OT:RR:CTF:CPMMA H312361 MMM/MAB
Mr. Robert Silverman
Grunfeld, Desiderio, Lebowitz, Silverman
& Klestadt, LLP
399 Park Avenue
New York, NY 10022-4877
RE: Revocation of NY N276739 and HQ 957022; Classification of sodium bicarbonate cartridges/bags
Dear Mr. Silverman:
This is in reference to New York Ruling Letter (NY) N276739, issued to you by U.S. Customs and Border Protection (CBP) on July 12, 2016, concerning classification of a "Bibag" from France, under the Harmonized Tariff Schedule of the United States (HTSUS). We have reviewed that decision, and determined that it is incorrect, and for the reasons set forth below, are revoking your ruling.
We have also reviewed Headquarters Ruling (HQ) 957022, dated January 24, 1995, and for similar reasons set forth below, are revoking that ruling.
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 (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), a notice of the proposed action was published in the Customs Bulletin, Volume 55, No. 47, on December 1, 2021. One comment, which is addressed below, was received in response to this notice.
In NY N276739, CBP described the subject merchandise, a "Bibag," as follows:
[T]he product at issue consists of a polyamide/polyethylene bag filled with sodium bicarbonate powder. The "Bibag" is secured to a "Bibag" connector for use with a hemodialysis machine. The sodium bicarbonate is automatically mixed with water to produce a saturated solution, which is used for hemodialysis. The "Bibag" is available in both 650 gram and 900 gram sizes. Your submission indicates that sodium bicarbonate power is the only substance contained in the disposable polyamide/polyethylene bag.
Additionally, in HQ 957022, CBP described the subject merchandise as follows:
The merchandise consists of "BiCart Column" cartridges, designed for use solely with dialysis machines. The cartridges are comprised of a specially shaped polypropylene cartridge containing 650 grams of sodium bicarbonate powder. They are imported in packages of ten units and are designed for one time use only. When attached to a special holder affixed to the kidney dialysis machine, the cartridge allows "online" production of the liquid bicarbonate concentrate required for dialysis.
In both rulings, CBP classified the merchandise in heading 2836, HTSUS, as a carbonate.
Whether the bicarbonate cartridges/bags are classified in heading 2836, HTSUS, as a "carbonate," heading 3004, HTSUS, as "Medicaments."
LAW AND ANALYSIS:
Merchandise imported into the United States 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 which 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 for all purposes.
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. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the heading and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. GRI 2(a) provides, in relevant part, that "[a]ny 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 articles has the essential character of the complete or finished article."
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The 2023 HTSUS provisions under consideration are as follows:
2836: Carbonates; peroxocarbonates (percarbonates); commercial ammonium carbonate containing ammonium carbamate:
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[.]
Note 2 to Section VI provides as follows:
Subject to Note 1 above, goods classifiable in heading 30.04, 30.05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 35.07 or 38.08 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the Nomenclature.
Note 3 to Chapter 30 provides as follows:
3. For the purposes of headings 3003 and 3004 and of note 4(d) to this chapter the following are to be treated--
(a) As unmixed products:
(2) All goods of chapter 28 or 29; and
Explanatory Notes 30.04 provides as follows:
This heading covers medicaments consisting of mixed or unmixed products, provided they are:
(a) Put up in measured doses or in forms such as tablets, ampoules, capsules, cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use.
(b) In packings for retail sale for therapeutic or prophylactic use. This refers to products (for example, sodium bicarbonate and tamarind powder) which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.
These indications (in any language) may be given by label, literature or otherwise. However, the mere indication of pharmaceutical or other degree of purity is not alone sufficient to justify classification in this heading.
There is no question that the sodium bicarbonate is a medicament consisting of unmixed products for therapeutic or prophylactic uses, therefore the issue is to determine within which heading it is properly classified. The subject merchandise is prima facie, classifiable in heading 2836.30, HTSUS, as sodium bicarbonate. However, as described in the EN 30.04, when used for therapeutic or prophylactic purposes and packed in a way that indicates such use, an unmixed product like sodium bicarbonate can be prima facie, classifiable in heading 3004, HTSUS.
