CLA-2 CO:R:C:S W557422 WAW
Ms. Jane B. O'Dell Peat Marwick
3100 Two Union Square 601 Union Street
Seattle, WA 98101-2327
RE: Eligibility of a cyclotron for duty-free treatment under
subheading 9810.00.80, HTSUS
Dear Ms. O'Dell:
This is in response to your letter dated May 10, 1993, on behalf of your client, General Atomics, requesting a ruling on whether a cyclotron to be imported into the U.S. is eligible for duty-free treatment under subheading 9810.00.80, Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
You state that General Atomics is a primary subcontractor to Ion Beam Applications, s.a.(IBA). IBA, a Belgian company, proposes to build a proton therapy facility for Massachusetts General Hospital (MGH). It is your understanding that the price for the entire contract has not been finalized to date, but the overall price for the facility, once it is installed, is expected to be approximately $20 million. The facility will include a cyclotron which will be manufactured in Belgium; the mountings, guidance system, and accessories will be of U.S. origin. The cyclotron will represent a large percentage of the overall contract price.
The cyclotron is known as a "230 MeV cyclotron," or "Cyclone 230." According to the manufacturer, it represents a new design of particle accelerator specifically developed for proton therapy, and inappropriate for other use. It is used to accelerate protons, the positively charged particles that make up the nucleus of the hydrogen atom, increasing their energy level until the particles contain sufficient energy to penetrate human tissue. This procedure is used for cancer therapy. Hydrogen gas is the material used as the source of the protons. Each hydrogen atom consists of a single proton and an electron; part of the
system strips the hydrogen atoms of their electrons and the protons which remain are accelerated and directed at the target.
Information submitted by the importer indicates that the use of the Cyclone 230 System involves four different sources of radiation:
During the acceleration process, a number of radioactive nuclides are produced in the machine itself. Extensive radioactive shielding of the machine and the surrounding environment is therefore necessary.
Once extracted from the cyclotron, the high energy beam goes through an energy degrader located in a beam line. The energy degrader is used to precisely modulate the energy level of the outgoing particles in order to give the beam the appropriate penetration energy corresponding to the exact location and depth of the cancer cells in the body. A number of radioactive substances are produced when the beam hits the degrader.
After the energy degrader, the proton beam can be sent directly to the patient to irradiate the cancer cells. In this process, the beam hitting the cancer cells produces radioactive substances in the body. These radioactive nuclides are also called radioactive tracers as they can be detected by an imaging device called a Positron Emission Tomography scanner to provide a "picture" of the treated area.
An alternative to sending the proton beam directly to the patient is the production of radioactive substances under the form of gamma radiation and high energy neutrons created upon collision of the proton beam with a Beryllium target located before the patient.
ISSUE:
Whether the cyclotron is eligible for duty-free treatment under subheading 9810.00.80, HTSUS.
LAW AND ANALYSIS:
Subheading 9810.00.80, HTSUS, provides:
"Articles imported for the use of any non-profit institution, whether public or private, established for educational, scientific, or therapeutic purposes; Articles utilizing any radioactive substance in medical diagnosis or therapeutic treatment, ... and parts and accessories of the foregoing"
Articles which meet all of the requirements of subheading 9810.00.80, HTSUS, are eligible for duty-free entry into the U.S.
The importer claims that the Cyclone 230 meets the requirements of subheading 9810.00.80, HTSUS, and should be entitled to duty-free treatment. In regard to the first requirement, MGH is organized as a non-profit institution under permit number E042697983, issued by the Commonwealth of Massachusetts. As a charitable hospital, it is deemed to qualify as an institution "established for therapeutic purposes."
Subheading 9810.00.80, HTSUS, also requires that the imported device use radioactive substances in medical diagnosis or therapy. You are of the opinion that the proton therapy system of which the Cyclone 230 forms an integral part works by creating a radioactive substance inside the body. You claim that the proton beam generated by the Cyclone 230 is radiation. You state that when the beam strikes the tumor being treated, it causes the disintegration of the atomic nuclei and the discharge of particles by the atoms of the tumor. As a result, the tumor becomes a radioactive substance.
Radioactivity is defined as the property possessed by some elements of spontaneously emitting alpha or beta rays and sometimes also gamma rays by the disintegration of the nuclei of atoms. Webster's New Collegiate Dictionary.
