Document B2kw31xGGzRZoBnZZDgJzRx4

APPENDIX A DtPAKTl.'.DNT CM* liCAl.UI. nMJCATIOM. AND WT.l.FARP ruiiuc iii.-Ai. iii r.i r<vic.x food and nmu; At>m 1/jirn?ation `. WAOMIIK.TON. I>.C. 1 August 21, 19VO Ur. Jerome H. Heckman Lav; Offices Keller and Heckman 1712 N Street, !>. W. Washington, D. C. 20036 Dear Ur. He demen: Thin is in response to your letter of July 23, 1970 in which yon ask for our views concerning section 1,21.1(e) of the food additive "emulations. This is the section which states in the rtoi'-to-l sentence: "If there is no nitration of a packaging compc'w r: f the package to the food, it dees not become a component of the rose. and thus is not a food additive." four question 'concerns subsccticn(s) (21 U.S.C. 321), parties lAI-ly as it relates to nictation of sub;;tunces from food psekaging materials. It is our position, as regards such substances, t if n food manufacturer, or his food packaging suppliers) has migration data which ostabl.ishcs that th.ere is no reasonable li):oli hood of rinration to food, he need not seek confirmation of h:- f' d^ofsic.n from the Food and Drum Administration that the pacha;; ;ng material is net a food additive. However, if he desires such cc n *firmation he should furnish the details of his scientific (extree tion) studies. Where the review of the extraction studies cor's firms a lack of potential for nitration, no regulation is necessary. Wo trust ` .his statement of our position is responsive to your letter. _ .. n: ' Sincerely yours, n \ rfiijiuApiiiim. T);onas W. Brown, Director Office of Compliance Bureau of roods. Pesticides and Product Safety ASI 00001163