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HQ 556243

December 2, 1991
CLA-2 CO:R:C:S 556243 SER


TARIFF NO.: 9817.00.96

Area Director of Customs
110 S. 4th Street
Room 137
Minneapolis, MN 55401

RE: Protest No. 3501-0-000234, contesting denial of duty-free treatment for defibrillator pacemakers under subheading 9817.00.96, HTSUSA; Nairobi Protocol; therapeutic

Dear Sir:

The above-referenced protest, filed by Global Transportation Services, Inc., on behalf of Medtronic, Inc., contests the assessment of duties by your office on pacemakers referred to as pacer-cardioverter-defibrillator, under subheading 9021.90.80, Harmonized Tariff Schedule of the United States Annotated (HTSUSA). The merchandise at issue was imported from Germany.


The merchandise at issue, referred to as the pacer- cardioverter-defibrillator (PCD), is a pacemaker which is designed to treat tachycardia or tachyarrthymia, conditions in which the heart beats too rapidly or irregularly. Whereas, conventional pacemakers treat bradycardia, or slow heart beating, the basic function of both the conventional and defibrillator pacemakers is identical--the use of electrical signals or pulses for the stimulation or steadying of the heartbeat or re- establishing the rhythm of an arrhythmic heart.


Whether the pacer-cardioverter-defibrillator is eligible for duty-free treatment under subheading 9817.00.96, HTSUSA.


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, HTSUSA. 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, HTSUSA, 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, HTSUSA, 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 as to whether the defibrillator pacemakers are "therapeutic" and, therefore, precluded from duty-free treatment under U.S. Note 4(b), has been raised by your office. 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 narrowlyn-3-
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 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 conditions. Therefore, the pacemakers at issue are not precluded from duty-free treatment as "therapeutic" articles under U.S. Note 4(b).

It should be noted that, as stated above, the basic function of the defibrillator pacemakers is identical to that of the conventional pacemakers-- the use of electrical signals or pulses for the stimulation or steadying of the heartbeat or re- establishing the rhythm of an arrhythmic heart. Therefore, had the pacer-cardioverter-defibrillator at issue been ineligible for duty-free treatment under subheading 9817.00.96, HTSUSA, the proper classification would be in subheading 9021.50.00, HTSUSA, which provides for "pacemakers for stimulating heart muscles", dutiable at the rate of 4.2% ad valorem.


The defibrillator pacemakers at issue, referred to as pacer- cardioverter-defibrillator, constitute articles specially designed for the use or benefit of the physically handicapped under subheading 9817.00.96, HTSUSA, and would not be precluded from duty-free treatment on the basis of the exclusion for "therapeutic" articles. Accordingly, you should grant this protest in full. A copy of this decision should be attached to the Customs Form 19, Notice of Action, to be returned to the protestant.


John Durant, Director
Commercial Rulings Division

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