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HQ 563002

May 26, 2004

CLA-2 RR:CR:SM 563002 KSG


TARIFF NO.: 9817.00.96

Port Director
U.S. Customs and Border Protection
2nd & Chestnut Streets
Philadelphia, PA 19106-2999

RE: Application for Further Review of Protest No. 1101-040100007; subheading 9817.00.96

Dear Director:

This is in reference to a Protest and Application for Further Review filed by Medtronic Inc. contesting the denial of duty-free treatment under subheading 9817.00.96, of the Harmonized Tariff Schedule of the United States (“HTSUS”) for imported drug pump pouches.


The imported article in this case is a non-sterile pump pouch -- a loose knit polyester pouch designed to house a Medtronic drug pump. The pouch creates a more stable fixation for the drug administration device when implanted into the body. The pouch is approximately 38 mm wide and 75 mm in length.

The drug pump is an implantable programmable battery operated device that stores and delivers medication according to the programmer and is used in the treatment of chronic pain that stems from initial injury, arthritis, cancer and infections.



Whether the imported drug pump pouches are eligible for duty-free treatment under subheading 9817.00.96, HTSUS.


The Agreement on the Importation of Educational, Scientific and Cultural Materials, known as the Florence Agreement, is an international agreement drafted by the United Nations Educational, Scientific, and Cultural Organization (UNESCO) and adopted by it in Florence, Italy, in July 1950 (17 UST 1835; TIAS 6129). It provides for duty-free treatment and the reduction of trade obstacles for imports of educational, scientific, and cultural materials in the interest of facilitating the international free flow of ideas and information. Materials falling within the coverage of the Florence Agreement include: books, publications and documents; works of art and collector’s pieces; visual and auditory materials; scientific instruments and apparatus; and articles for the blind.

The Nairobi Protocol to the Florence Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982 expanded the scope of the Florence Agreement primarily by expanding duty-free treatment for certain articles for the use or benefit of the handicapped in addition to providing duty-free treatment for articles for the blind. The 97th Congress passed Pub. L. 97-446 to ratify the Nairobi Protocol in the U.S. The Senate stated in its Report that one of the goals of this law was to benefit the handicapped and show U.S. support for the rights of the handicapped. The Senate, however, did state that it did not intend “that an insignificant adaptation would result in duty-free treatment for an entire relatively expensive article... the modification or adaptation must be significant so as to clearly render the article for use by handicapped persons.” S. Rep. No. 97-564, 97th Cong. 2nd Sess. (1982). The Senate was concerned that persons would misuse this tariff provision to avoid paying duties on expensive products.

Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 and Presidential Proclamation 5978 provided for the implementation of the Nairobi Protocol by inserting permanent provisions, subheadings 9817.00.92, 9817.00.94, and 9817.00.96, into the HTSUS. These tariff provisions specifically state that “articles specifically 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 3
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, states that 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.

As permanent or chronic pain substantially limits one or more major life activities, particularly working, persons suffering from permanent or chronic pain are considered physically handicapped as that term is defined in U.S. Note 4(a) to Subchapter XVII. Therefore, persons who suffer from permanent or chronic pain are considered handicapped within the meaning of U.S. Note 4(a).

The issue is whether the protestant has shown that the drug pump pouches are “specially designed or adapted” for the use or benefit of handicapped persons, which is required by the superior text in subheading 9817.0096, HTSUS.

The meaning of the phrase “specially designed or adapted” has been decided on a case-by-case basis. In HRL 556449, dated May 5, 1992, customs set forth factors it would consider in making this case-by-case determination. These factors include: 1) the physical properties of the article itself, i.e., whether the article is easily distinguishable, by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons; 2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would fugitive; 3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; 4) whether the articles are sold in specialty stores which serve handicapped individuals; and 5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped.

The protestant has not submitted sufficient evidence to show that the pouches are “specially designed or adapted” as required by the provision. The only evidence submitted is the dimensions of the pouches. We do not have a sample of the pouch and are not able to determine if there is anything unique about this article that would make general use improbable. The protestant cited several cases in which CBP ruled that the carrying case for a blood glucose system was eligible for subheading 9817.00.96, HTSUS, treatment. However, in those cases, the importer submitted detailed information showing that they marketed the carrying case to handicapped 4
persons and that it was designed for a very specific use and would not reasonably be useful to the general public. The protestant in this case has not submitted sufficient information to support a finding that the article was “specially designed or adapted” for the handicapped. Accordingly, we find that the protestant has not shown that the article is eligible for duty-free treatment under subheading 9817.00.96, HTSUS.


The protest should be denied in full. The protestant has not shown that the imported drug pump pouches are specially designed or adapted for the handicapped.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision should be accomplished prior to mailing of this decision. Sixty days from the date of this decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.


Myles B. Harmon, Director
Commercial Rulings Division

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