CLA-2-84:OT:RR:NC:N1:102

Mark Laumann
3M
Building 225-4S-18 St. Paul, MN 55144

RE: The tariff classification of valves and aluminum canisters for asthma inhalers from Great Britain

Dear Mr. Laumann:

In your letter dated November 9, 2010, you requested a tariff classification ruling. Samples were provided.

The merchandise at issue consists of valves and aluminum canisters that you indicate are designed to be used in the manufacture of pressure metered-dose inhalers (pMDI). These pMDIs act as drug delivery devices for the treatment of asthma.

The valves covered by your request are specially designed as parts of pMDIs. They are primarily made of steel and rubber and are designed to provide a uniform dose of asthma medication from the pMDI to the patient (who will inhale the medication into their lungs). You indicate that there are several types of valves with different compositions, and they can produce a dose size from 25 to 68 microliters (mcl), depending on the requirement of the pMDI.

The canisters discussed in your submission are made from aluminum, and range in capacity from 5ml to 22ml. You state that the canisters are specially designed and manufactured for use with pMDIs. The canisters will be imported separately and combined with the abovementioned valves, medication, and other plastic components to manufacture pMDIs after importation. You state that some canisters will be imported with fluorinated ethylene propylene (FEP) to reduce drug deposition, or a plasma coating to protect against degradation and corrosion. They may also be imported with rubber o-rings attached over the neck of the canisters.

The applicable subheading for the valves will be 8481.80.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for taps, cocks, valves and similar appliances, hand operated, of other materials. The rate of duty will be 3% ad valorem.

The applicable subheading for the aluminum canisters will be 7612.90.1030, Harmonized Tariff Schedule of the United States (HTSUS), which provides for aluminum casks, drums, cans, boxes and similar containers … for any material … other: of a capacity not exceeding 20 liters: cans of a capacity not exceeding 355 ml. The rate of duty will be 5.7% ad valorem.

In your submission you request consideration of a secondary classification for the valves and canisters under HTSUS 9817.00.96, which applies to articles specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. You argue that the valves and canisters are specially designed to be used in the manufacture of pMDIs, which will in turn be used to treat individuals suffering from asthma and other chronic obstructive pulmonary diseases.

As in New York Ruling Letter M85686, dated September 12, 2006, the inhalers are not excluded as “therapeutic” articles for the purposes of US Note 4(b)(iii) to Subchapter 17 of HTSUS Chapter 98, noting, for example, Headquarters Ruling Letter 561940, dated February 7, 2001. The drug treatment is not expected to heal or cure the underlying cause of the breathing problem.

Based on the information you provided, including previously submitted engineering drawings, both the valves and canisters were specially designed for use in pressure metered-dose inhalers for the treatment of asthma. You indicate that the valves and canisters are only suitable for use with pMDIs. Furthermore, Customs has previously found valves for pMDIs, similar to those covered by your ruling request, to be eligible for secondary classification in HTSUS 9817.00.96, in New York Ruling Letter M85686, dated September 12, 2006. As the valves and canisters are specially designed for use in pressure metered-dose inhalers, we agree that a secondary classification will apply for these items in HTSUS 9817.00.96 as parts specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind), free of duty and user fees (if any). Note that the requirement that you prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010. Also note that this classification has no effect on any quota, visa, or restricted merchandise

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 http://www.usitc.gov/tata/hts/.

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 classification in 9817.00.96 of these items, contact National Import Specialist J. Sheridan at (646) 733-3012. If you have any questions regarding the classification of the aluminum canisters, contact National Import Specialist Sharon Chung at (646) 733-3028. If you have any other questions regarding the ruling, contact National Import Specialist Kenneth T. Brock at (646) 733-3009.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division