CLA-2 RR:TC:SM 560190 BLS
Port Director
U.S. Customs Service
610 S. Canal Street
Chicago, Illinois 60607
RE: Application for Further Review of Protest No. 3901-9610-1884;
Nairobi Protocol; articles specially
designed for the physically handicapped; Travenol
Dear Sir:
This is in reference to your memorandum received on November
12, 1996, forwarding an Application For Further Review of the
above-captioned protest, timely filed by counsel on behalf of
Baxter Healthcare, concerning the eligibility of titanium
adapters used in peritoneal dialysis for duty-free entry under
subheading 9817.00.96, Harmonized Tariff Schedule of the United
States (HTSUS).
FACTS:
The titanium adapters were entered duty-free under
subheading 9817.00.96, HTSUS, as articles specially designed or
adapted for the use or benefit of physically or mentally
handicapped persons other than the blind. It is the port's
opinion that the articles are properly classifiable under
subheading 9018.90.75, HTSUS, as [i]nstruments and appliances
used in medical, surgical, dental or veterinary sciences, ; parts
and accessories thereof: [o]ther instruments and appliances and
parts and accessories thereof: [o]ther: [e]lectro-medical
instruments and appliances and parts and accessories thereof:
[o]ther; [o]ther.
In the accompanying memorandum submitted with the protest,
counsel describes peritoneal dialysis as a procedure where the
patient's own peritoneum is used as the filtering membrane (in
lieu of a hollow fiber dialyzer). A catheter is first surgically
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inserted into the patient's abdomen. The locking titanium
adapter is used to connect
the catheter to the connector set, which carries the cleansing
dialysis fluid to and from the patient's abdomen.
ISSUE:
Whether the titanium adapters are eligible for duty-free
treatment under subheading 9817.00.96, HTSUS.
LAW AND ANALYSIS;
The Nairobi Protocol to the Agreement on the Importation of
Educational, Scientific, and Cultural Materials Act of 1982,
established duty-free treatment for certain articles for the
handicapped. Presidential Proclamation 5978 and section 1121 of
the Omnibus Trade and Competitive Act of 1988, provided for the
implementation of the Nairobi Protocol into subheadings
9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. Prior to January
1, 1995, these tariff provisions provided duty-free treatment for
"[a]rticles specially designed or adapted for the use or benefit
of the blind or other physically or mentally handicapped
persons." However, Section B(12), Annex II of Presidential
Proclamation 6821 issued September 12, 1995 (60 FR No. 177,
September 13, 1995), deleted this language and substituted the
following:
"[A]rticles specially designed or adapted for
the use or benefit
of the blind or other physically or handicapped
persons; parts
and accessories (except parts and accessories of
braces and
artificial limb prosthetics) that are specially
designed or adapted
for use in the foregoing articles:"
Subheadings 9817.00.92 and 9817.00.94, HTSUS, cover specified
articles for the blind. Subheading 9817.00.96, HTSUS, provides
for other articles specially designed or adapted for the use or
benefit of physically or mentally handicapped persons other than
the blind.
U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS, ("Note
4(a)"), provides that, "the term 'blind or other physically or
mentally handicapped persons' includes any person suffering from
a permanent or chronic physical or mental impairment which
substantially limits one or more major life activities, such as
caring for one's
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self, performing manual tasks, walking, seeing, hearing,
speaking, breathing, learning, or working." However, U.S. Note
4(b)(i) provides that subheading 9817.00.96, HTSUS, does not
cover "articles for acute or transient disability".
In Travenol Laboratories, Inc. v. United States, Slip Op.
93-15 dated February 24, 1993 (27 Cust. Bull. 1), the plaintiff
imported certain medical devices (hollow fiber dialyzers,
arterio-venous fistula cannulation sets and arterial-venous blood
tubing sets) used in dialysis treatments of individuals with
End-stage renal Disease. The plaintiff claimed that the
merchandise was entitled to duty-free entry under the Nairobi
Protocol as "articles specially designed or adapted for the use
and benefit of the blind or other physically or mentally
handicapped persons." Customs argued that the medical devices
were "therapeutic" articles which are specifically excluded from
receiving duty-free treatment under the Nairobi Protocol.
In rendering its decision, the court in Travenol followed
the reasoning in Richards Medical Company v. United States, 13
CIT 519, 720 F. Supp. 998 (1989), aff'd, 910 F.2d 828 (Fed. Cir.
1990), and found that although there was evidence to support the
finding that kidney dialysis is life-sustaining, that process was
not "curative", which is the standard the courts have chosen to
equate with the tariff meaning of "therapeutic." Therefore, the
court held that the imported articles were entitled to duty-free
treatment.
Since in Travenol it was established that articles specially
designed or adapted for use in kidney dialysis are properly
classifiable under subheading 9817.00.96, HTSUS, the issue to be
resolved in the instant case is whether the titanium adapter is
an article "specially designed or adapted" for such use, or is a
part "specially designed or adapted for use in" such article.
Protestant has included with the protest certain Baxter
publications, relating to a description of peritoneal dialysis,
the "Aseptic Exchange Procedure", and the subject article and its
use. The adapter is described in one brochure as a "Locking
Titanium Adapter for peritoneal dialysis catheters." The
brochure describes the beneficial attributes of the article for
use in dialysis, including its strength, which is said to be
twice that of steel but only half the weight, and its resistance
to disinfectants and corrosion. The procedure for its use is
also described, and essentially involves attachment of the
adapter on one end to the catheter originating from the patient's
stomach, and the other end to a transfer set. The publication
describing the Aseptic
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Exchange Procedure includes a diagram depicting the entire
apparatus used in peritoneal dialysis, including the solution and
drain bags, the fill and drain lines,
transfer set, and titanium adapter, which, as noted, is used to
connect the catheter to the transfer set. There no evidence in
the record which reflects that the adapter was or could be used
other than for peritoneal dialysis applications.
Under the circumstances, we find that the locking titanium
adapters used in peritoneal kidney dialysis are articles
"specially designed or adapted for the use or benefit of the
blind or other physically or handicapped persons." Therefore,
the articles are properly classifiable under subheading
9817.00.96, HTSUS.
HOLDING:
Locking titanium adapters used in peritoneal kidney dialysis
are articles "specially designed or adapted for the use or
benefit of the blind or other physically or handicapped persons."
Accordingly, the articles are properly classifiable under
subheading 9817.00.96, HTSUS. The protest should be granted in
accordance with the foregoing.
In accordance with Section 3A(11)(b) of Customs Directive
099 3550- 065, dated August 4, 1993, Subject: Revised Protest
Directive, this decision should be mailed by your office to the
protestant attached to the Form 19, Notice of Action, no later
than 60 days from the date of this letter. Any reliquidation of
the entries in accordance with the decision must be accomplished
prior to mailing of the decision. Sixty days from the date of
the decision the Office of Regulations and Rulings will take
steps to make the decision available to customs personnel via the
Customs Ruling Module in ACS and the public via the Diskette
Subscription Service, Freedom of Information Act and other public
access channels.
Sincerely,
John
Durant, Director
Tariff
Classification Appeals Division