Document gDYJ9DVVZ6qoE59dYJGjZrRoQ

THI IOCIITY or THI PLAITICS INDUSTRY.INC **0 PAR* AVKNU'I ..NgW YORK, NSW YORK 10017 . Sll MU 7.S67B MINUTES MEETING OF SPI FOOD PACKAGING MATERIALS COMMITTEE Comncdore Hotel Nov Mf H. Y. August 23 j 1966 9:30 a.a. Present: George W. Ingle, Chairman, Monsanto Company, Hydrocarbons and Polymers Division, . Research Dept., Springfield 2, Mass. George T. Scribe, Vice-Chairman, Union Carbide Corp., .270 Park Avenue, New York, Rev York . Donald Bartholme, Standard Bag Div., Boise Cascade Corp*, Ciccer ii.'jc, .1. .'nachie', H*** Jersey Thomas M. Carty, SPI, 250 Park Avenue, New York, H. Y. Robert C. Cooney, H. Kohnstan A Co., 161 Avenue of the Americas, New York, N.-Y. L. J, DeCorte, Slnclair-Koppers Co., product Development, Frankfort Road, Monica, Pennsylvania 15061 : Harry R. Dlttnar, Vypak Corporation, P. 0. Box 55 Rockavay, If. J. 07666 Charles S, Doskov, Thatcher.Glass Mfg. Co*, live., 375 Park Avenue, Nev York, H. Y. Dr. A* W, Dovnes, Union Carbide Corp., Plasties Division, 270 Pa:k Avenue, . New York, N. Y. 10017 M. J. Dunn, H* Kohnstamm A Co., l6l Avenue of the Americas, Nev York, N.-Y. 10013 Leroy Durkin,- loco Container Co., U30 Park Avenue, Nev York, N. Y* 10022 R. A. Ferrell, Kennedy Car Liner & Bag. Co., ShelbyvlUe, Indiana - Dr. A. B, Flnestone, Foster-Grant Company, Inc., 289 N. Main Street, Leominster, Massachusetts 011*53 C, T. Fleenor, Marbon Chemical Div., Borg-Warner Corp., F. 0. Box 60, Washington, West Virginia B. J. Garce&u, I.C.I. (Organics), Inc., 53 Canal Street, Providence, Rhode Island : C. E. Graham, 2000 P Street, H.W., Suite 700, Washington, D. C, Jercme H. Heckman, Esq., SPI Counael Keller A Hectaan, 1712 H .Street, N.W., .Washington, D. C. K. A. Hochschwender, American Hoechst Corp., 777 Third Avenue, Nev York, N. Y. 10017 D. H. Hunter, Stauffer Chemical Co., Plastics Div., p. 0. Box 320, Delaware City, Delaware 19706 W. A. Knapp, Allied Chemical Corp., General Chemical Div., P. 0. Box li05, Morristown, N. J, Edmund Lambert, Maxbott Chemical, Div. Borg-Warner Corp., Washington, West Virginia j, R. S. McCartney, Standard Packaging Corp., 200 E. 42nd st., Nev York, N. Y. SPI-26970 i  29 R> M. Miller, .feredN, lad*, Mmvi trust SoUAlnt, VUatotco, StlMun 19699 J. A. Mitchell, t. 1. da Pent 4e Raws A Oe., & rUliBMt., Wltatftcten 96Del. Dr. x. Moyttfeidge, pood i pnn >----Pah UhOratories r MiurlseAvs. at.5oth tt, l^fyttrh 7?' Riev.Ycrk B. a. Murray, Ferro Corporation, Color Dlvisiea, U150 Bast 96th 8t., Cleveland, Ohio Dr. Valter Feist, Ci)auii Polymr Co.* 160 Teminal Ave., Clark, Rev Jersey w.-A. Pattersee, v*B Orace A Co,, Ckyovec Division* Duncan, Booth Carolina 29331* Z.F. Paata, I. I. du tot de tooure A Co,, la*,, Flla Dept., Vllalagtoa, Dal. D, W. Pugh, V. 6. Intotrial Chealeels Co., p, 0. to BOB, tuacola, Illinois G. A. Richter, Jr., Roh A Hum, the Doha A Baaa BI4|., Independence Mall Vaat, Philadelphia, pa, 19109 J. A. Rudy, Ovens-IUinoie, Plaatio Products Dir., Toledo, Obto L. J. RusaUoff, AUlad Chemical Cerp., P. Q. Box 365, Morristown, In Jartay R. f Rutherford, (half Research A Develepmat Carp., Dwight ildg., Kansas City, up. 8. V. 8chaefer, Diancnd AlhOi Co., to 191, reinesvilla, Ohio X. H. Schaeffer, Shall Cbmleel Co., 99 tot 90th Street, to York, If. Y. 10CC0 V. V. Sadarlund, Rational Starch A Chaaioal Corp., 1T00 V.Front St., Plainfield, Eev Jersey 07063 S. Shaman; V. R. Grace A Cc^pny, Eeaeercb Dlv., Clarksville, Md. M. E. totb, Ovene-Illinois, Plastic Product! Dlv., Adana A lUth 8t,, Toledo, Ohio C. J. Splegl, Continental Can Co., Inc., 7622 -South ftoelne Ava., Chicago* XU. 60620 P. C. fltrochlaln, Entry Industrie*, Inc., U900 Rata Avenue, Cincinnati, Ohio 45232 JVTorter, H. Kotos tana A Co,, Inc., 161 Avenue of the Ansrieas* Rea York, N. Y. W. M, Vaatvaar, The Dow: Chaalcal Co., U33 Bldg., Midland, Michigan ^ . D. E. Verslnger, Firestone Plastics Co., to 699, Pott*tows, Pa. ^ . Or, H. G. White, Shell Chemical Corporation, 30 Waat 30th Street,Rev York, V. Y. Charles L, Coad.it. Secretary. SPI, 230 Park Avenue, Kev York, R, Y, 10017 Under the.Chairmanship of OeorgeV, Ingle, Monsanto Cospeny, a Meting of the SPI Pood Packaging Material* Coonlttee vas called to order in the .Canaodore Hotel, New York City at 9*30 a.. Mr. Ingle, aa the first order of buslnesi1 referred to a detailed Agenda circulated prior to the. day1 a session and. In so doing, asked for the usual selfintroductions'. Minute* last Meeting Approved By way of reminder, Mr. Ingle said that the last Beating of the Ccmittee was held on March 3 1966- in Washington, D.C., and that shortly thereafter *11 ,aeaber* of the ccenlttee received copies of the Minute* of the aeetlng. He then Inquired as to whether there were toy additions or corrections to the Minutes of the March 3 meeting as circulated, and bearing none, declared the Minutes of the last meeting approved as published. . PruliMinary ReBSTk* Hy fluinam Inflla Before turning to the regular Agenda Items, Mr. Ingle reported on two special item to be called to the attention of the overall Coanlttee, at a result of discussions during a pre^neetlng session of the Steering Comlttee. SPI-26971 3 Firstly, Mr. Ingl* noted tbit the ^tearing Conltteo discussed tho possibility tad desirability of tryiag to bold spsolal resting at least once e jnu to- which appropriate PDA Staff aenbers voeld be invited end vmin bo uld to participate in com typa of Inforaal guestioo-ejwi-taever period designed to brine about a clearer and breeder understanding. of PDA's thinking it (Ivan tire. It vu pointed out.by Mr* Hoetaaa that this setter hii boon discussed in th# put with no definite doeioloo ando M to whether such sessions should bo bold. Ho stated.that, In hit opinion* uob resting* could Ugorove underetertlng of Industry probloat end, on tho otbor bond* those of rod In regulating packaging. Mr. Hactoaa pointed out that FDA Staffers have expressed on Interest in oueh o program to bln free time to tint In tho absence of objection* to tho Steering Coretttee's reeareeadetlca that efforts bo rede to arrange aucb a reetlng with official* of PDA, Mr* -Ingle announced tbit tba natter vill bo carried forvturd to that the next reeling till probably bs of this typo and vlll ba bald in Washington, p, c. vltb Invitod guest* froa.PDA* Mr. Ingle totad that it would bo highly dotlrobl* for such a resting to be set veil in advance to that Coredttee Mabort can send Hr. Heckman tultable questions and bo eon put thoa In order to that tho IDA pecgle vlll bovo ad opportunity to propers' answers prior to tho Booting. Turning to tho. second "opoolol item", ttr. Ingle reminded thet,frcm tlao to tire', tboro have boon discussion* about tho scop* and objective# of the Carelttee and tho question of vbotber consideration should bo given to ,ths stated tcopo since tho Carelttot has frequently boon asked .to go beyond strictly food packaging materials probloat* this bat boon tho esse, for ortaylo, In ecnaeetlon viVh drug applications probloat, 'there tho CcHltte* bat vorbod vltb tho Pharmaceutical Manufacturers Association. Mr. Inglo further aotod that, in roeont nontht, tho SIX Board of Directors bat asked bln ortbo. Coculttoo to consider a vide range of matters boyood tho original scope of activitios, o.|, occupational hygiene aottort as they relate to tba atnufacturo of foaa and FVC pipe, and am recently tbo poosiblo problem of vasto disposal ofplastic eontainers* Mr. Xbgle told that tho Board and- others undoubtedly hove a#Veft tbs Pood Packaging Materials Coreittee to coritidor thsao unrelated problems bocauso tbo Coonlttoo his available o good deal of proven expertise, both technical and legal, in the public health probloa ores. The not result* of some of tblo interplay is that tbo Steering Ccnslttee, rocogniiiny, tho fact that some of the items being referred ter it sre beyond the presently stat',:i scope of the Ceaalttee as outlined in tbo Bylavo drawn up in I960, believes consideration should be given now to changing ths naps of the .Ceaalttee and rovisirg the Bylava to coyer the range of.aattoro actually being handled. CM the other hand., the Steering Ceaalttee expressed tho View that sobs lens. closely related natters which have boon brought to tbo attention of the full Ccomiittee or its Chairman, should bo referred beck to the 6PX Board of Directors with the suggestion that perhaps those natters might nov properly bo handled by another. Coemittesj possibly e now one with title like MSPZ Bnvironaontol Health Comalvtoe", or eoaothing similar. SPI-26972 k On Motldn hy^A. V. Donnes, Union Carbide Oorporetloo, aeeoaAed by Mr. Villiaa Knapp of AlXldd Chsnlnal Corporation,ead uneatmusly pease4, the iteerlag Ccanittee vu instructed to review the priHflt lylm and develop a set, efiasi--landed eneagmnte to be subnltted to the full Ccnlttea at the earlieat possible opportunity. Ae reprimanded. amndmats ara to dealvlth eueb patters. as a possible Mat change, 4 redefinition of the aeope of the CoamLttee'e nativities, and any other changes that night appear generally lh order to the iteeriag Coraittae. Zt la understood, of course, that no such changes caa.be finalised without due notice and a proper vot* of the full Comdttee nt a duly constituted meting. limlnetlng Cqmlttee. Report Returning to the Agenda as prepared, Mr. Ingle noted that since the last meting he had appointed Fred V. AAaae, Continental Caa, aaChalrmn of .a Hcslnetlng Cesfeltta* empoeed of Mr. Adana and Messrs .V. M. Veetvee?, A Ppv Chanloal Ceapeay, and M. C. Stone*i Xeetnaa Cbeaifoal Product** Inc. Mr. Adam betas absent fro* the day's meting, Mr. Ingle called upon V. M. Veetveer to aaaounee the suggested elate of officers proposed by the nominating Comdttee and previously nailed to tha mahership. Mr. Veetveer presented the following elate: CHAJBMAH- Oftorgc V, Ingle, Monsanto Company . VICE CHAXRHAB- Robert K. Miller, Hereulea Inc. Three nanhera to tha Steering Committee: