CLA-2 RR:TC:MM 957817 KCC
S. Richard Shostak, Esq.
Stein Shostak Shostak & O'Hara
515 South Figueroa Street, Suite 1200
Los Angeles, California 90071-3329
RE: NY 895684 modified; "Accuset" and "Gemini" intravenous
solution administration sets; 9018.90.75; parts and
accessories of other electro-medical instruments; other
medical instruments and appliances; parts; accessories; EN
90.18; Travenol Laboratories, Inc.; HRLs 085366, 085088,
087704, 955025, 955650 and 951857; Note 2(a) and (b),
Chapter 90; GRI 1 and 3(a); relative specificity
Dear Mr. Shostak:
This is in regards to your letter dated April 6, 1995, on
behalf of Cal Pacifico and IMED Corporation, requesting
reconsideration of New York (NY) 895684 dated April 15, 1994, in
which the Area Director of Customs, New York Seaport, classified
the "Accuset" intravenous solution administration sets as parts
and accessories of other electro-medical instruments and
appliances under subheading 9018.90.75, Harmonized Tariff
Schedule of the United States (HTSUS), and the "Gemini"
intravenous solution administration sets as other medical
instruments and appliances under subheading 9018.90.80, HTSUS.
Specifically, your reconsideration request only concerns the
tariff classification of the "Gemini" intravenous solution
administration sets. Samples were submitted for our examination.
Information submitted at a meeting on August 16, 1995, was taken
into consideration in rendering this decision.
Pursuant to 625(c)(1), Tariff Act of 1930 (19 U.S.C.
1625(c)(1)), as amended by 623 of Title VI (Customs
Modernization) of the North American Free Trade Agreement
Implementation Act (Pub. L. 103-182, 107 Stat. 2057), notice of
the proposed modification of NY 895684 was published on October
11, 1995, in the Customs Bulletin, Volume 29, Number 41. Three
comments were received in response to this notice. Our analysis
of the comments is set forth in the LAW AND ANALYSIS section of
this ruling.
FACTS:
In NY 895684 the Area Director of Customs, New York Seaport,
classified the "Accuset" intravenous solution administration sets
("Accuset" sets) as parts and accessories of other electro-medical instruments and appliances under subheading 9018.90.75,
HTSUS. NY 895684 found that the "Gemini" intravenous solution
administration sets ("Gemini" sets) could operate by gravity as
any other standard intravenous solution administration sets and
therefore, classified the "Gemini" sets as other medical
instruments and appliances under subheading 9018.90.80, HTSUS.
Additionally, NY 895684 held that these sets were not eligible
for preferential tariff treatment under the North American Free
Trade Agreement (NAFTA) pursuant to General Note 12(b)(iv)(B),
HTSUS. However, in Headquarters Ruling Letter (HRL) 956751 dated
October 12, 1995, for purposes of NAFTA, we held that the
"Accuset" and "Gemini" sets were both considered "originating
goods" pursuant to General Note 12(b)(iv)(B), HTSUS, upon meeting
the applicable value content requirement and all other applicable
requirements. As HRL 956751 dealt solely with the NAFTA issue,
it assumed the classification of the "Accuset" and "Gemini" sets
in NY 895684 were correct.
You state that the classification of the "Accuset" sets
under subheading 9018.90.75, HTSUS, in NY 895684 and HRL 956751,
is correct. You now contend that the "Gemini" sets are also
classified under subheading 9018.90.75, HTSUS, as parts and
accessories of other electro-medical instruments and appliances .
Although your reconsideration request concerns only the "Gemini"
sets, it is our opinion that an examination of both the "Gemini"
and "Accuset" sets is necessary.
The articles under consideration are the "Accuset" and
"Gemini" intravenous solution administration sets which are
disposable I.V. tubing assemblies used in the medical industry
for infusions. Both intravenous solution administration sets are
composed of a drip chamber, Y site, slide clamp, roller clamp,
luer adapter and protection cap. The "Accuset" set has an
additional component, a cassette, which will fit into an
electronic infusion pump. A section of the tubing in the
"Gemini" set is made of silicon rubber which is more resilient
than plastic and is suitable for use with the type of pump which
regulates the flow of liquid by compressing and releasing the
silicon tubing. You contend that the "Accuset" and "Gemini" sets
are designed, function, marketed and used with pumps, and,
therefore, are to be classified as parts or accessories of the
pumps.
ISSUE:
Are the "Accuset" and "Gemini" sets classified under
subheading 9018.90.75, HTSUS, as parts and accessories of other
electro-medical instruments and appliances, or under subheading
9018.90.80, HTSUS, as other medical instruments and appliances?
