Document a153RNjQd63VDwGLn3oenZ8zR

MANUFACTURING CHEMISTS ASSOCIATION U2* Connecticut avenue, n. w * Washington, d c. 20009* (202) 493-6126 August 10, 1971 Mr. T. W. Hanavan E. I. du ;~ont de Nemours & Company 1007 Market Street Wilmington, Del. 19698 Dear Taylor; Thanks for your letter of August 9 regarding IDA's Guidelines on Chemistry and Tecnnology. I shall await Bill Knapp's thoughts on the suggestion that MCA offer technical com. ent, particularly with resoect to caper additives, before making any contact with FDA. In the meantime, I am informing Bob Miller by attaching to his copy of this letter a copy of your letter. Sincerely yours. /{Utith M. M. Hoover, Secretary Food, Drug, and Cosmetic Chemicals Committee V Zlt 1 - 1* C-z. m . {if*''' ' - Z isv.. ax /' yo <. TP />? >(W #, -fo &>/ / w >. IU-C nt^Cm^y Y jW**J*-c* O ^ cn->- SPJ /Z( f , .. fwcp Cuf e->- S/HvoA nttjtZf p^t ***** "PM'* A~^. -**>- *--0* ***4^-. 07 /*? i~tJC ---->-* r. ASI 00002812 LG-4SS4 REV 10*63 <JSSMt> E. I. du Pont de Nemours 51 Company Wilmington, Delaware 19898 legal department V August 9, 1971 Mr. Morgan M. Hoover Manufacturing Chemists Association 1825 Connecticut Avenue, R. V. Washington, D. C. 20009 Dear Morgan: The attached copy of a letter from Jerry Heckman to ,, members of SPI's FDfrCP Materials Cosnlttee Is generally selfexplanatory. Of significance Is the first full paragraph on page 2 In which Holts of FDA suggested passible MCA Interest la offering technical comment on the approach to food packaging , guidelines, particularly with respect to paper additives, unfortunately, Z was not In a position to be able to attend the June 18 seminar In which Holts'* working draft was dis cussed and possibly distributed; though Z suspect Bill Knapp, whom Z am copying on this letter, was. Zn any case, we can obtain a copy. Z don't think we should miss this opportunity to provide comment and since Bill Knapp, as Z recall, chaired the subcommittee on this question when FDA's proposed guide lines were Initially published several years ago, Z think It would be appropriate for him to reactivate his group and s t up a meeting with Holts. Hy this letter, Z am also asking Bill to comment on my suggestion. Sincerely, TWH:ema Attachment cc: William A. Knapp TSylor \U Banavan ASI 00002813 I josrm nn.rrH JKlfOMI', |I , 11 F.r If M A.N M. MTLHAN K1J.MAM II nOHr.Iir.SAM, JJ. KOHLWT H.nr.RN'AN WAYNT V 11UCR THOMAS J m'OHLS, JH DAVID L HILL MAKTIN W. HCHCOVIC1 HAHC If. SUAV-Nf TO: I.AW orKlCKS Kelleu and Heckman iria n si km:t, n w. WASlllNOTOX, D.C. 20036 August 4, 1971 SPI Pood, Drug, and Cosmetics Packaging Materials tielepuonh you coo-tiroo CABLD ADDMtSfS "KCI.MAN Re: Proposed Revision of FDA's Guidelines Dear Committee Members: As you may recall from my recent memo randum to you on the subject, Mr. Geary of the Food and Drug Administration invited Dan Dixler to sit in with various members of the FDA Staff on August 2 at a "working session" directed toj wards a proposed revision of the FDA's Guidelines l on Chemistry and Technology. The remainder of this letter constitutes Dan's report to me on this meeting. Present at the session for the FDA were A1 Holtz, who served as the informal chairman; Mr. Garnett Higginbotham; Henry Young (he is now in Petitions Control), Dr. Joseph MacLaughlin and Dr. John Howard. The attention of the group was directed towards the revision of a working draft that A1 Holtz had prepared in preparation for the June 18 Seminar. The entire discussion was directed toward indirect additives connected with plastics packaging. Mr. Holtz reiterated that paper additives presented different testing problems in that "equilibrium" extractions are often meaningless. He (stated that he had been in touch with a representative of the American Paper Institute (API) to obtain their assis tance and guidance in preparing a set of guidelines suitable for paper additives. He further stated that the API representa tive informed him that the paper industry. ASI 00002814 August 4, 1971 Page Two as such, considered that the testing and FDA status of paper additives should be in the province of the additive suppliers, not the problem of the paper-makers. i Since A1 felt that many of the leading paper additive suppliers were also active on this committee, he requested that I forward to the SPI-'F'DCPMC members his con- Itinuing request for industry cooperation in connection with paper additives. He suggested that those members who are also active in, for example, the