CLA-2-90:OT:RR:NC:2:235
Mr. Robert M. Kroslowitz
Xeltis, Inc.
1790 Hughes Landing Blvd., Suite 400
The woodlands, TX 77380
RE: The tariff classification of “Xeltis Bioabsorbable Pulmonary Valved Conduit” from Switzerland
Dear Mr. Kroslowitz:
In your letter dated February 21, 2017, you requested a classification ruling on a “Xeltis Bioabsorbable Pulmonary Valved Conduit,” which you also refer to as “Product Number PV-001” and “Xeltis PV-001.” In your letter, you have described the product at issue as a prosthetic and artificial heart valve, which will be used to replace defective heart valves in children. You state that this product is designed to be surgically implanted in the human body to replace a diseased, malformed, or malfunctioning pulmonary heart valve. In addition, the “Xeltis Bioabsorbable Pulmonary Valved Conduit” may also be used for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits.
The applicable subheading for the “Xeltis Bioabsorbable Pulmonary Valved Conduit” will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Orthopedic and fracture appliances, and parts and accessories thereof: Other artificial parts of the body and parts and accessories thereof: Other.” The general rate of duty will be Free.
In your letter, you also requested consideration of the instant product under the Nairobi Protocol. You state that the product at issue 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 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."
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 primary issue is whether the article is specially designed or adapted for the “use or benefit of the handicapped” within the meaning of Nairobi Protocol. Although the legislative history of the Nairobi Protocol discusses the concerns of Congress that the design, modification or adaptation of an article must be significant so as to clearly render the article for use by handicapped individuals, no specific definition of these terms was established by Congress. See, Senate Report (Finance Committee) No. 97-564, September 21, 1982). See also, Headquarters Ruling Letter (HRL) 951004 dated March 3, 1992. Since it is difficult to establish a clear definition of what is “specially designed or adapted," various factors must be utilized on a case-by-case basis to determine whether a given article is "specially designed or adapted" within the meaning of this statute.
It is our opinion that the “Xeltis Bioabsorbable Pulmonary Valved Conduit” described above is considered to be specially designed or adapted for the handicapped, and therefore, eligible for duty-free treatment under subheading 9817.00.96.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Nuccio Fera at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division