REC'D I.AW OFFICES Keileh md Heckman JOSEPH E KELLER JEROME H NOV 19 19G9 TELEPHONE 1713 N STREET. N W HECKMAN CHARLES M-MEEHAN WASHINGTON, !D. C- S0036 303 WILLIAM H. BOHOHESANI, JR. 396-3TOO CABLB AJ3DHESS "EELMAN ROBERT H.TIEHNaN WAYNE V. BLACK THOMAS J HTIOHES, JRDAVID L. HILL MARTIN W BERCOVICI No vein! e . ; 4 To All Members of The ill Ft.. d , Packag tog M ;; Dt.ug r; a Is .c;d Cosmetics Committee Gentlemen: The purpose oi tf j.s .ci ; : ; s co bring two matters to your attention si.ipis te :ause we believe they will be of gener.il interest to you. Firstly, we are enclosing herewith a copy of a paper entitled "The rood Additive Problem of Plastics Used In Food Packaging" given by Les Ram­ sey of the Food and Drug Administration at a Con­ ference of the Society of Plastics Engineers held in Dallas, Texas from November 4 through November 6. We were aware that Les was planning to give a talk at this meeting and requested a copy of his paper more than a month ago. His Secretary was good enough to supply us with one today, our understand­ ing being that the copies have just now been repro­ duced . We do not think you will find anything very new in Les' presentation. However, it might serve as a good status report for you. From our point of view, we were rather pleased no note the way in which Mr. Ramsey cited the work of the Society of the Plastics Industry, Inc in talking to another group. The second matter which we would like to call to your attention is the publication by the British Plastics Federation of a new document en­ titled "Plastics For Food Applications -- Code of Practice For Safety In Use." This publication will, for all practical purposes, supplant the previous BPF "Second Report Of The Toxicity Sub-Committee Of The Main Technical Committee; 1962; With Methods Of Analysis Of Representative Extractants." Further- ASI-PR 0000673 SPI Food, Drucr , and Cosmetics Pactacinn Materials Committee November 14, Page Two 1969 more, our contacts in England who have already been good enough to supply us with our cony of the new publication have indicated to us their hope that it will forestall any British push towards a regulatory scheme for incidental addi­ tives similar to that in effect in this country. Needless to say, we hope that this purpose wili be served. So that any of you who wish to do so can order a cony of the BPP ''Code of Practice", we are herewith enclosing (1) a copy of the let­ ter we received from the Federation on this sub­ ject, (2) a copy of the Brochure which came with the letter, and (3) a copy of the order blank form sent to us. matters, If you have any questions about these please do not hesitate to let us know. ASX-PR 0000674 THE FOOD ADDITIVE PROBLEM OF PLASTICS USED IN FOOD PACKAGING* by L. L. Ramsey Assistant Director for Regulatory Programs Bureau of Science Food and Drug Administration Consumer Protection and Environmental Health Service PHS, DHEW X welcome the opportunity here this afternoon to review with you some of the regulatory developments in the area of indirect food additives, which, of course, include the migratory substances from plastics used in food packaging. In response to industry's need we developed and Issued a document in August 1966 entitled "FDA Guidelines for Chemistry and Technology Requirements of Food Additive /Petitions." You are undoubtedly familiar with it. The purpose of this document was to elaborate and clarify the regulations with respect/ to the chemistry and technology data I / required for the clearance jot not only direct food additives but also / indirect food additives, the document. Itself, made it clear that it was not to be construed ai a regulation, that it set forth guidelines, not inflexible requirements. I In the Federal Register of August 8, 1967, FDA published a proposal i I to revise Its procedural regulations for food additive petitions. Quoting from this publication: *For preoentation at the National Technical Conference of the Society of Plastics Engineers, /November 4-6, 1969, Dallas, Texas* ** \ **. f * ■* t ASI-PR 0000675 . . I THE FOOD ADDITIVE PROBLEM OF PLASTICS USED IN FOOD PACKAGING* by L. L. Ramsey Assistant Director for Regulatory Programs Bureau of Science Food end Drug Administration Consumer Protection and Environmental Health Service FHSf DHEW I welcome the opportunity here this afternoon to review with you some of the regulatory developments in the area of Indirect food additives, which, of course. Include the migratory substances from plastics used In food packaging. In response to Industry's need we developed and Issued a document In August 1966 entitled "FDA Guidelines for Chemistry and Technology Requirements of Food Additive /petitions." You are undoubtedly familiar with It. The purpose of this document was to