Request for Reconsideration of NY N010919: Barefoot Science Group Marketing, Inc.; "Arch Activation Foot Strengthening System"

HQ H017181 August 25, 2008 CLA-2 OT:RR:CTF:TCM H017181GC CATEGORY: Classification TARIFF NO.: 6406.99.3060 Mr. Stephen Martorino Spectrum Customs Border Services 4050A Sladeview Cr. Mississauga, Ontario Canada L5L 5Y5 RE: Request for Reconsideration of NY N010919: Barefoot Science Group Marketing, Inc.; “Arch Activation Foot Strengthening System” Dear Mr. Martorino: Customs and Border Protection (CBP) has received your correspondence on behalf of your client Barefoot Science Group Marketing, Inc. (Barefoot), dated July, 30 2007, requesting reconsideration of New York Letter Ruling (NY) N010919, dated May 25, 2007. FACTS: NY N010919 pertains to Barefoot’s “Arch Activation Foot Strengthening System” (foot strengthening system), which consists of a pair of pre-cut EVA (ethylene vinyl acetate) insoles, which come in a full length and a three-quarter length variety. Each type of insole is packaged in pairs along with seven pairs of interchangeable inserts. The insoles can be sized to fit the end user after importation, but they are not made to measure upon entry. The inserts, which are of various densities, are composed of either neoprene or TPR (thermoplastic rubber), and are designed to fit into the insoles. The stated purpose of the foot strengthening system is to “stimulate” and “strengthen” the foot’s supporting muscle groups, thus ensuring a stable platform for the rest of the user’s body with the least amount of degenerative stress. As a result of this function, the foot strengthening system has been classified by the United States Food and Drug Administration (FDA) as a Class 1 medical device. In NY N010919, the subject merchandise is classified in subheading 6406.99.3060 of the Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, “[p]arts of footwear…; removable insoles, heel cushions and similar articles; gaiters…” ISSUE: Whether the subject merchandise is classifiable as an orthopedic appliance of heading 9021, HTSUS, or an article of heading 6406, HTSUS? LAW AND ANALYSIS: Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. The HTSUS provisions under consideration in this case are as follows: 6406 Parts of footwear (including uppers whether or not attached to soles other than outer soles); removable insoles, heel cushions and similar articles; gaiters, leggings and similar articles, and parts thereof: Other: 6406.99 Of other materials: 6406.99.30 Of rubber or plastics… 6406.99.3060 Other… * * * 9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: 9021.10.00 Orthopedic or fracture appliances, and parts and accessories thereof… 9021.10.0090 Other… Initially, we note that the subject merchandise is entered and packaged unassembed, as the “Arch Activation Foot Strengthening System” is not used until the inserts are attached to the removable insoles. Accordingly, GRI 2(a) states: Any reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article. It shall also include a reference to that article complete or finished (or falling to be classified as complete or finished by virtue of this rule), entered unassembled or disassembled. In understanding the language of the HTSUS, the Harmonized Commodity Description and Coding System Explanatory Notes (ENs) may be utilized. The ENs, though not dispositive or legally binding, provide commentary on the scope of each heading of the HTSUS, and are the official interpretation of the Harmonized System at the international level. CBP believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989). The EN to GRI 2(a) states the following, in pertinent part: (V) The second part of Rule 2 (a) provides that complete or finished articles presented unassembled or disassembled are to be classified in the same heading as the assembled article. When goods are so presented, it is usually for reasons such as requirements or convenience of packing, handling or transport. * * * (VII)… Unassembled components of an article which are in excess of the number required for that article when complete are to be classified separately. The term “essential character,” in the context of applying GRI 2(a), means “the attribute that serves to distinguish what an article is; that which is indispensable to the structure, core or condition of the good; the aggregate of distinctive component parts that establishes the identity of an article as what it is, its very essence”. HQ 967975, dated March 24, 2006. In the instant case, the subject merchandise, as entered, possesses the essential character of fully assembled insoles, as the user assembles the product simply by placing the pre-fitted insert into the removable insole, resulting in a complete insole. Because the subject merchandise is packaged with fourteen inserts, and only two of them are used at a time, the remaining twelve inserts are considered excess, and are thus classified separately. Here, the inserts happen to be classifiable in the same HTSUS provision as the removable insoles.