Once a company does graduate, how will EPA reduce the PMN review period from 90 days to 45 days?
EPA is not reducing the review period for a PMN from 90 to 45 days. There will be two concurrent review periods – a 90-day Premanufacture Notice (PMN) review period and a 45-day Test Marketing Exemption Application (TMEA) review period. Once a company graduates, they will be permitted to send in a PMN and a TMEA for the same substance at the same time, i.e., a simultaneous or combined submission of the PMN and TMEA. PMNs and TMEAs have different review periods 90 days for a PMN and 45 days for a TMEA. When a Graduate submits a combined PMN/TMEA, and if the TMEA is granted, the company is free to begin test marketing manufacture at day 45 under the provisions of the TMEA. Manufacture under a TMEA does not mean the substance would go on the TSCA inventory. When the PMN reaches day 90 and if EPA has not regulated the PMN, the company is free to begin commercial manufacture under the terms of the PMN. If the company made several batches of the substance under test marketing manufacture (be
EPA is not reducing the review period for a PMN from 90 to 45 days. There will be two concurrent review periods – a 90-day Premanufacture Notice (PMN) review period and a 45-day Test Marketing Exemption Application (TMEA) review period. Once a company graduates, they will be permitted to send in a PMN and a TMEA for the same substance at the same time, i.e., a simultaneous or combined submission of the PMN and TMEA. PMNs and TMEAs have different review periods – 90 days for a PMN and 45 days for a TMEA. When a Graduate submits a combined PMN/TMEA, and if the TMEA is granted, the company is free to begin test marketing manufacture at day 45 under the provisions of the TMEA. Manufacture under a TMEA does not mean the substance would go on the TSCA inventory. When the PMN reaches day 90 and if EPA has not regulated the PMN, the company is free to begin commercial manufacture under the terms of the PMN. If the company made several batches of the substance under test marketing manufacture (
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- Once a company does graduate, how will EPA reduce the PMN review period from 90 days to 45 days?