CLA-2 OT:RR:CTF:TCM H023360 JPJ
Eleanore Kelly-Kobayashi, Esq.
Rode & Qualey
Attorneys at Law
55 West 39th Street
New York, NY 10018
RE: Classification of Becton Dickinson BD Medimachine™ System
Dear Ms. Kelly-Kobayashi:
This letter is in response to your request of January 4, 2008, on behalf of Becton Dickinson and Company, (“Becton Dickinson”), to the National Commodity Specialist Division (“NCSD”) in New York in which you requested a binding ruling pertaining to the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of the Becton Dickinson BD Medimachine™ System. Your letter was forwarded to this office for a response.
FACTS:
The BD Medimachine™ System (“System”) is a standardized sample preparation system for the automated, mechanical disaggregation of solid animal or plant tissues for flow cytometric analysis, cell culture, or DNA amplification techniques. The System does not test or analyze tissue. The System is for laboratory use.
The System consists of three components: (1) the Medimachine™, (2) the Medicon™, and (3) the Filcon™, all manufactured in Italy. The System does not include any other components. The Medimachine™, the Medicon™, and the Filcon™ are packaged, imported, and sold separately. They are not imported as a set. As such, the user of the System can configure it in accordance with his particular needs. The customer decides on the quantity and type of Medicon™ and Filcon™ it needs and purchases them separately from the Medimachine™.
For example, the Medimachine™ is offered in a 115 V and a 230 V model; the Medicon™ is offered in two pore sizes, 35 µm and 50 µm, and is available in a sterile and a non-sterile type. The Filcon™ is offered in 10 µm, 20 µm, 30 µm, 50 µm, 70 µm, 100 µm, 200 µm, and 500 µm pore sizes, in packs of 100 and 300, and in a sterile and a non-sterile type.
According to the product literature, the compact Medimachine™ unit is the heart of the system. It works together with the Medicons™ and operates at a constant speed of approximately 80 rpm.
The Medicon™ is a disposable polyethylene chamber containing a rotating mincing device and an immobile stainless steel screen with approximately 100 hexagonal holes. Around each hole are 6 microblades designed for efficient cutting of hard and soft tissues.
After disaggregation of the tissue in the Medicon™, the cell suspension is filtered using a Filcon™ disposable filter device. The Filcon™ is constructed of nylon mesh with a plastic housing. Depending upon the chosen Filcon™ pore size, cells or cell aggregates pass through while larger particles are trapped. There are two types of Filcons™: a syringe-fitting form which can be used with either suction or compression and works well for quantities over 5 mL, and a cup type that works well for small quantities. You explain that the syringe type uses the manual pressure of the squirting action while the cup type uses gravity.
The steps followed when using the System for typical tissue disaggregation are as follows:
1. A small piece of tissue (up to 10 mm³), free of fat and necrosis, is inserted into the Medicon together with ~1.0 mL of the desired suspension buffer (PBS, etc.).
2. The Medicon is then inserted into the Medimachine and the machine is started. The machine can be run from 10 seconds to 4 minutes depending upon the tissue type and the resultant cell suspension desired. The disaggregation time can be standardized across labs for each tissue type and desired cell preparation. As the tissue is disaggregated, the cells pass through the screen into the suspension liquid in the bottom of the Medicon.
3. Once the tissue is disaggregated, the Medicon can be removed from the Medimachine. Remove the cover and use a syringe in the syringe port to recover the cell suspension. The Medicon may be rinsed with suspension buffer to ensure maximum cell recovery.
4. Select the appropriate Filcon pore size for isolation of the desired cells.
ISSUE:
What is the proper classification of the Becton Dickinson BD Medimachine™ System under the 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 may then be applied.