Manufacturing Chemists Association, may want to respond to his request through that organization. The first part of the session was devoted to efforts on my part to change the basic premise under which Holtz had worked from the point of view of eliminating the need to frle unnecessary petitions. Not unexpectedly, this proved to be an exercise in futility since delimiting the coverage of the law is as much a legal question as a technical one and, therefore, Mr. Holtz could not effectively negotiate in this sphere. We then began a point-by-point con sideration of Holtz's draft. The attempt was made to present as forcefully as pos-. sible industry's needs for: (a) eliminating demands for information not directly related to FDA's evaluation of the safety of an in direct additive, (b) clear and precise enunciation of the information the FDA does require and, (c) clearly indicating as optional that information which even FDA agrees is optional in certain cases. More specifically, for example, the draft required that data be presented re garding molecular weight and molecular weight distribution for every polymeric ASX 00002815 August 4, 1971 Page Three additive other than thermosets. This was objected to as being an unnecessary burden unneeded to assure the safety of an additive. In a similar vein, we urged that the Guide lines eliminate the mandatory request for an abrasion test; and raised the question as to whether this test is meaningful in any food packaging application. A good deal of attention was directed towards improving the clarity of the presenta tion so that a competent chemist who was a novice in petition-related chemistry could follow the Guidelines and obtain all the data that the FDA is likely to require. In this general area, it was urged that the format be organized so as to be both logical and internally consistent. The important question of the sensitiv ity and validation of analytical methods was discussed and the revised Guidelines should explicitly and clearly point out that all analytical methods must be properly validated. This will require the presentation in the petition of a complete discussion of the methods used (by reference to the literature where appropriate) and evidence proving that the method is effective for its use in the petition. Related to this is the question jof the sensitivity of the analytical method (used, particularly where "none" of a sought1 for substance is found; and it was urged that the sensitivity required be explicitly re lated to toxicological considerations. In this connection, the FDA personnel voiced the hope that the "soon-to-be-issuea" Guidelines on Toxicology would offer some clarification. A1 Holtz hoped that a new draft would be ready in about one month and indicated that he would then be in touch with us to further consider this new revision. ASI 00002816 August 4, 1971 Page Four It is our intention, of course, to con tinue working with the FDA as closely as we can. We will keep you fully informed. While writing to inform you about this act ivity in which we are engaging, and on the likely possibility that many of you may be wondering what has happened to the Minutes of the last Committee meeting, and the Transcript of the FDA Seminar, I thought I would take this opportunity to let you know that neither of these important matters has in any way been forgotten. As regards the Minutes, they are fully typed except for one small section. Due to a misunder standing, one of the reports given at the Meeting was not supplied to us although we previously thought that it had been. We have been in touch with the party whose report we have been awaiting and have been assured thae it will be in our hands this week. Thus, we should he able, to send the Minutes to Charlie Conait for reproduction next week. Relative to the Transcript, here we remain at the mercy of the Food and Drug Administration Staff which is still "editing" its portion of some of the presentations. My secretary has been contacting Mr. Kedzior almost daily in this connection and has been receiving promises that the FDA edited trans cript will be returned to us momentarily. I am hopeful that it will be in our hands soon but you should understand that even after we receive the document, it will probably require two or three weeks for retyping, reproduction, and distribution. We are sorry that you are being inconvenienced in this way but we are doing the best we can and will try to minimize your waiting time. ASI 00002817