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