Document YrabKJZNvRmzDpJ4goO0xg7qO

I 76-1 APR 2 2 *69 Manufacturing Chemists Association MINUTES OF MEETING FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE MCA Conference Room Washington, D. C, April 2, 1969 Members Present W. E. McCormick, Chairman T. R. Aalto R. N. Bell C. F. Hagan T. W. Hanavan W. A. Knapp W. H. Meyer R. M. Miller K. E. Mulford P. E. Neiman O. H. Peterson R. F. Philpitt Robert Ruark (for J. A. Korth) H. C. Spencer M. B. Ver Nooy (for C. P. Carpenter) M. M. Hoover, Secretary B. F. Goodrich Company Tenneco Chemicals, Inc. Stauffer Chemical Company Chas. Pfizer & Co. E. I. du Pont de Nemours & company Allied Chemical Corporation Procter & Gamble Company Hercules incorporated Atlas Chemical Industries Enjay Chemical Company Salsbury Laboratories Olin Mathieson Chemical Corporatio Corn Products Company Dow Chemical Company Union Carbide Corporation MCA Staff Members Absent F. R. Barron, Jr. C. P. Carpenter J. D. Early P. J. Franks V. H. Knoop, Vice Chairman J. A. Korth A. M. Schnitzer H. L. Schulman N. G. White Samuel Zuckerman American Cyanamid Company Union Carbide Corporation Monsanto Company Hoffmann-La Roche Inc. Mallinckrodt Chemical Works Corn Products Company Phillips Petroleum Company Washine Division Shell Chemical Company H. Kohnstamm & Co. ASI 00002284 i 76-2 1. MEETINGS a. Minutes of Last Meeting - The minutes of the October 10, 1969 meeting were approved as distributed. b. Next Meeting - The committee decided to hold the next meeting September 9, 1969 in either Washington or New York. 2. PERSONNEL The committee voted unanimously to recommend to the MCA Board of Directors that P. E. Neiman of Enjay Chemical Company be appointed a member of the committee. The secretary announced that Frank DiPrima has left Merck and therefore would no longer be a member of the committee, and that Mallinckrodt has indicated it will take action to reduce its membership on the committee to one since Washine has become a division of Mallinckrodt. 3. LIAISON a. MCA Board of Directors - Mr. Hagan conveyed Mr. Powers' regrets for not being able to attend the meeting. b. MCA Environmental Health Advisory Committee - No report was received on EHAC activities from the FDCCC representative who was absent. However, the secretary read to the committee Minute 5.3 from the minutes of the March 6, 1969 EHAC meeting which referred to three major subdivisions of a suggested MCA environmental health program five years hence, one of which is "Consumer and public pro tection in reference to chemical products, e.g., labeling, food additives, etc." The committee voted unanimously to advise EHAC that FDCCC feels it to be important for EHAC to consider food additives in its planning and to keep FDCCC advised concerning this. In back of this vote was considerable feeling that something should be done to counteract erroneous public impressions concerning the health aspects of food additives, now that it appears this and other environmental health subjects will be receiving major attention in the political arena, and before the problem assumes greater propor tions . 4. COMMITTEE PROJECTS a. International Food Standards - Dr. Spencer and Mr. Ruark reported on the Sixth Session of the FAO/WHO Codex Alimentarius Commission which they attended and which was held March 4-14, 1969 in Geneva. At this session, a number of commodity standards were recommended to go to governments for acceptance. Among these were a group for fats and oils. The recommended fats and oils standards ASI 00002285 76-3 provide for the use of some food additives which have not yet been endorsed by the Codex Committee on Food Additives, and which will be deleted from the final standards if this endorsement is not obtained at the next CCFA meeting in October, 1969. To expedite this endorse ment, the Institute of Shortening and Edible Oils has undertaken to obtain the necessary toxicological data for establishment of acceptable daily intakes (ADI's) by the FAO/WHO joint Expert Committee on Food Additives prior to CCFA action. To expedite the endorsement of food additives to be included in commodity standards not yet presented to the Codex Alimentarius Commission for adoption as a recommended standard, the FDCC Committee voted unanimously to request the secretary to notify MCA member companies of those food additives for which ADI's have not been determined so that data on them may be forwarded to the Expert Committee. The importance of having ADI's established for food additives was emphasized by Mr. Ruark, Dr. Spencer, and others. The FDCC Committee also recommended that the staff establish a continuing communication with the U.S. delegate to CCFA. Mr. Ruark and Dr. Spencer will work with the secretary to help establish a, meaningful and mutually beneficial relationship. Dr. Spencer expressed his appreciation to MCA for providing him the opportunity to serve as an industry advisor to the U.S. delegation. The attention of the committee was called to the Symposium on International Food Standards to be held the morning of May 13 in Chicago in conjunction with the annual meeting of the Institute of Food Technologists. This symposium will be chaired by F. M. Depew with the following participating in the discussion: D. G. Chapman, G. R. Grange, M. F. Markel, M. R. Stephens, J. B. Stine, and Viggo Enggaard. b. Proposed Good Manufacturing Practice Regulations - The secretary reported that the MCA statement concerning the revised proposed regulations was submitted to HEW February 17, 1969, and that copies of this statement were sent to the committee. He also reported on information received by phone from the FDA Bureau of Regulatory Compliance on April 1, 1969 concerning the status of these regulations. This information indicated that FDA is not prepared to provide for a blanket exemption for chemicals used for components of food as recommended by MCA, that a final regulation may be issued in the near future with 30 days allowed for compliance, and that FDA is prepared to amend the "regulations at any time an industry reaches the conclusion there are sound reasons for exemption. It was the consensus of the committee that a meeting with FDA was in order at this time, and the secretary was Requested to investigate this. ASI 00002286 l 76-4 c. Proposed Food Additive Procedural Regulations - Dr. Knapp referred to the report "Quantitative Guidelines for Toxicologically Insignificant Levels of Chemical Additives in Food" prepared recently for the NAS/NRC Food Protection Committee. It was brought out that FDA intends to issue a new proposal following its review of the FPC report. d. Protocols for Safety Evaluation - With respect to the FDA Advisory Committee activity, the secretary reported that the report of the Panel on Reproduction Studies has just been received by FDA, and that the report of the Panel on Cancer Testing is being drafted. He also reported that FDA has advised that a copy of each report could be made available to MCA following FDA review. The MCA state ment to each panel has been distributed to the committee. 5. OTHER ITEMS a. MCA Food Additives Manual - The secretary reported that there has been little demand in recent years for this manual, which deals with legislation, and requested the committee's advice concerning the need for updating. The committee, while recognizing that the. manual did serve a useful purpose in the past, voted unanimously to recommend no reprinting or updating. b. Microbiological Enforcement Activity - The chairman called the committee's attention to the item on this subject involving certain topical drugs and cosmetics which appeared in the TGA Executive Newsletter of February 18, 1969. c. Joseph F. Treon - Mr. Mulford informed the committee that Dr. Joseph F. Treon of Atlas Chemical Industries passed away recently, and the chairman requested the secretary to send an appropriate MCA letter to his widow. In the course of assisting the committee with special projects from time to time. Dr. Treon had become well-known and well-respected by committee members. 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