The tariff classification of chemical reagents imported in bulk from Canada

N256882 February 5, 2015 CLA-2-38:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3822.00.5090; 3824.90.9290 Ms. Deborah Stern Sandler, Travis & Rosenberg, P.A. 1000 NW 57th Court, Suite 600 Miami, FL 33126 RE: The tariff classification of chemical reagents imported in bulk from Canada Dear Ms. Stern: In your letter dated September 3, 2014, you requested a tariff classification ruling on behalf of Sekisui Diagnostics, LLC. We apologize for the delay as the information submitted was sent to our laboratory for analysis. The first product, Iron-SL Dissociating Reagent (R1), consists of an acidic buffer solution containing a surfactant, preservatives and stabilizers. It is used to dissociate the iron in serum from the transferrin. According to our laboratory, R1 is intended for the separation of iron (III) from the protein transferrin in human serum. The second product, Iron-SL Color Reagent (R2), consists of a solution containing ferene (chromogen) and stabilizers. The ferrous iron reacts with the ferene to form a blue chromophore. According to our laboratory, R2 functions by reducing iron (III) to iron (II), which then binds to ferene, to form a ferrous-ferene complex. The formation of a complex is observable visually and quantifiable. You state that R1 and R2 will be imported separately in bulk to make up an in vitro diagnostic test kit. This test kit, Iron-SL Assay, is used for the quantitative determination of iron in human serum. You further state that R1 and R2 will be imported separately and distributed in bulk to its customers. Afterwards, the customers will either measure out appropriate doses for use in the assay or they may package R1 and R2 into vials or kits. The applicable subheading for the Iron-SL Dissociating Reagent (R1) will be 3824.90.9290, Harmonized Tariff Schedule of the US (HTSUS), which provides for “Chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other.” The rate of duty will be 5 percent ad valorem. The applicable subheading for the Iron-SL Color Reagent (R2) will be 3822.00.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006: Other: Other.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. In your letter you suggest classification under subheading 3822.00.5090 which provides for "Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 30.02 or 30.06: Other: Other." You believe that both products, R1 and R2, are properly classifiable as diagnostic reagents of heading 3822, even when imported separately in bulk form. However, while we agree that R2 is considered to be a diagnostic reagent of heading 3822, we disagree with R1. In its condition as imported, R1 is merely used to prepare a serum sample for quantification by reagent R2. In our opinion, R1 is not used for the detection of iron in human serum and does not undergo an observable or measurable change. Based upon the forgoing, R1 is precluded from heading 3822 and will be classified elsewhere. This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov. 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 Heading 3822, contact National Import Specialist Judy Lee at [email protected]. If you have any questions regarding Heading 3824, contact National Import Specialist Patrick Day at [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division