CLA-2 CO:R:C:F 088828 EAB
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.
FACTS:
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.
ISSUE:
What is the proper tariff classification under the HTSUSA of
the adsorbent and apparatus used to purify biochemicals employing
an affinity chromatography technique?
LAW AND ANALYSIS:
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.
HOLDING:
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.
Sincerely,
John Durant, Director
Commercial Rulings Division