CLA-2-84:OT:RR:NC:1:120
Mr. Todd Witkum
NxStage Medical, Incorporated
350 Merrimack Street
Lawrence, MA 01843
RE: The tariff classification of a water purification system, a control unit, and a chassis from Mexico
Dear Mr. Witkum:
In your letter dated February 13, 2013, you requested a tariff classification and the application of the Nairobi Protocol.
The merchandise under consideration includes the Pureflow SL Dialysate Preparation System (PFSL), when imported as a complete device with all its components; and the control unit, model NX2000-1, and the chassis, model NX2000-2, when imported separately. 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. It is specifically creating dialysate for use in renal replacement therapy (hemodialysis) to be used in the home.
The PFSL system includes a control unit, a chassis, a PAK, and a SAK; 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, not for consideration in this ruling.
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 SAK 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.
When imported separately, the control unit is an integral, yet self-contained component part of the chassis. The control unit incorporates pumps, sensors, and a UV light. It monitors temperature parameters and other aspects of operation, and it is capable of terminating the operation of the machine for the safety of the user. The UV light enclosure is part of the purification process that works in conjunction with the filtration aspects to produce a usable, ultra-pure water supply for addition to the SAK concentrate. The conductivity sensor is one of three sensor types in the control unit, the other two being fluid detection sensors and temperature sensors that are linked to the monitoring units in the chassis. These two sensors will trigger the device to shut down if leaks are detected or temperature variances are exceeded. The conductivity sensor exists to test the completed batches of dialysate to ensure they have been properly reconstituted. A fail at that test will prompt the user to purge the dialysate batch. The pinch clamps direct the flow of the water and/or dialysate at various points in the process: first to the PAK, then to the conductivity sensor, and then either to purge or flow to the System One Cycler for use.
When imported separately, the chassis contains a warmer, known as an electrical heating element, located on the underside of its tub, which uses electrical resistance to generate heat. It also contains thermistors, which are heating monitors used to monitor the temperature of the dialysate. Regarding the heating function, it is for patient comfort and has no bearing on the creation /reconstitution of the dialysate taking place within the SAK. The chassis does not contain the PAK, SAK, and control unit at the time of importation.
Regarding the controller, you propose classification under HTSUS 9032.89. However, it does not perform “only” the function described in the definition of HTSUS 9032 in Note 7 to Chapter 90. It does not simply measure a variable and then issue the instructions to an actuator to maintain that variable at the level input by the user. Regarding flow, an example would be an apparatus that measured the flow exiting an irrigation pipe and then gave instructions to a motorized valve and/or a pump to maintain the output, e.g., 50 gallons per minute, as chosen by the user, “stabilized against disturbances” such as greater or lesser pressure upstream. Your import is quite different.
You ask if these items 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 subassemblies in question are specially designed or adapted for use in the Preparation System.
On that basis, a secondary classification will apply for these items 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.
The applicable subheading for the Pureflow SL Dialysate Preparation System will be 8421.21.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Filtering or purifying machinery and apparatus for liquids: For filtering or purifying water.” The rate of duty will be free.
The applicable subheading for the Control Unit, model NX2000-1, will be 8421.99.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Parts of machinery and apparatus for filtering or purifying water.” The rate of duty will be free.
The applicable subheading for the Chassis, model NX2000-2, will be 8421.99.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Parts of machinery and apparatus for filtering or purifying water.” The rate of duty will be free.
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).
If you have any questions specifically regarding the classification in 9817.00.96, HTSUS, of this item, contact National Import Specialist J. Sheridan at 646-733-3012. If you have any questions regarding the classifications in this ruling, contact National Import Specialist Denise Faingar at (646) 733-3010.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division