George T. Scribe, Union Carbide Corp. I, Frank Peake, i.I duPont da Henoura & Co., Inc. (Fila Department) M. . Snith, CveftS'IUlnols, Plastic! Product! Oiv. Thereupon, there being no other nominations for tha various offices to be filled, A. V. Downes, Union Carbide'Corporation, moved that tha .nomlnationr, be dosed, anr. that the Secretary be empowered ta cast a unanimous ballot for the slate as proposed by-Mr. Adeas'* Comlttee. Arnold B. Fineatone, Foster Grant Coaspeny, Inc.,' seconded the notion; the notion vea carried unanimously. It vaa noted that the .Incoming officers would serve a two-year tern and that the next election would be held In the Spring of 1S&0. Reports oh liaison With Other Qraanisatloni Hr. Ingle than called for the usual liaison reports fron other organizations conducting work of Interest to the overall SPI Coealttee. Phanaacauttcal Manufacturers Aaaocietlon A. W. Downes, Union Carbide Corporation, presented the following formal report on "SPI-PWA Unison": SPI-26973 - "A* a result of g joint totting July 8, 1966 of reppeMBtutivei tt the bps.Food Bottling Oeaaaetee, FNA, IU4 in rMd Packaging Caealttee, it i decided to reactivate aaRPX Iarpup to eerve u a liaison between , SPI and FNA * Plastic* Cotelttee. "The objective of this group id to dovslep peredetor* of dafinlng polyethylene resins acceptable for packaging dry drug* (pills, tablets, and powders) "A Beating of the 8PX-FMA liaison groig tea bean eeheduled for 9 a.a., Sapteteter S9th at Ota Alton -Carbide Mttt&g, tT* Paste Asoeet, *. T. ;i. z. "The 8PI representatives are ae follows t P. B* Cambell A* V Downes C. V. Ingle R. H. Miller K. Morgareidge Jules Plstky M. Z. Saltb W* M. Ueitveer Phillips Fetroleua Co. Union Carbide Monsanto Hercules. food It Drug Research Lab. Monsanto Owena-Illino..* Doe" After Mr. Downes gave hla report, Mr. Ingle called on Mr. Heeknaa'vho emphasised the necessity for distinguishing carefully between the wort and jairposaa of the food Packaging Material* Coaalttaa PMA Lialson CoMittse, and tba voyknov being under* taken by a special AdKoe Ccoaittee composed of rspresentativea froa the Food Packaging Material* Cotelttee, and asebers of the Food Bottling Coaalttee of the Plaetloa Bottle Division. It was indicated that everyone abould recognlss and appreciate the difference in the activities of these two groups, lest there be coacunnecessary confusion, airre both activities do have sobs relationship to the packaging of drugs in plastics, and both involve relatlonahlpa with the Pharmaceutical Manufacturera Assoclation. Hr. Kectean pointed outthst Mr. Downes' Cotelttee tea a longstanding one which had worked with the PMA Plastics Comittee In developing basic Inforvatlon on ,parenteral drug applications of plastics, which information is now published in the U.S. Pharmaciala and the Hstlonel Formularr. The work on parenteral drugs has made It Apparent that *oae orutuel benefits to botli the plastics ihduatry and the pharmaceutic*! industry night flow froa additional work looking-towards further publication of technical lafortetioo relative to the use of plastic* in drug applications. As astep In this direction, >te. Downes has hew reconstituted his etsndlflgPMA Liaison Ccmlttes of the Food packaging Materials Coettittee and will work kith the FMt Plastics CosaUttee in attempting to develop' information as to the rfgutreteanta,of the drug industry where It desires to package so-called dry drug* in polyethylene astertale. It was noted, incidentally, that the work will be cooMocbd by'concentration on the use of polyethylene for dry drugs iflplyso that .the project will not .becoise unduly ccoplicated at the outset. '*1 SPI-26974 Separate end tilde fro* this technical work, to be undertaken a pert of the continuing activity with PKA in thle area, the nev Ad Hoc Cconlttee, of which Mr. James A. Rudy of Owens-Illinois is the Chairman, has bean considering problems presented by the fact that, in supplying so-called "Master rile" information to FDA, plastics coispaniea have often specified particular trade-named resins rather than using generic descriptions, such es "polyethylene meeting the specifications in Section 121.2$01 of the Food Additive Regulations", etc. What this has led to is that FDA, In approving a new drug application, has at least impliedly frozen the packaging material which a drug manufacturer can use by giving the new drug approval on the basis of the Master File data, specifying a very specific proprietary resin. It haa become apparent for a number of reasons that bottle manufacturers, for example, would like to have more flexibility In this area eo that they could suhetltute different manufacturers1 resins, provided the reelns all meet the same baelc qualifications. In the course of investigating what might be done about this problem, Mr. Rudy's Ad Hoc Coesnittee had a meeting with the Pharmaceutical Manufacturers Association's representatives. At this meeting, it became apparent that the primary dob that sn'-st be done is probably educational. It was agreed that both the plastics Industry and the pharmaceutical Industry should be advised about the poeelbllity of supplying information to FDA which would enable a ;rlastioa bottle manufacturer, for example, to use various suppliers of polyethylene Instead of being limited to one particular brand.which might have.been specified in a Master File submission. The necessity for taking action to provide a bottle manufacturer with more flexibility, es far as raw materials use la concerned, ia obviously separate and apart from the technical work that may be done with the PMA Plastics Committee on refining write-ups of the drug industry's requirements, as far as packaging mate rials are concerned. Thus, the Ad Hoc Committee is presently proceeding on a basis which calls for the preparation of a draft bulletin or manual covering In some detail the way In which the new drug law operates, vis a vis its Impact on packap1 r.? materials and h'jw plenties Industry suppliers <f packages for the drug Industry ir1 f v'- better handle their Master File submissions so that they will not li A themselves "frozen" as far as the use of a particular trade-named plastic for a particular ls concerned. ' As of the moment, this work Is proceeding with Mr. Heckman drafting a proposed manual or bulletin for the Ad Hoc Committee to review end di6cusa with the Plastic Bottle Division. After tbla preliminary draft Is prepared and sent to Mr* Rudy, is likely that it will be discussed Informally with the Food end Drug Administrate. to obtain its reaction and, ultimately, the manual will be published end circulates as widely as possible. It Is hoped that the work of the Ad Hoc Committee will ultimately place the plastics Industry In a position where, in submitting Master File information to FDA, the practice will be to specify resins on a generic basis, so that substitutions of one trade-named product for another can be made without any necessity for a drug manufacturer to file supplemental drug applications to advise FDA about an In consequential switch in a package component. -7- The natural reluctance of drug manufacturers to flic such applications, thereby asking FDA to pass again on an already cleared drug product, la a primary factor which has deprived the plastics industry of the desired flexibility in substituting another supplier's resin or other component for those already specified In Master File Information, even where the components ere generically the same. 5P1 Food Bottling. Comlttee of Plastic Bottle Division On behalf of the SFI Food Bottling Coenittee, M. E. Smith, Owens-Illinois, indicated that the two principal areas he planned tc discuss at the day's meeting had been quite thoroughly detailed by Messrs. Downes end Heckman. He did note once more that every possible move is being made to arrive at broad parameters for suitable use of materials and that, as' an initial step, the joint effort between SP1 end Pi-iA has been extended to develop criteria for polyethylene resins acceptable for packaging dry drugs (pills, tablets and powders). .Mr. Smith indicated that after polyethylene is considered, the Ad Hoc Committee will then move on to consideration of other materials. (It was noted tangentially at this point that the University of Connecticut is doir.i some work in this area which would appear to deal with the subject of polyethylene and Its applicability to the 100 most used drugs. This is a completely Independent study.) Mr. Smith was then.asked by Robert Killer, Hercules Inc., to consent, on other items being considered by the SPI Food Bottling Committee which could be of interest to the Food Packaging Materials Cocsaittee. Mr. Smith referred to meetings with the Bureau of Weights and Measures, reporting that it has now been definitely ruled that a plastics milk bottle will be dealt with as a package, rather than as a "measuredfill" container, thereby eliminating the problem of meeting the requirement that plastic bottles comply with the fill requirements in Handbook W*. Continuing in another area, Mr. Smith reported that the National Conference on Interstate Milk Shipments has moved forward in its preparation of recosnaended in structions for sanitation inspectors. This work was actually consoenced a number of years ago and represents a cooperative effort by the U. S. Public Health Service, the Dairy Industry, and Syracuse University Research Corporation, looking towards the development of recomendeu inspection instructions to be used by local health officials. The instructions have, generally speaking, been finalised and will be published in substantially the present form reasonably soon. It is anticipated that they will be explained and Interpreted In a forthcoming special seminar to be conducted by Syracuse University Research Corporation for the benefit of local officials. In consenting on this matter. Mi*. Smith noted that there was some dissatisfaction among the members of the Plastics Bottle Division participating in this work relative to two of the provisions in the present draft of the aet of instructions. The provisions in question are Sections l6\a) and (d), the difficulty being primarily one of interpretation. There is some fear that these Sections might be read to lndlcats that no bottle for dairy use couU be molded on a machine which r -8- question baaarisen is becau** faction 16(a) of the instruction# does not oak* it clear that evcb equipment could be; um4 for tbe molding ct dairy bottles even though lt.hai been u**d for other, nonfood comtact eontaiaar* areytielea, provided the equipment 1# satisfactorily deified aftr u*e for molding non-food contact items. A simllartype of dissatisfaction exists with regard to Section 16(d) because it lavlles that a tolling plant operator vouid have to faparata cc^letely any equipment used to manufacture ,plmetie milk bottles frem other equipment used to manufacture articles not intended to edatact food*. * '.