MAY l 5 1969 LAW OFFICES Keller and Heckman JOSEPH E. KELLER .JEROME H. HECKMAN 1712 N STREET, N1 W, CHARLES M WILLIAM MEEHAN WASHINGTON, D. C . 2GO30 396-2700 ROBERT R.TIEHNAV wayne v. TELEPHONE H, BOROHESANI, JR, CABLE ADDRESS"KELMAN" black THOMAS J. H I'CJHES, J R DAVID I-HILL May 13. -969 To the Members of the SPI Food, Drug and Cosmetic Packaging Materials Committee Gentlemen: Following up cn cur recent correspondence concerning the new Food and Drug Administration pro­ posal relative to basic revisions in the future regulatory plan for certain classes of incidental food additives, the purpose of this letter is to bring you fully up to date on the most recent developments in this very important area. Pricr to telling you about some arrangements made during and after our anticipated conference with your Chairman, Bob Miller, on May 8, I thought I would call your attention to the coverage given the Ramsey letter of May 6 in the current issue of Food Chemical News. So that you can have the benefit of the trade publication report on Mr. Ramsey's letter, the proposed revision of Section 121-2500 included therewith, and the way in which Mr Rothschild, the Editor of Food Chemical News, has related t.h-s material t.o the socalled "Frawley proposal" and the National Academy of Sciences Task Force Report on "toxicological insigni­ ficance," we are herewith enclosing reproductions cf Pages 3 through 5 of this week's issue of Food Chemical News. Reproduction of this material was accomplished, as usual, with the permission of the publisher, Turning now tc some cf the arrangements made m the direction of following up on Mr. Ramsey's letter, we did discuss the entire matter at considerable length with Bob Miller when he was m our offices to help pre­ pare the next Food, Drug and Cosmetic Packaging Materials Committee meeting Agenda last week. During our discussion, we noted a number of areas m the FDA proposal which would seem to call for comment by the Society, and, hopefully, clarification by the Food and Drug Administration. As you would imagine, most of our concern centered around ASI-pr 0000746 the proposal to exempt fr__m the i. e jdi r ement tor the filing at petitions materials which wvuld not be expected to add more than 0 05 ppm ot a toed packag­ ing component, to a food. Among other things, we believe that this proposal should at least be clari­ fied substantially so that we oar. have some better idea of how . t will be implemented in day-to-day practice. We would expect that th.s is a subject which will be discussed extensively at out full Committee meeting on June 19 In addition, however, we are planning to give the matter some further thought, both independently, and in c injunct.on with ether industry groups Toward this latter end, and . r. Keeping With the authority given your Steering Committee to work with ether industries' representatives whenever an FDA proposal was advanced. Bob and 1 have now beer, m touch with E,nar Wulfsberg. acting cn behalf cf the American Paper Institute. Our mam purpose ir. con­ tacting Mr Wulfsberg was tc determine whether or not he believed a meet mg it ‘.he . nrer-mdas try representatives who met prior t: the Nat.cnu* Con­ ference on Indirect Food Add.tives m.ght be m order to discuss the Ramsey proposal as a premde to the indus t ry-by-mdus t. ry meetings FDA has suggested We were especially anxicus t.c knew whether Mr Wulfsberg would be willing to calx such a meeting since the American Paper Institute has previously acted as some­ thing of a spokesman for the informal inter-.ndustry group in, for examp.e, "quarterbacking" the letter which was sent tc Dr Goddard pt.tr tc the National Conference to urge the estabathment of a Gmerr.mentIndus try Advisory Committee Mr. Wulfsberg was most mmrested in cur suggestion for a meeting, has new cleared tne matter with his superiors, and is presently planning tc send out a meeting invitation to the i nter-mdust ty group.Arrangements have now progressed to the point where Mr. Wulfsberg will be .nviting representatives of all of the industry associations who participated in the National Conference to attend a session m Washington on June 3, 1969 Please understand that this m1. not be an open meeting. It is expected that there will be only a few representatives from each of the industry asso­ ciations invited so attendance or, our pare wTIi be limited to the members ofthe Steering Committee as a maximum. We shall, however, be reporting on this meetmg at cur June 19 meeting of cur Committee. ASI-PR 0000747 3 We hope that this letter wj.ii bring ail or yea completely up to date cn what ^s taking place Please do provide us vvith your comments on the FDA proposal, and by all means feel free to ret us know if you have any questions on any phase cl the Situa­ tion as it -s developing. ends ASI-PR 0000748 FOOD CHEMICAL NEWS Editors: Louis Rothschild, Jr.; Raymond Qalant Subscription Manager; Natalis Pargas r c ■V Lu May 12, 1969 W FDA ISSUES INDIRECT ADDITIVE "DISCUSSION DRAFT" PROPOSAL The Food and Drug Administration has formalized its staff paper on easing regulation, of indirect food additives to the extent of sending it as a "discussion draft notice of proposed rule making" to representatives of trade association which took part in the 196 8 FDA-industry conference on indirect additives"' (See FOOD CHEMICAL NEWS, Feb. 19, 1968, Pages 3, 10, and 18). The proposal, on which comments were requested, is essentially the same as an FDA staff paper which was circulated last year within the agency (See FOOD CHEMICAL NEWS, Aug. 19, Page 3). i Key point in the FDA proposal is an exemption from Food Additive Law clearance procedures for substances used "as components of food-contact articles provided any substance so used contributes no more than 0.05 p.D.m. of additive;to the contacted fpod as determinecTby analysis of the food, or%y appropriate extraction studies, oiSby calculation assuming 100% migration. " i i The key industry proposal, propounded by Hercules' Dr. John Frawley, would exempt from clearance procedures substances that migrate into the food supply at not morethan 0..1 p. p.m. These, under the, Frawley proposal, would be indirect additives used at less than 0.2% by weight of the food container. FDA Sticks to Need for Extraction Tests for Contacted Foods The key difference between the Frawley proposal and the FDA proposal is that the Frawley recommendations would exempt substances which can migrate to the food supply at no more than 0. 