The HTSUS provisions under consideration are as follows:
5911 Textile products and articles, for technical uses, specified in note 7 to this chapter:
8479 Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof:
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: apparatus for physical or chemical analysis
Note 1 to Section XVI, HTSUS, (chapter 84) states, in relevant part, that the section does not cover:
1. (m) Articles of chapter 90;
Note 2 to Section XVI, HTSUS, (chapter 84) states, in relevant part, as follows:
Subject to note 1 to this section, note 1 to chapter 84 and to note 1 to chapter 85, parts of machines (not being parts of the articles of heading 8484, 8544, 8545, 8546 or 8547) are to be classified according to the following rules:
(a) Parts which are goods included in any of the headings of chapter 84 or 85 (other than headings 8409, 8431, 8448, 8466, 8473, 8487, 8503, 8522, 8529, 8538 and 8548) are in all cases to be classified in their respective headings;
(b) Other parts, if suitable for use solely or principally with a particular kind of machine, or with a number of machines of the same heading (including a machine of heading 8479 or 8543) are to be classified with the machines of that kind or in heading 8409, 8431, 8448, 8466, 8473, 8503, 8522, 8529 or 8538 as appropriate. However, parts which are equally suitable for use principally with the goods of headings 8517 and 8525 to 8528 are to be classified in heading 8517;
* * *
The Harmonized Commodity Description and Coding System Explanatory Notes (EN’s) constitute the official interpretation of the Harmonized System. While not legally binding on the contracting parties, and therefore not dispositive, the EN’s provide a commentary on the scope of each heading of the Harmonized System and are thus useful in ascertaining the classification of merchandise under the HTSUS. CBP believes the EN’s should always be consulted. See T.D. 89 80, 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989).
The ENs to heading 84.79 provide in relevant part:
This heading is restricted to machinery having individual functions, which:
(a) Is not excluded from this Chapter by the operation of any Section or Chapter Note.
and (b) Is not covered more specifically by a heading in any other Chapter of the Nomenclature.
and (c) Cannot be classified in any other particular heading of this Chapter since:
(i) No other heading covers it by reference to its method of functioning, description or type.
and (ii) No other heading covers it by reference to its use or to the industry in which it is employed.
or (iii) It could fall equally well into two (or more) other such headings (general purpose machines).
* * *
The machinery of this heading is distinguished from the parts of machinery, etc., that fall to be classified in accordance with the general provisions concerning parts, by the fact that it has individual functions.
For this purpose the following are to be regarded as having “individual functions”:
Mechanical devices, with or without motors or other driving force, whose function can be performed distinctly from and independently of any other machine or appliance.
* * *
The ENs to heading 90.18 provide in relevant part:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc. Instruments and appliances for anatomical or autoptic work, dissection, etc., are also included, as are, under certain conditions, instruments and appliances for dental laboratories (see Part (II) below). The instruments of the heading may be made of any material (including precious metals).
* * *
You argue that the BD Medimachine™ is classifiable in heading 9018, HTSUS, because it is an instrument or appliance which is used only by researchers in professional practice for the dissection of tissues and assists medical professionals in preparing tissues for analysis. You also argue that the Medicons™ and the Filcons™ are classified along with the BD Medimachine™ in heading 9018, HTSUS, as parts and accessories of the BD Medimachine™.
You cite HQ 964888, dated July 12, 2002, which classified a P.A.L.M. Laser-MicroBeam System (“P.A.L.M.”) for the microdissection of large, homogenous cell areas, small cell clusters, and single cells in heading 9018, HTSUS. The P.A.L.M. consists of a microscope, a laser, a computer, and a micromanipulator. It performed microdissection by interfacing a pulsed ultra violet (UV) high beam quality laser with a standard inverted microscope through the epifluoresence port. However, as that ruling indicates, the P.A.L.M. “aids doctors and medical researchers in making a diagnosis, assist in in-vitro fertilization, and other medical procedures and research”.
The System, however, does not diagnose or prevent or treat an illness. It prepares “all tissue types” for subsequent analysis. Unlike the P.A.L.M., the System does not modify or change cells to treat an illness or a medical condition.
The product literature states that the System is a safe, standardized sample preparation system for the automated, mechanical disaggregation of solid and or plant tissues for flow cytometric analysis, cell culture, or DNA amplification. The product literature also states that it is used in the laboratory specifically for purposes of tissue preparation for subsequent analysis. You also confirm that the System does not analyze tissue, but simply prepares tissue for testing. As such, the System, and specifically the Medimachine™, the Medicons™, and the Filcons™, are not used principally in professional practice to make a diagnosis, to prevent or treat an illness, or to operate, etc. The product literature confirms that it is used in the laboratory for tissue disaggregation of solid animal or plant tissues for a variety of purposes.
