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

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 the inquiry on the “persons” for whose use and benefit the articles are “specially designed,” and not on any disorder that may incidentally afflict persons who use the subject merchandise. * * * . . . we must ask first, “for whose, if anyone’s, use and benefit is the article specially designed,” and then, “are those persons physically handicapped?” Id. The language of subheading 9817.00.96, HTSUS, states that the provision provides for “articles specially designed or adapted” for the use or benefit of the physically handicapped. The design and construction of an article may be indicative of whether it is specially designed or adapted for the use or benefit of the handicapped. The HTSUS does not establish a clear definition of what constitutes “specially designed or adapted for the use or benefit” of handicapped persons. In the absence of a clear definition, the Court of the International Trade stated that it may rely upon its own understanding of the terms or consult dictionaries and other reliable information. See Danze, Inc. v. United States, Slip Op. 18-69 (Ct. Int’l Trade 2018). Moreover, in analyzing this same provision in Sigvaris v. United States, the Court of International Trade construed these operative words as follows: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” [Webster’s] at 1647, 2186 . . . The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” [Webster’s] at 612 . . . . See Sigvaris, 227 F. Supp. 3d 1327 at 1336, Slip-Op 2017-60 (Ct. Int’l Trade 2017). See also, Sigvaris, 899 F.3d 1308, wherein the Court of Appeals for the Federal Circuit cited the definitions relied upon by the Court of International Trade in Sigvaris, in concluding that “articles specially designed for handicapped persons must be made with the specific purpose and intent to be used by or benefit handicapped persons rather than the general public.” The Court of Appeals for the Federal Circuit refined this requirement which it found to be incomplete. The court concluded that: to be “specially designed,” the subject merchandise must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others. Id. Finally, the legislative history further aids our analysis of these terms as used in subheading 9817.00.96, HTSUS. The Senate stated in its Report that one of the goals of this law was to benefit the handicapped and show U.S. support for the rights of the handicapped. The Senate stated, in relevant part: By providing for duty-free treatment of articles specially adapted for the blind or other physically or mentally handicapped persons, the committee does not intend that an insignificant adaptation would result in duty-free treatment for an entire relatively expensive article. Otherwise, the special tariff category will create incentives for commercially motivated tariff-avoidance schemes and pre-import and post-entry manipulation. Rather, the committee intends that, in order for an entire modified article to be accorded duty-free treatment, the modification or adaptation must be significant, so as clearly to render the article for use by handicapped persons. S. Rep. No. 97 564, 97th Cong. 2nd Sess. (1982). The Senate was concerned that persons would misuse this tariff provision to avoid paying duties on expensive products. Similarly, in Danze, supra, the Court of International Trade looked to the legislative history and noted that its interpretation of the terms “specially” and “designed” in its decision in Sigvaris comported with the legislative intent behind subheading 9817.00.96, HTSUS, that any modification or adaptation be “significant.” CBP has recognized several factors to be utilized and weighed against each other on a case-by-case basis when determining whether a particular product is “specially designed or adapted” for the benefit or use of handicapped persons. See U.S. Customs Serv. Implementation of the Duty-Free Provisions of the Nairobi Protocol, Annex E, to the Florence Agreement, T.D. 92-77, 26 Cust. B. & Dec. 240, 241 (1992) (“Implementation of the Nairobi Protocol”) at 243-244. These factors include: (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. See also Danze, supra; Sigvaris, 227 F.Supp.3d 1327, aff’d, 899 F.3d 1308. The court in Sigvaris, 899 F.3d. 1308, found that “[t]hese factors aid in assessing whether the subject merchandise is intended for the use or benefit of a specific class of persons to a greater extent than for the use or benefit of others.” The court adopted these factors into its analysis. The OptiChamber Diamond device is described as an accessory to a pMDI. So the question is whether a pMDI qualifies as an article for the use or benefit of the handicapped in subheading 9817.00.96, HTSUS. You reference New York Ruling Letter (NY) N133641, dated December 14, 2010, where CBP determined that valves and aluminum canisters designed to be used in the manufacture of pMDIs were determined to be classifiable in subheading 9817.00.96, HTSUS, as parts of articles specially designed or adapted for the use or benefit of the handicapped. We agree with the decision in that ruling as we agree that a pMDI, which is a delivery device for medication for individuals suffering from chronic respiratory conditions, such as asthma, qualifies as an article specially designed or adapted for the use or benefit of the handicapped. See also NY M85686, dated September 12, 2006. These devices are designed for a specific purpose, limited for use by those with permanent or chronic respiratory issues, and do not appear to be susceptible to other uses by the general public. As the OptiChamber Diamond device is an accessory of the pMDI, it is eligible for classification under subheading 9817.00.96, HTSUS, as an accessory to an article specially designed or adapted for the use or benefit of the handicapped. However, the OptiChamber Diamond device is not the article at issue in this ruling. The article at issue is the OptiChamber Diamond Exhaust Valve which is a part of the OptiChamber Diamond device. As the exhaust valve is a part of an accessory of an article which is specially designed or adapted for the use or benefit of the handicapped, the exhaust valve is not classifiable under subheading 9817.00.60, HTSUS. The provision allows for inclusion of parts of articles specially designed or adapted for the use or benefit of the handicapped or accessories to such articles. However, the exhaust valve is not a part of an article classifiable under 9817.00.60, HTSUS, but a part of an accessory. As such, it is not provided for within subheading 9817.00.60, HTSUS, and cannot be classified therein. HOLDING: The OptiChamber Diamond Exhaust Valve is not eligible for duty-free treatment under subheading 9817.00.96, HTSUS, because it is not a part or accessory to an article specially designed or adapted for the use or benefit of the handicapped, but is a part of an accessory. A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy of this ruling, it should be brought to the attention of the CBP officer handling the transaction. Sincerely, Monika R. Brenner, Chief Valuation and Special Programs Branch