EXHIBIT D Report of Thomas J. Hughes, Keller and Heckman On International Developments Prepared for SPI Food, Drug and Cosmetic Packaging Materials Committee Meeting Washington, D. C. November 7, 1968 Gentlemens It is indeed a pleasure for me to have this opportunity to report on some items of interest that have come to our atten­ tion on the international scene. As is the normal practice whenever the Committee discusses international developments, or any of the topics we cover for you, I invite you to interject yourselves during the course of my discussion as you "feel the urge and/or the need so that we can develop and cross-pollinate as much information on the subject as is possible. I don’t have to tell you that the international legislative and regulatory situation is so complex and expansive that we must rely on all of the members of the Committee who have occasion to deal with, or in, foreign countries in the food and food packaging areas to keep us apprised of the latest developments. UNITED KINGDOM To "get the ball rolling", I thought I would first touch on the present food packaging situatim in the United Kingdom. Those of you who were at the last Committee meet­ ing in New York, in April, will recall that following a lengthy discussion, then Chairman, George Ingle, appointed an ad hoc Subcommittee to consider the questicn of whether or not it might be desirable to draft a joint set of com­ ments bearing on an inquiry, drawn up by the British Food Addi­ tives and Contaminants Committee, and circulated to industry by the British Plastics Federation, which requested industry's views on several alternative proposals for the establishment of a food packaging regulatory scheme in the United Kingdom. A May 10, 1968 comment deadline date had been set by the British Committee. ft iO CJ BFG61436 ASI 00000713 2 After careful deliberation and discussion between the ad roc Subcommittee and your Steering Committee, the Sneering Committee decided that this Committee would not undertake to submit any comments on behalf of 5?I. ir. keeping with the Committee's Long-standing polity on such matters it was agreed that the question of whether or r.ot to submit comments on the British Food Additives and Contaminants Committee s proposal sh o-- .d be Left up to the md ividua. companies that had an in­ terest in the matter. 3 mce this Committee has neither the cap­ acity nor the facilities for effectively deali-g with foreign problems from an industry point of view it was felt that the ' individual company approach to the British situation would be best for all concerned. That brings me to the current stat-s of the situation in the United Kingdom, Actually we were most fortunate to have had a very recent opportunity to spend the better part of a day with Trevor Wells, of the British. F las tics Feder at 10:. ■ Mr, Heckman, Mr. Ingle and I took the opportunity of our delightful ar.d highly informative get-together vLth Mr ■ Wells to question him on the ■■chain of governmental authority over food-packaging ir. the United Kingdom and tve force and effect of the Laws and regulations prese-tly m effect in the United Kingdom, that might have any bearing 0: food packaging. I think it might be helpful for purposes of pitting the present efforts of the British Food Additives and Contami-ants Committee in perspective if I digress for a moment a-d briefly describe the governmental and legislative macrmery m Great Britain as it relates to food packaging. The British Ministry of Aar icu -cure Fisheries ar.d Food is the governmental entity with, primary respor.sibility over the administration and enforcement of the Food and Drugs Act of 1955It was also the sponsor of the Act whet presented to Parliament for consideration The Ministry is comparable to our own Executive Department of Health Ed. cat ion and Welfare Basically, the Food ar.d Drugs Act provides ir. sub­ stance. that 'thou shale not poiso- the people , and is in­ terpreted to apply to food packaging materials or containers only m the event that some food is poisoned ' BFG61438 ASI 00000715 4 a "migrant11 requiring Ministry approva.. This proposal has support on the Committee but is not necessarily considered to be "the leading candidate • (3) The third proposal. calls for the govern­ ment to refrain from adopting ar.y detai_sd legisla­ tion on the subject of food packaging as experiences m other countries, notably the U. 5, have proven that such legislation is neither practical nor nec­ essary o All that would be necessary to assure safety would be to require that the several packaging in­ dustries each adopt and adhere to a code of practice similar in design and scope to the Good Manufacturing Practices Regulations employed in this country; This approach is obviously the most desirable of the three, from industry's point of view, ar.d we are told by Mr. Wells, that this proposal is picking up increas­ ing support and momentum. With this prospect m mind, the Sritish F.astics Fed­ eration (BPF; which, as you know, is an organizaticn similar to our own SPI, has circulated, to the British plastics industry, a draft code of practice- for comment and approval by the SPF members. The draft, which was approved by the SFF Toxicity Com­ mittee before being circulated to the BFF membership. has been rejected by one British company, and efforts are presently under­ way to resolve the objections that have beer, raised? although, we are led to believe that the objections raised by the company in question, have seriously impaired the possible approval of a BPF Code of Practice at any time m the 'ear future. NETHERLANDS Turning next to the present status of the Dutch regu­ latory situation, the Dutch Ministry of Social Affairs and Public Health published, on July 25, 1968, a third version of a Draft Packaging and Food-Utensils Regulation with a twg-.ve-month comment period ending July 25, 1969, On May 6, 1968, the Ministry had promulgated Direc­ tives For Making Application For the Approval of An Additive in Packagmgs and Food-Utensils’, such Directives to be administered under the Packaging emd Food-Utensils Regulation, when the latter is ultimately finalised and formally adopted The Directives are, as we understand it. final and not open for comment. They are very similar in design and scope to the Procedural Regulations BFG61439 ASI 00000716 * ■ •. c: GJ iO CTi 5 qoverr.ir.g the filing of Food Additives Petitions in this country under Section 121.50 of the lode of Federal Regulations. Of particular significance. 1= Section 8 of the subject Directives which grants provisio-a. permission for the use of plastics materials and components, i- the Netherlands that were subject to applirable U. S, Food Additive Psaj.atior.s prior to TA'.ary 1.. 196 7. unless subsequent toxicity data ral_s for a re=pr-r=.isal of the substance. Substances which have beer regulated m the 'J, S. after January 1 1967, would be independently evaluated by the Nether­ lands and data, as specified ir. the Directives vou^d be required for purposes of obtaining Dutch governmental approval. Additionally Section 8 of the Directives provides that an additive could be placed on the list of acceptable additives without toxicity data having been supplied, provided that it could be demonstrated by appropriate extraction s-udies using water, 3% acetic acid. 15% ethanol and arachis oil as food simulating soiv-nts. that not more than 0.01 ppm of the additive will migrate into packaged food. This of course is a sort of adoption of the 1'. 