CLA-2 RR:CR:GC 962429 MGM
Mr. Arnaud Schmutz
BioSepra Inc.
111 Locke Drive
Marlborough, MA 01752
RE: “ProteinA Ceramic HyperD F,” “ProteinA Ceramic HyperD 20µm” and “Protein A Hyper D” Chromatography Media; NY 890709
Dear Mr. Schmutz:
This is in response to your letter of August 19, 1998, to the Customs National Commodity Specialist Division in New York, requesting a binding ruling, under the Harmonized Tariff Schedule of the United States (HTSUS), for “ProteinA Ceramic HyperD F” and “ProteinA Ceramic HyperD 20µm” chromatography media. Your letter was referred to this office for reply. We regret the delay.
New York Ruling Letter (NY) 890709, issued to Sepracor Inc., your predecessor in interest, on November 29, 1993, classified a similar product, “Protein A HyperD” chromatography medium, in subheading 3822.00.1090, HTSUS, which provides for “[d]iagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 3002 or 3006: [c]ontaining antigens or antisera:[o]ther.”
Upon further consideration of this matter, we have concluded that the correct classification of Protein A based chromatography media is under subheading 3822.00.5090, HTSUS, which provides for “[d]iagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 3002 or 3006: [o]ther: [o]ther.”
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 Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), notice of the proposed revocation of NY 890709 was published on September 8, 1999, in the CUSTOMS BULLETIN, Volume 33, Number 35/36. No comments were received in response to that notice.
FACTS:
“Protein A HyperD” chromatography medium consists of polystyrene beads bound to a number of Protein A ligands. “ProteinA Ceramic HyperD F” and “ProteinA Ceramic HyperD 20µm” differ from “Protein A HyperD” in that the bead substrate is a composite material of mineral ceramic and copolymer rather than polystyrene. Protein A ligands bind selectively to immunoglobulin G such that protein A based chromatography media are useful in column separation processes.
Immunoglobulin G is an antibody which is produced as part of the body’s immune response to the presence of certain foreign bodies called antigens (antibody generators). Immunoglobulin G binds to the antibody thereby identifying it as a target for immunological attack. Immunoglobulin G is also capable of binding to protein A. However, it does not bind to protein A in the same manner as it would bind to an antigen. It is the crystallizable fragment (Fc) portion of immunoglobulin G which binds to protein A, while the antigen-binding fragments (Fab) of immunoglobulin G bind with compatible antigens. Protein A does not stimulate the immune response.
ISSUE:
Is protein A an antigen such that protein A based chromatography media are diagnostic or laboratory reagents containing antigens of subheading 3822.00.10, HTSUS?
LAW AND ANALYSIS:
Merchandise imported into the United States 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 which 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 for all purposes.
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 understanding the language of 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).
In NY 890709 “Protein A HyperD” chromatography medium was classified in subheading 3822.00.10, HTSUS, as a diagnostic or laboratory reagent containing antigens. An antigen is “any substance which is capable, under appropriate conditions, of inducing a specific immune response and of reacting with the products of that response.” Dorland’s Medical Dictionary, 27th ed., 1988. Protein A is somewhat similar to an antigen in that it binds to an antibody, immunoglobulin G, however it does not induce an immune response and does not bind to the antigen-binding fragments of immunoglobulin G. Thus, protein A is not an antigen.
HOLDING:
Protein A based chromatography media, including “ProteinA Ceramic HyperD F” “ProteinA Ceramic HyperD 20µm” and “Protein A Hyper D” chromatography media are classified in subheading 3822.00.5090, HTSUS, as diagnostic or laboratory reagents not containing antigens or antisera.
NY 890709 is revoked. In accordance with 19 U. S.C. 1625(c)(1), this ruling will become effective 60 days after its publication in the CUSTOMS BULLETIN.
Sincerely,
John Durant, Director
Commercial Rulings Division