CERTAIN PHARMACEUTICAi S AND INTERMEDIATE. CHEMICALS: IDENTIFI­ CATION OF APPLICABLE 6-DIGIT HS SUBHEADINGS FOR PRODUCTS COVERED BY THE PROPOSED URUGUAY ROUND PHARMACEUTICAL AGREEMENT Investigation No. 332-322 USITC PUBLICATION 2507 JUNE 1992 ' ies International Trade Commission on, DC 20436 UNITED STATES INTERNATIONAL TRADE COMMISSION COMMISSIONERS Don E. Newquist, Chairman Anne E. Brunsdale, Vice Chairman David B. Rohr Carol T. Crawford Janet A. Nuzum Peter S. Watson Office of Operations Charles W. Ervin, Director Office of Industries Robert A. Rogowsky, Director This report was prepared principally by Elizabeth R. Nesbitt Project Leader Aimison Jonnard Edward Matusik David Michels James Raftery Office ofIndustries David Beck Office of Tariff Affairs and Trade Agreements With assistance from Paul Daniels James Gill Office ofInformation Resources Management Under the direction of John J. Gersic, Chief Energy & Chemicals Division and Edmund D. Cappuccilli, Chief Energy, Petroleum, Benzenoid Chemicals, and Rubber and Plastics Branch Energy & Chemicals Division Additional assistance provided by Brenda Carroll, Elaine Freeman, and Keith Hipp With special assistance from U.S. Customs Service Address all communications to Kenneth R. Mason, Secretary to the Commission United States International Trade Commission Washington, DC 20436 PREFACE This is the final report to the United States Trade Representative (USTR) pertaining to the U.S. International Trade Commission investigation No. 332-322, Certain Pharmaceuticals and Intermediate Chemicals: Identification of Applicable 6-Digit HS Subheadings for Products Covered by the Proposed Uruguay Round Pharmaceutical Agreement. The investigation was instituted following receipt of a letter from the USTR on January 27, 1992, requesting that the Commission conduct an investigation under section 332(g) of the Tariff Act of 1930.1 The OSTR asked that the Commission make its work available to the USTR and the public on a flow basis. The Conunission.was requested to submit its final report on this investigation to the USTR by June 1, 1992. The purpose of the investigation was to provide a listing of the 6-digit Harmonized Conunodity Description and Coding System (HS) subheadings for those pharmaceuticals having an International Nonproprietary Name (INN) and for certain intermediate chemical products (used primarily in the production of pharmaceuticals), as specified by the USTR, to be covered under the proposed "zero-for-zero" initiative on pharmaceuticals. This initiative is currently being negotiated under the Uruguay Round market access negotiations. The Commission was also asked to identify each instance where there is a known difference in opinion among countries on the classification of a product. The OSTR requested the Commissioner of the U.S. Customs Service to provide Commission staff with any necessary technical assistance. No public hearing was held in connection with this investigation. As indicated in the Commission's notice of institution, however, reproduced in appendix B as published in the Federal Register, the Commission released two interim reports to the public for conunent. Interested parties were requested to submit written statements to the Conunission regarding any perceived discrepancies between their current classifications for the chemicals under consideration and the classifications presented by the Conunission. The Conunission worked with Customs personnel to resolve any classification discrepancies presented by interested parties. The classifications presented in the Commission's report(s) are not intended to be, and will not be, binding upon Customs and should not be considered as formal or informal rulings or advice. 1 See appendix A for a copy of the OSTR's request. CONTENTS Preface i Purpose . v Approach and organization of report v Tables 1. Tariff Classifications: Pharmaceuticals having an INN and their corresponding HS subheadings; and known differences in country classifications 1-1 2. Tariff Classifications: Certain intermediate chemicals and their corresponding HS subheadings 2-1 Appendizes A. Copy of the letter of request from the United States Trade Representative • • • • • • • • • A-1 B. Copy of the Commission's notice of institution of investigation, as published in the Federal Register B-1 iii Purpose This report to the USTR provides the six-digit HS subheadings for the 6,358 pharmaceuticals and intermediate chemicals covered by the USTR request for Commission classification assistance. In indicating the classifications for these products, the Commission took into account relevant comments received from interested parties regarding the two interim reports to the public, as well as comments from the U.S. Customs Service regarding said