CLA-2 CO:R:C:F 088813 EAB
Matthew T. McGrath, Esquire
Barnes, Richardson & Colburn
1819 H Street, N.S.
Washington, D.C. 20006
Re: Classification of MP-633 and Ioversol
Dear Mr. McGrath:
This is in reply to your letter dated April 11, 1991, in
which you requested on behalf of Mallinckrodt Medical, Inc., a
binding ruling on the tariff classification under the Harmonized
Tariff Schedule of the United States Annotated (HTSUSA) of two
organic chemical compounds, MP-633 and Ioversol. You requested
confidential treatment of the chemical structure and chemical
name of compound MP-633, asserting under 5 U.S.C. 552(b)(4) that
each is a trade secret and any publication of either may cause
severe harm to your client's competitive position. By your
letter dated May 21, 1991, "The claim for confidentiality of
information relating to the chemical name, chemical structure,
and descriptions of improvements in the structure, of MP-633 is
hereby terminated."
Additional facts and arguments were presented at a meeting
held in U.S. Customs Service Headquarters on May 9, 1991, and in
a supplemental written submission dated May 21, 1991.
Attached to your initial and supplemental submissions were
structural diagrams of each compound. Three-dimensional models
of Ioversol and diatrizoic acid were presented at the
aforementioned meeting.
FACTS:
Several of the chemicals under consideration are used in a
medical setting as ingredients of substances injected for
radiographic diagnostic purposes. MP-633 is used in the U.S. to
manufacture an opacifying agent to be known as Ioversol. You
have given MP-633 the chemical name 5-[N-2-Acetoxyethyl)
acetoxyacetamido]-N,N'-bis(2,3-diacetoxypropyl)-2,4,6-
triiodoisophthalamide. You have given Ioversol the chemical name
N,N'-bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl)-glycolamido]-
2,4,6-triiodoisophthalamide. Examples of currently used X-ray
contrast agents are diatrizoic acid, metrizoic acid, iothalmic
acid and biligrafin acid, desirable characteristics of which
include high water solubility, low reactivity, low toxicity, low
osmolality, and low viscosity. Ioversol has been developed by
Mallinckrodt Medical, Inc., as another radiographic diagnostic
with characteristics that give it greater clinical desirability.
As stated during a meeting at U.S. Customs Headqurters on May 9,
1991, MP-633, developed by Mallinckrodt Medical, Inc., cannot be
used, in and of itself, as a radiographic diagnostic because it
is not water soluble. The common denominator of all of the
foregoing compounds, the radiographics and the intermediary, is
triiodobenzene, i.e., all of the compounds are derivatives of
triiodobenzene.
Diatrizoic acid, metrizoic acid and biligrafin acid and no
other compounds are classified eo nomine under subheading
2924.29.0500, HTSUSA. You are of the opinion that, having
similar structures and purposes to the foregoing compounds, both
MP-633 and Ioversol should be classified thereunder.
In your supplemental submission of May 21, 1991, you
withdrew that portion of your ruling request seeking
classification of the subject compounds as acyclic amides under
subheading 2924.10.1050, HTSUSA.
ISSUE:
What is the proper tariff classification under the HTSUSA of
the organic chemical compounds MP-633 and Ioversol?
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.
Pursuant thereto, and as the parties clearly agree, MP-633
and Ioversol are properly classified under subheading 2924.29,
HTSUSA. The question remains, how are they to be classified at
the national level?
You are of the opinion that MP-633 and Ioversol should be
classified under subheading 2924.29.0500, HTSUSA, asserting that
each compound is a radiographic diagnostic, just as are
diatrizoic, metrizoic and biligrafin acids. It is your belief
that each compound "possesses an essential resemblance to" the
three aromatic carboxy-amide function compounds set out in
subheading 2924.29.0500 (citing in part Smillie & Co. v. U.S., 12
Ct. Cust. App. 365, 367 (1924), wherein the court had to
determine the proper classification of ferromanganese according
to the definite trade understanding and designation of the term),
and conclude that classification of MP-633 and Ioversol under the
foregoing subheading is warranted as the difference between the
eo nomine compounds and the subject compounds is "in the nature
of an improvement, the essential character" of the eo nomine
compounds "being preserved or only incidentally altered," citing
in part FAG Bearings, Ltd. v. U.S., 9 CIT 227, 229 (1985), the
court therein relying on Robert Bosch Corp. v. U.S., 63 Cust. Ct.
96, 104 (1969) and other cases cited therewith.
