Document k6eev7RqN63yv7mdEZqZ26y5B

9310 .A (/ta ,, A<- , X_ ur / PROPOSED RULES <"u i\ ~t U/J . 1973 Copied by MCA for distribution to FOOD ADDITIVES CONTACTS FOOD. DRUG, AND COSMETIC CHEMICALS COMMITTEE April 16, 1973 Distr. "B" MMHoover the substances as food additives. Any substance excluded from the GRAS list review may be considered for GRAS af firmation at any future time on the basis of a petition submitted pursuant to S 121.40 (37 FR 25705). Therefore, pursuant to the Federal Food, Drug, and Cosmetic Act (secs. DEPARTMENT OF HEALTH, EDUCA TION, AND WELFARE 201 (s), 409, 701(a), 52 Stat. 1055, 72 Stat. 1784-1788, as amended; 21 U.S.C. 32l(s), 348, 371(a)) and under author Food and Drug Administration ity delegated to him (21 CFR 2.120), the [ 21 CFR Part 121 ] GENERALLY RECOGNIZED AS SAFE (GRAS) SUBSTANCES NO LONGER IN USE Proposal for Removal From GRAS List The Food and Drug Administration is conducting a study of the individual substances classified as generally recog nized as safe (GRAS) in 21 CFR 121.101. As a part of this study, the National Academy of Sciences, through its Food Protection Committee of the National Research Council, has conducted a com prehensive survey of the production and use of GRAS substances. This survey was made on the basis of a questionnaire provided to all producers, formulators, Commissioner proposes to amend part 121 by deleting from 121,101 the following substances: aluminum calcium alllcate DL-arglnine DL-aspartlc acid bentonite butane calcium ascorbate calcium glycerophos phate calcium hexometa- phosphate callcum pyrophos phate calcium sorbate cholic acid cuprous iodide manganese hypophosphite manganous oxide monoisopropyl cit rate D-pantothenyl alco hol potassium bisulfate potassium glycero phosphate propane DL-serlne sodium pantothenate sodium pectinate sodium potassium tartrate and users of these substances who could be located through various trade associ ation lists and other sources. Also, notice of the survey was given in the Federal Register of October 23, 1971 (36 FR 20546) to insure that all persons Inter ested in participating in the survey were afforded an opportunity to do so. A total of 750 organizations representing indi vidual processors, suppliers, manu facturers, and distributors were surveyed. The survey questionnaire provided, among other things, for the reporting by each participant of his total production of each GRAS substance manufactured during the year 1970. The results of the desoxycbollc acid dextrans dllauryl thlodlpro- plonlc acid ferrous lactate glychochollc acid gum guatac helium DL-hlstidlne llnolelc acid DL-lystne magnesium phos phate, tribaslc manganese citrate manganese gluconate manganese glycero phosphate sodium sesqulcarbonate sodium sorbate sodium tartrate sodium taurocholate stearyl citrate taurochollc add thlodlproplonlo acid DL-threonlne D-alpha tocopheryl acetate concen trate DL-tryptophan DL-tyroslne DL-vallne zinc chloride zlno gluconate zinc stearate survey reveal that a number of the sub stances listed in 21 CFR 121.101 appar ently are no longer In use. The Commissioner has concluded that it would be a needless and an unwar ranted expenditure of resources to evalu ate GRAS substances which are no longer in use. Accordingly, he proposes to delete the substances set forth below from 21 CFR 121.101 and the GRAS re view except for any of such substances for which adequate evidence of manu facture and/or use may be submitted in response to this proposal within 60 Interested persons may, on or before June 12,1973, file with the hearing clerk, Food and Drug Administration. Depart ment of Health, Education, and Welfare, room 6-88, 5600 Fishers Lane, Rockville, Md. 20852, written comments (prefer ably in qulntuplicate) regarding this no tice. Comments may be accompanied by a memorandum or brief in support thereof. Received comments may be seen in the above office during working hours, Monday through Friday. Dated April 5, 1973. days of its publication in the Federal William F. Randolph, Register. Acting Associate Commissioner If the evidence submitted for any such for Compliance. substance is limited to its use in animal feed, the substance will be excluded from (PH Doc.73-7157 Plied 4-12-73;8:4B ami the current GRAS review but will be continued in 121.101 limited to use in animal feed only. The objective of this action is solely to exclude from the GRAS list review substances that have been discontinued from human food use. Exclusion of these substances is not for the purpose and does not have the effect of classifying FEDERAL REGISTER, VOL 38, NO. 71--FRIDAY, APRIL 13, 1973 ASI 00003354