Document ykVxeNmRO21knx7J5mDKLgb3

Manufacturing Chemists Association MINUTES OF MEETING ;j FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE MCA Conference Room (Room 404) Washington, D. C. October 1, 1974 07/ Members Present: G. w. ingle. Chairman T. R. Aalto W. C. Bachtel (Pending) J. J, Bonin (for E. L. Hobson) R. S. Bryant Charles Feldberg W. j. Goebelbecker (Pending) W. A. Knapp J. A, Korth R. A. Moody Peter Morison J. J. Moyna J. M. Norris A. M. Schnitzer M. B. Ver Nooy (for C, P. Carpenter) Samuel Zuckerman M. M. Hoover, Secretary Guests Present: H. A. Birnbaum Max Goldfrank Walter Schleyer J. c. Weber Members Absent: C. P. Carpenter T. W. Hanavan E. L. Hobson W. H. Meyer R. M. Miller H. L. Schulman G. A. Sunshine R. G. Troup S. I. Trotz Monsanto Company Tenneco Chemicals, inc, B. F. Goodrich Chemical Co. Shell chemical Company Stauffer Chemical Company CPC International, inc. Pfizer, Inc. Allied Chemical Corporation CIBA-GEIGY Corporation Universal Oil Products Co. Eastman Chemical Products, Inc. Merck & Co., inc. Dow Chemical company Phillips Petroleum Co. Union Carbide Corporation H. Kohnstamm & Co. MCA Staff 3M Company Celanese corporation Philadelphia Quartz Co. Monsanto company Union Carbide Corporation E. 1. du Pont de Nemours & Co. Shell Chemical Company Procter & Gamble Company Hercules, Inc. Mallinckrodt, Incorporated ICI United States, Inc. J. T. Baker Chemical Co. Olin Corporation ASI 00003483 2- - I GENERAL MATTERS 1. MEETINGS a. Minutes of Last Meeting The minutes of the May 15, 1974 meeting of the full committee were approved as distributed. b. Future Meetings It was tentatively decided to hold the next meeting of the full committee March 19, 1975 in Washington. The chairman indicated that Mr. Sunshine plans to call a meeting of the Legislative and Regulatory Subcommittee for October 29, 1974 in Washington, and Mrs. Norris indicated she would call a meeting of the Scientific Subcommittee for a day during December 1974, also in Washington. 2. PERSONNEL The secretary read Mr. Hagan's letter of resignation due to new employment, and noted that Mr. Moody has been officially appointed a member of the committee. The committee voted unanimously to recommend to the MCA Board of Directors that W. C. Bachtel of B. F. Goodrich Chemical Company and W. J. Goebelbecker of Pfizer, Inc. (succeeding C. F. Hagan) be appointed members of the committee. II. SUBCOMMITTEE MATTERS 1. STEERING SUBCOMMITTEE G. W. Ingle, subcommittee chairman, reported on the meeting of the subcommittee held in the MCA Conference Room (Room 404) immediately prior to the meeting of the full committee on October 1, 1974. Present were Mrs. Norris and the secretary in addition to the chairman. Absent were Messrs. Meyer, Schulman, and Sunshine. The main topic for discussion was the NAS Symposium on Specifications for Food Ingredients (see minute Il3). 2. LEGISLATIVE AND REGULATORY SUBCOMMITTEE Mr. Ingle noted that a number of matters were brought to the attention of the subcommittee by the secretary since the last meeting of the full committee, that the absence of the subcommittee chairman was unavoidable, and that the subcommittee chairman plans a meeting of the subcommittee to be held October 29 as noted in ftSX 00003*84 in minute I-1-B. (No report was received from the subcommittee, and no meetings of the subcommittee were held since the last meeting of the full committee.) a. GRAS Affirmation With respect to the package of 26 documents in Part II of the September 23 Federal Register dealing with Food Additives and GRAS Substances, Mr. Bryant called attention to the proposed requirement for detailed description of method of manufacture in the notice for Methylparaben and Propylparaben, and Mr. Goldfrank referred to the notice titled "Electrolytic Diaphragm Process for Salt" which deals with a process instead of a substance. b. Recall Procedures Mr. ingle asked the committee to send any nonconfidential comments they may have concerning company recall procedures (bulk ingredients) to Mr. Trotz (copy to him, Mr. Sunshine, and the secretary). Mr. Trotz requested this item to be on the agenda, but could not attend. The secretary was requested to put this item on the agenda again for the next meeting. 