CLA-2-84:OT:RR:E:NC:1:120

Ms. Freya Wilkes
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92612

RE: The tariff classification of a Chromatography column containing separation media from Japan

Dear Ms. Wilkes:

In your letter dated July 8, 2009 you requested a tariff classification ruling.

The merchandise under consideration is model TSK-GEL SWxl, a Gel Filtration column. It is a High Performance Liquid Chomatograph (HPLC) column used in the field of Biotechnology for quality control of monoclonal antibodies and other biopharma products. The columns are metal tubes that feature porous silica particles with a shielded surface. They contain a separation media of the following compounds or a mixture thereof: ammonium sulfate, sodium azide, trifluoroacetic acid, and acetonitrile. The merchandise in the HPLC action prepares materials for a variety of uses requiring purified substances.

You propose classification of the HPLC columns in subheading 9027.20.8060, HTSUS, as non-electrical chromatographs, which are neither liquid nor gas chromatographs. Your importations are just the packed columns that are used up in the chromatography process and are not the instruments which include, among other things, the equipment for the liquid or gas to be “measured by means of a detector” as indicated in Harmonized System Explanatory Note 24 to 9027. Your specific use is in testing for sterility in the manufacturing process, not in an analysis to determine the compounds of a compound. HPLC columns are excluded from classification in Chapter 90 by Pharmacia Fine Chemicals, Inc. v. US, court number 77-7-01188 and by NY Ruling Letters C88729 and I84487, whether used in “laboratory or preproduction,” etc.

The applicable subheading for the TSK-GEL SWxl, Chromatography columns containing a separation media will be 8421.29.0065, Harmonized Tariff Schedule of the United States (HTSUS), which provides for filtering or purifying machinery and apparatus for liquids: other. The duty rate 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/.

Your inquiry does not provide enough information for us to give a classification ruling on the individual or mixed media when imported separately. Your request for a classification ruling should include product literature describing each chemical compound media and the function of each chemical. Please indicate whether these media are imported mixed and if so, please provide a complete chemical breakdown with the CAS number for each component as well as the percentage by weight of each component.

When this information is available, you may wish to consider resubmission of your request. We are returning any related samples, exhibits, etc. If you decide to resubmit your request, please include all of the material that we have returned to you.

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 Denise Faingar at (646) 733-3010.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division