When merchandise is prima facie classifiable under two or more headings or subheadings of the HTSUS, we apply GRI 3 to resolve the classification. Bauer Nike Hockey USA, Inc. v. United States, 393 F.3d 1246, 1251 (Fed. Cir. 2004). GRI 3(a) states that "[t]he heading which provides the most specific description shall be preferred to headings providing a more general description." "Under this so-called rule of relative specificity, we look to the provision with requirements that are more difficult to satisfy and that describe the article with the greatest degree of accuracy and certainty." Orlando Food Corp. v. United States, 140 F.3d 1437, 1441 (Fed. Cir. 1998).
Additionally, in determining which of the two headings at issue is more specific, courts have held that the general rule of customs jurisprudence is that "in the absence of legislative intent to the contrary, a product described by both a use provision and an eo nomine provision is generally more specifically provided for under the use provision." Orlando Food Corp., 140 F. 3d at 1441 (quoting United States v. Siemens Am., Inc., 653 F. 2d 471, 477 (C.C.P.A. 1981)).However, this rule is not mandatory, and only provides a "convenient rule of thumb for resolving issues where the competing provisions are otherwise in balance." United States v. Carl Zeiss, 195 F. 3d 1375, 1380 (Fed. Cir. 1999) (quoting United States v. Siemens Am., Inc., 653 F.2d at 478 n. 6); see also Totes Inc. v. United States, 69 F. 3d 495, 500 (Fed. Cir. 1995). This rule of thumb was only applicable where the alternative competing provisions were "in balance" or equally descriptive of the article being classified. Orlando Food Corp., 140 F. 3d at 1441.
Following Orlando, supra, the subject merchandise is more specifically classified in heading 3004, HTSUS. The subject merchandise is more intricate than general use sodium bicarbonate and heading 3004, HTSUS, describes the merchandise with the most accuracy, as it not only describes the "components," but provides for the use and packing of the merchandise. As a use provision, heading 3004, HTSUS, is more specific for sodium bicarbonate packaged for direct use in the dialysate solution which will correct metabolic acidosis in the treatment of kidney failure.
While NY N276739 and HQ 957022 reference GRI 5(b) as follows, GRI 5(b) is irrelevant to the subject merchandise.:
The polyamide/polyethylene bags are merely single-use, disposable containers for the conveyance and storage of the sodium bicarbonate powder, even if they are specially shaped to be connected for use with a hemodialysis machine, it does not alter the classification of the good pursuant to GRI 1. See NY N276739, dated July 12, 2016.
The cartridge themselves are merely containers for the conveyance and storage of the sodium bicarbonate, even if they are specially shaped in order to be incorporated in a dialysis machine. Goods are almost always transported in some form of container or package. However, even if that package is specially shaped, it does not alter the classification of the good pursuant to GRI 1. See HQ 957022, dated January 24, 1995.
The subject merchandise is classifiable under heading 3004, HTSUS, by application of GRI 1. The language in heading 3004, HTSUS, as well as the ENs to heading 3004, HTSUS, provide guidance to the type of specific packaging required by heading 3004, HTSUS.
In the comment we received, the commenter agreed with CBP's GRI 1 and 3(a) analysis and CBP proposed revocation of NY N276739 and HQ 957022.
Thus, subject merchandise is classified in heading 3004, HTSUS.
By application of GRIs 1 and 3(a) the sodium bicarbonate bags/cartridges are classified in heading 3004, HTSUS, specifically in subheading 3004.90.92, HTSUS, which provides for: "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: Other: Other." The 2023 column one general rate of duty for subheading 3004.90.92, HTSUS, is 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 the internet at https://hts.usitc.gov/current.
EFFECT ON OTHER RULINGS:
NY N276739, dated July 12, 2016, and HQ 957022, dated January 24, 1995, are hereby REVOKED in accordance with the above analysis.
In accordance with 19 U.S.C. 1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
 General Rules of Interpretation (GRI) 3(a).
 NY N276739, dated July 12, 2016, and HQ 957022, dated January 24, 1995, did not consider classification under heading 3004.