3 SCIENTIFIC SUBCOMMITTEE J. M. Norris, subcommittee chairman, reported on the meeting of the subcommittee held the afternoon of September 30, 1974, in the MCA Conference Room (Room 407). Present were Messrs. Aalto, Bryant, Knapp, Miller, Morison, Ver Nooy, and Weber in addition to Mrs. Norris and the secretary. Absent were Messrs. Schulman, Trotz, and Zuckerman. a. Food Additive Specifications The subcommittee on September 30 reviewed the latest draft agenda for the NAS Symposium on Specifications for Food Chemicals (now to be held next February or March), and recommended changing the title of the paper to be given by the MCA speaker from "GMP Guidelines, QC Requirements, FCC Specifications - Similarities and Differences" to "FCC Specifications - What They Mean to Industry", and to relocate this paper from the portion of the agenda principally allocated to FDA papers to the portion allocated to the Food Chemicals Codex. b. Toxicological Guidelines, Chemical and Technological Requirements, Delaney Clause _________________________________ The subcommittee took note of the information items concerning Toxicological Guidelines, Chemical and Technological Requirements of Food Additive Petitions, and the Delaney Clause, ASI 00003485 -4- which were part of the June 25 report of the meeting with the director of the FDA Bureau of Foods distributed to the full committee. c. GRAS Review The secretary reported to the subcommittee on the response to his letter of May 31 to MCA member companies (requested by the full committee at the May 15 meeting), asking to be advised of "deficiencies or omissions" encountered to date in connection with any phase of the GRAS Review. He noted that the response included only two letters describing such difficulties, one in connection with phosphates and the other in connection with water soluble gums. d. Hyperkinesis The secretary also called the attention of the sub committee to Mrs. Walton's request for advice concerning a response to the September 11 article in the Washington post titled "Concerning Hyperkinesis, Food Additives, and Crime", and noted the item on GMA activity related to hyperkinesis studies, which was part of the August 8 report on the meeting with GMA distributed to the full committee. The subcommittee recommended no response to the Washington Post Article. e. OTC Review The subcommittee decided to recommend no MCA action in connection with the notice in the September 13 Federal Register titled "Proposal to Establish Monograph for OTC Topical Antimicrobial Products", which constitutes part of the overall OTC Review. It was reported that CTFA is reviewing this notice. f. Drug ingredient Specifications The secretary reported that Andrew Schmitz of Pfizer has agreed to represent MCA at the 1975 USP Convention to be held next March 22 in Washington, and noted Dr. Aalto's letter (distributed to the full committee August 21) concerning the purchase of the National Formulary by the United States pharmocopeial Convention, Inc. and a proposal that the government take over the compendia. 9* GMP Guidelines With respect to Good Manufacturing Practice guide lines for food chemicals, the subcommittee recommended that the secretary check FDA to see what is being done. It was noted that the NAS Symposium on Specifications for Food Chemicals may shed some light on this. It was also observed that the drafting of such guidelines would be difficult due to the wide variety of processes, and that volunteering them might not be wise. ASI 00003486 _5~ h. Food Additive Specifications The full committee took action on that portion of Mrs. Norris' report dealing with the NAS Symposium on Specifications for Food Chemicals. It was agreed that the chairman would decide (in conjunction with the director of the NAS Food chemicals Codex) the title and scope of the presentation to be delivered by the MCA speaker, and decide upon the speaker among the current prospects. The speaker will then be requested to prepare a draft of the paper for comments by the committee and consideration of the subcommittee at its December meeting. 