CLA-2-84:OT:RR:NC:N1:104
Aaron Collett
Resolve Designs LLC
1478 N 1000 W
Mapleton, UT 84664
RE: The tariff classification of a pill crusher and plastic pouch from China.
Dear Mr. Collett:
In your letter dated September 4, 2019, you requested a tariff classification ruling.
The Resolve Designs LLC, RxCrush Pill Crushing System, is used to crush and pulverize hard medicament pills so the powder can be easily dissolved into liquid and injected into a patient through a feeding tube. To operate, the user inserts the pill into a plastic pill pouch, which is in turn positioned under the crush block. A manual process of moving the handle up and down breaks the pill. The plastic pill pouch is then moved under the roller and the handle is moved side to side to pulverize the pill into powder.
The crusher is imported in an incomplete, unassembled condition. Submitted information shows that the critical components necessary to perform the crushing function being imported are:
the Crush Block made of cast and machined aluminum with powder coating
the Pivot Block made of cast and machined stainless steel
the Handle made of machined stainless steel
the Roller made of machined polyvinyl chloride (PVC)
the Base Plate made of machined aluminum with powder coating
the Link made of machined stainless steel
the Anti-Rotation Plate made of cast stainless steel
After importation, the RxCrush Pill Crushing System is assembled with components sourced in the United States such as 1-1/2” snap ring, 2-5/8” snap rings, a PVC grip, 4-5/16” stainless steel press pins, 5-suction cups feet, 2-1/4” stainless steel screws, and a locktite.
You propose classification in heading 9018 of the Harmonized Tariff Schedule of the United States (HTSUS), which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences; parts and accessories thereof. We disagree. The Rx Crush Pill Crushing System (the Rx Crush Pill Crusher machine and the Rx Crush Pill Pouches) is not classifiable in heading 9018, HTSUS, because it is not used by practitioners in direct contact with a patient and not used directly in a professional practice to make a diagnosis, prevent or treat an illness, or perform surgery. The fact that the Rx Crush Pill Crushing machine and the Rx Crush Pill Pouches are classified as medical devices by the FDA has no binding effect on classification by CBP. "It is well established that statutes, regulations and administrative interpretations relating to "other than tariff purposes" are not determinative of customs classification disputes." Amersham Corp. v. United States, 5 CIT 49 at p. 56 (1983). Articles are classified by the FDA to protect public safety, not as guidance to customs classification. See Headquarters Ruling 085064 dated August 24, 1990.
Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRIs). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative section or chapter notes. Merchandise that cannot be classified in accordance with GRI 1 is to be classified in accordance with subsequent GRIs taken in order.
GRI 2(a) states as follows:
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.
Although the Crush Block, Pivot Block, Handle, Roller, Base Plate, Link, and Anti-Rotation Plate, in their condition at the time of importation, cannot perform the function of the finished pill crusher, it is the opinion of this office that the components possess the essential character of a complete pill crusher and are therefore classifiable in subheading 8479.82, HTSUS.
The applicable subheading for the Crush Block, Pivot Block, Handle, Roller, Base Plate, Link, and Anti-Rotation Plate, as described above imported together in one shipment, will be 8479.82.0080, HTSUS, which provides for “Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter, parts thereof: Other machines and mechanical appliances: Mixing, kneading, crushing, grinding, screening, sifting, homogenizing, emulsifying or stirring machines … Other”. The general rate of duty will be free.
The plastic pouch is to be used with the pill crusher device. It is intended to completely contain medicament dust while crushing hard pills. The pouch is about three inches by five inches and made of two clear plastic sheets that are 0.005 inches thick, sealed together on the sides. One end of the pouch is fitted with an ENFit syringe connection, and the other end is sealed with a zip seal. The pill is inserted in the pouch through the zip seal and then closed. The pouch with pill is then placed in the crusher machine to pulverize the pill into powder. The liquid from the syringe is inserted into the pouch and shaken until the contents are dissolved. Once dissolved, the content of the pouch are drawn out with the syringe, the syringe is then disconnected from the pouch, and the syringe contents are injected into the feeding tube of the patient. The pouch will be imported on its own and is not reusable.
The subject pouch would be considered an article of plastic and as it is not more specifically provided for elsewhere, the applicable subheading will be 3926.90.9990, HTSUS, which provides for “Other articles of plastics and articles of other materials of headings 3901 to 3914: Other: Other: Other.” The general rate of duty is 5.3 percent ad valorem.
Products of China classified under subheading 8479.82.0080, HTSUS, unless specifically excluded, are subject to the additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 8479.82.0080, HTSUS, listed above. See U.S. Note 20 to Subchapter III, Chapter 99, HTSUS.
Products of China classified under subheading 3926.90.9990, HTSUS, unless specifically excluded, are subject to the additional 15 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.15, in addition to subheading 3926.90.9990, HTSUS, listed above. See U.S. Note 20 to Subchapter III, Chapter 99, HTSUS.
The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the Section 301 trade remedy, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.
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 the World Wide Web at https://hts.usitc.gov/current.
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 Denise Hopkins at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division