CLA-2 RR:CR:GC 962437 MGM
Donald J. Gibbs
Manager of Manufacturing
Repligen Corporation
117 Fourth Avenue
Needham, MA 02494
RE: Repligen Protein A chromatography media; HQ 962429; HQ 963035
Dear Mr. Gibbs:
This is in response to your letter of November 6, 1998, in which you requested a binding ruling as to the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of a certain chromatography medium. We regret the delay.
FACTS:
Chromatography is a process where a mixture or solution is passed over or through some stationary medium and compounds are separated from one another based on their differing affinity for that medium. The chromatography medium at issue consists of Protein A ligands bound to agarose beads. Protein A ligands bind selectively to immunoglobulin G such that they are useful in isolating immunoglobulin G.
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. 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 the past, Customs classified merchandise similar to the instant goods in subheading 3822.00.10, HTSUS, as diagnostic or laboratory reagents containing antigens. See New York Ruling Letter (NY) 890709, dated November 29, 1993; NY 815127, dated October 6, 1995, as amended by NY 817126, dated December 6, 1995. 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. Customs has recently reclassified similar merchandise to reflect this analysis. See Headquarters Ruling Letter (HQ) 962429, dated October 13, 1999, and HQ 963035, dated December 9, 1999, for similar rulings.
HOLDING:
Protein A based chromatography media is classified in subheading 3822.00.5090, HTSUS, as diagnostic or laboratory reagents not containing antigens or antisera.
Sincerely,
John Durant, Director
Commercial Rulings Division