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HQ 089937


November 18, 1991

CLA-2 CO:R:C:M 089937 KCC

CATEGORY: CLASSIFICATION

TARIFF NO.: 9019.20.00

Michael K. Tomenga, Esq.
McKenna & Cuneo
1575 Eye Street, N.W.
Washington, D.C. 20005

RE: Aerosol Therapy Device; GRI 1; EN 90.19; Note 2(b), Chapter 90; apparatus

Dear Mr. Tomenga:

This is in response to your letter dated July 16, 1991, on behalf of Monaghan Medical Corporation, concerning the tariff classification of an aerosol therapy device under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).

FACTS:

The merchandise under consideration is an aerosol therapy device called the Aerochamber. The Aerochamber is a FDA- approved medical device that is used with a metered dose inhaler ("MDI") to deliver aerosol medication to asthma patients. The Aerochamber is in the shape of a tube measuring approximately 4 1/4 inches in length and 1 5/8 inches in diameter. The device acts as a temporary holding chamber for MDI-dispersed medication. At one end of the holding chamber is a plastic mouthpiece containing a one-way silicone inhalation "flapper" valve and exhalation ports. At the other end of the device is a rubber end cap with a port into which a standard MDI may be inserted. Imbedded in the rim of the end cap is a Flowsignal, a plastic whistle-like device. Except for the rubber port and silicone flapper valve, the Aerochamber is made entirely of medical grade plastic.

The patient uses the Aerochamber as follows: the patient inserts the MDI into the port end of the Aerochamber, shakes the entire apparatus, depresses the MDI cartridge to spray a measured amount of aerosol medication into the Aerochamber holding chamber, and slowly and evenly inhales the medication from the holding chamber through the Aerochamber mouthpiece. The medication is held in the Aerochamber holding chamber for a short period, which allows the patient a delay between firing the MDI and inhalation of the medication. If the patient attempts to inhale the aerosol medication too quickly, the Aerochamber flowsignal will sound, warning the patient to inhale more slowly.

ISSUE:

What is the proper tariff classification of the aerosol therapy device under the HTSUSA?

LAW AND ANALYSIS:

The classification of merchandise under the HTSUSA is governed by the General Rules of Interpretation (GRI's). GRI 1, HTSUSA, states in part that "for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes...."

Subheading 9019.20.00, HTSUSA, provides for "Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof...Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof" (emphasis added). Explanatory Note (EN) 90.19 of the Harmonized Description and Coding System (HCDCS) states that an "aerosol therapy apparatus" is "used for the application of a therapeutic agent in the treatment of pulmonary, cutaneous, oto-rhino- laryngologic, gynaecologic diseases, etc., by the dispersion (nebulisation) in the form of a mist of various medicinal solutions (hormones, vitamins, antibiotics, broncho-dilating preparations, essential oils, etc.). Some of these appliances are of the individual type (nebulisers) designed for connecting to cylinders of oxygen or compressed air...." HCDCS, EN 90.19, Vol. 4, p. 1495. The Explanatory Notes, although not dispositive, are to be looked to for the proper interpretation of the HTSUSA. 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The MDI, to which the Aerochamber is attached, meets the definition of an "aerosol therapy apparatus" in EN 90.19. An MDI is a device used by asthma patients to disperse or nebulize a liquid medicinal solution contained in an attached aerosol can (commonly a mast cell membrane stabilizer, steroid or bronchodilator) into the lungs in a mist form for the treatment of their disease. The MDI performs exactly the same function as the nebulizer described in EN 90.19.

In 1987, the Harmonized System Committee decided to include in the Harmonized Compendium of Classification Opinions a classification opinion written under the Customs Cooperation Council Nomenclature for applicability under the Harmonized System. This classification opinion held that a metered dose inhaler-like device is classifiable under subheading 9010.20, HTSUSA. The ruling specifically states that "aerosol therapy apparatus" encompasses:
an aerosol-type hand-spray, for use by a dentist or by the patient himself to spray the teeth or gums. The spray operates by means of compressed gas (e.g. CO2) contained in a screw-on cartridge; the action of the medicinal substance used and the massage resulting from spraying the mucous membranes clears the mouth and treats certain diseases (e.g. periodontitis).

Similarly to the Explanatory Notes, the issuance of a classification opinion in the Compendium Classification Opinions constitute the Customs Cooperation Council's (CCC) official interpretation of the Harmonized System. Although generally indicative of the proper interpretation of the various provisions, they are not legally binding on the contracting parties. Thus, while they should be consulted for guidance, these documents should not be treated as dispositive. T.D. 89- 90, 23 Cust. Bull. 36 (1989), and 54 Fed. Reg. 35127, 35128 (August 23, 1989).

We are of the opinion that the operation described in the Compendium Classification Opinion concerning the "metered dose inhaler-like device" is similar to the operation of the device in this case. The device in the CCC opinion that generates an aerosol-type spray by means of a compressed gas contained in a fluorocarbon-pressurized cartridge. The only distinction between the two devices seems to be that the MDI-generated medication is intended for treatment of a disease of the lungs rather than the diseases of the mouth.

Pursuant to Note 2(b), Chapter 90, HTSUSA, parts and accessories of apparatus, "...if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machine, instruments or apparatus of that kind." The Aerochamber is used solely with an aerosol therapy apparatus, an MDI. The Aerochamber is designed and marketed to be used exclusively with an MDI. The rubber port end of the device contains an opening which is designed to be fitted to an MDI and no other device. The sole function of the Aerochamber is to improve the application and enhance the therapeutic value of the MDI- generated aerosol therapy solutions. The Aerochamber was specifically developed to assist patients in coordinating discharge of aerosol medication from the MDI with proper inhalation, as well as to eliminate harmful side effects that result from discharge of the MDI directly into the patient's mouth. As the Aerochamber is designed for and specifically used
with an aerosol therapy apparatus, it is classified under subheading 9019.20.00, HTSUSA.

HOLDING:

The Aerochamber is properly classified under subheading 9019.20.00, HTSUSA, as "Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof...Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof."

Sincerely,

John Durant, Director
Commercial Rulings Division

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