Document OEL3mMGX4vZVL8r77kVVqXKap

JOSEPH E, KfiU-ER JEROME H. HECKMAN CHARLES M. MEEHAN william h BOROHESANI, JR, ROBERT R.TIERNAN WAYNE V. BLACK THOMAS J. HUGHES, JR, I,AW OFFICES Keller and Heckman 1TIS N STREET, N. W. WASHINGTON, D. C. 20030 March 1, 1968 HMK g jagg TELEPHONE see-sroo cable address "kelman" Mr- George W. Ingle Hydrocarbons and Polymers Division Research Department Monsanto Company Springfield, Massachusetts 01101 Re: Inter-industry Letter to Dr. Goddard Calling for Government-Industry Advisory Committee Dear George: As I believe all of us have anticipated, the situation here in Washington in the wake of the National Conference on Indirect Food Additives has been relatively quiet for the past two weeks, although we have had many informal indications from FDA Staff members to the effect that the presentations made by industry will undoubtedly bring about some kind of "corrective action" on FDA's part. I believe it is fair to say that those in and out of government who are most concerned about the indirect additive problem have been more or less mulling over what has developed so that tangible evidence of action on some official level has not, until today, been apparent. This morning we received a telephone call from the SPI office in New York indicating that the Food and Drug Administration, through Dr. Goddard's office, has now made at least one move by way of a reaction to the Conference, or more properly, to the inter-industry letter forwarded to Dr. Goddard just prior to the Conference. We reported to every one on the Committee about this letter and the way in which it was developed earlier. However, as a convenient way of refreshing recollections, and supplying everyone with a file copy of the letter ASI-PR 0000567 Mr. George W. Ingle March 1, 1968 Page Two in exactly the form in which it was submitted, we are herewith enclosing a reproduction of it. As you are aware, and as everyone else will note, the letter was filed over the signature of the President of the American Paper Institute who, with all of the other associations permission, noted that it was being filed on behalf of seven major industry groups, inclu ding SPI- A response to this letter from Dr. Goddard was apparently received by Mr. Locke some time this week. Actually, the logistics from our point of view are that a copy was sent to Ralph Harding, SPI1s Executive VicePresident, and was received this morning. Ralph's secretary was good enough to call us immediately and dictate the letter to us so that the copy of the response enclosed is a transcribed version. I am sure that it is reasonably accurate but we should be receiv ing the actual copy in the next day or so and can let you know then if there are any discrepancies. As you will see from looking over Dr. Goddard's response, it actually leaves a number of questions which will undoubtedly command your curiosity. Just for example, the letter does not indicate what FDA might do with the proposed "Procedural Regulations" to which we and others have lodged such serious objec tions. Furthermore, it seems to be FDA's view that it should hold some sort of separate conferences with the various industries, rather than follow the type of procedure indicated in Executive Order 11007 referenced so frequently during the National Conference on Indirect Food Additives. Rather than delay sending you information about the Goddard letter while we are attempting to develop more information on what FDA's overall intent might be, I thought it would be best to send the letter along immediately. At the same time, you may be assured that we shall be talking with various FDA Staff members in the next week or so in the hope that this may provide a little more insight into how the agency will deal with some of the problems at hand. ASI-PR 0000568 Mr. George W. Ingle March 1, 1968 Page Three We would hope to be in touch with the Committee further as we proceed along these lines but should anyone have a question in the meantime, we trust they will not hesitate to let us know. Cordially yours, ends cc SPI Food Packaging Materials Committee ASI-PR 0000569 Telephone Transcription Mr. Edwin A. Locke, Jr. American Paper Institute Dear Mr. Locke: Thank you for your letter of February 9 with reference to the indirect additives problem. We share your view that we should continue discussions in this area but rather than proceed as you suggested I would like to see us sit down with a limited number of industry representatives in a series of meetings. I am asking Dr. Summerson, Director of our Bureau of Science, to take the initiative in setting up these meetings on an industry-by-industry basis as soon as his people have gone over all of the points raised at the February 13, 14 meeting.I I hope you will find this course to be a workable one. Sincerely yours. Dr. James L. Goddard ASI-pp 0000570 American , Papei Oflitt *{ ikt ftuiitiit Institute 0 MADISON AVNNOM, 1TKW TOM, H. T. 10016 (NM) S66-6BOO February 9, 1968 Dr. James L. Goddard, Commissioner Food and Drug Administration Department of Health, Education, and Welfare 200 C Street, S.W. Washington, D.C. 20204 Dear Dr. Goddard: The industry groups named below welcome your review of the approach to "indirect food additives" (packaging materials, machinery lubricants, etc.) under the Federal Food, Drug and Cosmetic Act and the Conference which you have called for February 13 and 14 at which they and others will have an opportunity to express views. They have requested and authorized me to write you in their behalf. They believe you will agree that however valuable the Conference will be, it cannot take the place of round table discussion between your scientists and administrators and their in dustry counterparts. These organizations, which we believe represent the industries filing most of the in direct additives petitions, respectfully suggest 1 that soon after the conclusion of the Conference an "Industry-Government Advisory Committee" be ASI-PR 0000571 Dr. James L. Goddard, Convnissioner 2 created along the lines envisaged by Executive Order Number 11007 and in accordance with that Order. Such a committee would report its find ings and recommendations to you. Sincerely, EAL:al Edwin A. Locke, Jr. In behalf of: Adhesive Mfrs. Ass'n. of America American Paper Institute, Inc. American Petroleum Institute Can Manufacturers Institute Rubber Manufacturers Association Soap & Detergent Association Society of the Plastics Industry ASI-PR 0000572