CLA-2 RR:CR:GC 964888 RFA
Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue
39th Floor
New York, NY 10017
RE: P.A.L.M. Laser-MicroBeam System; Microdissection of Cells
Dear Mr. Leo:
This is in response to your letter dated January 31, 2001, to the Area Director of Customs in New York, on behalf of Carl Zeiss, Inc., concerning the tariff classification of the P.A.L.M. Laser-MicroBeam System under the Harmonized Tariff Schedule of the United States (HTSUS). As you are aware, this matter was referred to Customs Headquarters for response. In preparing this ruling, we also considered the information provided with your letters of September 21, 2001 and March 25, 2002.
FACTS:
The merchandise, labeled as the P.A.L.M. Laser-MicroBeam System, consists of a microscope, a laser, a computer, and a micromanipulator. It allows for the microdissection of large, homogeneous cell areas, small cell clusters and single cells. It performs microdissection by interfacing a pulsed ultra violet (UV) high beam quality laser with a standard inverted microscope through the epifluorescence port. The objective lens of the microscope then converges the laser light to produce an extremely high-density focal energy for laser microbeam microdissection. The focused laser beam induces a localized photodecomposition, ablating the tissue in the narrow focal point without
damage to the surrounding tissue. By combining this intense focal cutting tool with substage robotics, the laser beam can be positioned to cut around a selected area on a tissue section or to microdissect a single cell, creating a clear-cut gap between the selected and non-selected areas. The flexibility of this robotic tool enables specimens of any shape and size between 1 um and several hundred microns to be isolated. In addition, unwanted cells within a selected area can be selectively destroyed with a few laser shots to achieve entirely homogeneous samples.
Once the cells or tissue areas of interest are isolated, the operator can use the high energy generated by the focused laser light to catapult the dissected cells into a collecting vessel, usually the cap of a regular eppendorf-type microfuge tube. Using this technology, the Robot MicroBeam is able to microdissect and capture cells without the use of manual manipulation, preventing any chance of contamination.
The P.A.L.M. Laser-MicroBeam System can be used in many procedures, including: in pathology, it can be used for the dissection of single tumor cells without any nontumorous contamination; in oncology, the system along with molecular methods allows for the identification of genetical changes in different tumor stages; in reproduction medicine, it can assist in prenatal diagnosis, preimplantation diagnosis, and in embryo hatching; in veterinary medicine, it can be used in reproduction studies and animal breeding; and in plant biology, it can assist in food engineering.
ISSUE:
Whether the P.A.L.M. Laser-MicroBeam System is classifiable as instruments and appliances used in medical, surgical, dental or veterinary sciences under heading 9018, HTSUS?
LAW AND ANALYSIS:
Classification of merchandise under the HTSUS is in accordance with the General Rules of Interpretation (GRI's). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative section or chapter notes.
In your letters, you indicate that the principal use of the P.A.L.M. Laser-MicroBeam System is for molecular biological research and that the proper classification is under heading 9018. The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the official interpretation of the HTSUS. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 F.R. 35127, 35128 (August 23,
1989). EN 90.18, page 1802, states, in pertinent part, that: “[t]his heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc. Instruments and appliances for anatomical or autoptic work, dissection, etc., are also included”.
The P.A.L.M. Laser-MicroBeam System consists of four main components: a microscope, a laser, a computer and a micromanipulator, working together to allow for the microdissection of large, homogeneous cell areas, small cell clusters and single cells. Because these components work together to form a single unit, classification in this case is subject to Legal Note 3 to Chapter 90, HTSUS, which states that: “[t]he provisions of note 4 to section XVI apply also to this chapter.” Legal Note 4 to Section XVI, HTSUS, provides that: “[w]here a machine (including a combination of machines) consists of individual components (whether separate or interconnected by piping, by transmission devices, by electric cables or by other devices) intended to contribute together to a clearly defined function covered by one of the headings in chapter 84 or chapter 85, then the whole falls to be classified in the heading appropriate to that function.”
According to our research on the company’s website [www.palm-microlaser.com and www.palm-mikrolaser.com], this system uses optical devices to dissect cells for a variety of uses in the medical, surgical and veterinary sciences. Specifically, it aids doctors and medical researchers in making a diagnosis, assist in invitro fertilization, and other medical procedures and research. Based upon the application of Legal Note 3 to chapter 90, we find that the P.A.L.M. Laser-MicroBeam System meets the terms of heading 9018, which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences.
HOLDING:
The P.A.L.M. Laser-MicroBeam System is classifiable under subheading 9018.90.20, HTSUS, which provides for: “[I]nstruments and appliances used in medical, surgical, dental or veterinary sciences. . . : [o]ther instruments and appliances. . . : [o]ptical instruments and appliances . . . : [o]ther . . . .” The general, column one rate of duty is free.
Sincerely,
Myles B. Harmon, Acting Director
Commercial Rulings Division