CLA-2 RR:CR:GC 965024AM
Area Port Director
U.S. Customs Service
P.O. Box 1490
St. Albans, VT 05478
Re: Internal Advice Request 01/008: Extended Storage Platelet/Plasma Apheresis Set; 994E Harness
Dear Port Director:
This is in reference to a letter from your office dated May 3, 2001, regarding Internal Advice (01/008), which was initiated by letter dated April 30, 2001, by counsel on behalf of Haemonetics Corp., seeking classification of the Extended Storage Platelet/Plasma Apheresis Set; 994E Harness, pursuant to the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
Apheresis is the processes of separating blood components, such as plasma and platelets from red cells, and transfusing the unused components back into the donor or patient. The 994E Harness consists of over 70 components mainly tubing, collection bags and a centrifuge bowl along with the necessary clamps, filters, luer locks for pressure monitors and an intravenous needle necessary for blood collection, separation and transfusion. The 994E Harness is packaged in a molded plastic container with a paper top, identifying the contents, glued around the edges. It is a closed system with much of the air removed.
The 994E Harness is used in the following manner: the 994E Harness is threaded through the MCS® machine. The MCS® machine consists mainly of a centrifuge, three pumps, fittings for tubings, poles for collection and IV bags, blood pressure and system pressure monitors and a user panel consisting of donor flow lights, display screen and control panel. Saline and anti-coagulent fluids are hung. Pressure monitors are connected to the luer locks. Intravenous access is obtained on the donor/patient. The tubings are primed with anti-coagulant using the anti-coagulant pump. Whole blood is collected and pumped with anti-coagulant through the filter and to the centrifuge bowl where platelets and plasma are separated and collected in component bags. The third pump maintains flow through the system. The remaining blood products are then returned to the donor/patient by use of the blood pump. The collected components are heat sealed and detached for storage and transfusion into another patient, processing for albumin and protein fraction, gamma globulins, or coagulation concentrate products, or treatment of certain autoimmune diseases through the removal of plasma (plasmapheresis).
ISSUE:
Whether the 994E Harness is classifiable in heading 9018, HTSUS, as an accessory of an appliance used in medical, surgical, dental or veterinary sciences?
LAW AND ANALYSIS:
Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs.
In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89 80, 54 Fed. Reg. 35127 (August 23, 1989).
The HTSUS provisions under consideration are:
Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; 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:
* * * * * * * * * *
Section XVI, note 3, HTSUS, states " Unless the context otherwise requires, composite machines consisting of two or more machines fitted together to form a whole and other machines adapted for the purpose of performing two or more complementary or alternative functions are to be classified as if consisting only of that component or as being that machine which performs the principal function." EN 84.21 states, in pertinent part, the following: "The heading includes: . . .(11) Centrifuges for separating the plasma from blood." p. 1279).
Legal Note 2 to Chapter 90, HTSUS, states, in pertinent part, the following:
Subject to Note 1 above, parts and accessories for machines, apparatus, instruments or articles of this Chapter are to be classified according to the following rules :
Parts and accessories which are goods included in any of the headings of this chapter or of chapter 84, 85 or 91 (other than heading 8485, 8548 or 9033) are in all cases to be classified in their respective headings; . .
Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machines, instruments or apparatus of that kind;. . .
The ENs to heading 9018, HTSUS, state, in pertinent part, the following:
It should also be noted that a number of the instruments used in medicine or surgery (human or veterinary) are, in effect, tools (e.g., hammers, mallets, saws, chisels, gouges, forceps, pliers, spatulae, etc.), or articles of cutlery (scissors, knives, shears, etc.). Such articles are classified in this heading only when they are clearly identifiable as being for medical or surgical use by reason of their special shape, the ease with which they are dismantled for sterilisation, their better quality manufacture, the nature of the constituent metals or by their get-up (frequently packed in cases or boxes containing a set of instruments for a particular treatment : childbirth, autopsies, gynaecology, eye or ear surgery, veterinary cases for parturition, etc.) (emphasis added).