5 approach implied m FDA:s C-uidennes For Jhemistry and Technology Requirements of Food Additive Petitions-, We are to.c that the Dutch are closely w&triu-g the rest >f the world, particularly the L'„ S., to see how and t3 what extent the Frawley approach' wiLl be implemented m other countries before the Dutch perhaps undertake to modify the ppm criterion. We have just recently received a copy of the Dutch Directives and will circulate copies to the J:mmitt.ee m the very near future. We have also received a espy of the third Draft Packaging and Food-Vter.sils Reau._e.tior.s. but without the schedules to the draft, which contain prescriptions on the various permitted additives and components and “he methods of investi­ gation for enforcement of the Regulation, Chapter T of the schedules relates to polystyrene, polystyrene copolymers, poly­ ethylene. proproxyler.e, polyolefin copolymers. FVC, PVDC, anti­ oxidants for plastics and General Analytical Methods, and may be obtained by writing directly to. ’ Food Law Advisory Commission (Adviescommissle w&rerweti Dokter Reijersstraat 1.0 Leidschendam Netherlands, C-n C-5 Co 10 -'i -'i bFG6144° ASI 00000717 6 In summary then the Dutch are in the process of de­ vising a regulatory scheme for food packaging materials whLch, with certain listed exceptions, wi... require tr.e pre-clearance of additives ar.d materials by the Dutch government before such substances are listed as acceptable for food-packaging appli­ cations ir. the Netherlands, It should also be noted that the Dutch proposal for the regulation of indirect additives migrating from packaging materials is separate and apart from the Dutch regulations bearing on direct food additives BELGIUM Turning next to some recent developments m Belgium, the Belgian Ministry of Public Health and Families has promulgated a draft Royal Decree relative to the manufacture trade and util­ ization of items and materials which come r.t: contact with produce and food stuffs. Unfortunately, the copy able to obtain makes no reference indeed to any desire on the part have industry submit its views on give you any specific information of the draft Decree we have been to comment deadline dates, nor, of the Belgian government to the draft, so ! am u-able to m this regard The draft Decree purports to app„y only to those pack­ aging materials which are likely to become components of pro­ duce or food stuffs". Broad provisio'3 are also made for re­ questing the Belgian government to list food packaging materials or components, which are Likely to become components of food., on a positive list of approved materials. Here aqai'. the copy of the craft Decree we have makes no referer:e to required extrac­ tion methods or other data that must be supplied to the govern­ ment to establish safety but. from our past experience, we believe it very likely that the Belgians wi_i ultimately follow the Dutch lead and probably will end up adopting the same, or very similar criteria, as the Dutrh, In general, the draft Decree seeks to prohibit the use of food packaging materials or components, which are likely to become components of food if such material or component; (ai wilL contaminate the food with noxious substances in such quantity that the food becomes harmful or dangerous to health; or (b! wil.1 impart inoffensive substances to foods, but in undesirable quantities under the r.ormai conditions of use; or (c! will change the organoleptic characteristics of the food when m contact with food stuffs under normal conditions of use. BFG61441 ASI 00000718 ^ c •' £\ ^ £:j t* •S J CO - 7 - To summarize the situation m Belgium, we anticipate that the Belgians will ultimate./ adopt a packaging regulatory scheme similar m design and scope to the Dutch effort, so events m the Netherlands will have, we believe, a significant bearing or. the ultimate position the Belgia-s take with regard to the regulation of food packaing materials ITALY We have just recently beer, advised that, last April, the Italian Ministry of Public Health, m cooperation with a Committee established by the Italian National Association of the Chemical Industry, promulgated a positive list of ingredients acceptable for use m plastic food packaging materials. We have not seen the list as yet, but efforts are underway to obtain a translated version, and if and when we are able to procure the same, we shall be advising the Committee further m this connection. I should note that our experiences with the Italian government, and, indeed, the information we -ave recently re­ ceived, show a continuing spirit of cooperation between govern­ ment and industry. It is r.o secret that v* would certainly like to see the same type of cooperation in th ls country, ar.d I think we have seen some hopeful straws m the wrd as a direct result of the National Conference on Indirect Food Additives, as Jerry has already mentioned in his report. EEC In concluding my report, I wou;d iike to briefly touch on the current situation in the E E.C As most of you are prob­ ably aware, the interests of the plastic industry within the Common Market have generally beer, represented by the B.t.T.M.P. Some two years ago, in the interest of greater harmonization of the plastics industry within the E:E C., a Tomite Mixte; was established. The establishment of this Committee, which actually constituted the merger of several technical committees operating within the framework of the Common Market, coincided with the establishment, by the E E C:s Agricultural Division, of a Committee to study the problem of instituting a common regulatory approach to food packaging m the Common Market. The E.E.C. Committee, usually referred to as the Frar.ck Committee m honor of its Chairman, Professor R. Franck of Berlin, has received several proposals for Legislation on the BFG61442 ASI 00000719 8 subject, and is presently reviewing the procedures used by other countries in an effort to develop a workable and effective regu­ latory approach in the E.E.C. The plastics industry, through the Comite Mixte, has submitted a proposal to the Franck Committee which calls for the listing, on a Common Market ’positive list . of all plastic food packaging materials and components that are approved for use in at least two E.E.C. member countries, without further assessment. Plastic food packaging materials and components that have been approved in only one country will also be listed, but will be subject to removal from the list if objections are raised by a government toxicologist fran any of the member countries within a six month period of the date of listing. The Franck Committee is presently studying this proposal. Meanwhile, as an adjunct to this proposal, the B.I.T.M.P. has completed a draft listing of plastic food packaging materials and components it would recommend be included on such a positive list. As we understand it, the B.I.T.M.P has circulated the draft to the member countries for comment and approval before submitting the same to the Franck Committee. Apparently, West Germany has raised some objections to the draft listing, not on the substance of the list, but rather on the grounds that neither the Comite Mixte proposal nor the BIT M P. proposed list have "national" status as is normally required under the Rome Treaty for E.E.C. consideration. Therefore, it appears as though the biggest roadblocks in the way of any E.E.C. effort to regulate food packaging are in the nature of "political" rather than technical' hurdles. ★ sr That completes my report. I thank you for your atten­ tion and, again, if any of you have any additional information on these, or other countries of interest, I know that the Com­ mittee will appreciate hearing it. Thank you - N f O 03 CO BFG61443 © ASI 00000720 93 BFG61444 sf? -?e. 1970 THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 2SO PARK AVENUE • NEW YORK. NEW YORK 10017 • 212/687-2675 HIKtTES MEETING OF SFI FOOD, DRUG AND COafECIC PACKAGING MATERIALS COMMITTEE Shoreham Hotel Washington. D. C. February 26, 1970 9;40 a.m. Present: Robert M. Miller, Chairman. Hercules, Inc., 910 Market St., Delaware Trust Bldg., Wilmington, Delaware 19898 j Taylor W. Eanavan, Vice Chairman. E. I. du Pont de Nemours & Co., Inc., 1007 Market St., Film Dept., Wilmington, Delaware 19898 Watson B. Ackart, Union Carbide Corp., Chemicals & Plastics, One River Rd., Bound Brook, New Jersey 08805 Nelson Allen, E. 1. du|?ont de Nemours & Co., 910 Market St., Wilmington, Delaware 19898 Robert H. Anderson BASF Corp., 866 Third Ave., New