You state that the proton stream which is emitted from the cyclotron is not alpha radiation; "alpha particles" are defined as "positively charged particles given off by certain radioactive substances." They consist of two protons and two neutrons (neutrons carry no charge), and are the nucleus of helium atoms, as opposed to hydrogen atoms. Webster's New World Dictionary, Third College Edition. Since the proton radiation is comprised of hydrogen nuclei, it does not meet the dictionary definition of "alpha radiation," although it is similar in that both are positively charged.
It is your position that the proton beam generated by the Cyclone 230 is radiation. You state that when it strikes the tumor being treated, it causes the disintegration of the atomic nuclei and the discharge of particles by the atoms of the tumor. The tumor becomes a radioactive substance. You state that the difference between this process and that in which radioactive isotopes are created and injected into the patient is not whether or not a radioactive substance is used in the treatment, but merely whether the radioactive substance is external or internal to the body. In the conventional (external) treatment, a target is bombarded by the radiation and is then implanted into the body. In the approach to be used with Cyclone 230, the tumor itself becomes the radioactive substance.
We have previously held in Headquarters Ruling Letter (HRL) 071206 dated December 30, 1983, that a High Linear Energy Transfer Clinical Neutron Therapy System was an apparatus of the type provided for in item 854.10, Tariff Schedules of the United States (TSUS) (the precursor to subheading 9810.00.80, HTSUS).
The apparatus in HRL 071206 also incorporated a cyclotron used to accelerate positive ions which, upon collision with a target material, provided gamma radiation and high energy neutrons for use in diagnostic and medical procedures. This decision was based in part on C.I.E. 1385/61, wherein Customs concluded that a "scintigraph whole body scanner," which did not contain radioactive material, was nevertheless classifiable under the predecessor to item 854.10, TSUS, for the reason that it utilized radioactive isotopes which were administered directly to the patient.
In another case involving a Positron Imaging Facility which utilized three major systems, one of which was a cyclotron system, Customs held that there is nothing in the express terms of item 854.10, TSUS, which places any limitation as regards either the location of the radioactive material during such use or the manner in which the radioactive material is produced for such use. See HRL 553601 dated May 16, 1985.
Based on the information provided, we are of the opinion that the importer has shown that the Cyclone 230 utilizes a radioactive substance in medical diagnosis or treatment within the meaning of the tariff provision and consistent with HRL's 071206 and 553601 and C.I.E. 1385/61. Based on the principles stated in these rulings, the merchandise at issue in this case uses radioactive substances in its operation. The High Linear Energy Transfer Clinical Neutron Therapy System in HRL 071206 is very similar to the Cyclone 230 system, since it also included a cyclotron, a beam transport system and a rotating gantry irradiation device with the Beryllium target. The fact that the radioactive material is produced inside the patient's body as a result of the proton therapy system utilized by the Cyclone 230, does not mean that a radioactive substance is not used in the treatment. We have previously stated that the "apparatus utilizing any radioactive substance" did not have to contain the radioactive substance. See HRL 071206. Customs has previously found that an article will be eligible for duty-free treatment under this provision if the radioactive substance was injected into a patient, or contained in an object which was not part of the apparatus. In HRL 071206, before use of any kind, the Scanditronix apparatus did not contain any significant radioactive substance. During its use, however, and after the commencement of its first use to produce high energy neutron, the Scanditronix apparatus always utilized radioactive substances of various types. The importer states in this case that during the acceleration process, a number of radioactive nuclides are produced in the machine itself, requiring extensive radioactive
shielding (up to nine feet of concrete) of the machine and the surrounding environment. In this process, the proton beam which is sent to hit the cancer cells in the body produces radioactive substances in the body. Therefore, we find that the cyclone 230 satisfies all of the requirements under subheading 9810.00.80, HTSUS, and may enter into the U.S. free of duty.
HOLDING:
Based on the information provided, we are of the opinion that, as the Cyclone 230 is an apparatus utilizing a radioactive substance in medical diagnosis or therapeutic treatment, and is imported for the use of a public or private nonprofit institution established for educational, scientific, or therapeutic purposes, it will be eligible for duty-free treatment under subheading 9810.00.80, HTSUS, upon entry into the U.S.
Sincerely,
John Durant, Director
Commercial Rulings Division