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HQ 963035




December 9, 1999

CLA-2 RR:CR:GC 963035 MGM

CATEGORY: CLASSIFICATION

TARIFF NO.: 3822.00.5090

David M. Murphy, Esq.
Grunfeld, Desiderio, Lebowitz & Silverman LLP 245 Park Avenue
New York, NY 10167-0002

RE: Prosep® affinity chromatography media; NY 815127; NY 817126

Dear Mr. Murphy:

This office has determined that New York Ruling Letter (NY) 815127, dated October 6, 1995, issued to you on behalf of Bioprocessing Ltd., concerning the tariff classification of several affinity chromatography media, is partially in error. That ruling classified Prosep-A® and Prosep-G® chromatography media, as well as several other types of chromatography media, in subheading 3822.00.1010, Harmonized Tariff Schedule of the United States (HTSUS), as “[d]iagnostic or laboratory reagents on a backing...: containing antigens or antisera: [c]ontaining methyl chloroform (1,1,1-trichloromethane) or carbon tetrachloride.” NY 815127 was later amended by NY 817126, dated December 5, 1995, which advised you that the incorrect statistical suffix was provided and therefore these items were reclassified in subheading 3822.00.1090, HTSUS. This provision differs from subheading 3822.00.1010, HTSUS, in that it is for merchandise “other” than that containing methyl chloroform (1,1,1-trichloromethane) or carbon tetrachloride.

Upon review of NY 815127, as amended by NY 817126, Customs has concluded that Prosep-A® and Prosep-G® chromatography media are properly classified in subheading 3822.00.5090, HTSUS, the provision for “[d]iagnostic or laboratory reagents on a backing...: [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, 2186), notice of the proposed revocation was published on November 3, 1999, in Volume 33, Number 44 of the CUSTOMS BULLETIN. No comments were received in response to this notice.

FACTS:

Prosep-A® and Prosep-G® chromatography media consist of fine, porous high silica glass beads to which protein A or protein G ligands, respectively, have been affixed. Protein A and protein G ligands bind selectively to immunoglobulin G such that they are useful in column separation processes. Protein G ligand binds more efficiently to bovine, goat, and sheep immunoglobulin G than does protein A.

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 antigen thereby identifying it as a target for immunological attack. Immunoglobulin G is also capable of binding to protein A and protein G. However, it does not bind to protein A or protein G 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 and protein G, while the antigen-binding fragments (Fab) of immunoglobulin G bind with compatible antigens. Neither protein A nor protein G stimulates the immune response.

ISSUE:

Is protein A or protein G 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 815127, as amended by NY 817126, Prosep-A® and Prosep-G® chromatography media were classified in subheading 3822.00.10, HTSUS, as diagnostic or laboratory reagents 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 and protein G are somewhat similar to antigens in that each binds to an antibody, immunoglobulin G, however they do not induce an immune response and do not bind to the antigen-binding fragments of immunoglobulin G. Thus, neither protein A nor protein G is an antigen. See Headquarters Ruling Letter 962429, dated October 13, 1999, for a similar ruling.

HOLDING:

Protein A and protein G based chromatography media, including Prosep-A® and Prosep-G® chromatography media, are classified in subheading 3822.00.5090, HTSUS, as diagnostic or laboratory reagents not containing antigens or antisera.

NY 815127 and NY 817126 are modified.

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

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