York, New York 10022 Robert C. Asam, The Goodyear Tire & Rubber Co., Chemical Materials Dept., 1485 E. Archwood Ave., Akron, Ohio 44316 James Asbeck, B. F. Goodrich Chemical, 3135 Euclid Ave., Cleveland, Ohio 44115 Ralph P. Blodgett, Northern Petrochemical Co., 2223 Dodge St., Omaha, Nebraska 68102 Norman D. Bornstein, W. R. Grace & Co., Converted Plastics Group, P. 0. Box 464, Duncan, South Carolina 29334 Sal M. Cannavo, L. A. Dreyfus Co., P. 0. Box 500, South Plainfield, New Jersey 07080 Kenneth C. Conley, Development Division, Boxg-Warner Corp., Washington, West Virginia 29181 Paul P. Cundy, American Can Co., Box 702, Neenah, Wisconsin 54956 Richard A. Dannells, Dart Industries, Inc., P. 0. Box 37, Paraous, New Jersey 07652. o CO M O) BFG61445 hSI 00000793 2 Laverne J. De Cores, Sinclair-Kopper8 Co., Product Development, Frankfort Ed., Monaca, Pennsylvania 15061 Harry R. Dittmar, IMCO Container Co., Div. Ethyl Corp., 4240 Blue Ridge Boulevard, Kansas City, Missouri 64133 Daniel S. Dialer, A1RC0, Inc., Central Research Laboratory, Murray Hill, Hew Jersey 07971 R. J. Dowling, Uniroyal Chemical Division, Spencer St., Naugatuck, Connec­ ticut 00770 George W. Ferner, The Goodyear Tire & Rubber Co., Research Division, 1144 East Market St., Akron, Ohio 44316 Robert A. Ferrell, KLC Corp., Prospect & Hodell Sts., Shelbyville, Indiana 46176 Gerhard Fuchs, Allied Chemical Corp., P. 0. Box 405, Morristown, New Jersey 07960 P. R. Ginnings, Goodyear Tire & Rubber Co., Research Div., 142 Goodyear Blvd., Akron, Ohio 44316 S. F. Goodheart, Levey Div., Cities Service Co., 630 Glendale-Milford Rd., Cincinnati, Ohio 45215 Earl C. Haag, Jr., Mobay Chemical Co., Penn Lincoln Parkway W., Pittsburgh, Pennsylvania 15205 Richard H. Baas, The Goodyear Tire & Rubber Co., 1144 East Market St., Akron, Ohio 44316 Robert M. Hagins, Mobay Chemical Co., Penn Lincoln Parkway W., Pittsburgh, Pennsylvania 15205 Jerome H. Heckman, SPI General Counsel, Keller & Heckman, 1712 N St., N.W., Washington, D. C. 20036 Karl A. Eochs-.hwenrfer, American Hoechst Corp., P. 0. Box 2500, Somerville, New Jersey C8876 Thomas J. Kvghes, Keller a Heckman, 1712 N St., N.W., Washington, D. C. 20036 George W. lag’.i, Kcnsacto Co., 1101 17 St., N.W., Washington, D. C. 20036 John F. Jor.er, The Strndarc Oil Co. (SOHIO), Midland dicg-, Cleveland, Ohio 4411- James R. S. ¥. ■.'"artaey. Standard Packaging Corp., Ill Prospect St., Stamford, 06904 Gordon L. '.Iclntyre, Cities Service Co., Drawer #4, Cranbury. New Jersey Kenneth Mc-gareidge, Food & Drug Research Laboratories, Inc., Meurice Ave. & 58 st., Maspeth, New York 11378 Peter Morison, Eastman Chemical Products, Inc., Chemical Sales Div. & lieu lice 1 Service, Kingsport, Tennessee 37362 Francis d. llaiolsk:!, American Cyanamid Co., Building #3, Bound Brook, New Jersey CS305 James N. O’ Connor, The Dow Chemical Co., Legal Dept., 47 Bldg., Midland, Michigan 48640 B. Newell Olson, Reynolds Metals Co., Tenth & Byrd Sts., Richmond, Virginia 232;9 I. Frank rcake, E, I. du Pont de Nemours & Co., Inc., Film Dept., 1007 Market Sc., Wilmington, Delaware 19898 10 O' ^ OJ ro 03 W BFG61446 ASI 00000794 - J - Robert E. Rutherford, Gulf Oil Carp., 439 Seventh Av«.. Pi'-tsburah, Pennsylvania 15230 E. H. Schaeffer, Shell Chemical Co., 2525 Itirworth Or., Houston, Texas 77025 A. Merrill Schnitzer, Phillips Petroleum Co., Research and Development Dept., 356 Chemical Laboratories, Bartlesville, Oklahoma 74003 William W. Sederlund, National Starch & Chemical Corn., 1700 W. Front 3t., Plainfield, New Jersey 07470 C. Boyd Shaffer, American Cyanamia Co., Berdan Ave., Wayne, New Jersey 07470 Marc K. Shaye, Keller & Heckman, 1712 N St., N.W., Washington, D. C. 20036 Arthur W. Sheldon, M & T Chemicals, Inc., Woodbrldge and Randolph Aves., Rahway, New Jersey 07067 Anthony C. Signore, Monsanto Co., Packaging Div., Box 1019, Hartford, Connecticut 06100 Matthew E. Smith, Owens-Illinois, Plastics Products Div., 14th & Adams Sts., Toledo, Ohio 43624 Charles J. Spiegl, Continental Can Co., Inc., 7622 South Racine Ave., Chicago, Illinois 60620 M. C. Stone, Eastman Chemical Products, Inc., P. 0. Box 431, Kingsport, Tennessee 37662 Donald F. Thompson, AviSun Corp., R & D Div., Post Rd., Marcus Kook, Pennsyl­ vania 19061 Harry S. Turpack, Diamond Shamrock Corp., ?. 0. Box 191, Painesville, Ohio 44077 Philip J. Vanderhorst, E. I. du Pont de Nemours & Co., Inc., 1007 Market St., Wilmington, Delaware 19898 Edward J. Vendermark, Northern Petrochemical Co., 2223 Dodge St., Omaha, Nebraska 68102 Harold Warp, Flex-O-Glass, Inc., 1100 N. Cicero Ave., Chicago, Illinois 60611 Willard M. Weetvaer, The Dow Chemical Co., Quality Assurance, Dow Center, 2040 Bldg., Midland, Michigan 48640 George F. White, Jr., Reynolds Metals, Co., Tenth & Byrd Sts., Richmond, Virginia 23219 Heinrich Wirth, BASF Corp., Central Ave., South Kearny, New Jersey David L. Wolfe, U.S. Industrial Chemicals Co., Polymer Service Laboratories, Tuscola, Illinois 61953 Einar T. Wulfsberg, American Paper Institute, 1835 K St., N.W., Washington, D. C. 20006 Leo W. Ziemlak, Foster-Grant Co., Inc., Research & Development, 289 N. Main St., Leominster, Massachusetts 01453 Charles L. Condit, Secretary. SPI, 250 Park Ave., New York, New York 10017 Under the direction of General Chairman Robert M. Miller, Hercules, Inc., a full meeting of the SPI Food, Drug and Cosmetic Packaging Materials Com­ mittee convened in the Shoreham Hotel, Washington, D. C., on February 26, 1970, at 9:40 a.m. ASI 00000795 BFG61447 1 - R - Association., who presented the following formal report: ’*Tne June 19, 1969 report u£ this committee indicated that the methodology for testing polyolefin containers would be published in the next edition (XIII) of the National Formulary but would be limited to ophthalmic pro* ducts only. Ihis is proceeding on schedule. "Ur. Elmer 0. Krueger of the National Formulary Board and also of Abbott Laboratories contacted me last month with regard to the inclusion of a method for measuring lighc transmission. Although our group had recossreaded that this test be omitted from any write-up on the basis of unreproducible results obtained in our round-robin study, none-theless it was now proposed that the original method be resur­ rected. "Our committee was circulated and a brief statement was prepared describing the problem or measuring scattered light transmitted through translucent plastics with- a reference to ASIM-D-1003-61 and ASIM-D-7S1-61T end the socalled 'light integrating sphere.' Mr. Krueger was con­ vinced of the inadvisability of publishing the original method and our statement will be substituted in the pub­ lished procedures. "The June 1969 report also indicated that a proposal would be prepared covering the regulation of polyolefin containers for dry pharmaceuticals. A task group met in Detroit last August and prepared a draft of such a proposal which then vent through one revision by mail. Several ques­ tions were raised which necessitated another meeting of the task group which was held yesterday in Washington and which resulted in another draft. It is hoped that this draft can be circulated to the FD & C Packaging Materials Committee of the Society as a separate mailing in the near future. W. 5. Acfcart" Coasnenting ou che objective of the joint effort between the PMA and the SPI, Mr. Miller said that essentially it is one of starting out with the polyole­ fins and developing methodology for their use in packaging dry drug products; that following completion of this first phase of methodology, the PMA would be asked to approve its content and then consideration would be given to giving it to FDA for its consideration. £ CO tv O) BFG61448 ASI 00000796 15 - The ultimate objective of this entire program is to attempt to convince the Food and Drug Administration to include ir. Section 13C.9 o*1 the Drug Regu­ lations a provision which would make it permissible for drug companies to substitute one plastic bottle, or other container, for another provided that the materials used in manufacturing