Therefore, we conclude that the Medimachine™, the Medicons™, and the Filcons™ are not described by the text of heading 9018, HTSUS. The Medimachine™ is machinery having an individual function, i.e., the mechanical disaggregation of solid animal or plant tissues. The Medimachine™ is not excluded from Chapter 84 by any Section or Chapter Note, and it is not covered more specifically by a heading of any other Chapter of the HTSUS. Also, it cannot be classified in any other heading of this Chapter because no other heading covers it by reference to its method of functioning, description, type, its use or to the industry in which it is employed. Therefore the Medimachine™ is classifiable under heading 8479, HTSUS, specifically, subheading 8479.90.94, HTSUS. See EN 84.79 The Medimachine™, the Medicons™, and the Filcons™ are not excluded from Section XVI, and chapter 84, by Note 1(m) to Section XVI.
We note our decision is consistent with prior rulings in which CBP has previously classified sampling machines in heading 8479, HTSUS. See HQ W967842, dated August 21, 2009 (classifying an ALS 104 GC Auto-Sampler described as an automatic programmable sample injector in subheading 8479.89.98, HTSUS); HQ W967843, dated August 21, 2009 (classifying an Auto-Sampler platform used with the ABI Prism 3100 Genetic Analyzer in subheading 8479.89.98, HTSUS); NY G82571, dated October 20, 2000 (classifying a sample preparation machine used in laboratories to automate the preparation of samples prior to chromatographic testing in subheading 8479.89.97); HQ 087597, dated November 27, 1990 (classifying precipitation sampler and an air sampler in subheading 8479.89.90, HTSUS, and not in heading 9027, HTSUS because the machine prepared samples but performed no analysis); HQ 088242, dated November 27, 1990 (classifying a centrifugal air sampler in subheading 8479.89.90, HTSUS, and not in heading 9027, HTSUS, for the same reason); HQ 964001, dated February 12, 2001 (classifying an automated liquid sample processor machine in subheading 8479.89.97, HTSUS); HQ 965754, dated October 4, 2002 (classifying a CVS exhaust gas dilution system in subheading 8479.89.97, HTSUS).
We also note that our decision is consistent with CBP rulings classifying tissue processor machines in heading 8479, HTSUS. See NY A82904, dated May 15, 1996 (Tissue-Tek model 4640 rotary tissue processor machine used to prepare tissue specimens prior to examination of the specimens with a microscope classified in subheading 8479.89.9598, HTSUS); NY I84345, dated August 12, 2002, (an automated immunohistochemistry (IHC) and in-situ hybridization (ISH) tissue staining system classified in subheading 8479.89.9897, HTSUS, and not in heading 9018, HTSUS, because it was not used to diagnose or treat an illness, but are laboratory equipment used to stain a tissue sample for subsequent diagnostic analysis); and NY L83602, dated April 8, 2005, (a tissue processor used in a laboratory to prepare tissue specimens for examination with a microscope classified in subheading 8479.89.9897, HTSUS).
According to the product literature, the Medimachine™ works together with the Medicons™ and operates at a constant speed of approximately 80 rpm. The courts have considered the nature of “parts” under the HTSUS and two distinct though not inconsistent tests have resulted. In Bauerhin Technologies Limited Partnership, & John V. Carr & Son, Inc. v. United States, (“Bauerhin”) 110 F.3d 774 (Fed. Cir. 1997), the court identified two distinct lines of cases defining the word “part”. Consistent with United States v. Willoughby Camera Stores, (“Willoughby Camera”) 21 C.C.P.A. 322 (1933), one line of cases holds that a part of an article “is something necessary to the completion of that article without which the article to which it is to be joined, could not function as such article.” Id. at 324. The other line of cases evolved from United States v. Pompeo, (“Pompeo”) 43 C.C.P.A. 9 (1955), which held that a device may be a part of an article even though its use is optional and the article will function without it, if the device is dedicated for use upon the article, and, once installed, the article will not operate without it. Under either line of cases, an imported item is not a part if it is “a separate and distinct commercial entity”. ABB, Inc. v. United States, 28 Ct. Int’l Trade 1444, 1452-53 (2004). The definition of “parts” was also discussed in Rollerblade, Inc. v. United States, 282 F. 3d 1349, 1353 (Fed. Cir. 2002), wherein the court defined parts as “an essential element or constituent; integral portion which can be separated, replaced, etc.” Id. at 1353 (citing Webster’s New World Dictionary 984 (3d College Ed. 1988)).
