Document XegerOGM3eLVzgod7E07x2d

JOSEPH E! KELLEH JEROME i HECKMAN CHAHtES M. MEEHAN W11.I.TAM fj ROHCtHESANTI^JR ROBERT 1 f T1EHNAN WAYNE v BIACE THOMAS * r HT'OHES. JR, DAVID L HILL MAfiTlV ' ,T IJLHCOMCl LAW OFFICES Keldkr and Heckman 1712 X STREET, X W WASHINGTON, 13. C . 20036 November 24, 1969 telephone 308 396-2EOO CABLE ADDBESS 'EELMiN ' To: All Members of the SPI Food, drug and Cosmetics Packaging Materials Committee Gentlemen: Firstly, this is to apologize to you for a secretarial error we made in sending you our November 14 communication. In that letter, we indicated that we were enclosing copies of material we had received from the British Plas tics Federation relative to its newly published volume entitled "Plastics for Food Applications --Code of Practice for Safety in Use." Unfor tunately, the descriptive material and order blank were omitted from our mailing. We are remedying this error by sending you the material herewith. Let me also take this opportunity to thank those of you who called the omission to our attention. Since our November 14 letter was written, and with further reference to our November 10 communication, we have now received our supply of the Food Protection Committee-Food and Nutri tion Board National Academy of Sciences-National Research Council report entitled "Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Food." In accordance with our earlier promise, therefore, a copy of this docu ment is also enclosed with each copy of this letter. ASI-PR 0000652 November 24, 1969 Page 2 We now understand that there is at least some chance that the Food and Drug Administration will be making comments, or raising some ques tions, for the Food Protection Committee con cerning the report. The indications we have received are quite vague, and are really uncon firmed, but we get the impression that FDA is now most reluctant to move ahead with any sort of blanket substance type relaxation of its present food additive regulatory scheme in light of the climate created by the cyclamates and monosodium glutamate developments. These developments have, as has been pointed out earlier, given rise to much cynicism about blanket exemptions of any kind so the impact is being felt in a widening area. Just to show you how great the impact is, one of our good friends at FDA last week indi cated to me that he thought FDA should move back to a system of giving individual proprietary~ Clearances (such as is still the USDA approach), and should perhaps give up the whole concept of trying to clear substances by broad regulations. I assure you that I did not comment one way or the other on this idea. I must say, how ever, that I have long felt this to be an approach worthy of more consideration. Indeed, I believe I implied as much as long ago as 1966 when I presented my American Chemical Society paper entitled "The Packaging Industries and the Food Additives Amendment of 1958--It's Time for a Change in the Law." In any event, I think it is fair to say that we are now in a posture where we cannot expect truly immediate progress on the long anti cipated action to publish an amendment to section 121.2500 of the Food Additive Regulations. All of the information we have tends to indicate that FDA will be rethinking the matter, at least to some degree, and that further negotiations between FDA and the Food Protection Committee relative to its report are a likely prelude to additional developments. ASI-PR 0000653 November 24, 1969 Page 3 I do caution you to understand that the information I am attempting to convey is quite "iffy" so please do not give it undue impor tance, We shall continue to "keep our ear to the ground" so that we can pass on any informa tion that we receive. Finally, and with apologies for making this letter of the "omnibus" variety, I thought I would also use this opportunity to supply each of you with copies of the invitation and program announcement we have now received concerning the Thirteenth Joint Educational Conference spon sored by the Food and Drug Law Institute and the Food and Drug Administration. These conferences are open to any who desire to attend. If you wish to be present, all that you really need to do is to come to the meetings and register then. Many do register in advance, but this is optional. We hope you will find the information supplied in this letter of interest. If you have any questions or comments after reviewing the foregoing please, do not hesitate to let us know. Enclosures ASI-PR 0000654