The tariff classification of a plastic “sack” used in blood dialysis machines from Mexico

N316332 December 23, 2020 CLA-2-84:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 8421.99.0040; 9817.00.96 Juan C. Moreno Director Zisser Customs Law Group, PC 9355 Airway Road San Diego, California 92154 RE: The tariff classification of a plastic “sack” used in blood dialysis machines from Mexico Dear Mr. Moreno: In your letter dated December 7, 2020, on behalf of your client, NxStage Medical Inc., you requested a tariff classification and the application of the Nairobi Protocol. The merchandise under consideration is defined as a plastic “sack” used exclusively with NxStage Pureflow SL Dialysate Preparation System (PFSL) in blood dialysis machines. The proprietary sacks are imported with several plastic tubes, inlets, dose measurement indicators, as well as other adapters for connecting to the PFSL. The sacks are specially designed and configured to fit underneath the PFSL in a special compartment that has all the necessary inlets and outlets for connecting the various tubes and attachments. The “Conductivity Line” is connected directly to the PFSL. The "Dialysate Line” is connected to the NxStage System One Cycler (Hemodialysis Circuit System). The “Blue Line” is connected to the water “PAK” that is located to the left of the sack compartment. The “Other Lines” go in and out of the sack bag, mixing the concentrate with water to make dialysate. The Pureflow SL Dialysate Preparation System was ruled upon in N238446 (dated March 14, 2013) in which CBP determined the classification to be 8421.21.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof: Filtering or purifying machinery and apparatus for liquids: For filtering or purifying water.” The PFSL is a device designed to produce purified product water from ordinary tap water, which is then precisely mixed with sterile filtered dialysate concentrate to produce AAMI-quality dialysate. The device specifically creates dialysate for use in renal replacement therapy (hemodialysis) to be used in the home.  The complete PFSL system includes a control unit, a chassis, a PAK, and the “sack” (SAK) subject to his request; as well as a pre-treatment filter that is mounted to the back of the chassis’ metal cabinet. The PFSL will transfer dialysate via connected tubing to the System One Cycler, which is a hemodialysis circuit machine. The PFSL is hooked up to a domestic tap water supply to create ultra, pure de-ionized water to be added to the dialysate concentrate.  The tap water passes through the pre-treatment filter to a pump, housed in the self-contained control unit of the PFSL. The ultraviolet (UV) light enclosure component within the control unit breaks down chlorine and chloramines before the water is pumped into the PAK, which contains the replaceable filter cartridge used to purify and de-ionize the water. The sack is a plastic bag containing a precise amount of dialysate, which is a liquid chemical of fluid replenishment. All of the processed water is added to the SAK to reconstitute the dialysate. You propose classification under 3923.21.0095, HTSUS, which provides for “articles for the conveyance or packing of goods, of plastics: sacks and bags (including cones): of polymers of ethylene: Other: Other.”  We disagree. The sack has specialized functions of not only holding liquid but mixing and distributing as well. The sack comes with specialized tubing attached for use in the Pureflow SL Dialysate Preparation System and is required for the PFSL to operate. The applicable subheading for the plastic sacks will be 8421.99.0040, HTSUS, which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof: Parts: Other: Parts of machinery and apparatus for filtering or purifying water.” The general rate of duty will be free. In your request, you ask if the sacks are “eligible for importation under the Nairobi Protocol SPI.”  The United States, one of the signatories, has implemented part of the United Nations Nairobi Protocol, currently, via a provision for a secondary classification for articles for the handicapped in HTSUS 9817.00.92 through .96 and US Note 4 to Subpart 17 to Chapter 98. The US Court of International Trade held on February 3, 1993, in Travenol Laboratories v. US, Slip-op 93-15, that kidney dialysis procedures were not “therapeutic” in regard to the exclusion of “therapeutic articles” in US Note 4. The US Court of Appeals for the Federal Circuit held on August 3, 1990, in Richards Medical v. US, Appeal 89-1693, that specially designed instruments and apparatus used as integral elements in a “non-therapeutic” procedure for the handicapped were articles specially designed “for the benefit of the handicapped.” From the information provided, the Preparation System makes it more convenient for dialysis procedures to be performed in a home setting.  It is an article specially designed for the benefit of the handicapped, and the sacks in question are specially designed or adapted for use in the Preparation System. On that basis, a secondary classification will apply for the sacks in 9817.00.96, HTSUS, as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind), free of duty and user fees (if any).  Note that the requirement that the importer prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010.  Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or countervailing or dumping duties.  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. 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 Jason Christie at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division