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HQ 952179


September 30, 1992

CLA-2 CO:R:C:F 952179 EAB

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.39.0010

Martha A. Pierce, Import Specialist
Monsanto Agricultural Company
800 N. Lindbergh Boulevard
St. Louis, Missouri 63167

RE: Sometribove-zinc complex bovine somatotropin (BST); Posilac; bovine growth hormone; hormones; medicaments; 2937

Dear Ms. Pierce:

This is in reply to your letter dated May 21, 1992, in which you requested a written ruling on the classification of sometribove-zinc complex bovine somatotropin (BST) under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).

Although technical and scientific literature accompanies your request, no sample has been submitted to Customs.

FACTS:

Bovine somatotropin is a natural protein hormone produced in the pituitary glands of all cattle. When added to cattle feed, it promotes growth in young calves and milk production in mature cows.

Monsanto's sometribove-zinc complex BST ("Posilac") is a recombinant analogue of the naturally occurring hormone that is formulated with a sesame oil/aluminum monostearate excipient. The product will be provided commercially in single-dose plastic syringes that will be packaged 25 to a box containing needles and instructions for use by dairymen to augment the milk production of lactating cows.

The substance is manufactured in Austria. Following solution preparation are the fermentation, isolation, purifica- tion and freeze-drying steps in the production run, in the final step of which the bulk powder is mixed with sterilized excipient to yield the sterile, bulk formulated sometribove-zinc complex. The sterile formulation is then aseptically filled into unit- dose syringes which are then labelled and packaged for final use. Measuring and packaging may occur in Austria or Netherlands.

ISSUE:

What is the classification of sometribove-zinc complex bovine somatotropin formulated with an excipient and put up in measured doses to augment milk production in lactating cows?

LAW AND ANALYSIS:

Merchandise imported into the U.S. is classified under the HTSUSA. The tariff classification of merchandise under the HTSUSA is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context which otherwise requires, by the Additional U.S. Rules of Interpretation.

GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRI's taken in order.

Note 2, Section VI, HTSUSA, provides in part that goods classifiable in heading 3004 by reason of being put up in measured doses or for retail sale are to be classified in that heading and in no other heading of the tariff schedule. Since the product is a hormone that has been so put up, we are of the opinion that it is not classifiable under heading 2937, but under heading 3004.

HOLDING:

Sometribove-zinc complex bovine somatotropin formulated with an excipient and put up in measured doses to augment milk production in lactating cows is classifiable under subheading 3004.39.0010, HTSUSA, a provision for medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses; put up in measured doses or in forms or packings for retail sale; containing hormones or other products of heading 2937 but not containing antibiotics; other; for veterinary use.

Entries of merchandise classified under this subheading are dutiable at the column one general rate of 3.9 percent ad valorem.

Sincerely,

John Durant, Director
Commercial Rulings Division?

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