Document Dz5LvVENq0QnMx34b7X1K66B

' * ` ' '_ hi J LiiU-i^y l) ""THE FOOD ADDHIV: riiOflLCi 0" _ ' -~ MASTICS USED IN FOOD PACKAGING* ** * 4* . . ' ** -- /* ' i` L. L. Ramsey , ; Assistant Director for Regulatory Programs . Bureau of Science . *" Food end Drug Administration * Consumer Protection and Environmental Health Service TilS, DHEW * ( ` ,* * * '' , ' .* . . * * * X welcome the opportunity hero this afternoon to rervicnr with yoi\ nose of the regulatory developments in the area of indirect.: c:.a -* * '* * Additives, which, of course* include the migrat . / substances pled 'em used in food packaging, 1 '' ' In response to industry'o rieed we developed and issued a dcau:.\'z in August 1.9GS entitled MFDA Guidelines for Chcmiatry and Technology Requirementr of Foy3 Additive^Petitions,M You ore undoubtedly familiar with it. The purpose of this' document wao to elaborate and clarify the regulations with respect to the chemistry and technology darn T.'equircd for the /eleorance fof not only direct food additives but also indirect food additives.. JChe document, itself, mode it clear that it was not to be construed of n regulation, that it oet forth guidelines, / not inflexible .'requirements, I In the Federal Register of August 0, 196/, FDA published a nropcsbl IT to reviGc its procedural regulations for food additive petitions. Quoting / from this publication *For presentation at the National Technical Conference of the Society of Plactico Engineers, November 4-6, 1909, Dallas, Texas, Cv .* r i/; ,, , V ASl 00001181^ ;  -2- /.' "Xho Commissioner Jf Food and Drugs proponco that the pre.r,. food additive regulations be revised as act forth below to obt! in improvement in the quality end organization of food additive p e`; it fens A'/W.M.'-'I ml I'j t't.ytpI U` IheJ.t? Htbntifjy: rirvl'V by tl>cr V006 and I)ft!-:' t/ * Administration. The/need for ouch revision io based on the following: A.. /--A---l-m---o--s--t..hanll,ioof f the food edditivo petitions as originally eubmitt:dcdd *t*o-' the 'E'bia-dJ a--nd Drug Administration have been incomplete or / /' * have not adequately supported the regulation requested and, therefore, havexrcquircd subsequent supplementation, amendment, withdrawal, or , denial 'B* Scientific review of deficient and poorly organised petitions I io tn unnecessary burden that wastes the time nnd efforts of both Administration and industry acientistn." * \ .i ;. . This proposal prescribes the format and content of the petition i and its organisation in greater detail than previously, requires i' odequatc indexing, and requires a oumaary of tho petition. We received 53 communications, including one from the Society of Plastics Industry, commenting upon this proposal. Some of these communications were rather -* ! . voluminousi the opposing point of view boing argued in detail and at some lengtk. Three major issues were evident from these comments: J *: I. whether the analytical method end a aummary of the toxi cological information upon which a regulation has issued can properly be conc/dcred public information, . Whether it is proper to require that 10 year old data 6r /* older must be resubmitted. I * * l O'- * .*. *v,-. <So' .t -zJ yr, v .. , 1. . a * * r .V, *. ASI 00001182 *' / to listen, to obtain your vicwc'T.Trd recommendations (1) with rc^'.'h to poooiblc changes that caa.be made in FDA petition requirements r:.i i: criteria for evaluating the oafety of the indirect additives frer; for ' packaging materials and food processing equipment, and (2) with rogev:! to any po33lble changes in the ocientific or administrative handling of. this whole area of indirect food additives. Vo cannot, of courseaccept ony recommendations which sacrifice the consumer protection afforded by the Food Additives Amendment against unsafe amounts of foreign oubstanccs in the country's food su, ply. And perhaps this la the of the whole problem, he**; much of a health risk chould the conssrmer bo subjected to, for the risk from indirect food cddifciv however alight, cannot be summarily dismissed; it is merely a matter of degreo. . Absolute safety, like the absolute zero, can nevar be uneiuivocally demonstrated although in many instances it can be approached ever do closely. t,Te are indeed hopeful that we chall receive ocma practical and epecifia suggestions during this conference, suggestions that are both scientifically and administratively sound." At this conference, Lr. Frnwley reiterated his proposal as follows: "Thus, we propose three categories of food packaging components: 1) the;a used at 0.27* or less which cannot 'reasonably be expected' to nbove 0.2% which rny 'reasonably be expected* to become a component of food, 'but in fact do not,' and these oliould be considered nor.mlgrntcry, and 3) those used above 0,27. which are indeed food additivco ancj should Is subject to appropriate exami------ " "` * ` t'-\ lart." .I 3. Y,ucthcr it~ls proper t'6 Yfequiro dctoilo of-thc menufact /procesa for every additive. ~ , Iriyoddition end aside from tho procedural regulations the S.'/.ci of ndctics Industry ceiled upon this opportunity to recocted c ^. < major chance in the handling of indirect food additive petitions in volving traco amounto of food additives. Pointing to a paper presented by I?r. John P. Frawlcy at the notional meeting of the American Chemical Society in Hew York, September 1966, tho SPI objected atrongly to the need for migration' and toxicology studies where the usage level of a eubato^no in the packaging material waa leca than 0,27,, with certain exceptions. About this tine, tho dissatisfaction of a part of the food packaging .'ustry with FDA's requirement?' for clearance of in direct ft od additives also came to the attention of a congressional committee. - c S In order to provide an opportunity for the industry and other interested groups to review and discuss with FDA the scientific basis for its policy with respect to indirect food additives, the FDA scheduled a National Conference on Indirect Food Additives, Thio conference was h^ld in Washington, D, C., on