the bottle could be said tc be essentially equivalent when they are tested by the prescribed methodology. This cause would, of course, be materially aided if the test methodology and limits included in the draft SPI report could be cade the subject ox a National Formulary or U.G. Pharmacopoeia coverage. It it hoped tr.ar the Pharmaceutical Manufacturers Association might find the proposal suitable for such inclusion in its official publications and that the Food and Drug Administration might then be in a receptive frame of mica to cunead Section 130.9 so that substitutions of containers night be more readily made. The Liaison Conmiittee's draft report spells out the objectives, as well as the methodology and limits, in great detail so all members of the lull Com­ mittee will be fully informed about the natter when the draft if. circulated in the next few weeks. SPI Food and Drug Bottling Committee of the Plastic Bottle Division Chairman Miller next called upon M. E. Smith, Owens-Illinois, to deliver his regular report. Mr. Smith reported as follows: "The Sottle Division committee has met 'three times since our last June 19 meeting. Of interest to the Food, Drug and Cosmetic Packaging. Materials Conmtitcee would be: **Food Bottle Seminar: The Plastic Bottle Division is conducting a seminar on food bottling at the Hotel Commodore, Mew York, on March 18, 1970. From all indica­ tions there should be about 350 people in attendance. "SPI - MSDI: The task group of the bottling com­ mittee working with the Mayonnaise Salad Dressing Insti­ tute members have distributed over 13,500 containers for a round-robin testing of spoonable and pourable dressings in PYC bottles. Because of the number of containers required the initial testing is limited to PYC. A.11 coucaitv'-rs have been coded and identified only as octyl tin or cal­ cium sine stabilized PYC. Containers will be stored and tested over a six month period. Bather than go into the details of the tests here I suggest if anyone wants to know about the program, he should let me know and I’ll go over the whole program with him. ASI 00000797 EFG61449 1 - 16 "U.S. Public Health Service; The U.S. Public Health Service has published its third edition of its list of single service milk containers manufacturing plants that have been certified as meeting the USPHS sanitary guide­ lines. A new listing will be published again in January in which over 50 plants should be listed. "PMA Seminar: At cur last meeting we discussed plans for a two day seminar with the pharmaceutical people in the Hew York, New Jersey, and Philadelphia area. Hcpelullv vs will be better able to learn more of their problems at they switch to plastic packaging and at the same time give them better knowledge of plastics and what they can do tor them. No date has been set." American Paper Institute James S. S. McCartney delivered a formal report on the activities of the American Paper Institute of interest to the overall SPI Committee with special emphasis in his report on visitations the previous day with officials of the USDA. Mr. McCartney's report fellows: "A meeting of the API's Biological and Chemical Research Committee was held on February 17, 1970. Tils Committee is the API's counterpart to our SPI Food, Drug and Cosmetic Packaging Materials Committee in that it historically has been concerned with Federal regulations applicable to paper packaging materials. The agenda of the meeting contained several items of mutual interest to the API and SPI. These items have already been covered by Jerry Heckman in his usual thorough manner so there is not much to be added. "1. The reorganization of the FDA and what this is going to mean. The API will use all the contacts at its disposal to gain insight into the reorganization of the FDA, who is involved, what they are like and so on. Until things have settled down, little hope is seen for any con­ structive policy action. "2. The status of the GRAS list for food additives. The present review by the National Academy of Science of the GRAS list of food additives is limited to *.*5 Nk ' ' c/: o CO :■' U! BFG61450 ASI 00000798 17 dir esc t food additives and toe to indirect food additives. Therefore, it does not appear that this review will affect paper food packaging materials. "3. The USDA'a proposed regulations. The API prepared and filed conments on the proposed DSDA. regulations in Decernher. Specific proposals were offered for the sections on packaging materials and labeling. As a follow-up to the API* s action a meeting was held with Hr. John Sloan on February 25th attended by liner Wulfsberg, Paul Cundy and myself. "It is doubtful that Mr. Sloan had seen, the API's proposals and so a copy waa left with him. Mr. Sloan was very pleasant and had same interesting things to say: "(a) The DSDA will use the same procedure as in the past in the clearance of packaging materials. "(b) They are very interested in inks and adhesives and wish to know the specific ones being used. "(c) They do not accept the barrier theory because they do not know what a 'barrier' is. Any information on this subject would be most welcome. "(d) The USDA and FDA do not always see eye to eye on things and do not always use the same terminology. The FDA lists tinder the regulations on components of paper and paperboard items such as anti­ foam agents. The DSDA thinks of com­ ponents as films, board, etc., arc con­ siders such things as antifoam agents to be 'ingredients.' Thus when they request information on components in food packaging materials they are talking about the film or board as a whole and not all the items going into it. ASI 00000799 BFG61451 18 ”(e> The revised version for meat packaging materials will probably appear first in the proposed poultry regulations which should appear in the near future. One therefore, say get a preview of the packaging portion of the proposed meat regula­ tion in the poultry regulations. James R. S. McCartney” Can Manufacturers Institute Charles J. Spiegl, speaking on behalf of the Can. Manufacturers Institute, noted that all of the items and problems covered by the previous reports at Che day's session were of interest and concern to the Can Manufacturers Institute but that he had nothing to add to the information already provided. Report of Technical Information Subcommittee Willard M. Westveer, The Dow Chemical Company, and chairman of the Technical Information Subcommittee, touched on two main items at the day's session, noting first that his Subcommittee, or more properly tns Figments Task FoTce appointed by the Subcommittee, has been concerned for some four or five years now with developing appropriate methodology for determining whether or not specified colorants migrate from plastic packaging materials. Mr. westveer reminded everyone about the in-depth studies conducted by the Pigments Task Force, headed by Arnold Finestone, formerly of Foster-Grant Company, Inc. This work involved round-robin testing and an analytical study of extracted materials. Mr. Westveer reported that, at present, the technical information developed by the colorants task force has been reviewed by several members of the Connietee. George W. Ingle, in particular, has been reviewing the data to try to ascertain what further work, if any, needs to be done before it can be assembled in some sort of compilation suitable for study by the overall Committee, and the making of a decision as to what more can be done with it. It is believed that Mr. Ingle will be in a position to make specific recommendations for further evaluation of the data, and perhaps be able to present a documented report for the overall Committee to review at its next meeting on June 10 in Washington, D. C. It was noted by Mr. Westveer, at the time of the next meeting, Mr. Ingle will advise the overall Committee whether, in his opinion, more work such as perhaps further round-robin testing activity will be necessary to carry this study to a successful con­ clusion. I*. >,*! ^« o (?) K Gj IT. BFG61452 