1 p.p.m. - - without the need for extraction studies. The FDA proposal would require extraction studies to show that the substance could not migrate at more than 0. 05 p.p.m. into a specific food contacted. Thus, there will be some industry dissatisfaction that the FDA plan would still require extraction studies. However, there will also be some satisfaction that FDA has at least opened the door to the theory^of toxicological insignificance so far as food additives are concerned. FDA undoubtedly was influenced in preparing the draft proposd by the report ' of a National Academy of Sciences Task Force which recommended adoption of a philosophy of toxicological insignificance (See FOOD CHEMICAL NEWS, Feb. 3, Page 29; and April 14, Page 2). The report recommended that additives used for at least five years at a level up to 0.1 p.p.m. of the total diet be .con­ sidered "toxicologically insignificant. " The Task Force suggested that substances * * ASI-PR 0000749 Page 4 May 12, 196 9 FOO ) OIEMICAi NT used at higher levels than 0. ^p.p, m. ior for less than five years be weighed b' analogy with similar substances for which data is available. The agency did not go Jo the Task Force philosophy based on the level of an additive in the total diet. However, it did embrace the concept of toxicologica i insignificance. The NAS Task Force report was not mentioned by FDA in its draft proposal, since the language of the report has become embroiled1 in some controversy in an NAS publications committee. Thus, the report - - already well circulated - - has not officially been issued yet by NAS. FDA endorsement of a concept of toxicological insignificance, although limited in this case to indirect additives, may eventually have some significance for tl . field of direct food additives. Industry representatives with a stake in flavor substances hope that adoption of the "toxicologically insignificant" phildsophy may influence European experts who have tended to take a strict view of flavors in the past (See FOOD CHEMICAL NE.WS, April 2L Page 3). In addition to indirect additives migrating at no more than 0. 05 p.p.m. to con­ tacted food, the FDA proposal would exempt from clearance procedures, the following: (1) Components of articles intended for use in contact with dry solids with the surfaces containing no free fat or oil, provided the finished food-contact surface contains no free oils not otherwise permitted for such use. I (2) Components of articles intended for repeated use in contact with-bulk quantities of food, provided the finished food-contact article is thoroughly cleansed prior to^first use in contact with food. i (3) Components of defoaming agents employed prior to or during the sheet-forming operation in the manufacture of paper and paperboard intended for use in contact with food. (4) Components of food-packaging adhesives complying with the Food Additive Order for adhesives (§121.2520). These exemptions, if proposed in th^ Federal Register and finalized, would mean the deletion from the Subpart F Food Additive Regulations of a number of lists of substances. Among the Orders which might disappear, at least in part, are §121.2520 for adhesives, §121.2519 for defoaming agents used in the manu­ facture of paper and paperboard, §121.2571 for components of paper and paperboard in contact with dry food, ^nd §121.2562 for rubber articles intended for repeated use. The proposed exemptions also may make unnecessary Food Addi­ tive Order proposals under consideration for colorants for packaging materials. I Excluded from the exemptions would be: (1) Heavy metals, as identified under Heavy Metals Test in the Food Chemicals Codex, and compounds of such heavy ASI-PR 0000750 - .' r age f’OOO CHEMICA May 12, 1969 metals; (2) Substances prohibited under the Delaney Clause of the Food AduLti.', e Law, which bars clearance for potential carcinogens; and (3) "any other sub­ stances that have been demonstrated to produce toxic reactions when present at levels of 40 p. p. m. or less in the diet of man or animals. " The "40 p.p.m. " level for toxic reactions is a new section, replacing a more generally worded exclusion in the FDA draft of last year. Basically, it is intended to bar exemptions for agricultural chemicals and other biologically active substances. The NAS Task Force said that "no commercial compound has been demonstrated to produce toxic reactions below a dietary concentration of 40 p. p.m., " a calculation also made by Fbawley. In letters from FDA's L. L. Ramsey, Assistant Director of the Bureau of Science for Regulatory Programs, the trade associations which receive^ th document were told it is a "first response to comments received in connect on" with the conference on indirect additives. Ramsey invited comments, and aid the agency is willing to meet with trade association representative® on an industry-by-industry basis. j FDA had been urged to establish an industry advisory committee to help deal with the problem of indirect additives, but this approach was rejected. In the draft of the exemption proposal, FDA said: : "Having evaluated comments received in connection with the . . . conference, and other relevant information, the Commissioner . . . proposes that1 the food additive regulations be amended ... to provide for use of addi­ tional substances that under conditions of good manu­ facturing practice may be safely used as components of articles that contact food. Under the proposed conditions of use, these additional substances are not expected to become components of food in any toxicologically significant amount. " * The exemptions would be added to §121.2500(d) of the regulations governing indirect additives. This section now exempts substances which are "generally recognized as safe" for use in or on food or in food packaging, siibstances granted "prior sanctions, " and substances cleared under Food Additive Orders. NEW "NADER RAIDERS" TO PROBE CPEHS, FDA IN SUMMER 4 A new team of "Nader's Raiders, " composed of eight medical students from . schools around the country, is expected- in Washington this summer to concen­ trate on activities of the Consumer Protection and Environmental Health Service with particular emphasis on food purity and air pollution. ASI-PR 0000751