H314474

U.S. Department of Homeland Security Washington, DC 20229 U.S. Customs and Border Protection HQ H314474 December 3, 2020 OT:RR:CTF:VS H314474 CMR CATEGORY: Classification Robert Leo, Esq. Meeks, Sheppard, Leo & Pillsbury 4 Corporate Dr., Suite 292 570 Lexington Avenue Shelton, CT 06484 RE: Eligibility for duty-free treatment under subheading 9817.00.96, HTSUS, of plastic exhaust valve on a spacer or holding chamber used with a pMDI Dear Mr. Leo: This is in response to your request of September 29, 2020, submitted on behalf of your client, Respironics, Inc., for a ruling on the eligibility for duty-free treatment under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), of an OptiChamber Diamond Exhaust Valve from China. The proper classification of the exhaust valve is being examined by the Electronics, Machinery, Automotive, and International Nomenclature Branch, Regulations and Rulings, Office of Trade. This ruling is limited to the eligibility of the exhaust valve under subheading 9817.00.96, HTSUS, as a part of an article for the use or benefit of the handicapped. You have asked for confidential treatment for the names of customers referenced in your submission. Inasmuch as your request conforms to the requirements of 19 C.F.R. § 177.2(b)(7), your request for confidentiality is approved. The drawings and specifications which were submitted as attachments to your request for a binding ruling, and the names of customers contained in your submission will not be released to the public and will be referenced in this ruling. FACTS: You describe the OptiChamber Diamond Exhaust Valve as a part which is exclusively for use in an OptiChamber Diamond medical device. The OptiChamber Diamond medical device is a spacer and holder chamber for medication inhaled by asthma sufferers. It is described at https://www.healthstore.philips.com/breathing-respiratory-products/asthma-inhalers-spacers/optichamber-diamond-valved-holding-chamber-and-spacer.html as follows: OptiChamber Diamond is designed to allow medication to be delivered to the lungs. The anti-static material inside the tube allows the aerosol to be suspended longer, giving you more time to inhale. [footnote omitted]. You indicate that the exhaust valve is designed, manufactured and used exclusively with the OptiChamber Diamond device and is physically attached to the device. You describe the purpose of the device is “to reduce the effects of coordination issues associated with pMDIs (Pressurized metered dose inhalers – Asthma Sprays).” In your submission, you set forth how the device functions as follows: 1. The patient shakes the pMDI, inserts it into the back of the chamber. 2. The patient puts the chamber in his/her mouth and actuates the pMDI. 3. The patient then inhales causing the exhalation flap valve to close and the duckbill valve to open (this allows the aerosolized drug to flow from the chamber into the user’s lungs). 4. When the patient exhales, the duckbill valve closes, directing air flow out to the atmosphere through the exhaust flap valve. This prevents the patient from blowing any remaining drug out the back of the chamber. The remaining drug in the chamber is now available for the next inhalation cycle. 5. The patient could repeat the inhalation/exhalation cycle 6-8 times. ISSUE: Whether the OptiChamber Diamond Exhaust Valve is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: Before Customs and Border Protection (CBP) can determine if the OptiChamber Diamond Exhaust Valve, as a part of an OptiChamber Diamond device, is eligible for duty-free treatment under subheading 9817.00.96, HTSUS, we must determine whether the OptiChamber Diamond device is considered to be an article or an accessory for the use or benefit of the handicapped. The OptiChamber Diamond Exhaust “Valve” is a part of an OptiChamber Diamond device and is essentially a silicon flap that is attached to the mouthpiece of the OptiChamber Diamond. The flap opens and closes as an individual inhales or exhales through the device. If the OptiChamber Diamond device is considered an article for the use or benefit of the handicapped, then the valve at issue, as a part of the device, would be eligible for duty-free treatment under subheading 9817.00.96, HTSUS. However, if the OptiChamber Diamond device is considered an accessory to an article for the use or benefit of the handicapped, as a part of an accessory, the valve at issue would not be eligible for duty-free treatment under subheading 9817.00.96, HTSUS. You focus your submission on the OptiChamber Diamond Exhaust Valve and not on consideration of the OptiChamber Diamond device. You describe the OptiChamber Diamond device as a spacer or holder chamber for medication inhaled by asthma sufferers. Spacers and valved holding chambers are described on the Philips USA website as follows: Both spacers and valved holding chambers were designed as accessories to be used with your inhaler, puffer or pMDI to help deliver medication to your lungs where it is needed. A spacer is a generic term used to describe a tube-like accessory that extends the mouthpiece of the inhaler and directs the medication towards your mouth. A valved holding chamber is a spacer which contains valves to hold the aerosol for a short time. The valves open to release the medication when you breathe in. Regarding subheading 9817.00.96, HTSUS, it provides for: articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other. Subheading 9817.00.96 excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. Accordingly, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions. See subheading 9817.00.96, HTSUS; U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. Note 4(a) to Chapter 98, HTSUS, provides: (a) For purposes of subheadings 9817.00.92, 9817.00.94 and 9817.00.96, the term “blind or other physically or mentally handicapped persons” includes any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working. U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. This list of exemplar activities indicates that the term “handicapped persons” is to be liberally construed so as to encompass a wide range of conditions, provided the condition substantially interferes with a person’s ability to perform an essential daily task. While the HTSUS and subchapter notes do not provide a proper definition of “substantial” limitation, the inclusion of the word “substantially” denotes that the limitation must be “considerable in amount” or “to a large degree.” In the Court of Appeals for the Federal Circuit’s decision in Sigvaris, Inc. v. United States, 899 F.3d 1308 (Fed. Cir. 2018), the court found that the Court of International Trade reached the correct conclusion in finding the merchandise at issue therein, compression stockings, not eligible for subheading 9817.00.96, HTSUS, but the court disagreed with the lower court’s analysis. The court found that the Court of International Trade looked to the condition or disorder and whether it is a handicap. The court stated: The plain language of the heading focuses

Before Customs and Border Protection (CBP) can determine if the OptiChamber Diamond Exhaust Valve, as a part of an OptiChamber Diamond device, is eligible for duty-free treatment under subheading 9817.00.96, HTSUS, we must determine whether the OptiChamber Diamond device is considered to be an article or an accessory for the use or benefit of the handicapped. The OptiChamber Diamond Exhaust “Valve” is a part of an OptiChamber Diamond device and is essentially a silicon flap that is attached to the mouthpiece of the OptiChamber Diamond. The flap opens and closes as an individual inhales or exhales through the device. If the OptiChamber Diamond device is considered an article for the use or benefit of the handicapped, then the valve at issue, as a part of the device, would be eligible for duty-free treatment under subheading 9817.00.96, HTSUS. However, if the OptiChamber Diamond device is considered an accessory to an article for the use or benefit of the handicapped, as a part of an accessory, the valve at issue would not be eligible for duty-free treatment under subheading 9817.00.96, HTSUS. You focus your submission on the OptiChamber Diamond Exhaust Valve and not on consideration of the OptiChamber Diamond device. You describe the OptiChamber Diamond device as a spacer or holder chamber for medication inhaled by asthma sufferers. Spacers and valved holding chambers are described on the Philips USA website as follows:Both spacers and valved holding chambers were designed as accessories to be used with your inhaler, puffer or pMDI to help deliver medication to your lungs where it is needed.A spacer is a generic term used to describe a tube-like accessory that extends the mouthpiece of the inhaler and directs the medication towards your mouth. A valved holding chamber is a spacer which contains valves to hold the aerosol for a short time. The valves open to release the medication when you breathe in.Regarding subheading 9817.00.96, HTSUS, it provides for: articles sp