CLA-2 RR:CR:GC 966066 DSS
Mr. Larry Ordet
Sandler, Travis & Rosenberg, P.A.
5200 Blue Lagoon Drive
Miami, FL 33126-2022
RE: Request for Reconsideration of NY I84394; PET Cyclotron
Dear Mr. Ordet:
This is our decision on your request for reconsideration of New York Ruling letter (NY) I84394, on behalf of General Electric Medical Systems, filed against classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of Positron Emission Tomography (PET) cyclotrons under subheading 8543.19.00, HTSUS. After review of NY I84394, Customs has determined that the classification of PET cyclotrons under subheading 8543.19.00, HTSUS, is correct.
FACTS:
In NY I84394, dated August 16, 2002, we classified two PET cyclotrons as particle accelerators under subheading 8543.19.00, HTSUS. You argue that the subject PET cyclotrons are properly classified under subheading 9018.19.95, HTSUS, as other “electro-diagnostic medical apparatus.”
PET technology employs a diagnostic imaging technique to measure the metabolic activity of cells in the human body. It produces images of the body’s basic biochemistry or function that are not visible with other traditional diagnostic techniques, such as x-rays, computed tomography (CT) scans or Magnetic Resonance Imaging (MRI). It is used to visualize biochemical processes that may change in the human body with the onset of a serious disease. A PET Scan involves a small amount of radioactive material, or radiotracer, which is attached or tagged to a compound for use in the body. The radioactive drug thus formed is then administered to the patient, usually by injection, and a PET scanner images how the body processes the drug. 2
Cyclotrons are defined in the American Heritage Dictionary (2002) as circular particle accelerators in which charged subatomic particles generated at a central source are accelerated spirally outward as they gain energy in a plane perpendicular to a fixed magnetic field by an alternating electric field. Particle accelerators are devices employing electrostatic or electromagnetic fields to input kinetic energy to molecules, atomic or subatomic particles. Particle accelerators are also capable of producing radioactive areas and other radioactive hazards. They are designed and used for producing radioactive particles of varying degrees of energy and intensity. Accelerators were originally designed to research the structure of matter; today they are also used in many other applications, including producing radioisotopes, radiography and radiation therapy, induction of fusion, pumping for lasers, and detoxification of hazardous waste. See U.S. Department of Energy (DOE), Radiological Training for Accelerator Facilities: Student’s Guide at 7-10, at http://www.tis.eh.doe.gov/whs/rhmwp/RST/accel/sg.doc.
The PET cyclotrons in question are the PET Tracer Production System (PETrace) and the MINItrace PET Tracer Production System (MINItrace). A PET cyclotron is a particle accelerator that is used to produce short-lived radioisotopes. The cyclotron takes ions (either protons or deuterons) and charges them through the use of alternating electronic fields. The particles are kept in a circular orbit by a strong magnetic field as they gain energy. The cyclotrons used for PET generally produce particles with an energy of between 3 and 18 million electron volts. These particles are directed toward targets made of the starting isotope and through a nuclear reaction, produce positron-emitting radioisotopes, which have a half-life between 75 seconds and 110 minutes. The positron-emitting isotopes are transferred from the target to a separate chemical synthesis unit, which makes the radio-pharmaceutical used by the PET scanner to trace physiological processes in the body.
The HTSUS provisions under consideration are as follows:
Electrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof:
Particle Accelerators:
* * * *
8543.19.00 Other
* * * *
Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:
Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof:
* * * *
Scintigraphic apparatus
* * * *
Other:
Other:
Other:
ISSUE:
Whether PET cyclotrons are classified under subheading 8543.19.00, HTSUS, as particle accelerators or under subheading 9018.19.95, HTSUS, as other electro-diagnostic medical apparatus.
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs may then be applied.
