H311614

HQ H311614 September 11, 2020 OT:RR:CTF:VS H311614 EGJ CATEGORY: Classification TARIFF NO.: 9817.00.96 Jared Wessel Hogan Lovells US, LLP 555 Thirteenth Street NW Washington, DC 20004 RE: Subheading 9817.00.96, HTSUS; Adhesive pad for an Insulin Delivery System Dear Mr. Wessel: This is in response to your ruling request dated May 15, 2020, regarding the applicability of subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), to adhesive pads used to attach an insulin delivery system to the user’s body. FACTS: The Insulet Corporation (“Insulate”) is primarily engaged in the development, manufacturing, and sale of its proprietary Omnipod System, which is a tubeless, continuous insulin delivery system for people with insulin-dependent diabetes. The Omnipod unit (the “Pod”) is an insulin reservoir and delivery device; the instant adhesive pad allows the Pod to attach to the user’s skin. The user will affix the Pod to the area of the body where insulin injections would otherwise be made. The Pod can be worn for up to 72 hours and supply insulin through a cannula as needed. After 72 hours, the wearer disposes of the used Pod and attaches a new one. Insulate purchases and imports the adhesive pads from a manufacturer located in China. The adhesive pads are non-woven polyester fiber mats which are coated on one side with a polyacrylate adhesive mass. The products are then covered with siliconized release paper. Each pad is pulled through a rotary die-cutting machine in order to create seven customized cutouts which correspond to features only found on the Pod. These cutouts and features are essential to the proper use of the Pod, such as cutouts for the insulin filling port and the housing vent. The adhesive pads are imported solely for use by Insulet in the manufacture of the Pod in the United States. After importation, each adhesive pad is permanently bonded to a Pod. Further, Insulet does not separately sell the adhesive pad to third parties nor does it make further modifications to the pads in order to adapt them for use in other products. ISSUE: Whether the instant adhesive pads are eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons.” LAW AND ANALYSIS: Subheading 9817.00.96, HTSUS, came into effect in the United States through a series of international agreements and acts of Congress. Its basis is in the Agreement on the Importation of Educational, Scientific and Cultural Materials, opened for signature Nov. 22, 1950, 17 U.S.T. 1835, 131 U.N.T.S. 25, or Florence Agreement, drafted by the United Nations Educational, Scientific, and Cultural Organization (“UNESCO”) in July 1950. In 1976, UNESCO adopted the Nairobi Protocol to the Florence Agreement, which expanded the scope of products to include materials specially designed for handicapped persons. See Protocol to the Agreement on the Importation of Educational, Scientific, or Cultural Materials, opened for signature 1 Mar. 1977, 1259 U.N.T.S. 3. Congress ratified the Nairobi Protocol and enacted it into U.S. law in 1983. Pub. L. 97-446, § 161, 96 Stat. 2329, 2346 (1983). Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. No. 100-418, 102 Stat. 1107) and Presidential Proclamation 5978 implemented the Nairobi Protocol by inserting permanent provisions—specifically, subheadings 9817.00.92, 9817.00.94, and 9817.00.96—into the HTSUS. Subheading 9817.00.96, HTSUS, 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.” As the language of this provision indicates, classification 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 other physically or mentally handicapped persons,” and whether it falls within any of the enumerated exclusions. See U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS, states: 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. In HQ Ruling Letter (“HQ”) 561020, dated October 12, 1998, we determined that individuals with diabetes are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and may have work restrictions due to excessive urination, possible nausea, dizziness, and fainting. Concluding that people with diabetes suffer from a permanent or chronic physical impairment which substantially limits the major life activity of working, we found that a person suffering from diabetes is “physically handicapped” within the meaning of U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS. There is no dispute that the Pod, used as a continuous insulin delivery system for people with diabetes, is eligible for duty-free treatment under the Nairobi Protocol in subheading 9817.00.96, Harmonized Tariff Schedule of the United States. See HQ 563264 (May 6, 2005) (insulin starter kit classified in 9817, HTSUS), HQ 562887 (Jan. 7, 2004) (blood glucose test strips in heading 9817, HTSUS), HQ 562869 (Dec. 23, 2003) (insulin pump infusion set classified in heading 9817, HTSUS). The issue in the instant case is whether the adhesive pads are parts or accessories of articles that are “specifically designed or adapted” for the use or benefit of handicapped persons. First, we will determine whether the adhesive pads are parts or accessories. In The Pomeroy Collection Ltd. v. United States, 783 F.Supp. 2d 1257, 1260-1261 (Fed. Cir. 2011), the U.S. Court of Appeals for the Federal Circuit (CAFC) explains the courts’ two tests for “parts” of an article under the HTSUS. The CAFC states, in pertinent part, that: The appellate court has adopted two tests for determining whether merchandise may be classified as a part of an article. The first is when the article of which the merchandise in question is claimed to be a part "could not function as such article" without the claimed part. United States v. Willoughby Camera Stores, Inc., 21 C.C.P.A. 322, 324, Treas. Dec. 46851, T.D. 46851 (1933) (emphasis and citations omitted); see also Bauerhin Techs. Ltd. P'ship v. United States, 110 F.3d 774, 778 (Fed. Cir. 1997) (relying on this "oft-quoted passage" of Willoughby). Thus, for example, a lens that allows a camera to take colored photos is properly a part of such cameras -- without such lens, "cameras could not perform one of their proper functions - the taking of colored pictures," Willoughby, 21 C.C.P.A. at 326-27. The second test by which a piece of merchandise may qualify as a part of another article is if, when imported, the claimed part is "dedicated solely for use" in such article and, "when applied to that use," the claimed part meets the Willoughby test. United States v. Pompeo, 43 C.C.P.A. 9, 14 (1955). The example here is a supercharger that may be installed in a car engine -- although both the car engine and the supercharger are complete in themselves, the supercharger is dedicated solely for supercharging the car engine, and, when applied to that use -- i.e., when the article being considered is not just a car engine, but a supercharged car engine -- the supercharged car engine cannot function without the super charger, and so the Willoughby test is 

Subheading 9817.00.96, HTSUS, came into effect in the United States through a series of international agreements and acts of Congress. Its basis is in the Agreement on the Importation of Educational, Scientific and Cultural Materials, opened for signature Nov. 22, 1950, 17 U.S.T. 1835, 131 U.N.T.S. 25, or Florence Agreement, drafted by the United Nations Educational, Scientific, and Cultural Organization (“UNESCO”) in July 1950. In 1976, UNESCO adopted the Nairobi Protocol to the Florence Agreement, which expanded the scope of products to include materials specially designed for handicapped persons. See Protocol to the Agreement on the Importation of Educational, Scientific, or Cultural Materials, opened for signature 1 Mar. 1977, 1259 U.N.T.S. 3. Congress ratified the Nairobi Protocol and enacted it into U.S. law in 1983. Pub. L. 97-446, § 161, 96 Stat. 2329, 2346 (1983). Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. No. 100-418, 102 Stat. 1107) and Presidential Proclamation 5978 implemented the Nairobi Protocol by inserting permanent provisions—specifically, subheadings 9817.00.92, 9817.00.94, and 9817.00.96—into the HTSUS.Subheading 9817.00.96, HTSUS, 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.” As the language of this provision indicates, classification 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 other physically or mentally handicapped persons,” and whether it falls within any of the enumerated exclusions. See U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS, states:For purposes of subheadings 9817