( Thus, the primary issue is whether the assembled insoles fall under the terms of heading 6406, HTSUS, or heading 9021, HTSUS. Note 1(e) to Chapter 64, HTSUS, excludes “[o]rthopedic footwear or other orthopedic appliances, or parts thereof (heading 9021)” from coverage under Chapter 64, HTSUS. While Barefoot does not directly assert that the foot strengthening system is classifiable in heading 9021, HTSUS, the nature of its request for reconsideration of NY N010919 causes us to believe that Barefoot considers the subject merchandise to be a product of heading 9021, HTSUS, and thus excluded from Chapter 64 by operation of Note 1(e) to that chapter. Note 6 to Chapter 90, HTSUS, which pertains to the scope of heading 9021, HTSUS, reads: For the purposes of heading 9021, the expression “orthopedic appliances” means appliances for: Preventing or correcting bodily deformities; or Supporting or holding parts of the body following an illness, operation or injury. Orthopedic appliances include footwear and special insoles designed to correct orthopedic conditions, provided that they are either (1) made to measure or (2) mass-produced, entered singly and not in pairs and designed to fit either foot equally. Barefoot argues that its foot strengthening system constitutes an appliance for preventing or correcting bodily deformities. According to the literature submitted by Barefoot, the foot strengthening system’s principal function of ensuring a stable platform for the rest of the user’s body with the least amount of degenerative stress reduces the occurrence of many foot-related problems. The insoles are used with the removable inserts to fulfill this function. For the subject merchandise to fit within the scope of heading 9021, HTSUS, however, it must fit the definition of “orthopedic appliances” articulated by Note 6 to Chapter 90. The insoles must either be made to measure or, if mass-produced, must be entered singly and designed to fit either foot equally. In this case, the insoles that make up the foot strengthening system do not fit either requirement. As such, the language of Note 6 precludes the subject merchandise from being classifiable in heading 9021, HTSUS. To support the classification of the subject merchandise in heading 9021, Barefoot points out that the FDA has determined that the foot strengthening system is a Class 1 medical device. In furtherance of this line of reasoning, Barefoot notes that its foot strengthening system brings to the market a more effective alternative to traditional custom made orthotics/insoles. While the clinical data might support Barefoot’s contention in this regard, it remains that articles are classified by the FDA to protect public safety, not as guidance for classification of imported merchandise. See Amersham Corp. v. United States, 5 C.I.T. 49, 56, 564 F.Supp. 813, 817 (1983) (noting that “statutes, regulations and administrative interpretations relating to ‘other than tariff purposes’ are not determinative of [CBP] classification disputes.”); see also Headquarters Letter Ruling (HQ) 085064, dated August 24, 1990 and HQ 962181, dated January 13, 1999. While Barefoot’s foot strengthening system is a Class 1 medical device as determined by the FDA, the merchandise does not fit the definition of an orthopedic appliance articulated in Note 6 to Chapter 90, HTSUS. Consequently, it does not fit within the terms of heading 9021, HTSUS. As such, the subject removable insoles, along with the inserts, are classifiable under heading 6406, HTSUS, as “…removable insoles, heel cushions and similar articles…”. See also HQ 964981, dated September 10, 2001 and HQ 087508, dated September 27, 1990. HOLDING: By application of GRI 2(a) the components that make up the subject “Arch Activation Foot Strengthening System” are classifiable separately. The removable insoles combined with one pair of inserts are classified under heading 6406, HTSUS, and specifically provided for in subheading 6406.99.3060, HTSUS, which provides for: “[p]arts of footwear…; removable insoles, heel cushions and similar articles; gaiters…: Other: Of other materials: Of rubber or plastics… Other.” The remaining six pairs of inserts are classifiable under the same HTSUS provision. The general column one rate of duty is 5.3 per cent ad valorem. NY N010919, dated May 25, 2007, is thus AFFIRMED. Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov. Sincerely, Myles B. Harmon, Director Commercial and Trade Facilitation Division