Filing costs, PMNs

RRS assessed the cost of completing the PMN form by examining the costs that companies actually incurred in performing this task. RRS sent a questionnaire to all companies known to have filed a PMN form. In addition, RRS examined EPA s public files on the PMNs it has received. Average costs are shown in Table II,... 

Mean Total Filing Cost Economic Burden of Intermediates Economic Burden of Adverse PMNs... 

The Chemical Manufacturers Association (CMA) had reached similar conclusions about a year ago and filed a petition with EPA suggesting that there was a strong case to be made for exemptive relief under Section 5 (h)(4) of TSCA for many polymers, site-limited intermediates, and chemicals produced in volumes of less than 25,000 pounds per year. (An examination of the effect of PMN costs at various prices and levels of production reveals that the PMN cost, as a percentage of total cost per pound of product, generally rises most rapidly as output falls below 25,000 pounds. See the Appendix for a more detailed discussion.) It is CMA s firm belief that exemption could be granted in terms that would operate to assure "no unreasonable risk" to the public in terms of either health or the environment. 

The EPA requires companies to submit premanufacturing notices (PMNs) 90 days before a chemical s manufacture is started. EPA may stop the manufacture or prohibit certain uses. The PMN must include detailed information. They were initiated in 1979. Some 1,100 were filed from 1979-1981 and the number now averages 700 new PMNs per year. About 1-7% are chemicals of concern. The PMN system has been criticized by many in the industry. There has been a 54% decline in new chemical introductions since PMNs have been initiated. Eventually it may concentrate new product development into large companies that can afford the extra testing and administrative costs. 

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