JUN 1 S 19b j r.AW OFFICES Keller and Heckman JOSEPH R.KELLER JEROME 17iy N STREET, N, W. H, HECKMAN GHARI-ER M WASHINGTON', D, C. MEEHAN 20030 WIILIAM Ii, BOfiCHESAS’L-IH. CABLE ADDRESS "KEUJOLaJB ROBERT R.TlERS'AN WAYNE V, SLACK THOMAS J. HUjHES.-IR DAVID L.IIILI June 16, 1969 Mr. Robert M. Miller Hercules, Inc. Delaware Trust Building Wilmington, Delaware 19899 Dear Bob: Following up on our recent letter concerning the meeting of the inter-industry group to deal with the Food and Drug Administra­ tion on its new Section 121.2500 proposal, I am herewith enclosing reproductions of the Minutes of the meeting, as promised. The Minutes were prepared by Einar Wulfsberg and I believe you and the other members of our Committee will find them fully self-explanatory. As you are aware, the Committee appointed by the inter-industry group to conduct the actual negotiations with Food and Drug met m my office on .Friday . I am planning to report on its deliberations and all other phases of this interesting matter during our full Food, Drug and Cosmetic Packaging Material Committee sessions this week. Cordially yours end cc SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0000722 < , MINUTES OF THE MEETING OF THE INTER-INDUSTRY COM ITTEE ■ ON INDIRECT ADDITIVES JUNE 3, 1969 / THE MAYFLOWER HOTEL, WASHINGTON, D. C. The meeting was called at the invitation of the American Paper Institute as the principal for tfte several trade associations joining in the letter of February 9, 196$ to the Commissioner of Food and Drugs proposing an Industry Government Advisory Committee on Indirect Additives. The need for a meeting was prompted by the receipt-by each of the organizations of an FDA letter of May 6, 196 • (Li L. Ramsey, Assistant Director of Regulatory Programs, Bureau of Science) with a proposal for certain simplifications of the food additive regulations. Mr. Ramsey requested a discussion of the pro­ posal with FDA on an industry-by-industry basis. The objectives of this meeting were to insure a common understanding of the proposal and determine the degqee of consensus as to response which could be made to FDA. A roster of participants is attached. 1. Mr. Ross Wilcox, Chairman, reviewed the history of the efforts to achieve some simplification of the regulations on indirect food additives, beginning with the national conference in February 1968. He welcomed the participation of representatives from associa­ tions joining the.original'group for this meeting. 2. Mr. J. Heckman presented a counsel’s view of the FDA proposal. He agreed with the use of Sec. 121.2500 as a vehicle for the proposed changes. He expressed the view that the FDA proposal had merit as a first reponse,. He urged emphasis by all that the proposal be so regarded in discussions, with FDA. The current dilema requiring costly and time consuming studies is the product of increased sensitivity of analytical methods and the use of exaggerated solvents which combine to reveal minute amounts of substances which under real conditions have no relevance nor toxicological significance. Very desirable would be a ret,urn by FDA to the former practice of regarding extractived from packaging at 1 pmm level as insignificant as was done prior to the Food Additives Amendment. At no time then or since, has there been any experience in packaged food. As to the FDA proposal to exclude from the need for petition. substances calculated or demonstrated to migrate at less than than 0.05 ppm there is the problem that this figure does not correlate with extraction studies without relating to an expressed surface-volume ratio. With some standard ration it would appear that the 0.05 ppm level could serve an interim purpose as a baseline pending a more realistic critieron.' Mr. Heckman urged that FDA be persuaded to return to the praC ticeof providing letters of concurrence as to "not food additive" status of products where it is clearly demonstrated that there is no reasonable expectation of its becoming a component of food. Refusal of FDA to so recognize proprietary products since the era,,1960-61 has greatly inconvenienced sales to parties unfamiliar with FDA’s regulatory approach. ASI-PR 0000723 X 2 - - .3.. Dr. Jack Frawley discussed the FDA proposal with reference to its technical aspects. He remarked that he is not in complete agreement with Mr. Heckman on the need for FDA letters relating to company products citing the fact that the number of affected items sold by his firm made such approach impractical. In attempting to exclude substances from the need for petition action, FDA has certain options: (1) by level of use such as 0.2% in the package per Frawley proposal, (2) by excluding specific uses such as in adhesives, dry food containers, etc. To exempt on the basis of amount of use the options further include: (a) -in the package as above,.(b) in the food packaged, cf. the 0.05 ppm 'limit proposed by FDA and (3) in the total diet cf. the 0.1 ppm level of. toxicological insignificance of the National Research Council. Despite the lack of any scien­ tific correlation between actual food or the diet and packaging constituents, FDA clingy to criteria relating to packaging materials. / Any attempt to compare the current FDA proposal with the Frawley proposal'to the Hearing Clerk, October 23, 1967, leads to problems of interpretation of the language in subparagraph (5i) of the text. As a counter proposal Dr. Frawley suggested including the limit of 0.2% for components of food contact articles and a maximum of 0.5 parts per million extraction to food as demonstrated by appropriate tests or as calculated assuming 100% migration. Of particular significance in the FDA proposal is the fact that a level of toxicological insignificance is recognized. General Discussion 4. The question was raised whether FDA could go direct from the current proposal to a final order. The opinion was negative. * 5. The belief was expressed that FDA could be persuaded to meet the interested industries in a joint conference if deemed desirable. The difficulty, recognized was the size of such a group. « 6. On an industry by industry basis there is a need for ■some coordination of response. 