CLA-2 RR:CR:GC 963034AM
Port Director
U.S. Customs Service
#1 La Puntilla
San Juan, Puerto Rico 00901
Re: Protest No. 4909-99-100054; SQ28449
Dear Port Director:
This is our decision on Protest 4909-99-100054, timely filed by Bristol-Meyers Barceloneta on July 27, 1999, against your decision in the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of SQ28449 identified in four entries made in 1998 and 1999, all of which were liquidated on April 30, 1999.
FACTS:
SQ28449 is an ingredient used as a pharmaceutical intermediate in the manufacture of the fosinopril sodium (trade name Monopril®), an inhibitor of angiotensin convertin enzyme (ACE), used in the treatment of hypertension. SQ28449 has the chemical name (R*, S*)-[(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl) phosphinyl) acetic acid], and has been assigned CAS registry #123599-82-6.
Protestant entered the product under subheading 2931.00.30, HTSUS, the provision for "[O]ther organo-inorganic compounds: [A]romatic: [O]ther: [P]roducts described in additional U.S. note 3 to section VI." Pursuant to general note 13 to the HTSUS, products classified in subheading 2931.00.30 and listed in the pharmaceutical appendix to the HTSUS are entitled to duty free status. Protestant entered the merchandise free of duty claiming that SQ28449 was listed in table 3 of the pharmaceutical appendix.
The product listed in table 3 and claimed by protestant to be identical to the product in question is [(2-methyl-1-propionyloxypropoxy)(4-pheynylbutyl) phosphinoyl]acetic acid which is assigned CAS registry #123599-78-0. The CAS registry service also lists [(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl)phosphinyl) acetic acid] as an alternate name for the substance assigned CAS #123599-78-0. The name is identical to the name for SQ28449, CAS # 123599-82-6, except for the active optical isomer descriptor designation (R*, S*). An optical isomer of a substance contains the same elements but differs in the relative position of groups bound to the chiral carbons. The substance listed in the pharmaceutical appendix has no optical activity notation.
ISSUE:
Whether SQ28449, having the chemical name (R*, S*)-[(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl)phosphinyl) acetic acid], CAS registry #123599-82-6, is listed in table 3 of the pharmaceutical appendix to the HTSUS.
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 and, unless otherwise required, according to the remaining GRIs taken in their appropriate 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 understanding the language of 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 classification of the imported merchandise is not at issue. Rather, the issue stems from the appearance of a "K" in the "Special" column adjacent to subheading 2931.00.30, HTSUS. General note 13, HTSUS, provides in pertinent part, that "[W]henever a rate of duty of “Free” followed by the symbol “K” in parentheses appears in the “Special” subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision . . . shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. The note to table 3 of the pharmaceutical appendix states: "[T]his table enumerates further products which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known."
Protestant argues that CAS numbers do not determine whether an article is included in the pharmaceutical appendix and to so hold at this time violates an established practice. We agree that CAS numbers are not dispositive. However, protestant's statement that SQ 28499, also known as (R*, S*)-[(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl)phosphinyl) acetic acid], is listed in the pharmaceutical appendix to the HTSUS is incorrect.
Two isomers of the instant merchandise are listed in the pharmaceutical appendix thus:
[(2-Methyl-1-propionyloxypropoxy)(4-phenylbutyl)phosphinoyl) acetic acid, 123599-78-0
{(S)-[(R)-2-Methyl-1-propionyloxypropoxy](4-phenylbutyl)phosphinoyl}acetic acid 128948-01-6
Protestant states that SQ 28499, (R*, S*)-[(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl)phosphinyl) acetic acid], is listed because it is the stereo isomer of the first substance listed above. But the second substance is also a specific stereo isomer of the first substance. It is specifically listed as such because stereo isomers of substances listed in the pharmaceutical appendix are not included unless so named. Protestant's merchandise, (R*, S*)-[(2-methyl-l-(oxpropoxy)propoxy) (4-phenylbutyl)phosphinyl) acetic acid], is not so named.
This interpretation of the pharmaceutical appendix is hardly a departure from established practice. In HQ 961704/961716, dated October 4, 1998, Customs found that a product that consisted of four ingredients, all listed in the pharmaceutical appendix was nevertheless absent from the appendix. In that ruling Customs states: "A product is not entitled to duty-free treatment unless it is actually listed in the pharmaceutical appendix. Despite having each of its component compounds included in the appendix, this merchandise, a mixture of sennosides, is not itself listed in the pharmaceutical appendix. Customs has no statutory authority to expand the pharmaceutical appendix." Similarly, in HQ 954673, dated December 10, 1993, Customs held that Quizalofop-P-ethyl, an optical isomer of Quizalofop ethyl, was not classifiable under subheading 9902.30.58, a provision specifically provided to grant Quizalofop-ethyl duty free status. In that ruling, Customs notes that the substances have different CAS numbers and are used differently. Hence, as in the instant case, the substances are not the same and are not both listed in the pharmaceutical appendix unless listed specifically.
HOLDING:
The protest should be DENIED. SQ28499 is classified in subheading 2931.00.30, HTSUS, and is not listed in the pharmaceutical appendix to the tariff schedule.
In accordance with Section 3A(11)(b) of Customs Directive 099 3550 065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, 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 methods of public distribution.
Sincerely,
John A. Durant, Director
Commercial Rulings Division