H.R. 5339 Fenridazon-potassium is manufactured only in the United States, solely by Rohm and Haas Company for exclusive use by an affiliate, Rohm and Haas Seeds, Inc. Production facilities are located in Philadelphia and Bristol, Pennsylvania. Rohm and Haas began manufacturing this chemical in 1981 and has patents in the United States and other major western countries. It has no plans to sell this product to any company in the United States or in any other country. According to a company spokesman, demand is currently greater than present production capacity. However, the firm has decided to transfer production to facilities in the United Kingdom rather than build a multi-million dollar plant in the United States dedicated to production of this product. There was no U.S. production of mixtures of fenridazonpotassium and its formulation adjuvants prior to 1981. In 1982, domestic production data were reported to the International Trade Commission. However, these data are not publishable because they would reveal confidential business information. There were no imports of this chemical or its mixtures during 1979-83. There have been no exports of these products since all of the U.S. production has been for intracompany use at domestic plants. Current U.S. production and consumption data are not included in this report because they would reveal confidential business information. Comparison with Present Law Mixtures of fenridazon-potassium and its formulation adjuvants are classified as pesticides in TSUS item 408.38, a provision created by Presidential Proclamation 4768 (45 F.R. 45135). Item 408.38 has a column 1 duty rate of 0.8 cents per pound plus 9.7 percent ad valorem and a column 2 rate of 7 cents per pound plus 31 percent ad valorem. No preferential rate is provided for imports from least developed developing countries. However, articles imported from designated beneficiary developing countries and classified under item 408.38 are eligible for duty-free entry under the Generalized System of Preferences (GSP) and imports from designated Caribbean Basin countries are eligible for dutyfree treatment under the Caribbean Basin Initiative (CBI). The column 1 duty rate is not scheduled to be reduced through staging. H.R. 5339 Effect on Revenue Based on estimates concerning potential imports by Rohm and Haas, enactment of this legislation would likely result in a total loss of customs revenue during the period 1984-87 of approximately $400,000-$600,000, or approximately $100,000-$150,000 per year. Subcommittee Action Agency Reports The Department of Commerce had no objection to enactment of H.R. 5339 except that they did oppose the retroactive provision provided for in Section 2(b). The International Trade Commission submitted an informative report. Markup On June 27, 1984, the Subcommittee on Trade ordered H.R. 5339 favorably reported to the full Committee on Ways and Means by voice vote, with an amendment changing the effective date to 15 days after the date of enactment. SUMMARY OF TESTIMONY ON H.R. 5339 Administration Department of Commerce: No objection to enactment of H.R. 5339 execpt for the retroactive application of the duty suspension provided in Section 2 (b) of the bill, Commerce opposes provisions of retroactivity. Statements for the Record Supports Rohm and Haas Company: Fenridazonpotassium is not manufactured in the United States and its use in the production of hybrid wheat seed would be of substantial benefit to the United States. More rapid development of new hybrids will lead to increased crop yields and lower costs which would help hold the line against rising food costs in the U.S. and help U.S. farmers remain competitive in world markets. To suspend for a 3-year period the duty on amiodarone. Summary of the Provision H.R. 5368, if enacted, would suspend the duty on amiodarone until September 30, 1987. Section-by-Section Analysis Section 1 of H.R. 5368, if enacted, would amend subpart B of part 1 of the Appendix to the Tariff Schedules of the United States (19 U.S.C. 1202) by inserting in numerical sequence a new item TSUS 907.18 to suspend until September 30, 1987 the column 1 rate of duty on the drug amiodarone, provided for in item 412.12, part 1C, schedule 4. The column 2 rate of duty woudl not be affected. Section 2 makes the provision effective on or after the 15th day after the date of the enactment of this Act. Background and Justification The Food and Drug Administration (FDA) lists amiodarone as an investigatory new drug. Amiodarone has been imported into the United States for clinical trials which are being carried out through approximately 500 physicians and pharmacologists. According to the spokesman for the FDA advisory committee, consisting of independent physicians who are evaluating amiodarone, preliminary evidence indicates that the drug is a uniquely effective antiarrhythmic cardiovascular agent. The drug also acts a coronary vasodilator. There is no known domestic producer of amiodarone. Comparison with Present Law Amiodarone is classified under TSUS item 412.12 as a cardiovascular drug not provided for in the Chemical Appendix to the Tariff Schedules. This The column 1 rate of duty is 8 percent ad valorem. rate has been in effect since the provision was established (from item 407.85), effective July 1, 1980. The current column 1 rate reflects the full Multilateral Trade Negotiations (MTN) concession rate implemented without staging for articles classifiable under H.R. 5368 TSUS item 412.12. The pre-MTN rate, under item 407.85, was 1.7 cents per pound plus 12.5 percent ad valorem. The column 2 rate of duty is currently 7 cents per pound plus 65 percent ad valorem. Preferential rates of LDDC imports were not established for this item. Imports from designated beneficiary developing countries under TSUS item 412.12 are not eligible for duty-free entry under the Generalized System of Preferences (GSP). However, imports from designated Caribbean countries are eligible for duty-free treatment under the Caribbean Basin Initiative (CBI). Effect on Revenue The potential loss of revenue upon enactment of this legislation cannot be calculated because import value data are not available. The president of Sanofi, Inc. claims to have no knowledge of potential U.S. market for amiodarone if the drug is approved by the FDA for general use. Subcommittee Action Agency Reports The Department of Commerce has no objection to enactment of H.R. 5368. The International Trade Commission submitted an informative report. Markup On June 27, 1984, the Subcommittee on Trade ordered H.R. 5368 favorably reported to the full Committee on Ways and Means by voice vote, with technical amendments relating to the effective date of the provision. SUMMARY OF TESTIMONY ON H.R. 5368 Administration Department of Commerce: No objection to enactment of H.R. 5368. H.R. 5368 Page Three Statements for the Record Supports American Heart Association: Amiodarone has not been approved for marketing in the United States by the Food and Drug Administration. The drug has demonstrated to be highly effective as an antiarythmic drug and is currently marketed in several European countries. Enactment would allow research to continue in the United States in order to obtain approval by the Food and Drug Administration to market the drug in the U.S. |