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How a Chemical Intermediate PMN is Different from a "Regular" PMN Chemical Submission

When a potential chemical manufacturer wants to submit PMN on several substances in a synthetic series leading to a final product, there are several advantages for the Environmental Protection Agency in reviewing them together: the Agency can make a more complete evaluation of likely emissions and exposure, and there are economies in the review. In recognition of these advantages, and to encourage manufacturers to submit such PMNs together, the Agency will charge a reduced fee of $1,000.00 for the submission of PMN for each chemical intermediate in a synthetic pathway when accompanied by PMN for the final substance on that pathway. The final product is subject to a full user fee.

As is discussed elsewhere, the fee for a PMN submitted by a "small" manufacturer is reduced to $100 ("small" means less than $40 million in annual sales by the submitter company or it and its parent company together). There is no reduction in fee for intermediate PMNs filed by a "small" company to below the $100 level. It is, however, still helpful to the Agency to receive such applications together, and we encourage submitters to send them at the same time.

When several parallel synthetic sequences are being considered at once (usually this comes up when a submitter seeks approval of consolidated D, D', D", and D"', final products of the synthetic sequences A-->B-->C-->D, A'-->B'-->C' -->D', A'' B'' C'' D'', and A''' B''' C''' D''') then parallel intermediate stages (A, A', A'', and A''') can be consolidated.

 


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