dissolution of the product and its impurities." Obviously "front ending" is a major task and would involve considerable separation and cleanup. This is the rationale for the significant increased estimated cost for applying the Master Analytical Scheme (increasing from $3000 for water to $20 000 for commercial products). There is some misunderstanding on the part of Golton relative to cost estimates. Harrison's letter t h a t he cited refers to the cost of developing individual measurement methods for all impurities postulated to be in a product above 0.01% concentration. This is precisely what we want to avoid by use of a standard protocol, first for analysis to identify impurities (as opposed to postulating them) and next to provide a set of methods, categorized by compound properties, from which monitoring techniques could be selected for those compounds t h a t should be monitored. The detection level attained by the protocol would influence the reporting requirements as opposed to the arbitrary selection of 0.01%. T h e cost information in the Appendix to Harrison's letter is preceded by this statement: "The ACS has neither undertaken a formal cost study, nor conducted its own critical analysis of EPA's and industry's cost
estimates." Although the data are itemized, they are not substantiated. Nevertheless, I believe they are adequate for Harrison's purpose. Our cost data are not documented in detail, but we have a valid basis for substantiating them. However, we really shouldn't quibble over cost estimates of two entirely different approaches. We are proposing t h a t EPA invest one to three million dollars in methods development so t h a t a manufacturer can meet his premanufacturing data requirements for a few thousand dollars. T h e costs of chemical analyses are influenced by several variables and can be expressed in different terms. A discussion of the basis for our cost estimates is inappropriate for this letter, but we will communicate this information directly to Golton. I think we are on his side of this issue; I'm not sure he realizes this. Let me also assure Golton publicly t h a t no one is more opposed than I am to unwarranted regulation based on unsubstantiated claims. However, I am equally opposed to resisting clearly needed regulation simply because the evolutionary process of regulation fails to produce a perfect system on first attempt. Our goal, as stated in the article, is to provide "the largest amount of valuable information at the lowest
cost." We believe t h a t analytical ' chemists can make a major contribution to improved, cost-effective regulation by pursuing such objectives. Incidentally, since the article was submitted, a meeting was held in Atlanta, Georgia, at which the contractors who are developing the Master Analytical Scheme presented their ideas to 82 of the most highly respected organic analytical chemists in the country. (Representatives from both DuPont and Shell were among them.) Their response was most encouraging. Equally encouraging has been the direct response we received from the April article (1). T h a n k you for helping us in gaining this much appreciated and helpful advice. William T. Donaldson United States Environmental Protection Agency Environmental Research Laboratory Athens, Ga. 30605 References (1) W. T. Donaldson and A. W. Garrison, Anal. Chem., 51, 458A (1979). (2) Fed. Resist., 43 (132), 29707-10 (10 July 1978). (3) Fed. Regist., 44 (7), 2242-2348 (10 Jan. 1979). (4) Anna J. Harrison, letter to Douglas M. Costle, Sept. 22, 1978. ACS Reference No. OPP-30022.
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ANALYTICAL CHEMISTRY, VOL. 5 1 , NO. 9, AUGUST 1979 · 989 A
