THE COUNTRY OF ORIGIN MARKING OF A HIGH FLOW BLOOD FILTER; ARTICLE 509

N290038 October 4, 2017 MAR-2 OT:RR:NC:N1:105 CATEGORY: MARKING Adam Schmitt Haemonetics Corporation 400 Wood Road Braintree, MA 02184 RE: THE COUNTRY OF ORIGIN MARKING OF A HIGH FLOW BLOOD FILTER; ARTICLE 509 Dear Mr. Schmitt: This is in response to your letter dated September 1, 2017, requesting a ruling on the country of origin of imported blood transfusion filters. A sample was submitted with your letter for review. The product at issue is identified as the High Flow Blood Filter (Haemonetics part number SQ40SY). The product is described as a high-capacity, low priming volume microaggregate blood filter primarily used in blood transfusions. The High Flow Blood Filter consists of a filter unit combined with the requisite tubing, spike, clamps, and drip chamber that enables it to be used with a blood administration set. Based on the information provided, the product at issue is similar in form and function to the blood filter assemblies described in Headquarters Ruling Letter (HRL) H067643, dated October 5, 2009. The High Flow Blood Filter is said to consist of two main subassemblies. Subassembly A, manufactured in Puerto Rico, consists of the filter media, housing, and inlet and outlet for the blood to move to and from the filter. Subassembly B consists of components such as tubing, a spike, a drip chamber, clamps, connectors, and caps. These components hail from countries such as Mexico, the United States, and Italy. The final product in assembled in a Mexico by combining Subassembly A with the components of Subassembly B, after which point it is imported into the United States. In your submission you inquire about the country of origin of the finished High Flow Blood Filter imported into the US. 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 US 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 US the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. As stipulated in 19 CFR 134.1(b), "country of origin" is defined 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; however, for a good of a NAFTA country, the NAFTA Marking Rules determine the country of origin.” The NAFTA Marking Rules are defined, per 19 CFR 134.1(j), as the rules promulgated for purposes of determining whether a good is a good of a NAFTA country, and said rules are set forth in 19 CFR 102. Section 102.11 of the regulations (19 CFR 102.11) sets forth the hierarchy for determining the country of origin under the NAFTA marking rules. Per 19 CFR 102.11(a), the country of origin of a good is the country in which (1) The good is wholly obtained or produced; (2) The good is produced exclusively from domestic materials; or (3) Each foreign material incorporated in that good undergoes an applicable change in tariff classification set out in Section 102.20 and satisfies any other applicable requirements of that section, and all other applicable requirements of these rules are satisfied. As mentioned above, the High Flow Blood Filter is neither wholly obtained or produced in a single country, nor is it produced exclusively of domestic (i.e. Mexican) materials. Additionally, it does not appear that the product meets the requisite tariff shift set out in Section 102.20. Like the products described in HRL H067643, the High Blood Flow Filter would be classified in subheading 8421.29, Harmonized Tariff Schedule of the United States (HTSUS). Per 19 CFR 102.20(o), for finished products of subheading 8421.29, HTSUS, any non-originating components must undergo a tariff shift as follows: A change from subheading 8421.11 through 8421.39 from any other subheading, including another subheading within that group. While the non-originating components of Subassembly B meet the tariff shift, Subassembly A, produced in Puerto Rico, does not. Subassembly A, the element of the finished product that serves to filter the blood that travels through it, would be classified in the same subheading as the finished product, 8421.29, and thus does not meet the abovementioned tariff shift. When the country of origin cannot be determined on the basis of 19 CFR 102.11(a), the provisions of 19 CFR 102.11(b) may apply. 19 CFR 102.11(b) indicates, in pertinent part, that [e]xcept for a good that is specifically described in the Harmonized System as a set, or is classified as a set pursuant to General Rule of Interpretation 3, where the country cannot be determined under paragraph (a) of this section: (1) The country of origin of the good is the country or countries of origin of the single material that imparts the essential character to the good. The component that imparts the essential character to the High Flow Blood Filter is the filtering apparatus itself. This filtering apparatus, the main element of Subassembly A, is produced in Puerto Rico. As Puerto Rico is within the customs territory of the United States, the country of origin of the finished High Blood Flow Filter is the United States. If a good is determined to be of US origin, it is not subject to the country of origin marking requirements of 19 U.S.C. 1304. However, please note that the Federal Trade Commission (FTC) has jurisdiction concerning the phrase “Made in the USA” and similar claims of US origin. Inquiries on this matter should be directed to the FTC Division of Enforcement, 600 Pennsylvania Ave, NW, Washington DC 20580, or via the FTC’s website at http://www.ftc.gov. This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 CFR Part 181). 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 Evan Conceicao at evan.m.conceicao@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division