In interpreting the headings and subheadings, Customs looks to the Harmonized Commodity Description and Coding System Explanatory Notes (ENs). Although not legally binding, they provide a commentary on the scope of each heading of the HTSUS. It is Customs practice to follow, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The ENs state that heading 8543, HTSUS, covers all electrical appliances and apparatus which are not covered more specifically by a heading of any other Chapter of the Nomenclature, nor excluded by the operation of a Legal Note to Section XVI. Note 1(m) to Section XVI provides that Section XVI does not cover articles of Chapter 90. Thus, if the merchandise meets the terms of heading 9018, HTSUS, classification in heading 8543, HTSUS, is precluded.
Heading 9018, HTSUS, is a use provision, and provides for instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments. Additional U.S. Rule of Interpretation 1(a), HTSUS, states that in the absence of special language or context which otherwise requires, a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use.
You suggest that the instant PET cyclotrons are classifiable under subheading 9018.19.95, HTSUS, as “other electro-diagnostic apparatus.” It is our position that the instant cyclotrons are not electro-diagnostic apparatus.
In HQ 961998, dated May 7, 1999, we consulted the Webster’s II New Riverside University Dictionary 372 (1988) and Dorland’s Illustrated Medical Dictionary 458 (28th ed.) to obtain a definition of the terms “diagnostic” and “diagnosis.” We noted that the term “diagnosis” is defined as “the act or process of identifying or determining the nature of a disease by way of examination.” See also HQ 962048, dated July 29, 1999, and HQ 962596, dated April 13, 1999. The PET cyclotrons are used to produce the radio-isotope which is added to another compound to form the radiotracer used to produce the gamma radiation used in PET scanning. While the PET scanner itself is mentioned specifically in Subheading EN 9018.14, as an example of a scintigraphic apparatus, the cyclotron is a separate machine that is not connected to the scanner. The cyclotron itself is not used in an examination to scan the body or to diagnose a medical condition. They therefore are not classified as electro-diagnostic apparatus, in subheading 9018.19, HTSUS.
Nor can the instant cyclotrons be classified as an instrument or apparatus used in medical science. EN 90.18 states 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.” The PET cyclotrons are not classifiable as a medical instrument or apparatus. They are not used directly in a professional practice for diagnosis, prevention or treatment of diseases, the correction of deformities and defects, or the repair of injuries. They are used by trained chemists or physicists in a laboratory to create radioactive isotopes. Thus, the PET cyclotrons are not principally used in medical practice and are not classified as instruments used in medical science under heading 9018, HTSUS. See HQ 955887, dated August 4, 1994, and HQ 964267, dated February 2, 2001.
The instant cyclotrons, however, meet the criteria for inclusion in heading 8543, HTSUS: they are electrical apparatus; they perform the independent function of accelerating charged particles by means of a magnetic field; and they are not listed in any other heading in chapter 85.
In fact, EN 85.43 states in pertinent part that:
[h]eading [8543] includes . . . particle accelerators. These are devices for imparting high kinetic energy to charged particles (electrons, protons, etc.)
Particle accelerators are used mainly in nuclear research, but they also serve in the production of radioactive materials, in medical or industrial radiography, for the sterilisation [sic] of certain products, etc.
Particle accelerators usually consist of large installations (which may weigh several thousands of tons). They comprise a particle source, an acceleration chamber, and devices for producing high frequency voltage, variations of the flux or radio-frequencies which are used to accelerate the particles. They may contain one or more targets. . .
The particle accelerators covered by this heading include . . . cyclotrons.
The uses listed in EN 85.43 are not exhaustive, but are illustrative. Based on the information present, the instant PET cyclotrons fall under the definition of particle accelerator given in the EN.
Based on the foregoing analysis, PET cyclotrons are provided for in subheading 8543.19.00, HTSUS, as particle accelerators.
HOLDING:
Under the authority of GRI 1, PET cyclotrons are provided for in heading 8543, HTSUS. They are classified under subheading 8543.19.00, as “Electrical machines and apparatus, having individual functions, not specified or included elsewhere in this chapter; parts thereof: Particle Accelerators: . . . Other.”
EFFECT ON OTHER HOLDINGS:
NY I84394 is AFFIRMED.
Sincerely,
/s/
Myles B. Harmon
Director,
Commercial Rulings Division