LAW AND ANALYSIS:
The classification of merchandise under the HTSUS is
governed by the General Rules of Interpretation (GRIs). GRI 1,
HTSUS, states:
...for legal purposes, classification shall be determined
according to the terms of the headings and any relative
section or chapter notes and, provided such headings or
notes do not otherwise require, according to the following
provisions [the remaining GRIs].
The subheadings at issue are as follows:
9018.90 Instruments and appliances used in medical, surgical,
dental or veterinary sciences, including scintigraphic
apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories
thereof...Other instruments and appliances and parts
and accessories thereof...
9018.90.75 Other...Electro-medical instruments and
appliances and parts and accessories
thereof...Other...Other....
9018.90.80 Other...Other.
You contend that the "Accuset" and "Gemini" sets are
classifiable as parts or accessories of an electro-medical
instrument under heading 9018, HTSUS. It is our opinion that the
"Accuset" and "Gemini" sets are not classifiable as parts or
accessories of the pump, but as medical instruments and
appliances under heading 9018, HTSUS.
In understanding the language of the HTSUS, the Harmonized
Commodity Description and Coding System Explanatory Notes (ENs)
may be consulted. The ENs, although not dispositive nor legally
binding, provide a commentary on the scope of each heading of the
HTSUS and are generally indicative of the proper interpretation
of these headings. See, T.D. 89-80, 54 Fed. Reg. 35127, 35128,
(August 23, 1989). EN 90.18, pgs. 1487-1493, states that:
This heading covers a very wide range of instruments and
appliances which, in the vast majority of cases, are used
only in professional practice (e.g., by doctors, surgeons,
dentists, veterinary surgeons, midwives), either to make a
diagnosis, to prevent or treat an illness or to operate,
etc.
EN 90.18 proceeds to list numerous exemplars of the type of
medical instruments and appliances which are classifiable under
heading 9018, HTSUS, including needles, surgical knives,
catheters, suction tubes, syringes, intratracheal tubes,
intubation tubes, blood transfusion apparatus. We believe that
the intravenous solution administration sets are similar to the
type of medical instruments and apparatus listed in EN 90.18 and
they are medical instruments and apparatus used by doctors to
treat an illness or operate. Moreover, intravenous solution
administration sets have been classified as medical instruments
or appliances. See, Travenol Laboratories, Inc., v. United
States, C.D. 4812 (1979), which classified an intravenous
solution administration sets under item 709.27, Tariff Schedules
of the United States (TSUS)(the precursor tariff provision to
subheading 9018.90.80, HTSUS), as other medical, dental, surgical
and veterinary instruments, etc.
In HRL 085088 dated March 12, 1990, we considered the
classification of an I.V. solution administration sets, which
consisted of 49 inches of plastic tubing, with a drip chamber and
spike at one end, and a needle adapter with a protective covering
at the other end. The I.V. administration set was used for the
intravenous application of medication, blood serum, glucose
intravenous solution and sodium chloride intravenous solution.
We determined that the set was not classifiable as an electro-medical instrument, nor a part or an accessory of an electro-medical instrument, but as a medical instrument or appliance
under subheading 9018.90.80, HTSUS. In reaching this conclusion,
we stated as follows:
The I.V. Administration Set in question is not an electro-medical instrument or appliance, since it does not operate
by using electricity. Since the electrical functioning of a
dialysis machine does not depend upon the use of an I.V.
Administration Set, the I.V. Administration Set is not a
part of such a machine. Nor is the I.V. Administration Set
an accessory of an electro-medical instrument, since the set
does not supplement or assist the functioning of the
machine. An I.V. Administration Set is merely the
disposable conduit through which blood flows between the
patient and the machine. The set is used once and then
thrown away. Such a conveyance system is not a part or an
accessory.
Similarly, the "Accuset" and "Gemini" sets under
consideration, though designed for use with pumps, cannot be
classified as a part of the pump. Generally, a part of an
article "must be an internal, constituent or component part,
without which the article to which it is joined could not
function." See, HRL 951857 dated August 14, 1992. The pump's
function is to move liquid from a source bag or bottle to a
patient. Although, the pumps cannot move liquid without the sets
and a source bag or bottle with liquid attached, it is our
opinion that the pumps are a complete machine.
One commenter states that HRL 955650 dated March 14, 1994,
HRL 955025 dated April 29, 1994, and HRL 085366 dated December 4,
1989, support its position that a complete and separate article,
such as the intravenous solution administration sets, can be
classified as a part.
In HRL 955650, we considered the classification of bite-wing
tabs made of foamed polyurethane plastics, which are used to hold
X-ray film in place in the pertinent's mouth while an X-ray of
the teeth is taken. In HRL 955025, we considered the
classification of the Octostop II Pediatric Immobilization
System, which is principally used with X-ray apparatus to
maintain a child in a fixed position. Both the bite-wing tabs
and the immobilization system were classified according to Note
2(b), Chapter 90, HTSUS, under subheading 9022.90.60, HTSUS,
which provides for parts and accessories of apparatus based on
the use of X-rays.