elaborate and clarify / the regulations wfth respect/ to the chemistry and technology data required for the clearance of not only direct food additives but also / / indirect food additives. The document, itself, made it clear that It was not to be construed as a regulation, that It set forth guidelines, not inflexible requirements. i/ l In the Federal Register of August 8, 1967, FDA published a proposal i J to revise Its procedural regulations for food additive petitions. Quoting from this publication: *For preocntatlon at the National Technical Conference of the Society of Plastics Engineers, /November 4-6, 1969, Dallas, Texas* -> . f j ASI™PR 0000676 - 2 - "The Commit;sloner '1 io *rytfUi'‘ th'h fn htii ffj./. rrvJtv by th© l'ood r»id /><*V',1';U , ’ I* /* ASI-PR 0000677 ». 3 3. Whether It is proper to require details of the manufacturing tcjt process fqr every additive. / / In addition and aside from the procedural regulations the Society of Plastics Industry seized upon this opportunity to recommend a * major change in the handling of indirect food additive petitions In­ volving trace amounts of food additives. Pointing to a paper presented by Dr. John P. Frowley at the national meeting of the American Chemical Society In New York, September 1966, the SPI objected strongly to the need for migration and toxicology studies where the usage level of a substance in the packaging material was loss than 0.2%, with certain exceptions. About this time, the dissatisfaction of a part of tho food packaging industry with FDA's requirements for clearance of in­ direct food additives also came to the attention of a congressional committee. In order to provide an opportunity for the industry and other Interested groups to review and discuss with FDA the scientific basis for ltB policy with respect to indirect food additives, the FDA scheduled a National Conference on Indirect Food Additives. held In Washington, D. C., on February 13-14, 1968. This conference was It was well attended and while representatives of your organization did not appear on the 9 program, I believe your industry was well represented by speakers for The Society of the Plastics Industry, Inc. The representatives from FDA explained our present policy and reviewed the scientific basis for It. They made it clear, however, that FDA came primarily seeking information and advice. Quoting from the paper I presented: "I| conclusion. I would only remind you that we in the FDA are here primarily < ■ ’V-'. ASI-PR 0000678 h to listen, to obtain your views and recommendations (1) with regard to possible changes that can be made in FDA petition requirements and In criteria for evaluating the safety of the Indirect additives from food packaging materials and food processing equipment, and (2) with regard to any possible changes in the scientific or administrative handling of this whole area of indirect food additives. We cannot, of course, accept any recommendations which sacrifice the consumer protection afforded by the Food Additives Amendment against unsafe amounts of foreign substances in the country's food supply. And perhaps this is the crux of the whole problem, how much of a health risk should the consumer be subjected to, for the risk from indirect food additives, however slight, cannot be summarily dismissed; it is merely a matter of degree, Absolute safety, like the absolute zero, can never be unequivocally demonstrated although in many instances it can be approached ever so closely. We are indeed hopeful that we shall receive dome practical and specific suggestions during this conference, suggestions that are both scientifically and administratively sound." At this conference, Dr. Frawley reiterated his proposal as follows: "Thus, we propose three categories of food packaging components: 1) those used at 0.2% or less which cannot 'reasonably be expected* to become components of food, and these should be exempt, 2) those used above 0.2% which mny 'reasonably be expected* to become a component of food, 'but in fact do not.' and these should be considered nonraigratory, and 3) those used above 0.27, which are indeed food additives ancj should be subject to appropriate examinatiqn for safety and regulation under the lew." i . i - , * ■ - v. ASI-PR 0000679 f /• Ho explained further that a level of 0.27. or less of a component in the packages material or in the food contact surfaco would not be expected to contribute more than 0.1 ppm of an individual substance to the total diet of man and ho recorded thiB as insignificant toxicologicolly, He would exclude heavy metals and pesticides, how­ ever, from this concept of safety at 0.1 ppm, The Industry speakers at the conference genorally endorsed the essence of Dr. Frawley's proposal. Following this national conference wc in FDA