CLA-2-90:OT:RR:NC:N3:135
Ms. Diana Covarrubias
Cardinal Health
#1 Butterfield Trail
El Paso, TX 79906
RE: The country of origin and marking of hypodermic safety needles
Dear Ms. Covarrubias:
In your letter dated May 5, 2021, you requested a country of origin and marking ruling. A marked sample was not submitted with your letter for review.
The products under consideration are hypodermic safety needles individually packaged in a preformed sterile barrel film pocket, sealed closed with a sterile barrier paper lidding. Each hypodermic safety needle consists of four parts: (1) a stainless steel needle (also referred as a cannula) – a thin hollow tube with a sharp tip, (2) a plastic hub adapter (3) a plastic needle safety shield, and (4) a plastic needle sheath (cap).
The stainless steel needles/cannulae are purchased and imported into the United States. They are already cut to length and sharpened when imported and can be of Chinese, Japanese, French or South Korean origin. The plastic hub adapters, plastic needle safety shields and plastic needle sheaths are all manufactured through a molding process in the United States where the plastic pieces are then assembled with the purchased stainless steel needles, packaged, and sterilized. The assembly, packaging, and sterilization processes are described as follows:
Assembly Process:
The plastic molded components (hub, shield, sheath) are assembled with the stainless steel needle/cannula using UV epoxy in an automated sequential assembly process. Each component/raw material is added into the indexing sequence at the proper process step. As the machine indexes and builds the assembly, several stations within the process perform product alignment for quality/design, perform automated dimensional visual inspections utilizing high technology vision systems, and track the quality of individual parts all through the process until they are completed. This creates the needle assembly. The needle assemblies are then staged to await packaging.
Sterile Packaging Process:
The needle assembly is placed in a preformed sterile barrel film pocket, sealed closed with a sterile barrier paper lidding in a continuous automated packaging machine. The individual needles are cut/perforated into groups for placement into unit cartons of a specific count. The cartons containing the packaged assemblies receive an “Instruction For Use,” and the cartons are closed and lot coded. The cartons are then forwarded into an automated corrugated loading system, sealed closed, labelled, lot coded and then palletized for transport to sterilization.
Sterilization Process:
The corrugated cases are placed in metal carriers to transport through the irradiation process on a timed indexing sequence. The metal carriers progress through the irradiator maze, allowing products inside the carrier to be exposed to the appropriate dose of gamma irradiation. The metal carriers then exit the irradiator and are repalletized, shrink wrapped and staged, awaiting quality release, and distribution for fulfillment of customer orders.
COUNTRY OF ORIGIN
"Country of origin" is defined in 19 CFR 134.1(b) as "the 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. United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993). However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983).
In this case, the assembly process performed by the machine is relatively simple. It has been CBP’s position that a sterilization process does not effect a substantial transformation. The processing of the stainless steel needles/cannulae that occurs in the United States does not change the name, character or use of the needles/cannulae. In HQ H300744, dated February 20, 2019, CBP considered the processing of various stimulating probes. In the ruling, the U.S.-origin stimulating probes were processed in China to attach a leadwire of Korean origin using Chinese solder and a hand grip consisting of a U.S.-origin handle insert and a Korean origin plastic handle, and covered with a heat shrink from China, Japan, or the United States. The finished probes were then inserted into a protective cover from the United States and packaged in China. CBP ruled that the stimulating probes are not substantially transformed by the processing that occurs in China. The U.S.-origin stimulating probes were the essence of the finished products. As such, the country of origin of the completed stimulating probes was the United States.
Consequently, in this case, the assembly, sterilization, and packaging performed in the United States do not result in a substantial transformation of the stainless steel needles/cannulae. We find the stainless steel needles/cannulae are the essence of the of the hypodermic safety needles. They are the raison d'être of the hypodermic safety needles that are used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin. The plastic components are subsidiary to the use of the needles, such as serving as a female connector and protecting the user and the needles. Therefore, the country of origin of the hypodermic safety needles is China, Japan, France or South Korea depending on the country of origin of the stainless steel needles/cannulae.
MARKING
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.
The “ultimate purchaser” is defined in section 134.1(d), Customs and Border Protection (CBP) Regulations (19 CFR 134.1(d)), as the “last person in the U.S. to receive the article in the form in which it was imported.” If an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser.
As provided in section 134.41(b), Customs Regulations (19 CFR 134.41(b)), the country of origin marking is considered conspicuous if the ultimate purchaser in the U.S. is able to find the marking easily and read it without strain.
With regard to the permanency of a marking, section 134.41(a), Customs Regulations (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, section 134.44, Customs Regulations (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.
Section 134.22, CBP regulations (19 CFR 134.22), provides general rules for marking of containers or holders. Section 134.22(a), CBP regulations (19 CFR 134.22(a)), states:
[w]hen an article is excepted from the marking requirements by subpart D of this part, the outermost container or holder in which the article ordinarily reaches the ultimate purchaser shall be marked to indicate the country of origin of the article whether or not the article is marked to indicate its country of origin.
Pursuant to 19 U.S.C. 1304(a)(3)(D) and section 134.32(d), CBP Regulations (19 CFR 134.32(d)), articles for which the marking of the containers will reasonably indicate the country of origin of the articles are excepted from individual marking. This exception would apply, for example, in cases where the articles are imported in a properly marked container and CBP officials at the port of entry are satisfied that the ultimate purchaser will receive it in its original unopened marked container.
You did not describe how the hypodermic safety needles are sold and to whom they will be sold. CBP has ruled in the past that products that are imported for sale to or for use by medical facilities need not be individually marked as to their country of origin but rather could be marked on the packages or on the outside of the containers in which the products were packed, provided the medical facility receives the products in such properly marked packages or containers. See HQ H190655 (July 14, 2014). In this case, if the hypodermic safety needles are sold to or provided for use by medical facilities in corrugated boxes properly marked with the country of origin of the hypodermic safety needles, the hypodermic safety needles may be excepted from the country of origin marking requirements under section 304 of the Tariff Act of 1930 (19 U.S.C. § 1304 (a)(3)(D) and 19 CFR § 134.32 (d)).
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 Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division