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HQ 560190



February 28, 1997
CLA-2 RR:TC:SM 560190 BLS

CATEGORY: CLASSIFICATION

TARIFF NO.: 9817.00.96

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:

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
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
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

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

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