ASI 00000800 19 Mr. Wescveer then noted Chat, by custom, the chairman, of the Technical Information Subcommittee prepares for incorporation in the minutes of each overall Committee meeting a review of recently issued Tcod Additives regu­ lations deemed to be of interest. He then provided the Secretary with a document dated February 20, 1970, summarizing recently issued Food Additive Regulations of interest which have appeared in the Federal Register. (Please note: Attached hereto as Exhibit Westveer dated February 20, 1970.) C is the report prepared by Mr. In closing his discussion, Mr. Westveer noted that the Steering Committee has made some recommendations to him for improving the regular listing of recently issued regulations. Thus, in the future the reports will indicate the Federal Register citations for each regulation, and will include other clarifications as suggested. Report of Lawyers Advisory Caww* Chairman Miller called upon Vice Chairman Taylor W. Hanavan, E. I. du Pont de Nemours & Company, Inc., and present chairman of the Lawyers Advisory Committee, to discuss the legislative outlook, recent court decisions which it is felt should be brought to the attention of the Committee, and other matters. Mr. Hanavan delivered the following report: '*The bulk of this report with respect to pending or possible legislative activity consists primarily of a follow-up on various legislative possibilities reviewed at the last meeting of this committee. "The 'Child Protection and Toy Safety Act of 1969' noted as pending was passed by Congress, approved by the President on November 6, 1969, and went into effect early in January of 1970. This law amends the Federal Hazardous Substances Act by extending its coverages to toys or other articles intended for use by children which the Secretary by regulation determines present an electrical, mechanical, or thermal hazard. "This legislation also contained several 'housekeeping* amendments to the Federal Hazardous Substances Act, one of which would seem to impose a new labeling burden for certain products subject to the Act. Section 2(p)(l)(E) was amended to insert the word 'combustible' after the word 'flammable.' As a result, there may be a need of a front panel declaration 'combustible' as a statement of hazard which heretofore could be placed on the ASI 00000801 BFG61453 3 - 20 - back panel for products falling within the regulatory standard for combustibles. "You may recall at the last meeting we reviewed certain then pending bills cn occupational health and safety require­ ments. We noted that an anticipated administration bill had not yet been introduced, but it was expected to propose some sort of national occupational safety and heAlth board which would promulgate employee standards of safety and health. The Department of Labor would have a veto power over any proposed standard, but this veto could be overruled by the board in subsequent action by a majority vote of its five members. The administration proposed Senate Bill 2738 i.Jsvits) scc i'ouse Bill 13373 (Ayers); the House counterpart, has since been introduced in both houses. The Javits bill was referred to the Labor Subcommittee of the Senate Labor and /'ublic Welfare Committee and no hearings have as yet been scheduled. The Ayers Bill was referred to the Select Subcommittee on Labor of the House Education and Labor Committee. Hearings were held and the hearings were inconclusive. The administration bills as proposed not only gave the Secretary of Labov. a right to object to proposed safety standards subject to being overruled by a majority vote of the board, but also gave a similar objection right to the Department of Health, Education and Welfare on health questions. As a result of problems raised at the House hearings, a new administration proposal is expected. "Bearings were held on October 1 and 2 in connection with S-2162 (H.R. 6180), the Safe Packaging Act under which it vas proposed to give the Secretary of HEW the authority co set standards for safety closures of packaged products subject to Che Federal Hazardous Substances Act. The testimony covered the following: "1. No package is absolutely child-proof due to their curiosity and determination. Manufacturers of drugs and household chemicals should not be expected to do a parent job in protecting the child. “2. Imposing specific closure requirements would undermine innovation by industry cn developing newer and still better con­ tainers. n3. Legislation seems premature and should be held up until industry and independent researchers can make a thorough investiga­ tion of this problem. o GJ *0 05 BFG61454 •si ASI 00000802 1 - _1 - "Senator Moss has cade it clear that some sort of legislation will be enacted and compromise legislation is in the mill, chough nothing has as yet been introduced. "The recent decision in Robert L« Ackerlv v. Herbert L. Lev. Jr. should be of interest. This was an action brought by Mr. Ackerly to compel FDA under the 'Freedom of Information Act' to disclose records in the possession of the Commissioner which related to the degree or nature of carbon tetrachloride hazards which the FDA Commissioner in a Federal Regisc.r notice of February 16, 1968 proposed to bar from interstate caonsrce es a 'banned hazardous substance' within the purview cf the Federal Hazardous Substances Act. The United States Ccurt of Appeals for the District of Columbia was highly critics! of FDA's response to Mr. Ackerly’s initial request for documents and FDA's conduct thereafter. Ackerly's request wes cade by a letter dated March 6, 1968. FDA promptly replied with a list of material chat had already been published and turned down Mr. Ackerly's request as otherwise too broad. On appeal cs FDA's Information Review Officer, three additional memoranda were supplied but access to any other document was denied. These three documents were supplied to Acker ly on April 3, 1963, some two weeks after FDA's Federal P.egister deadline of March 16 for comments on FDA's proposal to ban carbon tetrachloride. On AnriI 22, at a cre-heaiing conference the FDA made available three additional documents. 'The Circuit Court made two pertinent comments with respect to FDA's handling of the situation. 'Ve are not im­ pressed with the timing in terms of the agency's responsiveness to the Congressional purposes evident in both the Freedom of Information Act and the statutory procedural scheme tor rule making by the Agency embodied in the Federal Focd, Drug and Cosmetics Act.' The Court also stated 'Ve confess to a consid­ erable lack of eathusiam for the caliber ox the Coimissior.cr’ s performance in this seemingly erratic discharge of his respon­ sibilities under the Freedom of Information Act.1 ''At the last meeting, we reviewed in considerable detail the implications of the U.S. Supreme Court's D-'fco decision (37 Law Week 4382) which, when coupled with its previous AMP decision, extended Che present definition of drugs in Section 201(g) of the Act to include & nylon ligature device and a diagnostic aid known as an antibiotic sensitivity disc. As a result, there was some question at that time concerning the extent to which FDA might attempt to bring within the statutory definition of drug by farther litigation or by regulation other ASI 00000803 BFG61455 21 therapeutic devices and diagnostic aids and require pre-market approval as to their safety and efficacy just as with new drug.'