surgical instrument sterilization trays is Poland.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 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 Ann Taub at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division