In Bosch, supra, the court was called upon to decide the
proper classification of automobile flasher units, back-up light
assemblies and starter solenoid switches. Customs had classified
the articles as "electrical switches, relays * * *, and other
electrical apparatus for making or breaking electrical circuits,"
a use provision; the importer claimed that the flasher units and
back-up light assemblies were more properly classifiable as
"electric lighting equipment designed for motor vehicles, and
parts thereof," an unlimited eo nomine provision, and that the
starter solenoid switches were more properly classifiable as
"ignition magnetos * * * and other electrical starting and
ignition equipment for internal combustion engines * * *; all the
foregoing and parts thereof," another unlimited eo nomine
provision. Stating that "electrical switches" are not "lighting
equipment" per se, and in view of the statutory rule of
interpretation, then General Interpretative Rule 10(ij), Tariff
Schedule of the United States, which provided "that a provision
for 'parts' 'does not prevail over a specific provision for such
part,'" the court held that Customs classification of the flasher
units and back-up light assemblies was proper, See Bosch, supra
at 102. With regard to the starter solenoid switches, the court
found that they were designed to and in fact did function both
mechanically and electrically, i.e., the electrical "switching"
of the device caused the mechanical propulsion and retraction of
a shaft that meshed with the starter motor, thus enabling the
automobile to be started "electrically" with an ignition key
rather than simply mechanically with, e.g., a crank. Finding
thusly, the court stated, "The principle is well settled that
where an article is in character or function something other than
as described by a specific statutory provision - either more
limited or more diversified - and the difference is significant,
it cannot find classification within such provision. It is said
to be more than the article described in the statute. [citations
omitted]" Bosch, supra, at 103-104. In obiter dictum immediately
following the foregoing, the court stated, "By contrast where the
difference is in the nature of improvement or amplification, and
the essential character is preserved or only incidentally
altered, the applicable rule is [citation omitted], that an
unlimited eo nomine statutory designation includes all forms of
the article in the absence of a contrary legislative intent or
commercial designation. [citations omitted]", id., at 104. The
court held that the starter solenoid switches were not electrical
switches, but other electrical starting and ignition equipment
for internal combustion engines, thereby giving the plaintiff a
partial victory.
We find the entirety of the foregoing quotation to be
instructive in this case. Diatrizoic acid, metrizoic acid and
biligrafin acid and no other compounds are listed eo nomine in
subheading 2924.29.0500, HTSUSA, which subheading is clearly a
limited, not unlimited provision. Both MP-633 and Ioversol are
something other than any of the compounds specifically identified
therein. MP-633 is more limited since it cannot be used as a
radiographic diagnostic. Ioversol is clearly, painstakingly and
intentionally so, more than any of the three compounds.
In Smillie, supra, the court was faced with a challenge to
Customs classification of a material alleged by the importer to
be other than ferromanganese. The court stated that "'a
commercial designation must be one existing and recognized in the
trade and commerce at and prior to the date of the tariff act in
which such designation occurred [citation omitted]' * * * This
rule, of course does not operate to exclude articles which are
not known at the time of the passage of the act, but which come
into being later. As to all such articles, the statute will be
held to apply if the articles possess an essential resemblance to
the ones named in the statute in those particulars which the
statute established as the criteria of the classification
[citation omitted]. But here no such question arises * * * the
term ferromanganese had a definite, uniform, and general meaning
and understanding in the trade at the time of the passage of the
tariff act of 1913." In that case, of course, the court was
addressing an eo nomine provision for, among other articles,
ferromanganese, and a limited use provision for materials named
therein together with other alloys used in the manufacture of
steel, not specially provided for.
Nor do we find any such question of essential resemblance
arising in this case. Clearly, there can be no commercial
designation for either MP-633 or Ioversol, since they are newly
developed. Nor can the statute, i.e., the HTSUSA subheading
sought by Mallinckrodt Medical, Inc., be held to apply since
there are no particulars, such as triiodobenzene derivatives,
established thereunder.
We are of the opinion that neither MP-633 nor Ioversol may
be classified under subheading 2924.29.0500, HTSUSA.
Chapter notes are part of the legal text of the HTSUSA and
are to be considered statutory provisions of law for all
purposes. See Sections 1204(a) and 1204(c) of the Omnibus Trade
and Competitiveness Act of 1988 (19 U.S.C. 1204(a) & (c)).
Moreover, as indicated above, chapter notes, together with the
terms of the headings and section notes, are the principal
authority by which merchandise is to be classified under the
schedule. See GRI 1. Therefore, chapter notes are to be
considered mandatory authority for the classification of
merchandise under the HTSUSA.
As provided in Subheading Note 1, Chapter 29, HTSUSA:
Within any one heading of this chapter, derivatives of
a chemical compound (or group of chemical compounds)
are to be classified in the same subheading as that
compound (or group of compounds) provided that they are
not more specifically covered by any other subheading
and that there is no residual subheading named "Other"
in the series of subheadings concerned.
In general consideration of the foregoing and in particular
view of the proviso set forth in the subheading note, we are of
the opinion that both MP-633 and Ioversol, both similar in
structure to iohexol, a triiodoisophthalamide identified in
endnote 191 to Chapter 29, are properly classified under
subheading 2924.29.4400 as other carboxyamide-function compounds
not elsewhere specified or included in the tariff schedule.
HOLDING:
MP-633 and Ioversol are properly classified under subheading
2924.29.4400, HTSUSA, which provides for carboxyamide-function
compounds; cyclic amides; other; aromatic; other; other products
described in additional U.S. note 3 to section VI. Merchandise
classified under this subheading is subject to a 13.5% ad valorem
rate of duty.
Sincerely,
John Durant, Director
Commercial Rulings Division