Document Exb95OzRjnEx8q9VwdEkbzmQ4

JOSEPH E KELLER JEROME H, HECKMAN CHARLES M MEEHAN WILLIAM H BOROnESANI. JR ROBERT R TIERNAN WAYNE V, BLACK DAVID I,- HILL MARTIN W BERCOVICI LELAND J BLAIR PETER M NEMKOV LAW OFFICES Keller and Heckman 1150 J7T STREET, N W, SUITE lOOO WASHINGTON, D-C- 20036 October 23, 1972 TELEPHON E 302 2<9t>-12*00 CABLE ADDRESS"KELMAN" TO: All Members of the SPI Food, Drug and Cosmetic Packaging Materials Committee RE: Food and Drug Administration "Proposal Regarding Regulation of Prior Sanctioned Food Ingredients;" 37 Fed. Reg. 16407 Gentlemen: Enclosed herewith, for your information, is a copy of a letter I have just received from John F. Jones of Vistron Corporation, Attached to the letter is a reproduction of a very brief Comment Vistron has made with reference to the Comments we filed on October 10, 1972. For all practical purposes, we think you will find both of these documents self-explanatory. You will note that they relate solely to the request we made in our Comments for the inclusion of SAN resins in what we hope will be ultimate publication by the Food and Drug Administration of a prior sanctioned "ingredients" list which will include all of the basic polymers covered in the so-called Lehman list. Mr. Jones was good enough to call us after his Comment was filed to let me know that the only pur pose of the filing was to amplify the SAN "specification" we gave FDA in our statement. As all of you know, we received the information for the specification we sub mitted from the companies known to be producing SAN. At the time, we certainly were not thinking of broadening the coverage so that it would include any of the new nitrile-based barrier resins. It is obvious that Vistron was concerned that our filing could have this effect, and therefore moved to protect whatever position it might have as a result of the relatively recent promulgation of Section 121.2614 of the Food Additive Regulations. ASI"PR 0001247 October 23, 1972 Page Two It seems to us that the Vistron filing is reasonable although we really have no way of knowing whether it might lead to any untoward consequences, i.e. an inadvertent undermining of the existing SAN prior sanctions, or, worse, the questioning by the Food and Drug Administration of the specifications for all of the other polymers described in the SPI Bulletin entitled "Good Manufacturing Practices Criteria for Plastic Resins Prior Sanctioned Under the Food Additives Amendment of 1958." It will be interesting to see how this entire matter develops although we suspect it will probably be some time before anything definitive takes place. in any event, you may be assured that we will keep you fully posted on developments. Enclosures ASI-PR 0001248 VISTRON CORPORATION MIDLAND BUILDING CiLVEIAND C> 0 .14 ; '5 October 19, 1972 Jerome H. Heckman, Esq. Keller and Hechucan 1150 17th Street, N. W. Suite 1000 Washington, D. C. 20036 Dear Jerry; Re: Pood and Drug Administration ''Proposal Regarding Regulation of Prior Sanctioned Food Ingredients"; 37 Fed. Reg, 16407 Enclosed is a copy of the comments we mailed to the Hearing Clerk on October l8, 1972, before I talked to you on the telephone. Please send me any further comments which you might file in this regard. As I said on the telephone, we had only the one objection to the definition of SAN resins, and we certainly do net xvish to be working at cross purposes with other members of the SPI. Very truly yours JFJ: m.r Enclosure John F. Jones Patent Counsel ASI-PR 0001249 V/I5TRON CORPORATION October 18# 1971 Hearing Clerk Departa?nt of Health# Education# and Welfare Boom 6-88 5600 Plahera lane Rockville# Maryland 20852 Dear Sir; ! Re: Pood and Drug AdiiCnistration 1 - "Proposal Regarding Regulation of Prior Sanctioned 5toc-d Ingredl? at311. 37 Fed. Rex. 16407 We have the following comme. -:a regarding the subject proposal and request that they be considered in spite of the fact that this letter la being submitted after the October 10# 1972# deadline* On or about October 10, 1972* The Society of the Plenties Industry# Inc, (CPI) (of which cy company is a mamb( ?) filed comments on the uubjeet proposal. We agree in general with the SPI comments with one exception--namely# item IV entitled "Proposal to List Poly (styrene-acrylonitrile)", The "SAN" resins which were used in food packaging prior to 1958 included such materials as "Luatran" of Monsanto# "Tyril" and "Styrex" of Etow, f,C 11" of Union Carbide# and others. It Is well known and documented that these SAN resins are copolymers of styrene and acrylonitrile composed of from 10 to 37# by weight of acrylonitrile and correspondingly 90 to 63$ by weight of styrene. The more preferred SAN resins contain from 20 to 35# by weight of acrylonitrile and correspondingly 80 to 65# by weight of styrene (Encyclo pedia o' Polymer Science and Tecnnology# Volume 1# page' . In view of this# we suggest should PDA decide to include SAN reaia3 on the GRAS list (Subwart E# 1SL.aooc) that the SAN resins included therein ej further defined as containing from 10 to 37# by weight of polymerized acrylonitrile and from 90 to 63# of polymerised styreru:. Respectfully submitted# J?J:mr John 7. Jones Attorney ASI-PR 0001250