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H.R. 7802
To amend the Tariff Schedules of the United States with respect to the rates of

duty on ephedrine, racephedrine, and their salts
U.S. INTERNATIONAL TRADE COMMISSION

PURPOSE OF THE LEGISLATION H.R. 7802, if enacted, would reduce the rate of duty on synthetically-derived ephedrine, racephedrine, and their salts by amending the Tariff Schedules of the United States (TSUS). The legislation also provides for staged duty reductions on these items through January 1, 1987. The bill would leave the current rate of duty and staged reductions for pseudoephedrine and its salts unchanged.

DESCRIPTION AND USES Plants of the genus Ephedra contain six optically active alkaloids, some of which are useful in medicine. The two major alkaloids of this plant genus are ephedrine and pseudoephedrine. Ephedrine and pseudoephedrine are stereoisomers; i.e., chemicals that differ from one another only in the way the atoms or groups of atoms of the chemical molecule are arranged in space. Stereoisomers are described as optically active because, if polarized light is passed through a medium containing one type of stereoisomer, the plane of polarization is rotated. If the isomer rotates the polarized light to the right it is known as dextrorotatory (d); if the polarized light is rotated to the left the isomer is called levorotatory (1). If the 'd” and the "l” isomers are mixed in equal portions, the mixture is not optically active and is called racemic (dl). Racephedrine, for example, is racemic (dl) ephedrine.

A rudimentary understanding of stereoisomers, as explained above, is useful in medicinal chemistry since, frequently, one stereoisomer of a chemical will be physiologically active while the other isomer may be inactive or have substantially different physiological properties. Ephedrine has two asymmetric carbon atoms and, therefore, there are four optically active forms; i.e., d- and l-ephedrine and d- and lpseudoephedrine. The l-ephedrine and d-pseudoephedrine isomers are the naturally occurring isomers.

Ephedrine is an adrenergic agent that acts physiologically as a local vasoconstrictor and causes a pronounced stimulation of the central nervous system. Ephedrine and its salts are used orally, intravenously, intramuscularly, and topically in treatment for a variety of conditions such as allergic disorders, colds, hypotensive conditions, and narcolepsy. It is employed locally to constrict the nasal mucosa and cause decongestion, to dilate the pupil, or the bronchi, and to diminish hyperemia. Systemically, ephedrine is used in the treatment of hay fever, asthma, urticaria, and low blood pressure.

Ephedrine and pseudoephedrine may be obtained by extraction from plant material of the genus Ephedra or they may be produced synthetically. Racephedrine is produced synthetically.

TARIFF TREATMENT Ephedrine and pseudoephedrine occur in nature in plants of the genus Ephedra. If produced from these plants and not artifically mixed, these products would be classifiable under TSUS item 437.22 with a column 1 rate 1 of 2 percent ad valorem and a column 2 rate of 10 percent ad valorem. If produced naturally but mixed artificially, these products would enter under TSUS item 437.24, with a column 1 rate of 2 percent ad valorem, a least developed developing country (LDDC) rates of free, and a column 2 rate of 25 percent ad valorem. Racephedrine does not occur naturally in these plants, but can be produced from naturally occurring material by racemization. If produced by racemization of naturally occurring material, racephedrine would be classifiable under TSUS item 437.20 with a column 1 rate of

The rates of duty in rate of duty column numbered 1 are Most-Favored-Nation (MFN) rates, and are applicable to imported produced from all countries except those Communist countries and areas enumerated in general headnote 3(f) of the TSUS. However, such rates would not apply to products of developing countries which are granted preferential tariff treatment under the GSP or under the "LDDC" rate of duty column.

2 The rates of duty in rate of duty column numbered 2 apply to imported products from those Communist countries and areas enumerated in general headnote 3(f) of the TSUS.

3 The rates of duty in rate of duty column “LDDC" are preferential rates (reflecting the full U.S. MTN concession rate for a particular item without staging) and are applicable to products of the least developed developing countries designated in general headnote 3(d) of the ISUS. If no rate of duty is provided in the “LDDC” column for a particular item, the rate of duty provided in column numbered 1 applies.

4.8 percent ad valorem, an LDDC rate of 3.7 percent ad valorem, and a column 2 rate of 25 percent ad valorem. The principal salts of ephedrine, pseudoephedrine, and racephedrine are the hydrochloride and sulfate salts and, if these salts were produced synthetically from naturally occurring material, would be classifiable under TSUS item 437.20. TSUS items 437.20, 437.22, and 437.24 are all eligible under the Generalized System of Preferences (GSP) for duty-free treatment.

Ephedrine, pseudoephedrine, racephedrine, and their salts are all benzenoid in structure and, if produced totally synthetically or from benzenoid precursors (within the meaning of the headnotes to part 1 of schedule 4 of the TSUŠ), are classifiable under TSUŠ item 411.32 with a column 1 rate of 15.5 percent ad valorem, an LDDC rate of 7.6 percent ad valorem, and a column 2 rate of duty of 7 cents per pound plus 48.5 percent ad valorem. TSUS item 411.32 is not GSP-eligible.

STRUCTURE OF THE DOMESTIC INDUSTRY In 1978, the latest year for which data are available, the sole domestic producer of ephedrine was the Upjohn Company, Kalamazoo, Michigan. Upjohn reportedly stopped producing ephedrine in 1980. Pseudoephedrine hydrochloride was produced by Burroughs Wellcome Company, Research Triangle Park, North Carolina, and Gane's Chemicals, Inc., New York, New York. Pseudoephedrine sulfate was produced by Gane's Chemicals, Inc. There was no domestic production of racephedrine or its salts reported in 1978.

DOMESTIC PRODUCTION Because of the limited number of domestic producers of ephedrine, pseudoephedrine, and their salts, production and sales data are not available because they can not be published without disclosing business-confidential information about the operations of individual companies.

U.S. IMPORTS Most of the imports of ephedrine, pseudoephedrine, racephedrine, and their salts are believed to have entered, in recent years, under current TSUS item 411.32 (formerly TSUS item 407.84). Sources familiar with trade in these products state that these alkaloids are produced from natural plant material in Mainland China. Since Most Favored Nation (MFN) status has been extended to that country, imports of these alkaloids classifiable under TSUS items 437.20, 437.22, or 437.24 are expected to increase.

Štatistical data for imports of ephedrine, pseudoephedrine, racephedrine, and their salts are available only for TSÚS item 411.32 (formerly TŚUSA item 407.8501) and these data have been published only since 1978. Data for 1978 and 1979 are tabulated in the following table. An estimated 75 percent of these totals are imports of ephedrine, racephedrine, and their salts; the remaining 25 percent are attributable to pseudoephedrine and its salts.

EPHEDRINE, PSEUDOEPHEDRINE, RACEPHEDRINE, AND THEIR SALTS: U.S. IMPORTS FOR

CONSUMPTION, 1978 AND 1979

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Based upon 1979 imports, the potential loss of customs revenue resulting from passage of this legislation would range from about $200,000 to $400,000 per year.

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