CLA-2-30:OT:RR:NC:N2:237
Ms. Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury
355 Lexington Avenue, Suite 1400
New York, New York 10017
RE: The tariff classification of cranioplastic and aneuroplastic repair kits from England.
Dear Ms. Abraham:
In your letter dated July 3, 2012, on behalf of DePuy Codman of Raynham MA, you requested a tariff classifications ruling. You provided samples and descriptive literature for our review. Your two samples are being returned.
The Cranioplastic Type 1 - Slow Set is a self-curing methyl methacrylate (MMA) resin for repairing cranial defects. The product consists of two complete sets of powder polymer (30g), liquid monomer (16.17g), plastic sleeve and booklet retail packed in a printed paperboard box. The powder and liquid are mixed in a sterile bowl, kneaded and shaped in the plastic sleeve, and then applied to the bone. The setting time is 14-20 minutes. The product is used by surgeons to bridge voids between cranial bones caused through an accident to the head or during surgery.
Aneuroplastic Type 2 - Fast Set is a fast self-curing methyl methacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The product consists of two complete sets of powdered polymer (30g), liquid monomer (16.17g), plastic sleeve and booklet retail packed in a printed paperboard box. The powder and liquid are mixed in a sterile vessel, kneaded and shaped in the plastic sleeve, and then applied to the aneurysm. The setting time is 5-10 minutes. The product is used by surgeons to encapsulate a herniated blood vessel in the brain, that has been identified as having a considerable risk of rupture.
In your letter, you suggest classification in heading 3004, HTSUS, which provides for other medicaments (excluding goods of 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. In our opinion, the products do not meet the definition in Explanatory Note (EN) 3004 (3) for: Bone graft substitutes, such as those made from surgical grade calcium sulfate, which are injected into a cavity of the fractured bone and spontaneously resorbed and replaced by bone tissue; these products provide a crystalline matrix on which new bone can grow as the matrix is resorbed. Furthermore, the products are not bone void fillers for tariff classification purposes. They do not contain surgical grade calcium sulfate but rather MMA, which is not resorbed and replaced with bone during the healing process.
The importer claims that the products are not indicated for use as bone reconstruction cements in heading 3006, HTSUS. However, use of MMA as a bone reconstruction cement is long-standing. MMA was first used as a cranioplastic material in 1940. MMA is used in various formulations for a wide variety of applications, including: cranioplasty, arthroplasty and aneuroplasty. In cranioplasty or arthroplasty, MMA restores the shape and appearance of the cranium or hip. In aneuroplasty, MMA replaces the natural protective structures of the brain. According to chapter 30 note 4 (f), bone reconstruction cements are to be classified in heading 3006 and in no other heading of the tariff schedule. EN 30.06 states: This heading also covers bone reconstruction cements, usually containing a hardener (curing agent) and activator and used, for example, for attaching prosthetic implants to existing bone; these cements usually cure at body temperature. The products are two part self-curing resin cements for filling and repairing cranial incisions and encapsulating herniated vessels reached through those incisions. Hardening at body temperature, the resins form a rigid external casing for the aneurysm, replace the natural protective structures of the brain and restore the shape and appearance of the cranium.
The applicable subheading for the cranioplastic and aneuroplastic kits will be 3006.40.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: Dental cements and other dental fillings; bone reconstruction cements. The rate of duty will be free.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Frank Cantone at (646) 733-3038.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division