CLA-2-35:OT:RR:NC:2:238
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 Germany
Dear Ms. Stern:
In your letter dated October 6, 2014, you requested a tariff classification ruling on behalf of Roche Diagnostics Operations, Inc. We apologize for the delay as the information submitted was sent to our laboratory for analysis.
The first product, R1, consists of N, N-bis(2-hydroxyethyl) glycine (Bicine) buffer, colipase (porcine pancreas), a detergent and a preservative. It is used to increase the specificity of the assay for pancreatic lipase. According to our laboratory, R1 is an enzyme solution that is mixed with other chemicals.
The second product, R3 (STAT R2), consists of a Tartrate buffer, 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6-methylresofurin) ester (chromogenic lipase substrate), taurodeoxycholate, a detergent and a preservative. This preparation reacts with lipase to form a red dye which is proportional to lipase activity and can be determined photometrically. According to our laboratory, R3 contains a chromogenic compound which when added to the sample produces a measurable color change.
You state that R1 and R3 will be imported separately in bulk to make up an enzymatic in vitro diagnostic test kit. This test kit, LIPC Lipase Colorimetric test, is used for the quantitative determination of lipase in human serum and plasma on Roche/Hitachi cobas c systems.
The applicable subheading for R1 imported in bulk will be 3507.90.7000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Enzymes: prepared enzymes not specified or included: Other: Other.” The rate of duty will be free.
The applicable subheading for R3 (STAT R2) imported in bulk 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 R3, are properly classifiable as diagnostic reagents of heading 3822, even when imported separately in bulk form. However, while we agree that R3 is considered to be a diagnostic reagent of heading 3822, we disagree with R1. In its condition as imported, R1 is merely used to increase the specificity of the test procedure. In our opinion, it is not used by itself for the detection of pancreatic lipase 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 the ruling, contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division