The bite-wing tabs and immobilization system were not
classified as medical instruments or appliances under heading
9018, HTSUS, because we determined that neither was used "to make
a diagnosis, to prevent or treat an illness or to operate, etc."
Although peripherally related to such uses, the bite-wing tabs
and immobilization system are not similar in function to the
extensive list of devices found in EN 90.18. Moreover, because
the devices are not themselves "based on the use of X-rays," nor
similar to the devices listed in heading 9022, HTSUS, they could
not be classified as X-ray apparatus under heading 9022, HTSUS.
In HRL 085366, we classified a tube string subassembly of
the Vital Vue Irrigation, Suction, and Illumination System
Disposable Surgical Instrument ("Vital Vue"), as a part of
electro-surgical apparatus under subheading 9018.90.60, HTSUS.
The commenter contends that if we classify the intravenous
solution administration sets as a medical instrument or appliance
under heading 9018, HTSUS, we must similarly classify the tube
string subassembly as a medical instrument or appliance.
The tube string subassembly is a component part of the Vital
Vue surgical instrument, which is used with the Vital Vue System.
The complete, Vital Vue surgical instrument would be classified
as a medical instrument or appliance. The tube string
subassembly, however, is an assembly of the medical instrument or
appliance (as the intravenous solution administration set's
"cassette" is an assembly of the intravenous solution
administration set). Accordingly, it was properly classified as
a part thereof under subheading 9018.90.60, HTSUS.
To further the position that the pump is a complete machine
without the intravenous solution administration sets, we set
forth the following analogy in the proposed modification:
However, as a photographic camera is a complete machine
without the film, the pumps are a complete machine
without the "Accuset" or "Gemini" sets. A camera's
components, such as the shutter release, film advance
lever, rewind knob and viewfinder eyepiece, function
without the addition of the film. Similarly, the
components of the pump function without the addition of
the "Accuset" or "Gemini" sets. A photographic camera,
when imported without film, is classified according to
GRI 1, HTSUS, under heading 9006, HTSUS (photographic
cameras), rather than as a GRI 2(a), HTSUS, "incomplete
or unfinished" articles. The pumps, if imported
without the "Accuset" or "Gemini" sets, would be
classified according to GRI 1, HTSUS, under heading
9018, HTSUS (medical apparatus). Therefore, it is our
opinion that the "Accuset" and "Gemini" sets are not
classified as parts of the pumps under subheading
9018.90.75, HTSUS.
Two comments stated that the above camera analogy does not
apply to the intravenous solution administration sets. The
comments state that film is not classified as "parts" of cameras;
not because the film and camera are complete and separate
articles, but because the film is identified eo nomine in the
HTSUS. They further state that relative specificity doctrine set
forth in GRI 3(a), HTSUS, firmly establishes that an eo nomine
tariff provision for an article takes precedence over a "parts"
provision, but that a "parts" provision does not take precedence
over a "basket" provision. Therefore, the commenters contend
that since subheading 9018.90.80, HTSUS, is the basket provision
of heading 9018, HTSUS, the intravenous solution administration
sets should be classified as "parts" under subheading 9018.90.75,
HTSUS. As discussed below, it is our opinion that we do not need
to resort to the doctrine of relative specificity in GRI 3(a),
HTSUS.
Alternatively, you contend that the "Accuset" and "Gemini'
sets are accessories to the pumps, and are classifiable under
subheading 9018.90.75, HTSUS. The term "accessory" is not
defined in either the HTSUS or the ENs. An accessory is
generally an article which is not necessary to enable the goods
with which it is used to fulfill their intended function. An
accessory must be identifiable as being intended solely or
principally for use with a specific article. Accessories are of
secondary or subordinate importance, not essential in and of
themselves. They must, however, somehow contribute to the
effectiveness of the principal article (e.g., facilitate the use
or handling of the principal article, widen the range of its
uses, or improve its operation.) See, HRL 087704 dated September
27, 1990, and HRL 951857.
As stated in HRL 085088, it is our opinion that disposable
intravenous solution administration sets which serve as a conduit
through which blood flows between the patient and the machine are
medical instruments or appliances in and of themselves and,
therefore, are classified under subheading 9018.90.80, HTSUS.
Generally, they are not classified as accessories of the pumps.
However, in this case the "Accuset" and "Gemini" sets, by their
design do appear to facilitate the use of the pumps. Features
such as the cassette in the "Accuset" set and the silicon tubing
and "Flo-Stop" slide clamp of the "Gemini" set, help regulate the
rate and flow of liquid passing through the pump. Therefore,
they are also viewed as accessories to the pumps.
