CLA-2-90:OT:RR:NC:N4:405
Mr. David Murphy Grunfeld, Desiderio. Lebowitz, Silverman & Klestadt LLP
399 Park Avenue, 25th Floor
New York, NY 10022
RE: The tariff classification of apheresis collection bags from France, Great Britain, and Mexico
Dear Mr. Murphy:
In your six page letter, plus attachments, dated September 20, 2010, on behalf of Haemonetics, Corp., you requested a tariff classification ruling. Four samples were provided.
The merchandise at issue consists of four items that are designed to be used with specific electro-medical blood collection systems. In your submission you describe the items as follows:
Part No. 53156 is a 1.5L Citroflex Plasticized PVC (CPP) single port bag that is used in the collection of platelets on the Haemonetics MCS® + 9000 automated collection device. This platelet storage bag is part of the LN 994CF-E-BA disposable set.
Part No. 53155-00 is a 1000ml single port PVC bag that is used in the collection of plasma with the 994CF-E-BA disposable set with the MCS® + 9000 automated collection device.
Part No. 51166-00 is a 1.5 liter PVC dual port bag that is used in the disposable set that collect platelets as stand alone products, or in combination with red cells and/or plasma such as the 994CF-CPP disposable set used on the MCS® + device. This bag is specifically used to collect the platelets.
Part No. 49346-00 is a 1000ml PVC dual port bag that is used in the disposable set that collects one unit of red cells and a jumbo unit of plasma (the LN 822-00 disposable set) used with the MCS® + 8150 device. This bag is specifically used to collect that plasma.
Per the Haemonetics website MCS is an acronym for Mobile Collection System.
You go on to state in your submission that “All products are made with medical-grade plastics to exacting standards. The tubing, ports, and shapes are unique to Haemonetics and made in exact specifications for the machines to which they will be attached. These machines cannot function without the specific bags attached to the machine, nor can the machine perform the function for which it is intended without these items.”
Neither your letter nor your attachments refer to the apparatus that these bags are used with as Apheresis apparatus other than a partial implication in the heading of your letter, which states “Re: Transfusion/Apheresis Collection bags.” However, when we contacted you, you agreed that the description found on the website www.donate-blood.com/site2/content/donor_faqs/donor_faqs.asp applied to the apparatus in question, in particular:
Q: What is an automated blood donation (also known as "apheresis")? A: Automated blood donation uses technology developed by Haemonetics Corporation.
You also agreed that the description found on the website
www.gmi-inc.com/CliniLab/Haemonetics%20mcs%209000.htm applied to these articles as well. The description states, in part:
“The Haemonetics MCS+® system addresses the traditional drawbacks of platelet therapy, because it automates the platelet collection process, permitting the collection of greater quantities of platelets from a single donor. The procedure works like this:
The machine collects whole blood from a healthy donor into a sterile, single use disposable kit. The blood flows into a plastic bowl (part of the disposable kit) and through centrifugal force is separated into its component parts. The platelets are harvested into a collection bag, and the remaining blood components - plasma and red cells - are returned to the donor. The advantages of this system are two-fold: (1) the collection of up to two therapeutic doses from a single donor, and (2) platelet transfusion safety for the recipients, thanks to the reduction or elimination of pooling….”
A useful definition of apheresis can be found at the University of Utah’s Medical Sciences Library website (library.med.utah.edu/WebPath/TUTORIAL/BLDBANK/BBAPHER.html). It describes apheresis as such:
“The process of apheresis involves removal of whole blood from a patient or donor. Within an instrument that is essentially designed as a centrifuge, the components of whole blood are separated. One of the separated portions is then withdrawn and the remaining components are retransfused into the patient or donor.
The components which are separated and withdrawn include:
Plasma (plasmapheresis)
Platelets (plateletpheresis)
Leukocytes (leukapheresis)
“…Whole blood is introduced into a chamber that is spinning, and the blood separates into components (P = plasma; PRP = platelet rich plasma; WBC = leukocytes; RBC = red blood cells) by gravity along the wall of the chamber. The component to be removed can be selected by moving the level of the aspiration device….”
Whether or not the specific apparatus in question will be used for both functions, apheresis apparatus can routinely be used either in blood donation to increase the amount of given blood fraction(s) that can be removed safely from a donor or in therapy to reduce the excess amount of a given blood fraction, e.g., platelets, in the patient’s blood. That is the reason that “patient or donor” is used in the above citation.
Headquarters Ruling Letter 965024 - AM, 2-13-2002, decided, in arriving at its conclusion regarding an imported Extended Storage Platelet/Plasma Apheresis Set, that an Apheresis apparatus, specifically a Haemonetics MCS apparatus, was not classified in HTSUS 8421 as a Centrifuge. 965024 noted that Harmonized System Explanatory Note I-11 to 8421 indicates that it includes “Centrifuges for separating the plasma from blood,” but distinguished apheresis apparatus, which simultaneously returns the uncollected blood fractions to the donor/patient, and classified the apheresis apparatus in HTSUS 9018.
You cited HRL 043504, 4-7-1975, in support of a classification in HTSUS 9018 for your imports and provided a copy to us when we requested it. It does provide a classification in the TSUS for plastic “blood transfer bags,” and, based on the 1987 version of the TSUS available on the USITC site, the language of TSUS heading 709.01 through .27 is very similar to that of HTSUS 9018. However, on its face, 043504 distinguished between plastic blood bags, imported with tubes and attached phlebotomy (hypodermic) needles, which combinations were classified TSUS 709.27 and plastic blood bags imported without phlebotomy (hypodermic) needles, which were classified in TSUS 774.60, which very similar to HTSUS 3926.
Your imports are imported with neither tubing nor phlebotomy needles, unlike the apheresis set classified in HTSUS 9018 in 965024. However, while “centrifuging” is cited in 043504 as one of the processing operations that the bags would be used in, it does not appear that those bags were specifically designed to receive blood fractions from an apheresis device as you indicate these items are. Therefore, consistent with New York Ruling Letter J80384 – 105, 2-11-2003, and the language of 965024, we do not believe it is necessary for your bags to be imported with attached phlebotomy needles, which is the distinction made in 043504.
We will assume for the purposes of this ruling that, if requested to do so, the importer would be able to provide documentary evidence such as drawings, etc. that these bags were made specifically for use to collect blood fractions from apheresis apparatus. See HRL 965546, 8-6-2002.
If not classified in HTSUS 9018, it appears these plastic bags, in themselves, would be classified in HTSUS 3926, which is not a specific heading, so HTSUS Add. US Rule of Interpretation 1-c (see HRLs 965968, 12-16-02, and 967233, 2-18-05) would not apply.
Within HTSUS 9018, HTSUS 9018.90.7580 applies, following 965024.
We agree that the applicable subheading for these four bags will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Electro-medical instruments and appliances and parts and accessories thereof. 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).
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 J. Sheridan at (646) 733-3012.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division