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Letter from Frederick Sperling to Joshua Lederberg

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  • Chemistry
  • Pharmacology


COLLEOE q F MEDICINE DEPARTMENT OF PHARMACOLOGY HOWARD UNIVERSITY WASHINGTON, D. C. 20001 January 18, 1970 Dr. Joshua Lederberg Genetics Department Stanford University Stanford,California 94305 Dear Dr. Lederbergt I returned from abroad a week ago and found your letter waiting. I have the impression that you would not object to a continuation of our dialogue. I did see your column of 11/29/69 and paxagraphs 4 and 5 are pertinant to the statement I made in my letter to you. You may recall the case of Agene, NC13. This bread softener was taken off the market when it was found that large, repet- itive doses caused "running fits" in dogs, This occurred prior to the Delaney Bill, At that time, a food additive could (not must) be withdrawn if any harm at any dose was shown. NC1 a was withdrawn. The Delaney Bill changed this very deliberately, so that if a ood additive was shown to safe under the intended condit ions of use, it was permitted to be used. In practice, under the regula- tions, not the statute, this meant establishing a no-effect level in chronic tests with a rodent (usually rats) and a ran-rodent (usually dosgs) species. The inten- ded use level needed to be at least at the no-effect level, and in practice, the use level was arbitrarily set at 100X below the no-effect level. Under the Delaney Bill, Agene m ight still be on the market, because among other things, the effect on dogs was due to the dogs' peculiar metabolism, Basically, recognition was given to the pharmacolgical, or dose-response, characteristics of food additive chemicals, The objectionable thing in the FDA procedures, as I pointed out in my prev- ious letter, is the arbitrary safety lim it, It is scdentifically irrational, and may be too small or too large, But regardless; if the Delaney Bill recognizes that there may be an effective no-effect level for liver damage, k idney damage, demyelination, etc. then the same shoud apply to carcino

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