In this situation, where the "Accuset" and "Gemini" sets are
classifiable as medical instruments and apparatus and as
accessories of pumps, Note 2, Chapter 90, HTSUS, which states
that:
...parts and accessories for machines, apparatus,
instruments or articles of this chapter are to be classified
according to the following rules:
(a) Parts and accessories which are goods included in any
of the headings of this chapter or of chapter 84, 85 or
91 (other than heading 8485, 8548 or 9033) are in all
cases to be classified in their respective headings;
(b) Other parts and accessories, if suitable for use solely
or principally with a particular kind of machine,
instrument or apparatus, or with a number of machines,
instruments or apparatus of the same heading (including
a machine, instrument or apparatus of heading 9010,
9013 or 9031) are to be classified with the machines,
instruments or apparatus of that kind....
It is our position that pursuant to Note 2(a), Chapter 90,
HTSUS, as the "Accuset" and "Gemini" sets are classifiable as
medical instruments and apparatus in heading 9018, HTSUS, they
must be so classified, regardless of whether they are also
classifiable as accessories of pumps. Therefore, pursuant to
Note 2(a), Chapter 90, HTSUS, the "Accuset" and "Gemini" sets are
classified under subheading 9018.90.80, HTSUS, as other medical
instruments and appliances.
However, the comments contend that the doctrine of relative
specificity in GRI 3(a), HTSUS, establishes classification of the
intravenous solution administration sets as accessories under
subheading 9018.90.75, HTSUS. GRI 3, HTSUS, states
"[w]hen...goods are, prima facie, classifiable under two or more
headings, classification shall be effected as follows:
(a) The heading which provides the most specific
description shall be preferred to headings providing a
more general description..."
Thus, an eo nomine tariff provision for an article takes
precedence over an "accessories" provision, but that an
"accessories" provision does not take precedence over a "basket"
provision. Therefore, the commenters contend that since
subheading 9018.90.80, HTSUS, is the basket provision of heading
9018, HTSUS, the intravenous solution administration sets should
be classified as "accessories" under subheading 9018.90.75,
HTSUS.
It is our opinion that resorting to GRI 3(a), HTSUS, in this
situation is incorrect. GRI 1, HTSUS, states that "...for legal
purposes, classification shall be determined according to the
terms of the headings and any relative section or chapter notes
and, provided such headings or notes do not otherwise require,
according to the following provisions [the remaining GRIs,
including GRI 3(a)]." Thus, classification is determined
according to the headings and the section or chapter notes, and
if the section or chapter notes do not otherwise require,
according to the remaining GRIs. In this case, Note 2, Chapter
90, directs classification of the intravenous solution
administration sets such that we do not need to proceed to the
remaining GRIs.
Note 2(a), Chapter 90, HTSUS, states that accessories which
are goods included in any of the headings of chapter 90, 84, 85
or 91 are in all cases to be classified in their respective
headings. In this case, the intravenous solution administration
sets are goods included in heading 9018, HTSUS, as medical
instruments and appliances. Heading 9018, HTSUS, also includes
the accessories of medical instruments and appliances. However,
this does not negate the use of Note 2(a), Chapter 90, HTSUS.
Note 2(a), Chapter 90, HTSUS, states that the classification of
the intravenous solution administration sets proceeds under
heading 9018, HTSUS, as medical instruments and appliances.
Therefore, we proceed through the six-digit and eight-digit
classification as medical instruments and appliances to
classification under subheading 9018.90.80, HTSUS, as other
medical instruments and appliance. We do not proceed to Note
2(b), Chapter 90, HTSUS, or to GRI 3(a), HTSUS. Classification
of the intravenous solution administration sets is made pursuant
to GRI 1, HTSUS, and Note 2(a), Chapter 90, HTSUS.
HOLDING:
The "Accuset" and "Gemini" intravenous solution
administration sets are classified under subheading 9018.90.80,
HTSUS, as other medical instruments and appliances. Articles
classified under this tariff provision are dutiable at the Column
1 rate of 6.3% ad valorem.
EFFECT ON OTHER RULINGS:
NY 895684, issued April 15, 1994, is modified as set forth
above. In accordance with 19 U.S.C. 1625(c)(1), this ruling
will become effective 60 days after publication in the Customs
Bulletin. Publication of rulings or decisions pursuant to 19
U.S.C. 1625(c)(1) does not constitute a change of practice or
position in accordance with 177.10(c)(1), Customs Regulations
(19 CFR 177.10(c)(1)).
Sincerely,
John Durant, Director
Tariff Classification Appeals
Division