MAR-1 OT:RR:NC:N1:139
Mr. Jarmo Kivinen
Chad International Inc.
2110 W Caleb Rd.
Phoenix, AZ 85085
RE: THE COUNTRY OF ORIGIN MARKING OF A STERILIZED, SINGLE USE, PRE-LOADED MELAWIN R MELATONIN IMPLANTER, 18 MG.
Dear Mr. Kivinen:
This is in response to your letter dated September 17, 2018, requesting a ruling on whether the country of origin marking is acceptable for a sterilized, single use, pre-loaded melatonin implanter, 18 mg. A marked sample was not submitted with your letter for review, but a proposed label was submitted.
The product is described as a sterilized, single use, pre-loaded Melatonin Implanter for dogs, composed of an 18mg Melawin melatonin implant and the syringe with a needle.
The implants are made in the U.S.A. then shipped to a subcontractor in China. There, each implant is installed in the hypodermic needle of the single use syringe, which is made in China.
The syringe-needle-implant combination is then packaged, sterilized, and shipped back to the U.S.A. You propose a country of origin marking on the label as “Melatonin Implant Made in the USA, Other Parts Made in China.”
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.
Section 134.1(b), U.S. Customs and Border Protection (CBP) Regulations (19 C.F.R. 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. 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).
As provided in section 134.41(b), CBP Regulations (19 C.F.R. 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.
In section 134.1(k), CBP Regulations (19 C.F.R. 134.1(k)), “Conspicuous” means capable of being easily seen with normal handling of the article or container.
With regard to the permanency of a marking, section 134.41(a), CBP Regulations (19 C.F.R. 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, CBP Regulations (19 C.F.R. 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.
In this case, we find that the process of installing the U.S origin implant into the hypodermic needle of the single use syringe does not constitute a substantial transformation. Each component maintains its original identity after they are combined.
Regarding whether the product can be marked as “Melatonin Implant Made in the USA, Other Parts Made in China,” goods of U.S. origin are excepted from the country of origin marking requirements of 19 U.S.C. 1304. Thus, it would be acceptable for the packaging to be marked to indicate only that the syringe-needle-implant combination is a product of China. However, if you also wish to identify the U.S. origin of the Melawin R melatonin implant, CBP would have no objection to a marking such as “Product of U.S.A. and China” or “Melatonin Implant Made in the USA, Other Parts Made in China.” In this regard, it should be noted that the marking of articles in whole or in part as “Product of U.S.A.” is a matter within the jurisdiction of the Federal Trade Commission (FTC) and we suggest that you contact that agency for a determination.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 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 Patrick Day at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division