H265715

HQ H265715 January 5, 2022 OT:RR:CTF:FTM H265715 TSM CATEGORY: Marking Donald S. Stein, Esq. Greenberg Traurig, LLP 800 Connecticut Avenue N.W. Suite 500 Washington, DC 20006 RE: Modification of HQ H016800 and HQ H190655; Country of origin marking of a certain MIC Percutaneous Placement Kit and Medical Kits. Dear Mr. Stein: This is in reference to Headquarters Ruling Letter (“HQ”) H016800, issued to your client, Avent Inc., on December 10, 2007, concerning the country of origin marking of a certain MIC Percutaneous Placement Kit (“PKK.”) In that ruling, U.S. Customs and Border Protection (“CBP”) determined that all components of the PKK kit and their country of origin need not be listed on the PKK kit packaging. Rather, the PKK kit packaging may be marked “Product of USA, Ireland and Mexico” or other words of similar meaning.  This is also in reference to HQ H190655, dated July 14, 2014, concerning the country of origin marking of certain medical kits. In that ruling, CBP determined that the containers of the imported medical kits must be marked with an accurate list of countries of origin of all the articles.  Upon additional review, we have found these determinations to be incorrect. For the reasons set forth below we hereby modify HQ H016800 and HQ H190655. Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625 (c)(1)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), a notice was published in the Customs Bulletin, Volume 55, No. 40, on October 13, 2021, proposing to modify HQ H016800 and HQ H190655, and to revoke any treatment accorded to substantially identical transactions. Two comments generally supporting the proposed action were received on or before November 12, 2021. FACTS: HQ H016800, describes the subject merchandise as follows: The merchandise at issue is identified as the “MIC Percutaneous Placement Kit.” The PPK is a medical device to initially place balloon-retained enteral feeding catheters for gastrostomy feeding. The PPK will be marketed to and used in hospitals and clinics by healthcare professionals. The PPK consists of a stoma measuring device, two syringes, 24fr dilator, a gastroplexy assembly (package containing four devices), scalpel, introducer needle, hemostat, guidewire and catheter. The stoma measuring device, 24fr dilator and catheter are from Mexico. The guidewire is from Ireland. The hemostat is from Pakistan. The syringes, gatroplexy assembly, scalpel and introducer needle are from the United States. The PPK is assembled in Mexico. The individual components of the PPK are not marked. The kit will be placed in a sealed package and sterilized. The sealed kit is then placed in individual shipping boxes. In HQ H016800, CBP found that all components of the PPK and their country of origin need not be listed on the packaging. Rather, the packaging may be marked “Product of USA, Ireland and Mexico,” “Components (or parts) produced in U.S., Ireland and Mexico” or other words of similar meaning. HQ H190655, describes the subject merchandise as follows: The instant merchandise consists of various medical kits, imported into the U.S. from Mexico. The kits contain numerous components, which are organized and packaged into sub-kits. The components include items such as needles, scissors, towels, catheters, sponges, scalpels, plastic bowls, forceps, gauzes, etc. The sub-kits group various components together into a single container—for example, a box with scissors of different sizes or a sealed bag with a catheter, needles, and blades. The components are sourced from various countries, including the U.S., Canada, Mexico, China, the Dominican Republic, South Korea, Thailand and Vietnam, are assembled into sub-kits by outside suppliers, and are packaged into a single container - the final medical kit - in Mexico. The components in the sub-kits may have different countries of origin. Upon importation into the U.S., some kits are sold directly to hospitals, and some are repacked, with additional components inserted into the finished kit. The imported kits are marked on the outside container with the names of countries from which the subject merchandise may originate, for example “Products of the U.S., Mexico, China, Taiwan.” The individual components are not marked. In HQ H190655, CBP found that the outer containers of the imported medical kits must be marked with an accurate list of the countries of origin of all the articles. ISSUE: Whether the containers for the PKK and medical kits at issue are marked in accordance with the requirements of Treasury Decision (“T.D.”) 91-7. LAW AND ANALYSIS: The marking statute, section 304 of the Tariff Act of 1930, as amended (19 U.S.C. § 1304) provides that, unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. § 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlaender & Co. Inc., 27 C.C.P.A. 297, 302, C.A.D. 104 (1940). The country of origin marking requirements and the exceptions of 19 U.S.C. § 1304 are set forth in Part 134, Customs Regulations (19 C.F.R. Part 134), which implements the country of origin marking requirements and exceptions of 19. U.S.C. § 1304. Section 134.41(b), Customs Regulations (19 C.F.R. § 134.41(b)), mandates that the ultimate purchaser in the United States must be able to find the marking easily and read it without strain. 19 C.F.R. § 134.1(d), defines the ultimate purchaser as generally the last person in the United States who will receive the article in the form in which it was imported. 19 C.F.R. § 134.32(d) provides that articles for which the marking of the containers will reasonably indicate the origin of the articles are excepted from marking requirements. The principles governing the country of origin marking of sets, mixtures, and composite goods, were addressed by CBP in Treasury Decision (“T.D.”) 91-7, 25 Cust. B. & Dec. 7 (January 8, 1991). In that decision, CBP determined in relevant part that for purposes of 19 U.S.C. § 1304, the relevant inquiry is whether the materials or components have been substantially transformed as a result of their inclusion in a set, mixture, or composite good. If the materials or components have not been substantially transformed, each component must be individually marked to indicate its own country of origin. In HQ H016800 and HQ H190655, CBP determined that the components of the PKK and medical kits, such as stoma measuring devices, syringes, dilators, gastroplexy assemblies, scalpels, needles, hemostats, guidewires, catheters, scissors, towels, sponges, plastic bowls, forceps, gauzes, etc., retained their different countries of origin. CBP further determined that the outer containers of the imported kits must be marked with an accurate list of the countries of origin of all the articles, for example “Product of USA, Ireland and Mexico,” “Products of the U.S., Mexico, China, Taiwan,” or other words of similar meaning. Upon review, we find that marking of the outer containers with a list of countries of origin of all articles contained within those containers, without reference to the country of origin of each individual article, is not consistent with T.D. 91-7. As discussed above, T.D. 91-7 requires each item, if 

The marking statute, section 304 of the Tariff Act of 1930, as amended (19 U.S.C. § 1304) provides that, unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. § 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlaender & Co. Inc., 27 C.C.P.A. 297, 302, C.A.D. 104 (1940). The country of origin marking requirements and the exceptions of 19 U.S.C. § 1304 are set forth in Part 134, Customs Regulations (19 C.F.R. Part 134), which implements the country of origin marking requirements and exceptions of 19. U.S.C. § 1304. Section 134.41(b), Customs Regulations (19 C.F.R. § 134.41(b)), mandates that the ultimate purchaser in the United States must be able to find the marking easily and read it without strain. 19 C.F.R. § 134.1(d), defines the ultimate purchaser as generally the last person in the United States who will receive the article in the form in which it was imported. 19 C.F.R. § 134.32(d) provides that articles for which the marking of the containers will reasonably indicate the origin of the articles are excepted from marking requirements. The principles governing the country of origin marking of sets, mixtures, and composite goods, were addressed by CBP in Treasury Decision (“T.D.”) 91-7, 25 Cust. B. & Dec. 7 (January 8, 1991). In that decision, CBP determined in relevant part