CLA-2 RR:CR:GC 967207 AM
Brian Burke, Esq.
Rode & Qualey
295 Madison Ave.
New York, NY 10017
RE: HQ 555520; “Safe Start IV Start Pak”
Dear Mr. Burke:
This is in reference to Headquarters Ruling Letter (HQ) 555520, issued to your client, Becton Dickinson and Company, on October 29, 1990, concerning the classification and qualification for duty exemptions available under chapter 98 of the Harmonized Tariff Schedule of the United States (HTSUS), of the “Safe Start IV Start Pak” and the "E-Z Prep Kit." We have reviewed the decision in HQ 555520 and have determined that the classification set forth in that ruling for the “Safe Start IV Start Pak” is in error. This ruling modifies HQ 555520 with respect to the classification, under the HTSUS, of the "Safe Start IV Start Pak" only.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. 1625(c)(1)), as amended by section 623 of Title VI, CBP published a notice in the November 10, 2004, Customs Bulletin, Volume 38, Number 46, proposing to modify Headquarters Ruling Letter (HQ) 555520, dated October 29, 1990, and to revoke any treatment accorded to substantially identical merchandise. No comments were received in response to this notice.
The "Safe Start IV Start Pak" consists of the following articles: a pair of seamless latex gloves, a Tegaderm® transparent dressing, an alcohol wipe, a povidine-iodine topical skin preparation solution, an ointment containing povidine-iodine, a latex tourniquet, gauze sponges, a roll of plastic tape, and an identification label.
The IV Start Pak is used in the following manner: the gloves are donned by the health care provider; the tourniquet is tied around the patient’s arm to identify a suitable vein and then loosened; the skin is cleansed with the iodine solution and then wiped away with the alcohol wipe and possibly the gauze sponge; the tourniquet is retied and the IV catheter (not included) is inserted into the patient’s vein, secured with the tape and possibly positioned with the gauze sponge; the ointment is applied to the insertion site and the Tegaderm® dressing is applied over it; the label is then filled out and applied on or near the dressing. The gauze and tape would also be used to cover the wound created if the IV insertion attempt was unsuccessful.
In HQ 555520, Customs and Border Protection ("CBP") classified the IV Start Pak as a "set" under GRI 3. Using GRI 3(c), the entire set was classified in heading 4821, HTSUS, the provision for the identification label. CBP reasoned that all of the articles in the set merited equal consideration and none provided the essential character of the set.
Whether the identification label in a kit consisting of a pair of seamless latex gloves, a Tegaderm® transparent dressing, an alcohol wipe, a Povidine-iodine topical skin preparation solution, an ointment containing Povidine-iodine, a latex tourniquet, gauze sponges, a roll of plastic tape, and an identification label equally merits consideration in a GRI 3(c) analysis of the merchandise.
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 related 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 HTSUSA. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
GRI 3(b) provides for the classification of goods put up in sets for retail sale. The rule states, in pertinent part, as follows:
(b) Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable.
Explanatory Note (X) (page 5) to GRI 3(b) states that the term "goods put up in sets for retail sale" means goods which:
(a) consist of at least two different articles which are, prima facie, classifiable in different headings;
(b) consist of products or articles put up together to meet a particular need or carry out a specific activity; and
(c) are put up in a manner suitable for sale directly to users without repacking.
GRI 3(c) states: "When goods cannot be classified by reference to 3(a) or 3(b), they shall be classified under the heading which occurs last in numerical order among those which equally merit consideration."
The kit consists of products that, if imported separately, are classifiable in the following subheadings of the HTSUS (2004):
3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale:
3004.90.91 Other (Povidine-iodine ointment and solution)
* * * * * *
3005 Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:
3005.10 Adhesive dressings and other articles having an adhesive layer:
3005.10.50 Other (Tegaderm dressing)
* * * * * *
3919 Self-adhesive plates, sheets, film, foil, tape, strip and other flat shapes, of plastics, whether or not in rolls:
3919.10 In rolls of a width not exceeding 20 cm:
3919.10.50 Other (plastic tape)
* * * * * *
4008 Plates, sheets, strip, rods and profile shapes, of vulcanized rubber other than hard rubber:
Of noncellular rubber:
4008.21.00 Plates, sheets, and strip (tourniquet)
* * * * * *
4015 Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber:
Gloves, mittens and mitts:
4015.19.05 Medical (latex glove)
* * * * * *
4821 Paper and paperboard labels of all kinds, whether or not printed:
4821.10.40 Other (label)
As a preliminary matter, we stated in HQ 555520, that the tourniquet was classified in subheading 4014.90.50. HTSUS, the provision for "Hygienic or pharmaceutical articles . . . of vulcanized rubber other than hard rubber . . . : other: other." In NY H83191, dated July 17, 2001, we classified a latex rubber tourniquet in 4008.21.00, HTSUS, the provision for strips of noncellular rubber. We find the latter ruling, stating that the tourniquet is more specifically classified as a rubber strip, to be correct.
In HQ 953472, dated March 21, 1994, Customs articulated its position that in order to be classifiable as a set, the individual components must be "used together or in conjunction with another for a single purpose [need] or activity." All of the components in HQ 555520 are used in the process of starting an intravenous line in a patient as described above. Furthermore, the set is sold to health care facilities without the need for repacking. Hence, the IV Start Pak is a set for purposes of GRI 3(b). The ruling then went on to classify the set in the last subheading in numerical order under GRI 3(c), finding that no one item gave the set its essential character.
GRI 3(c) directs us to consider which articles in the set merit consideration in determining the article that imparts the essential character to the set. While we agree with our determination in HQ 555520, that no one item gives this set its essential character, we find that not all of the articles equally merit consideration in the classification determination of this set. The kit is marketed as an IV Start Pak. The label is an informational device, not essential to the preparation, insertion or securing of the IV itself. In other words, it is ancillary in function to the start of the IV and de minimis in value.
Rather, the gloves, tourniquet, cleansing materials, and the dressing, are all essential to start and secure an IV and are of relatively equal size and weight. Hence, by application of GRI 3(c), the instant set is classified in subheading 4015.19.05, HTSUS, the subheading that occurs last in numerical order among those provisions that merit consideration.
The "Safe Start IV Start Pak" kit is classified in subheading 4015.19.0550, HTSUSA (annotated), the provision for " Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Other: Gloves: Medical: Other. The 2004 column 1 “General” rate of duty is "free." The tourniquet is classified in subheading 4008.21.0000, HTSUSA, the provision for "Plates, sheets, strip, rods and profile shapes, of vulcanized rubber other than hard rubber: Of noncellular rubber: Plates, sheets and strip." The 2004 column 1 “General” rate of duty is "free."
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUSA and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov.
EFFECT ON OTHER RULINGS:
HQ 555520 is modified in accordance with this ruling.
In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after publication in the Customs Bulletin.
Myles B. Harmon, Director
Commercial Rulings Division