.. The former '-oxmissionar of FDA, Dr. Ley, has publicly stated that FDA. has neither the funds nor Che manpower to follow-up the Difco and AMP decisions in this manner and to my knowledge FDA has not done so. However, we believe there is still another reason for FDA.' s unwillingness to capitalize on the scope of the Difco and AMP decisions. We understand that the administration is preparing a new device control bill which would require, at least with respect to new devices, FDA prior approval as to safety and efficacy before any marketing of same. Any effort to extend the Difco and AM? decisions into the device field might well prejudice the success of this type of legislation. We believe It would be safe to conclude that FDA will iova very slowly in this area at least until there is substantial evidence Chat Congress will noc enact the kind of device legislation that the administration apparently will offer." International Developments The Chairman next called upon Thomas J. Hughes, Keller and Reckrtsc, to report on latest developments abroad which have been brought to the Committee's attention. The Chairman reminded everyone that, although SPI cannot assume any direct responsibility to deal with regulatory matters In Europe and else­ where, it was recognized some time ego that it would he valuable to the Committee to be kept generally aware of what is going on overseas it the food and drug regulatory area. Thomas J. Hughes then delivered the following report: "Gentlemen: "I am glad to have this opportunity to report to you once again on the latest developments with regard to International regulations on food packaging materials, as w* have gleanc-.c: the same from a wide variety of sources. "During the course of my report, 1 would invite those of you who have any additional information with regard to a particu­ lar country or countries to interject and contribute to the general discussion. It is largely in this way that we have, over the years, been able to develop a good deal of pertinent information to fill at least some of the gaps in our mutual knowledge of what is happening overseas. ££ f O CO r>3 GO GD BFG61456 ASI 0000080* 23 ''UNITED KINGDOM "As you will note from your respective copies of the agenda for today's meeting, the first topic for my report is a discussion of the effort and objectives of the British Plastics Federation as evidenced by its draft document entitled | 'Plastics for Food Contact Applications—A Code of Practice for I Safety in Use.' Those of you who were at the last Committee meeting in June will recall our advising that the BPF Code had been submitted to the British Ministry of Agriculture, Fisheries and Food's Food Additives and Contaminants Committee in the hope that the FACC would adopt the same as an acceptaole methoa of 'industry self-regulation.’ “The BPF Code of Practice was made available for purchase last October, and our good friend, Trevor Veils, was kind enough to send us a complimentary copy. The Code is available for pur­ chase from the British Elastics Federation, 47 Piccadilly, London WI7 ODN, England. The price of the Code is 20 pounds in British I currency, approximately $43.00 in American currency. "Briefly, the Code sets forth the basic principles used in assessing the safety of plastics for food contact applications; reconmendations for additives, including 170 trade names and over 90 additional chemical names of additives showing quantities which nay be added to plastics for use in contact with food; and guidelines for extraction testing. Additionally, the Code includes a section on polymer specifications, covering these polymers commonly used in the packaging of foodstuffs. "The latest information we have is that the anticipated Food Additives and Contaminants Committee Report on the 'problem of the "leaching" of packaging chemicals into food1 has not. as yet, been officially issued. It is now expected that the FACC Report will be issued in the very near future and it is hoped that it will refrain from recommending the adoption of any detailed legislation on the subject of food packaging by the British Government and will, instead, recommend that packaging industries adhere to 'Codes of Practice' such as the one that has,now been published by the British Plastics Federation. "NETHERLANDS "Turning next to the current status of the third version of the Dutch 'Draft Packaging and Food Utensils Regulation,' to the best of our knowledge, the period for comment; on the sain body of the Draft expired last July, and the Draft now has what amounts to 'official' status in the Netherlands. ASI 00000805 24 "I am sure you will be interested to know that the Dutch Ministry of Social Affairs and Public Health has, during the past six months, published several additional 'schedules' to be appended to the subject Draft. The first, and perhacs most significant of these schedules, as far ss your Committee is concerned, listed specifications for acceptable plascic materials and antioxidants with a comment deadline date which expired on December 31, 1969. A schedule of 'paper materials' was issued at the same time. The most recent schedule contains specifications and test methods for use m determining the acceptability of eciorancs and pigments for plastic feed con­ tact materials. "We are advised that an 'official* comment deadline date of December 31, 1969 was also set for the colorants schedule. However, we have recently learned that the Dutch Government is still accepting comments on this subject. 'To summarize the Dutch situation, the Ministry of Social Affairs and Public Health continues to promulgate 'schedules' amending the original 'Draft Packaging and Food Utensils Regu­ lation. ' It is our understanding chat the Draft and several of the schedules appended thereto are now accorded what amounts to quasi-official status in the Netherlands even though no formal Notice has been given to this effect. ,!Ir anyone else on the Committee has additional informa­ tion. on the Dutch situation, we would appreciate hearing from you. "CODEX ALSnNTAEIUS CGMMIfGTON ACTIVITIES "From time to time we have reported to you on the status ot the Codex Alimencarius Commission activities. We became particularly interested in closely following tie Commission's efforts after a recocanendation was made, in the latter part of 1966, to the Commission by the Danish government calling for che Commission to give ’high priority. . . to tv.e problem oi the migration of chemicals Into food.' "The Commission, which is an arm of the FAC/T" 0 Codex Food Additive Constattee, end which is composed cf delegates from the governments participating in the FAO work, has estab­ lished a number of Committees to deal with various problems as they relate to foods, pesticides, labeling, and standards, etc For example, the following representative Coracittees are pres­ ently in the process of compiling reports for t'-e Commission: r. t-i C ' tw BFG61458 ASI 0000080 25 (1) the Food Hygiene Committee, (2) the Committee on Pesticide Residues, (3) the Codex Committee on Fats and Oils, and (4) the Coaaittee on Food Labeling, to name a feu. "As far as the direct interest of this Committee is con­ cerned, as ve reported at the last Committee meeting, the Commission has given 'low priority* to the problem of incidental additives, (i.e., food packaging materials), and has, as yet, done nothing at all with the recommendations made by the Danish government in 1966. "Our latest information is that, at the sixth session of the Codex Committee, held in the Netherlands from the 15th through eke 22nd of last October, the subject of 'packaging materials' was listed for consideration 'after 1971.' "OTHER MATTERS OF INTEREST "(1) EEC--Negotiations continue in the EEC on the subject cf food packaging and, now that the Dutch regulations have taken on a more 'official' status, it is anticipated that-the EEC will follow suit and, in due course, will adopt 'directives' very similar to those promulgated by the Dutch. "(2) We have also been advised that the West German Federal Health Office has prepared the first draft of a new 'German Food Law’ which will distinguish between 'direct' and 'indirect' food additives. The draft was apparently prepared several months ago, but we have not, as yet, been able to obtain a copy. 7£ anyone on the Committee has more information on the situation in Vest Germany, we would certainly appreciate hearing from him. "(3) One final point of interest to the Committee concerns the availability of several volumes of a work entitled 'Fundamental Principles and Objectives of Comparative Food Law.' The