***, Those go the food Bottling Caanlttae who are working on tbit setter Intend to recooMnd alight revision*. to Action* 16(a) and .(d) and It ta hoped that, by tbl* aaana or by suitable interpretive mtatemeats which-may be made at tha Syracuse University Seminar, a clarification of tha true latent of the Instructions will be affected so as to resolve these problems* In edmaanting generally on the.activities of the 3PJ Food Bottling CmmiitteeV J. A. Rudy, Owana*Ililoia, stated that ovary attempt should be made on a continuing haali to -make certain' that all government agonciea recognise API m an authority ln this whole field and look to it for guidance and Information, retber than to .other organisation*, or entities. Manufacturing Chaste ta' Association (Food-Additives Committee) Hr. Heckman reported that under data of August 16, 1966, ha received the following communication from Taylor V* Ktnavan, K. I. du Pant da Wemourg 4 Company, Inc. , relative' to tb< activities of IGA* Food, Drug, and C iiMtlct Committee: "The scheduled Spi stating on August 23 ccoos during a abort vacation period l.hava planned for scam time. As a result, I will not be able to attendv As the llaleea representative to MCAb Food, Drug, and Cosmetic Comalttee, I would, like to make the following report. The food. Drug, and Cosmetics. Coenlttee mat on April 13, 1966, an*?, no natters ef direct interest to the Pood Packaging Materials Committee vara discussed.n Other Liaison Reports . Mr. Ingle then inquired as to whether there might be any other information of in terest about relative activities of other organisations. A. W. Dovnes, Union Carbide, then oOted.ihet he recently received s very general inquiry from the National Flexilble Packaging Association, apparently asking for advice about tbe overall FDA regulatory situation. In tbe absence of a more detailed statement a* to Its special interests frdm IOTA, Mr. Downes indicated he will probably Attend Its next meeting.to try to sacartalA in depth just vbat particular problems are of Interest to this group.' Reference was alio made during this discussion to the forthcoming American Chemical Society Meeting, to .be ball in Hew York City during the week of September 12, and especially.-to its announced Symposium on plastics and costings Tor food contact applleatloni scheduled .to take place on. September l1*; It was pointed out frequently. SPI-26977 .9- during the dlscussloos at the days' meeting that several members of the food Packaging Materials Committee, as veil as Its Chairman and SP1 Counsel, are due to participate on the Sysqoslum Panel. Before closing the liaison discussions, Wendel F. Munro of American Cysnaald Coopany ccosented briefly that "the oldest, petition on FDA's Docket, namely SQCMA's Food Additive Petition.No. 367 relating to dyes and pigments for use with paper and paperboard, remains pending and in the same general atatus as reported on at the last meeting of the Food Packaging Materials Committee. Report of SPI Legal Counsel George W. Ingle then eelled on Jerome H. Heckman, Esquire, and SPI Counsel, for bis regular discussion of the status of pending SPI Petitions^ FDA organisational and procedural changes, and their future implications, and other matters of the type Mr. Heckman is charged to bring to the attention of the Coasalttee. Jcrtxne H> Heckman then gave the following formal report at today's session. It should be noted that, as is custernary, Kr. Heckman's comments were Interrupted from time to time for responses to questions and explanatory discussions. For the sake of coherence, the report, in edited*form, la set forth in toto first, with brief summaries of the questions or discussions that arose during the report covered thereafter. It is good to see all of you again in the course of our continuing mutual Odyssey through the straits of FDA pockaging industry regula tion. My report this time will necessarily be a little more ex temporaneous than I had planned. This is because the most significant development which has taken place since our last session, at least as I see it, is one that came to full blossom only last week. I hope that most of you have received our August 16 letter enclosing copies of the new FDA Guidelines so that you will know what I mean. Incidentally, ve have some additional copies in our office for those who might want them, but one of the reasons I circulated the Guidelines as soon as received the paper, Is so that it would not have to be duplicated for the Minutes. For the sake of meeting what I consider to be my normal obligations in giving you these reports, what I would like to do is go,over some of the general items of interest first and then cement on the Guidelines, their substance, status, and any possible follow-up action we would like to consider. Olefins Polymer Regulation Firstly, with regard to the Olefins Polymers Regulation, you will recall that the last time we met there was a matter in controversy because we were not satisfied with the Alkene-l-Copolymers defini tion in tbs new regulation as It was published. SPI-26978 - 10 - Since the last meeting, we have been able to obtain publication of a further revised regulation which has been made effective with revisions to neat, at least In essential part, the objections lodged on behalf of SPI, duPont, Phillips and Union Carbide. At the risk of over-generalising a rather complicated natter, I believe It is fair to aay that effective action of thia Committee, with the aid of those of its C3<spany_members directly Interested, enabled us to obtain e compromise type amendment of the Alkenc-l-Copolymers definition which at least permits the uses of the copolymers of known importance now, as far as I am aware. The new definition probably also covers many potential uses where no more than the usually small percentage of one to eight Carbon Atom Alkene-1Copolymers would be employed. There la room for broadening that regulation certainly. As a matter of fact, it has been further amended aince we got our last amendment to allow another use for non-crystalline polypropylene. Before passing on to other topics, I would like to remind you that in setting forth the extraction test methods in the new Olefins Polymer Regulation, a simplified procedure was published for poly propylene. A few of our Cccmittee members have expressed the opinion that this same procedure would be satisfactory for all of the olefins and should be made the official procedure for poly ethylene and the Alkene-l-CopolymcrB too. The .only reason this was not advocated when consideration was being given to the methods In the new regulation is that It was felt that, in order to tall FDA that these methods could be specified across-the-board, we would have to have at least given everybody In the Industry a chance to test their own materials with these methods, and this would have held things up too long at a time when there was a lot of pressure for the new regulation to issue. Thus, it was decided to leave the methodology question for a later day. Don Pugh of USI, and perhaps others of you, have indicated that you would like to see the methodology provided ifor in the regulation set forth only the polypropylene method, so it could be used across the board. Z might point out that there is really no reason why you cannot use the simpler method anyway if you want to, as long as you are satisfied that It will give you the aame assurance of compliance with the regulatory extraction criteria as the one set forth by FDA. FDA has indicated many times that this approach is perfectly proper. On the other hand, if the Regulation creates a true substantive problem because of the method set forth, further formal action can be considered end I would recommend that the matter he referred to the Technical Information Subcoesalttee for consideration. From the legal and procedural point of view, let me note that I really have no doubt but that FDA would be willing to amend the Olefins Polymer Regulation again to simplify the test procedure provision. What I cannot predict, however, in light of past ex perience, Is how many complicated aide roads of the regulatory SPI-26979 ptth vs might have to travel, bow aeny nev questions might be raised Just baM petition it filed, sad vbetbarer not vs would face presently unf areseeebla challenges by tin bringing to bear of IW* usually unpredictable inquisition techniques in dealing with petitions While not truly- trying to dissuade you entirely froq footing to hove on existing and apparently satisfactory regulation revised, X think you Bust recognise that it If virtually -isgosslble to predict what if going to happen, oven where you file a petition thot night iota to coll for tho simplest typo of action in the world. On the regulatory side, it seems to no that you have throe alterna tive* hero. One* you can stand on tho position that