* * * * * *
(L)Portable pneumo-thorax apparatus, blood transfusion apparatus, artificial leeches.
The heading also covers sterile hermetically sealed containers of plastics, from which air has been evacuated but containing a small quantity of anti-coagulant and fitted with an integral donor tube and a phlebotomy needle, used for the collection, storage and transfusion of human whole blood. However, special blood storage bottles of glass are excluded (heading 70.10).
EN 9018(I)(L), supra, describes blood and plasma collection tubing and bags familiar to blood and plasma donors. The instant harness is similar in that the blood collection containers are sterile and hermetically sealed from which most air has been evacuated and is fitted with a phlebotomy needle. Although the merchandise does not contain an integral donor tube or anticoagulent, it does have a sample pouch from which blood can be taken for testing and a spike for an anticoagulent bag. It also contains a centrifuge bowl. Furthermore, the merchandise performs the same function as the collection device described in EN 9018(I)(L) in that it is used to collect blood and blood products and transfuse the same.
Before considering the classification of the instant merchandise as a "part," we must first determine the classification of the MCS® machine. The MCS® machine is a composite machine consisting of three pumps, a centrifuge, a display monitor and control panel for collecting and transfusing blood products at the bedside. It is not a simple centrifuge, described in EN 8421(11), used to spin and separate blood components in the laboratory. The merchandise is clearly identifiable as a medical apparatus exclusively used in a medical context either in the immediate treatment of autoimmune disease or in the collection of blood components penultimate to the treatment of disease. As such, the MCS® machine is fully described at GRI 1 by the terms of heading 9018, HTSUS. See Sec. XVI note 3 and EN 90.18.
Since the MCS® machine is classifiable in heading 9018, HTSUS, then the 994E Harness is also classified in heading 9018, HTSUS, as a part unless it is considered a good, in its own right, of heading 8421, HTSUS, in accordance with Chapter 90, note 2(a). Here, the 994E Harness consists not only of a centrifuge bowl, but also tubings, collections bags, blood filters, an intravenous needle, and other components. The 994E Harness cannot be classified at GRI 1 as a good of heading 8421, HTSUS, because the merchandise as a whole is not simply a part of a centrifuge. Therefore, chapter 90 note 2(a) does not apply. Rather, the merchandise falls squarely within the purview of chapter 90 note 2(b) and remains classified in heading 9018, HTSUS, as a part of an apparatus used in medical science.
Arguendo, the 994E Harness is classifiable as a "part of a centrifuge" in heading 8421, HTSUS, it is also clearly identifiable as a part of an apparatus used in medical science as it is used solely in the MCS® machine. Again, the correct heading for classification of the merchandise is heading 9018, HTSUS, via the relative specificity rule of GRI 3.
This view is not inconsistent with a recent decision on filtering devices in the Compendium of Classification Opinions on the Harmonized Commodity Description and Coding System. See Opinion No. 8421.29/2 of the World Customs Organization's Compendium of Classification Opinions, Amending Supplement No. 25 (January 2000). The merchandise subject to the opinion, a dialyzer and a blood filter, both parts of machines used in medical science, were found to be filters in their own right, classifiable under heading 8421. The merchandise is not a centrifuge, or even a centrifuge bowl, but rather an intricate blood component collection/separation device that includes a centrifuge bowl. Hence, the instant merchandise is not analogous to that discussed in the Opinion.
HOLDING:
The Extended Storage Platelet/Plasma Aphersis Set; 994E Harness, is classified in subheading 9018.90.75, the provision for "[I]nstruments 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: [O]ther instruments and appliances and parts and accessories thereof: [E]lectro-medical instruments and appliances and parts and accessories thereof: [O]ther: [O]ther.
You are directed to mail this decision to the internal advice applicant, no later than 60 days from the date of this letter. On that date the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other public methods of distribution.
Sincerely,
John Durant, Director
Commercial Rulings Division