CLA-2-39:OT:RR:NC:N2:421

Ms. Arlene Mulet
Arlene Mulet Customs House Broker
P.O. Box 942195
Miami, FL 33194

RE: The tariff classification of a urine marker from Germany

Dear Ms. Mulet:

In your letter dated November 18, 2014, you requested a tariff classification ruling on behalf of Marker Test Diagnostics, Virginia. A sample was not provided with your letter.

The product, identified as “Marker Test UR-marker,” is a soft gel capsule containing the inactive ingredients of polyethylene glycol (PEG), capmul mcm, polysorbate 80, FD&C blue #1, glycerin and purified water. It is intended to be used as a urine marker in conjunction with a drug or alcohol screening test. Approximately 30 minutes after taking the capsule, the PEG is excreted in the individual’s urine. If the tested urine does not contain any PEG, or if the ratio is different from that which was mixed with the diluents, it indicates that the urine either does not belong to that individual or that the urine specimen has been altered. Use of this marker eliminates the need for supervision during the urine collection by eliminating the chance of falsification through sample substitution.

In your letter you suggest classification as a diagnostic reagent in subheading 3006.30.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for pharmaceutical goods specified in note 4 to chapter 30: opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient: other. Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). Pursuant to GRI 1, classification shall be determined according to the terms of the headings and any relevant section or chapter notes. The product does not meet the terms of heading 3006 since it acts as a urine identifier and does not function as a diagnostic reagent administered to a patient.

The applicable subheading for the Marker Test UR-marker will be 3907.20.0000, HTSUS, which provides for other polyethers, in primary forms. The rate of duty will be 6.5 percent ad valorem.

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., Washington, D.C. 20460, by calling the TSCA Assistance Line at (202) 554-1404, by fax at (202) 554-5603, by e-mail to: [email protected] or by visiting their website at www.epa.gov.

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/.

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 Joan Mazzola at [email protected].

Sincerely,

Gwenn Klein Kirschner
Director
National Commodity Specialist Division