you can use . flakier methodology anyway, if you went to eo, unless there Is some kind of special problem, why try to have the regulnttoo emended at . silt Two- ve could flit a petition and take our'chsncei , hoping that this is one that would go through easily, as a few of .thta do. Three- we could perhaps Juat advlfe FDA, by means of a latter or . some other informal filing, that tbs polypropylene nsthodology Is applicable to the othsr resins- assuming that the Ttchnletl Informa tion Subcommittee so decides -and suggest to FDA that it night went to tla^llfy the regulation on its own`notion. If,, this were done, we would not have filed a petition, and our status would be at least slightly different. There Is one other approach possibility that night be of help. If the Technical Information Subcommittee .can decide .that there is an adequate -relationship between the two nsthods, Z suspect, that we could probably obtain s latter free Pood and Drug agreeing that either method could he used, so that you could duplicate the letter for your customers if tbere is a customer relations problem here. Polystyrene Turning to perhaps the "second longest pending petition*1 at FDA, again.I simply do not have anything of substance to report on poly styrene. The last time I talked with anybody at FDA on the subject van last Friday, when Mr. Randolph told me that he has not really devoted any time to the matter recently, so he still has to draft a regulation. Of course, the essence of the problem, from a procedural point of view, la that FDA does not believe any practical problem exists because of the delay. Tha theory'la that polystyrene is prior sanctioned: as far atanybody knows, you can fall all of it you want under the "prior sanction" and, therefore, the issuance of a regulation from Mr. Randolph's point of view la not **aa important as working on other things." I %\r - 12 - Dependent or* bow this Conalttee feels about the Better, or bow the members of the Polystyrene Teak Group feel. If we want to elicit their views, 1 think that we might at thla point arrange for sane type of a Committee delegation visit to bring acre pressure to bear for the Issuance of a polystyrene regulation, assuming that the lack of one is creating some type of hardship. The delay may not be inhibiting sales per ae, but it would certainly be nice to lay to rest this problem for a couple of reasons. Frankly, it annoys me to have to report the same status every time but, more important, appropriate action might be helpful in some of these European situations where other countries are considering regula tions to govern polystyrene. Our government has a chance to provide some leadership here and maybe resolve seme very difficult problems that the Europeans are raising. I have used these argu ments with Mr. Randolph and with Mr. Ramsey, but so far they have not been overly stirred. Coatings Petition The only other SPI petition that is listed on the agenda is the Coatings forplestlcs Petition, which we consider Inactive although it has not been withdrawn formally. Especially in light of the new Guidelines that have been Issued, I would say that our plan, when and if the cccaslon demands, is to quietly withdraw that petition. Fortunately, it has never been "Noticed for Filing" so this will not present any apparent customer relations problems. The Guidelines make it clear that If FDA wants to insist on detailed data to support our petition it can do so, and we could not comply on any rational basis. The most Important thing to remember here is that, a good deal of time having passed since our Petition was filed, I believe most of the substances covered in the Petition,that were not conjectural as far as use is concerned, have been covered in one way or another under existing coatings regulations like the one^.for the polyolefins, and the one for repeated use articles. There have also been some regulatory amendments In the past few months with regard to some of the other coating materials regulations which Bob Miller is covering In his regular report. FDA Personnel Changes and New Policies , Now, let ae spend a few minutes on the so-called FDA organisational changes which might better be characterised thus far as a game of musical chairs. At the top level, Mr. J. Kenneth Kirk is now officially Associate Cotaniseioner for Compliance so that, in practical fact, ha is at the top of the chain of eoomand as far as Food Additive Petitions, among other things, are concerned. He has already moved to Arlington, to the new Crystal Plasa Building, where everyone in the Commissioner's Office will be soon. SPl-26981 Though it aay seem like a detail, I night remind you that a few years ago we went to some trouble to try to impress FSA with the idea that it would be very helpful if all the people who deal with Food Additive Petitions were in generally the same area, eo that they could confer with each other nore readily. Unfortunately, la the past few months there has been some new decentralisation sp that the .Division of Pood Additives and Standards people, for example Messrs. Holtz and Munsey who deal with indirect addltlvea, are back in the South Agriculture Building, separated from the Petitions Control Branch and the Division of Toxicological Evaluation. Aside from these relatively inconsequential changes, there is little' nore'of direct interest to report on the FDA reorganization front, per ae. For those of you who have not yet been thoroughly exposed, you should understand that far from things ever becoaing simpler at FDA, they usually become more and more complicated. As you nay know, over the years there have been constant complaints that FDA Ignores its statutory mandate to act on Food Additive Peti tions within the 180 day maximum permitted by its enabling law. This is one of the things that Dr. Goddard has been very disturbed . about.. He feels, that FDA should act within the. time allowed by Congress on any matter, and he has so advised the FDA Staff. There has now been an important change in FDA policy which has taken place in the usual quiet, unannounced way, allegedly because of the pressure Dr. Goddard is bringing to bear for more expeditious FDA action on the filings made with it. The situation is a little complicated, to I ask you to bear with me for a bit of explanation. To clarify as much as possible what the Staff has done to meet the Goddard requirement for more action, let me try to put the matter in perspective by starting from what has been and moving into what ia. Until the early part of this year, a^Food Additive Petition would almost never be "Noticed for Filing" within the 30 day period called for by Section 121.51 of the Food Additive Regulations. Instead, the petition was circulated for virtually complete revLev by the Divisions of Fo'id Additives and Standards, end Toxicological Evaluation, after which extensive inquiries were usually raised. The petition was then "Noticed for Filing" only after almost complete substantive resolution of any problems that came to light in this "pre-acceptance" review process. Even so, FDA seld^a took action to promulgate a requested indirect Food Additive Regulation within the 180 day statutory maximum time amoved for such action after a petition la "Noticed." Since the beginning of this year, FDA has generally speaking established a policy of filing all petitions promptly (l.a,, within the time Section 121.51 provides) so long as the petition . i4 . la prime facie complete. This la undoubtedly what was originally Intended by the procedural time-element safeguards set forth in the law and the regulations. Unfortunately, however, the new FDA Interest In crriplying vith statutory standards and eliminating its huge backlog of petitionsmalnly for indirect additives -has.brought into play a new twist, perhaps more properly characterized as a "backlash." In its anxiety to eliminate Its bocklog and industry's coeiplalnts about delays, FDA is often advising petitioners, sometimes at what amounts to the eleventh hour, (i.e., just before a 180 day deadline expires) that a Petition noticed for Filing cannot be acted upon favorably without some extensive new study or studies not previously requested in any way. Simultaneously, it will be stated that unless such data can be made available, the petition will be denied, or a request for "withdrawal without prejudice" may be filed within 30 days. In a number of these cases, the additional data requested might be a 90 day feeding study so that the petitioner really has no choice but to withdraw the petition`and suffer any commercial consequences Federal Register publication of the withdrawal might bring about. These consequences can Involve considerable loss of business, or at the very least, a need for some potent re-selling. For example, a customer might be using the petitioner's product on a "no-migration" basis, having been satisfactorily convinced that such use would present no real problem during some interim time while a Food Additive Regulation was being sought to provide more tangible "federal approval" not otherwise obtainable because of the FDA "no-migration" policy. Convincing such a customer that there is still no true safety problem, but only a procedural one when a "Uotlce of Withdrawal Without Prejudice" appears in the Federal Register relating to tho substance bo Is using will be, at best, difficult and could be loposalble. a Under such circumstances, as we see it, the new FDA policies seem overly rigid erd Impose a very Important additional Jeopardy for potential petitioners to consider. They may well work to reduce the petition backlog, not only by bringing about many withdrawals without prejudice, but also by discouraging the development of new products or the filing of petitions for any reason. Vie feel the approaches now in use exalt form over substance end should be re-evaluated, bearing in mind that the statutory