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.
ISSUE:
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.
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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 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
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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.
HOLDING:
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
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600 is eligible for duty-free treatment under subheading
9817.00.96, HTSUS.
Sincerely,
John Durant, Director
Commercial Rulings Division
cc: Supv. Import Specialist Larry Steele
Portland, Ore. 97209