CLA-2-90:RR:NC:N1:105 M85569

Mr. William J. Maloney
Rode & Qualey
55 West 39th Street
New York, NY 10018

RE: The tariff classification, country of origin marking, and status under 9817.00.96 of Pen Needles exported from Mexico

Dear Mr. Maloney:

In your letter dated August 1, 2006, for Becton Dickinson and Company, you requested a tariff classification ruling. Samples were submitted.

You state, “The product is a needle for use with insulin pens for the administration of insulin. A complete description of the product may be found at the following Becton Dickinson website: As set forth in the website description of the product, the shield is intended to prevent accidental needle sticks and also to provide greater comfort to the patient or user of the product.”

From the engineering drawings you have provided, it is clear that the subcomponents are made specifically for assembly into the BD Pen Needle. From a review of the internet, it appears that similar Pen Needles are currently used only in the injection of insulin for diabetics.

From the Instructions for Use on the BD website, the Pen Needle is pushed and twisted onto the larger “injector” which contains the insulin and is discarded after one use. The needle is pushed forward in use to pierce the skin and serve as a conduit for the insulin.

From the samples, other than the metal needle and the small spring, all the other multiple components are made of thin plastics.

We agree that the applicable subheading for the BD Pen Needle will be 9018.32.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Tubular metal needles and needles for sutures and parts and accessories thereof. The rate of duty will be free.

You specifically asked about its status under HTSUS, 9817.00.96. We do not consider the injection of insulin to be “therapeutic” for the purposes of US Note 4-b-iii to Subchapter 17 of HTSUS Chapter 98, noting New York Ruling Letter L82256-105, sent to you on 3-2-05, and Headquarters Ruling Letter 561940-KSG, dated 2-7-01.

On that basis a secondary classification will apply in HTSUS 9817.00.96 as specially designed or adapted for the use or benefit of the permanently or chronically, physically or mentally handicapped if all applicable entry requirements are met, including the filing with the Customs port of entry of the U.S. Department of Commerce form ITA-362P. This merchandise is already duty free, but if the importer elects to claim the secondary classification in Chapter 98 of 9817.00.96 and meets the entry requirements, no merchandise processing fee will apply to those importations, noting, e.g., Headquarters Ruling Letter 229110 IDL, 8-29-02, even if the merchandise does not meet the requirements for “NAFTA” exemption for the fee under Customs Regulation 24.23-c-3. Note that this classification has no effect on any quota, visa, or restricted merchandise requirements You also asked if the import will be exempt from country of origin marking.

You state, “As set forth on the bill of materials, all of the components, except the needle itself, are products of England.”

You state that the needle will be a product of the USA.

From the notation on the drawing of the metal spring, we understand the wire to be from England and that it is made into a spring in Mexico.

We consider the tubular metal needle to be the “single material that imparts the essential character” to the import in terms of CR 102.11-b-1. It is not excluded from consideration by CR 102.18-b since the needle, per se, imported into Mexico, does not undergo a tariff shift under the applicable rule of origin in CR 102.20-q.

Therefore, we agree that the country of origin of the Pen Needle is the United States and thus “that this article need not be marked with country of origin.” Per your request, the sample is being returned to you, in a separate mailing. 

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

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 J. Sheridan at 646-733-3012.


Robert B. Swierupski
National Commodity
Specialist Division