February 13-14, 1968. It was well attended t< arid while representatives of your organization did not appear on tho prrogrea, I believe your Industry was well represented by speakers for Tire Society of the Plastics Industry, Inc, The representatives from FL'A explained our present policy and reviewed the scientific basis for it. They made it clear, however, that FDA came primarily Decking ! information and advice. Quoting from the paper I presented; "In con- union. I would only remind you that ye in the FDA nro hero primarily O ' .V " : or*-A -<" ASI 00001184 llo explained further that VTcvol of 0,27. or "loco of o co;'-- . u(*' in the packaging material'or in the food contact surface would r.c bo expected to contribute core than 0,1 ppn of on individual cuV to the total diet of nan and ha recorded thio os inoignifleant toxicologically, lie 'would exclude heavy netals end pesticides, hc.:e'fcr, from this concept of safety at 0,1 ppm. Tho industry speakers at the conference generally endorsed the essence of Dr. Frawley's proposal. V Following this national conference wo in FDA undertook a renppraioal \ of our requirements and procedures for the indirect food additives in light o.f the recommendations and suggestions of industry and in light of our own experience during a dorado of administration of tho "cod Additives Ancni'ment. Thi3 reappraisal was initiated to deter, ina whe '.her an-1, changes should be made. While our own study vac underway v?e were inforaed that a task force on Toxicologic Insignificance had been established by the Food Protection Committee of tho Food and Nutrition Board., HAS-NkC, to study the broad problem of the safety,of minute amounts of substances in Dan's diet. The 1IAS-MRC report entitled "G nes for Estimating Toxicologically Insignificant Levels of Chemie Food" is the result of this, study and has Just been published. / until wo could have the benefi / risked n prn-publication copy ayed the development of any proposal bis report, However, we were fur- * Academy on a confidential basis - oc'vcral month:} ago and used it au me development of an in-house (Bureau If [ 0ji Science) proposal. A draft of thio proposal was oent to the industries ASI 00001185 r ' 6 * !* represented at L\national Conference for corr/ent and for dir' . r /, . with us. Wc concluded Chore discussions on the prop ml with the industry thia past September. i Thia in-house proposal vould amend tho regulations to permit the use of oubrtancoa (except heavy metals* carcinogens, and other substances that haVQ been demonstrated to produce toxic reactions when preaerp. at Zcvelt of 40 ppm. or lesa in the diet of can or animals) in food pr.ch.-^inj paterialo and other food contact curface3 no followsj * (1) As component*! of food-contact artic.lea provided any substance co tee a contributes no more than 0.05 ppza to tho contacted food; t# (2) As components of articles for use in contact with dry, non- ot.ty -ad; (3) As components of articles/ intended for repented use in Contact with bull*, quantities ofI fqood,. (4) Ao components of dcfor.n'ing agents employ_e*cd in tho manufacture of paper and paperboard intendiceqd for us: e in contact with food. (5) As components of food-packaging adhesives. / / ' " We have not yet reached a decision on whether or not to publish the proposal formally in the/Federal Regia Cor; and, of course* I ca unable to make any 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 none of the // ` uggcotion3 received which we have evaluated and found to be round. ^ ASI 00001186 Let* a turn out attention-asy_to the'processing of food add.' .v petitions. In finite of the Guidelines and tlic propoccd rcviiiie;i o' the procedural regulations, we continue to recoivc a high percentage of deficient petitions./ Tho Root/con'-T.en deficiency io a leek of' adequate extraction-daLa from which to estimate the likely mioration off packaging componen/c to food/ Another common deficiency io q // failure to identify fully the proposed packaging component by ita Chemical Abctrnctn name and by physical and chemical specifications. Identity io, an you undoubtedly appreciate, baoic to our consideration Vo aloo urge you to provide/n general summary of any petition you subm which will includa among otner things the following: tho' expected ~ quantity of the^food additive in individual foods or classes of feeds under tho proposed conditions of use, the maximum as well as the overage quantity to be expected,ir the total daily diet of the con ic/ margin of/anfety suraer, and the ciargi ifety provided by the animal feeding studies I The submission of an inadequate petition imposes en unnecessary burden upon our scientific Btaff ond more importantly from your view point rcsulto in costly delays in time for you, I would urgo you to mnko every effort to /assure yourself that the petition you submit io indeed fully supported by the necessary data and information when it is submitted. / r/ About one half of all food additive petitions received nre in the indirect area. /During the period July 1, I960, to June 30, 1969, we received a total of 121 food odditivo petitions; Cl of these wci'e for indirect additives. The rcccipto of petitions oince last June qrc continuing nt/about tho same rate. v*. :* '*''*. J>. F ".uvv-. . -. t < .* * t. # t ' " - T'*. ,' -. t ASI 00001187 -0- / Currently, v/i'th only on occasional exception, feed, addin; . .lions' ore beinj handled within the otatutory time limito. Thio worh :.r. recorded high priority and we expect to maintain thia level of performance irA t'< 0 future. Your cooperation in observing the Guidelines and the ru^ul.at.'.ons in preparing g6und, well organized food additive petitions will help ocoura tho realization of on important mutual coal of Industry and IDA, I the prompt prpeasring of the petitions.- . - * * - . ">* . , .,V' I' * / % r'.`* .% A*\.` 1 icirki&k ' I * V . ** ' " . * * '* !.*? * * v - -t ; * '* K ' X* `- '` *'1 . % <* , */v > '* #l*. ^ vi *J - V *1 .. V. ' *l . , 4 ; * . t % ' \\ ?I/ : * i *.t,,**' ,...,r c* o ASI 00001188 ^ .*