Port Director
Attn: Chief, Trade Operations Branch D
U.S. Customs & Border Protection
Building 77 JFK International Airport
Jamaica, NY 11430

Re: Protest and AFR # 4701-09-101167; subheading 9817.00.96, of the Harmonized Tariff Schedule of the United States (“HTSUS”); diabetic pen needles; lancets

Dear Port Director:

This is in response to the timely-filed Application for Further Review of Protest # 4701-09-101167, dated October 15, 2009, submitted by counsel on behalf of Becton Dickinson and Company (“BD”), contesting the denial of preferential tariff treatment for imported diabetic pen needles and lancets under subheading 9817.00.96, of the Harmonized Tariff Schedule of the United States (“HTSUS”).


This case involves two entries of merchandise, the first was filed on June 12, 2008 under subheading 9018.32.00, HTSUS, and liquidated on April 24, 2009, and consisted of pen needles (pen ndl 31g 8mm). The second entry was filed on June 24, 2009 and liquidated on May 8, 2009, and contained two line items for needles (pen ndl 31g 8mm and pen ndl 31g 5mm) both with the same classification under subheading 9018.32.0000, HTSUS, but each representing a separate invoice. We note the protestant protests the classification of two separate and different items, the BD Ultra-Fine 8mm pen needle and the BD Ultra-Fine lancets, for use by diabetics, classified as 9018.32.0000, HTSUS and 9018.39.0000, HTSUS, respectively. Your office claims that the BD Ultra-Fine pen needle is correctly classified in subheading 9018.32.00, HTSUS. We reiterate that this protest covers two entries, pen needles. The pen needles were classified and liquidated in subheading 9018.32.0000, HTSUS, which has a free rate of duty, but upon which the Merchandise Processing Fee is assessed.

ISSUE: Whether the imported diabetic pen needles are 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 Competitive 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 provide that "[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories . . . that are specifically designated or adopted for use in the foregoing articles" are eligible for duty-free treatment. United States Note 4(a) to Subchapter XVII, Chapter 98, HTSUS, provides: "For purposes of subheadings 9817.00.92, 9817.00.94 and 9817.00.96, 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)"), which established limits on classification of products in these subheadings, 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. CBP held in Headquarters Ruling Letter ("HRL") 561020, dated October 14, 1998, persons with diabetes are considered physically handicapped persons under U.S. Note 4(a) as 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. See also, HRL 563264, dated May 6, 2005, issued to Becton Dickinson Infusion Therapy Systems, wherein CBP determined that 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). Furthermore, in that same ruling letter CBP stated that diabetes treatment is not curative, and that the take home diabetic kits at issue in that case, in part made up of BD pen needles, are not therapeutic, nor of diagnostic use; thus, they were not excluded from subheading 9817.00.96, HTSUS, treatment by U.S. Note 4(b).

The port argues the protest should be denied based on NY N004313, issued to Becton Dickinson & Company, the protestant. We note that the products that were classified in that ruling were glucose tablets, and “BD Ultra Fine ( [sic] Lancet (product #325772).” The product is described as a metal needle like article encased in a plastic holder, with a flat cap, which is used primarily by diabetics to draw blood to test for blood-sugar levels, and was classified in subheading 9018.39.00, HTSUS. In addition, no claim for subheading 9817.00.00 was made in that ruling.

Thus, we note that the port’s sole rationale for denying the protest is the classification of BD Ultra Fine Lancets in NY N004313. By contrast, we note that the protestant argues the classification of lancets, those classified in subheading 9018.39.0000, HTSUS, are eligible for entry under 9817.00.96, HTSUS. However, the merchandise that is the subject of this protest, according to the line items in the above-cited entries, are BD Ultra Fine 8mm pen needles (product #320881). The BD Ultra Fine 8mm pen needles in the entries at issue were classified in subheading 9018.32.0000, HTSUS, and were not discussed in NY N004313, and thus that NY ruling is not dispositive.

Instead, protestant correctly cites to HQ 563264, supra, which does discuss Becton Dickinson pen needles, which when imported as part of a BD Getting Started Take Home Kit for diabetics, were entitled to duty-free treatment under 9817.00.96, HTSUS. In this case, the BD Ultra fine pen needles themselves, which as part of the aforementioned kit was determined to be specifically made and marketed to people with diabetes, also meet the requirements in United States Note 4(a) to Subchapter XVII, Chapter 98, HTSUS, as discussed above, and are not disqualified under U.S. Note 4(b), as they are to treat a physically handicapped person, a diabetic, and are not therapeutic nor of diagnostic use.

HOLDING: The BD Ultra Fine 8mm pen needles are entitled to duty-free treatment under subheading 9817.00.96, HTSUS. Consequently, the protest should be granted in full.

In accordance with the Protest/Petition Processing Handbook (CIS HB, December 2007), 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 the office of Regulations and Rulings 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.


Myles B. Harmon, Director
Commercial and Trade Facilitation Division