volumes, four of which are now available, have been prepared by Professor E. J. Bigwood, of the Dniversite Libre de Bruxelles, aod are an outstanding series on the principles of food law in many countries, including law and policies dealing with the subject of food packaging materials. Copies may be ordered by writing to the American agent appointed to handle the sale of the booits in this country. His name and address are as fallows: Mr. Albert J. Phiebig Box 352, White Plains, New York 10602 "Thank you." ASI 00000807 BFG61459 26 Chairman Miller commenced on che desirability of che Committee's members maintaining close liaison vith European countries such as che Dutch, English, and so forth. To emphasize the value of this he quoted parts of a communication he received from Dr. J. H. de Wilde dated January 15, 1970, in which Dr. de Wilde said: ’’Dear Bob, "Reverting to the large number of cases in which you have supplied information to the Dutch Food Law Committees, in particular for consideration by the Packaging Subcommittee and by the Preview Committee 'G4', I would like to use the opportunity of starting a new year, to thank you very much for your coopera* tion. Representing industry on several of these com­ mittees it helps tremendously when industry provides the facts and data on which a sensible legislation can be based. "Most of the Dutch officials know and admit that they do not have the technological experience and knowledge of facts to make the right decisions. When political pressure calls for regulations and industry is given the opportunity to supply basic data, lacking to do so will promote unnecessarily stringent regula­ tions. Avoiding this is in the interest of all of us aad it is Cor this reason that I am very pleased with your cooperation which I hope will coutinue." Other Business Chairman Miller then asked if there were any new business or other points of interest to be discussed. By way of reminder, he pointed out that the next meeting ot the Committee is, according to the Bylaws, the annuaL meeting and that, in even years, there is to be an election of officers. He then appointed the following Nominating Committee to develop a slate of proposed officers, i.e., a Chairman and Vice Chairman, to serve che Committee for the two years beginning June 1, 1970: Chairman: Paul F. Cundy, American Can Company George W. Ferner, The Goodyear Tire and Rubber Company Robert E. Rutherford, Gulf Oil Corporation The slate of officers, when prepared and forwarded to the Secretary by che Nominating Committee, will be circulated to Che membership at least thirty days prior to the next meeting. The election will then be held at the next meeting as prescribed in the Bylaws. BFG61460 ASI 000008C - 27 - Next Meeting Chairman Miller said that the next meeting of the overall Committee will be held oa Wednesday, June IQ, at the Mayflower Hotel, Washington, j. C. X X X The session then adjourned in order to attend a reception and luncheon mth Major General Fred J. Deimore,.Coordinator for Industry Relations, FT'A: Mr. Lessel L. Ramsey, Assistant Director for Regulations, Offica of CompLia-ce. Bureau of Foods, Pesticides and Product Safety, FDA; Mr. Alan Spihei, Food and Drug officer. Division of Regulations and Petitions -onerel. Office of Compliance, 3ureau of Foods, Pesticides and Product dafecy, FDA; and Mr. Herbert T. Behrens, Office of Marketed Drugs, Bureau of Drugs, FAA; to be followed, as pointed out in tha Secretary's Meeting Announcement, by an informal discussion with the officials. Immediately following luncheon. Chairman Miller ceiled “he group to oraar once more and introduced the aforementioned Food and Drug Administration staff members. The session with the FDA officials was, in general, quite informal. Brief reports were heard from Mr. Ramsey who discussed the organizational changes made at the Food and Drug Administration in the wake of the appointment of Commissioner Edwards. For the most part, Mr. Ramsey confirmed and restated the information given the Committee in Mr. Heckman's earlier remarks during the morning's business session. In addition, however, he noted that a complete "Statement of Organization, Functions, ana Delegations of Authority*' could be found in the February 25, 1970, Federal Register which, of course, would have been received by subscribers to the Register on the day of the i meeting. Mr. Ramsey did discuss the status of the proposal to amend Section 121.2500 of the Food Additive Regulations, but did so rather apologetically, noting that he had no definitive statement to make because FDA. is presently attempt­ ing to settle down tinder its new leadership and organization sc that nothing tangible could be reported about the prospects for adoption of some form of the proposal. To the further disappointment of many of the Committee members, Mr. Ramseys seemed to indicate chat, vkac with the cyclamaces problem having developed, and the frenzy of activity following it, it might be tome time before FDA does take action cn the proposal. Indeed, at me point, he termed it of "relatively low priority" in the overall scheme of FDA’s present concerns. After Mr. Ramsey's presentation. Chairman Miller t’ev introduced Mr. Alan Spiher who talked tc the Committee about his attempts to bring about some solution to the "colorants in packaging materials'1 -egulctory problem. ASI 00000809 BFG61461 - 28 - Mr. Esther's renarks were taped, as were his responses to various questions from che floor. The vetbetia transcription of Mr. ipiher's remarks follows: "As w®. have been in che recent past, and in the less recent past, and with relation to the proposal we did gee issued in the Federal Register in August of 1967 fer paper and paperboard, as 1 told Jerry and have toll some of the others of you, we're working on and trying to issue a similar regulation for colorants for plastics. There are considerable differences in the problems involved as we work on these things, i.e. between paper am paperboard, and the plastics. Sue I might discuss briefly some of the tilings that developed cn the paper and paperboard to get to the colorants that you are more interested la. "But there is, and I hope I won't be stealing the march here from the next person—About the SOCMA petition, as you know, we've had this around for some time, and based on. chat and other things, we did issue the proposal on paper and paperboard. It was our understanding at the beginning of this whole series of events which started in 1961, that when you're talking about paper—I can't trace this down—chat anytime you have a liquid in contact with che paper, there was generally a functional barrier of some sort between the paper and the liquid. 5o this was in the background of che way in which we drafted the proposed regulation which, if any of you have looked at it recently, limits the emouat of drainable weight in the food that is iu contact with the permissible paper and paperboard. We received then, a comment --couched then as an objection, of course, but simply a com­ ment from our standpoint, because the particular .regulation was in proposal stage—and they said 'you've done us wrong here, because you've cut out all of che types of paper cups— this kind of container that we use for liquids.' And it went on to talk a little bit more about this problem. Well, now this was from 1961 to 1966 or '67, we were laboring apparently, under a misapprehension that we didn't have to worry about things like chat because it would be taken care of by the tests proposed. "My purpose in mentioning this is simply to illustrate the fact chat we do have some problems with consaunic.ations and we have some problems in the same way, I believe, with_the plastic area because we are not getting che requests /_?etitionsT that we had hoped we would have for the various colorants that you might be wanting to use. For about eight or ni le colorants that were on the last extension list—and I'm sure ^„ *"J „ & C-0 w BFG61462 M ASI 00000810 29 there are sore colorar.cs