CLA-2-90:RR:NC:N1:105 L82256

Ms. Eleanore Kelly-Kobayashi
Rode & Qualey
55 West 39th Street
New York, NY 10018

RE: The Secondary Classification of Diabetic Syringe Kits exported from Mexico

Dear Ms. Kobayashi:

In your letter dated January 28, 2005, for Becton Dickinson Infusion Therapy Systems, you requested a tariff classification ruling. A sample was submitted.

As discussed, since you have not presented a sample of the other version with pin needles, corrected to pen needles per your telephone conversation with NIS Sheridan, this ruling applies only to the sample, which has syringes.

You requested a ruling on its HTS 1-97 classification, on its country of origin marking, and on its possible secondary classification in HTS 9817.00.96.

The first two issues that deal with the HTS 1-97 classification and the proper country of origin marking have been forwarded to the ORR office in Washington, DC for their reply to you.

Our reply to your third issue regarding the possible secondary classification in HTS 9817.00.96 is below.

You describe the sample:

“The subject merchandise, a sample of which is enclosed herein, is the BD Getting Started( Take Home Kit. The kit is a complimentary sample which will be given free of charge to patients who have recently begun injecting insulin as part of an overall diabetes therapy. The kit is described as a diabetes educational resource for insulin users. One version of the kit contains 10 single-use BD Ultra-Fine( insulin syringes in a plastic bag, 5 single-use BD Ultra-Fine( lancets in a plastic bag, BD( alcohol swabs, BD( glucose tablets for low blood sugar reactions and instructional literature on the care and treatment of diabetes.”

Per HRL 962132 SS, 10-26-00, the diabetics who use glucose monitors suffer from a permanent or chronic impairment which limits a major life activity. Since these sets will be distributed only to those diabetics having a severe enough condition to require insulin injections, that applies here a fortiori.

Per US Note 4-b-iii to Subchapter 17 of HTS Chapter 98, 9817.00.96 excludes therapeutic articles. However, as one example of its interpretation, HRL 561801 RFC, 2-28-02, held that surgery to remove a brain tumor was not “therapeutic” in that context since it did cure the underlying disease, whatever that might be, that caused the tumor to initially appear and grow. Since such surgery often causes the permanent end of all the negative symptoms and threat of death from the growth of the tumor, the injection of insulin using the syringes is even less “therapeutic” since it will always do so only temporarily and will never cause the islets of Langerhans to produce naturally the insulin needed to prevent future comas or death.

Although the insulin itself is not “therapeutic,” US Note 4-b-iv excludes “medicine and drugs.” However, the syringes in the set will be imported without insulin in them. The diabetic will use the syringes to draw the insulin from a bottle acquired separately so that exclusion does not apply.

On that basis a secondary classification will apply in HTS 9817.00.96, duty free, 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. We assume that the kit will be found to be classified in a duty free heading, but, while most NAFTA products, as this kit appears to be, are exempted from Merchandise Processing Fees (noting Customs Regulation 24.23-c-3), if you elect to claim the secondary classification in Chapter 98 of 9817.00.96 and meet the entry requirements, no MPF will apply to those importations per CR 24.23-c-1-i. However, you should not claim 9817.00.96 and present the ITA-362P for forwarding to the Department of Commerce if the shipments are already free of both duty and MPF. Note that this classification has no effect on any quota, visa, or restricted merchandise requirements. You requested return of your sample, but it is being forwarded to Customs Headquarters as indicated above.

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