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NY E89824

November 19, 1999

LA-2-90:RR:NC:MM:105 E89824


TARIFF NO.: 9021.30.0000

Ms. Katherine McMahon
Kamino International Transport
16-22 Griffin Way
Chelsea, MA 02150

RE: The tariff classification of Embosphere microspheres from France

Dear Ms. McMahon:

In your letter, dated October 12, 1999, for Biosphere Medical, you requested a tariff classification ruling.

The sample is a glass vial containing a clear liquid. The liquid has suspended within it a multitude of plastic microspheres, each of is far too small for its shape to be seen without a microscope. These microspheres are basically hollow balls of plastic, made to unusually exacting size tolerance for medical purposes and impregnated with gelatin.

A health care professional will inject a precise amount of the contents of the vial into a blood vessel. Each microsphere, which can compress substantially since it is hollow, will flow through the blood stream until it reaches a vessel that is too small for it to pass through. It will therefore, like a naturally formed embolism, block the flow of blood through that vessel. This is useful when the blood is going to a part of the body which is harmful, such as a growth.

From the point of view of the patient, the procedure is identical to one in which drugs are injected into a vessel to cause the nearby vessels to shrink, and thus block the blood flow. As you state, you originally believed that the import was a medicament in HTS 3004. However, you point out that the Food and Drug Administration will not regulate this item as a drug, but as a device. Accepting your information to be true, the decision of the FDA not to regulate the item as a drug under its statutes, written for the different purpose of protecting the public from medical related dangers and frauds, does not necessarily require it to be excluded from Medicaments under the HTS. However, we do agree that no item that does not achieve its intended purpose in or on the body by chemical action or by being metabolized can be a Medicament so this item is not classified in HTS 3004.

Although this item is, you state, regulated as a device by the FDA, we note that, once they decided it was not a drug, they basically could only regulate it as a device or not at all, which would seem quite inadvisable considering the obvious dangers as well as medical benefits inherent in the product We do not agree that microspheres, whose shapes cannot be seen with the naked eye, are classified as Instruments or Appliances in HTS 9018. These terms imply a much higher level of either complexity or direction by the medical care provider, for example, a scalpel. This is supported by of the dozens of exemplars in the Explanatory Notes to Harmonized System Heading 9018. Also, presumably on the same theory, the radioactive seeds used in treating cancers such as prostrate cancer are excluded from HS 9022, “Apparatus based on the use of ...radiations, whether or not for medical...purposes”, by its EN Exclusion-a and by EN III-C to HS 28.44.

Each microsphere, however, achieves a medically necessary purpose, is clearly artificial, will remain permanently in the patient’s body, and will continue to perform its intended function indefinitely. The word “part” does not imply any level of either complexity, size, or anything else (even electrons are parts of atoms) so “Other artificial parts of the body” applies on its face. EN III to HS 90.21 does state that they “wholly or partially replace defective parts of the body...” Normally an embolism is avoided whenever possible, instead of being produced artificially, as here. However, we believe the EN language has to be interpreted noting that this item did not exist at the time the EN was written. It was true at the time of its writing that the only artificial body parts that achieved a medically necessary purpose were ones that replaced defective parts, such as the tubes which replace damaged blood vessels. All Tariffs must be interpreted to include new items that fit the legal language of the provision. Explanatory material cannot be used to defeat the language’s intention.

The applicable subheading for this item will be 9021.30.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for other artificial parts of the body. The general rate of duty will be free.

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 James Sheridan at 212-637-7037.


Robert B. Swierupski
National Commodity

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