and regulatory deadlines were provided to protect industry from arbitrary Inordinate delays, not to provide the government with a convenient procedural device to clear Its petitions list without substantive determinations. As a minimum, FDA should exert evory effort to review e petition promptly after it is Noticed for Filing, and advise promptly as to any and all additional data deemed necessary. In moat cases, thla would give petitioners time to provide the data before the ISO day-time allowed for action on a petition, and FDA would still have its full time allotment to act in light of the provisions of Section 121.53 its Regulations. SPI-26983 :>1 15 In light of tba policy being followed now, there la still a new reason to consider the pros end coo# of.filing e petition very carefully; ' Z know this le Kwvtaal contrary to what FDA would like to eea because they constantly urge tho filing of petition*, but they alsoconticuellylMpoie mew roadblocks. If you have to worry about being equalled to "withdraw Without prejudice" at acme point, I would think that you might think a long tine before yau file- a petition and perhape --I throw this out for whatever it ie worth-- perhape you night want to have sen* type of cconitaent In writing, or group of coraitaaptf in writing, fron FDA to the effect' that data that you hare prepared la adequate to rupport the iaeuftnee of a regulation before you even file a petition, one possibility that you night consider is, prior *0 filing a . petition aubnittlng all of the .data that you would normally file in a petitionundereovar of a letter, asking only for FDA'a reaction on ths.date, !., "Is it adequate to support the issuance of a regulation?" ; You night have to wait a while for an answer, but probably tio longer than on regular petitions. You should, of course-, try to phrase such letters carefully so as to elicit aa direct and dispositive an answer as-poeelble, and then file the petition afterwards. Z mention thie possibility for whatever it night be worth end without any guarantees thst this ploy to avoid the new Jeopardy will work or . will not be "counterintelligenced." Recent -Cases of'Special Interest While I have not done thie previously, I would like to mention two court casee, at least for those of you who are lawyers j and Bayba for those of you who have the kind of problem they involve in your company once In-a while. Ths first case is reported as Joseph T, Lewis v Martha Baker db/s Baker*-s Pharmacy end Rlehardaon Merrali. Inc.. decided by the Suprene Court of the State of Oregon on April 20, 1966, The reason 1 think this case nay be of interest to you is because the Court held In effect., that, If there is gn existing FDA approval for a substance (in this case for > Drug),.this constitutes a factual finding that the substance li reasonably safe for. Its intended use and that, < therefore, a cause of action on the strict liability theory (i.e., without proof of. negligence ) in selling it to somebody does not lie, twy though-the substance hay have caused feme kind of serious illness. For rare, collate information you may vent' to read this case which la reported beginning with Paragraph 55^6 of. the CpH Products liability Reports* Ity neln reason in mentioning the Lewis ease is because It provides some assurance that, if yoy have Food Additive Regulation coverage or an FDA letter on product, an. added legal defense to liability for such things as allergic reactions exists. SPI-26984 '--ri. ~ * Ifi - The other s*** I want to Haitian la one daCided June 7, but publish#* only about tmVor o ago* . this la. tba *a*e of ^ow vitlTa aitJe}"on'afi^fpurs^SliT.aayTinlilats* 1a*u#V .but it nay be helpful in connection irith * bind of gueetlon ve receive froa soae of you all tbe-.tlae, lte., the iaattar of tba liability of covenants suppliers.,, tba quottlan boil# 4ovn to tba mtttr of what liability arista vben you supply a covenant, aanaooa-alaa nakea southing wlth.it, or changed .It, and tba final produot la alleged to oauaean injury because of tba eo^onaat; 2a tba Power Ski ease, tba Court *ay* 1* sending tba out back for further trial, that tba question of whether or not tba supplier of a component, ahoidd have known vfcst it uaa golaf to.be uaad for, an* therefore had aoaa raapoaalbillty'araa though It only supplied * eOgpoaaai, la a valid queetion to ba take* up.io-e trial, Tbia ease 1 raportad laPatagrepb 9579 of CCH's Products liability Reporter. _ Tha PDA Guidelines Turning to tha "Guidelines" that FDA boa now*nadc available to us, let na first nota here that we did |tt ism special treatment by Mr, Rsnsey Is asking tbase avallob1 to Us. They are colng to ba publlabad to is, This la not a latter on which ve hav * right to conent bfora. publication, according to IDA. Distribution will ba node byneens.of sending copies to everybody on tba Pood Additives Regulation# nailing Hat and those-of you who gat the nahdsanta to tba .Food Additive Regulations yill get tha docunsnt again that ray. I hava aooa problems vtth-the Guidelines --with tba substance of . the Guideline?*** and with aooa of tha little questions tbay raise. I know from eons of . the naabera of the 8t*erlng ;Cdnlttee that you have already cane up withiaone question!. . As far as tha etetus of these Guidelines go, at leait is y opinion, . I think that you bare to assum that tha PDA Staff will no* uae these as a cheok*off llat to- mam extent os' any petition filed. I suggestthla la to he expeeted oven, though it is contended by IDA that the notarialconstitutes only a sat of Guidelines ao that there la no real* force of lav behind than. - 1 think you have to assuae, as a practical natter they ere going to bfc looked et by every neabjer of ..tba staff every tins tbay look at a petition, and 1 think they naan vhat they say where it is. indicated that, if you are not supplying acne of the isforaatlon requested, you had better explain vtay. While ve have various problana fran the legal point of viev, for example with the natter of requiring data 00 intended technical effect, perhaps the fireV question to be considered la vhat, if anything, ve should do to take our ideas about the Guidelines knova. What I .^ SPI-26985 a  17 the Guideline t ibis hatting hi Juoh as you valid Uka/.ead thn consider yheiher cr mot-vei' should letPbl1sw:ttii W would Uki to make earn coMsats about the Ovldsllnes.. .'There are any,number"of approaches; you could use, for exhale, J tbini these Guidelines would fart food topic -for com of Um guaitioo-*Dd-eaewer sessions that v* might haw* with the TLA Staff at the forthoomlAg masting. The more tangible proposal that I advanced ee a. possibility yesterday, and that Z passoo bora far your consideration, la whether vt might ba well advised toaotaovledge receipt of copies of the document from Mr. Ramsey,.-letting bio knov that our CemUtea baa bean supplied with eoplaa and that tba members of tba :Canmitte* My have sqm . halpful commentsto make in duo courea. * Intbtsvay, va can infom bin ihmt w* arethinkingin terms of leading bin. som'-information, even though perhaps it nay toe several months bafora you sand in your coements. and tuggeetlonsj and va bare an opportunity to composite than and put a letter together, if thatra what you want to'do. I think tba floor should ba opaa for aueitlons and, discussion oo this : point now, as Z hava hsrsby concluded ay regular report. Thank you Questions. Co--ante. Actions Arising from Counsel's Report After Mr. Heckman's general discussion about the matter of aaendlag tbe polyolefins. test methods specified for .polyethylene and Alkene-l-Copolymers, and. after ecm* general observations by Hr.. Pugh of U. S. Industrial Chemicals "about -the entire situation, it wee decided to refer this natter to tba.Technical Information Sub* coonlttaa so that it nay: (1) Collecteuch data aa nay ba eraliable to show correlations between. tba so-called polypropylene method and tba methods now specified for polyethylene and Ethylene-Alkafie-l^Copolymers, and; (2) To make general reccMmndatlona to the full Coamittee In this area. It was. the conaensua of all those present that the Society should be moat reluctant; to file any petitionyith the Toad end Drug Administration to seek formal amendment. of the present Olefins Toly*er: Regulation, although it should perhaps make amllabjj the data and/or any-conclusions therefrom .that the Technical Infweatioh Sub- ccanittee is able toasaemble. After this Is done,, further consideration will be given to the best possible use to aske of this data, in line with Mr. Heckman's general racoeMndatione. ' . In reference to Mr.. Beckman's, announcement that the polystyrene petitions are still "in limbo", he bad poaaid eguestlon as to whether in reality the lack of a regula* tlcn on polystyrene is hampering the sales of naterlal.. It seemed to be the general consensus that it could not ba stated, aa a natter of fact, that the delay In the Issuance of a regulation la presenting any practical problem and, therefore, no instructions wart given as. to additional formal approaches to PDA. ' Mr. Heckman will, of course, continue to check With the appropriate FDA Staff Officials god use reasonable efforts to aae that the regulation la Issued as promptly s possible. SPI-26986 After considerable discussion of ths Guidelines problem, tbs general legal ststus of tbs Guidelines, and related matters, it'was agreed by tbs Crwmfttss that tbs following steps should bs tabsp: ; 1. Mr* Heclqnah was livetrusted to writs a abort letter to Mr. Kaaaey, ss prca^tly ss possible} to ecknovltigs receipt of the prtliainsry copies of the. guidelines and thank bia for the consideration given in providing this materiel so that it could bs and* available to tbs SPI Comitte# at its August.23 meeting* In thls-saas letter} Mr* Heckman is to indicate to Mr, Jleiarey tbst tbs ambers of the Comlttss are Interested in sufplyin. the Food end Drug. Administra tion with th*lr general. c;msnt,3 on the material set forth} end will be doing so. lb tbs near future'. 