Document wqYMNe7Lk8XpDD5KNyZNk23K3

FEB 1 3 1968 TELEPHONE HUDSON 3 6126 Manufacturing Chemists' Association, Inc. (FOUNDED 1872) 1825 Connecticut Avenue, N. W, Washington, D. C. 20009 February 12, 1968 TO: Members of the Food, Drug, and Cosmetic Chemicals Committee SUBJECT: MCA Statement re Proposed Good Manufacturing Practice Regulations Gentlemen: Enclosed is a copy of the MCA statement sent to HEW February 9. Sincerely yours, MMH:sjg Enclosure Morgan M. Hoover ASI 00002032 TFI FPHONF HUDSON Manufacturing Chemists' Association, Inc. fFOUNDED 1872} 1825 Connecticut Avenue, N, W. r;FOHf;i l( ui cktr '.'i iisa i ni l i imii Min n r Washington, D. C. 20009 February 9, 1968 Hearing Clerk Department of Health, Education, and Welfare Room 5440 330 independence Avenue, S. W. Washington, D. C. 20201 Dear Sir: The Manufacturing Chemists Association submits the following comments with respect to the proposed regulations covering "Current Good Manufacturing Practice (Sanitation) in Manufacture, Processing, Packing, or Holding" of human foods as published in the Federal Register of December 15, 1967. The Manufacturing Chemists Association is a nonprofit trade association of 184 United States and 14 Canadian company members representing more than 90 percent of the production capacity of basic industrial chemicals within these countries. As presently drawn, the proposed regulations purport to apply to the manufacture of "food" as that term is defined in Section 201 (f) of the federal Food, Drug, and Cosmetic Act. The defi nition includes chemicals which are used as components of foods. On behalf of those members of the Manufacturing Chemists Association which manufacture food additives, color additives, and other chemicals used in foods, we strongly urge the addition of a statement in the proposed regulations which says that food chemical plants, and the manufacture of food additives, color additives, and other chemicals used in food, are completely ex cluded from the coverage of these regulations. We believe that this exclusion was intended by the Food aid Drug Administration, and that this addition should be incorporated so as to avoid misunderstanding and confusion. Sincerely, / #W: G. H. Decker ASI 00002033