4. COMMUNICATIONS SUBCOMMITTEE Mr. Ingle reported on subcommittee activities in the absence of the subcommittee chairman, noting that the subcommittee met August 5, and that the minutes of this meeting have been distributed to the full committee. a. MCA Food Additives Booklet With respect to the MCA booklet "Food Additives: What They Are, How They Are used", he noted that the latest revision has been published, and copies were distributed to those present. b. MCA Food Additives VisualPresentation With respect to Mrs. Walton's request for a recommend ation concerning an updated MCA visual presentation to succeed "Ann's Additive Story", Mr. Ingle explained that the results of a survey made by the MCA Public Relations Department indicated that extension home economists, FDA consumer affairs officers, teachers, etc. want such an aid. The committee recommended that funds be secured for the updating. c. MCA Speakers With respect to MCA speakers, Mr. Ingle referred to the recent unsuccessful attempt to secure an industry spokesman to appear opposite Dr. verrett on the Panorama show of a local TV station, and reported that he has been requested to participate in a discussion of "How and When Should MCA Speak Up" at the October 15 meeting of the MCA Public Relations committee. HI. LIAISON REPORTS 1. COSMETIC, TOILETRY. AND FRAGRANCE ASSOCIATION The chairman reported that he and the secretary have not yet had an opportunity to meet with CTFA, as has been done ASI 00003487 6- - with FDA, GMA, and PMA. Mrs. Norris said that she met with Messrs. Merritt and Estrin on September 30, that they are concerned about fluorocarbons and ozone, and that they feel a closer association with raw material manufacturers should be established. 2. FOOD AND DRUG ADMINISTRATION The secretary referred to the meeting he and the chairman had with Dr. Wodicka on June21. A report on this meeting was sent to the committee June 25. Dr. Aalto reported that FDA is revising its drug GMP1s, and that the previous exemption for bulk ingredients is not in the draft. 3. GROCERY MANUFACTURERS OF AMERICA. The secretary referred to the meeting he and the chairman had with Dr. Harkins on July 29. A report on this meeting was sent to the committee August 8. With respect to the proposal to raise funds to expand and improve on the hyperkinesis research to be done under an HEW grant, Mr. Feldberg reported he has not yet learned of the decision of the GMA Board. With respect to the GRAS Review, Mr. Feldberg reported that GMA is continuing to send Literature Reviews for comment, and to handle those that "fall through the cracks." 4. INSTITUTE OF FOOD TECHNOLOGISTS Mr. Goldfrank reported that IFT is increasing its public information program. 5. NATIONAL ACADEMY OF SCIENCES The chairman reported that copies of the proceedings of the 1973 NAS forum "How Safe is Safe" have been sold out, and that another printing is due out soon. 6. PHARMACEUTICAL MANUFACTURERS ASSOCIATION The secretary referred to the meeting he and the chairman had with Dr. Adams on June 13. A report on this meeting was sent to the committee June 19. 7. SOCIETY OF THE PLASTICS INDUSTRY The chairman reported there has been no recent meeting of the counterpart SPI committee. ASI 00003480 a. UNITED NATIONS The secretary referred to his report on the latest meeting of the Codex Alimentarius Commission (sent to the committee July 24), noting particularly the successful attempt to place the justification for the use of food additives primarily with the Commodity Committees (where the experts in this type of determination reside), and to limit the role of the Codex Committee on Food Additives in this regard to verifying that justification is in accord with the General Principles for the use of Food Additives. 9. U. S, DEPARTMENT OF AGRICULTURE Mr. Morison called attention to the notice, distributed by the secretary September 23, pertaining to amendments to Sections 318.7 and 381.147 of the Meat and Poultry Inspection regulations. MMHtsh October 3, 1974 Distribution "A" M. f^Hoover, Secretary Food, Drug, and Cosmetic Chemicals Committee ASI 00003489