CLA-2 R:C:F 957738K

Port Director
U.S. Customs Service
10 Causeway St.
Boston, Massachusetts 02222-1059

RE: Application For Further Review of Protest No. 0401-94-100724; Human Placental Extract

Dear Port Director:

The following is our response to the referral by your office of the request for further review of the above-referenced protest received on March 20, 1995.

FACTS:

The consumption entries covering the merchandise imported from France, were liquidated between September 16, 1994 and November 18, 1994, under the provision for extracts of glands or other organs or of their secretions, subheading 3001.20.0000, Harmonized Tariff of the United States (HTSUS) (1994), with duty at the general rate of 1.5 percent ad valorem. (The rate of duty for 1995 and for 1996 is a free rate.) A timely protest under 19 U.S.C. 1514 was received on December 15, 1994. The protestant requested reliquidation of the entries under the provision for other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included, in subheading 3001.90.0000, HTSUS (1994), with a free rate of duty. A meeting was requested and held on May 2, 1996, at which time additional information was submitted. A further submission dated May 20, 1996, was submitted containing additional grounds and technical information to support the protestant's position. The merchandise consists of an ethanol extract derived from pressing and centrifugation of human placental tissue. After importation, the merchandise is used in the production of a product to treat Gaucher's disease.

ISSUE:

The issue is whether the term "organotherapy" includes the treatment of disease by the administration of human organs or extracts of glands or other organs or their secretions as well as those of animal origin so that the merchandise described above may be classified in subheading 3001.20.0000, HTSUS.

LAW AND ANALYSIS:

Heading 3001 and the subheadings of heading 3001, HTSUS, are as follows.

Heading 3001--Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secre- tions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included:

Subheading 3001.10.00--Glands and other organs, dried, whether or not powdered....... Subheading 3001.20.0000--Extracts of glands or other organs or of their secretions...... Subheading 3001.90.0000--Other........

The Explanatory Notes (EN) to the Harmonized Commodity Description and Coding System, represent the official interpretation of the tariff at the international level, facilitate classification under the HTSUS by offering guidance in understanding the scope of the headings and General Rules of Interpretation of the HTSUS. The protestant cited section (A) of the EN which refers to heading 3001 as covering "Glands and other organs of animal origin for organo-therapeutic uses..." to support the position that subheadings 3001.10.00 and 3001.20.0000, HTSUS, do not cover glands and other organs or extracts of glands or other organs or of their excretions that are of human origin and since the merchandise is of human origin, it is classified in subheading 3001.90.0000, HTSUS. The protestant furthers questions whether the merchandise is organotherapeutic, because, in its condition as imported, it is claimed that the extract has to under go further processing to produce a substance that has therapeutic potential. We do not accept either of these positions and dispense with discussion and proceed to consider the more important argument set forth by the protestant.

Heading 3001 provides, in part, for extracts of glands or other organs or of their secretions for organotherapeutic uses. Subheading 3001.20.0000, HTSUS, provides for extracts of glands or other organs or of their secretions. However, the heading requires that the merchandise covered by the subheading must be for "organotherapeutic uses".

Webster's Third New International Dictionary, unabridged (1968) defines the term "organotherapeutic" as "of, relating to, or used in organotherapy". The term "organotherapy" is defined as "a treatment of disease by the administration of animal organs or of their extracts". Other dictionaries contain similar definitions. The protestant opines that since the merchandise is of human rather than animal origin, it cannot be classified in subheading 3001.20.0000, HTSUS, as extracts of glands or other organs or of their secretions for organotherapeutic uses. Therefore, the protestant concludes that the merchandise is classified in the basket provision for other human or animal substances prepared for therapeutic or prophylactic uses not elsewhere specified or included, in subheading 3001.90.0000, HTSUS.

The protestant submitted technical information tracing the history of the origins of organotherapy to support the position that organotherapy only included animal organs or their extracts used in the treatment of disease. Our own technical research tends to support the protestant's position. Based upon the available information, we conclude that the term "organotherapy" does not include the treatment of disease by the administration of extracts of glands or other organs or their secretions of human origin.

The protestant also cites New York Ruling Letter 870664, dated February 12, 1992, and Headquarters Ruling Letter 089240, dated May 29, 1991, which held that skin tissues of human origin were classified in subheading 3001.90.0000, HTSUS, as other human or animal substances prepared for therapeutic or prophylactic uses. HOLDING:

The merchandise as described above, human placental tissue used in the treatment of Gaucher's disease, is classified as other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included, in subheading 3001.90.0000, HTSUS, with a 1994 free general rate of duty.

You are directed to allow the protest in full. In accordance with Section A(11)(b) of Customs Directive 099 3550-065, Revised Protest Directive, dated August 4, 1993, a copy of this decision attached to Customs Form 19, Notice of Action, should be provided by your office to the protestant no later than 60 days from the date of this decision and any reliquidations of entries in accordance with this decision must be accomplished prior thereto. Sixty days from the date of this decision the Office of Regulations and Rulings will take steps to make this decision available to Customs personnel via the Customs Rulings Module in ABCS and the public via the Diskette Subscription Service, Freedom of Information Act and other public access channels.

Sincerely,

John Durant, Director
Tariff Classification
Appeals Division