CLA-2 RR:CTF:VS H233570 KSG
Port Director
U.S. Customs and Border Protection
#1 La Puntilla Street
San Juan, Puerto Rico 00901
RE: Eligibility of vials for blood glucose test strips under subheading 9817.00.96; Nairobi Protocol; Protest # 4909-12-100459, Protest # 4909-12-100464
Dear Director:
This is in response to an Application for Further Review filed by counsel on behalf of Lifescan Products LLC, involving imported vials used for blood glucose test strips.
FACTS:
The imported vials are black plastic cylinders measuring approximately 1 inch in diameter by 1.75 inches in depth. Each has an attached cap and is coated with a desiccant which maintains the correct humidity necessary to preserve blood glucose test strips until they are used by a diabetic person who is using a Lifescan meter to test their blood glucose levels, generally one to two times a day. Subsequent to importation, each vial is filled with 28 to 30 test strips to be sold separately or in blood glucose monitoring kits.
Counsel states that the secondary classification of the vials is subheading 3923.30, of the Harmonized Tariff Schedule of the United States (“HTSUS”).
ISSUE:
Whether the imported vials are eligible for duty-free treatment under subheading 9817.00.96, HTSUS?
LAW AND ANALYSIS:
The Agreement on the Importation of Educational, Scientific and Cultural Materials, known as the Florence Agreement provides for duty-free treatment and the reduction of trade obstacles for imports of educational, scientific and cultural materials. The Nairobi Protocol to the Florence Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982 expanded the duty-free treatment for certain articles for the use or benefit of the handicapped. 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), Chapter 98, HTSUS (“U.S. Note 4(a)”), 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), Chapter 98, HTSUS (“U.S. Note 4(b)”), 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.
Customs held in Headquarters Ruling Letter ("HRL") 561020, dated October 14, 1998, that persons with diabetes are considered physically handicapped persons under U.S. Note 4(a) because they are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea, dizziness and fainting. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note 4(a).
The vials must be “specially designed or adapted” for the use or benefit of handicapped persons, as required by the superior text in subheading 9817.00.96, HTSUS, to qualify for duty-free treatment under subheading 9817.00.96. The vials are designed solely for the use of people with diabetes and there is no other primary use for the vials. CBP has previously ruled that diabetic pen needles and lancets (HQ H110795, dated August 5, 2011), glucose test strips for glucose test meters (HQ H039775, dated April 17, 2009), and carrying cases specifically designed to hold and carry blood glucose meters (HQ 563264, dated May 6, 2005), qualified for duty-free treatment under subheading 9817.00.96, HTSUS.
Further, none of the U.S. Note 4(b) exclusions apply. The vials are not related to the treatment of an acute disability, related to a cosmetic item or a drug or medicine. In Travenol Laboratories, Inc. v. United States, 813 F. Supp. 840 (CIT 1993), the court held that devices used with a dialysis machine were not therapeutic and therefore, the devices were eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The court found that kidney dialysis is not curative and that whether an article cures or heals is the standard with regard to the tariff meaning of the term “therapeutic”. Similarly, we find that diabetes treatment is not curative and the vials are not therapeutic. Further, there is no diagnostic use for the vials. Based on the above, we conclude that the vials are not excluded from subheading 9817.00.96, HTSUS, treatment by U.S. Note 4(b). Accordingly, we find that the vials are eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
HOLDING:
The imported vials are entitled to duty-free treatment under subheading 9817.00.96, HTSUS. The Protest is granted in full.
In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), 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 in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision, Regulations and Rulings of the Office of International Trade will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial Rulings Division