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HQ 557028

MARCH 19, 1993

CLA-2 CO:R:C:S 557028 BLS


Evelyn Appel-Schaefer
James J. Boyle & CO.
7505 N.E. Ambassador Place
Portland, OR 97220

RE: Nairobi Protocol; Specially designed or adapted for the handicapped; T.D. 92-77; HRL 556449; Richards

Dear Madam:

This is in reference to your letter dated November 17, 1993, requesting a ruling regarding the classification and eligibility for duty-free treatment under subheading 9817.00.96, Harmonized Tariff Schedules of the United States (HTSUS), of a pacemaker monitoring system, to be imported through Portland, Oregon, by Biotronik, Inc.

The system, identified as the "PMS 600", is described in the attached literature as "The Programming and Monitoring System for the Complete Pacemaker Follow-Up." Pursuant to the brochure, the system incorporates all factors necessary for "modern cardiac pacing therapy" utilizing the capabilities of the implanted Biotronik pulse generator (pacemaker). The PMS 600 provides "interrogation and transmission of pacing programs", and also "measurement and control routines, for example, the selection of the optimal rate response in sensor-driven rate-adaptive pacing, special test programs for dual chamber pacing systems, temporary program transmission, threshold tests, etc." The literature also provides that the System is designed "exclusively" for use with Biotronik programmable pacemakers.


Whether the Pacemaker Programming and Monitoring System is "specially designed or adapted" for the handicapped within the meaning of the Nairobi Protocol, and therefore eligible for duty- free treatment under subheading 9817.00.96, HTSUS.


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 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."

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.

In T.D. 92-77, dated August 3, 1992 (26 Cust. Bull. 35, dated August 26, 1992), the Customs Service set forth its position regarding certain issues arising under the Nairobi Protocol. "Issue 1" concerned the interpretation of the term "specially designed or adapted". We pointed out that a primary factor to be considered in determining whether an article was "specially designed and adapted" was whether the article was easily distinguishable, by properties of the design and the corresponding use specific to this unique design, from articles useful to non- handicapped individuals. Thus, if an article is solely dedicated to use by the handicapped, e.g., pacemaker or hearing aid, it is Customs position that this would be conclusive evidence that the
articles are "specially designed or adapted" for the handicapped for purposes of the Nairobi Protocol. This reasoning was used by the court in Richards Medical Co. v. United States, 720 F. Supp. 998 (CIT 1989), aff'd, 910 F. 2d 828 (Fed. Cir. 1990), when it stated that instruments used to implant the hip prosthetic devices at issue in that case, are "specially and exclusively designed for prosthetic implantation and have no other apparent use."

Furthermore, in Richards, the court held that the hip prostheses implanted in patients suffering from arthritis, and the instruments used to implant the prostheses, were not "therapeutic" for purposes of U.S. Note 4(b). The court held that "therapeutic" articles are those that are used to heal or cure the condition causing a handicap as opposed to those articles designed to compensate for, or adapt to, the handicapped condition. The court concluded that the instruments did not remove, eliminate, or lessen the disease which caused their handicapped condition, but rather were used to improve the handicapped persons' ability to walk. (See also, Headquarters Ruling Letters (HRL) 557030 and 557031, dated March 16, 1993. We also applied the rationale of Richards to pacemakers in HRL 556243, dated December 2, 1992, in holding that these devices do not heal or cure the underlying heart conditions of the handicapped persons who utilized them, but merely controlled and help those individuals adapt to their handicapped condition.)

In the instant situation, the descriptive literature provides that the PMS 600 is designed for use only with the Biotronik programmable pacemakers, which are themselves articles specially designed for the use of physically handicapped persons. The PMS 600 aids in selecting the appropriate pacemaker for the individual patient and in determining the appropriate pacing, and has other related capabilities. Since there is no other apparent use for the System, pursuant to the rationale set forth in T.D. 92-77, Richards, and the cited rulings, we find that the PMS 600 is "specially designed" for the benefit of a handicapped person within the meaning of the Nairobi Protocol.


The Pacemaker Programming and Monitoring System, PMS 600, is "specially designed or adapted" for the benefit of the handicapped within the meaning of the Nairobi Protocol. Accordingly, the PMS

600 is eligible for duty-free treatment under subheading 9817.00.96, HTSUS.


John Durant, Director
Commercial Rulings Division

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