2, All ambers of tbs' Comlttee, who desire to do so, art to submit to Mr... Hsotaen, in writing} any casaente, rittns*, or suggestions they night have in:connection vltb the Guidelines. `go ss to provide an orderly procedure, a deadline date of September 3 *** set for the submission of suck cements to Hr; Rtctanea 3, After September 30, Mr* Heckaso will attempt to sort out the comments received, And composite them in draft letter or set of comments, so that the etas can be rerlrcvlsted to'entire Committee* In ` this wsyr the views of the Cc-nittee will be elicited first and, thereafter, a'letter-or similar filing uill be sirxsitted to Idr . Ramsey relative to the Guidelines It is hoped that this will lead to some valuable clarifications, or perhaps even changes'In the PDA publication. Another possibility Is that thia work will provide the,basis for some Interesting question* end answer's at . the next meeting of the. food.Packaging Materials Committee, at which FDA officials are expected to be present. Report of lawyers* Advisory Subcaaalties Chairman ngle called upon George T. Scriba, Union Carbide Corporation and Chairman of the Coanlttee's Lawyers' Advisory. Subccaaltte*. Mr. Scribe, referring to the legislative outlook, indicated that there is essentially no Ismiioent activity relating dlrectiy to food packaging. He did diro'i1 attention to several items he felt should be brought to the attention of the over*.J. Committee,-if for. nothing else, as a means of keeping the grotip. informed of aattc-v. of general interest. Thus, he discussed briefly the new Rule No. 66 passed in Los Angeles, California, which relates to air pollution and more pertinently prescribes rather severe limits for tho emission of solvents by users. . Mr. Scribe indicated that details on Rule 66 Lay be obtained by copaunlcatlng with the National Paint, Varnish and Lacquer Association. H*xt, Hr. Scribe indicated tobildintloe li blA| given to sujtfleiienting the Federal Hazardous gubetaneee XAbeliag Act toy emending it to give FDA new Authority over unpectaged "baaardou# articles"i toy** #to, when a fladlag of petantial risk la m4. : 0*3298 cod Title IJ of H.R. 13066 are the Senate and House Bills' respectively under consideration which would provide the additional rgulatorypo*sr in this vn. */ Hr. Eexlba also directed the CcsBditee's attention to tbs so-eelled "Child Safety ,, Act" legislation proposed toy ean* or Title I of H.R. 13886 and 8*31$6. The portion of this legislation ofmoet direct interest to the plasties industry would appear to too 1 proposal* amend the Federal Food, Drug, end Caeeeties Act to require safety closures an bottle# ueed for household drugs, particularly aspirin, Hr. Seetayi swppleaanted Ms garths'* report In this regud by Infernlnf the CoK&ttee that Dr* Alien B. Coleman, Chairman ofan American Pediatries Association Child Safety fliwhittee, tone been intouebvith bln to vugfsat thntthe plastics ' Industry night n*ni to participate in a program to develop. standard* for eucb . safety closures,'alnee. it bee became apparent ct the hearings on H.R. 13066 held tbue for that'each standard* will toe needed, especially If action1 U token on. the legislative proposal. It Wee suggested ht this point, that the netter of developing CaMerclal Standards le always mere properly within the reel* of activity of the various productdivisions within the Society* In tbi Instance, the appropriate product division 1* the plas tie toot,tie group elnct It hee been developing cloture standard* in Other eree*. Thus, M. g* Smith of Owens-Illinois vet ashed to teke this setter up with the Pleetle Bottle Division, perhepe through it* Food Bottling Comalttes, or whatever other subgroup 1* eppropriete. Kr. 8*1th agreed to underteke this . assignment with Mr. Heckman, prcalling thet he would supply ecplee of ell background information on the subject made available to hi* by Dr* Coleman, Finally, Hr. Scribe celled the Conmittee'* attention to the proposed. amendments to the Administrative Procedures Act (APA) contained in 6.1336,- now before the Bouae .of Representatives Judiciary Committee, having been petted toy ihe. Senate in June. Kr. Scribe pointed Out that tble bill looks toward* strengthening the APA, io u to bring about further assurance thet those vho wst seal with federal agencies will be afforded effective procedural "due proceis." Ik-, scribe noted that, an the Senate Report on this legislation etatee, the continual ala of Congress la to try .to provide as micbtssurance as possible that those who dal with the agencies "will be treated aa citizens, and net aa subjects. *' Mr* scribe pointed out that, while it night appear that this Better is of interest only to lawyers, he believes everyone should at least' b* aware that procedural rigl *.5 are very invariant; and should, not toe foregone lightly In dealing with the Food and. Drug Administration which, after all, ha* no exenptlOn fro* complying with the requirement* of the Administrative procedures Act in it* rule-making and other activity. *J poet aestlng note: On flepteaber l, 1966 the Senate passed S.3290 with amandmenta* This Bill will bring unpackaged, as well's* packaged, . "hazardous articles", and household articles treated with pesticides, under the Act* It will algo give FDA power to ban hazardous toys and other children Vs articles fre* Interstate Connerc*. SPI-26988 Technical Information 3nbccm^ttes Chairman ingle celled 1900 Robert M. Miller, Rareulei, Inc., and Chairman of tba Technical Information tubccmmlttee. )>. mile.' *-implied -a vritteii report including bis regular1 lilting if recently lsrucd Pood Additives Regulations. Be then tewnted bTiefly on soon tf tb petitions filed since the lent Mating, those which have recently been withdrawn, and other highlight* of fcla report. (Tieaas Roto; Attached hereto es EXHIBIT A li the rc-'Trt sy Kr. itlllev on behalf of 'the Technical, Informs.'ov. Subccraittee.) Pigment! Teak feoup One of the Boat active phases of eetivityof the Technical Information Suhccmltt. : . MrV Hiller said,. relate! to the work of the apecial Pigments Task OroupuMer the .direction of Arnold B. Ptneeteoe of Boater Grant Ccepeny, Ine* ftt\ Millar then called upon Dr, Kneatone to give a .report onthiaectlvlty. Dr. Pineitibc noted1 that, earlier thie Tear, a camamlcation u aaot to all member* of the full Cc*dttee regaWM the membership1 Intereet in participating in e "round-robin" tasting program using the atonic- absorption evaluation Method to detendne heavy aatala extraction potential from plaitlce. When the firit ccnmmication did not produce such of a response. e second letter wee sent to everyone by the Secretary under date of May 20, 1266. Bov,at leaat sixteen .. companies have signified' preliminary intention to participate In the etonic absorption, evaluation program. Dr. Plneatone than read the following parti of a cmnunieatlon of August 8, 1966, ' covering the detaila of how tha .proposed round-robin testing program would be handled. "Subject: Pigmnte Teak Group Proposal far Atomic Absorption Evaluation" Program "The results of the letter 5/20/66 and attached questionnaire from the Pigments Tank Group Chairman to the STX Pood, Peckaging Materials Committee' membera concerning participation In a program to define the applicability of atonic abaorptlon toch* nlguea have been, tabulated. Tha atntlctlcs derived from the survey are. aa follow*: 'Sixteen oimg^ies have, signified preliminary intention to participate; .and this extremely gefteroufc recpooae will allow; ua to carry out the request of the Pood Packaging Materials Committee. 'Five natali are of primary interact (Cd, Hg, Jfl, Cu, Ct). 'Seven polymer type* are of primary interest (polyityrene, lqpact, ABS, Kyion, polyethylene, polypropylene and FVC). SPI-26989 'T^v . . - .. . 21 . 'At least two concentrations of each pigmsat (0.25 end ljl) should be checked. 'Six extraction conditions ere acquired.1 "considering the above faotors, a practical-program has been formulated to minimise the work load per participating cempeny while attempting to maximize consistency. *1. One company could supply ill five plgsmats necessary; 150 grass of each of. five types, should be sufficient for the' entire program. .. , '2; All euplsa of a polymer type would be made by one ccmpany, ^Therefore, seven companies vould prepare specimens from one polymer type at two Concentra tions sal frees five, pigments. retails of suggested specimen preparation are; etteobed to maximize uni- fonlty. '3. To keep the extraction verb at a minimum, each employ would extract only one polymer type* This would allow each of the seven polymer types to be ' extracted by two companies. .. j Total extraction per company: 1 material x 5.pigments * 2 concentrations * 1 blank 11 samples x 6 solvents 66 extraction .. samples* ... Details of modified extraction procedure are attached. *4. Total.work tar Atomic Absorption: 66 samples x 14 companies 924 analyse*. *5. Cost: Jarrell Ash has quoted 75 cents cost per ' analysis, which totals $70 per participating company. Allowing for contingencies, the analytical coat ptr . company should not exceed f125. '6. A .suggested .participation flow scheme and time table * Is attached.1 "The above program will not answer every question; however, It does incorporate. the suggestions made by those responding, to the Figments Task Group'* survey. In addition, it la workable and practical while covering the desired polymer, Betti and solvent combinations. A complete rouftd*robin has been suggested as an alternate^ with each company extracting each polymer typs. The number of extractions involved,, however,; makes this approach impractical. SPI-26990 i "Allowing the aeabert reeelving this yyqyotil time f<*. approval, * reply would >e to order ty August tt. Assuming ell