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HQ 088828

July 3, 1991

CLA-2 CO:R:C:F 088828 EAB


TARIFF NO.: 8421.99.0080

Joan V. Greenwood, Owner
Lexton Scientific International
Suite 200
211 East Ocean Boulevard
Long Beach, CA 90802

RE: Affinity chromatography gels and apparatus

Dear Ms. Greenwood:

This is in reply to your letter dated October 20, 1990, in which you request a binding ruling on the tariff classification under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) of affinity chromatography media and laboratory equipment for the use thereof.

In lieu of samples of either the media or the apparatus, you submitted scientific literature explaining the function and use of each.


Affinity chromatography is a procedure used to obtain a purification of biomolecules by employing a stationary solid phase, the adsorbent, consisting of a gel matrix such as agarose to which a selective ligand has been chemically coupled, and passing through it, or eluting, a particular liquid. Typical natural ligands for the manufacture of biospecific adsorbents are enzymes, antigens, hormones, boronic acid, deoxycholic acid and textile dyes.

Your company has developed and trademarked a synthetic line of ligands, MIMETIC TM. Their covalent bonding properties in the agarose based gel matrix of the adsorbent make them highly selective, such that purification of a given biochemical liquid through affinity chromatography is to a much greater degree than that achieved with natural ligands. You wish to import the MIMETIC TM gels in tubes. The apparatus that you wish to import, a Protein Isolation Kit (PIK), holds up to ten tubes, each tube filled with a different adsorbent. The idea is to take a sample biochemical, admit a volume of it to each tube, then separately analyze the ten eluents to determine which matrix afforded the highest purification. While the PIKs necessarily will be imported with MIMETIC TM filled tubes, you intend to import, as well, just MIMETIC TM filled tubes.


What is the proper tariff classification under the HTSUSA of the adsorbent and apparatus used to purify biochemicals employing an affinity chromatography technique?


Merchandise imported into the U.S. is classified under the HTSUSA. The tariff classification of merchandise under the HTSUSA is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context which otherwise requires, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUSA and are to be considered statutory provisions of law for all purposes. See Sections 1204(a) and (c) of the Omnibus Trade and Competitive Act of 1988 (19 U.S.C. 1204(a) & (c)).

GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule (i.e., (1) merchandise is to be classified under the 4-digit heading that most specifically describes the merchandise; (2) only 4-digit headings are comparable; and (3) merchandise must first satisfy the provisions of a 4-digit heading before consideration is given to classification under a subheading within this 4-digit heading) and any relative section or chapter notes and, unless otherwise required, according to the remaining GRI's taken in order.

We note that chromatographs and parts and accessories thereof are classified eo nomine under subheading 9027.20, HTSUSA. The superior heading thereof provides in part for "Instruments and apparatus for physical or chemical analysis * * * ; parts and accessories thereof." Emphasis supplied. This is a use provision, corresponding to item 711.88 under the former Tariff Schedule of the United States, which was subjected to analysis in Pharmacia Fine Chemicals, Inc. vs. U.S., 9 CIT 438 (1985). In determining the common meaning of the term "chemical analysis", the court stated that an instrument or apparatus is used for chemical analysis -

If it determines one or more ingredients of a substance either as to kind or amount; or if it performs a detailed examination of a complex chemical substance for the purpose of enabling one to understand its nature or to determine an essential feature; or if it determines what elements are present in a chemical substance.
id., 440, citations omitted. We are of the opinion that neither the adsorbents nor the PIKs are such instruments or apparatus, nor parts thereof. From the literature provided, the absence of a detector or any kind of digital, analogue or graphic device excludes them from being considered a chromatograph; they do not provide one with analytical data. Furthermore, and again from the literature provided, the PIKs are manufactured and intended to be used as stand-alone devices to provide highly purified biochemicals, and it is those eluents which subsequently and separately must be analyzed to determine their degree of purity. In other words, we find that the PIKs are not parts of analytical instruments. As to the MIMETIC TM adsorbents, we dismiss out of hand any consideration of them as being themselves "instruments"; we are of the opinion, however, that they are "parts". "The mere fact that two articles are designed to be used together is not alone sufficient to establish that either is a part of the other * * * It must also be shown that the article claimed to be a part subserves an essential purpose in the thing for which it is destined * * * 'the determining fact is not whether the alleged part can be used without the article, but whether the article can be used for its intended purpose without that part.'" Westfield Manufacturing Company vs. U.S., 191 F.Supp. 578, 580-581, (Cust.Ct. 1961), citations omitted. Whereas the PIKs cannot be used without the adsorbents, clearly the adsorbents are parts of the PIKs.

Heading 8421 provides in part for purifying apparatus and parts thereof. We are of the opinion that both the adsorbents and the PIKs are properly classifiable under this heading. We find that the PIKs are properly classifiable under subheading 8421.29.0050, HTSUSA, as are the adsorbents, being parts thereof.


Protein Isolation Kits and MIMETIC TM agarose based synthetic ligands are properly classified under subheading 8421.29.0050, HTSUSA, which provides for purifying apparatus, for liquids or gases; parts thereof; purifying apparatus for liquids; other; other. Merchandise classified under this subheading is subject to a 3.9% ad valorem rate of duty.


John Durant, Director
Commercial Rulings Division

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