7. The matter of continuing the request for an IndustryGovernment Advisory Committee for further dialogue on indirect additives was supported without dissent. 8. As attorneys, Higgs, Hanavan and Heckman questioned the clarity of the FDA proposal, for example, no basis is given for the studies needed to demonstrate toxicity at 40 ppm. 9. The urgency of effective simplification of U. S. Food Additive Regulations was urged by Mr. Heckman in view of the trend amoung foreign nations and-the international groups to follow U. S. patterns. ASI-PR 0000724 h * -3- llpon further discussion it appeared that the FDA proposa should be subjected to the study of a small group with a commission for further discussion with FDA. Sveral suggestions were so ori­ ented. Upon a motion made by Mr. Heckman, seconded, and unanimous]., carried, it was resolved: "that the Chairman of the inter-industry group should appoint a committee of approximately five persons to negotiate, on behalf of the entire group of associations with the officials of the Food and Drug Administration it deems most appro­ priate with a yiew towards (1) obtaining clarification of the so-called Ramsey proposal, and (2) attempting to bring about suitable changes including those set forth as the Frawley (i) and (ii) points. This committee shall have the authority to speak on behalf of the follow .j organizations:■ Can Manufacturers Institute, American Paper Institu' . American Petroleum Institute, Adhesives Manufacturers Association, The Society of the Plastics Industry, Inc., National Flexible Produ . ;s Association, Soap and Detergents Association, and the Aluminum Associ­ ation, and shall have the duty to report back to the inter-industry group on its efforts. The committee shall further take pains in its negotiations with FDA to point out that its task is to negotiate only on points of clarification of language of general interest, and to discuss the basic Frawley points (i) and (ii) concepts, it beingunderstood that the individual associations will deal separately with any problems related to the special limited interests of their mem­ bers, e. g. the Adhesives Manufacturers Association will deal by it­ self with the question of whether the Section 121.2520 adhesives components list should be deleted or continued." • * •* Note:i A copy of the text proposed by Dr. Frawley is attached. A committee consisting of the following was appointed by Chairman Ross C. Wilcox to implement the motion. Jerome H. Heckman John P. Frawley Lewellan Burnette Max Goldfrank' O'Neil M. Banks Einar T. Wulfsberg Society of the Plastics Industry Society of the Plastics Industry Soap and Detergent Association Adhesive Manufacturers Association American Petroleum Institute American Paper Institute In caucus, upon adjournment of the general meeting, the Committee agreed to meet on June 13, next In the office of Mr. J. Heckman. Minutes prepared by: ETW/sw x ASI-PR 0000725 Proposal § 121.2500 if-. John P. Frawiey nno General provisions applicable to Subpart F. * # » # « (d) *** (5) Substances (except heavy metals, as identified under Heavy Metals Test in Food Chemicals Codex, and compounds of such heavy metals; substances prohibited under §109 (c)(3)(A) of the Federal Food, Drug, and Cosmetic Act; and any other substances that have been demonstrated to produ *■ • h toxic reactions vhen present at levels of ho parts per million or less in * the diet of roan or animals) used as provided under subsection (i), (ii), (iii), (iv)? (v) or (vi) of this subparagraph: (i) As components of food-contact articles, provided any substance is present in the container or coating or other food contact surface at a level of 0.2% by weight or less. (ii)- As components of food-contact articles, provided any substance so used contributes no more than 0.5 parts per million of additive to the contacted food as determined by analysis of the food, or by appropriate extraction studies, or by calculation assuming 100 percent migration. (iii) As components of Articles intended for use in contact with dry food of type VIII described in table 1 of 5121.2526(c), provided the finished food-contact surface contains no free oils not otherwise permitted for such use. (iv) As components of articles intended for repeated use in contact with bulk quantities of food, provided the finished food-contact article is thoroughly cleansed prior to first use in contact with food. (v) As components of defoSming agents etaployed prior to or during the sheet-forming operation in the manufacture of paper and paperboard intended for use in contact,with food. ’ ’ (vi) X. As components of food-packaging adhesives complying with §121.2520. ASI-PR 0000726 A ATTENDSSI -EET A S I-P R 0 0 0 0 7 2 7 INTFR-IKpnRTRY COMMITTEE ON IN'-ERECT ADDITIVES JUNE 3, 1969 MAYFLOWER HOTEL PLEASE PRINT PARTICIPANTSASSOCIATION REPRESENTED Max Goldfrank W. W. Seaerlund MAILING ADDRESS Stein, Hall & Co., Inc., 605 Third Ave New York, N. Y. 10016 (212) '867-8484 * 11 National Starch & Chemical Corp.,1700 West Front St., Plainfield, New Jersey 07063 Reynolds Metals Co., 10th & Byrd Sts. Richmond, Virginia 23219 (201) 755-4100 American Petroleum Institute, 1271 Avenue of the Americas, New York New York 10020 Sun Oil Company, 1608 Walnut St. Philadelphia, Pa. 19103 CS^2) VI6-7000 American Can Co., Box 702, Neenah, Wisconsin 54956 (414) 722-4211 (312) FR2-6161 Aluminum Association 0. M. Banks American Petroleum Institute tt \V .aul F. Cundy American Paper Institute Joseph B. Higgs tt Container Corp. of America, 38 South Dearborn St., Chicago, 111. 60603 M. L. Taylor it Union Camp Corporation, 233 Broadway, New York, N. Y. 10007 n Ross Wilcox I, TELEPHONE Adhesives Manufacturers Assn B. Newell Olson W. Wayne Stewart - American Can Company, P. 0. Box 50, Princeton, N. J. 08540 (703) 649-1411 (215) KI6-1600 (212) C07-5300 I |(609) 921-2510 © CM .nrUnce Sheet, Ci PARTICIPANTS fs O o o ASSOCIATION REPRESENTED ", T. Wulfsberg MAILING ADDRESS American Paper Institute, 1835 K Street, N. W., Washington, D. C. 20006 TELEPHONE o a: a ! M ©