affinitive milts, the proiWif.M- outlined to tb* flov*eeheM,.could start August 2?. Dr . Eineetone pointed cut. that t|M present IntentIsa la tobave each cueg>any extract only one polymap type; with one laboratory. hsndjlag the eaiZyei* by atomic absorption* Wf doing this, the ooet to each efispapy, at fir* Plnasterne's report points eat. will be kept at a minimum, the eoat probably being around $70 and net exceeding $125 per eempeny. In referring egala to1''hie report as presented at the day'a Meting, fir'. Plneatone aald that it aay now be necaastry for him to revise the protocol for the prrpoeed round-robin program la light of the "guidelines* efelohibr. geekmaa vee able to Obtain from TOA Juat prior to the day'e meeting. Ibu, there Bay be a elicit Ad ditional delay In eoMeaelng the program. Zn response to a. question about overall lining' for completion of the Pigments Teak Oroup aaelgnaeati Dr.Flaentone aald that, hopefully, by-the hlddle of .October,, the actual evaluation will tovw been completed, and then It rill be up to hie Group to begin interpreting the data. Hr. Ingle eald that lie Wouldbope that poaaibly Dr. Flneetone would beve a completely definitive report on progress at the next neetlng of the Ccmmlttee. - Zn reapoaee to questions free aev ettendeea et the d-y'a station, Dr% Elncetone reminded that,, aa originally, edneeivad and a a still intended, the ala of the overall Committee la this'arte la to prepare a manual or detailed bulletin dealing v 1th the proper evaluation of the uea of plgMnta in plaetlea. International DevlopBiota Hr. Ingle noted that the Agendas for the peat several Matings have provided, for open discussion of International dsvelcpMnta, the objective being tb give the nehbera of the Coanlttet an opportunity to exchange inforMtlon on the status of packaging naterUla regulations as. they exist or are being promulgated In European countries and elsewhere to the*verid. Referring to the Dutch Food Paeknging Legislation, which*** discussed at earlier Meting* of the overall Condittee, Robert Miller stated that under date :of July 7 he bed ceanunieeted vitfa Jerome lit. Haokmma, Esq., regarding an up-to-date report which a Hercules representative in the Hague ha* provided on the projected Dutch food Packaging Lsgislatloo. ' He then read end eomanted generally on the following portions of his earlier latter, dealing with the packaging decree in the Hetberlands; "The meeting was told that the Minister has received so much crltlclsa on the present draft that another draft will ba prepared, with publica tion expected In the fourth quarter of this year. "This tvsv draft will permit'* total contaBinatlon of food by the packaging naterUl of lOO^ppm,. ihia la a victory for""industry, line* the goyermant representatives wanted to allow only 10 ppa. Analysis Mthoda to determine the amount of ContaBinatlon vlll not be given in the draft decree, another victory, for Industry. However, analytical methods to determine the content of packaging '* SPI-26991 materials; la the food will to be developed. .ginee the decree trill opacify contamltiatiom ,1 tfee food, strictly speaking It do loafer will be euftteient to use food simulating gelvente , but the consensus la theb the food law Inspectors villacewpt sibilating solvent* if the total cbatotuiafttloki la ion thou tbc 100 .ppm* If ore then 100 ppm it extract* tb solvents, an analytical procedure for the food will beve to bo supplied if the material ie to be used (seaming thie would result in loss then 1GO ppm). The government is interested in % comparison of extraction using food simulating solvents with actual migration to food sod eelced for any available,date (7DA Rut^trs Study). . "The current drnft decree state* that certain chemicals could not be used* The new draft probably will aay 'nay hot be present'. In the new draft there will be an .article to the effect that chemicals any be approved by 'Ministerial Decree*, permitting additions to the list without changing the law, which would tabs . much tine." A. w. Downes, Union Carbide Corporation, wade mention of tome general impressions which representatives of his ecaqpany have received upon visiting Europe recently. For instance, Mr. Downes said that one feeling th* Union Carbide people stressed isthat the foreign regulatory agencies seen fully aware of FDA food Additive Bsgulationa, but are at111 desirous of actually seeing any data used in obtaining FDA approvals- before they will approve food packaging aateriala exponents. Hr. Downes reminded that European agendas isy sometime* agree that an ingridient is safe in food, but still do not "want it. in the food", so extraction information is always relevant to then. Also, he mentioned information he has received confirming that different agencies within a country often vie with each other for a dominant position in any regulatory situation.. Dr* Finestone, Foster Grant Company, commented on his participation in Comlttees In the Netherlands-andelsewhere, most .pertinently the BIT {Bureau Internationale Terminal) which la edapoaed of representative* from industry in the else Common Market countries. Br.Flneston* noted that there is a continuing difference of opinion' among representatives of the six countries participating in BIT, ranging ell the way from a liberal point of view regarding materials coverage by Implication, to ft much nor* restrictive point of view,demanding positive listing of any "Input" substance used In making a packaging aaterial. Negotiations are always in progressto resolve major differences of opinion and the whole situation 1* further confused by tha problem of deciding among these countries as to whose concept of appropriate extraction tests, among other things, la to be accapted. Mr. Ingle noted that the subject of International developments will' be included on future agendas to allow for similar exchanges of information. Next Meeting Mr. Ingla stated his'understanding that the next seating is to be held in Washington, D. C., assuming arrsngemeata can be weds for the Coamlttee to meet with representatives of FDA aa.previously discussed. It-yaa agreed that the Steering Canutes will try to choose a day at the end of Ifweaber, or during the flrat week In December for these naxt'sesaions. There being no further business, the meeting; was adjourned at 2:?0 p.m. Respectfully .submitted, CLCjidh Charles I>. Cbndit, Secretary Enel* .% . i* SPI-26992 Auguat 85,1966 . Tba Technical Information 9ubcoaalttea hat sot ait formally eiace tba March 3, 1966 full CeMhlttee mating.Iheoaly major eurrent'projeet under iwntfiWtico la the colorant in plaatlee problem regarding FDA atatua, and ihla It being handled b'j pur Pi^enta ^iik QroMp under,tba Cbalraanahlp of Dr. Arnold Planatoon. Ha will report on thla (roup'a activities latar. One of the assigMMnts of tba Chairman of tba Technical Information 9ut> comlttee la to aarva. aa lialaon with tbe.3-A ftanderd* Ccmittee and tba Dairy and Food.Industries Supply Association,. tinea our last meeting, I would Ilka to report tbetthe proposed addition .of Ffcrlon 6 to tba 3*A Sanitary Standards for Plasties wtt adopted at the reoeotJ-A Beating 1a Qklahfu City* Official ooplaa have bean eent to the respired algeera feevulldatlee. Xn addition, a new tamdaut to tba 34 : Sanitary Standards for plastic* baa bean proposed to include ASS aa a new generic data of plastics vltb appropriate performance specifications 'ibis proposal mat go thrtnigbtbc usual approval* and. If approved* will b*.added to tba stkadards at ' tba next annual netting. Tba following final now food additive regulrtioos, mended regulationa, proposed regulations, withdrawal* of petitions, and notleaa of filing* deamd of Intaroat to the 8PX Pood Packaging Matarlala CoaBlttee, bava baan published In the Federal Register since our March 3, 1966 mating t sctioh tm .. pats ________ sumcr --' Piling 3/k/66 partially oxldlxad polyethylene u protective coating or component of coating.for fttab fruits and vegetable* 121.2531, 121.2589 121125k! Amendment Amendment ; 3AM Provide for uaea of aootbar mineral oil 3/9/66 Provide for emulsifiers In FVC dnd/ov vinyl chloride--vinyl acetate copol ymers for food contact 121.257k Withdrawal . 3/9/66 Add Bonochlorobansane to polycarbonate resins Filing .. 3/10/66 Provide for uaa of polyvinyl alcohol. 11 tabletlng adjuvant in vitamin concentrate* and multivitamin concentrates SPI-26993 I* suepeading agent In vinyl ehlorli* copolymer ratine and bydrogen-nbutyl-(36-endamfthylene-1,2,3*6' tetra-bydrocl*phthalete) at Bonaoer in vinyl chloride copol* ymer reelne Glycldyl acrylate and glycldyl aetheery'Utc as camoncttcre In vlnylldent chloride copolyacra Add eubstence as antioxidant for polyamide reelne Triethylene glycol In Ink for printing food contact material* Coated polycerbonete film SPI-26994 SBCTIOH - 121.2597 121.2503 121.2501 121.2507, 121.251U, 121.2569 121.2501 121.25U 121.2599 121,2570 131.2526 ' 121.25^1 TtgE_ -- Notice Filing Filing -AmewJmsnt Piling Amendment Amendment Notlea Key Reg. Amendment Withdrawal Withdrawal Amendment Mt V13/66 h/23/66 flPBJBCT BUG Pesticide Xaslduaa Ceattlttee-- Stetament for Ttylamentation of Report on No Seeidus and Eero Tolerance Notice 0f opportunity for hearing-- proposal to refuse to approve NLA with prejudice--heactran Injection 6ft in plastic eoatalnars 5/3/66 Provide for increaeed levels of .. acrylic modifier* in sanlrlgld and rigid pVC plastics 5/3/66 Provide for terpene resins In polymeric films 5/7/66 5/7/66 Olefin polymers--define copolymers . Provide :for use of W,h-bis(U-hydroxyphacyl) pentanolc acid-modlfl^c polyamide resins In coatings' 5/17/66 Additional uses or noncrystalline polypropylene- 5/13/66 Add sodium n-mikylbenseneauifonate as emulsifier 5/28/66 Order refusing approve1 of supplemantel NDA for Lextran Injection packaged in plastic containers 6/7/66 Vinylldane chloride cpolymer coatings for nylon film 6/7/66 Extraction tests unnecessary for ethylene-vinyl acetate copolymers In adhesive* 6/25/66 Use ofalicycllc petroleum hydro carbon retina 6/25/66 Vinyl chloride-cetyl vinyl ether copolymers . 