Document 1QxvxZdOZgB929Dx82BaVz6mo

JOSEPH E KELLEIi JEROME H HECKMAN CHARLES M MEEHAN WILLIAM H 0O8GHESA\I,JS ROBERT B.TXEBNAN WAYNE V, BLACK THOMAS J. HL'OHES, JR. davtd L HILL MABT1N Vt BEECQVICI LAW OFFICES Keller and Heckman lrifi N STREET, N W WASHINGTON, D,C. 20036 May 11, 1970 MAY 1 4 1970 TELEPHONE 02 S96-2TOO CABLE ADDRESS "KELMAN" Mr- Robert M. Miller Hercules, Inc. Delaware Trust Building Wilmington, Delaware 19899 Dear Bob: Following up once again on our recent cor respondence concerning the FDA "Statement of Policy" published on April 9, 1970, we thought it might be worthwhile to bring to your attention, and that of all of the other members of the Food, Drug and Cosmetic Packaging Materials Committee, the follow ing two bits of information: (1) We have been advised by our good friend Dinar Wulfsberg that he has seen recent letters sent by the Food and Drug Administration in response to miscellaneous inquiries, which letters apparently are setting forth the following "stock paragraph" on the practical import of the Statement: "Substances which have been regarded by the Food and Drug Administration in the past as generally recognized as safe (GRAS) or prior sanctioned (PS) or not food additives under conditions of intended use are now being reexamined in the light of current scien tific information and princi ples for evaluating safety. We anticipate that this review may require a lengthy period of time. In the meantime, we do not propose to initiate regulatory action adverse to their continued use without prior notification." ASI-PR 0000877 Mr. Robert M. Miller May 11, 1970 Page 2 (2) In addition, the May 4, 1970, issue of Chemical Engineering reflects contacts by this publica tion with FDA during which the Staff has apparently advised the press that its Statement of Policy "doesn't revoke permission to use the [GRAS or Prior Sanc tioned] additives." A copy of a sheet from the May 4 issue of Chemical Engineering is enclosed so that you can see all of its coverage of this matter. * As far as we are concerned, we are delighted to say that most of what is being said now serves to substantiate the opinions and advice we have been giving the Committee Since the Statement of Policy was issued. Cordially yours, Enclosure cc: SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0000878 JOSEPH E KELLER JEROME H HECKMAN CHARLES M MEEHAN WILLIAM H. BORGtlESANI, JR ROBERT IJ TIERNAN WAYNE V. BLACK THOMAS J. HUGHES, JR DAVID L.HILL MARTIN W. BERCOVICI LAW OFFICES Kelleh axd Heckman iris N STREET. N. W. WASHINGTON, X>.C. 20036 May 5, 1970 MAY 1070 TELEPHONE 803 300-3700 CABLE ADDRESS"KELMAN" Mr. Robert M. Miller Hercules, Inc. Delaware Trust Building Wilmington, Delaware 19899 Dear Bob: I thought you and the other members of the Food, Drug and Cosmetic Packaging Materials Com mittee might well be interested in the enclosed letter and accompanying memorandum sent to me recently by Bill Larkin of M & T Chemicals, Inc. Suffice it to say that we believe M & T is taking a very responsible position on the recent FDA "Statement of Policy" and its implications for PVC materials. Enclosures cc: SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0000880 M&T Chemicals Inc. SUBSIDIARY OF AMERICAN CAN COMPANY RESEARCH LABORATORY, P.0 BOX 1104, RAHWAY, NEW JERSEY 07065 April 24, 1970 Mr. Jerome H. Heckman Keller & Heckman 1712 N. Street, N.W. Washington, D. C. 20036 Re: SPI, Food Drug and Cosmetic Packaging Materials Committee Dear Jerry, Enclosed is a copy of a letter sent out today to all of our salesmen, sales correspondents, Technical Service and Marketing personnel. I hope that it will help to prevent the spread of misinformation. Feel free to advise members of the SPI Packaging Materials Committee of our action in this matter if it will be generally helpful. Very truly yours, M&T CHEMICALS INC. WAL/krf cc: J. Kaplan A. Sheldon R. Zedler W. A. Larkin Market Manager ASI-pr 0000881 INDUSTRIAL CHEMICALS PLATING SYSTEMi CERAMIC CHEMICALS COATINGS & INKS ` METALS RECOVERY S FG1 a L TO: Distribution FILE: Referring to yours of: Subject: ivj&T ChsmicaSs Inc. SUBSIDIARY or AMERICAN CAN COMPANY Inter-Office Correspondence FROM: W. A. Larkin Rahway Lab DATE: April 24, 1970 Referring to ours of: Non Tin Food Grade PVC Stabilizers On April 9th, the FDA issued an announcement in ' the Federal Register which, in essence, stated that anyone holding a letter of opinion from the FDA relative to the use of "generally recognized as safe" (GRAS) materials for any application would be required to forward cooi-es of these letters to the FDA for what we believe to be essentially review. It happens that a number of data sheets covering "non tin"food grade PVC stabilizers, including some of the "calcium"zinc systems refer to the compounds being sold as "generally recognized as safe". Several of our salesmen have already been asked, "Does this mean that only the octyltin stabilizers are approved for use since the non tin systems which were promoted as 'generally recognized as safe' must now clear a second review?" This is not the case. It must be remembered that even PVC polymer, itself, is the subject of prior sanctions and would fall in the same catagory as certain of the "non tin" stabilizer systems. -Our position is as follows. We believe that the recent FDA request involves only review of existing letters and that essentially nothing will change relative to the status of any non tin system currently in use. Further, having reviewed those, "non tin" systems being used as food grade PVC stabilizers we find that a great many are regulated by specific regulations and are not even the subject of the recent FDA request. There is a definite place for both"non tin" systems (calcium zinc) and for octyltin stabilized PVC. As representatives of M&T, contacting customers, you are instructed not to imply in any manner that there is any question relative to the safety of currentlv used 'non tin systems. This approach is not to be used as any kind of a selling point for the octyltin materials. The octyl tins offer specific advantages which, of course, you should continue to promote. Printed mUSA ASI-PR 0000882 TO: DATE PAGE The better processability of PVC compounds stabilized with octyltins, the greater output rates which can be achieved with octyltin systems, the exceptional clarity and the water blush resistance, as well as the superior physical property characteristics of the finished plastics containing octyltins are some of our major selling points. I know that I can depend on your cooperation in this matter. If you have any questions, or your customers have any questions, please refer them to me. CC; R. Zedler J. Kaplan P. Chapin ASI-PR 0000883