Chemicals manufactured for export only

A product for export only must be labeled or stamped to show that it is intended for export to qualify for this exemption. The statute goes on to state that the EPA may require testing under TSCA 4 of a chemical manufactured solely for export. 

Another source of the partial TSCA exemption for chemicals for export only is the Premanufacture Notification (PMN) regulations. The preamble to the original PMN regulations confirms that EPA did not adopt the proposed requirement that manufacturers of new chemicals solely for export submit notices under section 5(a) of the Act. ... 

Chemical substances, mixtures, or articles containing substances or mixtures manufactured, processed or distributed in commerce solely for export and labeled for export only are generally exempt from the provisions of TSCA. This exemption does not apply (i) to 8 reporting and recordkeeping requirements, (ii) if the EPA determines that the chemical substance, mixtures or article will present an unreasonable risk of injury to health or the environment in the United States, or (iii) if the EPA determines it requires testing to make the determination in sub provision (ii) above. An export notice will also not be required for chemicals denied entry into the United States that are being returned to the country of origin, unless a TSCA 5, 6, or 7 rule or order applies to the chemical. ... 

Before a company or organization can manufacture or import a new chemical, it must provide the USEPA with a Pre-Manufacture Notice (PMN) and must first identify whether the chemical can be considered new by comparing it to the USEPA s chemical inventory. The PMN must include a chemical description, plan for production, list of intended uses, and effects on health and the environment. Substances used only in research and development or for export do not require a PMN. 

Section 12(a) of TSCA exempts from PMN new chemical substances which are manufactured or processed solely for export and which wUl not be used in the U.S.. . . For substances to qualify as export-only chemicals, their processing must also be limited to activities which do not involve use. 

Once the cocaine has been legally produced from the coca leaf, it is exported to various countries for medicinal use, basically as a topical local anesthetic (applied to the surface, not injected, only treating a particular area). In the United States the crystalline powder is imported to pharmaceutical companies who process and package the cocaine for medical use. Merck Pharmaceutical Company and Mallinckrodt Chemical Works distribute cocaine in crystalline form (Hydrochloride Salt) in dark colored glass bottles to pharmacies and hospitals throughout the United States. Cocaine, in the alkaloid form (base drug containing no additives such as hydrochloride in the crystalline form) is rarely used for medicinal purposes. Cocaine hydrochloride crystals or flakes come in Vs, A and 1 ounce bottles from the manufacturer and has a wholesale price of approximately 20 to 25 per ounce (100% pure). 

Production, import/Export, Use, Release, and Disposal. Knowledge of production and use data for a chemical is important in predicting its potential for environmental contamination and human exposure. Since disulfoton is produced by only one manufacturer (SRI 1994), to maintain confidentiality, its recent production volume is not known. Similarly, data concerning the import and export volumes for disulfoton in recent years are not available. Estimates of its yearly use in the United States are available (Gianessi 1986 Gianessi and Puffer 1992 Goodrich et al. 1991 ... 

Many of the areas of the world which have served as outlets for our products have installed or plan to install capacity for the manufacture of many of these chemicals. Often the major impetus for the building of such facilities is a political and nationalistic one rather than an objective economic justification. Quite often there will be a demand for only part of the output and additional pressure will be put on world markets. Although only a small percentage of this country s heavy chemical sales are dependent on export, even a small reduction of markets in time of overcapacity can have a disproportionate effect. 

The export notification requirement applies to a TSCA regulated chemical substance, and is not dependent on its end use. For those export notifications required because the EPA has restricted certain end uses, export notification must be given to EPA without regard to the actual intended use. For example, if the EPA restricts use under 5 to permit only the manufacture of an article, notification of export must stiU be given even if the foreign purchaser intends to make other use of the chemical substance. ... 

---