FDCC 63-1 Manufacturing Chemists' Association, Inc. MINUTES OF MEETING FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE MCA Headquarters, Washington, D. C. November 17, 1965 MEMBERS PRESENT F. R. Barron, Jr., Vice Chairman T. R. Aalto R. N. Bell G. E. Best C. P. Carpenter C. D. Fentress (For R. P. Howard) J. P. Frawley (For J. G. Kunlholm) T. W. Hanavan A. F, Knight (For J. M. Stocker) 0. H. Peterson H. C. Spencer G. P. Vincent N. G. White Samuel Zuckennan M. M. Hoover, Secretary American Cyanamid Company Tenneco Chemicals, Inc. Stauffer Chemical Company Manufacturing Chemists' Assn. Union Carbide Corporation Phillips Petroleum Company Hercules Powder Company E. I. du Pont de Nemours & Co. Merck & Company Dr. Salsbury's Laboratories Dow Chemical Company Olin Mathleson Chemical Corp; Shell Chemical Company H. Kohnstam & Company Manufacturing Chemists' Assn. ASSOCIATE MEMBER PRESENT A. R. Marusi, Board Liaison Borden Company GUESTS PRESENT (Morning Session--Codex Allmentarius) J. R. Bonnar R. E. Bright F. H. Carman K. T. Karabatsos G. A. Lescislu Irving Lightbrown Guy McConnell B. T. McMillan A. L. Mente, Jr. W. C. Murphy J. A. Noone S. F. Rlepina C. M. Rosser C, B. Shaffer W. W. Sunderland J. J. Tepas J. W. Zukel General Aniline & Film Corp. Dow Coming Corp. Manufacturing Chemists' Assn. Velsicol Chemical Company Union Carbide Corporation Enjay Chemical Company Manufacturing Chemists' Assn. Allied Chemical Corporation U.S. Industrial Chemical Co. Eli Lilly & Company National Agricultural Chemicals Assn. National Assn, of Margarine Mfrs. FMC Corporation American Cyanamid Company Dow Chemical Company Olin Mathleson Chemical Corp* U. S. Rubber Company ASI 00001518 FDCC 68-2 MEMBERS ABSENT C. F. Hagan, Chairman R. P. Howard V. H. Knoop J. G. Kunlholm W, E. McCormick W. H. Meyer L. A. Miller K. E. Mulford H. L. Schulman J. T. Seawell D. A. Seligman J. M. Stocker R. G. Troup 1. Chas. Pfizer & Company Phillips Petroleum Company Mallinckrodt Chemical Works Hercules Powder Company B. F. Goodrich Company Procter & Gamble Company Monsanto Company Atlas Chemical Industries, Inc. Washine Chemical Corp. Com Products Company Hoffman-La Roche, Inc. Merck & Company J. T. Baker Chemical Company MINUTES OF LAST MEETING The minutes of the April 21, 1965 meeting held at the Washington Hilton Hotel were approved as distributed. 2. MEMBERSHIP Mr. Barron welcomed Mr. Marusi as the new Board Liaison Member for the committee. The secretary announced that J. D. Becker and A. L. Ringuette have resigned from the committee, and that Allied Chemical has nominated B. T. McMillan to serve in place of Mr. Becker. The secretary also announced that D. A. Seligman of HoffmanLa Roche has become a member of the committee following formal action by the MCA Board of Directors. 3. THIRD SESSION—CODEX ALIMENTARIUS COMMISSION The morning session was devoted principally to an informal report by Dr. Howard Spencer concerning the Third Session of the Joint FAO/WHO Codex Allmentarius Commission in Rome, October 19-29* 1965. The official report is to be Issued soon. This Third Session was attended by approximately 130 registrants. Including representatives and observers from 37 countries and 20 international organizations. The work of the commission was carried out In five languages (with simultaneous translations): English, French, Spanish, Russian and German. On the surface, at least, inter­ national politics were kept to a minimum. ,SI 0000161’ PDCC 68-3 Report of the Codex Committee on General Principles A report of the results of the first meeting of the Codex Committee on General Principles, which was held In Paris, October 4-8, 1965, under the chairmanship of Prance was presented to the commission. This report contained recommendations on the purpose and scope of the Codex Alimentarius, the nature of the Codex Standards, and methods of acceptance of such standards by governments. The following Is the text of the General Principles of the Codex Alimentarius adopted by the commission: "1. Purpose of the Codex Alimentarius The Codex Alimentarius Is a collection of internationally adopted food standards presented In a uniform manner. These food standards aim at protecting consumers' health and ensuring fair practices In the food trade. Their publication is Intended to guide and promote the elaboration and establishment of definitions and re­ quirements for foods, to assist in their harmonization and in so doing to facilitate international trade. "2. Scope of the Codex Alimentarius i The Codex Alimentarius is to include standards for all the principal foods, whether processed, semi-processed or raw, for distribution to the consumer. Materials for further processing into foods should be included to the extent necessary to achieve the purposes of the Codex Alimentarius as defined. The Codex Alimentarius is to include provision in respect of food hygiene, food additives, pesticide residues, contaminants, labelling and presentation, methods of analysis and sampling. "3. Nature of Codex Standards Codex Standards contain requirements for food aimed at ensuring for the consumer a sound, wholesome food product free from adulteration, correctly labelled and presented. In particular a Codex Standard for a given food product lays down the special requirements for that product, it being understood that the general provisions contained in the Codex Alimentarius shall apply except to the extent otherwise expressly provided for in a specific standard. "4. Acceptance of Codex Standards A Codex Standard so defined may be accepted by a country—in respect of trade and distribution of the food within its territory— in its entirety, or accepted with a declaration of more stringent requirements, or accepted as a target which will be put into effect after a stated number of years. Acceptance in its entirety or target acceptance would imply an undertaking by the importing country not to hinder within its territorial jurisdiction the distribution of food which conforms to the standard by any legal provisions re­ lating to the health of the consumer or to other food standard matters." ASI 00001520 PDDC 68-^ Report of the