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HQ 557302

March 17, 1993

CLA-2 CO:R:C:S 557302 RAH


TARIFF NO. 9817.00.96

Ms. Evelyn Appel-Schaefer
James J. Boyle & Co.
7505 N.E. Ambassador Place, Suite B
Portland, OR 97220

RE: Eligibility of Pacemakers for duty-free treatment under the Nairobi Protocol

Dear Ms. Schaefer:

This is in response to your letters of November 17, 1992, and April 8, 1993, requesting a binding ruling on the tariff classification of a Gemnos pacemaker under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS).


The Gemnos pacemaker is described as a "Multi-programmable implantable dual chamber pacemaker with 13 mode selections and polarity selection."


Whether the pacemaker is eligible for duty-free treatment under subheading 9817.00.96, HTSUS, upon importation into the U.S.


The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982, established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. These tariff provisions specifically state that "[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons" are eligible for duty-free treatment.

U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS, states 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." Clearly, those individuals who are suffering from heart problems which mandate the use of pacemakers are encompassed by this note.

U.S. Note 4(b), subchapter XVII, Chapter 98, HTSUS, which establishes limits on classification of products in these subheadings, states as follows:

(b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover--

(i) articles for acute or transient disability;

(ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled;

(iii) therapeutic and diagnostic articles; or

(iv) medicine or drugs.

The issue of what constitutes a "therapeutic" article under the Nairobi Protocol was addressed in Richards Medical Co. v. U.S., 720 F.Supp. 998 (CIT 1989), aff'd, 910 F.2d 828 (Fed.Cir. 1990), which held that "therapeutic" articles are those that are used to heal or cure the condition causing a handicap, as opposed to those articles which are designed to compensate for, or adapt to, the handicapped condition. In essence, this holding narrowly defines the term "therapeutic", and, as a result, limits the number of articles which would be precluded from duty-free treatment under U.S. Note 4(b) as "therapeutic".

The issue as to whether pacemakers are "therapeutic" and, therefore, precluded from duty-free treatment under U.S. Note 4(b), was decided in Headquarters Ruling Letter (HRL) 556243 dated December 2, 1991, in which we held that defibrillator pacemakers, as well as conventional pacemakers, do not heal or cure the underlying heart conditions of the handicapped individuals who utilize them; they merely control and help those individuals adapt to their handicapped condition and therefore are not precluded from duty-free treatment as "therapeutic" articles under U.S. Note 4(b)). Accordingly, based on the precedent set forth in HRL 556243, we find that the Gemnos pacemaker is not precluded from duty-free treatment as a "therapeutic" article under U.S. Note 4(b).


The pacemaker at issue constitutes an article specially designed for the use or benefit of the physically handicapped under subheading 9817.00.96, HTSUS, and will not be precluded from duty-free treatment on the basis of the exclusion for "therapeutic" articles.


John Durant, Director
Commercial Rulings Division

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