Excerpt
In the first edition of this book, I noted that unlike other industries, chemical industry has an added burden of complying with an all-encompassing Toxic Substances Control Act (TSCA) before it can manufacture, import, process or use its new products commercially. In the March 26, 2007 issue, the Chemical & Engineering News (C&EN), reporting on the March 8-9, 2007 GlobalChem conference, noted that the United States Environmental Protection Agency (USEPA) is concerned about the time and costs the Agency takes to review new commercial substances before they go on the market. The EPA cited that the biggest reason for the delay in completing its 90-review period is the repeated changes to a PMN after the Agency begins its review. While some of these changes are due to company-requested reengineering of the manufacturing process, other changes, as the EPA has previously noted, are ones that must be made on account of incorrect or incomplete PMNs. In this second edition, therefore, I have updated and expanded my book to help chemical manufacturers, processors and importers avoid such delays on both counts by providing improved understanding of the TSCA inventory requirements and my step-by-step processes to comply with them. For instance, in this edition, I have provided a schematic diagram to readily determine if the new polymeric substance can qualify for polymer exemption without going through the complicated and time-consuming EPA’s guidance document on the subject.
On December 18, 2006, European Union (EU) adopted Registration, Evaluation and Authorization of Chemicals (REACH) and the REACH became effective as of June 1, 2007. Unlike the present system of chemical regulations in EU, in the REACH system a) “The burden of proof will be on industry. It needs to demonstrate that the risk from the use of a chemical can be adequately controlled, and recommend appropriate measures. All actors in the supply chain will be obliged to ensure the safety of the chemical substances they handle” and b) “Industry will be responsible for assessing the safety of identified uses, prior to production and marketing.” (Quotes from http://ec.europa.eu/enterprise/reach/faq_en.htm) In regard to these changes in the system of chemical regulations in EU, Charles M. Auer, Director of the U. S. EPA’s Office of Pollution Prevention & Toxics, has said that “EPA’s assessment based on structure-activity relationships may be of some value to companies preparing submissions to register their substances in the European Union under the new Registration, Evaluation & Authorization of Chemicals program”(C&EN, October 1, 2007, p 29). And, in the same C&EN article, Michael P. Walls, Managing Director of the American Chemistry Council, said that, the North American effort “gets to result similar to that of REACH but faster”. Therefore, for a company seeking global registration of its new chemical, seeking relatively low-cost and fast assessment of the chemical under TSCA as a first step becomes all too obvious and that too motivated me to publish this updated and expanded second edition of my book.
Finally, I opted to publish the second edition of my book in 8.5” X 11” format to make it easier for the buyers of my book to copy the prescribed US EPA forms provided in Appendixes 7.5 and 7.6. This is in keeping with my objective to provide an up-to-date and one-stop source for the entire information one might need to both learn TSCA regulations as they relate to TSCA inventory requirements and conduct assessment of chemicals vis-à-vis TSCA inventory requirements. This is obviously necessary and useful for those in corporate environment who do not have an access to internet.
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