being used than are on that list— we did have some petitions in for a few colors :.r. plastic materials, and we had published the Notice of Filing of these. Then at long last we learned that the hone fer the modification of the sandwich test for testing colored plastics probably would not work, so we had to advice the petitioners of this, and we suggested another analytical method that thev (tight try out and use. This is now two years ago at least, and we have not as yet received anything from them, including the requested samples of colored plastics which we had requested from these three or four firms, so that we could cry out the analytical method we were proposing. "Ivhat I am trying to do at the present time is to develop a regulation which will be entitled 'Colorants and Fiaofi.es' and 1 will intend tc pick up all the colorants that are listed in the various regulations and bring them out into a single regulation, noc making any particular changes ia the thing. I will explain this in a moment or two. I would bring this into a single, particular regulation to which we can all refer when we are concerned primarily with colorants. In other words, I have colorant X. I want to know what, under the Federal Food, Drug and Cosmetic Act, can I put this in. Hopefully, then, this will point out to many of you thac we really do not have data on very many colorants that are suitable for plastics. And hopefully, this will show you that we need petitions from you in which you will advise us of your colorants thac need to be recognized by regulation. "Now, the idea sounds simple to do this, but when you cry to work it out practically with people, it's somewhat more of a problem. Some of the colorants are simple suostsnees, and the suggestion was made that we should, instead of simply listing the specific plastic substrates fox which these colorants were approved—we should say that you can use these simple coiorants in all plastics. But the, after proceeding in this fashion, we then find out that others have some concern in a few instances about some of the substances, and their possible toxicity and different extraction rates about which we have, really, no hard dnta. If you put them into on? substrate that we've already looked at, into another substrate, o.*i so on— and so at the moment I have a 'no' on that procedure that we had up to that point. lo I have to come back end start over again to try to come out with this type of regulation. But ny purpose, again, in mentioning this is thac we need more com­ munication as to the colorants which are being used in the various plastics materials, and which may be reasonably expected to migrate and hence, by definition at the present time, are food additives." ASI 00000811 BFG61463 30 - t_In response to various questions posed, Mr. Fpi'r.er had the following additional comments^/ "QUESTION: Mho is going to handle direct additives and indirect additives and who will inherit this color thing, since you have been moved up? ANSWER: This is one of the problems—I'm going to be stuck doing that, along with everything else. So—aul the rest or them, our personnel, has not changed. So they would be essentially the same people at you've talked to before—as of the present time. QUESTION: In connection with the use of colorants in plastics, do you have any change—do you have any guidelines to offer us in connection with extraction methods we can rely on, telling us that ve do or don't have a migration problem? For example, if you don't see the color getting into the food, is it therefore not an additive? ANSWER: This is the basic problem that became evident when we analyzed some of the data that showed up in the substances, or In the tests for the use of visual checking. The 'sandwich test' or the modification of the 'sandwich test,' where you would take a piece of colored plastic and squeeze it between some absorbent material with a solvent there, and then look at the paper. There is some very good wrrk done by one of the petitioners on a, I think it was a cadmium sulphide containing color, and ic passed the sandwich test. Sut they made the mistake or--I won't say that, ihey did a good job on it—they rook the colorless material that came through and ran it for cadmium, and found that I think it was up to 2,000 ppb. of cadmium came through. Tc became quite evident—on che basis of things like this, and other things—that we might be concerned about that which was coming through that we would not detect by the visual tests. So what we suggested then—and gave them the proposed analytical method—and we'll be glad to furnish this to anybody that wants it—was to cut up stripe of it and extract it, and even­ tually test it in some kind of extraction call, and then te«t the material that came out for the total extractives, and then run some kind of confirmatory test—and this was, of course, what we could not JO c.-; c v KCa w N BFG61464 ASI 00000812 32 provide for them, out we suggested they run seme kind of confirmatory test to see what was the actual make-up of the material chat came through. Assuming that there would be a suitable spectrophotomerric or even a spot test, as was used in the cese of the cadmium to determine some key part of it, whether or not it actually extracts through. I think this would be a suitable one for any plastic product. And if you can give us an idea of the sensitivity of die method used, of course, that would be sort of essen­ tial. QUESTION: Taking a number at random, suppose we don't see any concentration at 50 ppb, and it has no—like suppose it is an organic material that has no adverse known toxicity. Is this a food additive? ANSWER: You're not going to get me—-I will tell you this—in my opinion it is a food additive. This is my opinion. The reason I say that is, and Jerry here and I have these arguments all the time, that this—the way in which Congress worded the law, 'may reasonably be expected to become' is the point at which you deter­ mine whether it is a food additive or not, not after you have run an experiment. Because y«u ran the experiment because you had some reasonable expectat'or. that it might migrate. HECKMAN: /To the audience7 QUESTION: We axe one of the companies that received your sug­ gestions for testing but we have not submitted more data because we have been awaiting some action on the 'Ramsey proposal' since this could have an important bearing on everything. But if its bogged down, I suppose we should consider doing something mere on this— ANSWER: That's what we finally came to the conclusion, because the proposal seems to be, no telling when there will be some action." I'm glad you heard it directly' Finally, Major General Fred J. Delmore spoke to the group emphasizing his personal interest in seeing the lines of comunicstions between industry and the government expanded and strengthened. The thrust or General Delmore’s remarks were devoted to the subject of "government-industry" cooperation and chose present were urged to "speak out" on matters of concern to the plastics ASI 00000813 BFG61465 - 32 food packaging industry. "Unless FDA hears from industry on matters of concern," consented C-er.eral Delaore, "the Food and Drug Administration car. only surmise what the problems of industry are and what ;he most desirable and effective solutions so the problems might be." In closing. General Delmore praised SFI and the Committee for its continuing efforts to bring constructive reform to some of the problems surrounding the regulation of food packaging materials. Chairman Miller thanked the FDA representatives, on behalf of the Committee and expressed the hope that there would be many more opportunities in cl e future for such informal dialogue between the Food and Drug Administration and members of the plastics food packaging industry. There being no further business to come before the meeting, the same was adjourned at 3:15 p.m. Respectfully submitted, Charles L. Condit Secretary M C-: C' CO i'O CO BFG61466 ASI 00000814 ' ATI UlWii>CAM'