CLA-2 RR:CR:GC AM W967368
Ms. Rachelle Smith
Nippon Express USA, Inc.
Chicago Air Cargo Branch
95 N. Division St.
Bensenville, Il 60106
Re: Revocation of NY K81624; Protamine Sulfate (CAS 9009-65-8), imported in bulk form
Dear Ms. Smith:
This is in reference to New York Ruling Letter (NY) K81624, dated December 23, 2003, regarding the classification of Protamine Sulfate, pursuant to the Harmonized Tariff Schedule of the United States Annotated (HTSUSA). In that ruling, we classified the substance in subheading 3504.00.50, HTSUS, the provision for “Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: Other.” We have reviewed the ruling and find it to be incorrect. This ruling sets forth the correct classification.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by section 623 of Title VI, Customs and Border Protection (“CBP”) published a notice in the March 2, 2005, Customs Bulletin, Volume 39, Number 10, proposing to revoke New York Ruling Letter (NY) K81624, dated December 23, 2003, and to revoke any treatment accorded to substantially identical merchandise. One comment was received in response to this notice that supported the proposed revocation. The comment identified NY E89213, dated November 2, 1999, which also classified protamine sulfate, the same merchandise, in subheading 3504.00.50, HTSUS. Accordingly, NY E89213 is concurrently revoked in HQ 967663.
FACTS:
Protamine Sulfate is a polypeptide with specific amino acid sequences, extracted and isolated from salmon milt obtained from the testes of the fish. It is used in Insulin preparations for the treatment of Diabetes and as a Heparin antagonist in the treatment of clotting disorders. NY K81624 states that the subject product will be imported in 1 kg and 10 kg sealed polyethylene bags. The 1 kg bags will, in turn, be packed in sealed polyethylene bottles with screw-down caps, while the 10 kg bags will, in turn, be packed in sealed tin cans with tin caps.
ISSUE:
Whether Protamine Sulfate is an extract of a gland for organotherapeutic use, under heading 3001, HTSUS, or a protein substance, not elsewhere specified or included under heading 3504, HTSUS.
LAW AND ANALYSIS:
Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law.
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 GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs.
In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89 80, 54 Fed. Reg. 35127 (August 23, 1989).
The HTSUS provisions under consideration are:
3001: Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included:
3001.20.00 Extracts of glands or other organs or of their secretions......
* * * * * *
3504 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed:
3504.00.50 Other
The pertinent Explanatory Notes to heading 3001, read as follows:
This heading covers :
Glands and other organs of animal origin for organo-therapeutic uses (e.g., the brain, spinal cord, liver, kidneys, spleen, pancreas, mammary glands, testes, ovaries), dried, whether or not powdered.
Extracts of glands or other organs or of their secretions for organo-therapeutic uses, obtained by solvent extraction, precipitation, coagulation or by any other process. These extracts may be in solid, semi-solid or liquid form, or in solution or suspension in any media necessary for their preservation.
The EN to heading 3504 states, in pertinent part, that:
This heading covers:
* * * * *
(B) Other protein substances and their derivatives, not covered by a more specific heading in the Nomenclature, including in particular:
(1) Glutelins and prolamins . . . .
Globulins, . . . .
Glycinin, . . . .
(4) Keratins . . . .
(5) Nucleoprodeids, . . . .
(6) Protein isolates . . . .
“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.” (HQ 957738, dated July 19, 1996). Protamine Sulfate is derived from the testes of fish. This gland is included in EN 30.01 as one of the glands from which extracts of that heading may be derived. Protamine Sulfate is used in the medical treatment of diabetes and clotting disorders. Hence, it is described by the terms of heading 3001, HTSUS, as a glandular extract for organo-therapeutic uses. As such, it is precluded from classification in heading 3504, HTSUS, because it is specified elsewhere.
HOLDING:
Protamine Sulfate is classified in subheading 3001.20.0000, HTSUSA (Annotated), the provision for “Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: Extracts of glands or of other organs or their secretions.” The 2005 column 1, “General” duty rate is free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov/tata/hts.
EFFECT ON OTHER RULINGS:
NY K81624, dated December 23, 2003, is revoked.
Sincerely,
Myles B. Harmon, Director
Commercial Rulings Division