reports. Per the request of the USTR, Customs personnel have provided special assistance in the preparation of this report. Customs, as the legal authority for the classification of U.S. imports, assessed the likely classifications for these products, both on an ongoing basis and for the entire report. Given the time frame involved, the number of products presented, and the absence of a complete description of the products, it was not possible for each of the products to be covered in detail or for Customs to issue rulings or any binding determination with respect to the classification of the products concerned.2 Therefore, the classifications presented in the Commission's reports on this investigation are preliminary, intended at this time for advisory purposes. They should not be considered formal or informal Customs rulings or advice. Per the USTR request, this report also indicates instances in which there is a known difference in opinion among countries on the classification of a product.3 Approach and Organization of Report For the purposes of this investigation, the six-digit HS classifications were determined on the assumption that the chemical names provided represent separate chemically defined compounds. Certain known exceptions were treated accordingly. Most of the pharmaceuticals and interme~iate chemicals covered under the proposed initiative are classifiable in either chapter 29 or chapter 30 of the HS, or both, depending on their composition or on the form in which they are imported (i.e., in bulk, in dosage form, or packaged for retail). In those cases in which the product can be classified in both chapter 29 and chapter 30, the classification provided is that for chapter 29. Most separate chemically defined pharmaceuticals or intermediate chemicals imported in bulk form are classifiable in chapter 29. Within chapter 29, the classification depends primarily on the product's chemical structure and end use, as enumerated in the legal notes to that chapter. Pharmaceuticals imported either as mixtures or as finished products in dosage 2Letter to Chairman Newquist, dated Mar. 13, 1992, from the Commissioner of the U.S. Customs Service. 3To date, through the assistance of the Office of the USTR, the Commission has received lists of HS classifications from the EC and Sweden for purposes of comparison. The list from the EC contains over 90 percent of the INNs covered under the request from the USTR with corresponding HS numbers for a majority of the items. The Swedish list is abbreviated, addressing differences in classification of 19 INNs, based on comparison with the original EC list. v form or packaged for retail sale are generally classified in chapter 30. In some cases, certain products were classified in chapters other than 29 or 30 .. Examples include glycerol (chapter 15); 4-(6-fluoro-2-methylinden- 3-ylmethyl)phenylmethyl sulphide in the form of a solution in toluene (chapter 38); and certain polymerisation products of acrylic acid (chapter 39). This report includes two tables. The first table lists the INNs, sorted alphabetically, and their corresponding HS classifications. The HS classifications for approximately 125 of the INNs, as noted in the list, were not included in the two reports to the public because the chemical structures for the products were not available when the reports were released and, as such, no classification could be presented. Those parties interested in indicating any perceived discrepancies in the classifications for these products should submit written statements to the Director, Tariff Affairs/CATT Affairs, Room 507, Office of the United States Trade Representative, 600 17th Street, NW., Washington, DC 20506. Instances in which there is a known difference in opinion among countries ~n the classification of a product are also indicated on this table. The second table lists 273 intermediate chemicals (designated by the USTR for purposes of this study) and their HS classifications, sorted numerically by HS subheading. One of the HS classifications included in this list was not included in the two reports to the public. To date, the Commission has not received any lists of HS classifications for these intermediates from other countries for purposes of comparison. Differing naming conventions were used by the various companies that submitted the names of the intermediate chemicals to the USTR for inclusion in the agreement; however, to avoid possible confusion for the public, the Commission has not attempted to amend any of them to conform to a single convention. Further, the Commission has not altered the spellings of the INNs or chemical intermediate names from those contained in the incoming request. We would like to express our appreciation to the following groups for