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HQ 950639

November 18, 1991
CLA-2 CO:R:C:M 950639 KCC

CATEGORY: CLASSIFICATION

TARIFF NO.: 9019.20.00

Mr. Thomas C. Lloyd
3M Center
P.O. Box 33250
St. Paul, Minnesota 55133

RE: Aerosol Therapy Device; GRI 1; EN 90.19; revoke NYR 858796

Dear Mr. Lloyd:

This is in reference to a ruling issued to you by Customs in New York on January 8, 1991 (New York Ruling (NYR) 858796), concerning the tariff classification of an aerosol therapy device under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).

FACTS:

NYR 858796 held that an aerosol therapy device called the Autohaler was classified under subheading 3926.90.90, HTSUSA, which provides for other articles of plastics, other. The Autohaler is a breath-actuated inhaler which is designed to be used with an asthma drug in inhalation therapy. The Autohaler is designed to eliminate the difficult task of manually actuating the metering valve to release medication in synchrony with inhalation. After importation into the U.S., an aerosol can containing asthma medication is completely enclosed within the body of the device. To operate the Autohaler, the patient removes the mouthpiece cover, lifts the lever, and inhales through the mouthpiece. The act of inhalation actuates the metering valve and allows a dose of medication to be released. Following actuation, the lever is lowered, the mouthpiece cover replaced and the device stored until required.

ISSUE:

What is the proper tariff classification of the Autohaler 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...."

Upon reconsideration of the applicable law in question, we are of the opinion that the tariff classification in NYR 858796 is the incorrect classification for the Autohaler. The Autohaler is properly classified under subheading 9019.20.00, HTSUSA, which 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 Autohaler meets the definition of an "aerosol therapy apparatus" in EN 90.19. The Autohaler is a device used by asthma patients to disperse or nebulize a liquid medicinal solution (commonly a mast cell membrane stabilizer, steroid or bronchodilator) into the lungs in a mist form for the treatment of their disease. The Autohaler 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 is a device 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 Autohaler is intended for treatment of a disease of the lungs rather than the diseases of the mouth.

HOLDING:

The Autohaler 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."

In order to insure uniformity in Customs classification of merchandise of this type and to eliminate uncertainty, we are revoking NYR 858796. This letter is notice to you of the revocation of NYR 858796 under section 177.9(d)(1), Customs Regulations (19 CFR 177.9(d)(1)).

Sincerely,

John Durant, Director
Commercial Rulings Division

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