undertook a reappraisal of our requirements and procedures for the indirect food additives in light of the recommendations and suggestions of industry and in light of our own experience during a decade of administration of the Food Additives Amendment. This reappraisal was Initiated to determine whether any changes should be made. While our own study was underway we were Informed that a task force on Toxicologic Insignificance had been established by the Food Protection Committee of the Food and Nutrition Board, NAS-NRC, to study the broad problem of the safety of minute amounts of substances in man's diet. The NAS-NRC report entitled "Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Food" is the result of this study j and has Just been published. We delayed the development of any proposal until we could have the benefit jof this report. However, we were fur( nlshcd a pre-publication copy by the Academy on a confidential basis several months ago and used itj in the development of an in-house (Bureau of Science) proposal. A draff of this proposal was sent to the industries '■* ’ -. r » ASI-PR 0000680 _ .1 • - 6 - represented at the National Conference for comment and for discussions with us. We concluded those discussions on the proposal with the industry this past September, This in-house proposal would amend the regulations to permit the use of substances (except heavy metals, carcinogens, and other substances that have been demonstrated to produce toxic reactions when present at levels of AO ppm or less in the diet of man or animals) in food packaging materials and other food contact surfaces aa follows! (1) Aa components of food-contact articles provided any substance so used contributes no more than 0.05 ppm to the contacted food; (2) As components of articles for use In contact with dry, non- fatty food; (3) As components of articles/ Intended for repeated use in contact with bulk quantities of f<^>d. (A) u As components of defoai^ing agents employed In the manufacture of paper and paperboard intended for use in contact with food. (5) As components of foo^Z-pockaging adhesives. We hove not yet reached a decision on whether or not to publish / / the proposal formally in the/ Federal Register; and, of course, I am unable to moke avjy reliable/prediction in this regard, / We do Intend to finalize a revision of the food additive procedural regulations mentioned earlier, and we expect to adopt some of t|ie suggestions received whi^li wo have evaluated and found to be Bound. / 4 ftSI-PR 0000681 i t - 7 Let1e turn our attention now to the procesoing of food additive petitions. In spite of the Guidelines and the proposed revision of the procedural regulations, wc continue to receive a high percentage of deficient petitions. The moot^common deficiency is a lack of / adequate extraction*dnta from which to estimate tho likely migration of packaging components to food/ Another common deficiency Is a failure to identify fully the proposed packaging component by its Chemical Abstracts name and by physical and chemical specifications. Identity is, as yop undoubtedly appreciate, basic to our consideration. We also urge you jto provide/n general summary of any petition you submit which will include among other things the following: the expected quantity of the food additive in individual foods or classes of foods under the proposed conditions of use, the maximum as well as the average quantity to be expected in the total daily diet of the con­ sumer, and the margin of/safety provided by the animal feeding studies. / The submission of an inadequate petition imposes an unnecessary burden upon our scientific staff and more importantly from your view­ point results in costly delays In time for you. I would urge you to make every effort toy^ssure yourself that the petition you submit is Indeed fully supported by the necessary data and Information when it Is submitted. / • About one half of all food additive petitions received are iu the - indirect area, / During the period July 1, 1968, to June 30, 1969, we received a total of 121 food additive petitions; 61 of thane wc^e for / Indirect additives. The receipts of petitions since last June are continuing at about the same rate. ASI-PR 0000682 * •, * . ' i /^ / . *• * 8 - Currently, w^.th only nn occasional exception, food additive petitions / are being handle^ within the statutory timo limits. This work is accorded high priority and we expect to maintain this level of performance in the future. Your cooperation in observing the Guidelines and the regulations t in preparing sound, well organized food additive petitions will help I assure the realization of an important mutual goal of Industry and FDA, the prompt processing of the petitions. irkirMrfe i / / 4 i O' - „ AS1-PR 0000683 k f '