The product literature indicates that the Medimachine™ “works together with the Medicons™” and that the function and purpose of the Medicon™ is to provide the microblades to cut the hard and soft tissue. Because a user would not be able to operate the Medimachine™ without the Medicon™, the Medicon™ is essential and necessary to the functioning and purpose of the Medimachine™, which is hard and soft tissue disaggregation or dissection. To the extent that the Medicons™ are specifically designed to be inserted into the Medimachine™, and that the Medimachine™ will not operate without them, they are parts of the Medimachine™. Accordingly, we find that the Medicons™ are “parts”, as defined in Willoughby Camera and Pompeo.
Because the Medicon™ is solely or principally used in the Medimachine™, and is not excluded by note 1 to Section XVI or note 1 to Chapter 84, nor provided for as a good of other headings of Chapters 84 and 85 per note 2(a) to Section XVI, it is classifiable under subheading 8479.90.94, HTSUS, which provides for parts of the goods of subheading 8479.89.98, HTSUS.
The Filcons™, however, are not “parts” of the Medimachine™ as defined in Willoughby Camera and Pompeo. The product literature states that after disaggregation of the tissue in the Medicons, the cell suspension is filtered using a syringe and attaching a Filcon disposable filter device. The appropriate Filcon™ pore size is selected for isolation of the desired cells for subsequent analysis. Thus, we find that the Filcons™ are not essential and necessary to the functioning and purpose of the Medimachine™, which is hard and soft tissue disaggregation or dissection. Instead, the Filcon™ is used for the isolation of nuclei, cells, and cell clusters. Therefore, the Filcons™ are not classified as parts of the Medimachine™ under the terms of heading 8479, HTSUS.
Chapter 59, Note 7 states, in relevant part:
7. Heading 5911 applies to the following goods, which do not fall in any other heading of section XI:
. . .
(b) Textile articles (other than those of headings 5908 to 5910) of a kind used for technical purposes (for example, textile fabrics and felts, endless or fitted with linking devices, of a kind used in papermaking or similar machines (for example, for pulp or asbestos-cement), gaskets, washers, polishing discs and other machinery parts).
You explain that the Filcons™ come in two types, the luer-lock for the syringe type and the gravity cups. For the leur-lock syringe type, material is aspirated from the Medicon™ using a small syringe. If the user wants to filter out any debris, it can lock a Filcon™ onto the syringe and squirt it through the Filcon™ which would be attached to the end of the syringe. Alternatively, if the gravity cup is used, the material is also aspirated from the Medicon™ with a syringe. It is then placed onto the top of the final test tube and the user simply squirts the material into the cup and lets gravity take over. The Filcons™ come in a number of pore sizes for both types.
The Filcons™ were examined by the NCSD under a microscope, and the examination revealed that they are of a textile material. According to our internet research on the website of the Institute of Cell and Molecular Science (www.icms.qmul.ac.uk/flowcytometry) if cell suspensions are to be used for flow cytometry, and subsequent analysis, they should be filtered through nylon mesh. You have also confirmed that the filtering material used in the syringe type Filcon™ and the cup type Filcon™ is nylon mesh.
We find that the filtration of cell suspensions for the purpose of isolating nuclei, cells, and cell clusters is a technical purpose as specified in Note 7(b) to Chapter 59. Therefore, the Filcons™ meet the terms of heading 5911, HTSUS, and are classifiable therein. This finding is consistent with NY N053553, dated April 2, 2009, which classified a non-woven textile filtration media used to filter processed power plant water for analytical testing in subheading 5911.90.0080, HTSUS.
HOLDING:
The Medimachine™ is classifiable in heading 8479, HTSUS, specifically, subheading 8479.89.98, 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: Other: Other”. The 2010, general, column one rate of duty is 2.5% ad valorem.
The Medicon™ is classifiable in heading 8479, HTSUS, specifically, subheading 8479.90.94, HTSUS, which provides for, “Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof: Parts: Other”. The 2010, general, column one rate of duty is Free.
The Filcon™ is classifiable in heading 5911, HTSUS, specifically, subheading 5911.90.00, HTSUS, which provides for, “Textile products and articles, for technical uses, specified in note 7 to this chapter: Other”. The 2010, general, column one rate of duty is 3.8% ad valorem.
Duty rates are provided for 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/.
Sincerely,
Ieva K. O’Rourke, Chief
Tariff Classification and Marking Branch