6/25/66 Add substances u emulsifiers SPI-26995 sscnoii 121,2569 121.2526 121.2514 121.2541 121.2592 121.2513, 121.2527 121.2590 121.2566 121.2514 121.2527 121.2550 -- 121,2514 - WrtMA 4. TOT _ wn. SUBJSCT Withdrawal 6/30/66 Dlcyclobe.yl pU-Voalata a# plasticiser Amendment 7/2/66 Add item ae emulsifier for vlnylldene chloride eopolymer coatings .Amendment 7/2/66 Add certain acrylic - eopolymars as modifiers far epoxy redns Amendment 7/9/66 Add item as polymerisation emulsifier for FVC and/or vinyl cblorlde-viayl acetate copolymer* Withdrawal 7/12/66 Esters of gum rosin ` Piling 7/23/66 Use of 2v5*41(5*tert-butyl-benzoxatolyl-2*))thlopbeae aa optical brlgbtener In certain polymeric expounds . Revocation Amendment Amendment 7/27/66 7/28/66 Revoke 121.2513* antlfogglng agent; amend 121.2527 to provide for antistatic end/or antlfogglng agents, and add Mw substance* Previalone not applicable for use la adhesives Amendment 8/2/66 Add 2-hydroxy-4-n-oct6sybnt(>* phenone as stablliaar in poly* ethylene and polypropylene plastics Amendment ' 8/6/66 Add substances for can and comen'j mine 6/9/66 Provide for use of amine In added or extruded polyethylene food containers Amendment 8/12/66 Add certain Items, revise listing of subs.tance* for closures, with sealing gaskets Piling 6/19/66 Use of certain resins ae food contact, coatings Filing 8/19/66 Add. allyl alcohol to atyrsne copolymer# lU. SPI-26996 Filing ' ,{2 petitions) 8/20/66' Certain vinylidene chloride dopolyaars as coatings for nylon film Filing 8/20/66 Certain epoxy rastns and eerte'i*v polyethyleneimlne resins as components of coatings on poly propylene film TMm . Filing 8/SO/66 Certain ethylene-propylene polymare optionally containing a nanooRjugated bicyclodiene earn Filing 8/30/66 'Dlsyristyl thiodlproplonate as antioxidant -in plastics mm Filing 6/24/66 H-alkyi (cl4*Ci8)*l,3-prcpandir - mlne-N,))*,N*-trlscetlc eeid ss , antioxidant In certelo polymers It will b poted from th abov listing that there have been numerous notices of filing and amendments to existing regulation* since our last report. The tuny ^ filing notice* suggest that FDA is receiving numerous petitions and ere following the procedure. in the food Additive Regulation* of filing then before asking s "w complete review. 1 In addition! the above listing contains several more notices of withdrawal of petitions than usual,, again reflecting FDA's nav policy. Sevetal of these listed items already have been discussed, bu I would like to point out someof the others of interest: J .4 .I "] j j .j Several notices of filing have been published pertaining to coatings for plastics; among- them are a Morton Chemical Petition for vinylidene chloride copolymers doatings for nylon film and an FMC Petition to provide for the use of coated.polycarbonate film for food packaging. Already mentioned are.the amendments to 121.2501, one defining the copolymers, and the other providing additional uses of noncrystslline polypropylene. , . ;.-j ] 71 ,1 Two itiras of interest were FDA notices concerning the refusal to approve Pew Drop Applications by Fbamschem Corporation for Dextran Infection .it packaged In plastic containers. The first waa a notice of opportunity for a bearing and e proposal to refuse to approve the New Drug Application! while the second was the order refusing ap proval. The-carnal reader of these notices night gst the impression that the plastic containers were at fault, liberate the refusal actually was based on Inadequate tests of the packaged drug to demonstrate ita safety and stability. j 4 * / SPI-26997 -6 - An amendment to 121.2570, ethylaae-vlayl acetate copolymers u published, stating ***** the extrsetiosi tests in 121,2570 ir not ' pplieeble to tA,ct ethj'lene-vi&yl ecatste- espolyu^rs used in fpod pKlhltm iihnivMV -tin point of interest 1 that tha embedment . statsa tha toft if unnecessary because penltted use in adhesives undar the ecmdltlcae prescribed by 121.2520 if not fxpectedto result in Ignlfleent amounts becoming covenants of food. This ia ooa of tbe first ttaas that PDA has published such a statement. A petition baa been fllad by Robm-Haas to amend 121.2597 to provide for increased ,,lavela of aery-lie modlfiara in stmi-rlgid and rigid PVC plaitica. A patltion by Kureha Chemical Industry United for tbe use of vinyl ehloridt*eetyl vinyl ether eopdlynara ia food oontaet articles baa . bean Withdrawn'. Section 121.2513, AntlfogglAg Agents, mi revoked and 121.2527 was . amended to prorlda for antistatic and/or aatlfogglng agents, and new coapounds vara added. There also ware other petition* noted for antloxidaata a&d stabilisers. Another notiee of potential Ihtereat not mentioned at tbe meeting was publieh-c in the Federal Register of June 21, I966, Page 659b. This concerned a Notice-of Proposed Buie Making for Biological Products publisbed by tbe Public Health ^Barrier , where they refer to the requirements for containers and closures, These requirement, seem quite similar to.those for dyug containers, but I thought tba Ccwittee should be aware of. the*. That part of'tbe notice ielating to. than ia quoted below: "l7336 Physical etebliafcment, equipment, animals end care. (h> CootsInara and Closures. All final containers and closures shall ha maiia or material that vlU not hasten tbe deterioration . of the/product or otherwise render it leaa auitable for the In tended use* . All final containers and cloaurea shall be clean and free of surface solids, leecbabl* contaminants and other materials that will hasten tba deterioration of the product or otherwise render it leas suitable for the intended use. After filling, sealing aball' be performed in a msnner that will maintain the integrity of the product during ths dating period. In.addition, final container* and closures fear products intended for use by injection shall be sterile and frea fren pyrogens. Except as otherwise provided la the.regulations of this part, final con tainers for products intended for uae by injection shall be color less and sufficiently transparent to permit visual examination of the contents under, nornal light. AS soon as possible after filling, final containers shall ha labeled as prescribed In 173*50 et ssq., except that final container* may be stored without such' prescribed labeling, provided they are stored in a sealed receptable labeled both inside and outside with at least the proper name cf the produet, tba filling lot mssber, and date of filling." Respectfully submitted, * Robert M/NUle*. s'. .`a *n -*5 SPI-26998 SPI PMA Utlioa Orottp September IS. 1W * I a. m. 2TO Ptrk Avtiim. Kty Ybrk The following were in attendance; ' . SPI . ' 1 . ' <* , . 0 \ *f t * '* ' ` ' P. !.Campbell . PhlUlpa Petroleum- BarileavUle,. Qkiahoi A. w. Dovini *. Union CarfeidaPXbttlc* Olvtitmi itTO Part Avenue Na# Tart ( N. T. Rdbirt li; Miliar * H#rciile#,,Iie;, Wtlmlaftoiit Delaware v Kenneth Morgareidge -Foo&fciDrug Reaeirch-Mupatii, N, Y, A. C. Slihbri IftataatePiefcMfeg Dlviaiog 101 0r^ JtrMt,Bloo^ltd , Coul: M. E, Smith -Oven# BlS*oU ~14th 4 Adema Streeta ^ Toledo,Ohio . W. M. TTaatveer -DowCheinical- Midland, Michigan PMA PrwdBacker-Mercft3faarpAI>*hme,WetPotatvPi. Harold B. Bryant - BuntbidMi Ma. - Canter' <B-DV Baltimore, ltd, W, W. HUty - EliLilly*Company- bkdlaaapoli* , Indiaifa E. O; Krueger - AbbottXabdratertfa * North fChicagc,Ulinote Richard W. Pectoa-AbbCrttlAboratorlea-Worth Chicago, nilaou The purpoa* of tMa meettng waa to develop teat proceduree which would be eatiafactoryfqrprescribing Polyolefin Polymere acceptable for packaging dry .drugs (ptila,.tablet* ate.). TTie outlln* eubmitted by Mr. Krueger waa reviewed 1o determine whether, (here was a need for-any additional teate not. included In Hr. Krueger'a outline; - ` the queation of oxygen permeabUltywaadtecuaaed andtheconaeaeua . waa that if a* drug Vaa aenaittve to oxygen, It Would never be packaged in ptewtica.. o that a teat for oxygen tranamlaeioa waa uaaeeeaaary. \;Dr.Wajrtoe fciltypf Eli LiUy A Ccrnkpany -Uften dUcueaed ta detail the procedures which werarifmTnratwAod for the fallowing'thetadeemed neceaaary : both, to aatiaify the Drug laduatryae' wall a* FDA. SPI-26999 8wrl suggestion* war* mad* for elarijyiii and Infrodni tb* rteowiMnd#d pr*ctdm*t ud Dr, Hilty 1* to rewrtis the to*t yoetdorw mad abptlt'lbm to thegroup, It was eetlmated that It would probably be after tte flr*t of th* year before test work could b* started to develop limita tions for the following teats: 1/ Acute ^rstemlc Toxicity n. Beayy Metals at. NoawdUtU* Aestde* IV, Water TinenileeUin VY . Ught TteteiilMlsw Also although not originally pisneed for coaelderation wii the pipki|int;cf opMlwImlcdnig prodocts which would require 'an eyelrrltatisn test in addition to the lied citedabove. TWPMA'grdup pointed>ut that some definitionof identity of the Polyolofln woold bo required. gvi'"".- . It was agreed that tho-SPI representative would each draft ft suitable atatexhentfpr Ua Polyolefins and send ftaa tc A/V< l>owifit17t Part Awoi>, NowTork, W, T. hy Qetehdr ilth, These will be edited sad rooidMeittod for review by th* Teclmteal atesteimiidtt*. - No plans for another meeting appeared to be justified with tbs PMA group pending the development Of teat date based mi the procedures recommended. After receiving the drafts of the proposed Identity statement for polyolefine a meeting may be required of the 8PI Ltaiwoti Group with the Technical subcommittee of the food Peckagfrig.Committee to agree bn the proposed identity '' statement for Polyolefin*. The meeting adjourned at 11:50 a. m. AWD:MK A. W. Downes Chairman iSFI-Liaison Group copies, to: ees ir. C. U Cpodit, 8P1, 2*0 Park Awe, .New York Mr, J. Beckman, Keller A Heckman,!?!* N Strodt N.W^ .^Washington,!).C, SPI-27000