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HQ 967094




May 11, 2006

CLA-2 RR:CTF:TCM 967094 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 3906.90.50

Mr. Arnaud Schmutz
Biosepra Inc.
111 Locke Drive
Marlborough, MA 01752

RE: HQ 962429; Protein A HyperD, Protein A HyperD 20 μm and Protein A Ceramic HyperD F chromatography media

Dear Mr. Schmutz:

This is in reference to Headquarters Ruling Letter (HQ) 962429, dated October 13, 1999, regarding the classification of Protein A HyperD, Protein A HyperD 20 μm and Protein A Ceramic HyperD F chromatography media, pursuant to the Harmonized Tariff Schedule of the United States (HTSUS). In HQ 962429, we revoked New York ruling Letter (NY) 890709, dated October 13, 1999, which classified the merchandise in subheading 3822.00.10, as a reagent containing antigens, and classified the merchandise in subheading 3822.00.5090, HTSUS as a reagent not containing antigens. We have reviewed the ruling and find it to be incorrect in that the merchandise is not a reagent.

Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by Title VI, a notice was published in the March 15, 2006, CUSTOMS BULLETIN, Volume 40, Number 12, proposing to revoke Headquarters Ruling Letter (HQ) 962429, dated October 13, 1999, and New York Ruling Letter (NY) D84807, dated December 9, 1998, and to revoke any treatment accorded to substantially identical transactions. No comments were received in response to that notice.

FACTS:

In HQ 962429, we described the products thus:

‘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 20 μm’ 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.

The importer’s technical information states:

Ceramic HyperD affinity media are composite materials in bead form constituted of a co-polymeric crosslinked network distributed inside the pores of mineral ceramic composite particles. . . .

Mineral ceramic composite material acts as a solid skeleton, while polymer moity governs the exchange mechanism for macromolecule or particle adsorption. Mineral moiety is a mixture of sintered zirconium and calcium silicates obtained at very high temperature. The mineral surface is totally covered by a layer of organic polymer to revent any non-specific adsorption.

The hydrogel copolymer—carrying adsorption sites—is constructed by an in situ radical co-polymerization in association with cross-linking agents. The role of a crosslinker is to provide a tridimensional network insoluble in any solvent thus preventing any possible leakage of polymeric chains when in use. Affinity ligands are chemically attached onto the hydrogel. . . . .

ISSUE:

Are chromotography sorbents “analytical reagents” of heading 3822, HTSUS, or are they classified as to their essential character as “acrylic polymers” in heading 3906, 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).

The HTSUS provisions under consideration are as follows:

Diagnostic 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; certified reference materials:

Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006:

3822.00.50 Other

3906 Acrylic polymers in primary forms:

Other

Other

3906.90.5000 Other

EN 38.22 states, in pertinent part, the following:

This heading covers diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents, other than diagnostic reagents of heading 30.02 or diagnostic reagents designed to be administered to the patient and blood grouping reagents of heading 30.06. . . . Prepared laboratory reagents include not only diagnostic reagents, but also other analytical reagents used for purposes other than detection or diagnosis. Prepared diagnostic and laboratory reagents may be used in medical, veterinary, scientific or industrial laboratories, in hospitals, in industry, in the field or, in some cases, in the home.

In HQ 962429, we classified these substances as analytical reagents under GRI 1. We now believe this is incorrect. A reagent is “a substance employed as a test to determine the presence of some other substance by means of the reaction which is produced. Now, any substance employed in chemical reactions.” The Compact Oxford English Dictionary, Second Edition ( p. 271, 1991). Such substances are also called reactants. A reactant is defined as “a substance that is consumed in the course of a chemical reaction. It is sometimes known, especially in the older literature, as a reagent, but this term is better used in a more specialized sense as a test substance that is added to a system in order to bring about a reaction or to see whether a reaction occurs (e.g. an analytical reagent).” Compendium of Chemical Terminology, IUPAC Recommendations, Second Edition. (p. 342, 1997).

Typically, a reagent is mixed with another chemical, reacts with it, and is consumed in that reaction, creating a different set of chemicals. For instance, silver nitrate is a reagent used for the detection of certain halide ions (chloride, iodide, bromide), particularly for chloride. When clear silver nitrate and sodium chloride solutions are combined, the silver and chloride ions react with one another to form a silver chloride solid precipitate and a solution of sodium nitrate. Hence, the addition of silver nitrate to a clear sodium chloride solution allows one to detect the presence of chloride in the solution, because the white silver chloride precipitate could not have formed without its presence.

Separation media are not involved in such a reaction. Although separation media may contribute to the analysis of mixtures by separating them into their constituent parts, there is no chemical reaction that consumes the “reagent.” Rather, the instant sorbents are used in “adsorption chromatography,” the “separation of a chemical mixture (gas or liquid) by passing it over an adsorbent bed which adsorbs different compounds at different rates.” “Adsorption” is defined as “the surface retention of solid, liquid, or gas molecules, atoms, or ions by a solid or liquid . . . .” McGraw-Hill Dictionary of Scientific and Technical Terms, Fifth Ed., Parker, Sybil P., ed. (1994, p. 38). While the ENs specifically include a seemingly broad spectrum of reagents, including “other analytical reagents used for purposes other than detection or diagnosis,” separation media cannot be considered a reagent, analytical or otherwise, as explained above.

The HQ ruling recognizes that the substances are composite goods, yet fails to proceed to GRI 3 in classifying the substances. Cross-linked polymeric hydrogel is classifiable in heading 3906, HTSUS, as an “acrylic polymer,” and the porous ceramic substrate of zirconia and calcium silicates is classifiable elsewhere.

The hydrogel completely encloses the substrate. Therefore, the nature of each sorbent product only depends upon the composition of the hydrogel and is not affected by any potential chromatographic activity of the substrate. The hydrogel contains the ligand that captures the intended molecule whereas the porous mineral ceramic particles act as a rigid skeleton that improves the functioning of these products as chromatography media. Hence, under GRI 3(b), the essential character of the separation media is imparted by the hydrogel. This means that for Protein A HyperD, Protein A HyperD 20 μm and Protein A Ceramic HyperD F chromatography media, only heading 3906, HTSUS, the provision for “acrylic polymer” describes the material that gives the product its essential character.

HOLDING:

By application of GRI 3(b), Protein A HyperD, Protein A HyperD 20 μm and Protein A Ceramic HyperD F chromatography media, in bulk form, are classified in subheading 3906.90.50, HTSUS, the provision for "Acrylic polymers in primary forms: Other: Other: Other." The duty rate is 4.2% ad valorem.

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.

EFFECT ON OTHER RULINGS:

HQ 962429 is revoked.

In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after publication in the Customs Bulletin.

Sincerely,

Myles B. Harmon, Director

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