Codex Committee on Food Additives An excerpt from the Draft Report of the Third Session concerning the Codex Committee on Pood Additives and a Progress Report of the Joint FAO/WHO Expert Committee on Food Additives containing related information are attached to these minutes. The excerpt from the draft report is very Important in that it delineates the relationship between these two groups in working towards international tolerances for food additives. Furthermore, the procedures to be followed in submitting Information on food additives are outlined, and the responsibilities and guidelines are established for each of the committees and groups Involved. Dr. Spencer reported it is not too late to send data for consider­ ation by the Expert Committee at its December meeting in Rome. Sub­ stances to be considered are listed in the progress report. The next meeting of the Expert Committee will be in Copenhagen next June. Re­ quest for data will be sent out early in January. Substances to be considered at the June meeting are also listed in the progress report. Report of the Codex Committee on Pesticide Residues An excerpt from the Draft Report of the Third Session concerning the Codex Committee on Pesticide Residues and a Progress Report of the Joint Meeting of the WHO Expert Committee on Pesticide Residues and the FAO Committee on Pesticides in Agriculture and the PAO Working Party on Pesticide Residues containing related information are attac.’ to these minutes. Dr. Spencer took note of Dr. C. B. Shaffer's and Dr. J. P. Prawley’s participation as industry advisers to the U.S. delegate attending the January, 1966, meeting of the Codex Committee on Pesticide Residues in The Hague. He urged all those having problems relating to the subjects under consideration at this first meeting of the Codex Committee on Pesticide Residues to communicate directly with Dr. Shaffer or Dr. Prawley. Other Items Dr. Spencer stressed the extremely capable work done by Mr. John L. Harvey (PDA Deputy Commissioner) as the Commission Chairman and by Mr. Nathan Koenig (Special Assistant to the Administrator, Consumer and Marketing Service, Department of Agriculture) as Delegation Chairman. He mentioned the imminent retirement of both these men. He said further that it would be unwise for us as Industry men to get into argument as to the successor but we can make it known that the work of the commission is important to us and, consequently. It is imperative that a very capable man be given the responsibility of heading the U.S. Delegation and Chairmanship of the U.S. FAO Interagency Subcommittee on the Codex Alimentarlus. Moreover, the various government departments (HEW, Interior, Commerce and State) represented on this subcommittee should make well-qualified men available with sufficient time allotted ASX 00001521 FDCC 68-5 to carry out their work on Codex problems satisfactorily. These men from government should be given every encouragement to work out closer liaison with industry. In turn, industry must be ready to respond promptly to requests for technical help and information. Dr. Spencer thanked MCA for its part in proposing him as an industry adviser. He also expressed his gratitude to the companies which contributed to the trust fund established for the purpose^ of supporting the work of the U.S. delegation, which could not have been performed effectively without the trust fund. No further contributions will be needed since the two United Nations agencies will support the activity through their regular budgets beginning in 1966. 4. ENVIRONMENTAL HEALTH ADVISORY COMMITTEE Mr. Best reported on EHAC activity in the absence of Mr, Hagan. The Booz, Allen and Hamilton report, which is a feasibility study of a full-time environmental health information organization within MCA, was approved by the EHAC at Its November 11 meeting. It Is to be considered next by the Executive Committee of the Board of Directors on November 22. 5. TASK GROUP ON GOOD MANUFACTURING PRACTICE Mr. Barron reported for Mr. Knoop about the Task Group on Good Manufacturing Practice for Drug Ingredient Chemicals. The position of the task group has not changed since the last committee meeting. That Is, nothing is to be done until FDA shows its hand. 6. VITAMIN D REGULATION (FEDERAL REGISTER, PAGES 11140-1, Aug, 28, 1965) The committee voted unanimously to get the thinking of the Pharmaceutical Manufacturers Association regarding the proposed regulation, and to ask if It desires support from the MCA. 7. PUBLIC ADMINISTRATION SERVICE STUDY The secretary announced the availability of the Public Admini­ stration Service Study, which comprehensively surveys the state and local food and drug activities. Titled "A Study of State and Local Food and Drug Programs", it can be obtained from the FDA, Washington, D. C. 20204. 8. LIAISON ADVISORY COMMITTEE Dr. Spencer reported that the first bound edition of the Food Chemicals Codex may be published by June, 1966, Monographs are to be included. ASI 00001522 FDCC 68-6 Part IX of the loose leaf compilation was mailed November 15, ar^ Part X will be out by the end of December. This will complete the loose leaf edition. Dr. Spencer urged that comments as to accuracy, reflection of commercial practice, etc. be sent in even at this late stage. The project will continue under the auspices of the Food Protection Committee, and a second edition is scheduled for five years after the first. There will be adequate opportunity to add new materials. On December 7, Mr. Kirk will tell what the FDA thinks about the Food Chemicals Codex at the Food Protection Committee meeting. 9. MCA MANUALS The question of whether or not to revive the manual program was decided in the negative for the time being. Mr. Best reported that calls were relatively few for the two manuals that did emerge having to do with food additives. 10, NEXT MEETING The committee decided to hold its next meeting on Wednesday, April 13, 1966 at the MCA Headquarters in Washington. Respectfully submitted. Morgan M. Hoover MCA Staff Representative and Secretary Food, Drug, and Cosmetic Chemicals Committee MMH:sjg Attachment * 1 ASI 00001523