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HQ 952893


September 15,1993

CLA-2 CO:R:C:F 952893 JGH

CATEGORY: CLASSIFICATION

TARIFF NO.: 3823.90.5050

District Director of Customs
1 East Bay Street
Savannah, Georgia 31401

RE: Decision of Application for Further Review of Protest No. 1704-92-100327, on the Classification of Viaspan.

Dear Sir:

This protest involves the classification under the Harmonized Tariff Schedule of the United States (HTSUS), of Viaspan imported by Dupont Merck from the Netherlands, in April 1992.

FACTS:

Viaspan is described as a sterile, nonpyrogenic solution used for hypothermic flushing and preserving of human organs, such as, kidneys, livers or pancreas prior to transportation. The composition is given as:

Composition
Ingredient (grams per liter)
etherified starch 50.0 lactobionic acid 35.8 potassium phosphate monobasic 3.4 magnesium sulfate heptahydrate 1.2 raffinose pentahydrate 17.83 glutathione 0.9 allopurinol 0.1 adenosine 1.3 potassium hydroxide q.s. sodium hydroxide adjust pH water q.s.

Viaspan was entered under the provision for other modified starches in subheading 3505.10.00, HTSUS. However, Customs liquidated the entries under the provision for other medicaments in subheading 3004.90.60, HTSUS. - 2 -

ISSUE:

Whether Viaspan is classifiable as an modified starch in subheading 3505.10.000, HTSUS, or a mixture in subheading 3823.90.5050, HTSUS.

LAW AND ANALYSIS:

It is now acknowledged that since Viaspan is not used for therapeutic purposes, it is not classifiable as medicament in heading 3004, HTSUS. In fact, in September 1992, Customs issued a decision classifying Viaspan as a mixture in 3823.90.5050. (NYRL 877022)

In behalf of the importer it is claimed that Viaspan is classifiable as a modified starch, since this is its largest component and gives the product its essential character. General Rule of Interpretation 3(b), HTSUS. A statement from a research director of Dupont Merck is to the effect that Viaspan's purpose is to prevent destruction of the cells of the organs once they are out of the body, and that the modified starch is the only active ingredient; all of the "other constituents are considered inactive ingredients." While Viaspan is admitted not to be a 100 percent etherified starch, it is the largest component; the one, it is claimed, which performs the organ preservation function of the solution.

If, in fact, the above claims were true, there might be some merit to the argument that classification should be based on the product's essential character. However, it is believed that all of the components play a role in the solution's preservative function - the etherified starch is an element in controlling the osmotic cellular pressure; the monobasic potassium phosphate, magnesium sulphate heptahydrate, potassium hydroxide and sodium hydroxide all help to maintain the proper ph environment so that the organ will remain viable ex vivo; allopurinol is an oxidase inhibitor which decreases cell waste production and the raffinose pentahydrate provides readily available nourishment to the cells. Thus, it is the combination of all the components of the mixture which give Viaspan its preservation qualities.

HOLDING:

Viaspan is classifiable under the provision for other chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included, in subheading 3823.90.5050, HTSUS. - 3 -

The protest is denied, except to the extent that the reclassification as indicated above results in a partial allowance.

A copy of this decision should be attached to the From 19 Notice of Action sent to the protestant.

Sincerely,

John Durant, Director

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